Chapter 2100 Patentability...2141.01 Scope and Content of the Prior Art 2141.01(a) Analogous and Nonanalogous Art Differences Between Prior Art and Claimed Invention 2141.02 Rev. 08.2017,

Chapter 2100 Patentability

[Reserved]2101-2102

Patent Examination Process2103 Inventions Patentable - Requirementsof 35 U.S.C. 101

2104

Patent Eligible Subject Matter —Living Subject Matter

2105

Patent Subject Matter Eligibility2106 [Reserved]2106.01 [Reserved]2106.02 Eligibility Step 1: The FourCategories of Statutory Subject Matter

2106.03

Eligibility Step 2: Whether a Claimis Directed to a Judicial Exception

2106.04

Abstract Ideas2106.04(a) Examples of Claims That AreNot Directed To AbstractIdeas

2106.04(a)(1)

Examples of Concepts TheCourts Have Identified AsAbstract Ideas

2106.04(a)(2)

Laws of Nature, NaturalPhenomena & Products of Nature

2106.04(b)

The Markedly DifferentCharacteristics Analysis

2106.04(c)

Eligibility Step 2B: Whether a ClaimAmounts to Significantly More

2106.05

Improvements to the Functioningof a Computer or To Any OtherTechnology or Technical Field

2106.05(a)

Particular Machine2106.05(b) Particular Transformation2106.05(c) Well-Understood, Routine,Conventional Activity

2106.05(d)

Other Meaningful Limitations2106.05(e) Mere Instructions To Apply AnException

2106.05(f)

Insignificant Extra-SolutionActivity

2106.05(g)

Field of Use and TechnologicalEnvironment

2106.05(h)

Streamlined Analysis2106.06 Eligibility is Self Evident2106.06(a) Clear Improvement to aTechnology or to ComputerFunctionality

2106.06(b)

Formulating and SupportingRejections For Lack Of SubjectMatter Eligibility

2106.07

Formulating a Rejection For Lackof Subject Matter Eligibility

2106.07(a)

Evaluating Applicant's Response2106.07(b) Clarifying the Record2106.07(c)

Guidelines for Examination ofApplications for Compliance with theUtility Requirement

2107

General Principles Governing UtilityRejections

2107.01

Procedural Considerations Related toRejections for Lack of Utility

2107.02

Special Considerations for AssertedTherapeutic or PharmacologicalUtilities

2107.03

[Reserved]2108-2110

Claim Interpretation; BroadestReasonable Interpretation

2111

Plain Meaning2111.01 Effect of Preamble2111.02 Transitional Phrases2111.03 “Adapted to,” “Adapted for,”“Wherein,” “Whereby,” andContingent Clauses

2111.04

Functional and NonfunctionalDescriptive Material

2111.05

Requirements of Rejection Based onInherency; Burden of Proof

2112

Composition, Product, and ApparatusClaims

2112.01

Process Claims2112.02 Product-by-Process Claims2113 Apparatus and Article Claims —Functional Language

2114

Material or Article Worked Upon byApparatus

2115

[Reserved]2116 Novel, Unobvious Starting Materialor End Product

2116.01

Markush Claims2117 [Reserved]2118

-2120 Prior Art; General Level of OperabilityRequired to Make a Prima Facie Case

2121

Use of Prior Art in Rejections WhereOperability is in Question

2121.01

Compounds and Compositions —What Constitutes Enabling Prior Art

2121.02

Plant Genetics — What ConstitutesEnabling Prior Art

2121.03

Apparatus and Articles — WhatConstitutes Enabling Prior Art

2121.04

Discussion of Utility in the Prior Art2122 Rev. 08.2017, January 20182100-1

Rejection Over Prior Art’s BroadDisclosure Instead of PreferredEmbodiments

2123

Exception to the Rule That the CriticalReference Date Must Precede the FilingDate

2124

Tax Strategies Deemed Within thePrior Art

2124.01

Drawings as Prior Art2125 Availability of a Document as a“Patent” for Purposes of Rejection

2126

Under 35 U.S.C. 102(a) or Pre-AIA 35U.S.C. 102(a), (b), and (d)

Date of Availability of a Patent as aReference

2126.01

Scope of Reference’s DisclosureWhich Can Be Used to Reject Claims

2126.02

When the Reference Is a “Patent” butNot a “Publication”

Domestic and Foreign PatentApplications as Prior Art

2127

“Printed Publications” as Prior Art2128 Level of Public AccessibilityRequired

2128.01

Date Publication Is Available as aReference

2128.02

Admissions as Prior Art2129 [Reserved]2130 Anticipation — Application of 35 U.S.C.102

2131

Multiple Reference 35 U.S.C. 102Rejections

2131.01

Genus-Species Situations2131.02 Anticipation of Ranges2131.03 Secondary Considerations2131.04 Nonanalogous or Disparaging PriorArt

2131.05

Pre-AIA 35 U.S.C. 102(a)2132 Publications as Pre-AIA 35 U.S.C.102(a) Prior Art

2132.01

Pre-AIA 35 U.S.C. 102(b)2133 Rejections of Continuation-In-Part(CIP) Applications

2133.01

Rejections Based on Publications andPatents

2133.02

Rejections Based on “Public Use” or“On Sale”

2133.03

“Public Use”2133.03(a) “On Sale”2133.03(b) The “Invention”2133.03(c) “In This Country”2133.03(d)

Permitted Activity; ExperimentalUse

2133.03(e)

Commercial Exploitation2133.03(e)(1) Intent2133.03(e)(2) “Completeness” of theInvention

2133.03(e)(3)

Factors Indicative of anExperimental Purpose

2133.03(e)(4)

Experimentation and Degreeof Supervision and Control

2133.03(e)(5)

Permitted ExperimentalActivity and Testing

2133.03(e)(6)

Activity of an IndependentThird Party Inventor

2133.03(e)(7)

Pre-AIA 35 U.S.C. 102(c)2134 Pre-AIA 35 U.S.C. 102(d)2135

The Four Requirements of Pre-AIA35 U.S.C. 102(d)

2135.01

Pre-AIA 35 U.S.C. 102(e)2136 Status of U.S. Application as aReference

2136.01

Content of the Prior Art AvailableAgainst the Claims

2136.02

Critical Reference Date2136.03 Different Inventive Entity; Meaningof “By Another”

2136.04

Overcoming a Rejection UnderPre-AIA 35 U.S.C. 102(e)

2136.05

Pre-AIA 35 U.S.C. 102(f)2137 Inventorship2137.01 Applicability of Pre-AIA 35 U.S.C.103(c)

2137.02

Pre-AIA 35 U.S.C. 102(g)2138 Interference Practice2138.01 “The Invention Was Made in ThisCountry”

2138.02

“By Another Who Has NotAbandoned, Suppressed, orConcealed It”

2138.03

“Conception”2138.04 “Reduction to Practice”2138.05 “Reasonable Diligence”2138.06

[Reserved]2139-2140

Examination Guidelines forDetermining Obviousness Under 35U.S.C. 103

2141

Scope and Content of the Prior Art2141.01 Analogous and Nonanalogous Art2141.01(a)

Differences Between Prior Art andClaimed Invention

2141.02

2100-2Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE

Level of Ordinary Skill in the Art2141.03 Legal Concept of Prima FacieObviousness

2142

Examples of Basic Requirements of aPrima Facie Case of Obviousness

2143

Suggestion or Motivation To Modifythe References

2143.01

Reasonable Expectation of SuccessIs Required

2143.02

All Claim Limitations Must BeConsidered

2143.03

Supporting a Rejection Under 35 U.S.C.103

2144

Implicit Disclosure2144.01 Reliance on Scientific Theory2144.02 Reliance on Common Knowledge inthe Art or “Well Known” Prior Art

2144.03

Legal Precedent as Source ofSupporting Rationale

2144.04

Obviousness of Similar andOverlapping Ranges, Amounts, andProportions

2144.05

Art Recognized Equivalence for theSame Purpose

2144.06

Art Recognized Suitability for anIntended Purpose

2144.07

Obviousness of Species When PriorArt Teaches Genus

2144.08

Close Structural Similarity BetweenChemical Compounds (Homologs,Analogues, Isomers)

2144.09

Consideration of Applicant’s RebuttalArguments

2145

Pre-AIA 35 U.S.C. 103(c)2146 [Reserved]2147

-2149 Examination Guidelines for 35 U.S.C.102 and 103 as Amended by the First

2150

Inventor To File Provisions of theLeahy-Smith America Invents ActOverview of the Changes to 35 U.S.C.102 and 103 in the AIA

2151

Detailed Discussion of AIA 35 U.S.C.102(a) and (b)

2152

Effective Filing Date of the ClaimedInvention

2152.01

Prior Art Under AIA 35 U.S.C.102(a)(1) (Patented, Described in a

2152.02

Printed Publication, or in Public Use,on Sale, or Otherwise Available to thePublic)

Patented2152.02(a) Described in a Printed Publication2152.02(b) In Public Use2152.02(c) On Sale2152.02(d) Otherwise Available to the Public2152.02(e) No Requirement of "By Others"2152.02(f)

Admissions2152.03 The Meaning of "Disclosure"2152.04

Prior Art Exceptions Under 35 U.S.C.102(b)(1) to AIA 35 U.S.C. 102(a)(1)

2153

Prior Art Exception Under AIA 35U.S.C. 102(b)(1)(A) To AIA 35

2153.01

U.S.C. 102(a)(1) (Grace PeriodInventor Or Inventor-OriginatedDisclosure Exception)

Grace Period Inventor DisclosureException

2153.01(a)

Grace Period Inventor-OriginatedDisclosure Exception

2153.01(b)

Prior Art Exception Under AIA 35U.S.C. 102(b)(1)(B) to AIA 35 U.S.C.

2153.02

102(a)(1) (Inventor OrInventor-Originated Prior PublicDisclosure Exception)

Provisions Pertaining to Subject Matterin a U.S. Patent or Application

2154

Effectively Filed Before the EffectiveFiling Date of the Claimed Invention

Prior Art Under AIA 35 U.S.C.102(a)(2) “U.S. Patent Documents”

2154.01

WIPO Published Applications2154.01(a) Determining When SubjectMatter Was Effectively FiledUnder AIA 35 U.S.C. 102(d)

2154.01(b)

Requirement Of “Names AnotherInventor”

2154.01(c)

Prior Art Exceptions Under 35 U.S.C.102(b)(2) to AIA 35 U.S.C. 102(a)(2)

2154.02

Prior Art Exception Under AIA35 U.S.C. 102(b)(2)(A) to AIA

2154.02(a)

35 U.S.C. 102(a)(2)(Inventor-Originated DisclosureException)Prior Art Exception Under AIA35 U.S.C. 102(b)(2)(B) to AIA

2154.02(b)

35 U.S.C. 102(a)(2) (Inventor orInventor-Originated Prior PublicDisclosure Exception)Prior Art Exception Under AIA35 U.S.C. 102(b)(2)(C) to AIA

2154.02(c)

35 U.S.C. 102(a)(2) (Common

Rev. 08.2017, January 20182100-3

PATENTABILITY

Ownership or Obligation ofAssignment)

Use of Affidavits or Declarations Under37 CFR 1.130 To Overcome Prior ArtRejections

2155

Showing That the Disclosure WasMade by the Inventor or a JointInventor

2155.01

Showing That the Subject MatterDisclosed Had Been Previously

2155.02

Publicly Disclosed by the Inventor ora Joint InventorShowing That the Disclosure wasMade, or That Subject Matter had

2155.03

Been Previously Publicly Disclosed,by Another Who Obtained the SubjectMatter Disclosed Directly orIndirectly From the Inventor or a JointInventorEnablement2155.04 Who May File an Affidavit orDeclaration Under 37 CFR 1.130

2155.05

Situations in Which an Affidavit orDeclaration Is Not Available

2155.06

Joint Research Agreements2156 Improper Naming of Inventors2157 AIA 35 U.S.C. 1032158 Applicability Date Provisions andDetermining Whether an Application

2159

Is Subject to the First Inventor To FileProvisions of the AIA

Applications Filed Before March 16,2013

2159.01

Applications Filed on or After March16, 2013

2159.02

Applications Subject to the AIA butAlso Containing a Claimed Invention

2159.03

Having an Effective Filing DateBefore March 16, 2013Applicant Statement in TransitionApplications Containing a Claimed

2159.04

Invention Having an Effective FilingDate on or After March 16, 2013

[Reserved]2160 Three Separate Requirements forSpecification Under 35 U.S.C. 112(a) orPre-AIA 35 U.S.C. 112, First Paragraph

2161

Computer Programming, ComputerImplemented Inventions, and 35

2161.01

U.S.C. 112(a) or Pre-AIA 35 U.S.C.112, First Paragraph

Policy Underlying 35 U.S.C. 112(a) orPre-AIA 35 U.S.C. 112, First Paragraph

2162

Guidelines for the Examination ofPatent Applications Under the 35

2163

U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112,first paragraph, “Written Description”Requirement

Support for the Claimed SubjectMatter in Disclosure

2163.01

Standard for Determining ComplianceWith the Written DescriptionRequirement

2163.02

Typical Circumstances WhereAdequate Written Description IssueArises

2163.03

Burden on the Examiner with Regardto the Written DescriptionRequirement

2163.04

Changes to the Scope of Claims2163.05 Relationship of Written DescriptionRequirement to New Matter

2163.06

Amendments to Application WhichAre Supported in the OriginalDescription

2163.07

Inherent Function, Theory, orAdvantage

2163.07(a)

Incorporation by Reference2163.07(b) The Enablement Requirement2164

Test of Enablement2164.01 Undue Experimentation Factors2164.01(a) How to Make the ClaimedInvention

2164.01(b)

How to Use the ClaimedInvention

2164.01(c)

Working Example2164.02 Relationship of Predictability of theArt and the Enablement Requirement

2164.03

Burden on the Examiner Under theEnablement Requirement

2164.04

Determination of Enablement Basedon Evidence as a Whole

2164.05

Specification Must Be Enablingas of the Filing Date

2164.05(a)

Specification Must Be Enablingto Persons Skilled in the Art

2164.05(b)

Quantity of Experimentation2164.06 Examples of EnablementIssues-Missing Information

2164.06(a)

Examples of Enablement Issues— Chemical Cases

2164.06(b)

2100-4Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE

Examples of Enablement Issues– Computer Programming Cases

2164.06(c)

Relationship of EnablementRequirement to Utility Requirementof 35 U.S.C. 101

2164.07

Enablement Commensurate in ScopeWith the Claims

2164.08

Single Means Claim2164.08(a) Inoperative Subject Matter2164.08(b) Critical Feature Not Claimed2164.08(c)

The Best Mode Requirement2165 Considerations Relevant to Best Mode2165.01 Best Mode Requirement Comparedto Enablement Requirement

2165.02

Requirements for Rejection for Lackof Best Mode

2165.03

Examples of Evidence ofConcealment

2165.04

[Reserved]2166-2170

Two Separate Requirements for ClaimsUnder 35 U.S.C. 112 (b) or Pre-AIA 35U.S.C. 112, Second Paragraph

2171

Subject Matter Which the Inventor ora Joint Inventor Regards as TheInvention

2172

Unclaimed Essential Matter2172.01 Claims Must Particularly Point Outand Distinctly Claim the Invention

2173

Interpreting the Claims2173.01 Determining Whether ClaimLanguage is Definite

2173.02

Correspondence BetweenSpecification and Claims

2173.03

Breadth Is Not Indefiniteness2173.04 Specific Topics Related to IssuesUnder 35 U.S.C. 112(b) or Pre-AIA35 U.S.C. 112, Second Paragraph

2173.05

New Terminology2173.05(a) Relative Terminology2173.05(b) Numerical Ranges and AmountsLimitations

2173.05(c)

Exemplary Claim Language (“forexample,” “such as”)

2173.05(d)

Lack of Antecedent Basis2173.05(e) Reference to Limitations inAnother Claim

2173.05(f)

Functional Limitations2173.05(g) Alternative Limitations2173.05(h) Negative Limitations2173.05(i) Old Combination2173.05(j)

Aggregation2173.05(k) [Reserved]2173.05(l) Prolix2173.05(m) Multiplicity2173.05(n) Double Inclusion2173.05(o) Claim Directed to Product-By-Process or Product and Process

2173.05(p)

“Use” Claims2173.05(q) Omnibus Claim2173.05(r) Reference to Figures or Tables2173.05(s) Chemical Formula2173.05(t) Trademarks or Trade Names in aClaim

2173.05(u)

Mere Function of Machine2173.05(v) Practice Compact Prosecution2173.06

Relationship Between the Requirementsof 35 U.S.C. 112(a) and (b) or Pre-AIA

2174

35 U.S.C. 112, First and SecondParagraphs[Reserved]2175

-2180 Identifying and Interpreting a 35 U.S.C.112(f) or Pre-AIA 35 U.S.C. 112, SixthParagraph Limitation

2181

Search and Identification of the PriorArt

2182

Making a Prima Facie Case ofEquivalence

2183

Determining Whether an Applicant HasMet the Burden of Proving

2184

Nonequivalence After a Prima FacieCase Is MadeRelated Issues Under 35 U.S.C. 112(a)or (b) and Pre-AIA 35 U.S.C. 112, Firstor Second Paragraphs

2185

Relationship to the Doctrine ofEquivalents

2186

[Reserved]2187-2189

Prosecution Laches2190

Rev. 08.2017, January 20182100-5

PATENTABILITY

2101-2102 [Reserved]

2103 Patent Examination Process[R-08.2017]

I. DETERMINE WHAT APPLICANT HASINVENTED AND IS SEEKING TO PATENT

It is essential that patent applicants obtain a promptyet complete examination of their applications.Under the principles of compact prosecution, eachclaim should be reviewed for compliance with everystatutory requirement for patentability in the initialreview of the application, even if one or more claimsare found to be deficient with respect to somestatutory requirement. Thus, examiners should stateall reasons and bases for rejecting claims in the firstOffice action. Deficiencies should be explainedclearly, particularly when they serve as a basis fora rejection. Whenever practicable, examiners shouldindicate how rejections may be overcome and howproblems may be resolved. A failure to follow thisapproach can lead to unnecessary delays in theprosecution of the application.

Prior to focusing on specific statutory requirements,examiners must begin examination by determiningwhat, precisely, the applicant has invented and isseeking to patent, and how the claims relate to anddefine that invention. Examiners will review thecomplete specification, including the detaileddescription of the invention, any specificembodiments that have been disclosed, the claimsand any specific, substantial, and credible utilitiesthat have been asserted for the invention.

After obtaining an understanding of what applicantinvented, the examiner will conduct a search of theprior art and determine whether the invention asclaimed complies with all statutory requirements.

A. Identify and Understand Any Utility for theInvention

The claimed invention as a whole must be useful.The purpose of this requirement is to limit patentprotection to inventions that possess a certain levelof “real world” value, as opposed to subject matterthat represents nothing more than an idea or concept,

or is simply a starting point for future investigationor research (Brenner v. Manson, 383 U.S. 519,528-36, 148 USPQ 689, 693-96 (1966); In re Fisher,421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d1600, 1603-06 (Fed. Cir. 1993)).

Examiners should review the application to identifyany asserted utility. The applicant is in the bestposition to explain why an invention is believeduseful. Accordingly, a complete disclosure shouldcontain some indication of the practical applicationfor the claimed invention, i.e., why the applicantbelieves the claimed invention is useful. Such astatement will usually explain the purpose of theinvention or how the invention may be used (e.g., acompound is believed to be useful in the treatmentof a particular disorder). Regardless of the form ofstatement of utility, it must enable one ordinarilyskilled in the art to understand why the applicantbelieves the claimed invention is useful. See MPEP§ 2107 for utility examination guidelines. Anapplicant may assert more than one utility andpractical application, but only one is necessary.Alternatively, an applicant may rely on thecontemporaneous art to provide that the claimedinvention has a well-established utility.

B. Review the Detailed Disclosure and SpecificEmbodiments of the Invention To Understand What theApplicant Has Invented

The written description will provide the clearestexplanation of the applicant’s invention, byexemplifying the invention, explaining how it relatesto the prior art and explaining the relativesignificance of various features of the invention.Accordingly, examiners should continue theirevaluation by

(A) determining the function of the invention,that is, what the invention does when used asdisclosed (e.g., the functionality of a programmedcomputer); and

(B) determining the features necessary toaccomplish at least one asserted practical application.

Patent applicants can assist the USPTO by preparingapplications that clearly set forth these aspects of aninvention.

2100-6Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2101-2102

C. Review the Claims

The claims define the property rights provided by apatent, and thus require careful scrutiny. The goalof claim analysis is to identify the boundaries of theprotection sought by the applicant and to understandhow the claims relate to and define what theapplicant has indicated is the invention. Examinersmust first determine the scope of a claim bythoroughly analyzing the language of the claimbefore determining if the claim complies with eachstatutory requirement for patentability. See In reHiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523,1529 (Fed. Cir. 1998) (“[T]he name of the game isthe claim.”).

Examiners should begin claim analysis byidentifying and evaluating each claim limitation. Forprocesses, the claim limitations will define steps oracts to be performed. For products, the claimlimitations will define discrete physical structuresor materials. Product claims are claims that aredirected to either machines, manufactures orcompositions of matter.

Examiners should then correlate each claimlimitation to all portions of the disclosure thatdescribe the claim limitation. This is to be done inall cases, regardless of whether the claimed inventionis defined using means- (or step-) plus- functionlanguage. The correlation step will ensure thatexaminers correctly interpret each claim limitationin light of the specification.

The subject matter of a properly construed claim isdefined by the terms that limit the scope of the claimwhen given their broadest reasonable interpretation.It is this subject matter that must be examined. Asa general matter, grammar and the plain meaning ofterms as understood by one having ordinary skill inthe art used in a claim will dictate whether, and towhat extent, the language limits the claim scope. SeeMPEP § 2111.01 for more information on the plainmeaning of claim language. Language that suggestsor makes a feature or step optional but does notrequire that feature or step does not limit the scopeof a claim under the broadest reasonable claiminterpretation. The following types of claim languagemay raise a question as to its limiting effect:

(A) statements of intended use or field of use,including statements of purpose or intended use inthe preamble,

(B) “adapted to” or “adapted for” clauses,

(C) "wherein" or "whereby" clauses,

(D) contingent limitations,

(E) printed matter, or

(F) terms with associated functional language.

This list of examples is not intended to beexhaustive. The determination of whether particularlanguage is a limitation in a claim depends on thespecific facts of the case. See, e.g., Griffin v.Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431(Fed. Cir. 2002)(finding that a “wherein” clauselimited a process claim where the clause gave“meaning and purpose to the manipulative steps”).For more information about these types of claimlanguage and how to determine whether they havea limiting effect on claim scope, see MPEP §§2111.02 through 2111.05.

Examiners are to give claims their broadestreasonable interpretation in light of the supportingdisclosure. See MPEP § 2111. Disclosure may beexpress, implicit, or inherent. Examiners are to giveclaimed means- (or step-) plus- function limitationstheir broadest reasonable interpretation consistentwith all corresponding structures (or materials oracts) described in the specification and theirequivalents. See In re Aoyama, 656 F.3d 1293,1297, 99 USPQ2d 1936, 1939 (fed. Cir. 2011).Further guidance in interpreting the scope ofequivalents is provided in MPEP §§ 2181 through2186.

While it is appropriate to use the specification todetermine what applicant intends a term to mean, apositive limitation from the specification cannot beread into a claim that does not itself impose thatlimitation. See MPEP § 2111.01, subsection II. Asexplained in MPEP § 2111, giving a claim itsbroadest reasonable interpretation during prosecutionwill reduce the possibility that the claim, whenissued, will be interpreted more broadly than isjustified.

Finally, when evaluating the scope of a claim, everylimitation in the claim must be considered.

Rev. 08.2017, January 20182100-7

§ 2103PATENTABILITY

Examiners may not dissect a claimed invention intodiscrete elements and then evaluate the elements inisolation. Instead, the claim as a whole must beconsidered. See, e.g., Diamond v. Diehr, 450 U.S.175, 188-89, 209 USPQ 1, 9 (1981) (“In determiningthe eligibility of respondents’ claimed process forpatent protection under § 101, their claims must beconsidered as a whole. It is inappropriate to dissectthe claims into old and new elements and then toignore the presence of the old elements in theanalysis. This is particularly true in a process claimbecause a new combination of steps in a process maybe patentable even though all the constituents of thecombination were well known and in common usebefore the combination was made.”).

II. CONDUCT A THOROUGH SEARCH OF THEPRIOR ART

Prior to evaluating the claimed invention forpatentability, examiners are expected to conduct athorough search of the prior art. See MPEP §§ 904through 904.03 for more information about how toconduct a search. In many cases, the result of sucha search will contribute to examiners understandingof the invention. Both claimed and unclaimed aspectsof the invention described in the specification shouldbe searched if there is a reasonable expectation thatthe unclaimed aspects may be later claimed. A searchmust take into account any structure or materialdescribed in the specification and its equivalentswhich correspond to the claimed means- (or step-)plus- function limitation, in accordance with 35U.S.C. 112(f) and MPEP § 2181 through MPEP §2186.

III. DETERMINE WHETHER THE CLAIMEDINVENTION COMPLIES WITH 35 U.S.C. 101

A. Consider the Breadth of 35 U.S.C. 101 UnderControlling Law

Section 101 of title 35, United States Code, provides:

Whoever invents or discovers any new anduseful process, machine, manufacture, orcomposition of matter, or any new and usefulimprovement thereof, may obtain a patenttherefor, subject to the conditions andrequirements of this title.

35 U.S.C. 101 has been interpreted as imposing fourrequirements: (i) only one patent may be obtainedfor an invention; (ii) the inventor(s) must beidentified in an application filed on or afterSeptember 16, 2012 or must be the applicant inapplications filed before September 16, 2012; (iii)the claimed invention must be eligible for patenting;and, (iv) the claimed invention must be useful.

See MPEP § 2104 for a discussion of the fourrequirements, MPEP § 2106 for a discussion ofeligibility, and MPEP § 2107 for the utilityexamination guidelines.

The patent eligibility inquiry under 35 U.S.C. 101is a threshold inquiry. Even if a claimed inventionqualifies as eligible subject matter under 35 U.S.C.101, it must also satisfy the other conditions andrequirements of the patent laws, including therequirements for novelty (35 U.S.C. 102),nonobviousness (35 U.S.C. 103), and adequatedescription and definite claiming (35 U.S.C. 112). Bilski v. Kappos, 561 U.S. 593, 602, 95 USPQ2d1001, 1006 (2010). Therefore, examiners shouldavoid focusing on issues of patent-eligibility under35 U.S.C. 101 to the detriment of considering anapplication for compliance with the requirements of35 U.S.C. 102, 35 U.S.C. 103, and 35 U.S.C. 112,and should avoid treating an application solely onthe basis of patent-eligibility under 35 U.S.C. 101except in the most extreme cases.

IV. EVALUATE APPLICATION FORCOMPLIANCE WITH 35 U.S.C. 112

A . Determine Whether the Claimed Invention Complieswith 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, SecondParagraph Requirements

35 U.S.C. 112(b) contains two separate and distinctrequirements: (A) that the claim(s) set forth thesubject matter applicants regard as the invention,and (B) that the claim(s) particularly point out anddistinctly claim the invention. An application willbe deficient under the first requirement of 35 U.S.C.112(b) when evidence including admissions, otherthan in the application as filed, shows that anapplicant has stated what they regard the inventionto be is different from what is claimed (see MPEP§ 2171 - MPEP § 2172.01).

2100-8Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2103

An application fails to comply with the secondrequirement of 35 U.S.C. 112(b) when the claimsdo not set out and define the invention with areasonable degree of precision and particularity. Inthis regard, the definiteness of the language must beanalyzed, not in a vacuum, but always in light of theteachings of the disclosure as it would be interpretedby one of ordinary skill in the art. Applicant’s claims,interpreted in light of the disclosure, must reasonablyapprise a person of ordinary skill in the art of theinvention.

The scope of a limitation that invokes 35 U.S.C.112(f) is defined as the corresponding structure ormaterial set forth by the inventor in the writtendescription and equivalents thereof that perform theclaimed function. See MPEP § 2181 through MPEP§ 2186. See MPEP § 2173 et seq. for a discussionof a variety of issues pertaining to the 35 U.S.C.112(b) requirement that the claims particularly pointout and distinctly claim the invention.

B. Determine Whether the Claimed InventionComplies with 35 U.S.C. 112(a) or 35 U.S.C. 112, FirstParagraph Requirements

35 U.S.C. 112(a) contains three separate and distinctrequirements:

(A) adequate written description,

(B) enablement, and

(C) best mode.

1. Adequate Written Description

For the written description requirement, anapplicant’s specification must reasonably convey tothose skilled in the art that the applicant was inpossession of the claimed invention as of the dateof invention. See MPEP § 2163 for further guidancewith respect to the evaluation of a patent applicationfor compliance with the written descriptionrequirement.

2. Enabling Disclosure

An applicant’s specification must enable a personskilled in the art to make and use the claimedinvention without undue experimentation. The factthat experimentation is complex, however, will not

make it undue if a person of skill in the art typicallyengages in such complex experimentation.

See MPEP § 2164 et seq. for detailed guidance withregard to the enablement requirement of 35 U.S.C.112(a).

3. Best Mode

Determining compliance with the best moderequirement requires a two-prong inquiry:

(1) at the time the application was filed, did theinventor possess a best mode for practicing theinvention; and

(2) if the inventor did possess a best mode, doesthe written description disclose the best mode suchthat a person skilled in the art could practice it.

See MPEP § 2165 et seq. for additional guidance.Deficiencies related to disclosure of the best modefor carrying out the claimed invention are not usuallyencountered during examination of an applicationbecause evidence to support such a deficiency isseldom in the record. Fonar Corp. v. General Elec.Co., 107 F.3d 1543, 1548-49, 41 USPQ2d at1804-05.

V. DETERMINE WHETHER THE CLAIMEDINVENTION COMPLIES WITH 35 U.S.C. 102 AND103

Reviewing a claimed invention for compliance with35 U.S.C. 102 and 35 U.S.C.103 begins with acomparison of the claimed subject matter to what isknown in the prior art. See MPEP §§ 2131 - 2146and MPEP §§ 2150 - 2159 for specific guidance onpatentability determinations under 35 U.S.C. 102and 35 U.S.C. 103. If no differences are foundbetween the claimed invention and the prior art, thenthe claimed invention lacks novelty and is to berejected by USPTO personnel under 35 U.S.C. 102.Once differences are identified between the claimedinvention and the prior art, those differences mustbe assessed and resolved in light of the knowledgepossessed by a person of ordinary skill in the art.Against this backdrop, one must determine whetherthe invention would have been obvious to one ofordinary skill in the art. If not, the claimed inventionsatisfies 35 U.S.C. 103.

Rev. 08.2017, January 20182100-9


VI. CLEARLY COMMUNICATE FINDINGS,CONCLUSIONS AND THEIR BASES

Once examiners have concluded the above analysesof the claimed invention under all the statutoryprovisions, including 35 U.S.C. 101, 35 U.S.C. 112,35 U.S.C. 102, and 35 U.S.C. 103, they shouldreview all the proposed rejections and their bases toconfirm that they are able to set forth a prima faciecase of unpatentability. Only then should anyrejection be imposed in an Office action. The Officeaction should clearly communicate the findings,conclusions and reasons which support them.

2104 Inventions Patentable - Requirementsof 35 U.S.C. 101 [R-08.2017]

35 U.S.C. 101 Inventions patentable

Whoever invents or discovers any new and useful process,machine, manufacture, or composition of matter, or any newand useful improvement thereof may obtain a patent therefor,subject to the conditions and requirements of this title.

35 U.S.C. 101 has been interpreted as imposing fourrequirements.

First, whoever invents or discovers an eligibleinvention may obtain only ONE patent therefor. Thisrequirement forms the basis for statutory doublepatenting rejections when two applications claim thesame invention, i.e. claim identical subject matter.See MPEP § 804 for a full discussion of theprohibition against double patenting.

Second, the inventor(s) must be the applicant in anapplication filed before September 16, 2012, (exceptas otherwise provided in pre-AIA 37 CFR 1.41(b))and the inventor or each joint inventor must beidentified in an application filed on or afterSeptember 16, 2012. See MPEP § 2137.01 for adetailed discussion of inventorship, MPEP §602.01(c) et seq. for details regarding correction ofinventorship, and MPEP § 706.03(a), subsection IV,for rejections under 35 U.S.C. 101 and 115 (andpre-AIA 35 U.S.C. 102(f) for applications subjectto pre-AIA 35 U.S.C. 102) for failure to set forth thecorrect inventorship.

Third, a claimed invention must be eligible forpatenting. As explained in MPEP § 2106, there are

two criteria for determining subject matter eligibility:(a) first, a claimed invention must fall within one ofthe four statutory categories of invention, i.e.,process, machine, manufacture, or composition ofmatter; and (b) second, a claimed invention must bedirected to patent-eligible subject matter and not ajudicial exception (unless the claim as a wholeincludes additional limitations amounting tosignificantly more than the exception). See MPEP§ 2106 for a detailed discussion of the subject mattereligibility requirements and MPEP § 2105 for specialconsiderations for living subject matter.

Fourth, a claimed invention must be useful or havea utility that is specific, substantial and credible. SeeMPEP § 2107 for a detailed discussion of the utilityrequirement.

2105 Patent Eligible Subject Matter —Living Subject Matter [R-08.2017]

I. INTRODUCTION

Prior to 1980, it was widely believed that livingsubject matter was not eligible for patenting, eitherbecause such subject matter did not fall within astatutory category, or because it was a judicialexception to patent eligibility. However, the decisionof the Supreme Court in Diamond v. Chakrabarty,447 U.S. 303, 206 USPQ 193 (1980), made it clearthat the question of whether an invention embracesliving matter is irrelevant to the issue of patenteligibility. Note, however, that Congress hasexcluded claims directed to or encompassing ahuman organism from eligibility. See TheLeahy-Smith America Invents Act (AIA), Pub. L.112-29, sec. 33(a), 125 Stat. 284 (September 16,2011).

II. LIVING SUBJECT MATTER MAY BE PATENTELIGIBLE

A. Living Subject Matter May Be Directed To AStatutory Category

In Chakrabarty, the Supreme Court held that a claimto a genetically engineered bacterium was directedto at least one of the four statutory categories,because the bacterium was a “manufacture” and/ora “composition of matter.” In its opinion, the Court

2100-10Rev. 08.2017, January 2018


stated that “Congress plainly contemplated that thepatent laws would be given wide scope” because itchose to draft 35 U.S.C. 101 using “such expansiveterms as ‘manufacture’ and ‘composition of matter,’modified by the comprehensive ‘any.’” 447 U.S. at308, 206 USPQ at 197. The Court also determinedthat the distinction between living and inanimatethings was not relevant for subject matter eligibility.447 U.S. at 313, 206 USPQ at 199. Thus, the Courtheld that living subject matter with markedlydifferent characteristics from any found in nature,such as the claimed bacterium produced by geneticengineering, is not excluded from patent protectionby 35 U.S.C. 101. 447 U.S. at 310, 206 USPQ at197.

Following the reasoning in Chakrabarty, the Boardof Patent Appeals and Interferences determined thatanimals are patentable subject matter under 35U.S.C. 101. In Ex parte Allen, 2 USPQ2d 1425 (Bd.Pat. App. & Inter. 1987), the Board decided that anon-naturally occurring polyploid Pacific coastoyster could have been the proper subject of a patentunder 35 U.S.C. 101 if all the criteria forpatentability were satisfied. Shortly after the Allendecision, the Commissioner of Patents andTrademarks issued a notice (Animals - Patentability,1077 O.G. 24, April 21, 1987) stating that the Patentand Trademark Office "now considers nonnaturallyoccurring, non-human multicellular living organisms,including animals, to be patentable subject matterwithin the scope of 35 U.S.C. 101.

With respect to plant subject matter, the SupremeCourt held that patentable subject matter under 35U.S.C. 101 includes newly developed plant breeds,even though plant protection is also available underthe Plant Patent Act (35 U.S.C. 161 - 164) and thePlant Variety Protection Act (7 U.S.C. 2321 et.seq.). J.E.M. Ag Supply, Inc. v. Pioneer Hi-BredInt’ l, Inc., 534 U.S. 124, 143-46, 122 S.Ct. 593,605-06, 60 USPQ2d 1865, 1874 (2001) (The scopeof coverage of 35 U.S.C. 101 is not limited by thePlant Patent Act or the Plant Variety Protection Act;each statute can be regarded as effective because ofits different requirements and protections).

See MPEP § 2106.03 for a discussion of thecategories of statutory subject matter.

B. Living Subject Matter May Be Eligible for PatentProtection

The Supreme Court in Chakrabarty held a claim toa genetically engineered bacterium eligible, becausethe claimed bacterium was not a “product of nature”exception. As the Court explained, the modifiedbacterium was patentable because the patent claimwas not to a “hitherto unknown naturalphenomenon,” but instead had “markedly differentcharacteristics from any found in nature,” due to theadditional plasmids and resultant capacity fordegrading oil. 447 U.S. at 309-10, 206 USPQ at 197.

Subsequent judicial decisions have made clear thatthe Supreme Court’s decision in Chakrabarty is“central” to the eligibility inquiry with respect tonature-based products. See, e.g., Association forMolecular Pathology v. Myriad Genetics, Inc., 569U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972,1979 (2013). For example, the Federal Circuit hasindicated that “discoveries that possess ‘markedlydifferent characteristics from any found in nature,’… are eligible for patent protection.” In re RoslinInstitute (Edinburgh), 750 F.3d 1333, 1336, 110USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197).In Roslin, the claimed invention was a live-bornclone of a pre-existing, non-embryonic, donormammal selected from cattle, sheep, pigs, and goats.An embodiment of the claimed invention was thefamous Dolly the Sheep, which the court stated was“the first mammal ever cloned from an adult somaticcell.” Despite acknowledging that the method usedto create the claimed clones “constituted abreakthrough in scientific discovery”, the court reliedon Chakrabarty in holding the claims ineligiblebecause “Dolly herself is an exact genetic replica ofanother sheep and does not possess ‘markedlydifferent characteristics from any [farm animals]found in nature.’” Roslin, 750 F.3d at 1337, 110USPQ2d at 1671.

See MPEP § 2106.04 for a discussion of the judicialexceptions in general, MPEP § 2106.04(b),subsection II for a discussion of products of nature,and MPEP § 2106.04(c) for a discussion of themarkedly different characteristics analysis thatexaminers should use to determine whether a

Rev. 08.2017, January 20182100-11


nature-based product such as living subject matteris eligible for patent protection.

III. HUMAN ORGANISMS ARE NONSTATUTORYSUBJECT MATTER

Congress has excluded claims directed to orencompassing a human organism from patentability.The Leahy-Smith America Invents Act (AIA), PublicLaw 112-29, sec. 33(a), 125 Stat. 284, states:

Notwithstanding any other provision of law,no patent may issue on a claim directed to orencompassing a human organism.

The legislative history of the AIA includes thefollowing statement, which sheds light on themeaning of this provision:

[T]he U.S. Patent Office has already issuedpatents on genes, stems cells, animals withhuman genes, and a host of non-biologicproducts used by humans, but it has not issuedpatents on claims directed to human organisms,including human embryos and fetuses. Myamendment would not affect the former, butwould simply affirm the latter.

157 Cong. Rec. E1177-04 (testimony ofRepresentative Dave Weldon previously presentedin connection with the Consolidated AppropriationsAct, 2004, Public Law 108-199, 634, 118 Stat. 3,101, and later resubmitted with regard to the AIA;see 149 Cong. Rec. E2417-01). Thus, section 33(a)of the AIA codifies existing Office policy that humanorganisms are not patent-eligible subject matter.

If the broadest reasonable interpretation of theclaimed invention as a whole encompasses a humanorganism, then a rejection under 35 U.S.C. 101 andAIA sec. 33(a) must be made indicating that theclaimed invention is directed to a human organismand is therefore nonstatutory subject matter. Formparagraph 7.04.03 should be used; see MPEP §706.03(a). Furthermore, the claimed invention mustbe examined with regard to all issues pertinent topatentability, and any applicable rejections under 35U.S.C. 102, 103, or 112 must also be made.

2106 Patent Subject Matter Eligibility[R-08.2017]

I. TWO CRITERIA FOR SUBJECT MATTERELIGIBILITY

First, the claimed invention must be to one of thefour statutory categories. 35 U.S.C. 101 defines thefour categories of invention that Congress deemedto be the appropriate subject matter of a patent:processes, machines, manufactures and compositionsof matter. The latter three categories define “things”or “products” while the first category defines“actions” (i.e., inventions that consist of a series ofsteps or acts to be performed). See 35 U.S.C. 100(b)(“The term ‘process’ means process, art, or method,and includes a new use of a known process, machine,manufacture, composition of matter, or material.”).See MPEP § 2106.03 for detailed information onthe four categories.

Second, the claimed invention also must qualify aspatent-eligible subject matter, i.e., the claim mustnot be directed to a judicial exception unless theclaim as a whole includes additional limitationsamounting to significantly more than the exception.The judicial exceptions (also called “judiciallyrecognized exceptions” or simply “exceptions”) aresubject matter that the courts have found to beoutside of, or exceptions to, the four statutorycategories of invention, and are limited to abstractideas, laws of nature and natural phenomena(including products of nature). Alice Corp. Pty. Ltd.v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2354,110 USPQ2d 1976, 1980 (2014) (citing Ass'n forMolecular Pathology v. Myriad Genetics, Inc., 569U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972,1979 (2013). See MPEP § 2106.04 for detailedinformation on the judicial exceptions.

Because abstract ideas, laws of nature, and naturalphenomenon "are the basic tools of scientific andtechnological work", the Supreme Court hasexpressed concern that monopolizing these tools bygranting patent rights may impede innovation ratherthan promote it. See Alice Corp., 134 S. Ct. at 2354,110 USPQ2d at 1980; Mayo Collaborative Servs.v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101USPQ2d 1961, 1965 (2012). However, the Courthas also emphasized that an invention is not

2100-12Rev. 08.2017, January 2018


considered to be ineligible for patenting simplybecause it involves a judicial exception. Alice Corp.,134 S. Ct. at 2354, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ1, 8 (1981)). See also Thales Visionix Inc. v. UnitedStates, 850 F.3d. 1343, 1349, 121 USPQ2d 1898,1902 (Fed. Cir. 2017) (“That a mathematicalequation is required to complete the claimed methodand system does not doom the claims toabstraction.”). Accordingly, the Court has said thatan application of an abstract idea, law of nature ornatural phenomenon may be eligible for patentprotection. Alice Corp., 134 S. Ct. at 2354, 110USPQ2d at 1980 (citing Gottschalk v. Benson, 409U.S. 63, 67, 175 USPQ 673, 675 (1972)).

The Supreme Court in Mayo laid out a frameworkfor determining whether an applicant is seeking topatent a judicial exception itself, or a patent-eligibleapplication of the judicial exception. See AliceCorp., 134 S. Ct. at 2355, 110 USPQ2d at 1981(citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). Thisframework, which is referred to as the Mayo test orthe Alice/Mayo test, is discussed in further detail insubsection III, below. The first part of the Mayo testis to determine whether the claims are directed to anabstract idea, a law of nature or a naturalphenomenon (i.e., a judicial exception). Id. If theclaims are directed to a judicial exception, the secondpart of the Mayo test is to determine whether theclaim recites additional elements that amount tosignificantly more than the judicial exception. Id.citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at1966) The Supreme Court has described the secondpart of the test as the "search for an 'inventiveconcept'". Alice Corp., 134 S. Ct. at 2355, 110USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73,101 USPQ2d at 1966).

The Alice/Mayo two-part test is the only test thatshould be used to evaluate the eligibility of claimsu n d e r ex a m i n a t i o n . W h i l e t h emachine-or-transformation test is an important clueto eligibility, it should not be used as a separate testfor eligibility, but instead should be considered aspart of the "significantly more" determination in the Alice/Mayo test. Bilski v. Kappos, 561 U.S. 593,605, 95 USPQ2d 1001, 1007 (2010). See MPEP §2106.05(b) and MPEP § 2106.05(c) for morei n f o r m a t i o n a b o u t h o w t h e

machine-or-transformation test fits into the Alice/Mayo two-part framework. Likewise,eligibility should not be evaluated based on whetherthe claim recites a "useful, concrete, and tangibleresult," State Street Bank, 149 F.3d 1368, 1374, 47USPQ2d 1596, _ (Fed. Cir. 1998) (quoting In reAlappat, 33 F.3d 1526, 1544, 31 USPQ2d 1545, _(Fed. Cir. 1994)), as this test has been superseded. In re Bilski, 545 F.3d 943, 959-60, 88 USPQ2d1385, 1394-95 (Fed. Cir. 2008) (en banc), aff'd by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001(2010). See also TLI Communications LLC v. AVAutomotive LLC, 823 F.3d 607, 613, 118 USPQ2d1744, 1748 (Fed. Cir. 2016) (“It is well-settled thatmere recitation of concrete, tangible components isinsufficient to confer patent eligibility to anotherwise abstract idea”). The programmed computeror “special purpose computer” test of In re Alappat,33 F.3d 1526, 31 USPQ2d 1545 (Fed. Cir. 1994)(i.e., the rationale that an otherwise ineligiblealgorithm or software could be made patent-eligibleby merely adding a generic computer to the claimfor the “special purpose” of executing the algorithmor software) was also superseded by the SupremeCourt’s Bilski and Alice Corp. decisions. Eon Corp.IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015)(“[W]e note that Alappat has been superseded by Bilski, 561 U.S. at 605–06, and Alice Corp. v. CLSBank Int’l, 134 S. Ct. 2347 (2014)”); IntellectualVentures I LLC v. Capital One Bank (USA), N.A.,792 F.3d 1363, 1366, 115 USPQ2d 1636, 1639 (Fed.Cir. 2015) (“An abstract idea does not becomenonabstract by limiting the invention to a particularfield of use or technological environment, such asthe Internet [or] a computer”). Lastly, eligibilityshould not be evaluated based on whether theclaimed invention has utility, because “[u]tility isnot the test for patent-eligible subject matter.” Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369,1380, 118 USPQ2d 1541, 1548 (Fed. Cir. 2016).

Examiners are reminded that 35 U.S.C. 101 is notthe sole tool for determining patentability; 35 U.S.C.112 , 35 U.S.C. 102, and 35 U.S.C. 103 will provideadditional tools for ensuring that the claim meets theconditions for patentability. As the Supreme Courtmade clear in Bilski, 561 U.S. at 602, 95 USPQ2dat 1006:

Rev. 08.2017, January 20182100-13


The § 101 patent-eligibility inquiry is only athreshold test. Even if an invention qualifies asa process, machine, manufacture, orcomposition of matter, in order to receive thePatent Act’s protection the claimed inventionmust also satisfy ‘‘the conditions andrequirements of this title.’’ § 101. Thoserequirements include that the invention benovel, see § 102, nonobvious, see § 103, andfully and particularly described, see § 112.

II. ESTABLISH BROADEST REASONABLEINTERPRETATION OF CLAIM AS A WHOLE

It is essential that the broadest reasonableinterpretation (BRI) of the claim be established priorto examining a claim for eligibility. The BRI setsthe boundaries of the coverage sought by the claimand will influence whether the claim seeks to coversubject matter that is beyond the four statutorycategories or encompasses subject matter that fallswithin the exceptions. Evaluating eligibility basedon the BRI also ensures that patent eligibility under35 U.S.C. 101 does not depend simply on thedraftsman’s art. Alice, 134 S. Ct. at 2359, 2360, 110USPQ2d at 1984, 1985 (citing Parker v. Flook, 437U.S. 584, 593, 198 USPQ 193, 198 (1978) and Mayo, 566 U.S. at 72, 101 USPQ2d at 1966). SeeMPEP § 2111 for more information aboutdetermining the BRI.

Claim interpretation affects the evaluation of bothcriteria for eligibility. For example, in MentorGraphics v. EVE-USA, Inc., 851 F.3d 1275, 112USPQ2d 1120 (Fed. Cir. 2017), claim interpretationwas crucial to the court’s determination that claimsto a “machine-readable medium” were not to astatutory category. In Mentor Graphics, the courtinterpreted the claims in light of the specification,which expressly defined the medium asencompassing “any data storage device” includingrandom-access memory and carrier waves. Althoughrandom-access memory and magnetic tape arestatutory media, carrier waves are not because theyare signals similar to the transitory, propagatingsignals held to be non-statutory in Nuijten. 851 F.3dat 1294, 112 USPQ2d at 1133 (citing In re Nuijten,500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007)).Accordingly, because the BRI of the claims coveredboth subject matter that falls within a statutory

category (the random-access memory), as well assubject matter that does not (the carrier waves), theclaims as a whole were not to a statutory categoryand thus failed the first criterion for eligibility.

With regard to the second criterion for eligibility,the Alice/Mayo test, claim interpretation can affectthe first part of the test (whether the claims aredirected to a judicial exception). For example, thepatentee in Synopsys argued that the claimedmethods of logic circuit design were intended to beused in conjunction with computer-based designtools, and were thus not mental processes. Synopsys,Inc. v. Mentor Graphics Corp., 839 F.3d 1138,1147-49, 120 USPQ2d 1473, 1480-81 (Fed. Cir.2016). The court disagreed, because it interpretedthe claims as encompassing nothing other than puremental steps (and thus an abstract idea) because theclaims did not include any limitations requiringcomputer implementation. In contrast, the patenteein Enfish argued that its claimed self-referentialtable for a computer database was an improvementin an existing technology and thus not directed to anabstract idea. Enfish, LLC v. Microsoft Corp., 822F.3d 1327, 1336-37, 118 USPQ2d 1684, 1689-90(Fed. Cir. 2016). The court agreed with the patentee,based on its interpretation of the claimed “means forconfiguring” under 35 U.S.C. 112(f) as requiring afour-step algorithm that achieved the improvements,as opposed to merely any form of storing tabulardata. See also McRO, Inc. v. Bandai Namco GamesAmerica, Inc. 837 F.3d 1299, 1314, 120 USPQ2d1091, 1102 (Fed. Cir. 2016) (the claim’s constructionincorporated rules of a particular type that improvedan existing technological process). Claiminterpretation can also affect the second part of the Alice/Mayo test (whether the claim recites additionalelements that amount to significantly more than thejudicial exception). For example, in Amdocs (Israel)Ltd. v. Openet Telecom, Inc., where the court reliedon the construction of the term “enhance” (to requireapplication of a number of field enhancements in adistributed fashion) to determine that the claimentails an unconventional technical solution to atechnological problem. 841 F.3d 1288, 1300-01, 120USPQ2d 1527, 1537 (Fed. Cir. 2016).

2100-14Rev. 08.2017, January 2018


III. SUMMARY OF ANALYSIS AND FLOWCHART

Examiners should determine whether a claimsatisfies the criteria for subject matter eligibility byevaluating the claim in accordance with thefollowing flowchart. The flowchart illustrates thesteps of the subject matter eligibility analysis forproducts and processes that are to be used duringexamination for evaluating whether a claim is drawnto patent-eligible subject matter. It is recognized thatunder the controlling legal precedent there may bevariations in the precise contours of the analysis forsubject matter eligibility that will still achieve thesame end result. The analysis set forth hereinpromotes examination efficiency and consistencyacross all technologies.

As shown in the flowchart, Step 1 relates to thestatutory categories and ensures that the first criterionis met by confirming that the claim falls within oneof the four statutory categories of invention. SeeMPEP § 2106.03 for more information on Step 1.Step 2, which is the Supreme Court’s Alice/Mayotest, is a two-part test to identify claims that aredirected to a judicial exception (Step 2A) and to thenevaluate what more such claims recite to provide aninventive concept (Step 2B) (also called a practicalapplication) to the judicial exception. See MPEP §2106.04 for more information on Step 2A, andMPEP § 2106.05 for more information on Step 2B.

The flowchart also shows three pathways (A, B, andC) to eligibility:

Pathway A: Claims taken as a whole that fallwithin a statutory category (Step 1: YES) and, whichmay or may not recite a judicial exception, but whose

eligibility is self-evident can be found eligible atPathway A using a streamlined analysis. See MPEP§ 2106.06 for more information on this pathway andon self-evident eligibility.

Pathway B: Claims taken as a whole that fallwithin a statutory category (Step 1: YES) and arenot directed to a judicial exception (Step 2A: NO)are eligible at Pathway B. These claims do not needto go to Step 2B. See MPEP § 2106.04 for moreinformation about this pathway and Step 2A.

Pathway C: Claims taken as a whole that fallwithin a statutory category (Step 1: YES), aredirected to a judicial exception (Step 2A: YES), andrecite additional elements either individually or inan ordered combination that amount to significantlymore than the judicial exception (Step 2B: YES) areeligible at Pathway C. See MPEP § 2106.05 for moreinformation about this pathway and Step 2B.

Claims that could have been found eligible atPathway A (streamlined analysis), but are subjectedto further analysis at Steps 2A or Step 2B, willultimately be found eligible at Pathways B or C.Thus, if the examiner is uncertain about whether astreamlined analysis is appropriate, the examiner isencouraged to conduct a full eligibility analysis.However, if the claim is not found eligible at any ofPathways A, B or C, the claim is patent ineligibleand should be rejected under 35 U.S.C. 101.

Regardless of whether a rejection under 35 U.S.C.101 is made, a complete examination should be madefor every claim under each of the other patentabilityrequirements: 35 U.S.C. 102, 103, 112, and 101(utility, inventorship and double patenting) andnon-statutory double patenting. MPEP § 2103.

Rev. 08.2017, January 20182100-15


2100-16Rev. 08.2017, January 2018


2106.01 [Reserved]

2106.02 [Reserved]

2106.03 Eligibility Step 1: The FourCategories of Statutory Subject Matter[R-08.2017]

I. THE FOUR CATEGORIES

35 U.S.C. 101 enumerates four categories of subjectmatter that Congress deemed to be appropriatesubject matter for a patent: processes, machines,manufactures and compositions of matter. Asexplained by the courts, these “four categoriestogether describe the exclusive reach of patentablesubject matter. If a claim covers material not foundin any of the four statutory categories, that claimfalls outside the plainly expressed scope of § 101even if the subject matter is otherwise new anduseful.” In re Nuijten, 500 F.3d 1346, 1354, 84USPQ2d 1495, 1500 (Fed. Cir. 2007).

A process defines “actions”, i.e., an invention thatis claimed as an act or step, or a series of acts orsteps. As explained by the Supreme Court, a“process” is “a mode of treatment of certainmaterials to produce a given result. It is an act, ora series of acts, performed upon the subject-matterto be transformed and reduced to a different state orthing.” Gottschalk v. Benson, 409 U.S. 63, 70, 175USPQ 673, 676 (1972) (italics added) (quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed.139, 141 (1876)). Accord Nuijten, 500 F.3d at 1355,84 USPQ2d at 1501 (“The Supreme Court and thiscourt have consistently interpreted the statutory term‘process’ to require action”); NTP, Inc. v. Researchin Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d1763, 1791 (Fed. Cir. 2005) (“[A] process is a seriesof acts.”) (quoting Minton v. Natl. Ass’n. ofSecurities Dealers, 336 F.3d 1373, 1378, 67 USPQ2d1614, 1681 (Fed. Cir. 2003)). As defined in 35U.S.C. 100(b), the term “process” is synonymouswith “method.”

The other three categories (machines, manufacturesand compositions of matter) define the types ofphysical or tangible “things” or “products” thatCongress deemed appropriate to patent. Digitech

Image Techs. v. Electronics for Imaging, 758 F.3d1344, 1348, 111 USPQ2d 1717, 1719 (Fed. Cir.2014) (“For all categories except process claims, theeligible subject matter must exist in some physicalor tangible form.”). Thus, when determining whethera claimed invention falls within one of these threecategories, examiners should verify that the inventionis to at least one of the following categories and isclaimed in a physical or tangible form.

• A machine is a “concrete thing, consisting ofparts, or of certain devices and combination ofdevices.” Digitech, 758 F.3d at 1348-49, 111USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S.531, 570, 17 L. Ed. 650, 657 (1863)). This category“includes every mechanical device or combinationof mechanical powers and devices to perform somefunction and produce a certain effect or result.” Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501(quoting Corning v. Burden, 56 U.S. 252, 267, 14L. Ed. 683, 690 (1854)).

• A manufacture is “a tangible article that isgiven a new form, quality, property, or combinationthrough man-made or artificial means.” Digitech,758 F.3d at 1349, 111 USPQ2d at 1719-20 (citing Diamond v. Chakrabarty, 447 U.S. 303, 308, 206USPQ 193, 197 (1980)). As the courts haveexplained, manufactures are articles that result fromthe process of manufacturing, i.e., they wereproduced “from raw or prepared materials by givingto these materials new forms, qualities, properties,or combinations, whether by hand-labor or bymachinery.” Samsung Electronics Co. v. Apple Inc.,580 U.S. __, 137 S. Ct. 429, 435, 120 USPQ2d 1749,1752-3 (2016) (quoting Diamond v. Chakrabarty,447 U. S. 303, 308, 206 USPQ 193, 196-97 (1980)); Nuijten, 500 F.3d at 1356-57, 84 USPQ2d at 1502.Manufactures also include “the parts of a machineconsidered separately from the machine itself.” Samsung Electronics, 137 S. Ct. at 435, 120USPQ2d at 1753 (quoting 1 W. Robinson, The Lawof Patents for Useful Inventions §183, p. 270(1890)).

• A composition of matter is a “combination oftwo or more substances and includes all compositearticles.” Digitech, 758 F.3d at 1348-49, 111USPQ2d at 1719 (citation omitted). This categoryincludes all compositions of two or more substancesand all composite articles, “'whether they be theresults of chemical union or of mechanical mixture,

Rev. 08.2017, January 20182100-17

§ 2106.03PATENTABILITY

or whether they be gases, fluids, powders or solids.'” Chakrabarty, 447 U.S. at 308, 206 USPQ at 197(quoting Shell Dev. Co. v. Watson, 149 F. Supp.279, 280 (D.D.C. 1957); id. at 310 holdinggenetically modified microorganism to be amanufacture or composition of matter).

It is not necessary to identify a single category intowhich a claim falls, so long as it is clear that theclaim falls into at least one category. For example,because a microprocessor is generally understoodto be a manufacture, a product claim to themicroprocessor or a system comprising themicroprocessor satisfies Step 1 regardless of whetherthe claim falls within any other statutory category(such as a machine). It is also not necessary toidentify a “correct” category into which the claimfalls, because although in many instances it is clearwithin which category a claimed invention falls, aclaim may satisfy the requirements of more than onecategory. For example, a bicycle satisfies both themachine and manufacture categories, because it isa tangible product that is concrete and consists ofparts such as a frame and wheels (thus satisfying themachine category), and it is an article that wasproduced from raw materials such as aluminum oreand liquid rubber by giving them a new form (thussatisfying the manufacture category). Similarly, agenetically modified bacterium satisfies both thecomposition of matter and manufacture categories,because it is a tangible product that is a combinationof two or more substances such as proteins,carbohydrates and other chemicals (thus satisfyingthe composition of matter category), and it is anarticle that was genetically modified by humans tohave new properties such as the ability to digestmultiple types of hydrocarbons (thus satisfying themanufacture category).

Non-limiting examples of claims that are not directedto any of the statutory categories include:

• Products that do not have a physical ortangible form, such as information (often referredto as “data per se”) or a computer program per se(often referred to as “software per se”) when claimedas a product without any structural recitations;

• Transitory forms of signal transmission (oftenreferred to as “signals per se”), such as a propagatingelectrical or electromagnetic signal or carrier wave;and

• Subject matter that the statute expresslyprohibits from being patented, such as humans perse, which are excluded under The Leahy-SmithAmerica Invents Act (AIA), Public Law 112-29, sec.33, 125 Stat. 284 (September 16, 2011).

As the courts' definitions of machines, manufacturesand compositions of matter indicate, a product musthave a physical or tangible form in order to fallwithin one of these statutory categories. Digitech,758 F.3d at 1348, 111 USPQ2d at 1719. Thus, theFederal Circuit has held that a product claim to anintangible collection of information, even if createdby human effort, does not fall within any statutorycategory. Digitech, 758 F.3d at 1350, 111 USPQ2dat 1720 (claimed “device profile” comprising twosets of data did not meet any of the categoriesbecause it was neither a process nor a tangibleproduct). Similarly, software expressed as code ora set of instructions detached from any medium isan idea without physical embodiment. See MicrosoftCorp. v. AT&T Corp., 550 U.S. 437, 449, 82USPQ2d 1400, 1407 (2007); see also Benson, 409U.S. 67, 175 USPQ2d 675 (An "idea" is not patenteligible). Thus, a product claim to a softwareprogram that does not also contain at least onestructural limitation (such as a “means plus function”limitation) has no physical or tangible form, and thusdoes not fall within any statutory category. Anotherexample of an intangible product that does not fallwithin a statutory category is a paradigm or businessmodel for a marketing company. In re Ferguson,558 F.3d 1359, 1364, 90 USPQ2d 1035, 1039-40(Fed. Cir. 2009).

Even when a product has a physical or tangible form,it may not fall within a statutory category. Forinstance, a transitory signal, while physical and real,does not possess concrete structure that wouldqualify as a device or part under the definition of amachine, is not a tangible article or commodity underthe definition of a manufacture (even though it isman-made and physical in that it exists in the realworld and has tangible causes and effects), and isnot composed of matter such that it would qualifyas a composition of matter. Nuijten, 500 F.3d at1356-1357, 84 USPQ2d at 1501-03. As such, atransitory, propagating signal does not fall withinany statutory category. Mentor Graphics Corp. v.EVE-USA, Inc., 851 F.3d 1275, 1294, 112 USPQ2d

2100-18Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.03

1120, 1133 (Fed. Cir. 2017); Nuijten, 500 F.3d at1356-1357, 84 USPQ2d at 1501-03.

II. ELIGIBILITY STEP 1: WHETHER A CLAIMIS TO A STATUTORY CATEGORY

As described in MPEP § 2106, subsection III, Step1 of the eligibility analysis asks: Is the claim to aprocess, machine, manufacture or composition ofmatter? Like the other steps in the eligibility analysis,evaluation of this step should be made afterdetermining what applicant has invented byreviewing the entire application disclosure andconstruing the claims in accordance with theirbroadest reasonable interpretation (BRI). See MPEP§ 2106, subsection II for more information about theimportance of understanding what the applicant hasinvented, and MPEP § 2111 for more informationabout the BRI.

In the context of the flowchart in MPEP § 2106,subsection III, Step 1 determines whether:

• The claim as a whole does not fall within anystatutory category (Step 1: NO) and thus isnon-statutory, warranting a rejection for failure toclaim statutory subject matter as discussed in MPEP§ 706.03(a); or

• The claim as a whole falls within one or morestatutory categories (Step 1: YES), and thus must befurther analyzed to determine whether it qualifies aseligible at Pathway A or requires further analysis atStep 2A to determine if the claim is directed to ajudicial exception.

A claim whose BRI covers both statutory andnon-statutory embodiments embraces subject matterthat is not eligible for patent protection and thereforeis directed to non-statutory subject matter. Suchclaims fail the first step (Step 1: NO) and should berejected under 35 U.S.C. 101, for at least this reason.In such a case, it is a best practice for the examinerto point out the BRI and recommend an amendment,if possible, that would narrow the claim to thoseembodiments that fall within a statutory category.

For example, the BRI of machine readable mediacan encompass non-statutory transitory forms ofsignal transmission, such as a propagating electricalor electromagnetic signal per se. See In re Nuijten,

500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007).When the BRI encompasses transitory forms ofsignal transmission, a rejection under 35 U.S.C. 101as failing to claim statutory subject matter would beappropriate. Thus, a claim to a computer readablemedium that can be a compact disc or a carrier wavecovers a non-statutory embodiment and thereforeshould be rejected under 35 U.S.C. 101 as beingdirected to non-statutory subject matter. See, e.g.,Mentor Graphics v. EVE-USA, Inc., 851 F.3d at1294-95, 112 USPQ2d at 1134 (claims to a“machine-readable medium” were non-statutory,because their scope encompassed both statutoryrandom-access memory and non-statutory carrierwaves).

If a claim is clearly not within one of the fourcategories (Step 1: NO), then a rejection under 35U.S.C. 101 must be made indicating that the claimis directed to non-statutory subject matter. Formparagraphs 7.05 and 7.05.01 should be used; seeMPEP § 706.03(a). However, as shown in theflowchart in MPEP § 2106 subsection III, when aclaim fails under Step 1 (Step 1: NO), but it appearsfrom applicant’s disclosure that the claim could beamended to fall within a statutory category (Step 1:YES), the analysis should proceed to determinewhether such an amended claim would qualify aseligible at Pathway A, B or C. In such a case, it is abest practice for the examiner to recommend anamendment, if possible, that would resolve eligibilityof the claim.

2106.04 Eligibility Step 2: Whether a Claimis Directed to a Judicial Exception[R-08.2017]

I. JUDICIAL EXCEPTIONS

Determining that a claim falls within one of the fourenumerated categories of patentable subject matterrecited in 35 U.S.C. 101 (i.e., process, machine,manufacture, or composition of matter) in Step 1does not end the eligibility analysis, because claimsdirected to nothing more than abstract ideas (suchas mathematical algorithms), natural phenomena,and laws of nature are not eligible for patentprotection. Diamond v. Diehr, 450 U.S. 175, 185,209 USPQ 1, 7 (1981). Alice Corp. Pty. Ltd. v. CLSBank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976,

Rev. 08.2017, January 20182100-19


1980 (2014) (citing Association for MolecularPathology v. Myriad Genetics, Inc., 133 S. Ct. 2107,2116, 106 USPQ2d 1972, 1979 (2013)); Diamondv. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193,197 (1980); Parker v. Flook, 437 U.S. 584, 589,198 USPQ 193, 197 (1978); Gottschalk v. Benson,409 U.S. 63, 67-68, 175 USPQ 673, 675 (1972). Seealso Bilski v. Kappos, 561 U.S. 593, 601, 95USPQ2d 1001, 1005-06 (2010) (“The Court’sprecedents provide three specific exceptions to §101's broad patent-eligibility principles: ‘laws ofnature, physical phenomena, and abstract ideas’”)(quoting Chakrabarty, 447 U.S. at 309, 206 USPQat 197 (1980)).

In addition to the terms “laws of nature,” “naturalphenomena,” and “abstract ideas,” judiciallyrecognized exceptions have been described usingvarious other terms, including “physicalphenomena,” “products of nature,” “scientificprinciples,” “systems that depend on humanintelligence alone,” “disembodied concepts,” “mentalprocesses,” and “disembodied mathematicalalgorithms and formulas.” It should be noted thatthere are no bright lines between the types ofexceptions, and that many of the concepts identifiedby the courts as exceptions can fall under severalexceptions. For example, mathematical formulas areconsidered to be a judicial exception as they expressa scientific truth, but have been labelled by the courtsas both abstract ideas and laws of nature. Likewise,“products of nature” are considered to be anexception because they tie up the use of naturallyoccurring things, but have been labelled as both lawsof nature and natural phenomena. Thus, it issufficient for this analysis for the examiner toidentify that the claimed concept (the specific claimlimitation(s) that the examiner believes may recitean exception) aligns with at least one judicialexception.

The Supreme Court has explained that the judicialexceptions reflect the Court’s view that abstractideas, laws of nature, and natural phenomena are“the basic tools of scientific and technologicalwork”, and are thus excluded from patentabilitybecause “monopolization of those tools through thegrant of a patent might tend to impede innovationmore than it would tend to promote it.” Alice Corp.,134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting

Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978and Mayo Collaborative Servs. v. Prometheus Labs.Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965(2012)). The Supreme Court’s concern that drivesthis “exclusionary principle” is pre-emption. AliceCorp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. TheCourt has held that a claim may not preempt abstractideas, laws of nature, or natural phenomena; i.e., onemay not patent every “substantial practicalapplication” of an abstract idea, law of nature, ornatural phenomenon, even if the judicial exceptionis narrow (e.g., a particular mathematical formulasuch as the Arrhenius equation). See, e.g., Mayo,566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69,1971 (claims directed to “narrow laws that may havelimited applications” held ineligible); Flook, 437U.S. at 589-90, 198 USPQ at 197 (claims that didnot “wholly preempt the mathematical formula” heldineligible). This is because such a patent would “inpractical effect [] be a patent on the [abstract idea,law of nature or natural phenomenon] itself.” Benson, 409 U.S. at 71- 72, 175 USPQ at 676. Theconcern over preemption was expressed as early as1852. See Le Roy v. Tatham, 55 U.S. (14 How.)156, 175 (1852) (“A principle, in the abstract, is afundamental truth; an original cause; a motive; thesecannot be patented, as no one can claim in either ofthem an exclusive right.”).

While preemption is the concern underlying thejudicial exceptions, it is not a standalone test fordetermining eligibility. Rapid Litig. Mgmt. v.CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d1370, 1376 (Fed. Cir. 2016). Instead, questions ofpreemption are inherent in and resolved by thetwo-part framework from Alice Corp. and Mayo(the Alice/Mayo test referred to by the Office asSteps 2A and 2B). Synopsys, Inc. v. MentorGraphics Corp., 839 F.3d 1138, 1150, 120 USPQ2d1473, 1483 (Fed. Cir. 2016); Ariosa Diagnostics,Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379, 115USPQ2d 1152, 1158 (Fed. Cir. 2015). It is necessaryto evaluate eligibility using the Alice/Mayo test,because while a preemptive claim may be ineligible,the absence of complete preemption does notdemonstrate that a claim is eligible. Diamond v.Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1,10-11 n.14 (1981) (“We rejected in Flook theargument that because all possible uses of themathematical formula were not pre-empted, the

2100-20Rev. 08.2017, January 2018


claim should be eligible for patent protection”). Seealso Return Mail, Inc. v. U.S. Postal Service, -- F.3d--, -- USPQ2d –, slip op. at 34 (Fed. Cir. August 28,2017); Synopsys v. Mentor Graphics, 839 F.3d at1150, 120 USPQ2d at 1483; FairWarning IP, LLCv. Iatric Sys., Inc., 839 F.3d 1089, 1098, 120USPQ2d 1293, 1299 (Fed. Cir. 2016); IntellectualVentures I LLC v. Symantec Corp., 838 F.3d 1307,1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Sequenom, 788 F.3d at 1379, 115 USPQ2d at 1158.Several Federal Circuit decisions, however, havenoted the absence of preemption when finding claimseligible under the Alice/Mayo test. McRO, Inc. v.Bandai Namco Games Am. Inc., 837 F.3d 1299,1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016); Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir.2016); BASCOM Global Internet v. AT&T Mobility,LLC, 827 F.3d 1341, 1350-52, 119 USPQ2d 1236,1243-44 (Fed. Cir. 2016).

The Supreme Court’s decisions make it clear thatjudicial exceptions need not be old or long-prevalent,and that even newly discovered or novel judicialexceptions are still exceptions. For example, themathematical formula in Flook, the laws of naturein Mayo, and the isolated DNA in Myriad were allnovel or newly discovered, but nonetheless wereconsidered by the Supreme Court to be judicialexceptions because they were “‘basic tools ofscientific and technological work’ that lie beyondthe domain of patent protection.” Myriad, 133 S.Ct. at 2112, 2116, 106 USPQ2d at 1976, 1978(noting that Myriad discovered the BRCA1 andBRCA1 genes and quoting Mayo, 566 U.S. 71, 101USPQ2d at 1965); Flook, 437 U.S. at 591-92, 198USPQ2d at 198 (“the novelty of the mathematicalalgorithm is not a determining factor at all”); Mayo,566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (notingthat the claims embody the researcher's discoveriesof laws of nature). The Supreme Court’s citedrationale for considering even “just discovered”judicial exceptions as exceptions stems from theconcern that “without this exception, there wouldbe considerable danger that the grant of patentswould ‘tie up’ the use of such tools and thereby‘inhibit future innovation premised upon them.’” Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978-79(quoting Mayo, 566 U.S. at 86, 101 USPQ2d at1971). See also Myriad, 133 S. Ct. at 2117, 106

USPQ2d at 1979 (“Groundbreaking, innovative, oreven brilliant discovery does not by itself satisfy the§101 inquiry.”). The Federal Circuit has also appliedthis principle, for example, when holding a conceptof using advertising as an exchange or currency tobe an abstract idea, despite the patentee’s argumentsthat the concept was “new”. Ultramercial, Inc. v.Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc.v. Mentor Graphics Corp., 839 F.3d 1138, 1151,120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a newabstract idea is still an abstract idea”) (emphasis inoriginal).

For a detailed discussion of abstract ideas, see MPEP§ 2106.04(a); for a detailed discussion of laws ofnature, natural phenomena and products of nature,see MPEP § 2106.04(b).

II. ELIGIBILITY STEP 2A: WHETHER A CLAIMIS DIRECTED TO A JUDICIAL EXCEPTION

As described in MPEP § 2106, subsection III, Step2A of the Office’s eligibility analysis is the first partof the Alice/Mayo test, i.e., the Supreme Court’s“framework for distinguishing patents that claimlaws of nature, natural phenomena, and abstract ideasfrom those that claim patent-eligible applications ofthose concepts.” Alice Corp. Pty. Ltd. v. CLS BankInt'l, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981(2014) (citing Mayo, 566 U.S. at 77-78, 101USPQ2d at 1967-68). Like the other steps in theeligibility analysis, evaluation of this step should bemade after determining what applicant has inventedby reviewing the entire application disclosure andconstruing the claims in accordance with theirbroadest reasonable interpretation. See MPEP §2106, subsection II for more information about theimportance of understanding what the applicant hasinvented, and MPEP § 2111 for more informationabout the broadest reasonable interpretation.

Step 2A asks: Is the claim directed to a law of nature,a natural phenomenon (product of nature) or anabstract idea? A claim is directed to a judicialexception when a law of nature, a naturalphenomenon, or an abstract idea is recited (i.e., setforth or described) in the claim. While the terms“set forth” and “describe” are thus both equated with“recite”, their different language is intended to

Rev. 08.2017, January 20182100-21


indicate that there are different ways in which anexception can be recited in a claim. For instance, theclaims in Diehr set forth a mathematical equationin the repetitively calculating step, the claims in Mayo set forth laws of nature in the wherein clause,meaning that the claims in those cases containeddiscrete claim language that was identifiable as ajudicial exception. The claims in Alice Corp.,however, described the concept of intermediatedsettlement without ever explicitly using the words“intermediated” or “settlement.”

In the context of the flowchart in MPEP § 2106,subsection III, Step 2A determines whether:

• The claim as a whole is not directed to ajudicial exception (Step 2A: NO) and thus is eligibleat Pathway B, thereby concluding the eligibilityanalysis; or

• The claim as a whole is directed to a judicialexception (Step 2A: YES) and thus requires furtheranalysis at Step 2B to determine if the claim as awhole amounts to significantly more than theexception itself.

A claim directed to a judicial exception requirescloser scrutiny for eligibility because of the risk thatit will tie up the excluded subject matter and preventothers from using the law of nature, naturalphenomenon, or abstract idea. However, the courtshave carefully construed this “exclusionary principlelest it swallow all of patent law” because “allinventions at some level embody, use, reflect, restupon, or apply laws of nature, natural phenomenon,or abstract ideas.” Alice Corp., 134 S. Ct. at 2354,110 USPQ2d at 1980 (citing Mayo, 566 US at 71,101 USPQ2d at 1965). See also Enfish, LLC v.Microsoft Corp., 822 F.3d 1327, 1335, 118 USPQ2d1684, 1688 (Fed. Cir. 2016) (“The ‘directed to’inquiry, therefore, cannot simply ask whether theclaims involve a patent-ineligible concept, becauseessentially every routinely patent-eligible claiminvolving physical products and actions involves alaw of nature and/or natural phenomenon”).Examiners should accordingly be careful todistinguish claims that recite an exception (whichrequire further eligibility analysis) and claims thatmerely involve an exception (which are eligible anddo not require further eligibility analysis). Further,

examiners should consider the claim as a wholewhen performing the Step 2A analysis.

An example of a claim that recites a judicialexception is “A machine comprising elements thatoperate in accordance with F=ma.” This claim recitesthe principle that force equals mass timesacceleration (F=ma) and is therefore directed to alaw of nature exception. Because F=ma representsa mathematical formula, the claim could alternativelybe considered as directed to an abstract idea. Becausethis claim is directed to a judicial exception (Step2A: YES), it requires further analysis in Step 2B.An example of a claim that merely involves, or isbased on, an exception is a claim to “A teeter-tottercomprising an elongated member pivotably attachedto a base member, having seats and handles attachedat opposing sides of the elongated member.” Thisclaim is based on the concept of a lever pivoting ona fulcrum, which involves the natural principles ofmechanical advantage and the law of the lever.However, this claim does not recite these naturalprinciples and therefore is not directed to a judicialexception (Step 2A: NO). Thus, the claim is eligiblewithout further analysis.

Unless it is clear that the claim recites distinctexceptions, such as a law of nature and an abstractidea, care should be taken not to parse a recitedexception into multiple exceptions, particularly inclaims involving abstract ideas. For example, stepsin a claim that recite the manipulation of informationthrough a series of mental steps would be considereda single abstract idea for purposes of analysis ratherthan a plurality of separate abstract ideas to beanalyzed individually. However, a claim recitingmultiple exceptions is directed to at least one judicialexception (Step 2A: YES) regardless of whether themultiple exceptions are distinct from each other, andthus must be further analyzed in Step 2B. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d1322, 1326-27, 122 USPQ2d 1377, 1379-80 (Fed.Cir. 2017) (claim reciting multiple abstract ideas, i.e., the manipulation of information through a seriesof mental steps and a mathematical calculation, washeld directed to an abstract idea and thus subjectedto further analysis in part two of the Alice/Mayotest).

2100-22Rev. 08.2017, January 2018


2106.04(a) Abstract Ideas [R-08.2017]

The abstract idea exception has deep roots in theSupreme Court’s jurisprudence. See Bilski v.Kappos, 561 U.S. 593, 601-602, 95 USPQ2d 1001,1006 (2010) (citing Le Roy v. Tatham, 55 U.S. (14How.) 156, 174–175 (1853)). Despite this longhistory, the courts have declined to define abstractideas. Instead, they have often identified abstractideas by referring to earlier precedent, e.g., bycomparing a claimed concept to the conceptspreviously identified as abstract ideas by the courts. Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841F.3d 1288, 1294, 120 USPQ2d 1527, 1532 (Fed.Cir. 2016); Enfish, LLC v. Microsoft Corp., 822F.3d. 1327, 1334, 118 USPQ2d 1684, 1688 (Fed.Cir. 2016). For example, in Alice Corp., theSupreme Court identified the claimed systems andmethods as describing the concept of intermediatedsettlement, and then compared this concept to therisk hedging concept identified as an abstract ideain Bilski. Because this comparison revealed "nomeaningful distinction between the concept of riskhedging in Bilski and the concept of intermediatedsettlement at issue here”, the Court concluded thatthe concept of intermediated settlement was anabstract idea. Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2356-57, 110 USPQ2d 1976, 1982(2014). Similarly, the Federal Circuit in Amdocscompared the claims at issue with “eligible andineligible claims of a similar nature from past cases”as part of its eligibility analysis. 841 F.3d at1295-1300, 120 USPQ2d at 1533-1536.

Although the Supreme Court has not delimited theprecise contours of the abstract idea exception, it isclear from the body of judicial precedent thatsoftware and business methods are not excludedcategories of subject matter. For example, theSupreme Court concluded that business methods arenot “categorically outside of § 101's scope,” statingthat “a business method is simply one kind of‘method’ that is, at least in some circumstances,eligible for patenting under § 101.” Bilski, 561 U.S.at 607, 95 USPQ2d at 1008 (2010). See also ContentExtraction and Transmission, LLC v. Wells FargoBank, 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357(Fed. Cir. 2014) (“there is no categoricalbusiness-method exception”). Likewise, software isnot automatically an abstract idea, even if

performance of a software task involves anunderlying mathematical calculation or relationship.See, e.g., Thales Visionix, Inc. v. United States, 850F.3d 1343, 121 USPQ2d 1898, 1902 (“That amathematical equation is required to complete theclaimed method and system does not doom theclaims to abstraction.”); McRO, Inc. v. BandaiNamco Games Am. Inc., 837 F.3d 1299, 1316, 120USPQ2d 1091, 1103 (Fed. Cir. 2016) (methods ofautomatic lip synchronization and facial expressionanimation using computer-implemented rules werenot directed to an abstract idea); Enfish, 822 F.3dat 1336, 118 USPQ2d at 1689 (claims toself-referential table for a computer database werenot directed to an abstract idea).

Examiners should determine whether a claim recitesan abstract idea by (1) identifying the claimedconcept (the specific claim limitation(s) in the claimunder examination that the examiner believes maybe an abstract idea), and (2) comparing the claimedconcept to the concepts previously identified asabstract ideas by the courts to determine if it issimilar.

• If a claimed concept is similar to one or moreconcepts that were previously identified as abstractideas by the courts, it is reasonable to conclude thatthe concept is an abstract idea and find that the claimis directed to an abstract idea exception (Step 2A:YES). The claim then requires further analysis inStep 2B to determine whether any additionalelements in the claim add significantly more to theexception.

• If the claimed concept(s) is not similar to aconcept that was previously identified as an abstractidea by the courts and there is no basis forconcluding that the concept is an abstract idea, it isreasonable to find that the claim is not directed toan abstract idea exception. The claim is eligible (Step2A: NO) at Pathway B unless the claim recitesanother exception (such as a law of nature or naturalphenomenon).

I. CLAIMS THAT ARE DIRECTED TOIMPROVEMENTS IN COMPUTERFUNCTIONALITY OR OTHER TECHNOLOGYARE NOT ABSTRACT

When making the determination of whether a claimis directed to an abstract idea, examiners should keep

Rev. 08.2017, January 20182100-23

§ 2106.04(a)PATENTABILITY

in mind that some inventions pertaining toimprovements in computer functionality or toimprovements in other technologies are not abstractwhen appropriately claimed, and thus may be eligibleat Step 2A. Federal Circuit decisions providingexamples of such eligible claims include: Enfish,822 F.3d at 1339, 118 USPQ2d at 1691-92 (claimsto a self-referential table for a computer databasewere directed to an improvement in computercapabilities and not an abstract idea); McRO, Inc.v. Bandai Namco Games Am. Inc., 837 F.3d 1299,1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016)(claims to automatic lip synchronization and facialexpression animation were directed to animprovement in computer-related technology andnot an abstract idea); and Visual Memory LLC v.NVIDIA Corp., 867 F.3d 1253,1259-60, 123USPQ2d 1712, 1717 (Fed. Cir. 2017) (claims to anenhanced computer memory system were directedto an improvement in computer capabilities and notan abstract idea).

• In Enfish, the Federal Circuit concluded thatclaims to a self-referential database were not directedto an abstract idea, but rather an improvement tocomputer functionality. 822 F.3d at 1336, 118USPQ2d at 1689. It was the specification’sdiscussion of the prior art and how the inventionimproves the way the computer stores and retrievesdata in memory in combination with the specificdata structure recited in the claims that providedeligibility. 822 F.3d at 1337, 118 USPQ2d at 1690.The claim was not simply the addition of generalpurpose computers added post-hoc to an abstractidea, but a specific implementation of a solution toa problem in the software arts. 822 F.3d at 1339, 118USPQ2d at 1691

• In McRO, the Federal Circuit concluded thatthe claimed methods of automatic lipsynchronization and facial expression animationusing computer-implemented rules were not directedto an abstract idea. McRO, 837 F.3d at 1316, 120USPQ2d at 1103. The basis for the McRO court'sdecision was that the claims were directed to animprovement in computer animation and thus didnot recite a concept similar to previously identifiedabstract ideas in Flook, Bilski, and Alice, “wherethe claimed computer-automated process and theprior [uncomputerized] method were carried out inthe same way.” 837 F.3d at 1314-15, 120 USPQ2d

at 1102 The court relied on the specification'sexplanation of how the claimed rules enabled theautomation of specific animation tasks thatpreviously could not be automated. 837 F.3d at 1313,120 USPQ2d at 1101. The McRO court indicatedthat the incorporation of the particular claimed rulesin computer animation "improved [the] existingtechnological process", rather than merely used thecomputer a "tool to automate conventional activity".837 F.3d at 1314, 120 USPQ2d at 1102. The McROcourt also noted that the claims at issue described aspecific way (use of particular rules to set morphweights and transitions through phonemes) to solvethe problem of producing accurate and realistic lipsynchronization and facial expressions in animatedcharacters and thus were not directed to an abstractidea. 837 F.3d at 1313, 120 USPQ2d at 1101.

• In Visual Memory, LLC v. NVIDIA Corp.,867 F.3d 1253, 1254, 123 USPQ2d 1712, 1713 (Fed.Cir. 2017), the Federal Circuit concluded that claimsto an enhanced computer memory system were notdirected to an abstract idea. The basis for the court’sdecision was that the claims focused on a specificasserted improvement in computer capabilities (theuse of programmable operational characteristics thatare configurable based on the type of processor) andthus were not directed to the abstract idea ofcategorical data storage. 867 F.2d at 1259-60, 123USPQ2d at 1717. The court also relied on thespecification’s explanation of the multiple benefitsflowing from the claimed memory system, such asthe claimed system’s outperformance of prior artmemory systems and the disclosure of how theclaimed system can be used with different types ofprocessors without a tradeoff in processorperformance. 867 F.2d at 1259, 123 USPQ2d at1717.

When finding that a claim is directed to such animprovement, it is critical that examiners give theclaim its broadest reasonable interpretation (BRI)and evaluate both the specification and the claim.The specification should disclose sufficient detailssuch that one of ordinary skill in the art wouldrecognize the claimed invention as providing animprovement, and the claim itself must reflect theimprovement in technology. Other importantconsiderations are the extent to which the claimcovers a particular solution to a problem or aparticular way to achieve a desired outcome, as

2100-24Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.04(a)

opposed to merely claiming the idea of a solution oroutcome, and whether the BRI is limited to computerimplementation. See MPEP § 2106.05(a) for moreinformation about these principles, and how todetermine whether a claim improves the functioningof a computer or any other technology or technicalfield.

Examiners should also consult MPEP § 2106.05(a)for a discussion of cases in which the Federal Circuitdetermined that the claims did not reflect animprovement to computer-functionality or othertechnology. For instance, if a claimed process canbe performed without a computer, the Federal Circuithas indicated that it cannot improve computertechnology. Synopsys, Inc. v. Mentor GraphicsCorp., 839 F.3d 1138, 1139, 120 USPQ2d 1473(Fed. Cir. 2016) (a method of translating a logiccircuit into a hardware component description of alogic circuit “cannot be characterized as animprovement in a computer” because the methoddid not employ a computer and a skilled artisan couldperform all the steps mentally). The Federal Circuithas also indicated that mere automation of manualprocesses or increasing the speed of a process wherethese purported improvements come solely from thecapabilities of a general-purpose computer are notsufficient to show an improvement incomputer-functionality. FairWarning IP, LLC v.Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293,1296 (Fed. Cir. 2016); Credit Acceptance Corp. v.Westlake Services, 859 F.3d 1044, 1055, 123USPQ2d 1100, 1108-09 (Fed. Cir. 2017). Similarly,the Federal Circuit has indicated that a claim mustinclude more than conventional implementation ongeneric components or machinery to qualify as animprovement to an existing technology. See, e.g., Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d1253, 1264-65, 120 USPQ2d 1201, 1208-09 (Fed.Cir. 2016); TLI Communications LLC v. AV Auto.LLC, 823 F.3d 607, 612-13, 118 USPQ2d 1744,1747-48 (Fed. Cir. 2016). See MPEP § 2106.05(a)for further discussion of these cases, and additionalexamples of what the courts have indicated does anddoes not show an improvement tocomputer-functionality or other technology.

Although the question of whether a claim improvescomputer-functionality or other technology may beconsidered in either step of the Alice/Mayo test (Step

2A or 2B), examiners are encouraged to resolve thisquestion as early as possible in the eligibilityanalysis. For instance, a claim that is directed to aclear improvement in computer-related technologylike Enfish could be found eligible at Pathway Aunder the streamlined analysis discussed in MPEP§ 2106.06(b) or at Pathway B as not being directedto an abstract idea. Other claims may require the fulleligibility analysis, for example a claim that isdirected to an abstract idea rather than animprovement should be evaluated in Step 2B todetermine whether it amounts to significantly morethan the abstract idea. Examiners are reminded thateven if an improvement is not clear enough todemonstrate eligibility in Step 2A, it may stillcontribute to the eligibility of a claim in the Step 2Banalysis. Cf. Amdocs (Israel), Ltd. v. OpenetTelecom, Inc., 841 F.3d 1288, 1300-01, 120 USPQ2d1527, 1536-37 (Fed. Cir. 2016) (explaining that evenif the claims were considered to be directed toabstract ideas and not improvements, the claims wereeligible in Step 2B because the claimed improvementof a distributed network architecture operating in anunconventional fashion to reduce network congestionwhile generating networking accounting data recordsamounted to an inventive concept).

II. MORE INFORMATION ON CLAIMS THATARE, AND ARE NOT, DIRECTED TO ABSTRACTIDEAS

MPEP § 2106.04(a)(1) provides more informationabout claims that are not directed to abstract ideas(or other judicial exceptions) and thus are eligibleat Step 2A. These claims include claims that do notrecite abstract ideas, as well as claims that reciteabstract ideas but that are, when viewed as a whole,directed to an improvement of a technologicalprocess or the functioning of a computer and not toan abstract idea. See, e.g., McRO, 837 F.3d at 1315,120 USPQ2d at 1102-103 (claims to automatic lipsynchronization and facial expression animationwere directed to an improvement in computer-relatedtechnology); Enfish, 822 F.3d at 1336, 118 USPQ2dat 1689 (claims to self-referential table for acomputer database were directed to a specificimprovement to the way computers operate and notan abstract idea). Thus, examiners should considerthe principles discussed in MPEP § 2106.04(a)(1)

Rev. 08.2017, January 20182100-25


and MPEP § 2106.05(a) before making a conclusionas to whether a claim is directed to an abstract idea.

MPEP § 2106.04(a)(2) provides more informationabout the types of concepts the courts haveconsidered to be abstract ideas by associatingconcepts discussed in exemplary Supreme Court andFederal Circuit eligibility decisions with judicialdescriptors (e.g., “fundamental economic practices”)based on common characteristics. (e.g., “fundamentaleconomic practices”) described in exemplarySupreme Court and Federal Circuit eligibilitydecisions. It should be noted that these associationsare not mutually exclusive, i.e., some concepts maybe associated with more than one judicial descriptor.For example, the concept of hedging claimed in Bilski was described by the Supreme Court as botha method of organizing human activity and afundamental economic practice. Alice Corp., 134S. Ct. at 2356-57, 110 USPQ2d at 1982. Similarly,in Ultramercial, the Federal Circuit called theclaimed steps of displaying an advertisement inexchange for access to copyrighted media an “idea,”but this concept could also be considered organizinghuman activity because the claim describesadvertising. Ultramercial, Inc. v. Hulu, LLC, 772F.3d 709, 715, 112 USPQ2d 1750, 1754 (Fed. Cir.2014). Accordingly, examiners should rely on theconcepts identified in the cases, not the judicialdescriptors themselves, when determining whethera claimed concept is similar to a concept that thecourts have identified as an abstract idea.

2106.04(a)(1) Examples of Claims That AreNot Directed To Abstract Ideas [R-08.2017]

When evaluating a claim to determine whether itrecites an abstract idea, examiners should keep inmind that while “all inventions at some levelembody, use, reflect, rest upon, or apply laws ofnature, natural phenomenon, or abstract ideas”, notall claims are directed to an abstract idea. AliceCorp., 134 S. Ct. at 2354-55, 110 USPQ2d at1980-81 (citing Mayo, 566 US at 71, 101 USPQ2dat 1965). The Step 2A analysis articulated in MPEP§ 2106.04 accounts for this cautionary principle byrequiring a claim to recite (i.e., set forth or describe)an abstract idea in order to be directed to that idea,thereby separating claims reciting abstract ideas from

those that are merely based on or involve an abstractidea.

Before concluding that a claim is directed to anabstract idea, examiners should consider thefollowing principles, which are discussed withreference to non-limiting hypothetical examples ofclaims that are not directed to abstract ideas.

I. IF A CLAIM IS BASED ON OR INVOLVES ANABSTRACT IDEA, BUT DOES NOT RECITE IT,THEN THE CLAIM IS NOT DIRECTED TO ANABSTRACT IDEA

Some claims are not directed to an abstract ideabecause they do not recite anything similar to ajudicially-identified abstract idea, although it maybe apparent that at some level they are based on orinvolve an abstract idea.

Judicial decisions discussing such claims include Enfish, LLC v. Microsoft Corp., 822 F.3d 1327,1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016)(claims to self-referential table for a computerdatabase were based on, but not directed to, theconcept of organizing information using tabularformats), DDR Holdings, LLC v. Hotels.com, L.P.,773 F.3d 1245, 1258-59, 113 USPQ2d 1097,1106-07 (Fed. Cir. 2014) (claim to system that isprogrammed to modify conventional Internethyperlink protocol to dynamically produce adual-source hybrid webpage is not directed to anabstract idea because it does not recite an idea similarto those previously found by the courts to beabstract), and Trading Techs. Int’l, Inc. v. CQG,Inc., 675 Fed. App'x 1001 (Fed. Cir. 2017)(non-precedential) (claimed graphical user interfacethat improves the accuracy of trader transactions bydisplaying bid and asked prices in a particularmanner that prevents order entry at a changed priceis not directed to an abstract idea).

Non-limiting hypothetical examples of claims thatdo not set forth or describe an abstract idea include:

i. a printer comprising a belt, a roller, a printheadand at least one ink cartridge;

ii. a washing machine comprising a tub, a drivemotor operatively connected to the tub, a controller

2100-26Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.04(a)(1)

for controlling the drive motor, and a housing forcontaining the tub, drive motor, and controller;

iii. an earring comprising a sensor for takingperiodic blood glucose measurements and a memoryfor storing measurement data from the sensor;

iv. a method for sequencing BRCA1 genesequences comprising: amplifying by apolymerization chain reaction technique all or partof a BRCA1 gene from a tissue sample from ahuman subject using a set of primers to produceamplified nucleic acids; and sequencing theamplified nucleic acids; and

v. a method for loading BIOS into a localcomputer system which has a system processor andvolatile memory and non-volatile memory, themethod comprising the steps of: responding topowering up of the local computer system byrequesting from a memory location remote from thelocal computer system the transfer to and storage inthe volatile memory of the local computer systemof BIOS configured for effective use of the localcomputer system, transferring and storing suchBIOS, and transferring control of the local computersystem to such BIOS.

II. IF A CLAIM RECITES AN ABSTRACT IDEA,BUT THE CLAIM AS A WHOLE IS DIRECTED TOAN IMPROVEMENT OR OTHERWISE CLEARLYDOES NOT SEEK TO TIE UP THE ABSTRACTIDEA, THEN THE CLAIM IS NOT DIRECTED TOAN ABSTRACT IDEA

Some claims reciting an abstract idea are not directedto the abstract idea because they also reciteadditional elements (such as an improvement)demonstrating that the claims as a whole clearly donot seek to tie up the abstract idea. In such claims,the improvement, or other additional elements, shiftsthe focus of the claimed invention from the abstractidea that is incidentally recited. The types ofimprovements that the courts have identified asindicative of eligibility in the first step of the Alice/Mayo test (Step 2A) are discussed in MPEP§ 2106.05(a) and MPEP § 2106.06(b).

Judicial decisions discussing such claims include McRO, Inc. v. Bandai Namco Games America Inc.,837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-103(Fed. Cir. 2016) (claims to automatic lipsynchronization and facial expression animation are

directed to an improvement in computer-relatedtechnology and not to an abstract idea), and Enfish,822 F.3d at 1336, 118 USPQ2d at 1689 (claims toself-referential table for a computer database weredirected to a specific improvement to the waycomputers operate and not an abstract idea). Anotherrelevant case is Research Corporation TechnologiesInc. v. Microsoft Corp., 627 F.3d 859, 97 USPQ2d1274 (Fed. Cir. 2010), which discussed claims tohalftone rendering of a gray scale image using a bluenoise mask. While the claims in ResearchCorportation Technologies recited a step ofgenerating the blue noise mask (an iterativemathematical operation that is an abstract idea), theyalso recited additional steps that clearly improvedthe functioning of the claimed computer. 627 F.3dat 865, 868-69, 97 USPQ2d at 1278, 1280-81. Thusviewed in light of McRO and Enfish the claims aredirected to the recited improvement and not to theabstract idea.

Non-limiting hypothetical examples of claims thatare not directed to an abstract idea because of animprovement or other limitation that renders theeligibility of the claim self-evident include:

i. a method of cutting a blood vessel withsurgical shears having a surgical blade, an armhaving a cutting surface, and a pressure regulatorthat is designed to limit the force applied on thecutting surface to less than 45 psi, comprising:positioning a blood vessel between the surgical bladeand the cutting surface, and applying pressure to thearm so that it closes toward the blade, whereby thepressure regulator limits the applied force so that theblood vessel is cut cleanly;

ii. a robotic arm assembly comprising: a roboticarm having an end effector that is capable ofmovement along a predetermined motion path, asensor that obtains movement information about theend effector, and a control system that uses themovement information from the sensor to adjust thevelocity of the end effector in order to achieve asmooth motion along the predetermined motion path;

iii. an autofocus camera system comprising alens that forms an image, an image sensor forcapturing data from the formed image, a processorthat analyzes the captured data using an autofocusalgorithm to determine an optimal position for the

Rev. 08.2017, January 20182100-27

§ 2106.04(a)(1)PATENTABILITY

lens, and a drive mechanism that moves the lens intothe optimal position; and

iv. an internal combustion engine providingexhaust gas recirculation comprising: an air intakemanifold; an exhaust manifold; a combustionchamber to receive air from the air intake manifold,combust a combination of the received air and fuelto turn a drive shaft, and output resulting exhaustgas to the exhaust manifold; a throttle position sensorto detect the position of an engine throttle; an exhaustgas recirculation valve to regulate the flow ofexhaust gas from the exhaust manifold to the airintake manifold; and a control system, comprisinga processor and memory, to receive the enginethrottle position from the throttle position sensor,calculate a position of the exhaust gas recirculationvalve based upon the rate of change of the enginethrottle position and change the position of theexhaust gas recirculation valve to the calculatedposition.

2106.04(a)(2) Examples of Concepts TheCourts Have Identified As Abstract Ideas[R-08.2017]

I. "FUNDAMENTAL ECONOMIC PRACTICES"

The courts have used the phrases “fundamentaleconomic practices” or “fundamental economicconcepts” to describe concepts relating to theeconomy and commerce, such as agreementsbetween people in the form of contracts, legalobligations, and business relations. The term“fundamental” is used in the sense of beingfoundational or basic, and not in the sense ofnecessarily being “old” or “well-known.” See, e.g.,In re Smith, 815 F.3d 816, 818-19, 118 USPQ2d1245, 1247 (Fed. Cir. 2016) (describing a new setof rules for conducting a wagering game as a“fundamental economic practice”).

A. Concepts relating to agreements between peopleor performance of financial transactions

An example of a case identifying a concept relatingto performance of a financial transaction as abstractis buySAFE, Inc. v. Google, Inc., 765 F.3d. 1350,112 USPQ2d 1093 (Fed. Cir. 2014). The patenteein buySAFE claimed a method in which a computeroperated by the provider of a safe transaction service

receives a request for a performance guarantee foran online commercial transaction, the computerprocesses the request by underwriting the requestingparty in order to provide the transaction guaranteeservice, and the computer offers, via a computernetwork, a transaction guaranty that binds to thetransaction upon the closing of the transaction. 765F.3d at 1351-52, 112 USPQ2d at 1094. The FederalCircuit described the claims as directed to an abstractidea because they were “squarely about creating acontractual relationship--a ‘transaction performanceguaranty’.” 765 F.3d at 1355, 112 USPQ2d at 1096.

Another example is OIP Techs., Inc. v. Amazon.com,Inc., 788 F.3d 1359, 115 USPQ2d 1090 (Fed. Cir.2015). The patentee in OIP Techs. claimed methodsof pricing a product for sale comprising testing aplurality of prices, gathering statistics generatedabout how customers reacted to the offers testingthe prices, using that data to estimate outcomes (i.e.,mapping the demand curve over time for a givenproduct), and automatically selecting and offeringa new price based on the estimated outcome. 788F.3d at 1362, 115 USPQ2d at 1092. Citing Alice, Bilski, Ultramercial, and several otherdecisions, the Federal Circuit determined that theseclaims were directed to the concept of “offer-basedprice optimization, which was similar to other‘fundamental economic concepts’ found to beabstract ideas by the Supreme Court and this court.”788 F.3d at 1363, USPQ2d at 1092-93.

Other examples of this type of concept include:

i. hedging, Bilski v. Kappos, 561 U.S. 593, 609,95 USPQ2d 1001, 1009 (2010);

ii. processing an application for financing apurchase, Credit Acceptance Corp. v. WestlakeServices, 859 F.3d 1044, 1054, 123 USPQ2d 1100,1108 (Fed. Cir. 2017); and

iii. rules for conducting a wagering game, In reSmith, 815 F.3d 816, 818-19, 118 USPQ2d 1245,1247 (Fed. Cir. 2016).

B. Concepts relating to mitigating risks

An example of a case identifying a concept relatingto mitigating risk as abstract is Alice Corp. v. CLSBank, 134 S. Ct. 2347, 110 USPQ2d 1976 (2014).The patentee in Alice Corp. claimed a computerized

2100-28Rev. 08.2017, January 2018


scheme for mitigating “settlement risk”, i.e., therisk that only one party to an agreed-upon financialexchange will satisfy its obligation. 134 S. Ct. at2351-52, 110 USPQ2d at 1978-79. A computersystem is used as a third-party intermediary betweenthe parties to the exchange. The intermediary creates“shadow” credit and debit records (i.e., accountledgers) that mirror the balances in the parties’real-world accounts at “exchange institutions” (e.g.,banks). The intermediary updates the shadow recordsin real time as transactions are entered, allowingonly those transactions for which the parties’ updatedshadow records indicate sufficient resources tosatisfy their mutual obligations. At the end of theday, the intermediary instructs the relevant financialinstitutions to carry out the “permitted” transactionsin accordance with the updated shadow records, thusmitigating the risk that only one party will performthe agreed-upon exchange. 134 S. Ct. at 2356, 110USPQ2d at 1979. The Supreme Court determinedthat these claims were directed to the “abstract ideaof intermediated settlement”, which is “a buildingblock of the modern economy” and a “fundamentaleconomic practice long prevalent in our system ofcommerce” like the risk hedging in Bilski. 134 S.Ct. at 2355-56, 110 USPQ2d at 1982.


i. hedging, Bilski v. Kappos, 561 U.S. 593, 609,95 USPQ2d 1001, 1009 (2010); and

ii. financial instruments that are designed toprotect against the risk of investing in financialinstruments, In re Chorna, 656 Fed. App'x 1016,1021 (Fed. Cir. 2016) (non-precedential).

II. "CERTAIN METHODS OF ORGANIZINGHUMAN ACTIVITY"

The court have used the phrase “methods oforganizing human activity” to describe conceptsrelating to interpersonal and intrapersonal activities,such as managing relationships or transactionsbetween people, social activities, and humanbehavior; satisfying or avoiding a legal obligation;advertising, marketing, and sales activities orbehaviors; and managing human mental activity.The term “certain” qualifies this category descriptionas a reminder that (1) not all methods of organizinghuman activity are abstract ideas, and (2) this

category description does not cover human operationof machines.

A. Concepts relating to managing relationships ortransactions between people, or satisfying or avoidinga legal obligation

An example of a case identifying a concept relatingto managing relationships or transactions betweenpeople, or satisfying or avoiding a legal obligationas abstract is buySAFE, Inc. v. Google, Inc., 765F.3d. 1350, 112 USPQ2d 1093 (Fed. Cir. 2014). Thepatentee in buySAFE claimed a method in which acomputer operated by the provider of a safetransaction service receives a request for aperformance guarantee for an online commercialtransaction, the computer processes the request byunderwriting the requesting party in order to providethe transaction guarantee service, and the computeroffers, via a computer network, a transactionguaranty that binds to the transaction upon theclosing of the transaction. 765 F.3d at 1351-52, 112USPQ2d at 1094. The Federal Circuit described theclaims as directed to an abstract idea because theywere “squarely about creating a contractualrelationship--a ‘transaction performance guaranty’”.765 F.3d at 1355, 112 USPQ2d at 1096.

Another example is Dealertrack v. Huber, 674 F.3d1315, 101 USPQ2d 1325 (Fed. Cir. 2012). Thepatentee in Dealertrack claimed processes ofmanaging a credit application, comprising receivingcredit application data from a first source, selectivelyforwarding the credit application data to remotefunding sources, and then forwarding fundingdecision data from a remote funding source back tothe first source. 674 F.3d at 1331, 101 USPQ2d at1338. The Federal Circuit described the claims asdirected to an abstract idea or “basic concept” ofprocessing information through a clearing-house”like the hedging concept of Bilski. 674 F.3d at 1333,101 USPQ2d at 1339.

And another example is Bancorp Services., L.L.C.v. Sun Life Assurance Co. of Canada (U.S.), 687F.3d 1266, 103 USPQ2d 1425 (Fed. Cir. 2012). Thepatentee in Bancorp claimed methods and systemsfor managing a life insurance policy on behalf of apolicy holder, which comprised steps includinggenerating a life insurance policy including a stable

Rev. 08.2017, January 20182100-29


value protected investment with an initial valuebased on a value of underlying securities, calculatingsurrender value protected investment credits for thelife insurance policy; determining an investmentvalue and a value of the underlying securities for thecurrent day; and calculating a policy value and apolicy unit value for the current day. 687 F.3d at1270-71, 103 USPQ2d at 1427. The court describedthe claims as an “attempt to patent the use of theabstract idea of [managing a stable value protectedlife insurance policy] and then instruct the use ofwell-known [calculations] to help establish some ofthe inputs into the equation.” 687 F.3d at 1278, 103USPQ2d at 1433 (alterations in original) (citing Bilski).


i. arbitration, In re Comiskey, 554 F.3d 967,981, 89 USPQ2d 1655, 1665 (Fed. Cir. 2009);

ii. generating menus on a computer, Apple, Inc.v. Ameranth, Inc., 842 F.3d 1229, 1234, 120USPQ2d 1844, 1848 (Fed. Cir. 2016);

iii. generating rule-based tasks for processingan insurance claim, Accenture Global Services v.Guidewire Software, Inc., 728 F.3d 1336, 1338-39,108 USPQ2d 1173, 1175-76 (Fed. Cir. 2013);

iv. hedging, Bilski v. Kappos, 561 U.S. 593,595, 95 USPQ2d 1001, 1004 (2010);

v. mitigating settlement risk, Alice Corp. Pty.Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2352, 110USPQ2d 1976, 1979 (2014); and

vi. tax-free investing, Fort Props., Inc. v. Am.Master Lease, LLC, 671 F.3d 1317, 1322, 101USPQ2d 1785, 1788-89 (Fed. Cir. 2012).

B. Concepts relating to advertising, marketing, andsales activities or behaviors

An example of a case identifying a concept relatingto advertising, marketing, and sales activities orbehaviors as abstract is Apple, Inc. v. Ameranth,Inc., 842 F.3d 1229, 120 USPQ2d 1844 (Fed. Cir.2016). The patentee in Ameranth claimed a systemfor generating and transmitting menus, e.g., a systemcomprising a central processing unit, data storagedevice on which several menus are stored, anoperating system including a graphical user interface,and application software for generating a second

menu from the first menu, and transmitting thesecond menu to a wireless device or webpage. 842F.3d. at 1234, 120 USPQ2d at 1848. The FederalCircuit determined that the claims are directed to anabstract idea, which could be described as“generating menus …, or generating a second menufrom a first menu and sending the second menu toanother location [, or] taking orders from restaurantcustomers.” 842 F.3d. at 1240-41, 120 USPQ2d at1853. The court also described the claimed inventionas adding conventional computer components towell-known business practices, e.g., “a restaurantpreparing a device that can be used by a server takingorders from a customer.” 842 F.3d at 1242; 120USPQ2d at 1855.


i. structuring a sales force or marketingcompany, In re Ferguson, 558 F.3d 1359, 1364, 90USPQ2d 1035, 1038 (Fed. Cir. 2009);

ii. using advertising as an exchange or currency, Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715,112 USPQ2d 1750 (Fed. Cir. 2014); and

iii. using an algorithm for determining theoptimal number of visits by a business representativeto a client, In re Maucorps, 609 F.2d 481, 485, 203USPQ 812, 816 (CCPA 1979).

C. Concepts relating to managing human behavior

An example of a case identifying a concept relatingto managing human behavior as abstract is Intellectual Ventures I LLC v. Capital One Bank(USA), 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir.2015). The patentee in this case claimed methodscomprising storing user-selected pre-set limits onspending in a database, and when one of the limitsis reached, communicating a notification to the uservia a device. 792 F.3d. at 1367, 115 USPQ2d at1639-40. The Federal Circuit determined that theclaims were directed to the abstract idea of “trackingfinancial transactions to determine whether theyexceed a pre-set spending limit (i.e., budgeting)”,which “is not meaningfully different from the ideasfound to be abstract in other cases before theSupreme Court and our court involving methods oforganizing human activity.” 792 F.3d. at 1367-68,115 USPQ2d at 1640.

2100-30Rev. 08.2017, January 2018


Another example of this type of concept includes:

i. filtering content – BASCOM Global Internetv. AT&T Mobility, LLC, 827 F.3d 1341, 1345-46,119 USPQ2d 1236, 1239 (Fed. Cir. 2016) (findingthat filtering content was an abstract idea under step2A, but reversing an invalidity judgment ofineligibility due to an inadequate step 2B analysis);and

ii. a mental process that a neurologist shouldfollow when testing a patient for nervous systemmalfunctions, In re Meyer, 688 F.2d 789, 791-93,215 USPQ 193, 194-96 (CCPA 1982).

D. Concepts relating to tracking or organizinginformation

An example of a case identifying a concept relatingto tracking or organizing information as abstract is BASCOM Global Internet v. AT&T Mobility, LLC,827 F.3d 1341, 119 USPQ2d 1236 (Fed. Cir. 2016).The patentee in BASCOM claimed a system forfiltering content retrieved from an Internet computernetwork, comprising a local client computer and aremote ISP server that implements at least onefiltering scheme and a plurality of sets of logicalfiltering elements. 827 F.3d. at 1346, 119 USPQ2dat 1239. The Federal Circuit described the conceptof filtering content as an abstract idea and a “methodof organizing human behavior, similar to conceptspreviously found to be abstract.” 827 F.3d. at 1348,119 USPQ2d at 1241.

Another example is Intellectual Ventures I LLC v.Capital One Bank (USA), 792 F.3d 1363, 115USPQ2d 1636 (Fed. Cir. 2015). The patentee in thiscase claimed a system for providing web pagestailored to an individual user, comprising aninteractive interface having a display that depictscustomized content based on (1) information knownabout the user and (2) navigation data. 792 F.3d. at1369, 115 USPQ2d at 1641. The Federal Circuitdetermined that both types of customization wereabstract ideas. The court described the first type ofcustomization (tailoring content based on userinformation) as similar to how “newspaper insertshad often been tailored based on information knownabout the customer--for example, a newspaper mightadvertise based on the customer's location,” and thesecond type of customization (tailoring information

based on the time of day the website was visited) assimilar to how “a television channel might chooseto present a commercial for children's toys duringearly morning cartoon programs but beer during anevening sporting event.” 792 F.3d. at 1369-70, 115USPQ2d at 1641.


i. classifying and storing digital images in anorganized manner, TLI Communications, LLC v.AV Auto., LLC, 823 F.3d 607, 611-12, 118 USPQ2d1744, 1747 (Fed. Cir. 2016);

ii. collecting information, analyzing it, anddisplaying certain results of the collection andanalysis, Electric Power Group, LLC v. Alstom,S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739,1740 (Fed. Cir. 2016);

iii. encoding and decoding image data – RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322,1326, 122 USPQ2d 1377, 1379 (Fed. Cir. 2017);

iv. organizing information through mathematicalcorrelations, Digitech Image Techs., LLC v.Electronics for Imaging, Inc., 758 F.3d 1344, 1349,111 USPQ2d 1717, 1720 (Fed. Cir. 2014); and

v. receiving, screening, and distributing email, Intellectual Ventures I LLC v. Symantec Corp., 838F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed.Cir. 2016).

III. "AN IDEA 'OF ITSELF'"

The courts have used the phrase “an idea ‘of itself’”to describe an idea standing alone such as anuninstantiated concept, plan or scheme, as well as amental process (thinking) that “can be performed inthe human mind, or by a human using a pen andpaper.” CyberSource Corp. v. Retail Decisions, Inc.,654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed.Cir. 2011). As the Federal Circuit explained,“methods which can be performed mentally, orwhich are the equivalent of human mental work, areunpatentable abstract ideas--the ‘basic tools ofscientific and technological work’ that are open toall.’” 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673(1972)). “Courts have examined claims that requiredthe use of a computer and still found that theunderlying, patent-ineligible invention could be

Rev. 08.2017, January 20182100-31


performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir.2015).

In Electric Power Group, the Federal Circuitexplained that concepts of collecting and analyzinginformation fall within the “realm of abstract ideas”because information is intangible:

Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S.437, 451 n.12 (2007); Bayer AG v. HouseyPharm., Inc., 340 F.3d 1367, 1372 (Fed. Cir.2003). Accordingly, we have treated collectinginformation, including when limited toparticular content (which does not change itscharacter as information), as within the realmof abstract ideas. See, e.g., Internet Patents,790 F.3d at 1349; OIP Techs., Inc. v.Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed.Cir. 2015); Content Extraction & TransmissionLLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d1343, 1347 (Fed. Cir. 2014); Digitech ImageTechs., LLC v. Elecs. for Imaging, Inc., 758F.3d 1344, 1351 (Fed. Cir. 2014); CyberSourceCorp. v. Retail Decisions, Inc., 654 F.3d 1366,1370 (Fed. Cir. 2011). In a similar vein, wehave treated analyzing information by stepspeople go through in their minds, or bymathematical algorithms, without more, asessentially mental processes within theabstract-idea category. See, e.g., TLICommc’ns, 823 F.3d at 613; Digitech, 758 F.3dat 1351; SmartGene, Inc. v. AdvancedBiological Labs., SA, 555 F. App’x 950, 955(Fed. Cir. 2014); Bancorp Servs., L.L.C. v. SunLife Assurance Co. of Canada (U.S.), 687 F.3d1266, 1278 (Fed. Cir. 2012); CyberSourceCorp. v. Retail Decisions, Inc., 654 F.3d 1366,1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’lTrade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir.2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972).And we have recognized that merely presentingthe results of abstract processes of collectingand analyzing information, without more (suchas identifying a particular tool for presentation),is abstract as an ancillary part of such collection

and analysis. See, e.g., Content Extraction,776 F.3d at 1347; Ultramercial, Inc. v. Hulu,LLC, 772 F.3d 709, 715 (Fed. Cir. 2014).

Electric Power Group, LLC v. Alstom, S.A., 830F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42(Fed. Cir. 2016).

A. Concepts relating to data comparisons that can beperformed mentally or are analogous to human mentalwork

An example of a case identifying a concept relatingto a data comparison that can be performed mentallyas abstract is CyberSource Corp. v. Retail Decisions,654 F.3d 1366, 99 USPQ2d 1690 (Fed. Cir. 2011).The patentee in CyberSource claimed a method forverifying the validity of a credit card transactionover the Internet, and a computer-readable mediumcomprising program instructions for performing themethod. The method comprised obtaininginformation about other transactions that haveutilized an Internet address identified with the creditcard transaction to be verified, constructing a mapof credit card numbers based on the othertransactions, and utilizing the map to determine ifthe credit card transaction is valid. 654 F.3d at1367-68, 99 USPQ2d at 1692. Although the patenteeargued that the method could not be performedwithout the Internet, nothing in the claim requireduse of the Internet to obtain the data (as opposed toobtaining the data from a pre-compiled database).654 F.3d at 1370, 99 USPQ2d at 1693. The courttherefore concluded that the method could beperformed in the human mind, or by a human usinga pen and paper, and that the claim was thereforedirected to a mental process of “obtain[ing] andcompar[ing] intangible data pertinent to businessrisks.” 654 F.3d at 1370 and 1372, 99 USPQ2d at1694 and 1695.

Another example is University of Utah ResearchFoundation v. Ambry Genetics, 774 F.3d 755, 113USPQ2d 1241 (Fed. Cir. 2014). The patentee in Ambry Genetics claimed methods of screening ahuman’s genome for an altered BRCA gene,comprising comparing the sequence of the human’sBRCA gene with the sequence of the wild-type gene,and identifying any differences that arise. 774 F.3dat 763-764, 113 USPQ2d at 1246. The Federal

2100-32Rev. 08.2017, January 2018


Circuit determined that these claims were directedto the concept of “comparing BRCA sequences anddetermining the existence of alterations”, which wasan “abstract mental process”. Id.

An example of a case identifying a concept relatingto a data comparison that is analogous to humanmental work as abstract is Mortgage Grader, Inc.v. First Choice Loan Servs., 811 F.3d. 1314, 1324,117 USPQ2d 1693, 1699 (Fed. Cir. 2015). Thepatentee in Mortgage Grader claimed acomputer-implemented system for enablingborrowers to anonymously shop for loan packagesoffered by a plurality of lenders, comprising adatabase that stores loan package data from thelenders, and a computer system providing aninterface and a grading module. The interfaceprompts a borrower to enter personal information,which the grading module uses to calculate theborrower’s credit grading, and allows the borrowerto identify and compare loan packages in thedatabase using the credit grading. 811 F.3d. at 1318,117 USPQ2d at 1695. The Federal Circuitdetermined that these claims were directed to theconcept of “anonymous loan shopping”, which wasa concept that could be “performed by humanswithout a computer.” 811 F.3d. at 1324, 117USPQ2d at 1699.


i. collecting and comparing known information, Classen Immunotherapies, Inc. v. Biogen IDEC,659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed.Cir. 2011); and

ii. diagnosing an abnormal condition byperforming clinical tests and analyzing the results, In re Grams, 888 F.2d 835, 840, 12 USPQ2d 1824,1828 (Fed. Cir. 1989); see CyberSource, 654 F.3dat 1372 n.2, 99 USPQ2d at 1695 n.2 (describing theabstract idea in Grams).

B. Concepts relating to organizing or analyzinginformation in a way that can be performed mentally oris analogous to human mental work

An example of a case identifying a concept relatingto organizing or analyzing information in a way thatcan be performed mentally as abstract is Synopsys,Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120

USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, thepatentee claimed methods of logic circuit design,comprising converting a functional description of alevel sensitive latch into a hardware componentdescription of the latch. 839 F.3d at 1140; 120USPQ2d at 1475. Although the patentee argued thatthe claims were intended to be used in conjunctionwith computer-based design tools, the claims didnot include any limitations requiring computerimplementation of the methods and thus do notinvolve the use of a computer in any way. 839 F.3dat 1145; 120 USPQ2d at 1478-79. The courttherefore concluded that the claims “read on anindividual performing the claimed steps mentally orwith pencil and paper,” and were directed to a mentalprocess of “translating a functional description of alogic circuit into a hardware component descriptionof the logic circuit.” 839 F.3d at 1149-50; 120USPQ2d at 1482-83.

An example of a case identifying a concept relatingto organizing or analyzing information in a way thatis analogous to human mental work as abstract is Content Extraction and Transmission LLC v. WellsFargo Bank, N.A., 776 F.3d 1343, 113 USPQ2d 1354(Fed. Cir. 2014). In Content Extraction, the patenteeclaimed an application program interface comprisinga scanner that extracted data from hard copydocuments, a processor that recognized specificinformation from the extracted data, and a memorythat stored the recognized information. 776 F.3d at1345, 113 USPQ2d at 1356. The court determinedthat these claims were directed to the basic conceptof “data collection, recognition and storage”, statingthat humans have always performed these functionsand that banks have for some time reviewed checks,recognized relevant data such as the amount, accountnumber, and identity of the account holder, andstored that information in their records. 776 F.3d at1347, 113 USPQ2d at 1358. The patentee arguedthat “its claims are not drawn to an abstract ideabecause human minds are unable to process andrecognize the stream of bits output by a scanner”,but the court was unpersuaded, stating that “theclaims in Alice also required a computer thatprocessed streams of bits, but nonetheless werefound to be abstract.” Id. (citing Alice Corp., 134S. Ct. at 2358, 110 USPQ2d at 1983).

Rev. 08.2017, January 20182100-33


Another example is FairWarning IP, LLC v. IatricSys., Inc., 839 F.3d 1089, 120 USPQ2d 1293 (Fed.Cir. 2016). The patentee in FairWarning claimed asystem and method of detecting fraud and/or misusein a computer environment, comprising collectinginformation regarding accesses of a patient’spersonal health information, analyzing theinformation according to one of several rules (i.e.,related to accesses in excess of a specific volume,accesses during a pre-determined time interval, oraccesses by a specific user) to determine if theactivity indicates improper access, and providingnotification if it determines that improper access hasoccurred. 839 F.3d. at 1092, 120 USPQ2d at 1294.The court determined that these claims were directedto the concept of “collecting and analyzinginformation to detect misuse and notifying a userwhen misuse is detected”. The court also noted thatthe claimed rules here were unlike those in McRObecause they “are the same questions (thoughperhaps phrased with different words) that humansin analogous situations detecting fraud have askedfor decades, if not centuries.” 839 F.3d. at 1094-95,120 USPQ2d at 1296.


i. collecting, displaying, and manipulating data, Intellectual Ventures I LLC v. Capital One Fin.Corp., 850 F.3d 1332, 1340, 121 USPQ2d 1940,1946 (Fed. Cir. 2017);

ii. collecting information, analyzing it, anddisplaying certain results of the collection andanalysis, Electric Power Group, LLC v. Alstom,S.A., 830 F.3d 1350, 1351, 119 USPQ2d 1739, 1739(Fed. Cir. 2016);

iii. creating an index, and using that index tosearch for and retrieve data, Intellectual Ventures ILLC v. Erie Indem. Co., 850 F.3d 1315, 1327, 121USPQ2d 1928, 1936 (Fed. Cir. 2017);

iv. determining a price, using organizational andproduct group hierarchies, Versata Dev. Group v.SAP Am., Inc., 793 F.3d 1306, 1312-13, 115USPQ2d 1681, 1685 (Fed. Cir. 2015);

v. encoding and decoding image data, RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322,1326, 122 USPQ2d 1377, 1379 (Fed. Cir. 2017);

vi. organizing information through mathematicalcorrelations, Digitech Image Techs., LLC v.

Electronics for Imaging, Inc., 758 F.3d 1344,1350-51, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014);

vii. relaying mailing address data – Return Mail,Inc. v. U.S. Postal Service, -- F.3d --, -- USPQ2d –,slip op. at 30-31 (Fed. Cir. August 28, 2017); and

viii. retaining information in the navigation ofonline forms, Internet Patents Corp. v. ActiveNetwork, Inc., 790 F.3d 1343, 1348, 115 USPQ2d1414, 1417-18 (Fed. Cir. 2015).

C. Concepts described as ideas having no particularconcrete or tangible form

An example of a case identifying a concept as anidea having no particular concrete or tangible formas abstract is Ultramercial, Inc. v. Hulu, LLC, 772F.3d 709, 112 USPQ2d 1750 (Fed. Cir. 2014). Thepatentee in Ultramercial claimed an eleven-stepmethod for displaying an advertisement (ad) inexchange for access to copyrighted media,comprising steps of receiving copyrighted media,selecting an ad, offering the media in exchange forwatching the selected ad, displaying the ad, allowingthe consumer access to the media, and receivingpayment from the sponsor of the ad. 772 F.3d. at715, 112 USPQ2d at 1754. The Federal Circuitdetermined that the “combination of steps recites anabstraction—an idea, having no particular concreteor tangible form” and thus was directed to an abstractidea, which the court described as “using advertisingas an exchange or currency.” Id.

Another example is Versata Dev. Group v. SAPAmerica, Inc., 793 F.3d 1306, 115 USPQ2d 1681(Fed. Cir. 2015). The patentee in Versata claimeda system and method for determining a price of aproduct offered to a purchasing organization,comprising arranging a hierarchy of organizationalgroups and a hierarchy of product groups, storingpricing information associated with theorganizational and product groups, retrieving andsorting applicable pricing information, anddetermining the product price using the sortedpricing information. 793 F.3d at 1312-13, 115USPQ2d at 1685. The Federal Circuit described theclaims as “directed to the abstract idea ofdetermining a price, using organizational and productgroup hierarchies, in the same way that the claimsin Alice were directed to the abstract idea ofintermediated settlement, and the claims in Bilski

2100-34Rev. 08.2017, January 2018


were directed to the abstract idea of risk hedging.”793 F.3d at 1333; 115 USPQ2d at 1700. The courtalso stated that that “[u]sing organizational andproduct group hierarchies to determine a price is anabstract idea that has no particular concrete ortangible form or application. It is a building block,a basic conceptual framework for organizinginformation”. 793 F.3d at 1333-34; 115 USPQ2d at1701.

Another example of this type of concept is In reBrown, 645 Fed. App'x 1014, 1017 (Fed. Cir. 2016)(non-precedential). The applicant in Brown claimeda method of cutting hair that effectively allocateshair weight in opposition to head shape, comprisingidentifying a head shape, designating the head intoat least three partial zones, identifying at least threehair patterns, assigning at least one of the hairpatterns to each partial zone to either build weightor remove weight, and using scissors to cut hairaccording to the assigned hair pattern. Id. at 1015.The Federal Circuit described the claims as directedto “the abstract idea of assigning hair designs tobalance head shape”, because “[i]dentifying headshape and applying hair designs accordingly is anabstract idea capable, as the Board notes, of beingperformed entirely in one’s mind.” Id. at 1016-17.

IV. “MATHEMATICALRELATIONSHIPS/FORMULAS”

The phrase “mathematical relationships/formulas”is used to describe mathematical concepts such asmathematical algorithms, mathematical relationships,mathematical formulas, and calculations. The courtshave used the term “algorithm” to refer to bothmathematical procedures and mathematical formulas,including: a procedure for converting binary-codeddecimal numerals into pure binary form, Gottschalkv. Benson, 409 U.S. 63, 65, 175 USPQ2d 673, 674(1972); a mathematical formula for calculating analarm limit, Parker v. Flook, 437 U.S. 584, 588-89,198 USPQ2d 193, 195 (1978); and a series of stepsfor analyzing clinical data to ascertain the existenceand identity of an medical abnormality, and possiblecauses thereof. In re Grams, 888 F.2d 835, 837 andn.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989)(“It is of no moment that the algorithm is notexpressed in terms of a mathematical formula. Words

used in a claim operating on data to solve a problemcan serve the same purpose as a formula.”).

In the past, the Supreme Court sometimes describedmathematical concepts as laws of nature, and at othertimes described these concepts as judicial exceptionswithout specifying a particular type of exception.See, e.g., Benson, 409 U.S. at 65, 175 USPQ2d at674; Flook, 437 U.S. at 589, 198 USPQ2d at 197.More recent opinions of the Supreme Court,however, have affirmatively characterizedmathematical relationships and formulas as abstractideas. See, e.g., Alice Corp. Pty. Ltd. V. CLS BankInt’l, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976,1981 (describing Flook as holding “that amathematical formula for computing ‘alarm limits’in a catalytic conversion process was also apatent-ineligible abstract idea.”); Bilski v. Kappos,561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010(noting that the claimed “concept of hedging,described in claim 1 and reduced to a mathematicalformula in claim 4, is an unpatentable abstract idea,just like the algorithms at issue in Benson and Flook.”).

A. Concepts relating to a mathematical relationshipor formula

An example of a case identifying a concept relatingto a mathematical relationship or formula as ajudicial exception is Diamond v. Diehr, 450 U.S.175, 209 USPQ 1 (1981). The applicant in Diehrclaimed a method of operating a rubber-moldingpress, comprising providing an activation energyconstant (C) unique to a particular batch of rubberto be molded and a constant (x) that is dependent onthe geometry of the mold being used, constantlydetermining the temperature (Z) of the mold once ithas closed, repetitively calculating the total cure time(v) using the Arrhenius equation (ln(v) = CZ+x) andcomparing the total cure time with the elapsed time,and opening the press automatically when thecomparison indicates equivalence. 450 U.S. at 178n. 2 and 179 n.5; 209 USPQ at 1052 n. 2 and 1053n.5. The Supreme Court noted that a mathematicalformula such as the claimed Arrhenius equation isan exception like a scientific principle or naturalphenomenon, is non-statutory subject matter (anexception). 450 U.S. at 191-92 and n.14; 209 USPQat 1059 and n. 14. See also Mayo Collaborative

Rev. 08.2017, January 20182100-35


Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71,101 USPQ2d 1961, 1965 (2012) (noting that Diehr“pointed out that the basic mathematical equation,like a law of nature, was not patentable”).


i. an algorithm for converting binary codeddecimal to pure binary, Benson, 409 U.S. at 64, 175USPQ at 674;

ii. a formula for computing an alarm limit, Flook, 437 U.S. at 585, 198 USPQ at 195;

iii. a formula describing certain electromagneticstanding wave phenomena, Mackay Radio & Tel.Co. v. Radio Corp. of America, 306 U.S. 86, 91, 40USPQ 199, 201 (1939); and

iv. a mathematical formula for hedging, Bilski,561 U.S. at 599, 95 USPQ2d at 1004-05.

B. Concepts relating to performing mathematicalcalculations

An example of a case identifying a concept relatingto performing mathematical calculations as abstractis Bancorp Servs., LLC v. Sun Life Assur. Co. ofCanada (U.S.), 687 F.3d 1266, 103 USPQ2d 1425(Fed. Cir. 2012). The patentee in Bancorp claimedmethods and systems for managing a life insurancepolicy on behalf of a policy holder, which comprisedsteps including generating a life insurance policyincluding a stable value protected investment withan initial value based on a value of underlyingsecurities, calculating surrender value protectedinvestment credits for the life insurance policy;determining an investment value and a value of theunderlying securities for the current day; andcalculating a policy value and a policy unit value forthe current day. 687 F.3d at 1270-71, 103 USPQ2dat 1427. The court looked to the specification tounderstand the claims, and noted that “[a]s theformulae in the specification indicate, thedetermination of [the claimed] values, and theirsubsequent manipulation, is a matter of meremathematical computation.” Accordingly, the courtdetermined that the claim was directed to “theabstract idea of managing a stable value protectedlife insurance policy by performing calculations andmanipulating the results.” 687 F.3d at 1280, 103USPQ2d at 1434.

Another example is Digitech Image Techs., LLC v.Electronics for Imaging, Inc., 758 F.3d 1344, 111USPQ2d 1717 (Fed. Cir. 2014). The patentee in Digitech claimed methods of generating first andsecond data by taking existing information,manipulating the data using mathematical formulas,and organizing this information into a new form.The court explained that such claims were directedto an abstract idea because they described a processof organizing information through mathematicalcorrelations, like Flook's method of calculatingusing a mathematical formula. 758 F.3d at 1350, 111USPQ2d at 1721.


i. an algorithm for determining the optimalnumber of visits by a business representative to aclient, In re Maucorps, 609 F.2d 481, 482, 203USPQ 812, 813 (CCPA 1979);

ii. an algorithm for calculating parametersindicating an abnormal condition, In re Grams, 888F.2d 835, 836, 12 USPQ2d 1824, 1825 (Fed. Cir.1989); and

iii. calculating the difference between local andaverage data values, In re Abele, 684 F.2d 902, 903,214 USPQ 682, 683-84 (CCPA 1982).

2106.04(b) Laws of Nature, NaturalPhenomena & Products of Nature[R-08.2017]

Laws of nature and natural phenomena, as identifiedby the courts, include naturally occurringprinciples/relations and nature-based products thatare naturally occurring or that do not have markedlydifferent characteristics compared to what occurs innature. The courts have often described theseexceptions using other terms, including “physicalphenomena,” “scientific principles”, “natural laws,”and “products of nature.”

I. LAWS OF NATURE AND NATURALPHENOMENA, GENERALLY

The law of nature and natural phenomenonexceptions reflect the Supreme Court's view that thebasic tools of scientific and technological work arenot patentable, because the “manifestations of lawsof nature” are “part of the storehouse of knowledge,”

2100-36Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.04(b)

“free to all men and reserved exclusively to none.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, “anew mineral discovered in the earth or a new plantfound in the wild is not patentable subject matter”under Section 101. Diamond v. Chakrabarty, 447U.S. 303, 309, 206 USPQ 193, 197 (1980).“Likewise, Einstein could not patent his celebrated

law that E=mc2; nor could Newton have patentedthe law of gravity.” Id. Nor can one patent “a noveland useful mathematical formula,” Parker v. Flook,437 U.S. 584, 585, 198 USPQ 193, 195 (1978);electromagnetism or steam power, O’Reilly v.Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or“[t]he qualities of ... bacteria, ... the heat of the sun,electricity, or the qualities of metals,” Funk, 333U.S. at 130, 76 USPQ at 281; see also Le Roy v.Tatham, 55 U.S. (14 How.) 156, 175 (1853).

The courts have identified the following conceptsand products as examples of laws of nature or naturalphenomena:

i. isolated DNA, Ass’n for Molecular Pathologyv. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17,106 USPQ2d 1972, 1978-79 (2013);

ii. a cloned farm animal such as a sheep, In reRoslin Institute (Edinburgh), 750 F.3d 1333, 1337,110 USPQ2d 1668, 1671 (Fed. Cir. 2014);

iii. a correlation between variations innon-coding regions of DNA and allele presence incoding regions of DNA, Genetic Techs. Ltd. v.Merial LLC, 818 F.3d 1369, 1375, 118 USPQ2d1541, 1545 (Fed. Cir. 2016);

iv. a correlation that is the consequence of howa certain compound is metabolized by the body, Mayo Collaborative Servs. v. Prometheus Labs.,566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68(2012);

v. a correlation between the presence ofmyeloperoxidase in a bodily sample (such as bloodor plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True HealthDiagnostics, LLC, 859 F.3d 1352, 1361, 123USPQ2d 1081, 1087 (Fed. Cir. 2017);

vi. electromagnetism to transmit signals, O’Reilly v. Morse, 56 U.S. 62, 113 (1853);

vii. qualities of bacteria such as their ability tocreate a state of inhibition or non-inhibition in otherbacteria, Funk Bros., 333 U.S. at 130, 76 USPQ at281;

viii. single-stranded DNA fragments known as“primers”, University of Utah Research Foundationv. Ambry Genetics Corp., 774 F.3d 755, 761, 113USPQ2d 1241, 1244 (Fed. Cir. 2014);

ix. the chemical principle underlying the unionbetween fatty elements and water, Tilghman v.Proctor, 102 U.S. 707, 729 (1880); and

x. the existence of cell-free fetal DNA (cffDNA)in maternal blood, Ariosa Diagnostics, Inc. v.Sequenom, 788 F.3d 1371, 1373, 115 USPQ2d 1152,1153 (Fed. Cir. 2015).

The courts have also noted, however, that not everyclaim describing a natural ability or quality of aproduct, or describing a natural process, isnecessarily “directed to” a law of nature or naturalphenomenon. For example, a method of treatingcancer with chemotherapy is not directed to thecancer cells’ inability to survive chemotherapy, anda method of treating headaches with aspirin is notdirected to the human body’s natural response toaspirin. See Rapid Litig. Mgmt. v. CellzDirect, Inc.,827 F.3d 1042, 1048-49, 119 USPQ2d 1370, 1374(Fed. Cir. 2016) (claims reciting process steps offractionating, recovering, and cryopreservinghepatocytes held to be eligible, because they are notfocused on merely observing or detecting the abilityof hepatocytes to survive multiple freeze-thawcycles). Similarly, a method of producing a newcompound is not directed to the individualcomponents’ ability to combine to form the newcompound. Id. See also Tilghman v. Proctor, 102U.S. 707, 729 (1881) (claims reciting process stepsfor manufacturing fatty acids and glycerol byhydrolyzing fat at high temperature and pressurewere held to be eligible, because they are not focusedon the chemical principle that fat can be hydrolyzedinto its components).

As explained in MPEP § 2106.04, a claim that recitesa law of nature or a natural phenomenon is directedto a judicial exception (Step 2A: YES), and requiresfurther analysis in Step 2B to determine whether theclaim recites a patent-eligible application of theexception. A claim that does not recite a law ofnature or natural phenomenon is eligible (Step 2A:

Rev. 08.2017, January 20182100-37

§ 2106.04(b)PATENTABILITY

NO) at Pathway B unless the claim recites anotherexception (such as an abstract idea, or a product ofnature).

II. PRODUCTS OF NATURE

When a law of nature or natural phenomenon isclaimed as a physical product, the courts have oftenreferred to the exception as a “product of nature”.For example, the isolated DNA of Myriad and theprimers of Ambry Genetics were described asproducts of nature by the courts. Ass’n forMolecular Pathology v. Myriad Genetics, Inc., 133S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979(2013); University of Utah Research Foundation v.Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d1241, 1243 (Fed. Cir. 2014). As explained in thosedecisions, products of nature are considered to bean exception because they tie up the use of naturallyoccurring things, but they have been labeled as bothlaws of nature and natural phenomena. See MyriadGenetics, Inc., 133 S. Ct. at 2116-17, 106 USPQ2dat 1979 (claims to isolated DNA held ineligiblebecause they “claim naturally occurring phenomena”and are “squarely within the law of natureexception”); Funk Bros. Seed Co. v. Kalo InoculantCo., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948)(claims to bacterial mixtures held ineligible as“manifestations of laws of nature” and “phenomenaof nature”). Step 2A of the Office’s eligibilityanalysis uses the terms “law of nature” and “naturalphenomenon” as inclusive of “products of nature”.

It is important to keep in mind that product of natureexceptions include both naturally occurring productsand non-naturally occurring products that lackmarkedly different characteristics from any naturallyoccurring counterpart. See, e.g., Ambry Genetics,774 F.3d at 760, 113 USPQ2d at 1244 (“Contraryto Myriad's argument, it makes no difference thatthe identified gene sequences are syntheticallyreplicated. As the Supreme Court made clear, neithernaturally occurring compositions of matter, norsynthetically created compositions that arestructurally identical to the naturally occurringcompositions, are patent eligible.”). Thus, asynthetic, artificial, or non-naturally occurringproduct such as a cloned organism or a human-madehybrid plant is not automatically eligible because itwas created by human ingenuity or intervention.

See, e.g., In re Roslin Institute (Edinburgh), 750F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed.Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply,Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132,60 USPQ2d 1868-69 (2001) (hybrid plant). Instead,the key to the eligibility of all non-naturallyoccurring products is whether they possess markedlydifferent characteristics from any naturally occurringcounterpart.

When a claim recites a nature-based productlimitation, examiners should use the markedlydifferent characteristics analysis discussed in MPEP§ 2106.04(c) to evaluate the nature-based productlimitation and determine the answer to Step 2A.Nature-based products, as used herein, include botheligible and ineligible products and merely refer tothe types of products subject to the markedlydifferent characteristics analysis used to identifyproduct of nature exceptions. Examples ofnature-based products include the isolated gene andcDNA sequences of Myriad, the cloned farmanimals of Roslin, and the bacterium of Chakrabarty. As is evident from these examples,and as further discussed in MPEP § 2105, anature-based product that is a living organism (e.g.,a plant, an animal, a bacterium, etc.) is not excludedfrom patent protection merely because it is alive,and such a product is eligible for patenting if itsatisfies the markedly different characteristicsanalysis.

It is important to keep in mind that under thebroadest reasonable interpretation (BRI) of theclaims, a nature-based product limitation mayencompass both eligible and ineligible products. Forexample, a claim to a “cloned giraffe” may have aBRI encompassing cloned giraffes with markedlydifferent characteristics, as well as cloned giraffesthat lack markedly different characteristics and thusare products of nature. Cf. Roslin, 750 F.3d at1338-39, 110 USPQ2d at 1673 (applicant could notrely on unclaimed features to distinguish claimedmammals from donor mammals). Such a claim isdirected to a product of nature (Step 2A: YES). Ifthe claim is ultimately rejected as failing toencompass an inventive concept (Step 2B: NO), itis a best practice for the examiner to point out thebroadest reasonable interpretation and recommendan amendment, if possible, that would narrow the

2100-38Rev. 08.2017, January 2018


claim to those embodiments that are not directed toproducts of nature, or that are otherwise eligible.

For claims that recite a nature-based productlimitation (which may or may not be a product ofnature exception) but which are directed toinventions that clearly do not seek to tie up anyjudicial exception, examiners should considerwhether the streamlined eligibility analysis discussedin MPEP § 2106.06 is appropriate. In such cases, itwould not be necessary to conduct a markedlydifferent characteristics analysis.

2106.04(c) The Markedly DifferentCharacteristics Analysis [R-08.2017]

The markedly different characteristics analysis ispart of Step 2A, because the courts use this analysisto identify product of nature exceptions. Forexample, Chakrabarty relied on a comparison ofthe claimed bacterium to naturally occurring bacteriawhen determining that the claimed bacterium wasnot a product of nature because it had “markedlydifferent characteristics from any found in nature”. Diamond v. Chakrabarty, 447 U.S. 303, 310, 206USPQ 193, 197 (1980). Similarly, Roslin relied ona comparison of the claimed sheep to naturallyoccurring sheep when determining that the claimedsheep was a product of nature because it “does notpossess ‘markedly different characteristics from any[farm animals] found in nature.’” In re RoslinInstitute (Edinburgh), 750 F.3d 1333, 1337, 110USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ at 197(alterations in original)).

This section sets forth guidelines for performing themarkedly different characteristics analysis, includinginformation on when to perform the analysis, andhow to perform the analysis. Examiners shouldconsult these guidelines when performing aneligibility analysis of a claim that recites anature-based product limitation. Nature-basedproducts, as used herein, include both eligible andineligible products and merely refer to the types ofproducts subject to the markedly differentcharacteristics analysis used to identify product ofnature exceptions.

If the claim includes a nature-based product that hasmarkedly different characteristics, then the claimdoes not recite a product of nature exception and iseligible (Step 2A: NO) at Pathway B unless the claimrecites another exception (such as a law of nature orabstract idea, or a different natural phenomenon).For claims where the entire claim is a singlenature-based product (e.g., a claim to “a Lactobacillus bacterium”), once a markedlydifferent characteristic in that product is shown, nofurther analysis would be necessary for eligibilitybecause no product of nature exception is recited(i.e., Step 2B is not necessary because the answer toStep 2A is NO). For claims including limitations inaddition to the nature-based product, examinersshould consider whether the claim recites anotherexception and thus requires further eligibilityanalysis.

If the claim includes a nature-based product thatdoes not exhibit markedly different characteristicsfrom its naturally occurring counterpart in its naturalstate, then the claim is directed to a “product ofnature” exception (Step 2A: YES), and requiresfurther analysis in Step 2B to determine whether anyadditional elements in the claim add significantlymore to the exception.

I. WHEN TO PERFORM THE MARKEDLYDIFFERENT CHARACTERISTICS ANALYSIS

Because a nature-based product can be claimed byitself (e.g., “a Lactobacillus bacterium”) or as oneor more limitations of a claim (e.g., “a probioticcomposition comprising a mixture of Lactobacillusand milk in a container”), care should be taken notto overly extend the markedly differentcharacteristics analysis to products that when viewedas a whole are not nature-based. Instead, themarkedly different characteristics analysis shouldbe applied only to the nature-based productlimitations in the claim to determine whether thenature-based products are “product of nature”exceptions.

A. Product Claims

Where the claim is to a nature-based product by itself(e.g., a claim to “a Lactobacillus bacterium”), themarkedly different characteristics analysis should

Rev. 08.2017, January 20182100-39

§ 2106.04(c)PATENTABILITY

be applied to the entire product. See, e.g.,Chakrabarty, 447 U.S. at 305, 309-10, 206 USPQat 195, 197-98 (applying analysis to entire claimed“bacterium from the genus Pseudomonas containingtherein at least two stable energy-generatingplasmids, each of said plasmids providing a separatehydrocarbon degradative pathway”).

Where the claim is to a nature-based productproduced by combining multiple components (e.g.,a claim to “a probiotic composition comprising amixture of Lactobacillus and milk”), the markedlydifferent characteristics analysis should be appliedto the resultant nature-based combination, ratherthan its component parts. For instance, for theprobiotic composition example, the mixture of Lactobacillus and milk should be analyzed formarkedly different characteristics, rather than the Lactobacillus separately and the milk separately.See MPEP § 2106.04(c), subsection II, below, forfurther guidance on the markedly differentcharacteristic analysis.

Where the claim is to a nature-based product incombination with non-nature based elements (e.g.,a claim to “a yogurt starter kit comprising Lactobacillus in a container with instructions forculturing Lactobacillus with milk to produceyogurt”), the markedly different characteristicsanalysis should be applied only to the nature-basedproduct limitation. For instance, for the yogurt starterkit example, the Lactobacillus would be analyzedfor markedly different characteristics. The containerand instructions would not be subject to the markedlydifferent characteristics analysis as they are notnature-based products, but would be evaluated asadditional elements in Step 2B if it is determinedthat the Lactobacillus does not have markedlydifferent characteristics from any naturally occurringcounterpart and thus is a product of nature exception.See, e.g., Funk Bros. Seed Co. v. Kalo InoculantCo., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948)(although claims 7, 8, 13 and 14 recited an inoculantcomprising a bacterial mixture and a powder base,only the bacterial mixture was analyzed).

B. Product-by-Process Claims

For a product-by-process claim (e.g., a claim to acloned farm animal produced by a nuclear transfer

cloning method), the analysis turns on whether thenature-based product in the claim has markedlydifferent characteristics from its naturally occurringcounterpart. See MPEP § 2113 for more informationon product-by-process claims.

C. Process Claims

For a process claim, the general rule is that the claimis not subject to the markedly different analysis fornature-based products used in the process. This isbecause the analysis of a process claim should focuson the active steps of the process rather than theproducts used in those steps. For example, whenevaluating a claimed process of cryopreservinghepatocyte cells comprising performing densitygradient fractionation to separate viable andnon-viable hepatocytes, recovering the viablehepatocytes, and cryopreserving the recovered viablehepatocytes, the court did not subject the claim tothe markedly different characteristics analysis forthe nature-based products (the hepatocytes) used inthe process. Rapid Litig. Mgmt. v. CellzDirect, Inc.,827 F.3d 1042, 1049, 119 USPQ2d 1370, 1374 (Fed.Cir. 2016) (claims are directed to a process ofcreating a preparation of multi-cryopreservedhepatocytes, not to the preparation itself).

However, in the limited situation where a processclaim reciting a nature-based product is drafted insuch a way that there is no difference in substancefrom a product claim, the claim is subject to themarkedly different analysis for the recitednature-based product. These types of claims aredrafted in a way that focuses on the product ratherthan the process steps. For example, consider a claimthat recites, in its entirety, “a method of providingan apple.” Under the broadest reasonableinterpretation, this claim is focused on the apple fruititself, which is a nature-based product. Similarly,claims to detecting naturally occurring cell-free fetalDNA (cffDNA) in maternal blood were held to bedirected to the cffDNA, because the “existence andlocation of cffDNA is a natural phenomenon [andthus] identifying its presence was merely claimingthe natural phenomena itself.” Rapid Litig. Mgmt.,827 F.3d at 1048, 119 USPQ2d at 1374, (explainingthe holding in Ariosa Diagnostics, Inc. v. Sequenom,788 F.3d 1371, 115 USPQ2d 1152 (Fed. Cir. 2015)).

2100-40Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.04(c)

II. HOW TO PERFORM THE MARKEDLYDIFFERENT CHARACTERISTICS ANALYSIS

The markedly different characteristics analysiscompares the nature-based product limitation to itsnaturally occurring counterpart in its natural state.Markedly different characteristics can be expressedas the product’s structure, function, and/or otherproperties, and are evaluated based on what is recitedin the claim on a case-by-case basis. If the analysisindicates that a nature-based product limitation doesnot exhibit markedly different characteristics, thenthat limitation is a product of nature exception. Ifthe analysis indicates that a nature-based productlimitation does have markedly differentcharacteristics, then that limitation is not a productof nature exception.

Examiners should keep in mind that if thenature-based product limitation is naturallyoccurring, there is no need to perform the markedlydifferent characteristics analysis because thelimitation is by definition directed to a naturallyoccurring product and thus falls under the productof nature exception. However, if the nature-basedproduct limitation is not naturally occurring, forexample due to some human intervention, then themarkedly different characteristics analysis must beperformed to determine whether the claimed productlimitation is a product of nature exception.

This section sets forth guidelines for performing themarkedly different characteristics analysis, includinginformation on (a) selecting the appropriate naturallyoccurring counterpart(s) to the nature-based productlimitation, (b) identifying appropriate characteristicsfor analysis, and (c) evaluating characteristics todetermine whether they are “markedly different”.

A. Selecting The Appropriate Counterpart(s)

Because the markedly different characteristicsanalysis compares the nature-based productlimitation to its naturally occurring counterpart inits natural state, the first step in the analysis is toselect the appropriate counterpart(s) to thenature-based product.

When the nature-based product is derived from anaturally occurring thing, then the naturally

occurring thing is the counterpart. For example,assume that applicant claims deoxyacid A, which isa chemical derivative of a naturally occurringchemical called acid A. Because applicant createdthe claimed nature-based product (deoxyacid A) bymodifying the naturally occurring acid A, the closestnatural counterpart for deoxyacid A would be thenatural product from which it was derived, i.e., acidA. See, e.g., Chakrabarty, 447 U.S. at 305 and n.1,206 USPQ at 195 and n.1 (counterpart to geneticallymodified Pseudomonas bacterium containingmultiple plasmids is the naturally occurringunmodified Pseudomonas bacterium from which theclaimed bacterium was created); Roslin, 750 F.3dat 1337, 110 USPQ2d at 1671-72 (counterparts tocloned sheep are naturally occurring sheep such asthe donor ewe from which the clone was created).

Although the selected counterpart should be in itsnatural state, examiners should take care not toconfuse the counterpart with other material that mayoccur naturally with, or adjacent to, the counterpart.For example, assume that applicant claims a nucleicacid having a nucleotide sequence derived fromnaturally occurring gene B. Although gene B occursin nature as part of a chromosome, the closest naturalcounterpart for the claimed nucleic acid is gene B,and not the whole chromosome. See, e.g., Ass’n forMolecular Pathology v. Myriad Genetics, Inc., 133S. Ct. 2107, 2117-19, 106 USPQ2d 1972, 1979-81(2013) (comparing isolated BRCA1 genes andBRCA1 cDNA molecules to naturally occurringBRCA1 gene). Similarly, assume that applicantclaims a single-stranded piece of DNA (a primer)having a nucleotide sequence derived from the sensestrand of naturally occurring nucleic acid C.Although nucleic acid C occurs in nature as adouble-stranded molecule having a sense and anantisense strand, the closest natural counterpart forthe claimed nucleic acid is the sense strand of Conly. See, e.g., University of Utah ResearchFoundation v. Ambry Genetics, 774 F.3d 755, 760,113 USPQ2d 1241, 1241 (Fed. Cir. 2014)(comparing single-stranded nucleic acid to the samestrand found in nature, even though “single-strandedDNA cannot be found in the human body”).

When there are multiple counterparts to thenature-based product, the comparison should bemade to the closest naturally occurring counterpart.

Rev. 08.2017, January 20182100-41


For example, assume that applicant creates a clonedsheep D by transferring nuclear DNA from aFinn-Dorset sheep into an egg cell (which containsmitochondrial DNA) from a Scottish Blackfacesheep. Applicant then claims sheep D. Here, becausesheep D was created via combining DNA from twodifferent naturally occurring sheep of differentbreeds, there is no single closest natural counterpart.The examiner should therefore select the counterpartmost closely related to sheep D based on theexaminer’s expertise in the particular art. For theexample discussed here, the closest counterpartsmight be naturally occurring Finn-Dorset or ScottishBlackface sheep, as opposed to sheep of a differentbreed such as Bighorn sheep. Cf. Roslin, 750 F.3dat 1337, 110 USPQ2d at 1671-72 (claimed sheepproduced by nuclear transfer into an oocyte andsubsequent manipulation of natural embryonicdevelopment processes was compared to naturallyoccurring sheep such as the donor ewe from whichthe nuclear material was obtained). When thenature-based product is a combination producedfrom multiple components, the closest counterpartmay be the individual nature-based components ofthe combination. For example, assume that applicantclaims an inoculant comprising a mixture of bacteriafrom different species, e.g., some bacteria of speciesE and some bacteria of species F. Because there isno counterpart mixture in nature, the closestcounterparts to the claimed mixture are the individualcomponents of the mixture, i.e., each naturallyoccurring species by itself. See, e.g., Funk Bros.,333 U.S. at 130, 76 USPQ at 281 (comparingclaimed mixture of bacterial species to each speciesas it occurs in nature); Ambry Genetics, 774 F.3dat 760, 113 USPQ2d at 1244 (although claimed asa pair, individual primer molecules were comparedto corresponding segments of naturally occurringgene sequence). See MPEP § 2106.04(c), subsectionII. C.

If the claim is rejected as ineligible, it is a “bestpractice” for the examiner to identify the selectedcounterpart in the Office action if the record is notalready clear. This practice assists the applicant inresponding, and clarifies the record as to how theexaminer is interpreting the claim.

B. Identifying Appropriate Characteristics ForAnalysis

Because the markedly different characteristicsanalysis is based on comparing the characteristicsof the claimed nature-based product and itscounterpart, the second step in the analysis is toidentify appropriate characteristics to compare.

Appropriate characteristics must be possessed bythe claimed product, because it is the claim that mustdefine the invention to be patented. Cf. Roslin, 750F.3d at 1338, 110 USPQ2d at 1673 (unclaimedcharacteristics could not contribute to eligibility).Examiners can identify the characteristics possessedby the claimed product by looking at what is recitedin the claim language and encompassed within thebroadest reasonable interpretation of the nature-basedproduct. In some claims, a characteristic may beexplicitly recited. For example, in a claim to“deoxyribose”, the recited chemical name informsthose in the art of the structural characteristics of theproduct (i.e., the “deoxy” prefix indicates that ahydroxyl group has been removed as compared toribose). In other claims, the characteristic may beapparent from the broadest reasonable interpretationeven though it is not explicitly recited in the claim.For example, in a claim to “isolated gene B,” theexaminer would need to rely on the broadestreasonable interpretation of “isolated gene B” todetermine what characteristics the isolated gene has, e.g., what its nucleotide sequence is, and what, ifany, protein it encodes.

Appropriate characteristics can be expressed as thenature-based product’s structure, function, and/orother properties, and are evaluated on a case-by-casebasis. Non-limiting examples of the types ofcharacteristics considered by the courts whendetermining whether there is a marked differenceinclude:

• Biological or pharmacological functions oractivities;

• Chemical and physical properties;

• Phenotype, including functional and structuralcharacteristics; and

• Structure and form, whether chemical, geneticor physical.

2100-42Rev. 08.2017, January 2018


Examples of biological or pharmacological functionsor activities include, but are not limited to:

i. the protein-encoding information of a nucleicacid, Myriad, 133 S. Ct. at 2111, 2116-17, 106USPQ2d at 1979);

ii. or the ability of complementary nucleotidesequences to bind to each other, Ambry Genetics,774 F.3d at 760-61, 113 USPQ2d at 1244);

iii. the properties and functions of bacteria suchas the ability to infect certain leguminous plants, Funk Bros., 333 U.S. at 130-31, 76 USPQ2d at281-82;

iv. the ability to degrade certain hydrocarbons, Diamond v. Chakrabarty, 447 U.S. at 310, 206USPQ2d at 195; and

v. the ability of vitamin C to prevent and treatscurvy, In re King, 107 F.2d 618, 27 CCPA 754,756-57, 43 USPQ 400, 401-402 (CCPA 1939).

Examples of chemical and physical propertiesinclude, but are not limited to:

i. the alkalinity of a chemical compound, Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95,103-04 (S.D.N.Y. 1911); and

ii. the ductility or malleability of metals, In reMarden, 47 F.2d 958, 959, 18 CCPA 1057, 1059, 8USPQ 347, 349 (CCPA 1931).

Examples of phenotypic characteristics include, butare not limited to:

i. functional and structural characteristics suchas the shape, size, color, and behavior of anorganism, Roslin, 750 F.3d at 1338, 110 USPQ2dat 1672.

Examples of structure and form include, but are notlimited to:

i. physical structure or form such as the physicalpresence of plasmids in a bacterial cell, Chakrabarty, 447 U.S. at 305 and n.1, 206 USPQ2dat 195 and n.1;

ii. chemical structure and form such as achemical being a “nonsalt” and a “crystallinesubstance”, Parke-Davis, 189 F. at 100, 103;

iii. genetic structure such as the nucleotidesequence of DNA, Myriad, 133 S. Ct. at 2116, 2119,106 USPQ2d at 1979; and

iv. the genetic makeup (genotype) of a cell ororganism, Roslin, 750 F.3d at 1338-39, 110 USPQ2dat 1672-73.

C. Evaluating Characteristics To Determine WhetherThey Are “Markedly Different”

The final step in the markedly differentcharacteristics analysis is to compare thecharacteristics of the claimed nature-based productto its naturally occurring counterpart in its naturalstate, in order to determine whether thecharacteristics of the claimed product are markedlydifferent. The courts have emphasized that to showa marked difference, a characteristic must bechanged as compared to nature, and cannot be aninherent or innate characteristic of the naturallyoccurring counterpart or an incidental change in acharacteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at1974-75. Thus, in order to be markedly different,applicant must have caused the claimed product topossess at least one characteristic that is differentfrom that of the counterpart.

If there is no change in any characteristic, theclaimed product lacks markedly differentcharacteristics, and is a product of nature exception.If there is a change in at least one characteristic ascompared to the counterpart, and the change cameabout or was produced by applicant’s efforts orinfluences, then the change will generally beconsidered a markedly different characteristic suchthat the claimed product is not a product of natureexception.

(1) Examples of Products Having Markedly DifferentCharacteristics

In Chakrabarty, the Supreme Court identified aclaimed bacterium as a nature-based product havingmarkedly different characteristics. This bacteriumhad a changed functional characteristic, i.e., it wasable to degrade at least two different hydrocarbonsas compared to naturally occurring Pseudomonasbacteria that can only degrade a single hydrocarbon.The claimed bacterium also had a different structural

Rev. 08.2017, January 20182100-43


characteristic, i.e., it was genetically modified toinclude more plasmids than are found in a singlenaturally occurring Pseudomonas bacterium. TheSupreme Court considered these changedcharacteristics to be “markedly differentcharacteristics from any found in nature” due to theadditional plasmids and resultant capacity fordegrading multiple hydrocarbon components of oil.Therefore, the bacterium was eligible. Diamond v.Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193,197 (1980).

In Myriad, the Supreme Court identified a claimedfull-length complementary DNA (cDNA) of theBRCA1 gene as a nature-based product havingmarkedly different characteristics. This claimedcDNA had the same functional characteristics (i.e.,it encoded the same protein) as the naturallyoccurring gene, but had a changed structuralcharacteristic, i.e., a different nucleotide sequencecontaining only exons, as compared to the naturallyoccurring sequence containing both exons andintrons. The Supreme Court concluded that the“cDNA retains the naturally occurring exons ofDNA, but it is distinct from the DNA from which itwas derived. As a result, [this] cDNA is not a‘product of nature’” and is eligible. Myriad, 133 S.Ct. at 2119, 106 USPQ2d at 1981.

(2) Examples of Products Lacking Markedly DifferentCharacteristics

In Myriad, the Supreme Court made clear that notall changes in characteristics will rise to the level ofa marked difference, e.g., the incidental changesresulting from isolation of a gene sequence are notenough to make the isolated gene markedly different. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at1974-75. The patentee in Myriad had discoveredthe location of the BRCA1 and BRCA2 genes in thehuman genome, and isolated them, i.e., separatedthose specific genes from the rest of the chromosomeon which they exist in nature. As a result of theirisolation, the isolated genes had a different structuralcharacteristic than the natural genes, i.e., the naturalgenes had covalent bonds on their ends thatconnected them to the rest of the chromosome, butthe isolated genes lacked these bonds. However, theclaimed genes were otherwise structurally identicalto the natural genes, e.g., they had the same genetic

structure and nucleotide sequence as the BRCAgenes in nature. The Supreme Court concluded thatthese isolated but otherwise unchanged genes werenot eligible, because they were not different enoughfrom what exists in nature to avoid improperly tyingup the future use and study of the naturally occurringBRCA genes. See, e.g., Myriad, 133 S. Ct. at2113-14, 106 USPQ2d at 1977 (“Myriad's patentswould, if valid, give it the exclusive right to isolatean individual’s BRCA1 and BRCA2 genes … Butisolation is necessary to conduct genetic testing”)and 133 S. Ct. at 2118, 106 USPQ2d at 1980(describing how would-be infringers could not avoidthe scope of Myriad’s claims). In sum, the claimedgenes were different, but not markedly different,from their naturally occurring counterparts (theBRCA genes), and thus were product of natureexceptions.

In Ambry Genetics, the court identified claimedDNA fragments known as “primers” as products ofnature, because they lacked markedly differentcharacteristics. University of Utah ResearchFoundation v. Ambry Genetics Corp., 774 F.3d 755,113 USPQ2d 1241 (Fed. Cir. 2014). The claimedprimers were single-stranded pieces of DNA, eachof which corresponded to a naturally occurringdouble-stranded DNA sequence in or near the BRCAgenes. The patentee argued that these primers hadmarkedly different structural characteristics fromthe natural DNA, because the primers weresynthetically created and because “single-strandedDNA cannot be found in the human body”. The courtdisagreed, concluding that the primers’ structuralcharacteristics were not markedly different than thecorresponding strands of DNA in nature, becausethe primers and their counterparts had the samegenetic structure and nucleotide sequence. 774 F.3dat 760, 113 USPQ2d at 1243-44. The patentee alsoargued that the primers had a different function thanwhen they are part of the DNA strand because whenisolated as a primer, a primer can be used as astarting material for a DNA polymerization process.The court disagreed, because this ability to serve asa starting material is innate to DNA itself, and wasnot created or altered by the patentee:

In fact, the naturally occurring geneticsequences at issue here do not perform asignificantly new function. Rather, the naturally

2100-44Rev. 08.2017, January 2018


occurring material is used to form the first stepin a chain reaction--a function that is performedbecause the primer maintains the exact samenucleotide sequence as the relevant portion ofthe naturally occurring sequence. One of theprimary functions of DNA’s structure in natureis that complementary nucleotide sequencesbind to each other. It is this same function thatis exploited here--the primer binds to itscomplementary nucleotide sequence. Thus, justas in nature, primers utilize the innate abilityof DNA to bind to itself.

Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2dat 1244. In sum, because the characteristics of theclaimed primers were innate to naturally occurringDNA, they lacked markedly different characteristicsfrom nature and were thus product of natureexceptions. A similar result was reached in Marden,where the court held a claim to ductile vanadiumineligible, because the “ductility or malleability ofvanadium is . . . one of its inherent characteristicsand not a characteristic given to it by virtue of a newcombination with other materials or whichcharacteristic is brought about by some chemicalreaction or agency which changes its inherentcharacteristics”. In re Marden, 47 F.2d 958, 959,18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA1931).

In Roslin, the court concluded that claimed clonesof farm animals were products of nature, becausethey lacked markedly different characteristics fromthe counterpart farm animals found in nature. In reRoslin Institute (Edinburgh), 750 F.3d 1333, 1337,110 USPQ2d 1668, 1671 (Fed. Cir. 2014). Applicantcreated its clones (which included the famous clonedsheep named Dolly) by transferring the geneticmaterial of a donor into an oocyte (egg cell), lettingthe oocyte develop into an embryo, and thenimplanting the embryo into a surrogate animal whereit developed into a baby animal. The applicantargued that the clones, including Dolly, were eligiblebecause they were created via human ingenuity, andhad phenotypic differences such as shape, size andbehavior compared to their donors. The court wasunpersuaded, explaining that the clones were exactgenetic replicas of the donors and thus did notpossess markedly different characteristics. 750 F.3dat 1337, 110 USPQ2d at 1671-72 (“Roslin’s chief

innovation was the preservation of the donor DNAsuch that the clone is an exact copy of the mammalfrom which the somatic cell was taken. Such a copyis not eligible for patent protection.”). The courtnoted that the alleged phenotypic differences (e.g.,the fact that Dolly may have been taller or heavierthan her donor) could not make the clones markedlydifferent because these differences were not claimed.750 F.3d at 1338, 110 USPQ2d at 1672.

2106.05 Eligibility Step 2B: Whether a ClaimAmounts to Significantly More [R-08.2017]

I. THE SEARCH FOR AN INVENTIVE CONCEPT

While abstract ideas, natural phenomena, and lawsof nature are not eligible for patenting by themselves,claims that integrate these exceptions into aninventive concept are thereby transformed intopatent-eligible inventions. Alice Corp. Pty. Ltd. v.CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d1976, 1981 (2014) (citing Mayo CollaborativeServs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72,101 USPQ2d 1961, 1966 (2012)). Thus, the secondpart of the Alice/Mayo test is often referred to as asearch for an inventive concept. Id.

An inventive concept “cannot be furnished by theunpatentable law of nature (or natural phenomenonor abstract idea) itself.” Genetic Techs. v. MerialLLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546(Fed. Cir. 2016). See also Alice Corp., 134 S. Ct.at 2355, 110 USPQ2d at 1981 (citing Mayo, 566U.S. at 78, 101 USPQ2d at 1968 (after determiningthat a claim is directed to a judicial exception, “wethen ask, ‘[w]hat else is there in the claims beforeus?”) (emphasis added)); RecogniCorp, LLC v.Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d1377 (Fed. Cir. 2017) (“Adding one abstract idea(math) to another abstract idea (encoding anddecoding) does not render the claim non-abstract”).Instead, an “inventive concept” is furnished by anelement or combination of elements that is recitedin the claim in addition to (beyond) the judicialexception, and is sufficient to ensure that the claimas a whole amounts to significantly more than thejudicial exception itself. Alice Corp., 134 S. Ct. at2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S.at 72-73, 101 USPQ2d at 1966).

Rev. 08.2017, January 20182100-45


Evaluating additional elements to determine whetherthey amount to an inventive concept requiresconsidering them both individually and incombination to ensure that they amount tosignificantly more than the judicial exception itself.Because this approach considers all claim elements,the Supreme Court has noted that “it is consistentwith the general rule that patent claims ‘must beconsidered as a whole.’” Alice Corp., 134 S. Ct. at2355, 110 USPQ2d at 1981 (quoting Diamond v.Diehr, 450 U.S. 175, 188, 209 USPQ 1, 8-9 (1981)).Consideration of the elements in combination isparticularly important, because even if an additionalelement does not amount to significantly more onits own, it can still amount to significantly morewhen considered in combination with the otherelements of the claim. See, e.g., Rapid Litig. Mgmt.v. CellzDirect, 827 F.3d 1042, 1051, 119 USPQ2d1370, 1375 (Fed. Cir. 2016) (process recitingcombination of individually well-known freezingand thawing steps was “far from routine andconventional” and thus eligible); BASCOM GlobalInternet Servs. v. AT&T Mobility LLC, 827 F.3d1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir.2016) (inventive concept may be found in thenon-conventional and non-generic arrangement ofcomponents that are individually well-known andconventional).

Although the courts often evaluate considerationssuch as the conventionality of an additional elementin the eligibility analysis, the search for an inventiveconcept should not be confused with a novelty ornon-obviousness determination. See Mayo, 566 U.S.at 91, 101 USPQ2d at 1973 (rejecting “theGovernment’s invitation to substitute §§ 102, 103,and 112 inquiries for the better established inquiryunder § 101”). As made clear by the courts, the“‘novelty’ of any element or steps in a process, oreven of the process itself, is of no relevance indetermining whether the subject matter of a claimfalls within the § 101 categories of possiblypatentable subject matter.” Intellectual Ventures Iv. Symantec Corp., 838 F.3d 1307, 1315, 120USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQat 9). See also Synopsys, Inc. v. Mentor GraphicsCorp., 839 F.3d 1138, 1151, 120 USPQ2d 1473,1483 (Fed. Cir. 2016) (“a claim for a new abstractidea is still an abstract idea. The search for a § 101

inventive concept is thus distinct from demonstrating§ 102 novelty.”). In addition, the search for aninventive concept is different from an obviousnessanalysis under 35 U.S.C. 103. See, e.g., BASCOMGlobal Internet v. AT&T Mobility LLC, 827 F.3d1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir.2016) (“The inventive concept inquiry requires morethan recognizing that each claim element, by itself,was known in the art. . . . [A]n inventive conceptcan be found in the non-conventional andnon-generic arrangement of known, conventionalpieces.”). Specifically, lack of novelty under 35U.S.C. 102 or obviousness under 35 U.S.C. 103 ofa claimed invention does not necessarily indicatethat additional elements are well-understood, routine,conventional elements. Because they are separateand distinct requirements from eligibility,patentability of the claimed invention under 35U.S.C. 102 and 103 with respect to the prior art isneither required for, nor a guarantee of, patenteligibility under 35 U.S.C. 101. The distinctionbetween eligibility (under 35 U.S.C. 101) andpatentability over the art (under 35 U.S.C. 102 and/or103) is further discussed in MPEP § 2106.05(d).

A. Relevant Considerations For Evaluating WhetherAdditional Elements Amount To An Inventive Concept

The Supreme Court has identified a number ofconsiderations as relevant to the evaluation ofwhether the claimed additional elements amount toan inventive concept. The list of considerations hereis not intended to be exclusive or limiting. Additionalelements can often be analyzed based on more thanone type of consideration and the type ofconsideration is of no import to the eligibilityanalysis. Additional discussion of theseconsiderations, and how they were applied inparticular judicial decisions, is provided in in MPEP§ 2106.05(a) through (h).

Limitations that the courts have found to qualify as“significantly more” when recited in a claim with ajudicial exception include:

i. Improvements to the functioning of acomputer, e.g., a modification of conventionalInternet hyperlink protocol to dynamically producea dual-source hybrid webpage, as discussed in DDRHoldings, LLC v. Hotels.com, L.P., 773 F.3d 1245,

2100-46Rev. 08.2017, January 2018


1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir.2014) (see MPEP § 2106.05(a));

ii. Improvements to any other technology ortechnical field, e.g., a modification of conventionalrubber-molding processes to utilize a thermocoupleinside the mold to constantly monitor the temperatureand thus reduce under- and over-curing problemscommon in the art, as discussed in Diamond v.Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981)(see MPEP § 2106.05(a));

iii. Applying the judicial exception with, or byuse of, a particular machine, e.g., a Fourdriniermachine (which is understood in the art to have aspecific structure comprising a headbox, apaper-making wire, and a series of rolls) that isarranged in a particular way to optimize the speedof the machine while maintaining quality of theformed paper web, as discussed in Eibel ProcessCo. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65(1923) (see MPEP § 2106.05(b));

iv. Effecting a transformation or reduction of aparticular article to a different state or thing, e.g., aprocess that transforms raw, uncured synthetic rubberinto precision-molded synthetic rubber products, asdiscussed in Diehr, 450 U.S. at 184, 209 USPQ at21 (see MPEP § 2106.05(c));

v. Adding a specific limitation other than whatis well-understood, routine, conventional activity inthe field, or adding unconventional steps that confinethe claim to a particular useful application, e.g., anon-conventional and non-generic arrangement ofvarious computer components for filtering Internetcontent, as discussed in BASCOM Global Internetv. AT&T Mobility LLC, 827 F.3d 1341, 1350-51,119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP§ 2106.05(d)); or

vi. Other meaningful limitations beyondgenerally linking the use of the judicial exception toa particular technological environment, e.g., animmunization step that integrates an abstract idea ofdata comparison into a specific process ofimmunizing that lowers the risk that immunizedpatients will later develop chronic immune-mediateddiseases, as discussed in Classen ImmunotherapiesInc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (seeMPEP § 2106.05(e)).

Limitations that the courts have found not to beenough to qualify as “significantly more” whenrecited in a claim with a judicial exception include:

i. Adding the words “apply it” (or an equivalent)with the judicial exception, or mere instructions toimplement an abstract idea on a computer, e.g., alimitation indicating that a particular function suchas creating and maintaining electronic records isperformed by a computer, as discussed in AliceCorp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (seeMPEP § 2106.05(f));

ii. Simply appending well-understood, routine,conventional activities previously known to theindustry, specified at a high level of generality, tothe judicial exception, e.g., a claim to an abstractidea requiring no more than a generic computer toperform generic computer functions that arewell-understood, routine and conventional activitiespreviously known to the industry, as discussed in Alice Corp., 134 S. Ct. at 2359-60, 110 USPQ2d at1984 (see MPEP § 2106.05(d));

iii. Adding insignificant extra-solution activityto the judicial exception, e.g., mere data gatheringin conjunction with a law of nature or abstract ideasuch as a step of obtaining information about creditcard transactions so that the information can beanalyzed by an abstract mental process, as discussedin CyberSource v. Retail Decisions, Inc., 654 F.3d1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)(see MPEP § 2106.05(g)); or

iv. Generally linking the use of the judicialexception to a particular technological environmentor field of use, e.g., a claim describing how theabstract idea of hedging could be used in thecommodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d1001, 1010 (2010) or a claim limiting the use of amathematical formula to the petrochemical andoil-refining fields, as discussed in Parker v. Flook,437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978)(MPEP § 2106.05(h)).

It is notable that mere physicality or tangibility ofan additional element or elements is not a relevantconsideration in Step 2B. As the Supreme Courtexplained in Alice Corp., mere physical or tangibleimplementation of an exception is not in itself aninventive concept and does not guarantee eligibility:

Rev. 08.2017, January 20182100-47


The fact that a computer “necessarily exist[s]in the physical, rather than purely conceptual,realm,” is beside the point. There is no disputethat a computer is a tangible system (in § 101terms, a “machine”), or that manycomputer-implemented claims are formallyaddressed to patent-eligible subject matter. Butif that were the end of the § 101 inquiry, anapplicant could claim any principle of thephysical or social sciences by reciting acomputer system configured to implement therelevant concept. Such a result would make thedetermination of patent eligibility “dependsimply on the draftsman’s art,” Flook, supra,at 593, 98 S. Ct. 2522, 57 L. Ed. 2d 451,thereby eviscerating the rule that “‘[l]aws ofnature, natural phenomena, and abstract ideasare not patentable,’” Myriad, 133 S. Ct. 1289,186 L. Ed. 2d 124, 133).

Alice Corp., 134 S. Ct. at 2358-59, 110 USPQ2d at1983-84 (alterations in original). See also GeneticTechnologies Ltd. v. Merial LLC, 818 F.3d 1369,1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016)(steps of DNA amplification and analysis “do not,individually or in combination, provide sufficientinventive concept to render claim 1 patent eligible”merely because they are physical steps). Conversely,the presence of a non-physical or intangibleadditional element does not doom the claims,because tangibility is not necessary for eligibilityunder the Alice/Mayo test. Enfish, LLC v. MicrosoftCorp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir.2016) (“that the improvement is not defined byreference to ‘physical’ components does not doomthe claims”). See also McRO, Inc. v. Bandai NamcoGames Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d1091, 1102 (Fed. Cir. 2016), (holding that a processproducing an intangible result (a sequence ofsynchronized, animated characters was eligiblebecause it improved an existing technologicalprocess).

B. Examples Of How Courts Conduct The SearchFor An Inventive Concept

Alice Corp. provides an example of how courtsconduct the significantly more analysis. In this case,the Supreme Court analyzed claims to computersystems, computer readable media, and

computer-implemented methods, all of whichdescribed a scheme for mitigating “settlement risk,”which is the risk that only one party to anagreed-upon financial exchange will satisfy itsobligation. In part one of the Alice/Mayo test, theCourt determined that the claims were directed tothe abstract idea of mitigating settlement risk. AliceCorp., 134 S. Ct. at 2357, 110 USPQ2d at 1982. TheCourt then walked through part two of the Alice/Mayo test, in which:

• The Court identified the additional elementsin the claim, e.g., by noting that the method claimsrecited steps of using a computer to “createelectronic records, track multiple transactions, andissue simultaneous instructions”, and that the productclaims recited hardware such as a “data processingsystem” with a “communications controller” and a“data storage unit” (134 S. Ct. at 2359-2360, 110USPQ2d at 1984-85);

• The Court considered the additional elementsindividually, noting that all the computer functionswere “‘well-understood, routine, conventionalactivit[ies]’ previously known to the industry," eachstep “does no more than require a generic computerto perform generic computer functions”, and therecited hardware was “purely functional and generic”(134 S. Ct. at 2359-60, 110 USPQ2d at 1984-85);and

• The Court considered the additional elements“as an ordered combination,” and determined that“the computer components … ‘[a]dd nothing … thatis not already present when the steps are consideredseparately’” and simply recite intermediatedsettlement as performed by a generic computer.” Id.(citing Mayo, 566 U.S. at 79, 101 USPQ2d at 1972).

Based on this analysis, the Court concluded that theclaims amounted to “‘nothing significantly more’than an instruction to apply the abstract idea ofintermediated settlement using some unspecified,generic computer”, and therefore held the claimsineligible because they were directed to a judicialexception and failed the second part of the Alice/Mayo test. Alice Corp., 134 S. Ct. at 2360,110 USPQ2d at 1984.

BASCOM provides another example of how courtsconduct the significantly more analysis, and of thecritical importance of considering the additional

2100-48Rev. 08.2017, January 2018


elements in combination. In this case, the FederalCircuit vacated a judgment of ineligibility becausethe district court failed to properly perform thesecond step of the Alice/Mayo test when analyzinga claimed system for filtering content retrieved froman Internet computer network. BASCOM GlobalInternet v. AT&T Mobility LLC, 827 F.3d 1341, 119USPQ2d 1236 (Fed. Cir. 2016). The Federal Circuitagreed with the district court that the claims weredirected to the abstract idea of filtering Internetcontent, and then walked through the district court’sanalysis in part two of the Alice/Mayo test, notingthat:

• The district court properly identified theadditional elements in the claims, such as a “localclient computer,” “remote ISP server,” “Internetcomputer network,” and “controlled access networkaccounts” (827 F.3d at 1349, 119 USPQ2d at 1242);

• The district court properly considered theadditional elements individually, for example byconsulting the specification, which described eachof the additional elements as “well-known genericcomputer components” (827 F.3d at 1349, 119USPQ2d at 1242); and

• The district court should have considered theadditional elements in combination, because the“inventive concept inquiry requires more thanrecognizing that each claim element, by itself, wasknown in the art” (827 F.3d at 1350, 119 USPQ2dat 1242).

Based on this analysis, the Federal Circuit concludedthat the district court erred by failing to recognizethat when combined, an inventive concept may befound in the non-conventional and non-genericarrangement of the additional elements, i.e., theinstallation of a filtering tool at a specific location,remote from the end-users, with customizablefiltering features specific to each end user. 827 F.3dat 1350, 119 USPQ2d at 1242.

II. ELIGIBILITY STEP 2B: WHETHER THEADDITIONAL ELEMENTS CONTRIBUTE AN“INVENTIVE CONCEPT”

As described in MPEP § 2106, subsection III, Step2B of the Office’s eligibility analysis is the secondpart of the Alice/Mayo test, i.e., the SupremeCourt’s “framework for distinguishing patents that

claim laws of nature, natural phenomena, andabstract ideas from those that claim patent-eligibleapplications of those concepts.” Alice Corp. Pty.Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347,2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo,566 U.S. 66, 101 USPQ2d 1961 (2012)). Like theother steps in the eligibility analysis, evaluation ofthis step should be made after determining whatapplicant has invented by reviewing the entireapplication disclosure and construing the claims inaccordance with their broadest reasonableinterpretation. See MPEP § 2106, subsection II formore information about the importance ofunderstanding what the applicant has invented, andMPEP § 2111 for more information about thebroadest reasonable interpretation.

Step 2B asks: Does the claim recite additionalelements that amount to significantly more than thejudicial exception? Examiners should answer thisquestion by first identifying whether there are anyadditional elements (features/limitations/steps)recited in the claim beyond the judicial exception(s),and then evaluating those additional elementsindividually and in combination to determinewhether they contribute an inventive concept (i.e.,amount to significantly more than the judicialexception(s)).

This evaluation is made with respect to theconsiderations that the Supreme Court has identifiedas relevant to the eligibility analysis, which areintroduced generally in Part I.A of this section, anddiscussed in detail in MPEP § 2106.05(a) through(h). Many of these considerations overlap, and oftenmore than one consideration is relevant to analysisof an additional element. Not all considerations willbe relevant to every element, or every claim. Becausethe evaluation in Step 2B is not a weighing test, itis not important how the elements are characterizedor how many considerations apply from this list. Itis important to evaluate the significance of theadditional elements relative to applicant’s invention,and to keep in mind the ultimate question of whetherthe additional elements encompass an inventiveconcept.

In the context of the flowchart in MPEP § 2106,subsection III, Step 2B determines whether:

Rev. 08.2017, January 20182100-49


• The claim as a whole does not amount tosignificantly more than the exception itself (there isno inventive concept in the claim) (Step 2B: NO)and thus is not eligible, warranting a rejection forlack of subject matter eligibility and concluding theeligibility analysis; or

• The claim as a whole does amount tosignificantly more than the exception (there is aninventive concept in the claim) (Step 2B: YES), andthus is eligible at Pathway C, thereby concludingthe eligibility analysis.

Examiners should examine each claim for eligibilityseparately, based on the particular elements recitedtherein. Claims should not be judged to automaticallystand or fall with similar claims in an application.For instance, one claim may be ineligible becauseit is directed to a judicial exception withoutamounting to significantly more, but another claimdependent on the first may be eligible because itrecites additional elements that do amount tosignificantly more.

Unless it is clear that the claim recites distinctexceptions, such as a law of nature and an abstractidea, care should be taken not to parse the claim intomultiple exceptions, particularly in claims involvingabstract ideas. Accordingly, if possible examinersshould treat the claim for Step 2B purposes ascontaining a single judicial exception. If, however,the claim clearly recites a plurality of discreteexceptions, then for purposes of examinationefficiency, examiners should select one of theexceptions and conduct the eligibility analysis forthat selected exception. If the analysis indicates thatthe claim recites an additional element orcombination of elements that amount to significantlymore than the selected exception, then the claimshould be considered patent eligible. On the otherhand, if the claim does not recite any additionalelement or combination of elements that amounts tosignificantly more than the selected exception, thenthe claim should be considered ineligible. Universityof Utah Research Foundation v. Ambry Genetics,774 F.3d 755, 762, 113 USPQ2d 1241, 1246 (Fed.Cir. 2014) (because claims did not amount tosignificantly more than the recited abstract idea,court “need not decide” if claims also recited a lawof nature).

If the claim as a whole does recite significantly morethan the exception itself, the claim is eligible (Step2B: YES) at Pathway C, and the eligibility analysisis complete. If there are no meaningful limitationsin the claim that transform the exception into apatent-eligible application, such that the claim doesnot amount to significantly more than the exceptionitself, the claim is not patent-eligible (Step 2B: NO)and should be rejected under 35 U.S.C. 101. SeeMPEP § 2106.07 for information on how toformulate an ineligibility rejection.

2106.05(a) Improvements to the Functioningof a Computer or To Any Other Technologyor Technical Field [R-08.2017]

In determining patent eligibility, examiners shouldconsider whether the claim “purport(s) to improvethe functioning of the computer itself” or “any othertechnology or technical field.” Alice Corp. Pty. Ltd.v. CLS Bank Int’l, 134 S. Ct. 2347, 2359, 110USPQ2d 1976, 1984 (2014). This consideration hasalso been referred to as the search for a technologicalsolution to a technological problem. See e.g., DDRHoldings, LLC. v. Hotels.com, L.P., 773 F.3d 1245,1257, 113 USPQ2d 1097, 1105 (Fed. Cir. 2014); Amdocs (Israel), Ltd. v. Openet Telecom, Inc., 841F.3d 1288, 1300-01, 120 USPQ2d 1527, 1537 (Fed.Cir. 2016).

While improvements were evaluated in Alice Corp.as relevant to the search for an inventive concept(Step 2B), several decisions of the Federal Circuithave also evaluated this consideration whendetermining whether a claim was directed to anabstract idea (Step 2A). See, e.g., Enfish, LLC v.Microsoft Corp., 822 F.3d 1327, 1335-36, 118USPQ2d 1684, 1689 (Fed. Cir. 2016); McRO, Inc.v. Bandai Namco Games Am. Inc., 837 F.3d 1299,1314-16, 120 USPQ2d 1091, 1102-03 (Fed. Cir.2016); Visual Memory, LLC v. NVIDIA Corp., 867F.3d 1253, 1259-60, 123 USPQ2d 1712, 1717 (Fed.Cir. 2017). Thus, an examiner may evaluate whethera claim contains an improvement to the functioningof a computer or to any other technology or technicalfield at Step 2A or Step 2B, as well as whenconsidering whether the claim has such self-evidenteligibility that it qualifies for the streamlinedanalysis. See MPEP § 2106.04(a) and MPEP §2106.04(a)(1) for more information about

2100-50Rev. 08.2017, January 2018


improvements in the Step 2A context, and MPEP §2106.07(b) for more information aboutimprovements in the streamlined analysis context.

In finding that a claim is directed to such animprovement, the Federal Circuit has relied on thefocus of the claimed invention. E.g., Enfish, 822F.3d at 1335-36, 118 USPQ2d at 1689; McRO, 837F.3d at 1314-15, 120 USPQ2d at 1101-02. As such,it is critical that the claim be accorded its broadestreasonable interpretation (BRI) to determine thefocus of the claim as a whole. In accordance withprinciples of claim construction, the specificationshould be consulted in determining the claim’sbroadest reasonable interpretation (see MPEP §2111) and whether a claimed invention purports toimprove computer-functionality or existingtechnology.

If it is asserted that the invention improves uponconventional functioning of a computer, or uponconventional technology or technological processes,a technical explanation as to how to implement theinvention should be present in the specification. Thatis, the disclosure must provide sufficient details suchthat one of ordinary skill in the art would recognizethe claimed invention as providing an improvement.An indication that the claimed invention providesan improvement can include a discussion in thespecification that identifies a technical problem andexplains the details of an unconventional technicalsolution expressed in the claim, or identifiestechnical improvements realized by the claim overthe prior art. For example, in McRO, the court reliedon the specification’s explanation of how theparticular rules recited in the claim enabled theautomation of specific animation tasks thatpreviously could only be performed subjectively byhumans, when determining that the claims weredirected to improvements in computer animationinstead of an abstract idea. McRO, 837 F.3d at1313-14, 120 USPQ2d at 1100-01. In contrast, thecourt in Affinity Labs of Tex. v. DirecTV, LLC reliedon the specification’s failure to provide detailsregarding the manner in which the inventionaccomplished the alleged improvement when holdingthe claimed methods of delivering broadcast contentto cellphones ineligible. 838 F.3d 1253, 1263-64,120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).

After the examiner has consulted the specificationand determined that the disclosed invention improvestechnology, the claim must be evaluated to ensurethe claim itself reflects the improvement intechnology. Intellectual Ventures I LLC v. SymantecCorp., 838 F.3d 1307, 1316, 120 USPQ2d 1353,1359 (patent owner argued that the claimed emailfiltering system improved technology by shrinkingthe protection gap and mooting the volume problem,but the court disagreed because the claimsthemselves did not have any limitations thataddressed these issues). The full scope of the claimunder the BRI should be considered to determine ifthe claim reflects an improvement in technology(e.g., the improvement described in thespecification). In making this determination, it iscritical that examiners look at the claim “as a whole,”in other words, the claim should be evaluated “as anordered combination, without ignoring therequirements of the individual steps.” Whenperforming this evaluation, examiners should be“careful to avoid oversimplifying the claims” bylooking at them generally and failing to account forthe specific requirements of the claims. McRO, 837F.3d at 1313, 120 USPQ2d at 1100.

An important consideration in determining whethera claim is directed to an improvement in technologyis the extent to which the claim covers a particularsolution to a problem or a particular way to achievea desired outcome, as opposed to merely claimingthe idea of a solution or outcome. McRO, 837 F.3dat 1314-15, 120 USPQ2d at 1102-03; DDRHoldings, 773 F.3d at 1259, 113 USPQ2d at 1107.In this respect, the improvement considerationoverlaps with other Step 2B considerations,specifically the particular machine consideration(see MPEP § 2106.05(b)), and the mere instructionsto apply an exception consideration (see MPEP §2106.05(f)). Thus, evaluation of those otherconsiderations may assist examiners in making adetermination of whether a claim satisfies theimprovement consideration.

I. IMPROVEMENTS TO COMPUTERFUNCTIONALITY

In computer-related technologies, the examinershould determine whether the claim purports toimprove computer capabilities or, instead, invokes

Rev. 08.2017, January 20182100-51


computers merely as a tool. Enfish, LLC v. MicrosoftCorp., 822 F.3d 1327, 1336, 118 USPQ2d 1684,1689 (Fed. Cir. 2016). In Enfish, the court evaluatedthe patent eligibility of claims related to aself-referential database. Id. The court concludedthe claims were not directed to an abstract idea, butrather an improvement to computer functionality. Id. It was the specification’s discussion of the priorart and how the invention improved the way thecomputer stores and retrieves data in memory incombination with the specific data structure recitedin the claims that demonstrated eligibility. 822 F.3dat 1339, 118 USPQ2d at 1691. The claim was notsimply the addition of general purpose computersadded post-hoc to an abstract idea, but a specificimplementation of a solution to a problem in thesoftware arts. 822 F.3d at 1339, 118 USPQ2d at1691.

