40
1088 565 FEDERAL SUPPLEMENT, 2d SERIES caregiver for a person who is no longer the person she married. The court finds that she should be compensated for this intan- gible loss at a level close to that of her husband. Accordingly, the court finds that a general damages award for pain, suffer- ing and loss of life’s enjoyment in the amount of $1,000,000 is appropriate for Daniel Doyle and a general damages award of $750,000 is appropriate for Anne Doyle’s loss of consortium. Because the court finds comparative negligence by Daniel Doyle that operates to mitigate defendant Graske’s liability, Daniel Doyle’s total award of $3,597,947 must be reduced by 10%, or $359,794, re- sulting in a total damages award of $3,238,153 to Daniel Doyle. Anne Doyle’s damages are not subject to any reduction. Accordingly, in conformity with this opin- ion, a judgment in the amount of $3,238,153 will be entered in favor of plain- tiff Daniel Doyle, and a judgment in the amount of $750,000 will be entered in favor of plaintiff Anne Doyle and against defen- dant Leland Graske, together with taxable court costs. , THERASENSE, INC., Plaintiff, v. BECTON, DICKINSON AND COMPANY, Defendant. and Consolidated Cases. Nos. C 04–02123 WHA, C 04–03327 WHA, C 04–03732 WHA, C 05–03117 WHA. United States District Court, N.D. California. June 24, 2008. Background: Patentee brought patent in- fringement action against competitors, al- leging infringement of patent for sensor for use in whole blood without any protec- tive membrane. Defendants asserted inval- idity defense. Holdings: Following bench trial, the Dis- trict Court, William Alsup, J., held that: (1) patent claims were invalid as obvious; (2) patent was unenforceable by reason of inequitable conduct; (3) prior art was adequately disclosed in patent specification. Ordered accordingly. 1. Patents O66(1.20) Existence of protective membrane around electrode was optional, rather than required, in prior art patent for commer- cial electrochemical sensor for glucose, and thus patent for sensor for use in whole blood without any protective membrane was invalid for obviousness based on prior art; prior art patent disclosed basic struc- ture of active electrode and faster-acting chemistry, and stated that structure could optionally include protective membrane as an outer layer and that such membrane was preferable when used with live blood, and those skilled in art would have recog- nized electrochemistry would still have worked after removal of membrane. 2. Patents O16(2) Broad teachings do not have to be supported by specific experimental exam- ples in order to qualify as prior art in a patent examination. 3. Patents O16(3) For purposes of patent invalidity based on obviousness, the hypothetical person skilled in the art is presumed to

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Page 1: 1088 565 FEDERAL SUPPLEMENT, 2d SERIES - Patently-O · 2017-03-13 · 1088 565 FEDERAL SUPPLEMENT, 2d SERIES caregiver for a person who is no longer the person she married. The court

1088 565 FEDERAL SUPPLEMENT, 2d SERIES

caregiver for a person who is no longer theperson she married. The court finds thatshe should be compensated for this intan-gible loss at a level close to that of herhusband. Accordingly, the court finds thata general damages award for pain, suffer-ing and loss of life’s enjoyment in theamount of $1,000,000 is appropriate forDaniel Doyle and a general damagesaward of $750,000 is appropriate for AnneDoyle’s loss of consortium.

Because the court finds comparativenegligence by Daniel Doyle that operatesto mitigate defendant Graske’s liability,Daniel Doyle’s total award of $3,597,947must be reduced by 10%, or $359,794, re-sulting in a total damages award of$3,238,153 to Daniel Doyle. Anne Doyle’sdamages are not subject to any reduction.Accordingly, in conformity with this opin-ion, a judgment in the amount of$3,238,153 will be entered in favor of plain-tiff Daniel Doyle, and a judgment in theamount of $750,000 will be entered in favorof plaintiff Anne Doyle and against defen-dant Leland Graske, together with taxablecourt costs.

,

THERASENSE, INC., Plaintiff,

v.

BECTON, DICKINSON ANDCOMPANY, Defendant.

and Consolidated Cases.

Nos. C 04–02123 WHA, C 04–03327WHA, C 04–03732 WHA, C

05–03117 WHA.

United States District Court,N.D. California.

June 24, 2008.Background: Patentee brought patent in-fringement action against competitors, al-

leging infringement of patent for sensorfor use in whole blood without any protec-tive membrane. Defendants asserted inval-idity defense.

Holdings: Following bench trial, the Dis-trict Court, William Alsup, J., held that:

(1) patent claims were invalid as obvious;

(2) patent was unenforceable by reason ofinequitable conduct;

(3) prior art was adequately disclosed inpatent specification.

Ordered accordingly.

1. Patents O66(1.20)

Existence of protective membranearound electrode was optional, rather thanrequired, in prior art patent for commer-cial electrochemical sensor for glucose, andthus patent for sensor for use in wholeblood without any protective membranewas invalid for obviousness based on priorart; prior art patent disclosed basic struc-ture of active electrode and faster-actingchemistry, and stated that structure couldoptionally include protective membrane asan outer layer and that such membranewas preferable when used with live blood,and those skilled in art would have recog-nized electrochemistry would still haveworked after removal of membrane.

2. Patents O16(2)

Broad teachings do not have to besupported by specific experimental exam-ples in order to qualify as prior art in apatent examination.

3. Patents O16(3)

For purposes of patent invaliditybased on obviousness, the hypotheticalperson skilled in the art is presumed to

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1089THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

have full knowledge of all prior art in apatent.

4. Patents O23Patent for sensor for use in whole

blood without any protective membranedispensed with function contained in priorart patent, and thus patent did not disclosean invention; patent dispensed with mem-brane feature contained in prior art pat-ent.

5. Patents O23Deletion of a feature from a prior-art

device with a corresponding deletion of itsfunction is not an invention.

6. Patents O97Passages from submission by patentee

to European Patent Office (EPO) regard-ing prior art were ‘‘material’’ to prosecu-tion, and thus their disclosure to UnitedStates Patent and Trademark Office (PTO)during patent prosecution was obligatory,for purposes of patentee’s action againstcompetitor alleging infringement of patentfor sensor for use in whole blood withoutany protective membrane; statements toEPO were inconsistent with statementsmade to PTO examiner, and centered onprecise sentence in question, its meaning,and what it taught. 37 C.F.R. § 1.56(b)(2).

See publication Words and Phras-es for other judicial constructionsand definitions.

7. Patents O97Patentee’s attorney acted with specific

intent to deceive United States Patent andTrademark Office (PTO) and patent exam-iner during prosecution of patent for sen-sor for use in whole blood without anyprotective membrane, and thus patent wasunenforceable based on inequitable con-duct; attorney had no plausible reason forconsciously withholding submissions toEuropean Patent Office (EPO) duringprosecution that were inconsistent withstatements to PTO, and submissions were

material to prosecution. 37 C.F.R.§ 1.56(b)(2).

8. Patents O97

Withholding of submission to Europe-an Patent Office (EPO) regarding prior artfrom United States Patent and TrademarkOffice (PTO) during prosecution of patentfor sensor for use in whole blood withoutany protective membrane by patentee’s di-rector of research and development wasinequitable conduct, and thus patent wasunenforceable based on inequitable con-duct; once director made positive submis-sion to PTO, he was duty-bound to avoidmaking intentionally misleading submis-sion to PTO, statements were material,and director had no plausible reason forconcealing inconsistent EPO submissionsfrom PTO.

9. Patents O97

A declarant who makes a materiallyfalse and misleading statement under oathto the United States Patent and Trade-mark Office (PTO) cannot escape a chargeof inequitable conduct on the theory thathe advised the lawyer that the statementwas misleading and why.

10. Patents O66(1.20)

Patent for sensor for use in wholeblood without any protective membranewas invalid as obvious due to prior art; allbut one limitation in patent were disclosedexpressly by prior patents, and remaininglimitation, implementing two-electrodeconfiguration, was well known prior to pat-ent’s priority date.

11. Patents O16.5(1)

Often, it will be necessary for a courtto look to interrelated teachings of multi-ple patents, the effects of demands knownto the design community or present inthe marketplace, and the backgroundknowledge possessed by a person having

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1090 565 FEDERAL SUPPLEMENT, 2d SERIES

ordinary skill in the art, all in order todetermine whether there was an apparentreason to combine the known elements inthe fashion claimed by the patent at is-sue. 35 U.S.C.A. § 103.

12. Patents O16.5(4)

Where there is a design need or mar-ket pressure to solve a particular problemand there are only a discrete number ofpredictable solutions that led to the antici-pated success of the patent, the patent islikely the product not of innovation but ofordinary skill and common sense. 35U.S.C.A. § 103.

13. Patents O16(3)

When determining invalidity of a pat-ent, the decisionmaker must forget whathe or she has been taught at trial aboutthe claimed invention and cast the mindback to the time the invention was made,to occupy the mind of one skilled in the artwho is presented only with the references,and who is normally guided by the then-accepted wisdom in the art.

14. Patents O112.5

Patent invalidity must be proven byclear and convincing evidence. 35U.S.C.A. § 282.

15. Patents O99

Specification for patent for sensor foruse in whole blood without any protectivemembrane adequately disclosed limitation‘‘without an intervening membrane or oth-er whole blood filtering membrane,’’ asrequired to comport with written-descrip-tion requirement under patent law; thoseskilled in art would have thought inventorswere in possession of electrochemical sen-sor without a membrane for use in wholeblood as of time of application. 35U.S.C.A. §§ 112, 132.

16. Patents O99

To satisfy the written description re-quirement the disclosure of the prior appli-cation must convey with reasonable clarityto those skilled in the art that, as of thefiling date sought, the inventor was inpossession of the invention. 35 U.S.C.A.§ 112.

17. Patents O99

In order for a disclosure of prior artto be inherent, the missing descriptivematter must necessarily be present in theoriginal patent application’s specificationsuch that one skilled in the art wouldrecognize such disclosure. 35 U.S.C.A.§ 112.

Patents O328(2)

4,225,410, 4,388,166, 4,987,173, 5,682,-884. Cited.

Patents O328(2)

4,545,382. Cited as Prior Art.

Patents O328(2)

5,820,551. Unenforceable.

Jason Rantanen, Jeffrey I. Weinberger,John Walter Peck, Ted G. Dane, Esq.,Munger, Tolles & Olson LLP, Los Ange-les, CA, Rohit K. Singla, Munger Tolles &Olson, San Francisco, CA, David Wille,Matthew A. Hayenga, Baker Botts LLP,Dallas, TX, James W. Cannon, Jr., MariaW. Boyce, William P. Johnson, BakerBotts L.L.P., Austin, TX, Jose E. Rivera,Karen L. Hale, Abbott Park, IL, StevenMitby, Baker Botts LLP, Houston, TX, forPlaintiff.

Bradford J. Badke, Brandon H. Stroy,Brien P. Santarlas, Sanjeev Mehta, NealK. Dahiya, Ropes & Gray LLP, New York,NY, Mark D. Rowland, Mark Daniel Row-

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1091THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

land, Gabrielle Elizabeth Higgins, Ropes &Gray LLP, Palo Alto, CA, for Defendant.

FINDINGS OF FACT ANDCONCLUSIONS OF

LAW

WILLIAM ALSUP, District Judge.

INTRODUCTION

After a bench trial, this order consti-tutes the findings of fact and conclusions oflaw. Both sides have submitted lengthyproposed findings and conclusions. Rath-er than address each and every proposal,this order will find its own way throughthe evidence and arguments. Any propos-al that has been expressly agreed to by theopposing side, however, shall be deemedadopted even if not expressly stated here-in. That a proposal has not been express-ly covered herein does not necessarilymean it was rejected; it only means thatthe Court found it unnecessary to reach.

THE PROCEDURAL HISTORY OF THE CASE

Abbott Laboratories filed the first ofthese actions on May 28, 2004. Threesubsequent actions were filed. All con-cerned four United States patents ownedby Abbott and Therasense, Inc.1 U.S. Pat-ent No. 5,820,551 is the subject of thisorder. These actions were originally as-signed to The Honorable Martin J. Jen-kins. Judge Jenkins issued a first claimconstruction order for certain other pat-ents and a separate claim construction or-der for the 8551 patent. He also issuedthree separate summary judgment orders.The final one, dated April 3, 2008, involvedall parties and all patents in suit. Whilethe final summary judgment order dideliminate several infringement counts, sev-eral other claims were still viable. Imme-diately after issuing the final summary

judgment order, Judge Jenkins left thefederal bench, and all four cases came tothe undersigned.

All four cases were subsequently consol-idated and a trial date was set for May 27,2008. All defendants were permitted tofile one more round of summary judgmentmotions and each party was allowed mo-tions in limine. A technology tutorial forthe undersigned was also held. The mo-tions for summary judgment and motionsin limine were fully briefed. A first omni-bus order ruled on the motions for whichoral argument was not required. Argu-ment was then heard for the remainingpending motions. In a second omnibusorder, the final pending motions were de-cided. Defendant Roche Diagnostics Cor-poration subsequently settled on the eve oftrial.

During this time, the Court and counselalso addressed the shape of the trial. Itwas decided that a trial on the 8551 patentwould be held first with all defendants andwould be broken up into three separatephases: (i) invalidity and unenforceability;(ii) infringement (if needed); and (iii) will-fulness and damages (if needed). All par-ties then stipulated that phase one of the8551 trial would be tried to the bench.Defendants raised four issues for phaseone: inequitable conduct, obviousness,prosecution laches, and non-compliancewith the written-description requirement.

When the trial on the 8551 patent began,the remaining defendants were BayerHealthcare, LLC, Becton Dickinson &Company, and Nova Biomedical Corpora-tion (collectively ‘‘BD/Nova’’). Before trialbegan, Abbott made a request to add At-torney Lawrence Pope as a live trial wit-ness in its case-in-chief. During Attorney

1. Therasense is a wholly-owned subsidiary ofAbbott Laboratories, and the exclusive owner

of two of the other patents in suit.

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Pope’s deposition, Abbott’s counsel had onthree separate occasions insisted to de-fense counsel that Attorney Pope wouldnot appear in person at trial. This wassaid in aid of repeated instructions not toanswer. Attorney Pope was, therefore,scheduled to appear only through video-deposition. Based on Abbott’s insistenceat deposition that Attorney Pope would notappear live at trial, Abbott’s request tohave Attorney Pope appear as a live trialwitness was initially denied. This denialwas on the ground that it would be unfairto defendants, who had relied on the depo-sition representations to their detriment innot bringing Rule 37 motions. During tri-al, however, Abbott renewed its motion toallow Attorney Pope to testify in person attrial. The Court then asked Abbott tosubmit a sworn proffer showing the pro-posed statement of Attorney Pope’s testi-mony. Abbott submitted a declarationsigned by Attorney Pope detailing thefacts he would cover in his testimony. Be-cause of the seriousness of the accusationagainst Attorney Pope, the Court relentedand allowed Abbott to call Attorney Popein its case-in-chief on those topics raised inhis declaration.

