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Patent Subject Matter Eligibility: Navigating the New "Myriad" Guidelines Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework
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WEDNESDAY, APRIL 16, 2014
Presenting a 90-Minute Encore Presentation of the Teleconference with Live, Interactive Q&A
Donna M. Meuth, Associate General Counsel, Eisai, Andover, MA
Leslie McDonnell, Finnegan Henderson Farabow Garrett & Dunner, Boston, MA
Amelia Baur, Finnegan Henderson Farabow Garrett & Dunner, Boston, MA
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Patent Subject Matter Eligibility:
Navigating the New Myriad Guidelines
Analyzing Subject Matter and Avoiding Rejection
Under the USPTO’s Detailed Framework
May 15, 2014
Donna Meuth Leslie McDonell Amelia Baur
6 6
Disclaimer
• These materials are public information and have been prepared
solely for educational and entertainment purposes to contribute to
the understanding of U.S. intellectual property law. These materials
should not be taken as individualized legal advice and do not reflect
the views of FINNEGAN or EISAI, It is understood that each case is
fact-specific, and that the appropriate solution in any case will vary.
Therefore, these materials may or may not be relevant to any
particular situation. Thus, FINNEGAN, EISAI, and the panelists
cannot be bound either philosophically or as representatives of their
various present and future clients to the comments expressed in
these materials. The presentation of these materials does not
establish any form of attorney-client relationship with FINNEGAN,
EISAI, or the panelists. While every attempt was made to insure
that these materials are accurate, errors or omissions may be
contained therein, for which any liability is disclaimed.
7 7
The §101 Roller Coaster
• New guidelines are the USPTO’s sixth
attempt in five years to define patentable
subject matter:
1. August 2009 (machine-or-transformation)
2. January 2010 (computer-readable media)
3. July 2010 (Bilski)
4. July 2012 (Process Claims Involving Laws of Nature; Mayo)
5. June 2013 (Memorandum re Myriad)
6. March 2014 Procedure for Subject Matter Eligibility Analysis of Claims
Reciting or Involving Laws of Nature/Natural Principles, Natural
Phenomena, and/or Natural Products
8 8
Interim Guidelines Released
• 2012 Mayo Guidance; MPEP 2106.01: Process claims
involving Laws of Nature.
• June 13, 2013 Memo – Noted Supreme Court decision in Myriad: claims to isolated DNA
not patent-eligible. • “As of today, naturally occurring nucleic acids are not patent eligible
merely because they have been isolated.”
• March 4, 2014 Memo: New Guidance Replaces Both – “all claims (i.e., machine, composition, manufacture and process
claims) reciting or involving laws of nature/natural principles, natural
phenomena, and/or natural products should be examined using the
Guidance.”
– “examination procedure set forth in the Guidance is effective today
and supersedes the June 13,2013 memo[.]”
9 9
USPTO Guidance to Examiners
• Not a statute
• Important USPTO policy document
– Used to train patent examiners.
10 10
USPTO: The New Subject Matter Eligibility Guidance
• “For use in subject matter eligibility
determinations of all claims (i.e., machine,
composition, manufacture, and process claims)
reciting or involving laws of nature/natural
principles, natural phenomena, and/or natural
products.”
11 11
USPTO: Three-Step Analysis
“walk through the three questions in the flowchart … to
determine whether the claim is drawn to patent-
eligible subject matter. If not, then the claim is prima
facie ineligible, and the claim should be rejected[.]”
12 12
USPTO: Three-Step Analysis
1. Does a claim reciting one of the four statutory
categories of patent eligible subject matter?
(process, machine, manufacture, composition)
2. Does the claim recite or involve one or more
judicial exceptions?
(abstract ideas, laws of nature/natural principles,
natural phenomena, natural products)
3. Does the claim as a whole recite something
significantly different from the judicial exceptions?
13 13
USPTO: Three-Step Analysis
• “Recite or involve” appears to mean -- looks like,
sounds like, smells like, or is somehow derived
from or related to, a natural product, law,
phenomenon -- even if it is but a single component
in a multi-component composition.