Examples that the courts have indicated may showan improvement in computer-functionality:

i. A modification of conventional Internethyperlink protocol to dynamically produce adual-source hybrid webpage, DDR Holdings, 773F.3d at 1258-59, 113 USPQ2d at 1106-07;

ii. Inventive distribution of functionality withina network to filter Internet content, BASCOM GlobalInternet v. AT&T Mobility LLC, 827 F.3d 1341,1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016);

iii. A method of rendering a halftone digitalimage, Research Corp. Techs. v. Microsoft Corp.,627 F.3d 859, 868-69, 97 USPQ2d 1274, 1380 (Fed.Cir. 2010);

iv. A distributed network architecture operatingin an unconventional fashion to reduce networkcongestion while generating networking accountingdata records, Amdocs (Israel), Ltd. v. OpenetTelecom, Inc., 841 F.3d 1288, 1300-01, 120 USPQ2d1527, 1536-37 (Fed. Cir. 2016);

v. A memory system having programmableoperational characteristics that are configurablebased on the type of processor, which can be usedwith different types of processors without a tradeoffin processor performance, Visual Memory, LLC v.NVIDIA Corp., 867 F.3d 1253, 1259-60, 123USPQ2d 1712, 1717 (Fed. Cir. 2017);

vi. Technical details as to how to transmitimages over a cellular network or append

classification information to digital image data, TLICommunications LLC v. AV Auto. LLC, 823 F.3d607, 614-15, 118 USPQ2d 1744, 1749-50 (Fed. Cir.2016) (holding the claims ineligible because theyfail to provide requisite technical details necessaryto carry out the function);

vii. Particular structure of a server that storesorganized digital images, TLI Communications, 823F.3d at 612, 118 USPQ2d at 1747 (finding the useof a generic server insufficient to add inventiveconcepts to an abstract idea); and

viii. A particular way of programming ordesigning software to create menus, Apple, Inc. v.Ameranth, Inc., 842 F.3d 1229, 1241, 120 USPQ2d1844, 1854 (Fed. Cir. 2016).

It is important to note that in order for a methodclaim to improve computer functionality, thebroadest reasonable interpretation of the claim mustbe limited to computer implementation. That is, aclaim whose entire scope can be performed mentally,cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a methodof translating a logic circuit into a hardwarecomponent description of a logic circuit was foundto be ineligible because the method did not employa computer and a skilled artisan could perform allthe steps mentally). Similarly, a claimed processcovering embodiments that can be performed on acomputer, as well as embodiments that can bepracticed verbally or with a telephone, cannotimprove computer technology. See RecogniCorp,LLC v. Nintendo Co., 855 F.3d 1322, 1328, 122USPQ2d 1377, 1381 (Fed. Cir. 2017) (process forencoding/decoding facial data using image codesassigned to particular facial features held ineligiblebecause the process did not require a computer).

Examples that the courts have indicated may not besufficient to show an improvement incomputer-functionality:

i. Generating restaurant menus with functionallyclaimed features, Ameranth, 842 F.3d at 1245, 120USPQ2d at 1857;

ii. Accelerating a process of analyzing audit logdata when the increased speed comes solely fromthe capabilities of a general-purpose computer,

2100-52Rev. 08.2017, January 2018


FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089,1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016);

iii. Merely using a computer to perform anabstract idea, e.g., applying the functionality of acomputer and bar code system in the context ofprocessing returned mail, Return Mail, Inc. v. U.S.Postal Service, -- F.3d --, --, -- USPQ2d --, -- slipop. at 33 (Fed. Cir. August 28, 2017);

iv. Mere automation of manual processes, suchas using a generic computer to process an applicationfor financing a purchase, Credit Acceptance Corp.v. Westlake Services, 859 F.3d 1044, 1055, 123USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speedingup a loan-application process by enabling borrowersto avoid physically going to or calling each lenderand filling out a loan application, LendingTree, LLCv. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed.Cir. 2016) (non-precedential); and

v. Recording, transmitting, and archiving digitalimages by use of conventional or generic technologyin a nascent but well-known environment, withoutany assertion that the invention reflects an inventivesolution to any problem presented by combining acamera and a cellular telephone, TLICommunications, 823 F.3d at 611-12, 118 USPQ2dat 1747.

II. IMPROVEMENTS TO ANY OTHERTECHNOLOGY OR TECHNICAL FIELD

The courts have also found that improvements intechnology beyond computer functionality maydemonstrate patent eligibility. In McRO, the FederalCircuit held claimed methods of automatic lipsynchronization and facial expression animationusing computer-implemented rules to be patenteligible under 35 U.S.C. 101, because they were notdirected to an abstract idea. McRO, 837 F.3d at1316, 120 USPQ2d at 1103. The basis for the McROcourt's decision was that the claims were directed toan improvement in computer animation and thus didnot recite a concept similar to previously identifiedabstract ideas. Id. The court relied on thespecification's explanation of how the claimed rulesenabled the automation of specific animation tasksthat previously could not be automated. 837 F.3d at1313, 120 USPQ2d at 1101. The McRO courtindicated that it was the incorporation of theparticular claimed rules in computer animation that"improved [the] existing technological process",

unlike cases such as Alice where a computer wasmerely used as a tool to perform an existing process.837 F.3d at 1314, 120 USPQ2d at 1102. The McROcourt also noted that the claims at issue described aspecific way (use of particular rules to set morphweights and transitions through phonemes) to solvethe problem of producing accurate and realistic lipsynchronization and facial expressions in animatedcharacters, rather than merely claiming the idea ofa solution or outcome, and thus were not directed toan abstract idea. 837 F.3d at 1313, 120 USPQ2d at1101.

Examples that the courts have indicated may besufficient to show an improvement in existingtechnology include:

i. Particular computerized method of operatinga rubber molding press, e.g., a modification ofconventional rubber-molding processes to utilize athermocouple inside the mold to constantly monitorthe temperature and thus reduce under- andover-curing problems common in the art, Diamondv. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ1, 8 and 10 (1981);

ii. New telephone, server, or combinationthereof, TLI Communications LLC v. AV Auto. LLC,823 F.3d 607, 612, 118 USPQ2d 1744, 1747 (Fed.Cir. 2016);

iii. An advance in the process of downloadingcontent for streaming, Affinity Labs of Tex. v.DirecTV, LLC, 838 F.3d 1253, 1256, 120 USPQ2d1201, 1202 (Fed. Cir. 2016);

iv. Improved, particular method of digital datacompression, DDR Holdings, LLC. v. Hotels.com,L.P., 773 F.3d 1245, 1259, 113 USPQ2d 1097, 1107(Fed. Cir. 2014); Intellectual Ventures I v. SymantecCorp., 838 F.3d 1307, 1315, 120 USPQ2d 1353,1358 (Fed. Cir. 2016);

v. Particular method of incorporating virusscreening into the Internet, Symantec Corp., 838F.3d at 1321-22, 120 USPQ2d at 1362-63;

vi. Components or methods, such asmeasurement devices or techniques, that generatenew data, Electric Power Group, LLC v. Alstom,S.A., 830 F.3d 1350, 1355, 119 USPQ2d 1739, 1742(Fed. Cir. 2016);

Rev. 08.2017, January 20182100-53


vii. Particular configuration of inertial sensorsand a particular method of using the raw data fromthe sensors, Thales Visionix, Inc. v. United States,850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902(Fed. Cir. 2017);

viii. A specific, structured graphical userinterface that improves the accuracy of tradertransactions by displaying bid and asked prices in aparticular manner that prevents order entry at achanged price, Trading Techs. Int’l, Inc. v. CQG,Inc., 675 Fed. App'x 1001 (Fed. Cir. 2017)(non-precedential); and

ix. Improved process for preserving hepatocytesfor later use, Rapid Litig. Mgmt. v. CellzDirect, Inc.,827 F.3d 1042, 1050, 119 USPQ2d 1370, 1375 (Fed.Cir. 2016).

To show that the involvement of a computer assistsin improving the technology, the claims must recitethe details regarding how a computer aids themethod, the extent to which the computer aids themethod, or the significance of a computer to theperformance of the method. Merely adding genericcomputer components to perform the method is notsufficient. Thus, the claim must include more thanmere instructions to perform the method on a genericcomponent or machinery to qualify as animprovement to an existing technology. See MPEP§ 2106.05(f) for more information about mereinstructions to apply an exception.

Examples that the courts have indicated may not besufficient to show an improvement to technologyinclude:

i. A commonplace business method beingapplied on a general purpose computer, Alice Corp.,134 S. Ct. 2347, 110 USPQ2d 1976; Versata Dev.Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334,115 USPQ2d 1681, 1701 (Fed. Cir. 2015);

ii. Using well-known standard laboratorytechniques to detect enzyme levels in a bodilysample such as blood or plasma, Cleveland ClinicFoundation v. True Health Diagnostics, LLC, 859F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83,1088 (Fed. Cir. 2017);

iii. Gathering and analyzing information usingconventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118USPQ2d at 1747-48;

iv. Delivering broadcast content to a portableelectronic device such as a cellular telephone, whenclaimed at a high level of generality, Affinity Labsof Tex. v. Amazon.com, 838 F.3d 1266, 1270, 120USPQ2d 1210, 1213 (Fed. Cir. 2016); Affinity Labsof Tex. v. DirecTV, LLC, 838 F.3d 1253, 1262, 120USPQ2d 1201, 1207 (Fed. Cir. 2016);

v. A general method of screening emails on ageneric computer, Symantec, 838 F.3d at 1315-16,120 USPQ2d at 1358-59;

vi. An advance in the informational content ofa download for streaming, Affinity Labs of Tex. v.DirecTV, LLC, 838 F.3d 1253, 1263, 120 USPQ2d1201, 1208 (Fed. Cir. 2016); and

vii. Selecting one type of content (e.g., FM radiocontent) from within a range of existing broadcastcontent types, or selecting a particular genericfunction for computer hardware to perform (e.g.,buffering content) from within a range ofwell-known, routine, conventional functionsperformed by the hardware, Affinity Labs of Tex. v.DirecTV, LLC, 838 F.3d 1253, 1264, 120 USPQ2d1201, 1208 (Fed. Cir. 2016).

2106.05(b) Particular Machine [R-08.2017]

When determining whether a claim recitessignificantly more than a judicial exception,examiners should consider whether the judicialexception is applied with, or by use of, a particularmachine. "The machine-or-transformation test is auseful and important clue, and investigative tool”for determining whether a claim is patent eligibleunder § 101. Bilski v. Kappos, 561 U.S. 593, 604,95 USPQ2d 1001, 1007 (2010).

It is noted that while the application of a judicialexception by or with a particular machine is animportant clue, it is not a stand-alone test foreligibility. Id.

All claims must be evaluated for eligibility using thetwo-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exceptionat Step 2A, or amounts to significantly more thanany recited exception in Step 2B), then the claim iseligible even if it fails the machine-or-transformationtest ("M-or-T test"). Bilski v. Kappos, 561 U.S. 593,604, 95 USPQ2d 1001, 1007 (2010) (explaining that

2100-54Rev. 08.2017, January 2018


a claim may be eligible even if it does not satisfythe M-or-T test); McRO, Inc. v. Bandai NamcoGames Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d1091, 1102 (Fed. Cir. 2016) (“[T]here is nothing thatrequires a method ‘be tied to a machine or transforman article’ to be patentable”). And if a claim failsthe Alice/Mayo test (i.e., is directed to an exceptionat Step 2A and does not amount to significantly morethan the exception in Step 2B), then the claim isineligible even if it passes the M-or-T test. DDRHoldings, LLC v. Hotels.com, L.P., 773 F.3d 1245,1256, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014)(“[I]n Mayo, the Supreme Court emphasized thatsatisfying the machine-or-transformation test, byitself, is not sufficient to render a claimpatent-eligible, as not all transformations or machineimplementations infuse an otherwise ineligible claimwith an 'inventive concept.'”).

Examiners may find it helpful to evaluate other Step2B considerations such as the mere instructions toapply an exception consideration (see MPEP §2106.05(f)), the insignificant extra-solution activityconsideration (see MPEP § 2106.05(g)), and the fieldof use and technological environment consideration(see MPEP § 2106.05(h)), before making adetermination of whether an element (or combinationof elements) is a particular machine. For informationon the definition of the term “machine,” see MPEP§ 2106.03.

When determining whether a machine recited in aclaim provides significantly more, the followingfactors are relevant.

I. THE PARTICULARITY OR GENERALITY OFTHE ELEMENTS OF THE MACHINE ORAPPARATUS

The particularity or generality of the elements of themachine or apparatus, i.e., the degree to which themachine in the claim can be specifically identified(not any and all machines). One example of applyinga judicial exception with a particular machine is Mackay Radio & Tel. Co. v. Radio Corp. ofAmerica, 306 U.S. 86, 40 USPQ 199 (1939). In thiscase, a mathematical formula was employed to usestanding wave phenomena in an antenna system.The claim recited the particular type of antenna andincluded details as to the shape of the antenna and

the conductors, particularly the length and angle atwhich they were arranged. 306 U.S. at 95-96; 40USPQ at 203. Another example is Eibel Process,in which gravity (a law of nature or naturalphenomenon) was applied by a Fourdrinier machine(which was understood in the art to have a specificstructure comprising a headbox, a paper-makingwire, and a series of rolls) arranged in a particularway to optimize the speed of the machine whilemaintaining quality of the formed paper web. EibelProcess Co. v. Minn. & Ont. Paper Co., 261 U.S.45, 64-65 (1923).

It is important to note that a general purposecomputer that applies a judicial exception, such asan abstract idea, by use of conventional computerfunctions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709,716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir.2014). See also TLI Communications LLC v. AVAutomotive LLC, 823 F.3d 607, 613, 118 USPQ2d1744, 1748 (Fed. Cir. 2016) (mere recitation ofconcrete or tangible components is not an inventiveconcept); Eon Corp. IP Holdings LLC v. AT&TMobility LLC, 785 F.3d 616, 623, 114 USPQ2d1711, 1715 (Fed. Cir. 2015) (noting that Alappat’srationale that an otherwise ineligible algorithm orsoftware could be made patent-eligible by merelyadding a generic computer to the claim wassuperseded by the Supreme Court’s Bilski and AliceCorp. decisions). If applicant amends a claim to adda generic computer or generic computer componentsand asserts that the claim recites significantly morebecause the generic computer is 'speciallyprogrammed' (as in Alappat, now consideredsuperseded) or is a 'particular machine' (as in Bilski),the examiner should look at whether the addedelements provide significantly more than the judicialexception. Merely adding a generic computer,generic computer components, or a programmedcomputer to perform generic computer functionsdoes not automatically overcome an eligibilityrejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l,134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976,1983-84 (2014).

Rev. 08.2017, January 20182100-55


II. WHETHER THE MACHINE OR APPARATUSIMPLEMENTS THE STEPS OF THE METHOD

Integral use of a machine to achieve performance ofa method may provide significantly more, in contrastto where the machine is merely an object on whichthe method operates, which does not providesignificantly more. See CyberSource v. RetailDecisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690,1694 (Fed. Cir. 2011) ("We are not persuaded bythe appellant's argument that claimed method is tiedto a particular machine because it ‘would not benecessary or possible without the Internet.’ . . .Regardless of whether "the Internet" can be viewedas a machine, it is clear that the Internet cannotperform the fraud detection steps of the claimedmethod"). For example, as described in MPEP §2106.05(f), additional elements that invokecomputers or other machinery merely as a tool toperform an existing process will generally notamount to significantly more than a judicialexception. See, e.g., Versata Development Groupv. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d1681, 1702 (Fed. Cir. 2015) (explaining that in orderfor a machine to add significantly more, it must “playa significant part in permitting the claimed methodto be performed, rather than function solely as anobvious mechanism for permitting a solution to beachieved more quickly”).

III. WHETHER ITS INVOLVEMENT ISEXTRA-SOLUTION ACTIVITY OR AFIELD-OF-USE

Whether its involvement is extra-solution activityor a field-of-use, i.e., the extent to which (or how)the machine or apparatus imposes meaningful limitson the claim. Use of a machine that contributes onlynominally or insignificantly to the execution of theclaimed method (e.g., in a data gathering step or ina field-of-use limitation) would not providesignificantly more. See Bilski, 561 U.S. at 610, 95USPQ2d at 1009 (citing Parker v. Flook, 437 U.S.584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366,1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citationsomitted) (“[N]othing in claim 3 requires an infringerto use the Internet to obtain that data. The Internetis merely described as the source of the data. Wehave held that mere ‘[data-gathering] step[s] cannot

make an otherwise nonstatutory claim statutory.’”654 F.3d at 1375, 99 USPQ2d at 1694 (citationomitted)). See MPEP § 2106.05(g) & (h) for moreinformation on insignificant extra-solution activityand field of use, respectively.

2106.05(c) Particular Transformation[R-08.2017]

Another consideration when determining whether aclaim recites significantly more is whether the claimeffects a transformation or reduction of a particulararticle to a different state or thing. "[T]ransformationand reduction of an article ‘to a different state orthing’ is the clue to patentability of a process claimthat does not include particular machines." Bilski v.Kappos, 561 U.S. 593, 658, 95 USPQ2d 1001, 1007(2010) (quoting Gottschalk v. Benson, 409 U.S. 63,70, 175 USPQ 673, 676 (1972)). If such atransformation exists, the claims are likely to besignificantly more than any recited judicialexception.

It is noted that while the transformation of an articleis an important clue, it is not a stand-alone test foreligibility. Id.

All claims must be evaluated for eligibility using thetwo-part test from Alice/Mayo. If a claim passes the Alice/Mayo test (i.e., is not directed to an exceptionat Step 2A, or amounts to significantly more thanany recited exception in Step 2B), then the claim iseligible even if it “fails” the M-or-T test. Bilski v.Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007(2010) (explaining that a claim may be eligible evenif it does not satisfy the M-or-T test); McRO, Inc.v. Bandai Namco Games Am. Inc., 837 F.3d 1299,1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016)(“[T]here is nothing that requires a method ‘be tiedto a machine or transform an article’ to bepatentable”). And if a claim fails the Alice/Mayotest (i.e., is directed to an exception at Step 2A anddoes not amount to significantly more than theexception in Step 2B), then the claim is ineligibleeven if it passes the M-or-T test. DDR Holdings,LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256, 113USPQ2d 1097, 1104 (Fed. Cir. 2014) (“[I]n Mayo,the Supreme Court emphasized that satisfying themachine-or-transformation test, by itself, is notsufficient to render a claim patent-eligible, as not all

2100-56Rev. 08.2017, January 2018


transformations or machine implementations infusean otherwise ineligible claim with an “inventiveconcept.”).

Examiners may find it helpful to evaluate other Step2B considerations such as the mere instructions toapply an exception consideration (see MPEP §2106.05(f)), the insignificant extra-solution activityconsideration (see MPEP § 2106.05(g)), and the fieldof use and technological environment consideration(see MPEP § 2106.05(h)), before making adetermination of whether a claim satisfies theparticular transformation consideration.

An “article” includes a physical object or substance.The physical object or substance must be particular,meaning it can be specifically identified.“Transformation” of an article means that the“article” has changed to a different state or thing.Changing to a different state or thing usually meansmore than simply using an article or changing thelocation of an article. A new or different function oruse can be evidence that an article has beentransformed. Purely mental processes in whichthoughts or human based actions are “changed” arenot considered an eligible transformation. For data,mere “manipulation of basic mathematical constructs[i.e.,] the paradigmatic ‘abstract idea,’” has not beendeemed a transformation. CyberSource v. RetailDecisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d1690, 1695 n.2 (Fed. Cir. 2011) (quoting In reWarmerdam, 33 F.3d 1354, 1355, 1360 (Fed. Cir.1994)).

Tilghman v. Proctor, 102 U.S. 707 (1881), providesan example of effecting a transformation of aparticular article to a different state or thing. In thatcase, the claim was directed to a process ofsubjecting a mixture of fat and water to a high degreeof heat and included additional parameters relatingto the level of heat, the quantities of fat and water,and the strength of the mixing vessel. The claimedprocess, which used the natural principle that theelements of neutral fat require that they be severallyunited with an atomic equivalent of water in orderto separate and become free, resulted in thetransformation of the fatty bodies into fat acids andglycerine. Id. at 729

Where a transformation is recited in a claim, thefollowing factors are relevant to the significantlymore analysis:

1. The particularity or generality of thetransformation. According to the Supreme Court,an invention comprising a process of “‘tanning,dyeing, making waterproof cloth, vulcanizing Indiarubber [or] smelting ores’ . . . are instances . . . wherethe use of chemical substances or physical acts, suchas temperature control, changes articles or materials[in such a manner that is] sufficiently definite toconfine the patent monopoly within rather definitebounds.” Gottschalk v. Benson, 409 U.S. 63, 70,175 USPQ 673, 676 (1972) (discussing Corning v.Burden, 15 How. (56 U.S.) 252, 267-68 (1854)).Therefore, a more particular transformation wouldlikely provide significantly more.

2. The degree to which the recited article isparticular. A transformation applied to a genericallyrecited article or to any and all articles would likelynot provide significantly more than the judicialexception. A transformation that can be specificallyidentified, or that applies to only particular articles,is more likely to provide significantly more.

3. The nature of the transformation in termsof the type or extent of change in state or thing.A transformation resulting in the transformed articlehaving a different function or use, would likelyprovide significantly more, but a transformationresulting in the transformed article merely having adifferent location, would likely not providesignificantly more. For example, a process thattransforms raw, uncured synthetic rubber intoprecision-molded synthetic rubber products, asdiscussed in Diamond v. Diehr, 450 U.S. 175, 184,209 USPQ 1, 21 (1981)), provides significantlymore.

4. The nature of the article transformed.Transformation of a physical or tangible object orsubstance is more likely to provide significantlymore than the transformation of an intangibleconcept such as a contractual obligation or mentaljudgment.

5. Whether the transformation isextra-solution activity or a field-of-use (i.e., theextent to which (or how) the transformationimposes meaningful limits on the execution of theclaimed method steps). A transformation that

Rev. 08.2017, January 20182100-57


contributes only nominally or insignificantly to theexecution of the claimed method (e.g., in a datagathering step or in a field-of-use limitation) wouldnot provide significantly more. For example, in Mayo the Supreme Court found claims regardingcalibrating the proper dosage of thiopurine drugs tobe patent ineligible subject matter. The FederalCircuit had held that the step of administering thethiopurine drug demonstrated a transformation ofthe human body and blood. Mayo, 566 U.S. at 76,101 USPQ2d at 1967. The Supreme Court disagreed,finding that this step was only a field-of-uselimitation and did not provide significantly morethan the judicial exception. Id. See MPEP §2106.05(g) & (h) for more information oninsignificant extra-solution activity and field of use,respectively.

2106.05(d) Well-Understood, Routine,Conventional Activity [R-08.2017]

Another consideration when determining whether aclaim recites significantly more than a judicialexception is whether the additional element(s) arewell-understood, routine, conventional activitiespreviously known to the industry. If the additionalelement (or combination of elements) is a specificlimitation other than what is well-understood, routineand conventional in the field, for instance becauseit is an unconventional step that confines the claimto a particular useful application of the judicialexception, then this consideration favors eligibility.If, however, the additional element (or combinationof elements) is no more than well-understood,routine, conventional activities previously known tothe industry, which is recited at a high level ofgenerality, then this consideration does not favoreligibility.

DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d1245, 113 USPQ2d 1097 (Fed. Cir. 2014), providesan example of additional elements that favoredeligibility because they were more thanwell-understood, routine conventional activities inthe field. The claims in DDR Holdings were directedto systems and methods of generating a compositewebpage that combines certain visual elements of ahost website with the content of a third-partymerchant. 773 F.3d at 1248, 113 USPQ2d at 1099.The court found that the claim had additional

elements that amounted to significantly more thanthe abstract idea, because they modified conventionalInternet hyperlink protocol to dynamically producea dual-source hybrid webpage, which differed fromthe conventional operation of Internet hyperlinkprotocol that transported the user away from thehost’s webpage to the third party’s webpage whenthe hyperlink was activated. 773 F.3d at 1258-59,113 USPQ2d at 1106-07. Thus, the claims in DDRHoldings were eligible.

On the other hand, Mayo Collaborative Servs. v.Prometheus Labs., Inc., 566 U.S. 66, 67, 101USPQ2d 1961, 1964 (2010) provides an example ofadditional elements that were not an inventiveconcept because they were merely well-understood,routine, conventional activity previously known tothe industry, which were not by themselves sufficientto transform a judicial exception into a patent eligibleinvention. Mayo Collaborative Servs. v. PrometheusLabs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969(2012) (citing Parker v. Flook, 437 U.S. 584, 590,198 USPQ 193, 199 (1978) (the additional elementswere “well known” and, thus, did not amount to apatentable application of the mathematical formula)).In Mayo, the claims at issue recited naturallyoccurring correlations (the relationships between theconcentration in the blood of certain thiopurinemetabolites and the likelihood that a drug dosagewill be ineffective or induce harmful side effects)along with additional elements including telling adoctor to measure thiopurine metabolite levels inthe blood using any known process. 566 U.S. at77-79, 101 USPQ2d at 1967-68. The Court foundthis additional step of measuring metabolite levelsto be well-understood, routine, conventional activityalready engaged in by the scientific communitybecause scientists “routinely measured metabolitesas part of their investigations into the relationshipsbetween metabolite levels and efficacy and toxicityof thiopurine compounds.” 566 U.S. at 79, 101USPQ2d at 1968. Even when considered incombination with the other additional elements, thestep of measuring metabolite levels did not amountto an inventive concept, and thus the claims in Mayowere not eligible. 566 U.S. at 79-80, 101 USPQ2dat 1968-69.

2100-58Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.05(d)

I. EVALUATING WHETHER THE ADDITIONALELEMENTS ARE WELL-UNDERSTOOD,ROUTINE, CONVENTIONAL ACTIVITY

When making a determination whether the additionalelements in a claim amount to significantly morethan a judicial exception, the examiner shouldevaluate whether the elements define onlywell-understood, routine, conventional activity. Inthis respect, the well-understood, routine,conventional consideration overlaps with other Step2B considerations, particularly the improvementconsideration (see MPEP § 2106.05(a)), the mereinstructions to apply an exception consideration (seeMPEP § 2106.05(f)), and the insignificantextra-solution activity consideration (see MPEP §2106.05(g)). Thus, evaluation of those otherconsiderations may assist examiners in making adetermination of whether a particular element orcombination of elements is well-understood, routine,conventional activity.

In addition, examiners should keep in mind thefollowing points when determining whetheradditional elements define only well-understood,routine, conventional activity.

1. An additional element (or combination ofadditional elements) that is known in the art canstill be unconventional or non-routine. Thequestion of whether a particular claimed inventionis novel or obvious is “fully apart” from the questionof whether it is eligible. Diamond v. Diehr, 450 U.S.175, 190, 209 USPQ 1, 9 (1981). For example,claims may exhibit an improvement overconventional computer functionality even if theimprovement lacks novelty over the prior art.Compare, e.g., Enfish, LLC v. Microsoft Corp., 822F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016)(holding several claims from U.S. Patent Nos.6,151,604 and 6,163,775 eligible) with MicrosoftCorp. v. Enfish, LLC, 662 Fed. App'x. 981 (Fed. Cir.2016) (holding some of the same claims to beanticipated by prior art). The eligible claims in Enfish recited a self-referential database having twokey features: all entity types can be stored in a singletable; and the table rows can contain informationdefining the table columns. Enfish, 822 F.3d at 1332,118 USPQ2d at 1687. Although these features weretaught by a single prior art reference (thusanticipating the claims), Microsoft Corp., 662 F.3d

App'x. at 986, the features were not conventionaland thus were considered to reflect an improvementto existing technology. In particular, they enabledthe claimed table to achieve benefits overconventional databases, such as increased flexibility,faster search times, and smaller memoryrequirements. Enfish, 822 F.3d at 1337, 118USPQ2d at 1690.

2. A prior art search should not be necessaryto resolve the inquiry as to whether an additionalelement (or combination of additional elements)is well-understood, routine, conventional activity.Instead, examiners should rely on what the courtshave recognized, or those in the art would recognize,as elements that are well-understood, routine,conventional activity in the relevant field. As such,an examiner should only conclude that an element(or combination of elements) is well-understood,routine, conventional activity when the examinercan readily conclude, based on their expertise in theart, that the element is widely prevalent or incommon use in the relevant industry. If the elementis not widely prevalent or in common use, or isotherwise beyond those elements recognized in theart or by the courts as being well-understood, routineor conventional, then the element will in most casesfavor eligibility. For example, even if a particulartechnique (e.g., measuring blood glucose via anearring worn by a person with diabetes) would havebeen obvious to one of ordinary skill in the artbecause it was discussed in several widely-readscientific journals or used by a few scientists, mereknowledge of the particular technique or use of theparticular technique by a few scientists is notnecessarily sufficient to make the use of theparticular technique routine or conventional in therelevant field. The examiner in this situation wouldalready know, based on the examiner's expertise inthe field, that blood glucose is routinely andconventionally monitored by other techniques (e.g.,via placing a small droplet of blood on a diagnostictest strip, or via an implanted insulin pump with aglucose sensor). Thus, the examiner would not needto perform a prior art search in order to determinethat the particular claimed technique using theglucose-sensing earring was not well-understood,routine, conventional activity previously engaged inby scientists in the field.

3. Even if one or more additional elementsare well-understood, routine, conventional

Rev. 08.2017, January 20182100-59

§ 2106.05(d)PATENTABILITY

activity when considered individually, thecombination of additional elements may amountto an inventive concept. Diamond v. Diehr, 450U.S. at 188, 209 USPQ at 9 (1981) (“[A] newcombination of steps in a process may be patentableeven though all the constituents of the combinationwere well known and in common use before thecombination was made.”). For example, amicroprocessor that performs mathematicalcalculations and a clock that produces time data mayindividually be generic computer components thatperform merely generic computer functions, butwhen combined may perform functions that are notgeneric computer functions and thus be an inventiveconcept. See, e.g. Rapid Litig. Mgmt. v. CellzDirect,Inc., 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375(Fed. Cir. 2016) (holding that while the additionalsteps of freezing and thawing hepatocytes were wellknown, repeating those steps, contrary to what wastaught in the art, was not routine or conventional).For example, in BASCOM, even though the courtfound that all of the additional elements in the claimrecited generic computer network or Internetcomponents, the elements in combination amountedto significantly more because of thenon-conventional and non-generic arrangement thatprovided a technical improvement in the art. BASCOM Global Internet Servs. v. AT&T MobilityLLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236,1243-44 (2016).

In many instances, the specification of theapplication may indicate that additional elementsare well-known or conventional. See, e.g.,Intellectual Ventures v. Symantec, 838 F.3d at 1317;120 USPQ2d at 1359 (“The written description isparticularly useful in determining what iswell-known or conventional”); Internet PatentsCorp., 790 F.3d at 1348, 115 USPQ2d at 1418(relying on specification’s description of additionalelements as “well-known”, “common” and“conventional”); TLI Communications LLC v. AVAuto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744,1748 (Fed. Cir. 2016) (Specification describedadditional elements as “either performing basiccomputer functions such as sending and receivingdata, or performing functions ‘known’ in the art.”).

Even if the specification is silent, however, courtshave not required evidence to support a finding thatadditional elements were well understood, routine,

conventional activities, but instead have treated theissue as a matter appropriate for judicial notice. Assuch, a rejection should only be made if an examinerrelying on the examiner's expertise in the art canreadily conclude in the Step 2B inquiry that theadditional elements do not amount to significantlymore (Step 2B: NO). If the elements or functionsare beyond those recognized in the art or by thecourts as being well understood, routine,conventional activity, then the elements or functionswill in most cases amount to significantly more (Step2B: YES). For more information on formulating asubject matter eligibility rejection involvingwell-understood, routine, conventional activity, seeMPEP § 2106.07(a).

II. ELEMENTS THAT THE COURTS HAVERECOGNIZED AS WELL-UNDERSTOOD,ROUTINE, CONVENTIONAL ACTIVITY INPARTICULAR FIELDS

Because examiners should rely on what the courtshave recognized, or those of ordinary skill in the artwould recognize, as elements that describewell understood, routine activities, the followingsection provides examples of elements that havebeen recognized by the courts as well-understood,routine, conventional activity in particular fields. Itshould be noted, however, that many of theseexamples failed to satisfy other Step 2Bconsiderations (e.g., because they were recited at ahigh level of generality and thus were mereinstructions to apply an exception, or wereinsignificant extra-solution activity). Thus,examiners should carefully analyze additionalelements in a claim with respect to all relevant Step2B considerations, including this consideration,before making a conclusion as to whether theyamount to an inventive concept.

The courts have recognized the following computerfunctions as well understood, routine, andconventional functions when they are claimed in amerely generic manner (e.g., at a high level ofgenerality) or as insignificant extra-solution activity.

i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec,838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing anintermediary computer to forward information); TLICommunications LLC v. AV Auto. LLC, 823 F.3d

2100-60Rev. 08.2017, January 2018


607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016)(using a telephone for image transmission); OIPTechs., Inc., v. Amazon.com, Inc., 788 F.3d 1359,1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015)(sending messages over a network); buySAFE, Inc.v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d1093, 1096 (Fed. Cir. 2014) (computer receives andsends information over a network); but see DDRHoldings, LLC v. Hotels.com, L.P., 773 F.3d 1245,1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014)(“Unlike the claims in Ultramercial, the claims atissue here specify how interactions with theInternet are manipulated to yield a desired result aresult that overrides the routine and conventionalsequence of events ordinarily triggered by the clickof a hyperlink.” (emphasis added));

ii. Performing repetitive calculations, Flook,437 U.S. at 594, 198 USPQ2d at 199 (recomputingor readjusting alarm limit values); Bancorp Servicesv. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425,1433 (Fed. Cir. 2012) (“The computer required bysome of Bancorp’s claims is employed only for itsmost basic function, the performance of repetitivecalculations, and as such does not impose meaningfullimits on the scope of those claims.”);

iii. Electronic recordkeeping, Alice Corp., 134S. Ct. at 2359, 110 USPQ2d at 1984 (creating andmaintaining “shadow accounts”); Ultramercial, 772F.3d at 716, 112 USPQ2d at 1755 (updating anactivity log);

iv. Storing and retrieving information inmemory, Versata Dev. Group, Inc. v. SAP Am., Inc.,793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed.Cir. 2015); OIP Techs., 788 F.3d at 1363, 115USPQ2d at 1092-93;

v. Electronically scanning or extracting datafrom a physical document, Content Extraction andTransmission, LLC v. Wells Fargo Bank, 776 F.3d1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir.2014) (optical character recognition); and

vi. A web browser’s back and forward buttonfunctionality, Internet Patent Corp. v. ActiveNetwork, Inc., 790 F.3d 1343, 1348, 115 USPQ2d1414, 1418 (Fed. Cir. 2015).

This listing is not meant to imply that all computerfunctions are well understood, routine, conventionalactivities, or that a claim reciting a generic computercomponent performing a generic computer function

is necessarily ineligible. See e.g. Amdocs (Israel),Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1316,120 USPQ2d 1527, 1549 (Fed. Cir. 2016), BASCOMGlobal Internet Servs. v. AT&T Mobility LLC, 827F.3d 1341, 1348, 119 USPQ2d 1236, 1241 (Fed.Cir. 2016). Courts have held computer implementedprocesses not to be significantly more than anabstract idea (and thus ineligible) where the claimas a whole amounts to nothing more than genericcomputer functions merely used to implement anabstract idea, such as an idea that could be done bya human analog (i.e., by hand or by merely thinking).On the other hand, courts have heldcomputer-implemented processes to be significantlymore than an abstract idea (and thus eligible), wheregeneric computer components are able incombination to perform functions that are not merelygeneric. DDR Holdings, LLC v. Hotels.com, L.P.,773 F.3d 1245, 1257-59, 113 USPQ2d 1097,1105-07 (Fed. Cir. 2014).

The courts have recognized the following laboratorytechniques as well-understood, routine, conventionalactivity in the life science arts when they are claimedin a merely generic manner (e.g., at a high level ofgenerality) or as insignificant extra-solution activity.

i. Determining the level of a biomarker in bloodby any means, Mayo, 566 U.S. at 79, 101 USPQ2dat 1968; Cleveland Clinic Foundation v. True HealthDiagnostics, LLC, 859 F.3d 1352, 1362, 123USPQ2d 1081, 1088 (Fed. Cir. 2017);

ii. Using polymerase chain reaction to amplifyand detect DNA, Genetic Techs. v. Merial LLC, 818F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed.Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom,Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157(Fed. Cir. 2015);

iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at1157); Cleveland Clinic Foundation 859 F.3d at1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);

iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC,659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed.Cir. 2011);

v. Analyzing DNA to provide sequenceinformation or detect allelic variants, GeneticTechs., 818 F.3d at 1377; 118 USPQ2d at 1546;

Rev. 08.2017, January 20182100-61

§ 2106.05(d)PATENTABILITY

vi. Freezing and thawing cells, Rapid Litig.Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;

vii. Amplifying and sequencing nucleic acidsequences, University of Utah Research Foundationv. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d1241, 1247 (Fed. Cir. 2014); and

viii. Hybridizing a gene probe, Ambry Genetics,774 F.3d at 764, 113 USPQ2d at 1247.

Below are examples of other types of activity thatthe courts have found to be well-understood, routine,conventional activity when they are claimed in amerely generic manner (e.g., at a high level ofgenerality) or as insignificant extra-solution activity.

i. Recording a customer’s order, Apple, Inc. v.Ameranth, Inc., 842 F.3d 1229, 1244, 120 USPQ2d1844, 1856 (Fed. Cir. 2016);

ii. Shuffling and dealing a standard deck ofcards, In re Smith, 815 F.3d 816, 819, 118 USPQ2d1245, 1247 (Fed. Cir. 2016);

iii. Restricting public access to media byrequiring a consumer to view an advertisement, Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709,716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir.2014);

iv. Identifying undeliverable mail items,decoding data on those mail items, and creatingoutput data, Return Mail, Inc. v. U.S. Postal Service,-- F.3d --, -- USPQ2d --, slip op. at 32 (Fed. Cir.August 28, 2017);

v. Presenting offers and gathering statistics, OIPTechs., 788 F.3d at 1362-63, 115 USPQ2d at1092-93;

vi. Determining an estimated outcome andsetting a price, OIP Techs., 788 F.3d at 1362-63,115 USPQ2d at 1092-93; and

vii. Arranging a hierarchy of groups, sortinginformation, eliminating less restrictive pricinginformation and determining the price, Versata Dev.Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1331,115 USPQ2d 1681, 1699 (Fed. Cir. 2015).

2106.05(e) Other Meaningful Limitations[R-08.2017]

For a claim that is directed to a judicial exception tobe patent-eligible, it must include additional features

to ensure that the claim describes a process orproduct that applies the exception in a meaningfulway, such that it is more than a drafting effortdesigned to monopolize the exception. The claimshould add meaningful limitations beyond generallylinking the use of the judicial exception to aparticular technological environment to transformthe judicial exception into patent-eligible subjectmatter. The phrase “meaningful limitations” hasbeen used by the courts even before Alice and Mayoin various contexts to describe additional elementsthat provide an inventive concept to the claim as awhole. The considerations described in MPEP §2106.05(a)-(d) are meaningful limitations when theyamount to significantly more than the judicialexception. This broad label signals that there can beother considerations besides those described inMPEP § 2106.05(a)-(d) that when added to a judicialexception amount to meaningful limitations that cantransform a claim into patent-eligible subject matter.

Diamond v. Diehr provides an example of a claimthat recited meaningful limitations beyond generallylinking the use of the judicial exception to aparticular technological environment. 450 U.S. 175,209 USPQ 1 (1981). In Diehr, the claim wasdirected to the use of the Arrhenius equation (anabstract idea or law of nature) in an automatedprocess for operating a rubber-molding press. 450U.S. at 177-78, 209 USPQ at 4. The Court evaluatedadditional elements such as the steps of installingrubber in a press, closing the mold, constantlymeasuring the temperature in the mold, andautomatically opening the press at the proper time,and found them to be meaningful because theysufficiently limited the use of the mathematicalequation to the practical application of moldingrubber products. 450 U.S. at 184, 187, 209 USPQat 7, 8. In contrast, the claims in Alice Corp. v. CLSBank International did not meaningfully limit theabstract idea of mitigating settlement risk. 573 U.S.__, 134 S. Ct. 2347, 110 USPQ2d 1976 (2014). Inparticular, the Court concluded that the additionalelements such as the data processing system andcommunications controllers recited in the systemclaims did not meaningfully limit the abstract ideabecause they merely linked the use of the abstractidea to a particular technological environment (i.e.,“implementation via computers”) or werewell-understood, routine, conventional activity

2100-62Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.05(e)

recited at a high level of generality. 134 S. Ct. at2360, 110 USPQ2d at 1984-85.

Classen Immunotherapies Inc. v. Biogen IDECprovides another example of claims that recitedmeaningful limitations. 659 F.3d 1057, 100 USPQ2d1492 (Fed. Cir. 2011) (decision on remand from theSupreme Court, which had vacated the lower court’sprior holding of ineligibility in view of Bilski v.Kappos). In Classen, the claims recited methodsthat gathered and analyzed the effects of particularimmunization schedules on the later developmentof chronic immune-mediated disorders in mammalsin order to identify a lower risk immunizationschedule, and then immunized mammalian subjectsin accordance with the identified lower risk schedule(thereby lowering the risk that the immunized subjectwould later develop chronic immune-mediateddiseases). 659 F.3d at 1060-61; 100 USPQ2d at1495-6. Although the analysis step was an abstractmental process that collected and compared knowninformation, the immunization step was meaningfulbecause it integrated the results of the analysis intoa specific and tangible method that resulted in themethod “moving from abstract scientific principleto specific application.” 659 F.3d at 1066-68; 100USPQ2d at 1500-1. In contrast, in OIPTechnologies, Inc. v. Amazon.com, Inc., the courtdetermined that the additional steps to “test pricesand collect data based on the customer reactions”did not meaningfully limit the abstract idea ofoffer-based price optimization, because the stepswere well-understood, routine, conventionaldata-gathering activities. 788 F.3d 1359, 1363-64,115 USPQ2d 1090, 1093 (Fed. Cir. 2015).

When evaluating whether additional elementsmeaningfully limit the judicial exception, it isparticularly critical that examiners consider theadditional elements both individually and as acombination. When an additional element isconsidered individually by an examiner, theadditional element may be enough to qualify as“significantly more” if it meaningfully limits thejudicial exception. However, even in the situationwhere the individually-viewed elements do not addsignificantly more, those additional elements whenviewed in combination may amount to significantlymore than the judicial exception by meaningfullylimiting the exception. See Diamond v. Diehr, 450

U.S. 175, 188, 209 USPQ2d 1, 9 (1981) (“a newcombination of steps in a process may be patentableeven though all the constituents of the combinationwere well known and in common use before thecombination was made”); BASCOM Global InternetServs. V. AT&T Mobility LLC, 827 F.3d 1341, 1349,119 USPQ2d 1236, 1242 (Fed. Cir. 2016). It isimportant to note that, when appropriate, anexaminer may explain on the record why theadditional elements meaningfully limit the judicialexception.

2106.05(f) Mere Instructions To Apply AnException [R-08.2017]

Another consideration when determining whether aclaim recites significantly more than a judicialexception is whether the additional elements amountto more than a recitation of the words “apply it” (oran equivalent) or are more than mere instructions toimplement an abstract idea or other exception on acomputer. As explained by the Supreme Court, inorder to transform a judicial exception into apatent-eligible application, the additional elementor combination of elements must do “‘more thansimply stat[e] the [judicial exception] while addingthe words ‘apply it’”. Alice Corp. v. CLS Bank, 573U.S. __, 134 S. Ct. 2347, 2357, 110 USPQ2d 1976,1982-83 (2014) (quoting Mayo Collaborative Servs.V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101USPQ2d 1961, 1965). Thus, for example, claimsthat amount to nothing more than an instruction toapply the abstract idea using a generic computer donot render an abstract idea eligible. Alice Corp., 134S. Ct. at 2358, 110 USPQ2d at 1983. See also 134S. Ct. at 2389, 110 USPQ2d at 1984 (warning againsta § 101 analysis that turns on “the draftsman’s art”).

The Supreme Court has identified additionalelements as mere instructions to apply an exceptionin several cases. For instance, in Mayo, the SupremeCourt concluded that a step of determining thiopurinemetabolite levels in patients’ blood did not amountto significantly more than the recited laws of nature,because this additional element simply instructeddoctors to apply the laws by measuring themetabolites in any way the doctors (or medicallaboratories) chose to use. 566 U.S. at 79, 101USPQ2d at 1968. In Alice Corp., the claim recitedthe concept of intermediated settlement as performed

Rev. 08.2017, January 20182100-63

§ 2106.05(f)PATENTABILITY

by a generic computer. The Court found that therecitation of the computer in the claim amounted tomere instructions to apply the abstract idea on ageneric computer. 134 S. Ct. at 2359-60, 110USPQ2d at 1984. The Supreme Court also discussedthis concept in an earlier case, Gottschalk v. Benson,409 U.S. 63, 70, 175 USPQ 673, 676 (1972), wherethe claim recited a process for convertingbinary-coded-decimal (BCD) numerals into purebinary numbers. The Court found that the claimedprocess had no substantial practical applicationexcept in connection with a computer. Benson, 409U.S. at 71-72, 175 USPQ at 676. The claim simplystated a judicial exception (e.g., law of nature orabstract idea) while effectively adding words that“apply it” in a computer. Id.

Requiring more than mere instructions to apply anexception does not mean that the claim must benarrow in order to be eligible. The courts haveidentified some broad claims as eligible see, e.g., McRO, Inc. v. Bandai Namco Games Am. Inc.,837 F.3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016); Thales Visionix Inc. v. United States, 850 F.3d.1343, 121 USPQ2d 1898 (Fed. Cir. 2017), and somenarrow claims as ineligible see e.g., Ultramercial,Inc. v. Hulu, LLC, 772 F.3d 709, 112 USPQ2d 1750(Fed. Cir. 2014); Electric Power Group, LLC v.Alstom, S.A., 830 F.3d 1350, 119 USPQ2d 1739(Fed. Cir. 2016)). Thus, examiners should carefullyconsider each claim on its own merits, as well asevaluate all other relevant Step 2B considerations,before making a determination of whether an element(or combination of elements) is more than mereinstructions to apply an exception. For example,because this consideration often overlaps with theimprovement consideration (see MPEP §2106.05(a)), the particular machine and particulartransformation considerations (see MPEP §2106.05(b) and (c), respectively), and thewell-understood, routine, conventional consideration(see MPEP § 2106.05(d)), evaluation of those otherconsiderations may assist examiners in making adetermination of whether an element (or combinationof elements) is more than mere instructions to applyan exception.

For claim limitations that do not amount to morethan a recitation of the words “apply it” (or anequivalent), such as mere instructions to implement

an abstract idea on a computer, examiners shouldexplain why they do not meaningfully limit the claimin an eligibility rejection. For example, an examinercould explain that implementing an abstract idea ona generic computer, does not add significantly more,similar to how the recitation of the computer in theclaim in Alice amounted to mere instructions toapply the abstract idea of intermediated settlementon a generic computer. For more information onformulating a subject matter eligibility rejectioninvolving well-understood, routine, conventionalactivity see MPEP § 2106.07(a).

When determining whether a claim simply recites ajudicial exception with the words “apply it” (or anequivalent), such as mere instructions to implementan abstract idea on a computer, examiners mayconsider the following.

(1) Whether the claim recites only the idea of asolution or outcome i.e., the claim fails to recitedetails of how a solution to a problem isaccomplished. The recitation of claim limitationsthat attempt to cover any solution to an identifiedproblem with no restriction on how the result isaccomplished and no description of the mechanismfor accomplishing the result, does not providesignificantly more because this type of recitation isequivalent to the words “apply it”. See ElectricPower Group, LLC v. Alstom, S.A., 830 F.3d 1350,1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307,1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed.Cir. 2015). In contrast, claiming a particular solutionto a problem or a particular way to achieve a desiredoutcome may provide significantly more. See Electric Power, 830 F.3d at 1356, 119 USPQ2d at1743.

By way of example, in Intellectual Ventures I v.Capital One Fin. Corp., 850 F.3d 1332, 121 USPQ2d1940 (Fed. Cir. 2017), the steps in the claimsdescribed “the creation of a dynamic document basedupon ‘management record types’ and ‘primary recordtypes.’” 850 F.3d at 1339-40; 121 USPQ2d at1945-46. The claims were found to be directed tothe abstract idea of “collecting, displaying, andmanipulating data.” 850 F.3d at 1340; 121 USPQ2d

2100-64Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.05(f)

at 1946. In addition to the abstract idea, the claimsalso recited the additional element of modifying theunderlying XML document in response tomodifications made in the dynamic document. 850F.3d at 1342; 121 USPQ2d at 1947-48. Althoughthe claims purported to modify the underlying XMLdocument in response to modifications made in thedynamic document, nothing in the claims indicatedwhat specific steps were undertaken other thanmerely using the abstract idea in the context of XMLdocuments. The court thus held the claims ineligible,because the additional limitations provided only aresult-oriented solution and lacked details as to howthe computer performed the modifications, whichwas equivalent to the words “apply it”. 850 F.3d at1341-42; 121 USPQ2d at 1947-48 (citing ElectricPower Group., 830 F.3d at 1356, 1356, USPQ2d at1743-44 (cautioning against claims “so resultfocused, so functional, as to effectively cover anysolution to an identified problem”)).

Other examples where the courts have found theadditional elements to be mere instructions to applyan exception, because they recite no more than anidea of a solution or outcome include:

i. Remotely accessing user-specific informationthrough a mobile interface and pointers to retrievethe information without any description of how themobile interface and pointers accomplish the resultof retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir.2017);

ii. A general method of screening emails on ageneric computer without any limitations thataddressed the issues of shrinking the protection gapand mooting the volume problem, IntellectualVentures I v. Symantec Corp., 838 F.3d 1307, 1319,120 USPQ2d 1353, 1361 (Fed. Cir. 2016); and

iii. Wireless delivery of out-of-regionbroadcasting content to a cellular telephone via anetwork without any details of how the delivery isaccomplished, Affinity Labs of Texas v. DirecTV,LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201,1207 (Fed. Cir. 2016).

In contrast, recent cases have found that additionalelements are more than “apply it” or are not “mereinstructions” when the claim recites a technological

solution to a technological problem. In DDRHoldings, the court found that the additionalelements did amount to more than merely instructingthat the abstract idea should be applied on theInternet. DDR Holdings, LLC v. Hotels.com, L.P.,773 F.3d 1245, 1259, 113 USPQ2d 1097, 1107 (Fed.Cir. 2014). The claims at issue specified howinteractions with the Internet were manipulated toyield a desired result—a result that overrode theroutine and conventional sequence of eventsordinarily triggered by the click of a hyperlink. 773F.3d at 1258; 113 USPQ2d at 1106. In BASCOM,the court determined that the claimed combinationof limitations did not simply recite an instruction toapply the abstract idea of filtering content on theInternet. BASCOM Global Internet Servs. v. AT&TMobility, LLC, 827 F.3d 1341, 1350, 119 USPQ2d1236, 1243 (Fed. Cir. 2016). Instead, the claimrecited a “technology based solution” of filteringcontent on the Internet that overcome thedisadvantages of prior art filtering systems. 827 F.3dat 1350-51, 119 USPQ2d at 1243. Finally, in ThalesVisionix, the particular configuration of inertialsensors and the particular method of using the rawdata from the sensors was more than simply applyinga law of nature. Thales Visionix, Inc. v. UnitedStates, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898,1902 (Fed. Cir. 2017). The court found that theclaims provided a system and method that“eliminate[d] many ‘complications’ inherent inprevious solutions for determining position andorientation of an object on a moving platform.” Inother words, the claim recited a technologicalsolution to a technological problem. Id.

(2) Whether the claim invokes computers or othermachinery merely as a tool to perform an existingprocess. Use of a computer or other machinery inits ordinary capacity for economic or other tasks(e.g., to receive, store, or transmit data) or simplyadding a general purpose computer or computercomponents after the fact to an abstract idea (e.g., afundamental economic practice or mathematicalequation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellulartelephone); TLI Communications LLC v. AV Auto,LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748(Fed. Cir. 2016) (computer server and telephoneunit). Similarly, “claiming the improved speed or

Rev. 08.2017, January 20182100-65


efficiency inherent with applying the abstract ideaon a computer” does not provide an inventiveconcept. Intellectual Ventures I LLC v. Capital OneBank (USA), 792 F.3d 1363, 1367, 115 USPQ2d1636, 1639 (Fed. Cir. 2015). In contrast, a claim thatpurports to improve computer capabilities or toimprove an existing technology may providesignificantly more. McRO, Inc. v. Bandai NamcoGames Am. Inc., 837 F.3d 1299, 1314-15, 120USPQ2d 1091, 1101-02 (Fed. Cir. 2016); Enfish,LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36,118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). SeeMPEP § 2106.05(a) for a discussion ofimprovements to the functioning of a computer orto another technology or technical field.

TLI Communications provides an example of aclaim invoking computers and other machinerymerely as a tool to perform an existing process. Thecourt stated that the claims describe steps ofrecording, administration and archiving of digitalimages, and found them to be directed to the abstractidea of classifying and storing digital images in anorganized manner. 823 F.3d at 612, 118 USPQ2d at1747. The court then turned to the additionalelements of performing these functions using atelephone unit and a server and noted that theseelements were being used in their ordinary capacity(i.e., the telephone unit is used to make calls andoperate as a digital camera including compressingimages and transmitting those images, and the serversimply receives data, extracts classificationinformation from the received data, and stores thedigital images based on the extracted information).823 F.3d at 612-13, 118 USPQ2d at 1747-48. Inother words, the claims invoked the telephone unitand server merely as tools to execute the abstractidea. Thus, the court found that the additionalelements did not add significantly more to theabstract idea because they were simply applying theabstract idea on a telephone network without anyrecitation of details of how to carry out the abstractidea.

Other examples where the courts have found theadditional elements to be mere instructions to applyan exception, because they do no more than merelyinvoke computers or machinery as a tool to performan existing process include:

i. A commonplace business method ormathematical algorithm being applied on a generalpurpose computer, Alice Corp. Pty. Ltd. V. CLSBank Int’l, 134 S. Ct. 2347, 1357, 110 USPQ2d1976, 1983 (2014); Gottschalk v. Benson, 409 U.S.63, 64, 175 USPQ 673, 674 (1972); Versata Dev.Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334,115 USPQ2d 1681, 1701 (Fed. Cir. 2015);

ii. Generating a second menu from a first menuand sending the second menu to another location asperformed by generic computer components, Apple,Inc. v. Ameranth, Inc., 842 F.3d 1229, 1243-44, 120USPQ2d 1844, 1855-57 (Fed. Cir. 2016);

iii. A process for monitoring audit log data thatis executed on a general-purpose computer wherethe increased speed in the process comes solely fromthe capabilities of the general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089,1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016);

iv. A method of using advertising as an exchangeor currency being applied or implemented on theInternet, Ultramercial, Inc. v. Hulu, LLC, 772 F.3d709, 715, 112 USPQ2d 1750, 1754 (Fed. Cir. 2014);

v. Requiring the use of software to tailorinformation and provide it to the user on a genericcomputer, Intellectual Ventures I LLC v. CapitalOne Bank (USA), 792 F.3d 1363, 1370-71, 115USPQ2d 1636, 1642 (Fed. Cir. 2015); and

vi. A method of assigning hair designs to balancehead shape with a final step of using a tool (scissors)to cut the hair, In re Brown, 645 Fed. App'x 1014,1017 (Fed. Cir. 2016) (non-precedential).

(3) The particularity or generality of theapplication of the judicial exception. A claimhaving broad applicability across many fields ofendeavor may not provide meaningful limitationsthat amount to significantly more. For instance, aclaim that generically recites an effect of the judicialexception or claims every mode of accomplishingthat effect, amounts to a claim that is merely addingthe words “apply it” to the judicial exception. See Internet Patents Corporation v. Active Network,Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418(Fed. Cir. 2015) (The recitation of maintaining thestate of data in an online form without restriction onhow the state is maintained and with no descriptionof the mechanism for maintaining the state describes“the effect or result dissociated from any method by

2100-66Rev. 08.2017, January 2018


which maintaining the state is accomplished” anddoes not provide a meaningful limitation because itmerely states that the abstract idea should be appliedto achieve a desired result). See also O’Reilly v.Morse, 56 U.S. 62 (1854) (finding ineligible a claimfor “the use of electromagnetism for transmittingsignals at a distance”); The Telephone Cases, 126U.S. 1, 209 (1888) (finding a method of “transmittingvocal or other sound telegraphically ... by causingelectrical undulations, similar in form to thevibrations of the air accompanying the said vocal orother sounds,” to be ineligible, because it“monopolize[d] a natural force” and “the right toavail of that law by any means whatever.”).

In contrast, limitations that confine the judicialexception to a particular, practical application of thejudicial exception may amount to significantly more.For example, in BASCOM, the combination ofadditional elements, and specifically “the installationof a filtering tool at a specific location, remote fromthe end users, with customizable filtering featuresspecific to each end user” where the filtering tool atthe ISP was able to “identify individual accountsthat communicate with the ISP server, and toassociate a request for Internet content with aspecific individual account,” were held to bemeaningful limitations because they confined theabstract idea of content filtering to a particular,practical application of the abstract idea. 827 F.3dat 1350-51, 119 USPQ2d at 1243.

2106.05(g) Insignificant Extra-SolutionActivity [R-08.2017]

Another consideration when determining whether aclaim recites significantly more is whether theadditional elements add more than insignificantextra-solution activity to the judicial exception. Theterm “extra-solution activity” can be understood asactivities incidental to the primary process or productthat are merely a nominal or tangential addition tothe claim. Extra-solution activity includes bothpre-solution and post-solution activity. An exampleof pre-solution activity is a step of gathering datafor use in a claimed process, e.g., a step of obtaininginformation about credit card transactions, which isrecited as part of a claimed process of analyzing andmanipulating the gathered information by a seriesof steps in order to detect whether the transactions

were fraudulent. An example of post-solution activityis an element that is not integrated into the claim asa whole, e.g., a printer that is used to output a reportof fraudulent transactions, which is recited in a claimto a computer programmed to analyze andmanipulate information about credit card transactionsin order to detect whether the transactions werefraudulent.

As explained by the Supreme Court, the addition ofinsignificant extra-solution activity does not amountto an inventive concept, particularly when theactivity is well-understood or conventional. Parkerv. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196(1978). In Flook, the Court reasoned that “[t]henotion that post-solution activity, no matter howconventional or obvious in itself, can transform anunpatentable principle into a patentable processexalts form over substance. A competent draftsmancould attach some form of post-solution activity toalmost any mathematical formula”. 437 U.S. at 590;198 USPQ at 197; Id. (holding that step of adjustingan alarm limit variable to a figure computedaccording to a mathematical formula was“post-solution activity”). See also MayoCollaborative Servs. v. Prometheus Labs. Inc., 566U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012)(additional element of measuring metabolites of adrug administered to a patient was insignificantextra-solution activity). Examiners should carefullyconsider each claim on its own merits, as well asevaluate all other relevant Step 2B considerations,before making a determination of whether an element(or combination of elements) is insignificantextra-solution activity. In particular, evaluation ofthe particular machine and particular transformationconsiderations (see MPEP § 2106.05(b) and (c),respectively), the well-understood, routine,conventional consideration (see MPEP §2106.05(d)), and the field of use and technologicalenvironment consideration (see MPEP § 2106.05(h))may assist examiners in making a determination ofwhether an element (or combination of elements) isinsignificant extra-solution activity.

This consideration is similar to factors used in pastOffice guidance (for example, the now superseded Bilski and Mayo analyses) that were described asmere data gathering in conjunction with a law ofnature or abstract idea. When determining whether

Rev. 08.2017, January 20182100-67

§ 2106.05(g)PATENTABILITY

an additional element is insignificant extra-solutionactivity, examiners may consider the following:

(1) Whether the extra-solution limitation is wellknown. See Bilski v. Kappos, 561 U.S. 593, 611-12,95 USPQ2d 1001, 1010 (2010) (well-known randomanalysis techniques to establish the inputs of anequation were token extra-solution activity); Flook,437 U.S. at 593-95, 198 USPQ at 197 (a formulawould not be patentable by only indicating that iscould be usefully applied to existing surveyingtechniques); Intellectual Ventures I LLC v. ErieIndem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d1928, 1937 (Fed. Cir. 2017) (the use of a well-knownXML tag to form an index was deemed tokenextra-solution activity).

(2) Whether the limitation is significant (i.e. itimposes meaningful limits on the claim such thatit is not nominally or tangentially related to theinvention). See Ultramercial, Inc. v. Hulu, LLC,772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755(Fed. Cir. 2014) (restricting public access to mediawas found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242,120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patentsregarding electronic menus, features related to typesof ordering were found to be insignificantextra-solution activity).

(3) Whether the limitation amounts to necessarydata gathering and outputting, (i.e., all uses ofthe recited judicial exception require such datagathering or data output). See Mayo, 566 U.S. at79, 101 USPQ2d at 1968; OIP Techs., Inc. v.Amazon.com, Inc., 788 F.3d 1359, 1363, 115USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presentingoffers and gathering statistics amounted to mere datagathering).

Below are examples of activities that the courts havefound to be insignificant extra-solution activity.

• Mere Data Gathering:

i. Performing clinical tests on individuals toobtain input for an equation, In re Grams, 888 F.2d835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir.1989);

ii. Testing a system for a response, theresponse being used to determine system

malfunction, In re Meyers, 688 F.2d 789, 794; 215USPQ 193, 196-97 (CCPA 1982);

iii. Presenting offers to potential customersand gathering statistics generated based on the testingabout how potential customers responded to theoffers; the statistics are then used to calculate anoptimized price, OIP Technologies, 788 F.3d at1363, 115 USPQ2d at 1092-93;

iv. Obtaining information about transactionsusing the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir.2011);

v. Consulting and updating an activity log, Ultramercial, 772 F.3d at 715, 112 USPQ2d at1754; and

vi. Determining the level of a biomarker inblood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968.See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed.App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir.2012) (assessing or measuring data derived from anultrasound scan, to be used in a diagnosis).

• Selecting a particular data source or typeof data to be manipulated:

i. Limiting a database index to XML tags, Intellectual Ventures I LLC v. Erie Indem. Co., 850F.3d at 1328-29, 121 USPQ2d at 1937;

ii. Taking food orders from only table-basedcustomers or drive-through customers, Ameranth,842 F.3d at 1241-43, 120 USPQ2d at 1854-55;

iii. Selecting information, based on types ofinformation and availability of information in apower-grid environment, for collection, analysis anddisplay, Electric Power Group, LLC v. Alstom S.A.,830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742(Fed. Cir. 2016); and

iv. Requiring a request from a user to viewan advertisement and restricting public access, Ultramercial, 772 F.3d at 715-16, 112 USPQ2d at1754.

• Insignificant application:

i. Cutting hair after first determining the hairstyle, In re Brown, 645 Fed. App'x 1014, 1016-1017(Fed. Cir. 2016) (non-precedential); and

2100-68Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.05(g)

ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at1854-55.

Some cases have identified insignificant computerimplementation as an example of insignificantextra-solution activity. See e.g., Fort Props., Inc.v. Am. Master Lease LLC, 671 F.3d 1317, 1323-24,101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); Bancorp Servs., LLC v. Sun Life Assur. Co. ofCanada, 687 F.3d 1266, 1280-81, 103 USPQ2d1425, 1434-35 (Fed. Cir. 2012). Other cases haveconsidered these types of limitations as mereinstructions to apply a judicial exception. See MPEP§ 2106.05(f) for more information about insignificantcomputer implementation.

For claim limitations that add insignificantextra-solution activity to the judicial exception (e.g.,mere data gathering in conjunction with a law ofnature or abstract idea), examiners should explainin an eligibility rejection why they do notmeaningfully limit the claim. For example, anexaminer could explain that adding a final step ofstoring data to a process that only recites computingthe area of a space (a mathematical relationship)does not add a meaningful limitation to the processof computing the area. For more information onformulating a subject matter eligibility rejection, seeMPEP § 2106.07(a).

2106.05(h) Field of Use and TechnologicalEnvironment [R-08.2017]

Another consideration when determining whether aclaim recites significantly more than a judicialexception is whether the additional elements amountto more than generally linking the use of a judicialexception to a particular technological environmentor field of use. As explained by the Supreme Court,a claim directed to a judicial exception cannot bemade eligible “simply by having the applicantacquiesce to limiting the reach of the patent for theformula to a particular technological use.” Diamondv. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10n. 14 (1981). Thus, limitations that amount to merelyindicating a field of use or technological environmentin which to apply a judicial exception do not amountto significantly more than the exception itself.

The courts often cite to Parker v. Flook as providinga classic example of a field of use limitation. See, e.g., Bilski v. Kappos, 561 U.S. 593, 612, 95USPQ2d 1001, 1010 (2010) (“ Flook establishedthat limiting an abstract idea to one field of use oradding token postsolution components did not makethe concept patentable”) (citing Parker v. Flook,437 U.S. 584, 198 USPQ 193 (1978)). In Flook, theclaim recited steps of calculating an updated valuefor an alarm limit (a numerical limit on a processvariable such as temperature, pressure or flow rate)according to a mathematical formula “in a processcomprising the catalytic chemical conversion ofhydrocarbons.” 437 U.S. at 586, 198 USPQ at 196.Processes for the catalytic chemical conversion ofhydrocarbons were used in the petrochemical andoil-refining fields. Id. Although the applicant arguedthat limiting the use of the formula to thepetrochemical and oil-refining fields should makethe claim eligible because this limitation ensuredthat the claim did not preempt all uses of the formula,the Supreme Court disagreed and found that thislimitation did not amount to an inventive concept.437 U.S. at 588-90, 198 USPQ at 197-98. The Courtreasoned that to hold otherwise would “exalt[] formover substance”, because a competent claim draftercould attach a similar type of limitation to almostany mathematical formula. 437 U.S. at 590, 198USPQ at 197.

A more recent example of a limitation that does nomore than generally link a judicial exception to aparticular technological environment is Affinity Labsof Texas v. DirecTV, LLC, 838 F.3d 1253, 120USPQ2d 1201 (Fed. Cir. 2016). In Affinity Labs,the claim recited a broadcast system in which acellular telephone located outside the range of aregional broadcaster (1) requests and receivesnetwork-based content from the broadcaster via astreaming signal, (2) is configured to wirelesslydownload an application for performing thosefunctions, and (3) contains a display that allows theuser to select particular content. 838 F.3d at 1255-56,120 USPQ2d at 1202. The court identified theclaimed concept of providing out-of-region accessto regional broadcast content as an abstract idea, andnoted that the additional elements limited thewireless delivery of regional broadcast content tocellular telephones (as opposed to any and allelectronic devices such as televisions, cable boxes,

Rev. 08.2017, January 20182100-69

§ 2106.05(h)PATENTABILITY

computers, or the like). 838 F.3d at 1258-59, 120USPQ2d at 1204. Although the additional elementsdid limit the use of the abstract idea, the courtexplained that this type of limitation merely confinesthe use of the abstract idea to a particulartechnological environment (cellular telephones) andthus fails to add an inventive concept to the claims.838 F.3d at 1259, 120 USPQ2d at 1204.

There are no definitive tests for determining whethera particular claim limitation is a mere field of use oran attempt to generally link the use of a judicialexception to a particular technological environment.However, a common feature of many field of uselimitations (as well as other types of non-meaningfulclaim limitations) is an absence of integration intothe claim as a whole. For example, the additionalelement in Flook regarding the catalytic chemicalconversion of hydrocarbons was not integrated intothe claim, because it was merely an incidental ortoken addition to the claim that did not alter or affecthow the process steps of calculating the alarm limitvalue were performed. In contrast, the additionalelements in Diamond v. Diehr were integrated intothe claim as a whole and did not merely recitecalculating a cure time using the Arrhenius equation“in a rubber molding process”. Instead, the claim in Diehr recited specific limitations such as monitoringthe elapsed time since the mold was closed,constantly measuring the temperature in the moldcavity, repetitively calculating a cure time byinputting the measured temperature into theArrhenius equation, and opening the pressautomatically when the calculated cure time and theelapsed time are equivalent. 450 U.S. at 179, 209USPQ at 5, n. 5. These specific limitations act inconcert to transform raw, uncured rubber into curedmolded rubber, and thus integrate the Arrheniusequation into an improved rubber molding process.450 U.S. at 177-78, 209 USPQ at 4.

Examples of limitations that the courts havedescribed as merely indicating a field of use ortechnological environment in which to apply ajudicial exception include:

i. A step of administering a drug providing6-thioguanine to patients with an immune-mediatedgastrointestinal disorder, because limiting drugadministration to this patient population did no morethan simply refer to the relevant pre-existing

audience of doctors who used thiopurine drugs totreat patients suffering from autoimmune disorders, Mayo Collaborative Servs. v. Prometheus Labs.Inc., 566 U.S. 66, 78, 101 USPQ2d 1961, 1968(2012);

ii. Identifying the participants in a process forhedging risk as commodity providers and commodityconsumers, because limiting the use of the processto these participants did no more than describe howthe abstract idea of hedging risk could be used in thecommodities and energy markets, Bilski, 561 U.S.at 595, 95 USPQ2d at 1010;

iii. Limiting the use of the formula C = 2 (pi) rto determining the circumference of a wheel asopposed to other circular objects, because thislimitation represents a mere token acquiescence tolimiting the reach of the claim, Flook, 437 U.S. at595, 198 USPQ at 199;

iv. Specifying that the abstract idea ofmonitoring audit log data relates to transactions oractivities that are executed in a computerenvironment, because this requirement merely limitsthe claims to the computer field, i.e., to executionon a generic computer, FairWarning v. Iatric Sys.,839 F.3d 1089, 1094-95, 120 USPQ2d 1293, 1295(Fed. Cir. 2016);

v. Language specifying that the process steps ofvirus screening were used within a telephonenetwork or the Internet, because limiting the use ofthe process to these technological environments didnot provide meaningful limits on the claim, Intellectual Ventures I v. Symantec Corp., 838 F.3d1307, 1319-20, 120 USPQ2d 1353, 1361 (2016);

vi. Limiting the abstract idea of collectinginformation, analyzing it, and displaying certainresults of the collection and analysis to data relatedto the electric power grid, because limitingapplication of the abstract idea to power-gridmonitoring is simply an attempt to limit the use ofthe abstract idea to a particular technologicalenvironment, Electric Power Group, LLC v. AlstomS.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742(Fed. Cir. 2016);

vii. Language informing doctors to apply a lawof nature (linkage disequilibrium) for purposes ofdetecting a genetic polymorphism, because thislanguage merely informs the relevant audience thatthe law of nature can be used in this manner,

2100-70Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2106.05(h)

Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369,1379, 118 USPQ2d 1541, 1549 (Fed. Cir. 2016);

viii. Language specifying that the abstract ideaof budgeting was to be implemented using a“communication medium” that broadly included theInternet and telephone networks, because thislimitation merely limited the use of the exception toa particular technological environment, IntellectualVentures I v. Capital One Bank, 792 F.3d 1363,1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015);

ix. Specifying that the abstract idea of usingadvertising as currency is used on the Internet,because this narrowing limitation is merely anattempt to limit the use of the abstract idea to aparticular technological environment, Ultramercial,Inc. v. Hulu, LLC, 772 F.3d 709, 716, 112 USPQ2d1750, 1755 (Fed. Cir. 2014); and

x. Requiring that the abstract idea of creating acontractual relationship that guarantees performanceof a transaction (a) be performed using a computerthat receives and sends information over a network,or (b) be limited to guaranteeing online transactions,because these limitations simply attempted to limitthe use of the abstract idea to computerenvironments, buySAFE Inc. v. Google, Inc., 765F.3d 1350, 1354, 112 USPQ2d 1093, 1095-96 (Fed.Cir. 2014).

Examiners should be aware that the courts often usethe terms “technological environment” and “field ofuse” interchangeably, and thus for purposes of theeligibility analysis examiners should consider theseterms interchangeable. Examiners should also keepin mind that this consideration overlaps with otherStep 2B considerations, particularly insignificantextra-solution activity (see MPEP § 2106.05(g)).For instance, a data gathering step that is limited toa particular data source (such as the Internet) or aparticular type of data (such as power grid data orXML tags) could be considered to be bothinsignificant extra-solution activity and a field ofuse limitation. See, e.g., Ultramercial, 772 F.3d at716, 112 USPQ2d at 1755 (limiting use of abstractidea to the Internet); Electric Power, 830 F.3d at1354, 119 USPQ2d at 1742 (limiting application ofabstract idea to power grid data); IntellectualVentures I LLC v. Erie Indem. Co., 850 F.3d 1315,1328-29, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017)(limiting use of abstract idea to use with XML tags).Thus, examiners should carefully consider each

claim on its own merits, as well as evaluate all otherrelevant Step 2B considerations, before making adetermination on this consideration.

For claim limitations that generally link the use ofthe judicial exception to a particular technologicalenvironment or field of use, examiners shouldexplain in an eligibility rejection why they do notmeaningfully limit the claim. For example, anexaminer could explain that employing well-knowncomputer functions to execute an abstract idea, evenwhen limiting the use of the idea to one particularenvironment, does not add significantly more, similarto how limiting the abstract idea in Flook topetrochemical and oil-refining industries wasinsufficient. For more information on formulating asubject matter eligibility rejection, see MPEP §2106.07(a).

2106.06 Streamlined Analysis [R-08.2017]

For purposes of efficiency in examination, examinersmay use a streamlined eligibility analysis (PathwayA) when the eligibility of the claim is self-evident, e.g., because the claim clearly improves atechnology or computer functionality. However, ifthere is doubt as to whether the applicant iseffectively seeking coverage for a judicial exceptionitself, the full eligibility analysis (the Alice/Mayotest described in MPEP § 2106, subsection III)should be conducted to determine whether the claimrecites significantly more than the judicial exception.

The results of the streamlined analysis will alwaysbe the same as the full analysis, thus the streamlinedanalysis is not a means of avoiding a finding ofineligibility that would occur if a claim were toundergo the full eligibility analysis. Similarly, aclaim that qualifies as eligible after Step 2A(Pathway B) or Step 2B (Pathway C) of the fullanalysis would also be eligible if the streamlinedanalysis (Pathway A) were applied to that claim. Itmay not be apparent that an examiner employed thestreamlined analysis because the result is aconclusion that the claim is eligible, and there willbe no rejection of the claim on eligibility grounds.In practice, the record may reflect the conclusion ofeligibility simply by the absence of an eligibilityrejection or may include clarifying remarks, whenappropriate.

Rev. 08.2017, January 20182100-71


In the context of the flowchart in MPEP § 2106,subsection III, if, when viewed as a whole, theeligibility of the claim is self-evident (e.g., becausethe claim clearly improves a technology or computerfunctionality), the claim is eligible at Pathway A,thereby concluding the eligibility analysis.

2106.06(a) Eligibility is Self Evident[R-08.2017]

A streamlined eligibility analysis can be used for aclaim that may or may not recite a judicial exceptionbut, when viewed as a whole, clearly does not seekto tie up any judicial exception such that otherscannot practice it. Such claims do not need toproceed through the full analysis herein as theireligibility will be self-evident. On the other hand, aclaim that does not qualify as eligible after Step 2Bof the full analysis would not be suitable for thestreamlined analysis, because the claim lacksself evident eligibility.

For instance, a claim directed to a complexmanufactured industrial product or process thatrecites meaningful limitations along with a judicialexception may sufficiently limit its practicalapplication so that a full eligibility analysis is notneeded. As an example, a robotic arm assemblyhaving a control system that operates using certainmathematical relationships is clearly not an attemptto tie up use of the mathematical relationships andwould not require a full analysis to determineeligibility. Also, a claim that recites a nature-basedproduct, but clearly does not attempt to tie up thenature-based product, does not require a markedlydifferent characteristics analysis to identify a“product of nature” exception. As an example, aclaim directed to an artificial hip prosthesis coatedwith a naturally occurring mineral is not an attemptto tie up the mineral. Similarly, claimed productsthat merely include ancillary nature-basedcomponents, such as a claim that is directed to acellphone with an electrical contact made of gold ora plastic chair with wood trim, would not requireanalysis of the nature-based component to determinewhether the claims are directed to a “product ofnature” exception because such claims do not attemptto improperly tie up the nature-based product.

2106.06(b) Clear Improvement to aTechnology or to Computer Functionality[R-08.2017]

As explained by the Federal Circuit, someimprovements to technology or to computerfunctionality are not abstract when appropriatelyclaimed, and thus claims to such improvements donot always need to undergo the full eligibilityanalysis. Enfish, LLC v. Microsoft Corp., 822 F.3d1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir.2016). MPEP § 2106.05(a) provides details regardingimprovements to a technology or computerfunctionality.

For instance, claims directed to clear improvementsto computer-related technology do not need the fulleligibility analysis. Enfish, 822 F.3d at 1339, 118USPQ2d at 1691-92 (claims to a self-referential tablefor a computer database held eligible at step 1 of the Alice/Mayo test as not directed to an abstract idea).Claims directed to improvements to othertechnologies or technological processes, beyondcomputer improvements, may also avoid the fulleligibility analysis. McRO, Inc. v. Bandai NamcoGames Am. Inc., 837 F.3d 1299, 1316, 120 USPQ2d1091, 1103 (Fed. Cir. 2016) (claims to automatic lipsynchronization and facial expression animationfound eligible at Step 1 of the Alice/Mayo test asdirected to an improvement in computer-relatedtechnology). In these cases, when the claims wereviewed as a whole, their eligibility was self-evidentbased on the clear improvement, so no furtheranalysis was needed. Although the Federal Circuitheld these claims eligible at Step 2A as not beingdirected to abstract ideas, it would be reasonable foran examiner to have found these claims eligible atPathway A based on the clear improvement, or atPathway B (Step 2A) as not being directed to anabstract idea.

If the claims are a “close call” such that it is unclearwhether the claims improve technology or computerfunctionality, a full eligibility analysis should beperformed to determine eligibility. See BASCOMGlobal Internet v. AT&T Mobility LLC, 827 F.3d1341, 1349, 119 USPQ2d 1236, 1241 (Fed Cir.2016). Only when the claims clearly improvetechnology or computer functionality, or otherwisehave self-evident eligibility, should the streamlined

2100-72Rev. 08.2017, January 2018


analysis be used. For example, because the claimsin BASCOM described the concept of filteringcontent, which is a method of organizing humanbehavior previously found to be abstract, the FederalCircuit considered them to present a “close call” inthe first step of the Alice/Mayo test (Step 2A), andthus proceeded to the second step of the Alice/Mayotest (Step 2B) to determine their eligibility. Id.Although the Federal Circuit held these claimseligible at Step 2B (Pathway C) because theypresented a “technology-based solution” of filteringcontent on the Internet that overcame thedisadvantages of prior art filtering systems and thatamounted to significantly more than the recitedabstract idea, it also would be reasonable for anexaminer to have found these claims eligible atPathway A or B if the examiner had considered thetechnology-based solution to be an improvement tocomputer functionality.

2106.07 Formulating and SupportingRejections For Lack Of Subject MatterEligibility [R-08.2017]

Eligibility rejections must be based on failure tocomply with the substantive law under 35 U.S.C.101 as interpreted by judicial precedent. Thesubstantive law on eligibility is discussed in MPEP§ 2106.03 through 2106.06. Examination guidance,training, and explanatory examples discuss thesubstantive law and establish the policies andprocedures to be followed by examiners in evaluatingpatent applications for compliance with thesubstantive law, but do not serve as a basis for arejection. Accordingly, while it would be acceptablefor applicants to cite training materials or examplesin support of an argument for finding eligibility inan appropriate factual situation, applicants shouldnot be required to model their claims or responsesafter the training materials or examples to attaineligibility.

When evaluating a claimed invention for compliancewith the substantive law on eligibility, examinersshould review the record as a whole (e.g., thespecification, claims, the prosecution history, andany relevant case law precedent or prior art) beforereaching a conclusion with regard to whether theclaimed invention sets forth patent eligible subjectmatter. The evaluation of whether the claimed

invention qualifies as patent-eligible subject mattershould be made on a claim-by-claim basis, becauseclaims do not automatically rise or fall with similarclaims in an application. For example, even if anindependent claim is determined to be ineligible, thedependent claims may be eligible because they addlimitations amounting to significantly more than thejudicial exception recited in the independent claim.Thus, each claim in an application should beconsidered separately based on the particularelements recited therein.

If the evaluation of the claimed invention results ina conclusion that it is more likely than not that theclaim as a whole does not satisfy both criteria foreligibility (Step 1: NO and/or Step 2B: NO), thenexaminers should formulate an appropriate rejectionof that claim under Step 1 and/or Step 2B. Therejection should set forth a prima facie case ofineligibility under the substantive law. The conceptof the prima facie case is a procedural tool of patentexamination, which allocates the burdens goingforward between the examiner and applicant. Inparticular, the initial burden is on the examiner toexplain why a claim or claims are ineligible forpatenting clearly and specifically, so that applicanthas sufficient notice and is able to effectivelyrespond.

When an examiner determines a claim does not fallwithin a statutory category (Step 1: NO), therejection should provide an explanation of why theclaim is not directed to one of the four statutorycategories of invention. See MPEP § 706.03(a) forinformation on making the rejection, and MPEP §2106.03 for a discussion of Step 1 and the statutorycategories of invention.

When an examiner determines that a claim isdirected to a judicial exception (Step 2A: YES) anddoes not provide an inventive concept (Step 2B:NO), the rejection should provide an explanation foreach part of the Step 2 analysis. For example, therejection should identify the judicial exception byreferring to what is recited (i.e., set forth ordescribed) in the claim and explain why it isconsidered an exception, identify any additionalelements (specifically point to claimfeatures/limitations/steps) recited in the claim beyondthe identified judicial exception, and explain the

Rev. 08.2017, January 20182100-73


reason(s) that the additional elements takenindividually, and also taken as a combination, donot result in the claim as a whole amounting tosignificantly more than the judicial exception. SeeMPEP § 2106.04 for a discussion of Step 2A andthe judicial exceptions, MPEP § 2106.05 for adiscussion of Step 2B and the search for an inventiveconcept, and MPEP § 2106.07(a) for moreinformation on formulating an ineligibility rejection.

If the evaluation of the claimed invention results ina conclusion that it is more likely than not that theclaimed invention falls within a statutory category(Step 1: YES) and is either not directed to a judicialexception (Step 2A: NO) or is directed to a judicialexception and amounts to significantly more thanthe judicial exception (Step 2B: YES), then theexaminer should not reject the claim. Whenevaluating a response by applicant to a subject mattereligibility rejection, examiners must carefullyconsider all of applicant’s arguments and evidencepresented to rebut the rejection. If applicant properlychallenges the examiner’s findings, the rejectionshould be withdrawn or, if the examiner deems itappropriate to maintain the rejection, a rebuttal mustbe provided in the next Office action. This isdiscussed in greater detail in MPEP § 2106.07(b).

2106.07(a) Formulating a Rejection For Lackof Subject Matter Eligibility [R-08.2017]

After determining what the applicant invented andestablishing the broadest reasonable interpretationof the claimed invention (see MPEP § 2111), theeligibility of each claim should be evaluated as awhole using the analysis detailed in MPEP § 2106.If it is determined that the claim does not reciteeligible subject matter, a rejection under 35 U.S.C.101 is appropriate. When making the rejection, theOffice action must provide an explanation as to whyeach claim is unpatentable, which must besufficiently clear and specific to provide applicantsufficient notice of the reasons for ineligibility andenable the applicant to effectively respond.

Subject matter eligibility rejections under Step 1 arediscussed in MPEP § 706.03(a).

A subject matter eligibility rejection under Step 2should provide an explanation for each part of theStep 2 analysis:

• For Step 2A, the rejection should identify thejudicial exception by referring to what is recited(i.e., set forth or described) in the claim and explainwhy it is considered an exception. For example, ifthe claim is directed to an abstract idea, therejection should identify the abstract idea as it isrecited (i.e., set forth or described) in the claim andexplain why it corresponds to a concept that thecourts have identified as an abstract idea. Similarly,if the claim is directed to a law of nature or anatural phenomenon, the rejection should identifythe law of nature or natural phenomenon as it isrecited (i.e., set forth or described) in the claim andexplain using a reasoned rationale why it isconsidered a law of nature or natural phenomenon.

• For Step 2B, the rejection should identify anyadditional elements (specifically point to claimfeatures/limitations/steps) recited in the claim beyondthe identified judicial exception; and explain thereason(s) that the additional elements takenindividually, and also taken as a combination, donot result in the claim as a whole amounting tosignificantly more than the judicial exceptionidentified in Step 2A. For instance, when theexaminer has concluded that certain claim elementsrecite well understood, routine, conventionalactivities in the relevant field of art, the rejectionshould explain why the courts have recognized, orthose in the field would recognize, the additionalelements when taken both individually and as acombination to be well-understood, routine,conventional activities.

Under the principles of compact prosecution,regardless of whether a rejection under 35 U.S.C.101 is made based on lack of subject mattereligibility, a complete examination should be madefor every claim under each of the other patentabilityrequirements: 35 U.S.C. 102, 103, 112, and 101(utility, inventorship and double patenting) andnon-statutory double patenting. Thus, examinersshould state all non-cumulative reasons and basesfor rejecting claims in the first Office action.

2100-74Rev. 08.2017, January 2018


I. WHEN MAKING A REJECTION, IDENTIFYAND EXPLAIN THE JUDICIAL EXCEPTIONRECITED IN THE CLAIM (STEP 2A)

A subject matter eligibility rejection should point tothe specific claim limitation(s) that recites (i.e., setsforth or describes) the judicial exception. Therejection must identify the specific claim limitationsand explain why those claim limitations set forth ajudicial exception (e.g., an abstract idea). Where theclaim describes, but does not expressly set forth, thejudicial exception, the rejection must also explainwhat subject matter those limitations describe, andwhy the described subject matter is a judicialexception. See MPEP § 2106.04 for moreinformation about Step 2A of the eligibility analysis.

When the examiner has determined the claim recitesan abstract idea, the rejection should identify theabstract idea as it is recited (i.e., set forth ordescribed) in the claim, and explain why itcorresponds to a concept that the courts haveidentified as an abstract idea. See, for example, theconcepts identified in MPEP § 2106.04(a)(2). Citingto an appropriate court decision that supports theidentification of the subject matter recited in theclaim language as an abstract idea is a best practicethat will advance prosecution. Examiners should befamiliar with any cited decision relied upon inmaking or maintaining a rejection to ensure that therejection is reasonably tied to the facts of the caseand to avoid relying upon language taken out ofcontext. Examiners should not go beyond thoseconcepts that are similar to what the courts haveidentified as abstract ideas, and should avoid relyingupon or citing non-precedential decisions unless thefacts of the application under examination uniquelymatch the facts at issue in the non-precedentialdecisions. Examiners are reminded that a chart ofcourt decisions is available on the USPTO’s Internetwebsite (www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility).

Sample explanation: The claim recites the steps of sortinginformation by X, which is an abstract idea similar to theconcepts that have been identified as abstract by the courts, suchas organizing information through mathematical correlations in Digitech or data recognition and storage in Content Extraction.

When the examiner has determined the claim recitesa law of nature or a natural phenomenon, therejection should identify the law of nature or naturalphenomenon as it is recited (i.e., set forth ordescribed) in the claim and explain using a reasonedrationale why it is considered a law of nature ornatural phenomenon. See MPEP § 2106.04(b) formore information about laws of nature and naturalphenomena.

Sample explanation: The claim recites the correlation of X, andX is a law of nature because it describes a consequence of naturalprocesses in the human body, e.g., the naturally-occurringrelationship between the presence of Y and the manifestationof Z.

Sample explanation: The claim recites X, which is a naturalphenomenon because it occurs in nature and exists in principleapart from any human action.

When the examiner has determined the claim recitesa product of nature, the rejection should identifythe exception as it is recited (i.e., set forth ordescribed) in the claim, and explain using a reasonedrationale why the product does not have markedlydifferent characteristics from its naturally occurringcounterpart in its natural state. See MPEP §2106.04(b) for more information about products ofnature, and MPEP § 2106.04(c) for more informationabout the markedly different characteristics analysis.

Sample explanation: The claim recites X, which as explainedin the specification was isolated from naturally occurring Y. Xis a nature-based product, so it is compared to its closestnaturally occurring counterpart (X in its natural state) todetermine if it has markedly different characteristics. Becausethere is no indication in the record that isolation of X has resultedin a marked difference in structure, function, or other propertiesas compared to its counterpart, X is a product of natureexception.

II. WHEN MAKING A REJECTION, EXPLAINWHY THE ADDITIONAL CLAIM ELEMENTS DONOT RESULT IN THE CLAIM AS A WHOLEAMOUNTING TO SIGNIFICANTLY MORE THANTHE JUDICIAL EXCEPTION (STEP 2B)

After identifying the judicial exception in therejection, identify any additional elements(features/limitations/steps) recited in the claimbeyond the judicial exception and explain why theydo not add significantly more to the exception. Theexplanation should address the additional elements

Rev. 08.2017, January 20182100-75


https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility



both individually and as a combination whendetermining whether the claim as whole reciteseligible subject matter. It is important to rememberthat a new combination of steps in a process may bepatent eligible even though all the steps of thecombination were individually well known and incommon use before the combination was made. Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ1, 9 (1981). Thus, it is particularly critical to addressthe combination of additional elements, becausewhile individually-viewed elements may not appearto add significantly more, those additional elementswhen viewed in combination may amount tosignificantly more than the exception bymeaningfully limiting the judicial exception. SeeMPEP § 2106.05 for more information about Step2B of the eligibility analysis.

A rejection should be made only if it is readilyapparent to an examiner relying on the examiner'sexpertise in the art in the Step 2B inquiry that theadditional elements do not amount to claimingsignificantly more than the recited judicial exception.When making a rejection, it is important for theexaminer to explain the rationale underlying theconclusion so that applicant can effectively respond.On the other hand, when appropriate, the examinershould explain why the additional elements providean inventive concept by adding a meaningfullimitation to the claimed exception. See MPEP §2106.05 for a listing of considerations that courtshave found to qualify, and to not qualify, assignificantly more than an exception , and MPEP §2106.07(c) for more information on clarifying therecord when a claim is found eligible.

For example, when the examiner has concluded thatparticular claim limitations are well understood,routine, conventional activities (or elements) to thosein the relevant field, the rejection should explainwhy the courts have recognized, or those in therelevant field of art would recognize, those claimlimitations as being well-understood, routine,conventional activities. That is, the examiner shouldprovide a reasoned explanation that supports thatconclusion. See MPEP § 2106.05(d) for moreinformation about well understood, routine,conventional activities and elements.

For claim limitations that recite a generic computercomponent performing generic computer functionsat a high level of generality, such as using theInternet to gather data, examiners can explain whythese generic computing functions do notmeaningfully limit the claim. MPEP § 2106.05(d)lists some computer functions that the courts haverecognized as well-understood, routine, conventionalfunctions when they are claimed in a merely genericmanner. This listing is not meant to imply that allcomputer functions are well-understood, routine,conventional functions, or that a claim reciting ageneric computer component performing a genericcomputer function is necessarily ineligible.Examiners should keep in mind that the courts haveheld computer-implemented processes to besignificantly more than an abstract idea (and thuseligible), where generic computer components areable in combination to perform functions that arenot merely generic. DDR Holdings, LLC v.Hotels.com, LP, 773 F.3d 1245, 1258-59, 113USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See MPEP§ 2106.05(d) for more information about wellunderstood, routine, conventional activities andelements, and MPEP § 2106.05(f) for moreinformation about generic computing functions thatthe courts have found to be mere instructions toimplement a judicial exception on a computer.

For claim limitations that add insignificantextra-solution activity to the judicial exception (e.g.,mere data gathering in conjunction with a law ofnature or abstract idea, or that generally link the useof the judicial exception to a particular technologicalenvironment or field of use), examiners can explainwhy they do not meaningfully limit the claim. Forexample, adding a final step of storing data to aprocess that only recites computing the area of a twodimensional space (a mathematical relationship)does not add a meaningful limitation to the processof computing the area. As another example,employing well-known computer functions toexecute an abstract idea, even when limiting the useof the idea to one particular environment, does notadd significantly more, similar to how limiting thecomputer implemented abstract idea in Flook topetrochemical and oil-refining industries wasinsufficient. See Parker v. Flook, 437 U.S. 584,588-90, 198 USPQ 193, 197-98 (1978) (limiting useof mathematical formula to use in particular

2100-76Rev. 08.2017, January 2018


industries did not amount to an inventive concept).See MPEP § 2106.05(g) for more information aboutinsignificant extra-solution activity, and MPEP §2106.05(h) for more information about generallylinking use of a judicial exception to a particulartechnological environment or field of use.

In the event a rejection is made, it is a best practicefor the examiner to consult the specification todetermine if there are elements that could be addedto the claim to make it eligible. If so, the examinershould identify those elements in the Office actionand suggest them as a way to overcome the rejection.

III. EVIDENTIARY REQUIREMENTS IN MAKINGA § 101 REJECTION

The courts consider the determination of whether aclaim is eligible (which involves identifying whetheran exception such as an abstract idea is beingclaimed) to be a question of law. Rapid Litig. Mgmt.v. CellzDirect, 827 F.3d 1042, 1047, 119 USPQ2d1370, 1372 (Fed. Cir. 2016); OIP Techs. v.Amazon.com, 788 F.3d 1359, 1362, 115 USPQ2d1090, 1092 (Fed. Cir. 2015); DDR Holdings v.Hotels.com, 773 F.3d 1245, 1255, 113 USPQ2d1097, 1104 (Fed. Cir. 2014); In re Roslin Institute(Edinburgh), 750 F.3d 1333, 1335, 110 USPQ2d1668, 1670 (Fed. Cir. 2014); In re Bilski, 545 F.3d943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008)(en banc), aff’d by Bilski v. Kappos, 561 U.S. 593,95 USPQ2d 1001 (2010). Thus, the court does notrequire “evidence” that a claimed concept is ajudicial exception, and generally decides the legalconclusion of eligibility without resolving anyfactual issues. FairWarning IP, LLC v. Iatric Sys.,839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed.Cir. 2016) (citing Genetic Techs. Ltd. v. Merial LLC,818 F.3d 1369, 1373, 118 USPQ2d 1541, 1544 (Fed.Cir. 2016)); OIP Techs., 788 F.3d at 1362, 115USPQ2d at 1092; Content Extraction &Transmission LLC v. Wells Fargo Bank, N.A., 776F.3d 1343, 1349, 113 USPQ2d 1354, 1359 (Fed.Cir. 2014).

When determining whether claimed subject matteris judicially-excepted, the Federal Circuit typicallycompares the claimed subject matter to subjectmatter identified as an exception in its priorprecedent. Amdocs (Israel) Ltd. v. Openet Telecom,

Inc., 841 F.3d 1288, 1294, 120 USPQ2d 1527, 1532(Fed. Cir. 2016) (“[T]he decisional mechanismcourts now apply is to examine earlier cases in whicha similar or parallel descriptive nature can be seen[and consider] what prior cases were about, andwhich way they were decided.”) (citation omitted).The court has followed the same approach whenreviewing the correctness of the Office’s conclusionsthat particular claims were directed to abstract ideas.See, e.g., In re Smith, 815 F.3d 816, 818-19, 118USPQ2d 1245, 1247 (Fed. Cir. 2016) (review of arejection under 35 U.S.C. 101 in an ex parte appeal); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1241,120 USPQ2d 1844, 1854 (Fed. Cir. 2016) (reviewof a Board determination of unpatentability under35 U.S.C. 101 in a Covered Business Methodreview) and Versata Development Group v. SAPAmerica, Inc., 793 F.3d 1306, 1333-34, 115 USPQ2d1681, 1700-01 (Fed. Cir. 2015) (review of a Boarddetermination of unpatentability under 35 U.S.C.101 in a Covered Business Method review).

Similarly, the courts do not require any evidencewhen conducting the significantly more inquiry,even where additional elements were identified aswell-understood, routine and conventional in the art.See, e.g., Alice Corp., 134 S. Ct. at 2359-60, 110USPQ2d at 1984-85 (citing prior Supreme Courtdecisions in support of identifying additionalelements as “purely conventional” basic computingfunctions, and thus well-understood, routine,conventional activity); Smith, 815 F.3d at 819, 118USPQ2d at 1247 (identifying the steps of shufflingand dealing physical playing cards as “purelyconventional” activities, and thus well-understood,routine, conventional activity).

When performing the analysis at Step 2A, it issufficient for the examiner to provide a reasonedrationale that identifies the judicial exception recitedin the claim and explains why it is considered ajudicial exception. Therefore, there is no requirementfor the examiner to rely on evidence, such aspublications, to find that a claim is directed to ajudicial exception. Cf. Affinity Labs of Tex., LLC v.Amazon.com Inc., 838 F.3d 1266, 1271-72, 120USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirmingdistrict court decision that identified an abstract ideain the claims without relying on evidence); OIPTechs., Inc. v. Amazon.com, Inc., 788 F.3d 1359,

Rev. 08.2017, January 20182100-77


1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir.2015) (same); Content Extraction & TransmissionLLC v. Wells Fargo Bank, N.A., 776 F.3d 1343,1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. 2014)(same).

Similarly, at Step 2B, there is no requirement forevidence to support a finding that the claim does notrecite significantly more than the judicial exception(e.g., the additional limitations are well-understood,routine, conventional activities). However, ifavailable, sources of evidence can be provided tosupport the assertion or, when appropriate, to rebutan argument or evidence from applicant. In situationswhere the specification identifies certain elementsas conventional, that information can be used toprovide a basis for asserting that certain additionallimitations do not amount to significantly more whenmaking a rejection. When addressing a rebuttalargument, for example, a manual or handbookshowing conventional computer components orfunctions could be used to refute an argument thatusing a certain additional computer element is notroutine. Another source could be a patent thatillustrates the state of the art, such as a backgrounddiscussion of conventional components or actionsroutinely taken. The evidence would not be used toshow a lack of novelty, which is not part of the Step2B inquiry, but rather to show the state of the art.Another source of evidence is a court decision. Asone example, the court in Content Extraction notedthat use of a scanner to extract data from a documentwas well-known at the time of filing. 776 F.3d at1348, 113 USPQ2d at 1358. As another example, Versata described the steps of arranging, storing,retrieving, sorting, eliminating, and determininginformation with a computer as “normal, basicfunctions of a computer.” 793 F.3d at 1335, 115USPQ2d at 1702. Care should be taken to ensurethat the facts of any case law cited in support of afinding of conventionality comport with the facts ofthe application being examined. In other words, theexaminer should be familiar with the facts of thecase law before citing it for support in an Officeaction.

2106.07(b) Evaluating Applicant's Response[R-08.2017]

After examiners identify and explain in the recordthe reasons why a claim is directed to an abstractidea, natural phenomenon, or law of nature withoutsignificantly more, then the burden shifts to theapplicant to either amend the claim or make ashowing of why the claim is eligible for patentprotection.

In response to a rejection based on failure to claimpatent-eligible subject matter, applicant may: (i)amend the claim, e.g., to add additional elements ormodify existing elements so that the claim as a wholeamounts to significantly more than the judicialexception, and/or (ii) present persuasive argumentsor evidence based on a good faith belief as to whythe rejection is in error. When evaluating a response,examiners must carefully consider all of applicant'sarguments and evidence rebutting the subject mattereligibility rejection. If applicant has amended theclaim, examiners should determine the amendedclaim’s broadest reasonable interpretation and againperform the subject matter eligibility analysis.

If applicant's claim amendment(s) and/orargument(s) persuasively establish that the claim isnot directed to a judicial exception or is directed tosignificantly more than a judicial exception, therejection should be withdrawn. Applicant may arguethat a claim is eligible because the claim as a wholeamounts to significantly more than the judicialexception when the additional elements areconsidered both individually and in combination.When an additional element is consideredindividually by the examiner, the additional elementmay be enough to qualify as "significantly more" ifit meaningfully limits the judicial exception, e.g.,it improves another technology or technical field,improves the functioning of a computer itself, addsa specific limitation other than what iswell-understood, routine, conventional activity inthe field, or adds unconventional steps that confinethe claim to a particular useful application.

In addition, even if an element does not amount tosignificantly more on its own (e.g., because it ismerely a generic computer component performinggeneric computer functions), it can still amount to

2100-78Rev. 08.2017, January 2018


significantly more when considered in combinationwith the other elements of the claim. For example,generic computer components that individuallyperform merely generic computer functions (e.g., aCPU that performs mathematical calculations or aclock that produces time data) in some instances areable in combination to perform functions that arenot generic computer functions and therefore amountto significantly more than an abstract idea (and arethus eligible).

If applicant properly challenges the examiner'sfindings but the examiner deems it appropriate tomaintain the rejection, a rebuttal must be providedin the next Office action. Several examples ofappropriate examiner responses are provided below.

(1) If applicant challenges the identification ofan abstract idea that was based on a court case andthe challenge is not persuasive, an appropriateresponse would be an explanation as to why theabstract idea identified in the claim is similar to theconcept in the cited case. If the original rejection didnot identify a Supreme Court or Federal Circuitdecision in which a similar abstract idea was foundand applicant challenges identification of the abstractidea, the examiner would need to point to a case inwhich a similar abstract idea was identified andexplain why the abstract idea recited in the claimcorresponds to the abstract idea identified in the caseto maintain the rejection. Citation to a case thatsupports the original rationale would not beconsidered a new ground of rejection, unless thereis a change to the basic thrust of the rejection. SeeMPEP § 706.07(a) for a discussion of new groundsof rejection.

(2) If applicant responds to an examiner'sassertion that something is well-known, routine,conventional activity with a specific argument orevidence that the additional elements in a claim arenot well-understood, routine, conventional activitiespreviously engaged in by those in the relevant art,the examiner should reevaluate whether it is readilyapparent that the additional elements are in actualitywell-known, routine, conventional activities to thosewho work in the relevant field. It is especially, forthe examiner, necessary to fully reevaluate theirposition when such additional elements are notdiscussed in the specification as being known genericfunctions/components/activities or are not treated

by the courts as well-understood, routine,conventional activities. If the rejection is to bemaintained, the examiner should consider whetherevidence should be provided to further support therejection and clarify the record for appeal. See MPEP§ 2106.05(d) for examples of elements that the courtshave found to be well understood, routine andconventional activity.

(3) If applicant amends a claim to add a genericcomputer or generic computer components andasserts that the claim recites significantly morebecause the generic computer is 'speciallyprogrammed' (as in Alappat, now consideredsuperseded) or is a 'particular machine' (as in Bilski),the examiner should look at whether the addedelements provide significantly more than the judicialexception. Merely adding a generic computer,generic computer components, or a programmedcomputer to perform generic computer functionsdoes not automatically overcome an eligibilityrejection. Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2359-60, 110 USPQ2d 1976, 1984(2014). See also OIP Techs. v. Amazon.com, 788F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94 (Fed.Cir. 2015) (“Just as Diehr could not save the claimsin Alice, which were directed to ‘implement[ing]the abstract idea of intermediated settlement on ageneric computer’, it cannot save OIP's claimsdirected to implementing the abstract idea of priceoptimization on a generic computer.”) (citationsomitted).

(4) If applicant argues that the claim is specificand does not preempt all applications of theexception, the examiner should reconsider Step 2Aof the eligibility analysis, e.g., to determine whetherthe claim is directed to an improvement to thefunctioning of a computer or to any other technologyor technical field. If an examiner still determinesthat the claim is directed to a judicial exception, theexaminer should then reconsider in Step 2B whetherthe additional elements in combination (as well asindividually) amount to an inventive concept, e.g.,because they are more than the non-conventionaland non-generic arrangement of known, conventionalelements. Such reconsideration is appropriatebecause, although preemption is not a standalonetest for eligibility, it remains the underlying concernthat drives the two-part framework from Alice Corp.and Mayo (Steps 2A and 2B). Synopsys, Inc. v.Mentor Graphics Corp., 839 F.3d 1138, 1150, 120

Rev. 08.2017, January 20182100-79


USPQ2d 1473, 1483 (Fed. Cir. 2016); Rapid Litig.Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052,119 USPQ2d 1370, 1376 (Fed. Cir. 2016); AriosaDiagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,1379, 115 USPQ2d 1152, 1158 (Fed. Cir. 2015).

2106.07(c) Clarifying the Record [R-08.2017]

When the claims are deemed patent eligible, theexaminer may make clarifying remarks on therecord. For example, if a claim is found eligiblebecause it improves upon existing technology, theexaminer could reference the portion of thespecification that describes the claimed improvementand note the claim elements that produce thatimprovement. The clarifying remarks may be madeat any point during prosecution as well as with anotice of allowance.

Clarifying remarks may be useful in explaining therationale for a rejection as well. For instance,explaining the broadest reasonable interpretation(BRI) of a claim will assist applicant inunderstanding and responding to a rejection. As anexample, a rejection for failure to recite patenteligible subject matter in a claim to a computerreadable medium could include an explanation thatthe broadest reasonable interpretation of the claimcovers a carrier wave, which does not fall within oneof the four categories of invention, and a suggestionto overcome the rejection by submitting a narrowingamendment to cover the statutory embodiments.

2107 Guidelines for Examination ofApplications for Compliance with the UtilityRequirement [R-11.2013]

I. INTRODUCTION

The following Guidelines establish the policies andprocedures to be followed by Office personnel inthe evaluation of any patent application forcompliance with the utility requirements of 35U.S.C. 101 and 35 U.S.C. 112(a), or pre-AIA 35U.S.C. 112, first paragraph. These Guidelines havebeen promulgated to assist Office personnel in theirreview of applications for compliance with the utilityrequirement. The Guidelines do not alter thesubstantive requirements of 35 U.S.C. 101 and 35U.S.C. 112, nor are they designed to obviate the

examiner’s review of applications for compliancewith all other statutory requirements for patentability.The Guidelines do not constitute substantiverulemaking and hence do not have the force andeffect of law. Rejections will be based upon thesubstantive law, and it is these rejections which areappealable. Consequently, any perceived failure byOffice personnel to follow these Guidelines is neitherappealable nor petitionable.

II. EXAMINATION GUIDELINES FOR THEUTILITY REQUIREMENT

Office personnel are to adhere to the followingprocedures when reviewing patent applications forcompliance with the “useful invention” (“utility”)requirement of 35 U.S.C. 101 and 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph.

(A) Read the claims and the supporting writtendescription.

(1) Determine what the applicant hasclaimed, noting any specific embodiments of theinvention.

(2) Ensure that the claims define statutorysubject matter (i.e., a process, machine, manufacture,composition of matter, or improvement thereof).

(3) If at any time during the examination, itbecomes readily apparent that the claimed inventionhas a well-established utility, do not impose arejection based on lack of utility. An invention hasa well-established utility if (i) a person of ordinaryskill in the art would immediately appreciate whythe invention is useful based on the characteristicsof the invention (e.g., properties or applications ofa product or process), and (ii) the utility is specific,substantial, and credible.

(B) Review the claims and the supporting writtendescription to determine if the applicant has assertedfor the claimed invention any specific and substantialutility that is credible:

(1) If the applicant has asserted that theclaimed invention is useful for any particularpractical purpose (i.e., it has a “specific andsubstantial utility”) and the assertion would beconsidered credible by a person of ordinary skill inthe art, do not impose a rejection based on lack ofutility.

2100-80Rev. 08.2017, January 2018


(i) A claimed invention must have aspecific and substantial utility. This requirementexcludes “throw-away,” “insubstantial,” or“nonspecific” utilities, such as the use of a complexinvention as landfill, as a way of satisfying the utilityrequirement of 35 U.S.C. 101.

(ii) Credibility is assessed from theperspective of one of ordinary skill in the art in viewof the disclosure and any other evidence of record(e.g., test data, affidavits or declarations from expertsin the art, patents or printed publications) that isprobative of the applicant’s assertions. An applicantneed only provide one credible assertion of specificand substantial utility for each claimed invention tosatisfy the utility requirement.

(2) If no assertion of specific and substantialutility for the claimed invention made by theapplicant is credible, and the claimed invention doesnot have a readily apparent well-established utility,reject the claim(s) under 35 U.S.C. 101 on thegrounds that the invention as claimed lacks utility.Also reject the claims under 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, on the basisthat the disclosure fails to teach how to use theinvention as claimed. The 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, rejectionimposed in conjunction with a 35 U.S.C. 101rejection should incorporate by reference the groundsof the corresponding 35 U.S.C. 101 rejection.

(3) If the applicant has not asserted anyspecific and substantial utility for the claimedinvention and it does not have a readily apparentwell-established utility, impose a rejection under 35U.S.C. 101, emphasizing that the applicant has notdisclosed a specific and substantial utility for theinvention. Also impose a separate rejection under35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, on the basis that the applicant has notdisclosed how to use the invention due to the lackof a specific and substantial utility. The 35 U.S.C.101 and 35 U.S.C. 112 rejections shift the burdenof coming forward with evidence to the applicantto:

(i) Explicitly identify a specific andsubstantial utility for the claimed invention; and

(ii) Provide evidence that one of ordinaryskill in the art would have recognized that theidentified specific and substantial utility was

well-established at the time of filing. The examinershould review any subsequently submitted evidenceof utility using the criteria outlined above. Theexaminer should also ensure that there is an adequatenexus between the evidence and the properties ofthe now claimed subject matter as disclosed in theapplication as filed. That is, the applicant has theburden to establish a probative relation between thesubmitted evidence and the originally disclosedproperties of the claimed invention.

(C) Any rejection based on lack of utilityshould include a detailed explanation why theclaimed invention has no specific and substantialcredible utility. Whenever possible, the examinershould provide documentary evidence regardless ofpublication date (e.g., scientific or technical journals,excerpts from treatises or books, or U.S. or foreignpatents) to support the factual basis for the primafacie showing of no specific and substantial credibleutility. If documentary evidence is not available, theexaminer should specifically explain the scientificbasis for his or her factual conclusions.

(1) Where the asserted utility is notspecific or substantial, a prima facie showing mustestablish that it is more likely than not that a personof ordinary skill in the art would not consider thatany utility asserted by the applicant would bespecific and substantial. The prima facie showingmust contain the following elements:

(i) An explanation that clearly setsforth the reasoning used in concluding that theasserted utility for the claimed invention is not bothspecific and substantial nor well-established;

(ii) Support for factual findings reliedupon in reaching this conclusion; and

(iii) An evaluation of all relevantevidence of record, including utilities taught in theclosest prior art.

(2) Where the asserted specific andsubstantial utility is not credible, a prima facieshowing of no specific and substantial credible utilitymust establish that it is more likely than not that aperson skilled in the art would not consider credibleany specific and substantial utility asserted by theapplicant for the claimed invention. The prima facieshowing must contain the following elements:

(i) An explanation that clearly setsforth the reasoning used in concluding that the

Rev. 08.2017, January 20182100-81


asserted specific and substantial utility is notcredible;

(ii) Support for factual findings reliedupon in reaching this conclusion; and

(iii) An evaluation of all relevantevidence of record, including utilities taught in theclosest prior art.

(3) Where no specific and substantialutility is disclosed or is well-established, a primafacie showing of no specific and substantial utilityneed only establish that applicant has not asserted autility and that, on the record before the examiner,there is no known well-established utility.

(D) A rejection based on lack of utilityshould not be maintained if an asserted utility forthe claimed invention would be considered specific,substantial, and credible by a person of ordinary skillin the art in view of all evidence of record.

Office personnel are reminded that they must treatas true a statement of fact made by an applicant inrelation to an asserted utility, unless countervailingevidence can be provided that shows that one ofordinary skill in the art would have a legitimate basisto doubt the credibility of such a statement.Similarly, Office personnel must accept an opinionfrom a qualified expert that is based upon relevantfacts whose accuracy is not being questioned; it isimproper to disregard the opinion solely because ofa disagreement over the significance or meaning ofthe facts offered.

Once a prima facie showing of no specific andsubstantial credible utility has been properlyestablished, the applicant bears the burden ofrebutting it. The applicant can do this by amendingthe claims, by providing reasoning or arguments, orby providing evidence in the form of a declarationunder 37 CFR 1.132 or a patent or a printedpublication that rebuts the basis or logic of the primafacie showing. If the applicant responds to the primafacie rejection, the Office personnel should reviewthe original disclosure, any evidence relied upon inestablishing the prima facie showing, any claimamendments, and any new reasoning or evidenceprovided by the applicant in support of an assertedspecific and substantial credible utility. It is essentialfor Office personnel to recognize, fully consider and

respond to each substantive element of any responseto a rejection based on lack of utility. Only wherethe totality of the record continues to show that theasserted utility is not specific, substantial, andcredible should a rejection based on lack of utilitybe maintained.

If the applicant satisfactorily rebuts a prima facierejection based on lack of utility under 35 U.S.C.101, withdraw the 35 U.S.C. 101 rejection and thecorresponding rejection imposed under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

2107.01 General Principles Governing UtilityRejections [R-07.2015]

35 U.S.C. 101 Inventions patentable

Whoever invents or discovers any new and useful process,machine, manufacture, or composition of matter, or any newand useful improvement thereof may obtain a patent therefor,subject to the conditions and requirements of this title.

See MPEP § 2107 for guidelines for the examinationof applications for compliance with the utilityrequirement of 35 U.S.C. 101.

The Office must examine each application to ensurecompliance with the “useful invention” or utilityrequirement of 35 U.S.C. 101. In discharging thisobligation, however, Office personnel must keep inmind several general principles that controlapplication of the utility requirement. 35 U.S.C. 101has been interpreted as imposing four purposes. First,35 U.S.C. 101 limits an inventor to ONE patent fora claimed invention. If more than one patent issought, a patent applicant will receive a statutorydouble patenting rejection for claims included inmore than one application that are directed to thesame invention. See MPEP § 804. Second, theinventor(s) must be the applicant in an applicationfiled before September 16, 2012, (except asotherwise provided in pre-AIA 37 CFR 1.41(b)) andthe inventor or each joint inventor must be identifiedin an application filed on or after September 16,2012. See MPEP § 2137.01 for a detailed discussionof inventorship, MPEP § 602.01(c) et seq. for detailsregarding correction of inventorship, and MPEP §706.03(a), subsection IV, for rejections under 35U.S.C. 101 and 115 (and pre-AIA 35 U.S.C. 102(f)for applications subject to pre-AIA 35 U.S.C. 102)

2100-82Rev. 08.2017, January 2018


for failure to set forth the correct inventorship).Third, 35 U.S.C. 101 defines which categories ofinventions are eligible for patent protection. Aninvention that is not a machine, an article ofmanufacture, a composition or a process cannot bepatented. See Diamond v. Chakrabarty, 447 U.S.303, 206 USPQ 193 (1980); Diamond v. Diehr, 450U.S. 175, 209 USPQ 1 (1981); In re Nuijten, 500F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir.2007). Fourth, 35 U.S.C. 101 serves to ensure thatpatents are granted on only those inventions that are“useful.” This second purpose has a Constitutionalfooting — Article I, Section 8 of the Constitutionauthorizes Congress to provide exclusive rights toinventors to promote the “useful arts.” See CarlZeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20USPQ2d 1094 (Fed. Cir. 1991). Thus, to satisfy therequirements of 35 U.S.C. 101, an applicant mustclaim an invention that is statutory subject matterand must show that the claimed invention is “useful”for some purpose either explicitly or implicitly.Application of this latter element of 35 U.S.C. 101is the focus of these guidelines.

Deficiencies under the “useful invention”requirement of 35 U.S.C. 101 will arise in one oftwo forms. The first is where it is not apparent whythe invention is “useful.” This can occur when anapplicant fails to identify any specific and substantialutility for the invention or fails to disclose enoughinformation about the invention to make itsusefulness immediately apparent to those familiarwith the technological field of the invention. Brenner v. Manson, 383 U.S. 519, 148 USPQ 689(1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197,26 USPQ2d 1600 (Fed. Cir. 1993). The second typeof deficiency arises in the rare instance where anassertion of specific and substantial utility for theinvention made by an applicant is not credible.

I. SPECIFIC AND SUBSTANTIALREQUIREMENTS

To satisfy 35 U.S.C. 101, an invention must be“useful.” Courts have recognized that the term“useful” used with reference to the utilityrequirement can be a difficult term to define. Brenner v. Manson, 383 U.S. 519, 529, 148 USPQ689, 693 (1966) (simple everyday word like “useful”

can be “pregnant with ambiguity when appliedto the facts of life.”). Where an applicant has setforth a specific and substantial utility, courts havebeen reluctant to uphold a rejection under 35 U.S.C.101 solely on the basis that the applicant’s opinionas to the nature of the specific and substantial utilitywas inaccurate. For example, in Nelson v. Bowler,626 F.2d 853, 206 USPQ 881 (CCPA 1980), thecourt reversed a finding by the Office that theapplicant had not set forth a “practical” utility under35 U.S.C. 101. In this case the applicant assertedthat the composition was “useful” in a particularpharmaceutical application and provided evidenceto support that assertion. Courts have used the labels“practical utility,” “substantial utility,” or “specificutility” to refer to this aspect of the “usefulinvention” requirement of 35 U.S.C. 101. The Courtof Customs and Patent Appeals has stated:

Practical utility is a shorthand way ofattributing “real-world” value to claimedsubject matter. In other words, one skilled inthe art can use a claimed discovery in a mannerwhich provides some immediate benefit to thepublic.

Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ881, 883 (CCPA 1980).

Practical considerations require the Office to relyon the inventor’s understanding of his or herinvention in determining whether and in what regardan invention is believed to be “useful.” Because ofthis, Office personnel should focus on and bereceptive to assertions made by the applicant that aninvention is “useful” for a particular reason.

A. Specific Utility

A “specific utility” is specific to the subject matterclaimed and can “provide a well-defined andparticular benefit to the public.” In re Fisher, 421F.3d 1365, 1371, 76 USPQ2d 1225, 1230 (Fed. Cir.2005). This contrasts with a general utility thatwould be applicable to the broad class of theinvention. Office personnel should distinguishbetween situations where an applicant has discloseda specific use for or application of the invention andsituations where the applicant merely indicates that

Rev. 08.2017, January 20182100-83


the invention may prove useful without identifyingwith specificity why it is considered useful. Forexample, indicating that a compound may be usefulin treating unspecified disorders, or that thecompound has “useful biological” properties, wouldnot be sufficient to define a specific utility for thecompound. See, e.g., In re Kirk, 376 F.2d 936, 153USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906,153 USPQ 45 (CCPA 1967). Similarly, a claim toa polynucleotide whose use is disclosed simply as a“gene probe” or “chromosome marker” would notbe considered to be specific in the absence of adisclosure of a specific DNA target. See In reFisher, 421 F.3d at 1374, 76 USPQ2d at 1232 (“AnyEST [expressed sequence tag] transcribed from anygene in the maize genome has the potential toperform any one of the alleged uses…. Nothingabout [applicant’s] seven alleged uses set the fiveclaimed ESTs apart from the more than 32,000 ESTsdisclosed in the [ ] application or indeed from anyEST derived from any organism. Accordingly, weconclude that [applicant] has only disclosed generaluses for its claimed ESTs, not specific ones thatsatisfy § 101.”). A general statement of diagnosticutility, such as diagnosing an unspecified disease,would ordinarily be insufficient absent a disclosureof what condition can be diagnosed. Contrast thesituation where an applicant discloses a specificbiological activity and reasonably correlates thatactivity to a disease condition. Assertions fallingwithin the latter category are sufficient to identify aspecific utility for the invention. Assertions that fallin the former category are insufficient to define aspecific utility for the invention, especially if theassertion takes the form of a general statement thatmakes it clear that a “useful” invention may arisefrom what has been disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688(CCPA 1973).

B. Substantial Utility

“[A]n application must show that an invention isuseful to the public as disclosed in its current form,not that it may prove useful at some future date afterfurther research. Simply put, to satisfy the‘substantial’ utility requirement, an asserted use mustshow that the claimed invention has a significantand presently available benefit to the public.” Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The

claims at issue in Fisher were directed to expressedsequence tags (ESTs), which are short nucleotidesequences that can be used to discover what genesand downstream proteins are expressed in a cell. Thecourt held that “the claimed ESTs can be used onlyto gain further information about the underlyinggenes and the proteins encoded for by those genes.The claimed ESTs themselves are not an end of[applicant’s] research effort, but only tools to beused along the way in the search for a practicalutility…. [Applicant] does not identify the functionfor the underlying protein-encoding genes. Absentsuch identification, we hold that the claimed ESTshave not been researched and understood to the pointof providing an immediate, well-defined, real worldbenefit to the public meriting the grant of a patent.” Id. at 1376, 76 USPQ2d at 1233-34). Thus a“substantial utility” defines a “real world” use.Utilities that require or constitute carrying out furtherresearch to identify or reasonably confirm a “realworld” context of use are not substantial utilities.For example, both a therapeutic method of treatinga known or newly discovered disease and an assaymethod for identifying compounds that themselveshave a “substantial utility” define a “real world”context of use. An assay that measures the presenceof a material which has a stated correlation to apredisposition to the onset of a particular diseasecondition would also define a “real world” contextof use in identifying potential candidates forpreventive measures or further monitoring. On theother hand, the following are examples of situationsthat require or constitute carrying out further researchto identify or reasonably confirm a “real world”context of use and, therefore, do not define“substantial utilities”:

(A) Basic research such as studying theproperties of the claimed product itself or themechanisms in which the material is involved;

(B) A method of treating an unspecified diseaseor condition;

(C) A method of assaying for or identifying amaterial that itself has no specific and/or substantialutility;

(D) A method of making a material that itselfhas no specific, substantial, and credible utility; and

2100-84Rev. 08.2017, January 2018


(E) A claim to an intermediate product for usein making a final product that has no specific,substantial and credible utility.

Office personnel must be careful not to interpret thephrase “immediate benefit to the public” or similarformulations in other cases to mean that products orservices based on the claimed invention must be“currently available” to the public in order to satisfythe utility requirement. See, e.g., Brenner v.Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695(1966). Rather, any reasonable use that an applicanthas identified for the invention that can be viewedas providing a public benefit should be accepted assufficient, at least with regard to defining a“substantial” utility.

C. Research Tools

Some confusion can result when one attempts tolabel certain types of inventions as not being capableof having a specific and substantial utility based onthe setting in which the invention is to be used. Oneexample is inventions to be used in a research orlaboratory setting. Many research tools such as gaschromatographs, screening assays, and nucleotidesequencing techniques have a clear, specific andunquestionable utility (e.g., they are useful inanalyzing compounds). An assessment that focuseson whether an invention is useful only in a researchsetting thus does not address whether the inventionis in fact “useful” in a patent sense. Instead, Officepersonnel must distinguish between inventions thathave a specifically identified substantial utility andinventions whose asserted utility requires furtherresearch to identify or reasonably confirm. Labelssuch as “research tool,” “intermediate” or “forresearch purposes” are not helpful in determining ifan applicant has identified a specific and substantialutility for the invention.

II. WHOLLY INOPERATIVE INVENTIONS;“INCREDIBLE” UTILITY

An invention that is “inoperative” (i.e., it does notoperate to produce the results claimed by the patentapplicant) is not a “useful” invention in the meaningof the patent law. See, e.g., Newman v. Quigg,877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed.Cir. 1989); In re Harwood, 390 F.2d 985, 989,156 USPQ 673, 676 (CCPA 1968) (“An inoperative

invention, of course, does not satisfy the requirementof 35 U.S.C. 101 that an invention be useful.”).However, as the Federal Circuit has stated, “[t]oviolate [35 U.S.C.] 101 the claimed device must betotally incapable of achieving a useful result.” Brooktree Corp. v. Advanced Micro Devices, Inc.,977 F.2d 1555, 1571, 24 USPQ2d 1401, 1412 (Fed.Cir. 1992) (emphasis added). See also E.I. du PontDe Nemours and Co. v. Berkley and Co., 620 F.2d1247, 1260 n.17, 205 USPQ 1, 10 n.17 (8th Cir.1980) (“A small degree of utility is sufficient . . .The claimed invention must only be capable ofperforming some beneficial function . . . Aninvention does not lack utility merely because theparticular embodiment disclosed in the patent lacksperfection or performs crudely . . . A commerciallysuccessful product is not required . . . Nor is itessential that the invention accomplish all itsintended functions . . . or operate under all conditions. . . partial success being sufficient to demonstratepatentable utility . . . In short, the defense ofnon-utility cannot be sustained without proof of totalincapacity.” If an invention is only partiallysuccessful in achieving a useful result, a rejectionof the claimed invention as a whole based on a lackof utility is not appropriate. See In re Brana, 51F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995); Inre Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA), reh’g denied, 480 F.2d 879 (CCPA 1973); In reMarzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA1971).

Situations where an invention is found to be“inoperative” and therefore lacking in utility are rare,and rejections maintained solely on this ground bya federal court even rarer. In many of these cases,the utility asserted by the applicant was thought tobe “incredible in the light of the knowledge of theart, or factually misleading” when initiallyconsidered by the Office. In re Citron, 325 F.2d248, 253, 139 USPQ 516, 520 (CCPA 1963). Othercases suggest that on initial evaluation, the Officeconsidered the asserted utility to be inconsistent withknown scientific principles or “speculative at best”as to whether attributes of the invention necessaryto impart the asserted utility were actually presentin the invention. In re Sichert, 566 F.2d 1154, 196USPQ 209 (CCPA 1977). However cast, theunderlying finding by the court in these cases wasthat, based on the factual record of the case, it was

Rev. 08.2017, January 20182100-85


clear that the invention could not and did not workas the inventor claimed it did. Indeed, the use ofmany labels to describe a single problem (e.g., afalse assertion regarding utility) has led to some ofthe confusion that exists today with regard to arejection based on the “utility” requirement.Examples of such cases include: an inventionasserted to change the taste of food using a magneticfield (Fregeau v. Mossinghoff, 776 F.2d 1034, 227USPQ 848 (Fed. Cir. 1985)), a perpetual motionmachine (Newman v. Quigg, 877 F.2d 1575, 11USPQ2d 1340 (Fed. Cir. 1989)), a flying machineoperating on “flapping or flutter function” (In reHoughton, 433 F.2d 820, 167 USPQ 687 (CCPA1970)), a “cold fusion” process for producing energy (In re Swartz, 232 F.3d 862, 56 USPQ2d 1703 (Fed.Cir. 2000)), a method for increasing the energyoutput of fossil fuels upon combustion throughexposure to a magnetic field (In re Ruskin, 354 F.2d395, 148 USPQ 221 (CCPA 1966)), uncharacterizedcompositions for curing a wide array of cancers (Inre Citron, 325 F.2d 248, 139 USPQ 516 (CCPA1963)), and a method of controlling the aging process (In re Eltgroth, 419 F.2d 918, 164 USPQ 221(CCPA 1970)). These examples are fact specific andshould not be applied as a per se rule. Thus, in viewof the rare nature of such cases, Office personnelshould not label an asserted utility “incredible,”“speculative” or otherwise unless it is clear that arejection based on “lack of utility” is proper.

III. THERAPEUTIC OR PHARMACOLOGICALUTILITY

Inventions asserted to have utility in the treatmentof human or animal disorders are subject to the samelegal requirements for utility as inventions in anyother field of technology. In re Chilowsky, 229 F.2d457, 461-2, 108 USPQ 321, 325 (CCPA 1956)(“There appears to be no basis in the statutes ordecisions for requiring any more conclusive evidenceof operativeness in one type of case than another.The character and amount of evidence needed mayvary, depending on whether the alleged operationdescribed in the application appears to accord withor to contravene established scientific principles orto depend upon principles alleged but not generallyrecognized, but the degree of certainty as to theultimate fact of operativeness or inoperativenessshould be the same in all cases”); In re Gazave, 379

F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967)(“Thus, in the usual case where the mode ofoperation alleged can be readily understood andconforms to the known laws of physics andchemistry, operativeness is not questioned, and nofurther evidence is required.”). As such,pharmacological or therapeutic inventions thatprovide any “immediate benefit to the public” satisfy35 U.S.C. 101. The utility being asserted in Nelsonrelated to a compound with pharmacological utility. Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ881, 883 (CCPA 1980). Office personnel should relyon Nelson and other cases as providing generalguidance when evaluating the utility of an inventionthat is based on any therapeutic, prophylactic, orpharmacological activities of that invention.

Courts have repeatedly found that the mereidentification of a pharmacological activity of acompound that is relevant to an assertedpharmacological use provides an “immediate benefitto the public” and thus satisfies the utilityrequirement. As the Court of Customs and PatentAppeals held in Nelson v. Bowler:

Knowledge of the pharmacological activity ofany compound is obviously beneficial to thepublic. It is inherently faster and easier tocombat illnesses and alleviate symptoms whenthe medical profession is armed with an arsenalof chemicals having known pharmacologicalactivities. Since it is crucial to provideresearchers with an incentive to disclosepharmacological activities in as manycompounds as possible, we conclude thatadequate proof of any such activity constitutesa showing of practical utility.

Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ881, 883 (CCPA 1980).

In Nelson v. Bowler, the court addressed thepractical utility requirement in the context of aninterference proceeding. Bowler challenged thepatentability of the invention claimed by Nelson onthe basis that Nelson had failed to sufficiently andpersuasively disclose in his application a practicalutility for the invention. Nelson had developed andclaimed a class of synthetic prostaglandins modeled

2100-86Rev. 08.2017, January 2018


on naturally occurring prostaglandins. Naturallyoccurring prostaglandins are bioactive compoundsthat, at the time of Nelson’s application, had arecognized value in pharmacology (e.g., thestimulation of uterine smooth muscle which resultedin labor induction or abortion, the ability to raise orlower blood pressure, etc.). To support the utility heidentified in his disclosure, Nelson included in hisapplication the results of tests demonstrating thebioactivity of his new substituted prostaglandinsrelative to the bioactivity of naturally occurringprostaglandins. The court concluded that Nelson hadsatisfied the practical utility requirement inidentifying the synthetic prostaglandins aspharmacologically active compounds. In reachingthis conclusion, the court considered and rejectedarguments advanced by Bowler that attacked theevidentiary basis for Nelson’s assertions that thecompounds were pharmacologically active.

In In re Jolles, 628 F.2d 1322, 206 USPQ 885(CCPA 1980), an inventor claimed protection forpharmaceutical compositions for treatingleukemia. The active ingredient in the compositionswas a structural analog to a known anticancer agent.The applicant provided evidence showing that theclaimed analogs had the same generalpharmaceutical activity as the known anticanceragents. The court reversed the Board’s finding thatthe asserted pharmaceutical utility was “incredible,”pointing to the evidence that showed the relevantpharmacological activity.

In Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739(Fed. Cir. 1985), the Federal Circuit affirmed afinding by the Board of Patent Appeals andInterferences that a pharmacological utility had beendisclosed in the application of one party to aninterference proceeding. The invention that was thesubject of the interference count was a chemicalcompound used for treating blood disorders. Crosshad challenged the evidence in Iizuka’s specificationthat supported the claimed utility. However, theFederal Circuit relied extensively on Nelson v. Bowler in finding that Iizuka’s applicationhad sufficiently disclosed a pharmacological utilityfor the compounds. It distinguished the case fromcases where only a generalized “nebulous”expression, such as “biological properties,” had beendisclosed in a specification. Such statements, the

court held, “convey little explicit indicationregarding the utility of a compound.” Cross, 753F.2d at 1048, 224 USPQ at 745 (citing In re Kirk,376 F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)).

Similarly, courts have found utility for therapeuticinventions despite the fact that an applicant is at avery early stage in the development of apharmaceutical product or therapeutic regimen basedon a claimed pharmacological or bioactivecompound or composition. The Federal Circuit, in Cross v. Iizuka, 753 F.2d 1040, 1051, 224 USPQ739, 747-48 (Fed. Cir. 1985), commented on thesignificance of data from in vitro testing that showedpharmacological activity:

We perceive no insurmountable difficulty,under appropriate circumstances, in finding thatthe first link in the screening chain, in vitrotesting, may establish a practical utility for thecompound in question. Successful in vitrotesting will marshal resources and direct theexpenditure of effort to further in vivo testingof the most potent compounds, therebyproviding an immediate benefit to the public,analogous to the benefit provided by theshowing of an in vivo utility.

The Federal Circuit has reiterated that therapeuticutility sufficient under the patent laws is not to beconfused with the requirements of the FDA withregard to safety and efficacy of drugs to marketedin the United States.

FDA approval, however, is not a prerequisitefor finding a compound useful within themeaning of the patent laws. Scott v. Finney,34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120[(Fed.Cir. 1994)]. Usefulness in patent law, andin particular in the context of pharmaceuticalinventions, necessarily includes the expectationof further research and development. The stageat which an invention in this field becomesuseful is well before it is ready to beadministered to humans. Were we to requirePhase II testing in order to prove utility, theassociated costs would prevent many companiesfrom obtaining patent protection on promisingnew inventions, thereby eliminating an

Rev. 08.2017, January 20182100-87


incentive to pursue, through research anddevelopment, potential cures in many crucialareas such as the treatment of cancer.

In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.Cir. 1995). Accordingly, Office personnel shouldnot construe 35 U.S.C. 101, under the logic of“practical” utility or otherwise, to require that anapplicant demonstrate that a therapeutic agent basedon a claimed invention is a safe or fully effectivedrug for humans. See, e.g., In re Sichert, 566 F.2d1154, 196 USPQ 209 (CCPA 1977); In re Hartop,311 F.2d 249, 135 USPQ 419 (CCPA 1962); In reAnthony, 414 F.2d 1383, 162 USPQ 594 (CCPA1969); In re Watson, 517 F.2d 465, 186 USPQ 11(CCPA 1975).

These general principles are equally applicable tosituations where an applicant has claimed a processfor treating a human or animal disorder. In suchcases, the asserted utility is usually clear — theinvention is asserted to be useful in treating theparticular disorder. If the asserted utility is credible,there is no basis to challenge such a claim on thebasis that it lacks utility under 35 U.S.C. 101.

See MPEP § 2107.03 for special considerations forasserted therapeutic or pharmacological utilities.

IV. RELATIONSHIP BETWEEN 35 U.S.C. 112(a)or Pre-AIA 35 U.S.C. 112, FIRST PARAGRAPH,AND 35 U.S.C. 101

A deficiency under the utility prong of 35 U.S.C.101 also creates a deficiency under 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph. See Inre Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir.1995); In re Jolles, 628 F.2d 1322, 1326 n.10, 206USPQ 885, 889 n.11 (CCPA 1980); In re Fouche,439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA1971) (“If such compositions are in fact useless,appellant’s specification cannot have taught how touse them.”). Courts have also cast the 35 U.S.C.101/35 U.S.C. 112 relationship such that 35 U.S.C.112 presupposes compliance with 35 U.S.C. 101.See In re Ziegler, 992 F.2d 1197, 1200-1201, 26USPQ2d 1600, 1603 (Fed. Cir. 1993) (“The how touse prong of section 112 incorporates as a matter oflaw the requirement of 35 U.S.C. 101 that thespecification disclose as a matter of fact a practical

utility for the invention. ... If the application fails asa matter of fact to satisfy 35 U.S.C. § 101, then theapplication also fails as a matter of law to enableone of ordinary skill in the art to use the inventionunder 35 U.S.C. § 112.”); In re Kirk, 376 F.2d 936,942, 153 USPQ 48, 53 (CCPA 1967) (“Necessarily,compliance with § 112 requires a description of howto use presently useful inventions, otherwise anapplicant would anomalously be required to teachhow to use a useless invention.”). For example, theFederal Circuit noted, “[o]bviously, if a claimedinvention does not have utility, the specificationcannot enable one to use it.” In re Brana, 51 F.3d1560, 34 USPQ2d 1436 (Fed. Cir. 1995). As such,a rejection properly imposed under 35 U.S.C. 101for lack of utility should be accompanied with arejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. It is equally clear that arejection based on “lack of utility,” whethergrounded upon 35 U.S.C. 101 or 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph, rests onthe same basis (i.e., the asserted utility is notcredible). To avoid confusion, any lack of utilityrejection that is imposed on the basis of 35 U.S.C.101 should be accompanied by a rejection based on35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph. The 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, rejection should be setout as a separate rejection that incorporates byreference the factual basis and conclusions set forthin the 35 U.S.C. 101 rejection. The 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph, rejectionshould indicate that because the invention as claimeddoes not have utility, a person skilled in the art wouldnot be able to use the invention as claimed, and assuch, the claim is defective under 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph. A 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, rejection based on lack of utility shouldnot be imposed or maintained unless an appropriatebasis exists for imposing a utility rejection under35 U.S.C. 101. In other words, Office personnelshould not impose a 35 U.S.C. 112(a) or pre-AIA35 U.S.C. 112, first paragraph, rejection groundedon a “lack of utility” basis unless a 35 U.S.C. 101rejection is proper. In particular, the factual showingneeded to impose a rejection under 35 U.S.C. 101must be provided if a rejection under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,is to be imposed on “lack of utility” grounds.

2100-88Rev. 08.2017, January 2018


It is important to recognize that 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, addressesmatters other than those related to the question ofwhether or not an invention lacks utility. Thesematters include whether the claims are fullysupported by the disclosure (In re Vaeck, 947 F.2d488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991)),whether the applicant has provided an enablingdisclosure of the claimed subject matter (In reWright, 999 F.2d 1557, 1561-1562, 27 USPQ2d1510, 1513 (Fed. Cir. 1993)), whether the applicanthas provided an adequate written description of theinvention and whether the applicant has disclosedthe best mode of practicing the claimed invention (Chemcast Corp. v. Arco Indus. Corp., 913 F.2d923, 927-928, 16 USPQ2d 1033, 1036-1037 (Fed.Cir. 1990)). See also Transco Products Inc. v.Performance Contracting Inc., 38 F.3d 551, 32USPQ2d 1077 (Fed. Cir. 1994); GlaxoInc. v. Novopharm Ltd., 52 F.3d 1043, 34 USPQ2d1565 (Fed. Cir. 1995). The fact that an applicant hasdisclosed a specific utility for an invention andprovided a credible basis supporting that specificutility does not provide a basis for concluding thatthe claims comply with all the requirements of 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph. For example, if an applicant has claimeda process of treating a certain disease condition witha certain compound and provided a credible basisfor asserting that the compound is useful in thatregard, but to actually practice the invention asclaimed a person skilled in the relevant art wouldhave to engage in an undue amount ofexperimentation, the claim may be defective under35 U.S.C. 112, but not 35 U.S.C. 101. To avoidconfusion during examination, any rejection under35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, based on grounds other than “lack ofutility” should be imposed separately from anyrejection imposed due to “lack of utility” under 35U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph.

2107.02 Procedural Considerations Relatedto Rejections for Lack of Utility [R-11.2013]

I. THE CLAIMED INVENTION IS THE FOCUSOF THE UTILITY REQUIREMENT

The claimed invention is the focus of the assessmentof whether an applicant has satisfied the utilityrequirement. Each claim (i.e., each “invention”),therefore, must be evaluated on its own merits forcompliance with all statutory requirements.Generally speaking, however, a dependent claimwill define an invention that has utility if theindependent claim from which the dependent claimdepends is drawn to the same statutory class ofinvention as the dependent claim and the independentclaim defines an invention having utility. Anexception to this general rule is where the utilityspecified for the invention defined in a dependentclaim differs from that indicated for the inventiondefined in the independent claim from which thedependent claim depends. Where an applicant hasestablished utility for a species that falls within anidentified genus of compounds, and presents ageneric claim covering the genus, as a generalmatter, that claim should be treated as beingsufficient under 35 U.S.C. 101. Only where it canbe established that other species clearly encompassedby the claim do not have utility should a rejectionbe imposed on the generic claim. In such cases, theapplicant should be encouraged to amend the genericclaim so as to exclude the species that lack utility.

It is common and sensible for an applicant to identifyseveral specific utilities for an invention, particularlywhere the invention is a product (e.g., a machine, anarticle of manufacture or a composition of matter).However, regardless of the category of inventionthat is claimed (e.g., product or process), an applicantneed only make one credible assertion of specificutility for the claimed invention to satisfy 35 U.S.C.101 and 35 U.S.C. 112; additional statements ofutility, even if not “credible,” do not render theclaimed invention lacking in utility. See, e.g., Raytheon v. Roper, 724 F.2d 951, 958, 220 USPQ592, 598 (Fed. Cir. 1983), cert. denied, 469 U.S.835 (1984) (“When a properly claimed inventionmeets at least one stated objective, utility under 35U.S.C. 101 is clearly shown.”); In re Gottlieb, 328F.2d 1016, 1019, 140 USPQ 665, 668 (CCPA 1964)

Rev. 08.2017, January 20182100-89


(“Having found that the antibiotic is useful for somepurpose, it becomes unnecessary to decide whetherit is in fact useful for the other purposes ‘indicated’in the specification as possibly useful.”); In reMalachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA1976); Hoffman v. Klaus, 9 USPQ2d 1657 (Bd. Pat.App. & Inter. 1988). Thus, if applicant makes onecredible assertion of utility, utility for the claimedinvention as a whole is established.

Statements made by the applicant in the specificationor incident to prosecution of the application beforethe Office cannot, standing alone, be the basis for alack of utility rejection under 35 U.S.C. 101 or 35U.S.C. 112. Tol-O-Matic, Inc. v. PromaProdukt-Und Mktg. Gesellschaft m.b.h., 945 F.2d1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991)(It is not required that a particular characteristic setforth in the prosecution history be achieved in orderto satisfy 35 U.S.C. 101.). An applicant may includestatements in the specification whose technicalaccuracy cannot be easily confirmed if thosestatements are not necessary to support thepatentability of an invention with regard to anystatutory basis. Thus, the Office should not requirean applicant to strike nonessential statements relatingto utility from a patent disclosure, regardless of thetechnical accuracy of the statement or assertion itpresents. Office personnel should also be especiallycareful not to read into a claim unclaimed results,limitations or embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173,20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel,292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doingso can inappropriately change the relationship of anasserted utility to the claimed invention and raiseissues not relevant to examination of that claim.

II. IS THERE AN ASSERTED ORWELL-ESTABLISHED UTILITY FOR THECLAIMED INVENTION?

Upon initial examination, the examiner shouldreview the specification to determine if there areany statements asserting that the claimed inventionis useful for any particular purpose. A completedisclosure should include a statement whichidentifies a specific and substantial utility for theinvention.

A. An Asserted Utility Must Be Specific andSubstantial

A statement of specific and substantial utility shouldfully and clearly explain why the applicant believesthe invention is useful. Such statements will usuallyexplain the purpose of or how the invention may beused (e.g., a compound is believed to be useful inthe treatment of a particular disorder). Regardlessof the form of statement of utility, it must enableone ordinarily skilled in the art to understand whythe applicant believes the claimed invention is useful.

Except where an invention has a well-establishedutility, the failure of an applicant to specificallyidentify why an invention is believed to be usefulrenders the claimed invention deficient under 35U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. In such cases, theapplicant has failed to identify a “specific andsubstantial utility” for the claimed invention. Forexample, a statement that a composition has anunspecified “biological activity” or that does notexplain why a composition with that activity isbelieved to be useful fails to set forth a “specific andsubstantial utility.” Brenner v. Manson, 383 US519, 148 USPQ 689 (1966) (general assertion ofsimilarities to known compounds known to be usefulwithout sufficient corresponding explanation whyclaimed compounds are believed to be similarlyuseful insufficient under 35 U.S.C. 101); In reZiegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600,1604 (Fed. Cir. 1993) (disclosure that compositionis “plastic-like” and can form “films” not sufficientto identify specific and substantial utility forinvention); In re Kirk, 376 F.2d 936, 153 USPQ 48(CCPA 1967) (indication that compound is“biologically active” or has “biological properties”insufficient standing alone). See also In re Joly,376 F.2d 906, 153 USPQ 45 (CCPA 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ158, 165 (CCPA 1973) (contrasting description ofinvention as sedative which did suggest specificutility to general suggestion of “pharmacologicaleffects on the central nervous system” which didnot). In contrast, a disclosure that identifies aparticular biological activity of a compound andexplains how that activity can be utilized in aparticular therapeutic application of the compound

2100-90Rev. 08.2017, January 2018


does contain an assertion of specific and substantialutility for the invention.

Situations where an applicant either fails to indicatewhy an invention is considered useful, or where theapplicant inaccurately describes the utility shouldrarely arise. One reason for this is that applicants arerequired to disclose the best mode known to themof practicing the invention at the time they file theirapplication. An applicant who omits a descriptionof the specific and substantial utility of the invention,or who incompletely describes that utility, mayencounter problems with respect to the best moderequirement of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph.

B. No Statement of Utility for the Claimed Inventionin the Specification Does Not Per Se Negate Utility

Occasionally, an applicant will not explicitly statein the specification or otherwise assert a specific andsubstantial utility for the claimed invention. If nostatements can be found asserting a specific andsubstantial utility for the claimed invention in thespecification, Office personnel should determine ifthe claimed invention has a well-established utility.An invention has a well-established utility if (i) aperson of ordinary skill in the art would immediatelyappreciate why the invention is useful based on thecharacteristics of the invention (e.g., properties orapplications of a product or process), and (ii) theutility is specific, substantial, and credible. If aninvention has a well- established utility, rejectionsunder 35 U.S.C. 101 and 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, based onlack of utility should not be imposed. In re Folkers,344 F.2d 970, 145 USPQ 390 (CCPA 1965). Forexample, if an application teaches the cloning andcharacterization of the nucleotide sequence of awell-known protein such as insulin, and those skilledin the art at the time of filing knew that insulin hada well-established use, it would be improper to rejectthe claimed invention as lacking utility solelybecause of the omitted statement of specific andsubstantial utility.

If a person of ordinary skill would not immediatelyrecognize a specific and substantial utility for theclaimed invention (i.e., why it would be useful)based on the characteristics of the invention or

statements made by the applicant, the examinershould reject the application under 35 U.S.C. 101and under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C.112, first paragraph, as failing to identify a specificand substantial utility for the claimed invention. Therejection should clearly indicate that the basis of therejection is that the application fails to identify aspecific and substantial utility for the invention. Therejection should also specify that the applicant mustreply by indicating why the invention is believeduseful and where support for any subsequentlyasserted utility can be found in the specification asfiled. See MPEP § 2701.

If the applicant subsequently indicates why theinvention is useful, Office personnel should reviewthat assertion according to the standards articulatedbelow for review of the credibility of an assertedutility.

III. EVALUATING THE CREDIBILITY OF ANASSERTED UTILITY

A. An Asserted Utility Creates a Presumption of Utility

In most cases, an applicant’s assertion of utilitycreates a presumption of utility that will be sufficientto satisfy the utility requirement of 35 U.S.C. 101.See, e.g., In re Jolles, 628 F.2d 1322, 206 USPQ885 (CCPA 1980); In re Irons, 340 F.2d 974, 144USPQ 351 (CCPA 1965); In re Langer, 503 F.2d1380, 183 USPQ 288 (CCPA 1974); In re Sichert,566 F.2d 1154, 1159, 196 USPQ 209, 212-13 (CCPA1977). As the Court of Customs and Patent Appealsstated in In re Langer:

As a matter of Patent Office practice, aspecification which contains a disclosure ofutility which corresponds in scope to the subjectmatter sought to be patented must be taken assufficient to satisfy the utility requirement of§ 101 for the entire claimed subject matterunless there is a reason for one skilled in theart to question the objective truth of thestatement of utility or its scope.

In re Langer, 503 F.2d at 1391, 183 USPQ at 297(emphasis in original). The “Langer” test for utilityhas been used by both the Federal Circuit and theCourt of Customs and Patent Appeals in evaluation

Rev. 08.2017, January 20182100-91


of rejections under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, where the rejection isbased on a deficiency under 35 U.S.C. 101. In In reBrana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir.1995), the Federal Circuit explicitly adopted theCourt of Customs and Patent Appeals formulationof the “Langer” standard for 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph rejections,as it was expressed in a slightly reworded format in In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367,369 (CCPA 1971), namely:

[A] specification disclosure which contains ateaching of the manner and process of makingand using the invention in terms whichcorrespond in scope to those used in describingand defining the subject matter sought to bepatented must be taken as in compliance withthe enabling requirement of the first paragraphof § 112 unless there is reason to doubt theobjective truth of the statements containedtherein which must be relied on for enablingsupport. (emphasis added).

Thus, Langer and subsequent cases direct the Officeto presume that a statement of utility made by anapplicant is true. See In re Langer, 503 F.2d at 1391,183 USPQ at 297; In re Malachowski, 530 F.2d1402, 1404, 189 USPQ 432, 435 (CCPA 1976); Inre Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir.1995). For obvious reasons of efficiency and indeference to an applicant’s understanding of his orher invention, when a statement of utility isevaluated, Office personnel should not begin byquestioning the truth of the statement of utility.Instead, any inquiry must start by asking if there isany reason to question the truth of the statement ofutility. This can be done by simply evaluating thelogic of the statements made, taking intoconsideration any evidence cited by the applicant.If the asserted utility is credible (i.e., believablebased on the record or the nature of the invention),a rejection based on “lack of utility” is notappropriate. Clearly, Office personnel should notbegin an evaluation of utility by assuming that anasserted utility is likely to be false, based on thetechnical field of the invention or for other generalreasons.

Compliance with 35 U.S.C. 101 is a question of fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835(1984). Thus, to overcome the presumption of truththat an assertion of utility by the applicant enjoys,Office personnel must establish that it is more likelythan not that one of ordinary skill in the art woulddoubt (i.e., “question”) the truth of the statement ofutility. The evidentiary standard to be usedthroughout ex parte examination in setting forth arejection is a preponderance of the totality of theevidence under consideration. In re Oetiker, 977F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir.1992) (“After evidence or argument is submitted bythe applicant in response, patentability is determinedon the totality of the record, by a preponderance ofevidence with due consideration to persuasivenessof argument.”); In re Corkill, 771 F.2d 1496,1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). Apreponderance of the evidence exists when itsuggests that it is more likely than not that theassertion in question is true. Herman v. Huddleston,459 U.S. 375, 390 (1983). To do this, Officepersonnel must provide evidence sufficient to showthat the statement of asserted utility would beconsidered “false” by a person of ordinary skill inthe art. Of course, a person of ordinary skill musthave the benefit of both facts and reasoning in orderto assess the truth of a statement. This means that ifthe applicant has presented facts that support thereasoning used in asserting a utility, Office personnelmust present countervailing facts and reasoningsufficient to establish that a person of ordinary skillwould not believe the applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.Cir. 1995). The initial evidentiary standard usedduring evaluation of this question is a preponderanceof the evidence (i.e., the totality of facts andreasoning suggest that it is more likely than not thatthe statement of the applicant is false).

B. When Is an Asserted Utility Not Credible?

Where an applicant has specifically asserted that aninvention has a particular utility, that assertioncannot simply be dismissed by Office personnel asbeing “wrong,” even when there may be reason tobelieve that the assertion is not entirely accurate.Rather, Office personnel must determine if theassertion of utility is credible (i.e., whether the

2100-92Rev. 08.2017, January 2018


assertion of utility is believable to a person ofordinary skill in the art based on the totality ofevidence and reasoning provided). An assertion iscredible unless (A) the logic underlying the assertionis seriously flawed, or (B) the facts upon which theassertion is based are inconsistent with the logicunderlying the assertion. Credibility as used in thiscontext refers to the reliability of the statement basedon the logic and facts that are offered by theapplicant to support the assertion of utility.

One situation where an assertion of utility would notbe considered credible is where a person of ordinaryskill would consider the assertion to be “incrediblein view of contemporary knowledge” and wherenothing offered by the applicant would counter whatcontemporary knowledge might otherwise suggest.Office personnel should be careful, however, not tolabel certain types of inventions as “incredible” or“speculative” as such labels do not provide thecorrect focus for the evaluation of an assertion ofutility. “Incredible utility” is a conclusion, not astarting point for analysis under 35 U.S.C. 101. Aconclusion that an asserted utility is incredible canbe reached only after the Office has evaluated boththe assertion of the applicant regarding utility andany evidentiary basis of that assertion. The Officeshould be particularly careful not to start with apresumption that an asserted utility is, per se,“incredible” and then proceed to base a rejectionunder 35 U.S.C. 101 on that presumption.

Rejections under 35 U.S.C. 101 based on a lack ofcredible utility have been sustained by federal courtswhen, for example, the applicant failed to discloseany utility for the invention or asserted a utility thatcould only be true if it violated a scientific principle,such as the second law of thermodynamics, or a lawof nature, or was wholly inconsistent withcontemporary knowledge in the art. In re Gazave,379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967).Special care should be taken when assessing thecredibility of an asserted therapeutic utility for aclaimed invention. In such cases, a previous lack ofsuccess in treating a disease or condition, or theabsence of a proven animal model for testing theeffectiveness of drugs for treating a disorder inhumans, should not, standing alone, serve as a basisfor challenging the asserted utility under 35 U.S.C.101. See MPEP § 2107.03 for additional guidance

with regard to therapeutic or pharmacologicalutilities.

IV. INITIAL BURDEN IS ON THE OFFICE TOESTABLISH A PRIMA FACIE CASE ANDPROVIDE EVIDENTIARY SUPPORT THEREOF

To properly reject a claimed invention under35 U.S.C. 101, the Office must (A) make a primafacie showing that the claimed invention lacks utility,and (B) provide a sufficient evidentiary basis forfactual assumptions relied upon in establishing the prima facie showing. In re Gaubert, 524 F.2d 1222,1224, 187 USPQ 664, 666 (CCPA 1975)"Accordingly, the PTO must do more than merelyquestion operability - it must set forth factual reasonswhich would lead one skilled in the art to questionthe objective truth of the statement of operability."If the Office cannot develop a proper prima faciecase and provide evidentiary support for a rejectionunder 35 U.S.C. 101, a rejection on this groundshould not be imposed. See, e.g., In re Oetiker, 977F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir.1992) (“[T]he examiner bears the initial burden, onreview of the prior art or on any other ground, ofpresenting a prima facie case of unpatentability. Ifthat burden is met, the burden of coming forwardwith evidence or argument shifts to the applicant....If examination at the initial stage does not producea prima facie case of unpatentability, then withoutmore the applicant is entitled to grant of the patent.”).See also Fregeau v. Mossinghoff, 776 F.2d 1034,227 USPQ 848 (Fed. Cir. 1985) (applying primafacie case law to 35 U.S.C. 101); In re Piasecki,745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984).

The prima facie showing must be set forth in awell-reasoned statement. Any rejection based onlack of utility should include a detailed explanationwhy the claimed invention has no specific andsubstantial credible utility. Whenever possible, theexaminer should provide documentary evidenceregardless of publication date (e.g., scientific ortechnical journals, excerpts from treatises or books,or U.S. or foreign patents) to support the factualbasis for the prima facie showing of no specific andsubstantial credible utility. If documentary evidenceis not available, the examiner should specificallyexplain the scientific basis for his or her factualconclusions.

Rev. 08.2017, January 20182100-93


Where the asserted utility is not specific orsubstantial, a prima facie showing must establishthat it is more likely than not that a person ofordinary skill in the art would not consider that anyutility asserted by the applicant would be specificand substantial. The prima facie showing mustcontain the following elements:

(A) An explanation that clearly sets forth thereasoning used in concluding that the asserted utilityfor the claimed invention is neither both specific andsubstantial nor well-established;

(B) Support for factual findings relied upon inreaching this conclusion; and

(C) An evaluation of all relevant evidence ofrecord, including utilities taught in the closest priorart.

Where the asserted specific and substantial utility isnot credible, a prima facie showing of no specificand substantial credible utility must establish that itis more likely than not that a person skilled in theart would not consider credible any specific andsubstantial utility asserted by the applicant for theclaimed invention. The prima facie showing mustcontain the following elements:

(A) An explanation that clearly sets forth thereasoning used in concluding that the assertedspecific and substantial utility is not credible;

(B) Support for factual findings relied upon inreaching this conclusion; and

(C) An evaluation of all relevant evidence ofrecord, including utilities taught in the closest priorart.

Where no specific and substantial utility is disclosedor is well-established, a prima facie showing of nospecific and substantial utility need only establishthat applicant has not asserted a utility and that, onthe record before the examiner, there is no knownwell-established utility.

It is imperative that Office personnel use specificityin setting forth and initial rejection under 35 U.S.C.101 and support any factual conclusions made in the prima facie showing.

By using specificity, the applicant will be able toidentify the assumptions made by the Office in

setting forth the rejection and will be able to addressthose assumptions properly.

V. EVIDENTIARY REQUESTS BY AN EXAMINERTO SUPPORT AN ASSERTED UTILITY

In appropriate situations the Office may require anapplicant to substantiate an asserted utility for aclaimed invention. See In re Pottier, 376 F.2d 328,330, 153 USPQ 407, 408 (CCPA 1967) (“When theoperativeness of any process would be deemedunlikely by one of ordinary skill in the art, it is notimproper for the examiner to call for evidence ofoperativeness.”). See also In re Jolles, 628 F.2d1322, 1327, 206 USPQ 885, 890 (CCPA 1980); Inre Citron, 325 F.2d 248, 139 USPQ 516 (CCPA1963); In re Novak, 306 F.2d 924, 928, 134 USPQ335, 337 (CCPA1962). In In re Citron, the courtheld that when an “alleged utility appears to beincredible in the light of the knowledge of the art,or factually misleading, applicant must establish theasserted utility by acceptable proof.” 325 F.2d at253, 139 USPQ at 520. The court approved of theboard’s decision which affirmed the rejection under35 U.S.C. 101 “in view of the art knowledge of thelack of a cure for cancer and the absence of anyclinical data to substantiate the allegation.” 325 F.2dat 252, 139 USPQ at 519 (emphasis in original). Thecourt thus established a higher burden on theapplicant where the statement of use is incredible ormisleading. In such a case, the examiner shouldchallenge the use and require sufficient evidence ofoperativeness. The purpose of this authority is toenable an applicant to cure an otherwise defectivefactual basis for the operability of an invention.Because this is a curative authority (e.g., evidenceis requested to enable an applicant to support anassertion that is inconsistent with the facts of recordin the application), Office personnel should indicatenot only why the factual record is defective inrelation to the assertions of the applicant, but also,where appropriate, what type of evidentiary showingcan be provided by the applicant to remedy theproblem.

Requests for additional evidence should be imposedrarely, and only if necessary to support the scientificcredibility of the asserted utility (e.g., if the assertedutility is not consistent with the evidence of recordand current scientific knowledge). As the Federal

2100-94Rev. 08.2017, January 2018


Circuit recently noted, “[o]nly after the PTOprovides evidence showing that one of ordinary skillin the art would reasonably doubt the asserted utilitydoes the burden shift to the applicant to providerebuttal evidence sufficient to convince such a personof the invention’s asserted utility.” In re Brana, 51F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995) (citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51(CCPA 1981)). In Brana, the court pointed out thatthe purpose of treating cancer with chemicalcompounds does not suggest, per se, an incredibleutility. Where the prior art disclosed “structurallysimilar compounds to those claimed by applicantswhich have been proven in vivo to be effective aschemotherapeutic agents against various tumormodels . . ., one skilled in the art would be withoutbasis to reasonably doubt applicants’ asserted utilityon its face.” 51 F.3d at 1566, 34 USPQ2d at 1441.As courts have stated, “it is clearly improper for theexaminer to make a demand for further test data,which as evidence would be essentially redundantand would seem to serve for nothing except perhapsto unduly burden the applicant.” In re Isaacs, 347F.2d 887, 890, 146 USPQ 193, 196 (CCPA 1965).

VI. CONSIDERATION OF A REPLY TO A PRIMAFACIE REJECTION FOR LACK OF UTILITY

If a rejection under 35 U.S.C. 101 has been properlyimposed, along with a corresponding rejection under35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, the burden shifts to the applicant to rebutthe prima facie showing. In re Oetiker, 977 F.2d1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992)(“The examiner bears the initial burden, on reviewof the prior art or on any other ground, of presentinga prima facie case of unpatentability. If that burdenis met, the burden of coming forward with evidenceor argument shifts to the applicant. . . After evidenceor argument is submitted by the applicant inresponse, patentability is determined on the totalityof the record, by a preponderance of evidence withdue consideration to persuasiveness of argument.”).An applicant can do this using any combination ofthe following: amendments to the claims, argumentsor reasoning, or new evidence submitted in anaffidavit or declaration under 37 CFR 1.132, or in aprinted publication. New evidence provided by anapplicant must be relevant to the issues raised in therejection. For example, declarations in which

conclusions are set forth without establishing a nexusbetween those conclusions and the supportingevidence, or which merely express opinions, maybe of limited probative value with regard to rebuttinga prima facie case. In re Grunwell, 609 F.2d 486,203 USPQ 1055 (CCPA 1979); In re Buchner, 929F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). SeeMPEP § 716.01(a) through MPEP § 716.01(c).

If the applicant responds to the prima facie rejection,Office personnel should review the originaldisclosure, any evidence relied upon in establishingthe prima facie showing, any claim amendments,and any new reasoning or evidence provided by theapplicant in support of an asserted specific andsubstantial credible utility. It is essential for Officepersonnel to recognize, fully consider and respondto each substantive element of any response to arejection based on lack of utility. Only where thetotality of the record continues to show that theasserted utility is not specific, substantial, andcredible should a rejection based on lack of utilitybe maintained. If the record as a whole would makeit more likely than not that the asserted utility forthe claimed invention would be considered credibleby a person of ordinary skill in the art, the Officecannot maintain the rejection. In re Rinehart, 531F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976).

VII. EVALUATION OF EVIDENCE RELATED TOUTILITY

There is no predetermined amount or character ofevidence that must be provided by an applicant tosupport an asserted utility, therapeutic or otherwise.Rather, the character and amount of evidence neededto support an asserted utility will vary depending onwhat is claimed (Ex parte Ferguson, 117 USPQ 229(Bd. App. 1957)), and whether the asserted utilityappears to contravene established scientificprinciples and beliefs. In re Gazave, 379 F.2d 973,978, 154 USPQ 92, 96 (CCPA 1967); In reChilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325(CCPA 1956). Furthermore, the applicant does nothave to provide evidence sufficient to establish thatan asserted utility is true “beyond a reasonabledoubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ351, 354 (CCPA 1965). Nor must an applicantprovide evidence such that it establishes an assertedutility as a matter of statistical certainty.

Rev. 08.2017, January 20182100-95


Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ881, 883-84 (CCPA 1980) (reversing the Board andrejecting Bowler’s arguments that the evidence ofutility was statistically insignificant. The courtpointed out that a rigorous correlation is notnecessary when the test is reasonably predictive ofthe response). See also Rey-Bellet v. Englehardt,493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (datafrom animal testing is relevant to asserted humantherapeutic utility if there is a “satisfactorycorrelation between the effect on the animal and thatultimately observed in human beings”). Instead,evidence will be sufficient if, considered as a whole,it leads a person of ordinary skill in the art toconclude that the asserted utility is more likely thannot true.

2107.03 Special Considerations for AssertedTherapeutic or Pharmacological Utilities[R-08.2012]

The federal courts have consistently reversedrejections by the Office asserting a lack of utility forinventions claiming a pharmacological or therapeuticutility where an applicant has provided evidence thatreasonably supports such a utility. In view of this,Office personnel should be particularly careful intheir review of evidence provided in support of anasserted therapeutic or pharmacological utility.

I. A REASONABLE CORRELATION BETWEENTHE EVIDENCE AND THE ASSERTED UTILITYIS SUFFICIENT

As a general matter, evidence of pharmacologicalor other biological activity of a compound will berelevant to an asserted therapeutic use if there is areasonable correlation between the activity inquestion and the asserted utility. Cross v. Iizuka,753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); Inre Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ881 (CCPA 1980). An applicant can establish thisreasonable correlation by relying on statisticallyrelevant data documenting the activity of acompound or composition, arguments or reasoning,documentary evidence (e.g., articles in scientificjournals), or any combination thereof. The applicantdoes not have to prove that a correlation existsbetween a particular activity and an asserted

therapeutic use of a compound as a matter ofstatistical certainty, nor does he or she have toprovide actual evidence of success in treatinghumans where such a utility is asserted. Instead, asthe courts have repeatedly held, all that is requiredis a reasonable correlation between the activity andthe asserted use. Nelson v. Bowler, 626 F.2d 853,857, 206 USPQ 881, 884 (CCPA 1980).

II. STRUCTURAL SIMILARITY TO COMPOUNDSWITH ESTABLISHED UTILITY

Courts have routinely found evidence of structuralsimilarity to a compound known to have a particulartherapeutic or pharmacological utility as beingsupportive of an assertion of therapeutic utility fora new compound. In In re Jolles, 628 F.2d 1322,206 USPQ 885 (CCPA 1980), the claimedcompounds were found to have utility based on afinding of a close structural relationship todaunorubicin and doxorubicin and sharedpharmacological activity with those compounds,both of which were known to be useful in cancerchemotherapy. The evidence of close structuralsimilarity with the known compounds was presentedin conjunction with evidence demonstratingsubstantial activity of the claimed compounds inanimals customarily employed for screeninganticancer agents. Such evidence should be givenappropriate weight in determining whether oneskilled in the art would find the asserted utilitycredible. Office personnel should evaluate not onlythe existence of the structural relationship, but alsothe reasoning used by the applicant or a declarant toexplain why that structural similarity is believed tobe relevant to the applicant's assertion of utility.

III. DATA FROM IN VITRO OR ANIMALTESTING IS GENERALLY SUFFICIENT TOSUPPORT THERAPEUTIC UTILITY

If reasonably correlated to the particular therapeuticor pharmacological utility, data generated using invitro assays, or from testing in an animal model ora combination thereof almost invariably will besufficient to establish therapeutic or pharmacologicalutility for a compound, composition or process. Acursory review of cases involving therapeuticinventions where 35 U.S.C. 101 was the dispositiveissue illustrates the fact that the federal courts are

2100-96Rev. 08.2017, January 2018


not particularly receptive to rejections under 35U.S.C. 101 based on inoperability. Most striking isthe fact that in those cases where an applicantsupplied a reasonable evidentiary showingsupporting an asserted therapeutic utility, almostuniformly the 35 U.S.C. 101-based rejection wasreversed. See, e.g., In re Brana, 51 F.3d 1560, 34USPQ 1436 (Fed. Cir. 1995); Cross v. Iizuka, 753F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In reJolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ881, 883 (CCPA 1980); In re Malachowski, 530F.2d 1402, 189 USPQ 432 (CCPA 1976); In reGaubert, 530 F.2d 1402, 189 USPQ 432 (CCPA1975); In re Gazave, 379 F.2d 973, 154 USPQ 92(CCPA 1967); In re Hartop, 311 F.2d 249, 135USPQ 419 (CCPA 1962); In re Krimmel, 292 F.2d948, 130 USPQ 215 (CCPA 1961). Only in thosecases where the applicant was unable to comeforward with any relevant evidence to rebut a findingby the Office that the claimed invention wasinoperative was a 35 U.S.C. 101 rejection affirmedby the court. In re Citron, 325 F.2d 248, 253, 139USPQ 516, 520 (CCPA 1963) (therapeutic utilityfor an uncharacterized biological extract notsupported or scientifically credible); In re Buting,418 F.2d 540, 543, 163 USPQ 689, 690 (CCPA1969) (record did not establish a credible basis forthe assertion that the single class of compounds inquestion would be useful in treating disparate typesof cancers); In re Novak, 306 F.2d 924, 134 USPQ335 (CCPA 1962) (claimed compounds did not havecapacity to effect physiological activity upon whichutility claim based). Contrast, however, In re Butingto In re Gardner, 475 F.2d 1389, 177 USPQ 396(CCPA 1973), reh'g denied, 480 F.2d 879 (CCPA1973), in which the court held that utility for a genuswas found to be supported through a showing ofutility for one species. In no case has a federal courtrequired an applicant to support an asserted utilitywith data from human clinical trials.

If an applicant provides data, whether from in vitroassays or animal tests or both, to support an assertedutility, and an explanation of why that data supportsthe asserted utility, the Office will determine if thedata and the explanation would be viewed by oneskilled in the art as being reasonably predictive ofthe asserted utility. See, e.g., Ex parte Maas, 9USPQ2d 1746 (Bd. Pat. App. & Inter. 1987); Ex

parte Balzarini, 21 USPQ2d 1892 (Bd. Pat. App. &Inter. 1991). Office personnel must be careful toevaluate all factors that might influence theconclusions of a person of ordinary skill in the artas to this question, including the test parameters,choice of animal, relationship of the activity to theparticular disorder to be treated, characteristics ofthe compound or composition, relative significanceof the data provided and, most importantly, theexplanation offered by the applicant as to why theinformation provided is believed to support theasserted utility. If the data supplied is consistent withthe asserted utility, the Office cannot maintain arejection under 35 U.S.C. 101.

Evidence does not have to be in the form of datafrom an art-recognized animal model for theparticular disease or disease condition to which theasserted utility relates. Data from any test that theapplicant reasonably correlates to the asserted utilityshould be evaluated substantively. Thus, an applicantmay provide data generated using a particular animalmodel with an appropriate explanation as to whythat data supports the asserted utility. The absenceof a certification that the test in question is anindustry-accepted model is not dispositive of whetherdata from an animal model is in fact relevant to theasserted utility. Thus, if one skilled in the art wouldaccept the animal tests as being reasonably predictiveof utility in humans, evidence from those tests shouldbe considered sufficient to support the credibility ofthe asserted utility. In re Hartop, 311 F.2d 249, 135USPQ 419 (CCPA 1962); In re Krimmel, 292 F.2d948, 953, 130 USPQ 215, 219 (CCPA 1961); Exparte Krepelka, 231 USPQ 746 (Bd. Pat. App. &Inter. 1986). Office personnel should be careful notto find evidence unpersuasive simply because noanimal model for the human disease condition hadbeen established prior to the filing of the application.See In re Chilowsky, 229 F.2d 457, 461, 108 USPQ321, 325 (CCPA 1956) (“The mere fact thatsomething has not previously been done clearly isnot, in itself, a sufficient basis for rejecting allapplications purporting to disclose how to do it.”); In re Wooddy, 331 F.2d 636, 639, 141 USPQ 518,520 (CCPA 1964) (“It appears that no one on earthis certain as of the present whether the processclaimed will operate in the manner claimed. Yetabsolute certainty is not required by the law. Themere fact that something has not previously been

Rev. 08.2017, January 20182100-97


done clearly is not, in itself, a sufficient basis forrejecting all applications purporting to disclose howto do it.”).

IV. HUMAN CLINICAL DATA

Office personnel should not impose on applicantsthe unnecessary burden of providing evidence fromhuman clinical trials. There is no decisional law thatrequires an applicant to provide data from humanclinical trials to establish utility for an inventionrelated to treatment of human disorders (see In reIsaacs, 347 F.2d 889, 146 USPQ 193 (CCPA 1963); In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA1974)), even with respect to situations where noart-recognized animal models existed for the humandisease encompassed by the claims. Ex parteBalzarini, 21 USPQ2d 1892 (Bd. Pat. App. & Inter.1991) (human clinical data is not required todemonstrate the utility of the claimed invention, eventhough those skilled in the art might not accept otherevidence to establish the efficacy of the claimedtherapeutic compositions and the operativeness ofthe claimed methods of treating humans). Before adrug can enter human clinical trials, the sponsor,often the applicant, must provide a convincingrationale to those especially skilled in the art (e.g.,the Food and Drug Administration (FDA)) that theinvestigation may be successful. Such a rationalewould provide a basis for the sponsor’s expectationthat the investigation may be successful. In order todetermine a protocol for phase I testing, the firstphase of clinical investigation, some crediblerationale of how the drug might be effective or couldbe effective would be necessary. Thus, as a generalrule, if an applicant has initiated human clinical trialsfor a therapeutic product or process, Office personnelshould presume that the applicant has establishedthat the subject matter of that trial is reasonablypredictive of having the asserted therapeutic utility.

V. SAFETY AND EFFICACY CONSIDERATIONS

The Office must confine its review of patentapplications to the statutory requirements of thepatent law. Other agencies of the government havebeen assigned the responsibility of ensuringconformance to standards established by statute forthe advertisement, use, sale or distribution of drugs.The FDA pursues a two-prong test to provide

approval for testing. Under that test, a sponsor mustshow that the investigation does not pose anunreasonable and significant risk of illness or injuryand that there is an acceptable rationale for the study.As a review matter, there must be a rationale forbelieving that the compound could be effective. Ifthe use reviewed by the FDA is not set forth in thespecification, FDA review may not satisfy 35 U.S.C.101. However, if the reviewed use is one set forthin the specification, Office personnel mustbe extremely hesitant to challenge utility. In such asituation, experts at the FDA have assessed therationale for the drug or research study upon whichan asserted utility is based and found it satisfactory.Thus, in challenging utility, Office personnel mustbe able to carry their burden that there is no soundrationale for the asserted utility even though expertsdesignated by Congress to decide the issue havecome to an opposite conclusion. “FDA approval,however, is not a prerequisite for finding acompound useful within the meaning of the patentlaws.” In re Brana, 51 F.3d 1560, 34 USPQ2d 1436(Fed. Cir. 1995) (citing Scott v. Finney, 34 F.3d1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir.1994)).

Thus, while an applicant may on occasion need toprovide evidence to show that an invention will workas claimed, it is improper for Office personnel torequest evidence of safety in the treatment ofhumans, or regarding the degree of effectiveness.See In re Sichert, 566 F.2d 1154, 196 USPQ 209(CCPA 1977); In re Hartop, 311 F.2d 249, 135USPQ 419 (CCPA 1962); In re Anthony, 414 F.2d1383, 162 USPQ 594 (CCPA 1969); In re Watson,517 F.2d 465, 186 USPQ 11 (CCPA 1975); In reKrimmel, 292 F.2d 948, 130 USPQ 215 (CCPA1961); Ex parte Jovanovics, 211 USPQ 907 (Bd.Pat. App. & Inter. 1981).

VI. TREATMENT OF SPECIFIC DISEASECONDITIONS

Claims directed to a method of treating or curing adisease for which there have been no previouslysuccessful treatments or cures warrant careful reviewfor compliance with 35 U.S.C. 101. The credibilityof an asserted utility for treating a human disordermay be more difficult to establish where currentscientific understanding suggests that such a task

2100-98Rev. 08.2017, January 2018


would be impossible. Such a determination hasalways required a good understanding of the stateof the art as of the time that the invention was made.For example, prior to the 1980’s, there were anumber of cases where an asserted use in treatingcancer in humans was viewed as “incredible.” In reJolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA1969); Ex parte Stevens, 16 USPQ2d 1379 (Bd. Pat.App. & Inter. 1990); Ex parte Busse, 1 USPQ2d1908 (Bd. Pat. App. & Inter. 1986); Ex parteKrepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.1986); Ex parte Jovanovics, 211 USPQ 907 (Bd.Pat. App. & Inter. 1981). The fact that there is noknown cure for a disease, however, cannot serve asthe basis for a conclusion that such an inventionlacks utility. Rather, Office personnel mustdetermine if the asserted utility for the invention iscredible based on the information disclosed in theapplication. Only those claims for which an assertedutility is not credible should be rejected. In suchcases, the Office should carefully review what isbeing claimed by the applicant. An assertion that theclaimed invention is useful in treating a symptomof an incurable disease may be considered credibleby a person of ordinary skill in the art on the basisof a fairly modest amount of evidence or support.In contrast, an assertion that the claimed inventionwill be useful in “curing” the disease may require asignificantly greater amount of evidentiary supportto be considered credible by a person of ordinaryskill in the art. In re Sichert, 566 F.2d 1154, 196USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d1322, 206 USPQ 885 (CCPA 1980). See also Exparte Ferguson, 117 USPQ 229 (Bd. Pat. App. &Inter. 1957).

In these cases, it is important to note that the Foodand Drug Administration has promulgatedregulations that enable a party to conduct clinicaltrials for drugs used to treat life threatening andseverely-debilitating illnesses, even where noalternative therapy exists. See 21 CFR 312.80-88(1994). Implicit in these regulations is therecognition that experts qualified to evaluate theeffectiveness of therapeutics can and often do finda sufficient basis to conduct clinical trials of drugsfor incurable or previously untreatable illnesses.Thus, affidavit evidence from experts in the artindicating that there is a reasonable expectation of

success, supported by sound reasoning, usuallyshould be sufficient to establish that such a utility iscredible.


2111 Claim Interpretation; BroadestReasonable Interpretation [R-07.2015]

CLAIMS MUST BE GIVEN THEIR BROADESTREASONABLE INTERPRETATION IN LIGHT OFTHE SPECIFICATION

During patent examination, the pending claims mustbe “given their broadest reasonable interpretationconsistent with the specification.” The FederalCircuit’s en banc decision in Phillips v. AWHCorp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329(Fed. Cir. 2005) expressly recognized that theUSPTO employs the “broadest reasonableinterpretation” standard:

The Patent and Trademark Office (“PTO”)determines the scope of claims in patentapplications not solely on the basis of the claimlanguage, but upon giving claims their broadestreasonable construction “in light of thespecification as it would be interpreted by oneof ordinary skill in the art.” In re Am. Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1364[, 70USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed,the rules of the PTO require that applicationclaims must “conform to the invention as setforth in the remainder of the specification andthe terms and phrases used in the claims mustfind clear support or antecedent basis in thedescription so that the meaning of the terms inthe claims may be ascertainable by referenceto the description.” 37 CFR 1.75(d)(1).

See also In re Suitco Surface, Inc., 603 F.3d 1255,1259, 94 USPQ2d 1640, 1643 (Fed. Cir. 2010); Inre Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664,1667 (Fed. Cir. 2000).

Patented claims are not given the broadest reasonableinterpretation during court proceedings involvinginfringement and validity, and can be interpreted

Rev. 08.2017, January 20182100-99


based on a fully developed prosecution record. Incontrast, an examiner must construe claim terms inthe broadest reasonable manner during prosecutionas is reasonably allowed in an effort to establish aclear record of what applicant intends to claim. Thus,the Office does not interpret claims in the samemanner as the courts. In re Morris, 127 F.3d 1048,1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997); Inre Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320,1321-22 (Fed. Cir. 1989).

Because applicant has the opportunity to amend theclaims during prosecution, giving a claim its broadestreasonable interpretation will reduce the possibilitythat the claim, once issued, will be interpreted morebroadly than is justified. In re Yamamoto, 740 F.2d1569, 1571 (Fed. Cir. 1984); In re Zletz, 893 F.2d319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989)(“During patent examination the pending claimsmust be interpreted as broadly as their termsreasonably allow.”); In re Prater, 415 F.2d 1393,1404-05, 162 USPQ 541, 550-51 (CCPA 1969)(Claim 9 was directed to a process of analyzing datagenerated by mass spectrographic analysis of a gas.The process comprised selecting the data to beanalyzed by subjecting the data to a mathematicalmanipulation. The examiner made rejections under35 U.S.C. 101 and 35 U.S.C. 102. In the 35 U.S.C.102 rejection, the examiner explained that the claimwas anticipated by a mental process augmented bypencil and paper markings. The court agreed thatthe claim was not limited to using a machine to carryout the process since the claim did not explicitly setforth the machine. The court explained that “readinga claim in light of the specification, to therebyinterpret limitations explicitly recited in the claim,is a quite different thing from ‘reading limitationsof the specification into a claim,’ to thereby narrowthe scope of the claim by implicitly adding disclosedlimitations which have no express basis in theclaim.” The court found that applicant wasadvocating the latter, i.e., the impermissibleimportation of subject matter from the specificationinto the claim.). See also In re Morris, 127 F.3d1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed.Cir. 1997) (The court held that the PTO is notrequired, in the course of prosecution, to interpretclaims in applications in the same manner as a courtwould interpret claims in an infringement suit.Rather, the “PTO applies to verbiage of the proposed

claims the broadest reasonable meaning of the wordsin their ordinary usage as they would be understoodby one of ordinary skill in the art, taking into accountwhatever enlightenment by way of definitions orotherwise that may be afforded by the writtendescription contained in applicant’s specification.”).

The broadest reasonable interpretation does not meanthe broadest possible interpretation. Rather, themeaning given to a claim term must be consistentwith the ordinary and customary meaning of the term(unless the term has been given a special definitionin the specification), and must be consistent with theuse of the claim term in the specification anddrawings. Further, the broadest reasonableinterpretation of the claims must be consistent withthe interpretation that those skilled in the art wouldreach. In re Cortright, 165 F.3d 1353, 1359, 49USPQ2d 1464, 1468 (Fed. Cir. 1999) (The Board’sconstruction of the claim limitation “restore hairgrowth” as requiring the hair to be returned to itsoriginal state was held to be an incorrectinterpretation of the limitation. The court held that,consistent with applicant’s disclosure and thedisclosure of three patents from analogous arts usingthe same phrase to require only some increase inhair growth, one of ordinary skill would construe“restore hair growth” to mean that the claimedmethod increases the amount of hair grown on thescalp, but does not necessarily produce a full headof hair.). Thus the focus of the inquiry regarding themeaning of a claim should be what would bereasonable from the perspective of one of ordinaryskill in the art. In re Suitco Surface, Inc., 603 F.3d1255, 1260, 94 USPQ2d 1640, 1644 (Fed. Cir.2010); In re Buszard, 504 F.3d 1364, 84 USPQ2d1749 (Fed. Cir. 2007). In Buszard, the claim wasdirected to a flame retardant composition comprisinga flexible polyurethane foam reaction mixture. 504F.3d at 1365, 84 USPQ2d at 1750. The FederalCircuit found that the Board’s interpretation thatequated a “flexible” foam with a crushed “rigid”foam was not reasonable. Id. at 1367, 84 USPQ2dat 1751. Persuasive argument was presented thatpersons experienced in the field of polyurethanefoams know that a flexible mixture is different thana rigid foam mixture. Id. at 1366, 84 USPQ2d at1751.

2100-100Rev. 08.2017, January 2018


See MPEP § 2173.02 for further discussion of claiminterpretation in the context of analyzing claims forcompliance with 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph.

2111.01 Plain Meaning [R-08.2017]

[Editor Note: This MPEP section is applicable toapplications subject to the first inventor to file(FITF) provisions of the AIA except that the relevantdate is the "effective filing date" of the claimedinvention instead of the "time of the invention,"which is only applicable to applications subject topre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note)and MPEP § 2150 et seq.]

I. THE WORDS OF A CLAIM MUST BE GIVENTHEIR “PLAIN MEANING” UNLESS SUCHMEANING IS INCONSISTENT WITH THESPECIFICATION

Under a broadest reasonable interpretation, wordsof the claim must be given their plain meaning,unless such meaning is inconsistent with thespecification. The plain meaning of a term meansthe ordinary and customary meaning given to theterm by those of ordinary skill in the art at the timeof the invention. The ordinary and customarymeaning of a term may be evidenced by a variety ofsources, including the words of the claimsthemselves, the specification, drawings, and priorart. However, the best source for determining themeaning of a claim term is the specification - thegreatest clarity is obtained when the specificationserves as a glossary for the claim terms. The wordsof the claim must be given their plain meaning unlessthe plain meaning is inconsistent with thespecification. In re Zletz, 893 F.2d 319, 321, 13USPQ2d 1320, 1322 (Fed. Cir. 1989) (discussedbelow); Chef America, Inc. v. Lamb-Weston, Inc.,358 F.3d 1371, 1372, 69 USPQ2d 1857 (Fed. Cir.2004) (Ordinary, simple English words whosemeaning is clear and unquestionable, absent anyindication that their use in a particular contextchanges their meaning, are construed to mean exactlywhat they say. Thus, “heating the resultingbatter-coated dough to a temperature in the range of

about 400oF to 850oF” required heating the dough,rather than the air inside an oven, to the specifiedtemperature.).

The presumption that a term is given its ordinaryand customary meaning may be rebutted by theapplicant by clearly setting forth a differentdefinition of the term in the specification. In reMorris, 127 F.3d 1048, 1054, 44 USPQ2d 1023,1028 (Fed. Cir. 1997) (the USPTO looks to theordinary use of the claim terms taking into accountdefinitions or other “enlightenment” contained inthe written description); But c.f. In re Am. Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1369, 70 USPQ2d1827, 1834 (Fed. Cir. 2004) (“We have cautionedagainst reading limitations into a claim from thepreferred embodiment described in the specification,even if it is the only embodiment described, absentclear disclaimer in the specification.”). When thespecification sets a clear path to the claim language,the scope of the claims is more easily determinedand the public notice function of the claims is bestserved.

II. IT IS IMPROPER TO IMPORT CLAIMLIMITATIONS FROM THE SPECIFICATION

“Though understanding the claim language may beaided by explanations contained in the writtendescription, it is important not to import into a claimlimitations that are not part of the claim. Forexample, a particular embodiment appearing in thewritten description may not be read into a claimwhen the claim language is broader than theembodiment.” Superguide Corp. v. DirecTVEnterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898,906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004)(discussing recent cases wherein the court expresslyrejected the contention that if a patent describes onlya single embodiment, the claims of the patent mustbe construed as being limited to that embodiment); E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364,1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003)(“Interpretation of descriptive statements in apatent’s written description is a difficult task, as aninherent tension exists as to whether a statement isa clear lexicographic definition or a description ofa preferred embodiment. The problem is to interpretclaims ‘in view of the specification’ withoutunnecessarily importing limitations from thespecification into the claims.”); Altiris Inc. v.

Rev. 08.2017, January 20182100-101


Symantec Corp., 318 F.3d 1363, 1371, 65 USPQ2d1865, 1869-70 (Fed. Cir. 2003) (Although thespecification discussed only a single embodiment,the court held that it was improper to read a specificorder of steps into method claims where, as a matterof logic or grammar, the language of the methodclaims did not impose a specific order on theperformance of the method steps, and thespecification did not directly or implicitly require aparticular order). See also subsection IV., below.When an element is claimed using language fallingunder the scope of 35 U.S.C. 112(f) or pre-AIA35 U.S.C. 112, 6th paragraph (often broadly referredto as means- (or step-) plus- function language), thespecification must be consulted to determine thestructure, material, or acts corresponding to thefunction recited in the claim, and the claimedelement is construed as limited to the correspondingstructure, material, or acts described in thespecification and equivalents thereof. In reDonaldson, 16 F.3d 1189, 29 USPQ2d 1845 (Fed.Cir. 1994) (see MPEP § 2181- MPEP § 2186).

In Zletz, supra, the examiner and the Board hadinterpreted claims reading “normally solidpolypropylene” and “normally solid polypropylenehaving a crystalline polypropylene content” as beinglimited to “normally solid linear high homopolymersof propylene which have a crystalline polypropylenecontent.” The court ruled that limitations, not presentin the claims, were improperly imported from thespecification. See also In re Marosi, 710 F.2d 799,802, 218 USPQ 289, 292 (Fed. Cir. 1983) (“'[C]laimsare not to be read in a vacuum, and limitationstherein are to be interpreted in light of thespecification in giving them their ‘broadestreasonable interpretation.'” (quoting In re Okuzawa,537 F.2d 545, 548, 190 USPQ 464, 466 (CCPA1976)). The court looked to the specification toconstrue “essentially free of alkali metal” asincluding unavoidable levels of impurities but nomore.).

III. “PLAIN MEANING” REFERS TO THEORDINARY AND CUSTOMARY MEANING GIVENTO THE TERM BY THOSE OF ORDINARY SKILLIN THE ART

“[T]he ordinary and customary meaning of a claimterm is the meaning that the term would have to a

person of ordinary skill in the art in question at thetime of the invention, i.e., as of the effective filingdate of the patent application.” Phillips v. AWHCorp.,415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326(Fed. Cir. 2005) (en banc); Sunrace Roots Enter.Co. v. SRAM Corp., 336 F.3d 1298, 1302, 67USPQ2d 1438, 1441 (Fed. Cir. 2003); Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc.,334 F.3d 1294, 1298 67 USPQ2d 1132, 1136 (Fed.Cir. 2003) (“In the absence of an express intent toimpart a novel meaning to the claim terms, the wordsare presumed to take on the ordinary and customarymeanings attributed to them by those of ordinaryskill in the art.”).

The ordinary and customary meaning of a term maybe evidenced by a variety of sources, including thewords of the claims themselves, the specification,drawings, and prior art. However, the best sourcefor determining the meaning of a claim term is thespecification – the greatest clarity is obtained whenthe specification serves as a glossary for the claimterms. See, e.g., In re Abbott Diabetes Care Inc.,696 F.3d 1142, 1149-50, 104 USPQ2d 1337,1342-43 (Fed. Cir. 2012) (construing the term“electrochemical sensor” as “devoid of externalconnection cables or wires to connect to a sensorcontrol unit” to be consistent with “the language ofthe claims and the specification”); In re SuitcoSurface, Inc., 603 F.3d 1255, 1260-61, 94 USPQ2d1640, 1644 (Fed. Cir. 2010) (construing the term“material for finishing the top surface of the floor”to mean “a clear, uniform layer on the top surfaceof a floor that is the final treatment or coating of asurface” to be consistent with “the express languageof the claim and the specification”); Vitronics Corp.v. Conceptronic Inc., 90 F.3d 1576, 1583, 39USPQ2d 1573, 1577 (Fed. Cir. 1996) (construingthe term “solder reflow temperature” to mean “peakreflow temperature” of solder rather than the“liquidus temperature” of solder in order to remainconsistent with the specification).

It is also appropriate to look to how the claim termis used in the prior art, which includes prior artpatents, published applications, trade publications,and dictionaries. Any meaning of a claim term takenfrom the prior art must be consistent with the use ofthe claim term in the specification and drawings.Moreover , when the specification is clear about the

2100-102Rev. 08.2017, January 2018


scope and content of a claim term, there is no needto turn to extrinsic evidence for claim interpretation. 3M Innovative Props. Co. v. Tredegar Corp., 725F.3d 1315, 1326-28, 107 USPQ2d 1717, 1726-27(Fed. Cir. 2013) (holding that “continuousmicrotextured skin layer over substantially the entirelaminate” was clearly defined in the writtendescription, and therefore, there was no need to turnto extrinsic evidence to construe the claim).

IV. APPLICANT MAY BE OWNLEXICOGRAPHER AND/OR MAY DISAVOWCLAIM SCOPE

The only exceptions to giving the words in a claimtheir ordinary and customary meaning in the art are(1) when the applicant acts as their ownlexicographer; and (2) when the applicant disavowsor disclaims the full scope of a claim term in thespecification. To act as their own lexicographer, theapplicant must clearly set forth a special definitionof a claim term in the specification that differs fromthe plain and ordinary meaning it would otherwisepossess. The specification may also include anintentional disclaimer, or disavowal, of claim scope.In both of these cases, “the inventor’s intention, asexpressed in the specification, is regarded asdispositive.” Phillips v. AWH Corp., 415 F.3d 1303,1316 (Fed. Cir. 2005) (en banc). See also StarhomeGmbH v. AT&T Mobility LLC, 743 F.3d 849, 857,109 USPQ2d 1885, 1890-91 (Fed. Cir. 2014)(holding that the term “gateway” should be givenits ordinary and customary meaning of “a connectionbetween different networks” because nothing in thespecification indicated a clear intent to depart fromthat ordinary meaning); Thorner v. Sony ComputerEntm’t Am. LLC, 669 F.3d 1362, 1367-68, 101USPQ2d 1457, 1460 (Fed. Cir. 2012) (The assertedclaims of the patent were directed to a tactilefeedback system for video game controllerscomprising a flexible pad with a plurality ofactuators “attached to said pad.” The court held thatthe claims were not limited to actuators attached tothe external surface of the pad, even though thespecification used the word “attached” whendescribing embodiments affixed to the externalsurface of the pad but the word “embedded” whendescribing embodiments affixed to the internalsurface of the pad. The court explained that the plainand ordinary meaning of “attached” includes both

external and internal attachments. Further, there isno clear and explicit statement in the specificationto redefine “attached” or disavow the full scope ofthe term.).