After defendants closed their case-in-chief, Abbott moved for partial findingsunder Rule 52(c) that defendants hadfailed to meet their burden of proof withrespect to their defense of prosecutionlaches. The motion was granted on theground that defendants had failed to showany intent to delay prosecution of the 8551patent or that substantial prejudice result-ed from any such delay. Abbott alsomoved for partial findings as to defen-dants’ remaining invalidity defenses.These motions were all denied. Abbott

rested its case-in-chief on June 2 and clos-ing arguments were heard on June 3. Thisorder now follows.

THE UNITED KINGDOM WORK

United States Patent No. 4,545,382 (andits European counterpart) is a decisiveitem of prior art in this decision. Here isits story. In the late 1970’s and early1980’s, two research groups at the Univer-sity of Oxford and the University of Cran-field in the United Kingdom were workingon electrochemical sensors to detect theconcentration of specific components in so-lutions. In particular, they were interest-ed in developing electrochemical sensorsthat could be used to test glucose levels inhuman blood. Doctors Irving Higgins,Hugh Hill, and Elliot Plotkin were part ofthese research groups. In 1981, bothgroups teamed with a newly founded com-pany, Genetics International, which wasco-founded by James McCann. One goalwas to create the first commercial electro-chemical sensor for glucose.2

In 1981, the researchers filed their firstpatent application. This became the 8382patent in the United States and No. 0078,-636 B2 in the European Patent Office.The specification taught an improved elec-trochemical sensor for use in various liquidmixtures. The sensor was an electrodecoated with specified chemicals that gener-ated a tiny but detectable flow of electrici-ty in the presence of glucose. The tech-nology itself will be described below. Inbrief, the chemicals coated onto the elec-trode combined with glucose or whateverother ‘‘substrate’’ was being tested to gen-erate small currents of electricity, whichcould then be measured by an ammeter.

2. Dr. Anthony Turner, the defense invalidityexpert, was also involved in the initial re-search efforts that took place in the UnitedKingdom. He joined Dr. Higgins’ team at theUniversity of Cranfield in 1981 as a research

officer. He later became a project director in1983 after Genetics International began work-ing with the group. Dr. Gordon Sanghera, asstated in more detail below, was also involvedwith the research efforts by the two groups.

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1093THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

The higher the concentration of substrate,the higher the electrical current, and thehigher the meter reading. The patent dis-closed certain ferrocene chemistry that al-lowed for fasting testing.

Although the United States 8382 patentlived out its seventeen years without inci-dent, its EPO counterpart (i.e., the 8636)was eventually revoked based on a Germanprior-art reference that was cited by athird party in a European opposition pro-ceeding. That was in the mid–1990’s.The decision to revoke the patent wasappealed, however, and the patent waseventually reissued by a technical board ofappeal in the European Patent Office.Certain submissions made along the wayby Abbott’s predecessors, however, haveturned out to be important in this proceed-ing by reason of their non-disclosure to thePTO during prosecution of the 8551 patentin suit.

The research group continued its workon sensors for testing glucose levels inblood. Dr. Hill and his colleagues filedseveral additional patent applications,which were later combined to form a singleUnited States patent application. All par-ties herein agree that the resulting U.S.Patent No. 5,820,551—the patent in suit—claims priority to May 1983. JamesMcCann and Drs. Hill, Higgins and Gra-ham Davis were listed as the inventors.

Originally, the claimed invention of the8551 patent was the development of a dis-posable electrode strip whose electrodescould be covered by a single drop of solu-tion. These one-use strips would be in-serted into a convenient unit for digitalreadout of the level of a target compound(like glucose) in a test liquid mixture (likeblood). After a strip was used to generatea readout, it could be thrown away.

The 8551 patent was in prosecution forover fourteen years. During this period,Genetics International changed its name to

Medisense, Inc. Various claims were re-jected twelve times by the PTO examiner,David Shay. Eleven out of the twelve re-jections relied on the 8382 patent or itsEuropean counterpart, the 8636 patent.During this prolonged prosecution, Medi-sense amended the proposed claims sever-al times to overcome rejections by Exam-iner Shay—all without success. At times,Medisense also submitted declarationsfrom persons of ordinary skill in the art todistinguish its claims from the prior art.None of the proposed amendments everincluded a limitation for a sensor without afilter or a membrane.

In the meantime, several other compa-nies, including defendants Bayer Health-care, LLC, and Becton Dickinson & Com-pany, had begun manufacturing and sellingdisposable electrochemical sensors for dia-betic patients.

In 1996—while the 8551 patent was stillpending before the PTO—Medisense waspurchased by Abbott Laboratories. Afterthe acquisition, Abbott brought in one ofits in-house patent attorneys to take overthe prosecution of the 8551. That attorneywas Lawrence Pope. Attorney Popeworked in conjunction with several techni-cal employees at Medisense, including Dr.Gordon Sanghera, to ‘‘brainstorm’’ variousarguments regarding the patentability ofthe 8551. Dr. Sanghera had worked atMedisense since 1990. As of 1997, he wasits director of research and development inthe United States. His responsibilities in-cluded running competitive analysis in con-junction with the marketing departmentand supervising Abbott’s patent portfolio.Dr. Sanghera had also previously workedfor Dr. Hill at his laboratory at OxfordUniversity. He had researched electro-chemical sensors, but he had not beeninvolved in the research that led to anypatents involved herein. Dr. Sangherahad, however, attended the European op-

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position hearings and had been active incrafting the submissions made in that ap-peal.

Dr. Sanghera and Attorney Pope struckupon a new point of possible novelty previ-ously overlooked in the pending prosecu-tion. The new point was that the specifi-cation disclosed a sensor for use in wholeblood without any protective membrane.Trouble was, a passage in the earlier 8382patent already seemed to disclose mem-braneless sensors. That passage read(col.4:63–66):

Optionally, but preferably when beingused on live blood, a protective mem-brane surrounds both the enzyme andthe mediator layers, permeable to waterand glucose molecules.

To address this problem, Abbott decidedto assert, as a matter of extrinsic fact, thatin 1983 skilled artisans would have be-lieved that a membrane was essential evenin the face of the 8382 disclosure, i.e., theywould not have taken the quoted sentenceliterally.

Attorney Pope then held an interviewwith Examiner Shay on November 4, 1997.Examiner Shay summarized the interviewas follows (TX 469):

Applicant indicated that he would like tosubmit claims specifically covering acompound specific electrode with the fil-tering membrane absent. The Higginset al. (’382) disclosure was discussedesp[ecially] the paragraph spanning col-umns 4 & 5. It was determined thatsince Higgins et al. appear to requirethe membrane for use with whole blood(see example 8) an affidavit or otherevidentiary showing that at the time ofthe invention such a membrane was con-sidered essential would overcome thisteaching.

As arranged in the interview, AttorneyPope submitted a declaration by Dr.Sanghera on December 3, 1997, along with

amendments to the claims. The declara-tion stated in relevant part (TX 443):

THAT based on his historical knowledgehe is confident that on the filing date ofthe earliest application leading to thepresent application on June 6, 1983 andfor a considerable time thereafter oneskilled in the art would have felt that anactive electrode comprising an enzymeand a mediator would require a protec-tive membrane if it were to be used witha whole blood sample. Therefore he issure that one skilled in the art would notread lines 63 to 65 of column 4 of U.S.Patent No. 4,545,382 to teach that theuse of a protective membrane with awhole blood sample is optionally [sic] ormerely preferred.

The entire submission was aimed at over-coming the ‘‘optionally, but preferably’’sentence in the 8382 patent.

Attorney Pope submitted parallel re-marks stating that those of ordinary skillin the art believed that the use of a protec-tive membrane was ‘‘required’’ when test-ing whole blood and that they would haveunderstood the sentence in question asmere patent phraseology, not a technicalteaching. Based on Dr. Sanghera’s decla-ration and Attorney Pope’s remarks, Ex-aminer Shay finally approved the proposedclaims and the patent issued on October13, 1998. The foregoing findings will beamplified with many details below.

INVALIDITY

In this action, the central axis of conten-tion concerns membranes and, more par-ticularly, their use as a permeable layersurrounding the chemistry coated onto theactive electrode. Late in the fourteen-year prosecution, as stated, Abbott ad-vanced the theory that the 8551 specifica-tion revealed a sensor without a protectivemembrane. However, a key prior art ref-erence—the inventors’ own 8382 patent—

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1095THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

had already stated that such membraneswere optional and at most preferred incertain circumstances, as quoted above.This 8382 sentence was raised by the ex-aminer as having already taught thatmembranes were merely optional or pre-ferred. In response, as stated, Abbotttook the position (and still maintains) thatthe sentence would not have been under-stood in 1983 by those skilled in the art tohave modified a supposed conventionalwisdom that a membrane was necessaryfor testing in whole blood.3 Defendantsdisagree. They point out that the 8382sentence expressly stated that even forlive blood, a membrane was merely ‘‘pre-ferred’’ and that for all other cases it was‘‘optional.’’ In no case was it said to be‘‘required.’’

With this introduction of the central in-validity issue, this order will go back tosquare one. It will begin by setting forththe basic technology. It will then reviewthe 8382 patent, focusing on its entire dis-closure, including the sentence in question,so as to place that sentence in full context,all from the point of view of one skilled inthe art at the time of the alleged 8551invention (in 1983).

* * *

Although this summary of the technolo-gy is now stated in the present tense, thissummary was all known in the prior art.The electrochemistry involves an electrodecoated with an ‘‘enzyme’’ catalyst. Theenzyme is particularly selected to reactwith glucose or whatever the test sub-stance might be. Again, the substancebeing tested for is sometimes, as used byMedisense in the EPO proceedings, called

a ‘‘substrate.’’ 4 The enzyme-substratechemical reaction generates electrons.The electrons are passed via yet anotherchemical called a ‘‘mediator,’’ also coatedonto the electrode, to the active electrodeitself. The electrons then flow as a tinybut measurable electrical current down theactive electrode through an ammeter andback to the other uncoated electrode. Theblood droplet or other solution under testprovides an electrical path completing thecircuit between the electrodes. The word‘‘sensor’’ is sometimes used interchange-ably with the active electrode, i.e., theelectrode painted with the active chemis-try.

An analogy is to a battery. Batterychemicals generate electrons and thuselectricity, which can then be used to dowork, such as to drive a meter. In thetechnology at hand, the active chemistry isthe glucose, enzyme, and mediator. To-gether, they generate the electricity.

Thus, when blood is placed between andacross the electrodes, the chemicals coatedonto the active electrode go to work, gen-erating electricity or ‘‘signal.’’ The elec-tricity passes through an ammeter, whichdetects the current. The current will ide-ally be in proportion to the concentrationof glucose. In this way, the meter can becalibrated to progressive concentrations ofglucose. The user can then see when theglucose (or other substrate) is too low ortoo high. All of the foregoing was knownin the prior art.

* * *

One of the contributions of the 8382 pat-ent—which was concededly prior art to the

3. Live blood is inside the body and can onlybe tested in vivo. Whole blood is blood withall its constituent parts and can be in oroutside the body. In vitro refers to tests out-side the body, which must, in our context, beperformed on whole blood, not live blood.

4. The word substrate is used in the 8551 pat-ent in a second sense, namely to describe thebase on which the electrode is formed (see,e.g., col. 2:27, 33; col. 3:23). This is a sec-ond, different meaning.

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8551 patent—was a faster-acting ferrocenemediator coated onto an active electrodealong with an enzyme. Faster actingmeant faster response times and quickertest results.

In the ‘‘Background of the Invention,’’the inventors stated that the 8382 inventionwould have particular value for ‘‘in vivomeasuring or monitoring of components inbody fluids’’ (col.1:16–17) and said ‘‘thedetermination of glucose in a diabetic hu-man subject’’ was a primary application(col.1:20–21). The background stated fur-ther that the invention lent itself to tempo-rary or permanent implantation. Al-though ‘‘the provision of an implantableglucose sensor [was] a major object of theinvention’’ the inventors noted that ‘‘otherand broader objects [were] not hereby ex-cluded’’ (col.1:23–26). A few columns later,for example, the specification called outhome-testing kits with disposable sensors.After acknowledging that in vivo glucosesensors had already been proposed by oth-ers, the inventors stated that they hadrecently carried out in vitro studies.

Under ‘‘Summary of the Invention,’’ the8382 inventors stated that they had cometo realize that mediator compounds couldbe associated with the sensor electrodestructure itself to make such electrodesavailable for use by in vivo methods. The8382 invention was then described as asensor electrode composed of a combina-tion of enzyme and mediator (col.1:60–63).Preferably, the electrode was designed todetermine glucose in vivo (col.1:65–66). Along passage then described various medi-ators and enzymes (col. 2:1 to col. 4:55).Again, a significant contribution was theferrocene chemistry that was faster actingthan in the prior art, thus reducing re-sponse time.

At a few places in this passage, theinventors referenced membranes. For ex-

ample, two paragraphs stated (col. 3:53 tocol. 4:2):

In that form of the invention using poly-viologens, as exemplified in the threemodifications above, it is an objective tokeep loss of active material (enzyme ormediator) to a very low level, i.e., by thesurrounding membrane, co-immobilisa-tion or covalent bonding. In a differentform of the invention, however, still us-ing glucose oxidase, a rather higher levelof loss of active material is tolerated,giving a sensor electrode of reduced butstill useful life, coupled with improve[sic] sensitivity and selectivity.In this form of the invention the elec-trode is composed of particulate carbonmixed with a low molecular weight medi-ator disseminated throughout the elec-trode and glucose oxidase. Chloraniland/or fluoranil are useful mediator sub-stances. It is envisaged to constructfrom such an electrode a replaceablesensor tip to a needle-type probe forprojecting only into the dermis so as toallow ready replacement.

Put differently, after describing a mem-brane application, the ‘‘different form’’ ofthe invention dispensed with the mem-brane and thus ‘‘tolerated’’ a ‘‘rather high-er level of loss of active material’’ (due tothe absence of the immobilizing mem-brane). It was envisaged to have replace-able sensor tips for projecting into thedermis.

Another version called out ferrocene-glucose oxidase as ‘‘particularly valuable’’and stated ‘‘the enzyme layer is preferablyimmobilised at the surface of the underly-ing mediator, retained in a self-sustaininggel layer’’ or with ‘‘a retention layer there-over permeable to the glucose molecule’’(col.4:13–16). ‘‘Immobilisation’’ was a ref-erence to retaining the active chemicals onthe electrode so that they would not fallaway into the blood or other fluid. Then

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came the main sentence at the heart ofthis case (col.4:63–66):

Optionally, but preferably when beingused on live blood, a protective mem-brane surrounds both the enzyme andmediator layers, permeable to water andglucose molecules.

This allowed water and glucose to passthrough, kept in the chemicals, and keptout larger blood constituents like red bloodcorpuscles.