• It is not enough that the claim is directed to a
product or composition that is non-naturally
occurring – it must also be significantly different in
structure from naturally occurring products.
14 14
USPTO: Three-Step Analysis
• What does “significantly different” mean?
– Markedly different
– More than nominally, insignificantly, or tangentially related
– More than well understood, purely conventional, or routine in
the relevant field
– Not insignificant extra-solution activity
• Words such as “synthetic”, “isolated”,
“recombinant”+ “cDNA”, “composition”,
“primer”, “purified”, “vector” recited in a claim
do not influence the determination of significant
difference (Guidelines) (added in Training Slides)
15 15
USPTO: How to Analyze “Significantly Different”
• Factor-based analysis of whether claim as a
whole is “significantly different” from the judicial
exception
• Not a single, simple determination, but a
conclusion reached by weighing the relevant
factors, varying the weight accorded each factor
based on the facts of the application
– “[S]imilar to the Wands factor-based analysis”
• On balance, does the totality of the relevant
factors weigh toward eligibility?
16 16
Prometheus: “Significantly Different”
• “A process that focuses on the use of a natural law
also [must] contain other elements...an ‘inventive
concept,’ sufficient to ensure that the patent in practice
amounts to significantly more than a patent upon
the natural law itself.”
‒ Prometheus, citing Flook, Bilski, Diehr
• “Too broad an interpretation of this exclusionary
principle could eviscerate patent law. For all inventions
at some level embody, use, reflect, rest upon, or apply
laws of nature, natural phenomena, or abstract ideas.”
‒ Prometheus
17 17
USPTO Factors – Natural Product
Weigh Against Eligibility Weigh Towards Eligibility
g) claim recites a product that is not markedly different in structure from naturally occurring products
a) claim recites something that is non-naturally occurring and markedly different in structure from naturally occurring products
•Grounded in Chakrabarty? •“Here...the patentee has produced a new bacterium with markedly different characteristics from any found in nature and having the potential for significant utility. His discovery is not nature’s handiwork, but his own.” •The combination of bacteria in Funk Brothers was merely “the handiwork of nature.”
•Grounded in Myriad?
•“Separating [a BRCA] gene from its surrounding genetic material is not an act of invention.” •“cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived...except insofar as very short series of DNA may have no intervening introns”
18 18
USPTO Factors – Preclusion
Weigh Against Eligibility Weigh Towards Eligibility
h) claim recites elements at a high level of generality such that substantially all practical applications of the judicial exception are covered
b) claim recites elements that impose meaningful limits on scope, such that others are not substantially foreclosed from using the judicial exception
•Grounded?
•Precedent “warn[s] us against upholding patents to processes that too broadly preempt the use of a natural law.” – Prometheus, Benson, Flook
•A process must contain other elements “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself” – Prometheus
•Diehr sought only to foreclose the use of an equation in conjunction with all of the other steps of the claimed process – Prometheus
19 19
USPTO Factors – Significant Limits
Weigh Against Eligibility Weigh Towards Eligibility
k) claim recites elements that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception
c) claim recites elements that are more than nominally, insignificantly, or tangentially related to the judicial exception
•Grounded?
•“Flook stands for the proposition that the prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’” – Bilski •MPEP 2106 - Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility.
20 20
USPTO Factors – General/Particular Application
Weigh Against Eligibility Weigh Towards Eligibility
i. claim recites elements that must be used in order to apply the judicial exception
d) claim recites elements that do more than provide general instructions to apply or use the judicial exception
i. claim recites elements that amount to nothing more than a mere field of use
e) claim recites elements that include a particular machine or transformation of a particular article or integrates the judicial exception into a particular practical application
•Grounded in Prometheus? •The three process steps amount “to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.”
•It is not enough to limit the use of the natural law or formula to a particular technological environment ‒ citing Bilski and Diehr
21 21
More Process Cases?