A. Lexicography

An applicant is entitled to be their own lexicographerand may rebut the presumption that claim terms areto be given their ordinary and customary meaningby clearly setting forth a definition of the term thatis different from its ordinary and customarymeaning(s) in the specification at the time of filing.See In re Paulsen, 30 F.3d 1475, 1480, 31 USPQ2d1671, 1674 (Fed. Cir. 1994) (holding that an inventormay define specific terms used to describe invention,but must do so “with reasonable clarity,deliberateness, and precision” and, if done, must“‘set out his uncommon definition in some mannerwithin the patent disclosure’ so as to give one ofordinary skill in the art notice of the change” inmeaning) (quoting Intellicall, Inc. v. Phonometrics,Inc., 952 F.2d 1384, 1387-88, 21 USPQ2d 1383,1386 (Fed. Cir. 1992)).

Where an explicit definition is provided by theapplicant for a term, that definition will controlinterpretation of the term as it is used in the claim. Toro Co. v. White Consolidated Industries Inc., 199F.3d 1295, 1301, 53 USPQ2d 1065, 1069 (Fed. Cir.1999) (meaning of words used in a claim is notconstrued in a “lexicographic vacuum, but in thecontext of the specification and drawings”). Thus,if a claim term is used in its ordinary and customarymeaning throughout the specification, and the writtendescription clearly indicates its meaning, then theterm in the claim has that meaning. Old Town CanoeCo. v. Confluence Holdings Corp., 448 F.3d 1309,1317, 78 USPQ2d 1705, 1711 (Fed. Cir. 2006) (Thecourt held that “completion of coalescence” must begiven its ordinary and customary meaning ofreaching the end of coalescence. The court explainedthat even though coalescence could theoretically be“completed” by halting the molding process earlier,the specification clearly intended that completion ofcoalescence occurs only after the molding processreaches its optimum stage.).

However, it is important to note that any specialmeaning assigned to a term “must be sufficiently

Rev. 08.2017, January 20182100-103


clear in the specification that any departure fromcommon usage would be so understood by a personof experience in the field of the invention.” Multiform Desiccants Inc. v. Medzam Ltd., 133 F.3d1473, 1477, 45 USPQ2d 1429, 1432 (Fed. Cir.1998). See also Process Control Corp. v.HydReclaim Corp., 190 F.3d 1350, 1357,52 USPQ2d 1029, 1033 (Fed. Cir. 1999) and MPEP§ 2173.05(a).

In some cases, the meaning of a particular claimterm may be defined by implication, that is,according to the usage of the term in the context inthe specification. See Phillips v. AWH Corp., 415F.3d 1303, 1320-21, 75 USPQ2d 1321, 1332 (Fed.Cir. 2005) (en banc); Vitronics Corp. v.Conceptronic Inc., 90 F.3d 1576, 1583, 39 USPQ2d1573, 1577 (Fed. Cir. 1996). But where thespecification is ambiguous as to whether the inventorused claim terms inconsistent with their ordinarymeaning, the ordinary meaning will apply. Merck& Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364,1370 (Fed. Cir. 2005) (The Federal Circuit reversedthe district court’s construction of the claim term“about” as “exactly.” The appellate court explainedthat a passage in the specification the district courtrelied upon for the definition of “about” was tooambiguous to redefine “about” to mean “exactly” inclear enough terms. The appellate court held that“about” should instead be given its plain andordinary meaning of “approximately.”).

B. Disavowal

Applicant may also rebut the presumption of plainmeaning by clearly disavowing the full scope of theclaim term in the specification. Disavowal, ordisclaimer of claim scope, is only considered whenit is clear and unmistakable. See SciMed Life Sys.,Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d1337, 1341, 58 USPQ2d 1059, 1063 (Fed.Cir.2001)(“Where the specification makes clear that theinvention does not include a particular feature, thatfeature is deemed to be outside the reach of theclaims of the patent, even though the language ofthe claims, read without reference to thespecification, might be considered broad enough toencompass the feature in question.”); see also In reAm. Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1365-67(Fed. Cir. 2004) (refusing the limit claim term “user

computer” to only “single-user computers” eventhough “some of the language of the specification,when viewed in isolation, might lead a reader toconclude that the term . . . is meant to refer to acomputer that serves only a single user, thespecification as a whole suggests a construction thatis not so narrow”). But, in some cases, disavowal ofa broader claim scope may be made by implication,such as where the specification contains onlydisparaging remarks with respect to a feature andevery embodiment in the specification excludes thatfeature. In re Abbott Diabetes Care Inc., 696 F.3d1142, 1149-50, 104 USPQ2d 1337, 1342-43 (Fed.Cir. 2012) (holding that the broadest reasonableinterpretation of the claim term “electrochemicalsensor” does not include a sensor having “externalconnection cables or wires” because the specification“repeatedly, consistently, and exclusively depict[s]an electrochemical sensor without external cablesor wires while simultaneously disparaging sensorswith external cables or wires”). If the examinerbelieves that the broadest reasonable interpretationof a claim is narrower than what the words of theclaim otherwise suggest as the result of implicitdisavowal in the specification, then the examinershould make the interpretation clear on the record.

See also MPEP § 2173.05(a).

V. SUMMARY OF DETERMINING THEMEANING OF A CLAIM TERM THAT DOES NOTINVOKE 35 U.S.C. 112(f)

This flow chart indicates the decisions an examinerwould follow in order to ascertain the proper claiminterpretation based on the plain meaning definitionof BRI. With each decision in the flow chart, adifferent path may need to be taken to concludewhether plain meaning applies or a special definitionapplies.

The first question is to determine whether a claimterm has an ordinary and customary meaning to thoseof ordinary skill in the art. If so, then the examinershould check the specification to determine whetherit provides a special definition for the claim term. Ifthe specification does not provide a special definitionfor the claim term, the examiner should apply theordinary and customary meaning to the claim term.If the specification provides a special definition for

2100-104Rev. 08.2017, January 2018


the claim term, the examiner should use the specialdefinition. However, because there is a presumptionthat claim terms have their ordinary and customarymeaning and the specification must provide a clearand intentional use of a special definition for theclaim term to be treated as having a specialdefinition, an Office action should acknowledge andidentify the special definition in this situation.

Moving back to the first question, if a claim termdoes not have an ordinary and customary meaning,the examiner should check the specification todetermine whether it provides a meaning to the claim

term. If no reasonably clear meaning can be ascribedto the claim term after considering the specificationand prior art, the examiner should apply the broadestreasonable interpretation to the claim term as it canbe best understood. Also, the claim should berejected under 35 U.S.C. 112(b) and the specificationobjected to under 37 CFR 1.75(d).

If the specification provides a meaning for the claimterm, the examiner should use the meaning providedby the specification. It may be appropriate for anOffice action to clarify the meaning acknowledgeand identify the special definition in this situation.

2111.02 Effect of Preamble [R-08.2012]

The determination of whether a preamble limits aclaim is made on a case-by-case basis in light of the

facts in each case; there is no litmus test definingwhen a preamble limits the scope of a claim. Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289F.3d 801, 808, 62 USPQ2d 1781, 1785 (Fed. Cir.

Rev. 08.2017, January 20182100-105


2002). See id. at 808-10, 62 USPQ2d at 1784-86for a discussion of guideposts that have emergedfrom various decisions exploring the preamble’seffect on claim scope, as well as a hypotheticalexample illustrating these principles.

“[A] claim preamble has the import that the claimas a whole suggests for it.” Bell CommunicationsResearch, Inc. v. Vitalink Communications Corp.,55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed. Cir.1995). “If the claim preamble, when read in thecontext of the entire claim, recites limitations of theclaim, or, if the claim preamble is ‘necessary to givelife, meaning, and vitality’ to the claim, then theclaim preamble should be construed as if in thebalance of the claim.” Pitney Bowes, Inc. v.Hewlett-Packard Co., 182 F.3d 1298, 1305, 51USPQ2d 1161, 1165-66 (Fed. Cir. 1999). See also Jansen v. Rexall Sundown, Inc., 342 F.3d 1329,1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (Inconsidering the effect of the preamble in a claimdirected to a method of treating or preventingpernicious anemia in humans by administering acertain vitamin preparation to “a human in needthereof,” the court held that the claims’ recitation ofa patient or a human “in need” gives life andmeaning to the preamble’s statement of purpose.). Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478,481 (CCPA 1951) (A preamble reciting “[a]nabrasive article” was deemed essential to point outthe invention defined by claims to an articlecomprising abrasive grains and a hardened binderand the process of making it. The court stated “it isonly by that phrase that it can be known that thesubject matter defined by the claims is comprisedas an abrasive article. Every union of substancescapable inter alia of use as abrasive grains and abinder is not an ‘abrasive article.’” Therefore, thepreamble served to further define the structure ofthe article produced.).

I. PREAMBLE STATEMENTS LIMITINGSTRUCTURE

Any terminology in the preamble that limits thestructure of the claimed invention must be treatedas a claim limitation. See, e.g., Corning Glass Worksv. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257,9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (Thedetermination of whether preamble recitations are

structural limitations can be resolved only on reviewof the entirety of the application “to gain anunderstanding of what the inventors actuallyinvented and intended to encompass by the claim.”); Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801,14 USPQ2d 1871, 1876 (Fed. Cir. 1990)(determining that preamble language that constitutesa structural limitation is actually part of the claimedinvention). See also In re Stencel, 828 F.2d 751, 4USPQ2d 1071 (Fed. Cir. 1987) (The claim at issuewas directed to a driver for setting a joint of athreaded collar; however, the body of the claim didnot directly include the structure of the collar as partof the claimed article. The examiner did not considerthe preamble, which did set forth the structure of thecollar, as limiting the claim. The court found thatthe collar structure could not be ignored. While theclaim was not directly limited to the collar, the collarstructure recited in the preamble did limit thestructure of the driver. “[T]he framework - theteachings of the prior art - against which patentabilityis measured is not all drivers broadly, but driverssuitable for use in combination with this collar, forthe claims are so limited.” Id. at 1073, 828 F.2d at754.).

II. PREAMBLE STATEMENTS RECITINGPURPOSE OR INTENDED USE

The claim preamble must be read in the context ofthe entire claim. The determination of whetherpreamble recitations are structural limitations ormere statements of purpose or use “can be resolvedonly on review of the entirety of the [record] to gainan understanding of what the inventors actuallyinvented and intended to encompass by the claim.” Corning Glass Works, 868 F.2d at 1257, 9 USPQ2dat 1966. If the body of a claim fully and intrinsicallysets forth all of the limitations of the claimedinvention, and the preamble merely states, forexample, the purpose or intended use of theinvention, rather than any distinct definition of anyof the claimed invention’s limitations, then thepreamble is not considered a limitation and is of nosignificance to claim construction. Pitney Bowes,Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305,51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550,1553 (Fed. Cir. 1997) (“where a patentee defines astructurally complete invention in the claim body

2100-106Rev. 08.2017, January 2018


and uses the preamble only to state a purpose orintended use for the invention, the preamble is nota claim limitation”); Kropa v. Robie, 187 F.2d at152, 88 USPQ2d at 480-81 (preamble is not alimitation where claim is directed to a product andthe preamble merely recites a property inherent inan old product defined by the remainder of theclaim); STX LLC. v. Brine, 211 F.3d 588, 591, 54USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding thatthe preamble phrase “which provides improvedplaying and handling characteristics” in a claimdrawn to a head for a lacrosse stick was not a claimlimitation). Compare Jansen v. Rexall Sundown,Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154,1158 (Fed. Cir. 2003) (In a claim directed to amethod of treating or preventing pernicious anemiain humans by administering a certain vitaminpreparation to “a human in need thereof,” the courtheld that the preamble is not merely a statement ofeffect that may or may not be desired or appreciated,but rather is a statement of the intentional purposefor which the method must be performed. Thus theclaim is properly interpreted to mean that the vitaminpreparation must be administered to a human witha recognized need to treat or prevent perniciousanemia.); In re Cruciferous Sprout Litig., 301 F.3d1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed.Cir. 2002) (A claim at issue was directed to a methodof preparing a food rich in glucosinolates whereincruciferous sprouts are harvested prior to the 2-leafstage. The court held that the preamble phrase “richin glucosinolates” helps define the claimed invention,as evidenced by the specification and prosecutionhistory, and thus is a limitation of the claim(although the claim was anticipated by prior art thatproduced sprouts inherently “rich inglucosinolates”)).

During examination, statements in the preamblereciting the purpose or intended use of the claimedinvention must be evaluated to determine whetherthe recited purpose or intended use results in astructural difference (or, in the case of processclaims, manipulative difference) between the claimedinvention and the prior art. If so, the recitation servesto limit the claim. See, e.g., In re Otto, 312 F.2d937, 938, 136 USPQ 458, 459 (CCPA 1963) (Theclaims were directed to a core member for haircurlers and a process of making a core member forhair curlers. The court held that the intended use of

hair curling was of no significance to the structureand process of making.); In re Sinex, 309 F.2d 488,492, 135 USPQ 302, 305 (CCPA 1962) (statementof intended use in an apparatus claim did notdistinguish over the prior art apparatus). If a priorart structure is capable of performing the intendeduse as recited in the preamble, then it meets theclaim. See, e.g., In re Schreiber, 128 F.3d 1473,1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)(anticipation rejection affirmed based on Board’sfactual finding that the reference dispenser (a spoutdisclosed as useful for purposes such as dispensingoil from an oil can) would be capable of dispensingpopcorn in the manner set forth in appellant’s claim1 (a dispensing top for dispensing popcorn in aspecified manner)) and cases cited therein. See alsoMPEP § 2112 - MPEP § 2112.02.

However, a “preamble may provide context for claimconstruction, particularly, where … that preamble’sstatement of intended use forms the basis fordistinguishing the prior art in the patent’s prosecutionhistory.” Metabolite Labs., Inc. v. Corp. of Am.Holdings, 370 F.3d 1354, 1358-62, 71 USPQ2d1081, 1084-87 (Fed. Cir. 2004). The patent claim atissue was directed to a two-step method for detectinga deficiency of vitamin B12 or folic acid, involving

(i) assaying a body fluid for an “elevated level” ofhomocysteine, and (ii) “correlating” an “elevated”level with a vitamin deficiency. Id. at 1358-59, 71USPQ2d at 1084. The court stated that the disputedclaim term “correlating” can include comparing witheither an unelevated level or elevated level, asopposed to only an elevated level because addingthe “correlating” step in the claim during prosecutionto overcome prior art tied the preamble directly tothe “correlating” step. Id. at 1362, 71 USPQ2d at1087. The recitation of the intended use of“detecting” a vitamin deficiency in the preamblerendered the claimed invention a method for“detecting,” and, thus, was not limited to detecting“elevated” levels. Id.

See also Catalina Mktg. Int’l, 289 F.3d at 808-09,62 USPQ2d at 1785 (“[C]lear reliance on thepreamble during prosecution to distinguish theclaimed invention from the prior art transforms thepreamble into a claim limitation because suchreliance indicates use of the preamble to define, inpart, the claimed invention.…Without such reliance,

Rev. 08.2017, January 20182100-107


however, a preamble generally is not limiting whenthe claim body describes a structurally completeinvention such that deletion of the preamble phrasedoes not affect the structure or steps of the claimedinvention.” Consequently, “preamble languagemerely extolling benefits or features of the claimedinvention does not limit the claim scope withoutclear reliance on those benefits or features aspatentably significant.”). In Poly-America LP v.GSE Lining Tech. Inc., 383 F.3d 1303, 1310, 72USPQ2d 1685, 1689 (Fed. Cir. 2004), the courtstated that “a ‘[r]eview of the entirety of the ’047patent reveals that the preamble language relatingto ‘blown-film’ does not state a purpose or anintended use of the invention, but rather discloses afundamental characteristic of the claimed inventionthat is properly construed as a limitation of theclaim.’” Compare Intirtool, Ltd. v. Texar Corp., 369F.3d 1289, 1294-96, 70 USPQ2d 1780, 1783-84(Fed. Cir. 2004) (holding that the preamble of apatent claim directed to a “hand-held punch pliersfor simultaneously punching and connectingoverlapping sheet metal” was not a limitation of theclaim because (i) the body of the claim described a“structurally complete invention” without thepreamble, and (ii) statements in prosecution historyreferring to “punching and connecting” function ofinvention did not constitute “clear reliance” on thepreamble needed to make the preamble a limitation).

2111.03 Transitional Phrases [R-08.2017]

The transitional phrases “comprising”, “consistingessentially of” and “consisting of” define the scopeof a claim with respect to what unrecited additionalcomponents or steps, if any, are excluded from thescope of the claim. The determination of what is oris not excluded by a transitional phrase must be madeon a case-by-case basis in light of the facts of eachcase.

I. COMPRISING

The transitional term “comprising”, which issynonymous with “including,” “containing,” or“characterized by,” is inclusive or open-ended anddoes not exclude additional, unrecited elements ormethod steps. See, e.g., Mars Inc. v. H.J. Heinz Co.,377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed.Cir. 2004) (“[L]ike the term ‘comprising,’ the terms

‘containing’ and ‘mixture’ are open-ended.”). Invitrogen Corp. v. Biocrest Manufacturing, L.P.,327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed.Cir. 2003) (“The transition ‘comprising’ in a methodclaim indicates that the claim is open-ended andallows for additional steps.”); Genentech, Inc. v.Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608,1613 (Fed. Cir. 1997) (“Comprising” is a term of artused in claim language which means that the namedelements are essential, but other elements may beadded and still form a construct within the scope ofthe claim.); Moleculon Research Corp. v. CBS, Inc.,793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); Inre Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803(CCPA 1981); Ex parte Davis, 80 USPQ 448, 450(Bd. App. 1948) (“comprising” leaves “the claimopen for the inclusion of unspecified ingredientseven in major amounts”). In Gillette Co. v.Energizer Holdings Inc., 405 F.3d 1367, 1371-73,74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), thecourt held that a claim to “a safety razor blade unitcomprising a guard, a cap, and a group of first,second, and third blades” encompasses razors withmore than three blades because the transitionalphrase “comprising” in the preamble and the phrase“group of” are presumptively open-ended. “The word‘comprising’ transitioning from the preamble to thebody signals that the entire claim is presumptivelyopen-ended.” Id. In contrast, the court noted thephrase “group consisting of” is a closed term, whichis often used in claim drafting to signal a “Markushgroup” that is by its nature closed. Id. The court alsoemphasized that reference to “first,” “second,” and“third” blades in the claim was not used to show aserial or numerical limitation but instead was usedto distinguish or identify the various members of thegroup. Id.

II. CONSISTING OF

The transitional phrase “consisting of” excludes anyelement, step, or ingredient not specified in theclaim. In re Gray, 53 F.2d 520, 11 USPQ 255(CCPA 1931); Ex parte Davis, 80 USPQ 448, 450(Bd. App. 1948) (“consisting of” defined as “closingthe claim to the inclusion of materials other thanthose recited except for impurities ordinarilyassociated therewith”). But see Norian Corp. v.Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d1508, 1516 (Fed. Cir. 2004) (holding that a bone

2100-108Rev. 08.2017, January 2018


repair kit “consisting of” claimed chemicals wasinfringed by a bone repair kit including a spatula inaddition to the claimed chemicals because thepresence of the spatula was unrelated to the claimedinvention). A claim which depends from a claimwhich “consists of” the recited elements or stepscannot add an element or step.

When the phrase “consists of” appears in a clauseof the body of a claim, rather than immediatelyfollowing the preamble, there is an “exceptionallystrong presumption that a claim term set off with‘consisting of’ is closed to unrecited elements.” Multilayer Stretch Cling Film Holdings, Inc. v.Berry Plastics Corp., 831 F.3d 1350, 1359, 119USPQ2d 1773, 1781 (Fed. Cir. 2016) (a layer“selected from the group consisting of” specificresins is closed to resins other than those listed).However, the “consisting of” phrase limits only theelement set forth in that clause; other elements arenot excluded from the claim as a whole. Mannesmann Demag Corp. v. Engineered MetalProducts Co., 793 F.2d 1279, 230 USPQ 45 (Fed.Cir. 1986). See also In re Crish, 393 F.3d 1253, 73USPQ2d 1364 (Fed. Cir. 2004) (The claims at issue“related to purified DNA molecules having promoteractivity for the human involucrin gene (hINV).” Id.,73 USPQ2d at 1365. In determining the scope ofapplicant’s claims directed to “a purifiedoligonucleotide comprising at least a portion of thenucleotide sequence of SEQ ID NO:1 wherein saidportion consists of the nucleotide sequence from …to 2473 of SEQ ID NO:1, and wherein said portionof the nucleotide sequence of SEQ ID NO:1 haspromoter activity,” the court stated that the use of“consists” in the body of the claims did not limit theopen-ended “comprising” language in the claims(emphases added). Id. at 1257, 73 USPQ2d at 1367.The court held that the claimed promoter sequencedesignated as SEQ ID NO:1 was obtained bysequencing the same prior art plasmid and wastherefore anticipated by the prior art plasmid whichnecessarily possessed the same DNA sequence asthe claimed oligonucleotides. Id. at 1256 and 1259,73 USPQ2d at 1366 and 1369. The court affirmedthe Board’s interpretation that the transition phrase“consists” did not limit the claims to only the recitednumbered nucleotide sequences of SEQ ID NO:1and that “the transition language ‘comprising’allowed the claims to cover the entire involucrin

gene plus other portions of the plasmid, as long asthe gene contained the specific portions of SEQ IDNO:1 recited by the claim[s].” Id. at 1256, 73USPQ2d at 1366.).

A claim element defined by selection from a groupof alternatives (a Markush grouping; see MPEP §2117 and § 2173.05(h)) requires selection from aclosed group “consisting of” (rather than“comprising” or “including”) the alternativemembers. Abbott Labs. v. Baxter PharmaceuticalProducts Inc., 334 F.3d 1274, 1280, 67 USPQ2d1191, 1196-97 (Fed. Cir. 2003). If the claim elementis intended to encompass combinations or mixturesof the alternatives set forth in the Markush grouping,the claim may include qualifying language precedingthe recited alternatives (such as “at least onemember” selected from the group), or within the listof alternatives (such as “or mixtures thereof”). Id.In the absence of such qualifying language there isa presumption that the Markush group is closed tocombinations or mixtures. See Multilayer StretchCling Film Holdings, Inc. v. Berry Plastics Corp.,831 F.3d 1350, 1363-64, 119 USPQ2d 1773,1784-85 (Fed. Cir. 2016) (presumption that Markushgrouping does not encompass mixtures of listedresins overcome by intrinsic evidence in a dependentclaim and the specification).

III. CONSISTING ESSENTIALLY OF

The transitional phrase “consisting essentially of”limits the scope of a claim to the specified materialsor steps “and those that do not materially affect thebasic and novel characteristic(s)” of the claimedinvention. In re Herz, 537 F.2d 549, 551-52,190 USPQ 461, 463 (CCPA 1976) (emphasis inoriginal) (Prior art hydraulic fluid required adispersant which appellants argued was excludedfrom claims limited to a functional fluid “consistingessentially of” certain components. In finding theclaims did not exclude the prior art dispersant, thecourt noted that appellants’ specification indicatedthe claimed composition can contain any well-knownadditive such as a dispersant, and there was noevidence that the presence of a dispersant wouldmaterially affect the basic and novel characteristicof the claimed invention. The prior art compositionhad the same basic and novel characteristic(increased oxidation resistance) as well as additional

Rev. 08.2017, January 20182100-109


enhanced detergent and dispersant characteristics.).“A ‘consisting essentially of’ claim occupies amiddle ground between closed claims that are writtenin a ‘consisting of’ format and fully open claims thatare drafted in a ‘comprising’ format.” PPGIndustries v. Guardian Industries, 156 F.3d 1351,1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998).See also Atlas Powder v. E.I. duPont de Nemours& Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir.1984); In re Janakirama-Rao, 317 F.2d 951,137 USPQ 893 (CCPA 1963); Water TechnologiesCorp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097(Fed. Cir. 1988). For the purposes of searching forand applying prior art under 35 U.S.C. 102 and 103,absent a clear indication in the specification orclaims of what the basic and novel characteristicsactually are, “consisting essentially of” will beconstrued as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (“PPGcould have defined the scope of the phrase‘consisting essentially of’ for purposes of its patentby making clear in its specification what it regardedas constituting a material change in the basic andnovel characteristics of the invention.”). See also AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41,68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003)(Applicant’s statement in the specification that“silicon contents in the coating metal should notexceed about 0.5% by weight” along with adiscussion of the deleterious effects of siliconprovided basis to conclude that silicon in excess of0.5% by weight would materially alter the basic andnovel properties of the invention. Thus, “consistingessentially of” as recited in the preamble wasinterpreted to permit no more than 0.5% by weightof silicon in the aluminum coating.); In reJanakirama-Rao, 317 F.2d 951, 954, 137 USPQ893, 895-96 (CCPA 1963). If an applicant contendsthat additional steps or materials in the prior art areexcluded by the recitation of “consisting essentiallyof,” applicant has the burden of showing that theintroduction of additional steps or components wouldmaterially change the characteristics of applicant’sinvention. In re De Lajarte, 337 F.2d 870, 143USPQ 256 (CCPA 1964). See also Ex parteHoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App.& Inter. 1989) (“Although ‘consisting essentiallyof’ is typically used and defined in the context ofcompositions of matter, we find nothing intrinsicallywrong with the use of such language as a modifier

of method steps. . . [rendering] the claim open onlyfor the inclusion of steps which do not materiallyaffect the basic and novel characteristics of theclaimed method. To determine the steps includedversus excluded the claim must be read in light ofthe specification. . . . [I]t is an applicant’s burden toestablish that a step practiced in a prior art methodis excluded from his claims by ‘consisting essentiallyof’ language.”).

IV. OTHER TRANSITIONAL PHRASES

Transitional phrases such as “having” must beinterpreted in light of the specification to determinewhether open or closed claim language is intended.See, e.g., Lampi Corp. v. American Power ProductsInc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453(Fed. Cir. 2000) (interpreting the term “having” asopen terminology, allowing the inclusion of othercomponents in addition to those recited); CrystalSemiconductor Corp. v. TriTech MicroelectronicsInt’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953,1959 (Fed. Cir. 2001) (term “having” in transitionalphrase “does not create a presumption that the bodyof the claim is open”); Regents of the Univ. of Cal.v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d1398, 1410 (Fed. Cir. 1997) (in the context of acDNA having a sequence coding for human PI, theterm “having” still permitted inclusion of othermoieties). The transitional phrase “composed of”has been interpreted in the same manner as either“consisting of” or “consisting essentially of,”depending on the facts of the particular case. See AFG Industries, Inc. v. Cardinal IG Company, 239F.3d 1239, 1245, 57 USPQ2d 1776, 1780-81 (Fed.Cir. 2001) (based on specification and otherevidence, “composed of” interpreted in same manneras “consisting essentially of”); In re Bertsch, 132F.2d 1014, 1019-20, 56 USPQ 379, 384 (CCPA1942) (“Composed of” interpreted in same manneras “consisting of”; however, the court furtherremarked that “the words ‘composed of’ may undercertain circumstances be given, in patent law, abroader meaning than ‘consisting of.’”).

2100-110Rev. 08.2017, January 2018


2111.04 “Adapted to,” “Adapted for,”“Wherein,” “Whereby,” and ContingentClauses [R-08.2017]

I. "ADAPTED TO," "ADAPTED FOR,""WHEREIN," and "WHEREBY"

Claim scope is not limited by claim language thatsuggests or makes optional but does not require stepsto be performed, or by claim language that does notlimit a claim to a particular structure. However,examples of claim language, although notexhaustive, that may raise a question as to thelimiting effect of the language in a claim are:

(A) “adapted to” or “adapted for” clauses;

(B) “wherein” clauses; and

(C) “whereby” clauses.

The determination of whether each of these clausesis a limitation in a claim depends on the specificfacts of the case. See, e.g., Griffin v. Bertina, 283F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)(finding that a “wherein” clause limited a processclaim where the clause gave “meaning and purposeto the manipulative steps”). In In re Giannelli, 739F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed.Cir. 2014), the court found that an "adapted to"clause limited a machine claim where "the writtendescription makes clear that 'adapted to,' as used inthe [patent] application, has a narrower meaning,viz., that the claimed machine is designed orconstructed to be used as a rowing machine wherebya pulling force is exerted on the handles." In Hofferv. Microsoft Corp., 405 F.3d 1326, 1329, 74USPQ2d 1481, 1483 (Fed. Cir. 2005), the court heldthat when a “‘whereby’ clause states a condition thatis material to patentability, it cannot be ignored inorder to change the substance of the invention.” Id.However, the court noted that a “‘whereby clausein a method claim is not given weight when it simplyexpresses the intended result of a process steppositively recited.’” Id. (quoting Minton v. Nat’lAss’n of Securities Dealers, Inc., 336 F.3d 1373,1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).

II. CONTINGENT LIMITATIONS

The broadest reasonable interpretation of a method(or process) claim having contingent limitations

requires only those steps that must be performed anddoes not include steps that are not required to beperformed because the condition(s) precedent arenot met. For example, assume a method claimrequires step A if a first condition happens and stepB if a second condition happens. If the claimedinvention may be practiced without either the firstor second condition happening, then neither step Aor B is required by the broadest reasonableinterpretation of the claim. If the claimed inventionrequires the first condition to occur, then the broadestreasonable interpretation of the claim requires stepA. If the claimed invention requires both the firstand second conditions to occur, then the broadestreasonable interpretation of the claim requires bothsteps A and B.

The broadest reasonable interpretation of a system(or apparatus or product) claim having structure thatperforms a function, which only needs to occur if acondition precedent is met, requires structure forperforming the function should the condition occur.The system claim interpretation differs from amethod claim interpretation because the claimedstructure must be present in the system regardlessof whether the condition is met and the function isactually performed.

See Ex parte Schulhauser, Appeal 2013-007847(PTAB April 28, 2016) (precedential) for an analysisof contingent claim limitations in the context of bothmethod claims and system claims. In Schulhauser,both method claims and system claims recited thesame contingent step. When analyzing the claimedmethod as a whole, the PTAB determined that givingthe claim its broadest reasonable interpretation, “[i]fthe condition for performing a contingent step is notsatisfied, the performance recited by the step neednot be carried out in order for the claimed methodto be performed” (quotation omitted). Schulhauserat 10. When analyzing the claimed system as awhole, the PTAB determined that “[t]he broadestreasonable interpretation of a system claim havingstructure that performs a function, which only needsto occur if a condition precedent is met, still requiresstructure for performing the function should thecondition occur.” Schulhauser at 14. Therefore"[t]he Examiner did not need to present evidence ofthe obviousness of the [ ] method steps of claim 1that are not required to be performed under a

Rev. 08.2017, January 20182100-111


broadest reasonable interpretation of the claim (e.g.,instances in which the electrocardiac signal data isnot within the threshold electrocardiac criteria suchthat the condition precedent for the determining stepand the remaining steps of claim 1 has not beenmet);" however to render the claimed systemobvious, the prior art must teach the structure thatperforms the function of the contingent step alongwith the other recited claim limitations. Schulhauserat 9, 14.

See also MPEP § 2143.03.

2111.05 Functional and NonfunctionalDescriptive Material [R-08.2017]

USPTO personnel must consider all claim limitationswhen determining patentability of an invention overthe prior art. In re Gulack, 703 F.2d 1381, 1385,217 USPQ 401, 403-04 (Fed. Cir. 1983). Since aclaim must be read as a whole, USPTO personnelmay not disregard claim limitations comprised ofprinted matter. See Id. at 1384, 217 USPQ at 403;see also Diamond v. Diehr, 450 U.S. 175, 191, 209USPQ 1, 10 (1981). The first step of the printedmatter analysis is the determination that thelimitation in question is in fact directed towardprinted matter. Once it is determined that thelimitation is directed to printed matter, the examinermust then determine if the matter is functionally orstructurally related to the associated physicalsubstrate. See In re DiStefano, 808 F.3d 845, 117USPQ2d 1267-1268 (Fed. Cir. 2015). If a new andunobvious functional relationship between theprinted matter and the substrate does not exist.USPTO personnel need not give patentable weightto printed matter. See In re Lowry, 32 F.3d 1579,1583-84, 32 USPQ2d 1031, 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed.Cir. 2004). The rationale behind the printed mattercases, in which, for example, written instructionsare added to a known product, has been extended tomethod claims in which an instructional limitationis added to a method known in the art. Similar to theinquiry for products with printed matter thereon, insuch method cases the relevant inquiry is whether anew and unobvious functional relationship with theknown method exists. See In re Kao, 639 F.3d 1057,1072-73, 98 USPQ2d 1799, 1811-12 (Fed. Cir.2011); King Pharmaceuticals Inc. v. Eon Labs Inc.,

616 F.3d 1267, 1279, 95 USPQ2d 1833, 1842 (Fed.Cir. 2010).

I. DETERMINING WHETHER A FUNCTIONALRELATIONSHIP EXISTS BETWEEN PRINTEDMATTER AND ASSOCIATED PRODUCT (ORPROCESS)

A. Evidence Supporting a Functional Relationship

To be given patentable weight, the printed matterand associated product must be in a functionalrelationship. A functional relationship can be foundwhere the printed matter performs some functionwith respect to the product to which it is associated.See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035(citing Gulack, 703 F.2d at 1386, 217 USPQ at 404).For instance, indicia on a measuring cup performthe function of indicating volume within thatmeasuring cup. See In re Miller, 418 F.2d 1392,1396, 164 USPQ 46, 49 (CCPA 1969). A functionalrelationship can also be found where the productperforms some function with respect to the printedmatter to which it is associated. For instance, wherea hatband places a string of numbers in a certainphysical relationship to each other such that aclaimed algorithm is satisfied due to the physicalstructure of the hatband, the hatband performs afunction with respect to the string of numbers. See Gulack, 703 F.2d at 1386-87, 217 USPQ at 405.

B. Evidence Against a Functional Relationship

Where a product merely serves as a support forprinted matter, no functional relationship exists.These situations may arise where the claim as awhole is directed towards conveying a message ormeaning to a human reader independent of thesupporting product. For example a hatband withimages displayed on the hatband but not arrangedin any particular sequence. See Gulack, 703 F.2dat 1386, 217 USPQ at 404. Another example inwhich a product merely serves as a support wouldoccur for a deck of playing cards having images oneach card. See In re Bryan, 323 Fed. App'x 898(Fed. Cir. 2009) (unpublished). In Bryan theapplicant asserted that the printed matter allowedthe cards to be “collected, traded, and drawn”;“identify and distinguish one deck of cards fromanother”; and “enable[] the card to be traded and

2100-112Rev. 08.2017, January 2018


blind drawn”. However, the court found that thesefunctions do not pertain to the structure of theapparatus and where instead drawn to the methodor process of playing a game. See also Ex parteGwinn, 112 USPQ 439, 446-47 (Bd. Pat. App. &Int. 1955), in which the invention was directed to aset of dice by means of which a game may be played.The claims differed from the prior art solely by theprinted matter in the dice. The claims were properlyrejected on prior art because there was no newfeature of physical structure and no new relation ofprinted matter to physical structure. For example, aclaimed measuring tape having electrical wiringinformation thereon, or a generically claimedsubstrate having a picture of a golf ball thereupon,would lack a functional relationship as the claimsas a whole are directed towards conveying wiringinformation (unrelated to the measuring tape) or anaesthetically pleasing image (unrelated to thesubstrate) to the reader. Additionally, where theprinted matter and product do not depend upon eachother, no functional relationship exists. For example,in a kit containing a set of chemicals and a printedset of instructions for using the chemicals, theinstructions are not related to that particular set ofchemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2dat 1864.

II. FUNCTIONAL RELATIONSHIP BETWEENPRINTED MATTER AND ASSOCIATED PRODUCT(OR PROCESS) MUST BE NEW AND UNOBVIOUS

Once a functional relationship between the productand associated printed matter is found, theinvestigation shifts to the determination of whetherthe relationship is new and unobvious. For example,a claim to a color-coded indicia on a container inwhich the color indicates the expiration date of thecontainer may give rise to a functional relationship.The claim may, however, be anticipated by prior artthat reads on the claimed invention, or by acombination of prior art that teaches the claimedinvention.

III. MACHINE-READABLE MEDIA

When determining the scope of a claim directed toa computer-readable medium containing certainprogramming, the examiner should first look to therelationship between the programming and the

intended computer system. Where the programmingperforms some function with respect to the computerwith which it is associated, a functional relationshipwill be found. For instance, a claim tocomputer-readable medium programmed withattribute data objects that perform the function offacilitating retrieval, addition, and removal ofinformation in the intended computer system,establishes a functional relationship such that theclaimed attribute data objects are given patentableweight. See Lowry, 32 F.3d at 1583-84, 32 USPQ2dat 1035.

However, where the claim as a whole is directed toconveying a message or meaning to a human readerindependent of the intended computer system, and/orthe computer-readable medium merely serves as asupport for information or data, no functionalrelationship exists. For example, a claim to amemory stick containing tables of batting averages,or tracks of recorded music, utilizes the intendedcomputer system merely as a support for theinformation. Such claims are directed towardconveying meaning to the human reader rather thantowards establishing a functional relationshipbetween recorded data and the computer.

A claim directed to a computer readable mediumstoring instructions or executable code that recitesan abstract idea must be evaluated for eligibilityunder 35 U.S.C. 101. See MPEP § 2106.

2112 Requirements of Rejection Based onInherency; Burden of Proof [R-07.2015]


The express, implicit, and inherent disclosures of aprior art reference may be relied upon in the rejectionof claims under 35 U.S.C. 102 or 103. “The inherentteaching of a prior art reference, a question of fact,arises both in the context of anticipation andobviousness.” In re Napier, 55 F.3d 610, 613, 34

Rev. 08.2017, January 20182100-113


USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a35 U.S.C. 103 rejection based in part on inherentdisclosure in one of the references). See also In reGrasselli, 713 F.2d 731, 739, 218 USPQ 769, 775(Fed. Cir. 1983).

I. SOMETHING WHICH IS OLD DOES NOTBECOME PATENTABLE UPON THE DISCOVERYOF A NEW PROPERTY

“[T]he discovery of a previously unappreciatedproperty of a prior art composition, or of a scientificexplanation for the prior art’s functioning, does notrender the old composition patentably new to thediscoverer.” Atlas Powder Co. v. IRECO Inc., 190F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the claiming of a new use, new functionor unknown property which is inherently present inthe prior art does not necessarily make the claimpatentable. In re Best, 562 F.2d 1252, 1254, 195USPQ 430, 433 (CCPA 1977). In In re Crish, 393F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir.2004), the court held that the claimed promotersequence obtained by sequencing a prior art plasmidthat was not previously sequenced was anticipatedby the prior art plasmid which necessarily possessedthe same DNA sequence as the claimedoligonucleotides . The court stated that “just as thediscovery of properties of a known material doesnot make it novel, the identification andcharacterization of a prior art material also does notmake it novel.” Id. See also MPEP § 2112.01 withregard to inherency and product-by-process claimsand MPEP § 2141.02 with regard to inherency andrejections under 35 U.S.C. 103.

II. INHERENT FEATURE NEED NOT BERECOGNIZED AT THE TIME OF THEINVENTION

There is no requirement that a person ofordinary skill in the art would have recognized theinherent disclosure at the time of invention, but onlythat the subject matter is in fact inherent in the priorart reference. Schering Corp. v. Geneva Pharm.Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668(Fed. Cir. 2003) (rejecting the contention thatinherent anticipation requires recognition by a personof ordinary skill in the art before the critical date andallowing expert testimony with respect to

post-critical date clinical trials to show inherency);see also Toro Co. v. Deere & Co., 355 F.3d 1313,1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004)(“[T]he fact that a characteristic is a necessaryfeature or result of a prior-art embodiment (that isitself sufficiently described and enabled) is enoughfor inherent anticipation, even if that fact wasunknown at the time of the prior invention.”); AbbottLabs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319,51 USPQ2d 1307, 1310 (Fed.Cir.1999) (“If a productthat is offered for sale inherently possesses each ofthe limitations of the claims, then the invention ison sale, whether or not the parties to the transactionrecognize that the product possesses the claimedcharacteristics.”); Atlas Powder Co. v. IRECO, Inc.,190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947(Fed. Cir. 1999) (“Because ‘sufficient aeration’ wasinherent in the prior art, it is irrelevant that the priorart did not recognize the key aspect of [the]invention.... An inherent structure, composition, orfunction is not necessarily known.”); SmithKlineBeecham Corp. v. Apotex Corp., 403 F.3d 1331,1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005)(holding that a prior art patent to an anhydrous formof a compound “inherently” anticipated the claimedhemihydrate form of the compound becausepracticing the process in the prior art to manufacturethe anhydrous compound “inherently results in atleast trace amounts of” the claimed hemihydrateeven if the prior art did not discuss or recognize thehemihydrate); In re Omeprazole Patent Litigation,483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed.Cir. 2007) (The court noted that although theinventors may not have recognized that acharacteristic of the ingredients in the prior artmethod resulted in an in situ formation of aseparating layer, the in situ formation wasnevertheless inherent. “The record shows formationof the in situ separating layer in the prior art eventhough that process was not recognized at the time.The new realization alone does not render thatnecessary [sic] prior art patentable.”)

III. A REJECTION UNDER 35 U.S.C. 102/103 CANBE MADE WHEN THE PRIOR ART PRODUCTSEEMS TO BE IDENTICAL EXCEPT THAT THEPRIOR ART IS SILENT AS TO AN INHERENTCHARACTERISTIC

Where applicant claims a composition in terms of afunction, property or characteristic and the

2100-114Rev. 08.2017, January 2018


composition of the prior art is the same as that ofthe claim but the function is not explicitly disclosedby the reference, the examiner may make a rejectionunder both 35 U.S.C. 102 and 103, expressed as a102/103 rejection. “There is nothing inconsistent inconcurrent rejections for obviousness under35 U.S.C. 103 and for anticipation under 35 U.S.C.102.” In re Best, 562 F.2d 1252, 1255 n.4, 195USPQ 430, 433 n.4 (CCPA 1977). This samerationale should also apply to product, apparatus,and process claims claimed in terms of function,property or characteristic. Therefore, a 35 U.S.C.102/103 rejection is appropriate for these types ofclaims as well as for composition claims.

IV. EXAMINER MUST PROVIDE RATIONALEOR EVIDENCE TENDING TO SHOW INHERENCY

The fact that a certain result or characteristic mayoccur or be present in the prior art is not sufficientto establish the inherency of that result orcharacteristic. In re Rijckaert, 9 F.3d 1531, 1534,28 USPQ2d 1955, 1957 (Fed. Cir. 1993) (reversedrejection because inherency was based on whatwould result due to optimization of conditions, notwhat was necessarily present in the prior art); In reOelrich, 666 F.2d 578, 581-82, 212 USPQ 323, 326(CCPA 1981). Also, “[a]n invitation to investigateis not an inherent disclosure” where a prior artreference “discloses no more than a broad genus ofpotential applications of its discoveries.” MetaboliteLabs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d1354, 1367, 71 USPQ2d 1081, 1091 (Fed. Cir. 2004)(explaining that “[a] prior art reference that disclosesa genus still does not inherently disclose all specieswithin that broad category” but must be examinedto see if a disclosure of the claimed species has beenmade or whether the prior art reference merelyinvites further experimentation to find the species).

“In relying upon the theory of inherency, theexaminer must provide a basis in fact and/ortechnical reasoning to reasonably support thedetermination that the allegedly inherentcharacteristic necessarily flows from the teachingsof the applied prior art.” Ex parte Levy, 17 USPQ2d1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasisin original) (Applicant’s invention was directed toa biaxially oriented, flexible dilation catheter balloon(a tube which expands upon inflation) used, for

example, in clearing the blood vessels of heartpatients). The examiner applied a U.S. patent toSchjeldahl which disclosed injection molding atubular preform and then injecting air into thepreform to expand it against a mold (blow molding).The reference did not directly state that the endproduct balloon was biaxially oriented. It diddisclose that the balloon was “formed from a thinflexible inelastic, high tensile strength, biaxiallyoriented synthetic plastic material.” Id. at 1462(emphasis in original). The examiner argued thatSchjeldahl’s balloon was inherently biaxiallyoriented. The Board reversed on the basis that theexaminer did not provide objective evidence orcogent technical reasoning to support the conclusionof inherency.).

In In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429(Fed. Cir. 1997), the court affirmed a finding that aprior patent to a conical spout used primarily todispense oil from an oil can inherently performedthe functions recited in applicant’s claim to a conicalcontainer top for dispensing popped popcorn. Theexaminer had asserted inherency based on thestructural similarity between the patented spout andapplicant’s disclosed top, i.e., both structures hadthe same general shape. The court stated:

[N]othing in Schreiber’s [applicant’s] claimsuggests that Schreiber’s container is 'of adifferent shape’ than Harz’s [patent]. In fact, [] an embodiment according to Harz (Fig. 5) andthe embodiment depicted in figure 1 ofSchreiber’s application have the same generalshape. For that reason, the examiner wasjustified in concluding that the opening of aconically shaped top as disclosed by Harz isinherently of a size sufficient to ‘allow [ ]several kernels of popped popcorn to passthrough at the same time’ and that the taper ofHarz’s conically shaped top is inherently ofsuch a shape ‘as to by itself jam up the poppedpopcorn before the end of the cone and permitthe dispensing of only a few kernels at a shakeof a package when the top is mounted to thecontainer.’ The examiner therefore correctlyfound that Harz established a prima facie caseof anticipation.

Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.

Rev. 08.2017, January 20182100-115


V. ONCE A REFERENCE TEACHING PRODUCTAPPEARING TO BE SUBSTANTIALLYIDENTICAL IS MADE THE BASIS OF AREJECTION, AND THE EXAMINER PRESENTSEVIDENCE OR REASONING TENDING TO SHOWINHERENCY, THE BURDEN OF PRODUCTIONSHIFTS TO THE APPLICANT

“[T]he PTO can require an applicant to prove thatthe prior art products do not necessarily or inherentlypossess the characteristics of his [or her] claimedproduct. Whether the rejection is based on‘inherency’ under 35 U.S.C. 102, on ‘ prima facieobviousness’ under 35 U.S.C. 103, jointly oralternatively, the burden of proof is the same.” Inre Best, 562 F.2d 1252, 1255, 195 USPQ 430,433-34 (CCPA 1977) (footnote and citation omitted).The burden of proof is similar to that required withrespect to product-by-process claims. In reFitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596(CCPA 1980) (citing Best, 562 F.2d at 1255.

In Fitzgerald, the claims were directed to aself-locking screw-threaded fastener comprising ametallic threaded fastener having patches ofcrystallizable thermoplastic bonded thereto. Theclaim further specified that the thermoplastic had areduced degree of crystallization shrinkage. Thespecification disclosed that the locking fastener wasmade by heating the metal fastener to melt athermoplastic blank which is pressed against themetal. After the thermoplastic adheres to the metalfastener, the end product is cooled by quenching inwater. The examiner made a rejection based on aU.S. patent to Barnes. Barnes taught a self-lockingfastener in which the patch of thermoplastic wasmade by depositing thermoplastic powder on ametallic fastener which was then heated. The endproduct was cooled in ambient air, by cooling air orby contacting the fastener with a water trough. Thecourt first noted that the two fasteners were identicalor only slightly different from each other. “Bothfasteners possess the same utility, employ the samecrystallizable polymer (nylon 11), and have anadherent plastic patch formed by melting and thencooling the polymer.” Id. at 596 n.1, 619 F.2d at 70n.l. The court then noted that the Board had foundthat Barnes’ cooling rate could reasonably beexpected to result in a polymer possessing theclaimed crystallization shrinkage rate. Applicantshad not rebutted this finding with evidence that the

shrinkage rate was indeed different. They had onlyargued that the crystallization shrinkage rate wasdependent on the cool down rate and that the cooldown rate of Barnes was much slower than theirs.Because a difference in the cool down rate does notnecessarily result in a difference in shrinkage,objective evidence was required to rebut the35 U.S.C. 102/103 prima facie case.

In Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d1429, 1432 (Fed.Cir.1997), the court held thatapplicant’s declaration failed to overcome a primafacie case of anticipation because the declaration didnot specify the dimensions of either the dispensingtop that was tested or the popcorn that was used.Applicant’s declaration merely asserted that a conicaldispensing top built according to a figure in the priorart patent was too small to jam and dispense popcornand thus could not inherently perform the functionsrecited in applicant’s claims. The court pointed outthe disclosure of the prior art patent was not limitedto use as an oil can dispenser, but rather was broaderthan the precise configuration shown in the patent’sfigure. The court also noted that the Board of PatentAppeals and Interferences found as a factual matterthat a scaled-up version of the top disclosed in thepatent would be capable of performing the functionsrecited in applicant’s claim.

See MPEP § 2113 for more information on theanalogous burden of proof applied toproduct-by-process claims.

2112.01 Composition, Product, and Apparatus Claims [R-07.2015]

I. PRODUCT AND APPARATUS CLAIMS —WHEN THE STRUCTURE RECITED IN THEREFERENCE IS SUBSTANTIALLY IDENTICALTO THAT OF THE CLAIMS, CLAIMEDPROPERTIES OR FUNCTIONS ARE PRESUMEDTO BE INHERENT

Where the claimed and prior art products areidentical or substantially identical in structure orcomposition, or are produced by identical orsubstantially identical processes, a prima facie caseof either anticipation or obviousness has beenestablished. In re Best, 562 F.2d 1252, 1255, 195USPQ 430, 433 (CCPA 1977). “When the PTO

2100-116Rev. 08.2017, January 2018


shows a sound basis for believing that the productsof the applicant and the prior art are the same, theapplicant has the burden of showing that they arenot.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d1655, 1658 (Fed. Cir. 1990). Therefore, the primafacie case can be rebutted by evidence showing thatthe prior art products do not necessarily possess thecharacteristics of the claimed product. In re Best,562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985) (Claims weredirected to a titanium alloy containing 0.2-0.4% Moand 0.6-0.9% Ni having corrosion resistance. ARussian article disclosed a titanium alloy containing0.25% Mo and 0.75% Ni but was silent as tocorrosion resistance. The Federal Circuit held thatthe claim was anticipated because the percentagesof Mo and Ni were squarely within the claimedranges. The court went on to say that it wasimmaterial what properties the alloys had or whodiscovered the properties because the compositionis the same and thus must necessarily exhibit theproperties.).

See also In re Ludtke, 441 F.2d 660, 169 USPQ 563(CCPA 1971) (Claim 1 was directed to a parachutecanopy having concentric circumferential panelsradially separated from each other by radiallyextending tie lines. The panels were separated “suchthat the critical velocity of each successively largerpanel will be less than the critical velocity of theprevious panel, whereby said parachute willsequentially open and thus gradually decelerate.”The court found that the claim was anticipated byMenget. Menget taught a parachute having threecircumferential panels separated by tie lines. Thecourt upheld the rejection finding that applicant hadfailed to show that Menget did not possess thefunctional characteristics of the claims.); NorthamWarren Corp. v. D. F. Newfield Co., 7 F. Supp . 773,22 USPQ 313 (E.D.N.Y. 1934) (A patent to a pencilfor cleaning fingernails was held invalid because apencil of the same structure for writing was foundin the prior art.).

II. COMPOSITION CLAIMS — IF THECOMPOSITION IS PHYSICALLY THE SAME, ITMUST HAVE THE SAME PROPERTIES

“Products of identical chemical composition can nothave mutually exclusive properties.” In re Spada,911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed.Cir. 1990). A chemical composition and itsproperties are inseparable. Therefore, if the prior artteaches the identical chemical structure, theproperties applicant discloses and/or claims arenecessarily present. Id. (Applicant argued that theclaimed composition was a pressure sensitiveadhesive containing a tacky polymer while theproduct of the reference was hard and abrasionresistant. “The Board correctly found that the virtualidentity of monomers and procedures sufficed tosupport a prima facie case of unpatentability ofSpada’s polymer latexes for lack of novelty.”).

III. PRODUCT CLAIMS – NONFUNCTIONALPRINTED MATTER DOES NOT DISTINGUISHCLAIMED PRODUCT FROM OTHERWISEIDENTICAL PRIOR ART PRODUCT

Where the only difference between a prior artproduct and a claimed product is printed matter thatis not functionally related to the product, the contentof the printed matter will not distinguish the claimedproduct from the prior art. In re Ngai, 367 F.3d1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)(Claim at issue was a kit requiring instructions anda buffer agent. The Federal Circuit held that theclaim was anticipated by a prior art reference thattaught a kit that included instructions and a bufferagent, even though the content of the instructionsdiffered, explaining “[i]f we were to adopt[applicant’s] position, anyone could continuepatenting a product indefinitely provided that theyadd a new instruction sheet to the product.”). Seealso In re Gulack, 703 F.2d 1381, 1385-86, 217USPQ 401, 404 (Fed. Cir. 1983) (“Where the printedmatter is not functionally related to the substrate,the printed matter will not distinguish the inventionfrom the prior art in terms of patentability….[T]hecritical question is whether there exists any new andunobvious functional relationship between theprinted matter and the substrate.”); In re Miller, 418F.2d 1392, 1396 (CCPA 1969) (finding a new andunobvious relationship between a measuring cupand writing showing how to “half” a recipe); In re

Rev. 08.2017, January 20182100-117


Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947)(matters relating to ornamentation only which haveno mechanical function cannot be relied upon topatentably distinguish the claimed invention fromthe prior art); In re Xiao, 462 Fed. App'x 947,950-51 (Fed. Cir. 2011) (non-precedential)(affirming an obviousness rejection of claimsdirected to a tumbler lock that used letters insteadof numbers and had a wild-card label instead of oneof the letters); In re Bryan, 323 Fed. App'x 898, 901(Fed. Cir. 2009) (non-precedential) (printed matteron game cards bears no new and unobviousfunctional relationship to game board).

The court has extended the rationale in the printedmatter cases, in which, for example, writteninstructions are added to a known product, to methodclaims in which "an instruction limitation" (i.e., alimitation “informing” someone about the existenceof an inherent property of that method) is added toa method known in the art. King Pharmaceuticals,Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279, 95USPQ2d 1833, 1842 (2010). Similar to the inquiryfor products with printed matter thereon, for suchmethod cases the relevant inquiry is whether a newand unobvious functional relationship with theknown method exists. In King Pharma, the courtfound that the relevant determination is whether the"instruction limitation" has a "new and unobviousfunctional relationship" with the known method ofadministering the drug with food. Id.. The courtheld that the relationship was non-functional because"[i]nforming a patient about the benefits of a drugin no way transforms the process of taking the drugwith food." Id. That is, the actual method of takinga drug with food is the same regardless of whetherthe patient is informed of the benefits. Id. “In otherwords, the ‘informing’ limitation ‘in no way dependson the method, and the method does not depend onthe ‘informing’ limitation.’" Id. (citing In re Ngai,367 F.3d 1336, 1339 (Fed. Cir. 2004)); see also Inre Kao, 639 F.3d 1057, 1072-73, 98 USPQ2d 1799,1811-12 (Fed. Cir. 2011).

2112.02 Process Claims [R-07.2015]

I. PROCESS CLAIMS — PRIOR ART DEVICEANTICIPATES A CLAIMED PROCESS IF THE

DEVICE CARRIES OUT THE PROCESS DURINGNORMAL OPERATION

Under the principles of inherency, if a prior artdevice, in its normal and usual operation, wouldnecessarily perform the method claimed, then themethod claimed will be considered to be anticipatedby the prior art device. When the prior art device isthe same as a device described in the specificationfor carrying out the claimed method, it can beassumed the device will inherently perform theclaimed process. In re King, 801 F.2d 1324, 231USPQ 136 (Fed. Cir. 1986) (The claims weredirected to a method of enhancing color effectsproduced by ambient light through a process ofabsorption and reflection of the light off a coatedsubstrate. A prior art reference to Donley discloseda glass substrate coated with silver and metal oxide200-800 angstroms thick. While Donley disclosedusing the coated substrate to produce architecturalcolors, the absorption and reflection mechanisms ofthe claimed process were not disclosed. However,King’s specification disclosed using a coatedsubstrate of Donley’s structure for use in his process.The Federal Circuit upheld the Board’s finding that“Donley inherently performs the function disclosedin the method claims on appeal when that device isused in ‘normal and usual operation’” and found thata prima facie case of anticipation was made out. Id. at 138, 801 F.2d at 1326. It was up to applicantto prove that Donley's structure would not performthe claimed method when placed in ambient light.).See also In re Best, 562 F.2d 1252, 1255, 195 USPQ430, 433 (CCPA 1977) (Applicant claimed a processfor preparing a hydrolytically-stable zeoliticaluminosilicate which included a step of “coolingthe steam zeolite ... at a rate sufficiently rapid thatthe cooled zeolite exhibits a X-ray diffraction pattern....” All the process limitations were expresslydisclosed by a U.S. patent to Hansford except thecooling step. The court stated that any sample ofHansford’s zeolite would necessarily be cooled tofacilitate subsequent handling. Therefore, a primafacie case under 35 U.S.C. 102/103 was made.Applicant had failed to introduce any evidencecomparing X-ray diffraction patterns showing adifference in cooling rate between the claimedprocess and that of Hansford or any data showingthat the process of Hansford would result in aproduct with a different X-ray diffraction. Either

2100-118Rev. 08.2017, January 2018


type of evidence would have rebutted the primafacie case under 35 U.S.C. 102. A further analysiswould be necessary to determine if the process wasunobvious under 35 U.S.C. 103.); Ex parte Novitski,26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (TheBoard rejected a claim directed to a method forprotecting a plant from plant pathogenic nematodesby inoculating the plant with a nematode inhibitingstrain of P. cepacia. A U.S. patent to Dart disclosedinoculation using P. cepacia type Wisconsin 526bacteria for protecting the plant from fungal disease.Dart was silent as to nematode inhibition but theBoard concluded that nematode inhibition was aninherent property of the bacteria. The Board notedthat applicant had stated in the specification thatWisconsin 526 possesses an 18% nematodeinhibition rating.).

II. PROCESS OF USE CLAIMS — NEW ANDUNOBVIOUS USES OF OLD STRUCTURES ANDCOMPOSITIONS MAY BE PATENTABLE

The discovery of a new use for an old structure basedon unknown properties of the structure might bepatentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161,163 (CCPA 1957). However, when the claim recitesusing an old composition or structure and the “use”is directed to a result or property of that compositionor structure, then the claim is anticipated. In re May,574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA1978) (Claims 1 and 6, directed to a method ofeffecting nonaddictive analgesia (pain reduction) inanimals, were found to be anticipated by the appliedprior art which disclosed the same compounds foreffecting analgesia but which was silent as toaddiction. The court upheld the rejection and statedthat the applicants had merely found a new propertyof the compound and such a discovery did notconstitute a new use. The court went on to reversethe obviousness rejection of claims 2-5 and 7-10which recited a process of using a new compound.The court relied on evidence showing that thenonaddictive property of the new compound wasunexpected.). See also In re Tomlinson, 363 F.2d928, 150 USPQ 623 (CCPA 1966) (The claim wasdirected to a process of inhibiting light degradationof polypropylene by mixing it with one of a genusof compounds, including nickel dithiocarbamate. Areference taught mixing polypropylene with nickel

dithiocarbamate to lower heat degradation. The courtheld that the claims read on the obvious process ofmixing polypropylene with the nickeldithiocarbamate and that the preamble of the claimwas merely directed to the result of mixing the twomaterials. “While the references do not show aspecific recognition of that result, its discovery byappellants is tantamount only to finding a propertyin the old composition.” 363 F.2d at 934, 150 USPQat 628 (emphasis in original)).

2113 Product-by-Process Claims [R-08.2017]

I. PRODUCT-BY-PROCESS CLAIMS ARE NOTLIMITED TO THE MANIPULATIONS OF THERECITED STEPS, ONLY THE STRUCTUREIMPLIED BY THE STEPS

“[E]ven though product-by-process claims arelimited by and defined by the process, determinationof patentability is based on the product itself. Thepatentability of a product does not depend on itsmethod of production. If the product in theproduct-by-process claim is the same as or obviousfrom a product of the prior art, the claim isunpatentable even though the prior product was madeby a different process.” In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citationsomitted) (Claim was directed to a novolac colordeveloper. The process of making the developer wasallowed. The difference between the inventiveprocess and the prior art was the addition of metaloxide and carboxylic acid as separate ingredientsinstead of adding the more expensive pre-reactedmetal carboxylate. The product-by-process claimwas rejected because the end product, in both theprior art and the allowed process, ends up containingmetal carboxylate. The fact that the metalcarboxylate is not directly added, but is insteadproduced in-situ does not change the end product.).Furthermore, “[b]ecause validity is determined basedon the requirements of patentability, a patent isinvalid if a product made by the process recited ina product-by-process claim is anticipated by orobvious from prior art products, even if those priorart products are made by different processes.” AmgenInc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340,1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir.2009). See also Purdue Pharma v. Epic Pharma,811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016).

Rev. 08.2017, January 20182100-119


However, in the context of an infringement analysis,a product-by-process claim is only infringed by aproduct made by the process recited in the claim. Id. at 1370 (“a product in the prior art made by adifferent process can anticipate a product-by-processclaim, but an accused product made by a differentprocess cannot infringe a product-by-processclaim”).

The structure implied by the process steps shouldbe considered when assessing the patentability ofproduct-by-process claims over the prior art,especially where the product can only be defined bythe process steps by which the product is made, orwhere the manufacturing process steps would beexpected to impart distinctive structuralcharacteristics to the final product. See, e.g., In reGarnero, 412 F.2d 276, 279, 162 USPQ 221, 223(CCPA 1979) (holding “interbonded by interfusion”to limit structure of the claimed composite andnoting that terms such as “welded,” “intermixed,”“ground in place,” “press fitted,” and “etched” arecapable of construction as structural limitations).

II. ONCE A PRODUCT APPEARING TO BESUBSTANTIALLY IDENTICAL IS FOUND AND A35 U.S.C. 102/103 REJECTION MADE, THEBURDEN SHIFTS TO THE APPLICANT TO SHOWAN UNOBVIOUS DIFFERENCE

“The Patent Office bears a lesser burden of proof inmaking out a case of prima facie obviousness forproduct-by-process claims because of their peculiarnature” than when a product is claimed in theconventional fashion. In re Fessmann, 489 F.2d742, 744, 180 USPQ 324, 326 (CCPA 1974). Oncethe examiner provides a rationale tending to showthat the claimed product appears to be the same orsimilar to that of the prior art, although produced bya different process, the burden shifts to applicant tocome forward with evidence establishing anunobvious difference between the claimed productand the prior art product. In re Marosi, 710 F.2d798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) (Theclaims were directed to a zeolite manufactured bymixing together various inorganic materials insolution and heating the resultant gel to form acrystalline metal silicate essentially free of alkalimetal. The prior art described a process of makinga zeolite which, after ion exchange to remove alkali

metal, appeared to be “essentially free of alkalimetal.” The court upheld the rejection because theapplicant had not come forward with any evidencethat the prior art was not “essentially free of alkalimetal” and therefore a different and unobviousproduct.).

See also Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat.App. & Inter. 1989) (The prior art disclosed humannerve growth factor (b-NGF) isolated from humanplacental tissue. The claim was directed to b-NGFproduced through genetic engineering techniques.The factor produced seemed to be substantially thesame whether isolated from tissue or producedthrough genetic engineering. While the applicantquestioned the purity of the prior art factor, noconcrete evidence of an unobvious difference waspresented. The Board stated that the dispositive issueis whether the claimed factor exhibits anyunexpected properties compared with the factordisclosed by the prior art. The Board further statedthat the applicant should have made somecomparison between the two factors to establishunexpected properties since the materials appearedto be identical or only slightly different.).

III. THE USE OF 35 U.S.C. 102/103 REJECTIONSFOR PRODUCT-BY-PROCESS CLAIMS HAS BEENAPPROVED BY THE COURTS

“[T]he lack of physical description in aproduct-by-process claim makes determination ofthe patentability of the claim more difficult, sincein spite of the fact that the claim may recite onlyprocess limitations, it is the patentability of theproduct claimed and not of the recited process stepswhich must be established. We are therefore of theopinion that when the prior art discloses a productwhich reasonably appears to be either identical withor only slightly different than a product claimed ina product-by-process claim, a rejection basedalternatively on either section 102 or section 103 ofthe statute is eminently fair and acceptable. As apractical matter, the Patent Office is not equippedto manufacture products by the myriad of processesput before it and then obtain prior art products andmake physical comparisons therewith.” In re Brown,459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA1972). Office personnel should note that reliance onthe alternative grounds of 35 U.S.C. 102 or 35 U.S.C.

2100-120Rev. 08.2017, January 2018


103 does not eliminate the need to explain both theanticipation and obviousness aspects of therejections.

2114 Apparatus and Article Claims —Functional Language [R-07.2015]

For a discussion of case law which providesguidance in interpreting the functional portion ofmeans-plus-function limitations see MPEP § 2181- § 2186.

I. INHERENCY AND FUNCTIONALLIMITATIONS IN APPARATUS CLAIMS

Features of an apparatus may be recited eitherstructurally or functionally. In re Schreiber, 128F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir.1997). See also MPEP § 2173.05(g). If an examinerconcludes that a functional limitation is an inherentcharacteristic of the prior art, then to establish aprima case of anticipation or obviousness, theexaminer should explain that the prior art structureinherently possesses the functionally definedlimitations of the claimed apparatus. In re Schreiber,128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed.Cir. 2011). The burden then shifts to applicant toestablish that the prior art does not possess thecharacteristic relied on. In re Schreiber, 128 F.3dat 1478, 44 USPQ2d at 1432; In re Swinehart, 439F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971)(“where the Patent Office has reason to believe thata functional limitation asserted to be critical forestablishing novelty in the claimed subject mattermay, in fact, be an inherent characteristic of the priorart, it possesses the authority to require the applicantto prove that the subject matter shown to be in theprior art does not possess the characteristic reliedon”).

II. MANNER OF OPERATING THE DEVICE DOESNOT DIFFERENTIATE APPARATUS CLAIMFROM THE PRIOR ART

“[A]pparatus claims cover what a device is, notwhat a device does.” Hewlett-PackardCo. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469,15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis

in original). A claim containing a “recitation withrespect to the manner in which a claimed apparatusis intended to be employed does not differentiate theclaimed apparatus from a prior art apparatus” if theprior art apparatus teaches all the structurallimitations of the claim. Ex parte Masham, 2USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (Thepreamble of claim 1 recited that the apparatus was“for mixing flowing developer material” and thebody of the claim recited “means for mixing ..., saidmixing means being stationary and completelysubmerged in the developer material.” The claimwas rejected over a reference which taught all thestructural limitations of the claim for the intendeduse of mixing flowing developer. However, themixer was only partially submerged in the developermaterial. The Board held that the amount ofsubmersion is immaterial to the structure of themixer and thus the claim was properly rejected.).

III. A PRIOR ART DEVICE CAN PERFORM ALLTHE FUNCTIONS OF THE APPARATUS CLAIMAND STILL NOT ANTICIPATE THE CLAIM

Even if the prior art device performs all the functionsrecited in the claim, the prior art cannot anticipatethe claim if there is any structural difference. Itshould be noted, however, that means-plus-functionlimitations are met by structures which are equivalentto the corresponding structures recited in thespecification. In re Donaldson, 16 F.3d 1189, 1193,29 USPQ2d 1845, 1848 (Fed. Cir. 1994). See also In re Robertson, 169 F.3d 743, 745, 49 USPQ2d1949, 1951 (Fed. Cir. 1999) (The claims were drawnto a disposable diaper having three fasteningelements. The reference disclosed two fasteningelements that could perform the same function asthe three fastening elements in the claims. Thecourt construed the claims to require three separateelements and held that the reference did not disclosea separate third fastening element, either expresslyor inherently.).

IV. DETERMINING WHETHER ACOMPUTER-IMPLEMENTED FUNCTIONALCLAIM LIMITATION IS PATENTABLE OVERTHE PRIOR ART UNDER 35 U.S.C. 102 AND 103

Functional claim language that is not limited to aspecific structure covers all devices that are capableof performing the recited function. Therefore, if the

Rev. 08.2017, January 20182100-121


prior art discloses a device that can inherentlyperform the claimed function, a rejection under 35U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate.See In re Translogic Technology, Inc., 504 F.3d1249, 1258, 84 USPQ2d 1929, 1935-1936 (Fed. Cir.2007) (The claims were drawn to multiplexer circuit.The patent at issue claimed “coupled to” and“coupled to receive” between various portions ofthe circuitry. In reference to the claim phrase “inputterminals ‘coupled to receive’ first and second inputvariables,” the court held that “the claimed circuitdoes not require any specific input or connection …[a]s such, ‘coupled to’ and ‘coupled to receive’ areclearly different … [a]s shown in [the figures of the]patent, input terminals … only need to be ‘capableof receiving’ an input variable for the multiplexercircuit as claimed”. Therefore, the specificationsupported the claim construction “that ‘coupled toreceive’ means ‘capable of receiving.’”); Intel Corp.v. U.S. Int'l Trade Comm’n, 946 F.2d 821, 832, 20USPQ2d 1161, 1171 (Fed. Cir. 1991) (The courtheld that “programmable” claim language requiredonly that the accused product could be programmedto perform the claimed functionality.); In reSchreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429,1432 (Fed. Cir. 1997); In re Best, 562 F.2d 1252,1254, 195 USPQ 430, 433 (CCPA 1977); In reLudtke, 441 F.2d 660, 663-64, 169 USPQ 563,566-67 (CCPA 1971); In re Swinehart, 439 F.2d210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971)(“[I]t is elementary that the mere recitation of anewly discovered function or property, inherentlypossessed by things in the prior art, does not causea claim drawn to those things to distinguish over theprior art”). See MPEP § 2112 for more information.

Conversely, computer-implemented functional claimlimitations may narrow the functionality of thedevice, by limiting the specific structure capable ofperforming the recited function. NazomiCommunications, Inc. v. Nokia Corp., 739 F.3d1339, 1345, 109 USPQ2d 1258, 1262 (Fed Cir.2014) (The claims were drawn to a CPU that canperform processing of both register-based andstack-based instructions. Appellant allegedinfringement of the claims based on claimconstruction requiring only hardware capable ofperforming the claimed functionalities. Contrastedwith the finding of Intel Corp. v. U.S. Int'l TradeComm’n, 846 F.2d 821, 832, 20 USPQ2d 1161, 1171

(Fed. Cir. 1991), the court found that “[s]incehardware cannot meet these limitations in theabsence of enabling software, the claims are properlyconstrued as claiming an apparatus comprising acombination of hardware and software capable ofpracticing the claim limitations.”).

Computer-implemented functional claim limitationsmay also be broad because the term “computer” iscommonly understood by one of ordinary skill inthe art to describe a variety of devices with varyingdegrees of complexity and capabilities. In rePaulsen, 30 F.3d 1475, 1479-80, 31 USPQ2d 1671,1674 (Fed. Cir. 1994). Therefore, a claim containingthe term “computer” should not be construed aslimited to a computer having a specific set ofcharacteristics and capabilities, unless the term ismodified by other claim terms or clearly defined inthe specification to be different from its commonmeaning. Id. In Paulsen, the claims, directed to aportable computer, were rejected as anticipated under35 U.S.C. 102 by a reference that disclosed acalculator, because the term “computer” was giventhe broadest reasonable interpretation consistent withthe specification to include a calculator, and acalculator was considered to be a particular type ofcomputer by those of ordinary skill in the art. Id.

When determining whether a computer-implementedfunctional claim would have been obvious,examiners should note that broadly claiming anautomated means to replace a manual function toaccomplish the same result does not distinguish overthe prior art. See Leapfrog Enters., Inc. v.Fisher-Price, Inc., 485 F.3d 1157, 1161, 82 USPQ2d1687, 1691 (Fed. Cir. 2007) (“Accommodating aprior art mechanical device that accomplishes [adesired] goal to modern electronics would have beenreasonably obvious to one of ordinary skill indesigning children’s learning devices. Applyingmodern electronics to older mechanical devices hasbeen commonplace in recent years.”); In re Venner,262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958);see also MPEP § 2144.04. Furthermore,implementing a known function on a computer hasbeen deemed obvious to one of ordinary skill in theart if the automation of the known function on ageneral purpose computer is nothing more than thepredictable use of prior art elements according totheir established functions. KSR Int’l Co. v. Teleflex

2100-122Rev. 08.2017, January 2018


Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396(2007); see also MPEP § 2143, ExemplaryRationales D and F. Likewise, it has been found tobe obvious to adapt an existing process toincorporate Internet and Web browser technologiesfor communicating and displaying informationbecause these technologies had becomecommonplace for those functions. Muniauction,Inc. v. Thomson Corp., 532 F.3d 1318, 1326-27, 87USPQ2d 1350, 1357 (Fed. Cir. 2008).

For more information on the obviousnessdetermination, see MPEP § 2141.

2115 Material or Article Worked Upon byApparatus [R-07.2015]

MATERIAL OR ARTICLE WORKED UPON DOESNOT LIMIT APPARATUS CLAIMS

Claim analysis is highly fact-dependent. A claim isonly limited by positively recited elements. Thus,“[i]nclusion of the material or article worked uponby a structure being claimed does not impartpatentability to the claims.” In re Otto, 312 F.2d937, 136 USPQ 458, 459 (CCPA 1963); see also Inre Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).

In Otto, the claims were directed to a core memberfor hair curlers (i.e., a particular device) and amethod of making the core member (i.e., a particularmethod of making that device) and “not to a methodof curling hair wherein th[e] particular device isused.” 312 F.2d at 940. The court held thatpatentability of the claims cannot be based “upon acertain procedure for curling hair using th[e] deviceand involving a number of steps in the process.” Thecourt noted that “the process is irrelevant as is therecitation involving the hair being wound aroundthe core” in terms of determining patentability ofthe particular device. Id. Therefore, the inclusionof the material or article worked upon by a structurebeing claimed does not impart patentability to theclaims.

In Young, a claim to a machine for making concretebeams included a limitation to the concretereinforced members made by the machine as wellas the structural elements of the machine itself. Thecourt held that the inclusion of the article formed

within the body of the claim did not, without more,make the claim patentable.

In In re Casey, 370 F.2d 576, 152 USPQ 235(CCPA 1967), an apparatus claim recited “[a] tapingmachine comprising a supporting structure, a brushattached to said supporting structure, said brushbeing formed with projecting bristles whichterminate in free ends to collectively define a surfaceto which adhesive tape will detachably adhere, andmeans for providing relative motion between saidbrush and said supporting structure while saidadhesive tape is adhered to said surface.” Anobviousness rejection was made over a reference toKienzle which taught a machine for perforatingsheets. The court upheld the rejection stating that“the references in claim 1 to adhesive tape handlingdo not expressly or impliedly require any particularstructure in addition to that of Kienzle.” Id. at580-81. The perforating device had the structure ofthe taping device as claimed, the difference was inthe use of the device, and “the manner or method inwhich such machine is to be utilized is not germaneto the issue of patentability of the machine itself.” Id. at 580.

Note that this line of cases is limited to claimsdirected to machinery which works upon an articleor material in its intended use.

2116 [Reserved]

2116.01 Novel, Unobvious Starting Materialor End Product [R-08.2012]

All the limitations of a claim must be consideredwhen weighing the differences between the claimedinvention and the prior art in determining theobviousness of a process or method claim. SeeMPEP § 2143.03.

In re Ochiai, 71 F.3d 1565, 37 USPQ2d 1127 (Fed.Cir. 1995) and In re Brouwer, 77 F.3d 422,37 USPQ2d 1663 (Fed. Cir. 1996) addressed theissue of whether an otherwise conventional processcould be patented if it were limited to making orusing a nonobvious product. In both cases, theFederal Circuit held that the use of per se rules is

Rev. 08.2017, January 20182100-123


improper in applying the test for obviousness under35 U.S.C. 103. Rather, 35 U.S.C. 103 requires ahighly fact-dependent analysis involving taking theclaimed subject matter as a whole and comparing itto the prior art. “A process yielding a novel andnonobvious product may nonetheless be obvious;conversely, a process yielding a well-known productmay yet be nonobvious.” TorPharm, Inc. v. RanbaxyPharmaceuticals, Inc., 336 F.3d 1322, 1327, 67USPQ2d 1511, 1514 (Fed. Cir. 2003).

Interpreting the claimed invention as a wholerequires consideration of all claim limitations. Thus,proper claim construction requires treating languagein a process claim which recites the making or usingof a nonobvious product as a material limitation.The decision in Ochiai specifically dispelled anydistinction between processes of making a productand methods of using a product with regard to theeffect of any product limitations in either type ofclaim.

As noted in Brouwer, 77 F.3d at 425, 37 USPQ2dat 1666, the inquiry as to whether a claimedinvention would have been obvious is “highlyfact-specific by design.” Accordingly, obviousnessmust be assessed on a case-by-case basis. Thefollowing decisions are illustrative of the lack of per se rules in applying the test for obviousnessunder 35 U.S.C. 103 and of the fact-intensivecomparison of claimed processes with the prior art: In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed.Cir. 1985) (The examiner rejected a claim directedto a process in which patentable starting materialswere reacted to form patentable end products. Theprior art showed the same chemical reactionmechanism applied to other chemicals. The courtheld that the process claim was obvious over theprior art.); In re Albertson, 332 F.2d 379, 141 USPQ730 (CCPA 1964) (Process of chemically reducingone novel, nonobvious material to obtain anothernovel, nonobvious material was claimed. The processwas held obvious because the reduction reaction wasold.); In re Kanter, 399 F.2d 249, 158 USPQ 331(CCPA 1968) (Process of siliconizing a patentablebase material to obtain a patentable product wasclaimed. Rejection based on prior art teaching thesiliconizing process as applied to a different basematerial was upheld.); Cf. In re Pleuddemann, 910F.2d 823, 15 USPQ2d 1738 (Fed. Cir. 1990)

(Methods of bonding polymer and filler using anovel silane coupling agent held patentable eventhough methods of bonding using other silanecoupling agents were well known because theprocess could not be conducted without the newagent); In re Kuehl, 475 F.2d 658, 177 USPQ 250(CCPA 1973) (Process of cracking hydrocarbonsusing novel zeolite catalyst found to be patentableeven though catalytic cracking process was old. “Thetest under 103 is whether in view of the prior art theinvention as a whole would have been obvious atthe time it was made, and the prior art here does notinclude the zeolite, ZK-22. The obviousness of theprocess of cracking hydrocarbons with ZK-22 as acatalyst must be determined without reference toknowledge of ZK-22 and its properties.” 475 F.2dat 664-665, 177 USPQ at 255.); and In re Mancy,499 F.2d 1289, 182 USPQ 303 (CCPA 1974) (Claimto a process for the production of a known antibioticby cultivating a novel, unobvious microorganismwas found to be patentable.).

2117 Markush Claims [R-08.2017]

A “Markush” claim recites a list of alternativelyuseable members. In re Harnisch, 631 F.2d 716,719-20 (CCPA 1980); Ex parte Markush, 1925 Dec.Comm'r Pat. 126, 127 (1924). The listing of specifiedalternatives within a Markush claim is referred to asa Markush group or Markush grouping. Abbott Labsv. Baxter Pharmaceutical Products, Inc., 334 F.3d1274, 1280-81, 67 USPQ2d 1191, 1196-97 (Fed.Cir. 2003) (citing to several sources that describeMarkush groups). Claim language defined by aMarkush grouping requires selection from a closedgroup “consisting of” the alternative members. Id.at 1280, 67 USPQ2d at 1196. See MPEP § 2111.03,subsection II, for a discussion of the term “consistingof” in the context of Markush groupings.

Treatment of claims reciting alternatives is notgoverned by the particular format used (e.g.,alternatives may be set forth as “a material selectedfrom the group consisting of A, B, or C” or “whereinthe material is A, B, or C”). See, e.g., the Supplementary Examination Guidelines forDetermining Compliance with 35 U.S.C. 112 andfor Treatment of Related Issues in PatentApplications (“Supplementary Guidelines”), 76 Fed.Reg. 7162 (February 9, 2011). Claims that set forth

2100-124Rev. 08.2017, January 2018


a list of alternatives from which a selection is to bemade are typically referred to as Markush claims,after the appellant in Ex parte Markush, 1925 Dec.Comm’r Pat. 126, 127 (1924). Although the term“Markush claim” is used throughout the MPEP, anyclaim that recites alternatively usable members,regardless of format, should be treated as a Markushclaim. Inventions in metallurgy, refractories,ceramics, chemistry, pharmacology and biology aremost frequently claimed under the Markush formula,but purely mechanical features or process steps mayalso be claimed by using the Markush style ofclaiming. See, e.g., Fresenius USA, Inc. v. BaxterInt’l, Inc., 582 F.3d 1288, 1297-98 (Fed. Cir.2009)(claim to a hemodialysis apparatus required“at least one unit selected from the group consistingof (i) a dialysate-preparation unit, (ii) adialysate-circulation unit, (iii) anultrafiltrate-removal unit, and (iv) adialysate-monitoring unit” and a user/machineinterface operably connected thereto); In reHarnisch, 631 F.2d 716, 206 USPQ 300 (CCPA1980)(defining alternative moieties of a chemicalcompound with Markush groupings).

A Markush grouping is proper if the members of agroup share a single structural similarity and acommon use. See MPEP § 706.03(y) for guidelinesregarding the determination of whether a Markushgrouping is improper.

See MPEP § 2111.03 and MPEP § 2173.05(h) fordiscussions of when a Markush grouping may beindefinite under 35 U.S.C. 112(b) (e.g., if the list ofalternatives is not a closed grouping, or if a Markushgroup is so expansive that persons skilled in the artcannot determine the metes and bounds of theclaimed invention).

See MPEP § 803.02 for information pertaining tothe election, search, and examination of claims thatinclude at least one Markush grouping.


2121 Prior Art; General Level of OperabilityRequired to Make a Prima Facie Case[R-08.2017]

I. PRIOR ART IS PRESUMED TO BEOPERABLE/ENABLING

When the reference relied on expressly anticipatesor makes obvious all of the elements of the claimedinvention, the reference is presumed to be operable.Once such a reference is found, the burden is onapplicant to rebut the presumption of operability. Inre Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA1980). See also MPEP § 716.07. See also In reAntor Media Corp., 689 F.3d 1282, 103 USPQ2d1555 (Fed. Cir. 2012). Specifically, in In re AntorMedia Corp., the court stated:

“Consistent with the statutory framework and ourprecedent, we therefore hold that, during patentprosecution, an examiner is entitled to reject claims asanticipated by a prior art publication or patent withoutconducting an inquiry into whether or not that prior artreference is enabling. As long as an examiner makes aproper prima facie case of anticipation by giving adequatenotice under § 132, the burden shifts to the applicant tosubmit rebuttal evidence of nonenablement.”

In re Antor Media Corp., 689 F.3d at 1289, 103USPQ2d at 1559.

Where a reference appears to not be enabling on itsface, however, an applicant may successfullychallenge the cited prior art for lack of enablementby argument without supporting evidence. In reMorsa, 713 F.3d 104, 110, 106 USPQ2d 1327, 1332(Fed. Cir. 2013).

See also MPEP § 716.07.

II. WHAT CONSTITUTES AN “ENABLINGDISCLOSURE” DOES NOT DEPEND ON THETYPE OF PRIOR ART THE DISCLOSURE ISCONTAINED IN

The level of disclosure required within a referenceto make it an “enabling disclosure” is the same nomatter what type of prior art is at issue. It does not

Rev. 08.2017, January 20182100-125


matter whether the prior art reference is a U.S.patent, foreign patent, a printed publication or other.There is no basis in the statute (35 U.S.C. 102 or103) for discriminating either in favor of or againstprior art references on the basis of nationality. In reMoreton, 288 F.2d 708, 129 USPQ 227 (CCPA1961).

III. EFFICACY IS NOT A REQUIREMENT FORPRIOR ART ENABLEMENT

A prior art reference provides an enabling disclosureand thus anticipates a claimed invention if thereference describes the claimed invention insufficient detail to enable a person of ordinary skillin the art to carry out the claimed invention; “proofof efficacy is not required for a prior art referenceto be enabling for purposes of anticipation.” ImpaxLabs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366,1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). Seealso MPEP § 2122.

2121.01 Use of Prior Art in Rejections WhereOperability is in Question [R-08.2012]

“In determining that quantum of prior art disclosurewhich is necessary to declare an applicant’sinvention ‘not novel’ or ‘anticipated’ within section102, the stated test is whether a reference containsan ‘enabling disclosure’... .” In re Hoeksema, 399F.2d 269, 158 USPQ 596 (CCPA 1968). Thedisclosure in an assertedly anticipating referencemust provide an enabling disclosure of the desiredsubject matter; mere naming or description of thesubject matter is insufficient, if it cannot be producedwithout undue experimentation. Elan Pharm., Inc.v. Mayo Found. For Med. Educ. & Research, 346F.3d 1051, 1054, 68 USPQ2d 1373, 1376 (Fed. Cir.2003) (At issue was whether a prior art referenceenabled one of ordinary skill in the art to produceElan’s claimed transgenic mouse without undueexperimentation. Without a disclosure enabling oneskilled in the art to produce a transgenic mousewithout undue experimentation, the reference wouldnot be applicable as prior art.). A reference containsan “enabling disclosure” if the public was inpossession of the claimed invention before the dateof invention. “Such possession is effected if one ofordinary skill in the art could have combined thepublication’s description of the invention with his

[or her] own knowledge to make the claimedinvention.” In re Donohue, 766 F.2d 531, 226 USPQ619 (Fed. Cir. 1985).

I. 35 U.S.C. 102 REJECTIONS AND ADDITION OFEVIDENCE SHOWING REFERENCE ISOPERABLE

It is possible to make a 35 U.S.C. 102 rejection evenif the reference does not itself teach one of ordinaryskill how to practice the invention, i.e., how to makeor use the article disclosed. If the reference teachesevery claimed element of the article, secondaryevidence, such as other patents or publications, canbe cited to show public possession of the method ofmaking and/or using. In re Donohue, 766 F.2d at533, 226 USPQ at 621. See MPEP § 2131.01 formore information on 35 U.S.C. 102 rejections usingsecondary references to show that the primaryreference contains an “enabling disclosure.”

II. 35 U.S.C. 103 REJECTIONS AND USE OFINOPERATIVE PRIOR ART

“Even if a reference discloses an inoperative device,it is prior art for all that it teaches.” BeckmanInstruments v. LKB Produkter AB, 892 F.2d 1547,1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989).Therefore, “a non-enabling reference may qualifyas prior art for the purpose of determiningobviousness under 35 U.S.C. 103.” Symbol Techs.Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19USPQ2d 1241, 1247 (Fed. Cir. 1991).

2121.02 Compounds and Compositions —What Constitutes Enabling Prior Art[R-08.2017]

[Editor Note: This MPEP section is applicable toapplications subject to the first inventor to file(FITF) provisions of the AIA except that the relevantdate is the "effective filing date" of the claimedinvention instead of the "time of the invention" or"date of invention," which are only applicable toapplications subject to pre-AIA 35 U.S.C. 102. See35 U.S.C. 100 (note) and MPEP § 2150 et seq.]

2100-126Rev. 08.2017, January 2018


I. ONE OF ORDINARY SKILL IN THE ART MUSTBE ABLE TO MAKE OR SYNTHESIZE

Where a process for making the compound is notdeveloped until after the date of invention, the merenaming of a compound in a reference, without more,cannot constitute a description of the compound. Inre Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA1968). Note, however, that a reference is presumedoperable until applicant provides facts rebutting thepresumption of operability. In re Sasse, 629 F.2d675, 207 USPQ 107 (CCPA 1980). Therefore,applicant must provide evidence showing that aprocess for making was not known at the time of theinvention. See the following subsection for theevidentiary standard to be applied.

II. A REFERENCE DOES NOT CONTAIN AN“ENABLING DISCLOSURE” IF ATTEMPTS ATMAKING THE COMPOUND OR COMPOSITIONWERE UNSUCCESSFUL BEFORE THE DATE OFINVENTION

When a prior art reference merely discloses thestructure of the claimed compound, evidenceshowing that attempts to prepare that compoundwere unsuccessful before the date of invention willbe adequate to show inoperability. In re Wiggins,488 F.2d 538, 179 USPQ 421 (CCPA 1973).However, the fact that an author of a publication didnot attempt to make the compound disclosed, withoutmore, will not overcome a rejection based on thatpublication. In re Donohue, 766 F.2d 531, 226USPQ 619 (Fed. Cir. 1985) (In this case, theexaminer had made a rejection underpre-AIA 35 U.S.C. 102(b) over a publication, whichdisclosed the claimed compound, in combinationwith two patents teaching a general process ofmaking the particular class of compounds. Theapplicant submitted an affidavit stating that theauthors of the publication had not actuallysynthesized the compound. The court held that thefact that the publication’s author did not synthesizethe disclosed compound was immaterial to thequestion of reference operability. The patents wereevidence that synthesis methods were well known.The court distinguished Wiggins, in which a verysimilar rejection was reversed. In Wiggins, attemptsto make the compounds using the prior art methodswere all unsuccessful.). Compare In re Hoeksema,399 F.2d 269, 158 USPQ 596 (CCPA 1968) (A claim

to a compound was rejected over a patent to DeBoer which disclosed compounds similar in structureto those claimed (obvious homologs) and a processof making these compounds. Applicant respondedwith an affidavit by an expert named Wiley whichstated that there was no indication in the De Boerpatent that the process disclosed in De Boer couldbe used to produce the claimed compound and thathe did not believe that the process disclosed in DeBoer could be adapted to the production of theclaimed compound. The court held that the factsstated in this affidavit were legally sufficient toovercome the rejection and that applicant need notshow that all known processes are incapable ofproducing the claimed compound for this showingwould be practically impossible.).

2121.03 Plant Genetics — What ConstitutesEnabling Prior Art [R-08.2012]

THOSE OF ORDINARY SKILL MUST BE ABLETO GROW AND CULTIVATE THE PLANT

When the claims are drawn to plants, the reference,combined with knowledge in the prior art, mustenable one of ordinary skill in the art to reproducethe plant. In re LeGrice, 301 F.2d 929, 133 USPQ365 (CCPA 1962) (National Rose Society Annualof England and various other catalogues showedcolor pictures of the claimed roses and disclosed thatapplicant had raised the roses. The publications werepublished more than 1 year before applicant's filingdate. The court held that the publications did notplace the rose in the public domain. Information onthe grafting process required to reproduce the rosewas not included in the publications and suchinformation was necessary for those of ordinary skillin the art (plant breeders) to reproduce the rose.).Compare Ex parte Thomson, 24 USPQ2d 1618 (Bd.Pat. App. & Inter. 1992) (Seeds were commerciallyavailable more than 1 year prior to applicant’s filingdate. One of ordinary skill in the art could grow theclaimed cotton cultivar from the commerciallyavailable seeds. Thus, the publications describingthe cotton cultivar had “enabled disclosures.” TheBoard distinguished In re LeGrice by finding thatthe catalogue picture of the rose of In re LeGricewas the only evidence in that case. There was noevidence of commercial availability in enabling formsince the asexually reproduced rose could not be

Rev. 08.2017, January 20182100-127


reproduced from seed. Therefore, the public wouldnot have possession of the rose by its picture alone,but the public would have possession of the cottoncultivar based on the publications and the availabilityof the seeds.). In In re Elsner, 381 F.3d 1125, 1126,72 USPQ2d 1038, 1040 (Fed. Cir. 2004), prior tothe critical date of a plant patent application, theplant had been sold in Germany and a foreign PlantBreeder’s Rights (PBR) application for the sameplant had been published in the Community PlantVariety Office Official Gazette. The court held thatwhen (i) a publication identifies claimed the plant,(ii) a foreign sale occurs that puts one of ordinaryskill in the art in possession of the plant itself, and(iii) such possession permits asexual reproductionof the plant without undue experimentation to oneof ordinary skill in the art, then that combination offacts and events directly conveys the essentialknowledge of the invention and constitutes apre-AIA 35 U.S.C. 102(b) statutory bar. Id. at 1129,72 USPQ2d at 1041. Although the court agreed withthe Board that foreign sales may enable an otherwisenon-enabling printed publication, the case wasremanded for additional fact-finding in order todetermine if the foreign sales of the plant wereknown to be accessible to the skilled artisan and ifthe skilled artisan could have reproduced the plantasexually after obtaining it without undueexperimentation. Id. at 1131, 72 USPQ2d at 1043.

2121.04 Apparatus and Articles — WhatConstitutes Enabling Prior Art [R-08.2012]

PICTURES MAY CONSTITUTE AN “ENABLINGDISCLOSURE”

Pictures and drawings may be sufficiently enablingto put the public in the possession of the articlepictured. Therefore, such an enabling picture maybe used to reject claims to the article. However, thepicture must show all the claimed structural featuresand how they are put together. Jockmus v. Leviton,28 F.2d 812 (2d Cir. 1928). See also MPEP § 2125for a discussion of drawings as prior art.

2122 Discussion of Utility in the Prior Art[R-08.2017]

UTILITY NEED NOT BE DISCLOSED INREFERENCE

In order to constitute anticipatory prior art, areference must identically disclose the claimedcompound, but no utility need be disclosed by thereference. In re Schoenwald, 964 F.2d 1122, 1124,22 USPQ2d 1671, 1673 (Fed. Cir. 1992) (Theapplication claimed compounds used in ophthalmiccompositions to treat dry eye syndrome. Theexaminer found a printed publication whichdisclosed the claimed compound but did not disclosea use for the compound. The court found that theclaim was anticipated since the compound and aprocess of making it was taught by the reference.The court explained that “no utility need be disclosedfor a reference to be anticipatory of a claim to an oldcompound.” It is enough that the claimed compoundis taught by the reference.). See also Impax Labs.Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383,81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (“[P]roofof efficacy is not required for a prior art referenceto be enabling for purposes of anticipation.”).

2123 Rejection Over Prior Art’s BroadDisclosure Instead of Preferred Embodiments[R-08.2012]

I. PATENTS ARE RELEVANT AS PRIOR ARTFOR ALL THEY CONTAIN

“The use of patents as references is not limited towhat the patentees describe as their own inventionsor to the problems with which they are concerned.They are part of the literature of the art, relevant forall they contain.” In re Heck, 699 F.2d 1331,1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)(quoting In re Lemelson, 397 F.2d 1006, 1009, 158USPQ 275, 277 (CCPA 1968)).

A reference may be relied upon for all that it wouldhave reasonably suggested to one having ordinaryskill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493U.S. 975 (1989). See also Upsher-Smith Labs. v.Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d

2100-128Rev. 08.2017, January 2018


1213, 1215 (Fed. Cir. 2005) (reference disclosingoptional inclusion of a particular component teachescompositions that both do and do not contain thatcomponent); Celeritas Technologies Ltd. v.Rockwell International Corp., 150 F.3d 1354, 1361,47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (Thecourt held that the prior art anticipated the claimseven though it taught away from the claimedinvention. “The fact that a modem with a singlecarrier data signal is shown to be less than optimaldoes not vitiate the fact that it is disclosed.”).

See also MPEP § 2131.05 and § 2145, subsectionX.D., which discuss prior art that teaches away fromthe claimed invention in the context of anticipationand obviousness, respectively.

II. NONPREFERRED AND ALTERNATIVEEMBODIMENTS CONSTITUTE PRIOR ART

Disclosed examples and preferred embodiments donot constitute a teaching away from a broaderdisclosure or nonpreferred embodiments. In re Susi,440 F.2d 442, 169 USPQ 423 (CCPA 1971). “Aknown or obvious composition does not becomepatentable simply because it has been described assomewhat inferior to some other product for thesame use.” In re Gurley, 27 F.3d 551, 554, 31USPQ2d 1130, 1132 (Fed. Cir. 1994) (The inventionwas directed to an epoxy impregnatedfiber-reinforced printed circuit material. The appliedprior art reference taught a printed circuit materialsimilar to that of the claims but impregnated withpolyester-imide resin instead of epoxy. Thereference, however, disclosed that epoxy was knownfor this use, but that epoxy impregnated circuitboards have “relatively acceptable dimensionalstability” and “some degree of flexibility,” but areinferior to circuit boards impregnated withpolyester-imide resins. The court upheld the rejectionconcluding that applicant’s argument that thereference teaches away from using epoxy wasinsufficient to overcome the rejection since “Gurleyasserted no discovery beyond what was known inthe art.” Id. at 554, 31 USPQ2d at 1132.).Furthermore, “[t]he prior art’s mere disclosure ofmore than one alternative does not constitute ateaching away from any of these alternatives becausesuch disclosure does not criticize, discredit, orotherwise discourage the solution claimed….” In

re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141,1146 (Fed. Cir. 2004).

2124 Exception to the Rule That the CriticalReference Date Must Precede the Filing Date[R-11.2013]

IN SOME CIRCUMSTANCES A FACTUALREFERENCE NEED NOT ANTEDATE THE FILINGDATE

In certain circumstances, references cited to show auniversal fact need not be available as prior artbefore applicant’s filing date. In re Wilson, 311 F.2d266, 135 USPQ 442 (CCPA 1962). Such factsinclude the characteristics and properties of amaterial or a scientific truism. Some specificexamples in which later publications showing factualevidence can be cited include situations where thefacts shown in the reference are evidence “that, asof an application’s filing date, undue experimentationwould have been required, In re Corneil, 347 F.2d563, 568, 145 USPQ 702, 705 (CCPA 1965), or thata parameter absent from the claims was or was notcritical, In re Rainer, 305 F.2d 505, 507 n.3, 134USPQ 343, 345 n.3 (CCPA 1962), or that a statementin the specification was inaccurate, In re Marzocchi,439 F.2d 220, 223 n.4, 169 USPQ 367, 370 n.4(CCPA 1971), or that the invention was inoperativeor lacked utility, In re Langer, 503 F.2d 1380, 1391,183 USPQ 288, 297 (CCPA 1974), or that a claimwas indefinite, In re Glass, 492 F.2d 1228,1232 n.6,181 USPQ 31, 34 n.6 (CCPA 1974), or thatcharacteristics of prior art products were known, Inre Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA1962).” In re Koller, 613 F.2d 819, 823 n.5,204 USPQ 702, 706 n.5 (CCPA 1980) (quoting Inre Hogan, 559 F.2d 595, 605 n.17, 194 USPQ 527,537 n.17 (CCPA 1977) (emphasis in original)).However, it is impermissible to use a later factualreference to determine whether the application isenabled or described as required under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Koller, 613 F.2d 819, 823 n. 5, 204 USPQ702, 706 n.5 (CCPA 1980). References which donot qualify as prior art because they postdate theclaimed invention may be relied upon to show thelevel of ordinary skill in the art at or around the timethe invention was made. Ex parte Erlich, 22 USPQ1463 (Bd. Pat. App. & Inter. 1992).

Rev. 08.2017, January 20182100-129


2124.01 Tax Strategies Deemed Within thePrior Art [R-08.2012]


I. OVERVIEW

The Leahy-Smith America Invents Act (AIA), PublicLaw 112-29, sec. 14, 125 Stat. 284 (September 16,2011) provides that for purposes of evaluating aninvention for novelty and nonobviousness under 35U.S.C. 102 and 35 U.S.C. 103, any strategy forreducing, avoiding, or deferring tax liability(hereinafter "tax strategy"), whether known orunknown at the time of the invention or applicationfor patent, shall be deemed insufficient todifferentiate a claimed invention from the prior art.As a result, applicants will no longer be able to relyon the novelty or non-obviousness of a tax strategyembodied in their claims to distinguish them fromthe prior art. Any tax strategy will be consideredindistinguishable from all other publicly availableinformation that is relevant to a patent’s claim oforiginality. This provision aims to keep the abilityto interpret the tax law and to implement suchinterpretation in the public domain, available to alltaxpayers and their advisors.

The term "tax liability" is defined for purposes ofthis provision as referring to any liability for a taxunder any federal, state, or local law, or the law ofany foreign jurisdiction, including any statute, rule,regulation, or ordinance that levies, imposes, orassesses such tax liability.

There are two exclusions to this provision. The firstis that the provision does not apply to that part of aninvention that is a method, apparatus, technology,computer program product, or system, that is usedsolely for preparing a tax or information return orother tax filing, including one that records, transmits,transfers, or organizes data related to such filing.

The second is that the provision does not apply tothat part of an invention that is a method, apparatus,technology, computer program product, or system,that is used solely for financial management, to theextent that it is severable from any tax strategy ordoes not limit the use of any tax strategy by anytaxpayer or tax advisor.

This provision took effect on September 16, 2011,and applies to any patent application that is pendingon, or filed on or after, September 16, 2011, and toany patent issued on or after September 16, 2011.Accordingly, this provision will apply in areexamination or other post-grant proceeding onlyto patents issued on or after September 16, 2011.

II. EXAMINATION GUIDANCE FOR CLAIMSRELATING TO TAX STRATEGIES

The following procedure should be followed whenexamining claims relating to tax strategies.

1. Construe the claim in accordance with MPEP§ 2111 et seq.

2. Analyze the claim for compliance with 35U.S.C. 101 and 112 in accordance with currentguidance, which is unaffected by this provision.

3. Identify any limitations relating to a taxstrategy, as defined above (note the listedexclusions).

a. Inventions that fall within the scope ofAIA section 14 include those tax strategies especiallysuitable for use with tax-favored structures that mustmeet certain requirements, such as employee benefitplans, tax-exempt organizations, or other entitiesthat must be structured or operated in a particularmanner to obtain certain tax consequences.

b. Thus, AIA section 14 applies if the effectof an invention is to aid in satisfying the qualificationrequirements for a desired tax-favored entity status,to take advantage of the specific tax benefits offeredin a tax-favored structure, or to allow for taxreduction, avoidance, or deferral not otherwiseautomatically available in such entity or structure.

4. Evaluate the claim in view of the prior artunder 35 U.S.C. 102 and 103, treating any limitationsrelating to a tax strategy as being within the priorart, and not as a patentable difference between theclaim and the prior art. This approach is analogous

2100-130Rev. 08.2017, January 2018


to the treatment of printed matter limitations in aclaim as discussed at MPEP § 2112.01, subsectionIII.

Form paragraph 7.06 may be used to indicate claimlimitation(s) interpreted as a tax strategy. See MPEP§ 706.02(m).

III. EXAMPLES DIRECTED TOCOMPUTER-IMPLEMENTED METHODS

A computer-implemented method that is deemednovel and non-obvious would not be affected by thisprovision even if used for a tax purpose. Forexample, a novel and non-obviouscomputer-implemented method for manipulatingdata would not be affected by this provision even ifthe method organized data for a future tax filing.However, a prior art computer-implemented methodwould not become non-obvious by implementing anovel and non-obvious tax strategy. That is, thepresence of limitations relating to the tax strategywould not cause a claim that is otherwise within theprior art to become novel or non-obvious over theprior art.

Thus, for purposes of applying art to asoftware-related invention under 35 U.S.C. 102 and35 U.S.C. 103, claim limitations that are directedsolely to enabling individuals to file their incometax returns or assisting them with managing theirfinances should be given patentable weight, exceptthat claim limitations directed to a tax strategyshould not be given patentable weight.

2125 Drawings as Prior Art [R-08.2012]

I. DRAWINGS CAN BE USED AS PRIOR ART

Drawings and pictures can anticipate claims if theyclearly show the structure which is claimed. In reMraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972).However, the picture must show all the claimedstructural features and how they are put together. Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928). Theorigin of the drawing is immaterial. For instance,drawings in a design patent can anticipate or makeobvious the claimed invention as can drawings inutility patents. When the reference is a utility patent,it does not matter that the feature shown is

unintended or unexplained in the specification. Thedrawings must be evaluated for what they reasonablydisclose and suggest to one of ordinary skill in theart. In re Aslanian, 590 F.2d 911, 200 USPQ 500(CCPA 1979). See MPEP § 2121.04 for moreinformation on prior art drawings as “enableddisclosures.”

II. PROPORTIONS OF FEATURES IN ADRAWING ARE NOT EVIDENCE OF ACTUALPROPORTIONS WHEN DRAWINGS ARE NOT TOSCALE

When the reference does not disclose that thedrawings are to scale and is silent as to dimensions,arguments based on measurement of the drawingfeatures are of l i t t le value. See Hockerson-Halberstadt, Inc. v. Avia Group Int’l,222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed.Cir. 2000) (The disclosure gave no indication thatthe drawings were drawn to scale. “[I]t is wellestablished that patent drawings do not define theprecise proportions of the elements and may not berelied on to show particular sizes if the specificationis completely silent on the issue.”). However, thedescription of the article pictured can be relied on,in combination with the drawings, for what theywould reasonably teach one of ordinary skill in theart. In re Wright, 569 F.2d 1124, 193 USPQ 332(CCPA 1977) (“We disagree with the Solicitor’sconclusion, reached by a comparison of the relativedimensions of appellant’s and Bauer’s drawingfigures, that Bauer ‘clearly points to the use of achime length of roughly 1/2 to 1 inch for a whiskeybarrel.’ This ignores the fact that Bauer does notdisclose that his drawings are to scale. ... However,we agree with the Solicitor that Bauer’s teachingthat whiskey losses are influenced by the distancethe liquor needs to ‘traverse the pores of the wood’(albeit in reference to the thickness of thebarrelhead)” would have suggested the desirabilityof an increased chime length to one of ordinary skillin the art bent on further reducing whiskey losses.”569 F.2d at 1127, 193 USPQ at 335-36.)

2126 Availability of a Document as a“Patent” for Purposes of Rejection Under 35

Rev. 08.2017, January 20182100-131


U.S.C. 102(a) or Pre-AIA 35 U.S.C. 102(a),(b), and (d) [R-08.2017]

I. THE NAME “PATENT” ALONE DOES NOTMAKE A DOCUMENT AVAILABLE AS A PRIORART PATENT UNDER 35 U.S.C. 102(a) or Pre-AIA35 U.S.C. 102(a) OR (b)

What a foreign country designates to be a patent maynot be a patent for purposes of rejection under 35U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) and (b);it is the substance of the rights conferred and theway information within the “patent” is controlledthat is determinative. In re Ekenstam, 256 F.2d 321,118 USPQ 349 (CCPA 1958). See the nextsubsection for further explanation with respect towhen a document can be applied in a rejection as a“patent.” See MPEP § 2135.01 for a furtherdiscussion of the use of “patents” in pre-AIA 35U.S.C. 102(d) rejections.

II. A SECRET PATENT IS NOT AVAILABLE ASA REFERENCE UNDER 35 U.S.C. 102(a) or Pre-AIA35 U.S.C. 102(a) or (b) UNTIL IT IS AVAILABLETO THE PUBLIC BUT IT MAY BE AVAILABLEUNDER Pre-AIA 35 U.S.C. 102(d) AS OF GRANTDATE

Secret patents are defined as patents which areinsufficiently accessible to the public to constitute“printed publications.” Decisions on the issue ofwhat is sufficiently accessible to be a “printedpublication” are located in MPEP § 2128 - MPEP §2128.01.

Even if a patent grants an exclusionary right (isenforceable), it is not available as prior art under 35U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) or (b) ifit is secret or private. In re Carlson, 983 F.2d 1032,1037, 25 USPQ2d 1207, 1211 (Fed. Cir. 1992). Thedocument must be at least minimally available tothe public to constitute prior art. The patent issufficiently available to the public for the purposesof 35 U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) or(b) if it is laid open for public inspection ordisseminated in printed form. See, e.g., In reCarlson, 983 F.2d at 1037, 25 USPQ2d at 1211 (“Werecognize that Geschmacksmuster on display forpublic view in remote cities in a far-away land maycreate a burden of discovery for one without thetime, desire, or resources to journey there in person

or by agent to observe that which was registeredunder German law. Such a burden, however, is bylaw imposed upon the hypothetical person ofordinary skill in the art who is charged withknowledge of all contents of the relevant prior art.”).The date that the patent is made available to thepublic is the date it is available as a 35 U.S.C. 102(a)or pre-AIA 35 U.S.C. 102(a) or (b) reference. In reEkenstam, 256 F.2d 321, 118 USPQ 349 (CCPA1958). But a period of secrecy after granting thepatent has been held to have no effect in connectionwith pre-AIA 35 U.S.C. 102(d). These patents areusable in rejections under pre-AIA 35 U.S.C. 102(d)as of the date patent rights are granted. In reKathawala, 9 F.3d 942, 946, 28 USPQ2d 1785,1788-89 (Fed. Cir. 1993). See MPEP § 2135 - MPEP§ 2135.01 for more information on pre-AIA35 U.S.C. 102(d).

2126.01 Date of Availability of a Patent as aReference [R-11.2013]

DATE FOREIGN PATENT IS EFFECTIVE AS AREFERENCE IS USUALLY THE DATE PATENTRIGHTS ARE FORMALLY AWARDED TO ITSAPPLICANT

The date the patent is available as a reference isgenerally the date that the patent becomesenforceable. This date is the date the sovereignformally bestows patents rights to the applicant. Inre Monks, 588 F.2d 308, 200 USPQ 129 (CCPA1978). There is an exception to this rule when thepatent is secret as of the date the rights are awarded. In re Ekenstam, 256 F.2d 321, 118 USPQ 349(CCPA 1958).

Note that MPEP § 901.05 summarizes in tabularform dates of patenting for many foreign patents.For a list of cases that discuss the date of patentingcountries for purposes of pre-AIA 35 U.S.C. 102 inparticular, see Chisum, Patents § 3.06[4] n.2.

2126.02 Scope of Reference’s DisclosureWhich Can Be Used to Reject Claims When

2100-132Rev. 08.2017, January 2018


the Reference Is a “Patent” but Not a“Publication” [R-11.2013]

OFTEN UNCLAIMED DETAILS FOUND IN THEPATENT SPECIFICATION CAN BE RELIED ONEVEN IF PATENT IS SECRET

When the patented document is used as a patent andnot as a publication, the examiner is not restrictedto the information conveyed by the patent claimsbut may use any information provided in thespecification which relates to the subject matter ofthe patented claims when making a rejection under35 U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a), (b)or (d). Ex parte Ovist, 152 USPQ 709, 710 (Bd.App. 1963) (The claim of an Italian patent wasgeneric and thus embraced the species disclosed inthe examples, the Board added that the entirespecification was germane to the claimed inventionand upheld the examiner’s pre-AIA 35 U.S.C. 102(b)rejection.); In re Kathawala, 9 F.3d 942, 28USPQ2d 1785 (Fed. Cir. 1993) (The claims at issuewhere rejected under pre-AIA 35 U.S.C. 102(d) byapplicant’s own parent applications in Greece andSpain. The applicant argued that the “invention ...patented in Spain was not the same ‘invention’claimed in the U.S. application because the Spanishpatent claimed processes for making [compoundsfor inhibition of cholesterol biosynthesis] and claims1 and 2 were directed to the compounds themselves.” Id. at 944, 28 USPQ2d at 1786. The Federal Circuitheld that “when an applicant files a foreignapplication fully disclosing his invention and havingthe potential to claim his invention in a number ofways, the reference in section 102(d) to ‘invention... patented’ necessarily includes all disclosed aspectsof the invention.” Id. at 945-46, 28 USPQ2d at1789.).

Note that In re Fuge, 272 F.2d 954, 957, 124 USPQ105, 107 (CCPA 1959), does not conflict with theabove decisions. This decision simply states “that,at the least, the scope of the patent embraceseverything included in the [claim].” (emphasisadded).

The courts have interpreted the phrase “invention ...patented” in pre-AIA 35 U.S.C. 102(a), (b), and (d)the same way and have cited decisions withoutregard to which of these subsections of pre-AIA 35

U.S.C. 102 was at issue in the particular case at hand.Therefore, it does not seem to matter to whichsubsection of pre-AIA 35 U.S.C. 102 the cases aredirected; the court decisions are interchangeable asto this issue.

2127 Domestic and Foreign PatentApplications as Prior Art [R-07.2015]

I. ABANDONED APPLICATIONS, INCLUDINGPROVISIONAL APPLICATIONS

Abandoned Applications Disclosed to the Public CanBe Used as Prior Art

“An abandoned patent application may becomeevidence of prior art only when it has beenappropriately disclosed, as, for example, when theabandoned patent [application] is reference[d] in thedisclosure of another patent, in a publication, or byvoluntary disclosure under [former DefensivePublication rule] 37 CFR 1.139 [Reserved].” LeePharmaceutical v. Kreps, 577 F.2d 610, 613, 198USPQ 601, 605 (9th Cir. 1978). An abandonedpatent application becomes available as prior artonly as of the date the public gains access to it. See37 CFR 1.14(a)(1)(ii) and (iv). However, the subjectmatter of an abandoned application, including bothprovisional and nonprovisional applications, referredto in a prior art U.S. patent or U.S. patent applicationpublication may be relied on in a 35 U.S.C. 102(a)(2)or pre-AIA 35 U.S.C. 102(e) rejection based on thatpatent or patent application publication if thedisclosure of the abandoned application is actuallyincluded or incorporated by reference in the patent.Compare In re Lund, 376 F.2d 982, 991, 153 USPQ625, 633 (CCPA 1967) (The court reversed arejection over a patent which was acontinuation-in-part of an abandoned application.Applicant’s filing date preceded the issue date of thepatent reference. The abandoned applicationcontained subject matter which was essential to therejection but which was not carried over into thecontinuation-in-part. The court held that the subjectmatter of the abandoned application was notavailable to the public as of either the parent’s or thechild’s filing dates and thus could not be relied onin the pre-AIA 35 U.S.C. 102(e) rejection.). See alsoMPEP § 901.02. See MPEP § 2136.02 and MPEP§ 2136.03 for the 35 U.S.C. 102(e) date of a U.S.

Rev. 08.2017, January 20182100-133


patent claiming priority under 35 U.S.C. 119 or 35U.S.C. 120. See MPEP § 2154 for prior art under 35U.S.C. 102(a)(2).

II. APPLICATIONS WHICH HAVE ISSUED ASPATENTS

A. A 35 U.S.C. 102(a)(2) or Pre-AIA 35 U.S.C. 102(e)Rejection Cannot Rely on Matter Which Was Canceledfrom the Application and Thus Did Not Get Publishedin the Issued Patent

Canceled matter in the application file of a U.S.patent cannot be relied upon in a rejection under 35U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 102(e). ExParte Stalego, 154 USPQ 52, 53 (Bd. App. 1966).The canceled matter only becomes available as priorart as of the date the application issues into a patentsince this is the date the application file historybecomes available to the public. In re Lund, 376F.2d 982, 153 USPQ 625 (CCPA 1967). However,as discussed below, such matter may be available asprior art under 35 U.S.C. 102(a)(1) or pre-AIA 35U.S.C. 102(b). For more information on availableprior art for use in pre-AIA 35 U.S.C. 102(e)rejections see MPEP § 2136.02. For moreinformation on available prior art for use in 35U.S.C. 102(a)(2) rejections see MPEP § 2154 et seq.

B. A 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(b)Rejection Over a Published Application May Rely onInformation that Was Canceled Prior to Publication

Figures that had been canceled from a Canadianpatent application before issuance of the patent wereavailable as prior art under pre-AIA 35 U.S.C. 102(b)as of the date the application became publiclyaccessible. The patent at issue and its underlyingapplication were available for public inspection atthe Canadian Patent Office more than one yearbefore the effective filing date of the patents in suit. Bruckelmyer v. Ground Heaters, Inc., 445 F.3d1374, 78 USPQ2d 1684 (Fed. Cir. 2006).

III. FOREIGN APPLICATIONS OPEN FORPUBLIC INSPECTION (LAID OPENAPPLICATIONS)

Laid Open Applications May Constitute “Published”Documents

When the specification is not issued in printed formbut is announced in an official journal and anyonecan inspect or obtain copies, it is sufficientlyaccessible to the public to constitute a “publication”within the meaning of 35 U.S.C. 102(a)(1) orpre-AIA 35 U.S.C. 102(a) and (b). See In re Wyer,655 F.2d 221, 210 USPQ 790 (CCPA 1981).

Older cases have held that laid open patentapplications are not “published” and cannotconstitute prior art. Ex parte Haller, 103 USPQ 332(Bd. App. 1953). However, whether or not adocument is “published” for the purposes of 35U.S.C. 102 and 35 U.S.C. 103 depends on howaccessible the document is to the public. Astechnology has made reproduction of documentseasier, the accessibility of the laid open applicationshas increased. Items provided in easily reproducibleform have thus become “printed publications” as thephrase is used in 35 U.S.C. 102. In re Wyer, 655F.2d 221, 226, 210 USPQ 790, 794 (CCPA 1981)(Laid open Australian patent application held to bea “printed publication” even though only the abstractwas published because it was laid open for publicinspection, microfilmed, “diazo copies” weredistributed to five suboffices having suitablereproduction equipment and the diazo copies wereavailable for sale.). The contents of a foreign patentapplication should not be relied upon as prior artuntil the date of publication (i.e., the insertion intothe laid open application) can be confirmed by anexaminer’s review of a copy of the document. SeeMPEP § 901.05.

IV. PENDING U.S. APPLICATIONS

As specified in 37 CFR 1.14(a), all pending U.S.applications are preserved in confidence except forpublished applications (see also 35 U.S.C. 122(b)),reissue applications, and applications in which arequest to open the complete application toinspection by the public has been granted by theOffice (37 CFR 1.11(b)). However, if an application

2100-134Rev. 08.2017, January 2018


that has not been published has an assignee orinventor in common with the application beingexamined, a rejection will be proper in somecircumstances. For instance, when the claimsbetween the two applications are not independent ordistinct, a provisional double patenting rejection ismade. See MPEP § 804. If the copendingapplications differ by at least one inventor and atleast one of the applications would have beenobvious in view of the other, a provisional rejectionover 35 U.S.C. 102(a)(2) or 35 U.S.C. 102(e) or 35U.S.C. 103 is made when appropriate. See MPEP §706.02(f)(2), § 706.02(k), § 706.02(l)(1), §706.02(l)(3) and § 2154.

See MPEP § 706.02(a), § 804 , § 2136 et seq. and§ 2154 for information pertaining to rejectionsrelying on U.S. application publications.

2128 “Printed Publications” as Prior Art[R-08.2017]

I. A REFERENCE IS A “PRINTED PUBLICATION”IF IT IS ACCESSIBLE TO THE PUBLIC

A reference is proven to be a “printed publication”“upon a satisfactory showing that such documenthas been disseminated or otherwise made availableto the extent that persons interested and ordinarilyskilled in the subject matter or art, exercisingreasonable diligence, can locate it.” In re Wyer, 655F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp.738, 743, 148 USPQ 537, 540 (SDNY 1966)) (“Weagree that ‘printed publication’ should be approachedas a unitary concept. The traditional dichotomybetween ‘printed’ and ‘publication’ is no longervalid. Given the state of technology in documentduplication, data storage, and data retrieval systems,the ‘probability of dissemination’ of an item veryoften has little to do with whether or not it is‘printed’ in the sense of that word when it wasintroduced into the patent statutes in 1836. In anyevent, interpretation of the words ‘printed’ and‘publication’ to mean ‘probability of dissemination’and ‘public accessibility’ respectively, now seemsto render their use in the phrase ‘printed publication’somewhat redundant.”) In re Wyer, 655 F.2d at 226,210 USPQ at 794.

See also Carella v. Starlight Archery, 804 F.2d 135,231 USPQ 644 (Fed. Cir. 1986) (Starlight Archeryargued that Carella’s patent claims to an archerysight were anticipated under pre-AIA 35 U.S.C.102(a) by an advertisement in a Wisconsin BowHunter Association (WBHA) magazine and aWBHA mailer prepared prior to Carella’s filing date.However, there was no evidence as to when themailer was received by any of the addressees. Plus,the magazine had not been mailed until 10 days afterCarella’s filing date. The court held that since therewas no proof that either the advertisement or mailerwas accessible to any member of the public beforethe filing date there could be no rejection underpre-AIA 35 U.S.C. 102(a).).

II. ELECTRONIC PUBLICATIONS AS PRIOR ART

A. Status as a “Printed Publication”

An electronic publication, including an onlinedatabase or Internet publication (e.g. discussiongroup, forum, digital video, and social media post),is considered to be a “printed publication” withinthe meaning of 35 U.S.C. 102(a)(1) and pre-AIA 35U.S.C. 102(a) and (b) provided the publication wasaccessible to persons concerned with the art to whichthe document relates. See In re Wyer, 655 F.2d 221,227, 210 USPQ 790, 795 (CCPA 1981)(“Accordingly, whether information is printed,handwritten, or on microfilm or a magnetic disc ortape, etc., the one who wishes to characterize theinformation, in whatever form it may be, as a‘printed publication’ ... should produce sufficientproof of its dissemination or that it has otherwisebeen available and accessible to persons concernedwith the art to which the document relates and thusmost likely to avail themselves of its contents.’”(citations omitted).). See also Amazon.com v.Barnesandnoble.com, 73 F. Supp. 2d 1228,53 USPQ2d 1115, 1119 (W.D. Wash. 1999) (Pagesfrom a website were relied on by defendants as ananticipatory reference (to no avail), however statusof the reference as prior art was not challenged.); Inre Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed.Cir. 1994) (Database printouts of abstracts whichwere not themselves prior art publications wereproperly relied as providing evidence that thesoftware products referenced therein were “firstinstalled” or “released” more than one year prior to

Rev. 08.2017, January 20182100-135


applicant’s filing date.); Suffolk Tech v. AOL andGoogle, 752 F.3d 1358, 110 USPQ2d 2034 (Fed.Cir. 2014) (A newsgroup posting constituted priorart as it was directed to those having ordinary skillin the art and was publicly accessible because thepost was sufficiently disseminated.)

The Office policy requiring recordation of the fieldof search and search results (see MPEP § 719.05)weighs in favor of finding that Internet and onlinedatabase references cited by the examiner are“accessible to persons concerned with the art towhich the document relates and thus most likely toavail themselves of its contents.” Wyer, 655 F.2dat 221, 210 USPQ at 790. Office copies of anelectronic document must be retained if the samedocument may not be available for retrieval in thefuture. This is especially important for sources suchas the Internet and online databases.

B. Date of Availability

Prior art disclosures on the Internet or on an onlinedatabase are considered to be publicly available asof the date the item was publicly posted. Absentevidence of the date that the disclosure was publiclyposted, if the publication itself does not include apublication date (or retrieval date), it cannot be reliedupon as prior art under 35 U.S.C. 102(a)(1) andpre-AIA 35 U.S.C. 102(a) or (b). However, it maybe relied upon to provide evidence regarding thestate of the art. Examiners may ask the Scientificand Technical Information Center to find the earliestdate of publication or posting. See MPEP §901.06(a), subsection IV.G.

C. Extent of Teachings Relied Upon

An electronic publication, like any publication, maybe relied upon for all that it would have reasonablysuggested to one having ordinary skill in the art. SeeMPEP § 2121.01 and § 2123. Note, however, thatif an electronic document which is the abstract of apatent or printed publication is relied upon in arejection under 35 U.S.C. 102 or 35 U.S.C. 103, onlythe text of the abstract (and not the underlyingdocument) may be relied upon to support therejection. In situations where the electronic versionand the published paper version of the same or acorresponding patent or printed publication differ

appreciably, each may need to be cited and reliedupon as independent references based on what theydisclose.

D. Internet Usage Policy

See MPEP § 904.02(c) for the portions of theInternet Usage Policy pertaining to Internet searchingand documenting search strategies. See MPEP§ 707.05 for the proper citation of electronicdocuments.

III. EXAMINER NEED NOT PROVE ANYONEACTUALLY LOOKED AT THE DOCUMENT

One need not prove someone actually looked at apublication when that publication is accessible tothe public through a library or patent office. See Inre Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA1981); In re Hall, 781 F.2d 897, 228 USPQ 453(Fed. Cir. 1986).

2128.01 Level of Public AccessibilityRequired [R-07.2015]

I. A THESIS PLACED IN A UNIVERSITYLIBRARY MAY BE PRIOR ART IF SUFFICIENTLYACCESSIBLE TO THE PUBLIC

A doctoral thesis indexed and shelved in a library issufficiently accessible to the public to constituteprior art as a “printed publication.” In re Hall, 781F.2d 897, 228 USPQ 453 (Fed. Cir. 1986). Even ifaccess to the library is restricted, a reference willconstitute a “printed publication” as long as apresumption is raised that the portion of the publicconcerned with the art would know of the invention. In re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA1978).

In In re Hall, general library cataloging and shelvingpractices showed that a doctoral thesis deposited inuniversity library would have been indexed,cataloged and shelved and thus available to thepublic before the critical date. Compare In reCronyn, 890 F.2d 1158, 13 USPQ2d 1070 (Fed. Cir.1989) wherein doctoral theses were shelved andindexed by index cards filed alphabetically bystudent name and kept in a shoe box in the chemistrylibrary. The index cards only listed the student name

2100-136Rev. 08.2017, January 2018


and title of the thesis. In Cronyn, the court held thatthe students’ theses were not accessible to the public.The court reasoned that the theses had not been eithercataloged or indexed in a meaningful way sincethesis could only be found if the researcher’s namewas known, but the name bears no relationship tothe subject of the thesis. Notably, a dissenting judge,in Cronyn, indicated that since the theses wereshelved in the library, it was enough to make themsufficiently accessible to the public. The nature ofthe index was not determinative. Thedissenting judge relied on prior Board decisions (Gulliksen v. Halberg, 75 USPQ 252, 257 (Bd. App.1937) and Ex parte Hershberger, 96 USPQ 54, 56(Bd. App. 1952)), which held that shelving a singlecopy in a public library makes the work a “printedpublication.” While these Board decisions have notbeen expressly overruled, they have been criticizedin other decisions. See In re Tenney, 254 F.2d 619,117 USPQ 348 (CCPA 1958) (concurring opinionby J.Rich) (A document, of which there is but onecopy, whether it be handwritten, typewritten or onmicrofilm, may be technically accessible to anyonewho can find it. Such a document is not “printed”in the sense that a printing press has been used toreproduce the document. If only technicalaccessibility were required “logic would require theinclusion within the term [printed] of all unprintedpublic documents for they are all ‘accessible.’ Whilesome tribunals have gone quite far in that direction,as in the ‘college thesis cases’ I feel they have doneso unjustifiably and on the wrong theory. Knowledgeis not in the possession of the public where therehas been no dissemination, as distinguished fromtechnical accessibility...” The real significance ofthe word “printed” is grounded in the “ probabilityof wide circulation.”). See also Deep Welding, Inc.v. Sciaky Bros., 417 F.2d 1227, 163 USPQ 144 (7thCir. 1969) (calling the holding of Ex parteHershberger “extreme”). Compare In re Bayer, 568F.2d 1357, 196 USPQ 670 (CCPA 1978) (Areference will constitute a “printed publication” aslong as a presumption is raised that the portion ofthe public concerned with the art would know of theinvention even if accessibility is restricted to onlythis part of the public. But accessibility to applicant’sthesis was restricted to only three members of agraduate committee. There can be no presumptionthat those concerned with the art would have knownof the invention in this case.).

II. ORALLY PRESENTED PAPER CANCONSTITUTE A “PRINTED PUBLICATION” IFWRITTEN COPIES ARE AVAILABLE WITHOUTRESTRICTION

A paper which is orally presented in a forum opento all interested persons constitutes a “printedpublication” if written copies are disseminatedwithout restriction. Massachusetts Institute ofTechnology v. AB Fortia, 774 F.2d 1104, 1109, 227USPQ 428, 432 (Fed. Cir. 1985) (Paper orallypresented to between 50 and 500 persons at ascientific meeting open to all persons interested inthe subject matter, with written copies distributedwithout restriction to all who requested, is a printedpublication. Six persons requested and obtainedcopies.). An oral presentation at a scientific meetingor a demonstration at a trade show may be prior artunder 35 U.S.C. 102(a)(1)’s provision: “otherwiseavailable to the public.” See MPEP § 2152.02(e).

III. INTERNAL DOCUMENTS INTENDED TO BECONFIDENTIAL ARE NOT “PRINTEDPUBLICATIONS”

Documents and items only distributed internallywithin an organization which are intended to remainconfidential are not “printed publications” no matterhow many copies are distributed. There must be anexisting policy of confidentiality or agreement toremain confidential within the organization. Mereintent to remain confidential is insufficient. In reGeorge, 2 USPQ2d 1880 (Bd. Pat. App. & Inter.1987) (Research reports disseminated in-house toonly those persons who understood the policy ofconfidentiality regarding such reports are not printedpublications even though the policy was notspecifically stated in writing.); Garret Corp. v.United States, 422 F.2d 874, 878, 164 USPQ 521,524 (Ct. Cl.1970) (“While distribution to governmentagencies and personnel alone may not constitutepublication ... distribution to commercial companieswithout restriction on use clearly does.”); NorthernTelecom Inc. v. Datapoint Corp., 908 F.2d 931, 15USPQ2d 1321 (Fed. Cir. 1990) (Four reports on theAESOP-B military computer system which were notunder security classification were distributed to aboutfifty organizations involved in the AESOP-B project.One document contained the legend “Reproductionor further dissemination is not authorized.” The otherdocuments were of the class that would contain this

Rev. 08.2017, January 20182100-137


legend. The documents were housed in MitreCorporation’s library. Access to this library wasrestricted to those involved in the AESOP-B project.The court held that public access was insufficient tomake the documents “printed publications.”).

IV. PUBLICLY DISPLAYED DOCUMENTS CANCONSTITUTE A “PRINTED PUBLICATION” EVENIF THE DURATION OF DISPLAY IS FOR ONLYA FEW DAYS AND THE DOCUMENTS ARE NOTDISSEMINATED BY COPIES OR INDEXED IN ALIBRARY OR DATABASE

A publicly displayed document where persons ofordinary skill in the art could see it and are notprecluded from copying it can constitute a “printedpublication,” even if it is not disseminated by thedistribution of reproductions or copies and/orindexed in a library or database. As stated in In reKlopfenstein, 380 F.3d 1345, 1348, 72 USPQ2d1117, 1119 (Fed. Cir. 2004), “the key inquiry iswhether or not a reference has been made ‘publiclyaccessible.’” Prior to the critical date, afourteen-slide presentation disclosing the inventionwas printed and pasted onto poster boards. Theprinted slide presentation was displayed with noconfidentiality restrictions for approximately threecumulative days at two different industry events. Id.at 1347, 72 USPQ2d at 1118. The court noted that“an entirely oral presentation at a scientificconference that includes neither slides nor copies ofthe presentation is without question not a 'printedpublication' for the purposes of [pre-AIA] 35 U.S.C.§ 102(b). Furthermore, a presentation that includesa transient display of slides is likewise notnecessarily a ‘printed publication.’” Id. at 1349 n.4,72 USPQ2d at 1120 n.4. In resolving whether or nota temporarily displayed reference that was neitherdistributed nor indexed was nonetheless madesufficiently publicly accessible to count as a “printedpublication” under pre-AIA 35 U.S.C. 102(b), thecourt considered the following factors: “the lengthof time the display was exhibited, the expertise ofthe target audience, the existence (or lack thereof)of reasonable expectations that the material displayedwould not be copied, and the simplicity or ease withwhich the material displayed could have beencopied.” Id. at 1350, 72 USPQ2d at 1120. Uponreviewing the above factors, the court concludedthat the display “was sufficiently publicly accessibleto count as a ‘printed publication.’” Id. at 1352, 72

USPQ2d at 1121. See also Diomed, Inc. v.Angiodynamics, 450 F.Supp.2d 130 (D. Mass.2006)(a video that accompanied oral presentationsin Austria, Belgium, France, and Italy was held nota printed publication).

Note that an oral presentation at a scientific meetingor a demonstration at a trade show may be prior artunder 35 U.S.C. 102(a)(1)’s provision: “otherwiseavailable to the public.” See MPEP § 2152.02(e).

2128.02 Date Publication Is Available as aReference [R-08.2012]

I. DATE OF ACCESSIBILITY CAN BE SHOWNTHROUGH EVIDENCE OF ROUTINE BUSINESSPRACTICES

Evidence showing routine business practices can beused to establish the date on which a publicationbecame accessible to the public. Specific evidenceshowing when the specific document actuallybecame available is not always necessary. Constantv. Advanced Micro-Devices, Inc., 848 F.2d 1560,7 USPQ2d 1057 (Fed. Cir.), cert. denied, 988 U.S.892 (1988) (Court held that evidence submitted byIntel regarding undated specification sheets showinghow the company usually treated suchspecification sheets was enough to show that thesheets were accessible by the public before thecritical date.); In re Hall, 781 F.2d 897, 228 USPQ453 (Fed. Cir. 1986) (Librarian’s affidavitestablishing normal time frame and practice forindexing, cataloging and shelving doctoral thesesestablished that the thesis in question would havebeen accessible by the public before the criticaldate.).

II. A JOURNAL ARTICLE OR OTHERPUBLICATION BECOMES AVAILABLE AS PRIORART ON DATE OF IT IS RECEIVED BY AMEMBER OF THE PUBLIC

A publication disseminated by mail is not prior artuntil it is received by at least one member of thepublic. Thus, a magazine or technical journal iseffective as of the date when first person receives it,not the date it was mailed or sent to the publisher. In re Schlittler, 234 F.2d 882, 110 USPQ 304(CCPA 1956).

2100-138Rev. 08.2017, January 2018


2129 Admissions as Prior Art [R-08.2012]

I. ADMISSIONS BY APPLICANT CONSTITUTEPRIOR ART

A statement by an applicant in the specification ormade during prosecution identifying the work ofanother as “prior art” is an admission which can berelied upon for both anticipation and obviousnessdeterminations, regardless of whether the admittedprior art would otherwise qualify as prior art underthe statutory categories of 35 U.S.C. 102. RiverwoodInt’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354,66 USPQ2d 1331, 1337 (Fed. Cir. 2003); Constantv. Advanced Micro-Devices Inc., 848 F.2d 1560,1570, 7 USPQ2d 1057, 1063 (Fed. Cir. 1988).However, even if labeled as “prior art,” the work ofthe same inventive entity may not be consideredprior art against the claims unless it falls under oneof the statutory categories. Id.; see also Reading &Bates Construction Co. v. Baker Energy ResourcesCorp., 748 F.2d 645, 650, 223 USPQ 1168, 1172(Fed. Cir. 1984) (“[W]here the inventor continuesto improve upon his own work product, hisfoundational work product should not, without astatutory basis, be treated as prior art solely becausehe admits knowledge of his own work. It is commonsense that an inventor, regardless of an admission,has knowledge of his own work.”).

Consequently, the examiner must determine whetherthe subject matter identified as “prior art” isapplicant’s own work, or the work of another. In theabsence of another credible explanation, examinersshould treat such subject matter as the work ofanother.

II. DISCUSSION OF PRIOR ART INSPECIFICATION

Where the specification identifies work done byanother as “prior art,” the subject matter so identifiedis treated as admitted prior art. In re Nomiya, 509F.2d 566, 571, 184 USPQ 607, 611 (CCPA 1975)(holding applicant’s labeling of two figures in theapplication drawings as “prior art” to be anadmission that what was pictured was prior artrelative to applicant’s improvement).

III. JEPSON CLAIMS

Drafting a claim in Jepson format (i.e., the formatdescribed in 37 CFR 1.75(e); see MPEP §608.01(m)) is taken as an implied admission that thesubject matter of the preamble is the prior art workof another. In re Fout, 675 F.2d 297, 301, 213USPQ 532, 534 (CCPA 1982) (holding preamble of Jepson-type claim to be admitted prior art whereapplicant’s specification credited another as theinventor of the subject matter of the preamble).However, this implication may be overcome whereapplicant gives another credible reason for draftingthe claim in Jepson format. In re Ehrreich, 590F.2d 902, 909-910, 200 USPQ 504, 510 (CCPA1979) (holding preamble not to be admitted prior artwhere applicant explained that the Jepson formatwas used to avoid a double patenting rejection in aco-pending application and the examiner cited noart showing the subject matter of the preamble).Moreover, where the preamble of a Jepson claimdescribes applicant’s own work, such may not beused against the claims. Reading & BatesConstruction Co. v. Baker Energy Resources Corp.,748 F.2d 645, 650, 223 USPQ 1168, 1172 (Fed. Cir.1984); Ehrreich, 590 F.2d at 909-910, 200 USPQat 510.

IV. INFORMATION DISCLOSURE STATEMENT(IDS)

Mere listing of a reference in an informationdisclosure statement is not taken as an admissionthat the reference is prior art against the claims.Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d1346, 1354-55, 66 USPQ2d 1331, 1337-38 (Fed Cir.2003) (listing of applicant’s own prior patent in anIDS does not make it available as prior art absent astatutory basis); see also 37 CFR 1.97(h) (“Thefiling of an information disclosure statement shallnot be construed to be an admission that theinformation cited in the statement is, or is consideredto be, material to patentability as defined in §1.56(b).”).

Rev. 08.2017, January 20182100-139


2130 [Reserved]

2131 Anticipation — Application of 35 U.S.C.102 [R-08.2017]

A claimed invention may be rejected under 35 U.S.C.102 when the invention is anticipated (or is “notnovel”) over a disclosure that is available as priorart. To reject a claim as anticipated by a reference,the disclosure must teach every element required bythe claim under its broadest reasonable interpretation.See, e.g., MPEP § 2114, subsections II and IV.

“A claim is anticipated only if each and everyelement as set forth in the claim is found, eitherexpressly or inherently described, in a single priorart reference.” Verdegaal Bros. v. Union Oil Co. ofCalifornia, 814 F.2d 628, 631, 2 USPQ2d 1051,1053 (Fed. Cir. 1987). “When a claim covers severalstructures or compositions, either generically or asalternatives, the claim is deemed anticipated if anyof the structures or compositions within the scopeof the claim is known in the prior art.” Brown v.3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376(Fed. Cir. 2001) (claim to a system for setting acomputer clock to an offset time to address the Year2000 (Y2K) problem, applicable to records with yeardate data in “at least one of two-digit, three-digit, orfour-digit” representations, was held anticipated bya system that offsets year dates in only two-digitformats). See also MPEP § 2131.02. “The identicalinvention must be shown in as complete detail as iscontained in the ... claim.” Richardson v. SuzukiMotor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913,1920 (Fed. Cir. 1989). The elements must bearranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminologyis not required. In re Bond, 910 F.2d 831, 15USPQ2d 1566 (Fed. Cir. 1990). Note that, in somecircumstances, it is permissible to use multiplereferences in a 35 U.S.C. 102 rejection. See MPEP§ 2131.01.

2131.01 Multiple Reference 35 U.S.C. 102Rejections [R-11.2013]

Normally, only one reference should be used inmaking a rejection under 35 U.S.C. 102. However,

a 35 U.S.C. 102 rejection over multiple referenceshas been held to be proper when the extra referencesare cited to:

(A) Prove the primary reference contains an“enabled disclosure;”

(B) Explain the meaning of a term used in theprimary reference; or

(C) Show that a characteristic not disclosed inthe reference is inherent.

See subsections I-III below for more explanation ofeach circumstance.

I. TO PROVE REFERENCE CONTAINS AN“ENABLED DISCLOSURE”

Extra References and Extrinsic Evidence Can Be UsedTo Show the Primary Reference Contains an “EnabledDisclosure”

When the claimed composition or machine isdisclosed identically by the reference, an additionalreference may be relied on to show that the primaryreference has an “enabled disclosure.” In re Samour,571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In reDonohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir.1985) (Compound claims were rejected underpre-AIA 35 U.S.C. 102(b) over a publication in viewof two patents. The publication disclosed the claimedcompound structure while the patents taught methodsof making compounds of that general class. Theapplicant argued that there was no motivation tocombine the references because no utility waspreviously known for the compound and that the 35U.S.C. 102 rejection over multiple references wasimproper. The court held that the publication taughtall the elements of the claim and thus motivation tocombine was not required. The patents were onlysubmitted as evidence of what was in the public'spossession before applicant’s invention.).

II. TO EXPLAIN THE MEANING OF A TERMUSED IN THE PRIMARY REFERENCE

Extra References or Other Evidence Can Be Used toShow Meaning of a Term Used in the Primary Reference

Extrinsic evidence may be used to explain but notexpand the meaning of terms and phrases used in

2100-140Rev. 08.2017, January 2018


the reference relied upon as anticipatory of theclaimed subject matter. In re Baxter Travenol Labs.,952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991)(Baxter Travenol Labs. invention was directed to ablood bag system incorporating a bag containingDEHP, an additive to the plastic which improvedthe bag’s red blood cell storage capability. Theexaminer rejected the claims over a technicalprogress report by Becker which taught the sameblood bag system but did not expressly disclose thepresence of DEHP. The report, however, did discloseusing commercial blood bags. It also disclosed theblood bag system as “very similar to [Baxter]Travenol’s commercial two bag blood container.”Extrinsic evidence (depositions, declarations andBaxter Travenol’s own admissions) showed thatcommercial blood bags, at the time Becker’s reportwas written, contained DEHP. Therefore, one ofordinary skill in the art would have known that“commercial blood bags” meant bags containingDEHP. The claims were thus held to be anticipated.).

III. TO SHOW THAT A CHARACTERISTIC NOTDISCLOSED IN THE REFERENCE IS INHERENT

Extra Reference or Evidence Can Be Used To Show anInherent Characteristic of the Thing Taught by thePrimary Reference

“To serve as an anticipation when the reference issilent about the asserted inherent characteristic, suchgap in the reference may be filled with recourse toextrinsic evidence. Such evidence must make clearthat the missing descriptive matter is necessarilypresent in the thing described in the reference, andthat it would be so recognized by persons of ordinaryskill.” Continental Can Co. USA v. Monsanto Co.,948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50(Fed. Cir. 1991) (The court went on to explain that“this modest flexibility in the rule that ‘anticipation’requires that every element of the claims appear ina single reference accommodates situations in whichthe common knowledge of technologists is notrecorded in the reference; that is, wheretechnological facts are known to those in the fieldof the invention, albeit not known to judges.” 948F.2d at 1268, 20 USPQ at 1749-50.). Note that aslong as there is evidence of record establishinginherency, failure of those skilled in the art tocontemporaneously recognize an inherent property,

function or ingredient of a prior art reference doesnot preclude a finding of anticipation. Atlas PowderCo. v. IRECO, Inc., 190 F.3d 1342, 1349, 51USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior artreferences disclosed blasting compositionscontaining water-in-oil emulsions with identicalingredients to those claimed, in overlapping rangeswith the claimed composition. The only element ofthe claims arguably not present in the prior artcompositions was “sufficient aeration . . . entrappedto enhance sensitivity to a substantial degree.” TheFederal Circuit found that the emulsions describedin both references would inevitably and inherentlyhave “sufficient aeration” to sensitize the compoundin the claimed ranges based on the evidence of record(including test data and expert testimony). Thisfinding of inherency was not defeated by the factthat one of the references taught away from airentrapment or purposeful aeration.). See also In reKing, 801 F.2d 1324, 1327, 231 USPQ 136, 139(Fed. Cir. 1986); Titanium Metals Corp. v. Banner,778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir.1985). See MPEP § 2112 - § 2112.02 for case lawon inherency. Also note that the critical date ofextrinsic evidence showing a universal fact need notantedate the filing date. See MPEP § 2124.

2131.02 Genus-Species Situations [R-08.2017]

I. A SPECIES WILL ANTICIPATE A CLAIM TOA GENUS

“A generic claim cannot be allowed to an applicantif the prior art discloses a species falling within theclaimed genus.” The species in that case willanticipate the genus. In re Slayter, 276 F.2d 408,411, 125 USPQ 345, 347 (CCPA 1960); In reGosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir.1989) (Gosteli claimed a genus of 21 specificchemical species of bicyclic thia-aza compounds inMarkush claims. The prior art reference appliedagainst the claims disclosed two of the chemicalspecies. The parties agreed that the prior art specieswould anticipate the claims unless applicant wasentitled to his foreign priority date.).

II. A REFERENCE THAT CLEARLY NAMES THECLAIMED SPECIES ANTICIPATES THE CLAIM

Rev. 08.2017, January 20182100-141


NO MATTER HOW MANY OTHER SPECIES ARENAMED

A genus does not always anticipate a claim to aspecies within the genus. However, when the speciesis clearly named, the species claim is anticipated nomatter how many other species are additionallynamed. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat.App. & Inter. 1990) (The claimed compound wasnamed in a reference which also disclosed 45 othercompounds. The Board held that thecomprehensiveness of the listing did not negate thefact that the compound claimed was specificallytaught. The Board compared the facts to the situationin which the compound was found in the MerckIndex, saying that “the tenth edition of the MerckIndex lists ten thousand compounds. In our view,each and every one of those compounds is‘described’ as that term is used in [pre-AIA] 35U.S.C. 102(a), in that publication.”). Id. at 1718.See also In re Sivaramakrishnan, 673 F.2d 1383,213 USPQ 441 (CCPA 1982) (The claims weredirected to polycarbonate containing cadmiumlaurate as an additive. The court upheld the Board’sfinding that a reference specifically naming cadmiumlaurate as an additive amongst a list of many suitablesalts in polycarbonate resin anticipated the claims.The applicant had argued that cadmium laurate wasonly disclosed as representative of the salts and wasexpected to have the same properties as the othersalts listed while, as shown in the application,cadmium laurate had unexpected properties. Thecourt held that it did not matter that the salt was notdisclosed as being preferred, the reference stillanticipated the claims and because the claim wasanticipated, the unexpected properties wereimmaterial.).

III. A GENERIC DISCLOSURE WILLANTICIPATE A CLAIMED SPECIES COVEREDBY THAT DISCLOSURE WHEN THE SPECIESCAN BE “AT ONCE ENVISAGED” FROM THEDISCLOSURE

“[W]hether a generic disclosure necessarilyanticipates everything within the genus … dependson the factual aspects of the specific disclosure andthe particular products at issue.” Sanofi-Synthelabov. Apotex, Inc., 550 F.3d 1075, 1083, 89 USPQ2d1370, 1375 (Fed. Cir. 2008). See also OsramSylvania Inc. v. American Induction Tech. Inc., 701

F.3d 698, 706, 105 USPQ2d 1368, 1374 (Fed. Cir.2012) (“how one of ordinary skill in the art wouldunderstand the relative size of a genus or species ina particular technology is of critical importance”).

A reference disclosure can anticipate a claim evenif the reference does not describe “the limitationsarranged or combined as in the claim, if a person ofskill in the art, reading the reference, would ‘at onceenvisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed.Cir. 2015) (quoting In re Petering, 301 F.2d 676,681(CCPA 1962)). In Kennametal, the challengedclaim was to a cutting tool requiring a rutheniumbinding agent with a physical vapor deposition(PVD) coating. Claim 5 of the reference disclosedall the elements of the claimed coated cutting tool,however, ruthenium was one of five specifiedbinding agents and the claim did not specify aparticular coating technique. The specification ofthe reference disclosed PVD as one of three suitablecoating techniques. The Federal Circuit stated thatthe reference’s “express ‘contemplat[ion]’ of PVDcoatings provided sufficient evidence that areasonable mind could find that a person of skill inthe art… would immediately envisage applying aPVD coating. Thus, substantial evidence supportsthe Board's conclusion that [the reference] effectivelyteaches 15 combinations, of which one anticipatespending claim 1. Though it is true that there is noevidence in [the reference] of ‘actual performance’of combining the ruthenium binder and PVDcoatings, this is not required.” Kennametal, 780F.3d at 1383, 114 USPQ2d at 1255 (citationsomitted).

When a claimed compound is not specifically namedin a reference, but instead it is necessary to selectportions of teachings within the reference andcombine them, e.g., select various substituents froma list of alternatives given for placement at specificsites on a generic chemical formula to arrive at aspecific composition, anticipation can only be foundif the classes of substituents are sufficiently limitedor well delineated. Ex parte A, 17 USPQ2d 1716(Bd. Pat. App. & Inter. 1990). If one of ordinary skillin the art is able to “at once envisage” the specificcompound within the generic chemical formula, thecompound is anticipated. One of ordinary skill in

2100-142Rev. 08.2017, January 2018


the art must be able to draw the structural formulaor write the name of each of the compounds includedin the generic formula before any of the compoundscan be “at once envisaged.” One may look to thepreferred embodiments to determine whichcompounds can be anticipated. In re Petering, 301F.2d 676, 133 USPQ 275 (CCPA 1962).

In In re Petering, the prior art disclosed a generic

chemical formula “wherein X, Y, Z, P, and R'-represent either hydrogen or alkyl radicals, R a sidechain containing an OH group.” The court held thatthis formula, without more, could not anticipate a

claim to 7-methyl-9-[d, l'-ribityl]-isoalloxazinebecause the generic formula encompassed a vastnumber and perhaps even an infinite number ofcompounds. However, the reference also disclosed

preferred substituents for X, Y, Z, P, R, and R' as

follows: where X, P, and R' are hydrogen, where Yand Z may be hydrogen or methyl, and where R isone of eight specific isoalloxazines. The courtdetermined that this more limited generic classconsisted of about 20 compounds. The limitednumber of compounds covered by the preferredformula in combination with the fact that the numberof substituents was low at each site, the ringpositions were limited, and there was a largeunchanging structural nucleus, resulted in a findingthat the reference sufficiently described “each of thevarious permutations here involved as fully as if hehad drawn each structural formula or had writteneach name.” The claimed compound was 1 of these20 compounds. Therefore, the reference “described”the claimed compound and the reference anticipatedthe claims.

In In re Schauman, 572 F.2d 312, 197 USPQ5 (CCPA 1978), claims to a specific compound wereanticipated because the prior art taught a genericformula embracing a limited number of compoundsclosely related to each other in structure and theproperties possessed by the compound class of theprior art was that disclosed for the claimedcompound. The broad generic formula seemed todescribe an infinite number of compounds but claim1 was limited to a structure with only one variablesubstituent R. This substituent was limited to lowalkyl radicals. One of ordinary skill in the art would

at once envisage the subject matter within claim 1of the reference.

Compare In re Meyer, 599 F.2d 1026, 202 USPQ175 (CCPA 1979) (A reference disclosing “alkalinechlorine or bromine solution” embraces a largenumber of species and cannot be said to anticipateclaims to “alkali metal hypochlorite.”); AkzoN.V. v. International Trade Comm’n, 808 F.2d 1471,1 USPQ2d 1241 (Fed. Cir. 1986) (Claims to aprocess for making aramid fibers using a 98%solution of sulfuric acid were not anticipated by areference which disclosed using sulfuric acidsolution but which did not disclose using a 98%concentrated sulfuric acid solution.). See MPEP §2144.08 for a discussion of obviousness ingenus-species situations.

2131.03 Anticipation of Ranges [R-08.2017]

I. A SPECIFIC EXAMPLE IN THE PRIOR ARTWHICH IS WITHIN A CLAIMED RANGEANTICIPATES THE RANGE

“[W]hen, as by a recitation of ranges or otherwise,a claim covers several compositions, the claim is‘anticipated’ if one of them is in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985) (citing Inre Petering, 301 F.2d 676, 682, 133 USPQ 275, 280(CCPA 1962)) (emphasis in original) (Claims totitanium (Ti) alloy with 0.6-0.9% nickel (Ni) and0.2-0.4% molybdenum (Mo) were held anticipatedby a graph in a Russian article on Ti-Mo-Ni alloysbecause the graph contained an actual data pointcorresponding to a Ti alloy containing 0.25% Moand 0.75% Ni and this composition was within theclaimed range of compositions.).

II. PRIOR ART WHICH TEACHES A RANGEOVERLAPPING OR TOUCHING THE CLAIMEDRANGE ANTICIPATES IF THE PRIOR ARTRANGE DISCLOSES THE CLAIMED RANGEWITH “SUFFICIENT SPECIFICITY”

When the prior art discloses a range which touchesor overlaps the claimed range, but no specificexamples falling within the claimed range aredisclosed, a case by case determination must bemade as to anticipation. In order to anticipate the

Rev. 08.2017, January 20182100-143


claims, the claimed subject matter must be disclosedin the reference with “sufficient specificity toconstitute an anticipation under the statute.” Whatconstitutes a “sufficient specificity” is factdependent. If the claims are directed to a narrowrange, and the reference teaches a broader range,other facts of the case, must be considered whendetermining whether the narrow range is disclosedwith “sufficient specificity” to constitute ananticipation of the claims. Compare ClearValue Inc.v. Pearl River Polymers Inc., 668 F.3d 1340, 101USPQ2d 1773 (Fed. Cir. 2012) with Atofina v.Great Lakes Chem. Corp, 441 F.3d 991, 999, 78USPQ2d 1417, 1423 (Fed. Cir. 2006).

In ClearValue, the claim at issue was directed to aprocess of clarifying water with alkalinity below 50ppm, whereas the prior art taught that the sameprocess works for systems with alkalinity of 150ppm or less. In holding the claim anticipated, thecourt observed that “there is no allegation ofcriticality or any evidence demonstrating anydifference across the range.” Id. at 1345, 101USPQ2d at 1777. In Atofina, the court held that areference temperature range of 100-500 degrees Cdid not describe the claimed range of 330-450degrees C with sufficient specificity to beanticipatory, even though there was a slight overlapbetween the reference’s preferred range (150-350degrees C) and the claimed range. “[T]he disclosureof a range is no more a disclosure of the end pointsof the range than it is each of the intermediatepoints.” Id. at 1000, 78 USPQ2d at 1424. Patenteedescribed claimed temperature range as “critical” toenable the process to operate effectively, and showedthat one of ordinary skill would have expected thesynthesis process to operate differently outside theclaimed range.

If the prior art disclosure does not disclose a claimedrange with “sufficient specificity” to anticipate aclaimed invention, any evidence of unexpectedresults within the narrow range may render theclaims unobvious. See MPEP § 716.02 et seq. Thequestion of “sufficient specificity” is similar to thatof “clearly envisaging” a species from a genericteaching. See MPEP § 2131.02.

A 35 U.S.C. 102/103 combination rejection ispermitted if it is unclear if the reference teaches the

range with “sufficient specificity.” The examinermust, in this case, provide reasons for anticipationas well as a reasoned statement regardingobviousness. Ex parte Lee, 31 USPQ2d 1105 (Bd.Pat. App. & Inter. 1993) (expanded Board). For adiscussion of the obviousness of ranges see MPEP§ 2144.05.

III. PRIOR ART WHICH TEACHES A VALUE ORRANGE THAT IS VERY CLOSE TO, BUT DOESNOT OVERLAP OR TOUCH, THE CLAIMEDRANGE DOES NOT ANTICIPATE THE CLAIMEDRANGE

“[A]nticipation under § 102 can be found only whenthe reference discloses exactly what is claimed andthat where there are differences between thereference disclosure and the claim, the rejection mustbe based on § 103 which takes differences intoaccount.” Titanium Metals Corp. v. Banner, 778F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claimsto titanium (Ti) alloy with 0.8% nickel (Ni) and 0.3%molybdenum (Mo) were not anticipated by, althoughthey were held obvious over, a graph in a Russianarticle on Ti-Mo-Ni alloys in which the graphcontained an actual data point corresponding to a Tialloy containing 0.25% Mo and 0.75% Ni.).

2131.04 Secondary Considerations[R-08.2012]

Evidence of secondary considerations, such asunexpected results or commercial success, isirrelevant to 35 U.S.C. 102 rejections and thus cannotovercome a rejection so based. In re Wiggins, 488F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973).

2131.05 Nonanalogous or Disparaging PriorArt [R-08.2012]

“Arguments that the alleged anticipatory prior art is‘nonanalogous art’ or ‘teaches away from theinvention’ or is not recognized as solving theproblem solved by the claimed invention, [are] not‘germane’ to a rejection under section 102.” TwinDisc, Inc. v. United States, 231 USPQ 417, 424 (Cl.Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213USPQ 1, 7 (CCPA 1982)). See also StateContracting & Eng’ g Corp. v. Condotte America,Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488

2100-144Rev. 08.2017, January 2018


(Fed. Cir. 2003) (The question of whether a referenceis analogous art is not relevant to whether thatreference anticipates. A reference may be directedto an entirely different problem than the oneaddressed by the inventor, or may be from an entirelydifferent field of endeavor than that of the claimedinvention, yet the reference is still anticipatory if itexplicitly or inherently discloses every limitationrecited in the claims.).

A reference is no less anticipatory if, after disclosingthe invention, the reference then disparages it. Thequestion whether a reference “teaches away” fromthe invention is inapplicable to an anticipationanalysis. Celeritas Technologies Ltd. v. RockwellInternational Corp., 150 F.3d 1354, 1361, 47USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The priorart was held to anticipate the claims even though ittaught away from the claimed invention. “The factthat a modem with a single carrier data signal isshown to be less than optimal does not vitiate thefact that it is disclosed.”). See Upsher-Smith Labs.v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d1213, 1215 (Fed. Cir. 2005)(claimed compositionthat expressly excluded an ingredient heldanticipated by reference composition that optionallyincluded that same ingredient); see also AtlasPowder Co. v. IRECO, Inc., 190 F.3d 1342, 1349,51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Claimedcomposition was anticipated by prior art referencethat inherently met claim limitation of “sufficientaeration” even though reference taught away fromair entrapment or purposeful aeration.).

2132 Pre-AIA 35 U.S.C. 102(a) [R-11.2013]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions. See MPEP § 2152 etseq. for a detailed discussion of AIA 35 U.S.C.102(a) and (b).]

Pre-AIA 35 U.S.C. 102 Conditions for patentability; noveltyand loss of right to patent.

A person shall be entitled to a patent unless -

(a) the invention was known or used by others in thiscountry, or patented or described in a printed publication in thisor a foreign country, before the invention thereof by the applicantfor a patent.

*****

I. “KNOWN OR USED”

A. “Known or Used” Means Publicly Known or Used

“The statutory language ‘known or used by othersin this country’ [pre-AIA 35 U.S.C. 102(a)], meansknowledge or use which is accessible to the public.” Carella v. Starlight Archery, 804 F.2d 135, 231USPQ 644 (Fed. Cir. 1986). The knowledge or useis accessible to the public if there has been nodeliberate attempt to keep it secret. W. L. Gore &Assoc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ303 (Fed. Cir. 1983).

See MPEP § 2128 - § 2128.02 for case lawconcerning public accessibility of publications.

B. Another’s Sale of a Product Made by a SecretProcess Can Be a Pre-AIA 35 U.S.C. 102(a) Public Useif the Process Can Be Determined by Examining theProduct

“The nonsecret use of a claimed process in the usualcourse of producing articles for commercial purposesis a public use.” But a secret use of the processcoupled with the sale of the product does not resultin a public use of the process unless the public couldlearn the claimed process by examining the product.Therefore, secret use of a process by another, evenif the product is commercially sold, cannot result ina rejection under pre-AIA 35 U.S.C. 102(a) if anexamination of the product would not reveal theprocess. Id.

II. “IN THIS COUNTRY”

Only Knowledge or Use in the U.S. Can Be Used in aPre-AIA 35 U.S.C. 102(a) Rejection

The knowledge or use relied on in a pre-AIA 35U.S.C. 102(a) rejection must be knowledge or use“in this country.” Prior knowledge or use which isnot present in the United States, even if widespreadin a foreign country, cannot be the basis of arejection under pre-AIA 35 U.S.C. 102(a). Inre Ekenstam, 256 F.2d 321, 118 USPQ 349 (CCPA

Rev. 08.2017, January 20182100-145


1958). Note that the changes made to pre-AIA 35U.S.C. 104 by NAFTA (Public Law 103-182) andUruguay Round Agreements Act (Public Law103-465) do not modify the meaning of “in thiscountry” as used in pre-AIA 35 U.S.C. 102(a) andthus “in this country” still means in the United Statesfor purposes of pre-AIA 35 U.S.C. 102(a) rejections.

III. “BY OTHERS”

“Others” Means Any Combination of Authors orInventors Different Than the Inventive Entity

The term “others” in pre-AIA 35 U.S.C. 102(a) refersto any entity which is different from the inventiveentity. The entity need only differ by one person tobe “by others.” This holds true for all types ofreferences eligible as prior art under pre-AIA 35U.S.C. 102(a) including publications as well aspublic knowledge and use. Any other interpretationof pre-AIA 35 U.S.C. 102(a) “would negate the oneyear [grace] period afforded under § 102(b).” In reKatz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982).

IV. “PATENTED IN THIS OR A FOREIGNCOUNTRY”

See MPEP § 2126 for information on the use ofsecret patents as prior art.

2132.01 Publications as Pre-AIA 35 U.S.C.102(a) Prior Art [R-08.2017]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions. See MPEP § 2152 etseq. for a detailed discussion of AIA 35 U.S.C.102(a) and (b).

“Derivation” or "derived" as used in the discussionbelow is in the context of pre-AIA law. “Derivationproceedings” as created in the AIA are discussed inMPEP § 2310 et seq.]

I. Pre-AIA 35 U.S.C. 102(a) PRIMA FACIE CASEIS ESTABLISHED IF REFERENCE PUBLICATIONIS “BY OTHERS”

A prima facie case is made out under pre-AIA 35U.S.C. 102(a) if, within 1 year of the filing date, theinvention, or an obvious variant thereof, is describedin a “printed publication” whose authorship differsin any way from the inventive entity unless it isstated within the publication itself that thepublication is describing the inventor's or at leastone joint inventor's work. In re Katz, 687 F.2d 450,215 USPQ 14 (CCPA 1982). See MPEP § 2128 forcase law on what constitutes a “printed publication.”Note that when the reference is a U.S. patent, U.S.patent application publication, or certaininternational application publication published withinthe year prior to the application filing date, apre-AIA 35 U.S.C. 102(e) rejection should be made.See MPEP § 2136 - § 2136.05 for case law dealingwith pre-AIA 35 U.S.C. 102(e).

II. APPLICANT CAN REBUT PRIMA FACIE CASEBY SHOWING REFERENCE’S DISCLOSURE WASDERIVED FROM INVENTOR'S OR AT LEASTONE JOINT INVENTOR'S OWN WORK

An inventor's or at least one joint inventor'sdisclosure of his or her own work within the yearbefore the application filing date cannot be usedagainst the application as prior art under pre-AIA35 U.S.C. 102(a). In re Katz, 687 F.2d 450, 215USPQ 14 (CCPA 1982) (discussed below).Therefore, where the inventor or at least one jointinventor is one of the co-authors of a publicationcited against the application, the publication may beremoved as a reference by the filing of affidavitsmade out by the other authors establishing that therelevant portions of the publication originated with,or were obtained from, the inventor or at least onejoint inventor. Such affidavits are called disclaimingaffidavits. Ex parte Hirschler, 110 USPQ 384 (Bd.App. 1952). The rejection can also be overcome bysubmission of a specific declaration by the inventoror at least one joint inventor establishing that thearticle is describing the inventor's own work. In reKatz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982).However, if there is evidence that the co-author hasrefused to disclaim inventorship and believes himselfor herself to be an inventor, the inventor's affidavitor declaration will not be enough to establish that

2100-146Rev. 08.2017, January 2018


the inventor or the at least one joint inventor is thesole inventor of the subject matter in the article andthe rejection will stand. Ex parte Kroger, 219 USPQ370 (Bd. App. 1982) (discussed below). It is alsopossible to overcome the rejection by adding thecoauthors as joint inventors to the application if therequirements of 35 U.S.C. 116, third paragraph, aremet. In re Searles, 422 F.2d 431, 164 USPQ 623(CCPA 1970).

In In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA1982), Katz stated in a declaration that the coauthorsof the publication, Chiorazzi and Eshhar, “werestudents working under the direction and supervisionof the inventor, Dr. David H. Katz.” The court heldthat this declaration, in combination with the factthat the publication was a research paper, wasenough to establish Katz as the sole inventor andthat the work described in the publication was hisown. In research papers, students involved only withassay and testing are normally listed as coauthorsbut are not considered co-inventors.

In Ex parte Kroger, 219 USPQ 370 (Bd. App.1982), Kroger, Knaster and others were listed asauthors on an article on photovoltaic powergeneration. The article was used to reject the claimsof an application listing Kroger and Rod as inventors.Kroger and Rod submitted affidavits declaringthemselves to be the inventors. The affidavits alsostated that Knaster merely carried out assignmentsand worked under the supervision and direction ofKroger. The Board stated that if this were the onlyevidence in the case, it would be established, under In re Katz, that Kroger and Rod were the onlyinventors. However, in this case, there was evidencethat Knaster had refused to sign an affidavitdisclaiming inventorship and Knaster had introducedevidence into the case in the form of a letter to thePTO in which he alleged that he was a co-inventor.The Board held that the evidence had not been fullydeveloped enough to overcome the rejection. Notethat the rejection had been made under pre-AIA 35U.S.C. 102(f) but the Board treated the issue thesame as if it had arisen under pre-AIA 35 U.S.C.102(a). See also case law dealing with overcomingpre-AIA 35 U.S.C. 102(e) rejections as presented inMPEP § 2136.05. Many of the issues are the same.

III. A 37 CFR 1.131 AFFIDAVIT CAN BE USED TOOVERCOME A Pre-AIA 35 U.S.C. 102(a)REJECTION

When the reference is not a statutory bar underpre-AIA 35 U.S.C. 102(b), (c), or (d), applicant canovercome the rejection by swearing back of thereference through the submission of an affidavitunder 37 CFR 1.131. In re Foster, 343 F.2d 980,145 USPQ 166 (CCPA 1965). If the reference isdisclosing an inventor's or at least one joint inventor'sown work as derived from the inventor or jointinventor, either a 37 CFR 1.131 affidavit to antedatethe reference or a 37 CFR 1.132 affidavit to showderivation of the reference subject matter from theinventor or joint inventor and invention by theinventor or joint inventor may be submitted. In reFacius, 408 F.2d 1396, 161 USPQ 294 (CCPA1969). See MPEP § 715 for more information onwhen an affidavit under 37 CFR 1.131 can be usedto overcome a reference and what evidence isrequired.

2133 Pre-AIA 35 U.S.C. 102(b) [R-07.2015]




*****

(b) the invention was patented or described in a printedpublication in this or a foreign country or in public use or onsale in this country, more than one year prior to the date ofapplication for patent in the United States.

*****

Rev. 08.2017, January 20182100-147


I. THE 1-YEAR GRACE PERIOD IS EXTENDEDTO THE NEXT WORKING DAY IF IT WOULDOTHERWISE END ON A HOLIDAY OR WEEKEND

Publications, patents, public uses and sales mustoccur “more than one year prior to the date ofapplication for patent in the United States” in orderto bar a patent under pre-AIA 35 U.S.C. 102(b).However, applicant’s own activity will not bar apatent if the 1-year grace period expires on aSaturday, Sunday, or federal holiday and theapplication’s U.S. filing date is the next succeedingbusiness day. Ex parte Olah, 131 USPQ 41 (Bd.App. 1960). Despite changes to 37 CFR 1.6(a)(2)and 37 CFR 1.10 which require the PTO to accorda filing date to an application as of the date of depositas Priority Express Mail® with the U.S. PostalService in accordance with 37 CFR 1.10 (e.g., aSaturday filing date), the rule changes do not affectapplicant's concurrent right to defer the filing of anapplication until the next business day when the lastday for “taking any action” falls on a Saturday,Sunday, or a federal holiday (e.g., the last day of the1-year grace period falls on a Saturday).

II. THE 1-YEAR TIME BAR IS MEASURED FROMTHE U.S. FILING DATE

If one discloses his or her own work more than 1year before the filing of the patent application, thatperson is barred from obtaining a patent. In re Katz,687 F.2d 450, 454, 215 USPQ 14, 17 (CCPA 1982).The 1-year time bar is measured from the U.S. filingdate. Thus, applicant will be barred from obtaininga patent if the public came into possession of theinvention on a date before the 1-year grace periodending with the U.S. filing date. It does not matterhow the public came into possession of the invention.Public possession could occur by a public use, publicsale, a publication, a patent or any combination ofthese. In addition, the prior art need not be identicalto the claimed invention but will bar patentability ifit is an obvious variant thereof. In re Foster, 343F.2d 980, 145 USPQ 166 (CCPA 1966). See MPEP§ 706.02 regarding the effective U.S. filing date ofan application.

2133.01 Rejections of Continuation-In-Part(CIP) Applications [R-11.2013]


When applicant files a continuation-in-part whoseclaims are not supported by the parent application,the effective filing date is the filing date of the childCIP. Any prior art disclosing the invention or anobvious variant thereof having a critical referencedate more than 1 year prior to the filing date of thechild will bar the issuance of a patent under pre-AIA35 U.S.C. 102(b). Paperless Accounting v. BayArea Rapid Transit System, 804 F.2d 659, 665, 231USPQ 649, 653 (Fed. Cir. 1986).

2133.02 Rejections Based on Publicationsand Patents [R-11.2013]


I. APPLICANT’S OWN WORK WHICH WASAVAILABLE TO THE PUBLIC BEFORE THEGRACE PERIOD MAY BE USED IN A PRE-AIA 35U.S.C. 102(b) REJECTION

“Any invention described in a printed publicationmore than one year prior to the date of a patentapplication is prior art under Section 102(b), evenif the printed publication was authored by the patentapplicant.” De Graffenried v. United States,16 USPQ2d 1321, 1330 n.7 (Cl. Ct. 1990). “Once

2100-148Rev. 08.2017, January 2018


an inventor has decided to lift the veil of secrecyfrom his [or her] work, he [or she] must choosebetween the protection of a federal patent, or thededication of his [or her] idea to the public at large.” Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489U.S. 141, 148, 9 USPQ2d 1847, 1851 (1989).

II. A PRE-AIA 35 U.S.C. 102(b) REJECTIONCREATES A STATUTORY BAR TOPATENTABILITY OF THE REJECTED CLAIMS

A rejection under pre-AIA 35 U.S.C. 102(b) cannotbe overcome by affidavits and declarations under37 CFR 1.131 (Rule 131 Declarations), foreignpriority dates, or evidence that applicant himselfinvented the subject matter. Outside the 1-year graceperiod, applicant is barred from obtaining a patentcontaining any anticipated or obvious claims. In reFoster, 343 F.2d 980, 984, 145 USPQ 166, 170(CCPA 1965).

2133.03 Rejections Based on “Public Use”or “On Sale” [R-11.2013]

[Editor Note: This MPEP section has limitedapplicability to applications subject to examinationunder the first inventor to file (FITF) provisions ofthe AIA as set forth in 35 U.S.C. 100 (note). SeeMPEP § 2159 et seq. to determine whether anapplication is subject to examination under the FITFprovisions, and MPEP § 2150 et seq. forexamination of applications subject to thoseprovisions. See MPEP § 2152.02(c) through (e) fora detailed discussion of the public use and on saleprovisions of AIA 35 U.S.C. 102.]

Pre-AIA 35 U.S.C. 102(b) “contains several distinctbars to patentability, each of which relates to activityor disclosure more than one year prior to the date ofthe application. Two of these - the ‘public use’ andthe ‘on sale’ objections - are sometimes consideredtogether although it is quite clear that either mayapply when the other does not.” Dart Indus. v. E.I.du Pont de Nemours & Co., 489 F.2d 1359, 1365,179 USPQ 392, 396 (7th Cir. 1973). There may bea public use of an invention absent any sales activity.Likewise, there may be a nonpublic, e.g., “secret,”sale or offer to sell an invention which neverthelessconstitutes a statutory bar. Hobbs v. United States,

451 F.2d 849, 859-60, 171 USPQ 713, 720 (5th Cir.1971).

In similar fashion, not all “public use” and “on sale”activities will necessarily occasion the identicalresult. Although both activities affect how aninventor may use an invention prior to the filing ofa patent application, “non-commercial” pre-AIA 35U.S.C. 102(b) activity may not be viewed the sameas similar “commercial” activity. See MPEP§ 2133.03(a) and § 2133.03(e)(1). Likewise, “publicuse” activity by an applicant may not be consideredin the same light as similar “public use” activity byone other than an applicant. See MPEP § 2133.03(a)and § 2133.03(e)(7). Additionally, the concept of“experimental use” may have different significancein “commercial” and “non-commercial”environments. See MPEP § 2133.03(c) and§ 2133.03(e) - § 2133.03(e)(6).

It should be noted that pre-AIA 35 U.S.C. 102(b)may create a bar to patentability either alone, if thedevice in public use or placed on sale anticipates alater claimed invention, or in conjunction with 35U.S.C. 103, if the claimed invention would havebeen obvious from the device in conjunction withthe prior art. LaBounty Mfg. v. United States Int’lTrade Comm’n, 958 F.2d 1066, 1071, 22 USPQ2d1025, 1028 (Fed. Cir. 1992).

I. POLICY CONSIDERATIONS

(A) “One policy underlying the [on-sale] bar isto obtain widespread disclosure of new inventionsto the public via patents as soon as possible.” RCACorp. v. Data Gen. Corp., 887 F.2d 1056, 1062, 12USPQ2d 1449, 1454 (Fed. Cir. 1989).

(B) Another policy underlying the public useand on-sale bars is to prevent the inventor fromcommercially exploiting the exclusivity of his [orher] invention substantially beyond the statutorilyauthorized period. RCA Corp. v. Data Gen. Corp.,887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed.Cir. 1989). See MPEP § 2133.03(e)(1).

(C) Another underlying policy for the public useand on-sale bars is to discourage “the removal ofinventions from the public domain which the publicjustifiably comes to believe are freely available.” Manville Sales Corp. v. Paramount Sys., Inc.,

Rev. 08.2017, January 20182100-149


917 F.2d 544, 549, 16 USPQ2d 1587, 1591 (Fed.Cir. 1990).

2133.03(a) “Public Use” [R-08.2017]

[Editor Note: This MPEP section has limitedapplicability to applications subject to examinationunder the first inventor to file (FITF) provisions ofthe AIA as set forth in 35 U.S.C. 100 (note) . SeeMPEP § 2159 et seq. to determine whether anapplication is subject to examination under the FITFprovisions, and MPEP § 2150 et seq. forexamination of applications subject to thoseprovisions. See MPEP § 2152.02(c) through (e) fora detailed discussion of the public use and on saleprovisions of AIA 35 U.S.C. 102.]

I. TEST FOR “PUBLIC USE

The public use bar under pre-AIA 35 U.S.C. 102(b)arises where the invention is in public use before thecritical date and is ready for patenting. InvitrogenCorp. v. Biocrest Manufacturing L.P., 424 F.3d1374, 76 USPQ2d 1741 (Fed. Cir. 2005). Asexplained by the court,

The proper test for the public use prong of thepre-AIA § 102(b) statutory bar is whether thepurported use: (1) was accessible to the public;or (2) was commercially exploited. Commercialexploitation is a clear indication of public use,but it likely requires more than, for example, asecret offer for sale. Thus, the test for the publicuse prong includes the consideration ofevidence relevant to experimentation, as wellas, inter alia , the nature of the activity thatoccurred in public; public access to the use;confidentiality obligations imposed on membersof the public who observed the use; andcommercial exploitation…. That evidence isrelevant to discern whether the use was a publicuse that could raise a bar to patentability, butit is distinct from evidence relevant to the readyfor patenting component of Pfaff ’s two-parttest, another necessary requirement of a publicuse bar.

Id. at 1380, 76 USPQ2d at 1744 (citations omitted).See MPEP § 2133.03(c) for a discussion of the

“ready for patenting” prong of the public use and onsale statutory bars.

“[T]o constitute the public use of an invention it isnot necessary that more than one of the patentarticles should be publicly used. The use of a greatnumber may tend to strengthen the proof, but onewell defined case of such use is just as effectual toannul the patent as many.” Likewise, it is notnecessary that more than one person use theinvention. Egbert v. Lippmann, 104 U.S. 333, 336(1881).

II. PUBLIC KNOWLEDGE IS NOT NECESSARILYPUBLIC USE UNDER Pre-AIA 35 U.S.C. 102(b)

Mere knowledge of the invention by the public doesnot warrant rejection under pre-AIA 35 U.S.C.102(b). Pre-AIA 35 U.S.C. 102(b) bars public useor sale, not public knowledge. TP Labs., Inc. v.Professional Positioners, Inc., 724 F.2d 965, 970,220 USPQ 577, 581 (Fed. Cir. 1984).

Note, however, that public knowledge may providegrounds for rejection under pre-AIA 35 U.S.C.102(a). See MPEP § 2132.

A. Commercial Versus Noncommercial Use and theImpact of Secrecy

There are limited circumstances in which a secretor confidential use of an invention may give rise tothe public use bar. “[S]ecrecy of use alone is notsufficient to show that existing knowledge has notbeen withdrawn from public use; commercialexploitation is also forbidden.” Invitrogen, 424 F.3dat 1382, 76 USPQ2d at 1745-46 (The fact thatpatentee secretly used the claimed inventioninternally before the critical date to develop futureproducts that were never sold was by itselfinsufficient to create a public use bar topatentability.).

1. “Public Use” and “Non-secret Use” Are NotNecessarily Synonymous

“Public” is not necessarily synonymous with “non-secret.” The fact “that non-secret uses of the devicewere made [by the inventor or someone connectedwith the inventor] prior to the critical date is not

2100-150Rev. 08.2017, January 2018


itself dispositive of the issue of whether activitybarring a patent under pre-AIA 35 U.S.C. 102(b)occurred. The fact that the device was not hiddenfrom view may make the use not secret, butnonsecret use is not ipso facto ‘public use’ activity.Nor, it must be added, is all secret use ipso factonot ‘public use’ within the meaning of the statute,”if the inventor is making commercial use of theinvention under circumstances which preserve itssecrecy. TP Labs., Inc. v. Professional Positioners,Inc., 724 F.2d 965, 972, 220 USPQ 577, 583 (Fed.Cir. 1983) (citations omitted).

2. Even If the Invention Is Hidden, Inventor Who PutsMachine or Article Embodying the Invention in PublicView Is Barred from Obtaining a Patent as theInvention Is in Public Use

When the inventor or someone connected to theinventor puts the invention on display or sells it,there is a “public use” within the meaning ofpre-AIA 35 U.S.C. 102(b) even though by its verynature an invention is completely hidden from viewas part of a larger machine or article, if the inventionis otherwise used in its natural and intended way andthe larger machine or article is accessible to thepublic. In re Blaisdell, 242 F.2d 779, 783, 113USPQ 289, 292 (CCPA 1957); Hall v. Macneale,107 U.S. 90, 96-97 (1882); Ex parte Kuklo, 25USPQ2d 1387, 1390 (Bd. Pat. App. & Inter. 1992)(Display of equipment including the structuralfeatures of the claimed invention to visitors oflaboratory is public use even though public did notsee inner workings of device. The person to whomthe invention is publicly disclosed need notunderstand the significance and technicalcomplexities of the invention.).

3. There Is No Public Use If Inventor Restricted Useto Locations Where There Was a ReasonableExpectation of Privacy and the Use Was for His orHer Own Enjoyment

An inventor’s private use of the invention, for hisor her own enjoyment is not a public use. MoleculonResearch Corp. v. CBS, Inc., 793 F.2d 1261, 1265,229 USPQ 805, 809 (Fed. Cir. 1986) (Inventorshowed inventive puzzle to close friends while inhis dorm room and later the president of the companyat which he was working saw the puzzle on theinventor’s desk and they discussed it. Court held that

the inventor retained control and thus these actionsdid not result in a “public use.”).

4. The Presence or Absence of a ConfidentialityAgreement is Not Dispositive of the Public Use Issue

“The presence or absence of a confidentialityagreement is not dispositive of the public use issue,but ‘is one factor to be considered in assessing allthe evidence.’” Bernhardt, L.L.C. v. CollezioneEuropa USA, Inc., 386 F.3d 1371, 1380-81, 72USPQ2d 1901, 1909 (Fed. Cir. 2004) (quoting Moleculon Research Corp. v. CBS Inc., 793 F.2d1261, 1266, 229 USPQ 805, 808 (Fed. Cir. 1986)).The court stressed that it is necessary to analyze theevidence of public use in the context of policies thatunderlie the public use and on sale bar that include“‘discouraging removal of inventions from the publicdomain that the public justifiably believes are freelyavailable, prohibiting an extension of the period forexploiting an invention, and favoring prompt andwidespread disclosure of inventions.’” Bernhardt,386 F.3d at 1381, 72 USPQ2d at 1909. See also Invitrogen, 424 F.3d at 1379, 76 USPQ2d at 1744;MPEP § 2133.03, subsection I. Evidence that thecourt emphasized included the “‘nature of theactivity that occurred in public; the public access toand knowledge of the public use; [and] whether therewere any confidentiality obligations imposed onpersons who observed the use.’” Bernhardt, 386F.3d at 1381, 72 USPQ2d at 1909. For example, thecourt in Bernhardt noted that an exhibition displayat issue in the case “was not open to the public, thatthe identification of attendees was checked againsta list of authorized names by building security andlater at a reception desk near the showroom, thatattendees were escorted through the showroom, andthat the attendees were not permitted to make writtennotes or take photographs inside the showroom.” Id. The court remanded the issue of whether theexhibition display was a public use for furtherproceedings since the district court “focused on theabsence of any confidentiality agreements and didnot discuss or analyze how the totality of thecircumstances surrounding” the exhibition “comportswith the policies underlying the public use bar.” Id.

Rev. 08.2017, January 20182100-151


B. Use by Third Parties Deriving the Invention fromApplicant

An Invention Is in Public Use If the Inventor AllowsAnother To Use the Invention Without Restriction orObligation of Secrecy

“Public use” of a claimed invention under pre-AIA35 U.S.C. 102(b) occurs when the inventor allowsanother person to use the invention withoutlimitation, restriction or obligation of secrecy to theinventor.” In re Smith, 714 F.2d 1127, 1134, 218USPQ 976, 983 (Fed. Cir. 1983). The presence orabsence of a confidentiality agreement is not itselfdeterminative of the public use issue, but is onefactor to be considered along with the time, place,and circumstances of the use which show the amountof control the inventor retained over the invention. Moleculon Research Corp. v. CBS, Inc., 793 F.2d1261, 1265, 229 USPQ 805, 809 (Fed. Cir. 1986).See Ex parte C, 27 USPQ2d 1492, 1499 (Bd. Pat.App. & Inter. 1992) (Inventor sold inventive soybeanseeds to growers who contracted and were paid toplant the seeds to increase stock for later sale. Thecommercial nature of the use of the seed coupledwith the “on-sale” aspects of the contract andapparent lack of confidentiality requirements roseto the level of a “public use” bar.); Egbertv. Lippmann, 104 U.S. 333, 336 (1881) (Public usefound where inventor allowed another to useinventive corset insert, though hidden from viewduring use, because he did not impose an obligationof secrecy or restrictions on its use.).

C. Use by Independent Third Parties

Use by an Independent Third Party Is Public Use If ItSufficiently “Informs” the Public of the Invention or aCompetitor Could Reasonably Ascertain the Invention

Any “nonsecret” use of an invention by someoneunconnected to the inventor, such as someone whohas independently made the invention, in theordinary course of a business for trade or profit maybe a “public use,” Bird Provision Co. v. OwensCountry Sausage, Inc., 568 F.2d 369, 374-76, 197USPQ 134, 138-40 (5th Cir. 1978). Additionally,even a “secret” use by another inventor of a machineor process to make a product is “public” if the detailsof the machine or process are ascertainable byinspection or analysis of the product that is sold or

publicly displayed. Gillman v. Stern, 114 F.2d 28,46 USPQ 430 (2d Cir. 1940); Dunlop Holdings,Ltd. v. Ram Golf Corp., 524 F.2d 33, 36-7, 188USPQ 481, 483-484 (7th Cir. 1975). If the detailsof an inventive process are not ascertainable fromthe product sold or displayed and the third party haskept the invention as a trade secret then that use isnot a public use and will not bar a patent issuing tosomeone unconnected to the user. W.L. Gore &Assocs. v. Garlock, Inc., 721 F.2d 1540, 1550, 220USPQ 303, 310 (Fed. Cir. 1983). However, a devicequalifies as prior art if it places the claimed featuresin the public's possession before the critical dateeven if other unclaimed aspects of the device werenot publicly available. Lockwood v. AmericanAirlines, Inc., 107 F.3d 1505, 1570-71, 41 USPQ2d1961, 1964-65 (Fed. Cir. 1997) (Computerreservation system was prior art even though“essential algorithms of the SABRE software wereproprietary and confidential and...those aspects ofthe system that were readily apparent to the publicwould not have been sufficient to enable one skilledin the art to duplicate the [unclaimed aspects of the]system.”). The extent that the public becomes“informed” of an invention involved in public useactivity by one other than an applicant depends uponthe factual circumstances surrounding the activityand how these comport with the policies underlyingthe on sale and public use bars. Manville Sales Corp.v. Paramount Sys., Inc., 917 F.2d 544, 549, 16USPQ2d 1587, 1591 (Fed. Cir. 1990) (quoting KingInstrument Corp. v. Otari Corp., 767 F.2d 833, 860,226 USPQ 402, 406 (Fed. Cir. 1985)). By way ofexample, in an allegedly “secret” use by a third partyother than an applicant, if a large number ofemployees of such a party, who are not under apromise of secrecy, are permitted unimpeded accessto an invention, with affirmative steps by the partyto educate other employees as to the nature of theinvention, the public is “informed.” ChemithonCorp. v. Proctor & Gamble Co., 287 F. Supp. 291,308, 159 USPQ 139, 154 (D.Md. 1968), aff’d., 427F.2d 893, 165 USPQ 678 (4th Cir. 1970).

Even if public use activity by one other than anapplicant is not sufficiently “informing,” there maybe adequate grounds upon which to base a rejectionunder pre-AIA 35 U.S.C. 102(f) and pre-AIA 35U.S.C. 102(g). See Dunlop Holdings Ltd. v. Ram

2100-152Rev. 08.2017, January 2018


Golf Corp., 524 F.2d 33, 188 USPQ 481 (7th Cir.1975). See MPEP § 2137 and § 2138.

2133.03(b) “On Sale” [R-08.2017]


An impermissible sale has occurred if there was adefinite sale, or offer to sell, more than 1 year beforethe effective filing date of the U.S. application andthe subject matter of the sale, or offer to sell, fullyanticipated the claimed invention or would haverendered the claimed invention obvious by itsaddition to the prior art. Ferag AG v. Quipp, Inc.,45 F.3d 1562, 1565, 33 USPQ2d 1512, 1514 (Fed.Cir. 1995). The on-sale bar of pre-AIA 35 U.S.C.102(b) is triggered if the invention is both (1) thesubject of a commercial offer for sale not primarilyfor experimental purposes and (2) ready forpatenting. Pfaff v. Wells Elecs., Inc., 525 U.S. 55,67, 48 USPQ2d 1641, 1646-47 (1998). Traditionalcontract law principles are applied when determiningwhether a commercial offer for sale has occurred.See Linear Tech. Corp. v. Micrel, Inc., 275 F.3d1040, 1048, 61 USPQ2d 1225, 1229 (Fed. Cir.2001), petition for cert. filed, 71 USLW 3093 (July03, 2002) (No. 02-39); Group One, Ltd. v. HallmarkCards, Inc., 254 F.3d 1041,1047, 59 USPQ2d 1121,1126 (Fed. Cir. 2001) (“As a general proposition,we will look to the Uniform Commercial Code(‘UCC’) to define whether … a communication orseries of communications rises to the level of acommercial offer for sale.”).

I. THE MEANING OF “SALE”

A sale is a contract between parties wherein the selleragrees “to give and to pass rights of property” inreturn for the buyer’s payment or promise “to paythe seller for the things bought or sold.” In re

Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed.Cir. 1985). A contract for the sale of goods requiresa concrete offer and acceptance of that offer. See,e.g., Linear Tech., 275 F.3d at 1052-54, 61 USPQ2dat 1233-34 (Court held there was no sale within themeaning of pre-AIA 35 U.S.C. 102(b) whereprospective purchaser submitted an order for goodsat issue, but received an order acknowledgementreading “will advise-not booked.” Prospectivepurchaser would understand that order was notaccepted.).

“[T]o be ‘on sale’ under § 102(b), a product mustbe the subject of a commercial sale or offer for sale,”and to be a commercial sale it must be “one thatbears the general hallmarks of a sale pursuant toSection 2-106 of the Uniform Commercial Code.” Medicines Co. v. Hospira, Inc., 827 F.3d 1363, 1364119 USPQ2d 1329, 1330 (Fed. Cir. 2016) (en banc).The court in Medicines Co. went on to explain“[s]ection 2-106(1) of the Uniform CommercialCode describes a ‘sale’ as ‘the passing of title fromthe seller to the buyer for a price.’ U.C.C. § 2-106(1).The passage of title is a helpful indicator of whethera product is ‘on sale,’ as it suggests when theinventor gives up its interest and control over theproduct.” Id. at 1375, 119 USPQ2d at 1338. The Medicines Co. court held “a contract manufacturer’ssale to the inventor of manufacturing services whereneither title to the embodiments nor the right tomarket the same passes to the supplier does notconstitute an invalidating sale under § 102(b).” Id.at 1381, 119 USPQ2d at 1342.

A. Conditional Sale May Bar a Patent

An invention may be deemed to be “on sale” eventhough the sale was conditional. The fact that thesale is conditioned on buyer satisfaction does not,without more, prove that the sale was for anexperimental purpose. Strong v. General Elec. Co.,434 F.2d 1042, 1046, 168 USPQ 8, 12 (5th Cir.1970).

B. Nonprofit Sale May Bar a Patent

A “sale” need not be for profit to bar a patent. If thesale was for the commercial exploitation of theinvention, it is “on sale” within the meaning ofpre-AIA 35 U.S.C. 102(b). In re Dybel, 524 F.2d

Rev. 08.2017, January 20182100-153


1393, 1401, 187 USPQ 593, 599 (CCPA 1975)(“Although selling the devices for a profit wouldhave demonstrated the purpose of commercialexploitation, the fact that appellant realized no profitfrom the sales does not demonstrate the contrary.”).