The ‘‘Summary of the Invention’’ thenturned to various applications and specifi-cally called out implanted glucose sensors,digital readout diabetic home-testing kits,devices to take a blood sample from thefinger, place it on the sensor, amplify thesignal, and give a digital readout, and awatch-type device for monitoring glucoseinterstitial fluid in the skin with disposa-ble-sensor cartridges in the back, whichwould plug into the electrodes.

Next came a ‘‘Description of the Pre-ferred Embodiments.’’ In total, the 8382patent contained thirteen working exam-ples of preferred embodiments of the in-vention. Some of the examples describedvarious procedures for producing theworking chemistry of the sensor—i.e., theenzyme and mediator. Other examplesdescribed possible configurations of elec-trodes and electrochemical sensors. Eachwas configured slightly differently depend-ing on various test parameters, includingthe type of solution being tested. Some ofthe sensors included a membrane and oth-ers did not.

Examples 1 and 2 described purificationprocesses for producing quinoprotein glu-cose dehydrogenase—an enzyme used tocatalyze the chemical reaction. Examples3 and 4 explained the interaction betweenglucose oxidase (another enzyme) and fer-rocene—the mediator which allowed formuch faster and more linear testing thanthe prior art.

Example 5 described the construction ofan in vitro sensor with a glucose oxidaseenzyme and polyviologen mediator. Adialysis membrane was used. The pur-pose of the membrane was to block largermolecules from passing through to theworking chemistry. The sensor was test-ed in a buffered electromechanical cell.As the amount of glucose in the test solu-tion was increased, the current generatedby the sensor grew, thereby indicatingthat the electrode was acting as a glucosesensor. This same construction was usedin Example 6, except chloranil was used asthe mediator.

Example 7 taught a sensor configuredwith a glucose oxidase enzyme and a di-methyl ferrocene mediator designed foruse in interstitial fluid—i.e., skin. Beforethe sensor was used for testing, the elec-trode, mediator, and enzyme were dippedinto a solution of cellulose acetate, therebycreating a protective membrane over theworking chemistry and electrode. The ex-ample went on to state: ‘‘The small size ofsuch an electrode and its linear responseover a large range of glucose concentra-tions makes it possible to use the electrodefor in vivo glucose determination on bothseverely diabetic and normal individuals’’(col.8:54–59).

Example 8—entitled ‘‘In vitro sensor’’—was the most discussed embodiment attrial (col.8:63). The example began by de-scribing the construction of a sensor with aglucose oxidase enzyme and a ferrocenemediator. No membrane was applied.The example then explained that the sen-sor was first tested in ‘‘nitrogen-saturatedbuffer solution’’ (col.9:15). The results forthe test in buffer solution were then sum-marized. A cellulose acetate membranewas then applied to the sensor. The ex-ample went on to describe response timesfor that sensor in buffer and then, in a

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separate test, in blood. The exact lan-guage in the specification stated (col.9:26–33) (emphasis added):

With the same buffer, such an electrodemodified by a cellulose acetate mem-brane coating (produced as in Example7) gave response times of 36 seconds (2mM) and 72 seconds (6 mM). Withblood, this modified electrode gave re-sponse times of 36 seconds (blood with aknown 2mM glucose content) and 72 sec-onds (blood at known 6mM glucose con-tent).

The sensor constructed in Example 8 wasthus tested in two solutions. The examplefirst described was tested in buffer solu-tion. At this point in the specification, nomembrane was applied to the sensor. Amembrane was then placed on the sensor.The response times of the sensor with amembrane were subsequently set forth forthe same buffer solution and then, sepa-rately, for blood. It is Abbott’s contentionthat this example shows that a membranewas in fact required by the invention of the8382 patent when testing in whole or liveblood.

Example 9 taught the construction of anelectrode with a glucose dehydrogenaseenzyme and a ferrocene mediator. A dial-ysis membrane was used to cover the coat-ed electrode. Examples 10 and 11 wereminor variations of Example 9. Examples12 and 13 described further configurationsfor an electrode with a glucose dehydroge-nase enzyme and ferrocene mediator.

Finally, under the 8382 claims, Claim 1covered the sensor electrode coated withthe enzyme and mediator. All agree thatClaim 1 covered electrodes without limita-tion to either in vitro or in vivo use. Allagree that Claim 1 covered versions withand without membranes. Indeed, depen-dent Claim 12 narrowed the claim to sen-

sor electrodes having an outermost protec-tive membrane permeable to water andglucose molecules.

In sum, the 8382 disclosed the basicstructure of an active electrode and a fast-er-acting chemistry, stating that the struc-ture could optionally include a protectivemembrane as an outer layer and statingthat such a membrane was preferablewhen used with live blood, although theexamples involving blood employed a mem-brane.

* * *

Turning to the 8551 patent in suit, itsinventor group was virtually the same asfor the 8382, with slight adjustments.5 Itwas directed to a home-testing kit andmore specifically to a two-electrode strip(rather than a three-electrode strip) forone-time, disposable attachment to a han-dheld readout device. The electrodeswere coated with enzymes and mediators(‘‘preferably a ferrocene’’)—as in the 8382patent. The strip was described as ‘‘elon-gated’’ for ready handling and assembly.As with the 8382, the active electrode was‘‘preferably formed of carbon.’’ The inven-tors went on to say that carbon foil avail-able commercially as GRAPHOIL or PA-PYEX was a valuable electrode material.Various ‘‘objects’’ of the invention weredescribed, none of which related to a mem-brane or lack thereof. Many columnswere devoted to construction of the elec-trodes.

The subject of membranes was men-tioned only twice in the 8551 application.Under ‘‘Membrane Cover for Electrode,’’the inventors said that ‘‘it may be foundvaluable to exclude the sensor from inter-fering contact with larger molecules ortissue fluid components’’ and that this

5. Drs. Hill, Higgins, and Plotkin are listed asthe inventors on the 8382 patent. In context,

McCann and Drs. Hill, Higgins, and Davis arelisted as inventors on the 8551 patent.

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1099THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

could be done with a ‘‘surrounding mem-brane’’ (col.6:67–7:13). That passage brief-ly described how to make a membrane insitu. Later, a step-by-step constructionalsequence was given for an electrode strip.Seven steps were listed. Adding a mem-brane was not listed as a step (col.8:35–51),an omission since given great weight byAbbott. A later, optional modificationstated: ‘‘The electrode may then be cov-ered, on both sides, with a semipermeablemembrane of cellulose acetate (or polyure-thane), not shown, to block large interfer-ing species from contact with the elec-trode’’ (col.9:34–37).

Nowhere in the 8551 specification or theoriginal claims was there any suggestionthat treating the membrane as optional (oromitting it) was an inventive step. None-theless, this order appreciates that a legiti-mate invention may eventually be foundlurking in a disclosure even though theinventors missed it themselves for over adecade. See Newman v. Quigg, 877 F.2d1575, 1581 (Fed.Cir.1989). So this orderaccepts Abbott’s contention, at least forpurposes of argument, that the 8551 speci-fication disclosed an active electrode with-out a membrane for use with whole blood(as well as disclosing one with a membranefor use with whole blood). The decisivequestion remains whether or not the samegroup of inventors (with slight member-

ship changes) had already disclosed in the8382 patent that a membrane was merelypreferred for use with live blood and wasoptional in all other cases. This order nowturns to resolving that question.

* * *

[1] This order accepts Abbott’s propo-sition that prior to the 8382 patent, thoseskilled in the art typically employed amembrane on a sensor used with live orwhole blood, although one exception wasalready in print.6 That practice, however,was before the revelation in the 8382 pat-ent. The 8382 patent expressly stated thata protective membrane was optional in allcases except for live blood, in which case itwas preferred. In no case did the 8382patent state that a protective membranewas required.

In context, it seems clear why this wasso. The invention specified a faster-actingferrocene chemistry. This allowed forshorter response times, i.e., measurementtimes. This, in turn, reduced the raisond’etre for any membrane. For example,the faster response times reduced theprobability of the active chemicals beingwashed away in the bloodstream and re-duced the time within which red bloodcorpuscles could locate and foul the elec-trodes. (Fouling refers to the larger redblood cells accumulating on the electrode

6. U.S. Patent No. 4,388,166 (Suzuki) issuedon June 14, 1983, and was filed on May 15,1982. Although the various examples of elec-trochemical glucose sensors recited in the8166 all included some type of membrane, the8166 specification did expressly recognize thata glucose sensor (for blood) could be con-structed without any membrane as long as theuser could tolerate variations in measuredvalues. The specification stated (col.1:31–43)(emphasis added):

In the prior art electrochemical measuringapparatus, an enzyme electrode providedwith a semipermeable-membrane indeed al-lows for a stable measurement, but themeasurement takes a long time due to slow

response. On the other hand, an enzymeelectrode free of a semipermeable membranemakes a quick response, but has the draw-back that measurement is accompaniedwith noise, resulting in noticeable varia-tions in the measured values. Whether pro-vided with a semipermeable membrane ornot, the known enzyme electrode has thedrawback that it loses stability duringlengthy application.

The specification went on to explain that pri-or art glucose sensors (with and withoutmembranes) could be used in ‘‘blood, serum,or urine,’’ but with decreased sensitivity(col.1:48).

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and blocking the much smaller glucosemolecules from reaching the sensor.) Theindicated readings took about a minute,even less without any membrane. Therewas, therefore, less need for any mem-brane.7

As a matter of sentence structure, thesentence sets up two cases—an optionalcase and a preferred case:

Optionally, but preferably when beingused on live blood, a protective mem-brane surrounds both the enzyme andthe mediator layers, permeable to waterand glucose molecules.

Italics have been supplied here to illus-trate the structure. Ignoring the italicizedpreferred case, the sentence states: ‘‘Op-tionally, TTT a protective membrane sur-rounds both the enzyme and the mediatorlayers TTTT’’ That is the general, optionalcase. The exception, i.e., the preferredcase, is for live blood. That phrase isitalicized. The trial record is clear andconvincing that persons of ordinary skill inthe art understood the words ‘‘optionally’’and ‘‘preferably’’ in the same way as therest of us. There is no doubt that thoseskilled in the art would have understoodthat the sentence was trying to say exactlywhat has been laid out in this paragraph.8

Abbott contends that skilled artisanssimply would not have believed the sen-tence and would have had no reasonableexpectation of reliance on it by reason of aprevalent view that membranes were es-sential when testing in whole blood. Arevelation in a public disclosure cannot beerased from the prior art on the theory

that it contradicted the conventional wis-dom. The whole point of disclosures inpatents is to reveal something new. SeeAtlas Powder Co. v. Ireco, 190 F.3d 1342,1347 (Fed.Cir.1999).

Abbott has tied itself in knots contortingthe grammar to come up with an alterna-tive meaning. One example is Abbott’sProposed Finding No. 90, which reads:

Interpreted in light of the conventionalwisdom at the time, the ‘‘preferably’’language means that the membrane isoptional when an in vivo sensor does notcontact whole blood but that the mem-brane is required when the sensor con-tacts red blood cells in whole blood.

This contortion collapses on its ownweight. The sentence in question meantjust what it said and the ordinary artisanwould have so understood it.9

Contrary to Abbott, Example 8 in the8382 patent was consistent with the plainmeaning of this sentence. Example 8 wasone of the preferred embodiments. It de-scribed a ferrocene-glucose oxidase elec-trode. In the experiment described in Ex-ample 8, the sensor was tested in a buffersolution with two different glucose concen-trations, yielding response times of 24 and60 seconds, depending on the concentra-tion. Then a protective membrane wasapplied to the sensor. While still testingthe buffer concentration, the responsetimes went to 36 and 72 seconds, respec-tively. The same sensor—again with aprotective membrane—was tested in bloodsamples with the same concentration and36– and 72–second response times were

7. Abbott concedes that, for example, the D1reference in the EPO appeal described belowhad a response time of five to fifteen minutes.

8. The parties agree that in May 1983, a per-son of ordinary skill in the art would havehad a doctoral degree or postgraduate experi-ence working toward a Ph.D. Such a personwould also have had some level of experience

in actually constructing electrochemical sen-sors or would at least be familiar with them.

9. This order also rejects Abbott’s idea that theword ‘‘optionally’’ referred to use of a mem-brane as an alternative in lieu of some othertype of whole-blood filtering member.

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1101THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

again obtained. It is true that when thesensor was used in blood a protectivemembrane was used and that a protectivemembrane was not used with the firstbuffer solution. Nothing in Example 8,however, stated that a membrane was re-quired for use in blood. That a membranewas added seems to have been little morethan a way to investigate the time effect ofadding a membrane.

[2] It is also true, as Abbott urges,that no test recited in the preferred em-bodiments included a test on blood withouta membrane. There were, however, toofew blood examples among the embodi-ments to warrant any inference from thishappenstance. No doubt, the broad teach-ing of the sentence in question went be-yond the specifics of the preferred embodi-ments. That is often true in patents.Broad teachings do not have to be sup-ported by specific experimental examplesin order to qualify as prior art.

The 8382 sentence was then and remainscorrect, a fact that even Abbott does notchallenge. Membranes were never part ofthe electrochemistry itself. Rather, theyoffered certain mechanical advantages,provoked by two different concerns. Thefirst was human safety. For in vivo use,toxic materials might break away from thecoated sensor and pollute the bloodstream.To protect against this possibility, a mem-brane immobilized the active ingredients,i.e., retained them in place and thus re-duced the risk of breakaway. Reducedresponse times from faster chemistry,however, reduced the breakaway risk—forthe sensor could be removed sooner thanbefore. The second concern was the riskof ‘‘fouling.’’ This was the risk that redblood particles would stick to the activeelectrode and prevent glucose from inter-acting with the chemicals coated onto theelectrodes. If enough ‘‘fouling’’ occurred,the signal would be diminished below an

acceptable level and an erroneous readoutwould occur. Fouling might occur in liveblood or whole blood. In these proceed-ings, the supposed problem of fouling hasbeen exaggerated by Abbott. After thefaster chemistry disclosed in the 8382 pat-ent, the risk became more theoretical thanpractical, especially for one-use, disposableapplications. Subsequent diabetic kits us-ing the faster sensors have deleted themembrane with acceptable results. In sum,the 8382 statement in question was thenand remains correct.

Abbott’s idea that skilled artisans wouldhave read the sentence in question anddisbelieved it in 1983 is not plausible onthe trial record. Skilled artisans wouldhave known that deleting the membranewould simply have deleted their mechani-cal advantages. They would have known,however, that the electrochemistry wouldstill have worked. They would haveknown that the degree of fouling wouldhave depended on how long the sensor wasexposed to blood. They would have knownthat the risk of fouling would have beenreduced for faster-acting chemistry andreduced even more for sensors used onlyonce, i.e., disposable sensors with no accu-mulation of residue. They would haveknown that omitting the filter would havehad the further advantage of speeding upthe test time even more.