• “[T]he machine-or-transformation test is a useful
and important clue, an investigative tool, for
determining whether some claimed inventions are
processes under §101” ‒ Bilski
• The claimed elements in Mayo are steps that
must be taken by anyone who wants to make
use of the natural law ‒ Prometheus
• Steps in Flook’s process did not limit the claim to a
particular application of the concept of hedging
‒ Prometheus
22 22
USPTO Factors – Well-Understood,
Conventional, Routine
Weigh Against Eligibility Weigh Towards Eligibility
j) claim recites elements that are well-understood, purely conventional or routine in the relevant field
f) claim recites elements that add a feature that is more than well-understood, purely conventional or routine in the relevant field
•Grounded in Prometheus?
•The claimed elements “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field”
•“[D]etermining” step merely tells doctors to engage in well-understood, routine, conventional activity - citing Flook
23 23
USPTO 12 Factors Weigh Against Eligibility Weigh Towards Eligibility
g) claim recites a product that is not markedly different in structure from naturally occurring products
a) claim recites something that is non-naturally occurring and markedly different in structure from naturally occurring products
h) claim recites elements at a high level of generality such that substantially all practical applications of the judicial exception are covered
b) claim recites elements that impose meaningful limits on scope, such that others are not substantially foreclosed from using the judicial exception
k) claim recites elements that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception
c) claim recites elements that are more than nominally, insignificantly, or tangentially related to the judicial exception
i) claim recites elements that must be used in order to apply the judicial exception
d) claim recites elements that do more than provide general instructions to apply or use the judicial exception
l) claim recites elements that amount to nothing more than a mere field of use
e) claim recites elements that include a particular machine or transformation of a particular article or integrates the judicial exception into a particular practical application
j) claim recites elements that are well-understood, purely conventional or routine in the relevant field
f) claim recites elements that add a feature that is more than well-understood, purely conventional or routine in the relevant field
24 24
USPTO Examples
• Natural Products
• Combination of Natural Products
• Process/Diagnostic Claims
25 25
Example A: Composition Reciting
a Natural Product
• Claim 1: A stable energy-generating plasmid,
which provides a hydrocarbon degradative
pathway.
– Background: Such plasmids exist in nature in
bacteria.
– Analysis:
• Step 1: yes
• Step 2: yes
• Step 3: No. There is no structural difference between the
claimed plasmid and naturally occurring plasmids.
26 26
Example B: Composition Reciting a
Natural Product
• Claim 1: Purified amazonic acid
• Claim 2: Purified 5-methyl amazonic acid
Amazonian cherry tree Amazonic acid
27 27
Example B: Analysis for Purified Natural Product
• Claim 1: Purified amazonic acid
– No marked difference in structure between
purified acid and acid in plant.
– “Isolated”, “recombinant”, “synthetic” do not
confer eligibility.
Not eligible
28 28
• Claim 2: Purified 5-methyl amazonic acid
Example B: Analysis for Laboratory Derivative
of Natural Product
• Recites or involves judicial exception?
Yes, natural product
Analysis:
• Derivative is structurally different from acid in plant.
• Structural difference has created a functional difference.
“[W]hile not necessary to find a marked difference, the presence
of a functional difference makes a stronger case that structural
difference is a marked difference.”
Eligible
29 29
USPTO Examples
• Combination of Natural Products
30 30
Example A: Combination of Natural Products
• Claim 2: A bacterium from the genus Pseudomonas
containing therein at least two stable energy-generating
plasmids, each of said plasmids providing a separate
hydrocarbon degradative pathway.
31 31
Example D: Combination of Natural Products
– Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)
32 32
Claim: A fountain-style firework comprising:
(a) a sparking composition,
(b) calcium chloride,
(c) gunpowder,
(d) a cardboard body having a first compartment containing
the sparking composition and the calcium chloride and a
second compartment containing the gunpowder, and
(e) a plastic ignition fuse having one end extending into the
second compartment and the other end extending out of
the cardboard body.