C. A Single Sale or Offer To Sell May Bar a Patent

Even a single sale or offer to sell the invention maybar patentability under pre-AIA 35 U.S.C. 102(b). Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92,94 (1876); Atlantic Thermoplastics Co. v. FaytexCorp., 970 F.2d 834, 836-37, 23 USPQ2d 1481,1483 (Fed. Cir. 1992).

D. A Sale of Rights Is Not a Sale of the Invention andWill Not in Itself Bar a Patent

“[A]n assignment or sale of the rights in theinvention and potential patent rights is not a sale of‘the invention’ within the meaning of [pre-AIA]section 102(b).” Moleculon Research Corp. v. CBS,Inc., 793 F.2d 1261, 1267, 229 USPQ 805, 809 (Fed.Cir. 1986); see also Elan Corp., PLC v. AndrxPharms. Inc., 366 F.3d 1336, 1341, 70 USPQ2d1722, 1728 (Fed. Cir. 2004); In re Kollar, 286 F.3d1326, 1330 n.3, 1330-1331, 62 USPQ2d 1425, 1428n.3, 1428-1429 (Fed. Cir. 2002) (distinguishinglicenses which trigger the on-sale bar (e.g., astandard computer software license wherein theproduct is just as immediately transferred to thelicensee as if it were sold), from licenses that merelygrant rights to an invention which do not per setrigger the on-sale bar (e.g., exclusive rights tomarket the invention or potential patent rights)); Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d1041, 1049 n. 2, 59 USPQ2d 1121, 1129 n. 2 (Fed.Cir. 2001).

“[T]he mere sale of manufacturing services by acontract manufacturer to an inventor to createembodiments of a patented product for the inventordoes not constitute a ‘commercial sale’ of theinvention.” Medicines Co. v. Hospira, Inc., 827 F.3d1363, 1373 119 USPQ2d 1329, 1336 (Fed. Cir.2016) (en banc). The court in Medicines Co. furtherstated that “commercial benefit—even to both partiesin a transaction—is not enough to trigger the on-salebar of § 102(b); the transaction must be one in whichthe product is ‘on sale’ in the sense that it is

‘commercially marketed.’” Id. at 1373-74, 119USPQ2d at 1336-37.

E. Buyer Must Be Uncontrolled by the Seller orOfferer

A sale or offer for sale must take place betweenseparate entities. In re Caveney, 761 F.2d 671, 676,226 USPQ 1, 4 (Fed. Cir. 1985). Where the partiesto the alleged sale are related, whether there is astatutory bar depends on whether the seller socontrols the purchaser that the invention remains outof the public’s hands. Ferag AG v. Quipp, Inc., 45F.3d 1562, 1566, 33 USPQ2d 1512, 1515 (Fed. Cir.1995) (Where the seller is a parent company of thebuyer company, but the President of the buyercompany had “essentially unfettered” managementauthority over the operations of the buyer company,the sale was a statutory bar.).

II. OFFERS FOR SALE

“Only an offer which rises to the level of acommercial offer for sale, one which the other partycould make into a binding contract by simpleacceptance (assuming consideration), constitutes anoffer for sale under §102(b).” Group One, Ltd. v.Hallmark Cards, Inc., 254 F.3d 1041,1048, 59USPQ2d 1121, 1126 (Fed. Cir. 2001).

A. Rejected or Unreceived Offer for Sale Is EnoughTo Bar a Patent

Since the statute creates a bar when an invention isplaced “on sale,” a mere offer to sell is sufficientcommercial activity to bar a patent. In re Theis, 610F.2d 786, 791, 204 USPQ 188, 192 (CCPA 1979).Even a rejected offer may create an on sale bar. UMC Elecs. v. United States, 816 F.2d 647, 653, 2USPQ2d 1465, 1469 (Fed. Cir. 1987). In fact, theoffer need not even be actually received by aprospective purchaser. Wende v. Horine, 225 F. 501(7th Cir. 1915).

B. Delivery of the Offered Item Is Not Required

“It is not necessary that a sale be consummated forthe bar to operate.” Buildex v. Kason Indus., Inc.,849 F.2d 1461, 1463-64, 7 USPQ2d 1325, 1327-28(Fed. Cir. 1988) (citations omitted). See also

2100-154Rev. 08.2017, January 2018


Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d1326, 1333, 49 USPQ2d 1001, 1006-07 (Fed. Cir.1998) (A signed purchase agreement prior to thecritical date constituted a commercial offer; it wasimmaterial that there was no delivery of laterpatented caps and no exchange of money until aftercritical date.).

C. Seller Need Not Have the Goods “On Hand” Whenthe Offer for Sale Is Made

Goods need not be “on hand” and transferred at thetime of the sale or offer. The date of the offer forsale is the effective date of the “on sale” activity. J.A. La Porte, Inc. v. Norfolk Dredging Co., 787 F.2d1577, 1582, 229 USPQ 435, 438 (Fed. Cir. 1986).However, the invention must be complete and “readyfor patenting” (see MPEP § 2133.03(c)) before thecritical date. Pfaff v. Wells Elecs., Inc., 525 U.S. 55,67, 48 USPQ2d 1641, 1647 (1998). See also MicroChemical, Inc. v. Great Plains Chemical Co., 103F.3d 1538, 1545, 41 USPQ2d 1238, 1243 (Fed. Cir.1997) (The on-sale bar was not triggered by an offerto sell because the inventor “was not close tocompletion of the invention at the time of the allegedoffer and had not demonstrated a high likelihoodthat the invention would work for its intendedpurpose upon completion.”); Shatterproof GlassCorp. v. Libbey-Owens Ford Co., 758 F.2d 613, 225USPQ 634 (Fed. Cir. 1985) (Where there was noevidence that the samples shown to the potentialcustomers were made by the new process andapparatus, the offer to sell did not rise to the levelof an on sale bar.). Compare Barmag BarmerMaschinenfabrik AG v. Murata Mach., Ltd., 731F.2d 831, 221 USPQ 561 (Fed. Cir. 1984) (Wherea “make shift” model of the inventive product wasshown to the potential purchasers in conjunctionwith the offer to sell, the offer was enough to bar apatent under pre-AIA 35 U.S.C. 102(b).).

D. Material Terms of an Offer for Sale Must bePresent

“[A] communication that fails to constitute a definiteoffer to sell the product and to include material termsis not an ‘offer’ in the contract sense.” Elan Corp.,PLC v. Andrx Pharms. Inc., 366 F.3d 1336, 1341,70 USPQ2d 1722, 1728 (Fed. Cir. 2004). The courtstated that an “offer to enter into a license under a

patent for future sale of the invention covered by thepatent when and if it has been developed... is not anoffer to sell the patented invention that constitutesan on-sale bar.” Id., 70 USPQ2d at 1726.Accordingly, the court concluded that Elan’s letterwas not an offer to sell a product. In addition, thecourt stated that the letter lacked material terms ofa commercial offer such as pricing for the product,quantities, time and place of delivery, and productspecifications and that the dollar amount in the letterwas not a price term for the sale of the product butrather the amount requested was to form andcontinue a partnership, explicitly referred to as a“licensing fee.” Id.

III. SALE BY INVENTOR, ASSIGNEE OR OTHERSASSOCIATED WITH THE INVENTOR IN THECOURSE OF BUSINESS

A. Sale Activity Need Not Be Public

Unlike questions of public use, there is norequirement that “on sale” activity be “public.”“Public” as used in pre-AIA 35 U.S.C. 102(b)modifies “use” only. “Public” does not modify“sale.” Hobbs v. United States, 451 F.2d 849, 171USPQ 713, 720 (5th Cir. 1971).

B. Inventor’s Consent to the Sale Is Not a PrerequisiteTo Finding an On Sale Bar

If the invention was placed on sale by a third partywho obtained the invention from the inventor, apatent is barred even if the inventor did not consentto the sale or have knowledge that the invention wasembodied in the sold article. Electric StorageBattery Co. v. Shimadzu, 307 U.S. 5, 41 USPQ 155(1938); In re Blaisdell, 242 F.2d 779, 783, 113USPQ 289, 292 (CCPA 1957); CTS Corp. v. ElectroMaterials Corp. of America, 469 F. Supp. 801, 819,202 USPQ 22, 38 (S.D.N.Y. 1979).

C. Objective Evidence of Sale or Offer To Sell IsNeeded

In determining if a sale or offer to sell the claimedinvention has occurred, a key question to ask iswhether the inventor sold or offered for sale aproduct that embodies the invention claimed in theapplication. Objective evidence such as a description

Rev. 08.2017, January 20182100-155


of the inventive product in the contract of sale or inanother communication with the purchaser controlsover an uncommunicated intent by the seller todeliver the inventive product under the contract forsale. Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1567,33 USPQ2d 1512, 1516 (Fed. Cir. 1995) (On salebar found where initial negotiations and agreementcontaining contract for sale neither clearly specifiednor precluded use of the inventive design, but anorder confirmation prior to the critical date didspecify use of inventive design.). The purchaser neednot have actual knowledge of the invention for it tobe on sale. The determination of whether “the offeredproduct is in fact the claimed invention may beestablished by any relevant evidence, such asmemoranda, drawings, correspondence, andtestimony of witnesses.” RCA Corp. v. Data Gen.Corp., 887 F.2d 1056, 1060, 12 USPQ2d 1449, 1452(Fed. Cir. 1989). However, “what the purchaserreasonably believes the inventor to be offering isrelevant to whether, on balance, the offer objectivelymay be said to be of the patented invention.” Envirotech Corp. v. Westech Eng’g, Inc., 904 F.2d1571, 1576, 15 USPQ2d 1230, 1234 (Fed. Cir. 1990)(Where a proposal to supply a general contractorwith a product did not mention a new design but,rather, referenced a prior art design, theuncommunicated intent of the supplier to supply thenew design if awarded the contract did not constitutean “on sale” bar to a patent on the new design, eventhough the supplier’s bid reflected the lower cost ofthe new design.).

IV. SALES BY INDEPENDENT THIRD PARTIES

A. Sales or Offers for Sale by Independent ThirdParties Will Bar a Patent

Sale or offer for sale of the invention by anindependent third party more than 1 year before thefiling date of applicant’s patent will bar applicantfrom obtaining a patent. “An exception to this ruleexists where a patented method is kept secret andremains secret after a sale of the unpatented productof the method. Such a sale prior to the critical dateis a bar if engaged in by the patentee or patentapplicant, but not if engaged in by another.” In reCaveney, 761 F.2d 671, 675-76, 226 USPQ 1, 3-4(Fed. Cir. 1985).

B. Nonprior Art Publications Can Be Used as Evidenceof Sale Before the Critical Date

Abstracts identifying a product’s vendor containinginformation useful to potential buyers such as whomto contact, price terms, documentation, warranties,training and maintenance along with the date ofproduct release or installation before the inventor’scritical date may provide sufficient evidence of priorsale by a third party to support a rejection based onpre-AIA 35 U.S.C. 102(b) or 103. In re Epstein, 32F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994)(Examiner's rejection was based on nonprior artpublished abstracts which disclosed softwareproducts meeting the claims. The abstracts specifiedsoftware release dates and dates of first installationwhich were more than 1 year before applicant’sfiling date.).

2133.03(c) The “Invention” [R-11.2013]




*****

(b) the invention was…in public use or on sale in thiscountry, more than one year prior to the date of the applicationfor patent in the United States

*****

(Emphasis added).

I. THE INVENTION MUST BE “READY FORPATENTING”

In Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 66-68,48 USPQ2d 1641, 1647 (1998), the Supreme Courtenunciated a two-prong test for determining whether

2100-156Rev. 08.2017, January 2018


an invention was “on sale” within the meaning ofpre-AIA 35 U.S.C. 102(b) even if it has not yet beenreduced to practice. “[T]he on-sale bar applies whentwo conditions are satisfied before the critical date[more than one year before the effective filing dateof the U.S. application]. First, the product must bethe subject of a commercial offer for sale…. Second,the invention must be ready for patenting.” Id. at67, 119 S.Ct. at 311-12, 48 USPQ2d at 1646-47.

The Federal Circuit explained that the SupremeCourt’s “ready for patenting” prong applies in thecontext of both the on sale and public use bars. Invitrogen Corp. v. Biocrest Manufacturing L.P.,424 F.3d 1374, 1379, 76 USPQ2d 1741, 1744 (Fed.Cir. 2005) (“A bar under [pre-AIA] section 102(b)arises where, before the critical date, the inventionis in public use and ready for patenting.”). “Readyfor patenting,” the second prong of the Pfaff test,“may be satisfied in at least two ways: by proof ofreduction to practice before the critical date; or byproof that prior to the critical date the inventor hadprepared drawings or other descriptions of theinvention that were sufficiently specific to enable aperson skilled in the art to practice the invention.” Id. at 67, 199 S.Ct. at 311-12, 48 USPQ2d at 1647(The patent was held invalid because the inventionfor a computer chip socket was “ready for patenting”when it was offered for sale more than one year priorto the application filing date. Even though theinvention had not yet been reduced to practice, themanufacturer was able to produce the claimedcomputer chip sockets using the inventor’s detaileddrawings and specifications, and those socketscontained all elements of invention claimed in thepatent.). See also Weatherchem Corp. v. J.L. ClarkInc., 163 F.3d 1326, 1333, 49 USPQ2d 1001,1006-07 (Fed. Cir. 1998) (The invention was held“ready for patenting” since the detailed drawings ofplastic dispensing caps offered for sale “containedeach limitation of the claims and were sufficientlyspecific to enable person skilled in art to practicethe invention”.).

If the invention was actually reduced to practicebefore being sold or offered for sale more than 1year before filing of the application, a patent will bebarred. Vanmoor v. Wal-Mart Stores, Inc., 201 F.3d1363, 1366-67, 53 USPQ2d 1377, 1379 (Fed. Cir.2000) (“Here the pre-critical date sales were of

completed cartridges made to specifications thatremained unchanged to the present day, showingthat any invention embodied in the accusedcartridges was reduced to practice before the criticaldate. The Pfaff ready for patenting condition is alsosatisfied because the specification drawings,available prior to the critical date, were actually usedto produce the accused cartridges.”); In re Hamilton,882 F.2d 1576, 1580, 11 USPQ2d 1890, 1893 (Fed.Cir. 1989). “If a product that is offered for saleinherently possesses each of the limitations of theclaims, then the invention is on sale, whether or notthe parties to the transaction recognize that theproduc t possesses the c la imedcharacteristics.” Abbott Laboratories v. GenevaPharmaceuticals, Inc., 182 F.3d 1315, 1319, 51USPQ2d 1307, 1310 (Fed. Cir. 1999) (Claim for aparticular anhydrous crystalline form of apharmaceutical compound was held invalid underthe on-sale bar of pre-AIA 35 U.S.C. 102(b), eventhough the parties to the U.S. sales of the foreignmanufactured compound did not know the identityof the particular crystalline form.); STX LLC. v.Brine Inc., 211 F.3d 588, 591, 54 USPQ2d 1347,1350 (Fed. Cir. 2000) (Claim for a lacrosse stickwas held invalid under the on-sale bar despite theargument that it was not known at the time of salewhether the sticks possessed the recited “improvedplaying and handling characteristics.” “Subjectivequalities inherent in a product, such as ‘improvedplaying and handling’, cannot serve as an escapehatch to circumvent an on-sale bar.”). Actualreduction to practice in the context of an on-sale barissue usually requires testing under actual workingconditions in such a way as to demonstrate thepractical utility of an invention for its intendedpurpose beyond the probability of failure, unless byvirtue of the very simplicity of an invention itspractical operativeness is clear. Field v. Knowles,183 F.2d 593, 601, 86 USPQ 373, 379 (CCPA 1950); Steinberg v. Seitz, 517 F.2d 1359, 1363, 186 USPQ209, 212 (CCPA 1975).

The invention need not be ready for satisfactorycommercial marketing for sale to bar a patent. Atlantic Thermoplastics Co. v. Faytex Corp., 970F.2d 834, 836-37, 23 USPQ2d 1481, 1483 (Fed. Cir.1992).

Rev. 08.2017, January 20182100-157


II. INVENTOR HAS SUBMITTED A 37 CFR 1.131AFFIDAVIT OR DECLARATION

Affidavits or declarations submitted under 37 CFR1.131 to swear behind a reference may constitute,among other things, an admission that an inventionwas “complete” more than 1 year before the filingof an application. See In re Foster, 343 F.2d 980,987-88, 145 USPQ 166, 173 (CCPA 1965); DartIndus. v. E.I. duPont de Nemours & Co., 489 F.2d1359, 1365, 179 USPQ 392, 396 (7th Cir. 1973).Also see MPEP § 715.10.

III. SALE OF A PROCESS

A claimed process, which is a series of acts or steps,is not sold in the same sense as is a claimed product,device, or apparatus, which is a tangible item.“‘Know-how’ describing what the process consistsof and how the process should be carried out maybe sold in the sense that the buyer acquiresknowledge of the process and obtains the freedomto carry it out pursuant to the terms of thetransaction. However, such a transaction is not a‘sale’ of the invention within the meaning of[pre-AIA] §102(b) because the process has not beencarried out or performed as a result of thetransaction.” In re Kollar, 286 F.3d 1326, 1332,62 USPQ2d 1425, 1429 (Fed. Cir. 2002). However,sale of a product made by the claimed process bythe patentee or a licensee would constitute a sale ofthe process within the meaning of pre-AIA 35 U.S.C.102(b). See id. at 1333, 62 USPQ2d at 1429; D.L.Auld Co. v. Chroma Graphics Corp., 714 F.2d 1144,1147-48, 219 USPQ 13, 15-16 (Fed. Cir. 1983)(Even though the sale of a product made by aclaimed method before the critical date did not revealanything about the method to the public, the saleresulted in a “forfeiture” of any right to a patent tothat method); W.L. Gore & Assocs., Inc. v. Garlock,Inc., 721 F.2d 1540, 1550, 220 USPQ 303, 310 (Fed.Cir. 1983). The application of pre-AIA 35 U.S.C.102(b) would also be triggered by actuallyperforming the claimed process itself forconsideration. See Scaltech, Inc. v. Retec/Tetra,L.L.C., 269 F.3d 1321, 1328, 60 USPQ2d 1687,1691(Fed. Cir. 2001) (Patent was held invalid underpre-AIA 35 U.S.C. 102(b) based on patentee’s offerto perform the claimed process for treating oilrefinery waste more than one year before filing the

patent application). Moreover, the sale of a deviceembodying a claimed process may trigger the on-salebar. Minton v. National Ass’n. of Securities Dealers,Inc., 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1618(Fed. Cir. 2003) (finding a fully operationalcomputer program implementing and thusembodying the claimed method to trigger the on-salebar). However, the sale of a prior art device differentfrom that disclosed in a patent that is asserted afterthe critical date to be capable of performing theclaimed method is not an on-sale bar of the process. Poly-America LP v. GSE Lining Tech. Inc., 383F.3d 1303, 1308-09, 72 USPQ2d 1685, 1688-89(Fed. Cir. 2004) (stating that the transactioninvolving the sale of the prior art device did notinvolve a transaction of the claimed method butinstead only a device different from that describedin the patent for carrying out the claimed method,where the device was not used to practice theclaimed method until well after the critical date, andwhere there was evidence that it was not even knownwhether the device could perform the claimedprocess).

2133.03(d) “In This Country” [R-11.2013]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions. See MPEP § 2152.02(c)through (e) for a detailed discussion of the publicuse and on sale provisions of AIA 35 U.S.C. 102.]

For purposes of judging the applicability of thepre-AIA 35 U.S.C. 102(b) bars, public use or on saleactivity must take place in the United States. The“on sale” bar does not generally apply where bothmanufacture and delivery occur in a foreign country. Gandy v. Main Belting Co., 143 U.S. 587, 593(1892). However, “on sale” status can be found ifsubstantial activity prefatory to a “sale” occurs inthe United States. Robbins Co. v. Lawrence Mfg.Co., 482 F.2d 426, 433, 178 USPQ 577, 583 (9thCir. 1973). An offer for sale, made or originating inthis country, may be sufficient prefatory activity tobring the offer within the terms of the statute, even

2100-158Rev. 08.2017, January 2018


though sale and delivery take place in a foreigncountry. The same rationale applies to an offer by aforeign manufacturer which is communicated to aprospective purchaser in the United States prior tothe critical date. CTS Corp. v. Piher Int’l Corp., 593F.2d 777, 201 USPQ 649 (7th Cir. 1979).

2133.03(e) Permitted Activity; ExperimentalUse [R-11.2013]


The question posed by the experimental use doctrineis “whether the primary purpose of the inventor atthe time of the sale, as determined from an objectiveevaluation of the facts surrounding the transaction,was to conduct experimentation.” Allen Eng’g Corp.v. Bartell Indus., Inc., 299 F.3d 1336, 1354, 63USPQ2d 1769, 1780 (Fed. Cir. 2002) (quoting EZDock v. Schafer Sys., Inc., 276 F.3d 1347, 1356-57,61 USPQ2d 1289, 1295-96 (Fed. Cir. 2002)) (Linn,J., concurring). Experimentation must be the primarypurpose and any commercial exploitation must beincidental.

If the use or sale was experimental, there is no barunder pre-AIA 35 U.S.C. 102(b). “A use or sale isexperimental for purposes of pre-AIA section 102(b)if it represents a bona fide effort to perfect theinvention or to ascertain whether it will answer itsintended purpose.… If any commercial exploitationdoes occur, it must be merely incidental to theprimary purpose of the experimentation to perfectthe invention.” LaBounty Mfg. v. United States Int’lTrade Comm’n, 958 F.2d 1066, 1071, 22 USPQ2d1025, 1028 (Fed. Cir. 1992) (quoting PennwaltCorp. v. Akzona Inc., 740 F.2d 1573, 1581, 222USPQ 833, 838 (Fed. Cir. 1984)). “The experimentaluse exception…does not include market testingwhere the inventor is attempting to gauge consumer

demand for his claimed invention. The purpose ofsuch activities is commercial exploitation and notexperimentation.” In re Smith, 714 F.2d 1127, 1134,218 USPQ 976, 983 (Fed. Cir. 1983).

2133.03(e)(1) Commercial Exploitation[R-08.2017]


One policy of the on sale and public use bars is theprevention of inventors from exploiting theirinventions commercially more than 1 year prior tothe filing of a patent application. Therefore, ifapplicant’s precritical date activity is a sale or offerfor sale that is an attempt at market penetration, apatent is barred. Thus, even if there is bona fideexperimental activity, an inventor may notcommercially exploit an invention more than 1 yearprior to the filing date of an application. In re Theis,610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA1979).

I. THE COMMERCIAL ACTIVITY MUSTLEGITIMATELY ADVANCE DEVELOPMENT OFTHE INVENTION TOWARDS COMPLETION

As the degree of commercial exploitationsurrounding pre-AIA 35 U.S.C. 102(b) activityincreases, the burden on an applicant to establishclear and convincing evidence of experimentalactivity with respect to a public use becomes moredifficult. Where the examiner has found a primafacie case of a sale or an offer to sell, this burdenwill rarely be met unless clear and convincingnecessity for the experimentation is established bythe applicant. This does not mean, of course, thatthere are no circumstances which would permitalleged experimental activity in an atmosphere ofcommercial exploitation. In certain circumstances,

Rev. 08.2017, January 20182100-159

§ 2133.03(e)(1)PATENTABILITY

even a sale may be necessary to legitimately advancethe experimental development of an invention if theprimary purpose of the sale is experimental. In reTheis, 610 F.2d 786, 793, 204 USPQ 188, 194(CCPA 1979); Robbins Co. v. Lawrence Mfg. Co.,482 F.2d 426, 433, 178 USPQ 577, 582 (9th Cir.1973). However, careful scrutiny by the examinerof the objective factual circumstances surroundingsuch a sale is essential. See Ushakoff v. UnitedStates, 327 F.2d 669, 140 USPQ 341 (Ct.Cl. 1964); Cloud v. Standard Packaging Corp., 376 F.2d 384,153 USPQ 317 (7th Cir. 1967).

II. SIGNIFICANT FACTORS INDICATIVE OF“COMMERCIAL EXPLOITATION”

As discussed in MPEP § 2133.03, a policyconsideration in questions of pre-AIA 35 U.S.C.102(b) activity is premature “commercialexploitation” of a “completed” or “ready forpatenting” invention (see MPEP § 2133.03(c)). Theextent of commercial activity which constitutespre-AIA 35 U.S.C. 102(b) “on sale” status dependsupon the circumstances of the activity, the basicindicator being the subjective intent of the inventoras manifested through objective evidence. Thefollowing activities should be used by the examineras indicia of this subjective intent:

(A) Preparation of various contemporaneous“commercial” documents, e.g., orders, invoices,receipts, delivery schedules, etc.;

(B) Preparation of price lists (AkronBrass Co. v. Elkhart Brass Mfg. Co., 353 F.2d 704,709, 147 USPQ 301, 305 (7th Cir. 1965)) anddistribution of price quotations (Amphenol Corp. v.Gen'l Time Corp., 397 F.2d 431, 436, 158 USPQ113, 117 (7th Cir. 1968));

(C) Display of samples to prospective customers (Cataphote Corp. v. DeSoto ChemicalCoatings, Inc., 356 F.2d 24, 27, 148 USPQ 527, 529(9th Cir. 1966) mod. on other grounds, 358 F.2d732, 149 USPQ 159 (9th Cir.), cert. denied, 385U.S. 832 (1966); Chicopee Mfg. Corp. v. ColumbusFiber Mills Co., 165 F.Supp. 307, 323-325, 118USPQ 53, 65-67 (M.D.Ga. 1958));

(D) Demonstration of models or prototypes (General Elec. Co. v. United States, 206 USPQ 260,266-67 (Ct. Cl. 1979); Red Cross Mfg. v. Toro SalesCo., 525 F.2d 1135, 1140, 188 USPQ 241, 244-45

(7th Cir. 1975); Philco Corp. v. Admiral Corp., 199F. Supp. 797, 815-16, 131 USPQ 413, 429-30 (D.Del. 1961)), especially at trade conventions (Interroyal Corp. v. Simmons Co., 204 USPQ 562,563-65 (S.D. N.Y. 1979)), and even though no ordersare actually obtained (Monogram Mfg. v. F. & H.Mfg., 144 F.2d 412, 62 USPQ 409, 412 (9th Cir.1944));

(E) Use of an invention where an admission feeis charged (In re Josserand, 188 F.2d 486, 491, 89USPQ 371, 376 (CCPA 1951); Greenewalt v.Stanley, 54 F.2d 195, 12 USPQ 122 (3d Cir. 1931));and

(F) Advertising in publicity releases, brochures,and various periodicals (In re Theis, 610 F.2d 786,792 n.6, 204 USPQ 188, 193 n. 6 (CCPA 1979); Interroyal Corp. v. Simmons Co., 204 USPQ 562,564-66 (S.D.N.Y.1979); Akron Brass, Co. v. ElkhartBrass Mfg., Inc., 353 F.2d 704, 709, 147 USPQ 301,305 (7th Cir.1965); Tucker Aluminum Prods. v.Grossman, 312 F.2d 393, 394, 136 USPQ 244, 245(9th Cir. 1963)).

See MPEP § 2133.03(e)(4) for factors indicative ofan experimental purpose.

2133.03(e)(2) Intent [R-11.2013]


“When sales are made in an ordinary commercialenvironment and the goods are placed outside theinventor’s control, an inventor’s secretly heldsubjective intent to ‘experiment,’ even if true, isunavailing without objective evidence to support thecontention. Under such circumstances, the customerat a minimum must be made aware of theexperimentation.” LaBounty Mfg., Inc. v. UnitedStates Int’l Trade Comm’n, 958 F.2d 1066, 1072,22 USPQ2d 1025, 1029 (Fed. Cir. 1992) (quoting

2100-160Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2133.03(e)(2)

Harrington Mfg. Co. v. Powell Mfg. Co., 815 F.2d1478, 1480 n.3, 2 USPQ2d 1364, 1366 n.3 (Fed. Cir.1986); Paragon Podiatry Laboratory, Inc. v. KLMLabs., Inc., 984 F.2d 1182, 25 USPQ2d 1561 (Fed.Cir. 1993) (Paragon sold the inventive units to thetrade as completed devices without any disclosureto either doctors or patients of their involvement inalleged testing. Evidence of the inventor’s secretlyheld belief that the units were not durable and maynot be satisfactory for consumers was not sufficient,alone, to avoid a statutory bar.).

2133.03(e)(3) “Completeness” of theInvention [R-11.2013]


I. EXPERIMENTAL USE ENDS WHEN THEINVENTION IS ACTUALLY REDUCED TOPRACTICE

Experimental use “means perfecting or completingan invention to the point of determining that it willwork for its intended purpose.” Therefore,experimental use “ends with an actual reduction topractice.” RCA Corp. v. Data Gen. Corp., 887 F.2d1056, 1061, 12 USPQ2d 1449, 1453 (Fed. Cir.1989). If the examiner concludes from the evidenceof record that an applicant was satisfied that aninvention was in fact “complete,” awaiting approvalby the applicant from an organization such asUnderwriters’ Laboratories will not normallyovercome this conclusion. Interroyal Corp. v.Simmons Co., 204 USPQ 562, 566 (S.D.N.Y. 1979); Skil Corp. v. Rockwell Manufacturing Co., 358 F.Supp. 1257, 1261, 178 USPQ 562, 565 (N.D.Ill.1973), aff’d. in part, rev’d in part sub nom. SkilCorp. v. Lucerne Products Inc., 503 F.2d 745, 183USPQ 396, 399 (7th Cir. 1974), cert. denied, 420U.S. 974, 185 USPQ 65 (1975). See MPEP

§ 2133.03(c) for more information of whatconstitutes a “complete” invention.

The fact that alleged experimental activity does notlead to specific modifications or refinements of aninvention is evidence, although not conclusiveevidence, that such activity is not within the realmpermitted by the statute. This is especially the casewhere the evidence of record clearly demonstratesto the examiner that an invention was considered“complete” by an inventor at the time of the activity.Nevertheless, any modifications or refinementswhich did result from such experimental activitymust at least be a feature of the claimed inventionto be of any probative value. In re Theis, 610 F.2d786, 793, 204 USPQ 188, 194 (CCPA 1979).

II. DISPOSAL OF PROTOTYPES

Where a prototype of an invention has been disposedof by an inventor before the critical date, inquiry bythe examiner should focus upon the intent of theinventor and the reasonableness of the disposal underall circumstances. The fact that an otherwisereasonable disposal of a prototype involvesincidental income is not necessarily fatal. In reDybel, 524 F.2d 1393, 1399, n.5, 187 USPQ 593,597 n.5 (CCPA 1975). However, if a prototype isconsidered “complete” by an inventor and allexperimentation on the underlying invention hasceased, unrestricted disposal of the prototypeconstitutes a bar under pre-AIA 35 U.S.C. 102(b). In re Blaisdell, 242 F.2d 779, 113 USPQ 289(CCPA 1957); contra, Watson v. Allen, 254 F.2d342, 117 USPQ 68 (D.C. Cir. 1958).

2133.03(e)(4) Factors Indicative of anExperimental Purpose [R-11.2013]


Rev. 08.2017, January 20182100-161

§ 2133.03(e)(4)PATENTABILITY

The courts have considered a number of factors indetermining whether a claimed invention was thesubject of a commercial offer for sale primarily forpurposes of experimentation. “These factors include:(1) the necessity for public testing, (2) the amountof control over the experiment retained by theinventor, (3) the nature of the invention, (4) thelength of the test period, (5) whether payment wasmade, (6) whether there was a secrecy obligation,(7) whether records of the experiment were kept, (8)who conducted the experiment, ... (9) the degree ofcommercial exploitation during testing[,] ... (10)whether the invention reasonably requires evaluationunder actual conditions of use, (11) whether testingwas systematically performed, (12) whether theinventor continually monitored the invention duringtesting, and (13) the nature of contacts made withpotential customers.” Allen Eng’g Corp. v. BartellIndus., Inc., 299 F.3d 1336, 1353, 63 USPQ2d 1769,1780 (Fed. Cir. 2002) (quoting EZ Dock v. SchaferSys., Inc., 276 F.3d 1347, 1357, 61 USPQ2d 1289,1296 (Fed. Cir. 2002)) (Linn, J., concurring).Another critical attribute of experimentation is the“customer’s awareness of the purported testing inthe context of a sale.” Electromotive Div. of Gen.Motors Corp. v. Transportation Sys. Div. of Gen.Elec. Co., 417 F.3d 1203, 1241, 75 USPQ2d 1650,1658 (Fed. Cir. 2005).

Once alleged experimental activity is advanced byan applicant to explain a prima facie case underpre-AIA 35 U.S.C. 102(b), the examiner mustdetermine whether the scope and length of theactivity were reasonable in terms of the experimentalpurpose intended by the applicant and the nature ofthe subject matter involved. No one of, or particularcombination of, factors is necessarily determinativeof this purpose.

See MPEP § 2133.03(e)(1) for factors indicative ofcommercial exploitation.

2133.03(e)(5) Experimentation and Degreeof Supervision and Control [R-11.2013]

[Editor Note: This MPEP section has limitedapplicability to applications subject to examinationunder the first inventor to file (FITF) provisions ofthe AIA as set forth in 35 U.S.C. 100 (note). SeeMPEP § 2159 et seq. to determine whether an

application is subject to examination under the FITFprovisions, and MPEP § 2150 et seq. forexamination of applications subject to thoseprovisions. See MPEP § 2152.02(c) through (e) fora detailed discussion of the public use and on saleprovisions of AIA 35 U.S.C. 102.]

THE INVENTOR MUST MAINTAIN SUFFICIENTCONTROL OVER THE INVENTION DURINGTESTING BY THIRD PARTIES

The significant determinative factors in questionsof experimental purpose are the extent of supervisionand control maintained by an inventor over aninvention during an alleged period ofexperimentation , and the customer’s awareness ofthe experimentation. Electromotive Div. of Gen.Motors Corp. v. Transportation Sys. Div. of Gen.Elec. Co., 417 F.3d 1203, 1214,75 USPQ2d 1650,1658 (Fed. Cir. 2005)(“control and customerawareness ordinarily must be proven ifexperimentation is to be found”). Once a period ofexperimental activity has ended and supervision andcontrol has been relinquished by an inventor withoutany restraints on subsequent use of an invention, anunrestricted subsequent use of the invention is apre-AIA 35 U.S.C. 102(b) bar. In re Blaisdell, 242F.2d 779, 784, 113 USPQ 289, 293 (CCPA 1957).

2133.03(e)(6) Permitted ExperimentalActivity and Testing [R-11.2013]


I. DEVELOPMENTAL TESTING IS PERMITTED

Testing of an invention in the normal context of itstechnological development is generally within therealm of permitted experimental activity. Likewise,experimentation to determine utility, as that term

2100-162Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2133.03(e)(5)

is applied in 35 U.S.C. 101, may also constitutepermissible activity. See General Motors Corp. v.Bendix Aviation Corp., 123 F. Supp. 506, 521, 102USPQ 58, 69 (N.D.Ind. 1954). For example, wherean invention relates to a chemical composition withno known utility, i.e., a patent application for thecomposition could not be filed (35 U.S.C. 101; 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph), continued testing to find utility wouldlikely be permissible under pre-AIA 35 U.S.C.102(b), absent a sale of the composition or otherevidence of commercial exploitation.

II. MARKET TESTING IS NOT PERMITTED

Experimentation to determine product acceptance,i.e., market testing, is typical of a trader’s and notan inventor’s experiment and is thus not within thearea of permitted experimental activity. Smith &Davis Mfg. Co. v. Mellon, 58 F. 705, 707 (8th Cir.1893) Likewise, testing of an invention for thebenefit of appeasing a customer, or to conduct“minor ‘tune up’ procedures not requiring aninventor’s skills, but rather the skills of a competenttechnician,” are also not within the exception. In reTheis, 610 F.2d 786, 793, 204 USPQ 188, 193-94(CCPA 1979).

III. EXPERIMENTAL ACTIVITY IN THECONTEXT OF DESIGN APPLICATIONS

The public use of an ornamental design which isdirected toward generating consumer interest in theaesthetics of the design is not an experimental use. In re Mann, 861 F.2d 1581, 8 USPQ2d 2030 (Fed.Cir. 1988) (display of a wrought iron table at a tradeshow held to be public use). However,“experimentation directed to functional features ofa product also containing an ornamental design maynegate what otherwise would be considered a publicuse within the meaning of section 102(b).” ToneBrothers, Inc. v. Sysco Corp., 28 F.3d 1192, 1196,31 USPQ2d 1321, 1326 (Fed. Cir. 1994) (A studywherein students evaluated the effect of thefunctional features of a spice container design maybe considered an experimental use.).

2133.03(e)(7) Activity of an IndependentThird Party Inventor [R-08.2017]


EXPERIMENTAL USE EXCEPTION IS PERSONALTO AN APPLICANT

The statutory bars of pre-AIA 35 U.S.C. 102(b) areapplicable even though public use or on sale activityis by a party other than an applicant. Where anapplicant presents evidence of experimental activityby such other party, the evidence will not overcomethe prima facie case under pre-AIA 35 U.S.C.102(b) based upon the activity of such party unlessthe activity was under the supervision and controlof the applicant. Magnetics v. Arnold Eng’g Co.,438 F.2d 72, 74, 168 USPQ 392, 394 (7th Cir. 1971), Bourne v. Jones, 114 F.Supp. 413, 419, 98 USPQ206, 210 (S.D. Fla. 1951), aff'd., 207 F.2d 173, 98USPQ 205 (5th Cir. 1953), cert. denied, 346 U.S.897, 99 USPQ 490 (1953); contra, Watson v. Allen,254 F.2d 342, 117 USPQ 68 (D.C.Cir. 1958). Inother words, the experimental use activity exceptionis personal to an applicant.

2134 Pre-AIA 35 U.S.C. 102(c) [R-11.2013]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions.]



Rev. 08.2017, January 20182100-163


*****

(c) he has abandoned the invention.

*****

I. UNDER 35 U.S.C. 102(c), AN ABANDONMENTMUST BE INTENTIONAL

“Actual abandonment under pre-AIA 35 U.S.C.102(c) requires that the inventor intend to abandonthe invention, and intent can be implied from theinventor’s conduct with respect to the invention. Inre Gibbs, 437 F.2d 486, 168 USPQ 578 (CCPA1971). Such intent to abandon the invention will notbe imputed, and every reasonable doubt should beresolved in favor of the inventor.” Ex parte Dunne,20 USPQ2d 1479 (Bd. Pat. App. & Inter. 1991).

II. DELAY IN MAKING FIRST APPLICATION

Abandonment under pre-AIA 35 U.S.C. 102(c)requires a deliberate, though not necessarily express,surrender of any rights to a patent. To abandon theinvention the inventor must intend a dedication tothe public. Such dedication may be either expressor implied, by actions or inactions of the inventor.Delay alone is not sufficient to infer the requisiteintent to abandon. Moore v. United States, 194USPQ 423, 428 (Ct. Cl. 1977) (The drafting andretention in his own files of two patent applicationsby inventor indicates an intent to retain his invention;delay in filing the applications was not sufficient toestablish abandonment); but see Davis HarvesterCo., Inc. v. Long Mfg. Co., 252 F. Supp. 989,1009-10, 149 USPQ 420, 435-436 (E.D. N.C. 1966)(Where the inventor does nothing over a period oftime to develop or patent his invention, ridicules theattempts of another to develop that invention andbegins to show active interest in promoting anddeveloping his invention only after successfulmarketing by another of a device embodying thatinvention, the inventor has abandoned his inventionunder pre-AIA 35 U.S.C. 102(c).).

III. DELAY IN REAPPLYING FOR PATENTAFTER ABANDONMENT OF PREVIOUS PATENTAPPLICATION

Where there is no evidence of expressed intent orconduct by inventor to abandon his invention, delayin reapplying for patent after abandonment of aprevious application does not constitute

abandonment under pre-AIA 35 U.S.C. 102(c). Petersen v. Fee Int’l, Ltd., 381 F. Supp. 1071, 182USPQ 264 (W.D. Okla. 1974).

IV. DISCLOSURE WITHOUT CLAIMING IN APRIOR ISSUED PATENT

Any inference of abandonment (i.e., intent todedicate to the public) of subject matter disclosedbut not claimed in a previously issued patent isrebuttable by an application filed at any time beforea statutory bar arises. Accordingly, a rejection of aclaim of a patent application under pre-AIA35 U.S.C. 102(c) predicated solely on the issuanceof a patent which discloses the subject matter of theclaim in the application without claiming it wouldbe improper, regardless of whether there iscopendency between the application at issue and theapplication which issued as the patent. In re Gibbs,437 F.2d 486, 168 USPQ 578 (CCPA 1971).

V. ONLY WHEN THERE IS A PRIORITYCONTEST CAN A LAPSE OF TIME BAR APATENT

The mere lapse of time will not bar a patent. Theonly exception is when there is a priority contestunder pre-AIA 35 U.S.C. 102(g) and applicantabandons, suppresses or conceals the invention. Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082,1101, 227 USPQ 337, 350 (Fed. Cir. 1985).Abandonment, suppression and concealment aretreated by the courts under pre-AIA 35 U.S.C.102(g). See MPEP § 2138.03 for more informationon this issue.

2135 Pre-AIA 35 U.S.C. 102(d) [R-11.2013]




2100-164Rev. 08.2017, January 2018


*****

(d) the invention was first patented or caused to be patented,or was the subject of an inventor’s certificate, by the applicantor his legal representatives or assigns in a foreign country priorto the date of the application for patent in this country on anapplication for patent or inventor’s certificate filed more thantwelve months before the filing of the application in the UnitedStates.

*****

GENERAL REQUIREMENTS OF 35 U.S.C. 102(d)

Pre-AIA 35 U.S.C. 102(d) establishes four conditionswhich, if all are present, establish a bar against thegranting of a patent in this country:

(A) The foreign application must be filed morethan 12 months before the effective U.S. filing date(See MPEP § 706.02 regarding effective U.S. filingdate of an application);

(B) The foreign application must have been filedby the same applicant as in the United States or byhis or her legal representatives or assigns.

(C) The foreign patent or inventor’s certificatemust be actually granted (e.g., by sealing of thepapers in Great Britain) before the U.S. filing date.It need not be published.

(D) The same invention must be involved.

If such a foreign patent or inventor’s certificate isdiscovered by the examiner, the rejection is madeunder pre-AIA 35 U.S.C. 102(d) on the ground ofstatutory bar. See MPEP § 2135.01 for furtherclarification of each of the four requirements ofpre-AIA 35 U.S.C. 102(d).

2135.01 The Four Requirements of Pre-AIA35 U.S.C. 102(d) [R-11.2013]


I. FOREIGN APPLICATION MUST BE FILEDMORE THAN 12 MONTHS BEFORE THEEFFECTIVE U.S. FILING DATE

A. An Anniversary Date Ending on a Weekend orHoliday Results in an Extension to the Next BusinessDay

The U.S. application is filed in time to prevent apre-AIA 35 U.S.C. 102(d) bar from arising if it isfiled on the 1 year anniversary date of the filing dateof the foreign application. If this day is a Saturday,Sunday or federal holiday, the year would beextended to the following business day. See Ex parteOlah, 131 USPQ 41 (Bd. App. 1960). Despitechanges to 37 CFR 1.6(a)(2) and 37 CFR 1.10, whichrequire the PTO to accord a filing date to anapplication as of the date of deposit as PriorityExpress Mail® with the U.S. Postal Service inaccordance with 37 CFR 1.10 (e.g., a Saturday filingdate), the rule changes do not affect applicant’sconcurrent right to defer the filing of an applicationuntil the next business day when the last day for“taking any action” falls on a Saturday, Sunday, ora federal holiday (e.g., the last day of the 1-yeargrace period falls on a Saturday).

B. A Continuation-in-Part Breaks the Chain of Priorityas to Foreign as Well as U.S. Parents

In the case where applicant files a foreignapplication, later files a U.S. application claimingpriority based on the foreign application, and thenfiles a continuation-in-part (CIP) application whoseclaims are not entitled to the filing date of the U.S.parent, the effective filing date is the filing date ofthe CIP and applicant cannot obtain the benefit ofeither the U.S. parent or foreign application filingdates. In re Van Langenhoven, 458 F.2d 132, 137,173 USPQ 426, 429 (CCPA 1972). If the foreignapplication issues into a patent before the filing dateof the CIP, it may be used in a pre-AIA 35 U.S.C.102(d)/103 rejection if the subject matter added tothe CIP does not render the claims nonobvious overthe foreign patent. Ex parte Appeal No. 242-47, 196USPQ 828 (Bd. App. 1976) (Foreign patent can becombined with other prior art to bar a U.S. patent inan obviousness rejection based on pre-AIA 35 U.S.C.102(d)/103).

Rev. 08.2017, January 20182100-165


II. FOREIGN APPLICATION MUST HAVE BEENFILED BY SAME APPLICANT, HIS OR HERLEGAL REPRESENTATIVE OR ASSIGNS

Note that where the U.S. application was made bytwo or more inventors, it is permissible for theseinventors to claim priority from separateapplications, each to one of the inventors or asubcombination of inventors. For instance, a U.S.application naming inventors A and B may beentitled to priority from one application to A andone to B filed in a foreign country.

III. THE FOREIGN PATENT OR INVENTOR’SCERTIFICATE WAS ACTUALLY GRANTEDBEFORE THE U.S. FILING DATE

A. To Be “Patented” an Exclusionary Right Must BeAwarded to the Applicant

“Patented” means “a formal bestowal of patent rightsfrom the sovereign to the applicant.” In re Monks,588 F.2d 308, 310, 200 USPQ 129, 131 (CCPA1978); American Infra-Red Radiant Co. v. LambertIndus., 360 F.2d 977, 149 USPQ 722 (8th Cir.), cert.denied, 385 U.S. 920 (1966) (GermanGebrauchsmuster petty patent was held to be a patentusable in a pre-AIA 35 U.S.C. 102(d) rejection.Gebrauchmustern are not examined and only granta 6-year patent term. However, except as to duration,the exclusionary patent right granted is as extensiveas in the U.S.).

B. A Published Application Is Not a “Patent”

An application must issue into a patent before it canbe applied in a pre-AIA 35 U.S.C. 102(d) rejection. Ex parte Fujishiro, 199 USPQ 36 (Bd. App. 1977)(“Patenting,” within the meaning of pre-AIA 35U.S.C. 102(d), does not occur upon laying open ofa Japanese utility model application (kokai orkohyo)); Ex parte Links, 184 USPQ 429 (Bd. App.1974) (German applications, which have not yetbeen published for opposition, are published in theform of printed documents calledOffenlegungsschriften 18 months after filing. Theseapplications are unexamined or in the process ofbeing examined at the time of publication. The Boardheld that an Offenlegungsschrift is not a patent underpre-AIA 35 U.S.C. 102(d) even though someprovisional rights are granted. The Board explained

that the provisional rights are minimal and do notcome into force if the application is withdrawn orrefused.).

C. An Allowed Application Can Be a “Patent” forPurposes of Pre-AIA 35 U.S.C. 102(d) as of the DatePublished for Opposition Even Though It Has Not YetBeen Granted as a Patent

An examined application which has been allowedby the examiner and published to allow the publicto oppose the grant of a patent has been held to bea “patent” for purposes of rejection under pre-AIA35 U.S.C. 102(d) as of the date of publication foropposition if substantial provisional enforcementrights arise. Ex parte Beik, 161 USPQ 795 (Bd. App.1968) (This case dealt with examined Germanapplications. After a determination that anapplication is allowable, the application is publishedin the form of a printed document called anAuslegeschrift. The publication begins a period ofopposition were the public can present evidenceshowing unpatentability. Provisional patent rightsare granted which are substantially the same as thoseavailable once the opposition period is over and thepatent is granted. The Board found that anAuslegeschrift provides the legal effect of a patentfor purposes of rejection under pre-AIA 35 U.S.C.102(d).).

D. Grant Occurs When Patent Becomes Enforceable

The critical date of a foreign patent as a referenceunder pre-AIA 35 U.S.C. 102(d) is the date thepatent becomes enforceable (issued, sealed orgranted). In re Monks, 588 F.2d 308, 310, 200USPQ 129, 131 (CCPA 1978) (British referencebecame available as prior art on date the patent was“sealed” because as of this date applicant had theright to exclude others from making, using or sellingthe claimed invention.).

E. Pre-AIA 35 U.S.C. 102(d) Applies as of Grant DateEven If There Is a Period of Secrecy After Patent Grant

A period of secrecy after granting the patent, as inBelgium and Spain, has been held to have no effectin connection with pre-AIA 35 U.S.C. 102(d). Thesepatents are usable in rejections under pre-AIA 35U.S.C. 102(d) as of the date patent rights are granted.

2100-166Rev. 08.2017, January 2018


In re Kathawala, 9 F.3d 942, 28 USPQ2d 1789(Fed. Cir. 1993) (An invention is “patented” forpurposes of pre-AIA 35 U.S.C. 102(d) when thepatentee’s rights under the patent become fixed. Thefact that applicant’s Spanish application was notpublished until after the U.S. filing date is immaterialsince the Spanish patent was granted before U.S.filing.); Gramme Elec. Co. v. Arnoux andHochhausen Elec. Co., 17 F. 838, 1883 C.D. 418(S.D.N.Y. 1883) (Rejection made under apredecessor of pre-AIA 35 U.S.C. 102(d) based onan Austrian patent granted an exclusionary right for1 year but was kept secret, at the option of thepatentee, for that period. The court held that theAustrian patent grant date was the relevant dateunder the statute for purposes of pre-AIA 35 U.S.C.102(d) but that the patent could not have been usedto in a rejection under pre-AIA 35 U.S.C. 102(a) or(b).); In re Talbott, 443 F.2d 1397, 170 USPQ 281(CCPA 1971) (Applicant cannot avoid a pre-AIA35 U.S.C. 102(d) rejection by exercising an optionto keep the subject matter of a GermanGebrauchsmuster (petty patent) in secrecy until timeof U.S. filing.).

IV. THE SAME INVENTION MUST BE INVOLVED

“Same Invention” Means That the Application ClaimsCould Have Been Presented in the Foreign Patent

Under pre-AIA 35 U.S.C. 102(d), the “invention...patented” in the foreign country must be the sameas the invention sought to be patented in the U.S.When the foreign patent contains the same claimsas the U.S. application, there is no question that “theinvention was first patented... in a foreign country.” In re Kathawala, 9 F.3d 942, 945, 28 USPQ2d 1785,1787 (Fed. Cir. 1993). However, the claims neednot be identical or even within the same statutoryclass. If applicant is granted a foreign patent whichfully discloses the invention and which givesapplicant a number of different claiming options inthe U.S., the reference in pre-AIA 35 U.S.C. 102(d)to “‘invention... patented’ necessarily includes allthe disclosed aspects of the invention. Thus, the[pre-AIA] section 102(d) bar applies regardlesswhether the foreign patent contains claims to lessthan all aspects of the invention.” 9 F.3d at 946,28 USPQ2d at 1788. In essence, a pre-AIA 35 U.S.C.102(d) rejection applies if applicant’s foreign

application supports the subject matter of the U.S.claims. Id. at 944, 947, 28 USPQ2d at 1786, 1789(Applicant was granted a Spanish patent claiming amethod of making a composition. The patentdisclosed compounds, methods of use and processesof making the compounds. After the Spanish patentwas granted, the applicant filed a U.S. applicationwith claims directed to the compound but not theprocess of making it. The Federal Circuit held thatit did not matter that the claims in the U.S.application were directed to the composition insteadof the process because the foreign specificationwould have supported claims to the composition. Itwas immaterial that the formulations wereunpatentable pharmaceutical compositions in Spain.).

2136 Pre-AIA 35 U.S.C. 102(e) [R-11.2013]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note), except for determiningeligibility of SIRs as eligible prior art. See MPEP §2159 et seq. to determine whether an application issubject to examination under the FITF provisions,and MPEP § 2150 et seq. for examination ofapplications subject to those provisions.]


A person shall be entitled to a patent unless-

*****

(e) the invention was described in — (1) an application forpatent, published under section 122(b), by another filed in theUnited States before the invention by the applicant for patentor (2) a patent granted on an application for patent by anotherfiled in the United States before the invention by the applicantfor patent, except that an international application filed underthe treaty defined in section 351(a) shall have the effects for thepurposes of this subsection of an application filed in the UnitedStates only if the international application designated the UnitedStates and was published under Article 21(2) of such treaty inthe English language.

*****

Pre-AIA 35 U.S.C. 102(e) allows the use of certaininternational application publications and U.S. patentapplication publications, and certain U.S. patents asprior art under pre-AIA 35 U.S.C. 102(e) as of theirrespective U.S. filing dates, including certaininternational filing dates. The prior art date of a

Rev. 08.2017, January 20182100-167


reference under pre-AIA 35 U.S.C. 102(e) may bethe international filing date if the international filingdate was on or after November 29, 2000, theinternational application designated the UnitedStates, and the international application waspublished by the World Intellectual PropertyOrganization (WIPO) under the Patent CooperationTreaty (PCT) Article 21(2) in the English language.See MPEP § 706.02(f)(1) for examination guidelineson the application of pre-AIA 35 U.S.C. 102(e).References based on international applications thatwere filed prior to November 29, 2000 are subjectto the pre-AIPA version of 35 U.S.C. 102(e) (i.e.,the version in force on November 28, 2000). SeeMPEP § 2136.03 for additional information.

I. STATUTORY INVENTION REGISTRATIONS(SIRs) ARE ELIGIBLE AS PRIOR ART UNDER 35U.S.C. 102 and Pre-AIA 35 U.S.C. 102(e)

In accordance with former 35 U.S.C. 157(c), apublished SIR will be treated the same as a U.S.patent for all defensive purposes, usable as areference as of its filing date in the same manner asa U.S. patent. A SIR is prior art under all applicablesections of 35 U.S.C. 102 including pre-AIA 35U.S.C. 102(e). See MPEP § 1111.

II. DEFENSIVE PUBLICATIONS ARE NOT PRIORART AS OF THEIR FILING DATE

The Defensive Publication Program, availablebetween April 1968 and May 1985, provided for thevoluntary publication of the abstract of the technicaldisclosure of a pending application under certainconditions. A defensive publication is not a patentor an application publication under 35 U.S.C. 122(b);it is a publication. Therefore, it is prior art only asof its publication date. Ex parte Osmond, 191 USPQ334 (Bd. App. 1973). See MPEP § 711.06(a) formore information on Defensive Publications.

2136.01 Status of U.S. Application as aReference [R-11.2013]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subject

to examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions.]

I. WHEN THERE IS NO COMMON ASSIGNEE ORINVENTOR, A U.S. APPLICATION MUST ISSUEAS A PATENT OR BE PUBLISHED AS A SIR ORAS AN APPLICATION PUBLICATION BEFOREIT IS AVAILABLE AS PRIOR ART UNDER Pre-AIA35 U.S.C. 102(e)

In addition to U.S. patents and SIRs, certain U.S.application publications and certain internationalapplication publications are also available as priorart under pre-AIA 35 U.S.C. 102(e) as of theireffective U.S. filing dates (which will include certaininternational filing dates). See MPEP § 706.02(a).

II. WHEN THERE IS A COMMON ASSIGNEE ORINVENTOR, A PROVISIONAL Pre-AIA 35 U.S.C.102(e) REJECTION OVER AN EARLIER FILEDUNPUBLISHED APPLICATION CAN BE MADE

Based on the assumption that an application willripen into a U.S. patent (or into an applicationpublication), it is permissible to provisionally rejecta later application over an earlier filed, andunpublished, application under pre-AIA 35 U.S.C.102(e) when there is a common assignee or inventor.In re Irish, 433 F.2d 1342, 167 USPQ 764 (CCPA1970). In addition, a provisional pre-AIA 35 U.S.C.102(e) rejection may be made if the earlier filedcopending U.S. application has been published asredacted (37 CFR 1.217) and the subject matterrelied upon in the rejection is not supported in theredacted publication of the patent application. Sucha provisional rejection “serves to put applicant onnotice at the earliest possible time of the possibleprior art relationship between copendingapplications” and gives applicant the fullestopportunity to overcome the rejection by amendmentor submission of evidence. In addition, since bothapplications are pending and usually have the sameassignee, more options are available to applicant forovercoming the provisional rejection than if the otherapplication were already issued. Ex parte Bartfeld,16 USPQ2d 1714 (Bd. Pat. App. & Int. 1990) aff’don other grounds, 925 F.2d 1450, 17 USPQ2d 1885(Fed. Cir. 1991). Note that provisional rejectionsover pre-AIA 35 U.S.C. 102(e) are only authorizedwhen there is a common inventor or assignee,

2100-168Rev. 08.2017, January 2018


otherwise the copending application prior topublication must remain confidential. MPEP§ 706.02(f)(2) and MPEP § 706.02(k) discuss theprocedures to be used in provisional rejections overpre-AIA 35 U.S.C. 102(e) and pre-AIA 35 U.S.C.102(e)/103.

For applications filed on or after November 29, 1999or pending on or after December 10, 2004, aprovisional rejection under 35 U.S.C. 103(a) usingprior art under pre-AIA 35 U.S.C. 102(e) is notproper if the application contains evidence that theapplication and the prior art reference were ownedby the same person, or subject to an obligation ofassignment to the same person, at the time theinvention was made. The changes to pre-AIA 35U.S.C. 102(e) in the Intellectual Property and HighTechnology Technical Amendments Act of 2002(Public Law 107-273, 116 Stat. 1758 (2002)) didnot affect 35 U.S.C. 103(c) as amended onNovember 29, 1999. See MPEP § 706.02(l)(1)through § 706.02(l)(3) for information relating torejections under pre-AIA 35 U.S.C. 103 andevidence of common ownership.

In addition, certain non-commonly owned referencesmay be disqualified from being applied in a rejectionunder pre-AIA 35 U.S.C. 103(a) due to theCooperative Research and Technology EnhancementAct of 2004 (CREATE Act) (Public Law 108-453;118 Stat. 3596 (2004)), which was enacted onDecember 10, 2004 and was effective for all patentsgranted on or after December 10, 2004. TheCREATE Act amended pre-AIA 35 U.S.C. 103(c)to provide that subject matter developed by anotherperson shall be treated as owned by the same personor subject to an obligation of assignment to the sameperson for purposes of determining obviousness ifcertain conditions are met. Pre-AIA 35 U.S.C.103(c),as amended by the CREATE Act, continues to applyonly to subject matter which qualifies as prior artunder pre-AIA 35 U.S.C. 102(e), (f) or (g), andwhich is being relied upon in a rejection under 35U.S.C. 103. It does not apply to or affect subjectmatter which is applied in a rejection under pre-AIA35 U.S.C. 102 or a double patenting rejection (see37 CFR 1.78(c) and MPEP § 804). In addition, ifthe subject matter qualifies as prior art under anyother subsection of pre-AIA 35 U.S.C. 102 (e.g.,pre-AIA 35 U.S.C. 102(a) or (b)) it will not be

disqualified as prior art under pre-AIA 35 U.S.C.103(c). See also MPEP § 706.02(l)(1) through §706.02(l)(3) for information relating to rejectionsunder pre-AIA 35 U.S.C. 103 and evidence of jointresearch agreements.

2136.02 Content of the Prior Art AvailableAgainst the Claims [R-08.2017]

Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions.]

I. A 35 U.S.C. 102(e) REJECTION MAY RELY ONANY PART OF THE PATENT OR APPLICATIONPUBLICATION DISCLOSURE

Under pre-AIA 35 U.S.C. 102(e), the entiredisclosure of a U.S. patent, a U.S. patent applicationpublication, or an international applicationpublication having an earlier effective U.S. filingdate (which will include certain international filingdates) can be relied on to reject the claims. SunStuds, Inc. v. ATA Equip. Leasing, Inc., 872 F.2d978, 983, 10 USPQ2d 1338, 1342 (Fed. Cir. 1989).See MPEP § 706.02(a).

II. REFERENCE MUST ITSELF CONTAIN THESUBJECT MATTER RELIED ON IN THEREJECTION

When a U.S. patent, a U.S. patent applicationpublication, or an international applicationpublication is used to reject claims under pre-AIA35 U.S.C. 102(e), the disclosure relied on in therejection must be present in the issued patent orapplication publication. It is the earliest effectiveU.S. filing date (which will include certaininternational filing dates) of the U.S. patent orapplication publication being relied on as the criticalreference date and subject matter not included in thepatent or application publication itself can only beused when that subject matter becomes public.Portions of the patent application which werecanceled are not part of the patent or application

Rev. 08.2017, January 20182100-169


publication and thus cannot be relied on in a pre-AIA35 U.S.C. 102(e) rejection over the issued patent orapplication publication. Ex parte Stalego, 154 USPQ52 (Bd. App. 1966). Similarly, subject matter thatis disclosed in an abandoned, unpublished parentapplication but was not carried over into the childpatent or application publication may not be reliedon as prior art under pre-AIA 35 U.S.C. 102(e). Inre Klesper, 397 F.2d 882, 886, 158 USPQ 256, 258(CCPA 1968). See MPEP § 901.02 for moreinformation on availability of abandoned applicationsas prior art. Likewise, subject matter which isdisclosed in a parent application, but not includedin the child continuation-in-part (CIP) cannot berelied on in a pre-AIA 35 U.S.C. 102(e) rejectionover the issued or published CIP. In re Lund, 376F.2d 982, 153 USPQ 625 (CCPA 1967) (Theexaminer made a pre-AIA 35 U.S.C. 102(e) rejectionover an issued U.S. patent which was acontinuation-in-part (CIP). The parent applicationof the U.S. patent reference contained an exampleII which was not carried over to the CIP. The courtheld that the subject matter embodied in the canceledexample II could not be relied on as of either parentor child filing date. Thus, the use of example IIsubject matter to reject the claims under pre-AIA 35U.S.C. 102(e) was improper.).

Where a U.S. patent claims benefit to a provisionalapplication, at least one claim of the patent must besupported by the disclosure of the relied uponprovisional application in compliance withpre-AIA35 U.S.C. 112, first paragraph, in order for the patentto be usable as prior art under pre-AIA 35 U.S.C.102(e) as of the relied upon provisional application’sfiling date. See MPEP § 2136.03, subsection III.

III. THE SUPREME COURT HAS AUTHORIZED35 U.S.C. 103 REJECTIONS BASED ON PRE-AIA35 U.S.C. 102(e)

U.S. patents may be used as of their filing dates toshow that the claimed subject matter is anticipatedor obvious. Obviousness can be shown by combiningother prior art with the U.S. patent reference in a35 U.S.C. 103 rejection. Hazeltine Research v.Brenner, 382 U.S. 252, 147 USPQ 429 (1965).Similarly, certain U.S. application publications andcertain international application publications mayalso be used as of their earliest effective U.S. filing

dates (which will include certain international filingdates) to show that the claimed subject matter wouldhave been anticipated or obvious.

See MPEP § 706.02(1)(1) through § 706.02(l)(3) foradditional information on rejections under 35 U.S.C.103 and evidence of common ownership or a jointresearch agreement.

2136.03 Critical Reference Date [R-08.2017]


I. FOREIGN PRIORITY DATE

Reference’s Foreign Priority Date Under 35 U.S.C.119(a)-(d) and (f) Cannot Be Used as the Pre-AIA 35U.S.C. 102(e) Reference Date

Pre-AIA 35 U.S.C. 102(e) is explicitly limited tocertain references “filed in the United States beforethe invention thereof by the applicant” (emphasisadded). Foreign applications’ filing dates that areclaimed (via 35 U.S.C. 119(a)–(d), (f) or 35 U.S.C.365(a)) in applications, which have been publishedas U.S. or WIPO application publications or patentedin the U.S., may not be used as pre-AIA 35 U.S.C.102(e) dates for prior art purposes. This includesinternational filing dates claimed as foreign prioritydates under 35 U.S.C. 365(a).Therefore, the foreignpriority date of the reference under 35 U.S.C.119(a)-(d), (f), and 35 U.S.C. 365(a) cannot be usedto antedate the application filing date. In contrast,applicant may be able to overcome the pre-AIA 35U.S.C. 102(e) rejection by proving the applicant isentitled to the 35 U.S.C. 119 priority date which isearlier than the reference’s U.S. filing date. In reHilmer, 359 F.2d 859, 149 USPQ 480 (CCPA 1966) (Hilmer I) (Applicant filed an application with aright of priority to a German application. Theexaminer rejected the claims over a U.S. patent toHabicht based on its Swiss priority date. The U.S.filing date of Habicht was later than the application’s

2100-170Rev. 08.2017, January 2018


German priority date. The court held that thereference’s Swiss priority date could not be reliedon in a pre-AIA 35 U.S.C. 102(e) rejection. Becausethe U.S. filing date of Habicht was later than theearliest effective filing date (German priority date)of the application, the rejection was reversed.). SeeMPEP § 216 for information on procedures to befollowed in considering applicant's right of priority.

Note that certain international application (PCT)filings are considered to be “filings in the UnitedStates” for purposes of applying an applicationpublication as prior art. See MPEP § 706.02(a).

II. INTERNATIONAL (PCT) APPLICATIONS;INTERNATIONAL APPLICATIONPUBLICATIONS

A. International Application Filed On or AfterNovember 29, 2000

If the potential reference resulted from, or claimedthe benefit of, an international application, thefollowing must be determined:

(A) If the international application meets thefollowing three conditions:

(1) an international filing date on or afterNovember 29, 2000;

(2) designated the United States; and

(3) published under PCT Article 21(2) inEnglish,

the international filing date is a U.S. filing date forprior art purposes under pre-AIA 35 U.S.C. 102(e).If such an international application properly claimsbenefit to an earlier-filed U.S. or internationalapplication, or an earlier-filed U.S. provisionalapplication, apply the reference under pre-AIA 35U.S.C. 102(e) as of the earlier filing date, assumingall the conditions of pre-AIA 35 U.S.C. 102(e) and35 U.S.C. 119(e), 120, or 365(c) are met. In addition,the subject matter relied upon in the rejection mustbe disclosed in the earlier-filed application incompliance with 35 U.S.C. 112(a) /pre-AIA 35U.S.C. 112, first paragraph, in order to give thatsubject matter the benefit of the earlier filing dateunder pre-AIA 35 U.S.C. 102(e). Note, where theearlier application is an international application,the earlier international application must satisfy the

same three conditions (i.e., filed on or afterNovember 29, 2000, designated the U.S., and hadbeen published in English under PCT Article 21(2))for the earlier international filing date to be a U.S.filing date for prior art purposes under pre-AIA 35U.S.C.102(e).

(B) If the international application was filed onor after November 29, 2000, but did not designatethe United States or was not published in Englishunder PCT Article 21(2), do not treat theinternational filing date as a U.S. filing date. In thissituation, do not apply the reference as of itsinternational filing date, its date of completion ofthe 35 U.S.C. 371(c)(1), (2) and (4) requirements,or any earlier filing date to which such aninternational application claims benefit or priority.The reference may be applied under pre-AIA35 U.S.C. 102(a) or (b) as of its publication date, orpre-AIA 35 U.S.C. 102(e) as of any later U.S. filingdate of an application that properly claimed thebenefit of the international application (if applicable).

B. International Application Filed Before November29, 2000

References based on international applications thatwere filed prior to November 29, 2000 are subjectto the pre-AIPA version of 35 U.S.C. 102(e) (i.e.,the version in force on November 28, 2000) as setforth below.

Former 35 U.S.C. 102 Conditions for patentability; noveltyand loss of right to patent (as in force on November 28, 2000)

A person shall be entitled to a patent unless-

*****

(e) the invention was described in a patent granted on anapplication for patent by another filed in the United States beforethe invention thereof by the applicant for patent, or on aninternational application by another who has fulfilled therequirements of paragraphs (1), (2), and (4) of section 371(c)of this title before the invention thereof by the applicant forpatent.

*****

If an international application has an internationalfiling date prior to November 29, 2000, the referenceshould be applied under the provisions of 35 U.S.C.102 and 374 as in force on November 28, 2000 (priorto the AIPA amendments):

(1) For U.S. patents, apply the reference under35 U.S.C. 102(e) as in force on November 28, 2000

Rev. 08.2017, January 20182100-171


as of the earlier of the date of completion of therequirements of 35 U.S.C. 371(c)(1), (2) and (4) orthe filing date of the later-filed U.S. application thatclaimed the benefit of the international application;

(2) For U.S. application publications and WIPOpublications directly resulting from internationalapplications under PCT Article 21(2), never applythese references under 35 U.S.C. 102(e) as in forceon November 28, 2000. These references may beapplied as of their publication dates under pre-AIA35 U.S.C. 102(a) or (b);

(3) For U.S. application publications ofapplications that claim the benefit under 35 U.S.C.120 or 365(c) of an international application filedprior to November 29, 2000, apply the referenceunder 35 U.S.C. 102(e) as in force on November 28,2000 as of the actual filing date of the later-filedU.S. application that claimed the benefit of theinternational application.

Examiners should be aware that although apublication of, or a U.S. patent issued from, aninternational application may not be available asprior art under former 35 U.S.C. 102(e) as in forceon November 28, 2000 or under pre-AIA 35 U.S.C.102(e), the corresponding WIPO publication of aninternational application may have an earlier pre-AIA 35 U.S.C. 102(a) or (b) date.

III. BENEFIT OF PROVISIONAL APPLICATIONUNDER 35 U.S.C. 119(e)

The pre-AIA 35 U.S.C. 102(e) critical reference dateof a U.S. patent or U.S. application publications andcertain international application publications entitledto the benefit of the filing date of a provisionalapplication under 35 U.S.C. 119(e) is the filing dateof the provisional application with certain exceptionsif the provisional application(s) properly supportsthe subject matter relied upon to make the rejectionin compliance with 35 U.S.C 112(a)/ pre-AIA 35U.S.C. 112, first paragraph. See MPEP §706.02(f)(1), examples 5 to 9. Note that internationalapplications which (1) were filed prior to November29, 2000, or (2) did not designate the U.S., or (3)were not published in English under PCT Article21(2) by WIPO, may not be used to reach back(bridge) to an earlier filing date through a priorityor benefit claim for prior art purposes under pre-AIA35 U.S.C. 102(e). In addition, the reference date

under pre-AIA 35 U.S.C. 102(e) of a U.S. patentmay be the filing date of a relied upon provisionalapplication only if at least one of the claims in thepatent is supported by the written description of theprovisional application in compliance with pre-AIA35 U.S.C. 112, first paragraph. See DynamicDrinkware, LLC, v. National Graphics, Inc., 800F.3d 1375, 116 USPQ2d 1045 (Fed. Cir. 2015).

IV. BENEFIT OF NONPROVISIONALAPPLICATION UNDER 35 U.S.C. 120

Filing Date of U.S. Parent Application Can Only BeUsed as the Pre-AIA 35 U.S.C. 102(e) Date If It Supportsthe Subject Matter Relied Upon in the ContinuingApplication

For prior art purposes, a U.S. patent or patentapplication publication that claims the benefit of anearlier filing date under 35 U.S.C. 120 of a priornonprovisional application (i.e., a continuation,divisional, or continuation-in-part application) wouldbe accorded the earlier filing date as its prior art dateunder pre-AIA 35 U.S.C. 102(e), provided theearlier-filed application properly supports the subjectmatter relied upon in any rejection in compliancewith 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112,first paragraph. In other words, the subject matterused in the rejection must be disclosed in theearlier-filed application in compliance with 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, in order for that subject matter to beentitled to the earlier filing date under pre-AIA 35U.S.C. 102(e).

See also MPEP § 706.02(f)(1), examples 2 and 5 to9.

V. DATE OF CONCEPTION OR REDUCTION TOPRACTICE

Pre-AIA 35 U.S.C. 102(e) Reference Date Is the FilingDate, Not Date of Inventor’s Conception or Reductionto Practice

If a reference available under pre-AIA 35 U.S.C.102(e) discloses, but does not claim the subjectmatter of the claims being examined or an obviousvariant, the reference is not prior art under pre-AIA35 U.S.C. 102(g). Furthermore, the reference doesnot qualify as “prior art” under 35 U.S.C. 102 as of

2100-172Rev. 08.2017, January 2018


a date earlier than its filing date based upon any priorinventive activity that is disclosed in the U.S. patentor U.S. patent application publication in the absenceof evidence that the subject matter was actuallyreduced to practice in this country on an earlier date.See MPEP § 2138. When the cases are not ininterference, the effective date of the reference asprior art is its filing date in the United States (whichwill include certain international filing dates), asstated in pre-AIA 35 U.S.C. 102(e). See MPEP§ 706.02(a). The date that the prior art subject matterwas conceived or reduced to practice is of noimportance when pre-AIA 35 U.S.C. 102(g) is notat issue. Sun Studs, Inc. v. ATA Equip. Leasing, Inc.,872 F.2d 978, 983, 10 USPQ2d 1338, 1342 (Fed.Cir. 1989) (The defendant sought to invalidatepatents issued to Mason and Sohn assigned to SunStuds. The earliest of these patents issued in June1973. A U.S. patent to Mouat was found whichissued in March 1976 and which disclosed theinvention of Mason and Sohn. While the patent toMouat issued after the Mason and Sohn patents, itwas filed 7 months earlier than the earliest of theMason and Sohn patents. Sun Studs submittedaffidavits showing conception in 1969 and diligenceto the constructive reduction to practice and thereforeantedated the patent to Mouat. The defendant soughtto show that Mouat conceived the invention in 1966.The court held that conception of the subject matterof the reference only becomes an issue when theclaims of the conflicting patents cover inventionswhich are the same or obvious over one another.When pre-AIA 35 U.S.C. 102(e) applies but notpre-AIA 35 U.S.C. 102(g), the filing date of the priorart patent is the earliest date that can be used to rejector invalidate claims.).

2136.04 Different Inventive Entity; Meaningof “By Another” [R-08.2017]


I. IF THERE IS ANY DIFFERENCE IN THEINVENTIVE ENTITY, THE REFERENCE IS “BYANOTHER”

“Another” means other than applicants, In re Land,368 F.2d 866, 151 USPQ 621 (CCPA 1966), in otherwords, a different inventive entity. The inventiveentity is different if not all inventors are the same.The fact that the application and reference have oneor more inventors in common is immaterial. Exparte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App.& Inter. 1992) (The examiner made a pre-AIA 35U.S.C. 102(e) rejection based on an issued U.S.patent to three inventors. The rejected applicationwas a continuation-in-part of the issued parent withan extra inventor. The Board found that the patentwas “by another” and thus could be used in apre-AIA 35 U.S.C. 102(e)/103 rejection of theapplication.).

II. A DIFFERENT INVENTIVE ENTITY IS PRIMAFACIE EVIDENCE THAT THE REFERENCE IS“BY ANOTHER”

As stated by the House and Senate reports on thebills enacting section pre-AIA 35 U.S.C. 102(e) aspart of the 1952 Patent Act, this subsection of 102codifies the Milburn rule of Milburn v.Davis-Bournonville, 270 U.S. 390, 46 S. Ct. 324,1926 C.D. 303, 344 O.G. 817 (1926). The Milburnrule authorized the use of a U.S. patent containinga disclosure of the invention as a reference againsta later filed application as of the U.S. patent filingdate. The existence of an earlier filed U.S.application containing the subject matter claimed inthe application being examined indicates thatapplicant was not the first inventor. Therefore, a U.S.patent, a U.S. patent application publication orinternational application publication, by a differentinventive entity, whether or not the applicationshares some inventors in common with the patent,is prima facie evidence that the invention was made“by another” as set forth in pre-AIA 35 U.S.C.102(e). In re Mathews, 408 F.2d 1393, 161 USPQ276 (CCPA 1969); In re Facius, 408 F.2d 1396,161 USPQ 294 (CCPA 1969); Ex parteDesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. &Inter. 1992). See MPEP § 706.02(b) and § 2136.05for discussion of methods of overcoming pre-AIA35 U.S.C. 102(e) rejections.

Rev. 08.2017, January 20182100-173


2136.05 Overcoming a Rejection UnderPre-AIA 35 U.S.C. 102(e) [R-08.2017]


I. A PRE-AIA 35 U.S.C. 102(e) REJECTION CANBE OVERCOME BY ANTEDATING THE FILINGDATE OR SHOWING THAT DISCLOSURERELIED ON IS AN INVENTOR'S OR AT LEASTONE JOINT INVENTOR'S OWN WORK

When a prior U.S. patent, U.S. patent applicationpublication, or international application publicationis not a statutory bar, a pre-AIA 35 U.S.C. 102(e)rejection can be overcome by antedating the filingdate (see MPEP § 2136.03 regarding criticalreference date of pre-AIA 35 U.S.C. 102(e) priorart) of the reference by submitting an affidavit ordeclaration under 37 CFR 1.131 or by submitting anaffidavit or declaration under 37 CFR 1.132establishing that the relevant disclosure is aninventor's or at least one joint inventor's own work. In re Mathews, 408 F.2d 1393, 161 USPQ 276(CCPA 1969). The filing date can also be antedatedby an earlier foreign priority application orprovisional application if 35 U.S.C. 119 is met andthe foreign application or provisional application“supports” (conforms to 35 U.S.C. 112(a) or pre-AIA35 U.S.C. 112, first paragraph, requirements) allthe claims of the U.S. application. In re Gosteli, 872F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). Buta prior application which was not copending withthe application at issue cannot be used to antedate areference. In re Costello, 717 F.2d 1346, 219 USPQ389 (Fed. Cir. 1983). A terminal disclaimer also doesnot overcome a pre-AIA 35 U.S.C. 102(e) rejection.See, e.g., In re Bartfeld, 925 F.2d 1450, 17 USPQ2d1885 (Fed. Cir. 1991).

See MPEP § 706.02(b) for a list of methods whichcan be used to overcome rejections based on pre-AIA35 U.S.C. 102(e) rejections. For information on the

required contents of a 37 CFR 1.131 affidavit ordeclaration and the situations in which suchaffidavits and declarations are permitted. See MPEP§ 715. An affidavit or declaration under 37 CFR1.131 is not appropriate if the reference describesan inventor's or at least one joint inventor's ownwork. In this case, applicant must submit an affidavitor declaration under 37 CFR 1.132. See the nextsubsection for more information concerning therequirements of 37 CFR 1.132 affidavits anddeclarations.

II. A PRE-AIA 35 U.S.C. 102(e) REJECTION CANBE OVERCOME BY SHOWING THE REFERENCEIS DESCRIBING AN INVENTOR'S OR AT LEASTONE JOINT INVENTOR'S OWN WORK

“The fact that an application has named a differentinventive entity than a patent does not necessarilymake that patent prior art.” Applied Materials Inc.v. Gemini Research Corp., 835 F.2d 279, 15USPQ2d 1816 (Fed. Cir. 1988). The issue turns onwhat the evidence of record shows as to whoinvented the subject matter. In re Whittle, 454 F.2d1193, 1195, 172 USPQ 535, 537 (CCPA 1972). Infact, even if an inventor's or at least one jointinventor's work was publicly disclosed prior to thepatent application, the inventor's or at least one jointinventor's own work may not be used against theapplication subject to pre-AIA 35 U.S.C. 102 unlessthere is a time bar under pre-AIA 35 U.S.C. 102(b). In re DeBaun, 687 F.2d 459, 214 USPQ 933 (CCPA1982) (citing In re Katz, 687 F.2d 450, 215 USPQ14 (CCPA 1982)). Therefore, when the unclaimedsubject matter of a reference is an inventor's or atleast one joint inventor's own invention, a primafacie case based on the patent, U.S. patentapplication publication, or international applicationpublication, may be overcome by showing that thedisclosure is a description of the inventor's or at leastone joint inventor's own previous work. Such ashowing can be made by proving that the inventor(s)of the U.S. patent, U.S. patent applicationpublication, or the international applicationpublication, was associated with applicant (e.g., sameassignee) and learned of the inventor's or at least onejoint inventor's invention from the inventor or atleast one joint inventor directly or indirectly. In reMathews, 408 F.2d 1393, 161 USPQ 276 (CCPA1969). In the situation where one application is first

2100-174Rev. 08.2017, January 2018


filed naming sole inventor X and then a laterapplication is filed naming joint inventors X & Y,it must be proven that the joint invention was madefirst, was thereafter described in the sole inventor'spatent, or was thereafter described in the soleinventor's U.S. patent application publication orinternational application publication, and then thejoint application was filed. In re Land, 368 F.2d866, 151 USPQ 621 (CCPA 1966).

In In re Land, separate U.S. patents to Rogers andto Land were used to reject a joint application toRogers and Land under pre-AIA 35 U.S.C.102(e)/103. The inventors worked for the samecompany (Polaroid) and in the same laboratory. Allthe patents flowed from the same research. Inaddition, the patent applications were prepared bythe same attorneys, were interrelated and containedcross-references to each other. The court affirmedthe rejection because (1) the inventive entities of thepatents (one to Rogers and one to Land) weredifferent from the inventive entity of the jointapplication (Rogers and Land) and (2) Land andRogers brought their knowledge of their individualwork with them when they made the joint invention.There was no indication that the portions of thereferences relied on disclosed anything they didjointly. Neither was there any showing that whatthey did jointly was done before the filing of thereference patent applications.

See also In re Carreira, 532 F.2d 1356, 189 USPQ461 (CCPA 1976) (The examiner rejected claims toa joint application to Carreira, Kyrakakis, Solodar,and Labana under pre-AIA 35 U.S.C. 102(e) and103 in view of a U.S. patent issued to Tulagin andCarreira or a patent issued to Clark. The applicantssubmitted declarations under 37 CFR 1.132 byTulagin and Clark in which each declarant stated hewas “not the inventor of the use of compoundshaving a hydroxyl group in a position ortho to anazo linkage.” The court held that these statementswere vague and inconclusive because the declarantsdid not disclose the use of this generic compoundbut rather species of this generic compound in theirpatents and it was the species which met the claims.The declaration that each did not invent the use ofthe generic compound does not establish that Tulaginand Clark did not invent the use of the species.)

MPEP § 715.01(a), § 715.01(c), and § 716.10 setforth more information pertaining to the contentsand uses of affidavits and declarations under 37 CFR1.132 for antedating references. See MPEP§ 706.02(l)(1) for information pertaining to rejectionsunder pre-AIA 35 U.S.C. 102(e)/103 and theapplicability of pre-AIA 35 U.S.C. 103(c).

III. APPLICANT NEED NOT SHOW DILIGENCEOR REDUCTION TO PRACTICE WHEN THESUBJECT MATTER DISCLOSED IN THEREFERENCE IS APPLICANT’S OWN WORK

When the reference reflects an inventor's or at leastone joint inventor's own work, evidence of diligenceor reduction to practice does not need to be providedin order to establish that the inventor or at least onejoint inventor invented the subject matter disclosedin the reference. A showing that the referencedisclosure arose from an inventor's or at least onejoint inventor's work coupled with a showing ofconception by the inventor or at least one jointinventor before the filing date of the reference willovercome the pre-AIA 35 U.S.C. 102(e) rejection.The showing can be made by submission of anaffidavit under 37 CFR 1.132 by the inventor or atleast one joint inventor who invented the subjectmatter. The other joint inventors, if applicable, neednot submit an affidavit disclaiming inventorship,but, if submitted, a disclaimer by all other jointinventors should be considered by the examiner. Inre DeBaun, 687 F.2d 459, 214 USPQ 933 (CCPA1982) (Declaration submitted by DeBaun stated thathe was the inventor of subject matter disclosed inthe U.S. patent reference of DeBaun and Noll.Exhibits were attached to the declaration showingconception and included drawings DeBaun hadprepared and given to counsel for purposes ofpreparing the application which issued as thereference patent. The court held that, even thoughthe evidence was not sufficient to antedate the priorart patent under 37 CFR 1.131, diligence and/orreduction to practice was not required to showDeBaun invented the subject matter. Declarant’sstatement that he conceived the invention first wasenough to overcome the pre-AIA 35 U.S.C. 102(e)rejection.).

IV. CLAIMING OF INDIVIDUAL ELEMENTS ORSUBCOMBINATIONS IN A COMBINATIONCLAIM OF THE REFERENCE DOES NOT ITSELF

Rev. 08.2017, January 20182100-175


ESTABLISH THAT THE INVENTOR OR ATLEAST ONE JOINT INVENTOR INVENTEDTHOSE ELEMENTS

The existence of combination claims in a referenceis not evidence that the inventor or at least one jointinventor invented the individual elements orsubcombinations included if the elements andsubcombinations are not separately claimed apartfrom the combination. In re DeBaun, 687 F.2d 459,214 USPQ 933 (CCPA 1982) (citing In re Facius,408 F.2d 1396, 1406, 161 USPQ 294, 301 (CCPA1969)).

See also In re Mathews, 408 F.2d 1393, 161 USPQ276 (CCPA 1969) (On September 15, 1961, Deweyfiled an application disclosing and claiming a timedelay protective device for an electric circuit. Indisclosing the invention, Dewey completelydescribed, but did not claim, a “gating means 19”invented by Mathews which was usable in theprotective device. Dewey and Mathews werecoworkers at General Electric Company, theassignee. Mathews filed his application on March7, 1963, before the Dewey patent issued but almost18 months after its filing. The Mathews applicationdisclosed that “one illustration of a circuitembodying the present invention is shown incopending patent application S.N. 138,476-Dewey.”The examiner used Dewey to reject all the Mathewsclaims under pre-AIA 35 U.S.C. 102(e). In response,Mathews submitted an affidavit by Dewey under37 CFR 1.132. In the affidavit, Dewey stated thathe did not invent the gating means 19 but had learnedof the gating means through Mathews and that GEattorneys had advised that the gating means bedisclosed in Dewey’s application to comply with 35U.S.C. 112, first paragraph. The examiner arguedthat the only way to overcome a pre-AIA 35 U.S.C.102(e) rejection was by submitting an affidavit ordeclaration under 37 CFR 1.131 to antedate the filingdate of the reference. The court reversed therejection, holding that the totality of the evidenceon record showed that Dewey derived his knowledgefrom Mathews who is “the original, first and soleinventor.”).

2137 Pre-AIA 35 U.S.C. 102(f) [R-08.2017]

[Editor Note: This MPEP section is not applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions.

“Derivation” or "derived" as used in the discussionbelow is in the context of pre-AIA law. “Derivationproceedings” as created in the AIA are discussed inMPEP § 2310 et seq.]



*****

(f) he did not himself invent the subject matter sought tobe patented.

*****

Where it can be shown that an inventor or at leastone joint inventor “derived” an invention fromanother, a rejection under pre-AIA 35 U.S.C. 102(f)is proper. Ex parte Kusko, 215 USPQ 972, 974 (Bd.App. 1981) (“most, if not all, determinations undersection 102(f) involve the question of whether oneparty derived an invention from another”).

While derivation will bar the issuance of a patent tothe deriver, a disclosure by the deriver, absent a barunder pre-AIA 35 U.S.C. 102(b), will not bar theissuance of a patent to the party from which thesubject matter was derived. In re Costello, 717 F.2d1346, 1349, 219 USPQ 389, 390-91 (Fed. Cir. 1983)(“[a] prior art reference that is not a statutory barmay be overcome [in an application subject topre-AIA 35 U.S.C. 102] by two generally recognizedmethods”: an affidavit under 37 CFR 1.131, or anattribution affidavit under 37 CFR 1.132); In reFacius, 408 F.2d 1396, 1407, 161 USPQ 294, 302(CCPA 1969) (if an inventor or at least one jointinventor “… invented the subject matter upon whichthe relevant disclosure in the patent was based, thenthe patent may not be used as a reference againsthim notwithstanding the patent's silence as to the

2100-176Rev. 08.2017, January 2018


patentee's [inventive entity’s] source of that subjectmatter.”). See MPEP §§ 715.01 et seq. and 716.10

Where there is a published article identifying theauthorship (MPEP § 715.01(c)) or a patentidentifying the inventorship (MPEP § 715.01(a))that discloses subject matter being claimed in anapplication undergoing examination, the designationof authorship or inventorship does not raise apresumption of inventorship with respect to thesubject matter disclosed in the article or with respectto the subject matter disclosed but not claimed inthe patent so as to justify a rejection under pre-AIA35 U.S.C. 102(f). However, it is incumbent upon theapplicant of the application, in reply to an inquiryregarding the appropriate inventorship underpre-AIA subsection (f), or to rebut a rejection underpre-AIA 35 U.S.C. 102(a) or (e), to provide asatisfactory showing by way of affidavit under 37CFR 1.132 that the inventorship of the applicationis correct in that the reference discloses subjectmatter invented by the inventor or at least one jointinventor rather than derived from the author orinventive entity notwithstanding the authorship ofthe article or the inventorship of the patent,respectively. In re Katz, 687 F.2d 450, 455, 215USPQ 14, 18 (CCPA 1982) (inquiry is appropriateto clarify any ambiguity created by an articleregarding inventorship, and it is then incumbent uponthe applicant to provide “a satisfactory showing thatwould lead to a reasonable conclusion that [inventoror at least one joint inventor] is the…inventor” ofthe subject matter disclosed in the article and claimedin the application).

I. DERIVATION REQUIRES COMPLETECONCEPTION BY ANOTHER ANDCOMMUNICATION TO THE ALLEGED DERIVER

“The mere fact that a claim recites the use of variouscomponents, each of which can be argumentativelyassumed to be old, does not provide a proper basisfor a rejection under pre-AIA 35 U.S.C. 102(f).” Exparte Billottet, 192 USPQ 413, 415 (Bd. App. 1976).Derivation requires complete conception by anotherand communication of that conception by any meansto the party charged with derivation prior to any dateon which it can be shown that the one charged withderivation possessed knowledge of the invention.

Kilbey v. Thiele, 199 USPQ 290, 294 (Bd. Pat. Inter.1978).

See also Price v. Symsek, 988 F.2d 1187, 1190,26 USPQ2d 1031, 1033 (Fed. Cir. 1993); Hedgewickv. Akers, 497 F.2d 905, 908, 182 USPQ 167, 169(CCPA 1974). “Communication of a completeconception must be sufficient to enable one ofordinary skill in the art to construct and successfullyoperate the invention.” Hedgewick, 497 F.2d at 908,182 USPQ at 169. See also Gambro Lundia AB v.Baxter Healthcare Corp., 110 F.3d 1573, 1577, 42USPQ2d 1378, 1383 (Fed. Cir. 1997) (Issue inproving derivation is “whether the communicationenabled one of ordinary skill in the art to make thepatented invention.”).

II. PARTY ALLEGING DERIVATION DOES NOTHAVE TO PROVE AN ACTUAL REDUCTION TOPRACTICE, DERIVATION OF PUBLICKNOWLEDGE, OR DERIVATION IN THISCOUNTRY

The party alleging derivation “need not prove anactual reduction to practice in order to showderivation.” Scott v. Brandenburger, 216 USPQ326, 327 (Bd. App. 1982). Furthermore, theapplication of subsection (f) is not limited to publicknowledge derived from another, and “the site ofderivation need not be in this country to bar a deriverfrom patenting the subject matter.” Ex parteAndresen, 212 USPQ 100, 102 (Bd. App. 1981).

III. DERIVATION DISTINGUISHED FROMPRIORITY OF INVENTION

Although derivation and priority of invention bothfocus on inventorship, derivation addressesoriginality (i.e., who invented the subject matter),whereas priority focuses on which party firstinvented the subject matter. Price v. Symsek, 988F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir.1993).

IV. Pre-AIA 35 U.S.C. 102(f) MAY APPLY WHEREPre-AIA 35 U.S.C. 102(a) AND Pre-AIA 35 U.S.C.102(e) ARE NOT AVAILABLE STATUTORYGROUNDS FOR REJECTION

Pre-AIA 35 U.S.C. 102(f) does not require an inquiryinto the relative dates of a reference and the

Rev. 08.2017, January 20182100-177


application, and therefore may be applicable wherepre-AIA subsections (a) and (e) are not available forreferences having an effective date subsequent tothe effective filing date of the application beingexamined. However, for a reference having a datelater than the effective filing date of the applicationsome evidence may exist that the subject matter ofthe reference was derived from the inventor or atleast one joint inventor in view of the relative dates. Ex parte Kusko, 215 USPQ 972, 974 (Bd. App.1981) (The relative dates of the events are importantin determining derivation; a publication dated morethan a year after applicant’s filing date that merelylists as literary coauthors individuals other than theinventor is not the strong evidence needed to rebuta declaration by the inventor that he is the soleinventor.).

2137.01 Inventorship [R-07.2015]

The requirement that the applicant for a patent in anapplication filed before September 16, 2012 be theinventor(s) (except as otherwise provided in pre-AIA37 CFR 1.41), and that the inventor or each jointinventor be identified in applications filed on or afterSeptember 16, 2012, are characteristics of U.S.patent law not generally shared by other countries.Consequently, foreign applicants may misunderstandU.S. law regarding naming of the actual inventorscausing an error in the inventorship of a U.S.application that may claim priority to a previousforeign application under 35 U.S.C. 119. A requestunder 37 CFR 1.48 is required to correct any errorin naming the inventors in the U.S. application asfiled. See MPEP § 602.01(c) et seq. Foreignapplicants may need to be reminded of therequirement for the same inventor or at least onecommon joint inventor between a U.S. applicationand a 35 U.S.C. 119 priority application. See MPEP§ 213.02, subsection II.

If a determination is made that the inventive entitynamed in a U.S. application is not correct, such aswhen a request under 37 CFR 1.48(a) is not grantedor is not entered for technical reasons, but theadmission therein regarding the error in inventorshipis uncontroverted, a rejection should be made on thisbasis. See MPEP § 706.03(a), subsection IV, forrejections under 35 U.S.C. 101 and 35 U.S.C. 115(and pre-AIA 35 U.S.C. 102(f) for applications

subject to pre-AIA 35 U.S.C. 102) for failure to setforth the correct inventorship.

I. NAMING INVENTORSHIP

The inventor, or each individual who is a jointinventor of a claimed invention, in an applicationfor patent (other than a provisional application) mustexecute an oath or declaration directed to theapplication, except as provided for in 37 CFR 1.64.See MPEP § 602.01(a) for the requirements of aninventor’s oath or declaration in an application filedon or after September 16, 2012. See MPEP §602.01(b) for the requirements of an original oathor declaration in an application filed beforeSeptember 16, 2012.

For applications filed before September 16, 2012,pre-AIA 37 CFR 1.41(a)(1) defines the inventorshipof a nonprovisional application as that inventorshipset forth in the oath or declaration filed to complywith the requirements of pre-AIA 37 CFR 1.63,except as otherwise provided. Thus the party orparties executing an oath or declaration underpre-AIA 37 CFR 1.63 are presumed to be theinventors. Driscoll v. Cebalo, 5 USPQ2d 1477, 1481(Bd. Pat. Inter. 1982); In re DeBaun, 687 F.2d 459,463, 214 USPQ 933, 936 (CCPA 1982) (Theinventor of an element, per se, and the inventor ofthat element as used in a combination may differ.“The existence of combination claims does notevidence inventorship by the patentee of theindividual elements or subcombinations thereof ifthe latter are not separately claimed apart from thecombination.” (quoting In re Facius, 408 F.2d 1396,1406, 161 USPQ 294, 301 (CCPA 1969) (emphasisin original)); Brader v. Schaeffer, 193 USPQ 627,631 (Bd. Pat. Inter. 1976) (in regard to aninventorship correction: “[a]s between inventorstheir word is normally taken as to who are the actualinventors” when there is no disagreement).

II. AN INVENTOR MUST CONTRIBUTE TO THECONCEPTION OF THE INVENTION

The definition for inventorship can be simply stated:“The threshold question in determining inventorshipis who conceived the invention. Unless a personcontributes to the conception of the invention, he isnot an inventor. … Insofar as defining an inventor

2100-178Rev. 08.2017, January 2018


is concerned, reduction to practice, per se, isirrelevant [except for simultaneous conception andreduction to practice, Fiers v. Revel, 984 F.2d 1164,1168, 25 USPQ2d 1601, 1604-05 (Fed. Cir. 1993)].One must contribute to the conception to be aninventor.” In re Hardee, 223 USPQ 1122, 1123(Comm’r Pat. 1984). See also Board of Educationex rel. Board of Trustees of Florida State Univ. v.American Bioscience Inc., 333 F.3d 1330, 1340, 67USPQ2d 1252, 1259 (Fed. Cir. 2003) (“Inventionrequires conception.” With regard to the inventorshipof chemical compounds, an inventor must have aconception of the specific compounds being claimed.“[G]eneral knowledge regarding the anticipatedbiological properties of groups of complex chemicalcompounds is insufficient to confer inventorshipstatus with respect to specifically claimedcompounds.”); Ex parte Smernoff, 215 USPQ 545,547 (Bd. App. 1982) (“one who suggests an idea ofa result to be accomplished, rather than the meansof accomplishing it, is not an coinventor”). SeeMPEP § 2138.04 - § 2138.05 for a discussion ofwhat evidence is required to establish conception orreduction to practice.

III. AS LONG AS THE INVENTOR MAINTAINSINTELLECTUAL DOMINATION OVER MAKINGTHE INVENTION, IDEAS, SUGGESTIONS, ANDMATERIALS MAY BE ADOPTED FROM OTHERS

“In arriving at … conception [the inventor] mayconsider and adopt ideas and materials derived frommany sources … [such as] a suggestion from anemployee, or hired consultant … so long as hemaintains intellectual domination of the work ofmaking the invention down to the successful testing,selecting or rejecting as he goes…even if suchsuggestion [or material] proves to be the key thatunlocks his problem.” Morse v. Porter, 155 USPQ280, 283 (Bd. Pat. Inter. 1965). See also NewEngland Braiding Co. v. A.W. Chesterton Co., 970F.2d 878, 883, 23 USPQ2d 1622, 1626 (Fed. Cir.1992) (Adoption of the ideas and materials fromanother can become a derivation.).

IV. THE INVENTOR IS NOT REQUIRED TOREDUCE THE INVENTION TO PRACTICE

Difficulties arise in separating members of a teameffort, where each member of the team has

contributed something, into those members thatactually contributed to the conception of theinvention, such as the physical structure or operativesteps, from those members that merely acted underthe direction and supervision of the conceivers. Fritsch v. Lin, 21 USPQ2d 1737, 1739 (Bd. Pat.App. & Inter. 1991) (The inventor “took no part indeveloping the procedures…for expressing the EPOgene in mammalian host cells and isolating theresulting EPO product.” However, “it is not essentialfor the inventor to be personally involved in carryingout process steps…where implementation of thosesteps does not require the exercise of inventiveskill.”); In re DeBaun, 687 F.2d 459, 463, 214USPQ 933, 936 (CCPA 1982) (“there is norequirement that the inventor be the one to reducethe invention to practice so long as the reduction topractice was done on his behalf”).

See also Mattor v. Coolegem, 530 F.2d 1391, 1395,189 USPQ 201, 204 (CCPA 1976) (one followingoral instructions is viewed as merely a technician); Tucker v. Naito, 188 USPQ 260, 263 (Bd. Pat. Inter.1975) (inventors need not “personally construct andtest their invention”); Davis v. Carrier, 81 F.2d 250,252, 28 USPQ 227, 229 (CCPA 1936) (noninventor’swork was merely that of a skilled mechanic carryingout the details of a plan devised by another).

V. REQUIREMENTS FOR JOINT INVENTORSHIP

The inventive entity for a particular application isbased on some contribution to at least one of theclaims made by each of the named inventors.“Inventors may apply for a patent jointly eventhough (1) they did not physically work together orat the same time, (2) each did not make the sametype or amount of contribution, or (3) each did notmake a contribution to the subject matter of everyclaim of the patent.” 35 U.S.C. 116. “[T]he statuteneither states nor implies that two inventors can be‘joint inventors’ if they have had no contactwhatsoever and are completely unaware of eachother's work.” What is required is some “quantumof collaboration or connection.” In other words,“[f]or persons to be joint inventors under Section116, there must be some element of joint behavior,such as collaboration or working under commondirection, one inventor seeing a relevant report andbuilding upon it or hearing another’s suggestion at

Rev. 08.2017, January 20182100-179


a meeting.” Kimberly-Clark Corp. v. Procter &Gamble Distrib. Co., 973 F.2d 911, 916-17, 23USPQ2d 1921, 1925-26 (Fed. Cir. 1992); Moler v.Purdy, 131 USPQ 276, 279 (Bd. Pat. Inter. 1960)(“it is not necessary that the inventive concept cometo both [joint inventors] at the same time”).

Each joint inventor must generally contribute to theconception of the invention. A coinventor need notmake a contribution to every claim of a patent. Acontribution to one claim is enough. “The contributorof any disclosed means of a means-plus-functionclaim element is a joint inventor as to that claim,unless one asserting sole inventorship can show thatthe contribution of that means was simply areduction to practice of the sole inventor’s broaderconcept.” Ethicon Inc. v. United States SurgicalCorp., 135 F.3d 1456, 1460-63, 45 USPQ2d 1545,1548-1551 (Fed. Cir. 1998) (The electronicstechnician who contributed to one of the twoalternative structures in the specification to define“the means for detaining” in a claim limitation washeld to be a joint inventor.).

2137.02 Applicability of Pre-AIA 35 U.S.C.103(c) [R-11.2013]


Pre-AIA 35 U.S.C. 103(c) states that subsection (f)of pre-AIA 35 U.S.C. 102 will not precludepatentability where subject matter developed byanother person, that would otherwise qualify underpre-AIA 35 U.S.C. 102(f), and the claimed inventionof an application under examination were owned bythe same person, subject to an obligation ofassignment to the same person, or involved in a jointresearch agreement, which meets the requirementsof pre-AIA 35 U.S.C. 103(c)(2) and (c)(3), at thetime the invention was made. See MPEP § 706.02(l)and § 2146.

Inventorship is generally “by another” where thereare different inventive entities with at least oneinventor in common. For case law relating toinventorship by “another” involving differentinventive entities with at least one inventor incommon see Ex parte DesOrmeaux, 25 USPQ2d2040 (Bd. Pat. App. & Inter. 1992) (the presence ofa common inventor in a reference patent and apending application does not preclude thedetermination that the reference inventive entity isto “another” within the meaning of [pre-AIA] 35U.S.C. 102(e)) and the discussion of prior artavailable under pre-AIA 35 U.S.C. 102(e) in MPEP§ 2136.04.

2138 Pre-AIA 35 U.S.C. 102(g) [R-08.2017]

[Editor Note: This MPEP section has limitedapplicability to applications subject to examinationunder the first inventor to file (FITF) provisions ofthe AIA as set forth in 35 U.S.C. 100 (note). SeeMPEP § 2159 et seq. to determine whether anapplication is subject to examination under the FITFprovisions, MPEP § 2159.03 for the conditions underwhich this section applies to an AIA application, andMPEP § 2150 et seq. for examination of applicationssubject to those provisions.]



*****

(g) (1) during the course of an interference conducted undersection 135 or section 291, another inventor involved thereinestablishes, to the extent permitted in section 104, that beforesuch person’s invention thereof the invention was made by suchother inventor and not abandoned, suppressed, or concealed, or(2) before such person’s invention thereof, the invention wasmade in this country by another inventor who had notabandoned, suppressed, or concealed it. In determining priorityof invention under this subsection, there shall be considered notonly the respective dates of conception and reduction to practiceof the invention, but also the reasonable diligence of one whowas first to conceive and last to reduce to practice, from a timeprior to conception by the other.

Pre-AIA 35 U.S.C. 102(g) issues such as conception,reduction to practice and diligence, while morecommonly applied to interference matters, also arisein other contexts.

2100-180Rev. 08.2017, January 2018


Pre-AIA 35 U.S.C. 102(g) may form the basis foran ex parte rejection if: (1) the subject matter atissue has been actually reduced to practice byanother before the applicant’s invention; and (2)there has been no abandonment, suppression orconcealment. See, e.g., Amgen, Inc. v. ChugaiPharmaceutical Co., 927 F.2d 1200, 1205, 18USPQ2d 1016, 1020 (Fed. Cir. 1991); New IdeaFarm Equipment Corp. v. Sperry Corp., 916 F.2d1561, 1566, 16 USPQ2d 1424, 1428 (Fed. Cir.1990); E.I. DuPont de Nemours & Co. v. PhillipsPetroleum Co., 849 F.2d 1430, 1434, 7 USPQ2d1129, 1132 (Fed. Cir. 1988); Kimberly-Clark v.Johnson & Johnson, 745 F.2d 1437, 1444-46, 223USPQ 603, 606-08 (Fed. Cir. 1984). To qualify asprior art under pre-AIA 35 U.S.C. 102(g), however,there must be evidence that the subject matter wasactually reduced to practice, in that conception aloneis not sufficient. See Kimberly-Clark, 745 F.2d at1445, 223 USPQ at 607. While the filing of anapplication for patent is a constructive reduction topractice, the filing of an application does not in itselfprovide the evidence necessary to show an actualreduction to practice of any of the subject matterdisclosed in the application as is necessary to providethe basis for an ex parte rejection under pre-AIA35 U.S.C. 102(g). Thus, absent evidence showingan actual reduction to practice (which is generallynot available during ex parte examination), thedisclosure of a United States patent applicationpublication or patent falls under pre-AIA 35 U.S.C.102(e) and not under pre-AIA 35 U.S.C. 102(g). Cf. In re Zletz, 893 F.2d 319, 323, 13 USPQ2d 1320,1323 (Fed. Cir. 1989) (the disclosure in a referenceUnited States patent does not fall under pre-AIA 35U.S.C. 102(g) but under pre-AIA 35 U.S.C. 102(e)).

In addition, subject matter qualifying as prior artonly under pre-AIA 35 U.S.C. 102(g) may also bethe basis for an ex parte rejection under pre-AIA35 U.S.C. 103. See In re Bass, 474 F.2d 1276, 1283,177 USPQ 178, 183 (CCPA 1973) (in anunsuccessful attempt to utilize a 37 CFR 1.131affidavit relating to a combination application,applicants admitted that the subcombination screenof a copending application which issued as a patentwas earlier conceived than the combination).Pre-AIA 35 U.S.C. 103(c), however, states thatsubsection (g) of pre-AIA 35 U.S.C. 102 will notpreclude patentability where subject matter

developed by another person, that would otherwisequalify under pre-AIA 35 U.S.C. 102(g), and theclaimed invention of an application underexamination were owned by the same person, subjectto an obligation of assignment to the same person,or involved in a joint research agreement, whichmeets the requirements of pre-AIA 35 U.S.C.103(c)(2) and (c)(3), at the time the invention wasmade. See MPEP § 706.02(l) and § 2146.

For additional examples of pre-AIA 35 U.S.C.102(g) issues such as conception, reduction topractice and diligence outside the context ofinterference matters, see In re Costello, 717 F.2d1346, 219 USPQ 389 (Fed. Cir. 1983) (discussingthe concepts of conception and constructivereduction to practice in the context of a declarationunder 37 CFR 1.131), and Kawai v. Metlesics, 480F.2d 880, 178 USPQ 158 (CCPA 1973) (holdingconstructive reduction to practice for priority under35 U.S.C. 119 requires meeting the requirements of35 U.S.C. 101 and 35 U.S.C. 112).

2138.01 Interference Practice [R-08.2017]


I. PRE-AIA 35 U.S.C. 102(g) IS THE BASIS OFINTERFERENCE PRACTICE

Subsection (g) of pre-AIA 35 U.S.C. 102 is the basisof interference practice for determining priority ofinvention between two parties. See Bigham v.Godtfredsen, 857 F.2d 1415, 1416, 8 USPQ2d 1266,1267 (Fed. Cir. 1988), 35 U.S.C. 135, 37 CFR Part41, Subparts D and E and MPEP Chapter 2300. Aninterference is an inter partes proceeding directedat determining the first to invent as among the partiesto the proceeding, involving two or more pendingapplications naming different inventors or one ormore pending applications and one or more

Rev. 08.2017, January 20182100-181


unexpired patents naming different inventors. TheUnited States is unusual in having a first to inventrather than a first to file system in certainapplications. Paulik v. Rizkalla, 760 F.2d 1270,1272, 226 USPQ 224, 225 (Fed. Cir. 1985) (reviewsthe legislative history of the subsection in aconcurring opinion by Judge Rich). The first of manyto reduce an invention to practice around the sametime will be the sole party to obtain a patent in someinstances, Radio Corp. of America v. Radio Eng’gLabs., Inc., 293 U.S. 1, 2, 21 USPQ 353, 353-4(1934), unless another was the first to conceive andcouple a later-in-time reduction to practice withdiligence from a time just prior to when the secondconceiver entered the field to the first conceiver’sreduction to practice. Hull v. Davenport, 90 F.2d103, 105, 33 USPQ 506, 508 (CCPA 1937). See thepriority time charts below illustrating this point.Upon conclusion of an interference, subject matterclaimed by the losing party that was the basis of theinterference is rejected under pre-AIA 35 U.S.C.102(g), unless the acts showing prior invention werenot in this country.

It is noted that 35 U.S.C. 101 requires that whoeverinvents or discovers the claimed invention is theparty that must be named as the inventor(s) beforea parent may be granted. Where it can be shown thatan applicant has “derived” an invention fromanother, a rejection under pre-AIA 35 U.S.C. 102(f)is proper if applicable. Ex parte Kusko, 215 USPQ972, 974 (Bd. App. 1981) (“most, if not all,determinations under [pre-AIA] Section 102(f)involve the question of whether one party derivedan invention from another”); Price v. Symsek, 988F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir.1993) (Although derivation and priority of inventionboth focus on inventorship, derivation addressesoriginality, i.e., who invented the subject matter,whereas priority focuses on which party inventedthe subject matter first.).

II. PRIORITY TIME CHARTS

The following priority time charts illustrate theaward of invention priority in several situations. Thetime charts apply to interference proceedings andare also applicable to declarations or affidavits filedunder 37 CFR 1.131 to antedate references whichare available as prior art under pre-AIA 35 U.S.C.

102(a) or 102(e). Note, however, in the context of37 CFR 1.131, an applicant does not have to showthat the invention was not abandoned, suppressed,or concealed from the time of an actual reduction topractice to a constructive reduction to practicebecause the length of time taken to file a patentapplication after an actual reduction to practice isgenerally of no consequence except in aninterference proceeding. Paulik v. Rizkalla, 760 F.2d1270, 226 USPQ 224 (Fed. Cir. 1985). See thediscussion of abandonment, suppression, andconcealment in MPEP § 2138.03.

For purposes of analysis under 37 CFR 1.131, theconception and reduction to practice of the referenceto be antedated are both considered to be on theeffective filing date of domestic patent or foreignpatent or the date of printed publication.

In the charts, C = conception, R = reduction topractice (either actual or constructive), Ra = actualreduction to practice, Rc = constructive reduction topractice, and TD = commencement of diligence.

Example 1

A is awarded priority in an interference, or antedates B as areference in the context of a declaration or affidavit filed under37 CFR 1.131, because A conceived the invention before B andconstructively reduced the invention to practice before B reducedthe invention to practice. The same result would be reached ifthe conception date was the same for both inventors A and B.

2100-182Rev. 08.2017, January 2018


Example 2

A is awarded priority in an interference, or antedates B as areference in the context of a declaration or affidavit filed under37 CFR 1.131, if A can show reasonable diligence from TD (a

point just prior to B’s conception) until Rc because A conceivedthe invention before B, and diligently constructively reducedthe invention to practice even though this was after B reducedthe invention to practice.

Example 3

A is awarded priority in an interference in the absence ofabandonment, suppression, or concealment from Ra to Rc,because A conceived the invention before B, actually reducedthe invention to practice before B reduced the invention topractice, and did not abandon, suppress, or conceal the inventionafter actually reducing the invention to practice and beforeconstructively reducing the invention to practice.

A antedates B as a reference in the context of a declaration oraffidavit filed under 37 CFR 1.131 because A conceived theinvention before B and actually reduced the invention to practicebefore B reduced the invention to practice.

Example 4

A is awarded priority in an interference if A can show reasonablediligence from TD (a point just prior to B’s conception) until

Ra in the absence of abandonment, suppression, or concealmentfrom Ra to Rc, because A conceived the invention before B,diligently actually reduced the invention to practice (after Breduced the invention to practice), and did not abandon,suppress, or conceal the invention after actually reducing theinvention to practice and before constructively reducing theinvention to practice.

A antedates B as a reference in the context of a declaration oraffidavit filed under 37 CFR 1.131 because A conceived theinvention before B, and diligently actually reduced the inventionto practice, even though this was after B reduced the inventionto practice.

III. 37 CFR 1.131 DOES NOT APPLY ININTERFERENCE PROCEEDINGS

Interference practice operates to the exclusion of exparte practice under 37 CFR 1.131 which permitsan applicant to show an actual date of invention priorto the effective date of a reference or activity appliedunder pre-AIA 35 U.S.C. 102 or 103, as long as thereference is not a statutory bar under pre-AIA 35U.S.C. 102(b) or a U.S. patent applicationpublication claiming the same patentable invention.Ex parte Standish, 10 USPQ2d 1454, 1457 (Bd. Pat.App. & Inter. 1988) (An application claim to the“same patentable invention” claimed in a domesticpatent requires interference rather than an affidavitunder 37 CFR 1.131 to antedate the patent. The term“same patentable invention” encompasses a claimthat is either anticipated by or obvious in view ofthe subject matter recited in the patent claim.).Subject matter which is prior art under pre-AIA 35U.S.C. 102(g) and is subject to an interference is notopen to further inquiry under 37 CFR 1.131 duringthe interference proceeding.

Rev. 08.2017, January 20182100-183


IV. LOST COUNTS IN AN INTERFERENCE ARENOT, PER SE, STATUTORY PRIOR ART

Loss of an interference count alone does not makeits subject matter statutory prior art to losing party;however, lost count subject matter that is availableas prior art under 35 U.S.C. 102 may be used aloneor in combination with other references under 35U.S.C. 103. But see In re Deckler, 977 F.2d 1449,24 USPQ2d 1448 (Fed. Cir. 1992) (Under theprinciples of res judicata and collateral estoppel,Deckler was not entitled to claims that werepatentably indistinguishable from the claim lost ininterference even though the subject matter of thelost count was not available for use in an obviousnessrejection under 35 U.S.C. 103.).

2138.02 “The Invention Was Made in ThisCountry” [R-11.2013]


An invention is made when there is a conceptionand a reduction to practice. Dunn v. Ragin, 50 USPQ472, 474 (Bd. Pat. Inter. 1941). Prior art underpre-AIA 35 U.S.C. 102(g) is limited to an inventionthat is made. In re Katz, 687 F.2d 450, 454, 215USPQ 14, 17 (CCPA 1982) (the publication of anarticle, alone, is not deemed a constructive reductionto practice, and therefore its disclosure does notprove that any invention within the meaning ofpre-AIA 35 U.S.C. 102(g) has ever been made).

Subject matter under pre-AIA 35 U.S.C. 102(g) isavailable only if made in this country. Pre-AIA 35U.S.C. 104. Kondo v. Martel, 220 USPQ 47 (Bd.Pat. Inter. 1983) (acts of conception, reduction topractice and diligence must be demonstrated in thiscountry). Compare Colbert v. Lofdahl, 21 USPQ2d1068, 1071 (Bd. Pat. App. & Inter. 1991) (“[i]f theinvention is reduced to practice in a foreign country

and knowledge of the invention was brought intothis country and disclosed to others, the inventor canderive no benefit from the work done abroad andsuch knowledge is merely evidence of conceptionof the invention”).

In accordance with pre-AIA 35 U.S.C. 102(g)(1), aparty involved in an interference proceeding underpre-AIA 35 U.S.C. 135 or 291 may establish a dateof invention under pre-AIA 35 U.S.C. 104. Pre-AIA35 U.S.C. 104, as amended by GATT (Public Law103-465, 108 Stat. 4809 (1994)) and NAFTA (PublicLaw 103-182, 107 Stat. 2057 (1993)), provides thatan applicant can establish a date of invention in aNAFTA member country on or after December 8,1993 or in WTO member country other than aNAFTA member country on or after January 1, 1996.Accordingly, an interference count may be won orlost on the basis of establishment of invention byone of the parties in a NAFTA or WTO membercountry, thereby rendering the subject matter of thatcount unpatentable to the other party under theprinciples of res judicata and collateral estoppel,even though such subject matter is not available asstatutory prior art under pre-AIA 35 U.S.C. 102(g).See MPEP § 2138.01 regarding lost interferencecounts which are not statutory prior art.

2138.03 “By Another Who Has NotAbandoned, Suppressed, or Concealed It”[R-11.2013]


Pre-AIA 35 U.S.C. 102(g) generally makes availableas prior art within the meaning of 35 U.S.C. 103, theprior invention of another who has not abandoned,suppressed or concealed it. In re Bass, 474 F.2d1276, 177 USPQ 178 (CCPA 1973); In re Suska,589 F.2d 527, 200 USPQ 497 (CCPA 1979) (Theresult of applying the suppression and concealment

2100-184Rev. 08.2017, January 2018


doctrine is that the inventor who did not conceal (butwas the de facto last inventor) is treated legally asthe first to invent, while the de facto first inventorwho suppressed or concealed is treated as a laterinventor. The de facto first inventor, by hissuppression and concealment, lost the right to relyon his actual date of invention not only for prioritypurposes, but also for purposes of avoiding theinvention of the counts as prior art.).

“The courts have consistently held that an invention,though completed, is deemed abandoned, suppressed,or concealed if, within a reasonable time aftercompletion, no steps are taken to make the inventionpublicly known. Thus failure to file a patentapplication; to describe the invention in a publiclydisseminated document; or to use the inventionpublicly, have been held to constitute abandonment,suppression, or concealment.” Correge v. Murphy,705 F.2d 1326, 1330, 217 USPQ 753, 756 (Fed. Cir.1983) (quoting International Glass Co. v. UnitedStates, 408 F.2d 395, 403, 159 USPQ 434, 441 (Ct.Cl. 1968)). In Correge, an invention was actuallyreduced to practice, 7 months later there was a publicdisclosure of the invention, and 8 months thereaftera patent application was filed. The court held filinga patent application within 1 year of a publicdisclosure is not an unreasonable delay, thereforereasonable diligence must only be shown betweenthe date of the actual reduction to practice and thepublic disclosure to avoid the inference ofabandonment.

I. DURING AN INTERFERENCE PROCEEDING,AN INFERENCE OF SUPPRESSION ORCONCEALMENT MAY ARISE FROM DELAY INFILING PATENT APPLICATION

Once an invention is actually reduced to practice aninventor need not rush to file a patent application. Shindelar v. Holdeman, 628 F.2d 1337, 1341,207 USPQ 112, 116 (CCPA 1980). The length oftime taken to file a patent application after an actualreduction to practice is generally of no consequenceexcept in an interference proceeding. Paulik v.Rizkalla, 760 F.2d 1270, 1271, 226 USPQ 225, 226(Fed. Cir. 1985) (suppression or concealment maybe deliberate or may arise due to an inference froma “too long” delay in filing a patent application). Peeler v. Miller, 535 F.2d 647, 656, 190 USPQ

117,124 (CCPA 1976) (“mere delay, without more,is not sufficient to establish suppression orconcealment.” “What we are deciding here is thatMonsanto’s delay is not ‘merely delay’ and thatMonsanto's justification for the delay is inadequateto overcome the inference of suppression created bythe excessive delay.” The word “mere” does notimply a total absence of a limit on the duration ofdelay. Whether any delay is “mere” is decided onlyon a case-by-case basis.).

Where a junior party in an interference relies uponan actual reduction to practice to demonstrate firstinventorship, and where the hiatus in time betweenthe date for the junior party's asserted reduction topractice and the filing of its application isunreasonably long, the hiatus may give rise to aninference that the junior party in fact suppressed orconcealed the invention and the junior party will notbe allowed to rely upon the earlier actual reductionto practice. Young v. Dworkin, 489 F.2d 1277, 1280n.3, 180 USPQ 388, 391 n.3 (CCPA 1974)(suppression and concealment issues are to beaddressed on a case-by-case basis).

II. SUPPRESSION OR CONCEALMENT NEEDNOT BE ATTRIBUTED TO INVENTOR

Suppression or concealment need not be attributedto the inventor. Peeler v. Miller, 535 F.2d 647,653-54, 190 USPQ 117, 122 (CCPA 1976) (“fouryear delay from the time an inventor … completeshis work … and the time his assignee-employer filesa patent application is, prima facie, unreasonablylong in an interference with a party who filed first”); Shindelar v. Holdeman, 628 F.2d 1337, 1341-42,207 USPQ 112, 116-17 (CCPA 1980) (A patentattorney’s workload will not preclude a holding ofan unreasonable delay—a total of 3 months wasidentified as possible of excuse in regard to the filingof an application.).

III. INFERENCE OF SUPPRESSION ORCONCEALMENT IS REBUTTABLE

Notwithstanding a finding of suppression orconcealment, a constructive reduction to practicesuch as renewed activity just prior to other party’sentry into field coupled with the diligent filing of anapplication would still cause the junior party to

Rev. 08.2017, January 20182100-185


prevail. Lutzker v. Plet, 843 F.2d 1364, 1367-69, 6USPQ2d 1370, 1371-72 (Fed. Cir. 1988) (activitiesdirected towards commercialization not sufficientto rebut inference); Holmwood v. Cherpeck, 2USPQ2d 1942, 1945 (Bd. Pat. App. & Inter. 1986)(the inference of suppression or concealment maybe rebutted by showing activity directed to perfectingthe invention, preparing the application, or preparingother compounds within the scope of the genericinvention); Engelhardt v. Judd, 369 F.2d 408, 411,151 USPQ 732, 735 (CCPA 1966) (“We recognizethat an inventor of a new series of compounds shouldnot be forced to file applications piecemeal on eachnew member as it is synthesized, identified andtested for utility. A reasonable amount of time shouldbe allowed for completion of the research project onthe whole series of new compounds, and a furtherreasonable time period should then be allowed fordrafting and filing the patent application(s)thereon.”); Bogoslowsky v. Huse, 142 F.2d 75, 77,61 USPQ 349, 351 (CCPA 1944) (The doctrine ofsuppression and concealment is not applicable toconception without an actual reduction to practice.).

IV. ABANDONMENT

A finding of suppression or concealment may notamount to a finding of abandonment wherein a rightto a patent is lost. Steierman v. Connelly, 197 USPQ288, 289 (Comm'r Pat. 1976); Correge v. Murphy,705 F.2d 1326, 1329, 217 USPQ 753, 755 (Fed. Cir.1983) (an invention cannot be abandoned until it isfirst reduced to practice).

2138.04 “Conception” [R-08.2017]


Conception has been defined as “the completeperformance of the mental part of the inventive act”and it is “the formation in the mind of the inventor

of a definite and permanent idea of the complete andoperative invention as it is thereafter to be appliedin practice….” Townsend v. Smith, 36 F.2d 292,295, 4 USPQ 269, 271 (CCPA 1929). “[C]onceptionis established when the invention is made sufficientlyclear to enable one skilled in the art to reduce it topractice without the exercise of extensiveexperimentation or the exercise of inventive skill.” Hiatt v. Ziegler, 179 USPQ 757, 763 (Bd. Pat. Inter.1973). Conception has also been defined as adisclosure of an invention which enables one skilledin the art to reduce the invention to a practical formwithout “exercise of the inventive faculty.” Gunterv. Stream, 573 F.2d 77, 197 USPQ 482 (CCPA1978). See also Coleman v. Dines, 754 F.2d 353,224 USPQ 857 (Fed. Cir. 1985) (It is settled that inestablishing conception a party must showpossession of every feature recited in the count, andthat every limitation of the count must have beenknown to the inventor at the time of the allegedconception. Conception must be proved bycorroborating evidence.); Hybritech Inc. v.Monoclonal Antibodies Inc., 802 F. 2d 1367, 1376,231 USPQ 81, 87 (Fed. Cir. 1986) (Conception isthe “formation in the mind of the inventor, of adefinite and permanent idea of the complete andoperative invention, as it is hereafter to be appliedin practice.”); Hitzeman v. Rutter, 243 F.3d 1345,58 USPQ2d 1161 (Fed. Cir. 2001) (Inventor’s“hope” that a genetically altered yeast would produceantigen particles having the particle size andsedimentation rates recited in the claims did notestablish conception, since the inventor did not showthat he had a “definite and permanent understanding”as to whether or how, or a reasonable expectationthat, the yeast would produce the recited antigenparticles.).

I. CONCEPTION MUST BE DONE IN THE MINDOF THE INVENTOR

The inventor must form a definite and permanentidea of the complete and operable invention toestablish conception. Bosies v. Benedict, 27 F.3d539, 543, 30 USPQ2d 1862, 1865 (Fed. Cir. 1994)(Testimony by a noninventor as to the meaning ofa variable of a generic compound described in aninventor’s notebook was insufficient as a matter oflaw to establish the meaning of the variable because

2100-186Rev. 08.2017, January 2018


the testimony was not probative of what theinventors conceived.).

II. AS LONG AS THE INVENTOR MAINTAINSINTELLECTUAL DOMINATION OVER MAKINGTHE INVENTION, IDEAS, SUGGESTIONS, ANDMATERIALS MAY BE ADOPTED FROM OTHERS

An inventor may consider and adopt ideas,suggestions and materials derived from manysources: a suggestion from an employee, a hiredconsultant or a friend even if the adopted materialproves to be the key that unlocks the problem solong as the inventor “maintains intellectualdomination of the work of making the inventiondown to the successful testing, selecting orrejecting….” Morse v. Porter, 155 USPQ 280, 283(Bd. Pat. Inter. 1965); Staehelin v. Secher,24 USPQ2d 1513, 1522 (Bd. Pat. App. & Inter.1992) (“evidence of conception naming only one ofthe actual inventive entity inures to the benefit ofand serves as evidence of conception by the completeinventive entity”).

III. CONCEPTION REQUIRESCONTEMPORANEOUS RECOGNITION ANDAPPRECIATION OF THE INVENTION

There must be a contemporaneous recognition andappreciation of the invention for there to beconception. Silvestri v. Grant, 496 F.2d 593, 596,181 USPQ 706, 708 (CCPA 1974) (“an accidentaland unappreciated duplication of an invention doesnot defeat the patent right of one who, though laterin time was the first to recognize that whichconstitutes the inventive subject matter”); Invitrogen, Corp. v. Clontech Laboratories, Inc.,429 F.3d 1052, 1064, 77 USPQ2d 1161, 1169 (Fed.Cir. 2005) (In situations where there is unrecognizedaccidental duplication, establishing conceptionrequires evidence that the inventor actually madethe invention and understood the invention to havethe features that comprise the inventive subjectmatter at issue). Langer v. Kaufman, 465 F.2d 915,918, 175 USPQ 172, 174 (CCPA 1972) (new formof catalyst was not recognized when it was firstproduced; conception cannot be established nuncpro tunc). However, an inventor does not need toknow that the invention will work for there to becomplete conception. Burroughs Wellcome Co. v.Barr Labs., Inc., 40 F.3d 1223, 1228, 32 USPQ2d

1915, 1919 (Fed. Cir. 1994) (Draft patent applicationdisclosing treatment of AIDS with AZT recitingdosages, forms, and routes of administration wassufficient to collaborate conception whether or notthe inventors believed the inventions would workbased on initial screening tests.) Furthermore, theinventor does not need to appreciate the patentabilityof the invention. Dow Chem. Co. v. Astro-Valcour,Inc., 267 F.3d 1334, 1341, 60 USPQ2d 1519, 1523(Fed. Cir. 2001).

The first to conceive of a species is not necessarilythe first to conceive of the generic invention. In reJolley, 308 F.3d 1317, 1323 n.2, 64 USPQ2d 1901,1905 n.2 (Fed. Cir. 2002). Further, while conceptionof a species within a genus may constituteconception of the genus, conception of one speciesand the genus may not constitute conception ofanother species in the genus. Oka v. Youssefyeh,849 F.2d 581, 7 USPQ2d 1169 (Fed. Cir. 1988)(conception of a chemical requires both the idea ofthe structure of the chemical and possession of anoperative method of making it). See also Amgen,Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200,1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (inthe isolation of a gene, defining a gene by itsprincipal biological property is not sufficient forconception absent an ability to envision the detailedconstitution as well as a method for obtaining it); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d1601, 1605 (Fed. Cir. 1993) (“[b]efore reduction topractice, conception only of a process for making asubstance, without conception of a structural orequivalent definition of that substance, can at mostconstitute a conception of the substance claimed asa process” but cannot constitute conception of thesubstance; as “conception is not enablement,”conception of a purified DNA sequence coding fora specific protein by function and a method for itsisolation that could be carried out by one of ordinaryskill in the art is not conception of that material).

On rare occasions conception and reduction topractice occur simultaneously. Alpert v. Slatin,305 F.2d 891, 894, 134 USPQ 296, 299 (CCPA1962). “[I]n some unpredictable areas of chemistryand biology, there is no conception until theinvention has been reduced to practice.” MacMillanv. Moffett, 432 F.2d 1237, 1234-40, 167 USPQ 550,552-553 (CCPA 1970). See also Hitzeman v. Rutter,

Rev. 08.2017, January 20182100-187


243 F.3d 1345, 58 USPQ2d 1161 (Fed. Cir. 2001)(conception simultaneous with reduction to practicewhere appellant lacked reasonable certainty thatyeast’s performance of certain intracellular processeswould result in the claimed antigen particles); Dunnv. Ragin, 50 USPQ 472, 475 (Bd. Pat. Inter. 1941)(a new variety of asexually reproduced plant isconceived and reduced to practice when it is grownand recognized as a new variety). Under thesecircumstances, conception is not complete ifsubsequent experimentation reveals factualuncertainty which “so undermines the specificity ofthe inventor’s idea that it is not yet a definite andpermanent reflection of the complete invention as itwill be used in practice.” Burroughs Wellcome Co.v. Barr Labs., Inc., 40 F.3d 1223, 1229, 32 USPQ2d1915, 1920 (Fed. Cir. 1994).

IV. A PREVIOUSLY ABANDONED APPLICATIONWHICH WAS NOT COPENDING WITH ASUBSEQUENT APPLICATION IS EVIDENCEONLY OF CONCEPTION

An abandoned application with which no subsequentapplication was copending serves to abandon benefitof the application’s filing as a constructive reductionto practice and the abandoned application is evidenceonly of conception. In re Costello, 717 F.2d 1346,1350, 219 USPQ 389, 392 (Fed. Cir. 1983).

2138.05 “Reduction to Practice” [R-08.2017]


Reduction to practice may be an actual reduction ora constructive reduction to practice which occurswhen a patent application on the claimed inventionis filed. The filing of a patent application serves asconception and constructive reduction to practice ofthe subject matter described in the application. Thusthe inventor need not provide evidence of either

conception or actual reduction to practice whenrelying on the content of the patent application. Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d1128, 1130 (Fed. Cir. 1998). A reduction to practicecan be done by another on behalf of the inventor. De Solms v. Schoenwald, 15 USPQ2d 1507, 1510(Bd. Pat. App. & Inter. 1990). “While the filing ofthe original application theoretically constituted aconstructive reduction to practice at the time, thesubsequent abandonment of that application alsoresulted in an abandonment of the benefit of thatfiling as a constructive reduction to practice. Thefiling of the original application is, however,evidence of conception of the invention.” In reCostello, 717 F.2d 1346, 1350, 219 USPQ 389, 392(Fed. Cir. 1983)(The second application was notco-pending with the original application and it didnot reference the original application. Because ofthe requirements of 35 U.S.C. 120 had not beensatisfied, the filing of the original application wasnot recognized as constructive reduction to practiceof the invention.).

I. CONSTRUCTIVE REDUCTION TO PRACTICEREQUIRES COMPLIANCE WITH 35 U.S.C. 112(a)or PRE-AIA 35 U.S.C. 112, FIRST PARAGRAPH

When a party to an interference seeks the benefit ofan earlier-filed U.S. patent application, the earlierapplication must meet the requirements of 35 U.S.C.120 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112,first paragraph for the subject matter of the count.The earlier application must meet the enablementrequirement and must contain a written descriptionof the subject matter of the interference count. Hyattv. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128,1130 (Fed. Cir. 1998). Proof of a constructivereduction to practice requires sufficient disclosureunder the “how to use” and “how to make”requirements of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. Kawai v. Metlesics, 480F.2d 880, 886, 178 USPQ 158, 163 (CCPA 1973)(A constructive reduction to practice is not provenunless the specification discloses a practical utilitywhere one would not be obvious. Prior art whichdisclosed an anticonvulsant compound whichdiffered from the claimed compound only in theabsence of a -CH2- group connecting two functional

groups was not sufficient to establish utility of theclaimed compound because the compounds were

2100-188Rev. 08.2017, January 2018


not so closely related that they could be presumedto have the same utility.). The purpose of the writtendescription requirement is “to ensure that theinventor had possession, as of the filing date of theapplication relied on, of the specific subject matterlater claimed by him.” In re Edwards, 568 F.2d1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978).The written description must include all of thelimitations of the interference count, or the applicantmust show that any absent text is necessarilycomprehended in the description provided and wouldhave been so understood at the time the patentapplication was filed. Furthermore, the writtendescription must be sufficient, when the entirespecification is considered, such that the “necessaryand only reasonable construction” that would begiven it by a person skilled in the art is one thatclearly supports each positive limitation in the count. Hyatt v. Boone, 146 F.3d at 1354-55, 47 USPQ2dat 1130-1132 (Fed. Cir. 1998) (The claim could beread as describing subject matter other than that ofthe count and thus did not establish that the applicantwas in possession of the invention of the count.).See also Bigham v. Godtfredsen, 857 F.2d 1415,1417, 8 USPQ2d 1266, 1268 (Fed. Cir. 1988) (“[t]hegeneric term halogen comprehends a limited numberof species, and ordinarily constitutes a sufficientwritten description of the common halogen species,”except where the halogen species are patentablydistinct).

II. REQUIREMENTS TO ESTABLISH ACTUALREDUCTION TO PRACTICE

“In an interference proceeding, a party seeking toestablish an actual reduction to practice must satisfya two-prong test: (1) the party constructed anembodiment or performed a process that met everyelement of the interference count, and (2) theembodiment or process operated for its intendedpurpose.” Eaton v. Evans, 204 F.3d 1094, 1097, 53USPQ2d 1696, 1698 (Fed. Cir. 2000).

The same evidence sufficient for a constructivereduction to practice may be insufficient to establishan actual reduction to practice, which requires ashowing of the invention in a physical or tangibleform that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ223, 227 (CCPA 1976). For an actual reduction to

practice, the invention must have been sufficientlytested to demonstrate that it will work for its intendedpurpose, but it need not be in a commerciallysatisfactory stage of development. See, e.g., Scottv. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115,1118-19 (Fed. Cir. 1994) (citing numerous caseswherein the character of the testing necessary tosupport an actual reduction to practice varied withthe complexity of the invention and the problem itsolved). If a device is so simple, and its purpose andefficacy so obvious, construction alone is sufficientto demonstrate workability. King Instrument Corp.v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402,407 (Fed. Cir. 1985).

For additional cases pertaining to the requirementsnecessary to establish actual reduction to practicesee DSL Dynamic Sciences, Ltd. v. Union Switch &Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152,1155 (Fed. Cir. 1991) (“events occurring after analleged actual reduction to practice can call intoquestion whether reduction to practice has in factoccurred”); Fitzgerald v. Arbib, 268 F.2d 763,765-66, 122 USPQ 530, 531-32 (CCPA 1959) (“thereduction to practice of a three-dimensional designinvention requires the production of an articleembodying that design” in “other than a meredrawing”); Birmingham v. Randall, 171 F.2d 957,80 USPQ 371, 372 (CCPA 1948) (To establish anactual reduction to practice of an invention directedto a method of making a product, it is not enough toshow that the method was performed. “[S]uch aninvention is not reduced to practice until it isestablished that the product made by the process issatisfactory, and [ ] this may require successfultesting of the product.”).

III. TESTING REQUIRED TO ESTABLISH ANACTUAL REDUCTION TO PRACTICE

“The nature of testing which is required to establisha reduction to practice depends on the particular factsof each case, especially the nature of the invention.” Gellert v. Wanberg, 495 F.2d 779, 783, 181 USPQ648, 652 (CCPA 1974) (“an invention may be testedsufficiently … where less than all of the conditionsof actual use are duplicated by the tests”); Wells v.Fremont, 177 USPQ 22, 24-5 (Bd. Pat. Inter. 1972)(“even where tests are conducted under ‘bench’ orlaboratory conditions, those conditions must ‘fully

Rev. 08.2017, January 20182100-189


duplicate each and every condition of actual use’ orif they do not, then the evidence must establish arelationship between the subject matter, the testcondition and the intended functional setting of theinvention,” but it is not required that all theconditions of all actual uses be duplicated, such asrain, snow, mud, dust and submersion in water).

IV. REDUCTION TO PRACTICE REQUIRESRECOGNITION AND APPRECIATION OF THEINVENTION

The invention must be recognized and appreciatedfor a reduction to practice to occur. “The rule thatconception and reduction to practice cannot beestablished nunc pro tunc simply requires that inorder for an experiment to constitute an actualreduction to practice, there must have beencontemporaneous appreciation of the invention atissue by the inventor…. Subsequent testing or laterrecognition may not be used to show that a party hadcontemporaneous appreciation of the invention.However, evidence of subsequent testing may beadmitted for the purpose of showing that anembodiment was produced and that it met thelimitations of the count.” Cooper v. Goldfarb, 154F.3d 1321, 1331, 47 USPQ2d 1896, 1904 (Fed. Cir.1998) (citations omitted). Meitzner v. Corte, 537F.2d 524, 528, 190 USPQ 407, 410 (CCPA 1976)(there can be no conception or reduction to practiceof a new form or of a process using such a new formof an otherwise old composition where there hasbeen no recognition or appreciation of the existenceof the new form); Estee Lauder, Inc. v. L’Oreal S.A.,129 F.3d 588, 593, 44 USPQ2d 1610, 1615 (Fed.Cir. 1997) (“[W]hen testing is necessary to establishutility, there must be recognition and appreciationthat the tests were successful for reduction to practiceto occur.” A showing that testing was completedbefore the critical date, and that testing ultimatelyproved successful, was held insufficient to establisha reduction to practice before the critical date, sincethe success of the testing was not appreciated orrecognized until after the critical date.); Parker v.Frilette, 462 F.2d 544, 547, 174 USPQ 321, 324(CCPA 1972) (“[an] inventor need not understandprecisely why his invention works in order to achievean actual reduction to practice”).

V. RECOGNITION OF THE INVENTION BYANOTHER MAY INURE TO THE BENEFIT OFTHE INVENTOR

“Inurement involves a claim by an inventor that, asa matter of law, the acts of another person shouldaccrue to the benefit of the inventor.” Cooper v.Goldfarb, 154 F.3d 1321, 1331, 47 USPQ2d 1896,1904 (Fed. Cir. 1998). Before a non-inventor’srecognition of the utility of the invention can inureto the benefit of the inventor, the followingthree-prong test must be met: (1) the inventor musthave conceived of the invention, (2) the inventormust have had an expectation that the embodimenttested would work for the intended purpose of theinvention, and (3) the inventor must have submittedthe embodiment for testing for the intended purposeof the invention. Genentech, Inc. v. Chiron Corp.,220 F.3d 1345, 1354, 55 USPQ2d 1636, 1643 (Fed.Cir. 2000). In Genentech, a non-inventor hired bythe inventors to test yeast samples for the presenceof the fusion protein encoded by the DNA constructof the invention recognized the growth-enhancingproperty of the fusion protein, but did notcommunicate this recognition to the inventors. Thecourt found that because the inventors did not submitthe samples for testing growth-promoting activity,the intended purpose of the invention, the third prongwas not satisfied and the uncommunicatedrecognition of the activity of the fusion protein bythe non-inventor did not inure to their benefit. Seealso Cooper v. Goldfarb, 240 F.3d 1378, 1385, 57USPQ2d 1990, 1995 (Fed. Cir. 2001) (Cooper sentto Goldfarb samples of a material for use in vasculargrafts. At the time the samples were sent, Cooperwas unaware of the importance of the fibril lengthof the material. Cooper did not at any time laterconvey to, or request from, Goldfarb any informationregarding fibril length. Therefore, Goldfarb’sdetermination of the fibril lengths of the materialcould not inure to Cooper’s benefit.).

VI. IN AN INTERFERENCE PROCEEDING, ALLLIMITATIONS OF A COUNT MUST BE REDUCEDTO PRACTICE

The device reduced to practice must include everylimitation of the count. Fredkin v. Irasek, 397 F.2d342, 158 USPQ 280, 285 (CCPA 1968); everylimitation in a count is material and must be provedto establish an actual reduction to practice. Meitzner

2100-190Rev. 08.2017, January 2018


v. Corte, 537 F.2d 524, 528, 190 USPQ 407, 410(CCPA 1976). See also Hull v. Bonis, 214 USPQ731, 734 (Bd. Pat. Inter. 1982) (no doctrine ofequivalents—remedy is a preliminary motion toamend the count to conform to the proofs).

VII. CLAIMED INVENTION IS NOT ACTUALLYREDUCED TO PRACTICE UNLESS THERE IS AKNOWN UTILITY

Utility for the invention must be known at the timeof the reduction to practice. Wiesner v. Weigert, 666F.2d 582, 588, 212 USPQ 721, 726 (CCPA 1981)(except for plant and design inventions); Azar v.Burns, 188 USPQ 601, 604 (Bd. Pat. Inter. 1975) (acomposition and a method cannot be actuallyreduced to practice unless the composition and theproduct produced by the method have a practicalutility); Ciric v. Flanigen, 511 F.2d 1182, 1185,185 USPQ 103, 105-6 (CCPA 1975) (“when a countdoes not recite any particular utility, evidenceestablishing a substantial utility for any purpose issufficient to prove a reduction to practice”; “thedemonstrated similarity of ion exchange andadsorptive properties between the newly discoveredzeolites and known crystalline zeolites … haveestablished utility for the zeolites of the count”); Engelhardt v. Judd, 369 F.2d 408, 411, 151 USPQ732, 735 (CCPA 1966) (When considering an actualreduction to practice as a bar to patentability forclaims to compounds, it is sufficient to successfullydemonstrate utility of the compounds in animals forsomewhat different pharmaceutical purposes thanthose asserted in the specification for humans.); Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1384, 181USPQ 453, 455 (CCPA 1974) (Two categories oftests on laboratory animals have been consideredadequate to show utility and reduction to practice:first, tests carried out to prove utility in humanswhere there is a satisfactory correlation betweenhumans and animals, and second, tests carried outto prove utility for treating animals.).

VIII. A PROBABLE UTILITY MAY NOT BESUFFICIENT TO ESTABLISH UTILITY

A probable utility does not establish a practicalutility, which is established by actual testing orwhere the utility can be “foretold with certainty.” Bindra v. Kelly, 206 USPQ 570, 575 (Bd. Pat. Inter.

1979) (Reduction to practice was not established foran intermediate useful in the preparation of a secondintermediate with a known utility in the preparationof a pharmaceutical. The record established therewas a high degree of probability of a successfulpreparation because one skilled in the art may havebeen motivated, in the sense of 35 U.S.C. 103, toprepare the second intermediate from the firstintermediate. However, a strong probability of utilityis not sufficient to establish practical utility.); Wuv. Jucker, 167 USPQ 467, 472 (Bd. Pat. Inter. 1968)(screening test where there was an indication ofpossible utility is insufficient to establish practicalutility). But see Nelson v. Bowler, 628 F.2d 853,858, 206 USPQ 881, 885 (CCPA 1980) (Relevantevidence is judged as a whole for its persuasivenessin linking observed properties to suggested uses.Reasonable correlation between the two is sufficientfor an actual reduction to practice.).

2138.06 “Reasonable Diligence” [R-08.2017]


The diligence of pre-AIA 35 U.S.C. 102(g) relatesto reasonable “attorney-diligence” and“engineering-diligence” (Keizer v. Bradley, 270F.2d 396, 397, 123 USPQ 215, 216 (CCPA 1959)),which does not require that “an inventor or hisattorney … drop all other work and concentrate onthe particular invention involved….” Emery v.Ronden, 188 USPQ 264, 268 (Bd. Pat. Inter. 1974).

I. CRITICAL PERIOD FOR ESTABLISHINGDILIGENCE BETWEEN ONE WHO WAS FIRSTTO CONCEIVE BUT LATER TO REDUCE TOPRACTICE THE INVENTION

The critical period for diligence for a first conceiverbut second reducer begins not at the time ofconception of the first conceiver but just prior to the

Rev. 08.2017, January 20182100-191


entry in the field of the party who was first to reduceto practice and continues until the first conceiverreduces to practice. Hull v. Davenport, 90 F.2d 103,105, 33 USPQ 506, 508 (CCPA 1937) (“lack ofdiligence from the time of conception to the timeimmediately preceding the conception date of thesecond conceiver is not regarded as of importanceexcept as it may have a bearing upon his subsequentacts”). What serves as the entry date into the fieldof a first reducer is dependent upon what is beingrelied on by the first reducer, e.g., conception plusreasonable diligence to reduction to practice (Fritschv. Lin, 21 USPQ2d 1731, 1734 (Bd. Pat. App. &Inter. 1991), Emery v. Ronden, 188 USPQ 264, 268(Bd. Pat. Inter. 1974)); an actual reduction to practiceor a constructive reduction to practice by the filingof either a U.S. application (Rebstock v. Flouret,191 USPQ 342, 345 (Bd. Pat. Inter. 1975)) orreliance upon priority under 35 U.S.C. 119 of aforeign application (Justus v. Appenzeller,177 USPQ 332, 339 (Bd. Pat. Inter. 1971) (chain ofpriorities under 35 U.S.C. 119 and 120, priorityunder 35 U.S.C. 119 denied for failure to supplycertified copy of the foreign application duringpendency of the application filed within the twelfthmonth)).

II. THE ENTIRE PERIOD DURING WHICHDILIGENCE IS REQUIRED MUST BEACCOUNTED FOR BY EITHER AFFIRMATIVEACTS OR ACCEPTABLE EXCUSES

“A patent owner need not prove the inventor continuously exercised reasonable diligencethroughout the critical period; it must show therewas reasonably continuous diligence.” PerfectSurgical Techniques, Inc. v. Olympus Am., Inc., 841F.3d 1004, 1009, 120 USPQ2d 1605, 1609 (Fed.Cir. 2016) (emphasis in original) (citing TycoHealthcare Grp. v. Ethicon EndoSurgery, Inc., 774F.3d 968, 975, 112 USPQ2d 1979 (Fed. Cir. 2014)and Monsanto Co. v. Mycogen Plant Sci., Inc., 261F.3d 1356, 1370, 59 USPQ2d 1930, 1939 (Fed. Cir.2001)).

An applicant must account for the entire periodduring which diligence is required. Gould v.Schawlow, 363 F.2d 908, 919, 150 USPQ 634, 643(CCPA 1966) (Merely stating that there were noweeks or months that the invention was not worked

on is not enough.); In re Harry, 333 F.2d 920, 923,142 USPQ 164, 166 (CCPA 1964) (statement thatthe subject matter “was diligently reduced topractice” is not a showing but a mere pleading). A2-day period lacking activity has been held to befatal. In re Mulder, 716 F.2d 1542, 1545, 219 USPQ189, 193 (Fed. Cir. 1983) (37 CFR 1.131 issue); Fitzgerald v. Arbib, 268 F.2d 763, 766, 122 USPQ530, 532 (CCPA 1959) (Less than 1 month ofinactivity during critical period. Efforts to exploitan invention commercially do not constitutediligence in reducing it to practice. An actualreduction to practice in the case of a design for athree-dimensional article requires that it should beembodied in some structure other than a meredrawing.); Kendall v. Searles, 173 F.2d 986, 993,81 USPQ 363, 369 (CCPA 1949) (Diligence requiresthat applicants must be specific as to dates andfacts.).

The period during which diligence is required mustbe accounted for by either affirmative acts oracceptable excuses. Rebstock v. Flouret, 191 USPQ342, 345 (Bd. Pat. Inter. 1975); Rieser v. Williams,225 F.2d 419, 423, 118 USPQ 96, 100 (CCPA 1958)(Being last to reduce to practice, party cannot prevailunless he has shown that he was first to conceiveand that he exercised reasonable diligence duringthe critical period from just prior to opponent’s entryinto the field); Griffith v. Kanamaru, 816 F.2d 624,2 USPQ2d 1361 (Fed. Cir. 1987) (Court generallyreviewed cases on excuses for inactivity includingvacation extended by ill health and daily jobdemands, and held lack of university funding andpersonnel are not acceptable excuses.); Litchfieldv. Eigen, 535 F.2d 72, 190 USPQ 113 (CCPA 1976)(budgetary limits and availability of animals fortesting not sufficiently described); Morway v. Bondi,203 F.2d 741, 749, 97 USPQ 318, 323 (CCPA 1953)(voluntarily laying aside inventive concept in pursuitof other projects is generally not an acceptableexcuse although there may be circumstances creatingexceptions); Anderson v. Crowther, 152 USPQ 504,512 (Bd. Pat. Inter. 1965) (preparation of routineperiodic reports covering all accomplishments of thelaboratory insufficient to show diligence); Wu v.Jucker, 167 USPQ 467, 472-73 (Bd. Pat. Inter. 1968)(applicant improperly allowed test data sheets toaccumulate to a sufficient amount to justifyinterfering with equipment then in use on another

2100-192Rev. 08.2017, January 2018


project); Tucker v. Natta, 171 USPQ 494,498 (Bd.Pat. Inter. 1971) (“[a]ctivity directed toward thereduction to practice of a genus does not establish, prima facie, diligence toward the reduction topractice of a species embraced by said genus”); Justus v. Appenzeller, 177 USPQ 332, 340-1 (Bd.Pat. Inter. 1971) (Although it is possible that patenteecould have reduced the invention to practice in ashorter time by relying on stock items rather thanby designing a particular piece of hardware, patenteeexercised reasonable diligence to secure the requiredhardware to actually reduce the invention to practice.“[I]n deciding the question of diligence it isimmaterial that the inventor may not have taken theexpeditious course….”).

Examiners should weigh the body of evidence tomake the determination of whether there wasreasonably continuous diligence for the entire criticalperiod. This determination should be made with thepurpose of the diligence requirement, which “is toassure that, in light of the evidence as a whole, ‘theinvention as not abandoned or unreasonablydelayed.’” Perfect Surgical Techniques, Inc. v.Olympus Am., Inc. (Perfect Surgical), 841 F.3d 1004,1009, 120 USPQ2d 1605, 1609 (Fed. Cir. 2016)(citations omitted). In Perfect Surgical, the FederalCircuit stated:

Under this standard, an inventor is not required to workon reducing his invention to practice every day during thecritical period. … And periods of inactivity within thecritical period do not automatically vanquish a patentowner's claim of reasonable diligence…. In determiningwhether an invention antedates another, the point of thediligence analysis is not to scour the patent owner'scorroborating evidence in search of intervals of timewhere the patent owner has failed to substantiate somesort of activity. It is to assure that, in light of the evidenceas a whole, “the invention was not abandoned orunreasonably delayed.” ... That an inventor overseeing astudy did not record its progress on a daily, weekly, oreven monthly basis does not mean the inventor necessarilyabandoned his invention or unreasonably delayed it. Thesame logic applies to the preparation of a patentapplication: the absence of evidence that an inventor andhis attorney revised or discussed the application on a dailybasis is alone insufficient to determine that the inventionwas abandoned or unreasonably delayed. One must weighthe collection of evidence over the entire critical periodto make such a determination.

Our decision in In re Mulder, 716 F.2d 1542, 1542-46[219 USPQ 189] (Fed. Cir. 1983), does not instructotherwise. The Board cites In re Mulder for theproposition that “[e]ven a short period of unexplainedinactivity may be sufficient to defeat a claim of diligence.”…. In In re Mulder, a competing reference was publishedjust days before the patent at issue was constructivelyreduced to practice. …. The patent owner was tasked withshowing reasonable diligence during a critical periodlasting only two days. ... But the patent owner did notproduce any evidence of diligence during the criticalperiod. ... Nor could it point to any activity during themonths between the drafting of the application and thestart of the critical period. ... Although the critical periodspanned just two days, we declined to excuse the patentowner's complete lack of evidence. ... In re Mulder doesnot hold that an inventor's inactivity during a portion ofthe critical period can, without more, destroy a patentowner's claim of diligence.

Perfect Surgical, 841 F.3d at 1009, 120 USPQ2dat 1609 (citations omitted).

III. WORK RELIED UPON TO SHOWREASONABLE DILIGENCE MUST BE DIRECTLYRELATED TO THE REDUCTION TO PRACTICE

The work relied upon to show reasonable diligencemust be directly related to the reduction to practiceof the invention in issue. Naber v. Cricchi, 567 F.2d382, 384, 196 USPQ 294, 296 (CCPA 1977), cert.denied, 439 U.S. 826 (1978). See also Scott v.Koyama, 281 F.3d 1243, 1248-49, 61 USPQ2d 1856,1859 (Fed. Cir. 2002) (Activities directed at buildinga plant to practice the claimed process of producingtetrafluoroethane on a large scale constitutedefforts toward actual reduction to practice, and thuswere evidence of diligence. The court distinguishedcases where diligence was not found becauseinventors either discontinued development or failedto complete the invention while pursuing financingor other commercial activity.); In re Jolley, 308 F.3d1317, 1326-27, 64 USPQ2d 1901, 1908-09 (Fed.Cir. 2002) (diligence found based on research andprocurement activities related to the subject matterof the interference count). “[U]nder somecircumstances an inventor should also be able to relyon work on closely related inventions as support fordiligence toward the reduction to practice on aninvention in issue.” Ginos v. Nedelec, 220 USPQ831, 836 (Bd. Pat. Inter. 1983) (work on otherclosely related compounds that were considered to

Rev. 08.2017, January 20182100-193


be part of the same invention and which wereincluded as part of a grandparent application). “Thework relied upon must be directed to attaining areduction to practice of the subject matter of thecounts. It is not sufficient that the activity relied onconcerns related subject matter.” Gunn v. Bosch,181 USPQ 758, 761 (Bd. Pat. Inter. 1973) (An actualreduction to practice of the invention at issue whichoccurred when the inventor was working on adifferent invention “was fortuitous, and not the resultof a continuous intent or effort to reduce to practicethe invention here in issue. Such fortuitousness isinconsistent with the exercise of diligence towardreduction to practice of that invention.” 181 USPQat 761. Furthermore, evidence drawn towards workon improvement of samples or specimens generallyalready in use at the time of conception that are butone element of the oscillator circuit of the count doesnot show diligence towards the construction andtesting of the overall combination.); Broos v. Barton,142 F.2d 690, 691, 61 USPQ 447, 448 (CCPA 1944)(preparation of application in U.S. for foreign filingconstitutes diligence); De Solms v. Schoenwald,15 USPQ2d 1507 (Bd. Pat. App. & Inter. 1990)(principles of diligence must be given to inventor’scircumstances including skill and time; requirementof corroboration applies only to testimony ofinventor); Huelster v. Reiter, 168 F.2d 542, 78USPQ 82 (CCPA 1948) (if inventor was not able tomake an actual reduction to practice of the invention,he must also show why he was not able toconstructively reduce the invention to practice bythe filing of an application).

IV. DILIGENCE REQUIRED IN PREPARING ANDFILING PATENT APPLICATION

The diligence of attorney in preparing and filingpatent application inures to the benefit of theinventor. Conception was established at least as earlyas the date a draft of a patent application wasfinished by a patent attorney on behalf of theinventor. Conception is less a matter of signaturethan it is one of disclosure. Attorney does not preparea patent application on behalf of particular namedpersons, but on behalf of the true inventive entity.Six days to execute and file application is acceptable. Haskell v. Coleburne, 671 F.2d 1362, 213 USPQ192, 195 (CCPA 1982). See also Bey v. Kollonitsch,806 F.2d 1024, 231 USPQ 967 (Fed. Cir. 1986)

(Reasonable diligence is all that is required of theattorney. Reasonable diligence is established ifattorney worked reasonably hard on the applicationduring the continuous critical period. If the attorneyhas a reasonable backlog of unrelated cases whichthe attorney takes up in chronological order andcarries out expeditiously, that is sufficient. Work ona related case(s) that contributed substantially to theultimate preparation of an application can be creditedas diligence.). In “the preparation" of a patentapplication, "the absence of evidence that an inventorand his attorney revised or discussed the applicationon a daily basis is alone insufficient to determinethat the invention was abandoned or unreasonablydelayed." Perfect Surgical Techniques, Inc. v.Olympus Am., Inc., 841 F.3d 1004, 1009, 120USPQ2d 1605, 1609 (Fed. Cir. 2016).

V. END OF DILIGENCE PERIOD IS MARKED BYEITHER ACTUAL OR CONSTRUCTIVEREDUCTION TO PRACTICE

“[I]t is of no moment that the end of that period [fordiligence] is fixed by a constructive, rather than anactual, reduction to practice.” Justus v. Appenzeller,177 USPQ 332, 340-41 (Bd. Pat. Inter. 1971).


2141 Examination Guidelines forDetermining Obviousness Under 35 U.S.C.103 [R-08.2017]


35 U.S.C. 103 Conditions for patentability; non-obvioussubject matter

A patent for a claimed invention may not be obtained,notwithstanding that the claimed invention is not identicallydisclosed as set forth in section 102, if the differences betweenthe claimed invention and the prior art are such that the claimedinvention as a whole would have been obvious before theeffective filing date of the claimed invention to a person having

2100-194Rev. 08.2017, January 2018


ordinary skill in the art to which the claimed invention pertains.Patentability shall not be negated by the manner in which theinvention was made.

Pre-AIA 35 U.S.C. 103 Conditions for patentability;nonobvious subject matter

(a) A patent may not be obtained though the invention isnot identically disclosed or described as set forth in section 102,if the differences between the subject matter sought to bepatented and the prior art are such that the subject matter as awhole would have been obvious at the time the invention wasmade to a person having ordinary skill in the art to which saidsubject matter pertains. Patentability shall not be negatived bythe manner in which the invention was made.

*****

EXAMINATION GUIDELINES FORDETERMINING OBVIOUSNESS UNDER 35 U.S.C.103

These guidelines are intended to assist Officepersonnel to make a proper determination ofobviousness under 35 U.S.C. 103, and to provide anappropriate supporting rationale in view of the recentdecision by the Supreme Court in KSR InternationalCo. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d1385 (2007). The guidelines are based on theOffice’s current understanding of the law, and arebelieved to be fully consistent with the bindingprecedent of the Supreme Court. The KSR decisionreinforced earlier decisions that validated a moreflexible approach to providing reasons forobviousness. However, the Supreme Court’spronouncement in KSR overruled cases such as Inre Lee, 277 F.3d 1338, 61 USPQ2d 1430 (Fed. Cir.2002), insofar as those cases require record evidenceof an express reason to modify the prior art. As theFederal Circuit has explained:

At the time [of the decision in In re Lee], werequired the PTO to identify record evidenceof a teaching, suggestion, or motivation tocombine references because “[o]mission of arelevant factor required by precedent is bothlegal error and arbitrary agency action.”However, this did not preclude examiners fromemploying common sense. More recently [in DyStar Textilfarben GmbH v. C.H. PatrickCo., 464 F.3d 1356, 1366 (Fed. Cir. 2006)], weexplained that use of common sense does notrequire a “specific hint or suggestion in aparticular reference,” only a reasoned

explanation that avoids conclusorygeneralizations.

Perfect Web Technologies, Inc. v. InfoUSA, Inc.,587 F.3d 1324, 1329, 92 USPQ2d 1849, 1854 (Fed.Cir. 2009) (citations omitted).

In another case, the Federal Circuit also stated that:

“… we conclude that while ‘common sense’can be invoked, even potentially to supply alimitation missing from the prior art, it muststill be supported by evidence and a reasonedexplanation. In cases in which ‘common sense’is used to supply a missing limitation, asdistinct from a motivation to combine,moreover, our search for a reasoned basis forresort to common sense must be searching.And, this is particularly true where the missinglimitation goes to the heart of an invention.”

Arendi v. Apple, 832 F.3d 1355, 1363, 119 USPQ2d1822, 1827 (Fed. Cir. 2016).

These guidelines do not constitute substantive rulemaking and hence do not have the force and effectof law. They have been developed as a matter ofinternal Office management and are not intended tocreate any right or benefit, substantive or procedural,enforceable by any party against the Office.Rejections will continue to be based upon thesubstantive law, and it is these rejections that areappealable. Consequently, any failure by Officepersonnel to follow the guidelines is neitherappealable nor petitionable.

I. THE KSR DECISION AND PRINCIPLES OFTHE LAW OF OBVIOUSNESS

The Supreme Court in KSR reaffirmed the familiarframework for determining obviousness as set forthin Graham v. John Deere Co., 383 U.S. 1, 148USPQ 459 (1966), but stated that the Federal Circuith a d e r r e d b y a p p l y i n g t h eteaching-suggestion-motivation (TSM) test in anoverly rigid and formalistic way. KSR, 550 U.S. at404, 82 USPQ2d at 1391. Specifically, the SupremeCourt stated that the Federal Circuit had erred infour ways: (1) “by holding that courts and patent

Rev. 08.2017, January 20182100-195


examiners should look only to the problem thepatentee was trying to solve ” (Id. at 420, 82USPQ2d at 1397); (2) by assuming “that a personof ordinary skill attempting to solve a problem willbe led only to those elements of prior art designedto solve the same problem” (Id.); (3) by concluding“that a patent claim cannot be proved obvious merelyby showing that the combination of elements was‘obvious to try’” (Id. at 421, USPQ2d at 1397); and(4) by overemphasizing “the risk of courts and patentexaminers falling prey to hindsight bias” and as aresult applying “[r]igid preventative rules that denyfactfinders recourse to common sense” (Id.).

In KSR, the Supreme Court particularly emphasized“the need for caution in granting a patent based onthe combination of elements found in the priorart,” Id. at 415, 82 USPQ2d at 1395, and discussedcircumstances in which a patent might be determinedto be obvious. Importantly, the Supreme Courtreaffirmed principles based on its precedent that“[t]he combination of familiar elements accordingto known methods is likely to be obvious when itdoes no more than yield predictable results.” Id. at415-16, 82 USPQ2d at 1395. The Supreme Courtstated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416,82 USPQ2d at 1395. (1) “In United States v. Adams,. . . [t]he Court recognized that when a patent claimsa structure already known in the prior art that isaltered by the mere substitution of one element foranother known in the field, the combination mustdo more than yield a predictable result.” Id. (2) “In Anderson’s-Black Rock, Inc. v. Pavement SalvageCo., . . . [t]he two [pre-existing elements] incombination did no more than they would inseparate, sequential operation.” Id. at 416-17, 82USPQ2d at 1395. (3) “[I]n Sakraida v. AG Pro, Inc.,the Court derived . . . the conclusion that when apatent simply arranges old elements with eachperforming the same function it had been known toperform and yields no more than one would expectfrom such an arrangement, the combination isobvious.” Id. at 417, 82 USPQ2d at 1395-96(Internal quotations omitted.). The principlesunderlining these cases are instructive when thequestion is whether a patent application claimingthe combination of elements of prior art would havebeen obvious. The Supreme Court further stated that:

When a work is available in one field ofendeavor, design incentives and other marketforces can prompt variations of it, either in thesame field or a different one. If a person ofordinary skill can implement a predictablevariation, § 103 likely bars its patentability. Forthe same reason, if a technique has been usedto improve one device, and a person of ordinaryskill in the art would recognize that it wouldimprove similar devices in the same way, usingthe technique is obvious unless its actualapplication is beyond his or her skill. Id. at417, 82 USPQ2d at 1396.

When considering obviousness of a combination ofknown elements, the operative question is thus“whether the improvement is more than thepredictable use of prior art elements according totheir established functions.” Id.

The Supreme Court’s flexible approach to theobviousness inquiry is reflected in numerouspre- KSR decisions; see MPEP § 2144. That sectionprovides many lines of reasoning to support adetermination of obviousness based upon earlierlegal precedent that had condoned the use ofparticular examples of what may be consideredcommon sense or ordinary routine practice (e.g.,making integral, changes in shape, makingadjustable). Thus, the type of reasoning sanctionedby the opinion in KSR has long been part of thepatent examination process.

II. THE BASIC FACTUAL INQUIRES OF GRAHAM v. JOHN DEERE CO.

An invention that would have been obvious to aperson of ordinary skill at the time of the inventionis not patentable. See 35 U.S.C. 103 or pre-AIA 35U.S.C. 103(a). As reiterated by the Supreme Courtin KSR, the framework for the objective analysisfor determining obviousness under 35 U.S.C. 103 isstated in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Obviousness is a questionof law based on underlying factual inquiries. Thefactual inquiries enunciated by the Court are asfollows:

(A) Determining the scope and content of theprior art;

2100-196Rev. 08.2017, January 2018


(B) Ascertaining the differences between theclaimed invention and the prior art; and

(C) Resolving the level of ordinary skill in thepertinent art.

Objective evidence relevant to the issue ofobviousness must be evaluated by Office personnel. Id. at 17-18, 148 USPQ at 467. Such evidence,sometimes referred to as “secondary considerations,”may include evidence of commercial success,long-felt but unsolved needs, failure of others, andunexpected results. The evidence may be includedin the specification as filed, accompany theapplication on filing, or be provided in a timelymanner at some other point during the prosecution.The weight to be given any objective evidence ismade on a case-by-case basis. The mere fact that anapplicant has presented evidence does not mean thatthe evidence is dispositive of the issue ofobviousness.

The question of obviousness must be resolved onthe basis of the factual inquiries set forth above.While each case is different and must be decided onits own facts, the Graham factors, includingsecondary considerations when present, are thecontrolling inquiries in any obviousness analysis.The Graham factors were reaffirmed and reliedupon by the Supreme Court in its consideration anddetermination of obviousness in the fact situationpresented in KSR, 550 U.S. at 406-07, 82 USPQ2dat 1391 (2007). The Supreme Court has utilized the Graham factors in each of its obviousness decisionssince Graham. See Sakraida v. Ag Pro, Inc., 425U.S. 273, 189 USPQ 449, reh’g denied, 426 U.S.955 (1976); Dann v. Johnston, 425 U.S. 219, 189USPQ 257 (1976); and Anderson’s-Black Rock, Inc.v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ673 (1969). As stated by the Supreme Court in KSR,“While the sequence of these questions might bereordered in any particular case, the [ Graham]factors continue to define the inquiry thatcontrols.” KSR, 550 U.S. at 407, 82 USPQ2d at 1391.

Office Personnel As Factfinders

Office personnel fulfill the critical role of factfinderwhen resolving the Graham inquiries. It must beremembered that while the ultimate determinationof obviousness is a legal conclusion, the underlying

Graham inquiries are factual. When making anobviousness rejection, Office personnel musttherefore ensure that the written record includesfindings of fact concerning the state of the art andthe teachings of the references applied. In certaincircumstances, it may also be important to includeexplicit findings as to how a person of ordinary skillwould have understood prior art teachings, or whata person of ordinary skill would have known or couldhave done. Factual findings made by Officepersonnel are the necessary underpinnings toestablish obviousness.

Once the findings of fact are articulated, Officepersonnel must provide an explanation to supportan obviousness rejection under 35 U.S.C. 103. 35U.S.C. 132 requires that the applicant be notified ofthe reasons for the rejection of the claim so that theapplicant can decide how best to proceed. Clearlysetting forth findings of fact and the rationale(s) tosupport a rejection in an Office action leads to theprompt resolution of issues pertinent to patentability.

In short, the focus when making a determination ofobviousness should be on what a person of ordinaryskill in the pertinent art would have known at thetime of the invention, and on what such a personwould have reasonably expected to have been ableto do in view of that knowledge. This is so regardlessof whether the source of that knowledge and abilitywas documentary prior art, general knowledge inthe art, or common sense. What follows is adiscussion of the Graham factual inquiries.

A. Determining the Scope and Content of the PriorArt

In determining the scope and content of the prior art,Office personnel must first obtain a thoroughunderstanding of the invention disclosed and claimedin the application under examination by reading thespecification, including the claims, to understandwhat the applicant has invented. See MPEP § 904.The scope of the claimed invention must be clearlydetermined by giving the claims the “broadestreasonable interpretation consistent with thespecification.” See Phillips v. AWH Corp., 415 F.3d1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)and MPEP § 2111. Once the scope of the claimed

Rev. 08.2017, January 20182100-197


invention is determined, Office personnel must thendetermine what to search for and where to search.

1. What To Search For:

The search should cover the claimed subject matterand should also cover the disclosed features whichmight reasonably be expected to be claimed. SeeMPEP § 904.02. Although a rejection need not bebased on a teaching or suggestion to combine, apreferred search will be directed to finding referencesthat provide such a teaching or suggestion if theyexist.

2. Where To Search:

Office personnel should continue to follow thegeneral search guidelines set forth in MPEP § 904to § 904.03 regarding search of the prior art. Officepersonnel are reminded that, for purposes of 35U.S.C. 103, prior art can be either in the field ofapplicant’s endeavor or be reasonably pertinent tothe particular problem with which the applicant wasconcerned. See MPEP § 2141.01(a) for a discussionof analogous art. Furthermore, prior art that is in afield of endeavor other than that of the applicant (asnoted by the Court in KSR, “[w]hen a work isavailable in one field of endeavor, design incentivesand other market forces can prompt variations of it,either in the same field or a different one,” 550 U.S.at 417, 82 USPQ2d at 1396 (emphasis added)), orsolves a problem which is different from that whichthe applicant was trying to solve, may also beconsidered for the purposes of 35 U.S.C. 103. (TheCourt in KSR stated that “[t]he first error…in thiscase was…holding that courts and patent examinersshould look only to the problem the patentee wastrying to solve. The Court of Appeals failed torecognize that the problem motivating the patenteemay be only one of many addressed by the patent’ssubject matter…The second error [was]…that aperson of ordinary skill attempting to solve aproblem will be led only to those elements of priorart designed to solve the same problem.” 550 U.S.at 420, 82 USPQ2d at 1397. Federal Circuit caselaw prior to the Supreme Court’s decision in KSRis generally in accord with these statements by the KSR Court. See e.g., In re Dillon, 919 F.2d 688,693, 16 USPQ2d 1897, 1902 (Fed. Cir. 1990) (enbanc) (“[I]t is not necessary in order to establish a

prima facie case of obviousness that both astructural similarity between a claimed and prior artcompound (or a key component of a composition)be shown and that there be a suggestion in orexpectation from the prior art that the claimedcompound or composition will have the same or asimilar utility as one newly discovered byapplicant”) (emphasis added); In re Lintner, 458F.2d 1013, 1018, 173 USPQ 560, 562 (CCPA 1972)(“The fact that [applicant] uses sugar for a differentpurpose does not alter the conclusion that its use ina prior art composition would be prima facieobvious from the purpose disclosed in thereferences.”).

For a discussion of what constitutes prior art, seeMPEP § 901 to § 901.06(d) and § 2121 to § 2129.See MPEP § 2141.01(a) for a discussion ofanalogous art.

B. Ascertaining the Differences Between the ClaimedInvention and the Prior Art

Ascertaining the differences between the claimedinvention and the prior art requires interpreting theclaim language, see MPEP § 2111, and consideringboth the invention and the prior art as a whole. SeeMPEP § 2141.02.

C. Resolving the Level of Ordinary Skill in the Art

Any obviousness rejection should include, eitherexplicitly or implicitly in view of the prior artapplied, an indication of the level of ordinary skill.A finding as to the level of ordinary skill may beused as a partial basis for a resolution of the issueof obviousness.

The person of ordinary skill in the art is ahypothetical person who is presumed to have knownthe relevant art at the time of the invention. Factorsthat may be considered in determining the level ofordinary skill in the art may include: (1) “type ofproblems encountered in the art;” (2) “prior artsolutions to those problems;” (3) “rapidity withwhich innovations are made;” (4) “sophistication ofthe technology; and” (5) “educational level of activeworkers in the field." In re GPAC, 57 F.3d 1573,1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995). "Ina given case, every factor may not be present, and

2100-198Rev. 08.2017, January 2018


one or more factors may predominate.” Id. See also Custom Accessories, Inc. v. Jeffrey-Allan Indust.,Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed.Cir. 1986); Environmental Designs, Ltd. v. UnionOil Co., 713 F.2d 693, 696, 218 USPQ 865, 868(Fed. Cir. 1983).

“A person of ordinary skill in the art is also a personof ordinary creativity, not an automaton.” KSR, 550U.S. at 421, 82 USPQ2d at 1397. “[I]n many casesa person of ordinary skill will be able to fit theteachings of multiple patents together like pieces ofa puzzle.” Id. at 420, 82 USPQ2d at 1397. Officepersonnel may also take into account “the inferencesand creative steps that a person of ordinary skill inthe art would employ.” Id. at 418, 82 USPQ2d at1396.

In addition to the factors above, Office personnelmay rely on their own technical expertise to describethe knowledge and skills of a person of ordinary skillin the art. The Federal Circuit has stated thatexaminers and administrative patent judges on theBoard are “persons of scientific competence in thefields in which they work” and that their findingsare “informed by their scientific knowledge, as tothe meaning of prior art references to persons ofordinary skill in the art.” In re Berg, 320 F.3d 1310,1315, 65 USPQ2d 2003, 2007 (Fed. Cir. 2003). Inaddition, examiners “are assumed to have someexpertise in interpreting the references and to befamiliar from their work with the level of skill in theart .” PowerOasis, Inc. v. T-Mobile USA, Inc., 522F.3d 1299, 86 USPQ2d 1385 (Fed. Cir. 2008)(quoting Am. Hoist & Derrick Co. v. Sowa & Sons,725 F.2d 1350, 1360, 220 USPQ 763, 770 (Fed. Cir.1984). See MPEP § 2141 for a discussion of the levelof ordinary skill.

III. RATIONALES TO SUPPORT REJECTIONSUNDER 35 U.S.C. 103

Once the Graham factual inquiries are resolved,Office personnel must determine whether theclaimed invention would have been obvious to oneof ordinary skill in the art.

The obviousness analysis cannot be confinedby . . . overemphasis on the importance ofpublished articles and the explicit content of

issued patents. . . . . In many fields it may bethat there is little discussion of obvioustechniques or combinations, and it often maybe the case that market demand, rather thanscientific literature, will drive designtrends. KSR, 550 U.S. at 419, 82 USPQ2d at1396.

Prior art is not limited just to the references beingapplied, but includes the understanding of one ofordinary skill in the art. The prior art reference (orreferences when combined) need not teach or suggestall the claim limitations, however, Office personnelmust explain why the difference(s) between the priorart and the claimed invention would have beenobvious to one of ordinary skill in the art. The “mereexistence of differences between the prior art andan invention does not establish the invention’snonobviousness.” Dann v. Johnston, 425 U.S. 219,230, 189 USPQ 257, 261 (1976). The gap betweenthe prior art and the claimed invention may not be“so great as to render the [claim] nonobvious to onereasonably skilled in the art.” Id . In determiningobviousness, neither the particular motivation tomake the claimed invention nor the problem theinventor is solving controls. The proper analysis iswhether the claimed invention would have beenobvious to one of ordinary skill in the art afterconsideration of all the facts. See 35 U.S.C. 103 orpre-AIA 35 U.S.C. 103(a). Factors other than thedisclosures of the cited prior art may provide a basisfor concluding that it would have been obvious toone of ordinary skill in the art to bridge the gap. Therationales discussed below outline reasoning thatmay be applied to find obviousness in such cases.

If the search of the prior art and the resolution of the Graham factual inquiries reveal that an obviousnessrejection may be made using the familiarteaching-suggestion-motivation (TSM) rationale,then such a rejection should be made. Although theSupreme Court in KSR cautioned against an overlyrigid application of TSM, it also recognized thatTSM was one of a number of valid rationales thatcould be used to determine obviousness. (Accordingto the Supreme Court, establishment of the TSMapproach to the question of obviousness “captureda helpful insight.” 550 U.S. at 418, 82 USPQ2d at1396 (citing In re Bergel, 292 F.2d 955, 956-57,130 USPQ 206, 207-208 (1961)). Furthermore, the

Rev. 08.2017, January 20182100-199


Court explained that “[t]here is no necessaryinconsistency between the idea underlying the TSMtest and the Graham analysis.” 550 U.S. at 419, 82USPQ2d at 1396. The Supreme Court alsocommented that the Federal Circuit “no doubt hasapplied the test in accord with these principles [setforth in KSR] in many cases.” Id. Office personnelshould also consider whether one or more of theother rationales set forth below support a conclusionof obviousness. The Court in KSR identified anumber of rationales to support a conclusion ofobviousness which are consistent with the proper“functional approach” to the determination ofobviousness as laid down in Graham. KSR, 550U.S. at 415-21, 82 USPQ2d at 1395-97. Note thatthe list of rationales provided below is not intendedto be an all-inclusive list. Other rationales to supporta conclusion of obviousness may be relied upon byOffice personnel.

The key to supporting any rejection under 35 U.S.C.103 is the clear articulation of the reason(s) why theclaimed invention would have been obvious. TheSupreme Court in KSR noted that the analysissupporting a rejection under 35 U.S.C. 103 shouldbe made explicit. The Court quoting In re Kahn,441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed.Cir. 2006), stated that “‘[R]ejections on obviousnesscannot be sustained by mere conclusory statements;instead, there must be some articulated reasoningwith some rational underpinning to support the legalconclusion of obviousness.’” KSR, 550 U.S. at 418,82 USPQ2d at 1396. Exemplary rationales that maysupport a conclusion of obviousness include:

(A) Combining prior art elements according toknown methods to yield predictable results;

(B) Simple substitution of one known elementfor another to obtain predictable results;

(C) Use of known technique to improve similardevices (methods, or products) in the same way;

(D) Applying a known technique to a knowndevice (method, or product) ready for improvementto yield predictable results;

(E) “Obvious to try” – choosing from a finitenumber of identified, predictable solutions, with areasonable expectation of success;

(F) Known work in one field of endeavor mayprompt variations of it for use in either the same

field or a different one based on design incentivesor other market forces if the variations arepredictable to one of ordinary skill in the art;

(G) Some teaching, suggestion, or motivationin the prior art that would have led one of ordinaryskill to modify the prior art reference or to combineprior art reference teachings to arrive at the claimedinvention.

See MPEP § 2143 for a discussion of the rationaleslisted above along with examples illustrating howthe cited rationales may be used to support a findingof obviousness. See also MPEP § 2144 - § 2144.09for additional guidance regarding support forobviousness determinations.

IV. APPLICANT’S REPLY

Once Office personnel have established the Graham factual findings and concluded that the claimedinvention would have been obvious, the burden thenshifts to the applicant to (A) show that the Officeerred in these findings or (B) provide other evidenceto show that the claimed subject matter would havebeen nonobvious. 37 CFR 1.111(b) requiresapplicant to distinctly and specifically point out thesupposed errors in the Office’s action and reply toevery ground of objection and rejection in the Officeaction. The reply must present arguments pointingout the specific distinction believed to render theclaims patentable over any applied references.

If an applicant disagrees with any factual findingsby the Office, an effective traverse of a rejectionbased wholly or partially on such findings mustinclude a reasoned statement explaining why theapplicant believes the Office has erred substantivelyas to the factual findings. A mere statement orargument that the Office has not established a primafacie case of obviousness or that the Office’sreliance on common knowledge is unsupported bydocumentary evidence will not be consideredsubstantively adequate to rebut the rejection or aneffective traverse of the rejection under 37 CFR1.111(b). Office personnel addressing this situationmay repeat the rejection made in the prior Officeaction and make the next Office action final. SeeMPEP § 706.07(a).

2100-200Rev. 08.2017, January 2018


V. CONSIDERATION OF APPLICANT’SREBUTTAL EVIDENCE

Office personnel should consider all rebuttalevidence that is timely presented by the applicantswhen reevaluating any obviousness determination.Rebuttal evidence may include evidence of“secondary considerations,” such as “commercialsuccess, long felt but unsolved needs, [and] failureof others” (Graham v. John Deere Co., 383 U.S. at17, 148 USPQ at 467), and may also includeevidence of unexpected results. As set forth above,Office personnel must articulate findings of fact thatsupport the rationale relied upon in an obviousnessrejection. As a result, applicants are likely to submitevidence to rebut the fact finding made by Officepersonnel. For example, in the case of a claim to acombination, applicants may submit evidence orargument to demonstrate that:

(A) one of ordinary skill in the art could not havecombined the claimed elements by known methods(e.g., due to technological difficulties);

(B) the elements in combination do not merelyperform the function that each element performsseparately; or

(C) the results of the claimed combination wereunexpected.

Once the applicant has presented rebuttal evidence,Office personnel should reconsider any initialobviousness determination in view of the entirerecord. See, e.g., In re Piasecki, 745 F.2d 1468,1472, 223 USPQ 785, 788 (Fed. Cir. 1984); In reEli Lilly & Co., 902 F.2d 943, 945, 14 USPQ2d1741, 1743 (Fed. Cir. 1990). All the rejections ofrecord and proposed rejections and their bases shouldbe reviewed to confirm their continued viability. TheOffice action should clearly communicate theOffice’s findings and conclusions, articulating howthe conclusions are supported by the findings. Theprocedures set forth in MPEP § 706.07(a) are to befollowed in determining whether an action may bemade final.

See MPEP § 2145 concerning consideration ofapplicant’s rebuttal evidence. See also MPEP § 716to § 716.10 regarding affidavits or declarations filedunder 37 CFR 1.132 for purposes of traversinggrounds of rejection.

2141.01 Scope and Content of the Prior Art[R-11.2013]

[Editor Note: This MPEP section is applicable toapplications subject to the first inventor to file(FITF) provisions of the AIA except that the relevantdate is the "effective filing date" of the claimedinvention instead of the "time the invention wasmade," which is only applicable to applicationssubject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100(note) and MPEP § 2150 et seq.]

I. PRIOR ART AVAILABLE UNDER 35 U.S.C. 102IS AVAILABLE UNDER 35 U.S.C. 103

“Before answering Graham’s ‘content’ inquiry, itmust be known whether a patent or publication is inthe prior art under 35 U.S.C. § 102.” Panduit Corp.v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1USPQ2d 1593, 1597 (Fed. Cir.), cert. denied, 481U.S. 1052 (1987). Subject matter that is prior artunder 35 U.S.C. 102 can be used to support arejection under section 103. Ex parte Andresen, 212USPQ 100, 102 (Bd. Pat. App. & Inter. 1981) (“itappears to us that the commentator [of 35 U.S.C.A.]and the [congressional] committee viewed section103 as including all of the various bars to a patentas set forth in section 102.”).

Furthermore, admitted prior art can be relied uponfor both anticipation and obviousness determinations,regardless of whether the admitted prior art wouldotherwise qualify as prior art under the statutorycategories of 35 U.S.C. 102. Riverwood Int’l Corp.v. R.A. Jones & Co., 324 F.3d 1346, 1354, 66USPQ2d 1331, 1337 (Fed. Cir. 2003); Constant v.Advanced Micro-Devices Inc., 848 F.2d 1560, 1570,7 USPQ2d 1057, 1063 (Fed. Cir. 1988). See MPEP§ 2129 for discussion of admissions as prior art.

A 35 U.S.C. 103 rejection is based on 35 U.S.C.102(a)(1) or (a)(2) or pre-AIA 35 U.S.C. 102(a),102(b), 102(e), etc. depending on the type of priorart reference used and its publication or issue date.For instance, an obviousness rejection over a U.S.patent which was issued more than 1 year before thefiling date of the application subject to pre-AIA 35U.S.C. 102 is said to be a statutory bar just as if itanticipated the claims under pre-AIA 35 U.S.C.102(b). Analogously, an obviousness rejection based

Rev. 08.2017, January 20182100-201


on a publication which would be applied underpre-AIA 35 U.S.C. 102(a) if it anticipated the claimscan be overcome by swearing behind the publicationdate of the reference by filing an affidavit ordeclaration under 37 CFR 1.131.

For an overview of what constitutes prior art under35 U.S.C. 102, see MPEP § 901 - § 901.06(d),§ 2121 - § 2129 and § 2151 - § 2155.

II. SUBSTANTIVE CONTENT OF THE PRIORART

See MPEP § 2121 - § 2129 for case law relating tothe substantive content of the prior art (e.g.,availability of inoperative devices, extent to whichprior art must be enabling, broad disclosure ratherthan preferred embodiments, admissions, etc.).

III. CONTENT OF THE PRIOR ART ISDETERMINED AT THE TIME THE INVENTIONWAS MADE TO AVOID HINDSIGHT

The requirement “at the time the invention wasmade” is to avoid impermissible hindsight. SeeMPEP § 2145, subsection X.A. for a discussion ofrebutting applicants’ arguments that a rejection isbased on hindsight.

“It is difficult but necessary that the decisionmakerforget what he or she has been taught . . . about theclaimed invention and cast the mind back to the timethe invention was made (often as here many years),to occupy the mind of one skilled in the art. ...” W.L.Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d1540, 220 USPQ 303, 313 (Fed. Cir. 1983), cert.denied, 469 U.S. 851 (1984).

IV. PRE-AIA 35 U.S.C. 103(c) — EVIDENCEREQUIRED TO SHOW CONDITIONS OF PRE-AIA35 U.S.C. 103(c) APPLY

An applicant subject to pre-AIA 35 U.S.C. 102 whowants to avail himself or herself of the benefits ofpre-AIA 35 U.S.C. 103(c) has the burden ofestablishing that subject matter which only qualifiesas prior art under subsection (e), (f) or (g) of pre-AIA35 U.S.C. 102 used in a rejection under pre-AIA 35U.S.C. 103(a) and the claimed invention were, at thetime the invention was made, owned by the same

person or subject to an obligation of assignment tothe same person. Ex parte Yoshino, 227 USPQ 52(Bd. Pat. App. & Inter. 1985). Likewise, an applicantwho wants to avail himself or herself of the benefitsof the joint research provisions of pre-AIA 35 U.S.C.103(c) (for applications pending on or afterDecember 10, 2004) has the burden of establishingthat:

(A) the claimed invention was made by or onbehalf of parties to a joint research agreement thatwas in effect on or before the date the claimedinvention was made;

(B) the claimed invention was made as a resultof activities undertaken within the scope of the jointresearch agreement; and

(C) the application for patent for the claimedinvention discloses or is amended to disclose thenames of the parties to the joint research agreement.

This prior art disqualification is only applicable forsubject matter which only qualifies as prior art undersubsection (e), (f) or (g) of pre-AIA 35 U.S.C. 102used in a rejection under pre-AIA 35 U.S.C. 103(a).

Note that for applications filed prior to November29, 1999, and granted as patents prior to December10, 2004, pre-AIA 35 U.S.C. 103(c) is limited on itsface to subject matter developed by another personwhich qualifies as prior art only under subsection(f) or (g) of pre-AIA 35 U.S.C. 102. See MPEP §706.02(l)(1). See also In re Bartfeld, 925 F.2d 1450,1453-54, 17 USPQ2d 1885, 1888 (Fed. Cir. 1991)(Applicant attempted to overcome a pre-AIA 35U.S.C. 102(e)/103 rejection with a terminaldisclaimer by alleging that the public policy intentof pre-AIA 35 U.S.C 103(c) was to prohibit the useof “secret” prior art in obviousness determinations.The court rejected this argument, holding “We maynot disregard the unambiguous exclusion of § 102(e)from the statute’s purview.”).

See MPEP § 706.02(l)(2) for the requirements whichmust be met to establish common ownership or ajoint research agreement.

2100-202Rev. 08.2017, January 2018


2141.01(a) Analogous and Nonanalogous Art[R-08.2017]


I. TO RELY ON A REFERENCE UNDER 35 U.S.C.103, IT MUST BE ANALOGOUS PRIOR ART

In order for a reference to be proper for use in anobviousness rejection under 35 U.S.C. 103 , thereference must be analogous art to the claimedinvention. In re Bigio, 381 F.3d 1320, 1325, 72USPQ2d 1209, 1212 (Fed. Cir. 2004). The examinermust determine what is “analogous prior art” for thepurpose of analyzing the obviousness of the subjectmatter at issue. “Under the correct analysis, any needor problem known in the field of endeavor at thetime of the invention and addressed by the patent[or application at issue] can provide a reason forcombining the elements in the manner claimed. ” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420,82 USPQ2d 1385, 1397 (2007). This does not requirethat the reference be from the same field of endeavoras the claimed invention, in light of the SupremeCourt's instruction that “[w]hen a work is availablein one field of endeavor, design incentives and othermarket forces can prompt variations of it, either inthe same field or a different one.” Id. at 417, 82USPQ2d 1396. Rather, a reference is analogous artto the claimed invention if: (1) the reference is fromthe same field of endeavor as the claimed invention(even if it addresses a different problem); or (2) thereference is reasonably pertinent to the problemfaced by the inventor (even if it is not in the samefield of endeavor as the claimed invention). See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.

In order for a reference to be "reasonably pertinent"to the problem, it must “logically [] have commendeditself to an inventor's attention in considering hisproblem. ” In re ICON Health and Fitness, Inc., 496F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In reClay, 966 F.2d 656,658, 23 USPQ2d 1058, 1061

(Fed. Cir. 1992)). A recent decision from the U.S.Court of Appeals for the Federal Circuit, In re Klein,647 F.3d 1343, 98 USPQ2d 1991 (Fed. Cir. 2011),is instructive as to the "reasonably pertinent" prongfor determining whether a reference is analogousart. In determining whether a reference is reasonablypertinent, an examiner should consider the problemfaced by the inventor, as reflected - either explicitlyor implicitly - in the specification. In order to supporta determination that a reference is reasonablypertinent, it may be appropriate to include astatement of the examiner's understanding of theproblem. The question of whether a reference isreasonably pertinent often turns on how the problemto be solved is perceived. If the problem to be solvedis viewed in a narrow or constrained way, and sucha view is not consistent with the specification, thescope of available prior art may be inappropriatelylimited. It may be necessary for the examiner toexplain why an inventor seeking to solve theidentified problem would have looked to thereference in an attempt to find a solution to theproblem, i.e., factual reasons why the prior art ispertinent to the identified problem.

Any argument by the applicant that the examinerhas misconstrued the problem to be solved, and asa result has improperly relied on nonanalogous art,should be fully considered in light of thespecification. In evaluating the applicant's argument,the examiner should look to the teachings of thespecification and the inferences that wouldreasonably have been drawn from the specificationby a person of ordinary skill in the art as a guide tounderstanding the problem to be solved. A prior artreference not in the same field of endeavor as theclaimed invention must be reasonably pertinent tothe problem to be solved in order to qualify asanalogous art and be applied in an obviousnessrejection.