To be sure, in making these findings inthe preceding paragraph, the Court hasrelied on trial testimony and materials out-side the four corners of the patent andprior-art references. This, however, is be-cause Abbott itself has resorted to extrin-sic evidence and ‘‘conventional wisdom.’’That is, to overcome the 8382 prior-artsentence in question, Abbott has resortedto extrinsic evidence, arguing that skilledartisans would not have understood thesentence in light of prevailing practices.Therefore, it is entirely appropriate for the

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other side to likewise resort to extrinsicevidence as to how those skilled in the artwould have taken the 8382 sentence inquestion.

Abbott next argues that one skilled inthe art would have read the ‘‘optionally,but preferably’’ passage of the 8382 asmere ‘‘patent phraseology.’’ Notably, thepassage in question stated that a mem-brane was preferable ‘‘when being used onlive blood’’ (col.4:63–64). Defense ExpertTurner testified that even today’s implant-able electrochemical sensors used for test-ing glucose in live blood would use a mem-brane to ensure that toxic materials werenot released into the blood stream (Tr.333). He even went as far as saying thatthe FDA would likely not approve an im-plantable sensor without a membrane forsafety reasons, which was the reason aprotective membrane was preferable forlive blood. Unlike implantable sensorsused to test live blood, however, one-timedisposable sensors for in vitro testing (asdisclosed in the 8551 patent) had no suchsafety concerns. With in vitro testing, amembrane was motivated only by the po-tential of fouling the electrode. As tothem, the 8382 sentence in question taughtthat the membrane was merely optional.

The examiner was persuaded by Ab-bott’s view as a result of two consider-ations. One was the presence or absenceof a membrane in the 8382 examples, par-ticularly in Example 8. This argument isunpersuasive and rejected by this order,for the reasons stated above.

The other reason was based on an ex-trinsic evidentiary declaration withoutwhich the examiner said no allowancewould be made. This was the now-contro-versial declaration of Dr. Gordon Sangh-era. Although he was not a co-inventor,he had worked at Medisense and had be-come an Abbott employee at the time ofhis declaration. The entirety of his sub-

stantive statement to the examiner was asfollows (TX 443):

3. THAT he is familiar with U.S. Pat-ent No. 4,545,382 and with the history ofthe development of the technology dis-closed in this patent. In particular he isfamiliar with the beliefs and concerns ofthose skilled in the art in 1981 when thefirst application leading to this patentwas filed as well as in 1983 when thefirst application leading to the presentapplication was filed.4. THAT he is familiar with the teach-ings of U.S. Patent No. 4,987,173 toNankai et al. and in particular with theteachings of Examples 3 and 4 with re-gard to the construction of sensors foruse with serum and whole blood sam-ples.5. THAT based on his historical knowl-edge he is confiednt [sic] that on thefiling date of the earlist [sic] applicationleading to the present application onJune 6, 1983 and for a considerable timethereafter one skilled in the art wouldhave felt that an active electrode com-prising an enzyme and a mediator wouldrequire a protective membrane if it wereto be used with a whole blood sample.Therefore he is sure that one skilled inthe art would not read lines 63 to 65 ofcolumn 4 of U.S. Patent No. 4,545,382 toteach that the use of a protective mem-brane with a whole blood sample is op-tionally or merely preferred.6. THAT Examples 3 and 4 of U.S.Patent No. 4,897,173 provide evidencethat this concern about unprotected ac-tive electrodes for whole blood samplespersisted until at least the June 21, 1985filing date of the earliest applicationleading to this patent. The fact that theExample 3 teaching a sensor for usewith serum samples has no protectivemembrane but Example 4 teaching asensor for blood has a polycarbonate

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membrane is evidence that the authorsof this technical disclosure still believedthat active electrodes could not be di-rectly exposed to whole blood samples.

With the exception of the 8173 Nankaipatent, the declaration was conclusory andunsupported. The 8173 Nankai patent wasmore specific. It did, indeed, happen touse a filtration layer with whole blood anddid not use one with serum, as Abbottstates. The Nankai PCT filing date wasJune 19, 1986. Nankai did tend to supportthe ‘‘conventional wisdom’’ argument ad-vanced by Abbott.

But Nankai was and remains subject toa very important and overriding caveat.The Nankai specification made no refer-ence to the 8382 patent and said nothingabout the ‘‘optionally, but preferably’’ sen-tence. Nankai was silent on the key sen-tence. Nankai did not purport to construeit.

[3] Although for obviousness purposes,the hypothetical person skilled in the art ispresumed to have full knowledge of allprior art, that in no way means that wemust presume Nankai knew of the 8382sentence in question. Nankai was simplyone practitioner, not someone presumed tobe omniscient. His patent in no way ad-dressed the meaning of the key sentence.He may have been unaware of the keysentence, for all the record shows. Bycontrast, for our obviousness purposes, wemust presume the hypothetical artisanknew all of the prior art, including the keysentence at issue. See Custom Accesso-ries, Inc. v. Jeffrey–Allan Ind., Inc., 807F.2d 955, 962 (Fed.Cir.1986).

The decisive fact remains that thoseskilled in the art, had they read it, wouldhave understood the 8382 sentence as stat-ing that a protective membrane was pre-ferred in the case of live blood and optionalin all other cases. They would have un-derstood it as disagreeing with any view-

point that membranes were necessarywhen testing whole or live blood. Thevery purpose of a patent is to disclose newinformation to persons skilled in the art.

This order finds that the 8382 patenttaught those skilled in the art that—atleast when faster chemistry was em-ployed—a protective membrane was op-tional in all cases except the case of liveblood, in which case the protective mem-brane was preferred—but not required.The trial evidence and the plain languageof the disclosure are clear and convincingon this point. Abbott’s ‘‘conventional wis-dom’’ evidence is rejected.

The foregoing is sufficient. To this, itmust be said that the information withheldfrom the examiner, discussed momentarily,eviscerates any vestige of plausibility toAbbott’s extrinsic evidence, for that infor-mation from the applicants themselves nowshows that they knew full well the mean-ing of the very ‘‘optionally, but preferably’’sentence at the heart of this suit. Thisevidence, revealed for the first time inthese proceedings, also decidedly supportsthis order’s invalidity conclusion. This or-der rejects the Sanghera declaration andits supposed conventional wisdom.

* * *

[4, 5] There is a different aspect toAbbott’s entire theory that deserves com-ment. Deletion of a feature from a prior-art device with a corresponding deletion ofits function is not an invention. For exam-ple, if the prior art already discloses apencil with an eraser, one may not deletethe eraser and claim an eraserless pencilas an invention. The reason is that thedeletion of the eraser would also mean adeletion of its function. This would betrue even if the conventional wisdom wasthat all pencils came with erasers. SeeRichards v. Chase Elevator Co., 159 U.S.477, 486, 16 S.Ct. 53, 40 L.Ed. 225 (1895).

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Similarly, deletion of the protectivemembrane was not inventive in the 8551patent because there was a correspondingdeletion of its function. The loss of thisfunction was tolerable because the chemis-try was fast enough (at least by the time ofthe 8382 prior-art disclosure) to obtain ac-ceptable results without a membrane. Butassuming arguendo that skilled artisanshad uniformly believed that a membranewas necessary (despite the 8382 patent),the mere deletion of the membrane with acorresponding loss of its functions wouldnot warrant a patent.

It would be different if the 8551 patentdisclosed a specific configuration that pre-served the membrane’s function but with-out the membrane. Exactly what was dis-closed in the 8551 patent that compensatedfor the deletion of the membrane andguarded against fouling? The Court askedthis question several times during thebench trial. Clearly, the 8551 specificationand prosecution history were totally silenton this point.

At the closing argument, Abbott’s coun-sel argued—for the first time—that the8551 disclosed use of certain materials forconstructing the electrodes and that thesematerials were less sensitive to oxygen.Whereas the 8382 patent had taught car-bon as a preferred electrode, the 8551 pat-ent recommended carbon foil availablecommercially as GRAPHOIL or PAPYEX.The argument emerged that normally redblood cells (and their oxygen content)posed a noise hazard but that the elec-trodes specified in the 8551 were less sen-sitive to oxygen. Thus, it was said, amembrane could be safely deleted from anelectrode constructed from GRAPHOIL.

Nowhere in the specification, nowhere inthe prosecution history, and nowhere inthe trial evidence was this point made. Itsurfaced for the first time at closing argu-ment. Still, the Court has fully consideredit. It is easy to see why it has taken solong to invent this line of argument.

Both the 8382 and 8551 patents disclosedelectrodes that exhibited immunity fromoxygen. For example, the 8382 specifica-tion stated that the electrodes exhibited‘‘very low oxygen sensitivity.’’ This wouldallow ‘‘omission of the dilution step in-volved in blood analysis in current instru-ments,’’ the 8382 specification said(col.5:20–22). For its part, the 8551 patentstated that, for carbon foil, ‘‘oxygen inter-ference is minimal, there being less than4% change in signal between anaerobicand fully aerobic samples’’ (col.7:15–20).

Given that the 8382 had already dis-closed ‘‘very low oxygen sensitivity,’’ thelater statement in the 8551 patent was noimprovement on that score. The 8551statement was a passing comment on adesign consideration (concerning oxygensensitivity) that had been covered in theearlier patent and was covered again in thelater patent. Since the earlier patent hadalready achieved ‘‘very low’’ oxygen sensi-tivity, it is far-fetched to argue that thelater patent somehow solved that problem,much less solved it in a way that specifical-ly dispensed with the need for a mem-brane, a nexus nowhere made until at clos-ing argument in 2008.10

To return to the main point, the clear-cut fact remains that to the extent the 8551dispensed with the membrane, it also dis-

10. Interestingly, the Exactech product (thesame product Abbott contends embodies the8551 product for secondary consideration pur-poses) does not use GRAPHOIL as its elec-trode material, meaning whatever purportedbenefit that was captured as a result of the

GRAPHOIL was not present in the Exactechproduct. In fact, the Exactech product usedcarbon paste as its electrode material—thesame material disclosed in the 8382 patent(Tr. 780).

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1105THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

pensed with its function and thus no inven-tion was disclosed at all. This point wouldhold even if we indulged Abbott’s view ofthe conventional wisdom about membranesat the time.11

* * *

The main invalidity issue is the no-mem-brane limitation. The foregoing resolvesthat key component. The inequitable-con-duct issue is also anchored in the no-mem-brane limitation. This order, therefore,will now proceed directly to that issue forease of reader convenience and return la-ter to the less controverted limitations andcomplete the obviousness analysis.

INEQUITABLE CONDUCT

Turning to the defense of inequitableconduct, the ‘‘optionally, but preferably’’sentence remains at center stage. WhenAbbott acquired the pending applicationthat led to the 8551 patent, its in-houselawyer, Lawrence Pope, took over theprosecution. That was in 1997. He re-placed Fish & Richardson, who had beenunsuccessful for twelve years in obtainingallowance of any claims. Examiner Shayhad repeatedly rejected all proposedclaims over the 8382 patent.

Abbott ‘‘brainstorming’’ sessions wereheld to find a way to win claims on the8551 application. These sessions includedDr. Gordon Sanghera. The original inven-tors were not included. By this point,Abbott’s competitors were beginning tosell diabetic home-testing kits in competi-tion with the Exactech, the Medisense–Abbott product. Although Dr. Sangheradenied it at trial, this order finds that Dr.

Sanghera and Attorney Pope were moti-vated, in part, by marketplace develop-ments to find a claim to suppress competi-tion. The very day the 8551 patent issued,for example, Abbott asserted it in a pat-ent-infringement action against a home di-abetic kit made by Lifescan, Inc. There is,however, nothing wrong with seeking apatent in order to stifle competition, atleast under the patent laws, so long as thepatent is lawfully obtained.

The brainstorming sessions produced anargument never before advanced by theinventors or by prior counsel, namely thatthe 8551 specification taught that a protec-tive membrane was not necessary whentesting whole blood. This argument wasthen presented to Examiner Shay in anoral interview by Attorney Pope in No-vember 1997. With respect to novelty andthe prior art, they expressly discussed the8382 sentence. For convenience, this now-familiar sentence is repeated:

Optionally, but preferably when beingused on live blood, a protective mem-brane surrounds both the enzyme andthe mediator layers, permeable to waterand glucose molecules.

More specifically, the Interview Summary(TX 469) referenced the Higgins 8382 andPace 8410 patents and stated:

Applicant indicated that he would like tosubmit claims specifically covering acompound specific electrode with the fil-tering membrane absent. The Higgins,et al. (’382) disclosure was discussedesp[ecially] the paragraph spanning col-umns 4 & 5. It was determined that

11. Similarly, at the closing argument, Ab-bott’s counsel argued that the 8551 patentdisclosed a method for placing the workingchemistry onto the substrate—i.e., screenprinting—that may have contributed to thepurported success of the Exactech product.The only evidence on the record pertaining tothis subject is the testimony of Dr. Sanghera,

who stated that the Exactech’s electrode wasscreen printed (Tr. 788). Other than that,there is no evidence indicating that screenprinting helped eliminate the need for a mem-brane or that it was somehow novel over theprior art. Accordingly, counsel’s argument isrejected.

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since Higgins et al. appear to requirethe membrane for use with whole blood(see example 8) an affidavit or otherevidentiary showing that at the time ofthe invention such a membrane was con-sidered essential would overcome thisteaching.

A box was checked stating that an agree-ment had been reached. In short, theexaminer agreed to permit an evidentiaryshowing to overcome the presumed teach-ing of the ‘‘optionally, but preferably’’ sen-tence.

To this end, Attorney Pope prepared asworn declaration for the signature of Ab-bott’s Dr. Sanghera. Although he wasskilled in the art by the time of the decla-ration, Dr. Sanghera had not been skilledin the art at the time of the invention (and,as stated, had not been one of the inven-tors). This, of course, was not a require-ment for a declaration. Dr. Sangheraread, understood, and signed the declara-tion, knowing its purpose and knowing thatit would be submitted to the PTO to over-come the presumed teaching of the sen-tence. The declaration is quoted above.In brief, it stated that Dr. Sanghera wassure that one skilled in the art at the timeof the invention would not have read thesentence in question to teach that the useof a membrane with a whole-blood samplewas optional or even preferred. To thisend, Dr. Sanghera did not consult with anyof the inventors to learn what had beenconsidered optional, preferred, or essentialdespite the fact he still had a good rela-tionship with at least Inventor Hill. Helimited his research to literature.12

The declaration was filed for ExaminerShay along with an amendment and re-marks by Attorney Pope. The amendmentcancelled all prior claims and proposed

new claims, soon allowed. The attorney’sremarks (TX 470) are now set forth atlength with italics on the passages of par-ticular relevance:

At the interview the applicants’ under-signed representative explained that anew set of claims would be presentedwhich focus on the feature that the ac-tive electrode is directly exposed to awhole blood sample without the inter-vention of a barrier material such as amembrane or gel which filters out largermolecules or other blood components ex-pected to interfere with the active elec-trode’s operation. It was agreed thatthis embodiment was one of the optionsclearly disclosed in the present applica-tion. It was also agreed that the artgenerally taught the use of such protec-tive barriers on the effective filing dateof the present application.