Example C: Manufacture Claim Reciting Natural Products
(saltpeter, sulfur, charcoal)
33 33
Example C: Manufacture Claim Reciting Natural Products
• The PTO’s analysis is based on “broadest reasonable
interpretation” of “gunpowder” – Type I: A mixture of three naturally occurring materials:
potassium nitrate, sulfur and charcoal. Such a mixture is not
markedly different because none of the components have been changed.
– Type II: A glazed powder formed from four naturally occurring materials:
sodium nitrate, sulfur and charcoal are mixed and then granulated, and
then the granulated particles are coated with a thin layer of graphite. --
This glazed powder is structurally different from what exists in nature,
because the materials have been combined in a particular way to yield a
manufacture that is entirely different from a mere mixture of the raw
materials from which it was formed. In addition, the structural
difference results in a change to the properties of the powder
(it can no longer deliquesce due to the graphite coating). The
USPTO considers this powder to be markedly different from
what exists in nature.
34 34
Training Example: Composition Claim Reciting
Natural Products
2. A beverage composition comprising:
a) 99.5% pomelo juice; and
b) 0.5% vitamin E.
3. A beverage composition comprising pasteurized pomelo juice.
4. A beverage composition comprising:
a) pomelo juice; and
b) preservative X [non-natural].
1. A beverage composition comprising:
a) pomelo juice; and
b) a preservative.
35 35
Training Example: Alloy
No marked difference: factor (g) satisfied
Marked difference: factor (a) satisfied
•No structural difference
• Mere mixture or aggregation of naturally
occurring metals together as a “composition” does
not change the metals from what exists in nature.
36 36
Training Example: Alloy
Marked difference: factor (a) satisfiedrked difference:
factor (g) satisfied
Marked difference: factor (a) satisfied
•Markedly different in structure: •structural difference (the alloy is a solid solution of tin in copper,
which has a different crystalline arrangement of atoms than in the
natural metals)
•structural difference results in change to properties of alloy (the
alloy has a different color, tensile strength, hardness, and melting
point than either natural metal).
37 37
Example E: Composition Reciting
Two Natural Products
• Claim 1: A pair of primers, the first primer having the
sequence of SEQ ID NO:1 and the second primer having
the sequence of SEQ ID NO:2.
– Consider claim as a whole;
– Not found in nature together;
– Functionally different than individual pieces;
– Application not found in nature.
38 38
Hypothetical Variations
• USPTO has said that primers in a kit are not patent eligible.
• What if the primer pairs are in a test tube with buffer?
• What if the primer pairs are in a test tube with a
nonnaturally occurring buffer?
• What if the primer pairs are bound to their template DNA in
a first step of a PCR reaction?
39 39
You Put Da Lime In Da Coconut
You can drink it all up, but it may not be a patent-
eligible composition!
40 40
USPTO Examples
• Process/Diagnostic Claims
41 41
USPTO Subject Matter Eligibility Training Slides
41
42 42
Example B: Analysis for Method of Using Purified
Natural Product
• Claim 3: A method of treating colon cancer, comprising
administering a daily dose of purified amazonic acid to a
patient suffering from colon cancer for a period of from 10
days to 20 days, wherein said daily dose comprises about 0.75
to about 1.25 teaspoons of amazonic acid
Analysis: • Recites or involves judicial exception?
Yes, natural product
• Significant, non-conventional limitations, limited foreclosure
• Administration step is significant, particular manipulation
• Administration is more than general instruction to use
• Additional elements are more than routine and conventional
Eligible
43 43
Example F: Process Involving Natural Principle
• A method for determining whether a human patient
has degenerative disease X, comprising:
– Obtaining a blood sample from a human patient;
– Determining whether misfolded protein ABC is
present … by contacting the blood sample with
antibody XYZ and detecting ABC … using flow
cytometry…; and
– Diagnosing the patient as having degenerative
disease X if misfolded protein ABC was
determined to be present.