II. CONSIDER SIMILARITIES ANDDIFFERENCES IN STRUCTURE AND FUNCTION

While Patent Office classification of references andthe cross-references in the official search notes ofthe class definitions are some evidence of“nonanalogy” or “analogy” respectively, the courthas found “the similarities and differences instructure and function of the inventions to carry far

Rev. 08.2017, January 20182100-203


greater weight.” In re Ellis, 476 F.2d 1370, 1372,177 USPQ 526, 527 (CCPA 1973) (The structuralsimilarities and functional overlap between thestructural gratings shown by one reference and theshoe scrapers of the type shown by another referencewere readily apparent, and therefore the arts to whichthe reference patents belonged were reasonablypertinent to the art with which appellant’s inventiondealt (pedestrian floor gratings).).

III. ANALOGY IN THE CHEMICAL ARTS

See, for example, Ex parte Bland, 3 USPQ2d 1103(Bd. Pat App. & Inter. 1986) (Claims were drawnto a particulate composition useful as a preservativefor an animal foodstuff (or a method of inhibitingfungus growth in an animal foodstuff therewith)comprising verxite having absorbed thereonpropionic acid. All references were concerned withabsorbing biologically active materials on carriers,and therefore the teachings in each of the variousreferences would have been pertinent to the problemsin the other references and the invention at hand.); Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530,218 USPQ 871 (Fed. Cir. 1983) (Problemconfronting inventor was preventing electrostaticbuildup in PTFE tubing caused by hydrocarbon fuelflow while precluding leakage of fuel. Two prior artreferences relied upon were in the rubber hose art,both referencing the problem of electrostatic buildupcaused by fuel flow. The court found that becausePTFE and rubber are used by the same hosemanufacturers and experience the same and similarproblems, a solution found for a problemexperienced with either PTFE or rubber hosingwould be looked to when facing a problem with theother.); In re Mlot-Fijalkowski, 676 F.2d 666, 213USPQ 713 (CCPA 1982) (Problem faced byappellant was enhancement and immobilization ofdye penetrant indications. References which taughtthe use of dyes and finely divided developermaterials to produce colored images preferably in,but not limited to, the duplicating paper art wereproperly relied upon because the court found thatappellant’s problem was one of dye chemistry, anda search for its solution would include the dye artsin general.).

IV. ANALOGY IN THE MECHANICAL ARTS

See, for example, Stevenson v. Int'l Trade Comm.,612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA1979) (“In a simple mechanical invention a broadspectrum of prior art must be explored and it isreasonable to permit inquiry into other areas whereone of ordinary skill in the art would be aware thatsimilar problems exist.”). See also In re Bigio,381 F.3d 1320, 1325-26, 72 USPQ2d 1209, 1211-12(Fed. Cir. 2004). The patent application claimed a"hair brush" having a specific bristle configuration.The Board affirmed the examiner’s rejection of theclaims as being obvious in view of prior art patentsdisclosing toothbrushes. Id. at at 1323, 72 USPQ2dat 1210. The applicant disputed that the patentreferences constituted analogous art. On appeal, thecourt upheld the Board’s interpretation of the claimterm “hair brush” to encompass any brush that maybe used for any bodily hair, including facial hair. Id. at 1323-24, 72 USPQ2d at 1211. With this claiminterpretation, the court applied the “field ofendeavor test” for analogous art and determined thatthe references were within the field of applicant’sendeavor and hence was analogous art becausetoothbrushes are structurally similar to small brushesfor hair, and a toothbrush could be used to brushfacial hair. Id. at 1326, 72 USPQ2d at 1212.

Also see In re Deminski, 796 F.2d 436, 230 USPQ313 (Fed. Cir. 1986) (Applicant’s claims related todouble-acting high pressure gas transmission linecompressors in which the valves could be removedeasily for replacement. The Board relied uponreferences which taught either a double-acting pistonpump or a double-acting piston compressor. Thecourt agreed that since the cited pumps andcompressors have essentially the same function andstructure, the field of endeavor includes both typesof double-action piston devices for moving fluids.); Pentec, Inc. v. Graphic Controls Corp., 776 F.2d309, 227 USPQ 766 (Fed. Cir. 1985) (Claims at issuewere directed to an instrument marker pen body, theimprovement comprising a pen arm holding meanshaving an integrally molded hinged member forfolding over against the pen body. Although thepatent owners argued the hinge and fastener art wasnonanalogous, the court held that the problemconfronting the inventor was the need for a simpleholding means to enable frequent, secure attachment

2100-204Rev. 08.2017, January 2018


and easy removal of a marker pen to and from a penarm, and one skilled in the pen art trying to solvethat problem would have looked to the fastener andhinge art.); and Ex parte Goodyear Tire & RubberCo., 230 USPQ 357 (Bd. Pat. App. & Inter. 1985)(A reference in the clutch art was held reasonablypertinent to the friction problem faced by applicant,whose claims were directed to a braking material,because brakes and clutches utilize interfacingmaterials to accomplish their respective purposes.).

V. ANALOGY IN THE ELECTRICAL ARTS

See, for example, Medtronic, Inc. v. CardiacPacemakers, 721 F.2d 1563, 220 USPQ 97 (Fed.Cir. 1983) (Patent claims were drawn to a cardiacpacemaker which comprised, among othercomponents, a runaway inhibitor means forpreventing a pacemaker malfunction from causingpulses to be applied at too high a frequency rate.Two references disclosed circuits used in highpower, high frequency devices which inhibited therunaway of pulses from a pulse source. The courtheld that one of ordinary skill in the pacemakerdesigner art faced with a rate-limiting problem wouldlook to the solutions of others faced with ratelimiting problems, and therefore the references werein an analogous art.).

VI. EXAMPLES OF ANALOGY IN THE DESIGNARTS

See MPEP § 1504.03 for a discussion of the relevantcase law setting forth the general requirements foranalogous art in design applications.

For examples of analogy in the design arts, see Inre Rosen, 673 F.2d 388, 213 USPQ 347 (CCPA1982) (The design at issue was a coffee table ofcontemporary styling. The court held designs ofcontemporary furniture other than coffee tables, suchas the desk and circular glass table top designs ofthe references relied upon, would reasonably fallwithin the scope of the knowledge of the designerof ordinary skill.); Ex parte Pappas, 23 USPQ2d1636 (Bd. Pat. App. & Inter. 1992) (At issue was anornamental design for a feed bunk with an inclinedcorner configuration. Examiner relied uponreferences to a bunk lacking the inclined cornersclaimed by appellant and the Architectural Precast

Concrete Drafting Handbook. The Board found the Architectural Precast Concrete Drafting Handbookwas analogous art, noting that a bunk may be a woodor concrete trough, and that both references reliedupon “disclose structures in which at least oneupstanding leg is generally perpendicular to a baseportion to define a corner configuration between theleg and base portion.”); In re Butera, 1 F.3d 1252,28 USPQ2d 1399, 1400 (Fed. Cir. 1993)(unpublished - not citable as precedent) (The claimedinvention, a spherical design for a combined insectrepellent and air freshener, was rejected by the Boardas obvious over a single reference to a design for ametal ball anode. The court reversed, holding thereference design to be nonanalogous art. “A priordesign is of the type claimed if it has the samegeneral use as that claimed in the design patentapplication . . . . One designing a combined insectrepellent and air freshener would therefore not havereason to know of or look to a design for a metalball anode.”).

2141.02 Differences Between Prior Art andClaimed Invention [R-08.2017]


Ascertaining the differences between the prior artand the claims at issue requires interpreting the claimlanguage, and considering both the invention andthe prior art references as a whole. See MPEP § 2111- § 2116.01 for case law pertaining to claiminterpretation. See also MPEP § 2143.03 forexamples of types of claim language that may raisea question as to its limiting effect.

I. THE CLAIMED INVENTION AS A WHOLEMUST BE CONSIDERED

In determining the differences between the prior artand the claims, the question under 35 U.S.C. 103 isnot whether the differences themselves would havebeen obvious, but whether the claimed invention as

Rev. 08.2017, January 20182100-205


a whole would have been obvious. Stratoflex, Inc.v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871(Fed. Cir. 1983); Schenck v. Nortron Corp., 713F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claimswere directed to a vibratory testing machine (ahard-bearing wheel balancer) comprising a holdingstructure, a base structure, and a supporting meanswhich form “a single integral and gaplesslycontinuous piece.” Nortron argued the invention isjust making integral what had been made in fourbolted pieces, improperly limiting the focus to astructural difference from the prior art and failing toconsider the invention as a whole. The prior artperceived a need for mechanisms to dampenresonance, whereas the inventor eliminated the needfor dampening via the one-piece gapless supportstructure. “Because that insight was contrary to theunderstandings and expectations of the art, thestructure effectuating it would not have been obviousto those skilled in the art.” 713 F.2d at 785, 218USPQ at 700 (citations omitted).).

See also In re Hirao, 535 F.2d 67, 190 USPQ 15(CCPA 1976) (Claims were directed to a three stepprocess for preparing sweetened foods and drinks.The first two steps were directed to a process ofproducing high purity maltose (the sweetener), andthe third was directed to adding the maltose to foodsand drinks. The parties agreed that the first two stepswere unobvious but formed a known product andthe third step was obvious. The Solicitor argued thepreamble was directed to a process for preparingfoods and drinks sweetened mildly and thus thespecific method of making the high purity maltose(the first two steps in the claimed process) shouldnot be given weight, analogizing withproduct-by-process claims. The court held “due tothe admitted unobviousness of the first two steps ofthe claimed combination of steps, the subject matteras a whole would not have been obvious to one ofordinary skill in the art at the time the invention wasmade.” 535 F.2d at 69, 190 USPQ at 17 (emphasisin original). The preamble only recited the purposeof the process and did not limit the body of the claim.Therefore, the claimed process was a three stepprocess, not the product formed by two steps of theprocess or the third step of using that product.).

II. DISTILLING THE INVENTION DOWN TO A“GIST” OR “THRUST” OF AN INVENTIONDISREGARDS “AS A WHOLE” REQUIREMENT

Distilling an invention down to the “gist” or “thrust”of an invention disregards the requirement ofanalyzing the subject matter “as a whole.” W.L.Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540,220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469U.S. 851 (1984) (restricting consideration of theclaims to a 10% per second rate of stretching ofunsintered PTFE and disregarding other limitationsresulted in treating claims as though they readdifferently than allowed); Bausch & Lombv. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443,447-49, 230 USPQ 416, 419-20 (Fed. Cir. 1986), cert. denied, 484 U.S. 823 (1987) (District courtfocused on the “concept of forming ridgelessdepressions having smooth rounded edges using alaser beam to vaporize the material,” but“disregarded express limitations that the product bean ophthalmic lens formed of a transparentcross-linked polymer and that the laser marks besurrounded by a smooth surface of unsublimatedpolymer.”). See also Jones v. Hardy, 727 F.2d 1524,1530, 220 USPQ 1021, 1026 (Fed. Cir. 1984)(“treating the advantage as the invention disregardsstatutory requirement that the invention be viewed‘as a whole’”); Panduit Corp. v. Dennison Mfg. Co.,810 F.2d 1561, 1 USPQ2d 1593 (Fed. Cir. 1987), cert. denied, 481 U.S. 1052 (1987) (district courtimproperly distilled claims down to a one wordsolution to a problem).

III. DISCOVERING SOURCE/CAUSE OF APROBLEM IS PART OF “AS A WHOLE” INQUIRY

“[A] patentable invention may lie in the discoveryof the source of a problem even though the remedymay be obvious once the source of the problem isidentified. This is part of the ‘subject matter as awhole’ which should always be considered indetermining the obviousness of an invention under35 U.S.C. § 103.” In re Sponnoble, 405 F.2d 578,585, 160 USPQ 237, 243 (CCPA 1969). However,“discovery of the cause of a problem . . does notalways result in a patentable invention. . . . [A]different situation exists where the solution isobvious from prior art which contains the samesolution for a similar problem.” In re Wiseman, 596

2100-206Rev. 08.2017, January 2018


F.2d 1019, 1022, 201 USPQ 658, 661 (CCPA 1979)(emphasis in original).

In In re Sponnoble, the claim was directed to aplural compartment mixing vial wherein a centerseal plug was placed between two compartments fortemporarily isolating a liquid-containingcompartment from a solids-containing compartment.The claim differed from the prior art in the selectionof butyl rubber with a silicone coating as the plugmaterial instead of natural rubber. The prior artrecognized that leakage from the liquid to the solidscompartment was a problem, and considered theproblem to be a result of moisture passing aroundthe center plug because of microscopic fissuresinherently present in molded or blown glass. Thecourt found the inventor discovered the cause ofmoisture transmission was through the center plug,and there was no teaching in the prior art whichwould suggest the necessity of selecting applicant'splug material which was more impervious to liquidsthan the natural rubber plug of the prior art.

In In re Wiseman, 596 F.2d at 1022, 201 USPQ at661, claims directed to grooved carbon disc brakeswherein the grooves were provided to vent steam orvapor during a braking action to minimize fading ofthe brakes were rejected as obvious over a referenceshowing carbon disc brakes without grooves incombination with a reference showing grooves innoncarbon disc brakes for the purpose of cooling thefaces of the braking members and eliminating dust,thereby reducing fading of the brakes. The courtaffirmed the rejection, holding that even if applicantsdiscovered the cause of a problem, the solutionwould have been obvious from the prior art whichcontained the same solution (inserting grooves indisc brakes) for a similar problem.

IV. APPLICANTS ALLEGING DISCOVERY OF ASOURCE OF A PROBLEM MUST PROVIDESUBSTANTIATING EVIDENCE

Applicants who allege they discovered the sourceof a problem must provide evidence substantiatingthe allegation, either by way of affidavits ordeclarations, or by way of a clear and persuasiveassertion in the specification. In re Wiseman, 596F.2d 1019, 201 USPQ 658 (CCPA 1979)(unsubstantiated statement of counsel was

insufficient to show appellants discovered source ofthe problem); In re Kaslow, 707 F.2d 1366, 217USPQ 1089 (Fed. Cir. 1983) (Claims were directedto a method for redeeming merchandising couponswhich contain a UPC “5-by-5” bar code wherein,among other steps, the memory at each supermarketwould identify coupons by manufacturer andtransmit the data to a central computer to provide anaudit thereby eliminating the need for clearinghousesand preventing retailer fraud. In challenging thepropriety of an obviousness rejection, appellantargued he discovered the source of a problem(retailer fraud and manual clearinghouse operations)and its solution. The court found appellant’sspecification did not support the argument that hediscovered the source of the problem with respectto retailer fraud, and that the claimed invention failedto solve the problem of manual clearinghouseoperations.).

V. DISCLOSED INHERENT PROPERTIES AREPART OF “AS A WHOLE” INQUIRY

“In determining whether the invention as a wholewould have been obvious under 35 U.S.C. 103, wemust first delineate the invention as a whole. Indelineating the invention as a whole, we look notonly to the subject matter which is literally recitedin the claim in question... but also to those propertiesof the subject matter which are inherent in the subjectmatter and are disclosed in the specification. . . Justas we look to a chemical and its properties when weexamine the obviousness of a composition of matterclaim, it is this invention as a whole, and not somepart of it, which must be obvious under 35 U.S.C.103.” In re Antonie, 559 F.2d 618, 620, 195 USPQ6,8 (CCPA 1977) (emphasis in original) (citationsomitted) (The claimed wastewater treatment devicehad a tank volume to contractor area of 0.12 gal./sq.ft. The court found the invention as a whole was theratio of 0.12 and its inherent property that theclaimed devices maximized treatment capacityregardless of other variables in the devices. The priorart did not recognize that treatment capacity was afunction of the tank volume to contractor ratio, andtherefore the parameter optimized was notrecognized in the art to be a result-effectivevariable.). See also In re Papesch, 315 F.2d 381,391, 137 USPQ 43, 51 (CCPA 1963) (“From the

Rev. 08.2017, January 20182100-207


standpoint of patent law, a compound and all itsproperties are inseparable.”).

Obviousness cannot be predicated on what is notknown at the time an invention is made, even if theinherency of a certain feature is later established. Inre Rijckaert, 9 F.3d 1531, 28 USPQ2d 1955 (Fed.Cir. 1993). See MPEP § 2112 for the requirementsof rejections based on inherency.

VI. PRIOR ART MUST BE CONSIDERED IN ITSENTIRETY, INCLUDING DISCLOSURES THATTEACH AWAY FROM THE CLAIMS

A prior art reference must be considered in itsentirety, i.e., as a whole, including portions thatwould lead away from the claimed invention. W.L.Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540,220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469U.S. 851 (1984) (Claims were directed to a processof producing a porous article by expanding shaped,u n s i n t e r e d , h i g h l y c r y s t a l l i n epoly(tetrafluoroethylene) (PTFE) by stretching saidPTFE at a 10% per second rate to more than fivetimes the original length. The prior art teachingswith regard to unsintered PTFE indicated thematerial does not respond to conventional plasticsprocessing, and the material should be stretchedslowly. A reference teaching rapid stretching ofconventional plastic polypropylene with reducedcrystallinity combined with a reference teachingstretching unsintered PTFE would not suggest rapidstretching of highly crystalline PTFE, in light of thedisclosures in the art that teach away from theinvention, i.e., that the conventional polypropyleneshould have reduced crystallinity before stretching,and that PTFE should be stretched slowly). AlliedErecting v. Genesis Attachments, 825 F.3d 1373,1381, 119 USPQ2d 1132, 1138 (Fed. Cir. 2016)(“Although modification of the movable blades mayimpede the quick change functionality disclosed byCaterpillar, ‘[a] given course of action often hassimultaneous advantages and disadvantages, and thisdoes not necessarily obviate motivation tocombine.’” (quoting Medichem, S.A. v. Rolabo, S.L.,437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (FedCir. 2006) (citation omitted))).

However, “the prior art’s mere disclosure of morethan one alternative does not constitute a teaching

away from any of these alternatives because suchdisclosure does not criticize, discredit, or otherwisediscourage the solution claimed….” In re Fulton,391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed.Cir. 2004). See also MPEP § 2123.

2141.03 Level of Ordinary Skill in the Art[R-08.2012]

[Editor Note: This MPEP section is applicable toapplications subject to the first inventor to file(FITF) provisions of the AIA except that the relevantdate is the "effective filing date" of the claimedinvention instead of the "time of the invention" or"time the invention was made," which are onlyapplicable to applications subject to pre-AIA 35U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP §2150 et seq.]

I. FACTORS TO CONSIDER IN DETERMININGLEVEL OF ORDINARY SKILL

The person of ordinary skill in the art is ahypothetical person who is presumed to have knownthe relevant art at the time of the invention. Factorsthat may be considered in determining the level ofordinary skill in the art may include: (A) “type ofproblems encountered in the art;” (B) “prior artsolutions to those problems;” (C) “rapidity withwhich innovations are made;” (D) “sophisticationof the technology; and” (E) “educational level ofactive workers in the field. In a given case, everyfactor may not be present, and one or more factorsmay predominate.” In re GPAC, 57 F.3d 1573,1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus.,Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed.Cir. 1986 ); Environmental Designs, Ltd. V. UnionOil Co., 713 F.2d 693, 696, 218 USPQ 865, 868(Fed. Cir. 1983).

“A person of ordinary skill in the art is also a personof ordinary creativity, not an automaton.” KSR Int'lCo. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d1385, 1397 (2007). “[I]n many cases a person ofordinary skill will be able to fit the teachings ofmultiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d 1397. Office personnel mayalso take into account “the inferences and creative

2100-208Rev. 08.2017, January 2018


steps that a person of ordinary skill in the art wouldemploy.” Id. at 418, 82 USPQ2d at 1396.

The “hypothetical ‘person having ordinary skill inthe art’ to which the claimed subject matter pertainswould, of necessity have the capability ofunderstanding the scientific and engineeringprinciples applicable to the pertinent art.” Ex parteHiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App.& Inter. 1988) (The Board disagreed with theexaminer’s definition of one of ordinary skill in theart (a doctorate level engineer or scientist workingat least 40 hours per week in semiconductor researchor development), finding that the hypothetical personis not definable by way of credentials, and that theevidence in the application did not support theconclusion that such a person would require adoctorate or equivalent knowledge in science orengineering.).

References which do not qualify as prior art becausethey postdate the claimed invention may be reliedupon to show the level of ordinary skill in the art ator around the time the invention was made. Ex parteErlich, 22 USPQ 1463 (Bd. Pat. App. & Inter. 1992).Moreover, documents not available as prior artbecause the documents were not widely disseminatedmay be used to demonstrate the level of ordinaryskill in the art. For example, the document may berelevant to establishing "a motivation to combinewhich is implicit in the knowledge of one of ordinaryskill in the art." Nat'l Steel Car, Ltd. v. Can. Pac.Ry., Ltd., 357 F.3d 1319, 1338, 69 USPQ2d 1641,1656 (Fed. Cir. 2004) (holding that a drawing madeby an engineer that was not prior art can,nonetheless, “... be used to demonstrate a motivationto combine implicit in the knowledge of one ofordinary skill in the art”).

II. SPECIFYING A PARTICULAR LEVEL OFSKILL IS NOT NECESSARY WHERE THE PRIORART ITSELF REFLECTS AN APPROPRIATELEVEL

If the only facts of record pertaining to the level ofskill in the art are found within the prior art ofrecord, the court has held that an invention may beheld to have been obvious without a specific findingof a particular level of skill where the prior art itselfreflects an appropriate level. Chore-Time

Equipment, Inc. v. Cumberland Corp., 713 F.2d 774,218 USPQ 673 (Fed. Cir. 1983). See also Okajimav. Bourdeau, 261 F.3d 1350, 1355, 59 USPQ2d1795, 1797 (Fed. Cir. 2001).

III. ASCERTAINING LEVEL OF ORDINARYSKILL IS NECESSARY TO MAINTAINOBJECTIVITY

“The importance of resolving the level of ordinaryskill in the art lies in the necessity of maintainingobjectivity in the obviousness inquiry.” Ryko Mfg.Co. v. Nu-Star, Inc., 950 F.2d 714, 718, 21 USPQ2d1053, 1057 (Fed. Cir. 1991). The examiner mustascertain what would have been obvious to one ofordinary skill in the art at the time the invention wasmade, and not to the inventor, a judge, a layman,those skilled in remote arts, or to geniuses in the artat hand. Environmental Designs, Ltd. v. Union OilCo., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).

2142 Legal Concept of Prima FacieObviousness [R-07.2015]

The legal concept of prima facie obviousness is aprocedural tool of examination which applies broadlyto all arts. It allocates who has the burden of goingforward with production of evidence in each step ofthe examination process. See In re Rinehart, 531F.2d 1048, 189 USPQ 143 (CCPA 1976); In reLintner, 458 F.2d 1013, 173 USPQ 560 (CCPA1972); In re Saunders, 444 F.2d 599, 170 USPQ213 (CCPA 1971); In re Tiffin, 443 F.2d 394, 170USPQ 88 (CCPA 1971), amended, 448 F.2d 791,171 USPQ 294 (CCPA 1971); In re Warner, 379F.2d 1011, 154 USPQ 173 (CCPA 1967), cert.denied, 389 U.S. 1057 (1968). The examiner bearsthe initial burden of factually supporting any primafacie conclusion of obviousness. If the examinerdoes not produce a prima facie case, the applicantis under no obligation to submit secondary evidenceto show nonobviousness. If, however, the examinerdoes produce a prima facie case, the burden ofcoming forward with evidence or arguments shiftsto the applicant who may submit additional evidenceof nonobviousness, such as comparative test datashowing that the claimed invention possessesimproved properties not expected by the prior art.The decision of whether to submit evidence after a

Rev. 08.2017, January 20182100-209


rejection should be influenced by the goals ofcompact prosecution, which encourages the earlysubmission of such evidence. It is also noted thatevidence submitted after final rejection may bedenied entry into the record. The initial evaluationof prima facie obviousness thus relieves both theexaminer and applicant from evaluating evidencebeyond the prior art and the evidence in thespecification as filed until the art has been shown torender obvious the claimed invention.

To reach a proper determination under 35 U.S.C.103, the examiner must step backward in time andinto the shoes worn by the hypothetical “person ofordinary skill in the art” when the invention wasunknown and just before it was made. In view of allfactual information, the examiner must then make adetermination whether the claimed invention “as awhole” would have been obvious at that time to thatperson. Knowledge of applicant’s disclosure mustbe put aside in reaching this determination, yet keptin mind in order to determine the “differences,”conduct the search and evaluate the “subject matteras a whole” of the invention. The tendency to resortto “hindsight” based upon applicant's disclosure isoften difficult to avoid due to the very nature of theexamination process. However, impermissiblehindsight must be avoided and the legal conclusionmust be reached on the basis of the facts gleanedfrom the prior art.

ESTABLISHING A PRIMA FACIE CASE OFOBVIOUSNESS

The key to supporting any rejection under 35 U.S.C.103 is the clear articulation of the reason(s) why theclaimed invention would have been obvious. TheSupreme Court in KSR Int'l Co. v. Teleflex Inc., 550U.S. 538, 418, 82 USPQ2d 1385, 1396 (2007) notedthat the analysis supporting a rejection under 35U.S.C. 103 should be made explicit. The FederalCircuit has stated that "rejections on obviousnesscannot be sustained with mere conclusorystatements; instead, there must be some articulatedreasoning with some rational underpinning to supportthe legal conclusion of obviousness.” In re Kahn,441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed.Cir. 2006); see also KSR, 550 U.S. at 418, 82USPQ2d at 1396 (quoting Federal Circuit statementwith approval).

It remains true that “[t]he determination ofobviousness is dependent on the facts of each case.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075,1089, 89 USPQ2d 1370, 1379 (Fed. Cir. 2008)(citing Graham, 383 U.S. at 17-18, 148 USPQ 459,467 (1966)). If the examiner determines there isfactual support for rejecting the claimed inventionunder 35 U.S.C. 103, the examiner must thenconsider any evidence supporting the patentabilityof the claimed invention, such as any evidence inthe specification or any other evidence submitted bythe applicant. The ultimate determination ofpatentability is based on the entire record, by apreponderance of evidence, with due considerationto the persuasiveness of any arguments and anysecondary evidence. In re Oetiker, 977 F.2d 1443,24 USPQ2d 1443 (Fed. Cir. 1992). The legalstandard of “a preponderance of evidence” requiresthe evidence to be more convincing than theevidence which is offered in opposition to it. Withregard to rejections under 35 U.S.C. 103, theexaminer must provide evidence which as a wholeshows that the legal determination sought to beproved (i.e., the reference teachings establish a prima facie case of obviousness) is more probablethan not.

When an applicant submits evidence, whether in thespecification as originally filed or in reply to arejection, the examiner must reconsider thepatentability of the claimed invention. The decisionon patentability must be made based uponconsideration of all the evidence, including theevidence submitted by the examiner and the evidencesubmitted by the applicant. A decision to make ormaintain a rejection in the face of all the evidencemust show that it was based on the totality of theevidence. Facts established by rebuttal evidence mustbe evaluated along with the facts on which theconclusion of obviousness was reached, not againstthe conclusion itself. In re Eli Lilly & Co., 902 F.2d943, 14 USPQ2d 1741 (Fed. Cir. 1990).

See In re Piasecki, 745 F.2d 1468, 223 USPQ 785(Fed. Cir. 1984) for a discussion of the proper rolesof the examiner’s prima facie case and applicant’srebuttal evidence in the final determination ofobviousness. See MPEP § 706.02(j) for a discussionof the proper contents of a rejection under 35 U.S.C.103.

2100-210Rev. 08.2017, January 2018


2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-08.2017]

[Editor Note: This MPEP section is applicable toapplications subject to the first inventor to file(FITF) provisions of the AIA except that the relevantdate is the "effective filing date" of the claimedinvention instead of the "time of the invention" or"time the invention was made," which are onlyapplicable to applications subject to pre-AIA 35U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP §2150 et seq.]

The Supreme Court in KSR Int'l Co. v. Teleflex Inc.,550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97(2007) identified a number of rationales to supporta conclusion of obviousness which are consistentwith the proper “functional approach” to thedetermination of obviousness as laid down in Graham. The key to supporting any rejection under35 U.S.C. 103 is the clear articulation of thereason(s) why the claimed invention would havebeen obvious. The Supreme Court in KSR notedthat the analysis supporting a rejection under 35U.S.C. 103 should be made explicit. In Ball Aerosolv. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed.Cir. 2009), the Federal Circuit offered additionalinstruction as to the need for an explicit analysis.The Federal Circuit explained that the SupremeCourt’s requirement for an explicit analysis does notrequire record evidence of an explicit teaching of amotivation to combine in the prior art.

"[T]he analysis that "should be made explicit" refersnot to the teachings in the prior art of a motivationto combine, but to the court’s analysis. . . . Underthe flexible inquiry set forth by the Supreme Court,the district court therefore erred by failing to takeaccount of 'the inferences and creative steps,' or evenroutine steps, that an inventor would employ and byfailing to find a motivation to combine related piecesfrom the prior art." Ball Aerosol, 555 F.3d at 993,89 USPQ2d at 1877.

The Federal Circuit’s directive in Ball Aerosol wasaddressed to a lower court, but it applies to Officepersonnel as well. When setting forth a rejection,Office personnel are to continue to make appropriatefindings of fact as explained in MPEP § 2141 and §2143, and must provide a reasoned explanation as

to why the invention as claimed would have beenobvious to a person of ordinary skill in the art at thetime of the invention. This requirement forexplanation remains even in situations in whichOffice personnel may properly rely on intangiblerealities such as common sense and ordinaryingenuity.

I. EXEMPLARY RATIONALES

Exemplary rationales that may support a conclusionof obviousness include:

(A) Combining prior art elements according toknown methods to yield predictable results;

(B) Simple substitution of one known elementfor another to obtain predictable results;

(C) Use of known technique to improve similardevices (methods, or products) in the same way;

(D) Applying a known technique to a knowndevice (method, or product) ready for improvementto yield predictable results;

(E) “Obvious to try” – choosing from a finitenumber of identified, predictable solutions, with areasonable expectation of success;

(F) Known work in one field of endeavor mayprompt variations of it for use in either the samefield or a different one based on design incentivesor other market forces if the variations arepredictable to one of ordinary skill in the art;

(G) Some teaching, suggestion, or motivationin the prior art that would have led one of ordinaryskill to modify the prior art reference or to combineprior art reference teachings to arrive at the claimedinvention.

Note that the list of rationales provided is notintended to be an all-inclusive list. Other rationalesto support a conclusion of obviousness may be reliedupon by Office personnel. Any rationale employedmust provide a link between the factual findings andthe legal conclusion of obviousness.

It is important for Office personnel to recognize thatwhen they do choose to formulate an obviousnessrejection using one of the rationales suggested bythe Supreme Court in KSR and discussed herein,they are to adhere to the guidance provided regarding

Rev. 08.2017, January 20182100-211


the necessary factual findings. It remains Officepolicy that appropriate factual findings are requiredin order to apply the enumerated rationales properly.

The subsections below include discussions of eachrationale along with examples illustrating how thecited rationales may be used to support a finding ofobviousness. Some examples use the facts ofpre- KSR cases to show how the rationales suggestedby the Court in KSR may be used to support afinding of obviousness. The cases cited (from whichthe facts were derived) may not necessarily standfor the proposition that the particular rationale is thebasis for the court’s holding of obviousness, but theydo illustrate consistency of past decisions with thelines of reasoning laid out in KSR. Other examplesare post- KSR decisions that show how the FederalCircuit has applied the principles of KSR. Cases areincluded that illustrate findings of obviousness aswell as nonobviousness. Note that, in some instances,a single case is used in different subsections toillustrate the use of more than one rationale tosupport a finding of obviousness. It will often be thecase that, once the Graham inquiries have beensatisfactorily resolved, a conclusion of obviousnessmay be supported by more than one line ofreasoning.

A. Combining Prior Art Elements According to KnownMethods To Yield Predictable Results

To reject a claim based on this rationale, Officepersonnel must resolve the Graham factualinquiries. Then, Office personnel must articulate thefollowing:

(1) a finding that the prior art included eachelement claimed, although not necessarily in a singleprior art reference, with the only difference betweenthe claimed invention and the prior art being the lackof actual combination of the elements in a singleprior art reference;

(2) a finding that one of ordinary skill in the artcould have combined the elements as claimed byknown methods, and that in combination, eachelement merely performs the same function as itdoes separately;

(3) a finding that one of ordinary skill in the artwould have recognized that the results of thecombination were predictable; and

(4) whatever additional findings based on the Graham factual inquiries may be necessary, in viewof the facts of the case under consideration, toexplain a conclusion of obviousness.

The rationale to support a conclusion that the claimwould have been obvious is that all the claimedelements were known in the prior art and one skilledin the art could have combined the elements asclaimed by known methods with no change in theirrespective functions, and the combination yieldednothing more than predictable results to one ofordinary skill in the art. KSR, 550 U.S. at 416, 82USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement SalvageCo., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip.Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).“[I]t can be important to identify a reason that wouldhave prompted a person of ordinary skill in therelevant field to combine the elements in the waythe claimed new invention does.” KSR, 550 U.S. at418, 82 USPQ2d at 1396. If any of these findingscannot be made, then this rationale cannot be usedto support a conclusion that the claim would havebeen obvious to one of ordinary skill in the art.

Example 1:

The claimed invention in Anderson’s-Black Rock, Inc. v.Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969) wasa paving machine which combined several well-known elementsonto a single chassis. Standard prior art paving machinestypically combined equipment for spreading and shaping asphaltonto a single chassis. The patent claim included the well-knownelement of a radiant-heat burner attached to the side of the paverfor the purpose of preventing cold joints during continuous strippaving. The prior art used radiant heat for softening the asphaltto make patches, but did not use radiant heat burners to achievecontinuous strip paving. All of the component parts were knownin the prior art. The only difference was the combination of the“old elements” into a single device by mounting them on a singlechassis. The Court found that the operation of the heater was inno way dependent on the operation of the other equipment, andthat a separate heater could also be used in conjunction with astandard paving machine to achieve the same results. The Courtconcluded that “[t]he convenience of putting the burner togetherwith the other elements in one machine, though perhaps a matterof great convenience, did not produce a ‘new’ or ‘differentfunction’” and that to those skilled in the art the use of the oldelements in combination would have been obvious. Id. at 60,163 USPQ at 674.

Note that combining known prior art elements is not sufficientto render the claimed invention obvious if the results would not

2100-212Rev. 08.2017, January 2018


have been predictable to one of ordinary skill in the art. UnitedStates v. Adams, 383 U.S. 39, 51-52, 148 USPQ 479, 483-84(1966). In Adams, the claimed invention was to a battery withone magnesium electrode and one cuprous chloride electrodethat could be stored dry and activated by the addition of plainwater or salt water. Although magnesium and cuprous chloridewere individually known battery components, the Courtconcluded that the claimed battery was nonobvious. The Courtstated that “[d]espite the fact that each of the elements of theAdams battery was well known in the prior art, to combine themas did Adams required that a person reasonably skilled in theprior art must ignore” the teaching away of the prior art thatsuch batteries were impractical and that water-activated batterieswere successful only when combined with electrolytesdetrimental to the use of magnesium electrodes. Id. at 42-43,50-52, 148 USPQ at 480, 483. “[w]hen the prior art teachesaway from combining certain known elements, discovery ofsuccessful means of combining them is more likely to benonobvious.” KSR, 550 U.S. at 416, 82 USPQ2d at 1395.

Example 2:

The claimed invention in Ruiz v. A.B. Chance Co., 357 F.3d1270, 69 USPQ2d 1686 (Fed. Cir. 2004) was directed to asystem which employs a screw anchor for underpinning existingfoundations and a metal bracket to transfer the building loadonto the screw anchor. The prior art (Fuller) used screw anchorsfor underpinning existing structural foundations. Fuller used aconcrete haunch to transfer the load of the foundation to thescrew anchor. The prior art (Gregory) used a push pier forunderpinning existing structural foundations. Gregory taught amethod of transferring load using a bracket, specifically: a metalbracket transfers the foundation load to the push pier. The pieris driven into the ground to support the load. Neither referenceshowed the two elements of the claimed invention – screwanchor and metal bracket – used together. The court found that“artisans knew that a foundation underpinning system requiresa means of connecting the foundation to the load-bearingmember.” Id. at 1276, 69 USPQ2d at 1691.

The nature of the problem to be solved – underpinning unstablefoundations – as well as the need to connect the member to thefoundation to accomplish this goal, would have led one ofordinary skill in the art to choose an appropriate load bearingmember and a compatible attachment. Therefore, it would havebeen obvious to use a metal bracket (as shown in Gregory) incombination with the screw anchor (as shown in Fuller) tounderpin unstable foundations.

Example 3:

The case of In re Omeprazole Patent Litigation, 536 F.3d 1361,87 USPQ2d 1865 (Fed. Cir. 2008), is one in which the claimsin question were found to be nonobvious in the context of anargument to combine prior art elements. The invention involvedapplying enteric coatings to a drug in pill form for the purposeof ensuring that the drug did not disintegrate before reachingits intended site of action. The drug at issue was omeprazole,the generic name for gastric acid inhibitor marketed asPrilosec®. The claimed formulation included two layers ofcoatings over the active ingredient.

The district court found that Astra’s patent in suit was infringedby defendants Apotex and Impax. The district court rejectedApotex’s defense that the patents were invalid for obviousness.Apotex had argued that the claimed invention was obviousbecause coated omeprazole tablets were known from a prior artreference, and because secondary subcoatings in pharmaceuticalpreparations generally were also known. There was no evidenceof unpredictability associated with applying two different entericcoatings to omeprazole. However, Astra’s reason for applyingan intervening subcoating between the prior art coating andomeprazole had been that the prior art coating was actuallyinteracting with omeprazole, thereby contributing to undesirabledegradation of the active ingredient. This degradation ofomeprazole by interaction with the prior art coating had notbeen recognized in the prior art. Therefore, the district courtreasoned that based on the evidence available, a person ofordinary skill in the art would have had no reason to include asubcoating in an omeprazole pill formulation.

The Federal Circuit affirmed the district court’s decision thatthe claimed invention was not obvious. Even though subcoatingsfor enteric drug formulation were known, and there was noevidence of undue technical hurdles or lack of a reasonableexpectation of success, the formulation was nevertheless notobvious because the flaws in the prior art formulation that hadprompted the modification had not been recognized. Thus therewould have been no reason to modify the initial formulation,even though the modification could have been done. Moreover,a person of skill in the art likely would have chosen a differentmodification even if they had recognized the problem.

Office personnel should note that in this case the modificationof the prior art that had been presented as an argument forobviousness was an extra process step that added an additionalcomponent to a known, successfully marketed formulation. Theproposed modification thus amounted to extra work and greaterexpense for no apparent reason. This is not the same ascombining known prior art elements A and B when each wouldhave been expected to contribute its own known properties tothe final product. In the Omeprazole case, in view of theexpectations of those of ordinary skill in the art, adding thesubcoating would not have been expected to confer anyparticular desirable property on the final product. Rather, thefinal product obtained according to the proposed modificationswould merely have been expected to have the same functionalproperties as the prior art product.

The Omeprazole case can also be analyzed in view of thediscovery of a previously unknown problem by the patentee. Ifthe adverse interaction between active agent and coating hadbeen known, it might well have been obvious to use asubcoating. However, since the problem had not been previouslyknown, there would have been no reason to incur additionaltime and expense to add another layer, even though the additionwould have been technologically possible. This is true becausethe prior art of record failed to mention any stability problem,despite the acknowledgment during testimony at trial that therewas a known theoretical reason that omeprazole might be subjectto degradation in the presence of the known coating material.

Rev. 08.2017, January 20182100-213


Example 4:

The case of Crocs, Inc. v. U.S. Int'l Trade Comm'n, 598 F.3d1294, 93 USPQ 1777 (Fed. Cir. 2010), is a decision in whichthe claimed foam footwear was held by the Federal Circuit tobe nonobvious over a combination of prior art references.

The claims involved in the obviousness issue were from Crocs’U.S. Patent No. 6,993,858, and were drawn to footwear in whicha one-piece molded foam base section formed the top of theshoe (the upper) and the sole. A strap also made of foam wasattached to the foot opening of the upper, such that the strapcould provide support to the Achilles portion of the wearer’sfoot. The strap was attached via connectors that allowed it tobe in contact with the base section, and to pivot relative to thebase section. Because both the base portion and the strap weremade of foam, friction between the strap and the base sectionallowed the strap to maintain its position after pivoting. In otherwords, the foam strap did not fall under the force of gravity toa position adjacent to the heel of the base section.

The International Trade Commission (ITC) determined that theclaims were obvious over the combination of two pieces of priorart. The first was the Aqua Clog, which was a shoe thatcorresponded to the base section of the footwear of the ‘858patent. The second was the Aguerre patent, which taught heelstraps made of elastic or another flexible material. In the ITC’sview, the claimed invention was obvious because the prior artAqua Clog differed from the claimed invention only as to thepresence of the strap, and a suitable strap was taught by Aguerre.

The Federal Circuit disagreed. The Federal Circuit stated thatthe prior art did not teach foam heel straps, or that a foam heelstrap should be placed in contact with a foam base. The FederalCircuit pointed out that the prior art actually counseled againstusing foam as a material for the heel strap of a shoe.

The record shows that the prior art would actuallydiscourage and teach away from the use of foam straps.An ordinary artisan in this field would not add a foamstrap to the foam Aqua Clog because foam was likely tostretch and deform, in addition to causing discomfort fora wearer. The prior art depicts foam as unsuitable forstraps.

Id. at 1309, 93 USPQ2d at 1787-88.

The Federal Circuit continued, stating that even if – contrary tofact – the claimed invention had been a combination of elementsthat were known in the prior art, the claims still would havebeen nonobvious. There was testimony in the record that theloose fit of the heel strap made the shoe more comfortable forthe wearer than prior art shoes in which the heel strap wasconstantly in contact with the wearer’s foot. In the claimedfootwear, the foam heel strap contacted the wearer’s foot onlywhen needed to help reposition the foot properly in the shoe,thus reducing wearer discomfort that could arise from constantcontact. This desirable feature was a result of the frictionbetween the base section and the strap that kept the strap in placebehind the Achilles portion of the wearer’s foot. The Federal

Circuit pointed out that this combination “yielded more thanpredictable results.” Id. at 1310, 93 USPQ2d at 1788. Aguerrehad taught that friction between the base section and the strapwas a problem rather than an advantage, and had suggested theuse of nylon washers to reduce friction. Thus the Federal Circuitstated that even if all elements of the claimed invention hadbeen taught by the prior art, the claims would not have beenobvious because the combination yielded more than predictableresults.

The Federal Circuit’s discussion in Crocs serves as a reminderto Office personnel that merely pointing to the presence of allclaim elements in the prior art is not a complete statement of arejection for obviousness. In accordance with MPEP § 2143,subsection I.A.(3), a proper rejection based on the rationale thatthe claimed invention is a combination of prior art elements alsoincludes a finding that results flowing from the combinationwould have been predictable to a person of ordinary skill in theart. MPEP § 2143, subsection I.A.(3). If results would not havebeen predictable, Office personnel should not enter anobviousness rejection using the combination of prior art elementsrationale, and should withdraw such a rejection if it has beenmade.

Example 5:

Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356,89 USPQ2d 1535 (Fed. Cir. 2008), involved a segmented andmechanized cover for trucks, swimming pools, or otherstructures. The claim was found to be obvious over the prior artapplied.

A first prior art reference taught that a reason for making asegmented cover was ease of repair, in that a single damagedsegment could be readily removed and replaced when necessary.A second prior art reference taught the advantages of amechanized cover for ease of opening. The Federal Circuit notedthat the segmentation aspect of the first reference and themechanization function of the second perform in the same wayafter combination as they had before. The Federal Circuit furtherobserved that a person of ordinary skill in the art would haveexpected that adding replaceable segments as taught by the firstreference to the mechanized cover of the other would result ina cover that maintained the advantageous properties of both ofthe prior art covers.

Thus, the Sundance case points out that a hallmark of a properobviousness rejection based on combining known prior artelements is that one of ordinary skill in the art would reasonablyhave expected the elements to maintain their respectiveproperties or functions after they have been combined.

Example 6:

In the case of Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 91USPQ2d 1225 (Fed Cir. 2009), an “apparent reason to combine”in conjunction with the technical ability to optimize led to theconclusion that the claimed invention would have been obvious.

The invention in question was a method of treating meat toreduce the incidence of pathogens, by spraying the meat with

2100-214Rev. 08.2017, January 2018


an antibacterial solution under specified conditions. The partiesdid not dispute that a single prior art reference had taught all ofthe elements of the claimed invention, except for the pressurelimitation of “at least 50 psi.”

FMC had argued at the district court that the claimed inventionwould have been obvious in view of the first prior art referencementioned above in view of a second reference that had taughtthe advantages of spray-treating at pressures of 20 to 150 psiwhen treating meat with a different antibacterial agent. Thedistrict court did not find FMC’s argument to be convincing,and denied the motion for judgment as a matter of law that theclaim was obvious.

Disagreeing with the district court, the Federal Circuit statedthat “there was an apparent reason to combine these knownelements – namely to increase contact between the [antibacterialsolution] and the bacteria on the meat surface and to use thepressure to wash additional bacteria off the meat surface.” Id.at 1350, 91 USPQ2d at 1234. The Federal Circuit explained thatbecause the second reference had taught “using high pressureto improve the effectiveness of an antimicrobial solution whensprayed onto meat, and because an ordinarily skilled artisanwould have recognized the reasons for applying [the claimedantibacterial solution] using high pressure and would haveknown how to do so, Ecolab’s claims combining high pressurewith other limitations disclosed in FMC’s patent are invalid asobvious.” Id.

When considering the question of obviousness, Office personnelshould keep in mind the capabilities of a person of ordinaryskill. In Ecolab, the Federal Circuit stated:

Ecolab’s expert admitted that one skilled in the art wouldknow how to adjust application parameters to determinethe optimum parameters for a particular solution. Thequestion then is whether it would have been obvious tocombine the high pressure parameter disclosed in theBender patent with the PAA methods disclosed in FMC’s’676 patent. The answer is yes. Id.

If optimization of the application parameters had not been withinthe level of ordinary skill in the art, the outcome of the Ecolabcase may well have been different.

Example 7:

In the case of Wyers v. Master Lock Co., 616 F.3d 1231, 95USPQ2d 1525 (Fed. Cir. 2010), the Federal Circuit held thatthe claimed barbell-shaped hitch pin locks used to secure trailersto vehicles were obvious.

The court discussed two different sets of claims in Wyers, bothdrawn to improvements over the prior art hitch pin locks. Thefirst improvement was a removable sleeve that could be placedover the shank of the hitch pin lock so that the same lock couldbe used with towing apertures of varying sizes. The secondimprovement was an external flat flange seal adapted to protectthe internal lock mechanism from contaminants. Wyers had

admitted that each of several prior art references taught everyelement of the claimed inventions except for the removablesleeve and the external covering. Master Lock had argued thatthese references, in combination with additional referencesteaching the missing elements, would have rendered the claimsobvious. The court first addressed the question of whether theadditional references relied on by Master Lock were analogousprior art. As to the reference teaching the sleeve improvement,the court concluded that it dealt specifically with using a vehicleto tow a trailer, and was therefore in the same field of endeavoras Wyers’ sleeve improvement. The reference teaching thesealing improvement dealt with a padlock rather than a lock fora tow hitch. The court noted that Wyers’ specification hadcharacterized the claimed invention as being in the field oflocking devices, thus at least suggesting that the sealed padlockreference was in the same field of endeavor. However, the courtalso observed that even if sealed padlocks were not in the samefield of endeavor, they were nevertheless reasonably pertinentto the problem of avoiding contamination of a lockingmechanism for tow hitches. The court explained that theSupreme Court’s decision in KSR “directs [it] to construe thescope of analogous art broadly.” Id. at 1238, 95 USPQ2d at1530. For these reasons, the court found that Master Lock’sasserted references were analogous prior art, and thereforerelevant to the obviousness inquiry.

The court then turned to the question of whether there wouldhave been adequate motivation to combine the prior art elementsas had been urged by Master Lock. The court recalled the Graham inquiries, and also emphasized the “expansive andflexible” post-KSR approach to obviousness that must not “denyfactfinders recourse to common sense.” Id. at 1238, 95 USPQ2dat 1530-31. (quoting KSR, 550 U.S. at 415, 421, 82 USPQ2dat 1395, 1397). The court stated:

KSR and our later cases establish that the legaldetermination of obviousness may include recourse tologic, judgment, and common sense, in lieu of experttestimony. . . . Thus, in appropriate cases, the ultimateinference as to the existence of a motivation to combinereferences may boil down to a question of “commonsense,” appropriate for resolution on summary judgmentor JMOL.

Id. at 1240, 82 USPQ2d at 1531 (citing Perfect Web Techs.,Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1330, 92 USPQ2d, 1849,1854 (Fed. Cir. 2009); Ball Aerosol, 555 F.3d at 993, 89USPQ2d 1870, 1875 (Fed. Cir. 2009)).

After reviewing these principles, the court proceeded to explainwhy adequate motivation to combine had been established inthis case. With regard to the sleeve improvement, it pointed outthat the need for different sizes of hitch pins was well knownin the art, and that this was a known source of inconvenienceand expense for users. The court also mentioned the marketplaceaspect of the issue, noting that space on store shelves was at apremium, and that removable sleeves addressed this economicconcern. As to the sealing improvement, the court pointed outthat both internal and external seals were well-known means toprotect locks from contaminants. The court concluded that the

Rev. 08.2017, January 20182100-215


constituent elements were being employed in accordance withtheir recognized functions, and would have predictably retainedtheir respective functions when combined as suggested byMaster Lock. The court cited In re O’Farrell, 853 F.2d 894,904 (Fed. Cir. 1988) for the proposition that a reasonableexpectation of success is a requirement for a properdetermination of obviousness.

Office personnel should note that although the Federal Circuitinvoked the idea of common sense in support of a conclusionof obviousness, it did not end its explanation there. Rather, thecourt explained why a person of ordinary skill in the art at thetime of the invention, in view of the facts relevant to the case,would have found the claimed inventions to have been obvious.The key to supporting any rejection under 35 U.S.C. 103 is theclear articulation of the reason(s) why the claimed inventionwould have been obvious. The Supreme Court in KSR notedthat the analysis supporting a rejection under 35 U.S.C. 103should be made explicit. The Court quoting In re Kahn, 441F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), statedthat “[R]ejections on obviousness cannot be sustained by mereconclusory statements; instead, there must be some articulatedreasoning with some rational underpinning to support the legalconclusion of obviousness.” See MPEP § 2141, subsection III.Office personnel should continue to provide a reasonedexplanation for every obviousness rejection.

Example 8:

The claim in DePuy Spine, Inc. v. Medtronic Sofamor Danek,Inc., 567 F.3d 1314, 90 USPQ2d 1865 (Fed. Cir. 2009), wasdirected to a polyaxial pedicle screw used in spinal surgeriesthat included a compression member for pressing a screw headagainst a receiver member. A prior art reference (Puno) disclosedall of the elements of the claim except for the compressionmember. Instead, the screw head in Puno was separated fromthe receiver member to achieve a shock absorber effect, allowingsome motion between receiver member and the vertebrae. Themissing compression member was readily found in another priorart reference (Anderson), which disclosed an external fractureimmobilization splint for immobilizing long bones with a swivelclamp capable of polyaxial movement until rigidly secured bya compression member. It was asserted during trial that a personof ordinary skill would have recognized that the addition ofAnderson’s compression member to Puno’s device would haveachieved a rigidly locked polyaxial pedicle screw covered bythe claim.

In conducting its analysis, the Federal Circuit noted that the“predictable result” discussed in KSR refers not only to theexpectation that prior art elements are capable of beingphysically combined, but also that the combination would haveworked for its intended purpose. In this case, it was successfullyargued that Puno “teaches away” from a rigid screw becausePuno warned that rigidity increases the likelihood that the screwwill fail within the human body, rendering the device inoperativefor its intended purpose. In fact, the reference did not merelyexpress a general preference for pedicle screws having a “shockabsorber” effect, but rather expressed concern for failure andstated that the shock absorber feature “decrease[s] the chanceof failure of the screw of the bone-screw interface” because “it

prevent[s] direct transfer of load from the rod to the bone-screwinterface.” Thus, the alleged reason to combine the prior artelements of Puno and Anderson—increasing the rigidity of thescrew—ran contrary to the prior art that taught that increasingrigidity would result in a greater likelihood of failure. In viewof this teaching and the backdrop of collective teachings of theprior art, the Federal Circuit determined that Puno teaches awayfrom the proposed combination such that a person of ordinaryskill would have been deterred from combining the referencesas proposed. Secondary considerations evaluated by the FederalCircuit relating to failure by others and copying also supportedthe view that the combination would not have been obvious atthe time of the invention.

B. Simple Substitution of One Known Element forAnother To Obtain Predictable Results


(1) a finding that the prior art contained a device(method, product, etc.) which differed from theclaimed device by the substitution of somecomponents (step, element, etc.) with othercomponents;

(2) a finding that the substituted componentsand their functions were known in the art;

(3) a finding that one of ordinary skill in the artcould have substituted one known element foranother, and the results of the substitution wouldhave been predictable; and


The rationale to support a conclusion that the claimwould have been obvious is that the substitution ofone known element for another yields predictableresults to one of ordinary skill in the art. If any ofthese findings cannot be made, then this rationalecannot be used to support a conclusion that the claimwould have been obvious to one of ordinary skill inthe art.

Example 1:

The claimed invention in In re Fout, 675 F.2d 297, 213 USPQ532 (CCPA 1982) was directed to a method for decaffeinatingcoffee or tea. The prior art (Pagliaro) method produced adecaffeinated vegetable material and trapped the caffeine in afatty material (such as oil). The caffeine was then removed from

2100-216Rev. 08.2017, January 2018


the fatty material by an aqueous extraction process. Applicant(Fout) substituted an evaporative distillation step for the aqueousextraction step. The prior art (Waterman) suspended coffee inoil and then directly distilled the caffeine through the oil. Thecourt found that “[b]ecause both Pagliaro and Waterman teacha method for separating caffeine from oil, it would have been prima facie obvious to substitute one method for the other.Express suggestion to substitute one equivalent for another neednot be present to render such substitution obvious.” Id. at 301,213 USPQ at 536.

Example 2:

The claimed invention in In re O’Farrell, 853 F.2d 894,7 USPQ2d 1673 (Fed. Cir. 1988) was directed to a method forsynthesizing a protein in a transformed bacterial host speciesby substituting a heterologous gene for a gene native to the hostspecies. Generally speaking, protein synthesis in vivo followsa path from DNA to mRNA. Although the prior art Poliskyarticle (authored by two of the three inventors of the application)had explicitly suggested employing the method described forprotein synthesis, the inserted heterologous gene exemplifiedin the article was one that normally did not proceed all the wayto the protein production step, but instead terminated with themRNA. A second reference to Bahl had described a generalmethod of inserting chemically synthesized DNA into a plasmid.Thus, it would have been obvious to one of ordinary skill in theart to replace the prior art gene with another gene known to leadto protein production, because one of ordinary skill in the artwould have been able to carry out such a substitution, and theresults were reasonably predictable.

In response to applicant’s argument that there had beensignificant unpredictability in the field of molecular biology atthe time of the invention, the court stated that the level of skillwas quite high and that the teachings of Polisky, even takenalone, contained detailed enabling methodology and includedthe suggestion that the modification would be successful forsynthesis of proteins.

This is not a situation where the rejection is a statement that itwould have been “obvious to try” without more. Here there wasa reasonable expectation of success. “Obviousness does notrequire absolute predictability of success.” Id. at 903, 7 USPQ2dat 1681.

Example 3:

The fact pattern in Ruiz v. AB Chance Co., 357 F.3d 1270, 69USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2in subsection I.A., above.

The prior art showed differing load-bearing members anddiffering means of attaching the foundation to the member.Therefore, it would have been obvious to one of ordinary skillin the art to substitute the metal bracket taught in Gregory forFuller’s concrete haunch for the predictable result of transferringthe load.

Example 4:

The claimed invention in Ex parte Smith, 83 USPQ2d 1509(Bd. Pat. App. & Int. 2007), was a pocket insert for a boundbook made by gluing a base sheet and a pocket sheet of papertogether to form a continuous two-ply seam defining a closedpocket. The prior art (Wyant) disclosed at least one pocketformed by folding a single sheet and securing the folder portionsalong the inside margins using any convenient bonding method.The prior art (Wyant) did not disclose bonding the sheets toform a continuous two-ply seam. The prior art (Dick) discloseda pocket that is made by stitching or otherwise securing twosheets along three of its four edges to define a closed pocketwith an opening along its fourth edge.

In considering the teachings of Wyant and Dick, the Board“found that (1) each of the claimed elements is found within thescope and content of the prior art; (2) one of ordinary skill inthe art could have combined the elements as claimed by methodsknown at the time the invention was made; and (3) one ofordinary skill in the art would have recognized at the time theinvention was made that the capabilities or functions of thecombination were predictable.” Citing KSR, the Boardconcluded that “[t]he substitution of the continuous, two-plyseam of Dick for the folded seam of Wyant thus is no more thanthe simple substitution of one known element for another or themere application of a known technique to a piece of prior artready for improvement.

Example 5:

The claimed invention in In re ICON Health & Fitness, Inc.,496 F.3d 1374, 83 USPQ2d 1746 (Fed. Cir. 2007), was directedto a treadmill with a folding tread base that swivels into anupright storage position, including a gas spring connectedbetween the tread base and the upright structure to assist instably retaining the tread base in the storage position. Onreexamination, the examiner rejected the claims as obviousbased on a combination of references including an advertisement(Damark) for a folding treadmill demonstrating all of the claimelements other than the gas spring, and a patent (Teague) witha gas spring. Teague was directed to a bed that folds into acabinet using a novel dual-action spring that reverses force asthe mechanism passes a neutral position, rather than asingle-action spring that would provide a force pushing the bedclosed at all times. The dual-action spring reduced the forcerequired to open the bed from the closed position, while reducingthe force required to lift the bed from the open position.

The Federal Circuit addressed the propriety of making thecombination since Teague was in a different field than theapplication. Teague was found to be reasonably pertinent to theproblem addressed in the application because the foldingmechanism did not require any particular focus on treadmills,but rather generally addressed problems of supporting the weightof such a mechanism and providing a stable resting position.

The court also considered whether one skilled in the art wouldhave been led to combine the teachings of Damark and Teague.Appellant argued that Teague teaches away from the inventionbecause it directs one skilled in the art not to use single-action

Rev. 08.2017, January 20182100-217


springs and does not satisfy the claim limitations as thedual-action springs would render the invention inoperable. TheFederal Circuit considered these arguments and found that, whileTeague at most teaches away from using single-action springsto decrease the opening force, it actually instructed thatsingle-action springs provide the result desired by the inventors,which was to increase the opening force provided by gravity.As to inoperability, the claims were not limited to single-actionsprings and were so broad as to encompass anything that assistsin stably retaining the tread base, which is the function thatTeague accomplished. Additionally, the fact that thecounterweight mechanism from Teague used a large spring,which appellant argued would overpower the treadmillmechanism, ignores the modifications that one skilled in the artwould make to a device borrowed from the prior art. One skilledin the art would size the components from Teague appropriatelyfor the application.

ICON is another useful example for understanding the scopeof analogous art. The art applied concerned retainingmechanisms for folding beds, not treadmills. When determiningwhether a reference may properly be applied to an invention ina different field of endeavor, it is necessary to consider theproblem to be solved. It is certainly possible that a referencemay be drawn in such a way that its usefulness as a teaching isnarrowly restricted. However, in ICON, the problem to besolved was not limited to the teaching of the “treadmill” concept.The Teague reference was analogous art because “Teague andthe current application both address the need to stably retain afolding mechanism,” and because “nothing about ICON’sfolding mechanism requires any particular focus on treadmills,” Id. at 1378, 1380, 83 USPQ2d at 1749-50.

ICON is also informative as to the relationship between theproblem to be solved and existence of a reason to combine.“Indeed, while perhaps not dispositive of the issue, the findingthat Teague, by addressing a similar problem, providesanalogous art to ICON’s application goes a long way towardsdemonstrating a reason to combine the two references. BecauseICON’s broad claims read on embodiments addressing thatproblem as described by Teague, the prior art here indicates areason to incorporate its teachings.” Id. at 1380-81, 83 USPQ2dat 1751.

The Federal Circuit’s discussion in ICON also makes clear thatif the reference does not teach that a combination is undesirable,then it cannot be said to teach away. An assessment of whethera combination would render the device inoperable must not“ignore the modifications that one skilled in the art would maketo a device borrowed from the prior art.” Id. at 1382, 83USPQ2d at 1752.

Example 6:

Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 86 USPQ2d1110 (Fed. Cir. 2008), involved a stationary pest control devicefor electrocution of pests such as rats and gophers, in which thedevice is set in an area where the pest is likely to encounter it.The only difference between the claimed device and the priorart stationary pest control device was that the claimed deviceemployed a resistive electrical switch, while the prior art device

used a mechanical pressure switch. A resistive electrical switchwas taught in two prior art patents, in the contexts of a hand-heldpest control device and a cattle prod.

In determining that the claimed invention was obvious, theFederal Circuit noted that “[t]he asserted claims simply substitutea resistive electrical switch for the mechanical pressure switch”employed in the prior art device. Id. at 1344, 86 USPQ2d at1115. In this case, the prior art concerning the hand-held devicesrevealed that the function of the substituted resistive electricalswitch was well known and predictable, and that it could beused in a pest control device. According to the Federal Circuit,the references that taught the hand-held devices showed that“the use of an animal body as a resistive switch to complete acircuit for the generation of an electric charge was already wellknown in the prior art.” Id. Finally, the Federal Circuit notedthat the problem solved by using the resistive electrical switchin the prior art hand-held devices – malfunction of mechanicalswitches due to dirt and dampness – also pertained to the priorart stationary pest control device.

The Federal Circuit recognized Agrizap as “a textbook case ofwhen the asserted claims involve a combination of familiarelements according to known methods that does no more thanyield predictable results.” Id. Agrizap exemplifies a strong caseof obviousness based on simple substitution that was notovercome by the objective evidence of nonobviousness offered.It also demonstrates that analogous art is not limited to the fieldof applicant’s endeavor, in that one of the references that usedan animal body as a resistive switch to complete a circuit forthe generation of an electric charge was not in the field of pestcontrol.

Example 7:

The invention at issue in Muniauction, Inc. v. Thomson Corp.,532 F.3d 1318, 87 USPQ2d1350 (Fed. Cir. 2008), was a methodfor auctioning municipal bonds over the Internet. A municipalitycould offer a package of bond instruments of varying principalamounts and maturity dates, and an interested buyer would thensubmit a bid comprising a price and interest rate for eachmaturity date. It was also possible for the interested buyer tobid on a portion of the offering. The claimed inventionconsidered all of the noted parameters to determine the best bid.It operated on conventional Web browsers and allowedparticipants to monitor the course of the auction.

The only difference between the prior art bidding system andthe claimed invention was the use of a conventional Webbrowser. At trial, the district court had determined thatMuniauction’s claims were not obvious. Thomson argued thatthe claimed invention amounted to incorporating a Web browserinto a prior art auction system, and was therefore obvious inlight of KSR. Muniauction rebutted the argument by offeringevidence of skepticism by experts, copying, praise, andcommercial success. Although the district court found theevidence to be persuasive of nonobviousness, the Federal Circuitdisagreed. It noted that a nexus between the claimed inventionand the proffered evidence was lacking because the evidencewas not coextensive with the claims at issue. For this reason,

2100-218Rev. 08.2017, January 2018


the Federal Circuit determined that Muniauction’s evidence ofsecondary considerations was not entitled to substantial weight.

The Federal Circuit analogized this case to Leapfrog Enters.,Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 82 USPQ2d 1687(Fed. Cir. 2007). The Leapfrog case involved a determinationof obviousness based on application of modern electronics to aprior art mechanical children’s learning device. In Leapfrog,the court noted that market pressures would have prompted aperson of ordinary skill to use modern electronics in the priorart device. Similarly in Muniauction, market pressures wouldhave prompted a person of ordinary skill to use a conventionalWeb browser in a method of auctioning municipal bonds.

Example 8:

In Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293,84 USPQ2d 1197 (Fed. Cir. 2007), the claims were drawn tothe 5(S) stereoisomer of the blood pressure drug ramipril instereochemically pure form, and to compositions and methodsrequiring 5(S) ramipril. The 5(S) stereoisomer is one in whichall five stereocenters in the ramipril molecule are in the S ratherthan the R configuration. A mixture of various stereoisomersincluding 5(S) ramipril had been taught by the prior art. Thequestion before the court was whether the purified singlestereoisomer would have been obvious over the known mixtureof stereoisomers.

The record showed that the presence of multiple S stereocentersin drugs similar to ramipril was known to be associated withenhanced therapeutic efficacy. For example, when all of thestereocenters were in the S form in the related drug enalapril(SSS enalapril) as compared with only two stereocenters in theS form (SSR enalapril), the therapeutic potency was 700 timesas great. There was also evidence to indicate that conventionalmethods could be used to separate the various stereoisomers oframipril.

The district court saw the issue as a close case, because, in itsview, there was no clear motivation in the prior art to isolate5(S) ramipril. However, the Federal Circuit disagreed, and foundthat the claims would have been obvious. The Federal Circuitcautioned that requiring such a clearly stated motivation in theprior art to isolate 5(S) ramipril ran counter to the SupremeCourt’s decision in KSR, and the court stated:

Requiring an explicit teaching to purify the 5(S)stereoisomer from a mixture in which it is the activeingredient is precisely the sort of rigid application of theTSM test that was criticized in KSR.

Id. at 1301, 84 USPQ2d at 1204. The Aventis court also reliedon the settled principle that in chemical cases, structuralsimilarity can provide the necessary reason to modify prior artteachings. The Federal Circuit also addressed the kind ofteaching that would be sufficient in the absence of an explicitlystated prior art-based motivation, explaining that an expectationof similar properties in light of the prior art can be sufficient,even without an explicit teaching that the compound will havea particular utility.

In the chemical arts, the cases involving so-called “leadcompounds” form an important subgroup of the obviousnesscases that are based on substitution. The Federal Circuit has hada number of opportunities since the KSR decision to discussthe circumstances under which it would have been obvious tomodify a known compound to arrive at a claimed compound.The following cases explore the selection of a lead compound,the need to provide a reason for any proposed modification, andthe predictability of the result.

Example 9:

Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 87USPQ2d 1452 (Fed. Cir. 2008), concerns the pharmaceuticalcompound rabeprazole. Rabeprazole is a proton pump inhibitorfor treating stomach ulcers and related disorders. The FederalCircuit affirmed the district court’s summary judgment ofnonobviousness, stating that no reason had been advanced tomodify the prior art compound in a way that would destroy anadvantageous property.

Co-defendant Teva based its obviousness argument on thestructural similarity between rabeprazole and lansoprazole. Thecompounds were recognized as sharing a common core, and theFederal Circuit characterized lansoprazole as a “lead compound.”The prior art compound lansoprazole was useful for the sameindications as rabeprazole, and differed from rabeprazole onlyin that lansoprazole has a trifluoroethoxy substituent at the4-position of the pyridine ring, while rabeprazole has amethoxypropoxy substituent. The trifluoro substituent oflansoprazole was known to be a beneficial feature because itconferred lipophilicity to the compound. The ability of a personof ordinary skill to carry out the modification to introduce themethoxypropoxy substituent, and the predictability of the resultwere not addressed.

Despite the significant similarity between the structures, theFederal Circuit did not find any reason to modify the leadcompound. According to the Federal Circuit:

Obviousness based on structural similarity thus can beproved by identification of some motivation that wouldhave led one of ordinary skill in the art to select and thenmodify a known compound (i.e. a lead compound) in aparticular way to achieve the claimed compound. . . . Inkeeping with the flexible nature of the obviousnessinquiry, the requisite motivation can come from anynumber of sources and need not necessarily be explicit inthe art. Rather “it is sufficient to show that the claimedand prior art compounds possess a ‘sufficiently closerelationship . . . to create an expectation,’ in light of thetotality of the prior art, that the new compound will have‘similar properties’ to the old.” Id. at 1357, 87 USPQ2dat 1455. (citations omitted)

The prior art taught that introducing a fluorinated substituentwas known to increase lipophilicity, so a skilled artisan wouldhave expected that replacing the trifluoroethoxy substituent witha methoxypropoxy substituent would have reduced thelipophilicity of the compound. Thus, the prior art created the

Rev. 08.2017, January 20182100-219


expectation that rabeprazole would be less useful thanlansoprazole as a drug for treating stomach ulcers and relateddisorders because the proposed modification would havedestroyed an advantageous property of the prior art compound.The compound was not obvious as argued by Teva because,upon consideration of all of the facts of the case, a person ofordinary skill in the art at the time of the invention would nothave had a reason to modify lansoprazole so as to formrabeprazole.

Office personnel are cautioned that the term “lead compound”in a particular opinion can have a contextual meaning that mayvary from the way a pharmaceutical chemist might use the term.In the field of pharmaceutical chemistry, the term “leadcompound” has been defined variously as “a chemical compoundthat has pharmacological or biological activity and whosechemical structure is used as a starting point for chemicalmodifications in order to improve potency, selectivity, orpharmacokinetic parameters;” “[a] compound that exhibitspharmacological properties which suggest its development;”and “a potential drug being tested for safety and efficacy.” See,e.g., http://en.wikipedia.org/wiki/Lead_compound, accessedJanuary 13, 2010; www.combichemistry.com/glossary_k.html,a c c e s s e d J a n u a r y 1 3 , 2 0 1 0 ; a n dwww.buildingbiotechnology.com/glossary4.php, accessedJanuary 13, 2010.

The Federal Circuit in Eisai makes it clear that from theperspective of the law of obviousness, any known compoundmight possibly serve as a lead compound: “Obviousness basedon structural similarity thus can be proved by identification ofsome motivation that would have led one of ordinary skill inthe art to select and then modify a known compound (i.e. a leadcompound) in a particular way to achieve the claimedcompound.” Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455. Thus,Office personnel should recognize that a proper obviousnessrejection of a claimed compound that is useful as a drug mightbe made beginning with an inactive compound, if, for example,the reasons for modifying a prior art compound to arrive at theclaimed compound have nothing to do with pharmaceuticalactivity. The inactive compound would not be considered to bea lead compound by pharmaceutical chemists, but couldpotentially be used as such when considering obviousness. Officepersonnel might also base an obviousness rejection on a knowncompound that pharmaceutical chemists would not select as alead compound due to expense, handling issues, or other businessconsiderations. However, there must be some reason for startingwith that lead compound other than the mere fact that the “leadcompound” merely exists. See Altana Pharma AG v. TevaPharm. USA, Inc., 566 F.3d 999, 1007, 91 USPQ2d 1018, 1024(Fed. Cir. 2009) (holding that there must be some reason “toselect and modify a known compound”); Ortho-McNeil Pharm.,Inc. v. Mylan Labs, Inc., 520 F.3d 1358, 1364, 86 USPQ2d 1196,1201 (Fed. Cir. 2008).

Example 10:

The claimed chemical compound was also found to benonobvious in Procter & Gamble Co. v. Teva Pharm. USA,Inc., 566 F.3d 989, 90 USPQ2d 1947 (Fed. Cir. 2009). Thecompound at issue was risedronate – the active ingredient of

Procter & Gamble’s osteoporosis drug Actonel®. Risedronateis an example of a bisphosphonate, which is a class ofcompounds known to inhibit bone resorption.

When Procter & Gamble sued Teva for infringement, Tevadefended by arguing invalidity for obviousness over one ofProcter & Gamble’s earlier patents. The prior art patent did notteach risedronate, but instead taught thirty-six other similarcompounds including 2-pyr EHDP that were potentially usefulwith regard to osteoporosis. Teva argued obviousness on thebasis of structural similarity to 2-pyr EHDP, which is a positionalisomer of risedronate.

The district court found no reason to select 2-pyr EHDP as alead compound in light of the unpredictable nature of the art,and no reason to modify it so as to obtain risedronate. Inaddition, there were unexpected results as to potency andtoxicity. Therefore the district court found that Teva had notmade a prima facie case, and even if it had, it was rebutted byevidence of unexpected results.

The Federal Circuit affirmed the district court’s decision. TheFederal Circuit did not deem it necessary in this case to considerthe question of whether 2-pyr EHDP had been appropriatelyselected as a lead compound. Rather, the Federal Circuitreasoned that, if 2-pyr EHDP is presumed to be an appropriatelead compound, there must be both a reason to modify it so asto make risedronate and a reasonable expectation of success.Here, there was no evidence that the necessary modificationswould have been routine, so there would have been noreasonable expectation of success.

Procter & Gamble is also informative in its discussion of thetreatment of secondary considerations of non-obviousness.Although the court found that no prima facie case ofobviousness had been presented, it proceeded to analyze Procter& Gamble’s proffered evidence countering the alleged primafacie case in some detail, thus shedding light on the propertreatment of such evidence.

The Federal Circuit noted in dicta that even if a prima faciecase of obviousness had been established, sufficient evidenceof unexpected results was introduced to rebut such a showing.At trial, the witnesses consistently testified that the propertiesof risedronate were not expected, offering evidence thatresearchers did not predict either the potency or the low dose atwhich the compound was effective. Tests comparing risedronateto a compound in the prior art reference showed that risedronateoutperformed the other compound by a substantial margin, couldbe administered in a greater amount without an observable toxiceffect, and was not lethal at the same levels as the othercompound. The weight of the evidence and the credibility ofthe witnesses were sufficient to show unexpected results thatwould have rebutted an obviousness determination. Thus,nonobviousness can be shown when a claimed invention isshown to have unexpectedly superior properties when comparedto the prior art.

2100-220Rev. 08.2017, January 2018


The court then addressed the evidence of commercial successof risedronate and the evidence that risedronate met a long feltneed. The court pointed out that little weight was to be affordedto the commercial success because the competing product wasalso assigned to Procter & Gamble. However, the Federal Circuitaffirmed the district court’s conclusion that risedronate met along-felt, but unsatisfied need. The court rejected Teva’scontention that because the competing drug was available beforeActonel7, there was no unmet need that the invention satisfied.The court emphasized that whether there was a long-felt butunsatisfied need is to be evaluated based on the circumstancesas of the filing date of the challenged invention – not as of thedate that the invention is brought to market.

It should be noted that the lead compound cases do not standfor the proposition that identification of a single lead compoundis necessary in every obviousness rejection of a chemicalcompound. For example, one might envision a suggestion inthe prior art to formulate a compound having certain structurallydefined moieties, or moieties with certain properties. If a personof ordinary skill would have known how to synthesize such acompound, and the structural and/or functional result couldreasonably have been predicted, then a prima facie case ofobviousness of the claimed chemical compound might existeven without identification a particular lead compound. As asecond example, it could be possible to view a claimedcompound as consisting of two known compounds attached viaa chemical linker. The claimed compound might properly befound to have been obvious if there would have been a reasonto link the two, if one of ordinary skill would have known howto do so, and if the resulting compound would have been thepredictable result of the linkage procedure. Thus, Officepersonnel should recognize that in certain situations, it may beproper to reject a claimed chemical compound as obvious evenwithout identifying a single lead compound.

Example 11:

The decision reached by the Federal Circuit in Altana PharmaAG v. Teva Pharm. USA, Inc., 566 F.3d 999, 91 USPQ2d 1018(Fed. Cir. 2009), as discussed below, involved a motion forpreliminary injunction and did not include a final determinationof obviousness. However, the case is instructive as to the issueof selecting a lead compound.

The technology involved in Altana was the compoundpantoprazole, which is the active ingredient in Altana’s antiulcer

drug Protonix®. Pantoprazole belongs to a class of compoundsknown as proton pump inhibitors that are used to treat gastricacid disorders in the stomach.

Altana accused Teva of infringement. The district court deniedAltana’s motion for preliminary injunction for failure to establisha likelihood of success on the merits, determining that Teva haddemonstrated a substantial question of invalidity for obviousnessin light of one of Altana’s prior patents. Altana’s patentdiscussed a compound referred to as compound 12, which wasone of eighteen compounds disclosed. The claimed compoundpantoprazole was structurally similar to compound 12. Thedistrict court found that one of ordinary skill in the art would

have selected compound 12 as a lead compound formodification, and the Federal Circuit affirmed.

Obviousness of a chemical compound in view of its structuralsimilarity to a prior art compound may be shown by identifyingsome line of reasoning that would have led one of ordinary skillin the art to select and modify the prior art compound in aparticular way to produce the claimed compound. The necessaryline of reasoning can be drawn from any number of sources andneed not necessarily be explicitly found in the prior art of record.The Federal Circuit determined that ample evidence supportedthe district court’s finding that compound 12 was a naturalchoice for further development. For example, Altana’s prior artpatent claimed that its compounds, including compound 12,were improvements over the prior art; compound 12 wasdisclosed as one of the more potent of the eighteen compoundsdisclosed; the patent examiner had considered the compoundsof Altana’s prior art patent to be relevant during the prosecutionof the patent in suit; and experts had opined that one of ordinaryskill in the art would have selected the eighteen compounds topursue further investigation into their potential as proton pumpinhibitors.

In response to Altana’s argument that the prior art must pointto only a single lead compound for further development, theFederal Circuit stated that a “restrictive view of the leadcompound test would present a rigid test similar to theteaching-suggestion-motivation test that the Supreme Courtexplicitly rejected in KSR . . . . The district court in this caseemployed a flexible approach – one that was admittedlypreliminary – and found that the defendants had raised asubstantial question that one of skill in the art would have usedthe more potent compounds of [Altana’s prior art] patent,including compound 12, as a starting point from which to pursuefurther development efforts. That finding was not clearlyerroneous.” Id. at 1008, 91 USPQ2d at 1025.

C. Use of Known Technique To Improve SimilarDevices (Methods, or Products) in the Same Way


(1) a finding that the prior art contained a “base”device (method, or product) upon which the claimedinvention can be seen as an “improvement;”

(2) a finding that the prior art contained a“comparable” device (method, or product that is notthe same as the base device) that has been improvedin the same way as the claimed invention;

(3) a finding that one of ordinary skill in the artcould have applied the known “improvement”technique in the same way to the “base” device

Rev. 08.2017, January 20182100-221


(method, or product) and the results would have beenpredictable to one of ordinary skill in the art; and


The rationale to support a conclusion that the claimwould have been obvious is that a method ofenhancing a particular class of devices (methods, orproducts) has been made part of the ordinarycapabilities of one skilled in the art based upon theteaching of such improvement in other situations.One of ordinary skill in the art would have beencapable of applying this known method ofenhancement to a “base” device (method, or product)in the prior art and the results would have beenpredictable to one of ordinary skill in the art. TheSupreme Court in KSR noted that if the actualapplication of the technique would have been beyondthe skill of one of ordinary skill in the art, then usingthe technique would not have been obvious. KSR,550 U.S. at 417, 82 USPQ2d at 1396. If any of thesefindings cannot be made, then this rationale cannotbe used to support a conclusion that the claim wouldhave been obvious to one of ordinary skill in the art.

Example 1:

The claimed invention in In re Nilssen, 851 F.2d 1401, 7USPQ2d 1500 (Fed. Cir. 1988) was directed to a “means bywhich the self-oscillating inverter in a power-line-operatedinverter-type fluorescent lamp ballast is disabled in case theoutput current from the inverter exceeds some pre-establishedthreshold level for more than a very brief period.” Id. at 1402,7 USPQ2d at 1501 That is, the current output was monitored,and if the current output exceeded some threshold for a specifiedshort time, an actuation signal was sent and the inverter wasdisabled to protect it from damage.

The prior art (a USSR certificate) described a device forprotecting an inverter circuit in an undisclosed manner via acontrol means. The device indicated the high-load condition byway of the control means, but did not indicate the specificmanner of overload protection. The prior art (Kammiller)disclosed disabling the inverter in the event of a high-loadcurrent condition in order to protect the inverter circuit. That is,the overload protection was achieved by disabling the inverterby means of a cutoff switch.

The court found “it would have been obvious to one of ordinaryskill in the art to use the threshold signal produced in the USSRdevice to actuate a cutoff switch to render the inverterinoperative as taught by Kammiller.” Id. at 1403, 7 USPQ2dat 1502. That is, using the known technique of a cutoff switchfor protecting a circuit to provide the protection desired in the

inverter circuit of the USSR document would have been obviousto one of ordinary skill.

Example 2:

The fact pattern in Ruiz v. AB Chance Co., 357 F.3d 1270, 69USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2in subsection I.A.

The nature of the problem to be solved may lead inventors tolook at references relating to possible solutions to that problem. Id. at 1277, 69 USPQ2d at 1691. Therefore, it would have beenobvious to use a metal bracket (as shown in Gregory) with thescrew anchor (as shown in Fuller) to underpin unstablefoundations.

D. Applying a Known Technique to a Known Device(Method, or Product) Ready for Improvement To YieldPredictable Results


(1) a finding that the prior art contained a “base”device (method, or product) upon which the claimedinvention can be seen as an “improvement;”

(2) a finding that the prior art contained a knowntechnique that is applicable to the base device(method, or product);

(3) a finding that one of ordinary skill in the artwould have recognized that applying the knowntechnique would have yielded predictable resultsand resulted in an improved system; and


The rationale to support a conclusion that the claimwould have been obvious is that a particular knowntechnique was recognized as part of the ordinarycapabilities of one skilled in the art. One of ordinaryskill in the art would have been capable of applyingthis known technique to a known device (method,or product) that was ready for improvement and theresults would have been predictable to one ofordinary skill in the art. If any of these findingscannot be made, then this rationale cannot be usedto support a conclusion that the claim would havebeen obvious to one of ordinary skill in the art.

2100-222Rev. 08.2017, January 2018


Example 1:

The claimed invention in Dann v. Johnston, 425 U.S. 219, 189USPQ 257 (1976) was directed towards a system (i.e., computer)for automatic record keeping of bank checks and deposits. Inthis system, a customer would put a numerical category codeon each check or deposit slip. The check processing systemwould record these on the check in magnetic ink, just as it doesfor amount and account information. With this system in place,the bank can provide statements to customers that are brokendown to give subtotals for each category. The claimed systemalso allowed the bank to print reports according to a stylerequested by the customer. As characterized by the Court,“[u]nder respondent’s invention, then, a general purposecomputer is programmed to provide bank customers with anindividualized and categorized breakdown of their transactionsduring the period in question.” Id. at 222, 189 USPQ at 259.

BASE SYSTEM - The nature of the use of data processingequipment and computer software in the banking industry wasthat banks routinely did much of the record-keepingautomatically. In routine check processing, the system read anymagnetic ink characters identifying the account and routing.The system also read the amount of the check and then printedthat value in a designated area of the check. The check was thensent through a further data processing step which used themagnetic ink information to generate the appropriate recordsfor transactions and for posting to the appropriate accounts.These systems included generating periodic statements for eachaccount, such as the monthly statement sent to checking accountcustomers.

IMPROVED SYSTEM - The claimed invention supplementedthis system by recording a category code which could be usedto track expenditures by category. Again, the category code willbe a number recorded on the check (or deposit slip) which willbe read, converted into a magnetic ink imprint, and thenprocessed in the data system to include the category code. Thisenabled reporting of data by category as opposed to onlyallowing reporting by account number.

KNOWN TECHNIQUE - This is an application of a techniquefrom the prior art – the use of account numbers (generally usedto track an individual's total transactions) to solve the problemof how to track categories of expenditures to more finely accountfor a budget. That is, account numbers (identifying data capableof processing in the automatic data processing system) wereused to distinguish between different customers. Furthermore,banks have long segregated debits attributable to service chargeswithin any given separate account and have rendered theircustomers subtotals for those charges. Previously, one wouldhave needed to set up separate accounts for each category andthus receive separate reports. Supplementing the accountinformation with additional digits (the category codes) solvedthe problem by effectively creating a single account that can betreated as distinct accounts for tracking and reporting services.That is, the category code merely allowed what might previouslyhave been separate accounts to be handled as a single account,but with a number of sub-accounts indicated in the report.

The basic technique of putting indicia on data to enable standardsorting, searching, and reporting yielded no more than thepredictable outcome which one of ordinary skill would haveexpected to achieve with this common tool of the trade and wastherefore an obvious expedient. The Court held that “[t]he gapbetween the prior art and respondent’s system is simply not sogreat as to render the system nonobvious to one reasonablyskilled in the art.” Id. at 230, 189 USPQ at 261.

Example 2:

The fact pattern in In re Nilssen, 851 F.2d 1401, 7 USPQ2d1500 (Fed. Cir. 1988) is set forth above in Example 1 insubsection C.

The court found “it would have been obvious to one of ordinaryskill in the art to use the threshold signal produced in the USSRdevice to actuate a cutoff switch to render the inverterinoperative as taught by Kammiller.” Id. at 1403, 7 USPQ2dat 1502. The known technique of using a cutoff switch wouldhave predictably resulted in protecting the inverter circuit.Therefore, it would have been within the skill of the ordinaryartisan to use a cutoff switch in response to the actuation signalto protect the inverter.

Example 3:

The claimed invention in In re Urbanski, 809 F.3d 1237, 1244,117 USPQ2d 1499, 1504 (Fed. Cir. 2016) was directed to amethod of enzymatic hydrolysis of soy fiber to reduce waterholding capacity, requiring reacting the soy fiber and enzymein water for about 60-120 minutes. The claims were rejectedover two references, wherein the primary reference, Gross,taught using a reaction time of 5 to 72 hours and the secondaryreference, Wong, taught using a reaction time of 100 to 240minutes, preferably 120 minutes. The applicant argued thatmodifying the primary reference in the manner suggested bythe secondary reference would forego the benefits taught by theprimary reference, thereby teaching away from the combination.The court found there was sufficient motivation to combinebecause both references recognized reaction time and degree ofhydrolysis as result-effective variables, which can be varied tohave a predictable effect on the final product; and the primaryreference does not contain an express teaching away from theproposed modification. “Substantial evidence thus supports theBoard’s finding that a person of ordinary skill would have beenmotivated to modify the Gross process by using a shorterreaction time, in order to obtain the favorable propertiesdisclosed in Wong.”

E. “Obvious To Try” – Choosing From a FiniteNumber of Identified, Predictable Solutions, With aReasonable Expectation of Success


Rev. 08.2017, January 20182100-223


(1) a finding that at the time of the invention,there had been a recognized problem or need in theart, which may include a design need or marketpressure to solve a problem;

(2) a finding that there had been a finite numberof identified, predictable potential solutions to therecognized need or problem;

(3) a finding that one of ordinary skill in the artcould have pursued the known potential solutionswith a reasonable expectation of success; and


The rationale to support a conclusion that the claimwould have been obvious is that “a person ofordinary skill has good reason to pursue the knownoptions within his or her technical grasp. If this leadsto the anticipated success, it is likely that product[was] not of innovation but of ordinary skill andcommon sense. In that instance the fact that acombination was obvious to try might show that itwas obvious under § 103.” KSR, 550 U.S. at 421,82 USPQ2d at 1397. If any of these findings cannotbe made, then this rationale cannot be used tosupport a conclusion that the claim would have beenobvious to one of ordinary skill in the art.

The question of whether a claimed invention can beshown to be obvious based on an “obvious to try”line of reasoning has been explored extensively bythe Federal Circuit in several cases since the KSRdecision. The case law in this area is developingquickly in the chemical arts, although the rationalehas been applied in other art areas as well.

Some commentators on the KSR decision haveexpressed a concern that because inventive activitiesare always carried out in the context of what hascome before and not in a vacuum, few inventionswill survive scrutiny under an obvious to trystandard. The cases decided since KSR have provedthis fear to have been unfounded. Courts appear tobe applying the KSR requirement for “a finitenumber of identified predictable solutions” in amanner that places particular emphasis onpredictability and the reasonable expectations ofthose of ordinary skill in the art.

The Federal Circuit pointed out the challengingnature of the task faced by the courts – and likewiseby Office personnel – when considering the viabilityof an obvious to try argument: “The evaluation ofthe choices made by a skilled scientist, when suchchoices lead to the desired result, is a challenge tojudicial understanding of how technical advance isachieved in the particular field of science ortechnology.” Abbott Labs. v. Sandoz, Inc., 544 F.3d1341, 1352, 89 USPQ2d 1161, 1171 (Fed. Cir.2008). The Federal Circuit cautioned that anobviousness inquiry based on an obvious to tryrationale must always be undertaken in the contextof the subject matter in question, “including thecharacteristics of the science or technology, its stateof advance, the nature of the known choices, thespecificity or generality of the prior art, and thepredictability of results in the area of interest.” Id.

Example 1:

The claimed invention in Pfizer, Inc. v. Apotex, Inc., 480 F.3d1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to theamlodipine besylate drug product, which was sold in tablet form

in the United States under the trademark Norvasc®. Amlodipineand the use of besylate anions were both known at the time ofthe invention. Amlodipine was known to have the sametherapeutic properties as were being claimed for the amlodipinebesylate, but Pfizer discovered that the besylate form had bettermanufacturing properties (e.g., reduced “stickiness”).

Pfizer argued that the results of forming amlodipine besylatewould have been unpredictable and therefore nonobvious. Thecourt rejected the notion that unpredictability could be equatedwith nonobviousness here, because there were only a finitenumber (53) of pharmaceutically acceptable salts to be testedfor improved properties.

The court found that one of ordinary skill in the art havingproblems with the machinability of amlodipine would havelooked to forming a salt of the compound and would have beenable to narrow the group of potential salt-formers to a group of53 anions known to form pharmaceutically acceptable salts,which would be an acceptable number to form “a reasonableexpectation of success.”

Example 2:

The claimed invention in Alza Corp. v. Mylan Labs., Inc., 464F.3d 1286, 80 USPQ2d 1001 (Fed. Cir. 2006) was drawn tosustained-release formulations of the drug oxybutynin in whichthe drug is released at a specified rate over a 24-hour period.Oxybutynin was known to be highly water-soluble, and thespecification had pointed out that development ofsustained-release formulations of such drugs presented particularproblems.

2100-224Rev. 08.2017, January 2018


A prior art patent to Morella had taught sustained-releasecompositions of highly water-soluble drugs, as exemplified bya sustained-release formulation of morphine. Morella had alsoidentified oxybutynin as belonging to the class of highlywater-soluble drugs. The Baichwal prior art patent had taughta sustained-release formulation of oxybutynin that had a differentrelease rate than the claimed invention. Finally, the Wong priorart patent had taught a generally applicable method for deliveryof drugs over a 24-hour period. Although Wong mentionedapplicability of the disclosed method to several categories ofdrugs to which oxybutynin belonged, Wong did not specificallymention its applicability to oxybutynin.

The court found that because the absorption properties ofoxybutynin would have been reasonably predictable at the timeof the invention, there would have been a reasonable expectationof successful development of a sustained-release formulationof oxybutynin as claimed. The prior art, as evidenced by thespecification, had recognized the obstacles to be overcome indevelopment of sustained-release formulations of highlywater-soluble drugs, and had suggested a finite number of waysto overcome these obstacles. The claims were obvious becauseit would have been obvious to try the known methods forformulating sustained-release compositions, with a reasonableexpectation of success. The court was not swayed by argumentsof a lack of absolute predictability.

Example 3:

The Federal Circuit’s decision in In re Kubin, 561 F.3d 1351,90 USPQ2d 1417 (Fed. Cir. 2009), affirmed the Office’sdetermination in Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat.App. & Int. 2007) that the claims in question, directed to anisolated nucleic acid molecule, would have been obvious overthe prior art applied. The claim stated that the nucleic acidencoded a particular polypeptide. The encoded polypeptide wasidentified in the claim by its partially specified sequence, andby its ability to bind to a specified protein.

A prior art patent to Valiante taught the polypeptide encodedby the claimed nucleic acid, but did not disclose either thesequence of the polypeptide, or the claimed isolated nucleic acidmolecule. However, Valiante did disclose that by employingconventional methods such as those disclosed by a prior artlaboratory manual by Sambrook, the sequence of the polypeptidecould be determined, and the nucleic acid molecule could beisolated. In view of Valiante’s disclosure of the polypeptide,and of routine prior art methods for sequencing the polypeptideand isolating the nucleic acid molecule, the Board found that aperson of ordinary skill in the art would have had a reasonableexpectation that a nucleic acid molecule within the claimedscope could have been successfully obtained.

Relying on In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed.Cir. 1995), appellant argued that it was improper for the Officeto use the polypeptide of the Valiante patent together with themethods described in Sambrook to reject a claim drawn to aspecific nucleic acid molecule without providing a referenceshowing or suggesting a structurally similar nucleic acidmolecule. Citing KSR, the Board stated that “when there ismotivation to solve a problem and there are a finite number of

identified, predictable solutions, a person of ordinary skill hasgood reason to pursue the known options within his or hertechnical grasp. If this leads to anticipated success, it is likelythe product not of innovation but of ordinary skill and commonsense.” The Board noted that the problem facing those in theart was to isolate a specific nucleic acid, and there were a limitednumber of methods available to do so. The Board concludedthat the skilled artisan would have had reason to try thesemethods with the reasonable expectation that at least one wouldbe successful. Thus, isolating the specific nucleic acid moleculeclaimed was “the product not of innovation but of ordinary skilland common sense.”

The Board’s reasoning was substantially adopted by the FederalCircuit. However, it is important to note that in the Kubindecision, the Federal Circuit held that “the Supreme Court in KSR unambiguously discredited” the Federal Circuit’s decisionin Deuel, insofar as it “implies the obviousness inquiry cannotconsider that the combination of the claim’s constituent elementswas ‘obvious to try.’” Kubin, 561 F.3d at 1358, 90 USPQ2d at1422. Instead, Kubin stated that KSR “resurrects” the FederalCircuit’s own wisdom in O’Farrell, in which “to differentiatebetween proper and improper applications of ‘obvious to try,’”the Federal Circuit “outlined two classes of situations where‘obvious to try’ is erroneously equated with obviousness under§ 103.” Kubin, 561 F.3d at 1359, 90 USPQ2d at 1423. Thesetwo classes of situations are: (1) when what would have been“obvious to try” would have been to vary all parameters or tryeach of numerous possible choices until one possibly arrived ata successful result, where the prior art gave either no indicationof which parameters were critical or no direction as to which ofmany possible choices is likely to be successful; and (2) whenwhat was “obvious to try” was to explore a new technology orgeneral approach that seemed to be a promising field ofexperimentation, where the prior art gave only general guidanceas to the particular form of the claimed invention or how toachieve it. Id. (citing In re O’Farrell, 853 F.2d 894, 903, 7USPQ2d 1673, 1681 (Fed. Cir.)).

Example 4:

Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d1350, 83 USPQ2d 1169 (Fed. Cir. 2007), is an example of achemical case in which the Federal Circuit found that theclaimed invention was not obvious. The claimed compound waspioglitazone, a member of a class of drugs known asthiazolidinediones (TZDs) marketed by Takeda as a treatmentfor Type 2 diabetes. The Takeda case brings together theconcept of a “lead compound” and the obvious-to-try argument.

Alphapharm had filed an Abbreviated New Drug Applicationwith the Food and Drug Administration, which was a technicalact of infringement of Takeda’s patent. When Takeda broughtsuit, Alphapharm’s defense was that Takeda’s patent was invaliddue to obviousness. Alphapharm argued that a two-stepmodification – involving homologation and ring-walking – ofa known compound identified as “compound b” would haveproduced pioglitazone, and that it was therefore obvious.

The district court found that there would have been no reasonto select compound b as a lead compound. There were a large

Rev. 08.2017, January 20182100-225


number of similar prior art TZD compounds; fifty-four werespecifically identified in Takeda’s prior patent, and the districtcourt observed that “hundreds of millions” were more generallydisclosed. Although the parties agreed that compound brepresented the closest prior art, one reference taught certaindisadvantageous properties associated with compound b, whichaccording to the district court would have taught the skilledartisan not to select that compound as a lead compound. Thedistrict court found no prima facie case of obviousness, andstated that even if a prima facie case had been established, itwould have been overcome in this case in view of the unexpectedlack of toxicity of pioglitazone.

The Federal Circuit affirmed the decision of the district court,citing the need for a reason to modify a prior art compound. TheFederal Circuit quoted KSR, stating:

The KSR Court recognized that “[w]hen there is a designneed or market pressure to solve a problem and there area finite number of identified, predictable solutions, aperson of ordinary skill has good reason to pursue theknown options within his or her technical grasp.” KSR,550 U.S. at 421, 82 USPQ2d at 1397. In suchcircumstances, “the fact that a combination was obviousto try might show that it was obvious under § 103.” Id.That is not the case here. Rather than identify predictablesolutions for antidiabetic treatment, the prior art discloseda broad selection of compounds any one of which couldhave been selected as a lead compound for furtherinvestigation. Significantly, the closest prior art compound(compound b, the 6-methyl) exhibited negative propertiesthat would have directed one of ordinary skill in the artaway from that compound. Thus, this case fails to presentthe type of situation contemplated by the Court when itstated that an invention may be deemed obvious if it was“obvious to try.” The evidence showed that it was notobvious to try.

Takeda, 492 F.3d at 1359, 83 USPQ2d at 1176.

Accordingly, Office personnel should recognize that the obviousto try rationale does not apply when the appropriate factualfindings cannot be made. In Takeda, there was a recognizedneed for treatment of diabetes. However, there was no finitenumber of identified, predictable solutions to the recognizedneed, and no reasonable expectation of success. There werenumerous known TZD compounds, and although one clearlyrepresented the closest prior art, its known disadvantagesrendered it unsuitable as a starting point for further research,and taught the skilled artisan away from its use. Furthermore,even if there had been reason to select compound b, there hadbeen no reasonable expectation of success associated with theparticular modifications necessary to transform compound binto the claimed compound pioglitazone. Thus, an obviousnessrejection based on an obvious to try rationale was not appropriatein this situation.

Example 5:

The case of Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc.,520 F.3d 1358, 86 USPQ2d 1196 (Fed. Cir. 2008), providesanother example in which a chemical compound was determinednot to be obvious. The claimed subject matter was topiramate,which is used as an anti-convulsant.

In the course of working toward a new anti-diabetic drug,Ortho-McNeil’s scientist had unexpectedly discovered that areaction intermediate had anti-convulsant properties. Mylan’sdefense of invalidity due to obviousness rested on an obviousto try argument. However, Mylan did not explain why it wouldhave been obvious to begin with an anti-diabetic drug precursor,especially the specific one that led to topiramate, if one had beenseeking an anti-convulsant drug. The district court ruled onsummary judgment that Ortho-McNeil’s patent was not invalidfor obviousness.

The Federal Circuit affirmed. The Federal Circuit pointed outthat there was no apparent reason a person of ordinary skillwould have chosen the particular starting compound or theparticular synthetic pathway that led to topiramate as anintermediate. Furthermore, there would have been no reason totest that intermediate for anticonvulsant properties if treatingdiabetes had been the goal. The Federal Circuit recognized anelement of serendipity in this case, which runs counter to therequirement for predictability. Summarizing their conclusionwith regard to Mylan’s obvious to try argument, the FederalCircuit stated:

[T]his invention, contrary to Mylan’s characterization,does not present a finite (and small in the context of theart) number of options easily traversed to showobviousness. . . . KSR posits a situation with a finite, andin the context of the art, small or easily traversed, numberof options that would convince an ordinarily skilled artisanof obviousness. . . . [T]his clearly is not the easilytraversed, small and finite number of alternatives that KSR suggested might support an inference ofobviousness. Id. at 1364, 86 USPQ2d at 1201.

Thus, Ortho-McNeil helps to clarify the Supreme Court’srequirement in KSR for “a finite number” of predictablesolutions when an obvious to try rationale is applied: under theFederal Circuit’s case law “finite” means “small or easilytraversed” in the context of the art in question. As taught in Abbott, discussed above, it is essential that the inquiry be placedin the context of the subject matter at issue, and each case mustbe decided on its own facts.

Example 6:

In Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d1341, 91 USPQ2d 1569 (Fed. Cir. 2009), the claimed inventionwas an oral contraceptive containing micronized drospirenone

marketed as Yasmin®. The prior art compound drospirenonewas known to be a poorly water-soluble, acid-sensitivecompound with contraceptive effects. It was also known in the

2100-226Rev. 08.2017, January 2018


art that micronization improves the solubility of poorly watersoluble drugs.

Based on the known acid sensitivity, Bayer had studied howeffectively an enteric-coated drospirenone tablet delivered aformulation as compared to an intravenous injection of the sameformulation to measure the “absolute bioavailability” of thedrug. Bayer added an unprotected (normal) drospirenone tabletand compared its bioavailability to that of the enteric-coatedformulation and the intravenous delivery. Bayer expected tofind that the enteric-coated tablet would produce a lowerbioavailability than an intravenous injection, while the normalpill would produce an even lower bioavailability than theenteric-coated tablet. However, they found that despiteobservations that drospirenone would quickly isomerize in ahighly acidic environment (supporting the belief that an entericcoating would be necessary to preserve bioavailability), thenormal pill and the enteric-coated pill resulted in the samebioavailability. Following this study, Bayer developedmicronized drospirenone in a normal pill, the basis for thedisputed patent.

The district court found that a person having ordinary skill inthe art would have considered the prior art result that astructurally related compound, spirorenone, thoughacid-sensitive, would nevertheless absorb in vivo, would havesuggested the same result for drospirenone. It also found thatwhile another reference taught that drospirenone isomerizes invitro when exposed to acid simulating the human stomach, aperson of ordinary skill would have been aware of the study’sshortcomings, and would have verified the findings as suggestedby a treatise on the science of dosage form design, which wouldhave then showed that no enteric coating was necessary.

The Federal Circuit held that the patent was invalid because theclaimed formulation was obvious. The Federal Circuit reasonedthat the prior art would have funneled the formulator towardtwo options. Thus, the formulator would not have been requiredto try all possibilities in a field unreduced by the prior art. Theprior art was not vague in pointing toward a general approachor area of exploration, but rather guided the formulator preciselyto the use of either a normal pill or an enteric-coated pill.

It is important for Office personnel to recognize that the mereexistence of a large number of options does not in and of itselflead to a conclusion of nonobviousness. Where the prior artteachings lead one of ordinary skill in the art to a narrower setof options, then that reduced set is the appropriate one toconsider when determining obviousness using an obvious to tryrationale.

Example 7:

The case of Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075,89 USPQ2d 1370 (Fed. Cir. 2008), also sheds light on theobvious to try line of reasoning. The claimed compound wasclopidogrel, which is the dextrorotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate.Clopidogrel is an anti-thrombotic compound used to treat orprevent heart attack or stroke. The racemate, or mixture of

dextrorotatory and levorotatory (D- and L-) isomers of thecompound, was known in the prior art. The two forms had notpreviously been separated, and although the mixture was knownto have anti-thrombotic properties, the extent to which each ofthe individual isomers contributed to the observed properties ofthe racemate was not known and was not predictable.

The district court assumed that in the absence of any additionalinformation, the D-isomer would have been prima facie obviousover the known racemate. However, in view of the evidence ofunpredicted therapeutic advantages of the D-isomer presentedin the case, the district court found that any prima facie caseof obviousness had been overcome. At trial, the experts for bothparties testified that persons of ordinary skill in the art couldnot have predicted the degree to which the isomers would haveexhibited different levels of therapeutic activity and toxicity.Both parties’ experts also agreed that the isomer with greatertherapeutic activity would most likely have had greater toxicity.Sanofi witnesses testified that Sanofi’s own researchers hadbelieved that the separation of the isomers was unlikely to havebeen productive, and experts for both parties agreed that it wasdifficult to separate isomers at the time of the invention.Nevertheless, when Sanofi ultimately undertook the task ofseparating the isomers, it found that they had the “rarecharacteristic of ‘absolute stereoselectivity,’” whereby theD-isomer provided all of the favorable therapeutic activity butno significant toxicity, while the L-isomer produced notherapeutic activity but virtually all of the toxicity. Based onthis record, the district court concluded that Apotex had not metits burden of proving by clear and convincing evidence thatSanofi’s patent was invalid for obviousness. The Federal Circuitaffirmed the district court’s conclusion.

Office personnel should recognize that even when only a smallnumber of possible choices exist, the obvious to try line ofreasoning is not appropriate when, upon consideration of all ofthe evidence, the outcome would not have been reasonablypredictable and the inventor would not have had a reasonableexpectation of success. In Bayer, there were art-based reasonsto expect that both the normal pill and the enteric-coated pillwould be therapeutically suitable, even though not all prior artstudies were in complete agreement. Thus, the result obtainedwas not unexpected. In Sanofi, on the other hand, there wasstrong evidence that persons of ordinary skill in the art, prior tothe separation of the isomers, would have had no reason toexpect that the D-isomer would have such strong therapeuticadvantages as compared with the L-isomer. In other words, theresult in Sanofi was unexpected.

Example 8:

In Rolls-Royce, PLC v. United Tech. Corp., 603 F.3d 1325, 95USPQ2d 1097 (Fed. Cir. 2010), the Federal Circuit addressedthe obvious to try rationale in the context of a fan blade for jetengines. The case had arisen out of an interference proceeding.Finding that the district court had correctly determined that therewas no interference-in-fact because Rolls-Royce’s claims wouldnot have been obvious in light of United’s application, theFederal Circuit affirmed.

Rev. 08.2017, January 20182100-227


The Federal Circuit described the fan blade of the count asfollows:

Each fan blade has three regions – an inner, anintermediate, and an outer region. The area closest to theaxis of rotation at the hub is the inner region. The areafarthest from the center of the engine and closest to thecasing surrounding the engine is the outer region. Theintermediate region falls in between. The count defines afan blade with a swept-forward inner region, aswept-rearward intermediate region, and forward-leaningouter region.

Id. at 1328, 95 USPQ2d at 1099.

United had argued that it would have been obvious for a personof ordinary skill in the art to try a fan blade design in which thesweep angle in the outer region was reversed as compared withprior art fan blades from rearward to forward sweep, in orderto reduce endwall shock. The Federal Circuit disagreed withUnited’s assessment that the claimed fan blade would have beenobvious based on an obvious to try rationale. The Federal Circuitpointed out that in a proper obvious to try approach toobviousness, the possible options for solving a problem musthave been “known and finite.” Id. at 1339, 95 USPQ2d at 1107(citing Abbott, 544 F.3d at 1351, 89 USPQ2d at 1171). In thiscase, nothing in the prior art would have suggested that changingthe sweep angle as Rolls-Royce had done would have addressedthe issue of endwall shock. Thus, the Federal Circuit concludedthat changing the sweep angle “would not have presented itselfas an option at all, let alone an option that would have beenobvious to try.” Id. The decision in Rolls-Royce is a reminderto Office personnel that the obvious to try rationale can properlybe used to support a conclusion of obviousness only when theclaimed solution would have been selected from a finite numberof potential solutions known to persons of ordinary skill in theart.

Example 9:

The case of Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009),provides an example in which the Federal Circuit held that aclaimed method for managing bulk email distribution wasobvious on the basis of an obvious to try argument. In PerfectWeb, the method required selecting the intended recipients,transmitting the emails, determining how many of the emailshad been successfully received, and repeating the first threesteps if a pre-determined minimum number of intendedrecipients had not received the email.

The Federal Circuit affirmed the district court’s determinationon summary judgment that the claimed invention would havebeen obvious. Failure to meet a desired quota of email recipientswas a recognized problem in the field of email marketing. Theprior art had also recognized three potential solutions: increasingthe size of the initial recipient list; resending emails to recipientswho did not receive them on the first attempt; and selecting anew recipient list and sending emails to them. The last optioncorresponded to the fourth step of the invention as claimed.

The Federal Circuit noted that based on “simple logic,” selectinga new list of recipients was more likely to result in the desiredoutcome than resending to those who had not received the emailon the first attempt. There had been no evidence of anyunexpected result associated with selecting a new recipient list,and no evidence that the method would not have had areasonable likelihood of success. Thus, the Federal Circuitconcluded that, as required by KSR, there were a “finite numberof identified, predictable solutions,” and that the obvious to tryinquiry properly led to the legal conclusion of obviousness.

The Federal Circuit in Perfect Web also discussed the role ofcommon sense in the determination of obviousness. The districtcourt had cited KSR for the proposition that “[a] person ofordinary skill is also a person of ordinary creativity, not anautomaton,” and found that “the final step [of the claimedinvention] is merely the logical result of common senseapplication of the maxim ‘try, try again.’” In affirming thedistrict court, the Federal Circuit undertook an extendeddiscussion of common sense as it has been applied to theobviousness inquiry, both before and since the KSR decision.

The Federal Circuit pointed out that application of commonsense is not really an innovation in the law of obviousness whenit stated, “Common sense has long been recognized to informthe analysis of obviousness if explained with sufficientreasoning.” Perfect Web, 587 F.3d at 1328, 92 USPQ2d at 1853(emphasis added). The Federal Circuit then provided a reviewof a number of precedential cases that inform the understandingof common sense, including In re Bozek, 416 F.2d 1385, 1390,163 USPQ 545, 549 (CCPA 1969) (explaining that a patentexaminer may rely on “common knowledge and common senseof the person of ordinary skill in the art without any specifichint or suggestion in a particular reference”) and In re Zurko,258 F.3d 1379, 1383, 1385, 59 USPQ2d 1693 at 1695, 1697(Fed. Cir. 2001) (clarifying that a factual foundation is neededin order for an examiner to invoke “good common sense” in acase in which “basic knowledge and common sense was notbased on any evidence in the record”). The Federal Circuitimplicitly acknowledged in Perfect Web that the kind of strictevidence-based teaching, suggestion, or motivation required in In re Lee, 277 F.3d 1338, 1344, 61 USPQ2d 1430, 1434 (Fed.Cir. 2002), is not an absolute requirement for an obviousnessrejection in light of the teachings of KSR. The Federal Circuitexplained that “[a]t the time [of the Lee decision], we requiredthe PTO to identify record evidence of a teaching, suggestion,or motivation to combine references.” However, Perfect Webwent on to state that even under Lee, common sense couldproperly be applied when analyzing evidence relevant toobviousness. Citing DyStar Textilfarben GmbH v. C.H. PatrickCo., 464 F.3d 1356, 80 USPQ2d 1641 (Fed. Cir. 2006), and Inre Kahn, 441 F.3d 977, 78 USPQ2d 1329 (Fed. Cir. 2006), twocases decided shortly before the Supreme Court’s decision in KSR, the Federal Circuit noted that although “a reasonedexplanation that avoids conclusory generalizations” is requiredto use common sense, identification of a “specific hint orsuggestion in a particular reference” is not. See also Arendi v.Apple, 832 F.3d 1355, 119 USPQ2d 1822 (Fed. Cir. 2016)(finding that the Board had not provided a reasoned analysis,supported by the evidence of record, for why “common sense”taught the missing process step).

2100-228Rev. 08.2017, January 2018


F. Known Work in One Field of Endeavor May PromptVariations of It for Use in Either the Same Field or aDifferent One Based on Design Incentives or OtherMarket Forces if the Variations Are Predictable to Oneof Ordinary Skill in the Art


(1) a finding that the scope and content of theprior art, whether in the same field of endeavor asthat of the applicant’s invention or a different fieldof endeavor, included a similar or analogous device(method, or product);

(2) a finding that there were design incentivesor market forces which would have promptedadaptation of the known device (method, or product);

(3) a finding that the differences between theclaimed invention and the prior art wereencompassed in known variations or in a principleknown in the prior art;

(4) a finding that one of ordinary skill in the art,in view of the identified design incentives or othermarket forces, could have implemented the claimedvariation of the prior art, and the claimed variationwould have been predictable to one of ordinary skillin the art; and


The rationale to support a conclusion that theclaimed invention would have been obvious is thatdesign incentives or other market forces could haveprompted one of ordinary skill in the art to vary theprior art in a predictable manner to result in theclaimed invention. If any of these findings cannotbe made, then this rationale cannot be used tosupport a conclusion that the claim would have beenobvious to one of ordinary skill in the art.

Example 1:

The fact pattern in Dann v. Johnston, 425 U.S. 219, 189 USPQ257 (1976) is set forth above in Example 1 in subsection D.

The Court found that the problem addressed by applicant – theneed to give more detailed breakdown by a category of

transactions – was closely analogous to the task of keeping trackof the transaction files of individual business units. Id. at 229,189 USPQ at 261. Thus, an artisan in the data processing areawould have recognized the similar class of problem and theknown solutions of the prior art and it would have been wellwithin the ordinary skill level to implement the system in thedifferent environment. The Court held that “[t]he gap betweenthe prior art and respondent’s system is simply not so great asto render the system nonobvious to one reasonably skilled inthe art.” Id. at 230, 189 USPQ at 261.

Example 2:

The claimed invention in Leapfrog Enterprises, Inc. v.Fisher-Price, Inc., 485 F.3d 1157, 82 USPQ2d 1687 (Fed. Cir.2007) was directed to a learning device to help young childrenread phonetically. The claim read as follows:

An interactive learning device, comprising:

a housing including a plurality of switches;

a sound production device in communication with the switchesand including a processor and a memory;

at least one depiction of a sequence of letters, each letter beingassociable with a switch; and

a reader configured to communicate the identity of the depictionto the processor,

wherein selection of a depicted letter activates an associatedswitch to communicate with the processor, causing the soundproduction device to generate a signal corresponding to a soundassociated with the selected letter, the sound being determinedby a position of the letter in the sequence of letter.

The court concluded that the claimed invention would have beenobvious in view of the combination of two pieces of prior art,(1) Bevan (which showed an electro-mechanical toy for phoneticlearning), (2) the Super Speak & Read device (SSR) (anelectronic reading toy), and the knowledge of one of ordinaryskill in the art.

The court made clear that there was no technological advancebeyond the skill shown in the SSR device. The court stated that“one of ordinary skill in the art of children’s learning toys wouldhave found it obvious to combine the Bevan device with theSSR to update it using modern electronic components in orderto gain the commonly understood benefits of such adaptation,such as decreased size, increased reliability, simplified operation,and reduced cost. While the SSR only permits generation of asound corresponding to the first letter of a word, it does so usingelectronic means. The combination is thus the adaptation of anold idea or invention (Bevan) using newer technology that iscommonly available and understood in the art (the SSR).”

The court found that the claimed invention was but a variationon already known children’s toys. This variation presented no

Rev. 08.2017, January 20182100-229


nonobvious advance over other toys. The court made clear thatthere was no technological advance beyond the skill shown inthe SSR device. The court found that “[a]ccomodating a priorart mechanical device that accomplishes that goal to modernelectronics would have been reasonably obvious to one ofordinary skill in designing children’s learning devices. Applyingmodern electronics to older mechanical devices has beencommonplace in recent years.”

Example 3:

The claimed invention in KSR Int'l Co. v. Teleflex Inc., 550U.S. 398, 82 USPQ2d 1385 (2007), was an adjustable pedalassembly with a fixed pivot point and an electronicpedal-position sensor attached to the assembly support. Thefixed pivot point meant that the pivot was not changed as thepedal was adjusted. The placement of the sensor on the assemblysupport kept the sensor fixed while the pedal was adjusted.

Conventional gas pedals operated by a mechanical link whichadjusted the throttle based on the travel of the pedal from a setposition. The throttle controlled the combustion process and theavailable power generated by the engine. Newer cars usedcomputer controlled throttles in which a sensor detected themotion of the pedal and sent signals to the engine to adjust thethrottle accordingly. At the time of the invention, themarketplace provided a strong incentive to convert mechanicalpedals to electronic pedals, and the prior art taught a number ofmethods for doing so. The prior art (Asano) taught an adjustablepedal with a fixed pivot point with mechanical throttle control.The prior art (‘936 patent to Byler) taught an electronic pedalsensor which was placed on a pivot point in the pedal assemblyand that it was preferable to detect the pedal’s position in thepedal mechanism rather than in the engine. The prior art (Smith)taught that to prevent the wires connecting the sensor to thecomputer from chafing and wearing out, the sensor should beput on a fixed part of the pedal assembly rather than in or onthe pedal’s footpad. The prior art (Rixon) taught an adjustablepedal assembly (sensor in the footpad) with an electronic sensorfor throttle control. There was no prior art electronic throttlecontrol that was combined with a pedal assembly which keptthe pivot point fixed when adjusting the pedal.

The Court stated that “[t]he proper question to have asked waswhether a pedal designer of ordinary skill, facing the wide rangeof needs created by developments in the field of endeavor, wouldhave seen a benefit to upgrading Asano with a sensor.” Id. at424, 82 USPQ2d at 1399. The Court found that technologicaldevelopments in the automotive design would have prompteda designer to upgrade Asano with an electronic sensor. The nextquestion was where to attach the sensor. Based on the prior art,a designer would have known to place the sensor on anonmoving part of the pedal structure and the most obviousnonmoving point on the structure from which a sensor can easilydetect the pedal’s position was a pivot point. The Courtconcluded that it would have been obvious to upgrade Asano’sfixed pivot point adjustable pedal by replacing the mechanicalassembly for throttle control with an electronic throttle controland to mount the electronic sensor on the pedal support structure.

Example 4:

The claimed invention in Ex parte Catan, 83 USPQ2d 1568(Bd. Pat. App. & Int. 2007), was a consumer electronics deviceusing bioauthentication to authorize sub-users of an authorizedcredit account to place orders over a communication networkup to a pre-set maximum sub-credit limit.

The prior art (Nakano) disclosed a consumer electronics devicelike the claimed invention, except that security was providedby a password authentication device rather than abioauthentication device. The prior art (Harada) disclosed thatthe use of a bioauthentication device (fingerprint sensor) on aconsumer electronics device (remote control) to providebioauthentication information (fingerprint) was known in theprior art at the time of the invention. The prior art (Dethloff)also disclosed that it was known in the art at the time of theinvention to substitute bioauthentication for PIN authenticationto enable a user to access credit via a consumer electronicsdevice.

The Board found that the prior art “shows that one of ordinaryskill in the consumer electronic device art at the time of theinvention would have been familiar with using bioauthenticationinformation interchangeably with or in lieu of PINs toauthenticate users.” The Board concluded that one of ordinaryskill in the art of consumer electronic devices would have foundit obvious to update the prior art password device with themodern bioauthentication component and thereby gain,predictably, the commonly understood benefits of suchadaptation, that is, a secure and reliable authentication procedure.

G. Some Teaching, Suggestion, or Motivation in thePrior Art That Would Have Led One of Ordinary SkillTo Modify the Prior Art Reference or To Combine PriorArt Reference Teachings To Arrive at the ClaimedInvention


(1) a finding that there was some teaching,suggestion, or motivation, either in the referencesthemselves or in the knowledge generally availableto one of ordinary skill in the art, to modify thereference or to combine reference teachings;

(2) a finding that there was reasonableexpectation of success; and


2100-230Rev. 08.2017, January 2018


The rationale to support a conclusion that the claimwould have been obvious is that "a person ofordinary skill in the art would have been motivatedto combine the prior art to achieve the claimedinvention and whether there would have been areasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KGv. C.H. Patrick Co., 464 F.3d 1356, 1360, 80USPQ2d 1641, 1645 (Fed. Cir. 2006). If any of thesefindings cannot be made, then this rationale cannotbe used to support a conclusion that the claim wouldhave been obvious to one of ordinary skill in the art.

The courts have made clear that the teaching,suggestion, or motivation test is flexible and anexplicit suggestion to combine the prior art is notnecessary. The motivation to combine may beimplicit and may be found in the knowledge of oneof ordinary skill in the art, or, in some cases, fromthe nature of the problem to be solved. Id. at 1366,80 USPQ2d at 1649. “[A]n implicit motivation tocombine exists not only when a suggestion may begleaned from the prior art as a whole, but when the‘improvement’ is technology-independent and thecombination of references results in a product orprocess that is more desirable, for example becauseit is stronger, cheaper, cleaner, faster, lighter,smaller, more durable, or more efficient. Becausethe desire to enhance commercial opportunities byimproving a product or process is universal-and evencommon-sensical-we have held that there exists inthese situations a motivation to combine prior artreferences even absent any hint of suggestion in thereferences themselves. In such situations, the properquestion is whether the ordinary artisan possessesknowledge and skills rendering him capable ofcombining the prior art references.” Id. at 1368, 80USPQ2d at 1651.

2143.01 Suggestion or Motivation To Modifythe References [R-08.2017]

Obviousness can be established by combining ormodifying the teachings of the prior art to producethe claimed invention where there is some teaching,suggestion, or motivation to do so. In re Kahn, 441F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir.2006) (discussing rationale underlying themotivation-suggestion-teaching test as a guardagainst using hindsight in an obviousness analysis).

I. PRIOR ART SUGGESTION OF THE CLAIMEDINVENTION NOT NECESSARILY NEGATED BYDESIRABLE ALTERNATIVES

The disclosure of desirable alternatives does notnecessarily negate a suggestion for modifying theprior art to arrive at the claimed invention. In In reFulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir.2004), the claims of a utility patent application weredirected to a shoe sole with increased traction havinghexagonal projections in a “facing orientation.” 391F.3d at 1196-97, 73 USPQ2d at 1142. The Boardcombined a design patent having hexagonalprojections in a facing orientation with a utilitypatent having other limitations of the independentclaim. 391 F.3d at 1199, 73 USPQ2d at 1144.Applicant argued that the combination was improperbecause (1) the prior art did not suggest having thehexagonal projections in a facing (as opposed to a“pointing”) orientation was the “most desirable”configuration for the projections, and (2) the priorart “taught away” by showing desirability of the“pointing orientation.” 391 F.3d at 1200-01, 73USPQ2d at 1145-46. The court stated that “the priorart’s mere disclosure of more than one alternativedoes not constitute a teaching away from any of thesealternatives because such disclosure does notcriticize, discredit, or otherwise discourage thesolution claimed….” Id. In affirming the Board’sobviousness rejection, the court held that the priorart as a whole suggested the desirability of thecombination of shoe sole limitations claimed, thusproviding a motivation to combine, which need notbe supported by a finding that the prior art suggestedthat the combination claimed by the applicant wasthe preferred, or most desirable combination overthe other alternatives. Id. See also In re Urbanski,809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed.Cir. 2016).

In Ruiz v. A.B. Chance Co., 357 F.3d 1270,69 USPQ2d 1686 (Fed. Cir. 2004), the patentclaimed underpinning a slumping buildingfoundation using a screw anchor attached to thefoundation by a metal bracket. One prior artreference taught a screw anchor with a concretebracket, and a second prior art reference discloseda pier anchor with a metal bracket. The court foundmotivation to combine the references to arrive at theclaimed invention in the “nature of the problem to

Rev. 08.2017, January 20182100-231


be solved” because each reference was directed “toprecisely the same problem of underpinningslumping foundations.” Id. at 1276, 69 USPQ2d at1690. The court also rejected the notion that “anexpress written motivation to combine must appearin prior art references….” Id. at 1276, 69 USPQ2dat 1690.

II. WHERE THE TEACHINGS OF THE PRIORART CONFLICT, THE EXAMINER MUST WEIGHTHE SUGGESTIVE POWER OF EACHREFERENCE

The test for obviousness is what the combinedteachings of the references would have suggested toone of ordinary skill in the art, and all teachings inthe prior art must be considered to the extent thatthey are in analogous arts. Where the teachings oftwo or more prior art references conflict, theexaminer must weigh the power of each referenceto suggest solutions to one of ordinary skill in theart, considering the degree to which one referencemight accurately discredit another. In re Young, 927F.2d 588, 18 USPQ2d 1089 (Fed. Cir. 1991) (Priorart patent to Carlisle disclosed controlling andminimizing bubble oscillation for chemicalexplosives used in marine seismic exploration byspacing seismic sources close enough to allow thebubbles to intersect before reaching their maximumradius so the secondary pressure pulse was reduced.An article published several years later by Knudsenopined that the Carlisle technique does not yieldappreciable improvement in bubble oscillationsuppression. However, the article did not test theCarlisle technique under comparable conditionsbecause Knudsen did not use Carlisle’s spacing orseismic source. Furthermore, where the Knudsenmodel most closely approximated the patenttechnique there was a 30% reduction of thesecondary pressure pulse. On these facts, the courtfound that the Knudsen article would not havedeterred one of ordinary skill in the art from usingthe Carlisle patent teachings.).

III. FACT THAT REFERENCES CAN BECOMBINED OR MODIFIED MAY NOT BESUFFICIENT TO ESTABLISH PRIMA FACIEOBVIOUSNESS

The mere fact that references can be combined ormodified does not render the resultant combination

obvious unless the results would have beenpredictable to one of ordinary skill in the art. KSRInt'l Co. v. Teleflex Inc., 550 U.S. 538, 417, 82USPQ2d 1385, 1396 (2007) (“If a person of ordinaryskill can implement a predictable variation, § 103likely bars its patentability. For the same reason, ifa technique has been used to improve one device,and a person of ordinary skill in the art wouldrecognize that it would improve similar devices inthe same way, using the technique is obvious unlessits actual application is beyond his or her skill.”).

IV. MERE STATEMENT THAT THE CLAIMEDINVENTION IS WITHIN THE CAPABILITIES OFONE OF ORDINARY SKILL IN THE ART IS NOTSUFFICIENT BY ITSELF TO ESTABLISH PRIMAFACIE OBVIOUSNESS

A statement that modifications of the prior art tomeet the claimed invention would have been “‘wellwithin the ordinary skill of the art at the time theclaimed invention was made’” because the referencesrelied upon teach that all aspects of the claimedinvention were individually known in the art is notsufficient to establish a prima facie case ofobviousness without some objective reason tocombine the teachings of the references. Ex parteLevengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter.1993). ‘‘‘[R]ejections on obviousness cannot besustained by mere conclusory statements; instead,there must be some articulated reasoning with somerational underpinning to support the legal conclusionof obviousness.’” KSR, 550 U.S. at 418, 82 USPQ2dat 1396 (quoting In re Kahn, 441 F.3d 977, 988, 78USPQ2d 1329, 1336 (Fed. Cir. 2006)).

V. THE PROPOSED MODIFICATION CANNOTRENDER THE PRIOR ART UNSATISFACTORYFOR ITS INTENDED PURPOSE

If a proposed modification would render the priorart invention being modified unsatisfactory for itsintended purpose, then there is no suggestion ormotivation to make the proposed modification. Inre Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir.1984) (Claimed device was a blood filter assemblyfor use during medical procedures wherein both theinlet and outlet for the blood were located at thebottom end of the filter assembly, and wherein a gasvent was present at the top of the filter assembly.The prior art reference taught a liquid strainer for

2100-232Rev. 08.2017, January 2018


removing dirt and water from gasoline and otherlight oils wherein the inlet and outlet were at the topof the device, and wherein a pet-cock (stopcock)was located at the bottom of the device forperiodically removing the collected dirt and water.The reference further taught that the separation isassisted by gravity. The Board concluded the claimswere prima facie obvious, reasoning that it wouldhave been obvious to turn the reference deviceupside down. The court reversed, finding that if theprior art device were turned upside down it wouldbe inoperable for its intended purpose because thegasoline to be filtered would be trapped at the top,the water and heavier oils sought to be separatedwould flow out of the outlet instead of the purifiedgasoline, and the screen would become clogged.).But see In re Urbanski, 809 F.3d 1237, 1244, 117USPQ2d 1499, 1504 (Fed. Cir. 2016) (The patentclaims were directed to a method of enzymatichydrolysis of soy fiber to reduce water holdingcapacity, requiring reacting the soy fiber and enzymein water for about 60-120 minutes. The claims wererejected over two prior art references, wherein theprimary reference taught using a longer reaction timeof 5 to 72 hours and the secondary taught using areaction time of 100 to 240 minutes, preferably 120minutes. The applicant argued that modifying theprimary reference in the manner suggested by thesecondary reference would forego the benefits taughtby the primary reference, thereby teaching awayfrom the combination. The court held that both priorart references “suggest[ed] that hydrolysis time maybe adjusted to achieve different fiber properties.Nothing in the prior art teaches that the proposedmodification would have resulted in an ‘inoperable’process or a dietary fiber product with undesirableproperties.” (emphasis in original).

“Although statements limiting the function orcapability of a prior art device require fairconsideration, simplicity of the prior art is rarely acharacteristic that weighs against obviousness of amore complicated device with added function.” Inre Dance, 160 F.3d 1339, 1344, 48 USPQ2d 1635,1638 (Fed. Cir. 1998) (Court held that claimedcatheter for removing obstruction in blood vesselswould have been obvious in view of a first referencewhich taught all of the claimed elements except fora “means for recovering fluid and debris” incombination with a second reference describing a

catheter including that means. The court agreed thatthe first reference, which stressed simplicity ofstructure and taught emulsification of the debris, didnot teach away from the addition of a channel forthe recovery of the debris.). Similarly, in AlliedErecting v. Genesis Attachments, 825 F.3d 1373,1381, 119 USPQ2d 1132, 1138 (Fed. Cir. 2016), thecourt stated “[a]lthough modification of the movableblades may impede the quick change functionalitydisclosed by Caterpillar, ‘[a] given course of actionoften has simultaneous advantages anddisadvantages, and this does not necessarily obviatemotivation to combine’” (quoting Medichem, S.A.v. Rolabo, S.L., 437 F.3d 1157, 1165, 77 USPQ2d1865, 1870 (Fed Cir. 2006) (citation omitted)).

VI. THE PROPOSED MODIFICATION CANNOTCHANGE THE PRINCIPLE OF OPERATION OFA REFERENCE

If the proposed modification or combination of theprior art would change the principle of operation ofthe prior art invention being modified, then theteachings of the references are not sufficient torender the claims prima facie obvious. In re Ratti,270 F.2d 810, 813, 123 USPQ 349, 352 (CCPA1959) (Claims were directed to an oil sealcomprising a bore engaging portion with outwardlybiased resilient spring fingers inserted in a resilientsealing member. The primary reference relied uponin a rejection based on a combination of referencesdisclosed an oil seal wherein the bore engagingportion was reinforced by a cylindrical sheet metalcasing. The seal construction taught in the primaryreference required rigidity for operation, whereasthe seal in the claimed invention required resiliency.The court reversed the rejection holding the“suggested combination of references would requirea substantial reconstruction and redesign of theelements shown in [the primary reference] as wellas a change in the basic principle under which the[primary reference] construction was designed tooperate.”).

2143.02 Reasonable Expectation of SuccessIs Required [R-08.2012]

[Editor Note: This MPEP section is applicable toapplications subject to the first inventor to file(FITF) provisions of the AIA except that the relevant

Rev. 08.2017, January 20182100-233


date is the "effective filing date" of the claimedinvention instead of the "time the invention wasmade," which is only applicable to applicationssubject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100(note) and MPEP § 2150 et seq.]

A rationale to support a conclusion that a claimwould have been obvious is that all the claimedelements were known in the prior art and one skilledin the art could have combined the elements asclaimed by known methods with no change in theirrespective functions, and the combination wouldhave yielded nothing more than predictable resultsto one of ordinary skill in the art. KSR Int'l Co. v.Teleflex Inc., 550 U.S. 538, 416, 82 USPQ2d 1385,1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S.273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement SalvageCo., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equip.Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).

I. OBVIOUSNESS REQUIRES A REASONABLEEXPECTATION OF SUCCESS

Where there is a reason to modify or combine theprior art to achieve the claimed invention, the claimsmay be rejected as prima facie obvious providedthere is also a reasonable expectation of success. Inre Merck & Co., Inc., 800 F.2d 1091, 231 USPQ375 (Fed. Cir. 1986) (Claims directed to a methodof treating depression with amitriptyline (or nontoxicsalts thereof) were rejected as prima facie obviousover prior art disclosures that amitriptyline is acompound known to possess psychotropic propertiesand that imipramine is a structurally similarpsychotropic compound known to possessantidepressive properties, in view of prior artsuggesting the aforementioned compounds wouldbe expected to have similar activity because thestructural difference between the compoundsinvolves a known bioisosteric replacement andbecause a research paper comparing thepharmacological properties of these two compoundssuggested clinical testing of amitriptyline as anantidepressant. The court sustained the rejection,finding that the teachings of the prior art provide asufficient basis for a reasonable expectation ofsuccess.); Ex parte Blanc, 13 USPQ2d 1383 (Bd.Pat. App. & Inter. 1989) (Claims were directed to a

process of sterilizing a polyolefinic composition withhigh-energy radiation in the presence of a phenolicpolyester antioxidant to inhibit discoloration ordegradation of the polyolefin. Appellant argued thatit is unpredictable whether a particular antioxidantwill solve the problem of discoloration ordegradation. However, the Board found that becausethe prior art taught that appellant’s preferredantioxidant is very efficient and provides betterresults compared with other prior art antioxidants,there would have been a reasonable expectation ofsuccess.).

II. AT LEAST SOME DEGREE OFPREDICTABILITY IS REQUIRED; APPLICANTSMAY PRESENT EVIDENCE SHOWING THEREWAS NO REASONABLE EXPECTATION OFSUCCESS

Obviousness does not require absolute predictability,however, at least some degree of predictability isrequired. Evidence showing there was no reasonableexpectation of success may support a conclusion ofnonobviousness. In re Rinehart, 531 F.2d 1048,189 USPQ 143 (CCPA 1976) (Claims directed to amethod for the commercial scale production ofpolyesters in the presence of a solvent atsuperatmospheric pressure were rejected as obviousover a reference which taught the claimed methodat atmospheric pressure in view of a reference whichtaught the claimed process except for the presenceof a solvent. The court reversed, finding there wasno reasonable expectation that a process combiningthe prior art steps could be successfully scaled up inview of unchallenged evidence showing that theprior art processes individually could not becommercially scaled up successfully.). See also Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200,1207-08, 18 USPQ2d 1016, 1022-23 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991) (In the context ofa biotechnology case, testimony supported theconclusion that the references did not show that therewas a reasonable expectation of success.); In reO’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681(Fed. Cir. 1988) (The court held the claimed methodwould have been obvious over the prior art reliedupon because one reference contained a detailedenabling methodology, a suggestion to modify theprior art to produce the claimed invention, andevidence suggesting the modification would besuccessful.).

2100-234Rev. 08.2017, January 2018


III. PREDICTABILITY IS DETERMINED AT THETIME THE INVENTION WAS MADE

Whether an art is predictable or whether theproposed modification or combination of the priorart has a reasonable expectation of success isdetermined at the time the invention was made. Exparte Erlich, 3 USPQ2d 1011, 1016 (Bd. Pat. App.& Inter. 1986) (Although an earlier case reversed arejection because of unpredictability in the field ofmonoclonal antibodies, the court found “in this caseat the time this invention was made, one of ordinaryskill in the art would have been motivated to producemonoclonal antibodies specific for human fibroplastinterferon using the method of [the prior art] with areasonable expectation of success.”) (emphasis inoriginal).

2143.03 All Claim Limitations Must BeConsidered [R-08.2017]

“All words in a claim must be considered in judgingthe patentability of that claim against the prior art.” In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494,496 (CCPA 1970).

Examiners must consider all claim limitations whendetermining patentability of an invention over theprior art. In re Gulack, 703 F.2d 1381, 1385, 217USPQ 401, 403-04 (Fed. Cir. 1983). The subjectmatter of a properly construed claim is defined bythe terms that limit the scope of the claim whengiven their broadest reasonable interpretation. SeeMPEP § 2111 et seq. It is this subject matter thatmust be examined. The determination of whetherparticular language is a limitation in a claim dependson the specific facts of the case. See, e.g., Griffin v.Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431(Fed. Cir. 2002).

As a general matter, the grammar and ordinarymeaning of terms as understood by one havingordinary skill in the art used in a claim will dictatewhether, and to what extent, the language limits theclaim scope . Language that suggests or makes afeature or step optional but does not require thatfeature or step does not limit the scope of a claimunder the broadest reasonable claim interpretation.In addition, when a claim requires selection of anelement from a list of alternatives, the prior art

teaches the element if one of the alternatives is taughtby the prior art. See, e.g., Fresenius USA, Inc. v.Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir.2009).

The following types of claim language may raise aquestion as to its limiting effect (this list is notexhaustive):

• preamble (MPEP § 2111.02);

• clauses such as “adapted to,” adapted for,”“wherein,” and “whereby” (MPEP § 2111.04,subsection I);

• contingent limitations (MPEP § 2111.04,subsection II);

• printed matter (MPEP § 2111.05); and

• functional language associated with a claimterm (MPEP § 2181).

If an independent claim is nonobvious under 35U.S.C. 103, then any claim depending therefrom isnonobvious. In re Fine, 837 F.2d 1071, 5 USPQ2d1596 (Fed. Cir. 1988).

I. INDEFINITE LIMITATIONS MUST BECONSIDERED

A claim limitation which is considered indefinitecannot be disregarded. If a claim is subject to morethan one interpretation, at least one of which wouldrender the claim unpatentable over the prior art, theexaminer should reject the claim as indefinite under35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph (see MPEP § 706.03(d)) and should rejectthe claim over the prior art based on theinterpretation of the claim that renders the prior artapplicable. Ex parte Ionescu, 222 USPQ 537 (Bd.Pat. App. & Inter. 1984) (Claims on appeal wererejected on indefiniteness grounds only; the rejectionwas reversed and the case remanded to the examinerfor consideration of pertinent prior art.). Compare In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA1970) (if no reasonably definite meaning can beascribed to certain claim language, the claim isindefinite, not obvious) and In re Steele, 305 F.2d859,134 USPQ 292 (CCPA 1962) (it is improper torely on speculative assumptions regarding themeaning of a claim and then base a rejection under35 U.S.C. 103 on these assumptions).

Rev. 08.2017, January 20182100-235


II. LIMITATIONS WHICH DO NOT FINDSUPPORT IN THE ORIGINAL SPECIFICATIONMUST BE CONSIDERED

When evaluating claims for obviousness under35 U.S.C. 103, all the limitations of the claims mustbe considered and given weight, including limitationswhich do not find support in the specification asoriginally filed (i.e., new matter). Ex parte Grasselli,231 USPQ 393 (Bd. App. 1983) aff’d mem. 738F.2d 453 (Fed. Cir. 1984) (Claim to a catalystexpressly excluded the presence of sulfur, halogen,uranium, and a combination of vanadium andphosphorous. Although the negative limitationsexcluding these elements did not appear in thespecification as filed, it was error to disregard theselimitations when determining whether the claimedinvention would have been obvious in view of theprior art.).

2144 Supporting a Rejection Under 35 U.S.C.103 [R-07.2015]

When considering obviousness, Office personnelare cautioned against treating any line of reasoningas a per se rule. This section discusses supporting arejection under 35 U.S.C. 103 by reliance onscientific theory and legal precedent. In keeping withthe flexible approach to obviousness under KSR, aswell as the requirement for explanation, Officepersonnel may invoke legal precedent as a sourceof supporting rationale when warranted andappropriately supported. See MPEP § 2144.04. So,for example, automating a manual activity, makingportable, making separable, reversing or duplicatingparts, or purifying an old product may form the basisof a rejection. However, such rationales should notbe treated as per se rules, but rather must beexplained and shown to apply to the facts at hand.A similar caveat applies to any obviousness analysis.Simply stating the principle (e.g., “art recognizedequivalent,” “structural similarity”) withoutproviding an explanation of its applicability to thefacts of the case at hand is generally not sufficientto establish a prima facie case of obviousness.

I. RATIONALE MAY BE IN A REFERENCE, ORREASONED FROM COMMON KNOWLEDGE INTHE ART, SCIENTIFIC PRINCIPLES,

ART-RECOGNIZED EQUIVALENTS, OR LEGALPRECEDENT

The rationale to modify or combine the prior art doesnot have to be expressly stated in the prior art; therationale may be expressly or impliedly containedin the prior art or it may be reasoned from knowledgegenerally available to one of ordinary skill in the art,established scientific principles, or legal precedentestablished by prior case law. In re Fine, 837 F.2d1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones,958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992).See also In re Kotzab, 217 F.3d 1365, 1370, 55USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forthtest for implicit teachings); In re Eli Lilly & Co.,902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990)(discussion of reliance on legal precedent); In reNilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502(Fed. Cir. 1988) (references do not have to explicitlysuggest combining teachings); Ex parte Clapp, 227USPQ 972 (Bd. Pat. App. & Inter. 1985) (examinermust present convincing line of reasoning supportingrejection); and Ex parte Levengood, 28 USPQ2d1300 (Bd. Pat. App. & Inter. 1993) (reliance on logicand sound scientific reasoning).

II. THE EXPECTATION OF SOME ADVANTAGEIS THE STRONGEST RATIONALE FORCOMBINING REFERENCES

The strongest rationale for combining references isa recognition, expressly or impliedly in the prior artor drawn from a convincing line of reasoning basedon established scientific principles or legal precedent,that some advantage or expected beneficial resultwould have been produced by their combination. Inre Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1,5-6 (Fed. Cir. 1983). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir.2006) (“Indeed, we have repeatedly held that animplicit motivation to combine exists not only whena suggestion may be gleaned from the prior art as awhole, but when the ‘improvement’ istechnology-independent and the combination ofreferences results in a product or process that is moredesirable, for example because it is stronger, cheaper,cleaner, faster, lighter, smaller, more durable, ormore efficient. Because the desire to enhancecommercial opportunities by improving a product

2100-236Rev. 08.2017, January 2018


or process is universal—and evencommon-sensical—we have held that there exists inthese situations a motivation to combine prior artreferences even absent any hint of suggestion in thereferences themselves.”).

III. LEGAL PRECEDENT CAN PROVIDE THERATIONALE SUPPORTING OBVIOUSNESS ONLYIF THE FACTS IN THE CASE ARE SUFFICIENTLYSIMILAR TO THOSE IN THE APPLICATION

The examiner must apply the law consistently toeach application after considering all the relevantfacts. If the facts in a prior legal decision aresufficiently similar to those in an application underexamination, the examiner may use the rationaleused by the court. If the applicant has demonstratedthe criticality of a specific limitation, it would notbe appropriate to rely solely on the rationale usedby the court to support an obviousness rejection.“The value of the exceedingly large body ofprecedent wherein our predecessor courts and thiscourt have applied the law of obviousness toparticular facts, is that there has been built a widespectrum of illustrations and accompanyingreasoning, that have been melded into a fairlyconsistent application of law to a great variety offacts.” In re Eli Lilly & Co., 902 F.2d 943, 14USPQ2d 1741 (Fed. Cir. 1990).

IV. RATIONALE DIFFERENT FROMAPPLICANT’S IS PERMISSIBLE

The reason or motivation to modify the referencemay often suggest what the inventor has done, butfor a different purpose or to solve a differentproblem. It is not necessary that the prior art suggestthe combination to achieve the same advantage orresult discovered by applicant. See, e.g., In re Kahn,441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed.Cir. 2006) (motivation question arises in the contextof the general problem confronting the inventorrather than the specific problem solved by theinvention); Cross Med. Prods., Inc. v. MedtronicSofamor Danek, Inc., 424 F.3d 1293, 1323, 76USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One ofordinary skill in the art need not see the identicalproblem addressed in a prior art reference to bemotivated to apply its teachings.”); In re Lintner,458 F.2d 1013, 173 USPQ 560 (CCPA 1972)

(discussed below); In re Dillon, 919 F.2d 688, 16USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500U.S. 904 (1991) (discussed below).

In In re Lintner, the claimed invention was a laundrycomposition consisting essentially of a dispersant,cationic fabric softener, sugar, sequesteringphosphate, and brightener in specified proportions.The claims were rejected over the combination of aprimary reference which taught all the claimlimitations except for the presence of sugar, andsecondary references which taught the addition ofsugar as a filler or weighting agent in compositionscontaining cationic fabric softeners. Appellantargued that in the claimed invention, the sugar isresponsible for the compatibility of the cationicsoftener with the other detergent components. Thecourt sustained the rejection, stating “The fact thatappellant uses sugar for a different purpose does notalter the conclusion that its use in a prior artcomposition would be [ sic, would have been] primafacie obvious from the purpose disclosed in thereferences.” 173 USPQ at 562.

In In re Dillon, applicant claimed a compositioncomprising a hydrocarbon fuel and a sufficientamount of a tetra-orthoester of a specified formulato reduce the particulate emissions from thecombustion of the fuel. The claims were rejected asobvious over a reference which taught hydrocarbonfuel compositions containing tri-orthoesters fordewatering fuels, in combination with a referenceteaching the equivalence of tri-orthoesters andtetra-orthoesters as water scavengers in hydraulic(nonhydrocarbon) fluids. The Board affirmed therejection finding “there was a ‘reasonableexpectation’ that the tri- and tetra-orthoester fuelcompositions would have similar properties basedon ‘close structural and chemical similarity’ betweenthe tri- and tetra-orthoesters and the fact that boththe prior art and Dillon use these compounds ‘as fueladditives’.” 919 F.2d at 692, 16 USPQ2d at 1900.The court held “it is not necessary in order toestablish a prima facie case of obviousness . . . thatthere be a suggestion or expectation from the priorart that the claimed [invention] will have the sameor a similar utility as one newly discovered byapplicant,” and concluded that here a prima faciecase was established because “[t]he art provided themotivation to make the claimed compositions in the

Rev. 08.2017, January 20182100-237


expectation that they would have similar properties.”919 F.2d at 693, 16 USPQ2d at 1901 (emphasis inoriginal).

See MPEP § 2145, subsection II for case lawpertaining to the presence of additional advantagesor latent properties not recognized in the prior art.

2144.01 Implicit Disclosure [R-08.2012]

“[I]n considering the disclosure of a reference, it isproper to take into account not only specificteachings of the reference but also the inferenceswhich one skilled in the art would reasonably beexpected to draw therefrom.” In re Preda, 401 F.2d825, 826, 159 USPQ 342, 344 (CCPA 1968) (Aprocess for catalytically producing carbon disulfideby reacting sulfur vapor and methane in the presenceof charcoal at a temperature of “about 750-830°C”was found to be met by a reference which expresslytaught the same process at 700°C because thereference recognized the possibility of usingtemperatures greater than 750°C. The referencedisclosed that catalytic processes for convertingmethane with sulfur vapors into carbon disulfide attemperatures greater than 750°C (albeit withoutcharcoal) was known, and that 700°C was “muchlower than had previously proved feasible.”); In reLamberti, 545 F.2d 747, 750, 192 USPQ 278, 280(CCPA 1976) (Reference disclosure of a compoundwhere the R-S-R¢ portion has “at least onemethylene group attached to the sulfur atom” impliesthat the other R group attached to the sulfur atomcan be other than methylene and therefore suggestsasymmetric dialkyl moieties.).

2144.02 Reliance on Scientific Theory[R-08.2012]

The rationale to support a rejection under 35 U.S.C.103 may rely on logic and sound scientific principle. In re Soli, 317 F.2d 941, 137 USPQ 797 (CCPA1963). However, when an examiner relies on ascientific theory, evidentiary support for theexistence and meaning of that theory must beprovided. In re Grose, 592 F.2d 1161, 201 USPQ57 (CCPA 1979) (Court held that different crystalforms of zeolites would not have been structurallyobvious one from the other because there was nochemical theory supporting such a conclusion. The

known chemical relationship between structurallysimilar compounds (homologs, analogs, isomers)did not support a finding of prima facie obviousnessof claimed zeolite over the prior art because a zeoliteis not a compound but a mixture of compoundsrelated to each other by a particular crystalstructure.).

2144.03 Reliance on Common Knowledge inthe Art or “Well Known” Prior Art[R-08.2017]

In certain circumstances where appropriate, anexaminer may take official notice of facts not in therecord or rely on “common knowledge” in makinga rejection, however such rejections should bejudiciously applied.

PROCEDURE FOR RELYING ON COMMONKNOWLEDGE OR TAKING OFFICIAL NOTICE

The standard of review applied to findings of fact isthe “substantial evidence” standard under theAdministrative Procedure Act (APA), 5 U.S.C. 500 et seq. See In re Gartside, 203 F.3d 1305, 1315,53 USPQ2d 1769, 1775 (Fed. Cir. 2000). See alsoMPEP § 1216.01. In light of recent Federal Circuitdecisions as discussed below and the substantialevidence standard of review now applied to USPTOBoard decisions, the following guidance is providedin order to assist the examiners in determining whenit is appropriate to take official notice of factswithout supporting documentary evidence or to relyon common knowledge in the art in making arejection, and if such official notice is taken, whatevidence is necessary to support the examiner’sconclusion of common knowledge in the art.

A. Determine When It Is Appropriate To Take OfficialNotice Without Documentary Evidence To Support theExaminer’s Conclusion

Official notice without documentary evidence tosupport an examiner’s conclusion is permissible onlyin some circumstances. While “official notice” maybe relied on, these circumstances should be rarewhen an application is under final rejection or actionunder 37 CFR 1.113. Official notice unsupported bydocumentary evidence should only be taken by theexaminer where the facts asserted to be well-known,

2100-238Rev. 08.2017, January 2018


or to be common knowledge in the art are capableof instant and unquestionable demonstration as beingwell-known. As noted by the court in In re Ahlert,424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA1970), the notice of facts beyond the record whichmay be taken by the examiner must be “capable ofsuch instant and unquestionable demonstration as todefy dispute” (citing In re Knapp Monarch Co., 296F.2d 230, 132 USPQ 6 (CCPA 1961)). In Ahlert,the court held that the Board properly took judicialnotice that “it is old to adjust intensity of a flame inaccordance with the heat requirement.” See also Inre Fox, 471 F.2d 1405, 1407, 176 USPQ 340, 341(CCPA 1973) (the court took “judicial notice of thefact that tape recorders commonly erase tapeautomatically when new ‘audio information’ isrecorded on a tape which already has a recording onit”). In appropriate circumstances, it might bereasonable to take official notice of the fact that itis desirable to make something faster, cheaper,better, or stronger without the specific support ofdocumentary evidence. Furthermore, it might bereasonable for the examiner in a first Office actionto take official notice of facts by asserting thatcertain limitations in a dependent claim are old andwell known expedients in the art without the supportof documentary evidence provided the facts sonoticed are of notorious character and serve only to“fill in the gaps” which might exist in the evidentiaryshowing made by the examiner to support aparticular ground of rejection. In re Zurko, 258 F.3d1379, 1385, 59 USPQ2d 1693, 1697 (Fed. Cir.2001); Ahlert, 424 F.2d at 1092, 165 USPQ at 421.

It would not be appropriate for the examiner to takeofficial notice of facts without citing a prior artreference where the facts asserted to be well knownare not capable of instant and unquestionabledemonstration as being well-known. For example,assertions of technical facts in the areas of esoterictechnology or specific knowledge of the prior artmust always be supported by citation to somereference work recognized as standard in thepertinent art. In re Ahlert, 424 F.2d at 1091, 165USPQ at 420-21. See also In re Grose, 592 F.2d1161, 1167-68, 201 USPQ 57, 63 (CCPA 1979)(“[W]hen the PTO seeks to rely upon a chemicaltheory, in establishing a prima facie case ofobviousness, it must provide evidentiary support forthe existence and meaning of that theory.”); In re

Eynde, 480 F.2d 1364, 1370, 178 USPQ 470,474 (CCPA 1973) (“[W]e reject the notion thatjudicial or administrative notice may be taken of thestate of the art. The facts constituting the state of theart are normally subject to the possibility of rationaldisagreement among reasonable men and are notamenable to the taking of such notice.”).

It is never appropriate to rely solely on “commonknowledge” in the art without evidentiary supportin the record, as the principal evidence upon whicha rejection was based. Zurko, 258 F.3d at 1385, 59USPQ2d at 1697 (“[T]he Board cannot simply reachconclusions based on its own understanding orexperience—or on its assessment of what would bebasic knowledge or common sense. Rather, theBoard must point to some concrete evidence in therecord in support of these findings.”). While thecourt explained that, “as an administrative tribunalthe Board clearly has expertise in the subject matterover which it exercises jurisdiction,” it made clearthat such “expertise may provide sufficient supportfor conclusions [only] as to peripheral issues.” Id.at 1385-86, 59 USPQ2d at 1697. As the court heldin Zurko, an assessment of basic knowledge andcommon sense that is not based on any evidence inthe record lacks substantial evidence support. Id. at1385, 59 USPQ2d at 1697. See also Arendi v. Apple,832 F.3d 1355, 119 USPQ2d 1822 (Fed. Cir. 2016)(finding that the Board had not provided a reasonedanalysis, supported by the evidence of record, forwhy “common sense” taught the missing processstep).

B. If Official Notice Is Taken of a Fact, Unsupportedby Documentary Evidence, the Technical Line ofReasoning Underlying a Decision To Take Such NoticeMust Be Clear and Unmistakable

In certain older cases, official notice has been takenof a fact that is asserted to be “common knowledge”without specific reliance on documentary evidencewhere the fact noticed was readily verifiable, suchas when other references of record supported thenoticed fact, or where there was nothing of recordto contradict it. See In re Soli, 317 F.2d 941, 945-46,137 USPQ 797, 800 (CCPA 1963) (accepting theexaminer’s assertion that the use of “a control isstandard procedure throughout the entire field ofbacteriology” because it was readily verifiable and

Rev. 08.2017, January 20182100-239


disclosed in references of record not cited by theOffice); In re Chevenard, 139 F.2d 711, 713, 60USPQ 239, 241 (CCPA 1943) (accepting theexaminer’s finding that a brief heating at a highertemperature was the equivalent of a longer heatingat a lower temperature where there was nothing inthe record to indicate the contrary and where theapplicant never demanded that the examiner produceevidence to support his statement). If such notice istaken, the basis for such reasoning must be set forthexplicitly. The examiner must provide specificfactual findings predicated on sound technical andscientific reasoning to support the conclusion ofcommon knowledge. See Soli, 317 F.2d at 946, 37USPQ at 801; Chevenard, 139 F.2d at 713, 60USPQ at 241. The applicant should be presentedwith the explicit basis on which the examiner regardsthe matter as subject to official notice so as toadequately traverse the rejection in the next replyafter the Office action in which the commonknowledge statement was made.

C. If Applicant Challenges a Factual Assertion as NotProperly Officially Noticed or Not Properly Based UponCommon Knowledge, the Examiner Must Support theFinding With Adequate Evidence

To adequately traverse such a finding, an applicantmust specifically point out the supposed errors inthe examiner’s action, which would include statingwhy the noticed fact is not considered to be commonknowledge or well-known in the art. See 37 CFR1.111(b). See also Chevenard, 139 F.2d at 713, 60USPQ at 241 (“[I]n the absence of any demand byappellant for the examiner to produce authority forhis statement, we will not consider this contention.”).A general allegation that the claims define apatentable invention without any reference to theexaminer’s assertion of official notice would beinadequate. If applicant adequately traverses theexaminer’s assertion of official notice, the examinermust provide documentary evidence in the nextOffice action if the rejection is to be maintained. See37 CFR 1.104(c)(2). See also Zurko, 258 F.3d at1386, 59 USPQ2d at 1697 (“[T]he Board [orexaminer] must point to some concrete evidence inthe record in support of these findings” to satisfy thesubstantial evidence test). If the examiner is relyingon personal knowledge to support the finding ofwhat is known in the art, the examiner must provide

an affidavit or declaration setting forth specificfactual statements and explanation to support thefinding. See 37 CFR 1.104(d)(2).

If applicant does not traverse the examiner’sassertion of official notice or applicant’s traverse isnot adequate, the examiner should clearly indicatein the next Office action that the common knowledgeor well-known in the art statement is taken to beadmitted prior art because applicant either failed totraverse the examiner’s assertion of official noticeor that the traverse was inadequate. If the traversewas inadequate, the examiner should include anexplanation as to why it was inadequate.

D. Determine Whether the Next Office Action ShouldBe Made Final

If the examiner adds a reference in the next Officeaction after applicant’s rebuttal, and the newly addedreference is added only as directly correspondingevidence to support the prior common knowledgefinding, and it does not result in a new issue orconstitute a new ground of rejection, the Officeaction may be made final. If no amendments aremade to the claims, the examiner must not rely onany other teachings in the reference if the rejectionis made final. If the newly cited reference is addedfor reasons other than to support the prior commonknowledge statement and a new ground of rejectionis introduced by the examiner that is not necessitatedby applicant’s amendment of the claims, the rejectionmay not be made final. See MPEP § 706.07(a).

E. Summary

Any rejection based on assertions that a fact iswell-known or is common knowledge in the artwithout documentary evidence to support theexaminer’s conclusion should be judiciously applied.Furthermore, as noted by the court in Ahlert, anyfacts so noticed should be of notorious character andserve only to “fill in the gaps” in an insubstantialmanner which might exist in the evidentiary showingmade by the examiner to support a particular groundfor rejection. It is never appropriate to rely solely oncommon knowledge in the art without evidentiarysupport in the record as the principal evidence uponwhich a rejection was based. See Zurko, 258 F.3d

2100-240Rev. 08.2017, January 2018


at 1386, 59 USPQ2d at 1697; Ahlert, 424 F.2d at1092, 165 USPQ 421.

2144.04 Legal Precedent as Source ofSupporting Rationale [R-08.2017]

As discussed in MPEP § 2144, if the facts in a priorlegal decision are sufficiently similar to those in anapplication under examination, the examiner mayuse the rationale used by the court. Examplesdirected to various common practices which the courthas held normally require only ordinary skill in theart and hence are considered routine expedients arediscussed below. If the applicant has demonstratedthe criticality of a specific limitation, it would notbe appropriate to rely solely on case law as therationale to support an obviousness rejection.

I. AESTHETIC DESIGN CHANGES

In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA1947) (Claim was directed to an advertising displaydevice comprising a bottle and a hollow member inthe shape of a human figure from the waist up whichwas adapted to fit over and cover the neck of thebottle, wherein the hollow member and the bottletogether give the impression of a human body.Appellant argued that certain limitations in the upperpart of the body, including the arrangement of thearms, were not taught by the prior art. The courtfound that matters relating to ornamentation onlywhich have no mechanical function cannot be reliedupon to patentably distinguish the claimed inventionfrom the prior art.). But see Ex parte Hilton,148 USPQ 356 (Bd. App. 1965) (Claims weredirected to fried potato chips with a specifiedmoisture and fat content, whereas the prior art wasdirected to french fries having a higher moisturecontent. While recognizing that in some cases theparticular shape of a product is of no patentablesignificance, the Board held in this case the shape(chips) is important because it results in a productwhich is distinct from the reference product (frenchfries).).

II. ELIMINATION OF A STEP OR AN ELEMENTAND ITS FUNCTION

A. Omission of an Element and Its Function IsObvious if the Function of the Element Is Not Desired

Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter.1989) (Claims at issue were directed to a method forinhibiting corrosion on metal surfaces using acomposition consisting of epoxy resin, petroleumsulfonate, and hydrocarbon diluent. The claims wererejected over a primary reference which disclosedan anticorrosion composition of epoxy resin,hydrocarbon diluent, and polybasic acid saltswherein said salts were taught to be beneficial whenemployed in a freshwater environment, in view ofsecondary references which clearly suggested theaddition of petroleum sulfonate to corrosioninhibiting compositions. The Board affirmed therejection, holding that it would have been obviousto omit the polybasic acid salts of the primaryreference where the function attributed to such saltis not desired or required, such as in compositionsfor providing corrosion resistance in environmentswhich do not encounter fresh water.). See also Inre Larson, 340 F.2d 965, 144 USPQ 347 (CCPA1965) (Omission of additional framework and axlewhich served to increase the cargo carrying capacityof prior art mobile fluid carrying unit would havebeen obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA1975) (deleting a prior art switch member andthereby eliminating its function was an obviousexpedient).

B. Omission of an Element with Retention of theElement's Function Is an Indicia of Unobviousness

Note that the omission of an element and retentionof its function is an indicia of unobviousness. Inre Edge, 359 F.2d 896, 149 USPQ 556 (CCPA 1966)(Claims at issue were directed to a printed sheethaving a thin layer of erasable metal bonded directlyto the sheet wherein said thin layer obscured theoriginal print until removal by erasure. The prior artdisclosed a similar printed sheet which furthercomprised an intermediate transparent anderasure-proof protecting layer which preventederasure of the printing when the top layer was erased.The claims were found unobvious over the prior art

Rev. 08.2017, January 20182100-241


because the although the transparent layer of theprior art was eliminated, the function of thetransparent layer was retained since appellant’s metallayer could be erased without erasing the printedindicia.).

III. AUTOMATING A MANUAL ACTIVITY

In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194(CCPA 1958) (Appellant argued that claims to apermanent mold casting apparatus for molding trunkpistons were allowable over the prior art because theclaimed invention combined “old permanent-moldstructures together with a timer and solenoid whichautomatically actuates the known pressure valvesystem to release the inner core after a predeterminedtime has elapsed.” The court held that broadlyproviding an automatic or mechanical means toreplace a manual activity which accomplished thesame result is not sufficient to distinguish over theprior art.).

IV. CHANGES IN SIZE, SHAPE, OR SEQUENCEOF ADDING INGREDIENTS

A. Changes in Size/Proportion

In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA1955) (Claims directed to a lumber package “ofappreciable size and weight requiring handling bya lift truck” where held unpatentable over prior artlumber packages which could be lifted by handbecause limitations relating to the size of the packagewere not sufficient to patentably distinguish overthe prior art.); In re Rinehart, 531 F.2d 1048, 189USPQ 143 (CCPA 1976) (“mere scaling up of a priorart process capable of being scaled up, if such werethe case, would not establish patentability in a claimto an old process so scaled.” 531 F.2d at 1053, 189USPQ at 148.).

In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S.830, 225 USPQ 232 (1984), the Federal Circuit heldthat, where the only difference between the prior artand the claims was a recitation of relative dimensionsof the claimed device and a device having theclaimed relative dimensions would not performdifferently than the prior art device, the claimed

device was not patentably distinct from the prior artdevice.

B. Changes in Shape

In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA1966) (The court held that the configuration of theclaimed disposable plastic nursing container was amatter of choice which a person of ordinary skill inthe art would have found obvious absent persuasiveevidence that the particular configuration of theclaimed container was significant.).

C. Changes in Sequence of Adding Ingredients

Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)(Prior art reference disclosing a process of makinga laminated sheet wherein a base sheet is first coatedwith a metallic film and thereafter impregnated witha thermosetting material was held to render primafacie obvious claims directed to a process of makinga laminated sheet by reversing the order of the priorart process steps.). See also In re Burhans, 154 F.2d690, 69 USPQ 330 (CCPA 1946) (selection of anyorder of performing process steps is prima facieobvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA1930) (Selection of any order of mixing ingredientsis prima facie obvious.).

V. MAKING PORTABLE, INTEGRAL,SEPARABLE, ADJUSTABLE, OR CONTINUOUS

A. Making Portable

In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA1952) (Fact that a claimed device is portable ormovable is not sufficient by itself to patentablydistinguish over an otherwise old device unless thereare new or unexpected results.).

B. Making Integral

In re Larson, 340 F.2d 965, 968, 144 USPQ 347,349 (CCPA 1965) (A claim to a fluid transportingvehicle was rejected as obvious over a prior artreference which differed from the prior art inclaiming a brake drum integral with a clampingmeans, whereas the brake disc and clamp of the priorart comprise several parts rigidly secured together

2100-242Rev. 08.2017, January 2018


as a single unit. The court affirmed the rejectionholding, among other reasons, “that the use of a onepiece construction instead of the structure disclosedin [the prior art] would be merely a matter of obviousengineering choice.”); but see Schenck v. NortronCorp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983)(Claims were directed to a vibratory testing machine(a hard-bearing wheel balancer) comprising aholding structure, a base structure, and a supportingmeans which form “a single integral and gaplesslycontinuous piece.” Nortron argued that the inventionis just making integral what had been made in fourbolted pieces. The court found this argumentunpersuasive and held that the claims werepatentable because the prior art perceived a need formechanisms to dampen resonance, whereas theinventor eliminated the need for dampening via theone-piece gapless support structure, showing insightthat was contrary to the understandings andexpectations of the art.).

C. Making Separable

In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348,349 (CCPA 1961) (The claimed structure, a lipstickholder with a removable cap, was fully met by theprior art except that in the prior art the cap is “pressfitted” and therefore not manually removable. Thecourt held that “if it were considered desirable forany reason to obtain access to the end of [the priorart’s] holder to which the cap is applied, it would beobvious to make the cap removable for thatpurpose.”).

D. Making Adjustable

In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA1954) (Claims were directed to a handle for a fishingrod wherein the handle has a longitudinallyadjustable finger hook, and the hand grip of thehandle connects with the body portion by means ofa universal joint. The court held that adjustability,where needed, is not a patentable advance, andbecause there was an art-recognized need foradjustment in a fishing rod, the substitution of auniversal joint for the single pivot of the prior artwould have been obvious.).

E. Making Continuous

In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA1963) (Claim directed to a method of producing acementitious structure wherein a stable air foam isintroduced into a slurry of cementitious materialdiffered from the prior art only in requiring theaddition of the foam to be continuous. The courtheld the claimed continuous operation would havebeen obvious in light of the batch process of the priorart.).

VI. REVERSAL, DUPLICATION, ORREARRANGEMENT OF PARTS

A. Reversal of Parts

In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA1955) (Prior art disclosed a clock fixed to thestationary steering wheel column of an automobilewhile the gear for winding the clock moves withsteering wheel; mere reversal of such movement, sothe clock moves with wheel, was held to be anobvious modification.).

B. Duplication of Parts

In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA1960) (Claims at issue were directed to a water-tightmasonry structure wherein a water seal of flexiblematerial fills the joints which form between adjacentpours of concrete. The claimed water seal has a“web” which lies in the joint, and a plurality of “ribs”projecting outwardly from each side of the web intoone of the adjacent concrete slabs. The prior artdisclosed a flexible water stop for preventing passageof water between masses of concrete in the shape ofa plus sign (+). Although the reference did notdisclose a plurality of ribs, the court held that mereduplication of parts has no patentable significanceunless a new and unexpected result is produced.).

C. Rearrangement of Parts

In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA1950) (Claims to a hydraulic power press which readon the prior art except with regard to the position ofthe starting switch were held unpatentable becauseshifting the position of the starting switch would nothave modified the operation of the device.); In re

Rev. 08.2017, January 20182100-243


Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)(the particular placement of a contact in aconductivity measuring device was held to be anobvious matter of design choice). However, “[t]hemere fact that a worker in the art could rearrange theparts of the reference device to meet the terms of theclaims on appeal is not by itself sufficient to supporta finding of obviousness. The prior art must providea motivation or reason for the worker in the art,without the benefit of appellant’s specification, tomake the necessary changes in the reference device.” Ex parte Chicago Rawhide Mfg. Co., 223 USPQ351, 353 (Bd. Pat. App. & Inter. 1984).

VII. PURIFYING AN OLD PRODUCT

Pure materials are novel vis-à-vis less pure orimpure materials because there is a differencebetween pure and impure materials. Therefore, theissue is whether claims to a pure material areunobvious over the prior art. In re Bergstrom, 427F.2d 1394, 166 USPQ 256 (CCPA 1970). Purerforms of known products may be patentable, but themere purity of a product, by itself, does not renderthe product unobvious.

Factors to be considered in determining whether apurified form of an old product is obvious over theprior art include whether the claimed chemicalcompound or composition has the same utility asclosely related materials in the prior art, and whetherthe prior art suggests the particular form or structureof the claimed material or suitable methods ofobtaining that form or structure. In re Cofer, 354F.2d 664, 148 USPQ 268 (CCPA 1966) (Claims tothe free-flowing crystalline form of a compoundwere held unobvious over references disclosing theviscous liquid form of the same compound becausethe prior art of record did not suggest the claimedcompound in crystalline form or how to obtain suchcrystals.). However, in the case ofproduct-by-process claims, if a first prior art processis improved to enhance the purity of the productproduced by the process, and if the purified producthas no structural or functional difference from theproducts produced by other prior art processes, thenthe improvement in the first process that improvesthe purity of the product does not give rise topatentability. See Purdue Pharma v. Epic Pharma,

811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016).See also MPEP § 2113.

See also Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat.App. & Inter. 1987) (Claims to interleukin-2 (aprotein with a molecular weight of over 12,000)purified to homogeneity were held unpatentable overreferences which recognized the desirability ofpurifying interleukin-2 to homogeneity in a view ofa reference which taught a method of purifyingproteins having molecular weights in excess of12,000 to homogeneity wherein the prior art methodwas similar to the method disclosed by appellant forpurifying interleukin-2).

2144.05 Obviousness of Similar andOverlapping Ranges, Amounts, andProportions [R-08.2017]

See MPEP § 2131.03 for case law pertaining torejections based on the anticipation of ranges under35 U.S.C. 102 and 35 U.S.C. 102/103.

I. OVERLAPPING, APPROACHING, ANDSIMILAR RANGES, AMOUNTS, ANDPROPORTIONS

In the case where the claimed ranges “overlap or lieinside ranges disclosed by the prior art” a primafacie case of obviousness exists. In re Wertheim,541 F.2d 257, 191 USPQ 90 (CCPA 1976); Inre Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990) (The prior art taught carbon monoxideconcentrations of “about 1-5%” while the claim waslimited to “more than 5%.” The court held that“about 1-5%” allowed for concentrations slightlyabove 5% thus the ranges overlapped.); In reGeisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362,1365-66 (Fed. Cir. 1997) (Claim reciting thicknessof a protective layer as falling within a range of “50to 100 Angstroms” considered prima facie obviousin view of prior art reference teaching that “forsuitable protection, the thickness of the protectivelayer should be not less than about 10 nm [i.e., 100Angstroms].” The court stated that “by stating that‘suitable protection’ is provided if the protectivelayer is ‘about’ 100 Angstroms thick, [the prior artreference] directly teaches the use of a thicknesswithin [applicant’s] claimed range.”).

2100-244Rev. 08.2017, January 2018


Similarly, a prima facie case of obviousness existswhere the claimed ranges or amounts do not overlapwith the prior art but are merely close. TitaniumMetals Corp. of America v. Banner, 778 F.2d 775,783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Courtheld as proper a rejection of a claim directed to analloy of “having 0.8% nickel, 0.3% molybdenum,up to 0.1% iron, balance titanium” as obvious overa reference disclosing alloys of 0.75% nickel, 0.25%molybdenum, balance titanium and 0.94% nickel,0.31% molybdenum, balance titanium. “Theproportions are so close that prima facie one skilledin the art would have expected them to have the sameproperties.”). See also Warner-Jenkinson Co., Inc.v. Hilton Davis Chemical Co., 520 U.S. 17, 41USPQ2d 1865 (1997) (under the doctrine ofequivalents, a purification process using a pH of 5.0could infringe a patented purification processrequiring a pH of 6.0-9.0, explaining “[t]hat whichinfringes if later anticipates if earlier”); In re Aller,220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955) (Claimed process which was performed at atemperature between 40°C and 80°C and an acidconcentration between 25% and 70% was held to be prima facie obvious over a reference process whichdiffered from the claims only in that the referenceprocess was performed at a temperature of 100°Cand an acid concentration of 10%); In re Waite, 168F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d72, 74-75 (CCPA 1946) (prior art showed an anglein a groove of up to 90° and an applicant claimed anangle of no less than 120°); In re Swenson, 132 F.2d1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d329, 332 (CCPA 1941); In re Becket, 88 F.2d 684(CCPA 1937) (“Where the component elements ofalloys are the same, and where they approach soclosely the same range of quantities as is here thecase, it seems that there ought to be some noticeabledifference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); Inre Lilienfeld, 67 F.2d 920, 924 (CCPA 1933)(theprior art teaching an alkali cellulose containingminimal amounts of water, found by the Examinerto be in the 5-8% range, the claims sought to bepatented were to an alkali cellulose with varyinghigher ranges of water (e.g., “not substantially lessthan 13%,” “not substantially below 17%,” and“between about 13[%] and 20%”); K-Swiss Inc. v.Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir.2014)(reversing the Board's decision, in an appeal

of an inter partes reexamination proceeding, thatcertain claims were not prima facie obvious due tonon-overlapping ranges); Gentiluomo v. BrunswickBowling and Billiards Corp., 36 Fed. App'x 433(Fed. Cir. 2002)(non-precedential)(disagreeing withargument that overlapping ranges were required tofind a claim prima facie obvious).

"[A] prior art reference that discloses a rangeencompassing a somewhat narrower claimed rangeis sufficient to establish a prima facie case ofobviousness." In re Peterson, 315 F.3d 1325, 1330,65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Seealso In re Harris, 409 F.3d 1339, 74 USPQ2d 1951(Fed. Cir. 2005) (claimed alloy held obvious overprior art alloy that taught ranges of weightpercentages overlapping, and in most instancescompletely encompassing, claimed ranges;furthermore, narrower ranges taught by referenceoverlapped all but one range in claimed invention).However, if the reference’s disclosed range is sobroad as to encompass a very large number ofpossible distinct compositions, this might present asituation analogous to the obviousness of a specieswhen the prior art broadly discloses a genus. Id. Seealso In re Baird, 16 F.3d 380, 29 USPQ2d 1550(Fed. Cir. 1994); In re Jones, 958 F.2d 347, 21USPQ2d 1941 (Fed. Cir. 1992); MPEP § 2144.08.

A range can be disclosed in multiple prior artreferences instead of in a single prior art referencedepending on the specific facts of the case. IronGrip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir.2004). The patent claim at issue was directed to aweight plate having 3 elongated openings that servedas handles for transporting the weight plate. Multipleprior art patents each disclosed weight plates having1, 2 or 4 elongated openings. 392 F.3d at 1319, 73USPQ2d at 1226. The court stated that the claimedweight plate having 3 elongated openings fell withinthe “range” of the prior art and was thus presumedobvious. 392 F.3d at 1322, 73 USPQ2d at 1228. Thecourt further stated that the “range” disclosed inmultiple prior art patents is “a distinction without adifference” from previous range cases whichinvolved a range disclosed in a single patent sincethe “prior art suggested that a larger number ofelongated grips in the weight plates was beneficial…

Rev. 08.2017, January 20182100-245


thus plainly suggesting that one skilled in the artlook to the range appearing in the prior art.” Id.

II. ROUTINE OPTIMIZATION

A. Optimization Within Prior Art Conditions orThrough Routine Experimentation

Generally, differences in concentration ortemperature will not support the patentability ofsubject matter encompassed by the prior art unlessthere is evidence indicating such concentration ortemperature is critical. “[W]here the generalconditions of a claim are disclosed in the prior art,it is not inventive to discover the optimum orworkable ranges by routine experimentation.” Inre Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955) (Claimed process which wasperformed at a temperature between 40°C and 80°Cand an acid concentration between 25% and 70%was held to be prima facie obvious over a referenceprocess which differed from the claims only in thatthe reference process was performed at a temperatureof 100°C and an acid concentration of 10%.); seealso Peterson, 315 F.3d at 1330, 65 USPQ2d at1382 (“The normal desire of scientists or artisans toimprove upon what is already generally knownprovides the motivation to determine where in adisclosed set of percentage ranges is the optimumcombination of percentages.”); In re Hoeschele, 406F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimedelastomeric polyurethanes which fell within thebroad scope of the references were held to beunpatentable thereover because, among otherreasons, there was no evidence of the criticality ofthe claimed ranges of molecular weight or molarproportions.). For more recent cases applying thisprinciple, see Merck & Co. Inc. v. Biocraft Lab.Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling,897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990);and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362(Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112,118-19 (1874) (a change in form, proportions, ordegree “will not sustain a patent”); In re Williams,36 F.2d 436, 438 (CCPA 1929) (“It is a settledprinciple of law that a mere carrying forward of anoriginal patented conception involving only changeof form, proportions, or degree, or the substitutionof equivalents doing the same thing as the original

invention, by substantially the same means, is notsuch an invention as will sustain a patent, eventhough the changes of the kind may produce betterresults than prior inventions.”). See also KSR Int’lCo. v. Teleflex Inc., 550 U.S. 398, 416 (2007)(identifying “the need for caution in granting a patentbased on the combination of elements found in theprior art.”).

B. There is a Motivation to Optimize Result-EffectiveVariables

In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA1977), the CCPA held that a particular parametermust first be recognized as a result-effective variable,i.e., a variable which achieves a recognized result,before the determination of the optimum or workableranges of said variable might be characterized asroutine experimentation, because “obvious to try”is not a valid rationale for an obviousness finding.In KSR International Co. v. Teleflex Inc., 550 U.S.398 (2007), the Supreme Court held that “obviousto try” was a valid rationale for an obviousnessfinding, for example, when there is a “design need”or “market demand” and there are a “finite number”of solutions. 550 U.S. at 421 (“The same constrictedanalysis led the Court of Appeals to conclude, inerror, that a patent claim cannot be proved obviousmerely by showing that the combination of elementswas ‘[o]bvious to try.’ ... When there is a designneed or market pressure to solve a problem and thereare a finite number of identified, predictablesolutions, a person of ordinary skill has good reasonto pursue the known options within his or hertechnical grasp. If this leads to the anticipatedsuccess, it is likely the product not of innovation butof ordinary skill and common sense. In that instancethe fact that a combination was obvious to try mightshow that it was obvious under §103.”). Thus, after KSR, the presence of a known result-effectivevariable would be one, but not the only, motivationfor a person of ordinary skill in the art to experimentto reach another workable product or process.

2100-246Rev. 08.2017, January 2018


III. REBUTTAL OF PRIMA FACIE CASE OFOBVIOUSNESS

A. Showing That the Range Is Critical

Applicants can rebut a prima facie case ofobviousness by showing the criticality of the range.“The law is replete with cases in which the differencebetween the claimed invention and the prior art issome range or other variable within the claims. . . .In such a situation, the applicant must show that theparticular range is critical, generally by showing thatthe claimed range achieves unexpected resultsrelative to the prior art range.” In re Woodruff, 919F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Seealso Minerals Separation, Ltd. v. Hyde, 242 U.S.261, 271 (1916) (a patent based on a change in theproportions of a prior product or process (changingfrom 4-10% oil to 1% oil) must be confined to theproportions that were shown to be critical (1%)); Inre Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205(CCPA 1946) (“Where the issue of criticality isinvolved, the applicant has the burden of establishinghis position by a proper showing of the facts uponwhich he relies.”); In re Becket, 88 F.2d 684 (CCPA1937) (“Where the component elements of alloysare the same, and where they approach so closelythe same range of quantities as is here the case, itseems that there ought to be some noticeabledifference in the qualities of the respective alloys.”); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) (“Itis well established that, while a change in theproportions of a combination shown to be old, suchas is here involved, may be inventive, such changesmust be critical as compared with the proportionsused in the prior processes, producing a differencein kind rather than degree.”); In re Wells, 56 F.2d674, 675 (CCPA 1932) (“Changes in proportions ofagents used in combinations . . . in order to bepatentable, must be critical as compared with theproportions of the prior processes.”).

See MPEP § 716.02 - § 716.02(g) for a discussionof criticality and unexpected results.

B. Showing That the Prior Art Teaches Away

A prima facie case of obviousness may also berebutted by showing that the art, in any materialrespect, teaches away from the claimed invention.

In re Geisler, 116 F.3d 1465, 1471, 43 USPQ2d1362, 1366 (Fed. Cir. 1997) (Applicant argued thatthe prior art taught away from use of a protectivelayer for a reflective article having a thickness withinthe claimed range of “50 to 100 Angstroms.”Specifically, a patent to Zehender, which was reliedupon to reject applicant’s claim, included a statementthat the thickness of the protective layer “should benot less than about [100 Angstroms].” The court heldthat the patent did not teach away from the claimedinvention. “Zehender suggests that there are benefitsto be derived from keeping the protective layer asthin as possible, consistent with achieving adequateprotection. A thinner coating reduces light absorptionand minimizes manufacturing time and expense.Thus, while Zehender expresses a preference for athicker protective layer of 200-300 Angstroms, atthe same time it provides the motivation for one ofordinary skill in the art to focus on thickness levelsat the bottom of Zehender’s ‘suitable’ range- about100 Angstroms- and to explore thickness levelsbelow that range. The statement in Zehender that‘[i]n general, the thickness of the protective layershould be not less than about [100 Angstroms]’ fallsfar short of the kind of teaching that woulddiscourage one of skill in the art from fabricating aprotective layer of 100 Angstroms or less. [W]e aretherefore ‘not convinced that there was a sufficientteaching away in the art to overcome [the] strongcase of obviousness’ made out by Zehender.”). SeeMPEP § 2145, subsection X.D., for a discussion of“teaching away” references.

Applicant can rebut a presumption of obviousnessbased on a claimed invention that falls within a priorart range by showing “(1) [t]hat the prior art taughtaway from the claimed invention...or (2) that thereare new and unexpected results relative to the priorart.” Iron Grip Barbell Co., Inc. v. USA Sports, Inc.,392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed.Cir. 2004). The court found that patentee offeredneither evidence of teaching away of the prior artnor new and unexpected results of the claimedinvention drawn to a weight plate having 3 elongatedhandle openings. 392 F.3d at 1323, 73 USPQ2d at1229. The court then turned to consideringsubstantial evidence of pertinent secondary factorssuch as commercial success, satisfaction of along-felt need, and copying by others may alsosupport patentability. Id. Nevertheless, the court

Rev. 08.2017, January 20182100-247


found that Iron Grip failed to show evidence ofcommercial success, copying by others, orsatisfaction of a long felt need for the followingreasons: (A) Iron Grip’s licensing of its patent tothree competitors was insufficient to show nexusbetween the “merits of the invention and thelicenses,” and thus did not establish secondaryconsideration of commercial success; (B) in responseto Iron Grip’s argument that the competitor’sproduction of a three-hole plate is evidence ofcopying, the court stated that “[n]ot every competingproduct that falls within the scope of a patent isevidence of copying” since “[o]therwise everyinfringement suit would automatically confirm thenonobviousness of the patent;” and (C) althoughIron Grip offered as evidence that the absence of thethree-grip plate on the market prior to its patentshowed that the invention was nonobviousness, thecourt stated that “[a]bsent a showing of a long-feltneed or the failure of others, the mere passage oftime without the claimed invention is not evidenceof nonobviousness.” 392 F.3d at 1324-25,73 USPQ2d at 1229-30.

2144.06 Art Recognized Equivalence for theSame Purpose [R-08.2012]

I. COMBINING EQUIVALENTS KNOWN FORTHE SAME PURPOSE

“It is prima facie obvious to combine twocompositions each of which is taught by the priorart to be useful for the same purpose, in order toform a third composition to be used for the verysame purpose.... [T]he idea of combining them flowslogically from their having been individually taughtin the prior art.” In re Kerkhoven, 626 F.2d 846,850, 205 USPQ 1069, 1072 (CCPA 1980) (citationsomitted) (Claims to a process of preparing aspray-dried detergent by mixing together twoconventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279F.2d 274, 126 USPQ 186 (CCPA 1960) (Claimsdirected to a method and material for treating castiron using a mixture comprising calcium carbide andmagnesium oxide were held unpatentable over priorart disclosures that the aforementioned componentsindividually promote the formation of a nodularstructure in cast iron.); and Ex parte Quadranti,25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992)

(mixture of two known herbicides held prima facieobvious).

II. SUBSTITUTING EQUIVALENTS KNOWN FORTHE SAME PURPOSE

In order to rely on equivalence as a rationalesupporting an obviousness rejection, the equivalencymust be recognized in the prior art, and cannot bebased on applicant’s disclosure or the mere fact thatthe components at issue are functional or mechanicalequivalents. In re Ruff, 256 F.2d 590, 118 USPQ340 (CCPA 1958) (The mere fact that componentsare claimed as members of a Markush group cannotbe relied upon to establish the equivalency of thesecomponents. However, an applicant’s expressedrecognition of an art-recognized or obviousequivalent may be used to refute an argument thatsuch equivalency does not exist.); Smith v. Hayashi,209 USPQ 754 (Bd. of Pat. Inter. 1980) (The merefact that phthalocyanine and selenium function asequivalent photoconductors in the claimedenvironment was not sufficient to establish that onewould have been obvious over the other. However,there was evidence that both phthalocyanine andselenium were known photoconductors in the art ofelectrophotography. “This, in our view, presentsstrong evidence of obviousness in substituting onefor the other in an electrophotographic environmentas a photoconductor.” 209 USPQ at 759.).

An express suggestion to substitute one equivalentcomponent or process for another is not necessaryto render such substitution obvious. In re Fout, 675F.2d 297, 213 USPQ 532 (CCPA 1982).

2144.07 Art Recognized Suitability for anIntended Purpose [R-08.2012]

The selection of a known material based on itssuitability for its intended use supported a primafacie obviousness determination in Sinclair &Carroll Co. v. Interchemical Corp., 325 U.S. 327,65 USPQ 297 (1945) (Claims to a printing inkcomprising a solvent having the vapor pressurecharacteristics of butyl carbitol so that the ink wouldnot dry at room temperature but would dry quicklyupon heating were held invalid over a referenceteaching a printing ink made with a different solventthat was nonvolatile at room temperature but highly

2100-248Rev. 08.2017, January 2018


volatile when heated in view of an article whichtaught the desired boiling point and vapor pressurecharacteristics of a solvent for printing inks and acatalog teaching the boiling point and vapor pressurecharacteristics of butyl carbitol. “Reading a list andselecting a known compound to meet knownrequirements is no more ingenious than selectingthe last piece to put in the last opening in a jig-sawpuzzle.” 325 U.S. at 335, 65 USPQ at 301.).

See also In re Leshin, 277 F.2d 197, 125 USPQ 416(CCPA 1960) (selection of a known plastic to makea container of a type made of plastics prior to theinvention was held to be obvious); Ryco,Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d1323 (Fed. Cir. 1988) (Claimed agricultural baggingmachine, which differed from a prior art machineonly in that the brake means were hydraulicallyoperated rather than mechanically operated, was heldto be obvious over the prior art machine in view ofreferences which disclosed hydraulic brakes forperforming the same function, albeit in a differentenvironment.).

2144.08 Obviousness of Species When PriorArt Teaches Genus [R-07.2015]


I. EXAMINATION OF CLAIMS DIRECTED TOSPECIES BASED UPON A SINGLE PRIOR ARTREFERENCE

When a single prior art reference which discloses agenus encompassing the claimed species or subgenusbut does not expressly disclose the particular claimedspecies or subgenus, Office personnel should attemptto find additional prior art to show that thedifferences between the prior art primary referenceand the claimed invention as a whole would havebeen obvious. Where such additional prior art is notfound, Office personnel should consider the factorsdiscussed below to determine whether a single

reference 35 U.S.C. 103 rejection would beappropriate.

II. DETERMINE WHETHER THE CLAIMEDSPECIES OR SUBGENUS WOULD HAVE BEENOBVIOUS TO ONE OF ORDINARY SKILL IN THEPERTINENT ART AT THE TIME THE INVENTIONWAS MADE

The patentability of a claim to a specific compound,species, or subgenus embraced by a prior art genusshould be analyzed no differently than any otherclaim for purposes of 35 U.S.C. 103. “The section103 requirement of unobviousness is no different inchemical cases than with respect to other categoriesof patentable inventions.” In re Papesch, 315 F.2d381, 385, 137 USPQ 43, 47 (CCPA 1963). Adetermination of patentability under 35 U.S.C. 103should be made upon the facts of the particular casein view of the totality of the circumstances. See, e.g., In re Dillon, 919 F.2d 688, 692-93, 16 USPQ2d1897, 1901 (Fed. Cir. 1990) (en banc). Use of perse rules by Office personnel is improper fordetermining whether claimed subject matter wouldhave been obvious under 35 U.S.C. 103. See, e.g., In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663,1666 (Fed. Cir. 1996); In re Ochiai, 71 F.3d 1565,1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995); Inre Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552(Fed. Cir. 1994). The fact that a claimed species orsubgenus is encompassed by a prior art genus is notsufficient by itself to establish a prima facie caseof obviousness. In re Baird, 16 F.3d 380, 382, 29USPQ2d 1550, 1552 (Fed. Cir. 1994) (“The fact thata claimed compound may be encompassed by adisclosed generic formula does not by itself renderthat compound obvious.”); In re Jones, 958 F.2d347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992)(Federal Circuit has “decline[d] to extract from Merck [ & Co. v. Biocraft Laboratories Inc., 874F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] therule that... regardless of how broad, a disclosure ofa chemical genus renders obvious any species thathappens to fall within it.”).

A. Establishing a Prima Facie Case of Obviousness

A proper obviousness analysis involves a three-stepprocess. First, Office personnel should establish a prima facie case of unpatentability considering the

Rev. 08.2017, January 20182100-249


factors set out by the Supreme Court in Graham v.John Deere, 383 U.S. 1, 148 USPQ 459 (1966). See,e.g., In re Bell, 991 F.2d 781, 783, 26 USPQ2d1529, 1531 (Fed. Cir. 1993) (“The PTO bears theburden of establishing a case of prima facieobviousness.”); In re Rijckaert, 9 F.3d 1531, 1532,28 USPQ2d 1955, 1956 (Fed. Cir. 1993); In reOetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443,1444 (Fed. Cir. 1992). Graham at 17-18, 148 USPQat 467 requires that to make out a case ofobviousness, one must:

(A) determine the scope and contents of the priorart;

(B) ascertain the differences between the priorart and the claims in issue;

(C) determine the level of ordinary skill in thepertinent art; and

(D) evaluate any evidence of secondaryconsiderations.

If a prima facie case is established, the burden shiftsto applicant to come forward with rebuttal evidenceor argument to overcome the prima facie case. See,e.g., Bell, 991 F.2d at 783-84, 26 USPQ2d at 1531; Rijckaert, 9 F.3d at 1532, 28 USPQ2d at 1956; Oetiker, 977 F.2d at 1445, 24 USPQ2d at 1444 .Finally, Office personnel should evaluate the totalityof the facts and all of the evidence to determinewhether they still support a conclusion that theclaimed invention would have been obvious to oneof ordinary skill in the art at the time the inventionwas made. Graham, at 17-18, 148 USPQ at 467.

1. Determine the Scope and Content of the Prior Art

As an initial matter, Office personnel shoulddetermine the scope and content of the relevant priorart. Each reference must qualify as prior art under35 U.S.C. 102 (e.g., Panduit Corp. v. Dennison Mfg.Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, 1597(Fed. Cir. 1987) (“Before answering Graham’s‘content’ inquiry, it must be known whether a patentor publication is in the prior art under 35 U.S.C.§ 102.”)) and should be analogous art. See MPEP §2141.01(a) .

In the case of a prior art reference disclosing a genus,Office personnel should make findings as to:

(A) the structure of the disclosed prior art genusand that of any expressly described species orsubgenus within the genus;

(B) any physical or chemical properties andutilities disclosed for the genus, as well as anysuggested limitations on the usefulness of the genus,and any problems alleged to be addressed by thegenus;

(C) the predictability of the technology; and

(D) the number of species encompassed by thegenus taking into consideration all of the variablespossible.