* * *

The applicants’ representative pointedout that U.S. Patent No. 4,545,382 toHiggins et al teaches that active elec-trodes designed for use with whole bloodrequire a protective membrane. Henoted that the general teaching to thiseffect at lines 63 to 66 of column 4 ofthis patent was amplified and supportedby the specific working examples. Ineach working example in which an activeelectrode was prepared for use with awhole blood sample it was provided witha protective membrane by either deposi-tion of a cellulose acetate film or attach-ment of a dialysis membrane.

Example 8 at columns 8 and 9 wasnoted as being particularly instructivein this regard. An active electrode wasconstructed by successively coating theend of a carbon rod with ferrocene and

12. The Suzuki 8166 patent, however, whichhad expressly discussed deleting the mem-brane in blood tests, was not included in the

Sanghera declaration (see note 6, supra ).This order assumes that Dr. Sanghera wasunaware of Suzuki.

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1107THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

then glucose oxidase. This unprotectedactive electrode was first tested in nitro-gen saturated buffer and then in an airsaturated buffer to establish the impact,if any, of oxygen on the reaction; theimpact appears to have been minimal.Then at lines 22 to 33 the effect of acellulose acetate membrane on responsetime was investigated when the samplewas buffer and when it was blood. Inboth cases the response time appears tohave increased by as much as 50%, e.g.,from 24 to 36 seconds for a low level ofglucose. Nevertheless all the succeed-ing examples utilized a protective mem-brane. The clear implication is that theuse of protective membrane caused aslower response time but nonethelesswas needed for a whole blood sample.The art continued to believe that a bar-rier layer for whole blood sample wasnecessary for a considerable period.For instance, U.S. Patent No. 4,897,173to Nankai et al (copy accompanies thisresponse), which claims priority from1985, describes the production of elec-trodes for the measurement of glucose.In Example 3 at columns 4 and 5 anelectrode structure for serum (see line 6of column 5) is described which does notinvolve a protective membrane. In con-trast Example 4 at columns 5 and 6directed to an electrode for use withwhole blood (see lines 61–62 of column 5)teaches a filtration layer 21 with a poresize of one micron.One skilled in the art would not haveread the disclosure of the Higgins pat-ent (U.S.4,545,382) as teaching that theuse of a protective membrane withwhole blood samples was optional. Hewould not, especially in view of theworking examples, have read the option-ally, but preferably language at line 63of column 6 as a technical teaching butrather mere patent phraseology. This issupported by the Declaration under 37

C.F.R. 1.132 of Gordon Sanghera whichaccompanies the present amendment.

* * *

The Examiner is respectfully requestedto indicate the allowability of the cur-rently pending claims and issue a Noticeof Allowance. The applicants have es-tablished that a new claim limitationsupported by the present applicationprovides a patentable distinction overU.S. Patent No. 4,545,382, the key refer-ence in the prosecution of the presentapplication and its predecessors. Thereis no teaching or suggestion of unpro-tected active electrodes for use withwhole blood specimens in this patent orthe other prior art of record in thisapplication. Furthermore, the presentclaims are patentably distinct from theclaims of U.S. Patent No. 5,682,884.Therefore, this case is in condition forallowance.

In sum, Attorney Pope’s remarks statedthat the sentence in question would havebeen regarded as ‘‘mere patent phraseolo-gy’’ rather than a ‘‘technical teaching’’ andthat the art believed that a membrane was‘‘required’’ even for a considerable periodafter the 8382 patent, closing with: ‘‘Thereis no teaching or suggestion of unprotectedactive electrodes for use with whole bloodspecimens in this patent or the other priorart of record in this application.’’ In reli-ance on the submission, Examiner Shayallowed the new claims and the 8551 is-sued.

* * *

At the time of the interview and thesubmission, Attorney Pope and Dr. Sangh-era were well aware of previous represen-tations based on the same ‘‘optionally, butpreferably’’ sentence made by Medisenseto the European Patent Office in 1994–95.Attorney Pope and Dr. Sanghera, however,made a conscious and deliberate decision

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to withhold disclosure to the PTO of theseprior statements. This much is conceded.Abbott contends, however, that there wasno duty to disclose the earlier statementsand that there was no intent to deceive.On these latter points, the following wasproven at trial by clear and convincingevidence.

The 8636 patent—the European counter-part to the 8382—had been revoked in 1993in an opposition proceeding based on aGerman prior-art reference called D1. In1994, Medisense appealed, arguing that D1 was distinguishable on two grounds.The centerpiece of Medisense’s appeal re-lied on the very sentence in question—the‘‘optionally, but preferably’’ sentence.Overall, the 8636 and 8382 specificationswere virtually identical. In both, the ‘‘op-tionally, but preferably’’ sentence and itsimmediate context were completely identi-cal. Before the EPO, however, Medisensehad an incentive to advance the sentenceas an important teaching over the D1 ref-erence. Medisense submitted that the‘‘optionally, but preferably’’ sentence dem-onstrated that the 8382/8636 invention didnot need a membrane for measuring glu-cose in blood, whereas the D 1 device hadrequired one.

Specifically, D1 had disclosed an enzymeelectrode usable for glucose and coveredby a semipermeable membrane. Beforethe EPO, Medisense argued that the D1membrane was essential to the D1 inven-tion. By contrast, Medisense stated thatthe 8382/8636 membrane was merely op-tional. Medisense relied on the ‘‘optional-ly, but preferably’’ sentence as follows (TX311 at AL54151):

10. The above object is solved by aglucose sensor as defined in claim 1 ofthe patent in suit [8382/8636]. Apartfrom the important feature of utilizing aferrocene or ferrocene derivative as me-diator, another important difference

over D1 resides in that the claimed glu-cose sensor—contrary to that of D1which requires a membrane—does nothave and must not have a semipermea-ble membrane within the meaning of D1.Contrary to the semipermeable mem-brane of D1, the protective membraneoptionally utilized with the glucose sen-sor of the patent [in] suit is not control-ling the permeability of the substrate (asset forth above under IV.2), in the mem-brane of D1 the permeability for thesubstrate must be kept on a low value toachieve a linear relationship between themeasures [sic] currency and the sub-strate concentration in the test solution.Rather, in accordance with column 5,lines 30 to 33 of the patent in suit:

‘‘Optionally, but preferably when be-ing used on live blood, a protectivemembrane surrounds both the enzymeand the mediator layers, permeable towater and glucose molecules.’’

See also claim 10 of the patent in suit asgranted according to which the sensorelectrode has an outermost protectivemembrane (11) permeable to water andglucose molecules. Finally, see Exam-ple 7 in column 10, lines 19 to 26 report-ing that by using such a protective mem-brane the response time did not increasebut from 24 to 60 sec. (without mem-brane) to 36–76 sec. (with membrane).Accordingly, the purpose of the protec-tive membrane of the patent in suit,preferably to be used with in vivo meas-urements, is a safety measurement toprevent any course particles coming offduring use but not a permeability con-trol for the substrate.

The passage indented the ‘‘optionally,but preferably’’ sentence for emphasis, justas set out above. The bolded words werebolded by Medisense, just as set out above.The foregoing quotation is exactly the way

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1109THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

it was made by Medisense in January1994.

The ‘‘safety’’ purpose stated in the quo-tation helped to show, it deserves to besaid, why a protective membrane wasmerely ‘‘preferred’’ for live blood, i.e., invivo testing. It was optional in all casesbut when placed in a human bloodstream,a membrane was advisable to retain thechemistry aboard the electrode and, thus-ly, prevent toxic particles from circulatingwithin the patient.

In the same submission (TX 311 atAL54154), Medisense stated that D1 was‘‘strongly teaching away from the subjectmatter as claimed [in the 8382/8636] whichnot only does not require a membrane butmust not have a membrane. In otherwords, with the claimed subject matter,rather than keeping the permeability forthe substrate at a low level, there is freeaccess of the substrate to the electrodewithout any permeability limitation.’’

In May 1995, Medisense further statedin the same EPO appeal, again referringprecisely to the ‘‘optionally, but prefera-bly’’ sentence (TX 315):

It is submitted that this disclosure isunequivocally clear. The protectivemembrane is optional, however, it ispreferred when used on live blood inorder to prevent the larger constituentsof the blood, in particular erythrocytesfrom interfering with the electrode sen-sor. Furthermore it is said, that saidprotective membrane should not preventthe glucose molecules from penetration,the membrane is ‘‘permeable’’ to glucosemolecules. This teaches the skilled arti-san that, whereas the semipermeablemembrane of D 1 must be constructed,

for example by crosslinking, in such away that the membrane will in fact con-trol the permeability of the glucose atthe required low value, the purpose ofthe protective membrane in the patentin suit is not to control the permeationof the glucose molecules. For this veryreason the sensor electrode as claimeddoes not have (and must not have) asemipermeable membrane in the senseof D1. The fact that the same material(cellulose acetate) may be used both forthe semipermeable membrane of D 1and the protective membrane of the pat-ent in suit is not relevant. The decisivefeature is the modification (crosslinking)of said material to an extent so as tocontrol the permeation of the substrateglucose. Finding the semipermeablemembranes satisfying the requirementsset forth on page 3, lines 24 to 56 of D1is tedious and involves considerable trialand error work. Reproducability ofsuch membranes is always a critical fac-tor.

For the immediately quoted passage, ital-ics have been added by this order to drawattention to a particular statement. Thebolded words, however, were bolded in theoriginal. Medisense won the EPO appeal,based on the very arguments describedabove.

The submissions made to the EPO wereinconsistent with the submissions made tothe PTO in at least two important ways: 13

• The PTO was told that • The EPO was told thatthe 8382 required a under the 8382 a protec-membrane for use with tive membrane waswhole blood and that merely preferred andthose skilled in the art not required when deal-would not have under- ing with live blood andstood the ‘‘optionally, specifically quoted thebut preferably’’ sen- ‘‘optionally, but prefera-

13. Defendants have further made a plausiblecase that the two submissions were also in-consistent as to their use of Example 8 (Ex-ample 7 in the 8636). This inconsistency re-quires extended argument to develop and,

while plausible, is not as facially and directlyinconsistent as the above two points of con-flict. This order does not rely on the allegedExample 8 inconsistencies.

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tence to teach to the bly’’ sentence in sup-contrary. port.

• The PTO was told that • The EPO was told that

the ‘‘optionally, but the critical sentencepreferably’’ sentence was ‘‘unequivocallywould have been under- clear’’ and taughtstood by skilled arti- skilled artisans thatsans as ‘‘mere patent ‘‘the protective mem-phraseology’’ and not as brane [was] optional,a ‘‘technical teaching.’’ however it is preferred

when used on livebloodTTTT’’

Dr. Sanghera had been much involved inthe EPO appeal. He had helped developthe arguments and had even attended theoral argument before the EPO on June 20,1995. He was completely familiar with thepoints made in the EPO appeal by Medi-sense. Dr. Sanghera disclosed all of theEPO submissions to Attorney Pope, whoread and understood them.

Examiner Shay was focused on whetherthe 8382 patent disclosed filterless devicesfor use with whole blood. This, in truth,was the overriding question. The ‘‘option-ally, but preferably’’ sentence was the sin-gle roadblock to allowance. AttorneyPope and Dr. Sanghera knew this was so.Both decided to withhold the EPO materi-als from the PTO. Both knew that Dr.Sanghera’s declaration would be submittedto the PTO without disclosing the EPOsubmissions to the contrary. Both knewthat the EPO materials made affirmativestatements inconsistent with the declara-tion and the attorney remarks concerningthe 8382 sentence in question.

Inasmuch as the EPO submissions cen-tered on the same key sentence at issue inthe PTO as well as the key issue beforethe PTO, a reasonable examiner wouldhave plainly considered the EPO submis-sions to be highly material, given the con-tradictory teaching ascribed to the sen-tence.

* * *

In the United States, patent prosecu-tions are ex parte and non-public. Thismeans that applicants and their counsel

are the only ones able to make presenta-tions to examiners. This one-sidednesspersists until an allowance and grant,whereupon the patent is introduced to thepublic. In all proceedings leading up to agrant, therefore, there is no opponent tostate the counter case. Examiners andthe integrity of the entire process dependon the candor of counsel and applicants todisclose, if known, material adverse infor-mation. The duty of candor is codified at37 C.F.R. 1.56. At the relevant time, itstated as follows (emphasis added):

§ 1.56. Duty to disclose informationmaterial to patentability.(a) A patent by its very nature is affect-ed with a public interest. The publicinterest is best served, and the mosteffective patent examination occurswhen, at the time an application is beingexamined, the Office is aware of andevaluates the teachings of all informa-tion material to patentability. Each in-dividual associated with the filing andprosecution of a patent application has aduty of candor and good faith in dealingwith the Office, which includes a duty todisclose to the Office all informationknown to that individual to be materialto patentability as defined in this sec-tion. The duty to disclose informationexists with respect to each pendingclaim until the claim is cancelled or with-drawn from consideration, or the appli-cation becomes abandoned.

* * * * * *

However, no patent will be granted onan application in connection with whichfraud on the Office was practiced orattempted or the duty of disclosure wasviolated through bad faith or intentionalmisconduct. The Office encourages ap-plicants to carefully examine:

(1) prior art cited in search reports ofa foreign patent office in a counter-part application, and

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1111THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

(2) the closest information over whichindividuals associated with the filingor prosecution of a patent applicationbelieve any pending claim patentablydefines, to make sure that any materi-al information contained therein is dis-closed to the Office.

(b) Under this section, information ismaterial to patentability when it is notcumulative to information already ofrecord or being made of record in theapplication, and

(1) It establishes, by itself or in com-bination with other information, a pri-ma facie case of unpatentability of aclaim; or(2) It refutes, or is inconsistent with,a position the applicant takes in:(i) Opposing an argument of unpa-tentability relied on by the Office, or(ii) Asserting an argument of patent-ability.

A violation of this rule, if proven indistrict court, can lead to a bar againstenforcement of any claim in the patent.This is the defense of ‘‘inequitable con-duct.’’ The Federal Circuit has recentlysummarized the elements of proof for ineq-uitable conduct in McKesson Info. Solu-tions, Inc. v. Bridge Med., Inc., 487 F.3d897, 913 (Fed.Cir.2007):

A patent may be rendered unenforcea-ble for inequitable conduct if an appli-cant, with intent to mislead or deceivethe examiner, fails to disclose materialinformation or submits materially falseinformation to the PTO during prosecu-tion. Digital Control, Inc. v. CharlesMach. Works, 437 F.3d 1309, 1313 (Fed.Cir.2006).