44 44
Example F: Hypothetical Variations
• Flow Cytometry
– March 2014 PTO Training Materials suggest “flow
cytometry” is generic because no description of
whether it is a desk top or high speed machine or the
number of lasers used.
– What if spelled out the steps of flow cytometry, as with
the PCR example?
• Novel Ab vs. Known Ab
– Importing an obviousness analysis
– What if Ab XYZ is the only known Ab, or the only
“commercially viable Ab”?
– Prior USPTO guidelines of July 3, 2012
45 45
Example F: Hypothetical Variations
• Non-routine use of a known product – What makes a reagent or method step conventional?
– The ordering of the steps?
– If a reagent had only been used once before and for an
unrelated assay?
• If the Ab is new, consider removing the
stated natural correlation – A method of detecting mutant protein ABC by contacting
a sample with Ab XYZ.
46 46
Example E: Method Claim Involving Natural
Product
• Claim 2: A method of amplifying a target DNA sequence
comprising:
– Providing a reaction mixture comprising a double-
stranded target DNA, the pair of primers of claim 1…,
Taq polymerase, and a plurality of free nucleotides…
– Heating and cooling the reaction mixture to
predetermined temperatures for predetermined time
periods
– Repeating steps (b) and (c) at least 20 times
47 47
Example E: Hypothetical Variations
• Why is heating to a “predetermined temperature”
for a “predetermined time” considered a narrowing
element?
• What if claim indicated use of “PCR” rather than
spelling out the steps?
• What if claim more generally referred to a
polymerase rather than specifying Taq?
48 48
Reaction from Patent Community
• “USPTO May Reject Wide Range Of Patents Under New
Rules,” IP360, March 5, 2014.
• “10 Problems In The USPTO's New Training Memo,”
IP360, March 10, 2014.
• “Uncertainty Looms as PTO Expands Reach Of Myriad
Genetics Ruling, Attorneys Say,” IPLAW.BNA.COM, March
17, 2014.
• “IP Practitioners ‘Horrified’ By USPTO Guidelines On
Myriad,” Managing IP, March 27, 2014.
49 49
Litigation Update
• District Courts:
– Myriad v Ambry Genetics, Gene-by-Gene, GeneDx, Quest
Diagnostics, InVitae, and Lab Corp of America (D. Utah)
(preliminary injunction denied)
– Ariosa v. Sequenom (N.D. Cal.) (summary judgment granted)
– Genetic Technologies v. Agilent Technologies (N.D. Cal.) (motion to
dismiss denied)
– Genetic Technologies v. BMS, Pfizer, General Genetics
Corporation. Lab. Corp. of America
– Quest Diagnostics and InVitae v. Myriad (N.D. Cal.)
• Federal Circuit:
– In re Roslin Institute
50 50
Affirmative Uses of the New §101 Guidelines
• Licensing – Rely on new §101 interpretation as basis for getting out from under
a usurious license.
• Freedom-to-operate – Revisit invalidity analyses and opinions.
– Consider offensive strategies.
• PGR for recently-filed applications.
• Declaratory judgment possibilities.
• Litigation strategies. – New § 101 defenses available.
51 51
Defenses to §101 Rejections
• Add specificity to claims to narrow “scope of foreclosure” or
“impose meaningful limits on claim scope.”
• Add features that are more than well-understood, purely
conventional or routine to the claims.
• Include a particular machine or particular transfomation to
the claims.
• Recite structural differences between claimed subject
matter and natural product.
• Argue that Examiner has not accorded proper weight to
factors weighing toward eligibility.
52 52
§101 Rejections
• Interpretation of key Supreme Court cases:
• USPTO Guidelines
– “Myriad relied on Chakrabarty as “central to the eligibility
inquiry, and reaffirmed the Office’s reliance on
Chakrabarty’s criterion for eligibility of natural products
(i.e., whether the claimed product is a non-naturally
occurring product of human ingenuity that is markedly
different from naturally occurring products).”