2. Ascertain the Differences Between the ClosestDisclosed Prior Art Species or Subgenus of Recordand the Claimed Species or Subgenus

Once the structure of the disclosed prior art genusand that of any expressly described species orsubgenus within the genus are identified, Officepersonnel should compare it to the claimed speciesor subgenus to determine the differences. Throughthis comparison, the closest disclosed species orsubgenus in the prior art reference should beidentified and compared to that claimed. Officepersonnel should make explicit findings on thesimilarities and differences between the closestdisclosed prior art species or subgenus of record andthe claimed species or subgenus including findingsrelating to similarity of structure, properties andutilities. In Stratoflex, Inc. v. Aeroquip Corp., 713F.2d 1530, 1537, 218 USPQ 871, 877 (Fed. Cir.1983), the court noted that “the question under35 U.S.C. § 103 is not whether the differences[between the claimed invention and the prior art]would have been obvious” but “whether the claimedinvention as a whole would have been obvious.”(emphasis in original).

3. Determine the Level of Skill in the Art

Office personnel should evaluate the prior art fromthe standpoint of the hypothetical person havingordinary skill in the art at the time the claimedinvention was made. See, Ryko Mfg. Co. v. Nu-StarInc., 950 F.2d 714, 718, 21 USPQ2d 1053, 1057(Fed. Cir. 1991) (“The importance of resolving thelevel of ordinary skill in the art lies in the necessityof maintaining objectivity in the obviousnessinquiry.”); Uniroyal Inc. v. Rudkin-Wiley Corp.,

2100-250Rev. 08.2017, January 2018


837 F.2d 1044, 1050, 5 USPQ2d 1434, 1438 (Fed.Cir. 1988) (evidence must be viewed from positionof ordinary skill, not of an expert). In most cases,the only facts of record pertaining to the level ofskill in the art will be found within the prior artreference. However, any additional evidencepresented by applicant should be evaluated.

4. Determine Whether One of Ordinary Skill in theArt Would Have Been Motivated To Select theClaimed Species or Subgenus

In light of the findings made relating to the three Graham factors, Office personnel should determinewhether it would have been obvious to one ofordinary skill in the relevant art to make the claimedinvention as a whole, i.e., to select the claimedspecies or subgenus from the disclosed prior artgenus. To address this key issue, Office personnelshould consider all relevant prior art teachings,focusing on the following, where present.

(a) Consider the Size of the Genus

Consider the size of the prior art genus, bearing inmind that size alone cannot support an obviousnessrejection. There is no absolute correlation betweenthe size of the prior art genus and a conclusion ofobviousness. See, e.g., Baird, 16 F.3d at 383, 29USPQ2d at 1552. Thus, the mere fact that a prior artgenus contains a small number of members does notcreate a per se rule of obviousness. However, agenus may be so small that, when considered in lightof the totality of the circumstances, it wouldanticipate the claimed species or subgenus. Forexample, it has been held that a prior art genuscontaining only 20 compounds and a limited numberof variations in the generic chemical formulainherently anticipated a claimed species within thegenus because “one skilled in [the] art would...envisage each member” of the genus. In rePetering, 301 F.2d 676, 681, 133 USPQ 275,280 (CCPA 1962) (emphasis in original). Morespecifically, the court in Petering stated:

A simple calculation will show that, excludingisomerism within certain of the R groups, thelimited class we find in Karrer contains only20 compounds. However, we wish to point outthat it is not the mere number of compounds in

this limited class which is significant here but,rather, the total circumstances involved,including such factors as the limited numberof variations for R, only two alternatives for Yand Z, no alternatives for the other ringpositions, and a large unchanging parentstructural nucleus. With these circumstancesin mind, it is our opinion that Karrer hasdescribed to those with ordinary skill in this arteach of the various permutations here involvedas fully as if he had drawn each structuralformula or had written each name.

Id. (emphasis in original). Accord In re Schaumann,572 F.2d 312, 316, 197 USPQ 5, 9 (CCPA 1978)(prior art genus encompassing claimed species whichdisclosed preference for lower alkyl secondaryamines and properties possessed by the claimedcompound constituted description of claimedcompound for purposes of pre-AIA 35 U.S.C.102(b)). C.f., In re Ruschig, 343 F.2d 965, 974, 145USPQ 274, 282 (CCPA 1965) (Rejection of claimedcompound in light of prior art genus based on Petering is not appropriate where the prior art doesnot disclose a small recognizable class of compoundswith common properties.).

(b) Consider the Express Teachings

If the prior art reference expressly teaches aparticular reason to select the claimed species orsubgenus, Office personnel should point out theexpress disclosure and explain why it would havebeen obvious to one of ordinary skill in the art toselect the claimed invention. An express teachingmay be based on a statement in the prior art referencesuch as an art recognized equivalence. For example,see Merck & Co. v. Biocraft Labs., 874 F.2d 804,807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989)(holding claims directed to diuretic compositionscomprising a specific mixture of amiloride andhydrochlorothiazide were obvious over a prior artreference expressly teaching that amiloride was apyrazinoylguanidine which could be coadministeredwith potassium excreting diuretic agents, includinghydrochlorothiazide which was a named example,to produce a diuretic with desirable sodium andpotassium eliminating properties). See also, In reKemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309, 1312(Fed. Cir. 1996) (holding it would have been obvious

Rev. 08.2017, January 20182100-251


to combine teachings of prior art to achieve claimedinvention where one reference specifically refers tothe other).

(c) Consider the Teachings of Structural Similarity

Consider any teachings of a “typical,” “preferred,”or “optimum” species or subgenus within thedisclosed genus. If such a prior art species orsubgenus is structurally similar to that claimed, itsdisclosure may provide a reason for one of ordinaryskill in the art to choose the claimed species orsubgenus from the genus, based on the reasonableexpectation that structurally similar species usuallyhave similar properties. See, e.g., Dillon, 919 F.2dat 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214(“Structural relationships may provide the requisitemotivation or suggestion to modify knowncompounds to obtain new compounds. For example,a prior art compound may suggest its homologsbecause homologs often have similar properties andtherefore chemists of ordinary skill would ordinarilycontemplate making them to try to obtain compoundswith improved properties.”).

In making an obviousness determination, Officepersonnel should consider the number of variableswhich must be selected or modified, and the natureand significance of the differences between the priorart and the claimed invention. See, e.g., In re Jones,958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed.Cir. 1992) (reversing obviousness rejection of noveldicamba salt with acyclic structure over broad priorart genus encompassing claimed salt, wheredisclosed examples of genus were dissimilar instructure, lacking an ether linkage or being cyclic); In re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425(CCPA 1971) (the difference from the particularlypreferred subgenus of the prior art was a hydroxylgroup, a difference conceded by applicant “to be oflittle importance”). In the area of biotechnology, anexemplified species may differ from a claimedspecies by a conservative substitution (“thereplacement in a protein of one amino acid byanother, chemically similar, amino acid... [which]is generally expected to lead to either no change oronly a small change in the properties of the protein.” Dictionary of Biochemistry and Molecular Biology97 (John Wiley & Sons, 2d ed. 1989)). The effect

of a conservative substitution on protein functiondepends on the nature of the substitution and itslocation in the chain. Although at some locations aconservative substitution may be benign, in someproteins only one amino acid is allowed at a givenposition. For example, the gain or loss of even onemethyl group can destabilize the structure if closepacking is required in the interior of domains. JamesDarnell et al., Molecular Cell Biology 51 (2d ed.1990).

The closer the physical and/or chemical similaritiesbetween the claimed species or subgenus and anyexemplary species or subgenus disclosed in the priorart, the greater the expectation that the claimedsubject matter will function in an equivalent mannerto the genus. See, e.g., Dillon, 919 F.2d at 696, 16USPQ2d at 1904 (and cases cited therein). Cf. Baird,16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosureof dissimilar species can provide teaching away).

Similarly, consider any teaching or suggestion in thereference of a preferred species or subgenus that issignificantly different in structure from the claimedspecies or subgenus. Such a teaching may weighagainst selecting the claimed species or subgenusand thus against a determination of obviousness. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552(reversing obviousness rejection of species in viewof large size of genus and disclosed “optimum”species which differed greatly from and were morecomplex than the claimed species); Jones, 958 F.2dat 350, 21 USPQ2d at 1943 (reversing obviousnessrejection of novel dicamba salt with acyclic structureover broad prior art genus encompassing claimedsalt, where disclosed examples of genus weredissimilar in structure, lacking an ether linkage orbeing cyclic). For example, teachings of preferredspecies of a complex nature within a disclosed genusmay motivate an artisan of ordinary skill to makesimilar complex species and thus teach away frommaking simple species within the genus. Baird, 16F.3d at 382, 29 USPQ2d at 1552. See also Jones,958 F.2d at 350, 21 USPQ2d at 1943 (disclosed saltsof genus held not sufficiently similar in structure torender claimed species prima facie obvious).

Concepts used to analyze the structural similarity ofchemical compounds in other types of chemical casesare equally useful in analyzing genus-species cases.

2100-252Rev. 08.2017, January 2018


For example, a claimed tetra-orthoester fuelcomposition was held to be obvious in light of aprior art tri-orthoester fuel composition based ontheir structural and chemical similarity and similaruse as fuel additives. Dillon, 919 F.2d at 692-93,16 USPQ2d at 1900-02. Likewise, claims toamitriptyline used as an antidepressant were heldobvious in light of the structural similarity toimipramine, a known antidepressant prior artcompound, where both compounds were tricyclicdibenzo compounds and differed structurally onlyin the replacement of the unsaturated carbon atomin the center ring of amitriptyline with a nitrogenatom in imipramine. In re Merck & Co., 800 F.2d1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir.1986). Other structural similarities have been foundto support a prima facie case of obviousness. See,e.g., In re May, 574 F.2d 1082, 1093-95, 197 USPQ601, 610-11 (CCPA 1978) (stereoisomers); In reWilder, 563 F.2d 457, 460, 195 USPQ 426, 429(CCPA 1977) (adjacent homologs and structuralisomers); In re Hoch, 428 F.2d 1341, 1344, 166USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41(CCPA 1963) (omission of methyl group frompyrazole ring). Generally, some teaching of astructural similarity will be necessary to suggestselection of the claimed species or subgenus. Id.

(d) Consider the Teachings of Similar Properties orUses

Consider the properties and utilities of thestructurally similar prior art species or subgenus. Itis the properties and utilities that provide real worldmotivation for a person of ordinary skill to makespecies structurally similar to those in the prior art. Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In reStemniski, 444 F.2d 581, 586, 170 USPQ 343, 348(CCPA 1971). Conversely, lack of any known usefulproperties weighs against a finding of motivation tomake or select a species or subgenus. In re Albrecht,514 F.2d 1389, 1392, 1395-96, 185 USPQ 585, 587,590 (CCPA 1975) (The prior art compound soirritated the skin that it could not be regarded asuseful for the disclosed anesthetic purpose, andtherefore a person skilled in the art would not havebeen motivated to make related compounds.); Stemniski, 444 F.2d at 586, 170 USPQ at 348 (closestructural similarity alone is not sufficient to create

a prima facie case of obviousness when thereference compounds lack utility, and thus there isno motivation to make related compounds.).However, the prior art need not disclose a newlydiscovered property in order for there to be a primafacie case of obviousness. Dillon, 919 F.2d at 697,16 USPQ2d at 1904-05 (and cases cited therein). Ifthe claimed invention and the structurally similarprior art species share any useful property, thatwill generally be sufficient to motivate an artisan ofordinary skill to make the claimed species, e.g., id.For example, based on a finding that a tri-orthoesterand a tetra-orthoester behave similarly in certainchemical reactions, it has been held that one ofordinary skill in the relevant art would have beenmotivated to select either structure. 919 F.2d at 692,16 USPQ2d at 1900-01. In fact, similar propertiesmay normally be presumed when compounds arevery close in structure. Dillon, 919 F.2d at 693, 696,16 USPQ2d at 1901, 1904. See also In re Grabiak,769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir.1985) (“When chemical compounds have ‘veryclose’ structural similarities and similar utilities,without more a prima facie case may be made.”).Thus, evidence of similar properties or evidence ofany useful properties disclosed in the prior art thatwould be expected to be shared by the claimedinvention weighs in favor of a conclusion that theclaimed invention would have been obvious. Dillon,919 F.2d at 697-98, 16 USPQ2d at 1905; In reWilder, 563 F.2d 457, 461, 195 USPQ 426,430 (CCPA 1977); In re Lintner, 458 F.2d 1013,1016, 173 USPQ 560, 562 (CCPA 1972).

(e) Consider the Predictability of the Technology

Consider the predictability of the technology. See,e.g., Dillon, 919 F.2d at 692-97, 16 USPQ2d at1901-05; In re Grabiak, 769 F.2d 729, 732-33, 226USPQ 870, 872 (Fed. Cir. 1985). If the technologyis unpredictable, it is less likely that structurallysimilar species will render a claimed species obviousbecause it may not be reasonable to infer that theywould share similar properties. See, e.g. , In re May,574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA1978) (prima facie obviousness of claimed analgesiccompound based on structurally similar prior artisomer was rebutted with evidence demonstratingthat analgesia and addiction properties could not bereliably predicted on the basis of chemical structure);

Rev. 08.2017, January 20182100-253


In re Schechter, 205 F.2d 185, 191, 98 USPQ 144,150 (CCPA 1953) (unpredictability in the insecticidefield, with homologs, isomers and analogs of knowneffective insecticides having proven ineffective asinsecticides, was considered as a factor weighingagainst a conclusion of obviousness of the claimedcompounds). However, obviousness does not requireabsolute predictability, only a reasonable expectationof success, i.e., a reasonable expectation of obtainingsimilar properties. See , e.g. , In re O’Farrell, 853F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir.1988).

(f) Consider Any Other Teaching To Support theSelection of the Species or Subgenus

The categories of relevant teachings enumeratedabove are those most frequently encountered in agenus-species case, but they are not exclusive. Officepersonnel should consider the totality of the evidencein each case. In unusual cases, there may be otherrelevant teachings sufficient to support the selectionof the species or subgenus and, therefore, aconclusion of obviousness.

5. Make Express Fact-Findings and DetermineWhether They Support a Prima Facie Case ofObviousness

Based on the evidence as a whole (In re Bell, 991F.2d 781,784, 26 USPQ2d 1529, 1531 (Fed. Cir.1993); In re Kulling, 897 F.2d 1147, 1149,14 USPQ2d 1056, 1057 (Fed. Cir. 1990)), Officepersonnel should make express fact-findings relatingto the Graham factors, focusing primarily on theprior art teachings discussed above. The fact-findingsshould specifically articulate what teachings orsuggestions in the prior art would have motivatedone of ordinary skill in the art to select the claimedspecies or subgenus. Kulling, 897 F.2d at 1149, 14USPQ2d at 1058; Panduit Corp. v. Dennison Mfg.Co., 810 F.2d 1561, 1579 n.42, 1 USQP2d 1593,1606 n.42 (Fed. Cir. 1987). Thereafter, it should bedetermined whether these findings, considered as awhole, support a prima facie case that the claimedinvention would have been obvious to one ofordinary skill in the relevant art at the time theinvention was made.

2144.09 Close Structural Similarity BetweenChemical Compounds (Homologs, Analogues,Isomers) [R-08.2017]


I. REJECTION BASED ON CLOSE STRUCTURALSIMILARITY IS FOUNDED ON THEEXPECTATION THAT COMPOUNDS SIMILARIN STRUCTURE WILL HAVE SIMILARPROPERTIES

A prima facie case of obviousness may be madewhen chemical compounds have very close structuralsimilarities and similar utilities. “An obviousnessrejection based on similarity in chemical structureand function entails the motivation of one skilled inthe art to make a claimed compound, in theexpectation that compounds similar in structure willhave similar properties.” In re Payne, 606 F.2d 303,313, 203 USPQ 245, 254 (CCPA 1979). See Inre Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963) (discussed in more detail below) and Inre Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir.1990) (discussed below and in MPEP § 2144) foran extensive review of the case law pertaining toobviousness based on close structural similarity ofchemical compounds. See also MPEP § 2144.08,subsection II.A.4.(c).

II. HOMOLOGY AND ISOMERISM ARE FACTSWHICH MUST BE CONSIDERED WITH ALLOTHER RELEVANT FACTS IN DETERMININGOBVIOUSNESS

Compounds which are position isomers (compoundshaving the same radicals in physically differentpositions on the same nucleus) or homologs(compounds differing regularly by the successiveaddition of the same chemical group, e.g., by -CH2-

groups) are generally of sufficiently close structuralsimilarity that there is a presumed expectation thatsuch compounds possess similar properties. In

2100-254Rev. 08.2017, January 2018


re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA1977). See also In re May, 574 F.2d 1082, 197USPQ 601 (CCPA 1978) (stereoisomers prima facieobvious).

Isomers having the same empirical formula butdifferent structures are not necessarily consideredequivalent by chemists skilled in the art and thereforeare not necessarily suggestive of each other. Exparte Mowry, 91 USPQ 219 (Bd. App. 1950)(claimed cyclohexylstyrene not prima facie obviousover prior art isohexylstyrene). Similarly, homologswhich are far removed from adjacent homologs maynot be expected to have similar properties. Inre Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960)(prior art disclosure of C8 to C12 alkyl sulfates was

not sufficient to render prima facie obvious claimedC1 alkyl sulfate).

Homology and isomerism involve close structuralsimilarity which must be considered with all otherrelevant facts in determining the issue ofobviousness. In re Mills, 281 F.2d 218, 126 USPQ513 (CCPA 1960); In re Wiechert, 370 F.2d 927,152 USPQ 247 (CCPA 1967). Homology should notbe automatically equated with prima facieobviousness because the claimed invention and theprior art must each be viewed “as a whole.” In reLanger, 465 F.2d 896, 175 USPQ 169 (CCPA 1972)(Claims to a polymerization process using a stericallyhindered amine were held unobvious over a similarprior art process because the prior art disclosed alarge number of unhindered amines and only onesterically hindered amine (which differed from aclaimed amine by 3 carbon atoms), and thereforethe reference as a whole did not apprise the ordinaryartisan of the significance of hindered amines as aclass.).

III. PRESENCE OF A TRUE HOMOLOGOUS ORISOMERIC RELATIONSHIP IS NOTCONTROLLING

Prior art structures do not have to be true homologsor isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303,203 USPQ 245 (CCPA 1979) (Claimed and priorart compounds were both directed to heterocycliccarbamoyloximino compounds having pesticidalactivity. The only structural difference between the

claimed and prior art compounds was that the ringstructures of the claimed compounds had two carbonatoms between two sulfur atoms whereas the priorart ring structures had either one or three carbonatoms between two sulfur atoms. The court held thatalthough the prior art compounds were not truehomologs or isomers of the claimed compounds, thesimilarity between the chemical structures andproperties is sufficiently close that one of ordinaryskill in the art would have been motivated to makethe claimed compounds in searching for newpesticides.).

See also In re Mayne, 104 F.3d 1339, 41 USPQ2d1451 (Fed. Cir. 1997) (claimed protein was held tobe obvious in light of structural similarities to theprior art, including known structural similarity ofIle and Lev); In re Merck & Co., Inc., 800 F.2d1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed andprior art compounds used in a method of treatingdepression would have been expected to have similaractivity because the structural difference betweenthe compounds involved a known bioisostericreplacement) (see MPEP § 2144.08, subsectionII.A.4(c) for a more detailed discussion of the factsin the Mayne and Merck cases); In re Dillon, 919F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (Thetri-orthoester fuel compositions of the prior art andthe claimed tetra-orthoester fuel compositions wouldhave been expected to have similar properties basedon close structural and chemical similarity betweenthe orthoesters and the fact that both the prior artand applicant used the orthoesters as fuel additives.)(See MPEP § 2144 for a more detailed discussionof the facts in the Dillon case.).

Compare In re Grabiak, 769 F.2d 729, 226 USPQ871 (Fed. Cir. 1985) (substitution of a thioestergroup for an ester group in an herbicidal safenercompound was not suggested by the prior art); Inre Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir.1993) (The established relationship between anucleic acid and the protein it encodes in the geneticcode does not render a gene prima facie obviousover its corresponding protein in the same way thatclosely related structures in chemistry may create a prima facie case because there are a vast numberof nucleotide sequences that might encode for aspecific protein as a result of degeneracy in thegenetic code (i.e., the fact that most amino acids are

Rev. 08.2017, January 20182100-255


specified by more than one nucleotide sequence orcodon).); In re Deuel, 51 F.3d 1552, 1558-59, 34USPQ2d 1210, 1215 (Fed. Cir. 1995) (“A prior artdisclosure of the amino acid sequence of a proteindoes not necessarily render particular DNAmolecules encoding the protein obvious because theredundancy of the genetic code permits one tohypothesize an enormous number of DNA sequencescoding for the protein.” The existence of a generalmethod of gene cloning in the prior art is notsufficient, without more, to render obvious aparticular cDNA molecule.).

IV. PRESENCE OR ABSENCE OF PRIOR ARTSUGGESTION OF METHOD OF MAKING ACLAIMED COMPOUND MAY BE RELEVANT INDETERMINING PRIMA FACIE OBVIOUSNESS

“[T]he presence—or absence—of a suitablyoperative, obvious process for making a compositionof matter may have an ultimate bearing on whetherthat composition is obvious—or nonobvious—under35 U.S.C. 103.” In re Maloney, 411 F.2d 1321,1323, 162 USPQ 98, 100 (CCPA 1969).

“[I]f the prior art of record fails to disclose or renderobvious a method for making a claimed compound,at the time the invention was made, it may not belegally concluded that the compound itself is in thepossession of the public. In this context, we say thatthe absence of a known or obvious process formaking the claimed compounds overcomes apresumption that the compounds are obvious, basedon the close relationships between their structuresand those of prior art compounds.” In re Hoeksema,399 F.2d 269, 274-75, 158 USPQ 597, 601 (CCPA1968).

See In re Payne, 606 F.2d 303, 203 USPQ 245(CCPA 1979) for a general discussion ofcircumstances under which the prior art suggestsmethods for making novel compounds which are ofclose structural similarity to compounds known inthe prior art. It may be proper to apply “methodologyin rejecting product claims under 35 U.S.C. 103,depending on the particular facts of the case, themanner and context in which methodology applies,and the overall logic of the rejection.” Ex parteGoldgaber, 41 USPQ2d 1172, 1176 (Bd. Pat. App.& Inter. 1996).

V. PRESUMPTION OF OBVIOUSNESS BASED ONSTRUCTURAL SIMILARITY IS OVERCOMEWHERE THERE IS NO REASONABLEEXPECTATION OF SIMILAR PROPERTIES

The presumption of obviousness based on a referencedisclosing structurally similar compounds may beovercome where there is evidence showing there isno reasonable expectation of similar properties instructurally similar compounds. In re May, 574 F.2d1082, 197 USPQ 601 (CCPA 1978) (appellantproduced sufficient evidence to establish asubstantial degree of unpredictability in the pertinentart area, and thereby rebutted the presumption thatstructurally similar compounds have similarproperties); In re Schechter, 205 F.2d 185, 98 USPQ144 (CCPA 1953). See also Ex parte Blattner, 2USPQ2d 2047 (Bd. Pat. App. & Inter. 1987) (Claimsdirected to compounds containing a 7-memberedring were rejected as prima facie obvious over areference which taught 5- and 6-membered ringhomologs of the claimed compounds. The Boardreversed the rejection because the prior art taughtthat the compounds containing a 5-membered ringpossessed the opposite utility of the compoundscontaining the 6-membered ring, undermining theexaminer’s asserted prima facie case arising froman expectation of similar results in the claimedcompounds which contain a 7-membered ring.).

VI. IF PRIOR ART COMPOUNDS HAVE NOUTILITY, OR UTILITY ONLY ASINTERMEDIATES, CLAIMED STRUCTURALLYSIMILAR COMPOUNDS MAY NOT BE PRIMAFACIE OBVIOUS OVER THE PRIOR ART

If the prior art does not teach any specific orsignificant utility for the disclosed compounds, thenthe prior art is unlikely to render structurally similarclaims prima facie obvious in the absence of anyreason for one of ordinary skill in the art to makethe reference compounds or any structurally relatedcompounds. In re Stemniski, 444 F.2d 581,170 USPQ 343 (CCPA 1971).

See also In re Albrecht, 514 F.2d 1389, 1396, 185USPQ 585, 590 (CCPA 1975) (prior art referencestudied the local anesthetic activity of variouscompounds, and taught that compounds structurallysimilar to those claimed were irritating to human

2100-256Rev. 08.2017, January 2018


skin and therefore “cannot be regarded as usefulanesthetics.” 514 F.2d at 1393, 185 USPQ at 587).

Similarly, if the prior art merely disclosescompounds as intermediates in the production of afinal product, one of ordinary skill in the art wouldnot ordinarily stop the reference synthesis andinvestigate the intermediate compounds with anexpectation of arriving at claimed compounds whichhave different uses. In re Lalu, 747 F.2d 703,223 USPQ 1257 (Fed. Cir. 1984).

VII. PRIMA FACIE CASE REBUTTABLE BYEVIDENCE OF SUPERIOR OR UNEXPECTEDRESULTS

A prima facie case of obviousness based onstructural similarity is rebuttable by proof that theclaimed compounds possess unexpectedlyadvantageous or superior properties. In re Papesch,315 F.2d 381, 137 USPQ 43 (CCPA 1963) (affidavitevidence which showed that claimed triethylatedcompounds possessed anti-inflammatory activitywhereas prior art trimethylated compounds did notwas sufficient to overcome obviousness rejectionbased on the homologous relationship between theprior art and claimed compounds); In re Wiechert,370 F.2d 927, 152 USPQ 247 (CCPA 1967) (a 7-foldimprovement of activity over the prior art heldsufficient to rebut prima facie obviousness basedon close structural similarity).

However, a claimed compound may be obviousbecause it was suggested by, or structurally similarto, a prior art compound even though a particularbenefit of the claimed compound asserted bypatentee is not expressly disclosed in the prior art.It is the differences in fact in their respectiveproperties which are determinative ofnonobviousness. If the prior art compound does infact possess a particular benefit, even though thebenefit is not recognized in the prior art, applicant’srecognition of the benefit is not in itself sufficientto distinguish the claimed compound from the priorart. In re Dillon, 919 F.2d 688, 16 USPQ2d 1897(Fed. Cir. 1990).

See MPEP § 716.02 - § 716.02(g) for a discussionof evidence alleging unexpectedly advantageous orsuperior results.

2145 Consideration of Applicant’s RebuttalArguments [R-08.2012]


If a prima facie case of obviousness is established,the burden shifts to the applicant to come forwardwith arguments and/or evidence to rebut the primafacie case. See, e.g., In re Dillon, 919 F.2d 688,692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990).Rebuttal evidence and arguments can be presentedin the specification, In re Soni, 54 F.3d 746, 750,34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel,In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089,1094-95 (Fed. Cir. 1995), or by way of an affidavitor declaration under 37 CFR 1.132, e.g., Soni, 54F.3d at 750, 34 USPQ2d at 1687; In re Piasecki,745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed.Cir. 1984). However, arguments of counsel cannottake the place of factually supported objectiveevidence. See, e.g., In re Huang, 100 F.3d 135,139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ191, 196 (Fed. Cir. 1984).

Office personnel should consider all rebuttalarguments and evidence presented by applicants.See, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687(error not to consider evidence presented in thespecification). C.f., In re Alton, 76 F.3d 1168, 37USPQ2d 1578 (Fed. Cir. 1996) (error not to considerfactual evidence submitted to counter a 35 U.S.C.112 rejection); In re Beattie, 974 F.2d 1309, 1313,24 USPQ2d 1040, 1042-43 (Fed. Cir. 1992) (Officepersonnel should consider declarations from thoseskilled in the art praising the claimed invention andopining that the art teaches away from theinvention.); Piasecki, 745 F.2d at 1472, 223 USPQat 788 (“[Rebuttal evidence] may relate to any ofthe Graham factors including the so-calledsecondary considerations.”).

Rev. 08.2017, January 20182100-257


Rebuttal evidence may include evidence of“secondary considerations,” such as “commercialsuccess, long felt but unsolved needs, [and] failureof others.” Graham v. John Deere Co., 383 U.S. 1,148 USPQ 4459, 467. See also, e.g., In re Piasecki,745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir.1984) (commercial success). Rebuttal evidence mayalso include evidence that the claimed inventionyields unexpectedly improved properties orproperties not present in the prior art. Rebuttalevidence may consist of a showing that the claimedcompound possesses unexpected properties. Dillon,919 F.2d at 692-93, 16 USPQ2d at 1901. A showingof unexpected results must be based on evidence,not argument or speculation. In re Mayne, 104 F.3d1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed.Cir. 1997) (conclusory statements that claimedcompound possesses unusually low immune responseor unexpected biological activity that is unsupportedby comparative data held insufficient to overcome prima facie case of obviousness). Rebuttal evidencemay include evidence that the claimed invention wascopied by others. See, e.g., In re GPAC, 57 F.3d1573, 1580, 35 USPQ2d 1116, 1121 (Fed. Cir.1995); Hybritech Inc. v. Monoclonal Antibodies,802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir.1986). It may also include evidence of the state ofthe art, the level of skill in the art, and the beliefs ofthose skilled in the art. See, e.g., In re Oelrich, 579F.2d 86, 91-92, 198 USPQ 210, 214 (CCPA 1978)(Expert opinions regarding the level of skill in theart were probative of the Nonobviousness of theclaimed invention.); Piasecki, 745 F.2d at 1471,1473-74, 223 USPQ at 790 (Evidence ofnontechnological nature is pertinent to the conclusionof obviousness. The declarations of those skilled inthe art regarding the need for the invention and itsreception by the art were improperly discounted bythe Board.); Beattie, 974 F.2d at 1313, 24 USPQ2dat 1042-43 (Seven declarations provided by musicteachers opining that the art teaches away from theclaimed invention must be considered, but were notprobative because they did not contain facts and didnot deal with the specific prior art that was thesubject of the rejection.). For example, rebuttalevidence may include a showing that the prior artfails to disclose or render obvious a method formaking the compound, which would preclude aconclusion of obviousness of the compound. Aconclusion of obviousness requires that the

reference(s) relied upon be enabling in that it put thepublic in possession of the claimed invention. Thecourt in In re Hoeksema, 399 F.2d 269, 274,158 USPQ 596, 601 (CCPA 1968), stated:

Thus, upon careful reconsideration it is ourview that if the prior art of record fails todisclose or render obvious a method for makinga claimed compound, at the time the inventionwas made, it may not be legally concluded thatthe compound itself is in the possession of thepublic. [footnote omitted.] In this context, wesay that the absence of a known or obviousprocess for making the claimed compoundsovercomes a presumption that the compoundsare obvious, based on close relationshipsbetween their structures and those of prior artcompounds.

The Hoeksema court further noted that once a primafacie case of obviousness is made by the PTOthrough citation of references, the burden is on theapplicant to produce contrary evidence establishingthat the reference being relied on would not enablea skilled artisan to produce the different compoundsclaimed. Id. at 274-75, 158 USPQ at 601. See also Ashland Oil, Inc. v. Delta Resins & Refractories,Inc., 776 F.2d 281, 295, 297, 227 USPQ 657, 666,667 (Fed. Cir. 1985) (citing Hoeksema for theproposition above); In re Grose, 592 F.2d 1161,1168, 201 USPQ 57, 63-64 (CCPA 1979) (“One ofthe assumptions underlying a prima facieobviousness rejection based upon a structuralrelationship between compounds, such as adjacenthomologs, is that a method disclosed for producingone would provide those skilled in the art with amethod for producing the other... Failure of the priorart to disclose or render obvious a method for makingany composition of matter, whether a compound ora mixture of compounds like a zeolite, precludes aconclusion that the composition would have beenobvious.”).

Consideration of rebuttal evidence and argumentsrequires Office personnel to weigh the profferedevidence and arguments. Office personnel shouldavoid giving evidence no weight, except in rarecircumstances. Id. See also In re Alton, 76 F.3d1168, 1174-75, 37 USPQ2d 1578, 1582-83 (Fed.Cir. 1996). However, to be entitled to substantial

2100-258Rev. 08.2017, January 2018


weight, the applicant should establish a nexusbetween the rebuttal evidence and the claimedinvention, i.e., objective evidence of nonobviousnessmust be attributable to the claimed invention. TheFederal Circuit has acknowledged that applicantbears the burden of establishing nexus, stating:

In the ex parte process of examining a patentapplication, however, the PTO lacks the meansor resources to gather evidence which supportsor refutes the applicant’s assertion that the salesconstitute commercial success. C.f. Ex parteRemark, 15 USPQ2d 1498, 1503 ([BPAI] 1990)(evidentiary routine of shifting burdens in civilproceedings inappropriate in ex parteprosecution proceedings because examiner hasno available means for adducing evidence).Consequently, the PTO must rely upon theapplicant to provide hard evidence ofcommercial success.

In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d1685, 1689 (Fed. Cir. 1996). See also GPAC, 57F.3d at 1580, 35 USPQ2d at 1121; In re Paulsen,30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed.Cir. 1994) (Evidence of commercial success ofarticles not covered by the claims subject to the 35U.S.C. 103 rejection was not probative ofnonobviousness.). Additionally, the evidence mustbe reasonably commensurate in scope with theclaimed invention. See, e.g., In re Kulling, 897 F.2d1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir.1990); In re Grasselli, 713 F.2d 731, 743, 218USPQ 769, 777 (Fed. Cir. 1983). In re Soni, 54 F.3d746, 34 USPQ2d 1684 (Fed. Cir. 1995) does notchange this analysis. In Soni, the court declined toconsider the Office’s argument that the evidence ofnonobviousness was not commensurate in scopewith the claim because it had not been raised by theexaminer Id. 54 F.3d at 751, 34 USPQ2d at 1688.

When considering whether proffered evidence iscommensurate in scope with the claimed invention,Office personnel should not require the applicant toshow unexpected results over the entire range ofproperties possessed by a chemical compound orcomposition. See, e.g., In re Chupp, 816 F.2d 643,646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987).Evidence that the compound or compositionpossesses superior and unexpected properties in one

of a spectrum of common properties can be sufficientto rebut a prima facie case of obviousness. Id.

For example, a showing of unexpected results for asingle member of a claimed subgenus, or a narrowportion of a claimed range would be sufficient torebut a prima facie case of obviousness if a skilledartisan “could ascertain a trend in the exemplifieddata that would allow him to reasonably extend theprobative value thereof.” In re Clemens, 622 F.2d1029, 1036, 206 USPQ 289, 296 (CCPA 1980)(Evidence of the unobviousness of a broad rangecan be proven by a narrower range when one skilledin the art could ascertain a trend that would allowhim to reasonably extend the probative valuethereof.). But see, Grasselli, 713 F.2d at 743, 218USPQ at 778 (evidence of superior properties forsodium containing composition insufficient toestablish the non-obviousness of broad claims for acatalyst with “an alkali metal” where it was wellknown in the catalyst art that different alkali metalswere not interchangeable and applicant had shownunexpected results only for sodium containingmaterials); In re Greenfield, 571 F.2d 1185, 1189,197 USPQ 227, 230 (CCPA 1978) (evidence ofsuperior properties in one species insufficient toestablish the nonobviousness of a subgenuscontaining hundreds of compounds); In re Lindner,457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA1972) (one test not sufficient where there was noadequate basis for concluding the other claimedcompounds would behave the same way). However,an exemplary showing may be sufficient to establisha reasonable correlation between the showing andthe entire scope of the claim, when viewed by askilled artisan. See, e.g., Chupp, 816 F.2d at 646, 2USPQ2d at 1439; Clemens, 622 F.2d at 1036, 206USPQ at 296. On the other hand, evidence of anunexpected property may not be sufficient regardlessof the scope of the showing. Usually, a showing ofunexpected results is sufficient to overcome a primafacie case of obviousness. See, e.g., In re Albrecht,514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA1975). However, where the claims are not limitedto a particular use, and where the prior art providesother motivation to select a particular species orsubgenus, a showing of a new use may not besufficient to confer patentability. See Dillon, 919F.2d at 692, 16 USPQ2d at 1900-01. Accordingly,

Rev. 08.2017, January 20182100-259


each case should be evaluated individually based onthe totality of the circumstances.

Evidence pertaining to secondary considerationsmust be taken into account whenever present;however, it does not necessarily control theobviousness conclusion. See, e.g., Pfizer, Inc. v.Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d1321, 1339 (Fed. Cir. 2007) (“the record establish[ed] such a strong case of obviousness” that allegedlyunexpectedly superior results were ultimatelyinsufficient to overcome obviousness conclusion);Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir.2007) (“given the strength of the prima facie obviousness showing, the evidence on secondaryconsiderations was inadequate to overcome a finalconclusion” of obviousness); and Newell Cos., Inc.v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d1417, 1426 (Fed. Cir. 1988). Office personnel shouldnot evaluate rebuttal evidence for its “knockdown”value against the prima facie case, Piasecki, 745F.2d at 1473, 223 USPQ at 788, or summarilydismiss it as not compelling or insufficient. If theevidence is deemed insufficient to rebut the primafacie case of obviousness, Office personnel shouldspecifically set forth the facts and reasoning thatjustify this conclusion. See MPEP § 716 - § 716.10for additional information pertaining to theevaluation of rebuttal evidence submitted under 37CFR 1.132.

Many basic approaches that a practitioner may useto demonstrate nonobviousness also continue toapply in the post- KSR era. Since it is now clear thata strict teaching-suggestion-motivation approach isnot the only way to establish a prima facie case ofobviousness, it is true that practitioners have beenrequired to shift the emphasis of theirnonobviousness arguments to a certain degree.However, familiar lines of argument still apply,including teaching away from the claimed inventionby the prior art, lack of a reasonable expectation ofsuccess, and unexpected results. Indeed, they mayhave even taken on added importance in view of therecognition in KSR of a variety of possiblerationales.

The following cases exemplify the continuedapplication of the principle that when evidence has

been presented to rebut an obviousness rejection, itshould not be evaluated simply for its “knockdown”value. Rather, all evidence must be reweighed todetermine whether the claims are nonobvious.

Example 1:

The claims at issue in PharmaStem Therapeutics, Inc. v. Viacell,Inc., 491 F.3d 1342, 83 USPQ2d 1289 (Fed. Cir. 2007), weredirected to compositions comprising hematopoietic stem cellsfrom umbilical cord or placental blood, and to methods of usingsuch compositions for treatment of blood and immune systemdisorders. The composition claims required that the stem cellsbe present in an amount sufficient to effect hematopoieticreconstitution when administered to a human adult. The trialcourt had found that PharmaStem’s patents were infringed andnot invalid on obviousness or other grounds. On appeal, theFederal Circuit reversed the district court, determining that theclaims were invalid for obviousness.

The Federal Circuit discussed the evidence presented at trial. Itpointed out that the patentee, PharmaStem, had not invented anentirely new procedure or new composition. Rather,PharmaStem’s own specification acknowledged that it wasalready known in the prior art that umbilical cord and placentalblood-based compositions contained hematopoietic stem cells,and that hematopoietic stem cells were useful for the purposeof hematopoietic reconstitution. PharmaStem’s contribution wasto provide experimental proof that umbilical cord and placentalblood could be used to effect hematopoietic reconstitution inmice. By extrapolation, one of ordinary skill in the art wouldhave expected this reconstitution method to work in humans aswell.

The court rejected PharmaStem’s expert testimony thathematopoietic stem cells had not been proved to exist in cordblood prior to the experiments described in PharmaStem’spatents. The court explained that the expert testimony wascontrary to the inventors’ admissions in the specification, aswell as prior art teachings that disclosed stem cells in cord blood.In this case, PharmaStem’s evidence of nonobviousness wasoutweighed by contradictory evidence.

Despite PharmaStem’s useful experimental validation ofhematopoietic reconstitution using hematopoietic stem cellsfrom umbilical cord and placental blood, the Federal Circuitfound that the claims at issue would have been obvious. Therehad been ample suggestion in the prior art that the claimedmethod would have worked. Absolute predictability is not anecessary prerequisite to a case of obviousness. Rather, a degreeof predictability that one of ordinary skill would have found tobe reasonable is sufficient. The Federal Circuit concluded that“[g]ood science and useful contributions do not necessarilyresult in patentability.” Id. at 1364, 83 USPQ2d at 1304.

Example 2:

It was found to be an error in In re Sullivan, 498 F.3d 1345, 84USPQ2d 1034 (Fed. Cir. 2007), for the Board to fail to considerevidence submitted to rebut a prima facie case of obviousness.

2100-260Rev. 08.2017, January 2018


The claimed invention was directed to an antivenom compositioncomprising F(ab) fragments used to treat venomous rattlesnakebites. The composition was created from antibody moleculesthat include three fragments, F(ab)2, F(ab) and F(c), which haveseparate properties and utilities. There have been commerciallyavailable antivenom products that consisted of whole antibodiesand F(ab)2 fragments, but researchers had not experimentedwith antivenoms containing only F(ab) fragments because itwas believed that their unique properties would prevent themfrom decreasing the toxicity of snake venom. The inventor,Sullivan, discovered that F(ab) fragments are effective atneutralizing the lethality of rattlesnake venom, while reducingthe occurrence of adverse immune reactions in humans. Onappeal of the examiner’s rejection, the Board held that the claimwas obvious because all the elements of the claimed compositionwere accounted for in the prior art, and that the compositiontaught by that prior art would have been expected by a personof ordinary skill in the art at the time the invention was madeto neutralize the lethality of the venom of a rattlesnake.

Rebuttal evidence had not been considered by the Board becauseit considered the evidence to relate to the intended use of theclaimed composition as an antivenom, rather than thecomposition itself. Appellant successfully argued that even ifthe Board had shown a prima facie case of obviousness, theextensive rebuttal evidence must be considered. The evidenceincluded three expert declarations submitted to show that theprior art taught away from the claimed invention, an unexpectedproperty or result from the use of F(ab) fragment antivenom,and why those having ordinary skill in the art expectedantivenoms comprising F(ab) fragments to fail. The declarationsrelated to more than the use of the claimed composition. Whilea statement of intended use may not render a known compositionpatentable, the claimed composition was not known, and whetherit would have been obvious depends upon consideration of therebuttal evidence. Appellant did not concede that the onlydistinguishing factor of its composition is the statement ofintended use and extensively argued that its claimed compositionexhibits the unexpected property of neutralizing the lethality ofrattlesnake venom while reducing the occurrence of adverseimmune reactions in humans. The Federal Circuit found thatsuch a use and unexpected property cannot be ignored – theunexpected property is relevant and thus the declarationsdescribing it should have been considered.

Nonobviousness can be shown when a person of ordinary skillin the art would not have reasonably predicted the claimedinvention based on the prior art, and the resulting inventionwould not have been expected. All evidence must be consideredwhen properly presented.

Example 3:

The case of Hearing Components, Inc. v. Shure Inc., 600 F.3d1357, 94 USPQ2d 1385 (Fed. Cir. 2010), involved a disposableprotective covering for the portion of a hearing aid that isinserted into the ear canal. The covering was such that it couldbe readily replaced by a user as needed.

At the district court, Shure had argued that Hearing Components’patents were obvious over one or more of three different

combinations of prior art references. The jury disagreed, anddetermined that the claims were nonobvious. The district courtupheld the jury verdict, stating that in view of the conflictingevidence presented by the parties as to the teachings of thereferences, motivation to combine, and secondary considerations,the nonobviousness verdict was sufficiently grounded in theevidence.

Shure appealed to the Federal Circuit, but the Federal Circuitagreed with the district court that the jury’s nonobviousnessverdict had been supported by substantial evidence. AlthoughShure had argued before the jury that the Carlisle referencetaught an ear piece positioned inside the ear canal, HearingComponents’ credible witness countered that only the moldedduct and not the ear piece itself was taught by Carlisle as beinginside the ear canal. On the issue of combining references,Shure’s witness had given testimony described as “rather sparse,and lacking in specific details.” Id. at 1364, 94 USPQ2d at1397. In contradistinction, Hearing Components’ witness“described particular reasons why one skilled in the art wouldnot have been motivated to combine the references.” Id. Finally,as to secondary considerations, the Federal Circuit determinedthat Hearing Components had shown a nexus between thecommercial success of its product and the patent by providingevidence that “the licensing fee for a covered product was morethan cut in half immediately upon expiration” of the patent.

Although the Hearing Components case involves substantialevidence of nonobviousness in a jury verdict, it is neverthelessinstructive for Office personnel on the matter of weighingevidence. Office personnel routinely must consider evidence inthe form of prior art references, statements in the specification,or declarations under 37 CFR 1.131 or 1.132 . Other forms ofevidence may also be presented during prosecution. Officepersonnel are reminded that evidence that has been presentedin a timely manner should not be ignored, but rather should beconsidered on the record. However, not all evidence need beaccorded the same weight. In determining the relative weightto accord to rebuttal evidence, considerations such as whethera nexus exists between the claimed invention and the profferedevidence, and whether the evidence is commensurate in scopewith the claimed invention, are appropriate. The mere presenceof some credible rebuttal evidence does not dictate that anobviousness rejection must always be withdrawn. See MPEP §2145. Office personnel must consider the appropriate weight tobe accorded to each piece of evidence. An obviousness rejectionshould be made or maintained only if evidence of obviousnessoutweighs evidence of nonobviousness. See MPEP § 706,subsection I. (“The standard to be applied in all cases is the‘preponderance of the evidence’ test. In other words, anexaminer should reject a claim if, in view of the prior art andevidence of record, it is more likely than not that the claim isunpatentable.”). MPEP § 716.01(d) provides further guidanceon weighing evidence in making a determination of patentability.

I. ARGUMENT DOES NOT REPLACE EVIDENCEWHERE EVIDENCE IS NECESSARY

Attorney argument is not evidence unless it is anadmission, in which case, an examiner may use the

Rev. 08.2017, January 20182100-261


admission in making a rejection. See MPEP § 2129and § 2144.03 for a discussion of admissions as priorart.

The arguments of counsel cannot take the place ofevidence in the record. In re Schulze, 346 F.2d 600,602, 145 USPQ 716, 718 (CCPA 1965); In reGeisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir.1997) (“An assertion of what seems to follow fromcommon experience is just attorney argument andnot the kind of factual evidence that is required torebut a prima facie case of obviousness.”). SeeMPEP § 716.01(c) for examples of attorneystatements which are not evidence and which mustbe supported by an appropriate affidavit ordeclaration.

II. ARGUING ADDITIONAL ADVANTAGES ORLATENT PROPERTIES

Prima Facie Obviousness Is Not Rebutted by MerelyRecognizing Additional Advantages or Latent PropertiesPresent But Not Recognized in the Prior Art

Mere recognition of latent properties in the prior artdoes not render nonobvious an otherwise knowninvention. In re Wiseman, 596 F.2d 1019, 201 USPQ658 (CCPA 1979) (Claims were directed to groovedcarbon disc brakes wherein the grooves wereprovided to vent steam or vapor during a brakingaction. A prior art reference taught noncarbon discbrakes which were grooved for the purpose ofcooling the faces of the braking members andeliminating dust. The court held the prior artreferences when combined would overcome theproblems of dust and overheating solved by the priorart and would inherently overcome the steam orvapor cause of the problem relied upon forpatentability by applicants. Granting a patent on thediscovery of an unknown but inherent function (hereventing steam or vapor) “would remove from thepublic that which is in the public domain by virtueof its inclusion in, or obviousness from, the priorart.” 596 F.2d at 1022, 201 USPQ at 661.); In reBaxter Travenol Labs., 952 F.2d 388, 21 USPQ2d1281 (Fed. Cir. 1991) (Appellant argued that thepresence of DEHP as the plasticizer in a bloodcollection bag unexpectedly suppressed hemolysisand therefore rebutted any prima facie showing ofobviousness, however the closest prior art utilizing

a DEHP plasticized blood collection bag inherentlyachieved same result, although this fact wasunknown in the prior art.).

“The fact that appellant has recognized anotheradvantage which would flow naturally fromfollowing the suggestion of the prior art cannot bethe basis for patentability when the differences wouldotherwise be obvious.” Ex parte Obiaya, 227 USPQ58, 60 (Bd. Pat. App. & Inter. 1985) (The prior arttaught combustion fluid analyzers which usedlabyrinth heaters to maintain the samples at auniform temperature. Although appellant showedan unexpectedly shorter response time was obtainedwhen a labyrinth heater was employed, the Boardheld this advantage would flow naturally fromfollowing the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert.denied, 493 U.S. 1058 (1990) (unpublished — notcitable as precedent) (“The recitation of an additionaladvantage associated with doing what the prior artsuggests does not lend patentability to an otherwiseunpatentable invention.”).

In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA1972) and In re Dillon, 919 F.2d 688, 16 USPQ2d1897 (Fed. Cir. 1990) discussed in MPEP § 2144are also pertinent to this issue.

See MPEP § 716.02 - § 716.02(g) for a discussionof declaratory evidence alleging unexpected results.

III. ARGUING THAT PRIOR ART DEVICES ARENOT PHYSICALLY COMBINABLE

“The test for obviousness is not whether the featuresof a secondary reference may be bodily incorporatedinto the structure of the primary reference.... Rather,the test is what the combined teachings of thosereferences would have suggested to those of ordinaryskill in the art.” In re Keller, 642 F.2d 413, 425, 208USPQ 871, 881 (CCPA 1981). See also In re Sneed,710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir.1983) (“[I]t is not necessary that the inventions ofthe references be physically combinable to renderobvious the invention under review.”); and Inre Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA1973) (“Combining the teachings of references does

2100-262Rev. 08.2017, January 2018


not involve an ability to combine their specificstructures.”).

However, the claimed combination cannot changethe principle of operation of the primary referenceor render the reference inoperable for its intendedpurpose. See MPEP § 2143.01.

IV. ARGUING AGAINST REFERENCESINDIVIDUALLY

One cannot show nonobviousness by attackingreferences individually where the rejections arebased on combinations of references. In re Keller,642 F.2d 413, 208 USPQ 871 (CCPA 1981); Inre Merck & Co., Inc., 800 F.2d 1091, 231 USPQ375 (Fed. Cir. 1986).

V. ARGUING ABOUT THE NUMBER OFREFERENCES COMBINED

Reliance on a large number of references in arejection does not, without more, weigh against theobviousness of the claimed invention. In re Gorman,933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991)(Court affirmed a rejection of a detailed claim to acandy sucker shaped like a thumb on a stick basedon thirteen prior art references.).

VI. ARGUING LIMITATIONS WHICH ARE NOTCLAIMED

Although the claims are interpreted in light of thespecification, limitations from the specification arenot read into the claims. In re Van Geuns, 988 F.2d1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims toa superconducting magnet which generates a“uniform magnetic field” were not limited to thedegree of magnetic field uniformity required forNuclear Magnetic Resonance (NMR) imaging.Although the specification disclosed that the claimedmagnet may be used in an NMR apparatus, theclaims were not so limited.); Constant v. AdvancedMicro-Devices, Inc., 848 F.2d 1560, 1571-72, 7USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied,488 U.S. 892 (1988) (Various limitations on whichappellant relied were not stated in the claims; thespecification did not provide evidence indicatingthese limitations must be read into the claims to givemeaning to the disputed terms.); Ex

parte McCullough, 7 USPQ2d 1889, 1891 (Bd. Pat.App. & Inter. 1987) (Claimed electrode was rejectedas obvious despite assertions that electrode functionsdifferently than would be expected when used innonaqueous battery since “although the demonstratedresults may be germane to the patentability of abattery containing appellant’s electrode, they are notgermane to the patentability of the invention claimedon appeal.”).

See MPEP § 2111 - § 2116.01, for additional caselaw relevant to claim interpretation.

VII. ARGUING ECONOMIC INFEASIBILITY

The fact that a combination would not be made bybusinessmen for economic reasons does not meanthat a person of ordinary skill in the art would notmake the combination because of some technologicalincompatibility. In re Farrenkopf, 713 F.2d 714,219 USPQ 1 (Fed. Cir. 1983) (Prior art referencetaught that addition of inhibitors toradioimmunoassay is the most convenient, butcostliest solution to stability problem. The court heldthat the additional expense associated with theaddition of inhibitors would not discourage one ofordinary skill in the art from seeking the convenienceexpected therefrom.).

VIII. ARGUING ABOUT THE AGE OFREFERENCES

“The mere age of the references is not persuasive ofthe unobviousness of the combination of theirteachings, absent evidence that, notwithstandingknowledge of the references, the art tried and failedto solve the problem.” In re Wright, 569 F.2d 1124,1127, 193 USPQ 332, 335 (CCPA 1977) (100 yearold patent was properly relied upon in a rejectionbased on a combination of references.). See also Exparte Meyer, 6 USPQ2d 1966 (Bd. Pat. App. & Inter.1988) (length of time between the issuance of priorart patents relied upon (1920 and 1976) was notpersuasive of unobviousness).

IX. ARGUING THAT PRIOR ART ISNONANALOGOUS

See MPEP § 2141.01(a) for case law pertaining toanalogous art.

Rev. 08.2017, January 20182100-263


X. ARGUING IMPROPER RATIONALES FORCOMBINING REFERENCES

A. Impermissible Hindsight

Applicants may argue that the examiner’s conclusionof obviousness is based on improper hindsightreasoning. However, “[a]ny judgment onobviousness is in a sense necessarily a reconstructionbased on hindsight reasoning, but so long as it takesinto account only knowledge which was within thelevel of ordinary skill in the art at the time theclaimed invention was made and does not includeknowledge gleaned only from applicant’s disclosure,such a reconstruction is proper.” In re McLaughlin,443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA1971). Applicants may also argue that thecombination of two or more references is “hindsight”because “express” motivation to combine thereferences is lacking. However, there is norequirement that an “express, written motivation tocombine must appear in prior art references beforea finding of obviousness.” See Ruiz v. A.B. ChanceCo., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690(Fed. Cir. 2004). See MPEP § 2141 and § 2143 forguidance regarding establishment of a prima faciecase of obviousness.

B. Obvious To Try Rationale

An applicant may argue the examiner is applying animproper “obvious to try” rationale in support of anobviousness rejection.

An “obvious to try” rationale may support aconclusion that a claim would have been obviouswhere one skilled in the art is choosing from a finitenumber of identified, predictable solutions, with areasonable expectation of success. “ [A] person ofordinary skill has good reason to pursue the knownoptions within his or her technical grasp. If this leadsto the anticipated success, it is likely that product[was] not of innovation but of ordinary skill andcommon sense. In that instance the fact that acombination was obvious to try might show that itwas obvious under § 103.” KSR Int'l Co. v. TeleflexInc., 550 U.S. 538, 421, 82 USPQ2d 1385, 1397(2007).

“The admonition that ‘obvious to try’ is not thestandard under § 103 has been directed mainly attwo kinds of error. In some cases, what would havebeen ‘obvious to try’ would have been to vary allparameters or try each of numerous possible choicesuntil one possibly arrived at a successful result,where the prior art gave either no indication of whichparameters were critical or no direction as to whichof many possible choices is likely to be successful....In others, what was ‘obvious to try’ was to explorea new technology or general approach that seemedto be a promising field of experimentation, wherethe prior art gave only general guidance as to theparticular form of the claimed invention or how toachieve it.” In re O’Farrell, 853 F.2d 894, 903, 7USPQ2d 1673, 1681 (Fed. Cir. 1988) (citationsomitted) (The court held the claimed method wouldhave been obvious over the prior art relied uponbecause one reference contained a detailed enablingmethodology, a suggestion to modify the prior artto produce the claimed invention, and evidencesuggesting the modification would be successful.).

C. Lack of Suggestion To Combine References

A suggestion or motivation to combine referencesis an appropriate method for determiningobviousness, however it is just one of a number ofvalid rationales for doing so. The Court in KSRidentified several exemplary rationales to support aconclusion of obviousness which are consistent withthe proper “functional approach” to thedetermination of obviousness as laid down in Graham. KSR, 550 U.S. at 415-21, 82 USPQ2d at1395-97. See MPEP § 2141 and § 2143.

D. References Teach Away from the Invention orRender Prior Art Unsatisfactory for Intended Purpose

In addition to the material below, see MPEP§ 2141.02 (prior art must be considered in itsentirety, including disclosures that teach away fromthe claims) and MPEP § 2143.01 (proposedmodification cannot render the prior artunsatisfactory for its intended purpose or change theprinciple of operation of a reference).

2100-264Rev. 08.2017, January 2018


1. The Nature of the Teaching Is Highly Relevant

A prior art reference that “teaches away” from theclaimed invention is a significant factor to beconsidered in determining obviousness; however,“the nature of the teaching is highly relevant andmust be weighed in substance. A known or obviouscomposition does not become patentable simplybecause it has been described as somewhat inferiorto some other product for the same use.” Inre Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132(Fed. Cir. 1994) (Claims were directed to an epoxyresin based printed circuit material. A prior artreference disclosed a polyester-imide resin basedprinted circuit material, and taught that althoughepoxy resin based materials have acceptable stabilityand some degree of flexibility, they are inferior topolyester-imide resin based materials. The court heldthe claims would have been obvious over the priorart because the reference taught epoxy resin basedmaterial was useful for applicant’s purpose, applicantdid not distinguish the claimed epoxy from the priorart epoxy, and applicant asserted no discoverybeyond what was known to the art.).

Furthermore, “the prior art’s mere disclosure of morethan one alternative does not constitute a teachingaway from any of these alternatives because suchdisclosure does not criticize, discredit, or otherwisediscourage the solution claimed….” In re Fulton,391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed.Cir. 2004).

2. References Cannot Be Combined Where ReferenceTeaches Away from Their Combination

It is improper to combine references where thereferences teach away from their combination. Inre Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 779(Fed. Cir. 1983) (The claimed catalyst whichcontained both iron and an alkali metal was notsuggested by the combination of a reference whichtaught the interchangeability of antimony and alkalimetal with the same beneficial result, combined witha reference expressly excluding antimony from, andadding iron to, a catalyst.).

3. Proceeding Contrary to Accepted Wisdom IsEvidence of Nonobviousness

The totality of the prior art must be considered, andproceeding contrary to accepted wisdom in the artis evidence of nonobviousness. In re Hedges, 783F.2d 1038, 228 USPQ 685 (Fed. Cir. 1986)(Applicant’s claimed process for sulfonatingdiphenyl sulfone at a temperature above 127ºC wascontrary to accepted wisdom because the prior artas a whole suggested using lower temperatures foroptimum results as evidenced by charring,decomposition, or reduced yields at highertemperatures.).

Furthermore, “[k]nown disadvantages in old deviceswhich would naturally discourage search for newinventions may be taken into account in determiningobviousness.” United States v. Adams, 383 U.S. 39,52, 148 USPQ 479, 484 (1966).

E. Applicability of KSR to All Technologies

At the time the KSR decision was handed down,some observers questioned whether the principlesdiscussed were intended by the Supreme Court toapply to all fields of inventive endeavor. Argumentswere made that because the technology at issue inKSR involved the relatively well-developed andpredictable field of vehicle pedal assemblies, thedecision was relevant only to such fields. TheFederal Circuit has soundly repudiated such a notion,stating that KSR applies across technologies:

This court also declines to cabin KSR to the“predictable arts” (as opposed to the“unpredictable art” of biotechnology). In fact,this record shows that one of skill in thisadvanced art would find these claimed “results”profoundly “predictable.”

In re Kubin, 561 F.3d 1351, 1360, 90 USPQ2d 1417,1424 (Fed. Cir. 2009). Thus, Office personnel shouldnot withdraw any rejection solely on the basis thatthe invention lies in a technological area ordinarilyconsidered to be unpredictable.

Rev. 08.2017, January 20182100-265


XI. FORM PARAGRAPHS

See MPEP § 707.07(f) for form paragraphs 7.37through 7.38 which may be used where applicant’sarguments are not persuasive or are moot.

2146 Pre-AIA 35 U.S.C. 103(c) [R-11.2013]

[Editor Note: This MPEP section has limitedapplicability to applications subject to examinationunder the first inventor to file (FITF) provisions ofthe AIA as set forth in 35 U.S.C. 100 (note). SeeMPEP § 2159 et seq. to determine whether anapplication is subject to examination under the FITFprovisions, MPEP § 2156 for joint researchagreement prior art disqualification for applicationsubject to those provisions, and MPEP § 2150 etseq. for examination of applications subject to thoseprovisions.]

Pre-AIA 35 U.S.C. 103 Conditions of patentability;non-obvious subject matter.

*****

(c)(1) Subject matter developed by another person,which qualifies as prior art only under one or more ofsubsections (e), (f), and (g) of section 102, shall not precludepatentability under this section where the subject matter and theclaimed invention were, at the time the claimed invention wasmade, owned by the same person or subject to an obligation ofassignment to the same person.

(2) For purposes of this subsection, subject matterdeveloped by another person and a claimed invention shall bedeemed to have been owned by the same person or subject toan obligation of assignment to the same person if —

(A) the claimed invention was made by or onbehalf of parties to a joint research agreement that was in effecton or before the date the claimed invention was made;

(B) the claimed invention was made as a result ofactivities undertaken within the scope of the joint researchagreement; and

(C) the application for patent for the claimedinvention discloses or is amended to disclose the names of theparties to the joint research agreement.

(3) For purposes of paragraph (2), the term “jointresearch agreement” means a written contract, grant, orcooperative agreement entered into by two or more persons orentities for the performance of experimental, developmental, orresearch work in the field of the claimed invention.

Effective November 29, 1999, subject matter whichwas prior art under former 35 U.S.C. 103 viapre-AIA 35 U.S.C. 102(e) was disqualified as priorart against the claimed invention if that subject

matter and the claimed invention “were, at the timethe invention was made, owned by the same personor subject to an obligation of assignment to the sameperson.” This amendment to pre-AIA 35 U.S.C.103(c) was made pursuant to section 4807 of theAmerican Inventors Protection Act of 1999 (AIPA);see Public Law 106-113, 113 Stat. 1501, 1501A-591(1999). The changes to pre-AIA 35 U.S.C. 102(e)in the Intellectual Property and High TechnologyTechnical Amendments Act of 2002 (Public Law107-273, 116 Stat. 1758 (2002)) did not affect theexclusion under pre-AIA 35 U.S.C. 103(c) asamended on November 29, 1999. Subsequently, theCooperative Research and Technology EnhancementAct of 2004 (CREATE Act) (Public Law 108-453,118 Stat. 3596 (2004)) further amended pre-AIA 35U.S.C. 103(c) to provide that subject matterdeveloped by another person shall be treated asowned by the same person or subject to an obligationof assignment to the same person for purposes ofdetermining obviousness if three conditions are met:

(A) the claimed invention was made by or onbehalf of parties to a joint research agreement thatwas in effect on or before the date the claimedinvention was made;

(B) the claimed invention was made as a resultof activities undertaken within the scope of the jointresearch agreement; and

(C) the application for patent for the claimedinvention discloses or is amended to disclose thenames of the parties to the joint research agreement(hereinafter “joint research agreementdisqualification”).

These changes to pre-AIA 35 U.S.C. 103(c) applyto all patents (including reissue patents) granted onor after December 10, 2004 that are subject topre-AIA 35 U.S.C. 102. The amendment to pre-AIA35 U.S.C. 103(c) made by the AIPA to change“subsection (f) or (g)” to “one of more of subsections(e), (f), or (g)” applies to applications filed on orafter November 29, 1999. It is to be noted that, forall applications (including reissue applications), ifthe application is pending on or after December 10,2004, the 2004 changes to pre-AIA 35 U.S.C. 103(c),which effectively include the 1999 changes, apply;thus, the November 29, 1999 date of the priorrevision to pre-AIA 35 U.S.C. 103(c) is no longerrelevant. In a reexamination proceeding, however,

2100-266Rev. 08.2017, January 2018


one must look at whether or not the patent beingreexamined was granted on or after December 10,2004 to determine whether pre-AIA 35 U.S.C.103(c), as amended by the CREATE Act, applies.For a reexamination proceeding of a patent grantedprior to December 10, 2004 on an application filedon or after November 29, 1999, it is the 1999changes to pre-AIA 35 U.S.C. 103(c) that areapplicable to the disqualifying commonlyassigned/owned prior art provisions of pre-AIA 35U.S.C. 103(c). See MPEP § 706.02(l)(1) foradditional information regarding disqualified priorart under pre-AIA 35 U.S.C. 102(e)/103. For areexamination proceeding of a patent granted priorto December 10, 2004 on an application filed priorto November 29, 1999, neither the 1999 nor the 2004changes to pre-AIA 35 U.S.C. 103(c) are applicable.Therefore, only prior art under pre-AIA 35 U.S.C.102(f) or (g) used in a rejection under pre-AIA 35U.S.C. 103(a) may be disqualified under thecommonly assigned/owned prior art provisionpre-AIA of 35 U.S.C. 103(c).

Pre-AIA 35 U.S.C. 103(c), as amended by theCREATE Act, applies only to subject matter whichqualifies as prior art under pre-AIA 35 U.S.C.102(e), (f), or (g), and which is being relied upon ina rejection under 35 U.S.C. 103. If the rejection isanticipation under pre-AIA 35 U.S.C. 102(e), (f), or(g), pre-AIA 35 U.S.C. 103(c) cannot be relied uponto disqualify the subject matter in order to overcomeor prevent the anticipation rejection. Likewise,pre-AIA 35 U.S.C. 103(c) cannot be relied upon toovercome or prevent a double patenting rejection.See 37 CFR 1.78(c) and MPEP § 804. See alsoMPEP § 706.02(l) - § 706.02(l)(3).


2150 Examination Guidelines for 35 U.S.C.102 and 103 as Amended by the FirstInventor To File Provisions of theLeahy-Smith America Invents Act[R-11.2013]

[Editor Note: See MPEP § 2159 et seq. to determinewhether an application is subject to examinationunder the FITF provisions, and MPEP §

2131-MPEP § 2138 for examination of applicationssubject to pre-AIA 35 U.S.C. 102.]

Continued Applicability of pre-AIA 35 U.S.C. 102and 103: The Leahy-Smith America Invents Act(AIA) revised 35 U.S.C. 102 and thereby, thestandard to determine what prior art is availableduring examination of an application. See PublicLaw 112-29, 125 Stat. 284 (2011). The changes to35 U.S.C. 102 and 103 in the AIA do not apply toany application filed before March 16, 2013. Thus,any application filed before March 16, 2013, isgoverned by pre-AIA 35 U.S.C. 102 and 103 (i.e.,the application is a pre-AIA (first to invent)application (hereinafter “pre-AIA application”)).Note that neither the filing of a request for continuedexamination, nor entry into the national stage under35 U.S.C. 371, constitutes the filing of a newapplication. Accordingly, even if a request forcontinued examination under 37 CFR 1.114 is filedon or after March 16, 2013, in an application thatwas filed before March 16, 2013, the applicationremains subject to pre-AIA 35 U.S.C. 102 and 103.Submission of an amendment including a claim thatincludes new matter on or after March 16, 2013, alsodoes not affect an application’s status as a pre-AIAapplication. See 35 U.S.C. 132(a). Similarly, a PCTapplication filed under 35 U.S.C. 363 before March16, 2013, is subject to pre-AIA 35 U.S.C. 102 and103, regardless of whether the application enters thenational stage under 35 U.S.C. 371 before or afterMarch 16, 2013. Applications filed on or after March16, 2013 are also subject to pre-AIA 35 U.S.C. 102if the application has never contained a claim withan effective filing date on or after March 16, 2013and has never claimed the benefit of an applicationthat ever contained such a claim. MPEP §§2131-2138 provide examination guidance on theprior art available in the examination of applicationssubject to pre-AIA 35 U.S.C. 102.

2151 Overview of the Changes to 35 U.S.C.102 and 103 in the AIA [R-08.2017]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, and

Rev. 08.2017, January 20182100-267


MPEP § 2131-MPEP § 2138 for examination ofapplications subject to pre-AIA 35 U.S.C. 102.]

After the AIA, 35 U.S.C. 102 continues to set forththe scope of prior art that will preclude the grant ofa patent on a claimed invention, but revises whatqualifies as prior art. Specifically, AIA 35 U.S.C.102(a)(1) and (a)(2) set forth what qualifies as priorart. AIA 35 U.S.C. 102(a)(1) provides that a personis not entitled to a patent if the claimed inventionwas patented, described in a printed publication, orin public use, on sale, or otherwise available to thepublic before the effective filing date of the claimedinvention. AIA 35 U.S.C. 102(a)(2) provides that aperson is not entitled to a patent if the claimedinvention was described in a patent issued under 35U.S.C. 151, or in an application for patent publishedor deemed published under 35 U.S.C. 122(b), inwhich the patent or application, as the case may be,names another inventor, and was effectively filedbefore the effective filing date of the claimedinvention. AIA 35 U.S.C. 102(b) sets forthexceptions to prior art established in AIA 35 U.S.C.102(a). Specifically, AIA 35 U.S.C. 102(b)(1) setsforth exceptions to prior art established in AIA 35U.S.C. 102(a)(1), and AIA 35 U.S.C. 102(b)(2) setsforth exceptions to prior art established in AIA 35U.S.C. 102(a)(2).

The AIA also provides definitions in 35 U.S.C. 100of the meaning of the terms “claimed invention,”“effective filing date,” “inventor,” and “jointinventor” (or “coinventor”). The AIA defines theterm “claimed invention” in 35 U.S.C. 100(j) as thesubject matter defined by a claim in a patent or anapplication for a patent. The AIA defines the term“effective filing date” for a claimed invention in apatent or application for patent (other than a reissueapplication or reissued patent) in 35 U.S.C. 100(i)(1)as meaning the earlier of: (1) The actual filing dateof the patent or the application for the patentcontaining the claimed invention; or (2) the filingdate of the earliest provisional, nonprovisional,international (PCT), or foreign patent application towhich the patent or application is entitled to benefitor priority as to such claimed invention. The AIAdefines the term “inventor” in 35 U.S.C. 100(f) asthe individual or, if a joint invention, the individualscollectively who invented or discovered the subjectmatter of the invention, and in 35 U.S.C. 100(g)

defines the term “joint inventor” and “coinventor”to mean any one of the individuals who invented ordiscovered the subject matter of a joint invention.

As discussed previously, AIA 35 U.S.C. 102(a)(1)provides that a person is not entitled to a patent ifthe claimed invention was patented, described in aprinted publication, or in public use, on sale, orotherwise available to the public before the effectivefiling date of the claimed invention. Under pre-AIA35 U.S.C. 102(a) and (b), knowledge or use of theinvention (pre-AIA 35 U.S.C. 102(a)), or public useor sale of the invention (pre-AIA 35 U.S.C. 102(b)),was required to be in the United States to qualify asa prior art activity. Under the AIA, a prior publicuse, sale activity, or other disclosure has nogeographic requirement (i.e., need not be in theUnited States) to qualify as prior art.

AIA 35 U.S.C. 102(b)(1) provides that certaindisclosures made one year or less before the effectivefiling date of a claimed invention shall not be priorart under 35 U.S.C. 102(a)(1) with respect to theclaimed invention if: (1) The disclosure was madeby the inventor or joint inventor or by another whoobtained the subject matter disclosed directly orindirectly from the inventor or a joint inventor; or(2) the subject matter disclosed had, before suchdisclosure, been publicly disclosed by the inventoror a joint inventor or by another who obtained thesubject matter disclosed directly or indirectly fromthe inventor or a joint inventor. Thus, AIA 35 U.S.C.102(b)(1) effectively provides a one-year graceperiod (grace period) after a first inventor-originateddisclosure of an invention within which the inventor,assignee, obligated assignee, or other party havingsufficient interest may file a patent application whichis not subject to such disclosure and certain otherdisclosures as prior art. The one-year grace periodin AIA 35 U.S.C. 102(b)(1) is measured from thefiling date of the earliest U.S. or foreign patentapplication to which a proper benefit or priorityclaim to such invention has been asserted in thepatent or application and the earlier applicationsupports the claimed invention in the mannerrequired by 35 U.S.C. 112(a). Under pre-AIA 35U.S.C. 102(b), the one-year grace period is measuredfrom the filing date of the earliest application filedin the United States (directly or through the PCT)

2100-268Rev. 08.2017, January 2018


and not from the dates of earlier filed foreign patentapplications.

The date of invention is not relevant under AIA 35U.S.C. 102. Thus, a prior art disclosure could not bedisqualified or antedated by showing that theinventor invented the claimed invention prior to theeffective date of the prior art disclosure of the subjectmatter (e.g., under the provisions of 37 CFR 1.131).

As discussed previously, AIA 35 U.S.C. 102(a)(2)provides that a person is not entitled to a patent ifthe claimed invention was described in a U.S. patent,a U.S. patent application publication, or anapplication for patent deemed published under 35U.S.C. 122(b) (collectively referred to as “U.S.patent documents”), that names another inventor andwas effectively filed before the effective filing dateof the claimed invention. Under 35 U.S.C. 374, aWorld Intellectual Property Organization (WIPO)publication of a Patent Cooperation Treaty (PCT)international application that designates the UnitedStates is an application for patent deemed publishedunder 35 U.S.C. 122(b) for purposes of AIA 35U.S.C. 102(a)(2). Thus, under the AIA, WIPOpublications of PCT applications that designate theUnited States are treated as U.S. patent applicationpublications for prior art purposes, regardless of theinternational filing date, whether they are publishedin English, or whether the PCT internationalapplication enters the national stage in the UnitedStates. Accordingly, a WIPO publication of a PCTapplication (WIPO published application) thatdesignates the United States, a U.S. patent, or a U.S.patent application publication that names anotherinventor and was effectively filed before the effectivefiling date of the claimed invention, is prior art underAIA 35 U.S.C. 102(a)(2). Under pre-AIA 35 U.S.C.102(e), a WIPO published application designatingthe United States is treated as a U.S. patentapplication publication only if the PCT applicationwas filed on or after November 29, 2000, andpublished under PCT Article 21(2) in the Englishlanguage. See MPEP § 2136.03, subsection III.

AIA 35 U.S.C. 102(d) defines “effectively filed” forthe purpose of determining whether a particular U.S.patent document is prior art under AIA 35 U.S.C.102(a)(2) to a claimed invention. A U.S. patentdocument is considered to have been effectively filed

for purposes of its prior art effect under 35 U.S.C.102(a)(2) with respect to any subject matter itdescribes on the earlier of: (1) The actual filing dateof the patent or the application for patent; or (2) ifthe patent or application for patent is entitled to claimthe benefit of, or priority to, the filing date of anearlier U.S. provisional, U.S. nonprovisional,international (PCT), or foreign patent application,the filing date of the earliest such application thatdescribes the subject matter of the claimed invention.Thus, a U.S. patent document is effective as priorart as of the filing date of the earliest application towhich benefit or priority is claimed and whichdescribes the subject matter relied upon, regardlessof whether the earliest such application is a U.S.provisional or nonprovisional application, aninternational (PCT) application, or a foreign patentapplication.

AIA 35 U.S.C. 102(b)(2)(A) and (B) provide that adisclosure shall not be prior art to a claimedinvention under 35 U.S.C. 102(a)(2) if: (1) Thesubject matter disclosed was obtained directly orindirectly from the inventor or a joint inventor; or(2) the subject matter disclosed had, before suchsubject matter was effectively filed under 35 U.S.C.102(a)(2), been publicly disclosed by the inventoror a joint inventor or another who obtained thesubject matter disclosed directly or indirectly fromthe inventor or a joint inventor. Thus, under the AIA,a U.S. patent document that was not issued orpublished more than one year before the effectivefiling date of the claimed invention is not prior artto the claimed invention if: (1) The U.S. patentdocument was by another who obtained the subjectmatter disclosed from the inventor or a jointinventor; or (2) the inventor or a joint inventor, oranother who obtained the subject matter disclosedfrom an inventor or joint inventor, had publiclydisclosed the subject matter before the 35 U.S.C.102(d) (“effectively filed”) date of the U.S. patentdocument.

Additionally, AIA 35 U.S.C. 102(b)(2)(C) providesthat a disclosure made in a U.S. patent documentshall not be prior art to a claimed invention under35 U.S.C. 102(a)(2) if, not later than the effectivefiling date of the claimed invention, the subjectmatter disclosed and the claimed invention wereowned by the same person or subject to an obligation

Rev. 08.2017, January 20182100-269


of assignment to the same person. This provisionreplaces the exception in pre-AIA 35 U.S.C. 103(c)that applied only in the context of an obviousnessanalysis under 35 U.S.C. 103 to prior art that wascommonly owned at the time the claimed inventionwas made, and which qualified as prior art onlyunder pre-AIA 35 U.S.C. 102(e), (f), and/or (g).Thus, the AIA provides that certain prior patents andpublished patent applications of co-workers andcollaborators are not prior art either for purposes ofdetermining novelty (35 U.S.C. 102) ornonobviousness (35 U.S.C. 103). This exception,however, only removes disclosures as prior art underAIA 35 U.S.C. 102(a)(2), namely, U.S. patentdocuments that were not published, but that wereeffectively filed, before the effective filing date ofthe claimed invention. This exception is not effectiveto except prior art that is also available under 35U.S.C. 102(a)(1), that is, patents, printedpublications, public uses, sale activities, or otherpublicly available disclosures published or occurringbefore the effective filing date of the claimedinvention. A prior disclosure, as defined in AIA 35U.S.C. 102(a)(1), by a co-worker or collaborator isprior art under AIA 35 U.S.C. 102(a)(1) unless itfalls within an exception under AIA 35 U.S.C.102(b)(1), regardless of whether the subject matterof the prior disclosure and the claimed invention wascommonly owned not later than the effective filingdate of the claimed invention.

The AIA eliminates the provisions in pre-AIA 35U.S.C. 102(c) (abandonment of the invention),102(d) (premature foreign patenting), 102(f)(derivation), and 102(g) (prior invention by another,but see below for discussion of continued limitedapplicability). Under the AIA, abandonment of theinvention or premature foreign patenting is notrelevant to patentability. Prior invention by anotheris likewise not relevant to patentability under theAIA unless there is a prior disclosure or filing of anapplication by another. A situation in which anapplication names a person who is not the actualinventor as the inventor (pre-AIA 35 U.S.C. 102(f))will be handled in a derivation proceeding under 35U.S.C. 135, by a correction of inventorship under37 CFR 1.48 to name the actual inventor, or througha rejection under 35 U.S.C. 101 and 35 U.S.C. 115.See form paragraphs 7.04.101.aia and 7.04.102.aia.

AIA 35 U.S.C. 102(c) provides for commonownership of subject matter made pursuant to jointresearch agreements. Under 35 U.S.C. 100(h), theterm “joint research agreement” as used in AIA 35U.S.C. 102(c) is defined as a written contract, grant,or cooperative agreement entered into by two ormore persons or entities for the performance ofexperimental, developmental, or research work inthe field of the claimed invention. AIA 35 U.S.C.102(c) specifically provides that subject matterdisclosed and a claimed invention shall be deemedto have been owned by the same person or subjectto an obligation of assignment to the same personin applying the provisions of AIA 35 U.S.C.102(b)(2)(C) if: (1) The subject matter disclosed wasdeveloped and the claimed invention was made by,or on behalf of, one or more parties to a jointresearch agreement that was in effect on or beforethe effective filing date of the claimed invention; (2)the claimed invention was made as a result ofactivities undertaken within the scope of the jointresearch agreement; and (3) the application for patentfor the claimed invention discloses or is amended todisclose the names of the parties to the joint researchagreement.

AIA 35 U.S.C. 103 provides that a patent for aclaimed invention may not be obtained,notwithstanding that the claimed invention is notidentically disclosed as set forth in 35 U.S.C. 102,if the differences between the claimed invention andthe prior art are such that the claimed invention asa whole would have been obvious before theeffective filing date of the claimed invention to aperson having ordinary skill in the art to which theclaimed invention pertains. In addition, AIA 35U.S.C. 103 provides that patentability shall not benegated by the manner in which the invention wasmade. This provision tracks pre-AIA 35 U.S.C.103(a), except that the temporal focus for theobviousness inquiry is before the effective filingdate of the claimed invention, rather than at the timeof the invention. The provisions of pre-AIA 35U.S.C. 103(c) have been replaced with AIA 35U.S.C. 102(b)(2)(C) and (c), and the provisions ofpre-AIA 35 U.S.C. 103(b) pertaining tobiotechnological processes have been eliminated.

AIA 35 U.S.C. 102 and 103 took effect on March16, 2013. These new provisions apply to any patent

2100-270Rev. 08.2017, January 2018


application that contains or contained at any time:(1) a claim to a claimed invention that has aneffective filing date as defined in 35 U.S.C. 100(i)that is on or after March 16, 2013; or (2) adesignation as a continuation, divisional, orcontinuation-in-part of an application that containsor contained at any time a claim to a claimedinvention that has an effective filing date that is onor after March 16, 2013. Such an application isreferred to as an AIA (first inventor to file)application (hereinafter “AIA application”). AIA 35U.S.C. 102 and 103 also apply to any patent resultingfrom an AIA application. See Public Law 112-29,§ 3(n)(1), 125 Stat. at 293. See also MPEP § 2159 etseq. for guidance in determining whether anapplication is subject to AIA 35 U.S.C. 102 and 103.

The AIA provides that the provisions of pre-AIA 35U.S.C. 102(g) apply to each claim of an AIAapplication for patent if the patent application: (1)contains or contained at any time a claim to aclaimed invention having an effective filing date asdefined in 35 U.S.C. 100(i) that occurs before March16, 2013; or (2) is ever designated as a continuation,divisional, or continuation-in-part of an applicationthat contains or contained at any time a claim to aclaimed invention that has an effective filing datebefore March 16, 2013. Public Law 112-29, §3(n)(2), 125 Stat. at 293. Pre-AIA 35 U.S.C. 102(g)also applies to any patent resulting from an AIAapplication to which pre-AIA 35 U.S.C. 102(g)applied. See MPEP § 2138 for guidance onapplication of pre-AIA 35 U.S.C. 102(g) and formparagraph 7.14.aia.

If an application (1) contains or contained at anytime a claimed invention having an effective filingdate that is before March 16, 2013, or ever claimedthe benefit of an earlier filing date under 35 U.S.C.120, 121, or 365(c) based upon an earlier applicationthat ever contained a claimed invention having aneffective filing date as defined in 35 U.S.C. 100(i)that is before March 16, 2013, and (2) also containsor contained at any time any claimed inventionhaving an effective filing date as defined in 35U.S.C. 100(i) that is on or after March 16, 2013, orever claimed the benefit of an earlier filing dateunder 35 U.S.C. 119 , 120, 121, 365 or 386 basedupon an earlier application that ever contained aclaimed invention having an effective filing date as

defined in 35 U.S.C. 100(i) that is on or after March16, 2013, then AIA 35 U.S.C. 102 and 103 apply tothe application, and each claimed invention in theapplication is also subject to pre-AIA 35 U.S.C.102(g).

2152 Detailed Discussion of AIA 35 U.S.C.102(a) and (b) [R-11.2013]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2131-MPEP § 2138 for examination ofapplications subject to pre-AIA 35 U.S.C. 102.]

AIA 35 U.S.C. 102(a) defines the prior art that willpreclude the grant of a patent on a claimed inventionunless an exception in AIA 35 U.S.C. 102(b) isapplicable. Specifically, AIA 35 U.S.C. 102(a)provides that:

[a] person shall be entitled to a patent unless—

(1) the claimed invention was patented,described in a printed publication, or in publicuse, on sale, or otherwise available to the publicbefore the effective filing date of the claimedinvention; or

(2) the claimed invention was described ina patent issued under section 151, or in anapplication for patent published or deemedpublished under section 122(b), in which thepatent or application, as the case may be, namesanother inventor and was effectively filedbefore the effective filing date of the claimedinvention.

As an initial matter, Office personnel should notethat the introductory phrase “[a] person shall beentitled to a patent unless” remains unchanged fromthe pre-AIA version of 35 U.S.C. 102. Thus, 35U.S.C. 102 continues to provide that the Office bearsthe initial burden of explaining why the applicablestatutory or regulatory requirements have not beenmet if a claim in an application is to be rejected. TheAIA also does not change the requirement that

Rev. 08.2017, January 20182100-271


whenever a claim for a patent is rejected or anobjection or requirement is made, the Office shallnotify the applicant thereof and state the reasons forsuch rejection, objection, or requirement, and providesuch information and references as may be useful tothe applicant in judging of the propriety ofcontinuing the prosecution of the application. See35 U.S.C. 132, 37 CFR 1.104(c) and MPEP § 706.

The categories of prior art documents and activitiesare set forth in AIA 35 U.S.C. 102(a)(1) and thecategories of prior art patent documents are set forthin AIA 35 U.S.C. 102(a)(2). These documents andactivities are used to determine whether a claimedinvention is novel or nonobvious. The documentsupon which a prior art rejection under 35 U.S.C.102(a)(1) may be based are an issued patent, apublished application, and a non-patent printedpublication. The documents upon which a prior artrejection under 35 U.S.C. 102(a)(2) may be basedare U.S. patent documents only (see discussion ofU.S. patent documents in MPEP § 2151). Evidencethat the claimed invention was in public use, on sale,or otherwise available to the public may also be usedas the basis for a prior art rejection under 35 U.S.C.102(a)(1). Note that a printed publication that doesnot have a sufficiently early publication date to itselfqualify as prior art under AIA 35 U.S.C. 102(a)(1)may be competent evidence of a previous public use,sale activity, or other availability of a claimedinvention to the public where the public use, saleactivity, or other public availability does have asufficiently early date to qualify as prior art underAIA 35 U.S.C. 102(a)(1). See In re Epstein, 32 F.3d1559, 31 USPQ2d 1817 (Fed. Cir. 1994) and MPEP§ 2133.03(b), subsection III.C.

AIA 35 U.S.C. 102(b) sets out exceptions to AIA35 U.S.C. 102(a), in that prior art that otherwisewould be included in AIA 35 U.S.C. 102(a) shallnot be prior art if it falls within an exception underAIA 35 U.S.C. 102(b).

Exceptions to the categories of prior art defined inAIA 35 U.S.C. 102(a)(1) are provided in AIA 35U.S.C. 102(b)(1). Specifically, AIA 35 U.S.C.102(b)(1) states that “[a] disclosure made 1 year orless before the effective filing date of a claimedinvention shall not be prior art to the claimedinvention under subsection (a)(1) if—

(A) the disclosure was made by the inventor ora joint inventor or by another who obtained thesubject matter disclosed directly or indirectly fromthe inventor or a joint inventor; or

(B) the subject matter disclosed had, before suchdisclosure, been publicly disclosed by the inventoror a joint inventor or another who obtained thesubject matter disclosed directly or indirectly fromthe inventor or a joint inventor.”

Exceptions to the categories of prior art defined inAIA 35 U.S.C. 102(a)(2) are provided in AIA 35U.S.C. 102(b)(2). Specifically, AIA 35 U.S.C.102(b)(2) states that “[a] disclosure shall not be priorart to a claimed invention under subsection (a)(2)if—

(A) the subject matter disclosed was obtaineddirectly or indirectly from the inventor or a jointinventor;

(B) the subject matter disclosed had, before suchsubject matter was effectively filed under subsection(a)(2), been publicly disclosed by the inventor or ajoint inventor or another who obtained the subjectmatter disclosed directly or indirectly from theinventor or a joint inventor; or

(C) the subject matter disclosed and the claimedinvention, not later than the effective filing date ofthe claimed invention, were owned by the sameperson or subject to an obligation of assignment tothe same person.”

Although some of the provisions of AIA 35 U.S.C.102(a) and (b) are similar to pre-AIA 35 U.S.C.102(a), (b), and (e), the AIA has introduced a numberof important changes with respect to prior artdocuments and activities (collectively,“disclosures”). First, the availability of a U.S. patentdocument as prior art to a claimed invention ismeasured from the effective filing date of theclaimed invention as defined in 35 U.S.C. 100(i),which takes into account both foreign priority anddomestic benefit dates. Note that this differs frompractice under pre-AIA 35 U.S.C. 102 wherein theavailability of a patent document as prior art ismeasured from either “the date of the applicationfor patent in the United States” (pre-AIA 35 U.S.C.102(b)) or “the invention thereof by the applicantfor patent” (pre-AIA 35 U.S.C. 102(a) and (e)).Second, the AIA adopts a global view of prior art

2100-272Rev. 08.2017, January 2018


disclosures and thus does not require that a publicuse or sale activity be “in this country” to be a priorart activity. Finally, a catch-all “otherwise availableto the public” category of prior art is added.

2152.01 Effective Filing Date of the ClaimedInvention [R-08.2017]


Pre-AIA 35 U.S.C. 102(a) and (e) referencepatent-defeating activities occurring before theapplicant invented the claimed invention. AIA 35U.S.C. 102(a)(1) and (a)(2) make no mention of thedate of the invention, but instead concern documentsthat existed or activities that occurred “before theeffective filing date of the claimed invention.” As aresult, it is no longer possible to antedate or “swearbehind” certain prior art disclosures by making ashowing under 37 CFR 1.131 that the applicantinvented the claimed subject matter prior to theeffective date of the prior art disclosure.

The AIA defines the term “effective filing date” fora claimed invention in a patent or application forpatent (other than a reissue application or reissuedpatent) as the earliest of: (1) the actual filing date ofthe patent or the application for the patent containingthe claimed invention; or (2) the filing date of theearliest application for which the patent orapplication is entitled, as to such invention, to a rightof priority or the benefit of an earlier filing dateunder 35 U.S.C. 119, 120, 121, 365, or 386. See 35U.S.C. 100(i)(1). Thus, the one-year grace period(as defined in MPEP § 2151) in AIA 35 U.S.C.102(b)(1) is measured from the filing date of anyU.S. or foreign patent application to which the patentor application is entitled to benefit or priority as tosuch invention, whereas the one-year grace periodin pre-AIA 35 U.S.C. 102(b) is measured from onlythe filing date of the earliest application filed in theUnited States (directly or through the PCT).

As under pre-AIA law, the effective filing date of aclaimed invention is determined on a claim-by-claimbasis and not an application-by-application basis.That is, the principle that different claims in the sameapplication may be entitled to different effectivefiling dates vis-à-vis the prior art remains unchangedby the AIA. See MPEP § 706.02, subsection VI.However, it is important to note that although priorart is applied on a claim-by-claim basis, thedetermination of whether pre-AIA 35 U.S.C. 102and 35 U.S.C. 103 or AIA 35 U.S.C. 102 and 103apply is made on an application-by-application basis.MPEP § 2151 and MPEP § 2159 discuss theapplicability date provisions of section 3 of the AIA.

Finally, the AIA provides that the “effective filingdate” for a claimed invention in a reissued patent orapplication for a reissue patent shall be determinedby deeming the claim to the claimed invention tohave been contained in the patent for which reissuewas sought. See 35 U.S.C. 100(i)(2).

2152.02 Prior Art Under AIA 35 U.S.C.102(a)(1) (Patented, Described in a PrintedPublication, or in Public Use, on Sale, orOtherwise Available to the Public)[R-08.2017]


Prior art documents and activities which maypreclude patentability are set forth in AIA 35 U.S.C.102(a)(1). Such documents and activities includeprior patenting of the claimed invention, descriptionsof the claimed invention in a printed publication,public use of the claimed invention, placing theclaimed invention on sale, and otherwise making theclaimed invention available to the public. MPEP §§2152.02(a)–2152.02(f) discuss each prior artdocument and activity that might precludepatentability under AIA in turn.35 U.S.C. 102(a)(1)

Rev. 08.2017, January 20182100-273


2152.02(a) Patented [R-11.2013]


AIA 35 U.S.C. 102(a)(1) indicates that a prior patentof a claimed invention will preclude the grant of asubsequent patent on the claimed invention. Thismeans that if a claimed invention was patented inthis or a foreign country before the effective filingdate of the claimed invention, AIA 35 U.S.C.102(a)(1) precludes the grant of a patent on theclaimed invention. The effective date of the patentfor purposes of determining whether the patentqualifies as prior art under AIA 35 U.S.C. 102(a)(1)is the grant date of the patent. There is an exceptionto this rule if the patent is secret as of the date therights are awarded. See In re Ekenstam, 256 F.2d321, 323, 118 USPQ 349, 353 (CCPA 1958); seealso MPEP § 2126.01. In such situations, the patentis available as prior art as of the date the patent wasmade available to the public by being laid open forpublic inspection or disseminated in printed form.See In re Carlson, 983 F.2d 1032, 1037, 25 USPQ2d1207 (Fed. Cir. 1992); see also MPEP § 2126. Thephrase “patented” in AIA 35 U.S.C. 102(a)(1) hasthe same meaning as “patented” in pre-AIA 35U.S.C. 102(a) and (b). For a discussion of “patented”as used in pre-AIA 35 U.S.C. 102(a) and (b), seegenerally MPEP § 2126.

Although an invention may be described in a patentand not claimed therein, the grant date would alsobe the applicable prior art date for purposes ofrelying on the subject matter disclosed therein as“described in a printed publication,” provided thatthe patent was made available to the public on itsgrant date. Note that a U.S. patent that issues afterthe effective filing date of a claimed invention andis not available as prior art against that inventionunder AIA 35 U.S.C. 102(a)(1) could be availableas prior art under AIA 35 U.S.C. 102(a)(2).

2152.02(b) Described in a PrintedPublication [R-11.2013]


If a claimed invention is described in a patent,published patent application, or printed publication,such a document may be available as prior art underAIA 35 U.S.C. 102(a)(1). Both pre-AIA 35 U.S.C.102(a) and (b) and AIA 35 U.S.C. 102(a)(1) use theterm “described” with respect to an invention in aprior art printed publication. Likewise, AIA 35U.S.C. 102(a)(2) uses that term with respect to U.S.patents, U.S. patent application publications, andWIPO published applications. Thus, the Office doesnot view the AIA as changing the extent to which aclaimed invention must be described for a prior artdocument to anticipate the claimed invention under35 U.S.C. 102.

While the conditions for patentability of AIA 35U.S.C. 112(a) require a written description of theclaimed invention that would have enabled a personskilled in the art to make as well as use the invention,the prior art provisions of AIA 35 U.S.C. 102(a)(1)and (a)(2) require only that the claimed invention is“described” in a prior art document (patent,published patent application, or printed publication).The two basic requirements that must be met by aprior art document in order to describe a claimedinvention such that it is anticipated under AIA 35U.S.C. 102 are the same as those under pre-AIA 35U.S.C. 102. First, “each and every element of theclaimed invention” must be disclosed eitherexplicitly or inherently, and the elements must be“arranged or combined in the same way as in theclaim.” See In re Gleave, 560 F.3d 1331, 1334, 90USPQ2d 1235, 1237-38 (Fed. Cir. 2009), citing EliLilly & Co. v. Zenith Goldline Pharms., Inc., 471F.3d 1369, 1375, 81 USPQ2d 1324,1328 (Fed. Cir.2006); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d1359, 1370, 88 USPQ2d 1751, 1759 (Fed. Cir.2008); In re Bond, 910 F.2d 831, 832-33, 15

2100-274Rev. 08.2017, January 2018


USPQ2d 1566, 1567 (Fed. Cir. 1990). Second, aperson of ordinary skill in the art must have beenenabled to make the invention without undueexperimentation. See Gleave, 560 F.3d at 1334, 90USPQ2d at 1238 (citing Impax Labs., Inc. v. AventisPharms. Inc., 545 F.3d 1312, 1314, 88 USPQ2d1381, 1383 (Fed. Cir. 2008), and In re LeGrice, 301F.2d 929, 940-44, 133 USPQ 365, 372 (CCPA1962)). Thus, in order for a prior art document todescribe a claimed invention such that it isanticipated under AIA 35 U.S.C. 102(a)(1) or (a)(2),it must disclose all elements of the claimed inventionarranged as they are in the claim, and also providesufficient guidance to enable a person skilled in theart to make the claimed invention. There is, however,no requirement that a prior art document meet the“how to use” requirement of 35 U.S.C. 112(a) inorder to qualify as prior art. See Gleave, 560 F.3dat 1334, 90 USPQ2d at 1237-38; see also In reSchoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671,1673 (Fed. Cir. 1992) (holding that a claimedcompound was anticipated even though the prior artreference did not disclose a use for the compound); Schering Corp. v. Geneva Pharms., Inc., 339 F.3d1373, 1380-81, 67 USPQ2d 1664, 1670 (Fed. Cir.2003) (pointing out that actually reducing theinvention to practice is not necessary in order for aprior art reference to anticipate); Impax Labs, 468F.3d at 1382 (stating that “proof of efficacy is notrequired for a prior art reference to be enabling forpurposes of anticipation”). Furthermore, compliancewith the “how to make” requirement is judged fromthe viewpoint of a person of ordinary skill in the art,and thus does not require that the prior art documentexplicitly disclose information within the knowledgeof such a person. See In re Donohue, 766 F.2d 531,533, 226 USPQ 619, 621 (Fed. Cir. 1985).

There is an additional important distinction betweenthe written description that is necessary to supporta claim under 35 U.S.C. 112(a) and the descriptionsufficient to anticipate the subject matter of the claimunder AIA 35 U.S.C. 102(a)(1) or (a)(2). See Rasmussen v. SmithKline Beecham Corp., 413 F.3d1318, 75 USPQ2d 1297 (Fed. Cir. 2005). To providesupport for a claim under 35 U.S.C. 112(a), it isnecessary that the specification describe and enablethe entire scope of the claimed invention. However,in order for a prior art document to describe aclaimed invention under AIA 35 U.S.C. 102(a)(1)

or (a)(2), the prior art document need only describeand enable one skilled in the art to make a singlespecies or embodiment of the claimed invention. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562,19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (“As thecourt pointed out, ‘the description of a singleembodiment of broadly claimed subject matterconstitutes a description of the invention foranticipation purposes..., whereas the sameinformation in a specification might not alone beenough to provide a description of that invention forpurposes of adequate disclosure.’”) (quoting In reLukach, 442 F.2d 967, 970, 169 USPQ 795, 797(CCPA 1971)); see also In re Van Langenhoven,458 F.2d 132, 173 USPQ 426 (CCPA 1972), and Inre Ruscetta, 255 F.2d 687, 118 USPQ 101 (CCPA1958).

An anticipatory description it is not required in orderfor a disclosure to qualify as prior art, unless thedisclosure is being used as the basis for ananticipation rejection. In accordance with pre-AIAcase law concerning obviousness, a disclosure maybe cited for all that it would reasonably have madeknown to a person of ordinary skill in the art. Thus,the description requirement of AIA 35 U.S.C.102(a)(1) and (a)(2) does not preclude an examinerfrom applying a disclosure in an obviousnessrejection under AIA 35 U.S.C. 103 simply becausethe disclosure is not adequate to anticipate theclaimed invention.

2152.02(c) In Public Use [R-11.2013]


Under pre-AIA 35 U.S.C. 102(b), an invention thatwas “in public use” precluded the grant of a patentonly if such public use occurred “in this country.”See MPEP § 2133.03(d).

Under AIA 35 U.S.C. 102(a)(1), there is nogeographic limitation on where prior public use or

Rev. 08.2017, January 20182100-275


public availability occurs. Furthermore, a public usewould need to occur before the effective filing dateof the claimed invention to constitute prior art underAIA 35 U.S.C. 102(a)(1).

The pre-AIA case law also indicates that a publicuse will bar patentability if the public use occursbefore the critical date and the invention is ready forpatenting. Under pre-AIA 35 U.S.C. 102(b), thecritical date is the date that is one year prior to thedate of application for patent in the United States.See Invitrogen Corp. v. Biocrest Manufacturing.L.P., 424 F.3d 1374, 1379-80, 76 USPQ2d 1741,1744 (Fed. Cir. 2005) and MPEP § 2133. Underpre-AIA 35 U.S.C. 102(b), the uses of an inventionbefore the patent's critical date that constitute a“public use” fall into two categories: the use either“(1) was accessible to the public; or (2) wascommercially exploited.” See American SeatingCo. v. USSC Group, Inc., 514 F.3d 1262, 1267, 85USPQ2d 1683, 1685 (Fed. Cir. 2008) and MPEP §2133.03(a). Whether a use is a pre-AIA 35 U.S.C.102(b) public use also depends on who is makingthe use of the invention. “[W]hen an asserted prioruse is not that of the applicant, [pre-AIA 35 U.S.C.]102(b) is not a bar when that prior use or knowledgeis not available to the public.” See Woodland Trustv. Flowertree Nursery, Inc., 148 F.3d 1368, 1371,47 USPQ2d 1363, 1366 (Fed. Cir. 1998). In otherwords, a use by a third party who did not obtain theinvention from the inventor named in the applicationor patent is an invalidating use under pre-AIA 35U.S.C. 102(b) only if it falls into the first category:That the use was accessible to the public. See MPEP§ 2133.03(a), subsection II.C. On the other hand,“an inventor's own prior commercial use, albeit keptsecret, may constitute a public use or sale under[pre-AIA 35 U.S.C.] 102(b), barring him fromobtaining a patent.” See Woodland Trust, 148 F.3dat 1370, 47 USPQ2d at 1366 and MPEP §2133.03(a), subsection II.A. Also, an inventor createsa public use bar under pre-AIA 35 U.S.C. 102(b)when the inventor shows the invention to, or allowsit to be used by, another person who is “under nolimitation, restriction, or obligation ofconfidentiality” to the inventor. See AmericanSeating, 514 F.3d at 1267 and MPEP § 2133.03(a),subsection II.B.

Further, under pre-AIA 35 U.S.C. 102(a), “in orderto invalidate a patent based on prior knowledge oruse” by another in this country prior to the patent'spriority date, “that knowledge or use must have beenavailable to the public.” See Woodland Trust, 148F.3d at 1370, 47 USPQ2d at 1366 and MPEP § 2132,subsection I. Patent-defeating “use,” under pre-AIA35 U.S.C. 102(a) includes only that “use which isaccessible to the public.” See id. (quoting Carellav. Starlight Archery, 804 F.2d 135, 139, 231 USPQ644, 646 (Fed. Cir. 1986)).

As discussed previously, public use under AIA 35U.S.C. 102(a)(1) is limited to those uses that areavailable to the public. The public use provision ofAIA 35 U.S.C. 102(a)(1) thus has the samesubstantive scope, with respect to uses by either theinventor or a third party, as public uses underpre-AIA 35 U.S.C. 102(b) by unrelated third partiesor others under pre-AIA 35 U.S.C. 102(a).

As also discussed previously, once an examinerbecomes aware that a claimed invention has beenthe subject of a potentially public use, the examinershould require the applicant to provide informationshowing that the use did not make the claimedprocess accessible to the public.

2152.02(d) On Sale [R-11.2013]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2133.03 et seq. for information about onsale in regard to applications subject to pre-AIA 35U.S.C. 102.]

The pre-AIA case law indicates that on sale activitywill bar patentability if the claimed invention was:(1) the subject of a commercial sale or offer for sale,not primarily for experimental purposes; and (2)ready for patenting. See Pfaff v. Wells Elecs., Inc.,525 U.S. 55, 67, 48 USPQ2d 1641, 1646-47 (1998).Contract law principles apply in order to determinewhether a commercial sale or offer for sale occurred.In addition, the enablement inquiry is not applicableto the question of whether a claimed invention is

2100-276Rev. 08.2017, January 2018


“on sale” under pre-AIA 35 U.S.C. 102(b). See Epstein, 32 F.3d at 1568, 31 USPQ2d at 1824. Thephrase “on sale” in AIA 35 U.S.C. 102(a)(1) istreated as having the same meaning as “on sale” inpre-AIA 35 U.S.C. 102(b), except that the sale mustmake the invention available to the public. For adiscussion of “on sale” as used in pre-AIA 35 U.S.C.102(b), see generally MPEP § 2133.03(b) et seq.

Under pre-AIA 35 U.S.C. 102(b), if an inventionwas “on sale,” patentability was precluded only ifthe invention was on sale “in this country.” SeeMPEP § 2133.03(d). Under AIA 35 U.S.C.102(a)(1), there is no geographic limitation on wherethe sale or offer for sale may occur. Whenformulating a rejection, Office personnel shouldconsider evidence of sales activity, regardless ofwhere the sale activity took place.

The pre-AIA 35 U.S.C. 102(b) “on sale” provisionhas been interpreted as including commercial activityeven if the activity is secret. See MPEP § 2133.03(b),subsection III.A. AIA 35 U.S.C. 102(a)(1) uses thesame “on sale” term as pre-AIA 35 U.S.C. 102(b).The “or otherwise available to the public” residualclause of AIA 35 U.S.C. 102(a)(1), however,indicates that AIA 35 U.S.C. 102(a)(1) does notcover secret sales or offers for sale. For example, anactivity (such as a sale, offer for sale, or othercommercial activity) is secret (non-public) if it isamong individuals having an obligation ofconfidentiality to the inventor.

2152.02(e) Otherwise Available to the Public[R-11.2013]


AIA 35 U.S.C. 102(a)(1) provides a “catch-all”provision, which defines a new additional categoryof potential prior art not provided for in pre-AIA 35U.S.C. 102. Specifically, a claimed invention is notentitled to a patent if it was “otherwise available to

the public” before its effective filing date. This“catch-all” provision permits decision makers tofocus on whether the disclosure was “available tothe public,” rather than on the means by which theclaimed invention became available to the public orwhether a disclosure constitutes a “printedpublication” or falls within another category of priorart as defined in AIA 35 U.S.C. 102(a)(1). Theavailability of the subject matter to the public mayarise in situations such as a student thesis in auniversity library (see, e.g., In re Cronyn, 890 F.2d1158, 13 USPQ2d 1070 (Fed. Cir. 1989); In re Hall,781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986); Inre Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA1978) and MPEP § 2128.01, subsection I.); a posterdisplay or other information disseminated at ascientific meeting (see, e.g., In re Klopfenstein, 380F.3d 1345, 72 USPQ2d 1117 (Fed. Cir. 2004), Massachusetts Institute of Technology v. AB Fortia,774 F.2d 1104, 227 USPQ 428 (Fed. Cir. 1985) andMPEP § 2128.01, subsection IV.); subject matter ina laid-open patent application or patent (see, e.g., In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA1981); see also Bruckelmyer v. Ground Heaters,Inc., 445 F.3d 1374, 78 USPQ2d 1684 (Fed. Cir.2006)); a document electronically posted on theInternet (see, e.g., Voter Verified, Inc. v. PremierElection Solutions, Inc., 698 F.3d 1374, 104 USPQ2d1553 (Fed. Cir. 2012), In re Lister, 583 F.3d 1307,92 USPQ2d 1225 (Fed. Cir. 2009), SRI Int'l, Inc. v.Internet Sec. Sys., Inc., 511 F.3d 1186, 85 USPQ2d1489 (Fed. Cir. 2008), and MPEP § 2128); or acommercial transaction that does not constitute asale under the Uniform Commercial Code (see, e.g., Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d1041, 59 USPQ2d 1121 (Fed. Cir. 2001) and MPEP§ 2133.03(e)(1)). Even if a document or otherdisclosure is not a printed publication, or atransaction is not a sale, either may be prior art underthe “otherwise available to the public” provision ofAIA 35 U.S.C. 102(a)(1), provided that the claimedinvention is made sufficiently available to the public.

2152.02(f) No Requirement of "By Others"[R-11.2013]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 et

Rev. 08.2017, January 20182100-277


seq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2131-MPEP § 2138 for examination ofapplications subject to pre-AIA 35 U.S.C. 102.]

A key difference between pre-AIA 35 U.S.C. 102(a)and AIA 35 U.S.C. 102(a)(1) is the requirement inpre-AIA 35 U.S.C. 102(a) that the prior art relied onwas “by others.” Under AIA 35 U.S.C. 102(a)(1),there is no requirement that the prior art relied uponbe by others. Thus, any prior art which falls underAIA 35 U.S.C. 102(a)(1) need not be by another toconstitute potentially available prior art. However,disclosures of the subject matter made one year orless before the effective filing date of the claimedinvention by the inventor or a joint inventor oranother who obtained the subject matter directly orindirectly from the inventor or a joint inventor mayfall within an exception under AIA 35 U.S.C.102(b)(1) to AIA 35 U.S.C. 102(a)(1).

2152.03 Admissions [R-11.2013]


The Office will continue to treat admissions by theapplicant as prior art under the AIA. A statement byan applicant in the specification or made duringprosecution identifying the work of another as “priorart” is an admission which can be relied upon forboth anticipation and obviousness determinations,regardless of whether the admitted prior art wouldotherwise qualify as prior art under AIA 35 U.S.C.102. See Riverwood Int'l Corp. v. R.A. Jones & Co.,324 F.3d 1346, 1354, 66 USPQ2d 1331, 1337 (Fed.Cir. 2003); Constant v. Advanced Micro-DevicesInc., 848 F.2d 1560, 1570, 7 USPQ2d 1057, 1063(Fed. Cir.1988). For a discussion of admissions asprior art, see generally MPEP § 2129.

2152.04 The Meaning of "Disclosure"[R-11.2013]


The AIA does not define the term “disclosure,” andAIA 35 U.S.C. 102(a) does not use the term“disclosure.” AIA 35 U.S.C. 102(b)(1) and (b)(2),however, each state conditions under which a“disclosure” that otherwise falls within AIA 35U.S.C. 102(a)(1) or 102(a)(2) is not prior art underAIA 35 U.S.C. 102(a)(1) or 102(a)(2). Thus, theOffice is treating the term “disclosure” as a genericexpression intended to encompass the documentsand activities enumerated in AIA 35 U.S.C. 102(a)(i.e., being patented, described in a printedpublication, in public use, on sale, or otherwiseavailable to the public, or being described in a U.S.patent, U.S. patent application publication, or WIPOpublished application).

2153 Prior Art Exceptions Under 35 U.S.C.102(b)(1) to AIA 35 U.S.C. 102(a)(1)[R-11.2013]


See MPEP § 2153.01 for prior art exceptions basedon grace period inventor or inventor-originateddisclosures as provided for under AIA 35 U.S.C.102(b)(1)(A). See MPEP § 2153.02 for prior artexceptions based on inventor or inventor-originatedprior public disclosures.

2100-278Rev. 08.2017, January 2018


2153.01 Prior Art Exception Under AIA 35U.S.C. 102(b)(1)(A) To AIA 35 U.S.C.102(a)(1) (Grace Period Inventor OrInventor-Originated Disclosure Exception)[R-11.2013]


AIA 35 U.S.C. 102(b)(1)(A) provides exceptions tothe prior art provisions of AIA 35 U.S.C. 102(a)(1).These exceptions limit the use of an inventor's ownwork as prior art, when the inventor's own work hasbeen publicly disclosed by the inventor, a jointinventor, or another who obtained the subject matterdirectly or indirectly from the inventor or jointinventor not more than one year before the effectivefiling date of the claimed invention. AIA 35 U.S.C.102(b)(1)(A) provides that a disclosure which wouldotherwise qualify as prior art under AIA 35 U.S.C.102(a)(1) is not prior art if the disclosure was made:(1) One year or less before the effective filing dateof the claimed invention; and (2) by the inventor ora joint inventor, or by another who obtained thesubject matter directly or indirectly from the inventoror joint inventor. MPEP § 2153.01(a) discussesissues pertaining to disclosures within the graceperiod by the inventor or a joint inventor (“graceperiod inventor disclosures”) and MPEP §2153.01(b) discusses issues pertaining to disclosureswithin the grace period by another who obtained thesubject matter directly or indirectly from the inventoror joint inventor (“grace period inventor-originateddisclosures”). MPEP § 2152.01 discusses the“effective filing date” of a claimed invention.

2153.01(a) Grace Period Inventor DisclosureException [R-11.2013]



AIA 35 U.S.C. 102(b)(1)(A) first provides that adisclosure which would otherwise qualify as priorart under AIA 35 U.S.C. 102(a)(1) may bedisqualified as prior art if the disclosure is made: (1)one year or less before the effective filing date ofthe claimed invention; and (2) by the inventor or ajoint inventor. Thus, a disclosure that wouldotherwise qualify as prior art under AIA 35 U.S.C.102(a)(1) will not be treated as prior art by Officepersonnel if the disclosure is made one year or lessbefore the effective filing date of the claimedinvention, and the evidence shows that the disclosureis by the inventor or a joint inventor. What evidenceis necessary to show that the disclosure is by theinventor or a joint inventor requires case-by-casetreatment, depending upon whether it is apparentfrom the disclosure itself or the patent applicationspecification that the disclosure is by the inventoror a joint inventor.

Office personnel will not apply a disclosure as priorart under AIA 35 U.S.C. 102(a)(1) if it is apparentfrom the disclosure itself that it is by the inventor ora joint inventor. Specifically, Office personnel willnot apply a disclosure as prior art under AIA 35U.S.C. 102(a)(1) if the disclosure: (1) was made oneyear or less before the effective filing date of theclaimed invention; (2) names the inventor or a jointinventor as an author or an inventor; and (3) doesnot name additional persons as authors on a printedpublication or joint inventors on a patent. This meansthat in circumstances where an application namesadditional persons as joint inventors relative to thepersons named as authors in the publication (e.g.,the application names as joint inventors A, B, andC, and the publication names as authors A and B),and the publication is one year or less before theeffective filing date, it is apparent that the disclosureis a grace period inventor disclosure, and thepublication would not be treated as prior art underAIA 35 U.S.C. 102(a)(1). If, however, theapplication names fewer joint inventors than apublication (e.g., the application names as jointinventors A and B, and the publication names asauthors A, B and C), it would not be readily apparent

Rev. 08.2017, January 20182100-279


from the publication that it is by the inventor (i.e.,the inventive entity) or a joint inventor and thepublication would be treated as prior art under AIA35 U.S.C. 102(a)(1).

Applicants can include a statement designating anygrace period inventor disclosures in the specificationSee 37 CFR 1.77(b)(6) and MPEP § 608.01(a). Anapplicant is not required to use the format specifiedin 37 CFR 1.77 or identify any prior disclosures bythe inventor or a joint inventor (unless necessary toovercome a rejection), but identifying any priordisclosures by the inventor or a joint inventor mayexpedite examination of the application and saveapplicants (and the Office) the costs related to anOffice action and reply. If the patent applicationspecification contains a specific reference to a graceperiod inventor disclosure, the Office will considerit apparent from the specification that the priordisclosure is by the inventor or a joint inventor,provided that the prior disclosure does not nameadditional authors or joint inventors and there is noother evidence to the contrary. The applicant mayalso provide a copy of the grace period inventordisclosure (e.g., copy of a printed publication).

The Office has provided a mechanism for filing anaffidavit or declaration (under 37 CFR 1.130) toestablish that a disclosure is not prior art under AIA35 U.S.C. 102(a) due to an exception in AIA 35U.S.C. 102(b). See MPEP § 717. In the situations inwhich it is not apparent from the prior disclosure orthe patent application specification that the priordisclosure is by the inventor or a joint inventor, theapplicant may establish by way of an affidavit ordeclaration that a grace period disclosure is not priorart under AIA 35 U.S.C. 102(a)(1) because the priordisclosure was by the inventor or a joint inventor.MPEP § 2155.01 discusses the use of affidavits ordeclarations to show that the prior disclosure wasmade by the inventor or a joint inventor under theexception of AIA 35 U.S.C. 102(b)(1)(A) for a graceperiod inventor disclosure.

2153.01(b) Grace Period Inventor-OriginatedDisclosure Exception [R-11.2013]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as set

forth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2131-MPEP § 2138 for examination ofapplications subject to pre-AIA 35 U.S.C. 102.]

AIA 35 U.S.C. 102(b)(1)(A) also provides that adisclosure which would otherwise qualify as priorart under AIA 35 U.S.C. 102(a)(1) may bedisqualified as prior art if the disclosure was made:(1) one year or less before the effective filing dateof the claimed invention; and (2) by another whoobtained the subject matter directly or indirectlyfrom the inventor or a joint inventor. Thus, if a priordisclosure upon which the rejection is based is bysomeone who obtained the subject matter from theinventor or a joint inventor, and was made one yearor less before the effective filing date of the claimedinvention, the applicant may establish by way of anaffidavit or declaration that the prior disclosure isnot prior art under AIA 35 U.S.C. 102(a)(1) becausethe prior disclosure was by another who obtainedthe subject matter directly or indirectly from theinventor or a joint inventor. MPEP § 718 and MPEP§ 2155.03 discuss the use of affidavits or declarationsto show that a prior disclosure was by another whoobtained the subject matter disclosed directly orindirectly from the inventor or a joint inventor underthe exception of AIA 35 U.S.C. 102(b)(1)(A) for agrace period inventor-originated disclosure.

2153.02 Prior Art Exception Under AIA 35U.S.C. 102(b)(1)(B) to AIA 35 U.S.C.102(a)(1) (Inventor Or Inventor-OriginatedPrior Public Disclosure Exception)[R-11.2013]


AIA 35 U.S.C. 102(b)(1)(B) provides additionalexceptions to the prior art provisions of AIA 35U.S.C. 102(a)(1). These exceptions disqualify a

2100-280Rev. 08.2017, January 2018


disclosure of subject matter that occurs after thesubject matter had been publicly disclosed by theinventor, a joint inventor, or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor. Specifically, AIA 35U.S.C. 102(b)(1)(B) provides that a disclosure whichwould otherwise qualify as prior art under AIA 35U.S.C. 102(a)(1) (patent, printed publication, publicuse, sale, or other means of public availability) maybe disqualified as prior art if: (1) the disclosure wasmade one year or less before the effective filing dateof the claimed invention; and (2) the subject matterdisclosed had been previously publicly disclosed bythe inventor, a joint inventor, or another whoobtained the subject matter directly or indirectlyfrom the inventor or joint inventor. The previouspublic disclosure of the subject matter by theinventor, a joint inventor, or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor typically will be adisclosure within the one-year grace period (i.e., beeither a grace period inventor disclosure by theinventor or a joint inventor or be a grace periodinventor-originated disclosure by another whoobtained the subject matter directly or indirectlyfrom the inventor or joint inventor). However, if theprevious public disclosure of the subject matter wasmade outside the grace period, it would qualify asprior art under AIA 35 U.S.C. 102(a)(1) that couldnot be disqualified under AIA 35 U.S.C.102(b)(1)(A). MPEP § 2152.01 discusses the“effective filing date” of a claimed invention. MPEP§ 2155.02 discusses the use of affidavits ordeclarations to show that the subject matter disclosedhad, before such disclosure, been publicly disclosedby the inventor or a joint inventor, and MPEP §2155.03 discusses the use of affidavits ordeclarations to show that the disclosure was made,or that the subject matter had been previouslypublicly disclosed, by another obtained the subjectmatter disclosed directly or indirectly from theinventor or a joint inventor.

The exception in AIA 35 U.S.C. 102(b)(1)(B) appliesif the “subject matter disclosed [in the interveningdisclosure] had, before such [intervening] disclosure,been publicly disclosed by the inventor or a jointinventor (or another who obtained the subject matterdirectly or indirectly from the inventor or jointinventor).” See 35 U.S.C. 102(b)(1)(B). The

exception in AIA 35 U.S.C. 102(b)(1)(B) focuseson the “subject matter” that had been publiclydisclosed by the inventor or a joint inventor (oranother who obtained the subject matter directly orindirectly from the inventor or joint inventor). Thereis no requirement under AIA 35 U.S.C. 102(b)(1)(B)that the mode of disclosure by the inventor or a jointinventor (or another who obtained the subject matterdirectly or indirectly from the inventor or jointinventor) be the same as the mode of disclosure ofthe intervening grace period disclosure (e.g.,patenting, publication, public use, sale activity).There is also no requirement that the disclosure bythe inventor or a joint inventor be a verbatim oripsissimis verbis disclosure of the intervening graceperiod disclosure. See In re Kao, 639 F.3d 1057,1066 98 USPQ2d 1799, 1806 (Fed. Cir. 2011)(subject matter does not change as a function of howone chooses to describe it). What is required forsubject matter in an intervening grace perioddisclosure to be excepted under AIA 35 U.S.C.102(b)(1)(B) is that the subject matter of thedisclosure to be disqualified as prior art must havebeen previously publicly disclosed by the inventoror a joint inventor (or by another who obtained thesubject matter therefrom).

The exception in AIA 35 U.S.C. 102(b)(1)(B) appliesto the subject matter in the intervening grace perioddisclosure being relied upon as prior art for arejection under AIA 35 U.S.C. 102(a)(1) (anintervening disclosure) that was also publiclydisclosed by the inventor or a joint inventor (or byanother who obtained the subject matter therefrom)before such intervening disclosure. The subjectmatter of an intervening grace period disclosure thatis not in the inventor or inventor-originated priorpublic disclosure is available as prior art under AIA35 U.S.C. 102(a)(1). For example, if the inventor ora joint inventor had publicly disclosed elements A,B, and C, and a subsequent intervening grace perioddisclosure discloses elements A, B, C, and D, thenonly element D of the intervening grace perioddisclosure is available as prior art under AIA 35U.S.C. 102(a)(1).

In addition, if subject matter of an intervening graceperiod disclosure is simply a more generaldescription of the subject matter in the inventor orinventor-originated prior public disclosure, the

Rev. 08.2017, January 20182100-281


exception in AIA 35 U.S.C. 102(b)(1)(B) applies tosuch subject matter of the intervening grace perioddisclosure. For example, if the inventor or a jointinventor had publicly disclosed a species, and asubsequent intervening grace period disclosurediscloses a genus (i.e., provides a more genericdisclosure of the species), the intervening graceperiod disclosure of the genus is not available asprior art under AIA 35 U.S.C. 102(a)(1). Conversely,if the inventor or a joint inventor had publiclydisclosed a genus, and a subsequent interveninggrace period disclosure discloses a species, theintervening grace period disclosure of the specieswould be available as prior art under AIA 35 U.S.C.102(a)(1). Likewise, if the inventor or a jointinventor had publicly disclosed a species, and asubsequent intervening grace period disclosurediscloses an alternative species not also disclosedby the inventor or a joint inventor, the interveninggrace period disclosure of the alternative specieswould be available as prior art under AIA 35 U.S.C.102(a)(1).

Finally, AIA 35 U.S.C. 102(b)(1)(B) does not discuss“the claimed invention” with respect to either thesubject matter disclosed by the inventor or a jointinventor, or the subject matter of the subsequentintervening grace period disclosure. Any inquirywith respect to the claimed invention is whether ornot the subject matter in the prior art disclosure beingrelied upon anticipates or renders obvious theclaimed invention. A determination of whether theexception in AIA 35 U.S.C. 102(b)(1)(B) isapplicable to subject matter in an intervening graceperiod disclosure does not involve a comparison ofthe subject matter of the claimed invention to eitherthe subject matter in the inventor orinventor-originated prior public disclosure, or to thesubject matter of the subsequent intervening graceperiod disclosure.

2154 Provisions Pertaining to Subject Matterin a U.S. Patent or Application EffectivelyFiled Before the Effective Filing Date of theClaimed Invention [R-11.2013]



AIA 35 U.S.C. 102(a)(2) sets forth three types ofU.S. patent documents that are available as prior artas of the date they were effectively filed with respectto the subject matter relied upon in the document ifthey name another inventor. See MPEP §§ 2151,2154.01, and 2154.01(a) for a discussion of the typesof patent documents that qualify as prior art under35 U.S.C. 102(a)(2). See MPEP § 2154.02 et seq.for prior art exceptions under 35 U.S.C. 102(b)(2)to AIA 35 U.S.C. 102(a)(2).

2154.01 Prior Art Under AIA 35 U.S.C.102(a)(2) “U.S. Patent Documents”[R-11.2013]


AIA 35 U.S.C. 102(a)(2) sets forth three types ofpatent documents that are available as prior art as ofthe date they were effectively filed with respect tothe subject matter relied upon in the document ifthey name another inventor: (1) U.S. patents; (2)U.S. patent application publications; and (3) certainWIPO published applications. These documents arereferred to collectively as “U.S. patent documents.”These documents may have different prior art effectsunder pre-AIA 35 U.S.C. 102(e) than under AIA 35U.S.C. 102(a)(2). Note that a U.S. patent documentmay also be prior art under AIA 35 U.S.C. 102(a)(1)if its issue or publication date is before the effectivefiling date of the claimed invention in question.

If the issue date of the U.S. patent or publicationdate of the U.S. patent application publication orWIPO published application is not before theeffective filing date of the claimed invention, it maybe applicable as prior art under AIA 35 U.S.C.102(a)(2) if it was “effectively filed” before the

2100-282Rev. 08.2017, January 2018


effective filing date of the claimed invention inquestion with respect to the subject matter reliedupon to reject the claim. MPEP § 2152.01 discussesthe “effective filing date” of a claimed invention.AIA 35 U.S.C. 102(d) sets forth the criteria todetermine when subject matter described in a U.S.patent document was “effectively filed” for purposesof AIA 35 U.S.C. 102(a)(2).

2154.01(a) WIPO Published Applications[R-11.2013]


The WIPO publication of a PCT internationalapplication that designates the United States is anapplication for patent deemed published under 35U.S.C. 122(b) for purposes of AIA 35 U.S.C.102(a)(2) under 35 U.S.C. 374. Thus, under the AIA,WIPO publications of PCT applications thatdesignate the United States are treated as U.S. patentapplication publications for prior art purposes,regardless of the international filing date, whetherthey are published in English, or whether the PCTinternational application enters the national stage inthe United States. Accordingly, a U.S. patent, a U.S.patent application publication, or a WIPO publishedapplication that names another inventor and waseffectively filed before the effective filing date ofthe claimed invention, is prior art under AIA 35U.S.C. 102(a)(2). This differs from the treatment ofa WIPO published application under pre-AIA 35U.S.C. 102(e), where a WIPO published applicationis treated as a U.S. patent application publicationonly if the PCT application was filed on or afterNovember 29, 2000, designated the United States,and is published under PCT Article 21(2) in theEnglish language. See MPEP § 2136.03, subsectionII.

2154.01(b) Determining When SubjectMatter Was Effectively Filed Under AIA 35U.S.C. 102(d) [R-08.2017]


AIA 35 U.S.C. 102(d) provides that a U.S. patent,U.S. patent application publication, or WIPOpublished application (“U.S. patent document”) isprior art under AIA 35 U.S.C. 102(a)(2) with respectto any subject matter described in the patent orpublished application as of either its actual filingdate (AIA 35 U.S.C. 102(d)(1)), or the filing date ofa prior application to which there is a priority orbenefit claim (AIA 35 U.S.C. 102(d)(2)). A U.S.patent document “is entitled to claim” priority to, orthe benefit of, a prior-filed application if it fulfillsthe ministerial requirements of: (1) containing apriority or benefit claim to the prior-filed application;(2) being filed within the applicable filing periodrequirement (copending with or within twelvemonths of the earlier filing, as applicable); and (3)having a common inventor or being by the sameapplicant. See MPEP § 211 et. seq.

The AIA draws a distinction between actually beingentitled to priority to, or the benefit of, a prior-filedapplication according to the definition of “effectivefiling date” of a claimed invention in AIA 35 U.S.C.100(i)(1)(B), and merely being entitled to claimpriority to, or the benefit of, a prior-filed applicationaccording to the use of “effectively filed” in AIA 35U.S.C. 102(d). As a result of this distinction, thequestion of whether a patent or published applicationis actually entitled to priority or benefit with respectto any of its claims is not at issue in determining thedate the patent or published application was“effectively filed” for prior art purposes. Thus, thereis no need to evaluate whether any claim of a U.S.patent document is actually entitled to priority orbenefit under 35 U.S.C. 119, 120, 121, 365, or 386when applying such a document as prior art. SeeMPEP § 2136.03 for the reference date under

Rev. 08.2017, January 20182100-283


pre-AIA 35 U.S.C. 102(e) of U.S. patents, U.S.application publications, and internationalapplication publications entitled to the benefit of thefiling date of prior application under 35 U.S.C.119(e), 120, 121, or 365(c).

AIA 35 U.S.C. 102(d) requires that a prior-filedapplication to which a priority or benefit claim ismade must describe the subject matter from the U.S.patent document relied upon in a rejection. However,AIA 35 U.S.C. 102(d) does not require that thisdescription meet the enablement requirements of 35U.S.C. 112(a). As discussed previously with respectto AIA 35 U.S.C. 102(a)(1), the Office does not viewthe AIA as changing the extent to which a claimedinvention must be described for a prior art documentto anticipate the claimed invention under AIA 35U.S.C. 102.

The AIA also eliminates the so-called Hilmerdoctrine. Under the Hilmer doctrine, pre-AIA 35U.S.C. 102(e) limited the effective filing date forU.S. patents (and published applications) as priorart to their earliest U.S. filing date. In re Hilmer,359 F.2d 859, 149 USPQ 480 (CCPA 1966). Incontrast, AIA 35 U.S.C. 102(d) provides that if theU.S. patent document claims priority to one or moreprior-filed foreign or international applications under35 U.S.C. 119 or 365, the patent or publishedapplication was effectively filed on the filing dateof the earliest such application that describes thesubject matter. Therefore, if the subject matter reliedupon is described in the application to which thereis a priority or benefit claim, the U.S. patentdocument is effective as prior art as of the filing dateof the earliest such application, regardless of wherefiled. When examining an application to which theAIA changes in 35 U.S.C. 102 and 103 do not apply,Office personnel will continue to apply the Hilmerdoctrine, and foreign priority dates may not be usedin determining pre-AIA 35 U.S.C. 102(e) prior artdates. Note that the international filing date of apublished PCT application may be the pre-AIA 35U.S.C. 102(e) prior art date under pre-AIA law undercertain circumstances. See MPEP § 706.02(f).

2154.01(c) Requirement Of “Names AnotherInventor” [R-11.2013]


To qualify as prior art under AIA 35 U.S.C.102(a)(2), the prior art U.S. patent, U.S. patentapplication publication, or WIPO publishedapplication (“U.S. patent document”) must “name[] another inventor.” This means that if there is anydifference in inventive entity between the prior artU.S. patent document and the application underexamination or patent under reexamination, the U.S.patent document satisfies the “names anotherinventor” requirement of AIA 35 U.S.C. 102(a)(2).Thus, in the case of joint inventors, only one jointinventor needs to be different for the inventiveentities to be different. Even if there are one or morejoint inventors in common in a U.S. patent documentand the later-filed application under examination orpatent under reexamination, the U.S. patentdocument qualifies as prior art under AIA 35 U.S.C.102(a)(2) unless an exception in AIA 35 U.S.C.102(b)(2) is applicable.

2154.02 Prior Art Exceptions Under 35U.S.C. 102(b)(2) to AIA 35 U.S.C. 102(a)(2)[R-11.2013]


See MPEP § 2154.02(a) for prior art exceptions to35 U.S.C. 102(a)(2) under AIA 35 U.S.C.102(b)(2)(A) based on the inventor-originateddisclosure exception. See MPEP § 2154.02(b) for

2100-284Rev. 08.2017, January 2018


prior art exceptions to AIA 35 U.S.C. 102(a)(2)based on inventor or inventor-originated prior publicdisclosures as provided for in AIA 35 U.S.C.102(b)(2)(B). See MPEP § 2154.02(c) the prior artexception under AIA 35 U.S.C. 102(b)(2)(C) to AIA35 U.S.C. 102(a)(2) based on common ownershipor obligation of assignment.

2154.02(a) Prior Art Exception Under AIA35 U.S.C. 102(b)(2)(A) to AIA 35 U.S.C.102(a)(2) (Inventor-Originated DisclosureException) [R-11.2013]


AIA 35 U.S.C. 102(b)(2)(A) provides an exceptionto the prior art provisions of AIA 35 U.S.C.102(a)(2). This exception limits the use of aninventor's own work as prior art, when the inventor'sown work is disclosed in a U.S. patent, U.S. patentapplication publication, or WIPO publishedapplication (“U.S. patent document”) by anotherwho obtained the subject matter directly or indirectlyfrom the inventor or joint inventor.

Specifically, AIA 35 U.S.C. 102(b)(2)(A) providesthat a disclosure which would otherwise qualify asprior art under AIA 35 U.S.C. 102(a)(2) may bedisqualified as prior art if the subject matterdisclosed was obtained directly or indirectly fromthe inventor or a joint inventor. Thus, if the subjectmatter in a U.S. patent document upon which therejection is based is by another who obtained thesubject matter from the inventor or a joint inventor,the applicant may establish by way of an affidavitor declaration that a disclosure is not prior art underAIA 35 U.S.C. 102(a)(2). MPEP § 2155.03 discussesthe use of affidavits or declarations to show that thedisclosure was by another who obtained the subjectmatter disclosed directly or indirectly from theinventor or a joint inventor under the exception ofAIA 35 U.S.C. 102(b)(2)(A) for aninventor-originated disclosure.

2154.02(b) Prior Art Exception Under AIA35 U.S.C. 102(b)(2)(B) to AIA 35 U.S.C.102(a)(2) (Inventor or Inventor-OriginatedPrior Public Disclosure Exception)[R-08.2017]


AIA 35 U.S.C. 102(b)(2)(B) provides additionalexceptions to the prior art provisions of AIA 35U.S.C. 102(a)(2). These exceptions disqualify subjectmatter that was effectively filed by another after thesubject matter had been publicly disclosed by theinventor, a joint inventor, or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor.

Specifically, AIA 35 U.S.C. 102(b)(2)(B) providesthat a disclosure which would otherwise qualify asprior art under AIA 35 U.S.C. 102(a)(2) (a U.S.patent, U.S. patent application publication, or WIPOpublished application (“U.S. patent document”))may be disqualified as prior art if the subject matterdisclosed had been previously publicly disclosed bythe inventor, a joint inventor, or another whoobtained the subject matter directly or indirectlyfrom the inventor or joint inventor. The previouspublic disclosure of the subject matter by theinventor, a joint inventor, or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor must itself be a publicdisclosure (i.e., be either an inventor disclosure bythe inventor or a joint inventor or be aninventor-originated disclosure by another whoobtained the subject matter directly or indirectlyfrom the inventor or joint inventor). If a previouspublic disclosure by the inventor or which originatedwith the inventor is not within the grace period ofAIA 35 U.S.C. 102(b)(1), it would qualify as priorart under AIA 35 U.S.C. 102(a)(1), and could notbe disqualified under AIA 35 U.S.C. 102(b)(1).MPEP § 2155.02 discusses the use of affidavits ordeclarations to show that the subject matter disclosed

Rev. 08.2017, January 20182100-285


had, before such disclosure, been publicly disclosedby the inventor or a joint inventor, and MPEP §2155.03 discusses the use of affidavits ordeclarations to show that another who obtained thesubject matter disclosed directly or indirectly fromthe inventor or a joint inventor.

Similar to the previous discussion of AIA 35 U.S.C.102(b)(1)(B), the exception in AIA 35 U.S.C.102(b)(2)(B) applies if the “subject matter disclosed[in the intervening disclosure] had, before such[intervening] disclosure was effectively filed undersubsection (a)(2), been publicly disclosed by theinventor or a joint inventor or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor.” The exception in AIA35 U.S.C. 102(b)(2)(B) focuses on the “subjectmatter” that had been publicly disclosed by theinventor or a joint inventor (or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor). There is no requirementunder 35 U.S.C. 102(b)(2)(B) that the mode of priordisclosure by the inventor or a joint inventor (oranother who obtained the subject matter directly orindirectly from the inventor or joint inventor) be thesame as the mode of disclosure of the interveningU.S. patent document(e.g., patenting, publication,public use, sale activity). There is also norequirement that the prior disclosure by the inventoror a joint inventor be a verbatim or ipsissimis verbisdisclosure of the intervening U.S. patent document.What is required for subject matter in the interveningU.S. patent document to be excepted under AIA 35U.S.C. 102(b)(2)(B) is that the subject matter musthave been previously publicly disclosed by theinventor or a joint inventor (or another who obtainedthe subject matter directly or indirectly from theinventor or joint inventor).

The exception in AIA 35 U.S.C. 102(b)(2)(B) appliesonly to the subject matter in the intervening U.S.patent document being relied upon for a rejectionunder AIA 35 U.S.C. 102(a)(2) that was also publiclydisclosed by the inventor or a joint inventor (oranother who obtained the subject matter directly orindirectly from the inventor or joint inventor) beforethe date the subject matter relied upon waseffectively filed. The subject matter of an interveningU.S. patent document that was not previouslypublicly disclosed by the inventor or a joint inventor

(or by another who obtained the subject matter fromthe inventor or joint inventor) is available as priorart under AIA 35 U.S.C. 102(a)(2). For example, ifthe inventor or a joint inventor had publicly disclosedelements A, B, and C, and a subsequent interveningU.S. patent document discloses elements A, B, C,and D, then only element D of the intervening U.S.patent document is available as prior art under AIA35 U.S.C. 102(a)(2).

In addition, if subject matter of an intervening U.S.patent document is simply a more general descriptionof the subject matter previously publicly disclosedby the inventor or a joint inventor (or another whoobtained the subject matter directly or indirectlyfrom the inventor or joint inventor), the exceptionin AIA 35 U.S.C. 102(b)(2)(B) applies to suchsubject matter of the intervening U.S. patentdocument. For example, if the inventor or a jointinventor had publicly disclosed a species, and asubsequent intervening U.S. patent documentdiscloses a genus (i.e., provides a more genericdisclosure of the species), the disclosure of the genusin the intervening U.S. patent document is notavailable as prior art under AIA 35 U.S.C. 102(a)(2).Conversely, if the inventor or a joint inventor hadpublicly disclosed a genus, and a subsequentintervening U.S. patent document discloses a species,the disclosure of the species in the subsequentintervening U.S. patent document would be availableas prior art under AIA 35 U.S.C. 102(a)(2).Likewise, if the inventor or a joint inventor hadpublicly disclosed a species, and a subsequentintervening U.S. patent document discloses analternative species not also disclosed by the inventoror a joint inventor, the disclosure of the alternativespecies in the intervening U.S. patent documentwould be available as prior art under AIA 35 U.S.C.102(a)(2).

Finally, AIA 35 U.S.C. 102(b)(2)(B) does not discuss“the claimed invention” with respect to either thesubject matter disclosed by the inventor or a jointinventor, or the subject matter of the subsequentintervening U.S. patent document. Any inquiry withrespect to the claimed invention is whether or notthe subject matter in the prior art disclosure beingrelied upon anticipates or renders obvious theclaimed invention. A determination of whether theexception in AIA 35 U.S.C. 102(b)(2)(B) is

2100-286Rev. 08.2017, January 2018


applicable to subject matter in an intervening U.S.patent document does not involve a comparison ofthe subject matter of the claimed invention to eitherthe subject matter disclosed by the inventor or a jointinventor, or to the subject matter of the subsequentintervening U.S. patent document.

2154.02(c) Prior Art Exception Under AIA35 U.S.C. 102(b)(2)(C) to AIA 35 U.S.C.102(a)(2) (Common Ownership or Obligationof Assignment) [R-11.2013]


AIA 35 U.S.C. 102(b)(2)(C) provides an additionalexception to the prior art provisions of AIA 35U.S.C. 102(a)(2). The exception of AIA 35 U.S.C.102(b)(2)(C) disqualifies subject matter disclosedin a U.S. patent, U.S. patent application publication,or WIPO published application (“U.S. patentdocument”) from constituting prior art under AIA35 U.S.C. 102(a)(2) if the subject matter disclosedand the claimed invention, not later than the effectivefiling date of the claimed invention, “were ownedby the same person or subject to an obligation ofassignment to the same person.” AIA 35 U.S.C.102(b)(2)(C) resembles pre-AIA 35 U.S.C. 103(c)in that both concern common ownership, and offeran avenue by which an applicant may avoid certainprior art. However, there are significant differencesbetween AIA 35 U.S.C. 102(b)(2)(C) and pre-AIA35 U.S.C. 103(c).

If the provisions of AIA 35 U.S.C. 102(b)(2)(C) aremet, a U.S. patent document that might otherwisequalify as prior art under AIA 35 U.S.C. 102(a)(2)is not available as prior art under either AIA 35U.S.C. 102 or 103. This differs from pre-AIA 35U.S.C. 103(c) in which prior art can precludepatentability under pre-AIA 35 U.S.C. 102, even ifthe conditions of pre-AIA 35 U.S.C. 103(c) are met.The consequence of this distinction is that apublished application or an issued patent that falls

under the common ownership exception of AIA 35U.S.C. 102(b)(2)(C) may not be applied in either ananticipation or an obviousness rejection.

It is important to note the circumstances in whichthe AIA 35 U.S.C. 102(b)(2)(C) exception does notremove a U.S. patent document as a basis for arejection. The AIA 35 U.S.C. 102(b)(2)(C) exceptiondoes not apply to a disclosure that qualifies as priorart under AIA 35 U.S.C. 102(a)(1) (disclosures madebefore the effective filing date of the claimedinvention). Thus, if the issue date of a U.S. patentdocument is before the effective filing date of theclaimed invention, it may be prior art under AIA 35U.S.C. 102(a)(1), regardless of common ownershipor the existence of an obligation to assign. Also,even if a U.S. patent or U.S. published applicationis not prior art under AIA 35 U.S.C. 102 or 103 asa result of AIA 35 U.S.C. 102(b)(2)(C), a doublepatenting rejection (either statutory under 35 U.S.C.101 or non-statutory, sometimes calledobviousness-type) may still be made on the basis ofthe U.S. patent or U.S. patent application publication.Furthermore, the U.S. patent document that does notqualify as prior art as a result of AIA 35 U.S.C.102(b)(2)(C) may still be cited, in appropriatesituations, to indicate the state of the art whenmaking a lack of enablement rejection under 35U.S.C. 112(a). A document need not qualify as priorart to be applied in the context of double patenting,see MPEP § 804.03 (prior art disqualified under theCREATE Act may be the basis for a doublepatenting rejection), or enablement. See MPEP §2124.

The Office revised the rules of practice to includeprovisions that pertain to commonly owned or jointresearch agreement subject matter (37 CFR1.104(c)(4) and (c)(5)). 37 CFR 1.104(c)(4) appliesto an application that is subject to AIA 35 U.S.C.102 and 35 U.S.C. 103, and 37 CFR 1.104(c)(5)applies to an application that is subject to pre-AIA35 U.S.C. 102 and 103. Commonly owned subjectmatter under AIA 35 U.S.C. 102 and 103 is treatedunder 37 CFR 1.104(c)(4)(i), and commonly ownedsubject matter under pre-AIA 35 U.S.C. 102 and 103is treated under 37 CFR 1.104(c)(5)(i). See MPEP§ 706.02(l)(1).

Rev. 08.2017, January 20182100-287


A clear and conspicuous statement by the applicant(or the applicant's representative of record) that theclaimed invention of the application underexamination and the subject matter disclosed in theU.S. patent document applied as prior art wereowned by the same person or subject to an obligationof assignment to the same person not later than theeffective filing date of the claimed invention will besufficient to establish that the AIA 35 U.S.C.102(b)(2)(C) exception applies. Likewise, whenrelying on the provisions of pre-AIA 35 U.S.C.103(c), the applicant (or the applicant'srepresentative of record) can provide a similarstatement required to disqualify the cited prior art.The applicant may present supporting evidence suchas copies of assignment documents, but is notrequired to do so. Furthermore, the Office will notrequest corroborating evidence in the absence ofindependent evidence which raises doubt as to theveracity of such a statement. The statement underAIA 35 U.S.C. 102(b)(2)(C) will generally be treatedby Office personnel analogously to statements madeunder pre-AIA 35 U.S.C. 103(c). See MPEP §706.02(l)(2), subsection II.

2155 Use of Affidavits or Declarations Under37 CFR 1.130 To Overcome Prior ArtRejections [R-07.2015]


37 CFR 1.130 Affidavit or declaration of attribution or priorpublic disclosure under the Leahy-Smith America InventsAct.

(a) Affidavit or declaration of attribution. When any claimof an application or a patent under reexamination is rejected,the applicant or patent owner may submit an appropriate affidavitor declaration to disqualify a disclosure as prior art byestablishing that the disclosure was made by the inventor or ajoint inventor, or the subject matter disclosed was obtaineddirectly or indirectly from the inventor or a joint inventor.

(b) Affidavit or declaration of prior public disclosure.When any claim of an application or a patent underreexamination is rejected, the applicant or patent owner maysubmit an appropriate affidavit or declaration to disqualify adisclosure as prior art by establishing that the subject matter

disclosed had, before such disclosure was made or before suchsubject matter was effectively filed, been publicly disclosed bythe inventor or a joint inventor or another who obtained thesubject matter disclosed directly or indirectly from the inventoror a joint inventor. An affidavit or declaration under thisparagraph must identify the subject matter publicly disclosedand provide the date such subject matter was publicly disclosedby the inventor or a joint inventor or another who obtained thesubject matter disclosed directly or indirectly from the inventoror a joint inventor.

(1) If the subject matter publicly disclosed on that datewas in a printed publication, the affidavit or declaration mustbe accompanied by a copy of the printed publication.

(2) If the subject matter publicly disclosed on that datewas not in a printed publication, the affidavit or declaration mustdescribe the subject matter with sufficient detail and particularityto determine what subject matter had been publicly disclosedon that date by the inventor or a joint inventor or another whoobtained the subject matter disclosed directly or indirectly fromthe inventor or a joint inventor.

(c) When this section is not available . The provisions ofthis section are not available if the rejection is based upon adisclosure made more than one year before the effective filingdate of the claimed invention. The provisions of this sectionmay not be available if the rejection is based upon a U.S. patentor U.S. patent application publication of a patented or pendingapplication naming another inventor, the patent or pendingapplication claims an invention that is the same or substantiallythe same as the applicant's or patent owner's claimed invention,and the affidavit or declaration contends that an inventor namedin the U.S. patent or U.S. patent application publication derivedthe claimed invention from the inventor or a joint inventornamed in the application or patent, in which case an applicantor a patent owner may file a petition for a derivation proceedingpursuant to § 42.401 et seq. of this title.

(d) Applications and patents to which this section isapplicable. The provisions of this section apply to anyapplication for patent, and to any patent issuing thereon, thatcontains, or contained at any time:

(1) A claim to a claimed invention that has an effectivefiling date as defined in § 1.109 that is on or after March 16,2013; or

(2) A specific reference under 35 U.S.C. 120, 121,365(c), or 386(c) to any patent or application that contains, orcontained at any time, a claim to a claimed invention that hasan effective filing date as defined in § 1.109 that is on or afterMarch 16, 2013.

The Office has provided a mechanism in 37 CFR1.130 for filing an affidavit or declaration to establishthat a disclosure is not prior art under AIA 35 U.S.C.102(a) due to an exception in AIA 35 U.S.C. 102(b).Under 37 CFR 1.130(a), an affidavit or declarationof attribution may be submitted to disqualify adisclosure as prior art because it was made by theinventor or a joint inventor, or the subject matterdisclosed was obtained directly or indirectly from

2100-288Rev. 08.2017, January 2018


the inventor or a joint inventor. Under 37 CFR1.130(b), an affidavit or declaration of prior publicdisclosure may be submitted to disqualify anintervening disclosure as prior art if the subjectmatter disclosed had, before such disclosure wasmade or before such subject matter was effectivelyfiled in a U.S. patent, U.S. patent applicationpublication, or WIPO published application, beenpublicly disclosed by the inventor or a joint inventoror another who obtained the subject matter discloseddirectly or indirectly from the inventor or a jointinventor.

2155.01 Showing That the Disclosure WasMade by the Inventor or a Joint Inventor[R-11.2013]


AIA 35 U.S.C. 102(b)(1)(A) provides that a graceperiod disclosure shall not be prior art to a claimedinvention under AIA 35 U.S.C. 102(a)(1) if thedisclosure was made by the inventor or a jointinventor. An applicant may show that a disclosurewas made by the inventor or a joint inventor by wayof an affidavit or declaration under 37 CFR 1.130(a)(an affidavit or declaration of attribution). See Inre Katz, 687 F.2d 450, 455, 215 USPQ 14, 18 (CCPA1982) and MPEP § 718. Where the authorship of theprior art disclosure includes the inventor or a jointinventor named in the application, an “unequivocal”statement from the inventor or a joint inventor thatthe inventor or joint inventor (or some specificcombination of named inventors) invented thesubject matter of the disclosure, accompanied by areasonable explanation of the presence of additionalauthors, may be acceptable in the absence ofevidence to the contrary. See In re DeBaun, 687F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).However, a mere statement from the inventor or ajoint inventor without any accompanying reasonableexplanation may not be sufficient where there isevidence to the contrary. See Ex parte Kroger, 219

USPQ 370 (Bd. App. 1982) (affirming rejectionnotwithstanding declarations by the alleged actualinventors as to their inventorship in view of anonapplicant author submitting a letter declaring thenonapplicant author's inventorship). This is similarto the current process for disqualifying a publicationas not being by “others” discussed in MPEP §2132.01, except that AIA 35 U.S.C. 102(b)(1)(A)requires only that the disclosure be by the inventoror a joint inventor.

2155.02 Showing That the Subject MatterDisclosed Had Been Previously PubliclyDisclosed by the Inventor or a Joint Inventor[R-11.2013]


AIA 35 U.S.C. 102(b)(1)(B) provides that a graceperiod disclosure shall not be prior art to a claimedinvention under AIA 35 U.S.C. 102(a)(1) if subjectmatter disclosed had, before such disclosure, beenpublicly disclosed by the inventor or a joint inventor.Similarly, AIA 35 U.S.C. 102(b)(2)(B) provides thata disclosure shall not be prior art to a claimedinvention under AIA 35 U.S.C. 102(a)(2) if thesubject matter disclosed had, before such subjectmatter was effectively filed under AIA 35 U.S.C.102(a)(2), been publicly disclosed by the inventoror a joint inventor. An applicant may show that thesubject matter disclosed had been publicly disclosedby the inventor or a joint inventor before thedisclosure or effective filing date of the subjectmatter on which the rejection was based by way ofan affidavit or declaration under 37 CFR 1.130(b)(an affidavit or declaration of prior publicdisclosure). Specifically, the affidavit or declarationmust identify the subject matter publicly disclosedand establish the date and content of their earlierpublic disclosure. If the earlier public disclosure isa printed publication, the affidavit or declarationmust be accompanied by a copy of the printedpublication in accordance with37 CFR 1.130(b)(1).

Rev. 08.2017, January 20182100-289


If the earlier disclosure is not a printed publication,the affidavit or declaration must describe the earlierdisclosure with sufficient detail and particularity todetermine that the earlier disclosure is a publicdisclosure of the subject matter, as required by 37CFR 1.130(b)(2).

The manner of disclosure of subject matterreferenced in an affidavit or declaration under 37CFR 1.130(b)(2) is not critical. Just as the prior artprovision of AIA 35 U.S.C. 102(a)(1) encompassesany disclosure that renders a claimed invention“available to the public,” any manner of disclosuremay be evidenced in an affidavit or declaration under37 CFR 1.130(b). That is, when using an affidavitor declaration under 37 CFR 1.130(b) to disqualifyan intervening disclosure as prior art based on a priorpublic disclosure by an inventor or a joint inventor,it is not necessary for the subject matter to have beendisclosed in the same manner or using the samewords. For example, the inventor or a joint inventormay have publicly disclosed the subject matter inquestion via a slide presentation at a scientificmeeting, while the intervening disclosure of thesubject matter may have been made in a journalarticle. This difference in the manner of disclosureor differences in the words used to describe thesubject matter will not preclude the inventor fromsubmitting an affidavit or declaration under 37 CFR1.130(b) to disqualify the intervening disclosure(e.g., a journal article) as prior art.

2155.03 Showing That the Disclosure wasMade, or That Subject Matter had BeenPreviously Publicly Disclosed, by AnotherWho Obtained the Subject Matter DisclosedDirectly or Indirectly From the Inventor ora Joint Inventor [R-11.2013]


AIA 35 U.S.C. 102(b)(1)(A), 102(b)(1)(B),102(b)(2)(A), and 102(b)(2)(B) each provide similartreatment for disclosures of subject matter by anotherwho obtained the subject matter disclosed directlyor indirectly from the inventor or a joint inventor.Specifically, AIA 35 U.S.C. 102(b)(1)(A) providesthat a grace period disclosure shall not be prior artto a claimed invention under AIA 35 U.S.C.102(a)(1) if the disclosure was made by another whoobtained the subject matter disclosed directly orindirectly from the inventor or a joint inventor, andAIA 35 U.S.C. 102(b)(2)(A) provides that adisclosure shall not be prior art to a claimedinvention under AIA 35 U.S.C. 102(a)(2) if thesubject matter disclosed was obtained directly orindirectly from the inventor or a joint inventor.

In addition, AIA 35 U.S.C. 102(b)(1)(B) and102(b)(2)(B) respectively provide that a grace perioddisclosure under AIA 35 U.S.C. 102(a)(1), and thata disclosure under AIA 35 U.S.C. 102(a)(2) shallnot be prior art to a claimed invention, if the subjectmatter disclosed had, before such grace disclosurewas made or before such subject matter waseffectively filed according to 35 U.S.C. 102(a)(2),been publicly disclosed by another who obtained thesubject matter disclosed directly or indirectly fromthe inventor or a joint inventor. An applicant mayalso show that another obtained the subject matterdisclosed directly or indirectly from the inventor ora joint inventor in an affidavit or declaration under37 CFR 1.130(a) or (b). Thus, an applicant mayestablish a prior public disclosure by another duringthe grace period if the applicant can establish thatsubject matter disclosed originated with the inventoror a joint inventor and that the subject matter wascommunicated by the inventor or a joint inventor,directly or indirectly. Any documentation whichprovides evidence of the communication of thesubject matter by the inventor or a joint inventor tothe entity that made the disclosure of the subjectmatter directly or indirectly, such as by an assigneeof the inventor, should accompany the affidavit ordeclaration.

2155.04 Enablement [R-11.2013]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as set

2100-290Rev. 08.2017, January 2018


forth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2131-MPEP § 2138 for examination ofapplications subject to pre-AIA 35 U.S.C. 102.]

An affidavit or declaration under 37 CFR 1.130(a)or (b) need not demonstrate that the disclosure bythe inventor, a joint inventor, or another whoobtained the subject matter disclosed directly orindirectly from an inventor or a joint inventor wasan “enabling” disclosure of the subject matter withinthe meaning of 35 U.S.C. 112(a). Rather, an affidavitor declaration under 37 CFR 1.130 must show that:(1) the disclosure in question was made by theinventor or a joint inventor, or the subject matterdisclosed was obtained directly or indirectly fromthe inventor or a joint inventor (37 CFR 1.130(a));or (2) the subject matter disclosed had, before suchdisclosure was made or before such subject matterwas effectively filed, been publicly disclosed by theinventor or a joint inventor or another who obtainedthe subject matter disclosed directly or indirectlyfrom the inventor or a joint inventor (37 CFR1.130(b)).

2155.05 Who May File an Affidavit orDeclaration Under 37 CFR 1.130 [R-11.2013]


In accordance with 37 CFR 1.130, the applicant orpatent owner may submit an affidavit or declaration.When an assignee, obligated assignee, or personshowing sufficient proprietary interest is theapplicant under 35 U.S.C. 118 rather than theinventor, the inventor may sign an affidavit ordeclaration under 37 CFR 1.130 to disqualify adisclosure of the invention as prior art, but thedeclaration must be filed by a party having authorityto take action in the application. Authority to filepapers in an application generally does not lie withthe inventor if the inventor is not the applicant.

2155.06 Situations in Which an Affidavit orDeclaration Is Not Available [R-11.2013]


The provisions of 37 CFR 1.130 are not available ifthe rejection is based upon a disclosure made morethan one year before the effective filing date of theclaimed invention. A disclosure made more than oneyear before the effective filing date of a claimedinvention is prior art under AIA 35 U.S.C. 102(a)(1)that cannot be disqualified under AIA 35 U.S.C.102(b)(1).

Additionally, the provisions of 37 CFR 1.130 maynot be available if the rejection is based upon a U.S.patent or U.S. patent application publication naminganother inventor if: (1) the patent or pendingapplication claims an invention that is the same orsubstantially the same as the applicant's or patentowner's claimed invention; and (2) the affidavit ordeclaration contends that an inventor named in theU.S. patent or U.S. patent application publicationderived the claimed invention from the inventor ora joint inventor named in the application or patent.The provisions of 37 CFR 1.130 are not available ifit would result in the Office issuing or confirmingtwo patents containing patentably indistinct claimsto two different parties. See In re Deckler, 977 F.2d1449, 1451-52, 24 USPQ2d 1448, 1449 (Fed. Cir.1992) (35 U.S.C. 102 , 103, and 135 “clearlycontemplate—where different inventive entities areconcerned—only one patent should issue forinventions which are either identical to or notpatentably distinct from each other”) (quoting Aelonyv. Arni, 547 F.2d 566, 570, 192 USPQ 486, 490(CCPA 1977)). In this situation, an applicant orpatent owner may file a petition for a derivationproceeding pursuant to 37 CFR 42.401 et seq. (37CFR 1.130(c)).

Rev. 08.2017, January 20182100-291


2156 Joint Research Agreements [R-11.2013]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2131-MPEP § 2138 and MPEP § 2146 forexamination of applications subject to pre-AIA 35U.S.C. 102 and 35 U.S.C. 103.]

35 U.S.C. 102 Conditions for patentability; novelty.

*****

(c) COMMON OWNERSHIP UNDER JOINT RESEARCHAGREEMENTS.—Subject matter disclosed and a claimedinvention shall be deemed to have been owned by the sameperson or subject to an obligation of assignment to the sameperson in applying the provisions of subsection (b)(2)(C) if—

(1) the subject matter disclosed was developed and theclaimed invention was made by, or on behalf of, 1 or moreparties to a joint research agreement that was in effect on orbefore the effective filing date of the claimed invention;

(2) the claimed invention was made as a result ofactivities undertaken within the scope of the joint researchagreement; and

(3) the application for patent for the claimed inventiondiscloses or is amended to disclose the names of the parties tothe joint research agreement.

*****

AIA 35 U.S.C. 102(c) provides three conditions thatmust be satisfied in order for subject matter disclosedwhich might otherwise qualify as prior art, and aclaimed invention, to be treated as having beenowned by the same person or subject to an obligationof assignment to the same person in applyingcommon ownership provisions of AIA 35 U.S.C.102(b)(2)(C) in the context of a joint researchagreement. First, the subject matter disclosed musthave been developed and the claimed invention musthave been made by, or on behalf of, one or moreparties to a joint research agreement that was ineffect on or before the effective filing date of theclaimed invention. See 35 U.S.C. 102(c)(1). TheAIA defines the term “joint research agreement” asa written contract, grant, or cooperative agreemententered into by two or more persons or entities forthe performance of experimental, developmental, orresearch work in the field of the claimed invention.See 35 U.S.C. 100(h). Second, the claimed inventionmust have been made as a result of activities

undertaken within the scope of the joint researchagreement. See 35 U.S.C. 102(c)(2). Third, theapplication for patent for the claimed invention mustdisclose, or be amended to disclose, the names ofthe parties to the joint research agreement. See 35U.S.C. 102(c)(3). Joint research agreement subjectmatter under AIA 35 U.S.C. 102 and 103 is treatedunder 37 CFR 1.104(c)(5)(ii), joint researchagreement subject matter under pre-AIA 35 U.S.C.102 and 103 is treated under 37 CFR 1.104(c)(5)(ii).If these conditions are met, the joint researchagreement prior art is not available as prior art underAIA 35 U.S.C. 102(a)(2).

The provisions of AIA 35 U.S.C. 102(c) generallytrack those of the Cooperative Research andTechnology Enhancement Act of 2004 (CREATEAct). See MPEP § 706.02(l)(1). The majordifferences between AIA 35 U.S.C. 102(c) and theCREATE Act are that: (1) the AIA provision iskeyed to the effective filing date of the claimedinvention, while the CREATE Act focuses on thedate that the claimed invention was made; and (2)the CREATE Act provisions only apply toobviousness rejections and not to anticipationrejections.

In order to invoke a joint research agreement todisqualify a disclosure as prior art, the applicant (orthe applicant's representative of record) must providea statement that the disclosure of the subject matteron which the rejection is based and the claimedinvention were made by or on behalf of parties to ajoint research agreement under AIA 35 U.S.C.102(c). The statement must also assert that theagreement was in effect on or before the effectivefiling date of the claimed invention, and that theclaimed invention was made as a result of activitiesundertaken within the scope of the joint researchagreement. When relying on the provisions ofpre-AIA 35 U.S.C. 103(c), the applicant or hisattorney or agent of record can provide a similarstatement to disqualify the cited prior art as to theissue of obviousness. If the names of the parties tothe joint research agreement are not already statedin the application, it is necessary to amend theapplication to include the names of the parties to thejoint research agreement in accordance with 37 CFR1.71(g).

2100-292Rev. 08.2017, January 2018


As is the case with establishing common ownership,the applicant may, but is not required to, presentevidence supporting the existence of the jointresearch agreement. Furthermore, the Office willnot request corroborating evidence in the absenceof independent evidence which raises doubt as tothe existence of the joint research agreement.

As discussed previously, the AIA 35 U.S.C.102(b)(2)(C) exception does not apply to a disclosurethat qualifies as prior art under AIA 35 U.S.C.102(a)(1) (disclosures made before the effectivefiling date of the claimed invention). Thus, if theissue date or publication date of a U.S. patentdocument is before the effective filing date of theclaimed invention, it may be prior art under AIA 35U.S.C. 102(a)(1), regardless of the fact that theclaimed invention resulted from a joint researchagreement and the disclosure was by a party to theagreement.

2157 Improper Naming of Inventors[R-07.2015]

Although the AIA eliminated pre-AIA 35 U.S.C.102(f), the patent laws still require the naming ofthe actual inventor or joint inventors of the claimedsubject matter. See 35 U.S.C. 115(a) (“[a]napplication for patent that is filed under [35 U.S.C.]111(a) or commences the national stage under [35U.S.C.] 371 shall include, or be amended to include,the name of the inventor for any invention claimedin the application”). The Office presumes that thenamed inventor or joint inventors in the applicationare the actual inventor or joint inventors to be namedon the patent. See MPEP § 2137.01. Where anapplication names an incorrect inventorship, theapplicant should submit a request to correctinventorship under 37 CFR 1.48. See MPEP §602.01(c) et seq. In the rare situation where it clearthat the application does not name the correctinventorship and the applicant has not filed a requestto correct inventorship under 37 CFR 1.48, Officepersonnel should reject the claims under 35 U.S.C.101 and 35 U.S.C. 115. See MPEP § 706.03(a),subsection IV. Note that a rejection under pre-AIA35 U.S.C. 102(f) should not be made if theapplication is subject to examination under the firstinventor to file (FITF) provisions of the AIA. SeeMPEP § 2159 et seq. to determine whether an

application is subject to examination under the FITFprovisions, and MPEP § 2137 for informationpertaining to pre-AIA 35 U.S.C. 102(f).

2158 AIA 35 U.S.C. 103 [R-08.2017]

[Editor Note: This MPEP section is only applicableto applications subject to examination under the firstinventor to file (FITF) provisions of the AIA as setforth in 35 U.S.C. 100 (note). See MPEP § 2159 etseq. to determine whether an application is subjectto examination under the FITF provisions, andMPEP § 2141-MPEP § 2146 for information onpre-AIA 35 U.S.C. 103 and AIA 35 U.S.C. 103.]

AIA 35 U.S.C. 103 continues to set forth thenonobviousness requirement for patentability. Thereare, however, some important changes from pre-AIA35 U.S.C. 103.

The most significant difference between the AIA 35U.S.C. 103 and pre-AIA 35 U.S.C. 103(a) is thatAIA 35 U.S.C. 103 determines obviousness as ofthe effective filing date of the claimed invention,rather than as of the time that the claimed inventionwas made. Under pre-AIA examination practice, theOffice uses the effective filing date as a proxy forthe invention date, unless there is evidence of recordto establish an earlier date of invention. Thus, as apractical matter during examination, this distinctionbetween the AIA 35 U.S.C. 103 and pre-AIA 35U.S.C. 103 will result in a difference in practice onlywhen the case under examination is subject topre-AIA 35 U.S.C. 103 , and there is evidence in thecase concerning a date of invention prior to theeffective filing date. Such evidence is ordinarilypresented by way of an affidavit or declaration under37 CFR 1.131.

Next, AIA 35 U.S.C. 103 differs from that ofpre-AIA 35 U.S.C. 103 in that AIA 35 U.S.C. 103requires consideration of “the differences betweenthe claimed invention and the prior art,” whilepre-AIA 35 U.S.C. 103 refers to “the differencesbetween the subject matter sought to be patented andthe prior art.” This difference in terminology doesnot indicate the need for any difference in approachto the question of obviousness. As pointed out bythe Federal Circuit, “[t]he term ‘claims' has beenused in patent legislation since the Patent Act of

Rev. 08.2017, January 20182100-293


1836 to define the invention that an applicantbelieves is patentable.” Hoechst-Roussel Pharms.,Inc. v. Lehman, 109 F.3d 756, 758, 42 USPQ2d1220, 1222 (Fed. Cir. 1997) (citing Act of July 4,1836, ch. 357, § 6, 5 Stat. 117). Furthermore, in Graham v. John Deere, the second of the SupremeCourt's factual inquiries (the “Graham factors”) isthat the “differences between the prior art and theclaims at issue are to be ascertained.” 383 U.S. 1,17, 148 USPQ 459, 467. Thus, in interpreting 35U.S.C. 103 as enacted in the 1952 PatentAct—language that remained unchanged untilenactment of the AIA—the Court equated “thesubject matter sought to be patented” with the claims.

Further, AIA 35 U.S.C. 103 does not contain anyprovision similar to pre-AIA 35 U.S.C. 103(b).Pre-AIA 35 U.S.C. 103(b) is narrowly drawn,applying only to nonobviousness of biotechnologicalinventions, and even then, only when specificallyinvoked by the patent applicant. Pre-AIA 35 U.S.C.103(b) provides that under certain conditions, “abiotechnological process using or resulting in acomposition of matter that is novel under section102 and nonobvious under subsection [103(a)] ofthis section shall be considered nonobvious.” In viewof the case law since 1995, the need to invokepre-AIA 35 U.S.C. 103(b) has been rare. As statedin MPEP § 706.02(n), in view of the Federal Circuit'sdecisions in In re Ochiai, 71 F.3d 1565, 37 USPQ2d1127 (Fed. Cir. 1995) and In re Brouwer, 77 F.3d422, 37 USPQ2d 1663 (Fed. Cir. 1996), the need toinvoke pre-AIA 35 U.S.C. 103(b) rarely arose. Thosecases continue to retain their validity under the AIA.

Finally, AIA 35 U.S.C. 103 eliminates pre-AIA 35U.S.C. 103(c), but corresponding provisions havebeen introduced in AIA 35 U.S.C. 102(b)(2)(C) and102(c). Pre-AIA 35 U.S.C. 103(c) applied if subjectmatter qualified as prior art only under pre-AIA 35U.S.C. 102(e), (f), and/or (g), and only in the contextof obviousness under pre-AIA 35 U.S.C. 103(a). Ifsubject matter developed by another person wascommonly owned with the claimed invention, or ifthe subject matter was subject to an obligation ofassignment to the same person, at the time theclaimed invention was made, then pre-AIA 35 U.S.C.103(a) did not preclude patentability. Furthermore,under pre-AIA 35 U.S.C. 103(c), if a joint researchagreement was in place on or before the date that

the claimed invention was made, the claimedinvention was made as a result of activitiesundertaken within the scope of the joint researchagreement, and the application for patent disclosedor was amended to disclose the names of the partiesto the joint research agreement, common ownershipor an obligation to assign was deemed to exist. Asdiscussed previously, AIA 35 U.S.C. 102(b)(2)(C)and 102(c) expand on this concept. Under the AIA,the common ownership, obligation to assign, or jointresearch agreement must exist on or before theeffective filing date of the claimed invention, ratherthan on or before the date the invention was made.If the provisions of AIA 35 U.S.C. 102(b)(2)(C) aremet, a disclosure is not prior art at all, whereas underpre-AIA 35 U.S.C. 103(c) , certain prior art merelywas defined as not precluding patentability. Finally,disclosures disqualified as prior art under AIA 35U.S.C. 102(b)(2)(C) and 102(c) may not be appliedin either an anticipation or an obviousness rejection.However, such disclosures could be the basis forstatutory double patenting or non-statutory(sometimes referred to as obviousness-type) doublepatenting rejections.

Generally speaking, and with the exceptions notedherein, pre-AIA notions of obviousness will continueto apply under the AIA. AIA 35 U.S.C. 102(a)defines what is prior art both for purposes of noveltyunder AIA 35 U.S.C. 102 as well as for purposes ofobviousness under AIA 35 U.S.C. 103. See HazeltineRes., Inc. v. Brenner, 382 U.S. 252, 256, 147 USPQ429, 430 (1965) (a previously filed patent applicationto another pending in the Office, but not patented orpublished, at the time an application is filedconstitutes part of the “prior art” within the meaningof 35 U.S.C. 103). Thus, if a document qualifies asprior art under AIA 35 U.S.C. 102(a)(1) or (a)(2),and is not subject to an exception under AIA 35U.S.C. 102(b), it may be applied for what it describesor teaches to those skilled in the art in a rejectionunder AIA 35 U.S.C. 103. This is in accordance withpre-AIA case law indicating that in makingdeterminations under 35 U.S.C. 103, “it must beknown whether a patent or publication is in the priorart under 35 U.S.C. 102.” Panduit Corp. v. DennisonMfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593,1597 (Fed. Cir. 1987). However, while a disclosuremust enable those skilled in the art to make theinvention in order to anticipate under 35 U.S.C. 102,

2100-294Rev. 08.2017, January 2018


a non-enabling disclosure is prior art for all it teachesfor purposes of determining obviousness under 35U.S.C. 103 . Symbol Techs. Inc. v. Opticon Inc., 935F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir.1991); Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed.Cir. 1989) (“Even if a reference discloses aninoperative device, it is prior art for all that itteaches.”). Office personnel should continue tofollow guidance for formulating an appropriaterationale to support any conclusion of obviousness.See MPEP § 2141 et seq. and the guidancedocuments available at www.uspto.gov/patents/law/exam/ksr_training_materials.jsp.

2159 Applicability Date Provisions andDetermining Whether an Application IsSubject to the First Inventor To FileProvisions of the AIA [R-11.2013]

Because the changes to 35 U.S.C. 102 and 35 U.S.C.103 in the AIA apply only to specific applicationsfiled on or after March 16, 2013, determining theeffective filing date of a claimed invention forpurposes of applying AIA 35 U.S.C. 102 and 103provisions or pre-AIA 35 U.S.C. 102 and 103provisions is critical.

2159.01 Applications Filed Before March 16,2013 [R-11.2013]

The changes to 35 U.S.C. 102 and 103 in the AIAdo not apply to any application filed before March16, 2013. Thus, any application filed before March16, 2013, is governed by pre-AIA 35 U.S.C. 102 and103 (i.e., the application is a pre-AIA first to inventapplication). Note that neither the filing of a requestfor continued examination, nor entry into the nationalstage under 35 U.S.C. 371, constitutes the filing ofa new application. Accordingly, even if a requestfor continued examination under 37 CFR 1.114 isfiled on or after March 16, 2013, in an applicationthat was filed before March 16, 2013, the applicationremains subject to pre-AIA 35 U.S.C. 102 and 103.Similarly, a PCT application filed under 35 U.S.C.363 before March 16, 2013, is subject to pre-AIA35 U.S.C. 102 and 103, regardless of whether theapplication enters the national stage under 35 U.S.C.371 before or after March 16, 2013. Additionally,

adding claims after March 16, 2013 in an applicationfiled before March 16, 2013 via an amendmentwhich contains new matter does not make thechanges to 35 U.S.C. 102 and 35 U.S.C. 103 in theAIA applicable to the application because 35 U.S.C.132(a) prohibits the introduction of new matter intothe disclosure. If new matter is added viaamendment, claims directed to the new matter willbe rejected under pre-AIA 35 U.S.C. 112, firstparagraph. See MPEP § 608.04.

2159.02 Applications Filed on or AfterMarch 16, 2013 [R-11.2013]

AIA 35 U.S.C. 102 and 103 took effect on March16, 2013. AIA 35 U.S.C. 102 and 103 apply to anypatent application that contains or contained at anytime a claim to a claimed invention that has aneffective filing date that is on or after March 16,2013. If a patent application (1) contains or containedat any time a claim to a claimed invention havingan effective filing date as defined in 35 U.S.C. 100(i)that is on or after March 16, 2013 or (2) claims orever claimed the benefit of an earlier filing dateunder 35 U.S.C. 120 , 121, or 365 based upon anearlier application that ever contained such a claim,then AIA 35 U.S.C. 102 and 103 apply to theapplication, (i.e., the application is an AIAapplication). If there is ever even a single claim toa claimed invention in the application having aneffective filing date on or after March 16, 2013, AIA35 U.S.C. 102 and 103 apply in determining thepatentability of every claimed invention in theapplication. This is the situation even if theremaining claimed inventions all have an effectivefiling date before March 16, 2013, and even if theclaim to a claimed invention having an effectivefiling date on or after March 16, 2013, is canceled.

If an application filed on or after March 16, 2013,that did not previously contain any claim to aclaimed invention having an effective filing date onor after March 16, 2013, (a pre-AIA application) isamended to contain a claim to a claimed inventionhaving an effective filing date on or after March 16,2013, the application becomes an AIA application(AIA 35 U.S.C. 102 and 103 apply to theapplication), provided that the newly added claimedinvention has support under 35 U.S.C. 112(a) in theapplication filed on or after March 16, 2013. The

Rev. 08.2017, January 20182100-295


https://www.uspto.gov/patents/law/exam/ksr_training_materials.jsp

https://www.uspto.gov/patents/law/exam/ksr_training_materials.jsp

application also becomes subject to AIA 35 U.S.C.102 and 103 even if the claim to a claimed inventionhaving an effective filing date on or after March 16,2013, is subsequently canceled. If an amendmentafter an Office action causes the application tochange from being governed by pre-AIA 35 U.S.C.102 and 103 (from being a pre-AIA application) tobeing governed by AIA 35 U.S.C. 102 and 103 (tobeing a AIA application), any new ground ofrejection necessitated by the change in applicablelaw would be considered a new ground of rejectionnecessitated by an amendment for purposes ofdetermining whether the next Office action may bemade final. See MPEP § 706.07(a).

As 35 U.S.C. 132(a) prohibits the introduction ofnew matter into the disclosure, an application maynot contain a claim to a claimed invention that doesnot have support under 35 U.S.C. 112(a) in theapplication (that is directed to new matter). Thus,an application cannot “contain” a claim to a claimedinvention that is directed to new matter for purposesof determining whether the application evercontained a claim to a claimed invention having aneffective filing date on or after March 16, 2013.Amendments that are believed to contain new mattershould be treated as follows: (1) a new drawingshould not be entered if the examiner discovers thatthe drawing contains new matter (MPEP § 608.02,subsection II.); and (2) amendments to the writtendescription or claims involving new matter areordinarily entered, but the new matter is required tobe canceled from the written description and theclaims directed to the new matter are rejected under35 U.S.C. 112(a) (MPEP § 608.04). This process fortreating amendments containing new matter is purelyan administrative process for handling an amendmentseeking to introduce new matter into the disclosureof the invention in violation of 35 U.S.C. 132(a),and for resolving disputes between the applicant andan examiner as to whether a new drawing oramendment to the written description or claimswould actually introduce new matter into thedisclosure of the invention. Therefore, an amendment(other than a preliminary amendment filed on thesame day as such application) seeking to add a claimto a claimed invention that is directed to new matterin an application filed on or after March 16, 2013,that, as originally filed, discloses and claims onlysubject matter also disclosed in an earlier application

filed before March 16, 2013 to which the applicationfiled on or after March 16, 2013, is entitled topriority or benefit under 35 U.S.C. 119, 120, 121,or 365, would not change the application from apre-AIA application into an AIA application.

2159.03 Applications Subject to the AIA butAlso Containing a Claimed Invention Havingan Effective Filing Date Before March 16,2013 [R-11.2013]

Even if AIA 35 U.S.C. 102 and 103 apply to a patentapplication, pre-AIA 35 U.S.C. 102(g) also appliesto every claim in the application if it: (1) containsor contained at any time a claimed invention havingan effective filing date as defined in 35 U.S.C. 100(i)that occurs before March 16, 2013; or (2) is everdesignated as a continuation, divisional, orcontinuation-in-part of an application that containsor contained at any time such a claim. Pre-AIA 35U.S.C. 102(g) also applies to any patent resultingfrom an application to which pre-AIA 35 U.S.C.102(g) applied. See MPEP § 2138.

Thus, if an application contains, or contained at anytime, any claim having an effective filing date thatoccurs before March 16, 2013, and also contains, orcontained at any time, any claim having an effectivefiling date that is on or after March 16, 2013, eachclaim must be patentable under AIA 35 U.S.C. 102and 103, as well as pre-AIA 35 U.S.C. 102(g), forthe applicant to be entitled to a patent. However, anapplication will not otherwise be concurrentlysubject to both pre-AIA 35 U.S.C. 102 and 103 andAIA 35 U.S.C. 102 and 103.

For these reasons, when subject matter is claimedin an application filed on or after March 16, 2013having priority to or the benefit (e.g., under 35U.S.C. 120, 121, or 365(c)) of a prior applicationfiled before March 16, 2013, care must be taken toaccurately determine whether AIA or pre-AIA 35U.S.C. 102 and 103 applies to the application. SeeAlso MPEP § 2151.

2159.04 Applicant Statement in TransitionApplications Containing a Claimed Invention

2100-296Rev. 08.2017, January 2018


Having an Effective Filing Date on or AfterMarch 16, 2013 [R-11.2013]

The Office revised 37 CFR 1.55 and 1.78 to requirethat if a nonprovisional application filed on or afterMarch 16, 2013, claims the benefit of or priority toan application where the filing date of a foreign, U.S.provisional, U.S. nonprovisional, or internationalapplication is prior to March 16, 2013 (termed as “atransition application”), and also contains orcontained at any time a claimed invention having aneffective filing date on or after March 16, 2013, theapplicant must provide a statement to that effect(“the 37 CFR 1.55 or 1.78 statement”). Thisinformation will assist the Office in determiningwhether the transition application is subject to AIA35 U.S.C. 102 and 103 or pre-AIA 35 U.S.C. 102and 103. However, applicant is not required toprovide this information if the transition applicationclaims the benefit of an earlier transition applicationin which a 37 CFR 1.55 or 37 CFR 1.78 statementhas been filed. See 37 CFR 1.78(c)(6)(i). See alsoMPEP § 210.

2160 [Reserved]

2161 Three Separate Requirements forSpecification Under 35 U.S.C. 112(a) orPre-AIA 35 U.S.C. 112, First Paragraph[R-07.2015]

I. THE SPECIFICATION MUST INCLUDE AWRITTEN DESCRIPTION OF THE INVENTION,ENABLEMENT, AND BEST MODE OF CARRYINGOUT THE CLAIMED INVENTION

35 U.S.C. 112(a) (applicable to applications filed on orafter September 16, 2012) provides:

(a) IN GENERAL.—The specification shallcontain a written description of the invention,and of the manner and process of making andusing it, in such full, clear, concise, and exactterms as to enable any person skilled in the artto which it pertains, or with which it is mostnearly connected, to make and use the same,and shall set forth the best mode contemplated

by the inventor or joint inventor of carrying outthe invention.

The first paragraph of pre-AIA 35 U.S.C. 112(applicable to applications filed before September16, 2012) provides:

The specification shall contain a writtendescription of the invention, and of the mannerand process of making and using it, in such full,clear, concise, and exact terms as to enable anyperson skilled in the art to which it pertains, orwith which it is most nearly connected, to makeand use the same, and shall set forth the bestmode contemplated by the inventor of carryingout his invention. [emphasis added].

35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, firstparagraph require that the specification include thefollowing:

(A) A written description of the invention;

(B) The manner and process of making and usingthe invention (the enablement requirement); and

(C) The best mode contemplated by the inventorof carrying out his invention.

II. THE THREE REQUIREMENTS ARESEPARATE AND DISTINCT FROM EACH OTHER

The written description requirement is separate anddistinct from the enablement requirement. AriadPharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336,1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (enbanc) (If Congress had intended enablement to bethe sole description requirement of § 112, firstparagraph, the statute would have been writtendifferently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991)(While acknowledging that some of its casesconcerning the written description requirement andthe enablement requirement are confusing, theFederal Circuit reaffirmed that under 35 U.S.C. 112,first paragraph, the written description requirementis separate and distinct from the enablementrequirement and gave an example thereof.); In reBarker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977),cert. denied, 434 U.S. 1064 (1978). See also, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc.,

Rev. 08.2017, January 20182100-297


782 F.3d 671, 681-685, 114 USPQ2d 1349, 1356,1357 (Fed. Cir. 2015) (reversing and remanding thedistrict court's grant of summary judgment ofinvalidity for lack of an adequate written descriptionand lack of enablement because there were genuineissues of material fact regarding 1) whether theclaims had sufficient written description support(“[t]he fact that . . . the specification do[es] not speakin haec verba of accessing ‘disparate databases’ doesnot eliminate as a genuine issue of material fact thatthe existence of at least some discussion, andtherefore, possession, of the accessing of disparatedatabases, as claimed”); and 2) whether the claimswere enabled (“the effort it took the inventor toreduce the invention to practice does notconclusively show lack of enablement”). Aninvention may be described without the disclosurebeing enabling (e.g., a chemical compound for whichthere is no disclosed or apparent method of making),and a disclosure could be enabling withoutdescribing the invention (e.g., a specificationdescribing a method of making and using a paintcomposition made of functionally defined ingredientswithin broad ranges would be enabling forformulations falling within the description but wouldnot describe any specific formulation). See Inre Armbruster, 512 F.2d 676, 677, 185 USPQ 152,153 (CCPA 1975) (“[A] specification which‘describes’ does not necessarily also ‘enable’ oneskilled in the art to make or use the claimedinvention.”). Best mode is a separate and distinctrequirement from the enablement requirement. Inre Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA1969).

2161.01 Computer Programming, ComputerImplemented Inventions, and 35 U.S.C.112(a) or Pre-AIA 35 U.S.C. 112, FirstParagraph [R-08.2017]

The s ta tu tory requi rements forcomputer-implemented inventions are the same asfor all inventions, such as the subject mattereligibility and utility requirements under 35 U.S.C.101 (see MPEP §§ 2106 and 2107, respectively), thenovelty requirement of 35 U.S.C. 102, thenonobviousness requirement of 35 U.S.C. 103, thedefiniteness requirement of 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph, and thethree separate and distinct requirements of 35 U.S.C.

112(a) or pre-AIA 35 U.S.C. 112, first paragraph.In addition, claims with computer-implementedfunctional claim limitations may invoke 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.See MPEP § 2181, subsection II.B. and § 2181,subsection IV. for information regarding means- (orstep-) plus- function limitations.

I. DETERMINING WHETHER THERE ISADEQUATE WRITTEN DESCRIPTION FOR ACOMPUTER-IMPLEMENTED FUNCTIONALCLAIM LIMITATION

The 35 U.S.C. 112(a) or first paragraph of pre-AIA35 U.S.C. 112 contains a written descriptionrequirement that is separate and distinct from theenablement requirement. Ariad Pharm., Inc. v. EliLilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161,1167 (Fed. Cir. 2010) (en banc). To satisfy thewritten description requirement, the specificationmust describe the claimed invention in sufficientdetail that one skilled in the art can reasonablyconclude that the inventor had possession of theclaimed invention at the time of filing. LizardTech,Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336,1344-45, 76 USPQ2d 1724, 1731-32 (Fed. Cir.2005); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555,1562-64, 19 USPQ2d 1111, 1115-16 (Fed. Cir.1991). Specifically, the specification must describethe claimed invention in a manner understandableto a person of ordinary skill in the art in a way thatshows that the inventor actually invented the claimedinvention at the time of filing. Id.; Ariad, 598 F.3dat 1351, 94 USPQ2d at 1172. The function of thewritten description requirement is to ensure that theinventor had possession of the specific subject matterlater claimed as of the filing date of the applicationrelied on; how the specification accomplishes thisis not material. In re Herschler, 591 F.2d 693,700-01, 200 USPQ 711, 717 (CCPA 1979), furtherreiterated in In re Kaslow, 707 F.2d 1366, 217USPQ 1089 (Fed. Cir. 1983); see also MPEP §§2163 - 2163.04.

The written description requirement of 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,applies to all claims including original claims thatare part of the disclosure as filed. Ariad, 598 F.3dat 1349, 94 USPQ2d at 1170. As stated by theFederal Circuit, “[a]lthough many original claims

2100-298Rev. 08.2017, January 2018


will satisfy the written description requirement,certain claims may not.” Id. at 1349, 94 USPQ2dat 1170-71; see also LizardTech, Inc. v. Earth Res.Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d1724, 1730-33 (Fed. Cir. 2005); Regents of the Univ.of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43USPQ2d 1398, 1405-06 (Fed. Cir. 1997)(“Thedescription requirement of the patent statute requiresa description of an invention, not an indication of aresult that one might achieve if one made thatinvention.”). Problems satisfying the writtendescription requirement for original claims oftenoccur when claim language is generic or functional,or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at1171 ("The problem is especially acute with genusclaims that use functional language to define theboundaries of a claimed genus. In such a case, thefunctional claim may simply claim a desired result,and may do so without describing species thatachieve that result. But the specification mustdemonstrate that the applicant has made a genericinvention that achieves the claimed result and do soby showing that the applicant has invented speciessufficient to support a claim to thefunctionally-defined genus.").

For instance, generic claim language in the originaldisclosure does not satisfy the written descriptionrequirement if it fails to support the scope of thegenus claimed. Ariad, 598 F.3d at 1349-50, 94USPQ2d at 1171 (“[A]n adequate written descriptionof a claimed genus requires more than a genericstatement of an invention’s boundaries.”) (citing EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002)(holding that generic claim language appearing in ipsis verbis in the original specification did notsatisfy the written description requirement becauseit failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d1601, 1606 (Fed. Cir. 1993) (rejecting the argumentthat “only similar language in the specification ororiginal claims is necessary to satisfy the writtendescription requirement”).

The Federal Circuit has explained that a specificationcannot always support expansive claim languageand satisfy the requirements of 35 U.S.C. 112“merely by clearly describing one embodiment of

the thing claimed.” LizardTech v. Earth ResourceMapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d1731, 1733 (Fed. Cir. 2005). The issue is whether aperson skilled in the art would understand applicantto have invented, and been in possession of, theinvention as broadly claimed. In LizardTech, claimsto a generic method of making a seamless discretewavelet transformation (DWT) were held invalidunder 35 U.S.C. 112, first paragraph, because thespecification taught only one particular method formaking a seamless DWT and there was no evidencethat the specification contemplated a more genericmethod. “[T]he description of one method forcreating a seamless DWT does not entitle theinventor . . . to claim any and all means for achievingthat objective.” LizardTech, 424 F.3d at 1346, 76USPQ2d at 1733.

Similarly, original claims may lack writtendescription when the claims define the invention infunctional language specifying a desired result butthe specification does not sufficiently describe howthe function is performed or the result is achieved.For software, this can occur when the algorithm orsteps/procedure for performing the computerfunction are not explained at all or are not explainedin sufficient detail (simply restating the functionrecited in the claim is not necessarily sufficient). Inother words, the algorithm or steps/procedure takento perform the function must be described withsufficient detail so that one of ordinary skill in theart would understand how the inventor intended thefunction to be performed. See MPEP §§ 2163.02and 2181, subsection IV.

The level of detail required to satisfy the writtendescription requirement varies depending on thenature and scope of the claims and on the complexityand predictability of the relevant technology. Ariad,598 F.3d at 1351, 94 USPQ2d at 1172; Capon v.Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078,1083-84 (Fed. Cir. 2005). Computer-implementedinventions are often disclosed and claimed in termsof their functionality. For computer-implementedinventions, the determination of the sufficiency ofdisclosure will require an inquiry into the sufficiencyof both the disclosed hardware and the disclosedsoftware due to the interrelationship andinterdependence of computer hardware and software.The critical inquiry is whether the disclosure of the

Rev. 08.2017, January 20182100-299


application relied upon reasonably conveys to thoseskilled in the art that the inventor had possession ofthe claimed subject matter as of the filing date. Vasudenvan Sofware, Inc. v. MicroStrategy, Inc.,782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336,1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) inthe context of determining possession of a claimedmeans of accessing disparate databases).

When examining computer-implemented functionalclaims, examiners should determine whether thespecification discloses the computer and thealgorithm (e.g., the necessary steps and/orflowcharts) that perform the claimed function insufficient detail such that one of ordinary skill in theart can reasonably conclude that the inventorpossessed the claimed subject matter at the time offiling. It is not enough that one skilled in the artcould write a program to achieve the claimedfunction because the specification must explain howthe inventor intends to achieve the claimed functionto satisfy the written description requirement. See,e.g., Vasudevan Software, Inc. v. MicroStrategy,Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349,1356, 1357 (Fed. Cir. 2015) (reversing andremanding the district court’s grant of summaryjudgment of invalidity for lack of adequate writtendescription where there were genuine issues ofmaterial fact regarding “whether the specificationshow[ed] possession by the inventor of howaccessing disparate databases is achieved”). If thespecification does not provide a disclosure of thecomputer and algorithm in sufficient detail todemonstrate to one of ordinary skill in the art thatthe inventor possessed the invention a rejection under35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, for lack of written description must bemade. For more information regarding the writtendescription requirement, see MPEP § 2162- §2163.07(b). If the specification does not provide adisclosure of sufficient corresponding structure,materials, or acts that perform the entire claimedfunction of a means- (or step-) plus- functionlimitation in a claim under 35 U.S.C. 112(f) or thesixth paragraph of pre-AIA 35 U.S.C. 112, "theapplicant has in effect failed to particularly point outand distinctly claim the invention" as required bythe 35 U.S.C. 112(b) [or the second paragraph ofpre-AIA 35 U.S.C. 112]. In re Donaldson Co., 16

F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir.1994) (en banc). A rejection under 35 U.S.C. 112(b)or the second paragraph of pre-AIA 35 U.S.C. 112must be made in addition to the written descriptionrejection.

II. BEST MODE

The purpose of the best mode requirement is to“restrain inventors from applying for patents whileat the same time concealing from the public thepreferred embodiments of their inventions whichthey have in fact conceived.” In re Gay, 309 F.2d769, 772, 135 USPQ 311, 315 (CCPA 1962). Onlyevidence of concealment, “whether accidental orintentional,” is considered in judging the adequacyof the disclosure for compliance with the best moderequirement. Spectra-Physics, Inc. v. Coherent,Inc.,827 F.2d 1524, 1535, 3 USPQ2d 1737, 1745(Fed. Cir. 1987). "That evidence, in order to resultin affirmance of a best mode rejection, must tend toshow that the quality of an applicant’s best modedisclosure is so poor as to effectively result inconcealment." In re Sherwood, 613 F.2d 809,816-817, 204 USPQ 537, 544 (CCPA1980)(emphasis omitted); White Consol. Indus. v.Vega Servo-Control Inc., 214 USPQ 796, 824 (S.D.Mich. 1982), aff’d on related grounds, 713 F.2d788, 218 USPQ 961 (Fed. Cir. 1983); see also MPEP§§ 2165 - 2165.04.