* * * * * *

The materiality of information withheldduring prosecution may be judged bythe ‘‘reasonable examiner’’ standard.See id. at 1316. That is, ‘‘[m]ateriality

TTT embraces any information that areasonable examiner would substantiallylikely consider important in decidingwhether to allow an application to issueas a patent.’’ Akron Polymer, 148 F.3dat 1382 (citations omitted). Moreover,‘‘[i]nformation concealed from the PTOmay be material even though it wouldnot invalidate the patent.’’ Li SecondFamily, 231 F.3d at 1380. ‘‘However, awithheld otherwise material [piece of in-formation] is not material for the pur-poses of inequitable conduct if it ismerely cumulative to that informationconsidered by the examiner.’’ DigitalControl, 437 F.3d at 1319. ‘‘As this courthas previously noted, the scope and con-tent of prior art and what the prior artteaches are questions of fact.’’ Id.

‘‘The intent element of the offense is TTT

in the main proven by inferences drawnfrom facts, with the collection of infer-ences permitting a confident judgmentthat deceit has occurred.’’ Akron Poly-mer, 148 F.3d at 1384. ‘‘However, ineq-uitable conduct requires not intent towithhold, but rather intent to deceive.Intent to deceive cannot be inferred sim-ply from the decision to withhold [infor-mation] where the reasons given for thewithholding are plausible.’’ Dayco, 329F.3d at 1367. In addition, ‘‘a findingthat particular conduct amounts to‘gross negligence’ does not of itself justi-fy an inference of intent to deceive; theinvolved conduct, viewed in light of allthe evidence, including evidence indica-tive of good faith, must indicate suffi-cient culpability to require a finding ofintent to deceive.’’ Kingsdown Med.Consultants, Ltd. v. Hollister, Inc., 863F.2d 867, 876 (Fed.Cir.1988) (en banc inrelevant part).

‘‘The party asserting inequitable conductmust prove a threshold level of material-ity and intent by clear and convincing

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evidence.’’ Digital Control, 437 F.3d at1313. ‘‘The court must then determinewhether the questioned conductamounts to inequitable conduct by bal-ancing the levels of materiality and in-tent, ‘with a greater showing of onefactor allowing a lesser showing of theother.’ ’’ Id. (quoting Union Pac. Res.Co. v. Chesapeake Energy Corp., 236F.3d 684, 693 (Fed.Cir.2001)). ‘‘When,after a trial, the court has made factualfindings as to materiality and deceptiveintent, those factual findings are re-viewed for clear error, and the decisionof the ultimate issue of inequitable con-duct is reviewed for abuse of discretion.’’Digital Control, 437 F.3d at 1313.

* * * * * *

ATTORNEY POPE

This order will consider the requiredelements first as to Attorney Pope andthen as to Dr. Sanghera.

MATERIALITY

[6] Contrary to Attorney Pope and Ab-bott, the submissions made to the EPOwere not only material within the meaningof Rule 56, they were highly material.They were flatly inconsistent with themain point being made by Attorney Popeand Abbott to Examiner Shay. They cen-tered on the precise sentence in question,its meaning, and what it taught. Inconsis-tency is called out by Rule 56 as a specificindicium of materiality (§ 1.56(b)(2)).

Contrary to Attorney Pope and Abbott,the EPO submissions were not cumulative.While the ‘‘optionally but preferably’’ sen-tence was, of course, already of record, thesupposed issue was what it taught andeven whether it constituted a teaching atall insofar as those skilled in the art wereconcerned. On that score, there was noth-ing already of record (or being made ofrecord in the PTO) that duplicated thesame points made in the EPO appeal or

even came close to duplicating them.Thus, the examiner was led to believe thatthose skilled in the art would have had noreasonable expectation of success in tryingto implement the guidance of the sentencein question by deleting a membrane inwhole or live blood. The EPO submissionscertainly pointed the other way.

This is unlike the situation where a ref-erence is already before an examiner whocan draw his or her own conclusions as towhat it teaches and is able to discount spinoffered by counsel. See Innogenetics,N.V. v. Abbott Labs., 512 F.3d 1363, 1379(Fed.Cir.2008). Although the key sen-tence itself was indeed before ExaminerShay, the inquiry had shifted to a point ofextrinsic evidence. That is, ExaminerShay had acquiesced to Attorney Pope’srequest to resort to extrinsic evidence toshow that the sentence would have beenunderstood by skilled artisans differentlythan its words suggested. Having re-ceived permission to supply extrinsic evi-dence, Attorney Pope was duty-bound topresent any inconsistent extrinsic informa-tion known to him. In the arena of extrin-sic evidence, the examiner was unable tofend for himself. He had no way of know-ing what, if any, contrary extrinsic infor-mation had been left out of the Sangheradeclaration. He was completely depen-dent on Attorney Pope and Dr. Sangherato fully disclose any extrinsic information,pro and con, known to them on the factualpoint covered by the submission.

Abbott contends that most or all of thekey passages in the EPO appeal were, ineffect, dicta that need not have been raisedat all by Medisense before the EPO. Putdifferently, Medisense could possibly haveprevailed in the EPO appeal had it stuckto just one distinction over D 1, namelythat D 1 specified a different type of filterthan did the 8382/8636. It is true that theD1 needed a difusion-limiting filter

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1113THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

whereas the 8382/8636 referred to a blood-filtering membrane, which performed adifferent function. But the hard fact re-mains that Medisense did not so limit itsappeal. It clearly submitted to the EPOthat, in addition, the 8382/8636 needed nomembrane at all, invoking the very ‘‘op-tionally, but preferably’’ sentence at issue.Regardless of whether or not Medisenseneeded to make the second point in itsEPO appeal, Medisense did make thepoint. Since that point was inconsistentwith the PTO submission made later, Ab-bott was obligated to disclose it as part ofits extrinsic-fact submission.

In sum, this order finds that the pas-sages quoted above from the EPO submis-sion were material within the meaning ofRule 56, such that their disclosure to thePTO was obligatory.14

INTENT

[7] With respect to intent, AttorneyPope read the entire EPO appeal andmade a conscious decision to withhold thecontradictory material from the PTO. Thatis not sufficient to prove the intent re-quirement, of course, but there should beno doubt that conscious withholding oc-curred. Intent to deceive must be shown.The Court has carefully considered all ofthe facts and circumstances surroundingthe decision to withhold. In this regard,Abbott has asserted the attorney-clientprivilege. Nonetheless, some direct testi-mony emerged as to Attorney Pope’s ratio-nale for non-disclosure. His stated reasonwas that the EPO information was cumula-tive, an argument this order has alreadysolidly rejected. Without a doubt, Attor-ney Pope knew or should have known thatthe withheld information would have beenhighly material to the examiner, given thecentral question of what, if anything, the

‘‘optionally, but preferably’’ sentencetaught those skilled in the art. There wasno other information in the PTO recordthat came close to the clear-cut message ofthe withheld information.

Despite the insistence by Abbott (andAttorney Pope) during deposition and pre-trial that he would not be presented as atrial witness, the Court allowed Abbott toreverse field and to present him as a livetrial witness. Abbott and Attorney Popewere relieved from this representation dueto the seriousness of the misconductcharge and to give Attorney Pope everyopportunity to explain his conduct. Attor-ney Pope did not prove to be a convincingtrial witness. To the contrary, his trialexplanation for his withholding was notplausible and he was not credible. When,for example, Attorney Pope was shown theEPO appeal language quoting the sentencein question and immediately stating that‘‘[i]t is submitted that this disclosure isunequivocally clear,’’ he testified that hehad understood the ‘‘unequivocally clear’’characterization to refer only to the lastsix words of the 26–word sentence—thatis, to the concluding phrase ‘‘permeable towater and glucose molecules’’ and not toits other twenty words. Sadly, this ordermust find that Attorney Pope had no plau-sible reason for consciously withholdingthe EPO submissions and that he actedwith specific intent to deceive ExaminerShay and the PTO. In making this finding,this Court has taken into account the de-meanor of Attorney Pope during his trialtestimony.

Attorney Pope testified that his motivewas to obtain a strong patent. Therefore,he said he had no motive to conceal and tothus undermine the enforceability of the

14. The defense presented an experienced pat-ent attorney and former examiner, ThomasSmegal, to explain why the EPO items were

material. Abbott did not present a counterexpert.

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patent. This argument conveniently over-looks the fact that he consciously chose towithhold. Counsel who steer a course to-ward obtaining a strong patent should erron the side of disclosure, not nondisclo-sure. And, it must be said, after so manyrejections over so many years, it seemsclear that Abbott’s primary goal was toeke out some claim, saving a fight overenforceability for a later day.

Attorney Pope also said that patentprosecutors often write specificationsbroadly so as to support broad claims,cutting back on their claims as they goalong as necessary to avoid the prior art oras is otherwise necessary. Being aware ofthis alleged practice, he testified that he,therefore, read ‘‘optionally, but preferably’’as an overblown way for a prior patentprosecutor to have said ‘‘optionally, butalways.’’ This is unconvincing. First,there is no authority for this secret-codetheory. Words are supposed to meanwhat they say. Otherwise, our patent-disclosure system would collapse. Second,since the claims of the 8382 covered mem-braneless sensors used in blood, as bothsides agree, the specification must havebeen sufficient to support the membrane-less sensors.15

Although Abbott has not advanced thepoint clearly, the Court has considered thepossibility that Attorney Pope was con-fused over the difference between liveblood and whole blood. At trial, he statedthat he did not appreciate (until recently)that ‘‘live blood’’ referred to in vivo testswhereas ‘‘whole blood’’ referred to in vitrotests on blood removed from the body.Even if he had thought the two were syn-onymous, the materiality of the EPO state-ments would still have been manifest. Insome ways, the EPO statements would

have been even more material, for thoseEPO statements represented that a mem-brane was merely optional when used withblood. At all events, even if the sentenceand the EPO statements had said that amembrane was preferred for both live andwhole blood, the fact remains that ‘‘pre-ferred’’ does not mean ‘‘required,’’ whichwas a point made in the EPO appeal. Insum, this point of possible confusion offersno excuse.

BALANCING

Turning to the final step, this ordermust determine whether the questionedconduct amounts to inequitable conduct bybalancing the levels of materiality and in-tent, with a greater showing of one factorallowing a lesser showing of the other, asset forth above. In doing so, the under-signed is very mindful that patent prosecu-tors must make judgment calls about whatis and is not material. We must take careto respect their judgments without second-guessing them and to penalize only clear-cut violations of Rule 56.

The withheld extrinsic evidence herewas richly material. And, intent to de-ceive, not just to withhold, was clearly inthe mind of Attorney Pope, hard as it is toso conclude as to a professional. Bothshowings are strong. The balance is de-cidedly against Abbott. If concealment ofextrinsic information as close to the heartof the prosecution as was involved here isallowed to pass, then we would in effect beissuing licenses to deceive patent examin-ers in virtually all cases. Having searchedfor any credible explanation for the con-duct (and found none) and having takeninto account all possible inferences of goodfaith (and found none), this order finds andholds that Attorney Pope and Abbott were

15. Of course, it is true, as Abbott states, thatspecifications teach and claims claim. SRIInt’l. v. Matsushita Elec. Corp., 775 F.2d

1107, 1121 n. 14 (Fed.Cir.1985) (en banc ).Still, the specification must support theclaims.

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1115THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

guilty of inequitable conduct in advancingthe Sanghera declaration and attorney re-marks without also disclosing the inconsis-tent EPO submissions as to the meaning ofthe ‘‘optionally, but preferably’’ sentence.This has been proven by clear and convinc-ing evidence.

DR. SANGHERA

The analysis is largely similar for Dr.Sanghera but differs in some ways fromthat for Attorney Pope.

MATERIALITY

For the reasons stated above, the non-disclosed items were material.

INTENT

[8] Here, the intent analysis divergessomewhat from that for Attorney Pope,although it reaches the same conclusion.Once Dr. Sanghera disclosed the inconsis-tent EPO information to Attorney Pope,he ordinarily would have done all that Rule56 required. A specific Rule 56 provisostated that ‘‘[i]ndividuals other than theattorney, agent or inventor may complywith this section by disclosing informationto the attorney, agent or inventor.’’ Dr.Sanghera did so. He did disclose the EPOmaterials based on the very same sentenceto Attorney Pope.

[9] The problem is that he then madedirect representations to the PTO—repre-sentations that were materially misleadingby omission. He did not have to take thisextra step. Having done so, he was obli-gated to avoid intentional deception. Hissworn statements to the PTO about themeaning of the ‘‘optionally, but preferably’’sentence were known by him to be incon-sistent with his own company’s statementsto the EPO—statements he had himselfhelped craft. A declarant who makes a

materially false and misleading statementunder oath to the PTO cannot escape acharge of inequitable conduct on the theo-ry that he advised the lawyer that thestatement was misleading and why. (Inthis regard, no claim of good faith relianceon the advice of counsel was raised by Dr.Sanghera, a step that would have waivedany assertion of the privilege.) In sum,given the fact that Dr. Sanghera made apositive submission to the PTO, he washimself duty-bound to avoid making anintentionally misleading submission,whether or not he told Attorney Popeabout the inconsistency.

Although Abbott has not raised it, theCourt has, on its own, considered the pos-sibility that Dr. Sanghera somehow be-lieved that Attorney Pope would disclosethe EPO material in some other way and,thus, there was not a necessity for hisdeclaration to do so. Dr. Sanghera testi-fied at trial at Abbott’s behest (despite thefact that much trial time was earlier spenton video excerpts from his deposition).His trial testimony was clear and convinc-ing that he affirmatively participated inthe group discussion not to disclose theEPO submission, i.e., that he knew allalong that no one was going to disclose theEPO submissions (Tr. 757–58, 774, 776–78). As a trial witness, it must be saidthat Dr. Sanghera was impeached on sub-stantive points with his prior inconsistentstatements and exhibited an unconvincingdemeanor (e.g., Tr. 764–67, 772–73).16

At trial, the only explanation Dr. Sangh-era gave for his nondisclosure of the EPOproceedings and the arguments made byMedisense therein was that both he and

16. Contrary to his trial testimony, at his depo-sition Dr. Sanghera tried to distance himselffrom the decision of what was disclosed to thePTO by repeatedly stating that he merely

turned over to counsel all relevant informa-tion and let counsel decide what would bedisclosed (Sanghera Dep. 60, 62, 360–61).

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Attorney Pope thought that they were allirrelevant (Tr. 777:23–778:10):

Q. It’s your position, is it not, Dr.Sanghera, that you had no responsi-bility to disclose to the U.S. Patentand Trademark Office anythingabout the European Patent Officeproceedings?

A. It was my responsibility to discloseto the U.S. Patent Office everythingthat we deemed as a team, the tech-nical people, the Abbott counsel,that was relevant to that case forthe U.S. patent office. I don’t knowif that answers your question, butTTT

Q. But you didn’t disclose the informa-tion, correct?

A. We didn’t disclose lots of nonrele-vant information.

Q. And in particular, you did not dis-close the European Patent Officeproceedings to the U.S. Patent Of-fice?

A. We did not disclose those, no.

As stated, however, the unambiguous andclear-cut statements made to the EPOwere clearly relevant to the only issuebefore Examiner Shay, namely whetherthe ‘‘optionally, but preferably’’ sentencewas a teaching and, if so, what it taught.It plainly should have been disclosed toExaminer Shay for his independent consid-eration.