53 53
§101 Rejections
• USPTO Guidelines:
– “Thus, while the holding in Myriad was limited to
nucleic acids, Myriad is a reminder that the
claims reciting or involving natural products
should be examined for a marked difference
under Chakrabarty.”
• Does Chakrabarty hold that a “marked
difference” is necessary to show patent eligibility?
54 54
§101 Rejections
• The only question before the Chakrabarty Court
was whether a living organism is excluded under
§101 from patent eligibility.
• Chakrabarty’s bacteria was found by the Board not
to be a product of nature – this issue was not
appealed by the PTO.
55 55
§101 Rejections
• Chakrabarty’s “markedly different”
– Distinguishing Funk Bros. the Chakrabarty Court
stated “Here, by contrast, the patentee produced a
new bacterium with markedly different
characteristics from any found in nature . . . His
discovery is not nature’s handiwork, but his own,
accordingly it is [patent eligible]”
• Statement of fact vs. required threshold?
56 56
§101 Rejections
• Chakrabarty refers to the invention as a product of
human ingenuity ‘having a distinctive name,
character [and] use.’ Hartranft v. Wiegmann, 121
U. S. 609, 121 U. S. 615” (1887).
• Hartranft v. Wiegmann: “having a distinctive name,
character OR use.”
Hartranft v. Wiegmann
57 57
§101 Rejections
• USPTO Guidelines: – “Myriad also clarified that not every change to
a product will result in a marked difference,
and that the mere recitation of particular words
(e.g., ‘isolated’) in the claims does not
automatically confer eligibility.”
• The Myriad Court refers to “genes and the
information they encode” not being patent
eligible “simply because they have been isolated
from their surrounding material.”
58 58
§101 Rejections
• The Prometheus Court distinguished the claims at issue from claims
directed to a new drug or a new way of using an existing drug.
• PTO agrees that claims to a new way of existing drug do not involve a
law of nature
• PTO indicates that a new way of using a natural product must be
analyzed for patent eligibility
• Do examples suggest that if a natural product is involved, the method
must be limited to narrow applications requiring specific dosages and/or
treatment regimens to avoid foreclosure?
• Myriad Court: “[T]his cases does not involve patents on new
applications of knowledge about the [BRCA] genes.”
59 59
§101 Rejections
• “The Patent Act of 1952 (35 U.S.C.A. §101), as its
predecessors, authorizes a patent for ‘any new and useful
… composition of matter …, provided only that the
conditions for patentability, which are specified in
succeeding sections are met. There is nothing in the
language of the Act which precludes the issuance of a
patent upon a ‘product of nature’ when it is a ‘new and
useful composition of matter’ …”
– Merck & Co. v Olin Mathieson Chemical Corp., 253 F.2d
156 (4th Cir. 1958).
60 60
Internal Portfolio Examination
• Drafting new applications – Disclosure of non-routine or non-conventional modifications.
– Specific methods of use or applications of discoveries.
• Pending applications – Consider multiple layers of claims to account for possible litigation
outcomes and changes in law.
– Identify applications appropriate for appeal.
– Maintain pending applications in important families.
• Issued patents with no pending U.S. counterparts. – Consider scope of issued claims.
– Possible reissue to add dependent claims.
61 61
New Patent Profanity
• Carefully consider use of the following terms:
– In the specification
• Routine
• Conventional
• Well-understood
• Well-known
– In claims
• Analyze
• Compare
• Determine
62 62
Where Does This Leave Us?
• Inconsistent district court decisions
• Even more erratic and inconsistent examination for the
foreseeable future–increasingly reduced predictability,
increasing need to take cases through appeal process.
• Substantially increased uncertainty and IP expense for
biotechnology and other industries that rely on natural
products, methods of diagnosis, or methods of treatment.
63 63
Speaker Information
Leslie McDonell
leslie.mcdonell@finnegan.comel 617.646.1650
Amelia Baur.
amelia.baur@finnegan.com 617.646.1650
Donna Meuth.
Donna_Meuth@eisai.com
; Tel 617.646.1650
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