There are two factual inquiries to be made indetermining whether a specification satisfies the bestmode requirement. First, there must be a subjectivedetermination as to whether the inventor knew of abest mode of practicing the invention at the time theapplication was filed. Second, if the inventor had abest mode of practicing the invention in mind, theremust be an objective determination as to whetherthat best mode was disclosed in sufficient detail toallow one skilled in the art to practice it. FonarCorp. v. Gen. Elect. Co., 107 F.3d 1543, 41 USPQ2d1801, 1804 (Fed. Cir. 1997); Chemcast Corp. v.Arco Indus., 913 F.2d 923, 927-28, 16 USPQ2d1033, 1036 (Fed. Cir. 1990). “As a general rule,where software constitutes part of a best mode ofcarrying out an invention, description of such a bestmode is satisfied by a disclosure of the functions ofthe software. This is because, normally, writing codefor such software is within the skill of the art, not

2100-300Rev. 08.2017, January 2018


requiring undue experimentation, once its functionshave been disclosed. . . . [F]low charts or sourcecode listings are not a requirement for adequatelydisclosing the functions of software.” Fonar Corp.,107 F.3d at 1549, 41 USPQ2d at 1805 (citationsomitted).

III. DETERMINING WHETHER THE FULLSCOPE OF A COMPUTER-IMPLEMENTEDFUNCTIONAL CLAIM LIMITATION IS ENABLED

To satisfy the enablement requirement of 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,the specification must teach those skilled in the arthow to make and use the full scope of the claimedinvention without “undue experimentation.” See,e.g., In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d1510, 1513 (Fed. Cir. 1993); In re Wands, 858 F.2d731, 736-37, 8 USPQ2d 1400, 1402 (Fed. Cir. 1988).In In re Wands, the court set forth the followingfactors to consider when determining whether undueexperimentation is needed: (1) the breadth of theclaims; (2) the nature of the invention; (3) the stateof the prior art; (4) the level of one of ordinary skill;(5) the level of predictability in the art; (6) theamount of direction provided by the inventor; (7)the existence of working examples; and (8) thequantity of experimentation needed to make or usethe invention based on the content of the disclosure. Wands, 858 F.2d at 737, 8 USPQ2d 1404. Theundue experimentation determination is not a singlefactual determination; rather, it is a conclusionreached by weighing all the factual considerations. Id.

When basing a rejection on the failure of theapplicant’s disclosure to meet the enablementprovisions of 35 U.S.C. 112(a) or the first paragraphof pre-AIA 35 U.S.C. 112, USPTO personnel mustestablish on the record a reasonable basis forquestioning the adequacy of the disclosure to enablea person of ordinary skill in the art to make and usethe claimed invention without resorting to undueexperimentation. See In re Brown, 477 F.2d 946,177 USPQ 691 (CCPA 1973); In re Ghiron, 442F.2d 985, 169 USPQ 723 (CCPA 1971). OnceUSPTO personnel have advanced a reasonable basisfor questioning the adequacy of the disclosure, itbecomes incumbent on the applicant to rebut thatchallenge and factually demonstrate that the

application disclosure is sufficient. See In re Doyle,482 F.2d 1385, 1392, 179 USPQ 227, 232 (CCPA1973); In re Scarbrough, 500 F.2d 560, 566, 182USPQ 298, 302 (CCPA 1974); In re Ghiron, supra;see also MPEP §§ 2164 - 2164.08(c).

When a claim is not limited to any particularstructure for performing a recited function and doesnot invoke 35 U.S.C. 112(f), any claim languagereciting the ability to perform a function per se wouldtypically be construed broadly to cover any and allembodiments that perform the recited function.Because such a claim encompasses all devices orstructures that perform the recited function, there isa concern regarding whether the applicant'sdisclosure sufficiently enables the full scope ofprotection sought by the claim. In re Swinehart, 439F.2d 210, 213, 169 USPQ 226, 229 (CCPA 1971); AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore,439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA1971). Applicants who present broad claim languagemust ensure the claims are fully enabled.Specifically, the scope of the claims must be lessthan or equal to the scope of the enablement providedby the specification. Sitrick v. Dreamworks, LLC,516 F.3d 993, 999, 85 USPQ2d 1826, 1830 (Fed.Cir. 2008) (“The scope of the claims must be lessthan or equal to the scope of the enablement toensure that the public knowledge is enriched by thepatent specification to a degree at leastcommensurate with the scope of the claims.”(quotation omitted)).

For example, the claims in Sitrick were directed to“integrating” or “substituting” a user’s audio signalor visual image into a pre-existing video game ormovie. While the claims covered both video gamesand movies, the specification only taught the skilledartisan how to substitute and integrate user imagesinto video games. The Federal Circuit held that thespecification failed to enable the full scope of theclaims because the skilled artisan could not substitutea user image for a preexisting character image inmovies without undue experimentation. Specifically,the court recognized that one skilled in the art couldnot apply the teachings of the specification regardingvideo games to movies, because movies, unlike videogames, do not have easily separable characterfunctions. Because the specification did not teach

Rev. 08.2017, January 20182100-301


how the substitution and integration of characterfunctions for a user image would be accomplishedin movies, the claims were not enabled. Sitrick, 516F.3d at 999-1001, 85 USPQ2d at 1830-32.

In MagSil Corp. v. Hitachi Global Storage Techs.,Inc. 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir.2012), the Federal Circuit stated that “a patenteechooses broad claim language at the peril of losingany claim that cannot be enabled across its full scopeof coverage,” finding “one skilled in the art couldnot have taken the disclosure in the specificationregarding ‘change in the resistance by at least 10%at room temperature’ and achieved a change inresistance in the full scope of that term withoutundue experimentation." 687 F.3d at 1381-82. "Thus,the specification enabled a marginal advance overthe prior art, but did not enable at the time of filinga tunnel junction of resistive changes reaching evenup to 20%, let alone the more recent achievementsabove 600%.” The court held that the “claims [were]invalid for lack of enablement because their broadscope [was] not reasonably supported by the scopeof enablement in the specification.” 687 F.3d at1381-1382, 1384, 103 USPQ2d at 1771, 1772, 1774(“MagSil did not fully enable its broad claim scope.Therefore, it cannot claim an exclusive right toexclude later tri-layer tunnel junctions that greatlyexceed a 10% resistive change.”). See also Convolve, Inc. v. Compaq Computer Corp., 527F.App’x 910, 931 (Fed. Cir. 2013)(non-precedential), quoting MagSil Corp.)(affirminggrant of summary judgment of invalidity due to lackof enablement where the patentee “[b]y choosingsuch broad claim language, ... put itself ‘at the perilof losing any claim that cannot be enabled across itsfull scope of coverage.’”).

The specification need not teach what is well knownin the art. However, applicant cannot rely on theknowledge of one skilled in the art to supplyinformation that is required to enable the novelaspect of the claimed invention when the enablingknowledge is in fact not known in the art. ALZACorp. v. Andrx Pharms., LLC, 603 F.3d 935, 941,94 USPQ2d 1823, 1827 (Fed. Cir. 2010) (“ALZAwas required to provide an adequate enablingdisclosure in the specification; it cannot simply relyon the knowledge of a person of ordinary skill toserve as a substitute for the missing information in

the specification.”); Auto. Techs. Int’l, Inc. v. BMWof N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d1108, 1114-15 (Fed. Cir. 2007) (“Although theknowledge of one skilled in the art is indeed relevant,the novel aspect of an invention must be enabled inthe patent.”). The Federal Circuit has stated that “‘[i]tis the specification, not the knowledge of one skilledin the art, that must supply the novel aspects of aninvention in order to constitute adequateenablement.’” Auto. Technologies, 501 F.3d at 1283,84 USPQ2d at 1115 (quoting Genentech, Inc. v.Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d1001, 1005 (Fed. Cir. 1997)). The rule that aspecification need not disclose what is well knownin the art is “merely a rule of supplementation, nota substitute for a basic enabling disclosure.” Genentech, 108 F.3d at 1366, 42 USPQ2d 1005;see also ALZA Corp., 603 F.3d at 940-41, 94USPQ2d at 1827. Therefore, the specification mustcontain the information necessary to enable the novelaspects of the claimed invention. Id. at 941, 94USPQ2d at 1827; Auto. Technologies, 501 F.3d at1283-84, 84 USPQ2d at 1115 (“[T]he ‘omission ofminor details does not cause a specification to failto meet the enablement requirement. However, whenthere is no disclosure of any specific starting materialor of any of the conditions under which a processcan be carried out, undue experimentation isrequired.’”) (quoting Genentech, 108 F.3d at 1366,42 USPQ2d at 1005). For instance, in Auto.Technologies, the claim limitation “means responsiveto the motion of said mass” was construed to includeboth mechanical side impact sensors and electronicside impact sensors for performing the function ofinitiating an occupant protection apparatus. Auto.Technologies, 501 F.3d at 1282, 84 USPQ2d at 1114.The specification did not include any discussion ofthe details or circuitry involved in the electronic sideimpact sensor and thus, failed to apprise one ofordinary skill how to make and use the electronicsensor. Because the novel aspect of the inventionwas side impact sensors, the patentee could not relyon the knowledge of one skilled in the art to supplythe missing information. Auto. Technologies, 501F.3d at 1283, 84 USPQ2d at 1114.

A rejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph for lack of enablementmust be made when the specification does not enablethe full scope of the claim. USPTO personnel should

2100-302Rev. 08.2017, January 2018


establish a reasonable basis to question theenablement provided for the claimed invention andprovide reasons for the uncertainty of theenablement. For more information regarding theenablement requirement, see MPEP §§ 2164.01(a)- MPEP 2164.08(c), especially., MPEP § 2164.06(c)for examples of computer programming cases.

2162 Policy Underlying 35 U.S.C. 112(a) orPre-AIA 35 U.S.C. 112, First Paragraph[R-08.2017]

To obtain a valid patent, a patent application mustcontain a full and clear description of the inventionfor which a patent is sought in the manner prescribedby 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph. The requirement for an adequate writtendescription ensures that the public receivessomething in return for the exclusionary rights thatare granted to the inventor by a patent. The grant ofa patent helps to foster and enhance the developmentand disclosure of new ideas and the advancement ofscientific knowledge. Upon the grant of a patent inthe U.S., information contained in the patentbecomes a part of the information available to thepublic for further research and development, subjectonly to the patentee’s right to exclude others duringthe life of the patent.

In exchange for the patent rights granted, 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,sets forth the minimum requirements for the qualityand quantity of information that must be containedin a patent application to justify the grant of a patent.As discussed in more detail below, the patentee mustdisclose sufficient information to demonstrate thatthe inventor had possession of the invention at thetime of filing and to enable those skilled in the artto make and use the invention. The applicant mustnot conceal from the public the best way ofpracticing the invention that was known to thepatentee at the time of filing the patent application.Failure to fully comply with the disclosurerequirements could result in the denial of a patent,or in a holding of invalidity of an issued patent.

2163 Guidelines for the Examination ofPatent Applications Under the 35 U.S.C.112(a) or Pre-AIA 35 U.S.C. 112, first

paragraph, “Written Description”Requirement [R-08.2017]

The following Guidelines establish the policies andprocedures to be followed by Office personnel inthe evaluation of any patent application forcompliance with the written description requirementof 35 U.S.C. 112. These Guidelines are based on theOffice’s current understanding of the law and arebelieved to be fully consistent with binding precedentof the U.S. Supreme Court, as well as the U.S. Courtof Appeals for the Federal Circuit and its predecessorcourts.

The Guidelines do not constitute substantiverulemaking and hence do not have the force andeffect of law. They are designed to assist Officepersonnel in analyzing claimed subject matter forcompliance with substantive law. Rejections will bebased upon the substantive law, and it is theserejections that are appealable. Consequently, anyperceived failure by Office personnel to follow theseGuidelines is neither appealable nor petitionable.

These Guidelines are intended to form part of thenormal examination process. Thus, where Officepersonnel establish a prima facie case of lack ofwritten description for a claim, a thorough reviewof the prior art and examination on the merits forcompliance with the other statutory requirements,including those of 35 U.S.C. 101, 102, 103, and 112,is to be conducted prior to completing an Officeaction that includes a rejection for lack of writtendescription.

I. GENERAL PRINCIPLES GOVERNINGCOMPLIANCE WITH THE “WRITTENDESCRIPTION” REQUIREMENT FORAPPLICATIONS

35 U.S.C. 112(a) and the first paragraph of pre-AIA35 U.S.C. 112 require that the “specification shallcontain a written description of the invention ....”This requirement is separate and distinct from theenablement requirement. Ariad Pharm., Inc. v. EliLilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161,1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v.Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochesterv. G.D. Searle & Co., 358 F.3d 916, 920-23, 69

Rev. 08.2017, January 20182100-303


USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussingthe history and purpose of the written descriptionrequirement); In re Curtis, 354 F.3d 1347, 1357, 69USPQ2d 1274, 1282 (Fed. Cir. 2004) (“conclusiveevidence of a claim’s enablement is not equallyconclusive of that claim’s satisfactory writtendescription”). The written description requirementhas several policy objectives. “[T]he ‘essential goal’of the description of the invention requirement is toclearly convey the information that an applicant hasinvented the subject matter which is claimed.” Inre Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470,473 n.4 (CCPA 1977). Another objective is toconvey to the public what the applicant claims asthe invention. See Regents of the Univ. of Cal. v.Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398,1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089(1998). "The ‘written description’ requirementimplements the principle that a patent must describethe technology that is sought to be patented; therequirement serves both to satisfy the inventor’sobligation to disclose the technologic knowledgeupon which the patent is based, and to demonstratethat the patentee was in possession of the inventionthat is claimed." Capon v. Eshhar, 418 F.3d 1349,1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005).Further, the written description requirementpromotes the progress of the useful arts by ensuringthat patentees adequately describe their inventionsin their patent specifications in exchange for the rightto exclude others from practicing the invention forthe duration of the patent’s term.

To satisfy the written description requirement, apatent specification must describe the claimedinvention in sufficient detail that one skilled in theart can reasonably conclude that the inventor hadpossession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir.2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at1563, 19 USPQ2d at 1116. However, a showing ofpossession alone does not cure the lack of a writtendescription. Enzo Biochem, Inc. v. Gen-Probe, Inc.,323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed.Cir. 2002). For example, it is now well accepted thata satisfactory description may be found inoriginally-filed claims or any other portion of theoriginally-filed specification. See In re Koller, 613F.2d 819, 204 USPQ 702 (CCPA 1980); In re

Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA1973); In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976). However, that does not mean thatall originally-filed claims have adequate writtensupport. The specification must still be examined toassess whether an originally-filed claim has adequatewritten support.

An applicant shows possession of the claimedinvention by describing the claimed invention withall of its limitations using such descriptive means aswords, structures, figures, diagrams, and formulasthat fully set forth the claimed invention. Lockwoodv. Amer. Airlines, Inc., 107 F.3d 1565, 1572,41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possessionmay be shown in a variety of ways includingdescription of an actual reduction to practice, or byshowing that the invention was “ready for patenting”such as by the disclosure of drawings or structuralchemical formulas that show that the invention wascomplete, or by describing distinguishing identifyingcharacteristics sufficient to show that the applicantwas in possession of the claimed invention. See, e.g.,Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct.304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc.v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d1016, 1021 (Fed. Cir. 1991) (one must define acompound by “whatever characteristics sufficientlydistinguish it”). "Compliance with the writtendescription requirement is essentially a fact-basedinquiry that will ‘necessarily vary depending on thenature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An applicationspecification may show actual reduction to practiceby describing testing of the claimed invention or, inthe case of certain biological materials, byspecifically describing a deposit made in accordancewith 37 CFR 1.801 et seq. See Enzo Biochem, 323F.3d at 965, 63 USPQ2d at 1614 ("reference in thespecification to a deposit may also satisfy the writtendescription requirement with respect to a claimedmaterial"); see also Deposit of Biological Materialsfor Patent Purposes, Final Rule, 54 Fed. Reg. 34,864(August 22, 1989) (“The requirement for a specificidentification is consistent with the descriptionrequirement of the first paragraph of 35 U.S.C. 112,and to provide an antecedent basis for the biologicalmaterial which either has been or will be depositedbefore the patent is granted.” Id. at 34,876. “The

2100-304Rev. 08.2017, January 2018


description must be sufficient to permit verificationthat the deposited biological material is in fact thatdisclosed. Once the patent issues, the descriptionmust be sufficient to aid in the resolution ofquestions of infringement.” Id. at 34,880.) Such adeposit is not a substitute for a written descriptionof the claimed invention. The written description ofthe deposited material needs to be as complete aspossible because the examination for patentabilityproceeds solely on the basis of the writtendescription. See, e.g., In re Lundak, 773 F.2d 1216,227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg.at 34,880 (“As a general rule, the more informationthat is provided about a particular depositedbiological material, the better the examiner will beable to compare the identity and characteristics ofthe deposited biological material with the prior art.”).

A question as to whether a specification provides anadequate written description may arise in the contextof determining whether an original claim is describedsufficiently (see, e.g., LizardTech, Inc. v. EarthResource Mapping, Inc., 424 F.3d 1336, 1345, 76USPQ2d 1724, 1733 (Fed. Cir. 2005); EnzoBiochem, 323 F.3d at 968, 63 USPQ2d at 1616 (Fed.Cir. 2002); Eli Lilly, 119 F.3d 1559, 43 USPQ2d1398)), whether new or amended claims aresupported by the description of the invention in theapplication as filed (see, e.g., In re Wright, 866 F.2d422, 9 USPQ2d 1649 (Fed. Cir. 1989)), whether aclaimed invention is entitled to the benefit of anearlier priority date or effective filing date under 35U.S.C. 119, 120, 365, or 386 (see, e.g., NewRailhead Mfg. L.L.C. v. Vermeer Mfg. Co., 298 F.3d1290, 63 USPQ2d 1843 (Fed. Cir. 2002); Tronzov. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829(Fed. Cir. 1998); Fiers v. Revel, 984 F.2d 1164, 25USPQ2d 1601 (Fed. Cir. 1993); In re Ziegler, 992F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir.1993)), or whether a specification provides supportfor a claim corresponding to a count in aninterference (see, e.g., Martin v. Mayer, 823 F.2d500, 503, 3 USPQ2d 1333, 1335 (Fed. Cir. 1987); Fields v. Conover, 443 F.2d 1386, 170 USPQ 276(CCPA 1971)). Compliance with the writtendescription requirement is a question of fact whichmust be resolved on a case-by-case basis. Vas-Cath,Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at1116 (Fed. Cir. 1991).

A. Original Claims

There is a presumption that an adequate writtendescription of the claimed invention is present whenthe application is filed. In re Wertheim, 541 F.2d257, 263, 191 USPQ 90, 97 (CCPA 1976) (“[W]eare of the opinion that the PTO has the initial burdenof presenting evidence or reasons why personsskilled in the art would not recognize in thedisclosure a description of the invention defined bythe claims.”). However, as discussed in subsectionI, supra, issues of adequate written description mayarise even for original claims, for example, when anaspect of the claimed invention has not beendescribed with sufficient particularity such that oneskilled in the art would recognize that the applicanthad possession of the claimed invention at the timeof filing. The claimed invention as a whole may notbe adequately described if the claims require anessential or critical feature which is not adequatelydescribed in the specification and which is notconventional or known in the art. Consider the claim“A gene comprising SEQ ID NO:1.” The claim maybe construed to include specific structures in additionto SEQ ID NO:1, such as a promoter, a codingregion, or other elements. Although SEQ ID NO:1is fully disclosed, there may be insufficientdescription of other structures embraced by the claim(e.g., promoters, enhancers, coding regions, andother regulatory elements). For guidance on subjectmatter eligibility of such claims, see MPEP § 2106.

An invention described solely in terms of a methodof making and/or its function may lack writtendescriptive support where there is no described orart-recognized correlation between the disclosedfunction and the structure(s) responsible for thefunction. For example, the amino acid sequence ofa protein along with knowledge of the genetic codemight put an inventor in possession of the genus ofnucleic acids capable of encoding the protein, butthe same information would not place the inventorin possession of the naturally-occurring DNA ormRNA encoding the protein. See In re Bell, 991F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In reDeuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir.1995) (holding that a process could not render theproduct of that process obvious under 35 U.S.C.103). (For guidance on subject matter eligibility ofclaims to naturally-occurring compositions, see

Rev. 08.2017, January 20182100-305


MPEP § 2106.) The Federal Circuit has pointed outthat, under United States law, a description thatmerely renders a claimed invention obvious may notsufficiently describe the invention for the purposesof the written description requirement of 35 U.S.C.112. See Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at1405; compare Fonar Corp. v. Gen. Elec. Co., 107F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed. Cir.1997) (“As a general rule, where software constitutespart of a best mode of carrying out an invention,description of such a best mode is satisfied by adisclosure of the functions of the software. This isbecause, normally, writing code for such softwareis within the skill of the art, not requiring undueexperimentation, once its functions have beendisclosed.... Thus, flow charts or source code listingsare not a requirement for adequately disclosing thefunctions of software.”).

Written description issues may also arise if theknowledge and level of skill in the art would nothave permitted the ordinary artisan to immediatelyenvisage the claimed product arising from thedisclosed process. See, e.g., Fujikawa v. Wattanasin,93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed.Cir. 1996) (a “laundry list” disclosure of everypossible moiety does not necessarily constitute awritten description of every species in a genusbecause it would not “reasonably lead” those skilledin the art to any particular species); In re Ruschig,379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA1967) (“ If n-propylamine had been used in makingthe compound instead of n-butylamine, thecompound of claim 13 would have resulted.Appellants submit to us, as they did to the board, animaginary specific example patterned on specificexample 6 by which the above butyl compound ismade so that we can see what a simple change wouldhave resulted in a specific supporting disclosurebeing present in the present specification. Thetrouble is that there is no such disclosure, easythough it is to imagine it.” (emphasis in original)); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000)(“[T]he specification does not clearly disclose to theskilled artisan that the inventors ... considered theratio... to be part of their invention .... There istherefore no force to Purdue’s argument that thewritten description requirement was satisfied becausethe disclosure revealed a broad invention from which

the [later-filed] claims carved out a patentableportion”).

B. New or Amended Claims

The proscription against the introduction of newmatter in a patent application (35 U.S.C. 132 and251) serves to prevent an applicant from addinginformation that goes beyond the subject matteroriginally filed. See In re Rasmussen, 650 F.2d1212, 1214, 211 USPQ 323, 326 (CCPA 1981); seealso MPEP §§ 2163.06 through 2163.07 for a moredetailed discussion of the written descriptionrequirement and its relationship to new matter. Theclaims as filed in the original specification are partof the disclosure and, therefore, if an application asoriginally filed contains a claim disclosing materialnot found in the remainder of the specification, theapplicant may amend the specification to includethe claimed subject matter. In re Benno, 768 F.2d1340, 226 USPQ 683 (Fed. Cir. 1985). Thus, thewritten description requirement prevents an applicantfrom claiming subject matter that was not adequatelydescribed in the specification as filed. New oramended claims which introduce elements orlimitations that are not supported by the as-fileddisclosure violate the written descriptionrequirement. See, e.g., In re Lukach, 442 F.2d 967,169 USPQ 795 (CCPA 1971) (subgenus range wasnot supported by generic disclosure and specificexample within the subgenus range); In re Smith,458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA1972) (an adequate description of a genus may notsupport claims to a subgenus or species within thegenus).

While there is no in haec verba requirement, newlyadded claims or claim limitations must be supportedin the specification through express, implicit, orinherent disclosure. An amendment to correct anobvious error does not constitute new matter wherethe ordinary artisan would not only recognizethe existence of the error in the specification, butalso recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971). Withrespect to the correction of sequencing errors inapplications disclosing nucleic acid and/or aminoacid sequences, it is well known that sequencingerrors are a common problem in molecular biology.See, e.g., David Laehnemann et al., Denoising DNA

2100-306Rev. 08.2017, January 2018


deep sequencing data—high-throughput sequencingerrors and their correction, 17 Briefings inBioinformatics 154–1791 (2016); Peter Richterich,Estimation of Errors in ‘Raw’ DNA Sequences: AValidation Study, 8 Genome Research 251-59(1998). For example, if an application as filedincludes incorrect nucleic acid sequence informationand references a deposit of the sequenced materialmade in accordance with the requirements of 37 CFR1.801 et seq., an amendment to correct the nucleicacid sequence may be permissible where theamendment conforms the sequence information tothe compound described in the specification andcovered by the claims. See Cubist Pharm., Inc. v.Hospira, Inc., 805 F.3d 1112, 1118, 117 USPQ2d1054, 1059 (Fed. Cir. 2015)( “The fact that theinventors were mistaken as to one aspect of thestructure of daptomycin at the time the application[ ] was filed does not render the specificationinadequate to satisfy the written descriptionrequirement. It was enough that the specificationdisclosed relevant identifying characteristics thatdistinguished daptomycin from other compoundsand thus showed that the inventors had possessionof daptomycin, even though they may not have hadan accurate picture of the entire chemical structureof that compound.” Id. at 1120, 117 USPQ2d at1060.) Deposits made after the filing date may berelied upon to provide support for the correction ofsequence information only if applicant submits astatement in compliance with 37 CFR 1.804 statingthat the biological material which is deposited is thebiological material specifically defined in theapplication as filed.

Under certain circumstances, omission of a limitationcan raise an issue regarding whether the inventorhad possession of a broader, more generic invention.See, e.g., PIN/NIP, Inc. v. Platte Chem. Co., 304F.3d 1235, 1248, 64 USPQ2d 1344, 1353 (Fed. Cir.2002) (Claim for a method of inhibiting sproutgrowth on tubers by treating them with spaced, sequential application of two chemicals was heldinvalid for lack of adequate written description wherethe specification indicated that invention was amethod of applying a "composition" containing thetwo chemicals.); Gentry Gallery, Inc. v. BerklineCorp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir.1998) (claims to a sectional sofa comprising, interalia, a console and a control means were held invalid

for failing to satisfy the written descriptionrequirement where the claims were broadened byremoving the location of the control means); Johnson Worldwide Assoc. v. Zebco Corp., 175 F.3d985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999)(Stating that, in Gentry Gallery, the “court’sdetermination that the patent disclosure did notsupport a broad meaning for the disputed claim termswas premised on clear statements in the writtendescription that described the location of a claimelement--the ‘control means’ --as ‘the only possiblelocation’ and that variations were ‘outside the statedpurpose of the invention.’ … Gentry Gallery, then,considers the situation where the patent’s disclosuremakes crystal clear that a particular (i.e., narrow)understanding of a claim term is an ‘essentialelement of [the inventor’s] invention.’”); see also Tronzo v. Biomet, 156 F.3d at 1158-59, 47 USPQ2dat 1833 (Fed. Cir. 1998) (claims to generic cup shapewere not entitled to filing date of parent applicationwhich disclosed “conical cup” in view of thedisclosure of the parent application stating theadvantages and importance of the conical shape.).A claim that omits an element that applicantdescribes as an essential or critical feature of theinvention originally disclosed does not comply withthe written description requirement. See GentryGallery, 134 F.3d at 1480, 45 USPQ2d at 1503; Inre Sus, 306 F.2d 494, 504, 134 USPQ 301, 309(CCPA 1962) (“[O]ne skilled in this art would notbe taught by the written description of the inventionin the specification that any ‘aryl or substituted arylradical’ would be suitable for the purposes of theinvention but rather that only certain aryl radicalsand certain specifically substituted aryl radicals [i.e.,aryl azides] would be suitable for suchpurposes.”(emphasis in original)). A claim whichomits matter disclosed to be essential to the inventionas described in the specification or in otherstatements of record may also be subject to rejectionunder 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112,first paragraph, as not enabling, or under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph.See In re Mayhew, 527 F.2d 1229, 188 USPQ 356(CCPA 1976); In re Venezia, 530 F.2d 956, 189USPQ 149 (CCPA 1976); and In re Collier, 397F.2d 1003, 158 USPQ 266 (CCPA 1968). See alsoMPEP § 2172.01.

Rev. 08.2017, January 20182100-307


The fundamental factual inquiry is whether thespecification conveys with reasonable clarity to thoseskilled in the art that, as of the filing date sought,applicant was in possession of the invention as nowclaimed. See, e.g., Vas-Cath, Inc., 935 F.2d at1563-64, 19 USPQ2d at 1117.

II. METHODOLOGY FOR DETERMININGADEQUACY OF WRITTEN DESCRIPTION

A. Read and Analyze the Specification for Compliancewith 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, firstparagraph

Office personnel should adhere to the followingprocedures when reviewing patent applications forcompliance with the written description requirementof 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph. There is a presumption that an adequatewritten description of the claimed invention ispresent in the specification as filed, Wertheim, 541F.2d at 262, 191 USPQ at 96, thus the examiner hasthe initial burden, after a thorough reading andevaluation of the content of the application, ofpresenting evidence or reasons why a person skilledin the art would not recognize the written descriptionof the invention as providing adequate support forthe claimed invention. To make a prima facie case,it is necessary to identify the claim limitations thatare not adequately supported, and explain why theclaim is not fully supported by the disclosure. Forexample, in Hyatt v. Dudas, 492 F.3d 1365, 1371,83 USPQ2d 1373, 1376-1377 (Fed. Cir. 2007), theexaminer made a prima facie case by clearly andspecifically explaining why applicant’s specificationdid not support the particular claimed combinationof elements, even though applicant’s specificationlisted each and every element in the claimedcombination. The court found the “examiner wasexplicit that while each element may be individuallydescribed in the specification, the deficiency waslack of adequate description of their combination”and, thus, “[t]he burden was then properly shiftedto [inventor] to cite to the examiner where adequatewritten description could be found or to make anamendment to address the deficiency.” Id.; see also Stored Value Solutions, Inc. v. Card ActivationTechs., 499 Fed.App’x 5, 13-14 (Fed. Cir. 2012)(non-precedential) (Finding inadequate writtensupport for claims drawn to a method of processing

debit purchase transactions requiring three separateauthorization codes because “the written description[did] not contain a method that include[d] all threecodes” and “[e]ach authorization code is animportant claim limitation, and the presence ofmultiple authorization codes in [the claim] wasessential”.).

With respect to newly added or amended claims,applicant should show support in the originaldisclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir.2007) (citing MPEP § 2163.04 which provides thata “simple statement such as ‘applicant has notpointed out where the new (or amended) claim issupported, nor does there appear to be a writtendescription of the claim limitation ‘___’ in theapplication as filed’ may be sufficient where theclaim is a new or amended claim, the support for thelimitation is not apparent, and applicant has notpointed out where the limitation is supported.”); seealso MPEP §§ 714.02 and 2163.06 (“Applicantshould ... specifically point out the support for anyamendments made to the disclosure.”); and MPEP§ 2163.04 (“If applicant amends the claims andpoints out where and/or how the originally fileddisclosure supports the amendment(s), and theexaminer finds that the disclosure does notreasonably convey that the inventor had possessionof the subject matter of the amendment at the timeof the filing of the application, the examiner has theinitial burden of presenting evidence or reasoningto explain why persons skilled in the art would notrecognize in the disclosure a description of theinvention defined by the claims.”). The inquiry intowhether the description requirement is met is aquestion of fact that must be determined on acase-by-case basis. AbbVie Deutschland GmbH &Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285,1297, 111 USPQ2d 1780, 1788 (Fed. Cir. 2014)("Whether a patent claim is supported by an adequatewritten description is a question of fact."); In reSmith, 458 F.2d 1389, 1395, 173 USPQ 679, 683(CCPA 1972) (“Precisely how close [to the claimedinvention] the description must come to comply withSec. 112 must be left to case-by-casedevelopment.”); In re Wertheim, 541 F.2d at 262,191 USPQ at 96 (inquiry is primarily factual anddepends on the nature of the invention and the

2100-308Rev. 08.2017, January 2018


amount of knowledge imparted to those skilled inthe art by the disclosure).

1. For Each Claim, Determine What the Claim as aWhole Covers

Claim construction is an essential part of theexamination process. Each claim must be separatelyanalyzed and given its broadest reasonableinterpretation in light of and consistent with thewritten description. See, e.g., In re Katz InteractiveCall Processing Patent Litigation, 639 F.3d 1303,1319-1320, 97 USPQ2d 1737, 1750 (Fed. Cir. 2011)(stating that “[t]he construction of the claims [is]important to the written description analysis” andpatent holder’s failure “to point to a genuine factualdispute over whether the specification disclosed”the claimed subject matter made summary judgmentproper on that issue.); In re Morris, 127 F.3d 1048,1053-54, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997).The entire claim must be considered, including thepreamble language and the transitional phrase.“Preamble language” is that language in a claimappearing before the transitional phase, e.g., before“comprising,” “consisting essentially of,” or“consisting of.” The transitional term “comprising”(and other comparable terms, e.g., “containing,” and“including”) is “open-ended” in that it covers theexpressly recited subject matter, alone or incombination with unrecited subject matter. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501,42 USPQ2d 1608, 1613 (Fed. Cir. 1997)(“‘Comprising’ is a term of art used in claimlanguage which means that the named elements areessential, but other elements may be added and stillform a construct within the scope of the claim.”); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948)(“comprising” leaves the “claim open for theinclusion of unspecified ingredients even in majoramounts”); see also MPEP § 2111.03. “By using theterm ‘consisting essentially of,’ the drafter signalsthat the invention necessarily includes the listedingredients and is open to unlisted ingredients thatdo not materially affect the basic and novelproperties of the invention. A ‘consisting essentiallyof’ claim occupies a middle ground between closedclaims that are written in a ‘consisting of’ formatand fully open claims that are drafted in a‘comprising’ format.” PPG Indus. v. GuardianIndus., 156 F.3d 1351, 1354, 48 USPQ2d 1351,

1353-54 (Fed. Cir. 1998). For the purposes ofsearching for and applying prior art under 35 U.S.C.102 and 103, absent a clear indication in thespecification or claims of what the basic and novelcharacteristics actually are, “consisting essentiallyof” will be construed as equivalent to “comprising.”See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at1355 (“PPG could have defined the scope of thephrase ‘consisting essentially of’ for purposes of itspatent by making clear in its specification what itregarded as constituting a material change in thebasic and novel characteristics of the invention.”);see also AK Steel Corp. v. Sollac, 344 F3.d 1234,1239-1240, 68 USPQ2d 1280, 1283-84 (Fed. Cir.2003); In re Janakirama-Rao, 317 F.2d 951, 954,137 USPQ 893, 895-96 (CCPA 1963). If an applicantcontends that additional steps or materials in theprior art are excluded by the recitation of “consistingessentially of,” applicant has the burden of showingthat the introduction of additional steps orcomponents would materially change thecharacteristics of applicant’s invention. In re DeLajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964);see also MPEP § 2111.03. The claim as a whole,including all limitations found in the preamble (see Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801,14 USPQ2d 1871, 1876 (Fed. Cir. 1990)(determining that preamble language that constitutesa structural limitation is actually part of the claimedinvention)), the transitional phrase, and the body ofthe claim, must be sufficiently supported to satisfythe written description requirement. An applicantshows possession of the claimed invention bydescribing the claimed invention with all of itslimitations. Lockwood, 107 F.3d at 1572,41 USPQ2d at 1966.

The examiner should evaluate each claim todetermine if sufficient structures, acts, or functionsare recited to make clear the scope and meaning ofthe claim, including the weight to be given thepreamble. See, e.g., Bell Communications Research,Inc. v. Vitalink Communications Corp., 55 F.3d 615,620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995) (“[A]claim preamble has the import that the claim as awhole suggests for it.”); Corning Glass Works v.Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257,9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (Thedetermination of whether preamble recitations arestructural limitations can be resolved only on review

Rev. 08.2017, January 20182100-309


of the entirety of the application “to gain anunderstanding of what the inventors actuallyinvented and intended to encompass by the claim.”).The absence of definitions or details forwell-established terms or procedures should not bethe basis of a rejection under 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, for lack ofadequate written description. Limitations may not,however, be imported into the claims from thespecification.

2. Review the Entire Application to Understand HowApplicant Provides Support for the Claimed InventionIncluding Each Element and/or Step

Prior to determining whether the disclosure providesadequate written description for the claimed subjectmatter, the examiner should review the claims andthe entire specification, including the specificembodiments, figures, and sequence listings, tounderstand how applicant provides support for thevarious features of the claimed invention. Thedisclosure of an element may be critical where thoseof ordinary skill in the art would require it tounderstand that applicant was in possession of theinvention. Compare Rasmussen, 650 F.2d at 1215,211 USPQ at 327 (“one skilled in the art who readRasmussen’s specification would understand that itis unimportant how the layers are adhered, so longas they are adhered”) (emphasis in original), with Amgen, Inc. v. Chugai Pharm.Co., Ltd., 927 F.2d1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991)(“it is well established in our law that conception ofa chemical compound requires that the inventor beable to define it so as to distinguish it from othermaterials, and to describe how to obtain it”). Theanalysis of whether the specification complies withthe written description requirement calls for theexaminer to compare the scope of the claim with thescope of the description to determine whetherapplicant has demonstrated possession of the claimedinvention. Such a review is conducted from thestandpoint of one of ordinary skill in the art at thetime the application was filed (see, e.g., Wang Labs.,Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26USPQ2d 1767, 1774 (Fed. Cir. 1993)) and shouldinclude a determination of the field of the inventionand the level of skill and knowledge in the art. Forsome arts, there is an inverse correlation betweenthe level of skill and knowledge in the art and the

specificity of disclosure necessary to satisfy thewritten description requirement. Information whichis well known in the art need not be described indetail in the specification. See, e.g., Hybritech, Inc.v. Monoclonal Antibodies, Inc., 802 F.2d 1367,1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).However, sufficient information must be providedto show that the inventor had possession of theinvention as claimed.

3. Determine Whether There is Sufficient WrittenDescription to Inform a Skilled Artisan That Applicantwas in Possession of the Claimed Invention as a Wholeat the Time the Application Was Filed

(a) Original claims

Possession may be shown in many ways. Forexample, possession may be shown by describingan actual reduction to practice of the claimedinvention. Possession may also be shown by a cleardepiction of the invention in detailed drawings or instructural chemical formulas which permit a personskilled in the art to clearly recognize that applicanthad possession of the claimed invention. Anadequate written description of the invention maybe shown by any description of sufficient, relevant,identifying characteristics so long as a person skilledin the art would recognize that the inventor hadpossession of the claimed invention. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000)(the written description “inquiry is a factual one andmust be assessed on a case-by-case basis”); see also Pfaff v. Wells Elec., Inc., 55 U.S. at 66, 119 S.Ct.at 311, 48 USPQ2d at 1646 (“The word ‘invention’must refer to a concept that is complete, rather thanmerely one that is ‘substantially complete.’ It is truethat reduction to practice ordinarily provides the bestevidence that an invention is complete. But justbecause reduction to practice is sufficient evidenceof completion, it does not follow that proof ofreduction to practice is necessary in every case.Indeed, both the facts of the Telephone Cases andthe facts of this case demonstrate that one can provethat an invention is complete and ready for patentingbefore it has actually been reduced to practice.”).

A specification may describe an actual reduction topractice by showing that the inventor constructed an

2100-310Rev. 08.2017, January 2018


embodiment or performed a process that met all thelimitations of the claim and determined that theinvention would work for its intended purpose.Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMCElecs. Co. v. United States, 816 F.2d 647, 652, 2USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]herecannot be a reduction to practice of the invention ...without a physical embodiment which includes alllimitations of the claim.”); Estee Lauder Inc. v.L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610,1614 (Fed. Cir. 1997) (“[A] reduction to practicedoes not occur until the inventor has determined thatthe invention will work for its intended purpose.”);Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578,38 USPQ2d 1288, 1291 (Fed. Cir. 1996)(determining that the invention will work for itsintended purpose may require testing depending onthe character of the invention and the problem itsolves). Description of an actual reduction to practiceof a biological material may be shown by specificallydescribing a deposit made in accordance with therequirements of 37 CFR 1.801 et seq., especially37 CFR 1.804 and 1.809; see also subsection I. supra.

An applicant may show possession of an inventionby disclosure of drawings or structural chemicalformulas that are sufficiently detailed to show thatapplicant was in possession of the claimed inventionas a whole. See, e.g., Vas-Cath, 935 F.2d at 1565,19 USPQ2d at 1118 (“drawings alone may providea ‘written description’ of an invention as requiredby Sec. 112”); In re Wolfensperger, 302 F.2d 950,133 USPQ 537 (CCPA 1962) (the drawings ofapplicant’s specification provided sufficient writtendescriptive support for the claim limitation at issue); Autogiro Co. of Am. v. United States, 384 F.2d 391,398, 155 USPQ 697, 703 (Ct. Cl. 1967) (“In thoseinstances where a visual representation can flesh outwords, drawings may be used in the same mannerand with the same limitations as the specification.”); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“Inclaims involving chemical materials, genericformulae usually indicate with specificity what thegeneric claims encompass. One skilled in the art candistinguish such a formula from others and canidentify many of the species that the claimsencompass. Accordingly, such a formula is normallyan adequate description of the claimed genus.”). The

description need only describe in detail that whichis new or not conventional. See Hybritech v.Monoclonal Antibodies, 802 F.2d at 1384, 231 USPQat 94. This is equally true whether the claimedinvention is directed to a product or a process.

An applicant may also show that an invention iscomplete by disclosure of sufficiently detailed,relevant identifying characteristics which provideevidence that applicant was in possession of theclaimed invention, i.e., complete or partial structure,other physical and/or chemical properties, functionalcharacteristics when coupled with a known ordisclosed correlation between function and structure,or some combination of such characteristics. EnzoBiochem, 323 F.3d at 964, 63 USPQ2d at 1613(quoting the Written Description Guidelines, 66 Fed.Reg. at 1106, n. 49, stating that “if the art hasestablished a strong correlation between structureand function, one skilled in the art would be able topredict with a reasonable degree of confidence thestructure of the claimed invention from a recitationof its function”.). “Thus, the written descriptionrequirement may be satisfied through disclosure offunction and minimal structure when there is awell-established correlation between structure andfunction.” Id. (explaining that a claim to an antibodysatisfies the “function-structure test” where theantigen to which it binds has been fullycharacterized, and methods for making the antibodyare routine”).

For some biomolecules, examples of identifyingcharacteristics include a sequence, structure, bindingaffinity, binding specificity, molecular weight, andlength. Although structural formulas provide aconvenient method of demonstrating possession ofspecific molecules, other identifying characteristicsor combinations of characteristics may demonstratethe requisite possession. As explained by the FederalCircuit, “(1) examples are not necessary to supportthe adequacy of a written description; (2) the writtendescription standard may be met … even whereactual reduction to practice of an invention is absent;and (3) there is no per se rule that an adequatewritten description of an invention that involves abiological macromolecule must contain a recitationof known structure.” Falkner v. Inglis, 448 F.3d1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir.2006); see also Capon v. Eshhar, 418 F.3d at 1358,

Rev. 08.2017, January 20182100-311


76 USPQ2d at 1084 (“The Board erred in holdingthat the specifications do not meet the writtendescription requirement because they do not reiteratethe structure or formula or chemical name for thenucleotide sequences of the claimed chimeric genes”where the genes were novel combinations of knownDNA segments.). For example, disclosure of anantigen fully characterized by its structure, formula,chemical name, physical properties, or deposit in apublic depository provides an adequate writtendescription of an antibody claimed by its bindingaffinity to that antigen, if “generating the claimedantibody is so routine that possessing the [antigen]places the applicant in possession of an antibody.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed.Cir. 2011), distinguishing Noelle v. Lederman, 355F.3d 1343, 1349, 69 USPQ2d 1508, 1514 (Fed. Cir.2004) (holding there is a lack of written descriptivesupport for an unknown antibody defined by itsbinding affinity to an antigen that itself was notadequately described). Centocor concerned claimsto antibodies with specific properties, including highaffinity to a particular antigen, which wascharacterized in the prior art. The patent disclosedthe antigen, but did not disclose any antibodies withthe specific claimed properties. The court held thatthe claimed antibodies were not adequately describedbecause the generation of such antibodies was notpossible using conventional, routine orwell-developed technology as of the priority date ofthe patent.

Other ways of establishing possession of a claimedinvention may include unique cleavage by particularenzymes, isoelectric points of fragments, detailedrestriction enzyme maps, a comparison of enzymaticactivities, or antibody cross-reactivity. See Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966(Stating that the written description requirement maybe satisfied by using “such descriptive means aswords, structures, figures, diagrams, formulas, etc.,that fully set forth the claimed invention.”).Conversely, describing a composition by its functionalone typically will not suffice to sufficientlydescribe the composition. See Eli Lilly, 119 F.3 at1568, 43 USPQ2d at 1406 (Holding that descriptionof a gene’s function will not enable claims to thegene “because it is only an indication of what thegene does, rather than what it is.”); see also Fiers,

984 F.2d at 1169-71, 25 USPQ2d at 1605-06(discussing Amgen Inc. v. Chugai Pharm. Co., 927F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). Anadequate written description of a chemical inventionalso requires a precise definition, such as bystructure, formula, chemical name, or physicalproperties, and not merely a wish or plan forobtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir.2004) (The patent at issue claimed a method ofselectively inhibiting PGHS-2 activity byadministering a non-steroidal compound thatselectively inhibits activity of the PGHS-2 geneproduct, however the patent did not disclose anycompounds that can be used in the claimed methods.While there was a description of assays for screeningcompounds to identify those that inhibit theexpression or activity of the PGHS-2 gene product,there was no disclosure of which peptides,polynucleotides, and small organic moleculesselectively inhibit PGHS-2. The court held that“[w]ithout such disclosure, the claimed methodscannot be said to have been described.”).

If a claim limitation invokes 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph, it must beinterpreted to cover the corresponding structure,materials, or acts in the specification and“equivalents thereof.” See 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph. See also B. Braun Medical, Inc. v. Abbott Labs., 124 F.3d1419, 1424, 43 USPQ2d 1896, 1899 (Fed. Cir.1997). In considering whether there is 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,support for a means- (or step) plus- function claimlimitation, the examiner must consider not only theoriginal disclosure contained in the summary anddetailed description of the invention portions of thespecification, but also the original claims, abstract,and drawings. A means- (or step-) plus- functionclaim limitation is adequately described under 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, if: (1) The written description adequatelylinks or associates adequately described particularstructure, material, or acts to perform the functionrecited in a means- (or step-) plus- function claimlimitation; or (2) it is clear based on the facts of theapplication that one skilled in the art would haveknown what structure, material, or acts disclosed in

2100-312Rev. 08.2017, January 2018


the specification perform the function recited in ameans- (or step-) plus- function limitation. See Aristocrat Techs. Australia PTY Ltd. v. Int’l GameTech., 521 F.3d 1328, 1336-37, 86 USPQ2d 1235,1242 (Fed. Cir. 2008) ("'consideration of theunderstanding of one skilled in the art in no wayrelieves the patentee of adequately disclosingsufficient structure in the specification.' It is notenough for the patentee simply to state or later arguethat persons of ordinary skill in the art would knowwhat structures to use to accomplish the claimedfunction."), quoting Atmel Corp. v. InformationStorage Devices, Inc., 198 F.3d 1374, 1380, 53USPQ2d 1225, 1229 (Fed. Cir. 1999); Biomedino,LLC v. Waters Technologies Corp., 490 F.3d 946,953, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007) ("Theinquiry is whether one of skill in the art wouldunderstand the specification itself to disclose astructure, not simply whether that person would becapable of implementing a structure."). Note alsothat a rejection under 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph, “cannot standwhere there is adequate description in thespecification to satisfy 35 U.S.C. 112(a) or pre-AIA35 U.S.C. 112, first paragraph, regardingmeans-plus-function recitations that are not, per se,challenged for being unclear.” In re Noll, 545 F.2d141, 149, 191 USPQ 721, 727 (CCPA 1976). See"Supplemental Examination Guidelines forDetermining the Applicability of 35 U.S.C. 112,para. 6," 65 Fed. Reg. 38510, June 21, 2000; see alsoMPEP § 2181. However, when a means- (or step-)plus-function claim limitation is found to beindefinite based on failure of the specification todisclose sufficient corresponding structure, materials,or acts that perform the entire claimed function, thenthe claim limitation necessarily lacks an adequatewritten description. Thus, when a claim is rejectedas indefinite under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph because there is nocorresponding structure, materials, or acts, or aninadequate disclosure of corresponding structure,materials, or acts, for a means- (or step-)plus-function claim limitation, then the claim mustalso be rejected under 35 U.S.C. 112(a) or pre-AIA35 U.S.C. 112, first paragraph, for lack of anadequate written description.

What is conventional or well known to one ofordinary skill in the art need not be disclosed in

detail. See Hybritech Inc. v. Monoclonal Antibodies,Inc., 802 F.2d at 1384, 231 USPQ at 94. See also Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d1078, 1085 (Fed. Cir. 2005) (“The ‘writtendescription’ requirement must be applied in thecontext of the particular invention and the state ofthe knowledge…. As each field evolves, the balancealso evolves between what is known and what isadded by each inventive contribution.”). If a skilledartisan would have understood the inventor to be inpossession of the claimed invention at the time offiling, even if every nuance of the claims is notexplicitly described in the specification, then theadequate description requirement is met. See, e.g., Vas-Cath, 935 F.2d at 1563, 19 USPQ2d at 1116; Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ391, 395 (CCPA 1972) (stating “the description neednot be in ipsis verbis [i.e., “in the same words”] tobe sufficient”).

A claim which is limited to a single disclosedembodiment or species is analyzed as a claim drawnto a single embodiment or species, whereas a claimwhich encompasses two or more embodiments orspecies within the scope of the claim is analyzed asa claim drawn to a genus. See also MPEP §806.04(e).

i) For Each Claim Drawn to a Single Embodiment orSpecies:

(A) Determine whether the application describesan actual reduction to practice of the claimedinvention.

(B) If the application does not describe an actualreduction to practice, determine whether theinvention is complete as evidenced by a reductionto drawings or structural chemical formulas that aresufficiently detailed to show that applicant was inpossession of the claimed invention as a whole.

(C) If the application does not describe an actualreduction to practice or reduction to drawings orstructural chemical formula as discussed above,determine whether the invention has been set forthin terms of distinguishing identifying characteristicsas evidenced by other descriptions of the inventionthat are sufficiently detailed to show that applicantwas in possession of the claimed invention.

(1) Determine whether the application asfiled describes the complete structure (or acts of a

Rev. 08.2017, January 20182100-313


process) of the claimed invention as a whole. Thecomplete structure of a species or embodimenttypically satisfies the requirement that the descriptionbe set forth “in such full, clear, concise, and exactterms” to show possession of the claimed invention.35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph; cf. Fields v. Conover, 443 F.2d 1386,1392, 170 USPQ 276, 280 (CCPA 1971) (finding alack of written description because the specificationlacked the “full, clear, concise, and exact writtendescription” which is necessary to support theclaimed invention). If a complete structure isdisclosed, the written description requirement issatisfied for that species or embodiment, and arejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, for lack of writtendescription must not be made.

(2) If the application as filed does notdisclose the complete structure (or acts of a process)of the claimed invention as a whole, determinewhether the specification discloses other relevantidentifying characteristics sufficient to describe theclaimed invention in such full, clear, concise, andexact terms that a skilled artisan would recognizeapplicant was in possession of the claimed invention.For example, in the biotech art, if a strong correlationhas been established between structure and function,one skilled in the art would be able to predict witha reasonable degree of confidence the structure ofthe claimed invention from a recitation of itsfunction. Thus, the written description requirementmay be satisfied through disclosure of function andminimal structure when there is a well-establishedcorrelation between structure and function. Incontrast, without such a correlation, the capabilityto recognize or understand the structure from themere recitation of function and minimal structure ishighly unlikely. In this latter case, disclosure offunction alone is little more than a wish forpossession; it does not satisfy the written descriptionrequirement. See Eli Lilly, 119 F.3d at 1568, 43USPQ2d at 1406 (written description requirementnot satisfied by merely providing “a result that onemight achieve if one made that invention”); In reWilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73(Fed. Cir. 1984) (affirming a rejection for lack ofwritten description because the specification does“little more than outline goals appellants hope theclaimed invention achieves and the problems theinvention will hopefully ameliorate”).

Whether the specification shows that applicant wasin possession of the claimed invention is not a single,simple determination, but rather is a factualdetermination reached by considering a number offactors. Factors to be considered in determiningwhether there is sufficient evidence of possessioninclude the level of skill and knowledge in the art,partial structure, physical and/or chemical properties,functional characteristics alone or coupled with aknown or disclosed correlation between structureand function, and the method of making the claimedinvention. Disclosure of any combination of suchidentifying characteristics that distinguish theclaimed invention from other materials and wouldlead one of skill in the art to the conclusion that theapplicant was in possession of the claimed speciesis sufficient. See Eli Lilly, 119 F.3d at 1568, 43USPQ2d at 1406. The description needed to satisfythe requirements of 35 U.S.C. 112 “varies with thenature and scope of the invention at issue, and withthe scientific and technologic knowledge already inexistence.” Capon v. Eshhar, 418 F.3d at 1357, 76USPQ2d at 1084. Patents and printed publicationsin the art should be relied upon to determine whetheran art is mature and what the level of knowledge andskill is in the art. In most technologies which aremature, and wherein the knowledge and level of skillin the art is high, a written description questionshould not be raised for claims present in theapplication when originally filed, even if thespecification discloses only a method of making theinvention and the function of the invention.

In contrast, for inventions in emerging andunpredictable technologies, or for inventionscharacterized by factors not reasonably predictablewhich are known to one of ordinary skill in the art,more evidence is required to show possession. Forexample, disclosure of only a method of making theinvention and the function may not be sufficient tosupport a product claim other than aproduct-by-process claim. See, e.g., Fiers v. Revel,984 F.2d at 1169, 25 USPQ2d at 1605; Amgen,927 F.2d at 1206, 18 USPQ2d at 1021. Where theprocess has actually been used to produce theproduct, the written description requirement for aproduct-by-process claim is clearly satisfied;however, the requirement may not be satisfied whereit is not clear that the acts set forth in thespecification can be performed, or that the product

2100-314Rev. 08.2017, January 2018


is produced by that process. Furthermore, disclosureof a partial structure without additionalcharacterization of the product may not be sufficientto evidence possession of the claimed invention.See, e.g., Amgen, 927 F.2d at 1206, 18 USPQ2d at1021 (“A gene is a chemical compound, albeit acomplex one, and it is well established in our lawthat conception of a chemical compound requiresthat the inventor be able to define it so as todistinguish it from other materials, and to describehow to obtain it. Conception does not occur unlessone has a mental picture of the structure of thechemical, or is able to define it by its method ofpreparation, its physical or chemical properties, orwhatever characteristics sufficiently distinguish it.It is not sufficient to define it solely by its principalbiological property, e.g., encoding humanerythropoietin, because an alleged conception havingno more specificity than that is simply a wish toknow the identity of any material with that biologicalproperty. We hold that when an inventor is unableto envision the detailed constitution of a gene so asto distinguish it from other materials, as well as amethod for obtaining it, conception has not beenachieved until reduction to practice has occurred,i.e., until after the gene has been isolated.” (citationsomitted)). In such instances the alleged conceptionfails not merely because the field is unpredictableor because of the general uncertainty surroundingexperimental sciences, but because the conceptionis incomplete due to factual uncertainty thatundermines the specificity of the inventor’s idea ofthe invention. Burroughs Wellcome Co. v. BarrLabs. Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915,1920 (Fed. Cir. 1994). Reduction to practice in effectprovides the only evidence to corroborate conception(and therefore possession) of the invention. Id.

Any claim to a species that does not meet the testdescribed under at least one of (a), (b), or (c) mustbe rejected as lacking adequate written descriptionunder 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112,first paragraph.

ii) For each claim drawn to a genus:

The written description requirement for a claimedgenus may be satisfied through sufficient descriptionof a representative number of species by actualreduction to practice (see i)(A) above), reduction to

drawings (see i)(B) above), or by disclosure ofrelevant, identifying characteristics, i.e., structureor other physical and/or chemical properties, byfunctional characteristics coupled with a known ordisclosed correlation between function and structure,or by a combination of such identifyingcharacteristics, sufficient to show the applicant wasin possession of the claimed genus (see i)(C) above).See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.

A “representative number of species” means that thespecies which are adequately described arerepresentative of the entire genus. Thus, when thereis substantial variation within the genus, one mustdescribe a sufficient variety of species to reflect thevariation within the genus. See AbbVie DeutschlandGmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir.2014) (Claims directed to a functionally definedgenus of antibodies were not supported by adisclosure that “only describe[d] one type ofstructurally similar antibodies” that “are notrepresentative of the full variety or scope of thegenus.”). The disclosure of only one speciesencompassed within a genus adequately describes aclaim directed to that genus only if the disclosure“indicates that the patentee has invented speciessufficient to constitute the gen[us].” See EnzoBiochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.2004) (“[A] patentee of a biotechnological inventioncannot necessarily claim a genus after onlydescribing a limited number of species because theremay be unpredictability in the results obtained fromspecies other than those specifically enumerated.”).“A patentee will not be deemed to have inventedspecies sufficient to constitute the genus by virtueof having disclosed a single species when … theevidence indicates ordinary artisans could not predictthe operability in the invention of any species otherthan the one disclosed.” In re Curtis, 354 F.3d 1347,1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)(Claims directed to PTFE dental floss with afriction-enhancing coating were not supported by adisclosure of a microcrystalline wax coating wherethere was no evidence in the disclosure or anywhereelse in the record showing applicant conveyed thatany other coating was suitable for a PTFE dentalfloss.) On the other hand, there may be situations

Rev. 08.2017, January 20182100-315


where one species adequately supports a genus. See,e.g., Rasmussen, 650 F.2d at 1214, 211 USPQ at326-27 (disclosure of a single method of adheringlyapplying one layer to another was sufficient tosupport a generic claim to “adheringly applying”because one skilled in the art reading thespecification would understand that it is unimportanthow the layers are adhered, so long as they areadhered); In re Herschler, 591 F.2d 693, 697,200 USPQ 711, 714 (CCPA 1979) (disclosure ofcorticosteroid in DMSO sufficient to support claimsdrawn to a method of using a mixture of a“physiologically active steroid” and DMSO because“use of known chemical compounds in a mannerauxiliary to the invention must have a correspondingwritten description only so specific as to lead onehaving ordinary skill in the art to that class ofcompounds. Occasionally, a functional recitation ofthose known compounds in the specification maybe sufficient as that description.”); In re Smythe,480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA1973) (the phrase “air or other gas which is inert tothe liquid” was sufficient to support a claim to “inertfluid media” because the description of the propertiesand functions of the air or other gas segmentizingmedium would suggest to a person skilled in the artthat appellant’s invention includes the use of “inertfluid” broadly.).

The Federal Circuit has explained that a specificationcannot always support expansive claim languageand satisfy the requirements of 35 U.S.C. 112“merely by clearly describing one embodiment ofthe thing claimed.” LizardTech v. Earth ResourceMapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d1731, 1733 (Fed. Cir. 2005). The issue is whether aperson skilled in the art would understand applicantto have invented, and been in possession of, theinvention as broadly claimed. In LizardTech, claimsto a generic method of making a seamless discretewavelet transformation (DWT) were held invalidunder 35 U.S.C. 112, first paragraph, because thespecification taught only one particular method formaking a seamless DWT and there was no evidencethat the specification contemplated a more genericmethod. Id.; see also Tronzo v. Biomet, 156 F.3dat 1159, 47 USPQ2d at 1833 (Fed. Cir.1998)(holding that the disclosure of a species in aparent application did not provide adequate writtendescription support for claims to a genus in a child

application where the specification taught againstother species).

Satisfactory disclosure of a “representative number”depends on whether one of skill in the art wouldrecognize that the applicant was in possession of thenecessary common attributes or features possessedby the members of the genus in view of the speciesdisclosed. For inventions in an unpredictable art,adequate written description of a genus whichembraces widely variant species cannot be achievedby disclosing only one species within the genus. See,e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at1406. Instead, the disclosure must adequately reflectthe structural diversity of the claimed genus, eitherthrough the disclosure of sufficient species that are“representative of the full variety or scope of thegenus,” or by the establishment of “a reasonablestructure-function correlation.” Such correlationsmay be established “by the inventor as described inthe specification,” or they may be “known in the artat the time of the filing date.” See AbbVie, 759 F.3dat 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir.2014) (Holding that claims to all human antibodiesthat bind IL-12 with a particular binding affinity rateconstant (i.e., koff) were not adequately supported

by a specification describing only a single type ofhuman antibody having the claimed features becausethe disclosed antibody was not representative ofother types of antibodies in the claimed genus, asdemonstrated by the fact that other disclosedantibodies had different types of heavy and lightchains, and shared only a 50% sequence similarityin their variable regions with the disclosedantibodies.). Description of a representative numberof species does not require the description to be ofsuch specificity that it would provide individualsupport for each species that the genus embraces.For example, in the molecular biology arts, if anapplicant disclosed an amino acid sequence, it wouldbe unnecessary to provide an explicit disclosure ofnucleic acid sequences that encoded the amino acidsequence. Since the genetic code is widely known,a disclosure of an amino acid sequence wouldprovide sufficient information such that one wouldaccept that an applicant was in possession of the fullgenus of nucleic acids encoding a given amino acidsequence, but not necessarily any particular species.Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529,1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380,

2100-316Rev. 08.2017, January 2018


382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If arepresentative number of adequately describedspecies are not disclosed for a genus, the claim tothat genus must be rejected as lacking adequatewritten description under 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph.

(b) New Claims, Amended Claims, or ClaimsAsserting Entitlement to the Benefit of an EarlierPriority Date or Filing Date under 35 U.S.C. 119, 120,365, or 386

The examiner has the initial burden of presentingevidence or reasoning to explain why persons skilledin the art would not recognize in the originaldisclosure a description of the invention defined bythe claims. See Wertheim, 541 F.2d at 263, 191USPQ at 97 (“[T]he PTO has the initial burden ofpresenting evidence or reasons why persons skilledin the art would not recognize in the disclosure adescription of the invention defined by the claims.”).However, when filing an amendment an applicantshould show support in the original disclosure fornew or amended claims. See MPEP §§ 714.02 and2163.06 (“Applicant should ... specifically point outthe support for any amendments made to thedisclosure.”).

To comply with the written description requirementof 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, or to be entitled to an earlier priority dateor filing date under 35 U.S.C. 119, 120, 365, or 386,each claim limitation must be expressly, implicitly,or inherently supported in the originally fileddisclosure. When an explicit limitation in a claim“is not present in the written description whosebenefit is sought it must be shown that a person ofordinary skill would have understood, at the timethe patent application was filed, that the descriptionrequires that limitation.” Hyatt v. Boone, 146 F.3d1348, 1353, 47 USPQ2d 1128, 1131 (Fed. Cir.1998). See also In re Wright, 866 F.2d 422, 425, 9USPQ2d 1649, 1651 (Fed. Cir. 1989) (Originalspecification for method of forming images usingphotosensitive microcapsules which describesremoval of microcapsules from surface and warnsthat capsules not be disturbed prior to formation ofimage, unequivocally teaches absence ofpermanently fixed microcapsules and supportsamended language of claims requiring that

microcapsules be “not permanently fixed” tounderlying surface, and therefore meets descriptionrequirement of 35 U.S.C. 112.); In re Robins, 429F.2d 452, 456-57, 166 USPQ 552, 555 (CCPA 1970)(“[W]here no explicit description of a genericinvention is to be found in the specification[,] ...mention of representative compounds may providean implicit description upon which to base genericclaim language.”); In re Smith, 458 F.2d 1389, 1395,173 USPQ 679, 683 (CCPA 1972) (a subgenus isnot necessarily implicitly described by a genusencompassing it and a species upon which it reads); In re Robertson, 169 F.3d 743, 745, 49 USPQ2d1949, 1950-51 (Fed. Cir. 1999) (“To establishinherency, the extrinsic evidence ‘must make clearthat the missing descriptive matter is necessarilypresent in the thing described in the reference, andthat it would be so recognized by persons of ordinaryskill. Inherency, however, may not be establishedby probabilities or possibilities. The mere fact thata certain thing may result from a given set ofcircumstances is not sufficient.’” (citations omitted)); Yeda Research and Dev. Co. v. Abbott GMBH &Co., 837 F.3d 1341, 120 USPQ2d 1299 (Fed. Cir.2016) (“Under the doctrine of inherent disclosure,when a specification describes an invention that hascertain undisclosed yet inherent properties, thatspecification serves as adequate written descriptionto support a subsequent patent application thatexplicitly recites the invention’s inherentproperties.”) (citing Kennecott Corp. v. KyoceraInt’l, Inc., 835 F.2d 1419, 1423 (Fed. Cir. 1987)).Furthermore, each claim must include all elementswhich applicant has described as essential. See, e.g., Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175F.3d at 993, 50 USPQ2d at 1613; Gentry Gallery,Inc. v. Berkline Corp., 134 F.3d at 1479, 45 USPQ2dat 1503; Tronzo v. Biomet, 156 F.3d at 1159,47 USPQ2d at 1833.

If the originally filed disclosure does not providesupport for each claim limitation, or if an elementwhich applicant describes as essential or critical isnot claimed, a new or amended claim must berejected under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, as lacking adequatewritten description, or in the case of a priority orbenefit claim under 35 U.S.C. 119, 120, 365, or 386,the priority or benefit claim must be denied.

Rev. 08.2017, January 20182100-317


III. COMPLETE PATENTABILITYDETERMINATION UNDER ALL STATUTORYREQUIREMENTS AND CLEARLYCOMMUNICATE FINDINGS, CONCLUSIONS,AND THEIR BASES

The above only describes how to determine whetherthe written description requirement of 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,is satisfied. Regardless of the outcome of thatdetermination, Office personnel must complete thepatentability determination under all the relevantstatutory provisions of title 35 of the U.S. Code.

Once Office personnel have concluded analysis ofthe claimed invention under all the statutoryprovisions, including 35 U.S.C. 101, 112, 102, and103, they should review all the proposed rejectionsand their bases to confirm their correctness. Onlythen should any rejection be imposed in an Officeaction. The Office action should clearlycommunicate the findings, conclusions, and reasonswhich support them. When possible, the Officeaction should offer helpful suggestions on how toovercome rejections.

A. For Each Claim Lacking Written DescriptionSupport, Reject the Claim Under 35 U.S.C. 112(a) orPre-AIA 35 U.S.C. 112, first paragraph, for Lack ofAdequate Written Description

A description as filed is presumed to be adequate,unless or until sufficient evidence or reasoning tothe contrary has been presented by the examiner torebut the presumption. See, e.g., In re Marzocchi,439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA1971). The examiner, therefore, must have areasonable basis to challenge the adequacy of thewritten description. The examiner has the initialburden of presenting by a preponderance of evidencewhy a person skilled in the art would not recognizein an applicant’s disclosure a description of theinvention defined by the claims. Wertheim, 541 F.2dat 263, 191 USPQ at 97. In rejecting a claim, theexaminer must set forth express findings of factregarding the above analysis which support the lackof written description conclusion. These findingsshould:

(A) Identify the claim limitation at issue; and

(B) Establish a prima facie case by providingreasons why a person skilled in the art at the timethe application was filed would not have recognizedthat the inventor was in possession of the inventionas claimed in view of the disclosure of theapplication as filed. A general allegation of“unpredictability in the art” is not a sufficient reasonto support a rejection for lack of adequate writtendescription.

When appropriate, suggest amendments to the claimswhich can be supported by the application’s writtendescription, being mindful of the prohibition againstthe addition of new matter in the claims ordescription. See Rasmussen, 650 F.2d at 1214,211 USPQ at 326.

B. Upon Reply by Applicant, Again Determine thePatentability of the Claimed Invention, IncludingWhether the Written Description Requirement IsSatisfied by Reperforming the Analysis Described Abovein View of the Whole Record

Upon reply by applicant, before repeating anyrejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, for lack of writtendescription, review the basis for the rejection in viewof the record as a whole, including amendments,arguments, and any evidence submitted by applicant.If the whole record now demonstrates that the writtendescription requirement is satisfied, do not repeatthe rejection in the next Office action. If the recordstill does not demonstrate that the written descriptionis adequate to support the claim(s), repeat therejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, fully respond toapplicant’s rebuttal arguments, and properly treatany further showings submitted by applicant in thereply. When a rejection is maintained, any affidavitsrelevant to the 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, written descriptionrequirement, must be thoroughly analyzed anddiscussed in the next Office action. See In re Alton,76 F.3d 1168, 1176, 37 USPQ2d 1578, 1584 (Fed.Cir. 1996).

2163.01 Support for the Claimed SubjectMatter in Disclosure [R-11.2013]

A written description requirement issue generallyinvolves the question of whether the subject matter

2100-318Rev. 08.2017, January 2018


of a claim is supported by [conforms to] thedisclosure of an application as filed. If the examinerconcludes that the claimed subject matter is notsupported [described] in an application as filed, thiswould result in a rejection of the claim on the groundof a lack of written description under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,or denial of the benefit of the filing date of apreviously filed application. The claim should notbe rejected or objected to on the ground of newmatter. As framed by the court in In re Rasmussen,650 F.2d 1212, 211 USPQ 323 (CCPA 1981), theconcept of new matter is properly employed as abasis for objection to amendments to the abstract,specification or drawings attempting to add newdisclosure to that originally presented. While the testor analysis of description requirement and newmatter issues is the same, the examining procedureand statutory basis for addressing these issues differ.See MPEP § 2163.06.

2163.02 Standard for DeterminingCompliance With the Written DescriptionRequirement [R-11.2013]

The courts have described the essential question tobe addressed in a description requirement issue in avariety of ways. An objective standard fordetermining compliance with the written descriptionrequirement is, “does the description clearly allowpersons of ordinary skill in the art to recognize thathe or she invented what is claimed.” In re Gosteli,872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed.Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed.Cir. 1991), to satisfy the written descriptionrequirement, an applicant must convey withreasonable clarity to those skilled in the art that, asof the filing date sought, he or she was in possessionof the invention, and that the invention, in thatcontext, is whatever is now claimed. The test forsufficiency of support in a parent application iswhether the disclosure of the application relied upon“reasonably conveys to the artisan that the inventorhad possession at that time of the later claimedsubject matter.” Ralston Purina Co. v. Far-Mar-Co.,Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed.Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366,1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).

Whenever the issue arises, the fundamental factualinquiry is whether the specification conveys withreasonable clarity to those skilled in the art that, asof the filing date sought, applicant was in possessionof the invention as now claimed. See, e.g., Vas-Cath,Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicantshows possession of the claimed invention bydescribing the claimed invention with all of itslimitations using such descriptive means as words,structures, figures, diagrams, and formulas that fullyset forth the claimed invention. Lockwood v. Am.Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d1961, 1966 (Fed. Cir. 1997). Possession may beshown in a variety of ways including description ofan actual reduction to practice, or by showing thatthe invention was “ready for patenting” such as bythe disclosure of drawings or structural chemicalformulas that show that the invention was complete,or by describing distinguishing identifyingcharacteristics sufficient to show that the applicantwas in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct.304, 312, 48 USPQ2d 1641, 1647 (1998); Regentsof the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568,43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen,Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18USPQ2d 1016, 1021 (Fed. Cir. 1991) (one mustdefine a compound by “whatever characteristicssufficiently distinguish it”).

The subject matter of the claim need not be describedliterally (i.e., using the same terms or in haec verba)in order for the disclosure to satisfy the descriptionrequirement. If a claim is amended to include subjectmatter, limitations, or terminology not present in theapplication as filed, involving a departure from,addition to, or deletion from the disclosure of theapplication as filed, the examiner should concludethat the claimed subject matter is not described inthat application. This conclusion will result in therejection of the claims affected under 35 U.S.C.112(a) or pre-AIA 35 U.S.C.112, first paragraph -description requirement, or denial of the benefit ofthe filing date of a previously filed application, asappropriate.

See MPEP § 2163 for examination guidelinespertaining to the written description requirement.

Rev. 08.2017, January 20182100-319


2163.03 Typical Circumstances WhereAdequate Written Description Issue Arises[R-07.2015]

A description requirement issue can arise in anumber of different circumstances where it must bedetermined whether the subject matter of a claim issupported in an application as filed. See MPEP §2163 for examination guidelines pertaining to thewritten description requirement. Most typically, theissue will arise in the following circumstances:

I. AMENDMENT AFFECTING A CLAIM

An amendment to the claims or the addition of a newclaim must be supported by the description of theinvention in the application as filed. In re Wright,866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Anamendment to the specification (e.g., a change inthe definition of a term used both in the specificationand claim) may indirectly affect a claim even thoughno actual amendment is made to the claim.

II. RELIANCE ON FILING DATE OF PARENTAPPLICATION UNDER 35 U.S.C. 120

Under 35 U.S.C. 120, the claims in a U.S. applicationare entitled to the benefit of the filing date of anearlier filed U.S. application if the subject matter ofthe claim is disclosed in the manner provided by 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph in the earlier filed application. See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59,199 USPQ 782 (CCPA 1978).

III. RELIANCE ON PRIORITY UNDER 35 U.S.C.119

Under 35 U.S.C. 119(a) or (e), the claims in a U.S.application are entitled to the benefit of a foreignpriority date or the filing date of a provisionalapplication if the corresponding foreign applicationor provisional application supports the claims in themanner required by 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir.1993); Kawai v. Metlesics, 480 F.2d 880, 178USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d1008, 10 USPQ2d 1614 (Fed. Cir. 1989).

IV. SUPPORT FOR A CLAIM CORRESPONDINGTO A COUNT IN AN INTERFERENCE

In an interference proceeding, the claimcorresponding to a count must be supported by thespecification in the manner provided by 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Fields v. Conover, 443 F.2d 1386, 170 USPQ 276(CCPA 1971) (A broad generic disclosure to a classof compounds was not a sufficient writtendescription of a specific compound within the class.).Furthermore, when a party to an interference seeksthe benefit of an earlier-filed U.S. patent application,the earlier application must meet the requirementsof 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph for the subject matter of the count. Hyattv. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128,1130 (Fed. Cir. 1998).

V. ORIGINAL CLAIM NOT SUFFICIENTLYDESCRIBED

While there is a presumption that an adequate writtendescription of the claimed invention is present in thespecification as filed, In re Wertheim, 541 F.2d 257,262, 191 USPQ 90, 96 (CCPA 1976), a question asto whether a specification provides an adequatewritten description may arise in the context of anoriginal claim. An original claim may lack writtendescription support when (1) the claim defines theinvention in functional language specifying a desiredresult but the disclosure fails to sufficiently identifyhow the function is performed or the result isachieved or (2) a broad genus claim is presented butthe disclosure only describes a narrow species withno evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d1336, 1349-50 (Fed. Cir. 2010) (en banc). Thewritten description requirement is not necessarilymet when the claim language appears in ipsis verbisin the specification. “Even if a claim is supportedby the specification, the language of thespecification, to the extent possible, must describethe claimed invention so that one skilled in the artcan recognize what is claimed. The appearance ofmere indistinct words in a specification or a claim,even an original claim, does not necessarily satisfythat requirement.” Enzo Biochem, Inc. v. Gen-Probe,Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616(Fed. Cir. 2002).

2100-320Rev. 08.2017, January 2018


VI. INDEFINITENESS REJECTION OF A MEANS-(OR STEP-) PLUS-FUNCTION LIMITATION

A claim limitation expressed in means- (or step-)plus-function language “shall be construed to coverthe corresponding structure, material, or actsdescribed in the specification and equivalentsthereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph. If the specification fails todisclose sufficient corresponding structure, materials,or acts that perform the entire claimed function, thenthe claim limitation is indefinite because theapplicant has in effect failed to particularly point outand distinctly claim the invention as required by 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph. In re Donaldson Co., 16 F.3d 1189,1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (enbanc). Such a limitation also lacks an adequatewritten description as required by 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph, becausean indefinite, unbounded functional limitation wouldcover all ways of performing a function and indicatethat the inventor has not provided sufficientdisclosure to show possession of the invention.

2163.04 Burden on the Examiner withRegard to the Written DescriptionRequirement [R-11.2013]

The inquiry into whether the description requirementis met must be determined on a case-by-case basisand is a question of fact. In re Wertheim, 541 F.2d257, 262, 191 USPQ 90, 96 (CCPA 1976). Adescription as filed is presumed to be adequate,unless or until sufficient evidence or reasoning tothe contrary has been presented by the examiner torebut the presumption. See, e.g., In re Marzocchi,439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA1971). The examiner, therefore, must have areasonable basis to challenge the adequacy of thewritten description. The examiner has the initialburden of presenting by a preponderance of evidencewhy a person skilled in the art would not recognizein an applicant’s disclosure a description of theinvention defined by the claims. Wertheim, 541 F.2dat 263, 191 USPQ at 97.

I. STATEMENT OF REJECTION REQUIREMENTS

In rejecting a claim, the examiner must set forthexpress findings of fact which support the lack ofwritten description conclusion (see MPEP § 2163for examination guidelines pertaining to the writtendescription requirement). These findings should:

(A) Identify the claim limitation(s) at issue; and

(B) Establish a prima facie case by providingreasons why a person skilled in the art at the timethe application was filed would not have recognizedthat the inventor was in possession of the inventionas claimed in view of the disclosure of theapplication as filed. A general allegation of“unpredictability in the art” is not a sufficient reasonto support a rejection for lack of adequate writtendescription. A simple statement such as “Applicanthas not pointed out where the new (or amended)claim is supported, nor does there appear to be awritten description of the claim limitation ‘____’ inthe application as filed.” may be sufficient wherethe claim is a new or amended claim, the support forthe limitation is not apparent, and applicant has notpointed out where the limitation is supported.

See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that“[MPEP] § 2163.04 [subsection] (I)(B) as written isa lawful formulation of the prima facie standard fora lack of written description rejection.”).

When appropriate, suggest amendments to the claimswhich can be supported by the application’s writtendescription, being mindful of the prohibition againstthe addition of new matter in the claims ordescription. See Rasmussen, 650 F.2d at 1214,211 USPQ at 326.

II. RESPONSE TO APPLICANT’S REPLY

Upon reply by applicant, before repeating anyrejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, para. 1, for lack of written description,review the basis for the rejection in view of therecord as a whole, including amendments,arguments, and any evidence submitted by applicant.If the whole record now demonstrates that the writtendescription requirement is satisfied, do not repeatthe rejection in the next Office action. If the record

Rev. 08.2017, January 20182100-321


still does not demonstrate that the written descriptionis adequate to support the claim(s), repeat therejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, para. 1, fully respond to applicant’srebuttal arguments, and properly treat any furthershowings submitted by applicant in the reply. Whena rejection is maintained, any affidavits relevant tothe 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para.1, written description requirement, must bethoroughly analyzed and discussed in the next Officeaction. See In re Alton, 76 F.3d 1168, 1176, 37USPQ2d 1578, 1584 (Fed. Cir. 1996).

2163.05 Changes to the Scope of Claims[R-07.2015]

The failure to meet the written descriptionrequirement of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, commonly arises whenthe claims are changed after filing to either broadenor narrow the breadth of the claim limitations, or toalter a numerical range limitation or to use claimlanguage which is not synonymous with theterminology used in the original disclosure. Tocomply with the written description requirement of35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para.1, or to be entitled to an earlier priority date or filingdate under 35 U.S.C. 119, 120, or 365(c), each claimlimitation must be expressly, implicitly, or inherentlysupported in the originally filed disclosure. SeeMPEP § 2163 for examination guidelines pertainingto the written description requirement.

I. BROADENING CLAIM

A. Omission of a Limitation

Under certain circumstances, omission of a limitationcan raise an issue regarding whether the inventorhad possession of a broader, more generic invention.See, e.g., Gentry Gallery, Inc. v. Berkline Corp.,134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998)(claims to a sectional sofa comprising, inter alia, aconsole and a control means were held invalid forfailing to satisfy the written description requirementwhere the claims were broadened by removing thelocation of the control means.); Johnson WorldwideAssoc. v. Zebco Corp., 175 F.3d 985, 993,50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In GentryGallery, the “court’s determination that the patent

disclosure did not support a broad meaning for thedisputed claim terms was premised on clearstatements in the written description that describedthe location of a claim element--the ‘controlmeans’--as ‘the only possible location’ and thatvariations were ‘outside the stated purpose of theinvention.’ Gentry Gallery, 134 F.3d at 1479, 45USPQ2d at 1503. Gentry Gallery, then, considersthe situation where the patent’s disclosure makescrystal clear that a particular (i.e., narrow)understanding of a claim term is an ‘essentialelement of [the inventor’s] invention.’”); Tronzov. Biomet, 156 F.3d at 1158-59, 47 USPQ2d at 1833(Fed. Cir. 1998) (claims to generic cup shape werenot entitled to filing date of parent application whichdisclosed “conical cup” in view of the disclosure ofthe parent application stating the advantages andimportance of the conical shape.); In re Wilder, 736F.2d 1516, 222 USPQ 369 (Fed. Cir. 1984) (reissueclaim omitting “in synchronism” limitation withrespect to scanning means and indexing means wasnot supported by the original patent’s disclosure insuch a way as to indicate possession, as of theoriginal filing date, of that generic invention.).

A claim that omits an element which applicantdescribes as an essential or critical feature of theinvention originally disclosed does not comply withthe written description requirement. See GentryGallery, 134 F.3d at 1480, 45 USPQ2d at 1503; Inre Sus, 306 F.2d 494, 504, 134 USPQ 301, 309(CCPA 1962) (“[O]ne skilled in this art would notbe taught by the written description of the inventionin the specification that any ‘aryl or substituted arylradical’ would be suitable for the purposes of theinvention but rather that only certain aryl radicalsand certain specifically substituted aryl radicals [i.e.,aryl azides] would be suitable for such purposes.”)(emphasis in original). Compare In re Peters, 723F.2d 891, 221 USPQ 952 (Fed. Cir. 1983) (In areissue application, a claim to a display device wasbroadened by removing the limitations directed tothe specific tapered shape of the tips withoutviolating the written description requirement. Theshape limitation was considered to be unnecessarysince the specification, as filed, did not describe thetapered shape as essential or critical to the operationor patentability of the claim.). A claim which omitsmatter disclosed to be essential to the invention asdescribed in the specification or in other statements

2100-322Rev. 08.2017, January 2018


of record may also be subject to rejection under 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. 1, asnot enabling, or under 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, para. 2. See In re Mayhew, 527 F.2d1229, 188 USPQ 356 (CCPA 1976); In re Venezia,530 F.2d 956, 189 USPQ 149 (CCPA 1976); and Inre Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA1968). See also MPEP § 2172.01.

B. Addition of Generic Claim

The written description requirement for a claimedgenus may be satisfied through sufficient descriptionof a representative number of species. A“representative number of species” means that thespecies which are adequately described arerepresentative of the entire genus. Thus, when thereis substantial variation within the genus, one mustdescribe a sufficient variety of species to reflect thevariation within the genus. See AbbVie DeutschlandGmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir.2014) (Claims directed to a functionally definedgenus of antibodies were not supported by adisclosure that “only describe[d] one type ofstructurally similar antibodies” that “are notrepresentative of the full variety or scope of thegenus.”). The disclosure of only one speciesencompassed within a genus adequately describes aclaim directed to that genus only if the disclosure“indicates that the patentee has invented speciessufficient to constitute the gen[us].” See EnzoBiochem, 323 F.3d at 966, 63 USPQ2d at 1615. “Apatentee will not be deemed to have invented speciessufficient to constitute the genus by virtue of havingdisclosed a single species when … the evidenceindicates ordinary artisans could not predict theoperability in the invention of any species other thanthe one disclosed.” In re Curtis, 354 F.3d 1347,1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)(Claims directed to PTFE dental floss with afriction-enhancing coating were not supported by adisclosure of a microcrystalline wax coating wherethere was no evidence in the disclosure or anywhereelse in the record showing applicant conveyed thatany other coating was suitable for a PTFE dentalfloss.) On the other hand, there may be situationswhere one species adequately supports a genus. See,e.g., In re Rasmussen, 650 F.2d 1212, 1214, 211USPQ 323, 326-27 (CCPA 1981) (disclosure of a

single method of adheringly applying one layer toanother was sufficient to support a generic claim to“adheringly applying” because one skilled in the artreading the specification would understand that it isunimportant how the layers are adhered, so long asthey are adhered); In re Herschler, 591 F.2d 693,697, 200 USPQ 711, 714 (CCPA 1979) (disclosureof corticosteriod in DMSO sufficient to supportclaims drawn to a method of using a mixture of a“physiologically active steroid” and DMSO because“use of known chemical compounds in a mannerauxiliary to the invention must have a correspondingwritten description only so specific as to lead onehaving ordinary skill in the art to that class ofcompounds. Occasionally, a functional recitation ofthose known compounds in the specification maybe sufficient as that description.”); In re Smythe,480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA1973) (the phrase “air or other gas which is inert tothe liquid” was sufficient to support a claim to “inertfluid media” because the description of the propertiesand functions of the air or other gas segmentizingmedium would suggest to a person skilled in the artthat appellant’s invention includes the use of “inertfluid” broadly.). However, in Tronzo v. Biomet, 156F.3d 1154, 1159, 47 USPQ2d 1829, 1833 (Fed. Cir.1998), the disclosure of a species in the parentapplication did not suffice to provide writtendescription support for the genus in the childapplication where the specification taught againstother species. See also In re Gosteli, 872 F.2d 1008,10 USPQ2d 1614 (Fed. Cir. 1989) (generic andsubgeneric claims in the U.S. application were notentitled to the benefit of foreign priority where theforeign application disclosed only two of thespecies encompassed by the broad generic claim andthe subgeneric Markush claim that encompassed 21compounds).

II. NARROWING OR SUBGENERIC CLAIM

The introduction of claim changes which involvenarrowing the claims by introducing elements orlimitations which are not supported by the as-fileddisclosure is a violation of the written descriptionrequirement of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. See, e.g., Fujikawa v.Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895,1905 (Fed. Cir. 1996) (a “laundry list” disclosure ofevery possible moiety does not constitute a written

Rev. 08.2017, January 20182100-323


description of every species in a genus because itwould not “reasonably lead” those skilled in the artto any particular species); In re Ruschig, 379 F.2d990, 995, 154 USPQ 118, 123 (CCPA 1967) (“ Ifn-propylamine had been used in making thecompound instead of n-butylamine, the compoundof claim 13 would have resulted. Appellants submitto us, as they did to the board, an imaginary specificexample patterned on specific example 6 by whichthe above butyl compound is made so that we cansee what a simple change would have resulted in aspecific supporting disclosure being present in thepresent specification. The trouble is that there is nosuch disclosure, easy though it is to imagine it.”)(emphasis in original); Rozbicki v. Chiang, 590Fed.App’x 990, 996 (Fed. Cir. 2014)(non-precedential) (The court found that patentee,“while attempting to obtain the broadest claimlanguage possible during prosecution, cannot nowimproperly narrow its language by importinglimitations not supported by the claim language orwritten description.”). In Ex parte Ohshiro,14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), theBoard affirmed the rejection under 35 U.S.C. 112,first paragraph, of claims to an internal combustionengine which recited “at least one of said piston andsaid cylinder (head) having a recessed channel.” TheBoard held that the application which disclosed acylinder head with a recessed channel and a pistonwithout a recessed channel did not specificallydisclose the “species” of a channeled piston.

While these and other cases find that recitation ofan undisclosed species may violate the descriptionrequirement, a change involving subgenericterminology may or may not be acceptable.Applicant was not entitled to the benefit of a parentfiling date when the claim was directed to a subgenus(a specified range of molecular weight ratios) wherethe parent application contained a generic disclosureand a specific example that fell within the recitedrange because the court held that subgenus rangewas not described in the parent application. Inre Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA1971). On the other hand, in Ex parte Sorenson, 3USPQ2d 1462 (Bd. Pat. App. & Inter. 1987), thesubgeneric language of “aliphatic carboxylic acid”and “aryl carboxylic acid” did not violate the writtendescription requirement because species fallingwithin each subgenus were disclosed as well as the

generic carboxylic acid. See also In re Smith, 458F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972)(“Whatever may be the viability of aninductive-deductive approach to arriving at a claimedsubgenus, it cannot be said that such a subgenus isnecessarily described by a genus encompassing itand a species upon which it reads.” (emphasisadded)). Each case must be decided on its own factsin terms of what is reasonably communicated tothose skilled in the art. In re Wilder, 736 F.2d 1516,1520, 222 USPQ 369, 372 (Fed. Cir. 1984).

III. RANGE LIMITATIONS

With respect to changing numerical rangelimitations, the analysis must take into account whichranges one skilled in the art would considerinherently supported by the discussion in the originaldisclosure. In the decision in In re Wertheim, 541F.2d 257, 191 USPQ 90 (CCPA 1976), the rangesdescribed in the original specification included arange of “25%- 60%” and specific examples of“36%” and “50%.” A corresponding new claimlimitation to “at least 35%” did not meet thedescription requirement because the phrase “at least”had no upper limit and caused the claim to readliterally on embodiments outside the “25% to 60%”range, however a limitation to “between 35% and60%” did meet the description requirement.

See also Purdue Pharma L.P. v. Faulding Inc.,230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487(Fed. Cir. 2000) (“[T]he specification does notclearly disclose to the skilled artisan that theinventors... considered the... ratio to be part of theirinvention.... There is therefore no force to Purdue’sargument that the written description requirementwas satisfied because the disclosure revealed a broadinvention from which the [later-filed] claims carvedout a patentable portion”). Compare Union Oil ofCal. v. Atl. Richfield Co., 208 F.3d 989, 997, 54USPQ2d 1227, 1232-33 (Fed. Cir. 2000)(Description in terms of ranges of chemicalproperties which work in combination with rangesof other chemical properties to produce anautomotive gasoline that reduces emissions wasfound to provide an adequate written descriptioneven though the exact chemical components of eachcombination were not disclosed and the specificationdid not disclose any distinct embodiments

2100-324Rev. 08.2017, January 2018


corresponding to any claim at issue. “[T]he PatentAct and this court’s case law require only sufficientdescription to show one of skill in the . . . art thatthe inventor possessed the claimed invention at thetime of filing.”).

2163.06 Relationship of Written DescriptionRequirement to New Matter [R-11.2013]

Lack of written description is an issue that generallyarises with respect to the subject matter of a claim.If an applicant amends or attempts to amend theabstract, specification or drawings of an application,an issue of new matter will arise if the content of theamendment is not described in the application asfiled. Stated another way, information contained inany one of the specification, claims or drawings ofthe application as filed may be added to any otherpart of the application without introducing newmatter.

There are two statutory provisions that prohibit theintroduction of new matter. The first provision is 35U.S.C. 132, which provides that no amendment shallintroduce new matter into the disclosure of theinvention. The second provision is 35 U.S.C. 251,which provides that no new matter shall beintroduced into the application for reissue.

I. TREATMENT OF NEW MATTER

If new subject matter is added to the disclosure,whether it be in the abstract, the specification, or thedrawings, the examiner should object to theintroduction of new matter under 35 U.S.C. 132 or251 as appropriate, and require applicant to cancelthe new matter. If new matter is added to the claims,the examiner should reject the claims under 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph - written description requirement. In reRasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA1981). The examiner should still consider the subjectmatter added to the claim in making rejections basedon prior art since the new matter rejection may beovercome by applicant.

When the claims have not been amended, per se,but the specification has been amended to add newmatter, a rejection of the claims under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,

should be made whenever any of the claimlimitations are affected by the added material.

When an amendment is filed in reply to an objectionor rejection based on 35 U.S.C. 112(a) or pre-AIA35 U.S.C. 112, first paragraph, a study of the entireapplication is often necessary to determine whetheror not “new matter” is involved. Applicant shouldtherefore specifically point out the support for anyamendments made to the disclosure.

II. REVIEW OF NEW MATTER OBJECTIONSAND/OR REJECTIONS

A rejection of claims is reviewable by the PatentTrial and Appeal Board, whereas an objection andrequirement to delete new matter is subject tosupervisory review by petition under 37 CFR 1.181.If both the claims and specification contain newmatter either directly or indirectly, and there hasbeen both a rejection and objection by the examiner,the issue becomes appealable and should not bedecided by petition.

III. CLAIMED SUBJECT MATTER NOTDISCLOSED IN REMAINDER OF SPECIFICATION

The claims as filed in the original specification arepart of the disclosure and therefore, if an applicationas originally filed contains a claim disclosingmaterial not disclosed in the remainder of thespecification, the applicant may amend thespecification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed.Cir. 1985). Form paragraph 7.44 may be used whereoriginally claimed subject matter lacks properantecedent basis in the specification. See MPEP §608.01(o).

2163.07 Amendments to Application WhichAre Supported in the Original Description[R-08.2017]

Amendments to an application which are supportedin the original description are NOT new matter.

I. REPHRASING

Mere rephrasing of a passage does not constitutenew matter. Accordingly, a rewording of a

Rev. 08.2017, January 20182100-325


passage where the same meaning remains intact ispermissible. In re Anderson, 471 F.2d 1237,176 USPQ 331 (CCPA 1973). The mere inclusionof dictionary or art recognized definitions known atthe time of filing an application may not beconsidered new matter. If there are multipledefinitions for a term and a definition is added to theapplication, it must be clear from the application asfiled that applicant intended a particular definition,in order to avoid an issue of new matter and/or lackof written description. See, e.g., Schering Corp. v.Amgen, Inc., 222 F.3d 1347, 1352-53, 55 USPQ2d1650, 1654 (Fed. Cir. 2000). In Schering, theoriginal disclosure was drawn to recombinant DNAmolecules and used the term “leukocyte interferon.”Shortly after the filing date, a scientific committeeabolished the term in favor of “IFN-(a),” since thelatter term more specifically identified a particularpolypeptide and since the committee found thatleukocytes also produced other types of interferon.The court held that the subsequent amendment tothe specification and claims substituting the term“IFN-(a)” for “leukocyte interferon” merely renamedthe invention and did not constitute new matter. Theclaims were limited to cover only the interferonsubtype coded for by the inventor’s original deposits.

II. OBVIOUS ERRORS

An amendment to correct an obvious error does notconstitute new matter where one skilled in the artwould not only recognize the existence of error inthe specification, but also the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA1971).

Where a foreign priority document under 35 U.S.C.119 is of record in the U.S. application file, applicantmay not rely on the disclosure of that document tosupport correction of an error in the pending U.S.application. Ex parte Bondiou, 132 USPQ 356 (Bd.Pat. App. & Int. 1961). This prohibition appliesregardless of the language of the foreign prioritydocuments because a claim for priority is simply aclaim for the benefit of an earlier filing date forsubject matter that is common to two or moreapplications, and does not serve to incorporate thecontent of the priority document in the applicationin which the claim for priority is made. Thisprohibition does not apply where the U.S. application

explicitly incorporates the foreign priority documentby reference. For applications filed on or afterSeptember 21, 2004, where all or a portion of thespecification or drawing(s) is inadvertently omittedfrom the U.S. application, a claim under 37 CFR1.55 for priority of a prior-filed foreign applicationthat is present on the filing date of the application isconsidered an incorporation by reference of theprior-filed foreign application as to the inadvertentlyomitted portion of the specification or drawing(s),subject to the conditions and requirements of 37 CFR1.57(a). See 37 CFR 1.57(a) and MPEP § 217 .

Where a U.S. application as originally filed was ina non-English language and an English translationthereof was subsequently submitted pursuant to37 CFR 1.52(d), if there is an error in the Englishtranslation, applicant may rely on the disclosure ofthe originally filed non-English language U.S.application to support correction of an error in theEnglish translation document.

2163.07(a) Inherent Function, Theory, orAdvantage [R-08.2017]

By disclosing in a patent application a device thatinherently performs a function or has a property,operates according to a theory or has an advantage,a patent application necessarily discloses thatfunction, theory or advantage, even though it saysnothing explicit concerning it. The application maylater be amended to recite the function, theory oradvantage without introducing prohibited newmatter. In re Reynolds, 443 F.2d 384, 170 USPQ94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178USPQ 279 (CCPA 1973); Yeda Research and Dev.Co. v. Abbott GMBH & Co., 837 F.3d 1341, 120USPQ2d 1299 (Fed. Cir. 2016) (“Under the doctrineof inherent disclosure, when a specification describesan invention that has certain undisclosed yet inherentproperties, that specification serves as adequatewritten description to support a subsequent patentapplication that explicitly recites the invention’sinherent properties.” (citing Kennecott Corp. v.Kyocera Int’l, Inc., 835 F.2d 1419, 1423 (Fed. Cir.1987))). “To establish inherency, the extrinsicevidence ‘must make clear that the missingdescriptive matter is necessarily present in the thingdescribed in the reference, and that it would be sorecognized by persons of ordinary skill. Inherency,

2100-326Rev. 08.2017, January 2018


however, may not be established by probabilities orpossibilities. The mere fact that a certain thing mayresult from a given set of circumstances is notsufficient.’” In re Robertson, 169 F.3d 743, 745, 49USPQ2d 1949, 1950-51 (Fed. Cir. 1999) (citationsomitted).

2163.07(b) Incorporation by Reference[R-11.2013]

Instead of repeating some information contained inanother document, an application may attempt toincorporate the content of another document or partthereof by reference to the document in the text ofthe specification. The information incorporated isas much a part of the application as filed as if thetext was repeated in the application, and should betreated as part of the text of the application as filed.Replacing the identified material incorporated byreference with the actual text is not new matter. See37 CFR 1.57 and MPEP § 608.01(p) for Officepolicy regarding incorporation by reference. SeeMPEP § 2181 for the impact of incorporation byreference on the determination of whether applicanthas complied with the requirements of 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraphwhen 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,sixth paragraph is invoked.

2164 The Enablement Requirement[R-11.2013]

The enablement requirement refers to therequirement of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph that the specificationdescribe how to make and how to use the invention.The invention that one skilled in the art must beenabled to make and use is that defined by theclaim(s) of the particular application or patent.

The purpose of the requirement that the specificationdescribe the invention in such terms that one skilledin the art can make and use the claimed invention isto ensure that the invention is communicated to theinterested public in a meaningful way. Theinformation contained in the disclosure of anapplication must be sufficient to inform those skilledin the relevant art how to both make and use theclaimed invention. However, to comply with 35

U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, it is not necessary to “enable one ofordinary skill in the art to make and use a perfected,commercially viable embodiment absent a claimlimitation to that effect.” CFMT, Inc. v. Yieldup Int’lCorp., 349 F.3d 1333, 1338, 68 USPQ2d 1940, 1944(Fed. Cir. 2003) (an invention directed to a generalsystem to improve the cleaning process forsemiconductor wafers was enabled by a disclosureshowing improvements in the overall system).Detailed procedures for making and using theinvention may not be necessary if the description ofthe invention itself is sufficient to permit thoseskilled in the art to make and use the invention. Apatent claim is invalid if it is not supported by anenabling disclosure.

The enablement requirement of 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, is separateand distinct from the written description requirement. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563,19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991) (“thepurpose of the ‘written description’ requirement isbroader than to merely explain how to ‘make anduse’”). See also MPEP § 2161. Therefore, the factthat an additional limitation to a claim may lackdescriptive support in the disclosure as originallyfiled does not necessarily mean that the limitationis also not enabled. In other words, even if a newlimitation is not described in the original disclosure,the addition of a new limitation in and of itself maynot create an enablement problem provided that oneskilled in the art could make and use the claimedinvention with the new limitation. Consequently,such limitations must be analyzed for bothenablement and description using their separate anddistinct criteria.

Furthermore, when the limitation is not described inthe specification portion of the application as filedbut is in the claims, the limitation in and of itselfmay enable one skilled in the art to make and usethe claimed invention. When claimed subject matteris only presented in the claims and not in thespecification portion of the application, thespecification should be objected to for lacking therequisite support for the claimed subject matter usingform paragraph 7.44. See MPEP § 2163.06. This isan objection to the specification only and enablementissues should be treated separately.

Rev. 08.2017, January 20182100-327


2164.01 Test of Enablement [R-08.2012]

Any analysis of whether a particular claim issupported by the disclosure in an application requiresa determination of whether that disclosure, whenfiled, contained sufficient information regarding thesubject matter of the claims as to enable one skilledin the pertinent art to make and use the claimedinvention. The standard for determining whether thespecification meets the enablement requirement wascast in the Supreme Court decision of MineralsSeparation Ltd. v. Hyde, 242 U.S. 261, 270 (1916)which postured the question: is the experimentationneeded to practice the invention undue orunreasonable? That standard is still the one to beapplied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d1400, 1404 (Fed. Cir. 1988). Accordingly, eventhough the statute does not use the term “undueexperimentation,” it has been interpreted to requirethat the claimed invention be enabled so that anyperson skilled in the art can make and use theinvention without undue experimentation. In reWands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed.Cir. 1988). See also United States v. Telectronics,Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed.Cir. 1988) (“The test of enablement is whether onereasonably skilled in the art could make or use theinvention from the disclosures in the patent coupledwith information known in the art without undueexperimentation.”). A patent need not teach, andpreferably omits, what is well known in the art. Inre Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331,1332 (Fed. Cir. 1991); Hybritech, Inc. v.Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384,231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied,480 U.S. 947 (1987); and LindemannMaschinenfabrik GMBH v. American Hoist &Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481,489 (Fed. Cir. 1984). Any part of the specificationcan support an enabling disclosure, even abackground section that discusses, or evendisparages, the subject matter disclosed therein. Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361,77 USPQ2d 1041 (Fed. Cir. 2005)(discussion ofproblems with a prior art feature does not mean thatone of ordinary skill in the art would not know howto make and use this feature). Determiningenablement is a question of law based on underlyingfactual findings. In re Vaeck, 947 F.2d 488, 495, 20USPQ2d 1438, 1444 (Fed. Cir. 1991); Atlas Powder

Co. v. E.I. du Pont de Nemours & Co., 750 F.2d1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984).

UNDUE EXPERIMENTATION

The fact that experimentation may be complex doesnot necessarily make it undue, if the art typicallyengages in such experimentation. In re CertainLimited-Charge Cell Culture Microcarriers, 221USPQ 1165, 1174 (Int’l Trade Comm'n 1983), aff’d. sub nom., Massachusetts Institute ofTechnology v. A.B. Fortia, 774 F.2d 1104, 227USPQ 428 (Fed. Cir. 1985). See also In re Wands,858 F.2d at 737, 8 USPQ2d at 1404. The test ofenablement is not whether any experimentation isnecessary, but whether, if experimentation isnecessary, it is undue. In re Angstadt, 537 F.2d 498,504, 190 USPQ 214, 219 (CCPA 1976).

2164.01(a) Undue Experimentation Factors[R-08.2012]

There are many factors to be considered whendetermining whether there is sufficient evidence tosupport a determination that a disclosure does notsatisfy the enablement requirement and whether anynecessary experimentation is “undue.” These factorsinclude, but are not limited to:

(A) The breadth of the claims;

(B) The nature of the invention;

(C) The state of the prior art;

(D) The level of one of ordinary skill;

(E) The level of predictability in the art;

(F) The amount of direction provided by theinventor;

(G) The existence of working examples; and

(H) The quantity of experimentation needed tomake or use the invention based on the content ofthe disclosure.

In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400,1404 (Fed. Cir. 1988) (reversing the PTO’sdetermination that claims directed to methods fordetection of hepatitis B surface antigens did notsatisfy the enablement requirement). In Wands, thecourt noted that there was no disagreement as to thefacts, but merely a disagreement as to the

2100-328Rev. 08.2017, January 2018


interpretation of the data and the conclusion to bemade from the facts. In re Wands, 858 F.2d at736-40, 8 USPQ2d at 1403-07. The court held thatthe specification was enabling with respect to theclaims at issue and found that “there wasconsiderable direction and guidance” in thespecification; there was “a high level of skill in theart at the time the application was filed;” and “all ofthe methods needed to practice the invention werewell known.” 858 F.2d at 740, 8 USPQ2d at 1406.After considering all the factors related to theenablement issue, the court concluded that “it wouldnot require undue experimentation to obtainantibodies needed to practice the claimed invention.” Id., 8 USPQ2d at 1407.

It is improper to conclude that a disclosure is notenabling based on an analysis of only one of theabove factors while ignoring one or more of theothers. The examiner’s analysis must consider allthe evidence related to each of these factors, and anyconclusion of nonenablement must be based on theevidence as a whole. 858 F.2d at 737, 740, 8USPQ2d at 1404, 1407.

A conclusion of lack of enablement means that,based on the evidence regarding each of the abovefactors, the specification, at the time the applicationwas filed, would not have taught one skilled in theart how to make and/or use the full scope of theclaimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d1510, 1513 (Fed. Cir. 1993).

The determination that “undue experimentation”would have been needed to make and use the claimedinvention is not a single, simple factualdetermination. Rather, it is a conclusion reached byweighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.These factual considerations are discussed more fullyin MPEP § 2164.08 (scope or breadth of the claims),§ 2164.05(a) (nature of the invention and state ofthe prior art), § 2164.05(b) (level of one of ordinaryskill), § 2164.03 (level of predictability in the artand amount of direction provided by the inventor),§ 2164.02 (the existence of working examples) and§ 2164.06 (quantity of experimentation needed tomake or use the invention based on the content ofthe disclosure).

2164.01(b) How to Make the ClaimedInvention [R-08.2012]

As long as the specification discloses at least onemethod for making and using the claimed inventionthat bears a reasonable correlation to the entire scopeof the claim, then the enablement requirement of35 U.S.C. 112 is satisfied. In re Fisher, 427 F.2d833, 839, 166 USPQ 18, 24 (CCPA 1970). Failureto disclose other methods by which the claimedinvention may be made does not render a claiminvalid under 35 U.S.C. 112. Spectra-Physics, Inc.v. Coherent, Inc., 827 F.2d 1524, 1533, 3 USPQ2d1737, 1743 (Fed. Cir. 1987), cert. denied, 484 U.S.954 (1987).

Naturally, for unstable and transitory chemicalintermediates, the “how to make” requirement doesnot require that the applicant teach how to make theclaimed product in stable, permanent or isolatableform. In re Breslow, 616 F.2d 516, 521, 205 USPQ221, 226 (CCPA 1980).

A key issue that can arise when determining whetherthe specification is enabling is whether the startingmaterials or apparatus necessary to make theinvention are available. In the biotechnical area, thisis often true when the product or process requires aparticular strain of microorganism and when themicroorganism is available only after extensivescreening.

The court in In re Ghiron, 442 F.2d 985, 991, 169USPQ 723, 727 (CCPA 1971), made clear that if thepractice of a method requires a particular apparatus,the application must provide a sufficient disclosureof the apparatus if the apparatus is not readilyavailable. The same can be said if certain chemicalsare required to make a compound or practice achemical process. In re Howarth, 654 F.2d 103,105, 210 USPQ 689, 691 (CCPA 1981).

2164.01(c) How to Use the Claimed Invention[R-08.2017]

If a statement of utility in the specification containswithin it a connotation of how to use, and/or the artrecognizes that standard modes of administrationare known and contemplated, 35 U.S.C. 112 is

Rev. 08.2017, January 20182100-329


satisfied. In re Johnson, 282 F.2d 370, 373, 127USPQ 216, 219 (CCPA 1960); In re Hitchings, 342F.2d 80, 87, 144 USPQ 637, 643 (CCPA 1965); seealso In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d1436, 1441 (Fed. Cir. 1995).

For example, it is not necessary to specify the dosageor method of use if it is known to one skilled in theart that such information could be obtained withoutundue experimentation. If one skilled in the art,based on knowledge of compounds having similarphysiological or biological activity, would be ableto discern an appropriate dosage or method of usewithout undue experimentation, this would besufficient to satisfy 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. The applicant need notdemonstrate that the invention is completely safe.See also MPEP §§ 2107.01 and 2107.03.

When a compound or composition claim is limitedby a particular use, enablement of that claim shouldbe evaluated based on that limitation. See In reVaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444(Fed. Cir. 1991) (claiming a chimeric gene capableof being expressed in any cyanobacterium and thusdefining the claimed gene by its use).

In contrast, when a compound or composition claimis not limited by a recited use, any enabled use thatwould reasonably correlate with the entire scope ofthat claim is sufficient to preclude a rejection fornonenablement based on how to use. If multiple usesfor claimed compounds or compositions aredisclosed in the application, then an enablementrejection must include an explanation, sufficientlysupported by the evidence, why the specificationfails to enable each disclosed use. In other words, ifany use is enabled when multiple uses are disclosed,the application is enabling for the claimed invention.

2164.02 Working Example [R-11.2013]

Compliance with the enablement requirement of 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, does not turn on whether an example isdisclosed. An example may be “working” or“prophetic.” A working example is based on workactually performed. A prophetic example describesan embodiment of the invention based on predicted

results rather than work actually conducted or resultsactually achieved.

An applicant need not have actually reduced theinvention to practice prior to filing. In Gould v.Quigg, 822 F.2d 1074, 1078, 3 USPQ 2d 1302, 1304(Fed. Cir. 1987), as of Gould’s filing date, no personhad built a light amplifier or measured a populationinversion in a gas discharge. The court held that “Themere fact that something has not previously beendone clearly is not, in itself, a sufficient basis forrejecting all applications purporting to disclose howto do it.” 822 F.2d at 1078, 3 USPQ2d at 1304(quoting In re Chilowsky, 229 F.2d 457, 461, 108USPQ 321, 325 (CCPA 1956)).

The specification need not contain an example if theinvention is otherwise disclosed in such manner thatone skilled in the art will be able to practice itwithout an undue amount of experimentation. Inre Borkowski, 422 F.2d 904, 908, 164 USPQ 642,645 (CCPA 1970).

Lack of a working example, however, is a factor tobe considered, especially in a case involving anunpredictable and undeveloped art. But because onlyan enabling disclosure is required, applicant neednot describe all actual embodiments.

I. NONE OR ONE WORKING EXAMPLE

When considering the factors relating to adetermination of non-enablement, if all the otherfactors point toward enablement, then the absenceof working examples will not by itself render theinvention non-enabled. In other words, lack ofworking examples or lack of evidence that theclaimed invention works as described should neverbe the sole reason for rejecting the claimed inventionon the grounds of lack of enablement. A singleworking example in the specification for a claimedinvention is enough to preclude a rejection whichstates that nothing is enabled since at least thatembodiment would be enabled. However, a rejectionstating that enablement is limited to a particularscope may be appropriate.

The presence of only one working example shouldnever be the sole reason for rejecting claims as beingbroader than the enabling disclosure, even though it

2100-330Rev. 08.2017, January 2018


is a factor to be considered along with all the otherfactors. To make a valid rejection, one must evaluateall the facts and evidence and state why one wouldnot expect to be able to extrapolate that one exampleacross the entire scope of the claims.

II. CORRELATION: IN VITRO/ IN VIVO

The issue of “correlation” is related to the issue ofthe presence or absence of working examples.“Correlation” as used herein refers to the relationshipbetween in vitro or in vivo animal model assaysand a disclosed or a claimed method of use. An invitro or in vivo animal model example in thespecification, in effect, constitutes a “workingexample” if that example “correlates” with adisclosed or claimed method invention. If there isno correlation, then the examples do not constitute“working examples.” In this regard, the issue of“correlation” is also dependent on the state of theprior art. In other words, if the art is such that aparticular model is recognized as correlating to aspecific condition, then it should be accepted ascorrelating unless the examiner has evidence thatthe model does not correlate. Even with suchevidence, the examiner must weigh the evidence forand against correlation and decide whether oneskilled in the art would accept the model asreasonably correlating to the condition. In re Brana,51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed.Cir. 1995) (reversing the PTO decision based onfinding that in vitro data did not support in vivoapplications).

Since the initial burden is on the examiner to givereasons for the lack of enablement, the examinermust also give reasons for a conclusion of lack ofcorrelation for an in vitro or in vivo animal modelexample. A rigorous or an invariable exactcorrelation is not required, as stated in Cross v.Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747(Fed. Cir. 1985):

[B]ased upon the relevant evidence as a whole,there is a reasonable correlation between thedisclosed in vitro utility and an in vivoactivity, and therefore a rigorous correlation isnot necessary where the disclosure ofpharmacological activity is reasonable based

upon the probative evidence. (Citationsomitted.)

III. WORKING EXAMPLES AND A CLAIMEDGENUS

For a claimed genus, representative examplestogether with a statement applicable to the genus asa whole will ordinarily be sufficient if one skilledin the art (in view of level of skill, state of the artand the information in the specification) wouldexpect the claimed genus could be used in thatmanner without undue experimentation. Proof ofenablement will be required for other members ofthe claimed genus only where adequate reasons areadvanced by the examiner to establish that a personskilled in the art could not use the genus as a wholewithout undue experimentation.

2164.03 Relationship of Predictability of theArt and the Enablement Requirement[R-08.2012]

The amount of guidance or direction needed toenable the invention is inversely related to theamount of knowledge in the state of the art as wellas the predictability in the art. In re Fisher, 427 F.2d833, 839, 166 USPQ 18, 24 (CCPA 1970). The“amount of guidance or direction” refers to thatinformation in the application, as originally filed,that teaches exactly how to make or use theinvention. The more that is known in the prior artabout the nature of the invention, how to make, andhow to use the invention, and the more predictablethe art is, the less information needs to be explicitlystated in the specification. In contrast, if little isknown in the prior art about the nature of theinvention and the art is unpredictable, thespecification would need more detail as to how tomake and use the invention in order to be enabling.See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004)(“Nascent technology, however, must be enabledwith a ‘specific and useful teaching.’ The lawrequires an enabling disclosure for nascenttechnology because a person of ordinary skill in theart has little or no knowledge independent from thepatentee’s instruction. Thus, the public’s end of thebargain struck by the patent system is a full enabling

Rev. 08.2017, January 20182100-331


disclosure of the claimed technology.” (citationsomitted)).

The “predictability or lack thereof” in the art refersto the ability of one skilled in the art to extrapolatethe disclosed or known results to the claimedinvention. If one skilled in the art can readilyanticipate the effect of a change within the subjectmatter to which the claimed invention pertains, thenthere is predictability in the art. On the other hand,if one skilled in the art cannot readily anticipate theeffect of a change within the subject matter to whichthat claimed invention pertains, then there is lack ofpredictability in the art. Accordingly, what is knownin the art provides evidence as to the question ofpredictability. In particular, the court in In reMarzocchi, 439 F.2d 220, 223-24, 169 USPQ 367,369-70 (CCPA 1971), stated:

[I]n the field of chemistry generally, there maybe times when the well-known unpredictabilityof chemical reactions will alone be enough tocreate a reasonable doubt as to the accuracy ofa particular broad statement put forward asenabling support for a claim. This willespecially be the case where the statement is,on its face, contrary to generally acceptedscientific principles. Most often, additionalfactors, such as the teachings in pertinentreferences, will be available to substantiate anydoubts that the asserted scope of objectiveenablement is in fact commensurate with thescope of protection sought and to support anydemands based thereon for proof. [Footnoteomitted.]

The scope of the required enablement variesinversely with the degree of predictability involved,but even in unpredictable arts, a disclosure of everyoperable species is not required. A singleembodiment may provide broad enablement in casesinvolving predictable factors, such as mechanical orelectrical elements. In re Vickers, 141 F.2d 522,526-27, 61 USPQ 122, 127 (CCPA 1944); Inre Cook, 439 F.2d 730, 734, 169 USPQ 298, 301(CCPA 1971). However, in applications directed toinventions in arts where the results are unpredictable,the disclosure of a single species usually does notprovide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191

(CCPA 1938). In cases involving unpredictablefactors, such as most chemical reactions andphysiological activity, more may be required. Inre Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24(CCPA 1970) (contrasting mechanical and electricalelements with chemical reactions and physiologicalactivity). See also In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); Inre Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445(Fed. Cir. 1991). This is because it is not reasonablypredictable from the disclosure of one species, whatother species will work.

2164.04 Burden on the Examiner Under theEnablement Requirement [R-08.2017]

Before any analysis of enablement can occur, it isnecessary for the examiner to construe the claims.For terms that are not well-known in the art, or forterms that could have more than one meaning, it isnecessary that the examiner select the definition thatthe examiner intends to use when examining theapplication, based on their understanding of whatapplicant intends it to mean, and explicitly set forththe meaning of the term and the scope of the claimwhen writing an Office action. See Genentech v.Wellcome Foundation, 29 F.3d 1555, 1563-64, 31USPQ2d 1161, 1167-68 (Fed. Cir. 1994).

In order to make a rejection, the examiner has theinitial burden to establish a reasonable basis toquestion the enablement provided for the claimedinvention. In re Wright, 999 F.2d 1557, 1562, 27USPQ2d 1510, 1513 (Fed. Cir. 1993) (examinermust provide a reasonable explanation as to why thescope of protection provided by a claim is notadequately enabled by the disclosure). Aspecification disclosure which contains a teachingof the manner and process of making and using aninvention in terms which correspond in scope tothose used in describing and defining the subjectmatter sought to be patented must be taken as beingin compliance with the enablement requirement of35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, unless there is a reason to doubt theobjective truth of the statements contained thereinwhich must be relied on for enabling support.Assuming that sufficient reason for such doubtexists, a rejection for failure to teach how to makeand/or use will be proper on that basis. In

2100-332Rev. 08.2017, January 2018


re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367,370 (CCPA 1971). As stated by the court, “it isincumbent upon the Patent Office, whenever arejection on this basis is made, to explain why itdoubts the truth or accuracy of any statement in asupporting disclosure and to back up assertions ofits own with acceptable evidence or reasoning whichis inconsistent with the contested statement.Otherwise, there would be no need for the applicantto go to the trouble and expense of supporting hispresumptively accurate disclosure.” 439 F.2d at 224,169 USPQ at 370 (emphasis in original).

According to In re Bowen, 492 F.2d 859, 862-63,181 USPQ 48, 51 (CCPA 1974), the minimalrequirement is for the examiner to give reasonsexplaining the uncertainty of the enablement. Thisstandard is applicable even when there is no evidencein the record of operability without undueexperimentation beyond the disclosed embodiments.See also In re Brana, 51 F.3d 1560, 1566, 34USPQ2d 1436, 1441 (Fed. Cir. 1995) (citing Inre Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51(CCPA 1981)) (discussed in MPEP § 2164.07regarding the relationship of the enablementrequirement to the utility requirement of 35 U.S.C.101).

While the analysis and conclusion of a lack ofenablement are based on the factors discussed inMPEP § 2164.01(a) and the evidence as a whole, itis not necessary to discuss each factor in theenablement rejection. However, it is improper toconclude that a disclosure is not enabling based onan analysis of only one of the above factors whileignoring one or more of the others. The examiner’sanalysis must consider all the evidence related toeach of these factors, and any conclusion ofnonenablement must be based on the evidence as awhole. In re Wands, 858 F.2d 731, 737, 740, 8USPQ2d 1400, 1404, 1407 (Fed. Cir. 1988). Theexplanation of the rejection should focus on thosefactors, reasons, and evidence that lead the examinerto conclude e.g., that the specification fails to teachhow to make and use the claimed invention withoutundue experimentation, or that the scope of anyenablement provided to one skilled in the art is notcommensurate with the scope of protection soughtby the claims. This can be done by making specificfindings of fact, supported by the evidence, and then

drawing conclusions based on these findings of fact.For example, doubt may arise about enablementbecause information is missing about one or moreessential parts or relationships between parts whichone skilled in the art could not develop withoutundue experimentation. In such a case, the examinershould specifically identify what information ismissing and why one skilled in the art could notsupply the information without undueexperimentation. See MPEP § 2164.06(a).References should be supplied if possible to supporta prima facie case of lack of enablement, but arenot always required. In re Marzocchi, 439 F.2d 220,224, 169 USPQ 367, 370 (CCPA 1971). However,specific technical reasons are always required.

In accordance with the principles of compactprosecution, if an enablement rejection isappropriate, the first Office action on the meritsshould present the best case with all the relevantreasons, issues, and evidence so that all suchrejections can be withdrawn if applicant providesappropriate convincing arguments and/or evidencein rebuttal. Providing the best rejection in the firstOffice action will also allow the second Office actionto be made final should applicant fail to provideappropriate convincing arguments and/or evidence.Citing new references and/or expanding argumentsin a second Office action could prevent that Officeaction from being made final. The principles ofcompact prosecution also dictate that if anenablement rejection is appropriate and the examinerrecognizes limitations that would render the claimsenabled, the examiner should note such limitationsto applicant as early in the prosecution as possible.

In other words, the examiner should always look forenabled, allowable subject matter and communicateto applicant what that subject matter is at the earliestpoint possible in the prosecution of the application.

2164.05 Determination of Enablement Basedon Evidence as a Whole [R-08.2017]

Once the examiner has weighed all the evidence andestablished a reasonable basis to question theenablement provided for the claimed invention, theburden falls on applicant to present persuasivearguments, supported by suitable proofs wherenecessary, that one skilled in the art would be able

Rev. 08.2017, January 20182100-333


to make and use the claimed invention using theapplication as a guide. In re Brandstadter, 484 F.2d1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973).The evidence provided by applicant need not beabsolute but merely convincing to one skilled in theart.

Applicant may submit factual affidavits under 37CFR 1.132 or cite references to show what oneskilled in the art knew at the time of filing theapplication. A declaration or affidavit is, itself,evidence that must be considered. The weight to givea declaration or affidavit will depend upon theamount of factual evidence the declaration oraffidavit contains to support the conclusion ofenablement. In re Buchner, 929 F.2d 660, 661, 18USPQ2d 1331, 1332 (Fed. Cir. 1991) (Stating thatan “expert’s opinion on [an] ultimate legalconclusion must be supported by something morethan a conclusory statement”); cf. In re Alton, 76F.3d 1168, 1174, 37 USPQ2d 1578, 1583 (Fed. Cir.1996) (declarations relating to the written descriptionrequirement should have been considered).

Applicant should be encouraged to provide evidencedemonstrating that the disclosure enables the claimedinvention. In chemical and biotechnical applications,evidence actually submitted to the FDA to obtainapproval for clinical trials may be submitted, but isnot required. Considerations made by the FDA forapproving clinical trials are different from thosemade by the USPTO in determining whether a claimis enabled. See Scott v. Finney, 34 F.3d 1058, 1063,32 USPQ2d 1115, 1120 (Fed. Cir. 1994) (“Testingfor full safety and effectiveness of a prosthetic deviceis more properly left to the [FDA].”). Once thatevidence is submitted, it must be weighed with allother evidence according to the standards set forthabove so as to reach a determination as to whetherthe disclosure enables the claimed invention.

To overcome a prima facie case of lack ofenablement, applicant must present argument and/orevidence that the disclosure would have enabled oneof ordinary skill in the art to make and use theclaimed invention at the time of filing. This does notpreclude applicant from providing a declaration afterthe filing date which demonstrates that the claimedinvention works. However, the examiner shouldcarefully compare the steps, materials, and

conditions used in the experiments of the declarationwith those disclosed in the application to make surethat they are commensurate in scope; i.e., that theexperiments used the guidance in the specificationas filed and what was well known to one of skill inthe art at the time of filing. Such a showing also mustbe commensurate with the scope of the claimedinvention, i.e., must reasonably enable the full scopeof the claimed invention.

The examiner must then weigh all the evidencebefore him or her, including the specification, anynew evidence supplied by applicant, and anyevidence and scientific reasoning previouslypresented in the rejection and then decide whetherthe claimed invention is enabled. The examinershould never make this determination based onpersonal opinion. The determination should alwaysbe based on the weight of all the evidence of record.

2164.05(a) Specification Must Be Enablingas of the Filing Date [R-08.2017]

Whether the specification would have been enablingas of the filing date involves consideration of thenature of the invention, the state of the prior art, andthe level of skill in the art. The initial inquiry is intothe nature of the invention, i.e., the subject matterto which the claimed invention pertains. The natureof the invention becomes the backdrop to determinethe state of the art and the level of skill possessedby one skilled in the art.

The state of the prior art is what one skilled in theart would have known, at the time the applicationwas filed, about the subject matter to which theclaimed invention pertains. The relative skill of thosein the art refers to the skill of those in the art inrelation to the subject matter to which the claimedinvention pertains at the time the application wasfiled. See MPEP § 2164.05(b).

The state of the prior art provides evidence for thedegree of predictability in the art and is related tothe amount of direction or guidance needed in thespecification as filed to meet the enablementrequirement. The state of the prior art is also relatedto the need for working examples in thespecification.

2100-334Rev. 08.2017, January 2018


The state of the art for a given technology is notstatic in time. It is entirely possible that a disclosurewhich would not have been enabled if filed onJanuary 2, 1990 might be enabled if the samedisclosure had been filed on January 2, 1996.Therefore, the state of the prior art must be evaluatedfor each application based on its filing date.

35 U.S.C. 112 requires the specification to beenabling only to a person “skilled in the art to whichit pertains, or with which it is most nearlyconnected.” In general, the pertinent art should bedefined in terms of the problem to be solved ratherthan in terms of the technology area, industry, trade,etc. for which the invention is used.

The specification need not disclose what iswell-known to those skilled in the art and preferablyomits that which is well-known to those skilled andalready available to the public. In re Buchner, 929F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir.1991); Hybritech, Inc. v. Monoclonal Antibodies,Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed.Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. AmericanHoist & Derrick Co., 730 F.2d 1452, 1463, 221USPQ 481, 489 (Fed. Cir. 1984).

The state of the art existing at the filing date of theapplication is used to determine whether a particulardisclosure is enabling as of the filing date. ChironCorp. v. Genentech Inc., 363 F.3d 1247, 1254, 70USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (Statingthat “a patent document cannot enable technologythat arises after the date of application.”).Information published for the first time after thefiling date generally cannot be used to show whatwas known at the time of filing. In re Gunn, 537F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA1976); In re Budnick, 537 F.2d 535, 538, 190 USPQ422, 424 (CCPA 1976) (In general, if an applicantseeks to use a patent to prove the state of the art forthe purpose of the enablement requirement, thepatent must have an issue date earlier than theeffective filing date of the application.). While a laterdated publication cannot supplement an insufficientdisclosure in a prior dated application to make itenabling, an applicant can offer the testimony of anexpert based on the publication as evidence of thelevel of skill in the art at the time the application

was filed. Gould v. Quigg, 822 F.2d 1074, 1077,3 USPQ2d 1302, 1304 (Fed. Cir. 1987).

In general, the examiner should not use post-filingdate references to demonstrate that a patent is notenabled. Exceptions to this rule could occur if alater-dated reference provides evidence of what oneskilled in the art would have known on or before theeffective filing date of the patent application. In reHogan, 559 F.2d 595, 605, 194 USPQ 527, 537(CCPA 1977). If a publication demonstrates thatthose of ordinary skill in the art would find that aparticular invention was not enabled years after thefiling date, the publication would be evidence thatthe claimed invention was not possible at the timeof filing. See In re Wright, 999 F.2d 1557, 1562, 27USPQ2d 1510, 1513-14 (Fed. Cir. 1993) (The courtfound that an article published 5 years after the filingdate of the application adequately supported theexaminer’s position that the physiological activityof certain viruses was sufficiently unpredictable sothat a person skilled in the art would not havebelieved that the success with one virus and oneanimal could be extrapolated successfully to allviruses with all living organisms. Accordingly, thecourt held that the applicant’s earlier-filed claimsnot limited to the specific virus or the specific animalwere nonenabled).

2164.05(b) Specification Must Be Enablingto Persons Skilled in the Art [R-08.2017]

The relative skill of those in the art refers to the skilllevel of those in the art in the technological field towhich the claimed invention pertains. Wheredifferent arts are involved in the invention, thespecification is enabling if it enables persons skilledin each art to carry out the aspect of the inventionapplicable to their specialty. In re Naquin, 398 F.2d863, 866, 158 USPQ 317, 319 (CCPA 1968).

When an invention, in its different aspects, involvesdistinct arts, the specification is enabling if it enablesthose skilled in each art, to carry out the aspectproper to their specialty. “If two distinct technologiesare relevant to an invention, then the disclosure willbe adequate if a person of ordinary skill in each ofthe two technologies could practice the inventionfrom the disclosures.” Technicon InstrumentsCorp. v. Alpkem Corp., 664 F. Supp. 1558, 1578, 2

Rev. 08.2017, January 20182100-335


USPQ2d 1729, 1742 (D. Ore. 1986), aff’d in part,vacated in part, rev’d in part, 837 F. 2d 1097 (Fed.Cir. 1987) (unpublished opinion), appeal afterremand, 866 F. 2d 417, 9 USPQ 2d 1540 (Fed. Cir.1989). In Ex parte Zechnall, 194 USPQ 461 (Bd.Pat. App. & Int. 1973), the Board stated “appellants’disclosure must be held sufficient if it would enablea person skilled in the electronic computer art, incooperation with a person skilled in the fuel injectionart, to make and use appellants’ invention.” 194USPQ at 461.

2164.06 Quantity of Experimentation[R-08.2012]

The quantity of experimentation needed to beperformed by one skilled in the art is only one factorinvolved in determining whether “undueexperimentation” is required to make and use theinvention. “[A]n extended period of experimentationmay not be undue if the skilled artisan is givensufficient direction or guidance.” In re Colianni,561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA1977).“ ‘The test is not merely quantitative, since aconsiderable amount of experimentation ispermissible, if it is merely routine, or if thespecification in question provides a reasonableamount of guidance with respect to the direction inwhich the experimentation should proceed.’” In reWands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404(Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d489, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)).Time and expense are merely factors in thisconsideration and are not the controlling factors. United States v. Telectronics Inc., 857 F.2d 778,785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988), cert.denied, 490 U.S. 1046 (1989).

In the chemical arts, the guidance and ease incarrying out an assay to achieve the claimedobjectives may be an issue to be considered indetermining the quantity of experimentation needed.For example, if a very difficult and time consumingassay is needed to identify a compound within thescope of a claim, then this great quantity ofexperimentation should be considered in the overallanalysis. Time and difficulty of experiments are notdeterminative if they are merely routine. Quantityof examples is only one factor that must beconsidered before reaching the final conclusion that

undue experimentation would be required. In reWands, 858 F.2d at 737, 8 USPQ2d at 1404.

I. EXAMPLE OF REASONABLEEXPERIMENTATION

In United States v. Telectronics, Inc., 857 F.2d 778,8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied,490 U.S. 1046 (1989), the court reversed the findingsof the district court for lack of clear and convincingproof that undue experimentation was needed. Thecourt ruled that since one embodiment (stainlesssteel electrodes) and the method to determinedose/response was set forth in the specification, thespecification was enabling. The question of time andexpense of such studies, approximately $50,000 and6-12 months standing alone, failed to show undueexperimentation.

II. EXAMPLE OF UNREASONABLEEXPERIMENTATION

In In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ723, 727-28 (CCPA 1971), functional “blockdiagrams” were insufficient to enable a personskilled in the art to practice the claimed inventionwith only a reasonable degree of experimentationbecause the claimed invention required a“modification to prior art overlap computers,” andbecause “many of the components which appellantsillustrate as rectangles in their drawing necessarilyare themselves complex assemblages . . . . It iscommon knowledge that many months or yearselapse from the announcement of a new computerby a manufacturer before the first prototype isavailable. This does not bespeak of a routineoperation but of extensive experimentation anddevelopment work. . . .”

2164.06(a) Examples of EnablementIssues-Missing Information [R-08.2017]

It is common that doubt arises about enablementbecause information is missing about one or moreessential claim elements or relationships betweenelements which one skilled in the art could notdevelop without undue experimentation. In such acase, the examiner should specifically identify whatinformation is missing and why the missinginformation is needed to provide enablement.

2100-336Rev. 08.2017, January 2018


I. ELECTRICAL AND MECHANICAL DEVICESOR PROCESSES

Enablement serves the dual function of ensuringadequate disclosure of the claimed invention and ofpreventing claims broader than the disclosedinvention. Broad claim language is used at the perilof losing any claim that cannot be enabled across itsfull scope. For example, in MagSil Corp. v. HitachiGlobal Storage Technologies, Inc., 687 F.3d 1377,103 USPQ2d 1769 (Fed. Cir. 2012), the claim reciteda change in resistance by at least 10% at roomtemperature, but the specification contained noshowing that the knowledge of a person of ordinaryskill in the art at the time of filing would have beenable to achieve resistive changes in values thatgreatly exceed 10% without undue experimentation(noting that it took nearly 12 years ofexperimentation to achieve modern values above600%). Similarly in Auto. Techs. Int'l, Inc. v. BMWof N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d1108, 1115 (Fed. Cir. 2007), a claim limitationmeans responsive to the motion of a mass wasconstrued to include both mechanical and electronicside impact sensors for performing the function ofinitiating an occupant protection apparatus. Thespecification did not disclose any details or circuitryfor electronic side impact sensors, and thus, failedto apprise one of ordinary skill how to make and usethe electronic sensor.

A disclosure of an electrical circuit apparatus,depicted in the drawings by block diagrams withfunctional labels, was held to be nonenabling in Inre Gunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406(CCPA 1976), where there was no indication in thespecification as to whether the parts represented byboxes were “off the shelf” or must be specificallyconstructed or modified for applicant’s system. Alsothere were no details in the specification of how theparts should be interconnected, timed and controlledso as to obtain the specific operations desired by theapplicant. In In re Donohue, 550 F.2d 1269, 193USPQ 136 (CCPA 1977), the lack of enablementwas caused by lack of information in thespecification about a single block labeled “LOGIC”in the drawings. See also Union Pac. Res. Co. v.Chesapeake Energy Corp., 236 F.3d 684, 57USPQ2d 1293 (Fed. Cir. 2001) (Claims directed toa method of determining the location of a horizontal

borehole in the earth failed to comply withenablement requirement of 35 U.S.C. 112 becausecertain computer programming details used toperform claimed method were not disclosed in thespecification, and the record showed that a personof skill in art would not understand how to“compare” or “rescale” data as recited in the claimsin order to perform the claimed method.).

In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA1971), involved a method of facilitating transfersfrom one subset of program instructions to anotherwhich required modification of prior art “overlapmode” computers. The Board rejected the claims onthe basis that, inter alia, the disclosure wasinsufficient to satisfy the requirements of 35 U.S.C.112, first paragraph and was affirmed. The Boardfocused on the fact that the drawings were “blockdiagrams, i.e., a group of rectangles representing theelements of the system, functionally labeled andinterconnected by lines.” 442 F.2d at 991, 169 USPQat 727. The specification did not particularly identifyeach of the elements represented by the blocks orthe relationship therebetween, nor did it specifyparticular apparatus intended to carry out eachfunction. The Board further questioned whether theselection and assembly of the required componentscould be carried out routinely by persons of ordinaryskill in the art.

An adequate disclosure of a device may requiredetails of how complex components are constructedand perform the desired function. The claim beforethe court in In re Scarbrough, 500 F.2d 560, 182USPQ 298 (CCPA 1974), was directed to a systemwhich comprised several component parts (e.g.,computer, timing and control mechanism, A/Dconverter, etc.) only by generic name and overallultimate function. The court concluded that therewas not an enabling disclosure because thespecification did not describe how “complexelements known to perform broadly recited functionsin different systems would be adaptable for use inAppellant’s particular system with only a reasonableamount of experimentation” and that “anunreasonable amount of work would be required toarrive at the detailed relationships appellant says thathe has solved.” 500 F.2d at 566, 182 USPQ at 302.

Rev. 08.2017, January 20182100-337


II. MICROORGANISMS

Patent applications involving living biologicalproducts, such as microorganisms, as criticalelements in the process of making the invention,present a unique question with regard to availability.For example, in In re Argoudelis, 434 F.2d 1390,168 USPQ 99 (CCPA 1970), the court consideredthe enablement of claims drawn to a fermentativemethod of producing two novel antibiotics using aspecific microorganism and claims to the novelantibiotics so produced. As stated by the court, “aunique aspect of using microorganisms as startingmaterials is that a sufficient description of how toobtain the microorganism from nature cannot begiven.” 434 F.2d at 1392, 168 USPQ at 102. It wasdetermined by the court that availability of thebiological product via a public depository providedan acceptable means of meeting the writtendescription and the enablement requirements of 35U.S.C. 112, first paragraph.

To satisfy the enablement requirement a deposit mustbe made “prior to issue” but need not be made priorto filing the application. In re Lundak, 773 F.2d1216, 1223, 227 USPQ 90, 95 (Fed. Cir. 1985).

The availability requirement of enablement mustalso be considered in light of the scope or breadthof the claim limitations. The Board considered thisissue in an application which claimed a fermentativemethod using microorganisms belonging to a species.Applicants had identified three novel individualstrains of microorganisms that were related in sucha way as to establish a new species ofmicroorganism, a species being a broaderclassification than a strain. The three specific strainshad been appropriately deposited. The issue beforethe Board focused on whether the specificationenabled one skilled in the art to make any memberof the species other than the three strains which hadbeen deposited. The Board concluded that the verbaldescription of the species was inadequate to allowa skilled artisan to make any and all members of theclaimed species. Ex parte Jackson, 217 USPQ 804,806 (Bd. Pat. App. & Int. 1982).

See MPEP § 2402 - § 2411.03 for a detaileddiscussion of the deposit rules. See MPEP § 2411.01

for rejections under 35 U.S.C. 112 based on depositissues.

III. DRUG CASES

See MPEP § 2107 - § 2107.03 for a discussion ofthe utility requirement under 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, in drugcases.

2164.06(b) Examples of Enablement Issues— Chemical Cases [R-08.2012]

The following summaries should not be relied on tosupport a case of lack of enablement withoutcarefully reading the case.

I. SEVERAL DECISIONS RULING THAT THEDISCLOSURE WAS NONENABLING

(A) In Enzo Biochem, Inc. v. Calgene, Inc.,188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999),the court held that two patents with claims directedto genetic antisense technology (which aims tocontrol gene expression in a particular organism),were invalid because the breadth of enablement wasnot commensurate in scope with the claims. Bothspecifications disclosed applying antisensetechnology in regulating three E. coli genes. Despitethe limited disclosures, the specifications assertedthat the “[t]he practices of this invention aregenerally applicable with respect to any organismcontaining genetic material which is capable of beingexpressed … such as bacteria, yeast, and othercellular organisms.” Thus, the court construed theclaims to encompass the application of antisensemethodology in a broad range of organisms.Ultimately, the court relied on the fact that (1) theamount of direction presented and the number ofworking examples provided in the specification werevery narrow compared to the wide breadth of theclaims at issue, (2) antisense gene technology washighly unpredictable, and (3) the amount ofexperimentation required to adapt the practice ofcreating antisense DNA from E. coli to other typesof cells was quite high, especially in light of therecord, which included notable examples of theinventor’s own failures to control the expression ofother genes in E. coli and other types of cells.Thus, the teachings set forth in the specification

2100-338Rev. 08.2017, January 2018


provided no more than a “plan” or “invitation” forthose of skill in the art to experiment using thetechnology in other types of cells.

(B) In In re Wright, 999 F.2d 1557, 27 USPQ2d1510 (Fed. Cir. 1993), Wright's 1983 applicationdisclosed a vaccine against the RNA tumor virusknown as Prague Avian Sarcoma Virus, a memberof the Rous Associated Virus family. Wright claimeda vaccine “comprising an immunologically effectiveamount” of a viral expression product usingfunctional language. Id. at 1559, 27 USPQ2d at1511. The examiner rejected Wright's claimscovering all RNA viruses as well as all avian RNAviruses. The examiner provided a teaching that, in1988, a vaccine for another retrovirus (i.e., HIV)remained an intractable problem. This evidence,along with evidence that the RNA viruses were adiverse and complicated genus, convinced theFederal Circuit that the invention was not enabledfor either all retroviruses or even for avianretroviruses.

(C) In In re Goodman, 11 F.3d 1046, 29USPQ2d 2010 (Fed. Cir. 1993), Goodman's 1985application functionally claimed a method ofproducing protein in plant cells by expressing aforeign gene. The court stated that “[n]aturally, thespecification must teach those of skill in the art ‘howto make and use the invention as broadly as it isclaimed.’” Id. at 1050, 29 USPQ2d at 2013.Although protein expression in dicotyledonous plantcells was enabled, the claims covered proteinexpression in any plant cell. The examiner providedevidence that even as late as 1987, use of the claimedmethod in monocot plant cells was not enabled. Id.at 1051, 29 USPQ2d at 2014.

(D) In In re Vaeck, 947 F.2d 488, 495,20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the courtfound that several claims to a chimeric gene capableof being expressed in Cyanobacteria cells were notsupported by an enabling disclosure. The courtdetermined that claims at issue were not limited toany particular genus or species of cyanobacteria andthe specification mentioned nine genera and theworking examples employed one species ofcyanobacteria. The court then reasoned that theclaims were not enabled after “[t]aking into accountthe relatively incomplete understanding of thebiology of cyanobacteria as of appellants’ filing date,as well as the limited disclosure by appellants of the

particular cyanobacterial genera operative in theclaimed invention....”

(E) In In re Colianni, 561 F.2d 220, 222-23,195 USPQ 150, 152 (CCPA 1977), the courtaffirmed a rejection under 35 U.S.C. 112, firstparagraph, because the claims were directed to amethod of mending a fractured bone by applying“sufficient” ultrasonic energy to the bone, butapplicant’s specification did not define whatconstituted a “sufficient” dosage or teach one ofordinary skill how to select the appropriate intensity,frequency, or duration of the ultrasonic energy.

II. SEVERAL DECISIONS RULING THAT THEDISCLOSURE WAS ENABLING

(A) In PPG Indus. v. Guardian Indus., 75 F.3d1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir.1996), the court found PPG’s claims to aUV-absorbing, ceramide-free glass enabled, eventhough PPG’s specification included severalexamples in which faulty UV transmittance datamade it appear as though the production of a ceriumoxide-free glass satisfying the UV transmittancelimitation would be difficult, because thespecification indicated that such glass could be made.The specification was also found to indicate how tominimize the cerium content while maintaining lowUV transmittance.

(B) In In re Wands, 858 F.2d 731, 8 USPQ2d1400 (Fed. Cir. 1988), the court reversed therejection for lack of enablement under 35 U.S.C.112, first paragraph, concluding that undueexperimentation would not be required to practicethe claimed immunoassay using monoclonalantibodies to detect hepatitis B-surface antigen(HBsAg). The court found that the nature ofmonoclonal antibody technology was such thatexperiments first involve the entire attempt to makemonoclonal hybridomas to determine which onessecrete antibody with the desired characteristics. Thecourt found that the specification also providedconsiderable direction and guidance on how topractice the claimed invention and presented workingexamples, that all of the methods needed to practicethe invention were well known, and that there wasa high level of skill in the art at the time theapplication was filed. Furthermore, the applicantcarried out the entire procedure for making amonoclonal antibody against HBsAg three times and

Rev. 08.2017, January 20182100-339


each time was successful in producing at least oneantibody which fell within the scope of the claims.

(C) In In re Bundy, 642 F.2d 430, 434, 209USPQ 48, 51-52 (CCPA 1981), the court ruled thatappellant’s disclosure was sufficient to enable oneskilled in the art to use the claimed analogs ofnaturally occurring prostaglandins even though thespecification lacked any examples of specificdosages, because the specification taught that thenovel prostaglandins had certain pharmacologicalproperties and possessed activity similar to knownE-type prostaglandins.

2164.06(c) Examples of Enablement Issues– Computer Programming Cases [R-08.2017]

To establish a reasonable basis for questioning theadequacy of a disclosure, the examiner must presenta factual analysis of a disclosure to show that aperson skilled in the art would not be able to makeand use the claimed invention without resorting toundue experimentation.

In computer applications, it is not unusual for theclaimed invention to involve two areas of prior artor more than one technology, e.g., an appropriatelyprogrammed computer and an area of application ofsaid computer. White Consol. Indus. v. VegaServo-Control, Inc., 214 USPQ 796, 821 (S.D.Mich.1982). In regard to the “skilled in the art” standard,in cases involving both the art of computerprogramming, and another technology, the examinermust recognize that the knowledge of persons skilledin both technologies is the appropriate criteria fordetermining sufficiency. See In re Naquin, 398 F.2d863, 158 USPQ 317 (CCPA 1968); In re Brown,477 F.2d 946, 177 USPQ 691 (CCPA 1973); WhiteConsol. Indus., 214 USPQ at 822, aff’d on relatedgrounds, 713 F.2d 788, 218 USPQ 961 (Fed. Cir.1983).

In a typical computer application, systemcomponents are often represented in a “blockdiagram” format, i.e., a group of hollow rectanglesrepresenting the elements of the system, functionallylabeled, and interconnected by lines. Such blockdiagram computer cases may be categorized into (A)systems that include but are more comprehensivethan a computer and (B) systems wherein the blockelements are totally within the confines of a

computer. For instances where a computer inventionis claimed using functional language, that is notlimited to a specific structure, see MPEP § 2161.01.

I. BLOCK ELEMENTS MORE COMPREHENSIVETHAN A COMPUTER

The first category of such block diagram casesinvolves systems which include a computer as wellas other system hardware and/or softwarecomponents. In order to meet the burden ofestablishing a reasonable basis for questioning theadequacy of such disclosure, the examiner shouldinitiate a factual analysis of the system by focusingon each of the individual block element components.More specifically, such an inquiry should focus onthe diverse functions attributed to each block elementas well as the teachings in the specification as tohow such a component could be implemented. Ifbased on such an analysis, the examiner canreasonably contend that more than routineexperimentation would be required by one ofordinary skill in the art to implement such acomponent or components, then enablement of thecomponent or components should specifically bechallenged by the examiner as part of a 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,rejection. Additionally, the examiner shoulddetermine whether certain of the hardware orsoftware components depicted as block elements arethemselves complex assemblages which have widelydiffering characteristics and which must be preciselycoordinated with other complex assemblages. Undersuch circumstances, a reasonable basis may exist forchallenging such a functional block diagram formof disclosure. See In re Ghiron, 442 F.2d 985, 169USPQ 723 (CCPA 1971) and In re Brown, supra.Even if the applicant has cited prior art patents orpublications to demonstrate that particular blockdiagram hardware or software components are old,it should not always be considered as self-evidenthow such components are to be interconnected tofunction in a disclosed complex manner. See In reScarbrough, 500 F.2d 560, 566, 182 USPQ 298, 301(CCPA 1974) and In re Forman, 463 F.2d 1125,1129, 175 USPQ 12, 16 (CCPA 1972).

For example, where the specification provides in ablock diagram disclosure of a complex system thatincludes a microprocessor and other system

2100-340Rev. 08.2017, January 2018


components controlled by the microprocessor, amere reference to a commercially availablemicroprocessor, without any description of theprecise operations to be performed by themicroprocessor, fails to disclose how such amicroprocessor would be properly programmed to(1) either perform any required calculations or (2)coordinate the other system components in the propertimed sequence to perform the functions disclosedand claimed. If a particular program is disclosed insuch a system, the program should be carefullyreviewed to ensure that its scope is commensuratewith the scope of the functions attributed to such aprogram in the claims. In re Brown, 477 F.2d at951, 177 USPQ at 695. If (1) the disclosure fails todisclose any program and (2) more than routineexperimentation would be required of one skilled inthe art to generate such a program, the examinerclearly would have a reasonable basis for challengingthe sufficiency of such a disclosure. The amount ofexperimentation that is considered routine will varydepending on the facts and circumstances ofindividual cases and should be reviewed on acase-by-case basis. No exact numerical standard hasbeen fixed by the courts, but the “amount of requiredexperimentation must, however, be reasonable.” White Consol. Indus., 713 F.2d at 791, 218 USPQat 963. One court apparently found that the amountof experimentation involved was reasonable wherea skilled programmer was able to write a generalcomputer program, implementing an embodimentform, within four hours. Hirschfield v. Banner, 462F. Supp. 135, 142, 200 USPQ 276, 279 (D.D.C.1978), aff’d, 615 F.2d 1368 (D.C. Cir. 1986), cert. denied, 450 U.S. 994 (1981). Another courtfound that, where the required period ofexperimentation for skilled programmers to developa particular program would run to one to two manyears, this would be “a clearly unreasonablerequirement” (White Consol. Indus., 713 F.2d at791, 218 USPQ at 963).

II. BLOCK ELEMENTS WITHIN A COMPUTER

The second category of block diagram cases occursmost frequently in pure data processing applicationswhere the combination of block elements is totallywithin the confines of a computer, where there is nointerfacing with external apparatus other than normalinput/output devices. In some instances, it has been

found that particular kinds of block diagramdisclosures were sufficient to meet the enablingrequirement of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. See In re Knowlton,481 F.2d 1357, 178 USPQ 486 (CCPA 1973), In reComstock, 481 F.2d 905, 178 USPQ 616 (CCPA1973). The Comstock and Knowlton decisionsturned on the appellants’ disclosure of (1) a referenceto and reliance on an identified prior art computersystem, and (2) an operative computer program forthe referenced prior art computer system. In Knowlton, the disclosure was presented in such adetailed fashion that the individual program's stepswere specifically interrelated with the operativestructural elements in the referenced prior artcomputer system. The court in Knowlton indicatedthat the disclosure did not merely consist of a cursoryexplanation of flow diagrams or a bare group ofprogram listings together with a reference to aproprietary computer in which they might be run.The disclosure was characterized as going intoconsiderable detail in explaining theinterrelationships between the disclosed hardwareand software elements. Under such circumstances,the court considered the disclosure to be concise aswell as full, clear, and exact to a sufficient degreeto satisfy the literal language of 35 U.S.C. 112, firstparagraph. It must be emphasized that because ofthe significance of the program listing and thereference to and reliance on an identified prior artcomputer system, absent either of these items, ablock element disclosure within the confines of acomputer should be scrutinized in precisely the samemanner as the first category of block diagram casesdiscussed above.

Regardless of whether a disclosure involves blockelements more comprehensive than a computer orblock elements totally within the confines of acomputer, USPTO personnel, when analyzingmethod claims, must recognize that the specificationmust be adequate to teach how to practice theclaimed method. If such practice requires a particularapparatus, then the application must provide asufficient disclosure of that apparatus if such is notalready available. See In re Ghiron, 442 F.2d 985,991, 169 USPQ 723, 727 (CCPA 1971) and In reGunn, 537 F.2d 1123, 1128, 190 USPQ 402, 406(CCPA 1976). When USPTO personnel questionthe adequacy of computer system or computer

Rev. 08.2017, January 20182100-341


programming disclosures, the reasons for findingthe specification to be nonenabling should besupported by the record as a whole. In this regard,it is also essential for USPTO personnel toreasonably challenge evidence submitted by theapplicant. For example, in In re Naquin, supra, anaffiant’s statement that the average computerprogrammer was familiar with the subroutinenecessary for performing the claimed process, washeld to be a statement of fact as it was unchallengedby USPTO personnel. In other words, unless USPTOpersonnel present a reasonable basis for challengingthe disclosure in view of the record as a whole, a 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, rejection in a computer system orcomputer programming application may not besustained on appeal. See In re Naquin, supra, and In re Morehouse, 545 F.2d 162, 165-66, 192 USPQ29, 32 (CCPA 1976).

While no specific universally applicable rule existsfor recognizing an insufficiently disclosedapplication involving computer programs, anexamining guideline to generally follow is tochallenge the sufficiency of disclosures that fail toinclude the programmed steps, algorithms orprocedures that the computer performs necessary toproduce the claimed function. These can bedescribed in any way that would be understood byone of ordinary skill in the art, such as with areasonably detailed flowchart which delineates thesequence of operations the program must perform.In programming applications where the softwaredisclosure only includes a flowchart, as thecomplexity of functions and the generality of theindividual components of the flowchart increase, thebasis for challenging the sufficiency of such aflowchart becomes more reasonable because thelikelihood of more than routine experimentationbeing required to generate a working program fromsuch a flowchart also increases.

As stated earlier, once USPTO personnel haveadvanced a reasonable basis or presented evidenceto question the adequacy of a computer system orcomputer programming disclosure, the applicantmust show that the specification would enable oneof ordinary skill in the art to make and use theclaimed invention without resorting to undueexperimentation. In most cases, efforts to meet this

burden involve submitting affidavits, referencingprior art patents or technical publications, presentingarguments of counsel, or combinations of theseapproaches.

III. AFFIDAVIT PRACTICE (37 CFR 1.132)

In computer cases, affidavits must be criticallyanalyzed. Affidavit practice at the outset usuallyinvolves analyzing the skill level and/orqualifications of the affiant, which should be of theperson of ordinary skill in the art. When an affiant’sskill level is higher than that required by the personof ordinary skill in the art for a particular application,an examiner may challenge the affidavit asinsufficient should the affiant not submit evidencedemonstrating the amount of experimentationrequired by a person of ordinary skill in the art toimplement the invention. An affiant having a skilllevel or qualifications above that of the person ofordinary skill in the art would require lessexperimentation to implement the claimed inventionthan that for the person of ordinary skill. Similarly,an affiant having a skill level or qualifications belowthat of the person of ordinary skill in the art wouldrequire more experimentation to implement theclaimed invention than that for the person of ordinaryskill in the art. In either situation, the standard of theperson of ordinary skill in the art would not havebeen met.

In computer systems or programming cases, theproblems with a given affidavit, which relate to thesufficiency of disclosure issue, generally involveaffiants submitting few facts to support theirconclusions or opinions. Some affidavits may go sofar as to present conclusions on the ultimate legalquestion of sufficiency. In re Brandstadter, 484F.2d 1395, 179 USPQ 286 (CCPA 1973), illustratesthe extent of the inquiry into the factual basisunderlying an affiant’s conclusions or opinions. In Brandstadter, the invention concerned a storedprogram controller (computer) programmed tocontrol the storing, retrieving, and forwarding ofmessages in a communications system. Thedisclosure consisted of broadly defined blockdiagrams of the structure of the invention and noflowcharts or program listings of the programs ofthe controller. The court quoted extensively fromthe examiner’s Office actions and examiner’s answer

2100-342Rev. 08.2017, January 2018


in its opinion where it was apparent that the examinerconsistently argued that the disclosure was merelya broad system diagram in the form of labeled blockdiagrams along with statements of a myriad ofdesired results. Various affidavits were presented inwhich the affiants stated that all or some of thesystem circuit elements in the block diagrams wereeither well-known in the art or “could beconstructed” by the skilled design engineer, that thecontroller was “capable of being programmed” toperform the stated functions or results desired, andthat the person having ordinary skill in the art “coulddesign or construct or was able to program” thesystem. The court did consider the affiants’statements as being some evidence on the ultimatelegal question of enablement but concluded that thestatements failed in their purpose since they recitedconclusions or opinions with few facts to support orbuttress these conclusions. With reference to the lackof a disclosed computer program or even a flowchartof the program to control the message switchingsystem, the record contained no evidence as to thenumber of programmers needed, the number ofman-hours and the level of skill of the programmersto produce the program required to practice theinvention.

Factual evidence directed to the amount of time andeffort and level of knowledge required for thepractice of the invention from the disclosure, andknowledge in the art can be expected to rebut a prima facie case of nonenablement, but not opinionevidence directed to the ultimate legal question ofenablement. See Hirschfield, 462 F. Supp. at 143,200 USPQ at 281. Where an affidavit shows that aninventor described the problem to be solved to anaffiant, which then enabled the affiant to generate acomputer program to solve the problem, such anaffidavit will fail to demonstrate that the applicationalone would have taught a person of ordinary skillin the art how to make and use the claimed invention.See In re Brown, 477 F.2d at 951, 177 USPQ at695. In Brown, the court indicated that it had notbeen factually established that the applicant had notconveyed to the affiant vital and additionalinformation in their several meetings in addition tothat set out in the application. For an affidavit to berelevant to the determination of enablement, it mustbe probative of the level of skill of the person ofordinary skill in the art as of the time the applicant

filed his application. See In re Gunn, 537 F.2d 1123,1128, 190 USPQ 402, 406 (CCPA 1976). In thatcase, each of the affiants stated what was known atthe time the affiant executed the affidavit, and notwhat was known at the time the applicant filed hisapplication.

IV. REFERENCING PRIOR ART DOCUMENTS

The commercial availability of an identified priorart computer system is very pertinent to the issue ofenablement. But in some cases, this approach maynot be sufficient to meet the applicant’s burden.Merely citing excerpts from technical publicationsin an affidavit in order to satisfy the enablementrequirement is not sufficient if it is not made clearthat a person skilled in the art would know which,or what parts, of the cited circuits could be used toconstruct the claimed device or how they could beinterconnected to act in combination to produce therequired results. See In re Forman, 463 F.2d 1125,1129, 175 USPQ 12, 16 (CCPA 1972). This analysiswould appear to be less critical where the circuitscomprising applicant’s system are essentiallystandard components of an identified prior artcomputer system and a standard device attachedthereto.

Prior art patents and patent application publicationsare often relied on by applicants to show the stateof the art for purposes of enablement. However,these documents must have a publication date earlierthan the effective filing date of the application underconsideration. See In re Budnick, 537 F.2d 535,538, 190 USPQ 422, 424 (CCPA 1976). Ananalogous point was made in In re Gunn, supra,where the court indicated that patents issued afterthe filing date of the application under examinationare not evidence of subject matter known to anyperson skilled in the art since their subject mattermay have been known only to the patentees and thePatent and Trademark Office.

Merely citing prior art patents to demonstrate thatthe challenged components are old may not besufficient proof since, even if each of the enumerateddevices or labeled blocks in a block diagramdisclosure were old, per se, this would not make itself-evident how each would be interconnected tofunction in a disclosed complex combination manner.

Rev. 08.2017, January 20182100-343


Therefore, the specification in effect must set forththe integration of the prior art; otherwise, it is likelythat undue experimentation, or more than routineexperimentation would be required to implement theclaimed invention. See In re Scarbrough, 500 F.2d560, 565, 182 USPQ 298, 301 (CCPA 1974). Thecourt also noted that any cited patents which are usedby the applicant to demonstrate that particular boxdiagram hardware or software components are oldmust be analyzed as to whether such patents aregermane to the instant invention and as to whethersuch patents provide better detail of disclosure as tosuch components than an applicant’s own disclosure.Also, any patent or publication cited to provideevidence that a particular programming techniqueis well-known in the programming art does notdemonstrate that one of ordinary skill in the art couldmake and use correspondingly disclosedprogramming techniques unless both the known anddisclosed programming techniques are ofapproximately the same degree of complexity. See In re Knowlton, 500 F.2d 566, 572, 183 USPQ 33,37 (CCPA 1974).

V. ARGUMENTS OF COUNSEL

Arguments of counsel may be effective inestablishing that an examiner has not properly metthe burden or has otherwise erred in the examiner'sposition. However, it must be emphasized thatarguments of counsel alone cannot take the place ofevidence in the record once an examiner hasadvanced a reasonable basis for questioning thedisclosure. See In re Budnick, 537 F.2d at 538,190 USPQ at 424; In re Schulze, 346 F.2d 600, 145USPQ 716 (CCPA 1965); In re Cole, 326 F.2d 769,140 USPQ 230 (CCPA 1964). For example, in a casewhere the record consisted substantially ofarguments and opinions of applicant’s attorney, thecourt indicated that factual affidavits could haveprovided important evidence on the issue ofenablement. See In re Knowlton, 500 F.2d at 572,183 USPQ at 37; In re Wiseman, 596 F.2d 1019,201 USPQ 658 (CCPA 1979).

2164.07 Relationship of EnablementRequirement to Utility Requirement of 35U.S.C. 101 [R-11.2013]

The requirement of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph as to how to use theinvention is different from the utility requirement of35 U.S.C. 101. The requirement of 35 U.S.C. 101 isthat some specific, substantial, and credible use beset forth for the invention. On the other hand, 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph requires an indication of how the use(required by 35 U.S.C. 101) can be carried out, i.e.,how the invention can be used.

If an applicant has disclosed a specific andsubstantial utility for an invention and provided acredible basis supporting that utility, that fact alonedoes not provide a basis for concluding that theclaims comply with all the requirements of 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph.For example, if an applicant has claimed a processof treating a certain disease condition with a certaincompound and provided a credible basis for assertingthat the compound is useful in that regard, but toactually practice the invention as claimed a personskilled in the relevant art would have to engage inan undue amount of experimentation, the claim maybe defective under 35 U.S.C. 112, but not 35 U.S.C.101. To avoid confusion during examination, anyrejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, based on grounds otherthan “lack of utility” should be imposed separatelyfrom any rejection imposed due to “lack of utility”under 35 U.S.C. 101 and 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph.

I. WHEN UTILITY REQUIREMENT IS NOTSATISFIED

A. Not Useful or Operative

If a claim fails to meet the utility requirement of35 U.S.C. 101 because it is shown to be nonusefulor inoperative, then it necessarily fails to meet thehow-to-use aspect of the enablement requirement of35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph. As noted in In re Fouche, 439 F.2d 1237,169 USPQ 429 (CCPA 1971), if “compositions arein fact useless, appellant’s specification cannot have

2100-344Rev. 08.2017, January 2018


taught how to use them.” 439 F.2d at 1243, 169USPQ at 434. The examiner should make bothrejections (i.e., a rejection under 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph and arejection under 35 U.S.C. 101) where the subjectmatter of a claim has been shown to be nonusefulor inoperative.

The 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112,first paragraph, rejection should indicate that becausethe invention as claimed does not have utility, aperson skilled in the art would not be able to use theinvention as claimed, and as such, the claim isdefective under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. A 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, rejectionshould not be imposed or maintained unless anappropriate basis exists for imposing a rejectionunder 35 U.S.C. 101. In other words, Officepersonnel should not impose a 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph, rejectiongrounded on a “lack of utility” basis unless a 35U.S.C. 101 rejection is proper. In particular, thefactual showing needed to impose a rejection under35 U.S.C. 101 must be provided if a 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,rejection is to be imposed on “lack of utility”grounds. See MPEP § 2107 - § 2107.03 for a moredetailed discussion of the utility requirements of 35U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 112,first paragraph.

B. Burden on the Examiner

When the examiner concludes that an applicationclaims an invention that is nonuseful, inoperative,or contradicts known scientific principles, the burdenis on the examiner to provide a reasonable basis tosupport this conclusion. Rejections based on 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, and 35 U.S.C. 101 should be made.

Examiner Has Initial Burden To Show That One ofOrdinary Skill in the Art Would Reasonably Doubtthe Asserted Utility

The examiner has the initial burden of challengingan asserted utility. Only after the examiner hasprovided evidence showing that one of ordinary skillin the art would reasonably doubt the asserted utility

does the burden shift to the applicant to providerebuttal evidence sufficient to convince one ofordinary skill in the art of the invention’s assertedutility. In re Fisher, 421 F.3d 1365, 76 USPQ2d1225 (Fed. Cir. 2005); In re Swartz, 232 F.3d 862,863, 56 USPQ2d 1703, 1704 (Fed. Cir. 2000); Inre Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436,1441 (Fed. Cir. 1995) (citing In re Bundy, 642 F.2d430, 433, 209 USPQ 48, 51 (CCPA 1981)).

C. Rebuttal by Applicant

If a rejection under 35 U.S.C. 101 has been properlyimposed, along with a corresponding rejection under35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, the burden shifts to the applicant to rebutthe prima facie showing. In re Oetiker, 977 F.2d1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir.1992). There is no predetermined amount orcharacter of evidence that must be provided by anapplicant to support an asserted utility. Rather, thecharacter and amount of evidence needed to supportan asserted utility will vary depending on what isclaimed (Ex parte Ferguson, 117 USPQ 229, 231(Bd. App. 1957)), and whether the asserted utilityappears to contravene established scientificprinciples and beliefs. In re Gazave, 379 F.2d 973,978, 154 USPQ 92, 96 (CCPA 1967 ); In reChilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325(CCPA 1956). Furthermore, the applicant does nothave to provide evidence sufficient to establish thatan asserted utility is true “beyond a reasonabledoubt.” In re Irons, 340 F.2d 974, 978, 144 USPQ351, 354 (CCPA 1965). Instead, evidence will besufficient if, considered as a whole, it leads a personof ordinary skill in the art to conclude that theasserted utility is more likely than not true. SeeMPEP § 2107.02 for a more detailed discussion ofconsideration of a reply to a prima facie rejectionfor lack of utility and evaluation of evidence relatedto utility.

II. WHEN UTILITY REQUIREMENT ISSATISFIED

In some instances, the utility of the claimed inventionwill be provided, but the skilled artisan will not knowhow to effect that use. In such a case, no rejectionwill be made under 35 U.S.C. 101, but a rejectionwill be made under 35 U.S.C. 112(a) or pre-AIA 35

Rev. 08.2017, January 20182100-345


U.S.C. 112, first paragraph. As pointed out in Mowry v. Whitney, 81 U.S. (14 Wall.) 620 (1871),an invention may in fact have great utility, i.e., maybe “a highly useful invention,” but the specificationmay still fail to “enable any person skilled in the artor science” to use the invention. 81 U.S. (14 Wall.)at 644.

2164.08 Enablement Commensurate in ScopeWith the Claims [R-11.2013]

All questions of enablement are evaluated againstthe claimed subject matter. The focus of theexamination inquiry is whether everything withinthe scope of the claim is enabled. Accordingly, thefirst analytical step requires that the examinerdetermine exactly what subject matter isencompassed by the claims. See, e.g., AK SteelCorp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d1280, 1287 (Fed. Cir. 2003) (When a range isclaimed, there must be reasonable enablement of thescope of the range. Here, the claims at issueencompassed amounts of silicon as high as 10% byweight, however the specification includedstatements clearly and strongly warning that a siliconcontent above 0.5% by weight in an aluminumcoating causes coating problems. Such statementsindicate that higher amounts will not work in theclaimed invention.). The examiner should determinewhat each claim recites and what the subject matteris when the claim is considered as a whole, not whenits parts are analyzed individually. No claim shouldbe overlooked. With respect to dependent claims,35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourthparagraph, should be followed. These paragraphsstate “a claim in a dependent form shall be construedto incorporate by reference all the limitations of theclaim to which it refers” and requires the dependentclaim to further limit the subject matter claimed.

The Federal Circuit has repeatedly held that “thespecification must teach those skilled in the art howto make and use the full scope of the claimedinvention without ‘undue experimentation’.” In reWright, 999 F.2d 1557, 1561, 27 USPQ2d 1510,1513 (Fed. Cir. 1993). Nevertheless, not everythingnecessary to practice the invention need be disclosed.In fact, what is well-known is best omitted. In reBuchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332(Fed. Cir. 1991). All that is necessary is that one

skilled in the art be able to practice the claimedinvention, given the level of knowledge and skill inthe art. Further the scope of enablement must onlybear a “reasonable correlation” to the scope of theclaims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970).

With respect to the breadth of a claim, the relevantconcern is whether the scope of enablement providedto one skilled in the art by the disclosure iscommensurate with the scope of protection soughtby the claims. AK Steel Corp. v. Sollac, 344 F.3d1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir.2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ236, 239 (CCPA 1971). See also Plant Genetic Sys.,N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339,65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged“pioneer status” of invention irrelevant toenablement determination).

The propriety of a rejection based upon the scope ofa claim relative to the scope of the enablementconcerns (1) how broad the claim is with respect tothe disclosure and (2) whether one skilled in the artcould make and use the entire scope of the claimedinvention without undue experimentation.

An enabling disclosure may be set forth by specificexample or broad terminology; the exact form ofdisclosure is not dispositive. In re Marzocchi, 439F.2d 220, 223-24 169 USPQ 367, 370 (CCPA 1971).A rejection of a claim under 35 U.S.C. 112 asbroader than the enabling disclosure is a 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,enablement rejection and not a 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph,definiteness rejection. Claims are not rejected asbroader than the enabling disclosure under 35 U.S.C.112 for noninclusion of limitations dealing withfactors which must be presumed to be within thelevel of ordinary skill in the art; the claims need notrecite such factors where one of ordinary skill in theart to whom the specification and claims are directedwould consider them obvious. In re Skrivan, 427F.2d 801, 806, 166 USPQ 85, 88 (CCPA 1970). Onedoes not look to the claims but to the specificationto find out how to practice the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d1540, 1558, 220 USPQ 303, 316-17 (Fed. Cir. 1983); In re Johnson, 558 F.2d 1008, 1017, 194 USPQ

2100-346Rev. 08.2017, January 2018


187, 195 (CCPA 1977). In In re Goffe, 542 F.2d564, 567, 191 USPQ 429, 431 (CCPA 1976), thecourt stated:

[T]o provide effective incentives, claims mustadequately protect inventors. To demand thatthe first to disclose shall limit his claims towhat he has found will work or to materialswhich meet the guidelines specified for“preferred” materials in a process such as theone herein involved would not serve theconstitutional purpose of promoting progressin the useful arts.

When analyzing the enabled scope of a claim, theteachings of the specification must not be ignoredbecause claims are to be given their broadestreasonable interpretation that is consistent with thespecification. “That claims are interpreted in lightof the specification does not mean that everythingin the specification must be read into the claims.” Raytheon Co. v. Roper Corp., 724 F.2d 951, 957,220 USPQ 592, 597 (Fed. Cir. 1983), cert. denied,469 U.S. 835 (1984).

The record must be clear so that the public will havenotice as to the patentee’s scope of protection whenthe patent issues. If a reasonable interpretation ofthe claim is broader than the description in thespecification, it is necessary for the examiner tomake sure the full scope of the claim is enabled.Limitations and examples in the specification do notgenerally limit what is covered by the claims.

The breadth of the claims was a factor consideredin Amgen v. Chugai Pharm. Co., 927 F.2d 1200, 18USPQ2d 1016 (Fed. Cir. 1991), cert. denied,502 U.S. 856 (1991). In Amgen, the patent claimswere directed to a purified DNA sequence encodingpolypeptide analogs of the protein erythropoietin(EPO). The court stated that:

Amgen has not enabled preparation of DNAsequences sufficient to support itsall-encompassing claims. . . . [D]espiteextensive statements in the specificationconcerning all the analogs of the EPO gene thatcan be made, there is little enabling disclosureof particular analogs and how to make them.

Details for preparing only a few EPO analoggenes are disclosed. . . . This disclosure mightwell justify a generic claim encompassing theseand similar analogs, but it represents inadequatesupport for Amgen’s desire to claim all EPOgene analogs. There may be many other geneticsequences that code for EPO-type products.Amgen has told how to make and use only afew of them and is therefore not entitled toclaim all of them.

927 F.2d at 1213-14, 18 USPQ2d at 1027. However,when claims are directed to any purified and isolatedDNA sequence encoding a specifically namedprotein where the protein has a specifically identifiedsequence, a rejection of the claims as broader thanthe enabling disclosure is generally not appropriatebecause one skilled in the art could readily determineany one of the claimed embodiments.

See also In re Wright, 999 F.2d 1557, 1562,27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (Theevidence did not show that a skilled artisan wouldhave been able to carry out the steps required topractice the full scope of claims which encompass“any and all live, non-pathogenic vaccines, andprocesses for making such vaccines, which elicitimmunoprotective activity in any animal toward anyRNA virus.” (original emphasis)); In re Goodman,11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015 (Fed.Cir. 1993) (The specification did not enable thebroad scope of the claims for producing mammalianpeptides in plant cells because the specificationcontained only an example of producinggamma-interferon in a dicot species, and there wasevidence that extensive experimentation would havebeen required for encoding mammalian peptide intoa monocot plant at the time of filing); In re Fisher,427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970)(Where applicant claimed a composition suitable forthe treatment of arthritis having a potency of “atleast” a particular value, the court held that the claimwas not commensurate in scope with the enablingdisclosure because the disclosure was not enablingfor compositions having a slightly higher potency.Simply because applicant was the first to achieve acomposition beyond a particular threshold potencydid not justify or support a claim that woulddominate every composition that exceeded thatthreshold value.); In re Vaeck, 947 F.2d 488, 495,

Rev. 08.2017, January 20182100-347


20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (Given therelatively incomplete understanding in thebiotechnological field involved, and the lack of areasonable correlation between the narrow disclosurein the specification and the broad scope of protectionsought in the claims, a rejection under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraphfor lack of enablement was appropriate.).

If a rejection is made based on the view that theenablement is not commensurate in scope with theclaim, the examiner should identify the subjectmatter that is considered to be enabled.

2164.08(a) Single Means Claim [R-11.2013]

A single means claim, i.e., where a means recitationdoes not appear in combination with another recitedelement of means, is subject to an enablementrejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983)(A single means claim which covered everyconceivable means for achieving the stated purposewas held nonenabling for the scope of the claimbecause the specification disclosed at most onlythose means known to the inventor.). When claimsdepend on a recited property, a fact situationcomparable to Hyatt is possible, where the claimcovers every conceivable structure (means) forachieving the stated property (result) while thespecification discloses at most only those known tothe inventor.

2164.08(b) Inoperative Subject Matter[R-08.2012]

The presence of inoperative embodiments within thescope of a claim does not necessarily render a claimnonenabled. The standard is whether a skilled personcould determine which embodiments that wereconceived, but not yet made, would be inoperativeor operative with expenditure of no more effort thanis normally required in the art. Atlas Powder Co. v.E.I. du Pont de Nemours & Co., 750 F.2d 1569,1577, 224 USPQ 409, 414 (Fed. Cir. 1984)(prophetic examples do not make the disclosurenonenabling).

Although, typically, inoperative embodiments areexcluded by language in a claim (e.g., preamble),the scope of the claim may still not be enabled whereundue experimentation is involved in determiningthose embodiments that are operable. A disclosureof a large number of operable embodiments and theidentification of a single inoperative embodimentdid not render a claim broader than the enabled scopebecause undue experimentation was not involved indetermining those embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ214, 218 (CCPA 1976). However, claims readingon significant numbers of inoperative embodimentswould render claims nonenabled when thespecification does not clearly identify the operativeembodiments and undue experimentation is involvedin determining those that are operative. AtlasPowder Co. v. E.I. duPont de Nemours & Co., 750F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir.1984); In re Cook, 439 F.2d 730, 735, 169 USPQ298, 302 (CCPA 1971).

2164.08(c) Critical Feature Not Claimed[R-08.2012]

A feature which is taught as critical in a specificationand is not recited in the claims should result in arejection of such claim under the enablementprovision section of 35 U.S.C. 112. See Inre Mayhew, 527 F.2d 1229, 1233, 188 USPQ 356,358 (CCPA 1976). In determining whether anunclaimed feature is critical, the entire disclosuremust be considered. Features which are merelypreferred are not to be considered critical. Inre Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431(CCPA 1976).

Limiting an applicant to the preferred materials inthe absence of limiting prior art would not serve theconstitutional purpose of promoting the progress inthe useful arts. Therefore, an enablement rejectionbased on the grounds that a disclosed criticallimitation is missing from a claim should be madeonly when the language of the specification makesit clear that the limitation is critical for the inventionto function as intended. Broad language in thedisclosure, including the abstract, omitting anallegedly critical feature, tends to rebut the argumentof criticality.

2100-348Rev. 08.2017, January 2018


2165 The Best Mode Requirement[R-08.2017]

I. REQUIREMENT FOR A DISCLOSURE OF THEBEST MODE

A third requirement of 35 U.S.C. 112(a) (applicableto applications filed on or after September 16, 2012)is that:

The specification. . . shall set forth the bestmode contemplated by the inventor or jointinventor of carrying out the invention.

The third requirement of the first paragraph ofpre-AIA 35 U.S.C. 112 (applicable to applicationsfiled before September 16, 2012) is that:

The specification. . . shall set forth the bestmode contemplated by the inventor of carryingout his invention.

The best mode requirement is a safeguard againstthe desire on the part of some people to obtain patentprotection without making a full disclosure asrequired by the statute. The requirement does notpermit inventors to disclose only what they know tobe their second-best embodiment, while retainingthe best for themselves. In re Nelson, 280 F.2d 172,126 USPQ 242 (CCPA 1960).

Determining compliance with the best moderequirement requires a two-prong inquiry. First, itmust be determined whether, at the time theapplication was filed, the inventor possessed a bestmode for practicing the invention. This is asubjective inquiry which focuses on the inventor’sstate of mind at the time of filing. Second, if theinventor did possess a best mode, it must bedetermined whether the written description disclosedthe best mode such that a person skilled in the artcould practice it. This is an objective inquiry,focusing on the scope of the claimed invention andthe level of skill in the art. Eli Lilly & Co. v. BarrLabs. Inc., 251 F.3d 955, 963, 58 USPQ2d 1865,1874 (Fed. Cir. 2001). All applicants are requiredto disclose for the claimed subject matter the bestmode contemplated by the inventor even if theinventor was not the discoverer of that mode.

Benger Labs. Ltd. v. R.K. Laros Co., 209 F. Supp.639, 135 USPQ 11 (E.D. Pa. 1962).

Failure to disclose the best mode need not rise to thelevel of active concealment or inequitable conductin order to support a rejection. Where an inventorknows of a specific material or method that willmake possible the successful reproduction of theclaimed invention, but does not disclose it, the bestmode requirement has not been satisfied. UnionCarbide Corp. v. Borg-Warner, 550 F.2d 355, 193USPQ 1 (6th Cir. 1977).

II. IMPACT OF FAILURE TO DISCLOSE THEBEST MODE PURSUANT TO THE AIA

Section 15 of the Leahy-Smith America Invents Act(AIA), Public Law 112-29, 125 Stat. 284 (September16, 2011), did not eliminate the requirement inpre-AIA 35 U.S.C. 112, first paragraph, for adisclosure of the best mode, (see 35 U.S.C. 112(a))but effective September 16, 2011, it amended 35U.S.C. 282 (the provision that sets forth defenses ina patent validity or infringement proceeding) toprovide that the failure to disclose the best modeshall not be a basis on which any claim of a patentmay be canceled or held invalid or otherwiseunenforceable. As this change is applicable only inpatent validity or infringement proceedings, it doesnot alter current patent examining practices as setforth above for evaluation of an application forcompliance with the best mode requirement of 35U.S.C. 112 .

Prior to September 16, 2011, for an inventionclaimed in a later-filed application to receive thebenefit of the filing date of an earlier-filedapplication, 35 U.S.C. 119(e) and 120 required thatthe invention claimed in the later-filed applicationbe disclosed in the earlier-filed application in themanner provided by pre-AIA 35 U.S.C. 112, firstparagraph. Section 15 of the Leahy-Smith AmericaInvents Act also amended 35 U.S.C. 119(e) and 120to modify this requirement such that the disclosurein the earlier filed application must be made in themanner provided by pre-AIA 35 U.S.C. 112, firstparagraph, "other than the requirement to disclosethe best mode." This change should not noticeablyimpact patent examining procedure. MPEP § 201.08provides that there is no need to determine whether

Rev. 08.2017, January 20182100-349


the earlier-filed application contains a disclosure ofthe invention claimed in the later filed applicationin compliance with pre-AIA 35 U.S.C. 112, firstparagraph, unless the filing date of the earlier-filedapplication is actually necessary (e.g., to overcomea reference). Examiners should consult with theirsupervisors if it appears that an earlier-filedapplication does not disclose the best mode forcarrying out a claimed invention and the filing dateof the earlier-filed application is actually necessary.35 U.S.C. 119(e) and 120 were further amendedeffective for applications filed on or after September16, 2012 to refer to 35 U.S.C. 112(a) rather thanpre-AIA 35 U.S.C. 112, first paragraph.

2165.01 Considerations Relevant to BestMode [R-11.2013]

I. DETERMINE WHAT IS THE INVENTION

Determine what the invention is — the invention isdefined in the claims. The specification need not setforth details not relating to the essence of theinvention. In re Bosy, 360 F.2d 972, 149 USPQ 789(CCPA 1966). See also Northern Telecom Ltd. v.Samsung Elec. Co., 215 F.3d 1281, 55 USPQ2d 1065(Fed. Cir. 2000) (Unclaimed matter that is unrelatedto the operation of the claimed invention does nottrigger the best mode requirement); Eli Lilly & Co.v. Barr Lab. Inc., 251 F.3d 955, 966, 58 USPQ2d1865, 1877 (Fed. Cir. 2001) (“[P]atentee’s failureto disclose an unclaimed preferred mode foraccomplishing a routine detail does not violate thebest mode requirement because one skilled in theart is aware of alternative means for accomplishingthe routine detail that would still produce the bestmode of the claimed invention.”).

II. SPECIFIC EXAMPLE IS NOT REQUIRED

There is no statutory requirement for the disclosureof a specific example — a patent specification is notintended nor required to be a productionspecification. In re Gay, 309 F.2d 768, 135 USPQ311 (CCPA 1962).

The absence of a specific working example is notnecessarily evidence that the best mode has not beendisclosed, nor is the presence of one evidence thatit has. Best mode may be represented by a preferred

range of conditions or group of reactants. In reHonn, 364 F.2d 454, 150 USPQ 652 (CCPA 1966).

III. DESIGNATION AS BEST MODE IS NOTREQUIRED

There is no requirement in the statute that applicantspoint out which of their embodiments they considerto be their best; that the disclosure includes the bestmode contemplated by applicants is enough to satisfythe statute. Ernsthausen v. Nakayama, 1 USPQ2d1539 (Bd. Pat. App. & Inter. 1985).

IV. UPDATING BEST MODE IS NOT REQUIRED

There is no requirement to update in the context ofa foreign priority application under 35 U.S.C. 119, Standard Oil Co. v. Montedison, S.p.A., 494 F.Supp.370, 206 USPQ 676 (D.Del. 1980) (better catalystdeveloped between Italian priority and U.S. filingdates). Furthermore, it is not necessary to update thebest mode in applications claiming the benefit of anearlier filing date under 35 U.S.C. 119(e) or 120,which indicate that the disclosure in the earlier filedapplication must be made in the manner providedby 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, "other than the requirement to disclosethe best mode." See MPEP § 2165, subsection II.

V. DEFECT IN BEST MODE CANNOT BE CUREDBY NEW MATTER

If the best mode contemplated by the inventor at thetime of filing the application is not disclosed, sucha defect cannot be cured by submitting anamendment seeking to put into the specificationsomething required to be there when the patentapplication was originally filed. In re Hay, 534 F.2d917, 189 USPQ 790 (CCPA 1976).

Any proposed amendment of this type (adding aspecific mode of practicing the invention notdescribed in the application as filed) should betreated as new matter. New matter under 35 U.S.C.132 and 251 should be objected to and coupled witha requirement to cancel the new matter.

2100-350Rev. 08.2017, January 2018


2165.02 Best Mode Requirement Comparedto Enablement Requirement [R-11.2013]

The best mode requirement is a separate and distinctrequirement from the enablement requirement of 35U.S.C. 112(a) or the first paragraph of pre-AIA 35U.S.C. 112. In re Newton, 414 F.2d 1400, 163USPQ 34 (CCPA 1969).

The best mode provision of 35 U.S.C. 112 is notdirected to a situation where the application fails toset forth any mode — such failure is equivalent tononenablement. In re Glass, 492 F.2d 1228,181 USPQ 31 (CCPA 1974).

The enablement requirement looks to placing thesubject matter of the claims generally in thepossession of the public. If, however, the applicantdevelops specific instrumentalities or techniqueswhich are recognized by the applicant at the time offiling as the best way of carrying out the invention,then the best mode requirement imposes anobligation to disclose that information to the publicas well. Spectra-Physics, Inc. v. Coherent, Inc., 827F.2d 1524, 3 USPQ 2d 1737 (Fed. Cir.), cert.denied, 484 U.S. 954 (1987).

2165.03 Requirements for Rejection for Lackof Best Mode [R-11.2013]

I. ASSUME BEST MODE IS DISCLOSED UNLESSTHERE IS EVIDENCE TO THE CONTRARY

The examiner should assume that the best mode isdisclosed in the application, unless evidence ispresented that is inconsistent with that assumption.It is extremely rare that a best mode rejectionproperly would be made in ex parte prosecution.The information that is necessary to form the basisfor a rejection based on the failure to set forth thebest mode is rarely accessible to the examiner, butis generally uncovered during inter partesproceedings.

II. EXAMINER MUST DETERMINE WHETHERTHE INVENTOR KNEW THAT ONE MODE WASBETTER THAN ANOTHER, AND IF SO,WHETHER THE DISCLOSURE IS ADEQUATE TO

ENABLE ONE OF ORDINARY SKILL IN THE ARTTO PRACTICE THE BEST MODE

According to the approach used by the court in Chemcast Corp. v. Arco Indus., 913 F.2d 923,16 USPQ2d 1033 (Fed. Cir. 1990), a proper bestmode analysis has two components:

(A) Determine whether, at the time theapplication was filed, the inventor knew of a modeof practicing the claimed invention that the inventorconsidered to be better than any other.

The first component is a subjective inquiry becauseit focuses on the inventor’s state of mind at the timethe application was filed. Unless the examiner hasevidence that the inventors had information in theirpossession

(1) at the time the application was filed

(2) that a mode was considered to be betterthan any others by the inventors,

there is no reason to address the second componentand there is no proper basis for a best mode rejection.If the facts satisfy the first component, then, andonly then, is the following second componentanalyzed:

(B) Compare what was known in (A) with whatwas disclosed - is the disclosure adequate to enableone skilled in the art to practice the best mode?

Assessing the adequacy of the disclosure in thisregard is largely an objective inquiry that dependson the level of skill in the art. Is the informationcontained in the specification disclosure sufficientto enable a person skilled in the relevant art to makeand use the best mode?

A best mode rejection is proper only when the firstinquiry can be answered in the affirmative, and thesecond inquiry answered in the negative with reasonsto support the conclusion that the specification isnonenabling with respect to the best mode.

2165.04 Examples of Evidence ofConcealment [R-08.2017]

In determining the adequacy of a best modedisclosure, only evidence of concealment (accidental

Rev. 08.2017, January 20182100-351


or intentional) is to be considered. That evidencemust tend to show that the quality of an applicant’sbest mode disclosure is so poor as to effectivelyresult in concealment.

I. EXAMPLES — BEST MODE REQUIREMENTSATISFIED

In one case, even though the inventor had moreinformation in his possession concerning thecontemplated best mode than was disclosed (a knowncomputer program) the specification was held todelineate the best mode in a manner sufficient torequire only the application of routine skill toproduce a workable digital computer program. Inre Sherwood, 613 F.2d 809, 204 USPQ 537 (CCPA1980).

In another case, the claimed subject matter was atime controlled thermostat, but the application didnot disclose the specific Quartzmatic motor whichwas used in a commercial embodiment. The courtconcluded that failure to disclose the commercialmotor did not amount to concealment since similarclock motors were widely available and widelyadvertised. There was no evidence that the specificQuartzmatic motor was superior except possibly inprice. Honeywell v. Diamond, 499 F.Supp 924, 208USPQ 452 (D.D.C. 1980).

There was held to be no violation of the best moderequirement even though the inventor did notdisclose the only mode of calculating the stretch ratefor plastic rods that he used because that mode wouldhave been employed by those of ordinary skill in theart at the time the application was filed. W.L. Gore& Assoc., Inc. v. Garlock Inc., 721 F.2d 1540, 220USPQ 303 (Fed. Cir. 1983).

There was no best mode violation where the patenteefailed to disclose in the specification “[k]nown waysto perform a known operation” to practice theclaimed invention. “Known ways of performing aknown operation cannot be deemed intentionallyconcealed absent evidence of intent to deliberatelywithhold that information.” High ConcreteStructures Inc. v. New Enter. Stone & Lime Co.,377 F.3d 1379, 1384, 71 USPQ2d 1948, 1951 (Fed.Cir. 2004). The unintentional failure to disclose inthe specification the use of a crane to support the

patented frame in order to carry out the method ofloading and tilting the frame was held not to defeatthe best mode requirement because one of ordinaryskill in the art would understand and use a crane tomove heavy loads. Id. “The best mode requirementof [35 U.S.C.] § 112 is not violated by unintentionalomission of information that would be readily knownto persons in the field of the invention.” Id.

There was no best mode violation where there wasno evidence that the monoclonal antibodies used bythe inventors differed from those obtainableaccording to the processes described in thespecification. It was not disputed that the inventorsobtained the antibodies used in the invention byfollowing the procedures in the specification, thatthese were the inventors’ preferred procedures, andthat the data reported in the specification was for theantibody that the inventors had actually used. Scripps Clinic and Research Found. v. Genentech,Inc., 927 F.2d 1565, 18 USPQ 2d 1001 (Fed. Cir.1991).

Where an organism was created by the insertion ofgenetic material into a cell obtained from generallyavailable sources, all that was required to satisfy thebest mode requirement was an adequate descriptionof the means for carrying out the invention, notdeposit of the cells. As to the observation that noscientist could ever duplicate exactly the cell usedby applicants, the court observed that the issue iswhether the disclosure is adequate, not that an exactduplication is necessary. Amgen, Inc. v. ChugaiPharm. Co., 927 F.2d 1200, 18 USPQ 2d 1016 (Fed.Cir. 1991).

There was held to be no violation of the best moderequirement where the Solicitor argued thatconcealment could be inferred from the disclosurein a specification that each analog is “surprisinglyand unexpectedly more useful than one of thecorresponding prostaglandins . . . for at least one ofthe pharmacological purposes.” It was argued thatappellant must have had test results to substantiatethis statement and this data should have beendisclosed. The court concluded that no withholdingcould be inferred from general statements ofincreased selectivity and narrower spectrum ofpotency for these novel analogs, conclusions whichcould be drawn from the elementary pharmacological

2100-352Rev. 08.2017, January 2018


testing of the analogs. In re Bundy, 642 F.2d 430,435, 209 USPQ 48, 52 (CCPA 1981).

II. EXAMPLES — BEST MODE REQUIREMENTNOT SATISFIED

The best mode requirement was held to be violatedwhere inventors of a laser failed to disclose detailsof their preferred TiCuSil brazing method whichwere not contained in the prior art and were contraryto criteria for the use of TiCuSil as contained in theliterature. Spectra-Physics, Inc. v. Coherent, Inc.,827 F.2d 1524, 3 USPQ 2d 1737 (Fed. Cir. 1987).

The best mode requirement was violated because aninventor failed to disclose whether to use a specificsurface treatment that he knew was necessary to thesatisfactory performance of his invention, eventhough how to perform the treatment itself wasknown in the art. The argument that the best moderequirement may be met solely by reference to whatwas known in the prior art was rejected as incorrect. Dana Corp. v. IPC Ltd. P'ship, 860 F.2d 415,8 USPQ2d 1692 (Fed. Cir. 1988).