Dr. Sanghera testified that he did thinkthe statements made to the EPO and PTOwere inconsistent. According to Dr.Sanghera, the statements made to theEPO were specifically directed at distin-guishing the D1 reference on the sole issueof whether or not the 8382/8636 patentrequired a diffusion-limiting membrane—apoint not at issue with the 8551 patent. AsDr. Sanghera stated (Tr. 777):

The European proceedings revolvedaround the use of a diffusion limitingmembrane because we were making ar-guments about novelty and inventive-ness over the La Roche prior art, andwe discussed the first chemistry and the,therefore the lack of a requirement of adiffusion-limiting membrane. This theU.S. case. We were talking about bloodseparation membranes and filters andthe two are completely separate piecesof technology.

Nonetheless, the statements made to theEPO regarding the 8636 patent plainlywent beyond this point of distinction andsubmitted that it was ‘‘unequivocally clear’’that the 8382/8636 needed no membrane atall for use with blood. Whether or notMedisense needed to make the point to theEPO, it did make the point. Dr. Sangheraknew the point had been made. His effortat trial to excise that part of the EPOproceeding and to pretend it never hap-pened was disingenuous.

Taking into account all possible infer-ences of good faith, this order concludesthat Dr. Gordon Sanghera had no plausiblereason for concealing the inconsistent EPOsubmissions and that he consciously madesworn statements to the EPO that weredeliberately misleading by reason of theomission of the inconsistent EPO submis-sions. His unconvincing trial demeanorhas been a factor in this determination.

BALANCING

Once again, both materiality and intenthave been proven on the strong end of thescale, so the overall balance is decidedlyagainst Abbott and Dr. Sanghera. And, itshould be said that sworn statements tothe PTO ought to be regarded with areasonable degree of reverence and candorrather than as an opportunity to tailor-make convenient extrinsic ‘‘facts’’ to as-

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1117THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

suage a key point of concern to the exam-iner.

* * *

This Court is well aware that inequitableconduct has become a knee-jerk and often-abused response by those accused of pat-ent infringement. Judges ought to viewsuch defenses with skepticism, as hasJudge Rader in a recent dissent. SeeAventis Pharma. v. Amphastar, 525 F.3d1334, 1349 (Fed.Cir.2008) (Rader, J.). Weshould insist on every inch of the clear-and-convincing standard. Here, however,that standard has been met. The presentdefense is not an abuse—far from it. Ifthe conduct here proven were blessed,then the duty to provide inconsistent infor-mation under Rule 56 would be a deadletter.

INVALIDITY CONCLUDED

[10] To complete the obviousness anal-ysis, this order now resumes with the re-maining limitations, i.e., all limitations oth-er than the no-membrane analysis. Inbrief, this order finds that the differencesbetween the other limitations and the priorart were paper thin and readily apparentto skilled artisans at the time of the al-leged invention.

CLAIM 1

Claim 1 is the only independent claim ofthe 8551 patent. It recited (col.13:29–17):

1. A single use disposable electrodestrip for attachment to the signal read-out circuitry of a sensor to detect acurrent representative of the concentra-tion of a compound in a drop of a wholeblood sample comprising:

a) an elongated support having a sub-stantially flat, planar surface, adaptedfor releasable attachment to saidreadout circuitry;b) a first conductor extending alongsaid surface and comprising a conduc-

tive element for connection to saidreadout circuitry;

c) an active electrode on said strip inelectrical contact with said first con-ductor and positioned to contact saidwhole blood sample;

d) a second conductor extendingalong said surface comprising a con-ductive element for concentration tosaid readout circuitry;

e) a reference counterelectrode inelectrical contact with said secondconductor and positioned to contactsaid whole blood sample.

wherein said active electrode is config-ured to be exposed to said whole bloodsample without an intervening mem-brane or other whole blood filteringmembrane

and is formed by coating a portion of thefirst conductor with a mixture of or lay-ers of an enzyme which catalyzes a re-dox reaction with said compound inwhole blood and a mediator compoundwhich transfers electrons from said re-dox reaction to said first conductor

to create a current representative of theconcentration of said compound in saidwhole blood sample

and wherein said active electrode whichis formed on a portion of said conductoris not in electrical contact with said ref-erence counterelectrode but these elec-trodes are so dimensioned and posi-tioned that they can be simultaneouslycompletely covered by a single drop ofwhole blood such that this drop providesan electrical path between these elec-trodes to support said current represen-tative of the concentration of said com-pound in said whole blood sample.

These paragraphs are now considered inturn.

* * *

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1118 565 FEDERAL SUPPLEMENT, 2d SERIES

A single use disposable electrode stripfor attachment to the signal readout cir-cuitry of a sensor to detect a currentrepresentative of the concentration of acompound in a drop of a whole bloodsample comprising:

a) an elongated support having a sub-stantially flat, planar surface, adaptedfor releasable attachment to saidreadout circuitry;

U.S. Patent No. 4,225,410 (Pace) taughtthe use of a disposable-electrode cartridgethat attached to readout circuitry to meas-ure the levels of a target substance in asolution—e.g., glucose in blood—by detect-ing current. The figures below are fromthe 8410 patent.

The cartridge 10 shown in Figure 1 (analternative design is shown in Figure 1 a)contained a matrix of sensors 14. Userswould place their finger above the sensormatrix of the circuitry in cartridge 10 anddispense a drop of blood. The cartridge10 could then be connected to the readoutdevice shown in Figure 3 through a socketconnection, and the results of the testcould be read out across screen 33. Afterthe test was complete, the user could takeout the cartridge and throw it away. Thecartridge was flat and elongated so as tomore readily allow the user to connect andremove it from the readout device. The8410 patent further described the use ofenzyme electrodes for detection of glucosein blood.

* * *

b) a first conductor extending along saidsurface and comprising a conductive ele-

ment for connection to said readout cir-cuitry;

This claim limitation merely referred tothe actual conductive wires that connectthe electrodes (where the electrochemistryoccurs) to the readout circuitry. Thewires carried electricity and simply al-lowed current to flow to the readout circui-try. Both the 8410 and 8382 patents readi-ly disclosed this limitation. For example,the 8410 specification stated (col.7:37–43):

The interconnectors each terminate inan electrical connection projecting fromthe end of the chip which is adapted tomate with a snap-in electrical connectordisposed in a slot of [the readout circui-try]. The connection of the chip over-hangs the tray TTT and includes a slotfor keying into connector of [the readoutcircuitry].

Likewise, the 8382 patent disclosed conduc-tive wires connecting an electrode to read-

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1119THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

out circuitry (col.8:35). It was elementarythat no circuit could be completed withouta conductor between the readout circuitryand the electrode.

* * *

c) an active electrode on said strip inelectrical contact with said first conduc-tor and positioned to contact said wholeblood sample;

The term ‘‘an active electrode’’ has beenconstrued herein to mean ‘‘an electrodethat incorporates conductive material, anda mixture of or layers of an enzyme andmediator.’’ The phrase ‘‘in electrical con-tact with said first conductor’’ was con-strued to mean ‘‘such that the active elec-trode is connected or positioned in such away that electricity can flow between theactive electrode and the first conductor.’’As stated above, the active electrode wasessentially where all of the actual electro-chemistry occurs in the sensor. A media-tor and enzyme covered the electrode andcollectively act to transfer electrons be-tween the glucose molecules in blood tothe active electrode to the conductors. Afaster-acting chemistry that generatedmore electrons more quickly was, in effect,a principal invention in the 8382 patent.The 8382 specification recited (col.4:8–12):

In a particularly valuable form of theinvention, however, the electrode com-prises a carbon core, a layer of ferroceneor a ferrocene derivative at a surfacethereof and a layer of glucose oxidase orglucose dehydrogenase at the surface ofthe ferrocene layer.

The 8382 specification, among others,plainly already revealed active electrodes:a conductive material (i.e., a carbon core),an enzyme (i.e., glucose oxidase), and amediator (i.e., ferrocene).

* * *

d) a second conductor extending alongsaid surface comprising a conductive ele-

ment for concentration to said readoutcircuitry;

For the same reasons set forth underelement (b), this limitation was disclosed inboth the 8410 and 8382 patents.

* * *

e) a reference counterelectrode in elec-trical contact with said second conductorand positioned to contact said wholeblood sample;

At its simplest level, this limitation sup-plied the completion of the electrical cir-cuit, the blood itself being the last link inthe electrical path. There were no chemi-cals on the reference counterelectrode.Judge Jenkins construed the term ‘‘a ref-erence counterelectrode in electrical con-tact with said second conductor and posi-tioned to contact said whole blood sample’’as follows:

an electrode that (1) is used to completean electrical circuit with the active elec-trode during the glucose measurement;(2) is positioned or connected in such away that electricity can flow between thesecond conductor and the electrode; (3)has a known potential relative to a stan-dard; and (4) maintains its potentialwith only insignificant variation duringthe measurement.

The reference counterelectrode must thusmeet four separate requirements. Thefirst two requirements relate to the elec-trode’s function to ‘‘counter’’ the activeelectrode and complete the circuit. Thelast two requirements relate to the elec-trode’s function to serve as a ‘‘reference’’to the active electrode by maintaining aknown potential relative to a standard—e.g., ground. The 8551 specification de-scribed the reference electrode as a ‘‘coat-ing applied to the elongated support TTT

formed by screen printing’’ and consistingof a silver-silver chloride layer (Ag/AgCl)(col. 2:6–11 and col. 4:57).

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Although both the 8410 and 8382 patentsdisclosed the use of reference electrodesand counter electrodes, they only did so inthe context of a three-electrode configura-tion: one electrode served as the activeelectrode, one electrode served as thecounter, and one electrode served as thereference. For instance, the 8382 patentstated that the ‘‘[active] electrode was con-nected to a potentiostat, together with asuitable counter electrode and calomel ref-erence electrode and placed in a solutioncontaining glucose’’ (col. 8:35–38). Accord-ingly, in the 8410 and 8382 patents therewas no single electrode that served as boththe reference and counter to the activeelectrode.

During the earlier stages of prosecution,Medisense argued that the two-electrodeconfiguration in the 8551 specification wasa point of novelty over the prior art. Spe-cifically, in an information disclosure state-ment received by the PTO on June 30,1988, Medisense contended (TX 5):

Claim 1 now features a two-electrodestrip in which the active current-measur-ing electrode is an enzyme deposit onthe same strip that includes a secondreference electrode. This two-electrodestrip is far more convenient, and cheap-er to make, than the prior art current-measuring devices. None of those de-vices discloses a simple dry two-elec-trode strip and nothing in those refer-ences would render such a simple stripobvious.

In the subsequent office action signed onOctober 28, 1988, Examiner Shay rejectedthis point of novelty:

ASAH, Kurita, Miyawaki, MITS, Huetet al, Smith et al, a Fromowitz et al,Takinishi et al, Brown et al, and Higginset al all teach various electrode and/oramplifies [sic] configurations.

In fact, two-electrode configurationswere common in the prior art. For in-

stance, the Wingard reference (publishedin February 1983) disclosed a sensor witha platinum active electrode (i.e., the elec-trode coated with the enzyme) connectedto a reference counterelectrode. As withthe 8551 patent, the reference counterelec-trode was silver-silver chloride (Ag/AgCl).Wingard stated (TX 480):

The basic design of the amperometricglucose oxidase-oxygen electrode sensorfor in vivo glucose determination is es-sentially that of Updike and HickTTTT Inthe oxygen electrode an external poten-tial is applied to hold the platinum ca-thode 0.6–.0.8V more negative than thesilver-silver chloride anode and thus toproduce a current that is related to theconcentration of oxygen that reaches theplatinum surface.

Defendants cited to other prior art refer-ences (including an undergraduate text-book) that contained similar disclosures.At trial, Dr. Turner persuasively testifiedthat a person having ordinary skill in theart would have been motivated to combinethe teachings of two-electrode systemswith the sensors described in the 8382 and8410 patents. This is not surprising giventhe strong overlap between the subjectmatter of the references.

Abbott argues that defendants havefailed to show that the prior art citedaligns with Judge Jenkins’ claim construc-tion for a reference counterelectrode. Notso. As stated, the reference counterelec-trode must primarily serve two functions:(i) to provide a reference voltage for theactive electrode and (ii) to counter theactive electrode and complete the circuit.It is clear from the language cited abovefrom Wingard that its electrode served asa reference voltage to the active elec-trode—‘‘an external potential is applied tohold the platinum cathode 0.6–.0.8V morenegative than the silver-silver chloride an-ode.’’ As to the second function, the pre-

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1121THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

requisite to serve as a counter electrodewas that the same current pass through itand the active electrode. The counterelectrode (and the blood added by theuser) collectively act to close the circuit sothat current can thereby flow. The elec-trode in the sensor circuit disclosed inWingard met this criterion. Current waspassed from it to the active electrode tocomplete the circuit (‘‘amperometric’’ asstated in Wingard).17

This order therefore finds that ‘‘a refer-ence counterelectrode in electrical contactwith said second conductor and positionedto contact said whole blood sample’’ wasdisclosed in Wingard. This order furtherfinds that a person having ordinary skill inthe art would have had a motivation tocombine Wingard with the teachings of the8382 and 8410 patents.

* * *

wherein said active electrode is config-ured to be exposed to said whole bloodsample without an intervening mem-brane or other whole blood filteringmembrane;

For the reasons set forth above andwhich will not be reviewed again here, theno-membrane limitation was taught by the8382 patent (col.4:63–66).

* * *

and is formed by coating a portion of thefirst conductor with a mixture of or lay-ers of an enzyme which catalyzes a re-dox reaction with said compound inwhole blood and a mediator compound

which transfers electrons from said re-dox reaction to said first conductor;

For the same reasons detailed in thesection above relating to the active elec-trode, this limitation was disclosed by theprior art—in particular, the 8382 patent.

* * *to create a current representative of theconcentration of said compound in saidwhole blood sample;

The 8382 expressly taught this limita-tion. It recited (col. 8:41–42), ‘‘[a] currentis produced which is proportional to theglucose concentration.’’ This current wasthen measured and subsequently extrapo-lated to yield a measure of the amount ofglucose in the target blood sample.

* * *and wherein said active electrode whichis formed on a portion of said conductoris not in electrical contact with said ref-erence counterelectrode but these elec-trodes are so dimensioned and posi-tioned that they can be simultaneouslycompletely covered by a single drop ofwhole blood such that this drop providesan electrical path between these elec-trodes to support said current represen-tative of the concentration of said com-pound in said whole blood sample.