2171 Two Separate Requirements for ClaimsUnder 35 U.S.C. 112 (b) or Pre-AIA 35 U.S.C.112, Second Paragraph [R-11.2013]

35 U.S.C. 112 Specification

*****

(b) CONCLUSION.—The specification shall concludewith one or more claims particularly pointing out and distinctlyclaiming the subject matter which the inventor or a joint inventorregards as the invention.

*****

Pre-AIA 35 U.S.C. 112 Specification

*****

The specification shall conclude with one or more claimsparticularly pointing out and distinctly claiming the subjectmatter which the applicant regards as his invention.

*****

Two separate requirements are set forth in 35 U.S.C.112(b) and pre-AIA 35 U.S.C. 112, secondparagraph, namely that:

(A) the claims must set forth the subject matterthat the inventor or a joint inventor regards as theinvention; and

(B) the claims must particularly point out anddistinctly define the metes and bounds of the subjectmatter to be protected by the patent grant.

The first requirement is a subjective one because itis dependent on what the inventor or a joint inventorfor a patent regards as his or her invention. Note thatalthough pre-AIA 35 U.S.C. 112, second paragraph,uses the phrase "which applicant regards as hisinvention," pre-AIA 37 CFR 1.41(a) provides thata patent is applied for in the name or names of theactual inventor or inventors.

The second requirement is an objective one becauseit is not dependent on the views of the inventor orany particular individual, but is evaluated in thecontext of whether the claim is definite — i.e.,whether the scope of the claim is clear to ahypothetical person possessing the ordinary level ofskill in the pertinent art.

Although an essential purpose of the examinationprocess is to determine whether or not the claimsdefine an invention that is both novel andnonobvious over the prior art, another essentialpurpose of patent examination is to determinewhether or not the claims are precise, clear, correct,and unambiguous. The uncertainties of claim scopeshould be removed, as much as possible, during theexamination process.

The inquiry during examination is patentability ofthe invention as the inventor or a joint inventorregards it. If the claims do not particularly point outand distinctly claim that which the inventor or a jointinventor regards as his or her invention, theappropriate action by the examiner is to reject theclaims under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph. In re Zletz, 893 F.2d 319,13 USPQ2d 1320 (Fed. Cir. 1989). If a rejection isbased on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph, the examiner should furtherexplain whether the rejection is based onindefiniteness or on the failure to claim what theinventor or a joint invention regards as the invention. Ex parte Ionescu, 222 USPQ 537, 539 (Bd. Pat.App. & Inter. 1984).

Rev. 08.2017, January 20182100-353


2172 Subject Matter Which the Inventor ora Joint Inventor Regards as The Invention[R-11.2013]

I. FOCUS FOR EXAMINATION

A rejection based on the failure to satisfy thisrequirement is appropriate only where an inventorhas stated, somewhere other than in the applicationas filed, that the invention is something differentfrom what is defined by the claims. In other words,the invention set forth in the claims must bepresumed, in the absence of evidence to the contrary,to be that which the inventor or a joint inventorregards as the invention. In re Moore, 439 F.2d1232, 169 USPQ 236 (CCPA 1971).

II. EVIDENCE TO THE CONTRARY

Evidence that shows that a claim does not correspondin scope with that which an inventor regards as aninventor’s invention may be found, for example, incontentions or admissions contained in briefs orremarks filed by applicant (see e.g., Solomon v.Kimberly-Clark Corp., 216 F.3d 1372, 55 USPQ2d1279 (Fed. Cir. 2000) and In re Prater, 415 F.2d1393, 162 USPQ 541 (CCPA 1969)), or in affidavitsfiled under 37 CFR 1.132 (see, e.g., In re Cormany,476 F.2d 998, 177 USPQ 450 (CCPA 1973)). Thecontent of the specification is not used as evidencethat the scope of the claims is inconsistent with thesubject matter which an inventor regards as his orher invention. As noted in In re Ehrreich, 590 F.2d902, 200 USPQ 504 (CCPA 1979), agreement, orlack thereof, between the claims and the specificationis properly considered only with respect to 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph; itis irrelevant to compliance with the 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph.

III. SHIFT IN CLAIMS PERMITTED

35 U.S.C. 112(b) or the second paragraph of pre-AIA35 U.S.C. 112 does not prohibit the inventor or ajoint inventor from changing what he or she regardsas the invention during the pendency of theapplication. In re Saunders, 444 F.2d 599, 170USPQ 213 (CCPA 1971) (permitting claims andsubmission of comparative evidence with respect toclaimed subject matter which originally was only

the preferred embodiment within much broaderclaims (directed to a method)). The fact that claimsin a continuation application were directed tooriginally disclosed subject matter which had notbeen regarded as part of the invention when theparent application was filed was held not to preventthe continuation application from receiving benefitsof the filing date of the parent application under 35U.S.C. 120. In re Brower, 433 F.2d 813, 167 USPQ684 (CCPA 1970).

2172.01 Unclaimed Essential Matter[R-11.2013]

A claim which omits matter disclosed to be essentialto the invention as described in the specification orin other statements of record may be rejected under35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, as not enabling. In re Mayhew, 527 F.2d1229, 188 USPQ 356 (CCPA 1976). See also MPEP§ 2164.08(c). Such essential matter may includemissing elements, steps or necessary structuralcooperative relationships of elements described bythe applicant(s) as necessary to practice theinvention.

In addition, a claim which fails to interrelate essentialelements of the invention as defined by applicant(s)in the specification may be rejected under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,for failure to point out and distinctly claim theinvention. See In re Venezia, 530 F.2d 956, 189USPQ 149 (CCPA 1976); In re Collier, 397 F.2d1003, 158 USPQ 266 (CCPA 1968). But see Exparte Nolden, 149 USPQ 378, 380 (Bd. Pat. App. &Inter. 1965) (“[I]t is not essential to a patentablecombination that there be interdependency betweenthe elements of the claimed device or that all theelements operate concurrently toward the desiredresult”); Ex parte Huber, 148 USPQ 447, 448-49(Bd. Pat. App. & Inter. 1965) (A claim does notnecessarily fail to comply with 35 U.S.C. 112,second paragraph where the various elements do notfunction simultaneously, are not directly functionallyrelated, do not directly intercooperate, and/or serveindependent purposes.).

2100-354Rev. 08.2017, January 2018


2173 Claims Must Particularly Point Outand Distinctly Claim the Invention[R-11.2013]

Optimizing patent quality by providing clear noticeto the public of the boundaries of the inventivesubject matter protected by a patent grant fostersinnovation and competitiveness. Accordingly,providing high quality patents is one of the agency’sguiding principles. The Office recognizes that issuingpatents with clear and definite claim language is akey component to enhancing the quality of patentsand raising confidence in the patent process.

35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph requires that a patent applicationspecification shall conclude with one or more claimsparticularly pointing out and distinctly claiming thesubject matter which the applicant regards as his orher invention. In patent examining parlance, theclaim language must be “definite” to comply with35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph. Conversely, a claim that does not complywith this requirement of 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph is “indefinite.”

The primary purpose of this requirement ofdefiniteness of claim language is to ensure that thescope of the claims is clear so the public is informedof the boundaries of what constitutes infringementof the patent. A secondary purpose is to provide aclear measure of what applicants regard as theinvention so that it can be determined whether theclaimed invention meets all the criteria forpatentability and whether the specification meets thecriteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C.112, first paragraph with respect to the claimedinvention.

It is of utmost importance that patents issue withdefinite claims that clearly and precisely informpersons skilled in the art of the boundaries ofprotected subject matter. Therefore, claims that donot meet this standard must be rejected under 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph as indefinite. Such a rejection requiresthat the applicant respond by explaining why thelanguage is definite or by amending the claim, thusmaking the record clear regarding the claimboundaries prior to issuance. As an indefiniteness

rejection requires the applicant to respond byexplaining why the language is definite or byamending the claim, such rejections must clearlyidentify the language that causes the claim to beindefinite and thoroughly explain the reasoning forthe rejection.

2173.01 Interpreting the Claims [R-08.2017]


A fundamental principle contained in 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraphis that applicants are their own lexicographers. Theycan define in the claims what they regard as theirinvention essentially in whatever terms they chooseso long as any special meaning assigned to a termis clearly set forth in the specification. See MPEP §2111.01. Applicant may use functional language,alternative expressions, negative limitations, or anystyle of expression or format of claim which makesclear the boundaries of the subject matter for whichprotection is sought. As noted by the court in In reSwinehart, 439 F.2d 210, 160 USPQ 226 (CCPA1971), a claim may not be rejected solely becauseof the type of language used to define the subjectmatter for which patent protection is sought.

I. BROADEST REASONABLE INTERPRETATION

The first step to examining a claim to determine ifthe language is definite is to fully understand thesubject matter of the invention disclosed in theapplication and to ascertain the boundaries of thatsubject matter encompassed by the claim. Duringexamination, a claim must be given its broadestreasonable interpretation consistent with thespecification as it would be interpreted by one ofordinary skill in the art. Because the applicant hasthe opportunity to amend claims during prosecution,giving a claim its broadest reasonable interpretationwill reduce the possibility that the claim, once issued,will be interpreted more broadly than is justified. In

Rev. 08.2017, January 20182100-355


re Yamamoto, 740 F.2d 1569, 1571, 222 USPQ 934,936 (Fed. Cir. 1984); In re Zletz, 893 F.2d 319, 321,13 USPQ2d 1320, 1322 (Fed. Cir. 1989) (“Duringpatent examination the pending claims must beinterpreted as broadly as their terms reasonablyallow.”). The focus of the inquiry regarding themeaning of a claim should be what would bereasonable from the perspective of one of ordinaryskill in the art. In re Suitco Surface, Inc., 603 F.3d1255, 1260, 94 USPQ2D 1640, 1644 (Fed. Cir.2010); In re Buszard, 504 F.3d 1364, 84 USPQ2d1749 (Fed. Cir. 2007). In Buszard, the claim wasdirected to a flame retardant composition comprisinga flexible polyurethane foam reaction mixture. Buszard, 504 F.3d at 1365, 84 USPQ2d at 1749.The Federal Circuit found that the Board’sinterpretation that equated a “flexible” foam with acrushed “rigid” foam was not reasonable. Id. at1367, 84 USPQ2d at 1751. Persuasive argument waspresented that persons experienced in the field ofpolyurethane foams know that a flexible mixture isdifferent than a rigid foam mixture. Id. at 1366, 84USPQ2d at 1751. See MPEP § 2111 for a fulldiscussion of broadest reasonable interpretation.

Under a broadest reasonable interpretation, wordsof the claim must be given their plain meaning,unless such meaning is inconsistent with thespecification. The plain meaning of a term meansthe ordinary and customary meaning given to theterm by those of ordinary skill in the art at the timeof the invention. The ordinary and customarymeaning of a term may be evidenced by a variety ofsources, including the words of the claimsthemselves, the specification, drawings, and priorart. However, the best source for determining themeaning of a claim term is the specification - thegreatest clarity is obtained when the specificationserves as a glossary for the claim terms. Thepresumption that a term is given its ordinary andcustomary meaning may be rebutted by the applicantby clearly setting forth a different definition of theterm in the specification. In re Morris, 127 F.3d1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997)(the USPTO looks to the ordinary use of the claimterms taking into account definitions or other“enlightenment” contained in the writtendescription); But c.f. In re Am. Acad. of Sci. Tech.Ctr., 367 F.3d 1359, 1369, 70 USPQ2d 1827, 1834(Fed. Cir. 2004) (“We have cautioned against reading

limitations into a claim from the preferredembodiment described in the specification, even ifit is the only embodiment described, absent cleardisclaimer in the specification.”); In re Bigio, 381F.3d 1320, 1325, 72 USPQ2d 1209, 1211 (Fed. Cir.2004) (The claims at issue were drawn to a “hairbrush.” The court upheld the Board’s refusal toimport from the specification a limitation that wouldapply the term only to hairbrushes for the scalp.“[T]his court counsels the PTO to avoid thetemptation to limit broad claim terms solely on thebasis of specification passages."). When thespecification sets a clear path to the claim language,the scope of the claims is more easily determinedand the public notice function of the claims is bestserved. See MPEP § 2111.01 for a full discussionof the plain meaning of claim language.

If an Office action has issued where the plainmeaning of the claim terms was used, applicant maypoint out that the term has been given a specialdefinition. Since there is a presumption that claimterms are given their plain meaning, and the use ofspecial definitions is an exception, the applicant mustpoint to where the specification as filed provides aclear and intentional use of a special definition forthe claim term to be treated as having a specialdefinition.

An applicant may not add a special definition ordisavowal after the filing date of the application.However, an applicant may point out or explain inremarks where the specification as filed contains aspecial definition or disavowal.

II. DETERMINE WHETHER OR NOT EACHCLAIM LIMITATION INVOKES 35 U.S.C. 112(f)or Pre-AIA 35 U.S.C. 112, sixth paragraph

As part of the claim interpretation analysis,examiners should determine whether each limitationinvokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,sixth paragraph or not. If the claim limitation invokes35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, the claim limitation must “be construedto cover the corresponding structure, material, oracts described in the specification and equivalentsthereof.” 35 U.S.C. 112(f) and pre-AIA 35 U.S.C.112, sixth paragraph; see also In re Donaldson Co.,16 F.3d 1189, 1193, 29 USPQ2d 1845, 1849 (Fed.

2100-356Rev. 08.2017, January 2018


Cir. 1994) (en banc) (“[W]e hold that paragraph sixapplies regardless of the context in which theinterpretation of means-plus-function languagearises, i.e., whether as part of a patentabilitydetermination in the PTO or as part of a validity orinfringement determination in a court.”). See MPEP§ 2181, subsection I. for more information regardingthe determination of whether a limitation invokes35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, and means- (or step-) plus- function claimlimitations.

2173.02 Determining Whether ClaimLanguage is Definite [R-08.2017]


During prosecution, applicant has an opportunityand a duty to amend ambiguous claims to clearlyand precisely define the metes and bounds of theclaimed invention. The claim places the public onnotice of the scope of the patentee’s right to exclude.See, e.g., Johnson & Johnston Assoc. Inc. v. R.E.Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225,1228 (Fed. Cir. 2002) (en banc). As the FederalCircuit stated in Halliburton Energy Servs., Inc. v.M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654,1663 (Fed. Cir. 2008):

We note that the patent drafter is in the bestposition to resolve the ambiguity in the patentclaims, and it is highly desirable that patentexaminers demand that applicants do so inappropriate circumstances so that the patentcan be amended during prosecution rather thanattempting to resolve the ambiguity inlitigation.

A decision on whether a claim is indefinite under35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph requires a determination of whether thoseskilled in the art would understand what is claimed

when the claim is read in light of the specification. Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d1343, 1350, 94 USPQ2d 1241, 1245 (Fed. Cir.2010); Orthokinetics, Inc. v. Safety Travel Chairs,Inc., 806 F.2d 1565, 1 USPQ2d 1081 (Fed. Cir.1986). In Orthokinetics, a claim directed to a wheelchair included the phrase “so dimensioned as to beinsertable through the space between the doorframeof an automobile and one of the seats thereof.” 806F.2d at 1568, 1 USPQ2d at 1082. The court foundthe phrase to be as accurate as the subject matterpermits, since automobiles are of various sizes. Id.at 1576, 1 USPQ2d at 1088. “As long as those ofordinary skill in the art realized the dimensions couldbe easily obtained, § 112, 2d para. requires nothingmore.” Id. Claim terms are typically given theirordinary and customary meaning as understood byone of ordinary skill in the pertinent art, and thegenerally understood meaning of particular termsmay vary from art to art. Therefore, it is importantto analyze claim terms in view of the application’sspecification from the perspective of those skilledin the relevant art since a particular term used in onepatent or application may not have the same meaningwhen used in a different application. Medrad, Inc.v. MRI Devices Corp., 401 F.3d 1313, 1318, 74USPQ2d 1184, 1188 (Fed. Cir. 2005).

I. CLAIMS UNDER EXAMINATION ARECONSTRUED DIFFERENTLY THAN PATENTEDCLAIMS

Patented claims are not given the broadest reasonableinterpretation during court proceedings involvinginfringement and validity, and can be interpretedbased on a fully developed prosecution record. While"absolute precision is unattainable" in patentedclaims, the definiteness requirement "mandatesclarity." Nautilus, Inc. v. Biosig Instruments, Inc.,527 U.S. ____, 134 S. Ct. 2120, 2129, 110 USPQ2d1688, 1693 (2014). A court will not find a patentedclaim indefinite unless the claim interpreted in lightof the specification and the prosecution history failsto "inform those skilled in the art about the scope ofthe invention with reasonable certainty." Id. at 1689.

The Office does not interpret claims when examiningpatent applications in the same manner as the courts. In re Packard, 751 F.3d 1307, 1312, 110 USPQ2d1785, 1788 (Fed. Cir. 2014); In re Morris, 127 F.3d

Rev. 08.2017, January 20182100-357


1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir.1997); In re Zletz, 893 F.2d 319, 321-22, 13USPQ2d 1320, 1321-22 (Fed. Cir. 1989). The Officeconstrues claims by giving them their broadestreasonable interpretation during prosecution in aneffort to establish a clear record of what the applicantintends to claim. Such claim construction duringprosecution may effectively result in a lowerthreshold for ambiguity than a court's determination. Packard, 751 F.3d at 1323-24, 110 USPQ2d at1796-97 (Plager, J., concurring). However, applicanthas the ability to amend the claims duringprosecution to ensure that the meaning of thelanguage is clear and definite prior to issuance orprovide a persuasive explanation (with evidence asnecessary) that a person of ordinary skill in the artwould not consider the claim language unclear. Inre Buszard, 504 F.3d 1364, 1366, 84 USPQ2d 1749,1750 (Fed. Cir. 2007)( claims are given theirbroadest reasonable interpretation during prosecution“to facilitate sharpening and clarifying the claims atthe application stage”); see also In re Yamamoto,740 F.2d 1569, 1571, 222 USPQ 934, 936 (Fed. Cir.1984); In re Zletz, 893 F.2d 319, 322, 13 USPQ2d1320, 1322 (Fed. Cir. 1989).

See MPEP § 2111 et seq. for a detailed discussionof claim interpretation during the examinationprocess. The lower threshold is also applied becausethe patent record is in development and not fixedduring examination, and the agency does not relyon it for interpreting claims. Packard, 751 F.3d at1325 (Plager, J., concurring). Burlington Indus. Inc.v. Quigg, 822 F.2d 1581, 1583, 3 USPQ2d 1436,1438 (Fed. Cir. 1987) (“Issues of judicial claimconstruction such as arise after patent issuance, forexample during infringement litigation, have noplace in prosecution of pending claims before thePTO, when any ambiguity or excessive breadth maybe corrected by merely changing the claim.”).

During examination, after applying the broadestreasonable interpretation to the claim, if the metesand bounds of the claimed invention are not clear,the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTOhas initially issued a well-grounded rejection thatidentifies ways in which language in a claim isambiguous, vague, incoherent, opaque, or otherwiseunclear in describing and defining the claimed

invention, and thereafter the applicant fails toprovide a satisfactory response, the USPTO canproperly reject the claim as failing to meet thestatutory requirements of § 112(b).”); Zletz, 893F.2d at 322, 13 USPQ2d at 1322. For example, ifthe language of a claim, given its broadest reasonableinterpretation, is such that a person of ordinary skillin the relevant art would read it with more than onereasonable interpretation, then a rejection under 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph is appropriate. Examiners, however, arecautioned against confusing claim breadth with claimindefiniteness. A broad claim is not indefinite merelybecause it encompasses a wide scope of subjectmatter provided the scope is clearly defined. Instead,a claim is indefinite when the boundaries of theprotected subject matter are not clearly delineatedand the scope is unclear. For example, a genus claimthat covers multiple species is broad, but is notindefinite because of its breadth, which is otherwiseclear. But a genus claim that could be interpreted insuch a way that it is not clear which species arecovered would be indefinite (e.g., because there ismore than one reasonable interpretation of whatspecies are included in the claim). See MPEP §2173.05(h), subsection I., for more informationregarding the determination of whether a Markushclaim satisfies the requirements of 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph.

II. THRESHOLD REQUIREMENTS OF CLARITYAND PRECISION

The examiner’s focus during examination of claimsfor compliance with the requirement for definitenessof 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, is whether the claim meets thethreshold requirements of clarity and precision setforth in the statute, not whether more suitablelanguage or modes of expression are available. Whenthe examiner is satisfied that patentable subjectmatter is disclosed, and it is apparent to the examinerthat the claims are directed to such patentable subjectmatter, the examiner should allow claims whichdefine the patentable subject matter with the requireddegree of particularity and distinctness. Somelatitude in the manner of expression and the aptnessof terms should be permitted so long as 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,is satisfied. Examiners are encouraged to suggest

2100-358Rev. 08.2017, January 2018


claim language to applicants to improve the clarityor precision of the language used, but should notinsist on their own preferences if other modes ofexpression selected by applicants satisfy the statutoryrequirement.

The essential inquiry pertaining to this requirementis whether the claims set out and circumscribe aparticular subject matter with a reasonable degreeof clarity and particularity. “As the statutorylanguage of ‘particular[ity]' and 'distinct[ness]'indicates, claims are required to be cast in clear—asopposed to ambiguous, vague, indefinite—terms. Itis the claims that notify the public of what is withinthe protections of the patent, and what is not.” Packard, 751 F.3d at 1313. Definiteness of claimlanguage must be analyzed, not in a vacuum, but inlight of:

(A) The content of the particular applicationdisclosure;

(B) The teachings of the prior art; and

(C) The claim interpretation that would be givenby one possessing the ordinary level of skill in thepertinent art at the time the invention was made.

In reviewing a claim for compliance with 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,the examiner must consider the claim as a whole todetermine whether the claim apprises one of ordinaryskill in the art of its scope and, therefore, serves thenotice function required by 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph, byproviding clear warning to others as to whatconstitutes infringement of the patent. See, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372,1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). Seealso In re Larsen, 10 Fed. App'x 890 (Fed. Cir.2001) (The preamble of the Larsen claim recitedonly a hanger and a loop but the body of the claimpositively recited a linear member. The courtobserved that the totality of all the limitations of theclaim and their interaction with each other must beconsidered to ascertain the inventor’s contributionto the art. Upon review of the claim in its entirety,the court concluded that the claim at issue apprisesone of ordinary skill in the art of its scope and,therefore, serves the notice function required by 35U.S.C. 112.).

If the language of the claim is such that a person ofordinary skill in the art could not interpret the metesand bounds of the claim so as to understand how toavoid infringement, a rejection of the claim under35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph, is appropriate. See Morton Int’l, Inc. v.Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d1190, 1195 (Fed. Cir. 1993). However, if thelanguage used by applicant satisfies the statutoryrequirements of 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, the claim must notbe rejected under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph.

Examiners should note that Office policy is not toemploy per se rules to make technical rejections.Examples of claim language which have been heldto be indefinite set forth in MPEP § 2173.05(d) arefact specific and should not be applied as per serules.

III. RESOLVING INDEFINITE CLAIMLANGUAGE

A. Examiner Must Establish a Clear Record

Examiners are urged to carefully carry out theirresponsibilities to see that the application filecontains a complete and accurate picture of theOffice’s consideration of the patentability of anapplication. See MPEP § 1302.14, subsection I. Inorder to provide a complete application file historyand to enhance the clarity of the prosecution historyrecord, an examiner should provide clearexplanations of all actions taken during prosecutionof the application. See MPEP § 707.07(f). Thus,when a rejection under 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph, is appropriatebased on the examiner’s determination that a claimterm or phrase is prima facie indefinite, theexaminer should clearly communicate in an Officeaction any findings and reasons which support therejection and avoid a mere conclusion that the claimterm or phrase is indefinite. See MPEP § 706.03 andMPEP § 707.07(g).

MPEP § 2173.05 provides numerous examples ofrationales that may support a rejection under 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph, such as functional claim limitations,

Rev. 08.2017, January 20182100-359


relative terminology/terms of degree, lack ofantecedent basis, etc. Only by providing a completeexplanation in the Office action as to the basis fordetermining why a particular term or phrase used inthe claim is “vague and indefinite” will the examinerenhance the clarity of the prosecution history record.

B. An Office Action Should Provide a SufficientExplanation

The Office action must set forth the specific term orphrase that is indefinite and why the metes andbounds are unclear. Since a rejection requires theapplicant to respond by explaining why claimlanguage would be recognized by a person ofordinary skill in the art as definite or by amendingthe claim, the Office action should provide enoughinformation for the applicant to prepare a meaningfulresponse. “Because claims delineate the patentee’sright to exclude, the patent statute requires that thescope of the claims be sufficiently definite to informthe public of the bounds of the protected invention,i.e., what subject matter is covered by the exclusiverights of the patent.” Halliburton Energy Servs.,Inc. v. M-I LLC, 514 F.3d 1244, 1249, 85 USPQ2d1654, 1658 (Fed. Cir. 2008). Thus, claims are giventheir broadest reasonable interpretation duringprosecution “to facilitate sharpening and clarifyingthe claims at the application stage” when claims arereadily changed. In re Buszard, 504 F.3d 1364, 1366(Fed. Cir. 2007); see also In re Yamamoto, 740 F.2d1569, 1571 (Fed. Cir. 1984); In re Zletz, 893 F.2d319, 322, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).

To comply with 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, applicants arerequired to make the terms that are used to definethe invention clear and precise, so that the metes andbounds of the subject matter that will be protectedby the patent grant can be ascertained. See MPEP §2173.05(a), subsection I. It is important that a personof ordinary skill in the art be able to interpret themetes and bounds of the claims so as to understandhow to avoid infringement of the patent thatultimately issues from the application beingexamined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d1464, 1470 (Fed. Cir. 1993)); see also HalliburtonEnergy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658(“Otherwise, competitors cannot avoid infringement,

defeating the public notice function of patentclaims.”). Examiners should bear in mind that “[a]nessential purpose of patent examination is to fashionclaims that are precise, clear, correct, andunambiguous. Only in this way can uncertainties ofclaim scope be removed, as much as possible, duringthe administrative process.” Zletz, 893 F.2d at 322,13 USPQ2d at 1322.

Accordingly, when rejecting a claim as prima facieindefinite under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, the examiner shouldprovide enough information in the Office action topermit applicant to make a meaningful response, asthe indefiniteness rejection requires the applicant toexplain or provide evidence as to why the claimlanguage is not indefinite or amend the claim. Forexample, in making a prima facie case ofindefiniteness, the examiner should point out thespecific term or phrase that is indefinite, explain indetail why such term or phrase renders the metesand bounds of the claim scope unclear and, wheneverpracticable, indicate how the indefiniteness issuesmay be resolved to overcome the rejection. SeeMPEP § 707.07(d). If the applicant does notadequately respond to the prima facie case, theexaminer may make the indefiniteness rejection final. Packard, 751 F.3d at 1312.

The focus during the examination of claims forcompliance with the requirement for definitenessunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, is whether the claim meets thethreshold requirements of clarity and precision, notwhether more suitable language or modes ofexpression are available. See MPEP § 2173.02,subsection II. Examiners are encouraged to suggestclaim language to applicants to improve the clarityor precision of the language used, but should notinsist on their own preferences if other modes ofexpression selected by applicants satisfy the statutoryrequirement. Furthermore, when the examinerdetermines that more information is necessary toascertain the meaning of a claim term, a requirementfor information under 37 CFR 1.105 may beappropriate. See MPEP § 704.10 regardingrequirements for information.

It is highly desirable to have applicants resolveambiguity by amending the claims during

2100-360Rev. 08.2017, January 2018


prosecution of the application rather than attemptingto resolve the ambiguity in subsequent litigation ofthe issued patent. Halliburton Energy Servs., 514F.3d at 1255. Thus, in response to an examiner’srejection for indefiniteness, an applicant may resolvethe ambiguity by amending the claim, or byproviding a persuasive explanation on the recordthat a person of ordinary skill in the relevant artwould not consider the claim language unclear. Inre Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014).For the latter option, in some cases, it may benecessary for the applicant to provide a separatedefinition (such as from an art-recognized dictionary)to show how the ordinarily-skilled artisan wouldhave understood the claim language at issue. Id.

If the examiner considers applicant’s argumentsand/or amendments to be persuasive, the examinershould indicate in the next Office communicationthat the previous rejection under 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph, hasbeen withdrawn and provide an explanation as towhat prompted the change in the examiner’s position(e.g., by making specific reference to portions ofapplicant’s remarks).

By providing an explanation as to the action taken,the examiner will enhance the clarity of theprosecution history record. As noted by the SupremeCourt in Festo Corp. v. Shoketsu Kinzoku KogyoKabushiki Co., 535 U.S. 722, 122 S.Ct. 1831, 1838,62 USPQ2d 1705, 1710 (2002), a clear and completeprosecution file record is important in that“[p]rosecution history estoppel requires that theclaims of a patent be interpreted in light of theproceedings in the PTO during the applicationprocess.” In Festo, the Court held that “a narrowingamendment made to satisfy any requirement of thePatent Act may give rise to an estoppel.” Withrespect to amendments made to comply with therequirements of 35 U.S.C. 112, the Court stated that“[i]f a § 112 amendment is truly cosmetic, then itwould not narrow the patent’s scope or raise anestoppel. On the other hand, if a § 112 amendmentis necessary and narrows the patent’s scope—evenif only for the purpose of betterdescription—estoppel may apply.” Id. at 1840, 62USPQ2d at 1712. The Court further stated that“when the court is unable to determine the purposeunderlying a narrowing amendment—and hence a

rationale for limiting the estoppel to the surrenderof particular equivalents—the court should presumethat the patentee surrendered all subject matterbetween the broader and the narrower language…thepatentee should bear the burden of showing that theamendment does not surrender the particularequivalent in question.” Id. at 1842, 62 USPQ2d at1713. Thus, whenever possible, the examiner shouldmake the record clear by providing explicit reasoningfor making or withdrawing any rejection related to35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph.

C. Provide Claim Interpretation in Reasons forAllowance When Record is Unclear

Pursuant to 37 CFR 1.104(e), if the examinerbelieves that the record of the prosecution as a wholedoes not make clear the reasons for allowing a claimor claims, the examiner may set forth such reasoningin reasons for allowance. Further, prior to allowance,the examiner may also specify allowable subjectmatter and provide reasons for indicating suchallowable subject matter in an Officecommunication. See MPEP § 1302.14, subsectionI. One of the primary purposes of 37 CFR 1.104(e)is to improve the quality and reliability of issuedpatents by providing a complete file history whichshould clearly reflect the reasons why the applicationwas allowed. Such information facilitates evaluationof the scope and strength of a patent by the patenteeand the public and may help avoid or simplifysubsequent litigation of an issued patent. See MPEP§ 1302.14, subsection I. In meeting the need for theapplication file history to speak for itself, it isincumbent upon the examiner in exercising theirresponsibility to the public to see that the file historyis complete. See MPEP § 1302.14, subsection I.

For example, when allowing a claim based on aclaim interpretation which might not be readilyapparent from the record of the prosecution as awhole, the examiner should set forth in reasons forallowance the claim interpretation applied indetermining that the claim is allowable over the priorart. See MPEP § 1302.14, subsection II.G. This isespecially the case where the application is allowedafter an interview. The examiner should ensure,however, that statements of reasons for allowancedo not place unwarranted interpretations, whether

Rev. 08.2017, January 20182100-361


broad or narrow, upon the claims. See MPEP §1302.14, subsection I.

D. Open Lines of Communication with the Applicant– When Indefiniteness Is the Only Issue, AttemptResolution through an Interview before Resorting to aRejection

Examiners are reminded that interviews can be aneffective examination tool and are encouraged toinitiate an interview with the applicant or applicant’srepresentative at any point during the pendency ofan application, if the interview can help furtherprosecution, shorten pendency, or provide a benefitto the examiner or applicant. Issues of claiminterpretation and clarity of scope may lendthemselves to resolution through an examinerinterview. For example, the examiner may initiatean interview to discuss, among other issues, thebroadest reasonable interpretation of a claim, themeaning of a particular claim limitation, and thescope and clarity of preamble language, functionallanguage, intended use language, andmeans-plus-function limitations, etc.

An interview can serve to develop and clarify suchissues and lead to a mutual understanding betweenthe examiner and the applicant, potentiallyeliminating the need for the examiner to resort tomaking a rejection under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph. Theexaminer is reminded that the substance of anyinterview, whether in person, by video conference,or by telephone must be made of record in theapplication, whether or not an agreement wasreached at the interview. See MPEP § 713.04; seealso 37 CFR 1.2 (“The action of the Patent andTrademark Office will be based exclusively on thewritten record in the Office. No attention will bepaid to any alleged oral promise, stipulation, orunderstanding in relation to which there isdisagreement or doubt.”). Examples of 35 U.S.C.112 issues that should be made of record after theinterview include: why the discussed claim term isor is not sufficiently clear; why the discussed claimterm is or is not inconsistent with the specification;why the discussed claim term does or does notinvoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,sixth paragraph (and if it does, the identification ofcorresponding structure, material, or acts in the

specification for a 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph limitation); and anyclaim amendments discussed that would resolveidentified ambiguities.

2173.03 Correspondence BetweenSpecification and Claims [R-08.2017]

The specification should ideally serve as a glossaryto the claim terms so that the examiner and the publiccan clearly ascertain the meaning of the claim terms.Correspondence between the specification and claimsis required by 37 CFR 1.75(d)(1), which providesthat claim terms must find clear support orantecedent basis in the specification so that themeaning of the terms may be ascertainable byreference to the specification. Glossaries of termsused in the claims are a helpful device for ensuringadequate definition of terms used in claims. If thespecification does not provide the needed supportor antecedent basis for the claim terms, thespecification should be objected to under 37 CFR1.75(d)(1). See MPEP § 608.01(o) and MPEP §2181, subsection IV. Applicant will be required tomake appropriate amendment to the description toprovide clear support or antecedent basis for theclaim terms provided no new matter is introduced,or amend the claim.

A claim, although clear on its face, may also beindefinite when a conflict or inconsistency betweenthe claimed subject matter and the specificationdisclosure renders the scope of the claim uncertainas inconsistency with the specification disclosure orprior art teachings may make an otherwise definiteclaim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989,169 USPQ 95 (CCPA 1971); In re Hammack, 427F.2d 1378, 166 USPQ 204 (CCPA 1970). Forexample, a claim with a limitation of “the clampmeans including a clamp body and first and secondclamping members, the clamping members beingsupported by the clamp body” was determined to beindefinite because the terms “first and secondclamping members” and “clamp body” were foundto be vague in light of the specification whichshowed no “clamp member” structure being“supported by the clamp body.” In re Anderson,1997 U.S. App. Lexis 167 (Fed. Cir. January 6,

2100-362Rev. 08.2017, January 2018


1997) (unpublished). In Cohn, a claim was directedto a process of treating an aluminum surface withan alkali silicate solution and included a furtherlimitation that the surface has an “opaque”appearance. Id. The specification, meanwhile,associated the use of an alkali silicate with a glazedor porcelain-like finish, which the specificationdistinguished from an opaque finish. Cohn, 438F.2d at 993. Noting that no claim may be read apartfrom and independent of the supporting disclosureon which it is based, the court found that the claimwas internally inconsistent based on the description,definitions and examples set forth in the specificationrelating to the appearance of the surface aftertreatment, and therefore indefinite. Id.

2173.04 Breadth Is Not Indefiniteness[R-07.2015]

Breadth of a claim is not to be equated withindefiniteness. In re Miller, 441 F.2d 689, 169USPQ 597 (CCPA 1971); In re Gardner, 427 F.2d786, 788, 166 USPQ 138, 140 (CCPA 1970)("Breadth is not indefiniteness."). A broad claim isnot indefinite merely because it encompasses a widescope of subject matter provided the scope is clearlydefined. But a claim is indefinite when theboundaries of the protected subject matter are notclearly delineated and the scope is unclear. Forexample, a genus claim that covers multiple speciesis broad, but is not indefinite because of its breadth,which is otherwise clear. But a genus claim thatcould be interpreted in such a way that it is not clearwhich species are covered would be indefinite (e.g.,because there is more than one reasonableinterpretation of what species are included in theclaim).

Undue breadth of the claim may be addressed underdifferent statutory provisions, depending on thereasons for concluding that the claim is too broad.If the claim is too broad because it does not set forththat which applicants regard as their invention asevidenced by statements outside of the applicationas filed, a rejection under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph, wouldbe appropriate. If the claim is too broad because itis not supported by the original description or by anenabling disclosure, a rejection under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,

would be appropriate. If the claim is too broadbecause it reads on the prior art, a rejection undereither 35 U.S.C. 102 or 103 would be appropriate.

2173.05 Specific Topics Related to IssuesUnder 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C.112, Second Paragraph [R-11.2013]

The following sections are devoted to a discussionof specific topics where issues under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,have been addressed. These sections are not intendedto be an exhaustive list of the issues that can ariseunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, but are intended to provideguidance in areas that have been addressed withsome frequency in recent examination practice. Thecourt and Board decisions cited are representative.As with all appellate decisions, the results are largelydictated by the facts in each case. The use of thesame language in a different context may justify adifferent result.

See MPEP § 2181 for guidance indetermining whether an applicant has complied withthe requirements of 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, when 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph,is invoked.

2173.05(a) New Terminology [R-07.2015]

I. THE MEANING OF EVERY TERM SHOULD BEAPPARENT

The meaning of every term used in a claim shouldbe apparent from the prior art or from thespecification and drawings at the time the applicationis filed. Claim language may not be “ambiguous,vague, incoherent, opaque, or otherwise unclear indescribing and defining the claimed invention.” Packard, 751 F.3d at 1311. Applicants need notconfine themselves to the terminology used in theprior art, but are required to make clear and precisethe terms that are used to define the inventionwhereby the metes and bounds of the claimedinvention can be ascertained. During patentexamination, the pending claims must be given thebroadest reasonable interpretation consistent withthe specification. In re Morris, 127 F.3d 1048, 1054,

Rev. 08.2017, January 20182100-363


44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In rePrater, 415 F.2d 1393, 162 USPQ 541 (CCPA1969). See also MPEP § 2111 - § 2111.01. Whenthe specification states the meaning that a term inthe claim is intended to have, the claim is examinedusing that meaning, in order to achieve a completeexploration of the applicant’s invention and itsrelation to the prior art. In re Zletz, 893 F.2d 319,13 USPQ2d 1320 (Fed. Cir. 1989).

II. THE REQUIREMENT FOR CLARITY ANDPRECISION MUST BE BALANCED WITH THELIMITATIONS OF THE LANGUAGE

Courts have recognized that it is not onlypermissible, but often desirable, to use new termsthat are frequently more precise in describing anddefining the new invention. In re Fisher, 427 F.2d833, 166 USPQ 18 (CCPA 1970). Although it isdifficult to compare the claimed invention with theprior art when new terms are used that do not appearin the prior art, this does not make the new termsindefinite.

New terms are often used when a new technologyis in its infancy or is rapidly evolving. Therequirements for clarity and precision must bebalanced with the limitations of the language andthe science. If the claims, read in light of thespecification, reasonably apprise those skilled in theart both of the utilization and scope of the invention,and if the language is as precise as the subject matterpermits, the statute (35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph) demands no more. Packard, 751 F.3d at 1313 (“[H]ow much clarity isrequired necessarily invokes some standard ofreasonable precision in the use of language in thecontext of the circumstances.”). This does not meanthat the examiner must accept the best effort ofapplicant. If the language is not considered as preciseas the subject matter permits, the examiner shouldprovide reasons to support the conclusion ofindefiniteness and is encouraged to suggestalternatives that would not be subject to rejection.

III. TERMS USED CONTRARY TO THEIRORDINARY MEANING MUST BE CLEARLYREDEFINED IN THE WRITTEN DESCRIPTION

Consistent with the well-established axiom in patentlaw that a patentee or applicant is free to be his orher own lexicographer, a patentee or applicant mayuse terms in a manner contrary to or inconsistentwith one or more of their ordinary meanings if thewritten description clearly redefines the terms. See,e.g., Process Control Corp. v. HydReclaim Corp.,190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed.Cir. 1999) (“While we have held many times that apatentee can act as his own lexicographer tospecifically define terms of a claim contrary to theirordinary meaning,” in such a situation the writtendescription must clearly redefine a claim term “soas to put a reasonable competitor or one reasonablyskilled in the art on notice that the patentee intendedto so redefine that claim term.”); Hormone ResearchFoundation Inc. v. Genentech Inc., 904 F.2d 1558,15 USPQ2d 1039 (Fed. Cir. 1990). Accordingly,when there is more than one meaning for a term, itis incumbent upon applicant to make clear whichmeaning is being relied upon to claim the invention.Until the meaning of a term or phrase used in a claimis clear, a rejection under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph isappropriate. It is appropriate to compare the meaningof terms given in technical dictionaries in order toascertain the accepted meaning of a term in the art. In re Barr, 444 F.2d 588, 170 USPQ 330 (CCPA1971). See also MPEP § 2111.01.

2173.05(b) Relative Terminology [R-08.2017]

The use of relative terminology in claim language,including terms of degree, does not automaticallyrender the claim indefinite under 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph. SeattleBox Co., Inc. v. Industrial Crating & Packing, Inc.,731 F.2d 818, 221 USPQ 568 (Fed. Cir. 1984).Acceptability of the claim language depends onwhether one of ordinary skill in the art wouldunderstand what is claimed, in light of thespecification.

2100-364Rev. 08.2017, January 2018


I. TERMS OF DEGREE

Terms of degree are not necessarily indefinite.“Claim language employing terms of degree haslong been found definite where it provided enoughcertainty to one of skill in the art when read in thecontext of the invention." Interval Licensing LLCv. AOL, Inc., 766 F.3d 1364, 1370, 112 USPQ2d1188, 1192-93 (Fed. Cir. 2014) (citing Eibel ProcessCo. v. Minnesota & Ontario Paper Co., 261 U.S.45, 65-66 (1923) (finding ‘substantial pitch’sufficiently definite because one skilled in the art‘had no difficulty … in determining what was thesubstantial pitch needed’ to practice the invention)).Thus, when a term of degree is used in the claim,the examiner should determine whether thespecification provides some standard for measuringthat degree. Hearing Components, Inc. v. Shure Inc.,600 F.3d 1357, 1367, 94 USPQ2d 1385, 1391 (Fed.Cir. 2010); Enzo Biochem, Inc., v. Applera Corp.,599 F.3d 1325, 1332, 94 USPQ2d 1321, 1326 (Fed.Cir. 2010); Seattle Box Co., Inc. v. Indus. Crating& Packing, Inc., 731 F.2d 818, 826, 221 USPQ 568,574 (Fed. Cir. 1984). If the specification does notprovide some standard for measuring that degree, adetermination must be made as to whether one ofordinary skill in the art could nevertheless ascertainthe scope of the claim (e.g., a standard that isrecognized in the art for measuring the meaning ofthe term of degree). For example, in Ex parteOetiker, 23 USPQ2d 1641 (Bd. Pat. App. & Inter.1992), the phrases “relatively shallow,” “of the orderof,” “the order of about 5mm,” and “substantialportion” were held to be indefinite because thespecification lacked some standard for measuringthe degrees intended.

The claim is not indefinite if the specificationprovides examples or teachings that can be used tomeasure a degree even without a precise numericalmeasurement (e.g., a figure that provides a standardfor measuring the meaning of the term of degree).See, e.g., Interval Licensing LLC v. AOL, Inc., 766F.3d 1364, 1371-72, 112 USPQ2d 1188, 1193 (Fed.Cir. 2014) (observing that although there is noabsolute or mathematical precision required, “[t]heclaims, when read in light of the specification andthe prosecution history, must provide objectiveboundaries for those of skill in the art”).

During prosecution, an applicant may also overcomean indefiniteness rejection by providing evidencethat the meaning of the term of degree can beascertained by one of ordinary skill in the art whenreading the disclosure. For example, in EnzoBiochem, the applicant submitted a declarationunder 37 CFR 1.132 showing examples that met theclaim limitation and examples that did not. EnzoBiochem, 599 F.3d at 1335, 94 USPQ2d at 1328(noting that applicant overcame an indefinitenessrejection over “not interfering substantially” claimlanguage by submitting a declaration under 37 CFR1.132 listing eight specific linkage groups thatapplicant declared did not substantially interfere withhybridization or detection).

Even if the specification uses the same term ofdegree as in the claim, a rejection is proper if thescope of the term is not understood when read inlight of the specification. While, as a generalproposition, broadening modifiers are standard toolsin claim drafting in order to avoid reliance on thedoctrine of equivalents in infringement actions, whenthe scope of the claim is unclear a rejection under35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph, is proper. See In re Wiggins, 488 F. 2d538, 541, 179 USPQ 421, 423 (CCPA 1973).

When relative terms are used in claims wherein theimprovement over the prior art rests entirely uponsize or weight of an element in a combination ofelements, the adequacy of the disclosure of astandard is of greater criticality.

II. REFERENCE TO AN OBJECT THAT ISVARIABLE MAY RENDER A CLAIM INDEFINITE

A claim may be rendered indefinite by reference toan object that is variable. See, e.g., Ex parteMiyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter.2008) (precedential) and Ex parte Brummer, 12USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). In Miyazaki, the Board held that claims to a largeprinter were not sufficiently definite because:

The language of claim 1 attempts to claim theheight of the paper feeding unit in relation to auser of a specific height who is performingoperations on the printer.... Claim 1 fails to

Rev. 08.2017, January 20182100-365


specify, however, a positional relationship ofthe user and the printer to each other.

Miyazaki, 89 USPQ2d at 1212. In Brummer, theBoard held that a limitation in a claim to a bicyclethat recited “said front and rear wheels so spaced asto give a wheelbase that is between 58 percent and75 percent of the height of the rider that the bicyclewas designed for” was indefinite because therelationship of parts was not based on any knownstandard for sizing a bicycle to a rider, but on a riderof unspecified build. Brummer, 12 USPQ2d at 1655.

On the other hand, a claim limitation specifying thata certain part of a pediatric wheelchair be “sodimensioned as to be insertable through the spacebetween the doorframe of an automobile and one ofthe seats” was held to be definite. Orthokinetics,Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1USPQ2d 1081 (Fed. Cir. 1986). The court stated thatthe phrase “so dimensioned” is as accurate as thesubject matter permits, noting that the patent lawdoes not require that all possible lengthscorresponding to the spaces in hundreds of differentautomobiles be listed in the patent, let alone thatthey be listed in the claims.

III. APPROXIMATIONS

A. “About”

In determining the range encompassed by the term“about”, one must consider the context of the termas it is used in the specification and claims of theapplication. Ortho-McNeil Pharm., Inc. v. CaracoPharm. Labs., Ltd., 476 F.3d 1321, 1326, 81USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore& Associates, Inc. v. Garlock, Inc., 721 F.2d 1540,220 USPQ 303 (Fed. Cir. 1983), the court held thata limitation defining the stretch rate of a plastic as“exceeding about 10% per second” is definitebecause infringement could clearly be assessedthrough the use of a stopwatch. However, in anothercase, the court held that claims reciting “at leastabout” were invalid for indefiniteness where therewas close prior art and there was nothing in thespecification, prosecution history, or the prior art toprovide any indication as to what range of specificactivity is covered by the term “about.” Amgen, Inc.

v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18USPQ2d 1016 (Fed. Cir. 1991).

B. “Essentially”

The phrase “a silicon dioxide source that isessentially free of alkali metal” was held to bedefinite because the specification containedguidelines and examples that were consideredsufficient to enable a person of ordinary skill in theart to draw a line between unavoidable impurities instarting materials and essential ingredients. Inre Marosi, 710 F.2d 799, 218 USPQ 289 (CCPA1983). The court further observed that it would beimpractical to require applicants to specify aparticular number as a cutoff between their inventionand the prior art.

C. “Similar”

The term “similar” in the preamble of a claim thatwas directed to a nozzle “for high-pressure cleaningunits or similar apparatus” was held to be indefinitesince it was not clear what applicant intended tocover by the recitation “similar” apparatus. Exparte Kristensen, 10 USPQ2d 1701 (Bd. Pat. App.& Inter. 1989).

A claim in a design patent application which read:“The ornamental design for a feed bunk or similarstructure as shown and described.” was held to beindefinite because it was unclear from thespecification what applicant intended to cover bythe recitation of “similar structure.” Exparte Pappas, 23 USPQ2d 1636 (Bd. Pat. App. &Inter. 1992).

D. “Substantially”

The term “substantially” is often used in conjunctionwith another term to describe a particularcharacteristic of the claimed invention. It is a broadterm. In re Nehrenberg, 280 F.2d 161, 126 USPQ383 (CCPA 1960). The court held that the limitation“to substantially increase the efficiency of thecompound as a copper extractant” was definite inview of the general guidelines contained in thespecification. In re Mattison, 509 F.2d 563, 184USPQ 484 (CCPA 1975). The court held that thelimitation “which produces substantially equal E and

2100-366Rev. 08.2017, January 2018


H plane illumination patterns” was definite becauseone of ordinary skill in the art would know what wasmeant by “substantially equal.” AndrewCorp. v. Gabriel Electronics, 847 F.2d 819,6 USPQ2d 2010 (Fed. Cir. 1988).

E. “Type”

The addition of the word “type” to an otherwisedefinite expression (e.g., Friedel-Crafts catalyst)extends the scope of the expression so as to renderit indefinite. Ex parte Copenhaver, 109 USPQ 118(Bd. Pat. App. & Inter. 1955). Likewise, the phrase“ZSM-5-type aluminosilicate zeolites” was held tobe indefinite because it was unclear what “type” wasintended to convey. The interpretation was mademore difficult by the fact that the zeolites defined inthe dependent claims were not within the genus ofthe type of zeolites defined in the independent claim. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. &Inter. 1986).

IV. SUBJECTIVE TERMS

When a subjective term is used in the claim, theexaminer should determine whether the specificationsupplies some standard for measuring the scope ofthe term, similar to the analysis for a term of degree.Some objective standard must be provided in orderto allow the public to determine the scope of theclaim. A claim that requires the exercise ofsubjective judgment without restriction may renderthe claim indefinite. In re Musgrave, 431 F.2d 882,893, 167 USPQ 280, 289 (CCPA 1970). Claim scopecannot depend solely on the unrestrained, subjectiveopinion of a particular individual purported to bepracticing the invention. Datamize LLC v. PlumtreeSoftware, Inc., 417 F.3d 1342, 1350, 75 USPQ2d1801, 1807 (Fed. Cir. 2005)); see also IntervalLicensing LLC v. AOL, Inc., 766 F.3d 1364, 1373,112 USPQ2d 1188 (Fed. Cir. 2014) (holding theclaim phrase “unobtrusive manner” indefinitebecause the specification did not “provide areasonably clear and exclusive definition, leavingthe facially subjective claim language without anobjective boundary”).

For example, in Datamize, the invention wasdirected to a computer interface screen with an“aesthetically pleasing look and feel.” Datamize,

417 F.3d at 1344-45. The meaning of the term“aesthetically pleasing” depended solely on thesubjective opinion of the person selecting featuresto be included on the interface screen. Nothing inthe intrinsic evidence (e.g., the specification)provided any guidance as to what design choiceswould result in an “aesthetically pleasing” look andfeel. Id. at 1352. The claims were held indefinitebecause the interface screen may be “aestheticallypleasing” to one user but not to another. Id. at 1350.See also Ex parte Anderson, 21 USPQ2d 1241 (Bd.Pat. App. & Inter. 1991) (the terms “comparable”and “superior” were held to be indefinite in thecontext of a limitation relating the characteristics ofthe claimed material to other materials).

During prosecution, the applicant may overcome arejection by amending the claim to remove thesubjective term, or by providing evidence that themeaning of the term can be ascertained by one ofordinary skill in the art when reading the disclosure.However, “[f]or some facially subjective terms, thedefiniteness requirement is not satisfied by merelyoffering examples that satisfy the term within thespecification.” DDR Holdings, LLC v. Hotels.com,L.P., 773 F.3d 1245, 1261, 113 USPQ2d 1097, 1108(Fed. Cir. 2014).

2173.05(c) Numerical Ranges and AmountsLimitations [R-11.2013]

Generally, the recitation of specific numerical rangesin a claim does not raise an issue of whether a claimis definite.

I. NARROW AND BROADER RANGES IN THESAME CLAIM

Use of a narrow numerical range that falls within abroader range in the same claim may render theclaim indefinite when the boundaries of the claimare not discernible. Description of examples andpreferences is properly set forth in the specificationrather than in a single claim. A narrower range orpreferred embodiment may also be set forth inanother independent claim or in a dependent claim.If stated in a single claim, examples and preferenceslead to confusion over the intended scope of theclaim. In those instances where it is not clear whetherthe claimed narrower range is a limitation, a rejection

Rev. 08.2017, January 20182100-367


under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph should be made. The Examinershould analyze whether the metes and bounds of theclaim are clearly set forth. Examples of claimlanguage which have been held to be indefinite are(A) “a temperature of between 45 and 78 degreesCelsius, preferably between 50 and 60 degreesCelsius”; and (B) “a predetermined quantity, forexample, the maximum capacity.”

While a single claim that includes both a broad anda narrower range may be indefinite, it is not improperunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112,second paragraph, to present a dependent claim thatsets forth a narrower range for an element than therange set forth in the claim from which it depends.For example, if claim 1 reads “A circuit … whereinthe resistance is 70-150 ohms.” and claim 2 reads“The circuit of claim 1 wherein the resistance is70-100 ohms.”, then claim 2 should not be rejectedas indefinite.

II. OPEN-ENDED NUMERICAL RANGES

Open-ended numerical ranges should be carefullyanalyzed for definiteness. For example, when anindependent claim recites a composition comprising“at least 20% sodium” and a dependent claim setsforth specific amounts of nonsodium ingredientswhich add up to 100%, apparently to the exclusionof sodium, an ambiguity is created with regard tothe “at least” limitation (unless the percentages ofthe nonsodium ingredients are based on the weightof the nonsodium ingredients). On the other hand,the court held that a composition claimed to have atheoretical content greater than 100% (i.e., 20-80%of A, 20-80% of B and 1-25% of C) was notindefinite simply because the claims may be read intheory to include compositions that are impossiblein fact to formulate. It was observed that subjectmatter which cannot exist in fact can neitheranticipate nor infringe a claim. In re Kroekel, 504F.2d 1143, 183 USPQ 610 (CCPA 1974).

In a claim directed to a chemical reaction process,a limitation required that the amount of oneingredient in the reaction mixture should “bemaintained at less than 7 mole percent” based on theamount of another ingredient. The examiner arguedthat the claim was indefinite because the limitation

sets only a maximum amount and is inclusive ofsubstantially no ingredient resulting in terminationof any reaction. The court did not agree, holding thatthe claim was clearly directed to a reaction process,and explaining that “[t]he imposition of a maximumlimit on the quantity of one of the reactants withoutspecifying a minimum does not warrant distortingthe overall meaning of the claim to precludeperforming the claimed process.” In re Kirsch, 498F.2d 1389, 1394, 182 USPQ 286, 290 (CCPA 1974).

Some terms have been determined to have thefollowing meanings in the factual situations of thereported cases: the term “up to” includes zero as alower limit, In re Mochel, 470 F.2d 638, 176 USPQ194 (CCPA 1974); and “a moisture content of notmore than 70% by weight” reads on dry material, Ex parte Khusid, 174 USPQ 59 (Bd. App. 1971).

III. “EFFECTIVE AMOUNT”

The common phrase “an effective amount” may ormay not be indefinite. The proper test is whether ornot one skilled in the art could determine specificvalues for the amount based on the disclosure. See In re Mattison, 509 F.2d 563, 184 USPQ 484(CCPA 1975). The phrase “an effective amount . . .for growth stimulation” was held to be definite wherethe amount was not critical and those skilled in theart would be able to determine from the writtendisclosure, including the examples, what an effectiveamount is. In re Halleck, 422 F.2d 911, 164 USPQ647 (CCPA 1970). The phrase “an effective amount”has been held to be indefinite when the claim failsto state the function which is to be achieved andmore than one effect can be implied from thespecification or the relevant art. In re Fredericksen,213 F.2d 547, 102 USPQ 35 (CCPA 1954). Themore recent cases have tended to accept a limitationsuch as “an effective amount” as being definite whenread in light of the supporting disclosure and in theabsence of any prior art which would give rise touncertainty about the scope of the claim. In Exparte Skuballa, 12 USPQ2d 1570 (Bd. Pat. App. &Inter. 1989), the Board held that a pharmaceuticalcomposition claim which recited an “effectiveamount of a compound of claim 1” without statingthe function to be achieved was definite, particularlywhen read in light of the supporting disclosure which

2100-368Rev. 08.2017, January 2018


provided guidelines as to the intended utilities andhow the uses could be effected.

2173.05(d) Exemplary Claim Language (“forexample,” “such as”) [R-07.2015]

Description of examples or preferences is properlyset forth in the specification rather than the claims.If stated in the claims, examples and preferencesmay lead to confusion over the intended scope of aclaim. In those instances where it is not clear whetherthe claimed narrower range is a limitation, a rejectionunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph should be made. The examinershould analyze whether the metes and bounds of theclaim are clearly set forth. Note that the mere use ofthe phrase "such as" or "for example" in a claim doesnot by itself render the claim indefinite.

Examples of claim language which have been heldto be indefinite because the intended scope of theclaim was unclear are:

(A) “R is halogen, for example, chlorine”;

(B) “material such as rock wool or asbestos” Exparte Hall, 83 USPQ 38 (Bd. App. 1949);

(C) “lighter hydrocarbons, such, for example,as the vapors or gas produced” Ex parte Hasche,86 USPQ 481 (Bd. App. 1949);

(D) “normal operating conditions such as whilein the container of a proportioner” Exparte Steigerwald, 131 USPQ 74 (Bd. App. 1961);and

(E) “coke, brick, or like material”. Ex parteCaldwell, 1906 C.D. 58 (Comm’r Pat. 1906).

The above examples of claim language which havebeen held to be indefinite are fact specific and shouldnot be applied as per se rules. See MPEP § 2173.02for guidance regarding when it is appropriate tomake a rejection under 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph.

2173.05(e) Lack of Antecedent Basis[R-08.2017]

A claim is indefinite when it contains words orphrases whose meaning is unclear. In re Packard,

751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed.Cir. 2014). The lack of clarity could arise where aclaim refers to “said lever” or “the lever,” where theclaim contains no earlier recitation or limitation ofa lever and where it would be unclear as to whatelement the limitation was making reference.Similarly, if two different levers are recited earlierin the claim, the recitation of “said lever” in the sameor subsequent claim would be unclear where it isuncertain which of the two levers was intended.A claim which refers to “said aluminum lever,”but recites only “a lever” earlier in the claim, isindefinite because it is uncertain as to the lever towhich reference is made. Obviously, however, thefailure to provide explicit antecedent basis for termsdoes not always render a claim indefinite. If thescope of a claim would be reasonably ascertainableby those skilled in the art, then the claim is notindefinite. Ex parte Porter, 25 USPQ2d 1144, 1145(Bd. Pat. App. & Inter. 1992) (“controlled stream offluid” provided reasonable antecedent basis for “thecontrolled fluid”). Inherent components of elementsrecited have antecedent basis in the recitation of thecomponents themselves. For example, the limitation“the outer surface of said sphere” would not requirean antecedent recitation that the sphere has an outersurface. See Bose Corp. v. JBL, Inc., 274 F.3d 1354,1359, 61 USPQ2d 1216, 1218-19 (Fed. Cir 2001)(holding that recitation of “an ellipse” providedantecedent basis for “an ellipse having a majordiameter” because “[t]here can be no dispute thatmathematically an inherent characteristic of anellipse is a major diameter”).

I. EXAMINER SHOULD SUGGESTCORRECTIONS TO ANTECEDENT PROBLEMS

Antecedent problems in the claims are typicallydrafting oversights that are easily corrected oncethey are brought to the attention of applicant. Theexaminer’s task of making sure the claim languagecomplies with the requirements of the statute shouldbe carried out in a positive and constructive way,so that minor problems can be identified and easilycorrected, and so that the major effort is expendedon more substantive issues. However, even thoughindefiniteness in claim language is of semanticorigin, it is not rendered unobjectionable simplybecause it could have been corrected. In re

Rev. 08.2017, January 20182100-369

§ 2173.05(e)PATENTABILITY

Hammack, 427 F.2d 1384, 1388 n.5, 166 USPQ 209,213 n.5 (CCPA 1970).

II. A CLAIM TERM WHICH HAS NOANTECEDENT BASIS IN THE DISCLOSURE ISNOT NECESSARILY INDEFINITE

The mere fact that a term or phrase used in the claimhas no antecedent basis in the specificationdisclosure does not mean, necessarily, that the termor phrase is indefinite. There is no requirement thatthe words in the claim must match those used in thespecification disclosure. Applicants are given a greatdeal of latitude in how they choose to define theirinvention so long as the terms and phrases useddefine the invention with a reasonable degree ofclarity and precision.

III. A CLAIM IS NOT PER SE INDEFINITE IFTHE BODY OF THE CLAIM RECITESADDITIONAL ELEMENTS WHICH DO NOTAPPEAR IN THE PREAMBLE

The mere fact that the body of a claim recitesadditional elements which do not appear in theclaim’s preamble does not render the claim indefiniteunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph. See In re Larsen, 10 Fed. App'x890 (Fed. Cir. 2001) (The preamble of the Larsenclaim recited only a hanger and a loop but the bodyof the claim positively recited a linear member. Theexaminer rejected the claim under 35 U.S.C. 112,second paragraph, because the omission from theclaim’s preamble of a critical element (i.e., a linearmember) renders that claim indefinite. The courtreversed the examiner’s rejection and stated that thetotality of all the limitations of the claim and theirinteraction with each other must be considered toascertain the inventor’s contribution to the art. Uponreview of the claim in its entirety, the courtconcluded that the claim at issue apprises one ofordinary skill in the art of its scope and, therefore,serves the notice function required by 35 U.S.C. 112,paragraph 2.).

2173.05(f) Reference to Limitations inAnother Claim [R-11.2013]

A claim which makes reference to a preceding claimto define a limitation is an acceptable claim

construction which should not necessarily be rejectedas improper or confusing under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph. Forexample, claims which read: “The product producedby the method of claim 1.” or “A method ofproducing ethanol comprising contacting amylosewith the culture of claim 1 under the followingconditions .....” are not indefinite under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,merely because of the reference to another claim.See also Ex parte Porter, 25 USPQ2d 1144 (Bd.Pat. App. & Inter. 1992) (where reference to “thenozzle of claim 7” in a method claim was held tocomply with 35 U.S.C. 112, second paragraph).However, where the format of making reference tolimitations recited in another claim results inconfusion, then a rejection would be proper under35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph.

When examining a dependent claim, the examinershould also determine whether the claim complieswith 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112,fourth paragraph. See MPEP § 608.01(n), subsectionII.

2173.05(g) Functional Limitations[R-08.2017]

A claim term is functional when it recites a feature“by what it does rather than by what it is” (e.g., asevidenced by its specific structure or specificingredients). In re Swinehart, 439 F.2d 210, 212,169 USPQ 226, 229 (CCPA 1971). There is nothinginherently wrong with defining some part of aninvention in functional terms. Functional languagedoes not, in and of itself, render a claim improper. Id. In fact, 35 U.S.C. 112(f) and pre-AIA 35 U.S.C.112, sixth paragraph, expressly authorize a form offunctional claiming (means- (or step-) plus- functionclaim limitations discussed in MPEP § 2181 et seq.).Functional language may also be employed to limitthe claims without using the means-plus-functionformat. See, e.g., K-2 Corp. v. Salomon S.A., 191F.3d 1356, 1363, 52 USPQ2d 1001, 1005 (Fed. Cir.1999). Unlike means-plus-function claim languagethat applies only to purely functional limitations, Phillips v. AWH Corp., 415 F.3d 1303, 1311, 75USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc)(“Means-plus-function claiming applies only to

2100-370Rev. 08.2017, January 2018


purely functional limitations that do not provide thestructure that performs the recited function.”),functional claiming often involves the recitation ofsome structure followed by its function. For example,in In re Schreiber, the claims were directed to aconical spout (the structure) that “allow[ed] severalkernels of popped popcorn to pass through at thesame time” (the function). In re Schreiber, 128 F.3d1473, 1478, 44 USPQ2d 1429, 1431 (Fed. Cir.1997). As noted by the court in Schreiber, “[a]patent applicant is free to recite features of anapparatus either structurally or functionally.” Id.

A functional limitation must be evaluated andconsidered, just like any other limitation of the claim,for what it fairly conveys to a person of ordinaryskill in the pertinent art in the context in which it isused. A functional limitation is often used inassociation with an element, ingredient, or step of aprocess to define a particular capability or purposethat is served by the recited element, ingredient orstep. In Innova/Pure Water Inc. v. Safari WaterFiltration Sys. Inc., 381 F.3d 1111, 1117-20, 72USPQ2d 1001, 1006-08 (Fed. Cir. 2004), the courtnoted that the claim term “operatively connected”is “a general descriptive claim term frequently usedin patent drafting to reflect a functional relationshipbetween claimed components,” that is, the term“means the claimed components must be connectedin a way to perform a designated function.” “In theabsence of modifiers, general descriptive terms aretypically construed as having their full meaning.” Id. at 1118, 72 USPQ2d at 1006. In the patent claimat issue, “subject to any clear and unmistakabledisavowal of claim scope, the term ‘operativelyconnected’ takes the full breath of its ordinarymeaning, i.e., ‘said tube [is] operatively connectedto said cap’ when the tube and cap are arranged ina manner capable of performing the function offiltering.” Id. at 1120, 72 USPQ2d at 1008.

Other examples of permissible function languageinclude the following.

It was held that the limitation used to define a radical on achemical compound as “incapable of forming a dye with saidoxidizing developing agent” although functional, was perfectlyacceptable because it set definite boundaries on the patentprotection sought. In re Barr, 444 F.2d 588, 170 USPQ 330(CCPA 1971).

In a claim that was directed to a kit of component parts capableof being assembled, the court held that limitations such as“members adapted to be positioned” and “portions . . . beingresiliently dilatable whereby said housing may be slidablypositioned” serve to precisely define present structural attributesof interrelated component parts of the claimed assembly. In reVenezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976).

Notwithstanding the permissible instances, the useof functional language in a claim may fail “toprovide a clear-cut indication of the scope of thesubject matter embraced by the claim” and thus beindefinite. In re Swinehart, 439 F.2d 210, 213(CCPA 1971). For example, when claims merelyrecite a description of a problem to be solved or afunction or result achieved by the invention, theboundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir.2008) (noting that the Supreme Court explained thata vice of functional claiming occurs “when theinventor is painstaking when he recites what hasalready been seen, and then uses convenientlyfunctional language at the exact point of novelty”)(quoting General Elec. Co. v. Wabash ApplianceCorp., 304 U.S. 364, 371 (1938)); see also UnitedCarbon Co. v. Binney & Smith Co., 317 U.S. 228,234 (1942) (holding indefinite claims that recitedsubstantially pure carbon black “in the form ofcommercially uniform, comparatively small, roundedsmooth aggregates having a spongy or porousexterior”). Further, without reciting the particularstructure, materials or steps that accomplish thefunction or achieve the result, all means or methodsof resolving the problem may be encompassed bythe claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly& Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173(Fed. Cir. 2010) (en banc). See also Datamize LLCv. Plumtree Software Inc., 75 USPQ2d 1801 (Fed.Cir. 2005) where a claim directed to a software basedsystem for creating a customized computer interfacescreen recited that the screen be "aestheticallypleasing," which is an intended result and does notprovide a clear cut indication of scope because itimposed no structural limits on the screen. Unlimitedfunctional claim limitations that extend to all meansor methods of resolving a problem may not beadequately supported by the written description ormay not be commensurate in scope with the enablingdisclosure, both of which are required by 35 U.S.C.112(a) and pre-AIA 35 U.S.C. 112, first paragraph.

Rev. 08.2017, January 20182100-371

§ 2173.05(g)PATENTABILITY

In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197(Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94USPQ2d at 1167. For instance, a single means claimcovering every conceivable means for achieving thestated result was held to be invalid under 35 U.S.C.112, first paragraph because the court recognizedthat the specification, which disclosed only thosemeans known to the inventor, was not commensuratein scope with the claim. Hyatt, 708 F.2d at 714-715,218 USPQ at 197. For more information regardingthe written description requirement and enablementrequirement under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, see MPEP §§2161-2164.08(c). Examiners should keep in mindthat whether or not the functional limitation complieswith 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, is a different issue from whetherthe limitation is properly supported under 35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph,or is distinguished over the prior art.

When a claim limitation employs functionallanguage, the examiner’s determination of whetherthe limitation is sufficiently definite will be highlydependent on context (e.g., the disclosure in thespecification and the knowledge of a person ofordinary skill in the art). Halliburton Energy Servs.,514 F.3d at 1255, 85 USPQ2d at 1663. For example,a claim that included the term “fragile gel” wasfound to be indefinite because the definition of theterm in the specification was functional, i.e., the fluidis defined by what it does rather than what it is(“ability of the fluid to transition quickly from gelto liquid, and the ability of the fluid to suspend drillcuttings at rest”), and it was ambiguous as to therequisite degree of the fragileness of the gel, theability of the gel to suspend drill cuttings (i.e., gelstrength), and/or some combination of the two. Halliburton Energy Servs., 514 F.3d at 1255-56, 85USPQ2d at 1663. In another example, the claimsdirected to a tungsten filament for electricincandescent lamps were held invalid for includinga limitation that recited “comparatively large grainsof such size and contour as to prevent substantialsagging or offsetting during a normal orcommercially useful life for such a lamp or otherdevice.” General Elec. Co., 304 U.S. at 370-71,375. The Court observed that the prior art filamentsalso “consisted of comparatively large crystals” butthey were “subject to offsetting” or shifting, and the

Court further found that the phrase “of such size andcontour as to prevent substantial sagging andoffsetting during a normal or commercially usefullife for a lamp or other device” did not adequatelydefine the structural characteristics of the grains(e.g., the size and contour) to distinguish the claimedinvention from the prior art. Id. at 370. Similarly, aclaim was held invalid because it recited “sustantially(sic) pure carbon black in the form of commerciallyuniform, comparatively small, rounded smoothaggregates having a spongy or porous exterior.” United Carbon Co., 317 U.S. at 234. In the latterexample, the Court observed various problems withthe limitation: “commercially uniform” meant onlythe degree of uniformity buyers desired;“comparatively small” did not add anything becauseno standard for comparison was given; and “spongy”and “porous” are synonyms that the Court foundunhelpful in distinguishing the claimed inventionfrom the prior art. Id. at 233.

In comparison, a claim limitation reciting“transparent to infrared rays” was held to be definitebecause the specification showed that a substantialamount of infrared radiation was always transmittedeven though the degree of transparency varieddepending on certain factors. Swinehart, 439 F.2dat 214, 169 USPQ at 230. Likewise, the claims inanother case were held definite because applicantprovided “a general guideline and examplessufficient to enable a person of ordinary skill in theart to determine whether a process uses a silicondioxide source ‘essentially free of alkali metal’ tomake a reaction mixture ‘essentially free of alkalimetal’ to produce a zeolitic compound ‘essentiallyfree of alkali metal.’” In re Marosi, 710 F.2d 799,803, 218 USPQ 289, 293 (Fed. Cir. 1983).

Examiners should consider the following factorswhen examining claims that contain functionallanguage to determine whether the language isambiguous: (1) whether there is a clear cut indicationof the scope of the subject matter covered by theclaim; (2) whether the language sets forthwell-defined boundaries of the invention or onlystates a problem solved or a result obtained; and (3)whether one of ordinary skill in the art would knowfrom the claim terms what structure or steps areencompassed by the claim. These factors areexamples of points to be considered when

2100-372Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2173.05(g)

determining whether language is ambiguous and arenot intended to be all inclusive or limiting. Otherfactors may be more relevant for particular arts. Theprimary inquiry is whether the language leaves roomfor ambiguity or whether the boundaries are clearand precise.

During prosecution, applicant may resolve theambiguities of a functional limitation in a numberof ways. For example: (1) “the ambiguity might beresolved by using a quantitative metric (e.g., numericlimitation as to a physical property) rather than aqualitative functional feature” (see HalliburtonEnergy Servs., 514 F.3d at 1255-56, 85 USPQ2d at1663); (2) applicant could demonstrate that the“specification provide[s] a formula for calculatinga property along with examples that meet the claimlimitation and examples that do not” (see id. at 1256,85 USPQ2d at 1663 (citing Oakley, Inc. v. SunglassHut Int’l, 316 F.3d 1331, 1341, 65 USPQ2d 1321,1326 (Fed. Cir. 2003))); (3) applicant coulddemonstrate that the specification provides a generalguideline and examples sufficient to teach a personskilled in the art when the claim limitation wassatisfied (see Marosi, 710 F.2d at 803, 218 USPQat 292); or (4) applicant could amend the claims torecite the particular structure that accomplishes thefunction.

2173.05(h) Alternative Limitations[R-08.2017]

I. MARKUSH GROUPS

A claim which recites a list of alternatives to definea limitation is an acceptable claim constructionwhich should not necessarily be rejected as confusingunder 35 U.S.C. 112(b) or as improper. See MPEP§ 706.03(y) for guidelines regarding thedetermination of whether a Markush grouping isimproper.

Treatment of claims reciting alternatives is notgoverned by the particular format used (e.g.,alternatives may be set forth as “a material selectedfrom the group consisting of A, B, and C” or“wherein the material is A, B, or C”). See, e.g., the Supplementary Examination Guidelines forDetermining Compliance with 35 U.S.C. 112 andfor Treatment of Related Issues in Patent

Applications (“Supplementary Guidelines”), 76 Fed.Reg. 7162, 7166 (February 9, 2011). Claims that setforth a list of alternatives from which a selection isto be made are typically referred to as Markushclaims, after the appellant in Ex parte Markush,1925 Dec. Comm’r Pat. 126, 127 (1924). The listingof specified alternatives within a Markush claim isreferred to as a Markush group or Markush grouping. Abbott Labs v. Baxter Pharmaceutical Products,Inc., 334 F.3d 1274, 1280-81, 67 USPQ2d 1191,1196-97 (Fed. Cir. 2003) (citing to several sourcesthat describe Markush groups).

See MPEP § 2117 for a general discussion ofMarkush claims, MPEP § 706.03(y) for guidelinesregarding the determination of whether a Markushgrouping is improper, and MPEP § 803.02 for adiscussion of election requirements in Markushclaims.

A Markush grouping is a closed group ofalternatives, i.e., the selection is made from a group“consisting of” (rather than “comprising” or“including”) the alternative members. Abbott Labs.,334 F.3d at 1280, 67 USPQ2d at 1196. If a Markushgrouping requires a material selected from an openlist of alternatives (e.g., selected from the group“comprising” or “consisting essentially of” therecited alternatives), the claim should generally berejected under 35 U.S.C. 112(b) as indefinite becauseit is unclear what other alternatives are intended tobe encompassed by the claim. If a claim is intendedto encompass combinations or mixtures of thealternatives set forth in the Markush grouping, theclaim may include qualifying language precedingthe recited alternatives (such as “at least onemember” selected from the group), or within the listof alternatives (such as “or mixtures thereof”). Id.at 1281. See also MPEP § 2111.03.

A Markush grouping may include a large numberof alternatives, and as a result a Markush claim mayencompass a large number of alternative membersor embodiments, but a claim is not necessarilyindefinite under 35 U.S.C. 112(b) for such breadth. In re Gardner, 427 F.2d 786, 788, 166 USPQ 138,140 (CCPA 1970) (“Breadth is not indefiniteness.”).In certain circumstances, however, a Markush groupmay be so expansive that persons skilled in the artcannot determine the metes and bounds of the

Rev. 08.2017, January 20182100-373

§ 2173.05(h)PATENTABILITY

claimed invention. For example, if a claim definesa chemical compound using one or more Markushgroups, and that claim encompasses a massivenumber of distinct alternative members, the claimmay be indefinite under 35 U.S.C. 112(b) if oneskilled in the art cannot determine its metes andbounds due to an inability to envision all of thecompounds defined by the Markush group(s). Insuch a circumstance, a rejection of the claim forindefiniteness under 35 U.S.C. 112(b) is appropriate.

The use of Markush claims of diminishing scopeshould not, in itself, be considered a sufficient basisfor objection to or rejection of claims. However, ifsuch a practice renders the claims indefinite or if itresults in undue multiplicity, an appropriate rejectionshould be made.

Similarly, the double inclusion of an element bymembers of a Markush group is not, in itself,sufficient basis for objection to or rejection of claims.Rather, the facts in each case must be evaluated todetermine whether or not the multiple inclusion ofone or more elements in a claim renders that claimindefinite. The mere fact that a compound may beembraced by more than one member of a Markushgroup recited in the claim does not necessarily renderthe scope of the claim unclear. For example, theMarkush group, “selected from the group consistingof amino, halogen, nitro, chloro and alkyl” shouldbe acceptable even though “halogen” is generic to“chloro.” See, e.g., Eli Lilly & Co. v. TevaParenteral Meds., 845 F.3d 1357, 1371,121 USPQ2d1277, 1287 (Fed. Cir. 2017) (redundancy ofincluding both “vitamin B12” and “cyanocobalamin”(which were recognized on the record as referencingthe same compound) within a Markush group ofmethylmalonic acid lowering agents did not renderthe claims indefinite).

II. “OPTIONALLY”

Another alternative format which requires someanalysis before concluding whether or not thelanguage is indefinite involves the use of the term“optionally.” In Ex parte Cordova, 10 USPQ2d1949 (Bd. Pat. App. & Inter. 1989) the language“containing A, B, and optionally C” was consideredacceptable alternative language because there wasno ambiguity as to which alternatives are covered

by the claim. A similar holding was reached withregard to the term “optionally” in Ex parte Wu, 10USPQ2d 2031 (Bd. Pat. App. & Inter. 1989). In theinstance where the list of potential alternatives canvary and ambiguity arises, then it is proper to makea rejection under 35 U.S.C. 112(b) and explain whythere is confusion.

2173.05(i) Negative Limitations [R-08.2017]

The current view of the courts is that there is nothinginherently ambiguous or uncertain about a negativelimitation. So long as the boundaries of the patentprotection sought are set forth definitely, albeitnegatively, the claim complies with the requirementsof 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph. Some older cases were critical ofnegative limitations because they tended to definethe invention in terms of what it was not, rather thanpointing out the invention. Thus, the court observedthat the limitation “R is an alkenyl radical other than2-butenyl and 2,4-pentadienyl” was a negativelimitation that rendered the claim indefinite becauseit was an attempt to claim the invention by excludingwhat the inventors did not invent rather thandistinctly and particularly pointing out what they didinvent. In re Schechter, 205 F.2d 185, 98 USPQ144 (CCPA 1953).

A claim which recited the limitation “saidhomopolymer being free from the proteins, soaps,resins, and sugars present in natural Hevea rubber”in order to exclude the characteristics of the priorart product, was considered definite because eachrecited limitation was definite. In re Wakefield, 422F.2d 897, 899, 904, 164 USPQ 636, 638, 641 (CCPA1970). In addition, the court found that the negativelimitation “incapable of forming a dye with saidoxidized developing agent” was definite because theboundaries of the patent protection sought wereclear. In re Barr, 444 F.2d 588, 170 USPQ 330(CCPA 1971).

Any negative limitation or exclusionary proviso musthave basis in the original disclosure. If alternativeelements are positively recited in the specification,they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ187, 196 (CCPA 1977) (“[the] specification, havingdescribed the whole, necessarily described the part

2100-374Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2173.05(i)

remaining.”). See also Ex parte Grasselli, 231USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d453 (Fed. Cir. 1984). In describing alternativefeatures, the applicant need not articulate advantagesor disadvantages of of each feature in order to laterexclude the alternative features. See InphiCorporation v. Netlist, Inc., 805 F.3d 1350, 1356-57,116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). Themere absence of a positive recitation is not basis foran exclusion. Any claim containing a negativelimitation which does not have basis in the originaldisclosure should be rejected under 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph, as failingto comply with the written description requirement.Note that a lack of literal basis in the specificationfor a negative limitation may not be sufficient toestablish a prima facie case for lack of descriptivesupport. Ex parte Parks, 30 USPQ2d 1234, 1236(Bd. Pat. App. & Inter. 1993). See MPEP § 2163 -§ 2163.07(b) for a discussion of the writtendescription requirement of 35 U.S.C. 112(a) andpre-AIA 35 U.S.C. 112, first paragraph.

2173.05(j) Old Combination [R-11.2013]

A CLAIM SHOULD NOT BE REJECTED ON THEGROUND OF OLD COMBINATION

With the passage of the 1952 Patent Act, the courtsand the Board have taken the view that a rejectionbased on the principle of old combination is NOLONGER VALID. Claims should be consideredproper so long as they comply with the provisionsof 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph.

A rejection on the basis of old combination wasbased on the principle applied in LincolnEngineering Co. v. Stewart-Warner Corp., 303 U.S.545, 37 USPQ 1 (1938). The principle was that aninventor who made an improvement or contributionto but one element of a generally old combination,should not be able to obtain a patent on the entirecombination including the new and improvedelement. A rejection required the citation of a singlereference which broadly disclosed a combination ofthe claimed elements functionally cooperating insubstantially the same manner to producesubstantially the same results as that of the claimedcombination. The case of In re Hall, 208 F.2d 370,

100 USPQ 46 (CCPA 1953) illustrates an applicationof this principle.

The court pointed out in In re Bernhart, 417 F.2d1395, 163 USPQ 611 (CCPA 1969) that the statutorylanguage (particularly point out and distinctly claim)is the only proper basis for an old combinationrejection, and in applying the rejection, that languagedetermines what an applicant has a right andobligation to do. A majority opinion of the Board ofAppeals held that Congress removed the underlyingrationale of Lincoln Engineering in the 1952 PatentAct, and thereby effectively legislated that decisionout of existence. Ex parte Barber, 187 USPQ 244(Bd. App. 1974). Finally, the Court of Appeals forthe Federal Circuit, in Radio Steel and Mfg. Co. v.MTD Products, Inc., 731 F.2d 840, 221 USPQ 657(Fed. Cir. 1984), followed the Bernhart case, andruled that a claim was not invalid under LincolnEngineering because the claim complied with therequirements of 35 U.S.C. 112, second paragraph.Accordingly, a claim should not be rejected on theground of old combination.

2173.05(k) Aggregation [R-08.2012]

A claim should not be rejected on the ground of“aggregation.” In re Gustafson, 331 F.2d 905, 141USPQ 585 (CCPA 1964) (an applicant is entitled toknow whether the claims are being rejected under35 U.S.C. 101, 102, 103, or 112); In re Collier,397 F.2d 1003, 1006, 158 USPQ 266, 268 (CCPA1968) (“[A] rejection for ‘aggregation’ isnon-statutory.”).

If a claim omits essential matter or fails to interrelateessential elements of the invention as defined byapplicant(s) in the specification, see MPEP§ 2172.01.

2173.05(l) [Reserved]

2173.05(m) Prolix [R-08.2012]

Examiners should reject claims as prolix onlywhen they contain such long recitations orunimportant details that the scope of the claimed

Rev. 08.2017, January 20182100-375

§ 2173.05(m)PATENTABILITY

invention is rendered indefinite thereby. Claims arerejected as prolix when they contain long recitationsthat the metes and bounds of the claimed subjectmatter cannot be determined.

2173.05(n) Multiplicity [R-11.2013]

37 CFR 1.75 Claim(s).

(a) The specification must conclude with a claimparticularly pointing out and distinctly claiming the subjectmatter which the applicant regards as his invention or discovery.

(b) More than one claim may be presented provided theydiffer substantially from each other and are not undulymultiplied.

*****

Where, in view of the nature and scope of applicant’sinvention, applicant presents an unreasonablenumber of claims which are repetitious andmultiplied, the net result of which is to confuse ratherthan to clarify, a rejection on undue multiplicitybased on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph, may be appropriate. As notedby the court in In re Chandler, 319 F.2d 211, 225,138 USPQ 138, 148 (CCPA 1963), “applicantsshould be allowed reasonable latitude in stating theirclaims in regard to number and phraseologyemployed. The right of applicants to freedom ofchoice in selecting phraseology which truly pointsout and defines their inventions should not beabridged. Such latitude, however, should not beextended to sanction that degree of repetition andmultiplicity which beclouds definition in a maze ofconfusion. The rule of reason should be practicedand applied on the basis of the relevant facts andcircumstances in each individual case.” See also Inre Flint, 411 F.2d 1353, 1357, 162 USPQ 228, 231(CCPA 1969). Undue multiplicity rejections basedon 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, should be applied judiciously andshould be rare.

If an undue multiplicity rejection under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,is appropriate, the examiner should contact applicantby telephone explaining that the claims are undulymultiplied and will be rejected under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph.Note MPEP § 408. The examiner should also requestthat applicant select a specified number of claimsfor purpose of examination. If applicant is willing

to select, by telephone, the claims for examination,an undue multiplicity rejection on all the claimsbased on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph, should be made in the nextOffice action along with an action on the merits onthe selected claims. If applicant refuses to complywith the telephone request, an undue multiplicityrejection of all the claims based on 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph, shouldbe made in the next Office action. Applicant’s replymust include a selection of claims for purpose ofexamination, the number of which may not be greaterthan the number specified by the examiner. Inresponse to applicant’s reply, if the examiner adheresto the undue multiplicity rejection, it should berepeated and the selected claims will be examinedon the merits. This procedure preserves applicant’sright to have the rejection on undue multiplicityreviewed by the Patent Trail and Appeal Board.

Also, it is possible to reject one claim over anallowed claim if they differ only by subject matterold in the art. This ground of rejection is set forth in Ex parte Whitelaw, 1915 C.D. 18, 219 O.G. 1237(Comm’r Pat. 1914). The Ex parte Whitelawdoctrine is restricted to cases where the claims areunduly multiplied or are substantial duplicates. Exparte Kochan, 131 USPQ 204, 206 (Bd. App. 1961).

2173.05(o) Double Inclusion [R-08.2012]

There is no per se rule that “double inclusion” isimproper in a claim. In re Kelly, 305 F.2d 909, 916,134 USPQ 397, 402 (CCPA 1962) (“Automaticreliance upon a ‘rule against double inclusion’ willlead to as many unreasonable interpretations as willautomatic reliance upon a ‘rule allowing doubleinclusion’. The governing consideration is not double inclusion, but rather is what is a reasonableconstruction of the language of the claims.”). Oldercases, such as Ex parte White, 759 O.G. 783 (Bd.App. 1958) and Ex parte Clark, 174 USPQ 40 (Bd.App. 1971) should be applied with care, accordingto the facts of each case.

The facts in each case must be evaluated todetermine whether or not the multiple inclusion ofone or more elements in a claim gives rise toindefiniteness in that claim. The mere fact that acompound may be embraced by more than one

2100-376Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2173.05(n)

member of a Markush group recited in the claimdoes not lead to any uncertainty as to the scope ofthat claim for either examination or infringementpurposes. On the other hand, where a claim directedto a device can be read to include the same elementtwice, the claim may be indefinite. Ex parteKristensen, 10 USPQ2d 1701 (Bd. Pat. App. & Inter.1989).

2173.05(p) Claim Directed to Product-By-Process or Product and Process [R-08.2017]

There are many situations where claims arepermissively drafted to include a reference to morethan one statutory class of invention.

I. PRODUCT-BY-PROCESS

A product-by-process claim, which is a productclaim that defines the claimed product in terms ofthe process by which it is made, is proper. PurduePharma v. Epic Pharma, 811 F.3d 1345, 1354, 117USPQ2d 1733, 1739 (Fed. Cir. 2016); In re Luck,476 F.2d 650, 177 USPQ 523 (CCPA 1973); In rePilkington, 411 F.2d 1345, 162 USPQ 145 (CCPA1969); and In re Steppan, 394 F.2d 1013, 156 USPQ143 (CCPA 1967). A claim to a device, apparatus,manufacture, or composition of matter may containa reference to the process in which it is intended tobe used without being objectionable under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,so long as it is clear that the claim is directed to theproduct and not the process.

An applicant may present claims of varying scopeeven if it is necessary to describe the claimed productin product-by-process terms. Ex parte Pantzer, 176USPQ 141 (Bd. App. 1972).

II. PRODUCT AND PROCESS IN THE SAMECLAIM

A single claim which claims both an apparatus andthe method steps of using the apparatus is indefiniteunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph. See In re Katz Interactive CallProcessing Patent Litigation, 639 F.3d 1303, 1318,97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with aninterface means for providing automated voice

messages…to certain of said individual callers, wherein said certain of said individual callersdigitally enter data” was determined to be indefinitebecause the italicized claim limitation is not directedto the system, but rather to actions of the individualcallers, which creates confusion as to when directinfringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377,1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), inwhich a system claim that recited “an input means”and required a user to use the input means was foundto be indefinite because it was unclear “whetherinfringement … occurs when one creates a systemthat allows the user [to use the input means], orwhether infringement occurs when the user actuallyuses the input means.”); Ex parte Lyell, 17 USPQ2d1548 (Bd. Pat. App. & Inter. 1990) (claim directedto an automatic transmission workstand and themethod of using it held ambiguous and properlyrejected under 35 U.S.C. 112, second paragraph).

2173.05(q) “Use” Claims [R-11.2013]

Attempts to claim a process without setting forthany steps involved in the process generally raises anissue of indefiniteness under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph. Forexample, a claim which read: “[a] process for usingmonoclonal antibodies of claim 4 to isolate andpurify human fibroblast interferon” was held to beindefinite because it merely recites a use withoutany active, positive steps delimiting how this use isactually practiced. Ex parte Erlich, 3 USPQ2d 1011(Bd. Pat. App. & Inter. 1986).

Other decisions suggest that a more appropriate basisfor this type of rejection is 35 U.S.C. 101. In Exparte Dunki, 153 USPQ 678 (Bd. App. 1967), theBoard held the following claim to be an improperdefinition of a process: “The use of a high carbonaustenitic iron alloy having a proportion of freecarbon as a vehicle brake part subject to stress bysliding friction.” In Clinical Products Ltd. v.Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C.1966), the district court held the following claimwas definite, but that it was not a proper processclaim under 35 U.S.C. 101: “The use of a sustainedrelease therapeutic agent in the body of ephedrineabsorbed upon polystyrene sulfonic acid.”

Rev. 08.2017, January 20182100-377

§ 2173.05(q)PATENTABILITY

Although a claim should be interpreted in light ofthe specification disclosure, it is generally consideredimproper to read limitations contained in thespecification into the claims. See In re Prater, 415F.2d 1393, 162 USPQ 541 (CCPA 1969) and In reWinkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA1975), which discuss the premise that one cannotrely on the specification to impart limitations to theclaim that are not recited in the claim.

I. A “USE” CLAIM SHOULD BE REJECTEDUNDER ALTERNATIVE GROUNDS BASED ON 35U.S.C 101 AND 112

In view of the split of authority as discussed above,the most appropriate course of action would be toreject a “use” claim under alternative grounds basedon 35 U.S.C. 101 and 112 .

II. BOARD HELD STEP OF “UTILIZING” WASNOT INDEFINITE

It is often difficult to draw a fine line betweenwhat is permissible, and what is objectionable fromthe perspective of whether a claim is definite. In thecase of Ex parte Porter, 25 USPQ2d 1144 (Bd. Pat.App. & Inter. 1992), the Board held that a claimwhich clearly recited the step of “utilizing” was notindefinite under 35 U.S.C. 112, second paragraph.(Claim was to “A method for unloading nonpacked,nonbridging and packed, bridging flowable particlecatalyst and bead material from the opened end ofa reactor tube which comprises utilizing the nozzleof claim 7.”).

2173.05(r) Omnibus Claim [R-11.2013]

Some applications are filed with an omnibus claimwhich reads as follows: A device substantially asshown and described. This claim should be rejectedunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, because it is indefinite in that itfails to point out what is included or excluded by theclaim language. See Ex parte Fressola, 27 USPQ2d1608 (Bd. Pat. App. & Inter. 1993), for a discussionof the history of omnibus claims and an explanationof why omnibus claims do not comply with therequirements of 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph.

Such a claim can be rejected using form paragraph7.35. See MPEP § 706.03(d).

For cancellation of such a claim by examiner’samendment, see MPEP § 1302.04(b).

2173.05(s) Reference to Figures or Tables[R-08.2012]

Where possible, claims are to be complete inthemselves. Incorporation by reference to a specificfigure or table “is permitted only in exceptionalcircumstances where there is no practical way todefine the invention in words and where it is moreconcise to incorporate by reference than duplicatinga drawing or table into the claim. Incorporation byreference is a necessity doctrine, not for applicant’sconvenience.” Ex parte Fressola, 27 USPQ2d 1608,1609 (Bd. Pat. App. & Inter. 1993) (citationsomitted).

Reference characters corresponding to elementsrecited in the detailed description and the drawingsmay be used in conjunction with the recitation ofthe same element or group of elements in the claims.See MPEP § 608.01(m).

2173.05(t) Chemical Formula [R-11.2013]

Claims to chemical compounds and compositionscontaining chemical compounds often use formulasthat depict the chemical structure of the compound.These structures should not be considered indefinitenor speculative in the absence of evidence that theassigned formula is in error. The absence ofcorroborating spectroscopic or other data cannot bethe basis for finding the structure indefinite. See Exparte Morton, 134 USPQ 407 (Bd. App. 1961), and Ex parte Sobin, 139 USPQ 528 (Bd. App. 1962).

A claim to a chemical compound is not indefinitemerely because a structure is not presented orbecause a partial structure is presented. For example,the claim language at issue in In re Fisher, 427 F.2d833, 166 USPQ 18 (CCPA 1970) referred to achemical compound as a “polypeptide of at least 24amino acids having the following sequence.” Arejection under pre-AIA 35 U.S.C. 112, secondparagraph, for failure to identify the entire structure

2100-378Rev. 08.2017, January 2018

MANUAL OF PATENT EXAMINING PROCEDURE§ 2173.05(r)

was reversed and the court held: “While the absenceof such a limitation obviously broadens the claimand raises questions of sufficiency of disclosure, itdoes not render the claim indefinite.” Chemicalcompounds may be claimed by a name thatadequately describes the material to one skilled inthe art. See Martin v. Johnson, 454 F.2d 746, 172USPQ 391 (CCPA 1972). A compound of unknownstructure may be claimed by a combination ofphysical and chemical characteristics. See Exparte Brian, 118 USPQ 242 (Bd. App. 1958). Acompound may also be claimed in terms of theprocess by which it is made without raising an issueof indefiniteness.

2173.05(u) Trademarks or Trade Names ina Claim [R-11.2013]

The presence of a trademark or trade name in a claimis not, per se, improper under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph, but theclaim should be carefully analyzed to determine howthe mark or name is used in the claim. It is importantto recognize that a trademark or trade name is usedto identify a source of goods, and not the goodsthemselves. Thus a trademark or trade name doesnot identify or describe the goods associated withthe trademark or trade name. See definitions oftrademark and trade name in MPEP § 608.01(v).

If the trademark or trade name is used in a claim asa limitation to identify or describe a particularmaterial or product, the claim does not comply withthe requirements of the 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph. Ex parte Simpson,218 USPQ 1020 (Bd. App. 1982). The claim scopeis uncertain since the trademark or trade name cannotbe used properly to identify any particular materialor product. In fact, the value of a trademark wouldbe lost to the extent that it became descriptive of aproduct, rather than used as an identification of asource or origin of a product. Thus, the use of atrademark or trade name in a claim to identify ordescribe a material or product would not only rendera claim indefinite, but would also constitute animproper use of the trademark or trade name.

If a trademark or trade name appears in a claim andis not intended as a limitation in the claim, thequestion of why it is in the claim should be

addressed. If its presence in the claim causesconfusion as to the scope of the claim, then the claimshould be rejected under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph.

2173.05(v) Mere Function of Machine[R-11.2013]

Process or method claims are not subject to rejectionby U.S. Patent and Trademark Office examinersunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph, solely on the ground that theydefine the inherent function of a disclosed machineor apparatus. In re Tarczy-Hornoch, 397 F.2d 856,158 USPQ 141 (CCPA 1968). The court in Tarczy-Hornoch held that a process claim, otherwisepatentable, should not be rejected merely becausethe application of which it is a part discloses anapparatus which will inherently carry out the recitedsteps.

2173.06 Practice Compact Prosecution[R-07.2015]

I. INTERPRET THE CLAIM AND APPLY ARTWITH AN EXPLANATION OF HOW ANINDEFINITE TERM IS INTERPRETED

The goal of examination is to clearly articulate anyrejection early in the prosecution process so that theapplicant has the chance to provide evidence ofpatentability and otherwise reply completely at theearliest opportunity. See MPEP § 706. Under theprinciples of compact prosecution, the examinershould review each claim for compliance with everystatutory requirement for patentability in the initialreview of the application and identify all of theapplicable grounds of rejection in the first Officeaction to avoid unnecessary delays in the prosecutionof the application. See 37 CFR 1.104(a)(1) (“Ontaking up an application for examination or a patentin a reexamination proceeding, the examiner shallmake a thorough study thereof and shall make athorough investigation of the available prior artrelating to the subject matter of the claimedinvention. The examination shall be complete withrespect both to compliance of the application . . .with the applicable statutes and rules and to thepatentability of the invention as claimed, as well as

Rev. 08.2017, January 20182100-379


with respect to matters of form, unless otherwiseindicated.”).

Thus, when the examiner determines that a claimterm or phrase renders the claim indefinite, theexaminer should make a rejection based onindefiniteness under 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph, as well as arejection(s) in view of the prior art under 35 U.S.C.102 or 103 that renders the prior art applicable basedon the examiner’s interpretation of the claim. See In re Packard, 751 F.3d 1307, 1312 (Fed. Cir. 2014)(stating that the prima facie case is appropriatelyused for making an indefiniteness rejection). Whenmaking a rejection over prior art in thesecircumstances, it is important that the examinerstate on the record how the claim term or phraseis being interpreted with respect to the prior artapplied in the rejection. By rejecting each claim onall reasonable grounds available, the examiner canavoid piecemeal examination. See MPEP § 707.07(g)(“Piecemeal examination should be avoided as muchas possible. The examiner ordinarily should rejecteach claim on all valid grounds available . . . .”).

II. PRIOR ART REJECTION OF CLAIMREJECTED AS INDEFINITE

All words in a claim must be considered in judgingthe patentability of a claim against the prior art. Inre Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA1970). The fact that terms may be indefinite doesnot make the claim obvious over the prior art. Whenthe terms of a claim are considered to be indefinite,at least two approaches to the examination of anindefinite claim relative to the prior art are possible.

First, where the degree of uncertainty is notgreat, and where the claim is subject to more thanone interpretation and at least one interpretationwould render the claim unpatentable over the priorart, an appropriate course of action would be for theexaminer to enter two rejections: (A) a rejectionbased on indefiniteness under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph; and (B)a rejection over the prior art based on theinterpretation of the claims which renders the priorart applicable. See, e.g., Ex parte Ionescu,222 USPQ 537 (Bd. App. 1984). When making arejection over prior art in these circumstances, it is

important for the examiner to point out how theclaim is being interpreted. Second, where there is agreat deal of confusion and uncertainty as to theproper interpretation of the limitations of a claim, itwould not be proper to reject such a claim on thebasis of prior art. As stated in In re Steele, 305 F.2d859, 134 USPQ 292 (CCPA 1962), a rejection under35 U.S.C. 103 should not be based on considerablespeculation about the meaning of terms employedin a claim or assumptions that must be made as tothe scope of the claims.

The first approach is recommended from anexamination standpoint because it avoids piecemealexamination in the event that the examiner’s 35U.S.C. 112, second paragraph rejection is notaffirmed, and may give applicant a betterappreciation for relevant prior art if the claims areredrafted to avoid the 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph rejection.

2174 Relationship Between the Requirementsof 35 U.S.C. 112(a) and (b) or Pre-AIA 35U.S.C. 112, First and Second Paragraphs[R-11.2013]

The requirements of 35 U.S.C. 112(a) and (b) or thefirst and second paragraphs of pre-AIA 35 U.S.C.112 are separate and distinct. If a description or theenabling disclosure of a specification is notcommensurate in scope with the subject matterencompassed by a claim, that fact alone does notrender the claim imprecise or indefinite or otherwisenot in compliance with 35 U.S.C. 112(b) or pre-AIA35 U.S.C. 112, second paragraph; rather, the claimis based on an insufficient disclosure (35 U.S.C.112(a) or pre-AIA 35 U.S.C. 112, first paragraph)and should be rejected on that ground. Inre Borkowski, 422 F.2d 904, 164 USPQ 642 (CCPA1970). If the specification discloses that a particularfeature or element is critical or essential to thepractice of the invention, failure to recite or includethat particular feature or element in the claims mayprovide a basis for a rejection based on the groundthat those claims are not supported by an enablingdisclosure. In re Mayhew, 527 F.2d 1229, 188 USPQ356 (CCPA 1976). In Mayhew, the examiner arguedthat the only mode of operation of the processdisclosed in the specification involved the use of acooling zone at a particular location in the processing

2100-380Rev. 08.2017, January 2018


cycle. The claims were rejected because they failedto specify either a cooling step or the location of thestep in the process. The court was convinced thatthe cooling bath and its location were essential, andheld that claims which failed to recite the use of acooling zone, specifically located, were notsupported by an enabling disclosure (35 U.S.C. 112,first paragraph).

In addition, if a claim is amended to include aninvention that is not described in the application asfiled, a rejection of that claim under 35 U.S.C. 112(a)or pre-AIA 35 U.S.C. 112, first paragraph, as beingdirected to subject matter that is not described in thespecification as filed may be appropriate. Inre Simon, 302 F.2d 737, 133 USPQ 524 (CCPA1962). In Simon, which involved a reissueapplication containing claims to a reaction productof a composition, applicant presented claims to areaction product of a composition comprising thesubcombination A+B+C, whereas the original claimsand description of the invention were directed to acomposition comprising the combinationA+B+C+D+E. The court found no significantsupport for the argument that ingredients D+E werenot essential to the claimed reaction product andconcluded that claims directed to the reaction productof a subcombination A+B+C were not described (35U.S.C. 112, first paragraph) in the application asfiled. See also In re Panagrossi, 277 F.2d 181, 125USPQ 410 (CCPA 1960).


2181 Identifying and Interpreting a 35 U.S.C.112(f) or Pre-AIA 35 U.S.C. 112, SixthParagraph Limitation [R-08.2017]

This section sets forth guidelines for the examinationof 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, “means or step plus function” limitationsin a claim. These guidelines are based on the Office’scurrent understanding of the law and are believed tobe fully consistent with binding precedent of theSupreme Court, the Federal Circuit and the FederalCircuit’s predecessor courts. These guidelines donot constitute substantive rulemaking and hence donot have the force and effect of law.

The Court of Appeals for the Federal Circuit, in its en banc decision In re Donaldson Co., 16 F.3d1189, 1194, 29 USPQ2d 1845, 1850 (Fed. Cir.1994), held that a “means-or-step-plus-function”limitation should be interpreted as follows:

Per our holding, the “broadest reasonableinterpretation” that an examiner may givemeans-plus-function language is that statutorilymandated in paragraph six. Accordingly, thePTO may not disregard the structure disclosedin the specification corresponding to suchlanguage when rendering a patentabilitydetermination.

Therefore, the broadest reasonable interpretation ofa claim limitation that invokes 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph, is thestructure, material or act described in thespecification as performing the entire claimedfunction and equivalents to the disclosed structure,material or act. As a result, section 112(f) or pre-AIAsection 112, sixth paragraph, limitations will, insome cases, be afforded a more narrow interpretationthan a limitation that is not crafted in “means plusfunction” format.

I. DETERMINING WHETHER A CLAIMLIMITATION INVOKES 35 U.S.C. 112(f) orPRE-AIA 35 U.S.C. 112, SIXTH PARAGRAPH

The USPTO must apply 35 U.S.C. 112(f) or pre-AIA35 U.S.C. 112, sixth paragraph in appropriate cases,and give claims their broadest reasonableinterpretation, in light of and consistent with thewritten description of the invention in theapplication. See Donaldson, 16 F.3d at 1194, 29USPQ2d at 1850 (stating that 35 U.S.C. 112, sixthparagraph “merely sets a limit on how broadly thePTO may construe means-plus-function languageunder the rubric of reasonable interpretation’”). TheFederal Circuit has held that applicants (andreexamination patentees) before the USPTO havethe opportunity and the obligation to define theirinventions precisely during proceedings before theUSPTO. See In re Morris, 127 F.3d 1048, 1056–57,44 USPQ2d 1023, 1029–30 (Fed. Cir. 1997) (35U.S.C. 112, second paragraph places the burden ofprecise claim drafting on the applicant); In re Zletz,893 F.2d 319, 322, 13 USPQ2d 1320, 1322 (Fed.

Rev. 08.2017, January 20182100-381


Cir. 1989) (manner of claim interpretation that isused by courts in litigation is not the manner of claiminterpretation that is applicable during prosecutionof a pending application before the USPTO); SageProds., Inc. v. Devon Indus., Inc., 126 F.3d 1420,1425, 44 USPQ2d 1103, 1107 (Fed. Cir. 1997)(patentee who had a clear opportunity to negotiatebroader claims during prosecution but did not do so,may not seek to expand the claims through thedoctrine of equivalents, for it is the patentee, not thepublic, who must bear the cost of failure to seekprotection for this foreseeable alteration of itsclaimed structure).

If a claim limitation recites a term and associatedfunctional language, the examiner should determinewhether the claim limitation invokes 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.The claim limitation is presumed to invoke 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraphwhen it explicitly uses the term “means” or “step”and includes functional language. That presumptionis overcome when the limitation further includes thestructure necessary to perform the recited function. TriMed, Inc. v. Stryker Corp., 514 F.3d 1256,1259-60, 85 USPQ2d 1787, 1789 (Fed. Cir. 2008)(“Sufficient structure exists when the claim languagespecifies the exact structure that performs thefunction in question without need to resort to otherportions of the specification or extrinsic evidencefor an adequate understanding of the structure.”);see also Altiris, Inc. v. Symantec Corp., 318 F.3d1363, 1376, 65 USPQ2d 1865, 1874 (Fed. Cir.2003).

By contrast, a claim limitation that does not use theterm “means” or “step” will trigger the rebuttablepresumption that 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph does not apply. See,e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1310,75 USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d1359, 1369, 62 USPQ2d 1658, 1664 (Fed. Cir.2002); Personalized Media Commc’ns, LLC v. ITC,161 F.3d 696, 703-04, 48 USPQ2d 1880, 1886–87(Fed. Cir. 1998). The presumption is overcome when"the claim term fails to 'recite sufficiently definitestructure' or else recites 'function without recitingsufficient structure for performing that function.'" Williamson v. Citrix Online, LLC, 792 F.3d 1339,

1348, 115 USPQ2d 1105, 1111 (Fed. Cir. 2015) (enbanc) (quoting Watts v. XL Systems, Inc., 232 F.3d877, 880 (Fed. Cir. 2000); see also PersonalizedMedia Communications, LLC v. International TradeCommission, 161 F. 3d 696, 704 (Fed. Cir. 1998).Instead of using "means" or "step" in such cases, asubstitute term acts as a generic placeholder for theterm "means" and would not be recognized by oneof ordinary skill in the art as being sufficientlydefinite structure for performing the claimedfunction. "The standard is whether the words of theclaim are understood by persons of ordinary skill inthe art to have a sufficiently definite meaning as thename for structure." Williamson, 792 F.3d at 1349,115 USPQ2d at 1111; see also Greenberg v. EthiconEndo-Surgery, Inc., 91 F.3d 1580, 1583, 39 USPQ2d1783, 1786 (Fed. Cir. 1996).

Accordingly, examiners will apply 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph to a claimlimitation if it meets the following 3-prong analysis:

(A) the claim limitation uses the term “means”or “step” or a term used as a substitute for “means”that is a generic placeholder (also called a nonceterm or a non-structural term having no specificstructural meaning) for performing the claimedfunction;

(B) the term “means” or “step” or the genericplaceholder is modified by functional language,typically, but not always linked by the transitionword “for” (e.g., “means for”) or another linkingword or phrase, such as "configured to" or "so that";and

(C) the term “means” or “step” or the genericplaceholder is not modified by sufficient structure,material, or acts for performing the claimed function.

A. The Claim Limitation Uses the Term “Means” or“Step” or a Generic Placeholder (A Term That Is SimplyA Substitute for “Means”)

With respect to the first prong of this analysis, aclaim element that does not include the term “means”or “step” triggers a rebuttable presumption that 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, does not apply. When the claim limitationdoes not use the term “means,” examiners shoulddetermine whether the presumption that 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, paragraph 6 does

2100-382Rev. 08.2017, January 2018


not apply is overcome. The presumption may beovercome if the claim limitation uses a genericplaceholder (a term that is simply a substitute forthe term “means”). The following is a list ofnon-structural generic placeholders that may invoke35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,paragraph 6: “mechanism for,” “module for,”“device for,” “unit for,” “component for,”“element for,” “member for,” “apparatus for,”“machine for,” or “system for.” Welker BearingCo., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst.of Tech. v. Abacus Software, 462 F.3d 1344, 1354,80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2dat 1886–87; Mas-Hamilton Group v. LaGard, Inc.,156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017(Fed. Cir. 1998). This list is not exhaustive, and othergeneric placeholders may invoke 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, paragraph 6.

However, 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, paragraph 6 will not apply if persons of ordinaryskill in the art reading the specification understandthe term to have a sufficiently definite meaning asthe name for the structure that performs the function,even when the term covers a broad class of structuresor identifies the structures by their function (e.g.,“filters,” “brakes,” “clamp,” “screwdriver,” and“locks”). Apex Inc. v. Raritan Computer, Inc., 325F.3d 1364, 1372-73, 66 USPQ2d 1444, 1451-52(Fed. Cir. 2003); CCS Fitness, 288 F.3d at 1369,62 USPQ2d at 1664; Watts v. XL Sys. Inc., 232 F.3d877, 880-81, 56 USPQ2d 1836, 1839 (Fed. Cir.2000); Personalized Media, 161 F.3d at 704, 48USPQ2d at 1888; Greenberg v. EthiconEndo-Surgery, Inc., 91 F.3d 1580, 1583, 39 USPQ2d1783, 1786 (Fed. Cir. 1996) (“Many devices taketheir names from the functions they perform.”) Theterm is not required to denote a specific structure ora precise physical structure to avoid the applicationof 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,paragraph 6. See Watts, 232 F.3d at 880, 56USPQ2d at 1838; Inventio AG v. ThyssenkruppElevator Americas Corp., 649 F.3d 1350, 99USPQ2d 1112 (Fed. Cir. 2011) (holding that theclaim terms "modernizing device" and "computingunit" when read in light of the specification connotedsufficient, definite structure to one of skill in the artto preclude application of 35 U.S.C. 112, sixth

paragraph). The following are examples of structuralterms that have been found not to invoke 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, paragraph 6:“circuit,” “detent mechanism,” “digital detector,”“reciprocating member,” “connector assembly,”“perforation,” “sealingly connected joints,” and“eyeglass hanger member.” See Mass. Inst. of Tech.,462 F.3d at 1355-1356, 80 USPQ2d at 1332 (thecourt found the recitation of "aesthetic correctioncircuitry" sufficient to avoid pre-AIA 35 U.S.C. 112,paragraph 6, treatment because the term circuit,combined with a description of the function of thecircuit, connoted sufficient structure to one ofordinary skill in the art.); Linear Tech. Corp. v.Impala Linear Corp., 379 F.3d 1311, 1321, 72USPQ2d 1065, 1071 (Fed. Cir. 2004); Apex, 325F.3d at 1373, 66 USPQ2d at 1452; Greenberg, 91F.3d at 1583-84, 39 USPQ2d at 1786; PersonalizedMedia, 161 F.3d at 704-05, 39 USPQ2d at 1786; CCS Fitness, 288 F.3d at 1369-70, 62 USPQ2d at1664-65; Cole v. Kimberly-Clark Corp., 102 F.3d524, 531 (Fed. Cir. 1996); Watts, 232 F.3d at 881,56 USPQ2d at 1839; Al-Site Corp. v. VSI Int’l, Inc.,174 F.3d 1308, 1318-19, 50 USPQ2d 1161, 1166-67(Fed. Cir. 1999).

For a term to be considered a substitute for “means,”and lack sufficient structure for performing thefunction, it must serve as a generic placeholder andthus not limit the scope of the claim to any specificmanner or structure for performing the claimedfunction. It is important to remember that there areno absolutes in the determination of terms used asa substitute for “means” that serve as genericplaceholders. The examiner must carefully considerthe term in light of the specification and thecommonly accepted meaning in the technologicalart. Every application will turn on its own facts.

If the examiner has not interpreted a claim limitationas invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph and an applicant wishes to havethe claim limitation treated under 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph, applicantmust either: (A) amend the claim to include thephrase “means” or “step”; or (B) rebut thepresumption that 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph does not apply byshowing that the claim limitation is written as afunction to be performed and does not recite

Rev. 08.2017, January 20182100-383


sufficient structure, material, or acts to perform thatfunction. See Watts, 232 F.3d at 881, 56 USPQ2dat 1839 (Fed. Cir. 2000) (Claim limitations wereheld not to invoke 35 U.S.C. 112, sixth paragraph,because the absence of the term “means” raised thepresumption that the limitations were not inmeans-plus-function form and the applicant did notrebut that presumption.); see also Masco Corp. v.United States, 303 F.3d 1316, 1327, 64 USPQ2d1182, 1189 (Fed. Cir. 2002) (“[W]here a methodclaim does not contain the term ‘step[s] for,’ alimitation of that claim cannot be construed as astep-plus-function limitation without a showing thatthe limitation contains no act.”).

Some of the following examples illustrate situationswhere the term “means” or “step” was not used buteither the Board or courts nevertheless determinedthat the claim limitation fell within the scope of 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph. Note that the examples are fact specificand should not be applied as per se rules. See Signtech USA, Ltd. v. Vutek, Inc., 174 F.3d 1352,1356, 50 USPQ2d 1372, 1374–75 (Fed. Cir.1999)(“ink delivery means positioned on …” invokes35 U.S.C. 112, sixth paragraph since the phrase “inkdelivery means” is equivalent to “means for inkdelivery”); Seal-Flex, Inc. v. Athletic Track andCourt Construction, 172 F.3d 836, 850, 50 USPQ2d1225, 1234 (Fed. Cir. 1999) (Rader, J., concurring)(“Claim elements without express step-plus-functionlanguage may nevertheless fall within Section 112,Para. 6 if they merely claim the underlying functionwithout recitation of acts for performing thatfunction…. In general terms, the ‘underlyingfunction’ of a method claim element corresponds to what that element ultimately accomplishes inrelationship to what the other elements of the claimand the claim as a whole accomplish. ‘Acts,’ on theother hand, correspond to how the function isaccomplished…. If the claim element uses the phrase‘step for,’ then Section 112, Para. 6 is presumed toapply…. On the other hand, the term ‘step’ aloneand the phrase ‘steps of’ tend to show that Section112, Para. 6 does not govern that limitation.”); Personalized Media, 161 F.3d at 703–04, 48USPQ2d at 1886–87 (Fed. Cir. 1998); Mas-Hamilton, 156 F.3d at 1213, 48 USPQ2d at1016 (Fed. Cir. 1998) (“lever moving element formoving the lever” and “movable link member for

holding the lever…and for releasing the lever” wereconstrued as means-plus-function limitationsinvoking 35 U.S.C. 112, sixth paragraph since theclaimed limitations were described in terms of theirfunction rather than their mechanical structure); Ethicon, Inc. v. United States Surgical Corp., 135F.3d 1456, 1463, 45 USPQ2d 1545, 1550 (Fed. Cir.1998) (“use of the word ‘means’ gives rise to apresumption that the inventor used the termadvisedly to invoke the statutory mandates formeans-plus-function clauses”) (quotation omitted).However, compare Al-Site Corp. v. VSI Int’l, Inc.,174 F.3d 1308, 1317-19, 50 USPQ2d 1161, 1166-67(Fed. Cir. 1999) (holding that although the claimelements “eyeglass hanger member” and “eyeglasscontacting member” include a function, these claimelements do not invoke 35 U.S.C. 112, sixthparagraph because the claims themselves containsufficient structural limitations for performing thesefunctions); O.I. Corp. v. Tekmar, 115 F.3d 1576,1583, 42 USPQ2d 1777, 1782 (Fed. Cir. 1997)(method claim that paralleled means-plus-functionapparatus claim but lacked “step for” language didnot invoke 35 U.S.C. 112, sixth paragraph).

When applicant uses the term “means” or “step” inthe preamble, a rejection under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph may beappropriate when it is unclear whether the preambleis reciting a means- (or step-) plus- functionlimitation or whether the preamble is merely statingthe intended use of the claimed invention. Ifapplicant uses a structural or generic placeholderwith the word “for” or other linking word in thepreamble, the examiner should not construe suchphrase as reciting a means-plus-function limitation.

The Examiner is reminded that, absent adetermination that a claim limitation invokes 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, the broadest reasonable interpretationwill not be limited to “corresponding structure…and equivalents thereof.” Morris, 127 F.3d at 1055,44 USPQ2d at 1028 (“no comparable mandate inthe patent statute that relates the claim scope ofnon-§ 112 paragraph 6 claims to particular matterfound in the specification”).

2100-384Rev. 08.2017, January 2018


B. The Term “Means” or “Step” or the GenericPlaceholder Must Be Modified By Functional Language

With respect to the second prong of this analysis, itmust be clear that the element in the claims is setforth, at least in part, by the function it performs asopposed to the specific structure, material, or actsthat perform the function. See York Prod., Inc. v.Central Tractor Farm & Family Center, 99 F.3d1568, 1574, 40 USPQ2d 1619, 1624 (Fed. Cir. 1996)(holding that a claim limitation containing the term“means” does not invoke pre-AIA 35 U.S.C. 112,sixth paragraph, if the claim limitation does not linkthe term “means” to a specific function). CaterpillarInc. v. Detroit Diesel Corp., 961 F.Supp. 1249, 1255,41 USPQ2d 1876, 1882 (N.D. Ind. 1996) (statingthat pre-AIA 35 U.S.C. 112, sixth paragraph,“applies to functional method claims where theelement at issue sets forth a step for reaching aparticular result, but not the specific technique orprocedure used to achieve the result.”); O.I. Corp.,115 F.3d at 1582-83, 42 USPQ2d at 1782 (Withrespect to process claims, “[pre-AIA 35 U.S.C. 112,sixth paragraph] is implicated only when steps plusfunction without acts are present…. If we were toconstrue every process claim containing stepsdescribed by an ‘ing’ verb, such as passing, heating,reacting, transferring, etc., into a step-plus-function,we would be limiting process claims in a mannernever intended by Congress.” (emphasis in original));see also Baran v. Medical Device Techs., Inc., 616F.3d 1309, 1317, 96 USPQ2d 1057, 1063 (Fed. Cir.2010) (the claimed function may include thefunctional language that precedes the phrase “meansfor.”). However, “the fact that a particularmechanism…is defined in functional terms is notsufficient to convert a claim element containing thatterm into a ‘means for performing a specifiedfunction’ within the meaning of section 112(6).” Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d1580, 1583, 39 USPQ2d 1783, 1786 (Fed. Cir. 1996)(“detent mechanism” defined in functional termswas not intended to invoke 35 U.S.C. 112, sixthparagraph); see also Al-Site Corp. v. VSIInternational Inc., 174 F.3d 1308, 1318, 50 USPQ2d1161, 1166–67 (Fed. Cir. 1999) (although the claimelements “eyeglass hanger member” and “eyeglasscontacting member” include a function, these claimelements do not invoke pre-AIA 35 U.S.C. 112, sixthparagraph, because the claims themselves contain

sufficient structural limitations for performing thosefunctions). Also, a statement of function appearingonly in the claim preamble is generally insufficientto invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph. O.I. Corp., 115 F.3d at 1583,42 USPQ2d at 1782 (“[A] statement in a preambleof a result that necessarily follows from performinga series of steps does not convert each of those stepsinto step- plus-function clauses. The steps of‘passing’ are not individually associated in the claimswith functions performed by the steps of passing.”).

The mere use of the term “means” with no associatedfunction rebuts the presumption that 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph, isinvoked. A function must be recited within the claimlimitation, but it is not necessary that a particularformat be used. Typically, the claim limitation willuse the linking word “for” to associate “means” ora generic placeholder with the function. However,other linking words may be used, such as “so that”or “configured to”, provided it is clear that the claimelement is reciting a function. In certaincircumstances, it is also not necessary to use alinking word if other words used with “means”, orthe generic placeholder, convey the function. Suchwords, however, cannot convey specific structurefor performing the function or the phrase will not betreated as invoking 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph. For example, “inkdelivery means”, “module configured to deliver ink”and “means for ink delivery” could all be interpretedas claim elements that invoke 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph. See Signtech USA, 174 F.3d at 1356.

C. The Term “Means” or “Step” or the GenericPlaceholder Must Not Be Modified By SufficientStructure, Material, or Acts for Achieving the SpecifiedFunction

With respect to the third prong of this analysis, theterm “means” or “step” or the generic placeholderrecited in the claim must not be modified bysufficiently definite structure, material, or acts forachieving the specified function. See Seal-Flex, 172F.3d at 849, 50 USPQ2d at 1234 (Radar, J.,concurring) (“Even when a claim element useslanguage that generally falls under thestep-plus-function format, however, [35 U.S.C.] 112

Rev. 08.2017, January 20182100-385


¶ 6 still does not apply when the claim limitationitself recites sufficient acts for performing thespecified function.”); Envirco Corp. v. ClestraCleanroom, Inc., 209 F.3d 1360, 54 USPQ2d 1449(Fed. Cir. 2000) (holding “second baffle means”does not invoke 35 U.S.C. 112, sixth paragraph,because the word “baffle” itself imparts structureand the claim further recites the structure of thebaffle); Rodime PLC v. Seagate Technology, Inc.,174 F.3d 1294, 1303–04, 50 USPQ2d 1429, 1435–36(Fed. Cir. 1999) (holding “positioning means formoving” does not invoke 35 U.S.C. 112, sixthparagraph, because the claim further provides a listof the structure underlying the means and thedetailed recitation of the structure for performingthe moving function removes this element from thepurview of 35 U.S.C. 112, sixth paragraph); Colev. Kimberly-Clark Corp., 102 F.3d 524, 531, 41USPQ2d 1001, 1006 (Fed. Cir. 1996) (holding“perforation means…for tearing” does not invoke35 U.S.C. 112, sixth paragraph, because the claimdescribes the structure supporting the tearingfunction (i.e., perforation)). In other situations, theFederal Circuit has come to a different conclusion.See Unidynamics Corp. v. Automatic Prod. Int’l,157 F.3d 1311, 1319, 48 USPQ2d 1099, 1104 (Fed.Cir. 1998) (holding that “spring means” invokes35 U.S.C. 112, sixth paragraph).

Examiners will apply 35 U.S.C. 112(f) or pre-AIA35 U.S.C. 112, sixth paragraph to a claim limitationthat uses the term “means” or “step” or genericplaceholder associated with functional language,unless that term is (1) preceded by a structuralmodifier, defined in the specification as a particularstructure or known by one skilled in the art, thatdenotes the type of structural device (e.g., “filters”),or (2) modified by sufficient structure or materialfor achieving the claimed function.

A limitation will not invoke 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph if there isa structural modifier that further describes the term“means” or “step” or the generic placeholder. Forexample, although a generic placeholder like“mechanism” standing alone may invoke 35 U.S.C.112(f) 35 U.S.C. 112, sixth paragraph when coupledwith a function, it will not invoke 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph when itis preceded by a structural modifier (e.g., “detent

mechanism”). Greenberg, 91 F.3d at 1583, 39USPQ2d at 1786 (holding that the term “detentmechanism” did not to invoke 35 U.S.C. 112, sixthparagraph because the structural modifier “detent”denotes a type of structural device with a generallyunderstood meaning in the mechanical arts). Bycontrast, a generic placeholder (e.g., “mechanism,”“element,” “member”) coupled with a function mayinvoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,sixth paragraph when it is preceded by anon-structural modifier that does not have anygenerally understood structural meaning in the art(e.g., “colorant selection mechanism,” “lever movingelement,” or “movable link member”). See Massachusetts Inst. of Tech., 462 F.3d at 1354, 80USPQ2d at 1231 (The claim recited use of a colorantselection mechanism, to which the court performeda means-plus-function analysis under pre-AIA 35U.S.C. 112, sixth paragraph. The court held that theterm "colorant selection", which modifies the genericterm "mechanism", was not defined in thespecification, had no dictionary definition, nor anygenerally understood meaning in the art, the termdoes not connote sufficient structure to a person ofordinary skill in the art to avoid pre-AIA 35 U.S.C.112, sixth paragraph treatment.); Mas-Hamilton,156 F.3d at 1214-1215, 48 USPQ2d at 1017.

To determine whether a word, term, or phrasecoupled with a function denotes structure, examinersshould check whether: (1) the specification providesa description sufficient to inform one of ordinaryskill in the art that the term denotes structure; (2)general and subject matter specific dictionariesprovide evidence that the term has achievedrecognition as a noun denoting structure; and (3) theprior art provides evidence that the term has anart-recognized structure to perform the claimedfunction. Ex parte Rodriguez, 92 USPQ2d 1395,1404 (Bd. Pat. App. & Int. 2009) (precedential).“The standard is whether the words of the claim areunderstood by persons of ordinary skill in the art tohave a sufficiently definite meaning as the name forstructure.” Williamson v. Citrix Online, LLC, 792F.3d 1339, 1349, 115 USPQ2d 1105, 1111 (Fed.Cir. 2015).

During examination, however, applicants have theopportunity and the obligation to define theirinventions precisely, including whether a claim

2100-386Rev. 08.2017, January 2018


limitation invokes 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph. Thus, if the term“means” or “step” or a generic placeholder ismodified by sufficient structure, material or acts forachieving the specified function, the USPTO willconsider that presumption has been rebutted and willnot apply 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph, until such modifying languageis deleted from the claim limitation.

It is necessary to decide on an element by elementbasis whether 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph, applies. Not all terms in ameans-plus-function or step-plus-function clause arelimited to what is disclosed in the written descriptionand equivalents thereof, since 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph, appliesonly to the interpretation of the means or step thatperforms the recited function. See, e.g., IMSTechnology Inc. v. Haas Automation Inc., 206 F.3d1422, 54 USPQ2d 1129 (Fed. Cir. 2000) (the term“data block” in the phrase “means to sequentiallydisplay data block inquiries” was not the means thatcaused the sequential display, and its meaning wasnot limited to the disclosed embodiment andequivalents thereof). Each claim must beindependently reviewed to determine theapplicability of 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph, even where theapplication contains substantially similar processand apparatus claims. O.I. Corp., 115 F.3d at1583-1584, 42 USPQ2d at 1782 (“We understandthat the steps in the method claims are essentially inthe same language as the limitations in the apparatusclaim, albeit without the ‘means for’ qualification….Each claim must be independently reviewed in orderto determine if it is subject to the requirements ofsection 112, ¶ 6. Interpretation of claims would beconfusing indeed if claims that are not means- orstep- plus function were to be interpreted as if theywere, only because they use language similar to thatused in other claims that are subject to thisprovision.”).

Where a claim limitation meets the 3-prong analysisand is being treated under 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph, theexaminer will include a statement in the Officeaction that the claim limitation is being treated under35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth

paragraph. See MPEP § 2181, subsection VI., below.If a claim limitation uses the term “means” or “step,”but the examiner determines that either the secondprong or the third prong of the 3-prong analysis isnot met, then in these situations, the examiner mustinclude a statement in the Office action explainingthe reasons why a claim limitation which uses theterm “means” or “step” is not being treated under35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph.

In the event that it is unclear whether the claimlimitation falls within the scope of 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph, arejection under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, may be appropriate.

II. DESCRIPTION NECESSARY TO SUPPORT ACLAIM LIMITATION WHICH INVOKES 35 U.S.C.112(f) or Pre-AIA 35 U.S.C. 112, SIXTHPARAGRAPH

35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph states that a claim limitation expressed inmeans- (or step-) plus-function language “shall beconstrued to cover the correspondingstructure…described in the specification andequivalents thereof.” “If one employs means plusfunction language in a claim, one must set forth inthe specification an adequate disclosure showingwhat is meant by that language. If an applicant failsto set forth an adequate disclosure, the applicant hasin effect failed to particularly point out and distinctlyclaim the invention as required by the 35 U.S.C.112(b) [or the second paragraph of pre-AIA section112].” In re Donaldson Co., 16 F.3d 1189, 1195,29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc).

A. The Corresponding Structure Must Be DisclosedIn the Specification Itself in a Way That One Skilled Inthe Art Will Understand What Structure Will Performthe Recited Function

The proper test for meeting the definitenessrequirement is that the corresponding structure (ormaterial or acts) of a means- (or step-) plus-functionlimitation must be disclosed in the specification itselfin a way that one skilled in the art will understandwhat structure (or material or acts) will perform therecited function. See Atmel Corp. v. InformationStorage Devices, Inc., 198 F.3d 1374, 1381, 53

Rev. 08.2017, January 20182100-387


USPQ2d 1225, 1230 (Fed. Cir. 1999). In Atmel, thepatentee claimed an apparatus that included a “highvoltage generating means” limitation, therebyinvoking 35 U.S.C. 112, sixth paragraph. Thespecification incorporated by reference a non-patentdocument from a technical journal, which describeda particular high voltage generating circuit. TheFederal Circuit concluded that the title of the articlein the specification may, by itself, be sufficient toindicate to one skilled in the art the precise structureof the means for performing the recited function,and it remanded the case to the district court “toconsider the knowledge of one skilled in the art thatindicated, based on unrefuted testimony, that thespecification disclosed sufficient structurecorresponding to the high-voltage means limitation.” Id. at 1382, 53 USPQ2d at 1231.

The disclosure of the structure (or material or acts)may be implicit or inherent in the specification if itwould have been clear to those skilled in the art whatstructure (or material or acts) corresponds to themeans- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997). If there is no disclosure of structure, materialor acts for performing the recited function, the claimfails to satisfy the requirements of 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph. “[A]bare statement that known techniques or methodscan be used does not disclose structure” in thecontext of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir.2007) (Disclosure that an invention “may becontrolled by known differential pressure, valvingand control equipment” was not a disclosure of anystructure corresponding to the claimed “controlmeans for operating [a] valving ” and the claim washeld indefinite). See also Budde v. Harley-Davidson,Inc., 250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806(Fed. Cir. 2001); Cardiac Pacemakers, Inc. v. St.Jude Med., Inc., 296 F.3d 1106, 1115-18, 63USPQ2d 1725, 1731-34 (Fed. Cir. 2002) (Courtinterpreted the language of the “third monitoringmeans for monitoring the ECG signal…for activating…” to require the same means to perform bothfunctions and the only entity referenced in thespecification that could possibly perform bothfunctions is the physician. The court held that

excluding the physician, no structure accomplishesthe claimed dual functions. Because no structuredisclosed in the embodiments of the inventionactually performs the claimed dual functions, thespecification lacks corresponding structure asrequired by 35 U.S.C. 112, sixth paragraph, and failsto comply with 35 U.S.C. 112, second paragraph.).

Whether a claim reciting an element in means- (orstep-) plus-function language fails to comply with35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph, because the specification does notdisclose adequate structure (or material or acts) forperforming the recited function is closely related tothe question of whether the specification meets thedescription requirement in 35 U.S.C. 112(a) orpre-AIA 35 U.S.C. 112, first paragraph. See In reNoll, 545 F.2d 141, 149, 191 USPQ 721, 727 (CCPA1976) (unless the means-plus-function language isitself unclear, a claim limitation written inmeans-plus- function language meets the definitenessrequirement in 35 U.S.C. 112, second paragraph, solong as the specification meets the writtendescription requirement in 35 U.S.C. 112, firstparagraph). In Aristocrat Techs. Australia PTY Ltd.v. Int’l Game Tech., 521 F.3d 1328, 1336-37, 86USPQ2d 1235, 1242 (Fed. Cir. 2008), the courtstated:

Enablement of a device requires only thedisclosure of sufficient information so that aperson of ordinary skill in the art could makeand use the device. A section 112[(f) orpre-AIA] paragraph 6 disclosure, however,serves the very different purpose of limitingthe scope of the claim to the particular structuredisclosed, together with equivalents. … Forexample, in Atmel Corp. v. InformationStorage Devices, Inc., 198 F.3d 1374, 1380[,53 USPQ2d 1225, 1230] (Fed. Cir. 1999), thecourt embraced the proposition that‘consideration of the understanding of oneskilled in the art in no way relieves the patenteeof adequately disclosing sufficient structure inthe specification.’ It is not enough for thepatentee simply to state or later argue thatpersons of ordinary skill in the art would knowwhat structures to use to accomplish theclaimed function. The court in Biomedino, LLCv. Waters Technologies Corp., 490 F.3d 946,

2100-388Rev. 08.2017, January 2018


953[, 83 USPQ2d 1118, 1123] (Fed. Cir. 2007),put the point this way: "The inquiry is whetherone of skill in the art would understand thespecification itself to disclose a structure, notsimply whether that person would be capableof implementing that structure."

The invocation of 35 U.S.C. 112(f) or pre-AIA35 U.S.C. 112, sixth paragraph, does not exempt anapplicant from compliance with 35 U.S.C. 112(a)and 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,first and second paragraphs. See Donaldson, 16F.3d at 1195, 29 USPQ2d at 1850; In re Knowlton,481 F.2d 1357, 1366, 178 USPQ 486, 493 (CCPA1973) (“[The sixth paragraph of section 112] cannotbe read as creating an exception either to thedescription requirement of the first paragraph … orto the definiteness requirement found in the secondparagraph of section 112. Means-plus-functionlanguage can be used in the claims, but the claimsmust still accurately define the invention.”).

Under certain limited circumstances, the writtendescription does not have to explicitly describe thestructure (or material or acts) corresponding to ameans- (or step-) plus-function limitation toparticularly point out and distinctly claim theinvention as required by 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph. See Dossel, 115 F.3d at 946, 42 USPQ2d at 1885. Underproper circumstances, drawings may provide awritten description of an invention as required by35 U.S.C. 112. Vas-Cath, Inc. v. Mahurkar, 935F.2d 1555, 1565, 19 USPQ2d 1111, 1118 (Fed. Cir.1991). Further, disclosure of structure correspondingto a means-plus-function limitation may be implicitin the written description if it would have been clearto those skilled in the art what structure must performthe function recited in the means-plus-functionlimitation. See Atmel Corp. v. Information StorageDevices Inc., 198 F.3d 1374, 1379, 53 USPQ2d1225, 1228 (Fed. Cir. 1999) (stating that the “oneskilled in the art” analysis should apply indetermining whether sufficient structure has beendisclosed to support a means-plus-functionlimitation); Dossel, 115 F.3d at 946–47, 42 USPQ2dat 1885 (“Clearly, a unit which receives digital data,performs complex mathematical computations andoutputs the results to a display must be implementedby or on a general or special purpose computer

(although it is not clear why the written descriptiondoes not simply state ‘computer’ or some equivalentphrase).”).

B. Computer-Implemented Means-Plus-FunctionLimitations

As noted above, when rendering patentabilitydeterminations the Office may not disregard thestructure disclosed in the specification correspondingto the means-plus-function language. “[W]hen thedisclosed structure is a computer programmed tocarry out an algorithm, ‘the disclosed structure isnot the general purpose computer, but rather thatspecial purpose computer programmed to performthe disclosed algorithm.’” In re Aoyama, 656 F.3d1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011)(quoting WMS Gaming, Inc. v. Int’l Game Tech.,184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed.Cir. 1999)); see also In re Alappat, 33 F.3d 1526,1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994) (enbanc). In cases involving a special purposecomputer-implemented means-plus-functionlimitation, the Federal Circuit has consistentlyrequired that the structure be more than simply ageneral purpose computer or microprocessor andthat the specification must disclose an algorithm forperforming the claimed function. See, e.g., NoahSystems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat,521 F.3d at 1333, 86 USPQ2d at 1239.

For a computer-implemented means-plus-functionclaim limitation invoking 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph, a generalpurpose computer is usually only sufficient as thecorresponding structure for performing a generalcomputing function (e.g., “means for storing data”),but the corresponding structure for performing aspecific function is required to be more than simplya general purpose computer or microprocessor. In In re Katz Interactive Call Processing PatentLitigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737,1747 (Fed. Cir. 2011) (citations omitted), the courtstated:

Those cases involved specific functions thatwould need to be implemented by programminga general purpose computer to convert it intoa special purpose computer capable of

Rev. 08.2017, January 20182100-389


performing those specified functions. Bycontrast, in the seven claims identified above, Katz has not claimed a specific functionperformed by a special purpose computer, buthas simply recited the claimed functions of‘processing,’ ‘receiving,’ and ‘storing.’ Absenta possible narrower construction of the terms‘processing,’ ‘receiving,’ and ‘storing,’discussed below, those functions can beachieved by any general purpose computerwithout special programming. As such, it wasnot necessary to disclose more structure thanthe general purpose processor that performsthose functions. Those seven claims do not runafoul of the rule against purely functionalclaiming, because the functions of ‘processing,’‘receiving,’ and ‘storing’ are coextensive withthe structure disclosed, i.e., a general purposeprocessor.

To claim a means for performing a specificcomputer-implemented function and then to discloseonly a general purpose computer as the structuredesigned to perform that function amounts to purefunctional claiming. Aristocrat, 521 F.3d 1328 at1333, 86 USPQ2d at 1239. In this instance, thestructure corresponding to a 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph claimlimitation for a computer-implemented function mustinclude the algorithm needed to transform the generalpurpose computer or microprocessor disclosed inthe specification. Aristocrat, 521 F.3d at 1333, 86USPQ2d at 1239; Finisar Corp. v. DirecTV Group,Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623(Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l GameTech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391(Fed. Cir. 1999). The corresponding structure is notsimply a general purpose computer by itself but thespecial purpose computer as programmed to performthe disclosed algorithm. Aristocrat, 521 F.3d at1333, 86 USPQ2d at 1239. Thus, the specificationmust sufficiently disclose an algorithm to transforma general purpose microprocessor to the specialpurpose computer. See Aristocrat, 521 F.3d at 1338,86 USPQ2d at 1241. (“Aristocrat was not requiredto produce a listing of source code or a highlydetailed description of the algorithm to be used toachieve the claimed functions in order to satisfy 35U.S.C. § 112 ¶ 6. It was required, however, to atleast disclose the algorithm that transforms the

general purpose microprocessor to a ‘special purposecomputer programmed to perform the disclosedalgorithm.’” (quoting WMS Gaming, 184 F.3d at1349, 51 USPQ2d at 1391.)) An algorithm is defined,for example, as “a finite sequence of steps forsolving a logical or mathematical problem orperforming a task.” Microsoft Computer Dictionary,Microsoft Press, 5th edition, 2002. Applicant mayexpress the algorithm in any understandable termsincluding as a mathematical formula, in prose, in aflow chart, or “in any other manner that providessufficient structure.” Finisar, 523 F.3d at 1340, 86USPQ2d at 1623; see also Intel Corp. v. VIA Techs.,Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941(Fed. Cir. 2003); In re Dossel, 115 F.3d 942,946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376,1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); Inre Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.

The Federal Circuit case law regarding specialpurpose computer-implemented means-plus-functionclaims is divided into two distinct groups. The firstgroup includes cases in which the specificationdiscloses no algorithm, and the second groupincludes cases in which the specification doesdisclose an algorithm, but an issue exists as towhether the disclosure is adequate to perform theentire claimed function(s). The sufficiency of thealgorithm is determined in view of what one ofordinary skill in the art would understand assufficient to define the structure and make theboundaries of the claim understandable. See Noah,675 F.3d at 1313, 102 USPQ2d at 1417.

Accordingly, a rejection under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph isappropriate if the specification discloses nocorresponding algorithm associated with a computeror microprocessor. Aristocrat, 521 F.3d at 1337-38,86 USPQ2d at 1242. For example, mere referenceto a general purpose computer with appropriateprogramming without providing an explanation ofthe appropriate programming, or simply reciting“software” without providing detail about the meansto accomplish a specific software function, wouldnot be an adequate disclosure of the correspondingstructure to satisfy the requirements of 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239;

2100-390Rev. 08.2017, January 2018


Finisar, 523 F.3d at 1340-41, 86 USPQ2d at 1623.In addition, merely referencing a specializedcomputer (e.g., a “bank computer”), some undefinedcomponent of a computer system (e.g., “accesscontrol manager”), “logic,” “code,” or elements thatare essentially a black box designed to perform therecited function, will not be sufficient because theremust be some explanation of how the computer orthe computer component performs the claimedfunction. Blackboard, Inc. v. Desire2Learn, Inc.,574 F.3d 1371, 1383-85, 91 USPQ2d 1481, 1491-93(Fed. Cir. 2009); Net MoneyIN, Inc. v. VeriSign,Inc., 545 F.3d 1359, 1366-67, 88 USPQ2d 1751,1756-57 (Fed. Cir. 2008); Rodriguez, 92 USPQ2dat 1405-06.

If the specification explicitly discloses an algorithm,the sufficiency of the disclosure of the algorithmmust be determined in light of the level of ordinaryskill in the art. Aristocrat, 521 F.3d at 1337, 86USPQ2d at 1241; AllVoice Computing PLC v.Nuance Commc’ns, Inc., 504 F.3d 1236, 1245, 84USPQ2d 1886, 1893 (Fed. Cir. 2007); Intel Corp.,319 F.3d at 1366-67, 65 USPQ2d 1934, 1941(knowledge of a person of ordinary skill in the artcan be used to make clear how to implement adisclosed algorithm). The examiner should determinewhether one skilled in the art would know how toprogram the computer to perform the necessary stepsdescribed in the specification (i.e., the invention isenabled), and that the inventor was in possession ofthe invention (i.e., the invention meets the writtendescription requirement). Thus, the specificationmust sufficiently disclose an algorithm to transforma general purpose microprocessor to a specialpurpose computer so that a person of ordinary skillin the art can implement the disclosed algorithm toachieve the claimed function. Aristocrat, 521 F.3dat 1338, 86 USPQ2d at 1242.

A rejection under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph is also appropriate ifthe specification discloses an algorithm but thealgorithm is not sufficient to perform the entireclaimed function. For example, for a function thatincludes two distinct functional components,disclosure of an algorithm that is sufficient toperform one of the functions but not the other wouldnot be adequate to satisfy the requirements of 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second

paragraph. The disclosure of structure to support onefunction cannot fill in the gaps in the specificationfor structure needed to perform a different function.Where a disclosed algorithm supports some, but notall, of the functions associated with ameans-plus-function limitation, the specification istreated as if no algorithm has been disclosed at all.Moreover, attempting to fill in the gaps of thespecification by importing off the shelf software orasserting that individuals of ordinary skill in the artwould understand how to accomplish the functiondescribed with the assistance of such off the shelfsoftware does not solve the inadequacy of thedisclosure. Noah, 675 F.3d at 1318, 102 USPQ2dat 1421.

In several Federal Circuit cases, the patentees arguedthat the requirement for the disclosure of analgorithm can be avoided if one of ordinary skill inthe art is capable of writing the software to converta general purpose computer to a special purposecomputer to perform the claimed function. See, e.g., Blackboard, 574 F.3d at 1385, 91 USPQ2d at 1493; Biomedino, 490 F.3d at 952, 83 USPQ2d at 1123; Atmel Corp., 198 F.3d at 1380, 53 USPQ2d at 1229.Such argument was found to be unpersuasivebecause the understanding of one skilled in the artdoes not relieve the patentee of the duty to disclosesufficient structure to support means-plus-functionclaim terms. Blackboard, 574 F.3d at 1385, 91USPQ2d at 1493 (“A patentee cannot avoidproviding specificity as to structure simply becausesomeone of ordinary skill in the art would be ableto devise a means to perform the claimed function.”); Atmel Corp., 198 F.3d at 1380, 53 USPQ2d at 1229(“[C]onsideration of the understanding of one skilledin the art in no way relieves the patentee ofadequately disclosing sufficient structure in thespecification.”). The specification must explicitlydisclose the algorithm for performing the claimedfunction, and simply reciting the claimed functionin the specification will not be a sufficient disclosurefor an algorithm which, by definition, must containa sequence of steps. Blackboard, 574 F.3d at 1384,91 USPQ2d at 1492 (stating that language thatsimply describes the function to be performeddescribes an outcome, not a means for achieving thatoutcome); Microsoft Computer Dictionary, MicrosoftPress, 5th edition, 2002; see also EncyclopaediaBritannica, Inc. v. Alpine Elecs., Inc., 355 Fed. App'x

Rev. 08.2017, January 20182100-391


389, 394-95 (Fed. Cir. 2009) (holding that implicitor inherent disclosure of a class of algorithms forperforming the claimed functions is not sufficient,and the purported “one-step” algorithm is not analgorithm at all) (unpublished).

Often the supporting disclosure for acomputer-implemented invention discusses theimplementation of the functionality of the inventionthrough hardware, software, or a combination ofboth. In this situation, a question can arise as towhich mode of implementation supports themeans-plus-function limitation. The language of 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph requires that the recited “means” forperforming the specified function shall be construedto cover the corresponding “structure or material”described in the specification and equivalentsthereof. Therefore, by choosing to use ameans-plus-function limitation and invoke 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph,applicant limits that claim limitation to the disclosedstructure, i.e., implementation by hardware or thecombination of hardware and software, andequivalents thereof. Therefore, the examiner shouldnot construe the limitation as covering pure softwareimplementation.

However, if there is no corresponding structuredisclosed in the specification (i.e., the limitation isonly supported by software and does not correspondto an algorithm and the computer or microprocessorprogrammed with the algorithm), the limitationshould be deemed indefinite as discussed above, andthe claim should be rejected under 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph. It isimportant to remember that claims must beinterpreted as a whole; so, a claim that includes ameans-plus-function limitation that corresponds tosoftware per se (and is thus indefinite for lackingstructural support in the specification) is notnecessarily directed as a whole to software per seunless the claim lacks other structural limitations.

As noted below in subsection III., if it is unclearwhether there is sufficient supporting structure orwhether the algorithm is adequate to perform theentire claimed function, it is appropriate to reject theclaim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph.

C. The Supporting Disclosure Clearly Links orAssociates the Disclosed Structure, Material, or Acts tothe Claimed Function

The structure disclosed in the written description ofthe specification is the corresponding structure onlyif the written description of the specification or theprosecution history clearly links or associates thatstructure to the function recited in a means- (or step-)plus-function claim limitation under 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph. See B.Braun Medical Inc., v. Abbott Laboratories, 124F.3d 1419, 1424, 43 USPQ2d 1896, 1900 (Fed. Cir.1997). The requirement that a particular structurebe clearly linked with the claimed function in orderto qualify as corresponding structure is the quid proquo for the convenience of employing 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph,and is also supported by the requirement of 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph, that an invention must be particularlypointed out and distinctly claimed. See MedicalInstrumentation & Diagnostics Corp. v. Elekta AB,344 F.3d 1205, 1211, 68 USPQ2d 1263, 1268. Fora means- (or step-) plus- function claim limitationthat invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph, a rejection under 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,is appropriate if one of ordinary skill in the art cannotidentify what structure, material, or acts disclosedin the written description of the specification performthe claimed function.

III. DETERMINING 35 U.S.C. 112(b) or Pre-AIA 35U.S.C. 112 SECOND PARAGRAPH COMPLIANCEWHEN 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112SIXTH PARAGRAPH IS INVOKED

Once the examiner determines that a claim limitationis a means-plus-function limitation invoking 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, the examiner should determine theclaimed function and then review the writtendescription of the specification to determine whetherthe corresponding structure, material, or acts thatperform the claimed function are disclosed. Notethat drawings may provide a written description ofan invention as required by 35 U.S.C. 112. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1565,19 USPQ2d 1111, 1117 (Fed. Cir. 1991). Thecorresponding structure, material, or acts may be

2100-392Rev. 08.2017, January 2018


disclosed in the original drawings, figures, tables,or sequence listing. However, the correspondingstructure, material, or acts cannot include anystructure, material, or acts disclosed only in thematerial incorporated by reference or a prior artreference. See Pressure Prods. Med. Supplies, Inc.v. Greatbatch Ltd., 599 F.3d 1308, 1317, 94 USPQ2d1261, 1267 (Fed. Cir. 2010) (stating, “[s]implymentioning prior art references in a patent does notsuffice as a specification description to give thepatentee outright claim to all of the structuresdisclosed in those references.”); Atmel Corp. v. Info.Storage Devices, Inc., 198 F.3d 1374, 1381, 53USPQ2d 1225, 1230 (Fed. Cir. 1999). The disclosuremust be reviewed from the point of view of oneskilled in the relevant art to determine whether thatperson would understand the written description todisclose the corresponding structure, material, oracts. Tech. Licensing Corp. v. Videotek, Inc., 545F.3d 1316, 1338, 88 USPQ2d 1865, 1879 (Fed. Cir.2008); Med. Instrumentation & Diagnostics Corp.v. Elekta AB, 344 F.3d 1205, 1211-12, 68 USPQ2d1263, 1269 (Fed. Cir. 2003). To satisfy thedefiniteness requirement under 35 U.S.C. 112(b) or35 U.S.C. 112, second paragraph, the writtendescription must clearly link or associate thecorresponding structure, material, or acts to theclaimed function. Telcordia Techs., Inc. v. CiscoSystems, Inc., 612 F.3d 1365, 1376, 95 USPQ2d1673, 1682 (Fed. Cir. 2010). A rejection under 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph is appropriate if the written descriptionfails to link or associate the disclosed structure,material, or acts to the claimed function, or if thereis no disclosure (or insufficient disclosure) ofstructure, material, or acts for performing the claimedfunction. Donaldson, 16 F.3d at 1195, 29 USPQ2dat 1850. A bare statement that known techniques ormethods can be used would not be a sufficientdisclosure to support a means-plus-functionlimitation. Biomedino, LLC v. Waters Techs. Corp.,490 F.3d 946, 953, 83 USPQ2d 1118, 1123 (Fed.Cir. 2007).

A rejection under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph may be appropriatein the following situations when examiningmeans-plus-function claim limitations under 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph:

(1) when it is unclear whether a claim limitationinvokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,sixth paragraph;

(2) when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph is invoked and there is nodisclosure or there is insufficient disclosure ofstructure, material, or acts for performing the claimedfunction; and/or

(3) when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph is invoked and the supportingdisclosure fails to clearly link or associate thedisclosed structure, material, or acts to the claimedfunction.

When the examiner cannot identify thecorresponding structure, material, or acts, a rejectionunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph should be made. In some cases, arequirement for information under 37 CFR 1.105may be made to require the identification of thecorresponding structure, material, or acts. See MPEP§ 704.11(a), Example R. If a requirement forinformation under 37 CFR 1.105 is made and theapplicant states that the applicant lacks suchinformation or the reply does not identify thecorresponding structure, material, or acts, a rejectionunder 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112,second paragraph should be made. For moreinformation, see MPEP § 704.12 (“Replies torequirements for information must be complete andfiled within the time period set including anyextensions. Failure to reply within the time periodset will result in the abandonment of theapplication.”).

If the written description sets forth the correspondingstructure, material, or acts in compliance with 35U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph, the claim limitation must “be construedto cover the corresponding structure, material, oracts described in the specification and equivalentsthereof.” 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph. However, functional limitationsthat are not recited in the claim, or structurallimitations from the written description that areunnecessary to perform the claimed function, cannotbe imported into the claim. Welker Bearing, 550F.3d at 1097, 89 USPQ2d at 1294; Wenger Mfg.,Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225,1233, 57 USPQ2d 1679, 1685 (Fed. Cir. 2001).

Rev. 08.2017, January 20182100-393


The following guidance is provided to determinewhether applicant has complied with therequirements of 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, when 35 U.S.C.112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph,is invoked:

(A) If the corresponding structure, material oracts are described in the specification in specificterms (e.g., an emitter-coupled voltage comparator),are linked to or associated with the claimed functionand one skilled in the art could identify the structure,material or acts from that description as beingadequate to perform the claimed function, then therequirements of 35 U.S.C. 112(b) and (f) or pre-AIA35 U.S.C. 112, second and sixth paragraphs and aresatisfied. See Atmel, 198 F.3d at 1382, 53 USPQ2d1231.

(B) If the corresponding structure, material oracts are described in the specification in broadgeneric terms and the specific details of which areincorporated by reference to another document (e.g.,attachment means disclosed in U.S. Patent No. X,which is hereby incorporated by reference, or acomparator as disclosed in the Y article, which ishereby incorporated by reference), Office personnelmust review the description in the specification,without relying on any material from theincorporated document, and apply the “one skilledin the art” analysis to determine whether one skilledin the art could identify the corresponding structure(or material or acts) for performing the recitedfunction to satisfy the definiteness requirement of35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, secondparagraph. See Default Proof Credit Card System,Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 75USPQ2d 1116 (Fed. Cir. 2005) (“The inquiry under[35 U.S.C.] § 112, ¶ 2, does not turn on whether apatentee has ‘incorporated by reference’ materialinto the specification relating to structure, but insteadasks first ‘whether structure is described in thespecification, and, if so, whether one skilled in theart would identify the structure from thatdescription.’”).

(1) If one skilled in the art would be able toidentify the structure, material or acts from thedescription in the specification for performing therecited function, then the requirements of 35 U.S.C.112(b) or pre-AIA 35 U.S.C. 112, second paragraph,are satisfied. See Dossel, 115 F.3d at 946-47, 42

USPQ2d at 1885 (The function recited in themeans-plus-function limitation involved“reconstructing” data. The issue was whether thestructure underlying this “reconstructing” functionwas adequately described in the written descriptionto satisfy 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112, second paragraph. The court stated that“[n]either the written description nor the claims usesthe magic word ‘computer,’ nor do they quotecomputer code that may be used in the invention.Nevertheless, when the written description iscombined with claims 8 and 9, the disclosuresatisfies the requirements of Section 112, Para. 2.”The court concluded that based on the specific factsof the case, one skilled in the art would recognizethe structure for performing the “reconstructing”function since “a unit which receives digital data,performs complex mathematical computations andoutputs the results to a display must be implementedby or on a general or special purpose computer.”).See also Intel Corp. v. VIA Technologies, Inc, 319F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir.2003) (The “core logic” structure that was modifiedto perform a particular program was held to beadequate corresponding structure for a claimedfunction although the specification did not discloseinternal circuitry of the core logic to show exactlyhow it must be modified.)

(2) If one skilled in the art would not be ableto identify the structure, material or acts fromdescription in the specification for performing therecited function, then applicant will be required toamend the specification to contain the materialincorporated by reference, including the clear linkor associated structure, material or acts to thefunction recited in the claim. See 37 CFR 1.57(c)(3).Applicant should not be required to insert all of thesubject matter described in the entire referenceddocument into the specification. To maintain aconcise specification, applicant should only includethe relevant portions of the referenced document thatcorrespond to the means- (or step-) plus-functionlimitation. See Atmel, 198 F.3d at 1382, 53 USPQ2dat 1230 (“All one needs to do…is to recite somestructure corresponding to the means in thespecification…so that one can readily ascertain whatthe claim means and comply with the particularityrequirement of Para. 2.”).

2100-394Rev. 08.2017, January 2018


IV. DETERMINING WHETHER 35 U.S.C. 112(a)or Pre-AIA 35 U.S.C. 112, FIRST PARAGRAPHSUPPORT EXISTS

A means- (or step-) plus-function limitation that isfound to be indefinite under 35 U.S.C. 112(b) orpre-AIA 35 U.S.C. 112, second paragraph, based onfailure of the specification to disclose correspondingstructure, material or act that performs the entireclaimed function may also lack adequate writtendescription and/or not be sufficiently enabled tosupport the full scope of the claim. The principalfunction of claims is to provide notice of theboundaries of the right to exclude by defining thelimits of the invention, and means-plus-functionclaims rely on the disclosure to define those limits.Accordingly, an inadequate disclosure may give riseto both an indefiniteness rejection for ameans-plus-function limitation and a failure tosatisfy the written description and enablementrequirements of section 112(a) or pre-AIA section112, first paragraph. The Federal Circuit hasrecognized the problem of providing a sufficientdisclosure for functional claiming, particularly withgeneric claim language, explaining that “Theproblem is especially acute with genus claims thatuse functional language to define the boundaries ofa claimed genus. In such a case, the functional claimmay simply claim a desired result, and may do sowithout describing species that achieve that result.But the specification must demonstrate that theapplicant has made a generic invention that achievesthe claimed result and do so by showing that theapplicant has invented species sufficient to supporta claim to the functionally-defined genus.” AriadPharmaceuticals Inc. v. Eli & Lilly Co., 598 F.3d1336, 1349, 94 USPQ2d 1161, 1171 (Fed. Cir. 2010) (en banc).

Thus, the means- (or step-) plus- function claimsmust still be analyzed to determine whether thereexists corresponding adequate support for such claimunder 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112,first paragraph. In considering whether there is 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph support for the claim limitation, theexaminer must consider not only the originaldisclosure contained in the summary and detaileddescription of the invention portions of thespecification, but also the original claims, abstract,

and drawings. See In re Mott, 539 F.2d 1291, 1299,190 USPQ 536, 542–43 (CCPA 1976) (claims); Inre Anderson, 471 F.2d 1237, 1240, 176 USPQ 331,333 (CCPA 1973) (claims); Hill-Rom Co. v. KineticConcepts, Inc., 209 F.3d 1337, 54 USPQ2d 1437(Fed. Cir. 2000) (unpublished) (abstract); In reArmbruster, 512 F.2d 676, 678–79, 185 USPQ 152,153–54 (CCPA 1975) (abstract); Anderson, 471F.2d at 1240, 176 USPQ at 333 (abstract); Vas-CathInc. v. Mahurkar, 935 F.2d 1555, 1564, 19 USPQ2d1111, 1117 (drawings); In re Wolfensperger, 302F.2d 950, 955–57, 133 USPQ 537, 541– 43 (CCPA1962) (drawings).

Merely restating a function associated with ameans-plus-function limitation is insufficient toprovide the corresponding structure for definiteness.See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at1419; Blackboard, 574 F.3d at 1384; Aristocrat,521 F.3d at 1334, 86 USPQ2d at 1239. It followstherefore that such a mere restatement of functionin the specification without more description of themeans that accomplish the function would also likelyfail to provide adequate written description undersection 112(a) or pre-AIA section 112, firstparagraph.

37 CFR 1.75(d)(1) provides, in part, that “the termsand phrases used in the claims must find clearsupport or antecedent basis in the description so thatthe meaning of the terms in the claims may beascertainable by reference to the description.” In thesituation in which the written description onlyimplicitly or inherently sets forth the structure,materials, or acts corresponding to a means- (orstep-) plus-function, and the examiner concludesthat one skilled in the art would recognize whatstructure, materials, or acts perform the functionrecited in a means- (or step-) plus-function, theexaminer should either: (A) have the applicant clarifythe record by amending the written description suchthat it expressly recites what structure, materials, oracts perform the function recited in the claimelement; or (B) state on the record what structure,materials, or acts perform the function recited in themeans- (or step-) plus-function limitation. Even ifthe disclosure implicitly sets forth the structure,materials, or acts corresponding to a means- (orstep-) plus-function claim element in compliancewith 35 U.S.C. 112(a) and (b) or pre-AIA 35 U.S.C.

Rev. 08.2017, January 20182100-395


112, first and second paragraphs, the USPTO maystill require the applicant to amend the specificationpursuant to 37 CFR 1.75(d) and MPEP § 608.01(o)to explicitly state, with reference to the terms andphrases of the claim element, what structure,materials, or acts perform the function recited in theclaim element in a manner that does not addprohibited new matter to the specification. See 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph (“An element in a claim for a combinationmay be expressed as a means or step for performinga specified function without the recital of structure,material, or acts in support thereof, and such claimshall be construed to cover the correspondingstructure, material, or acts described in thespecification and equivalents thereof.” (emphasisadded)); see also B. Braun Medical, 124 F.3d at1424, 43 USPQ2d at 1900 (holding that “pursuantto this provision [35 U.S.C. 112, sixth paragraph],structure disclosed in the specification is‘corresponding’ structure only if the specificationor prosecution history clearly links or associates thatstructure to the function recited in the claim. Thisduty to link or associate structure to function is the quid pro quo for the convenience of employing 112,paragraph 6.”); Medical Instrumentation andDiagnostic Corp. v. Elekta AB, 344 F.3d 1205, 1218,68 USPQ2d 1263, 1268 (Fed. Cir. 2003) (Althoughone of skill in the art would have been able to writea software program for digital to digital conversion,such software did not fall within the scope of “meansfor converting” images as claimed because nothingin the specification or prosecution history clearlylinked or associated such software with the functionof converting images into a selected format.); Wolfensperger, 302 F.2d at 955, 133 USPQ at 542(just because the disclosure provides support for aclaim element does not mean that the USPTO cannotenforce its requirement that the terms and phrasesused in the claims find clear support or antecedentbasis in the written description).

V. SINGLE MEANS CLAIMS

A single means claim is a claim that recites ameans-plus-function limitation as the only limitationof a claim. 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph, by its terms is limited to “anelement in a claim for a combination.” Therefore,single means claims that do not recite a combination

cannot invoke section 112(f) or pre-AIA section 112,sixth paragraph. As such, they are not limited to thestructure, material or act disclosed in thespecification that performs the claimed function.Thus, a single means limitation that is properlyconstrued will cover all means of performing theclaimed function. The long-recognized problem witha single means claim is that it covers everyconceivable means for achieving the stated result,while the specification discloses at most only thosemeans known to the inventor. In re Hyatt, 708 F.2d712, 218 USPQ 195 (Fed. Cir. 1983). A claim ofsuch breadth reads on subject matter that is notenabled by the specification, and therefore, shouldbe rejected under section 112(a) or pre-AIA section112, first paragraph. See also MPEP § 2164.08(a).

It is important to distinguish between claims thatrecite multiple functional limitations (a commonpractice particularly in the computer-related arts)and claims that recite a single element inmeans-plus-function terms (rare in most arts). Incomputer-implemented inventions, a microprocessormay be programmed with different algorithms, witheach algorithm performing a separate function. Eachof these separately programmed functions should beinterpreted as a separate element.

Applicants frequently draft claims tocomputer-related inventions using a shorthanddrafting technique that recites a generic placeholder,such as a “system”, that performs a series offunctions. This shorthand drafting technique doesnot avoid invoking 35 U.S.C. 112(f) or pre-AIAsection 112, sixth paragraph. See MPEP § 2181,subsection II.B. Each function recited in this mannershould be interpreted as a separate section 112(f) orpre-AIA section 112, sixth paragraph limitation.

For example, consider the following claim:

9. An image processing assembly that filters pixel values,comprising:

a system configured to:

extract a first pixel value; and

compare the first pixel value to a pixel thresholdto filter pixel values that exceed the threshold value.

2100-396Rev. 08.2017, January 2018


Assume the specification that supports this claim discloses thatthe system is a microprocessor programmed with two separatealgorithms, one for performing the extraction and another forcomparing the pixel values. A proper interpretation would treatthese elements as separate limitations each of which invoketreatment under section 112(f) or pre-AIA section 112, sixthparagraph since the word “system” has no structural meaningand in this case is serving as a generic placeholder for “means”.

The claim elements under 35 U.S.C. 112(f) or pre-AIA section112, sixth paragraph would be interpreted as:

system configured to extract a first pixel value;and

system configured to compare the first pixelvalue to a pixel threshold to filter pixel values thatexceed the threshold value.

This claim would not be considered a "single means"claim.

Compare this type of claim to the claim in Hyattthat was found to recite only a single element, whichis drafted in “means-plus-function” format but failsto be in a combination.

35. A Fourier transform processor for generating Fouriertransformed incremental output signals in response toincremental input signals, said Fourier transform processorcomprising incremental means for incrementally generating theFourier transformed incremental output signals in response tothe incremental input signals.

In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195,197 (Fed. Cir. 1983) (A single means claim whichcovered every conceivable means for achieving thestated purpose was held nonenabling for the scopeof the claim because the specification disclosed atmost only those means known to the inventor.)

VI. ENSURE THAT THE RECORD IS CLEAR

When an examiner interprets a claim limitation underthe provisions of 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph, the Office action shouldspecify that the examiner has done so. When claimterms other than “means” or "step" are determinedto invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph, the reasons why the claim wasinterpreted as invoking 35 U.S.C. 112(f) or pre-AIA35 U.S.C. 112, sixth paragraph, should also beclearly stated in the Office action. For example, theOffice action can include a statement that a certain

claim limitation is expressed in functional termscoupled to a generic placeholder (e.g., “module for,”)that does not connote structure and therefore invokestreatment under 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph. When the examiner hasdetermined that 35 U.S.C. 112(f) or pre-AIA 35U.S.C. 112, sixth paragraph applies, the examinermay also specify what the specification identifies asthe corresponding structure.

The two rebuttable presumptions regarding theapplication of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C.112, sixth paragraph, noted in subsection I., above,should be established in the prosecution record. Ifone of the presumptions is rebutted, an explanationof the reasons that the presumption is rebutted shouldbe provided on the record. In particular, clarificationshould be provided when the claim uses the word“means” or "step" and section 112(f) or pre-AIAsection 112, sixth paragraph, is not invoked or whenthe claim uses a substitute for the word “means” or"step" (a generic placeholder) and section 112(f) orpre-AIA section 112, sixth paragraph, is invoked.By this, the applicant and the public are notified asto the claim construction used by the examinerduring prosecution. Also, if the applicant intends adifferent claim construction, the issue can beclarified early in prosecution.

The presumptions noted above are as follows. Thefirst presumption is that use of the word “means” or"step" in a claim creates a rebuttable presumptionthat the claim element is to be treated in accordancewith 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112,sixth paragraph. The presumption is rebutted when“means” or "step" is not modified by function orwhen the function is recited with sufficient structureor material within the claim itself to perform therecited function. The second presumption is thatabsence of the word “means” or "step" in a claimcreates a rebuttable presumption that the claimelement is not to be treated in accordance with 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph. The presumption is rebutted when theclaim element recites function but fails to recitesufficiently definite structure or material to performthat function. See MPEP § 706.03 for applicableform paragraphs. Additionally, if the correspondingstructure for the claimed function is not clearlyidentifiable in the specification, the Office action

Rev. 08.2017, January 20182100-397


should, nevertheless, attempt to identify whatstructure is most closely associated with the means-(or step-) plus-function limitation to facilitate a priorart search. This is especially true when there maybe confusion as to which disclosed implementationof the invention supports the limitation, as explainedin subsection II.B., above.

When allowing a claim that was treated under 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, the examiner should indicate that theclaim was interpreted under the provisions of 35U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph in reasons for allowance if such anexplanation has not previously been made of record.As noted above, the indication should also clarifythe associated structure if not readily apparent in thespecification.

2182 Search and Identification of the PriorArt [R-08.2017]

The application of a prior art reference to a means-(or step-) plus-function limitation requires that theprior art element perform the identical functionspecified in the claim. However, if a prior artreference only teaches identity of function to thatspecified in a claim, then an examiner carries theinitial burden of proof for showing that the prior artstructure or step is the same as or equivalent to thestructure, material, or acts described in thespecification which has been identified ascorresponding to the claimed means- (or step-)plus-function. Similarly, if the prior art referenceteaches the identical structure or acts but is silentabout performing the claimed function, a reasonablepresumption is that the prior art structure inherentlyperforms the same function. The examiner mustprovide a “sound basis for believing” that the priorart structure or acts would be capable of performingthe claimed function. In re Spada, 911 F.2d 705,708, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). SeeMPEP § 2114, subsection I, for more informationon establishing inherency for functional limitations.

The means- (or step-) plus- function limitationshould be interpreted in a manner consistent withthe specification disclosure. The Federal Circuitexplained the two step analysis involved inconstruing means- (or step-) plus- function

limitations in Golight Inc. v. Wal-Mart Stores Inc.,355 F.3d 1327, 1333-34, 69 USPQ2d 1481, 1486(Fed. Cir. 2004):

The first step in construing ameans-plus-function claim limitation is todefine the particular function of the claimlimitation. Budde v. Harley-Davidson, Inc.,250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806(Fed. Cir. 2001). “The court must construe thefunction of a means-plus-function limitation toinclude the limitations contained in the claimlanguage, and only those limitations.” CardiacPacemakers, Inc. v. St. Jude Med., Inc., 296F.3d 1106, 1113, 63 USPQ2d 1725, 1730 (Fed.Cir. 2002). The next step in construing ameans-plus-function claim limitation is to lookto the specification and identify thecorresponding structure for that function.“Under this second step, ‘structure disclosedin the specification is “corresponding” structureonly if the specification or prosecution historyclearly links or associates that structure to thefunction recited in the claim.’” Med.Instrumentation & Diagnostics Corp. v. ElektaAB, 344 F.3d 1205, 1210, 68 USPQ2d 1263,1267 (Fed. Cir. 2003) (quoting B. Braun Med.Inc. v. Abbott Labs., 124 F.3d 1419, 1424, 43USPQ2d 1896, 1900 (Fed. Cir. 1997)).

If the specification defines what is meant by thelimitation for the purposes of the claimed invention,the examiner should interpret the limitation as havingthat meaning. If no definition is provided, somejudgment must be exercised in determining the scopeof the limitation. See, e.g., B. Braun Medical, Inc.v. Abbott Labs., 124 F.3d 1419, 1424, 43 USPQ2d1896, 1900 (Fed. Cir. 1997) (“We hold that, pursuantto [35 U.S.C. 112, sixth paragraph], structuredisclosed in the specification is ‘corresponding’structure only if the specification or prosecutionhistory clearly links or associates that structure tothe function recited in the claim. This duty to linkor associate structure to function is the quid pro quofor the convenience of employing 112, paragraph6.” The court refused to interpret ameans-plus-function limitation as corresponding toa disclosed valve seat structure, as argued bypatentee, since there was no indication in thespecification or prosecution history that this structure

2100-398Rev. 08.2017, January 2018


corresponds to the recited function, and there wasan explicitly clear association between that functionand a traverse cross section bar structure disclosedin the specification.).

2183 Making a Prima Facie Case ofEquivalence [R-08.2017]


If the examiner finds that a prior art element

(A) performs the function specified in the claim,

(B) is not excluded by any explicit definitionprovided in the specification for an equivalent, and

(C) is an equivalent of the means- (or step-)plus-function limitation,

the examiner should provide an explanation andrationale in the Office action as to why the priorart element is an equivalent. See In re Bond, 910F.2d 831, 833, 15 USPQ2d 1566, 1568 (Fed. Cir.1990) ("The disclosed and prior art structures arenot identical, but the claim may nonetheless beanticipated. … However, the Board made no findingthat the delay means of claim 1 and that embodiedin the Curtis device are structurally equivalent.Accordingly, its decision as to the anticipation ofclaim 1 is deficient and must be vacated.”)

Factors that will support a conclusion that the priorart element is an equivalent are:

(A) the prior art element performs the identicalfunction specified in the claim in substantially thesame way, and produces substantially the sameresults as the corresponding element disclosed in thespecification. Kemco Sales, Inc. v. Control PapersCo., 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir.2000) (An internal adhesive sealing the innersurfaces of an envelope pocket was not held to beequivalent to an adhesive on a flap which attachedto the outside of the pocket. Both the claimed

invention and the accused device performed the samefunction of closing the envelope. But the accuseddevice performed it in a substantially different way(by an internal adhesive on the inside of the pocket)with a substantially different result (the adhesiveattached the inner surfaces of both sides of thepocket)); Odetics Inc. v. Storage Tech. Corp., 185F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed.Cir. 1999); Lockheed Aircraft Corp. v. UnitedStates, 193 USPQ 449, 461 (Ct. Cl. 1977). Theconcepts of equivalents as set forth in Graver Tank& Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85USPQ 328 (1950) are relevant to any “equivalents”determination. Polumbo v. Don-Joy Co., 762 F.2d969, 975 n.4, 226 USPQ 5, 8-9 n.4 (Fed. Cir. 1985).

(B) a person of ordinary skill in the art wouldhave recognized the interchangeability of the elementshown in the prior art for the corresponding elementdisclosed in the specification. Caterpillar Inc. v.Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305(Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc.,174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed.Cir. 1999); Chiuminatta Concrete Concepts, Inc.v. Cardinal Indus. Inc., 145 F.3d 1303, 1309, 46USPQ2d 1752, 1757 (Fed. Cir. 1998); LockheedAircraft Corp. v. United States, 193 USPQ 449, 461(Ct. Cl. 1977 ); Data Line Corp. v. MicroTechnologies, Inc., 813 F.2d 1196, 1 USPQ2d 2052(Fed. Cir. 1987).

(C) there are insubstantial differences betweenthe prior art element and the corresponding elementdisclosed in the specification. IMS Technology, Inc.v. Haas Automation, Inc., 206 F.3d 1422, 1436,54 USPQ2d 1129, 1138 (Fed. Cir. 2000); Warner-Jenkinson Co. v. Hilton Davis ChemicalCo., 520 U.S. 17, 41 USPQ2d 1865, 1875 (1997); Valmont Industries, Inc. v. Reinke Mfg. Co., 983F.2d 1039, 25 USPQ2d 1451 (Fed. Cir. 1993). Seealso Caterpillar Inc. v. Deere & Co., 224 F.3d1374, 56 USPQ2d 1305 (Fed. Cir. 2000) (A structurelacking several components of the overall structurecorresponding to the claimed function and alsodiffering in the number and size of the parts may beinsubstantially different from the disclosed structure.The limitation in a means- (or step-) plus-functionclaim is the overall structure corresponding to theclaimed function. The individual components of anoverall structure that corresponds to the claimedfunction are not claim limitations. Also, potentialadvantages of a structure that do not relate to the

Rev. 08.2017, January 20182100-399


claimed function should not be considered in anequivalents determination under 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph).

A showing of at least one of the above-noted factorsby the examiner should be sufficient to support aconclusion that the prior art element is an equivalent.The examiner should then conclude that the claimedlimitation is met by the prior art element. In additionto the conclusion that the prior art element is anequivalent, examiners should also demonstrate,where appropriate, why it would have been obviousto one of ordinary skill in the art at the time of theinvention to substitute applicant’s describedstructure, material, or acts for that described in theprior art reference. See In re Brown, 459 F.2d 531,535, 173 USPQ 685, 688 (CCPA 1972). The burdenthen shifts to applicant to show that the elementshown in the prior art is not an equivalent of thestructure, material or acts disclosed in theapplication. In re Mulder, 716 F.2d 1542, 219 USPQ189 (Fed. Cir. 1983). No further analysis ofequivalents is required of the examiner untilapplicant disagrees with the examiner’s conclusion,and provides reasons why the prior art elementshould not be considered an equivalent. See also Inre Walter, 618 F.2d 758, 768, 205 USPQ 397,407-08 (CCPA 1980) (treating 35 U.S.C. 112, sixthparagraph, in the context of a determinationof statutory subject matter and noting “[i]fthe functionally-defined disclosed means and theirequivalents are so broad that they encompass anyand every means for performing the recited functions. . . the burden must be placed on the applicant todemonstrate that the claims are truly drawn tospecific apparatus distinct from other apparatuscapable of performing the identical functions”); Inre Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226,229 (CCPA 1971) (treating as improper a rejectionunder 35 U.S.C. 112, second paragraph, of functionallanguage, but noting that “where the Patent Officehas reason to believe that a functional limitationasserted to be critical for establishing novelty in theclaimed subject matter may, in fact, be an inherentcharacteristic of the prior art, it possesses theauthority to require the applicant to prove that thesubject matter shown to be in the prior art does notpossess the characteristics relied on”); Inre Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA1980) (indicating that the burden of proof can beshifted to the applicant to show that the subject

matter of the prior art does not possess thecharacteristic relied on whether the rejection is basedon inherency under 35 U.S.C. 102 or obviousnessunder 35 U.S.C. 103).

See MPEP § 2184 when determining whether theapplicant has successfully met the burden of provingthat the prior art element is not equivalent to thestructure, material or acts described in the applicant’sspecification.

IF NONEQUIVALENCE SHOWN, EXAMINERMUST CONSIDER OBVIOUSNESS

However, even where the applicant has met thatburden of proof and has shown that the prior artelement is not equivalent to the structure, materialor acts described in the applicant’s specification, theexaminer must still make a 35 U.S.C. 103 analysisto determine if the claimed means- (or step-)plus-function is obvious from the prior art to one ofordinary skill in the art. Thus, while a finding ofnonequivalence prevents a prior art element fromanticipating a means- (or step-) plus-functionlimitation in a claim, it does not prevent the prior artelement from rendering the claim limitation obviousto one of ordinary skill in the art. Because the exactscope of an “equivalent” may be uncertain, it wouldbe appropriate to apply a 35 U.S.C. 102/103 rejectionwhere the balance of the claim limitations areanticipated by the prior art relied on. A similarapproach is authorized in the case ofproduct-by-process claims because the exact identityof the claimed product or the prior art productcannot be determined by the examiner. In re Brown,450 F.2d 531, 173 USPQ 685 (CCPA 1972). Inaddition, although it is normally the best practice torely on only the best prior art references in rejectinga claim, alternative grounds of rejection may beappropriate where the prior art shows elements thatare different from each other, and different from thespecific structure, material or acts described in thespecification, yet perform the function specified inthe claim.

2184 Determining Whether an ApplicantHas Met the Burden of Proving

2100-400Rev. 08.2017, January 2018


Nonequivalence After a Prima Facie Case IsMade [R-11.2013]

The specification need not necessarily describe theequivalents of the structures, material, or actscorresponding to the means-(or step-) plus-functionclaim element. See In re Noll, 545 F.2d 141, 149-50,191 USPQ 721, 727 (CCPA 1976) (if the meaningof equivalents is well understood in patent law, thenan applicant need not describe in his specificationthe full range of equivalents of his invention). Cf. Hybritech Inc. v. Monoclonal Antibodies, Inc.,802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir.1986) (“a patent need not teach, and preferablyomits, what is well known in the art”). Where,however, the specification is silent as to whatconstitutes equivalents and the examiner has madeout a prima facie case of equivalence, the burdenis placed upon the applicant to show that a prior artelement which performs the claimed function is notan equivalent of the structure, material, or actsdisclosed in the specification. See In re Mulder, 716F.2d 1542, 1549, 219 USPQ 189, 196 (Fed. Cir.1983).

If the applicant disagrees with the inference ofequivalence drawn from a prior art reference, theapplicant may provide reasons why the applicantbelieves the prior art element should not beconsidered an equivalent to the specific structure,material or acts disclosed in the specification. Suchreasons may include, but are not limited to:

(A) Teachings in the specification that particularprior art is not equivalent;

(B) Teachings in the prior art reference itselfthat may tend to show nonequivalence; or

(C) 37 CFR 1.132 affidavit evidence of factstending to show nonequivalence.

I. TEACHINGS IN APPLICANT’SSPECIFICATION

When the applicant relies on teachings in applicant’sown specification, the examiner must make sure thatthe applicant is interpreting the means- (or step-)plus- function limitation in the claim in a mannerwhich is consistent with the disclosure in thespecification. If the specification defines what ismeant by “equivalents” to the disclosed

embodiments for the purpose of the claimed means-(or step-) plus- function, the examiner shouldinterpret the limitation as having that meaning. If nodefinition is provided, some judgment must beexercised in determining the scope of “equivalents.”Generally, an “equivalent” is interpreted asembracing more than the specific elements describedin the specification for performing the specifiedfunction, but less than any element that performs thefunction specified in the claim. See, e.g., NOMOSCorp. v. BrainLAB USA Inc., 357 F.3d, 1364, 1368,69 USPQ2d 1853, 1856 (Fed. Cir. 2004) (where onlyone embodiment is described, the correspondingstructure is limited to that embodiment andequivalents thereof). To interpret means- (or step-)plus-function limitations as limited to a particularmeans (or step) set forth in the specification wouldnullify the provisions of 35 U.S.C. 112 requiringthat the limitation shall be construed to cover thestructure described in the specification andequivalents thereof. D.M.I., Inc. v. Deere & Co.,755 F.2d 1570, 1574, 225 USPQ 236, 238 (Fed. Cir.1985).

The scope of equivalents embraced by a claimlimitation is dependent on the interpretation of an“equivalent.” The interpretation will vary dependingon how the element is described in the supportingspecification. The claim may or may not be limitedto particular structure, material or acts (e.g., steps)as opposed to any and all structure, material or actsperforming the claimed function, depending on howthe specification treats that question. See, e.g., Ishida Co. v. Taylor, 221 F.3d 1310, 55 USPQ2d1449 (Fed. Cir. 2000) (The court construed the scopeof a means-plus-function claim element where thespecification disclosed two structurally very differentembodiments for performing the claimed functionby looking separately to each embodiment todetermine corresponding structures. The courtdeclined to adopt a single claim constructionencompassing both embodiments since it would beso broad as to describe systems both with andwithout the fundamental structural features of eachembodiment.).

If the disclosure is so broad as to encompass any andall structures, materials or acts for performing theclaimed function, the claims must be readaccordingly when determining patentability. When

Rev. 08.2017, January 20182100-401


this happens the limitation otherwise provided by“equivalents” ceases to be a limitation on the scopeof the claim in that an equivalent would be anystructure, material or act other than the onesdescribed in the specification that perform theclaimed function. For example, this situation willoften be found in cases where (A) the claimedinvention is a combination of elements, one or moreof which are selected from elements that are old, per se, or (B) apparatus claims are treated asindistinguishable from method claims. See, forexample, In re Meyer, 688 F.2d 789, 215 USPQ193 (CCPA 1982); In re Abele, 684 F.2d 902, 909,214 USPQ 682, 688 (CCPA 1982); In re Walter,618 F.2d 758, 767, 205 USPQ 397, 406-07 (CCPA1980); In re Maucorps, 609 F.2d 481, 203 USPQ812 (CCPA 1979); In re Johnson, 589 F.2d 1070,200 USPQ 199 (CCPA 1978); and In re Freeman,573 F.2d 1237, 1246, 197 USPQ 464, 471 (CCPA1978).

On the other end of the spectrum, the “equivalents”limitation as applied to a claim may also operate toconstrict the claim scope to the point of coveringvirtually only the disclosed embodiments. This canhappen in circumstances where the specificationdescribes the invention only in the context of aspecific structure, material or act that is used toperform the function specified in the claim.

II. FACTORS TO BE CONSIDERED IN DECIDINGEQUIVALENCE

When deciding whether an applicant has met theburden of proof with respect to showingnonequivalence of a prior art element that performsthe claimed function, the following factors may beconsidered. First, unless an element performs theidentical function specified in the claim, it cannotbe an equivalent for the purposes of 35 U.S.C. 112(f)or pre-AIA 35 U.S.C. 112, sixth paragraph. Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d931, 4 USPQ2d 1737 (Fed. Cir. 1987), cert. denied,484 U.S. 961 (1988).

Second, while there is no litmus test for an“equivalent” that can be applied with absolutecertainty and predictability, there are several indiciathat are sufficient to support a conclusion that oneelement is or is not an “equivalent” of a different

element in the context of 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph. Indicia thatwill support a conclusion that one element is or isnot an equivalent of another are set forth in MPEP§ 2183.

III. MERE ALLEGATIONS OFNONEQUIVALENCE ARE NOT SUFFICIENT

In determining whether arguments or 37 CFR 1.132evidence presented by an applicant are persuasivethat the element shown in the prior art is not anequivalent, the examiner should consider and weighas many of the above-indicated or other indicia asare presented by applicant, and should determinewhether, on balance, the applicant has met theburden of proof to show nonequivalence. However,under no circumstance should an examiner acceptas persuasive a bare statement or opinion that theelement shown in the prior art is not an equivalentembraced by the claim limitation. Moreover, if anapplicant argues that the means- (or step-)plus-function language in a claim is limited to certainspecific structural or additional functionalcharacteristics (as opposed to “equivalents” thereof)where the specification does not describe theinvention as being only those specific characteristics,the claim should not be allowed until the claim isamended to recite those specific structural oradditional functional characteristics. Otherwise, aclaim could be allowed having broad functionallanguage which, in reality, is limited to only thespecific structure or steps disclosed in thespecification. This would be contrary to public policyof granting patents which provide adequate noticeto the public as to a claim’s true scope.

IV. APPLICANT MAY AMEND CLAIMS

Finally, as in the past, applicant has the opportunityduring proceedings before the Office to amend theclaims so that the claimed invention meets all thestatutory criteria for patentability. An applicant maychoose to amend the claim by further limiting thefunction so that there is no longer identity of functionwith that taught by the prior art element, or theapplicant may choose to replace the claimed means-(or step-) plus-function limitation with specificstructure, material or acts that are not described inthe prior art.

2100-402Rev. 08.2017, January 2018


2185 Related Issues Under 35 U.S.C. 112(a)or (b) and Pre-AIA 35 U.S.C. 112, First orSecond Paragraphs [R-08.2017]

Interpretation of claims as set forth in MPEP § 2181may create some uncertainty as to what applicantregards as the invention. If this issue arises, it shouldbe addressed in a rejection under 35 U.S.C. 112(b)or pre-AIA 35 U.S.C. 112, second paragraph. While35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, permits a particular form of claimlimitation, it cannot be read as creating an exceptioneither to the description, enablement or best moderequirements of 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph or the definitenessrequirement of 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph. In re Knowlton, 481F.2d 1357, 178 USPQ 486 (CCPA 1973).

If a means- (or step-) plus-function limitation recitedin a claim is not supported by correspondingstructure, material or acts in the specificationdisclosure, the following rejections should beconsidered:

(A) under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, as not being supportedby an enabling disclosure because the person skilledin the art would not know how to make and use theinvention without a description of elements toperform the function. Note that the description of anapparatus with block diagrams describing thefunction, but not the structure, of the apparatus isnot fatal under the enablement requirement of 35U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, firstparagraph, as long as the structure is conventionaland can be determined without an undue amount ofexperimentation. In re Ghiron, 442 F.2d 985, 991,169 USPQ 723, 727 (CCPA 1971);

(B) under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph as lacking adequatewritten description because the specification doesnot describe the claimed invention in sufficient detailthat one skilled in the art can reasonably concludethat the inventor had possession of the claimedinvention. As an example, if the means- (or step-)plus-function limitation is computer-implemented,and the specification does not provide a disclosureof the computer and algorithm in sufficient detail todemonstrate to one of ordinary skill in the art that

the inventor possessed the invention , see MPEP §2161.01 and MPEP § 2181, subsection IV, arejection under 35 U.S.C. 112(a) or pre-AIA 35U.S.C. 112, first paragraph, for lack of writtendescription must be made;

(C) under 35 U.S.C. 112(b) or pre-AIA 35U.S.C. 112, second paragraph, as being indefinite.See Noah Systems v. Intuit, 675 F.3d 1302, 1311-19,102 USPQ.2d 1410, 1415-21 (Fed. Cir. 2012); Inre Aoyama, 656 F.3d 1293, 1297-98, 99 U.S.P.Q.2d1936, 1940 (Fed. Cir. 2011); Finisar Corp. v.DirecTV Group, Inc., 523 F.3d 1323, 1340-41, 86USPQ2d 1609, 1622-23 (Fed. Cir. 2008); and MPEP§ 2181; and

(D) under 35 U.S.C. 102 or 103 where the priorart anticipates or renders obvious the claimed subjectmatter including the means or step that performs thefunction specified in the claim, the theory being thatsince there is no corresponding structure, etc., in thespecification to limit the means- (or step-) plus-function limitation, an equivalent is any element thatperforms the specified function.

2186 Relationship to the Doctrine ofEquivalents [R-08.2017]

The doctrine of equivalents arises in the context ofan infringement action. If an accused product orprocess does not literally infringe a patentedinvention, the accused product or process may befound to infringe under the doctrine of equivalents.The essential objective inquiry is: “Does the accusedproduct or process contain elements identical orequivalent to each claimed element of the patentedinvention?” Warner-Jenkinson Co. v. Hilton DavisChemical Co., 520 U.S. 17, 41 USPQ2d 1865, 1875(1997). In determining equivalence, “[a]n analysisof the role played by each element in the context ofthe specific patent claim will thus inform the inquiryas to whether a substitute element matches thefunction, way, and result of the claimed element, orwhether the substitute plays a role substantiallydifferent from the claimed element.” 41 USPQ2d at1875.

35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixthparagraph, permit means- (or step-) plus-functionlimitations in claims to combinations, “with theproviso that application of the broad literal languageof such claims must be limited to only those means

Rev. 08.2017, January 20182100-403


that are ‘equivalent’ to the actual means shown inthe patent specification. This is an application of thedoctrine of equivalents in a restrictive role,narrowing the application of broad literal claimelements.” 41 USPQ2d at 1870. Accordingly,decisions involving the doctrine of equivalentsshould be considered, but should not undulyinfluence a determination under 35 U.S.C. 112(f) orpre-AIA 35 U.S.C. 112, sixth paragraph, during exparte examination. See MPEP § 2183.


2190 Prosecution Laches [R-08.2012]

The Federal Circuit affirmed a rejection of claimsin a patent application on the ground that applicanthad forfeited his right to a patent under the doctrineof prosecution history laches for unreasonable andundue delay in prosecution. In re Bogese, 303 F.3d1362, 1369, 64 USPQ2d 1448, 1453 (Fed. Cir. 2002)(Applicant “filed twelve continuation applicationsover an eight-year period and did not substantivelyadvance prosecution when required and given anopportunity to do so by the PTO.”). While there areno firm guidelines for determining when laches istriggered, it applies only in egregious cases ofunreasonable and unexplained delay in prosecution.For example, where there are “multiple examples ofrepetitive filings that demonstrate a pattern ofunjustified delayed prosecution,” laches may betriggered. Symbol Tech. Inc. v. Lemelson Med.,Educ., & Research Found., 422 F.3d 1378, 1385,76 USPQ2d 1354, 1360 (Fed. Cir. 2005)(Courtdiscussed difference between legitimate reasons forrefiling patent applications and refilings for thebusiness purpose of delaying the issuance ofpreviously allowed claims.). An examiner shouldobtain approval from the TC Director before makinga rejection on the grounds of prosecution historylaches.

2100-404Rev. 08.2017, January 2018