This limitation required that the activeelectrode and reference counter electrodebe positioned in such a manner so that asingle drop of blood could cover both. Thetwo electrodes, however, could not be inelectrical contact with one another. Asdescribed above, the 8410 patent disclosed

17. In three-electrode configurations, no cur-rent would pass through the reference elec-trode. All the current would be shared be-tween the active electrode and the counterelectrode. The reference electrode was mere-ly used to apply a known potential to bias thecircuit. Where the parasitic resistance of theclosed circuit or the current running throughthe closed circuit was small, however, a two-electrode configuration was more tolerable

because of the small (and unwanted) voltagedrop that would result from the parasitic re-sistance (i.e., Ohm’s Law, voltage equals theproduct of current and resistance). The de-termination of whether a two-versus-three-electrode system was used therefore centeredon whether the system could handle the de-creased accuracy of a two-electrode configu-ration (TX 316).

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1122 565 FEDERAL SUPPLEMENT, 2d SERIES

a disposable cartridge comprising a matrixof sensors. The user would prick theirfinger and place a drop of blood over thecartridge. In so doing, the sensors in thematrix would be covered by the user’ssingle drop of blood.

In addition, one of the preferred embod-iments disclosed in the 8382 patent was aneedle electrode that could be used fortests within the body—i.e., in vivo. Thisembodiment was as follows:

The user could prick themselves with theneedle 16. Blood would then enterthrough the side windows 18 and come intocontact with the electrodes in the device.In this way, current was generated andcould subsequently be measured. In thesame fashion, because the needle electrodewas so small, the user could have easilyapplied a drop of blood to the side windows18 outside of the body instead of placingthe needle in the body. Dr. Turner testi-fied that if a drop of blood were applied inthis manner, the device would still functionproperly. Abbott has offered no evidenceto the contrary.

CLAIM 2

Claim 2 stated: ‘‘The electrode strip ofclaim 1 wherein the compound is glucoseand the enzyme is glucose oxidase or glu-cose dehydrogenase’’ (col.14:18–20). Aspreviously discussed, there were multiplereferences and teachings in the 8382 patentto testing glucose levels in blood using aglucose oxidase or glucose dehydrogenase

enzyme (col.1:66–68) (‘‘The enzyme istherefore preferably a glucose oxidase, orpossibly a glucose dehydrogenase, for ex-ample a bacterial glucose dehydrogenase.’’)

CLAIM 3

Claim 3 stated: ‘‘The electrode strip ofclaim 1 wherein said conductive elementsof the first and second conductors for con-nection to the readout circuitry are posi-tioned toward one end of said elongatedsupport and said active electrode and ref-erence counterelectrode are positioned re-mote from said end’’ (col.14:21–25). Claim3 required that the active electrode andreference counterelectrode both be posi-tioned on the opposite end of the stripfrom the portion of the conductors thatconnect to the readout circuitry. As illus-trated in Figure 1a of the 8410 patent(shown above), the sensors 14 were placedon one end of the cartridge while theelectrical connections 27 for the readoutcircuitry were at the other end. The 8410patent thus disclosed this limitation.

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1123THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

CLAIM 4

Claim 4 stated: ‘‘The electrode strip ofclaim 1 wherein said conductive elementsof said first and second conductors areconfigured to allow reasonable attachmentwith a socket on a read out meter whichcarries said signal readout circuitry’’(col.14:26–29). For the same reasons setforth above, the 8410 patent disclosed thisfurther limitation to claim 1 (col.7:37–43).

* * *

[11, 12] Under 35 U.S.C. 103, a patentmay not be obtained if the differencesbetween the claimed invention and the pri-or art would have been ‘‘obvious’’ at thetime the invention was made to a personhaving ordinary skill in the art to whichthe patent is directed. The SupremeCourt recently addressed the issue of obvi-ousness in KSR Int’l Co. v. Teleflex Inc.,––– U.S. ––––, 127 S.Ct. 1727, 167 L.Ed.2d705 (2007). There, the Supreme Courtreversed the Federal Circuit’s rejection ofsummary judgment of obviousness. In sodoing, the Supreme Court emphasized thatthe obviousness inquiry is pragmatic andflexible: ‘‘A person of ordinary skill is alsoa person of ordinary creativity, not anautomaton.’’ Id. at 1742. The SupremeCourt further stressed that if a personhaving ordinary skill in the art would havebeen able to implement a predictable vari-ation of the prior art to yield the claimedinvention, Section 103 would likely bar pat-entability. As the Supreme Court statedin KSR Int’l Co., 127 S.Ct. at 1740–41.:

Often, it will be necessary for a court tolook to interrelated teachings of multiplepatents; the effects of demands knownto the design community or present inthe marketplace; and the backgroundknowledge possessed by a person havingordinary skill in the art, all in order todetermine whether there was an appar-ent reason to combine the known ele-

ments in the fashion claimed by thepatent at issue.

Where there is ‘‘a design need or marketpressure’’ to solve a particular problemand there are only a discrete number ofpredictable solutions that led to the antici-pated success of the patent, ‘‘[the patent]is likely the product not of innovation butof ordinary skill and common sense.’’ Id.at 1742.

Under this practical approach, this orderfinds all asserted claims of the 8551 patentto be obvious in light of the prior art. Allbut one limitation was disclosed expresslyby the 8382 and/or 8441 patents. The re-maining limitation, implementing a two-electrode configuration, was well knownprior to the 8551 patent’s priority date.Each reference relied on above to showobviousness was expressly aimed at thespecific subject matter covered by the 8551patent—i.e., construction of electrochemi-cal sensors that could be used to measureglucose levels in blood. One skilled in theart would therefore have readily thoughtto combine these references.

* * *

The Federal Circuit has held that ‘‘sec-ondary considerations, when present, mustbe considered in determining obviousness.’’Ruiz v. A.B. Chance Co., 234 F.3d 654, 667(Fed.Cir.2000); see also Stratoflex, Inc. v.Aeroquip Corp., 713 F.2d 1530, 1538 (Fed.Cir.1983) (‘‘evidence of secondary consider-ation may often be the most probative andcogent evidence in the record. It mayoften establish that an invention appearingto have been obvious in light of the priorart was not. It is to be considered as partof all the evidence, not just when the deci-sionmaker remains in doubt after review-ing the art’’). Originally, three factorswere regarded as secondary consider-ations: commercial success, long-felt butunsolved needs, and failure of others.Graham v. John Deere Co. of Kansas City,

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1124 565 FEDERAL SUPPLEMENT, 2d SERIES

383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545(1966). Since then, several additional fac-tors have been taken into account by theFederal Circuit, including: copying by oth-ers, praise of the invention, unexpectedresults, disbelief of experts, general skepti-cism of those in the art, commercial acqui-escence, and simultaneous development.18

Evidence of secondary considerations,however, only has probative value wherethere is ‘‘a nexus between the merits of theclaimed invention and the secondary con-sideration.’’ Ashland Oil, Inc. v. DeltaResins & Refractories, Inc., 776 F.2d 281,306 n. 42 (Fed.Cir.1985). The burden ofproof as to this connection or nexus re-sides with the patentee. Demaco Corp. v.F. Von Langsdorff Licensing Ltd., 851F.2d 1387, 1392 (Fed.Cir.1988).

Here, Abbott has primarily offeredthree grounds to support its showing ofsecondary considerations: (i) the commer-cial success of the Medisense–Abbott–Ex-actech product; (ii) a long-felt need for theExactech product; and (iii) an alleged at-tempt to design around the 8551 patent bya competitor.

Steven Scott, the former project manag-er for Abbott’s Exactech, testified thatover one billion test strips were sold overthe lifetime of the Exactech product. Hefurther testified that at the time the Exac-tech was released in September 1987, noother competitor had an electrochemicalstrip on the market. According to Abbott,before the Exactech product was released,diabetic patients had to use colormetrictest strips that were far less convenientbecause they required the user to followprecise instructions that could easily bebotched to produce inaccurate results.

This order assumes all of Abbott’s rep-resentations regarding the Exactech prod-uct were true. Nonetheless, Abbott hasfailed to show that the success of the Ex-actech product was attributable to the 8551patent. Significantly, the Exactech prod-uct was released in September 1987—twoyears after the 8382 patent issued and overseven years before the 8551 applicationwas filed. Both Dr. Sanghera and Scotttestified that Medisense marked the Exac-tech product packaging with the 8382 pat-ent before and after the 8551 patent issued.Abbott’s expert, Dr. Jay Johnson, admit-ted that the Exactech product was coveredby claim 1 of the 8382 patent (Tr. 552:15–18):

Q: But all these limitations that yousee in the Claim 1 of the Higgins8382 patent are met by the Exac-tech strip. We just walked throughthem.

A. Yes.

Dr. Sanghera acknowledged on multipleoccasions the novelty behind the inventionof the 8382 patent—an invention for whichAbbott received the full term of a patent.Nothing on the record demonstrates thatthe purported novelty behind the 8551 pat-ent contributed to the success of the Exac-tech product. Abbott has therefore failedto show the requisite nexus between theclaims of the 8551 patent and the Exactechproduct. The record instead demonstratesthat the success of the Exactech productwas more attributable to the fast-workingchemistry disclosed in the 8382 patent.

Abbott next proffers the testimony ofJames McCann (Genetics International’sformer founder) to support its showing ofsecondary considerations. McCann is cur-

18. See Ecolochem, Inc. v. Southern CaliforniaEdison Co., 227 F.3d 1361, 1379–80 (Fed.Cir.2000); Monarch Knitting Mach. Corp. v. Sul-zer Morat GmbH, 139 F.3d 877, 885 (Fed.Cir.1998); Advanced Display Systems v. Kent

State Univ., 212 F.3d 1272, 1285–85 (Fed.Cir.2000); Interconnect Planning Corp. v. Feil,774 F.2d 1132, 1144 (Fed.Cir.1985); EWPCorp. v. Reliance Universal, Inc., 755 F.2d898, 907 (Fed.Cir.1985).

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1125THERASENSE, INC. v. BECTON, DICKINSON AND CO.Cite as 565 F.Supp.2d 1088 (N.D.Cal. 2008)

rently employed at Cambridge SensorsLtd., a company also engaged in the manu-facture of glucose sensors. At his deposi-tion, McCann testified that CambridgeSensors redesigned one of its sensors in anattempt to design around the 8551 patentby placing a mesh layer on the activeelectrode and moving the enzyme abovethe mesh layer. He stated (McCann Dep.140–41):

Q. Was that version created in an ef-fort to design around the 8551 pat-ent?

A. Yes.

* * * * * *

Q. Okay you made that redesign in aneffort to avoid the claims of the8551?

A. Yes.

It is not clear exactly how much weightMcCann’s testimony should be given.Both parties have been unable to cite toany decision where such evidence was con-sidered or discounted when assessing sec-ondary considerations. Cambridge Sen-sor’s design-around efforts could shownothing more than its desire to avoid thethreat of litigation, meaning it would shedlittle light on the validity or novelty of the8551 patent. On the other hand, the rede-sign may be relevant to show that theindustry regarded the 8551 patent as likelyvalid and enforceable. In any case, howev-er, this evidence by itself is not enough totip the scales. Given the absence of otherfactors weighing in favor of secondary con-siderations, it would be a far leap to pre-clude a finding of obviousness based onsuch scant evidence.

* * *

[13] Many inventions seem obvious af-ter the fact but that, of course, is not thetest for invalidity:

It is difficult but necessary that thedecision maker forget what he or she

has been taught at trial about theclaimed invention and cast the mindback to the time the invention was made(often as here many years), to occupythe mind of one skilled in the art who ispresented only with the references, andwho is normally guided by the then-accepted wisdom in the art.

W.L. Gore & Associates, Inc. v. Garlock,Inc., 721 F.2d 1540, 1553 (Fed.Cir.1983).

[14] A patent is presumed valid, andthe burden of establishing invalidity as toany claim of a patent rests upon the partyasserting such invalidity. 35 U.S.C. 282.Invalidity must be proven by clear andconvincing evidence. Although not suscep-tible to precise definition, ‘‘clear and con-vincing’’ evidence has been described asevidence which produces in the mind of thetrier of fact ‘‘an abiding conviction that thetruth of [the] factual contentions are high-ly probable.’’ Buildex, Inc. v. Kason In-dus., Inc., 849 F.2d 1461, 1463 (Fed.Cir.1988).

Viewing the prior art in whole, oneskilled in the art would have deemed the8551 patent as a necessary and logical re-sult of the teachings already a part of thepublic domain. The main claim elementsat issue in trial were the deletion of themembrane and the implementation of atwo-electrode system. On the former ele-ment, the 8382 patent expressly disclosedthat a membrane was optional but pre-ferred on live blood. It was not required.On the latter element, two-electrode con-figurations were common and even dis-closed in an undergraduate electrochemis-try textbook. The remaining elements ofclaims 1–4 were not novel either; theywere readily taught by the prior art.Those in the field would have appreciatedthat combining these elements was a pre-dictable variation on the prior art.

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1126 565 FEDERAL SUPPLEMENT, 2d SERIES

WRITTEN DESCRIPTION

[15–17] Pursuant to 35 U.S.C. 112 ¶ 1,a patent specification is required to ‘‘con-tain a written description of the invention,and of the manner and process of makingand using it, in such full, clear, concise,and exact terms as to enable any personskilled in the art to which it pertains, orwith which it is most nearly connected, tomake and use the same.’’ The written-description requirement and its corollary,the new-matter prohibition of 35 U.S.C.132, serve to ensure that the patent appli-cant was in full possession of the claimedsubject matter at the time the originalapplication was filed. ‘‘To satisfy the writ-ten description requirement the disclosureof the prior application must convey withreasonable clarity to those skilled in theart that, as of the filing date sought, [theinventor] was in possession of the inven-tion.’’ PowerOasis, Inc. v. T–Mobile USA,Inc., 522 F.3d 1299, 1306 (Fed.Cir.2008)(emphasis in original). Any disclosure re-lied on must be actual or inherent. Inorder for a disclosure to be inherent, ‘‘themissing descriptive matter must necessari-ly be present in the [original] application’sspecification such that one skilled in theart would recognize such disclosure.’’Tronzo v. Biomet, Inc., 156 F.3d 1154,1159 (Fed.Cir.1998).

Defendants contend that the 8551 speci-fication fails to comport with the written-description requirement. In particular,defendants argue there was no adequatewritten description in the 8551 specificationto support the claim limitation ‘‘without anintervening membrane or other wholeblood filtering membrane.’’ It is true thatthe no-membrane idea was not expresslycalled out in the specification and, indeed,was at most lurking in its penumbra.Nonetheless, the relevant inquiry is wheth-er those skilled in the art would havethought the inventors were in possession

of an electrochemical sensor without amembrane for use in whole blood as ofMay 1983. Contrary to the defense, thisorder finds that those skilled in the artwould have recognized such disclosure inthe 8551 specification. Plaintiff’s ExpertJohnson gave a detailed description of anembodiment disclosed in the 8551 specifica-tion describing a membraneless sensorthat could be used in whole blood (col.8:27–52). On direct examination, defense Ex-pert Turner admitted that the 8551 dis-closed a glucose sensor without a mem-brane that could be used in blood (Tr. 249):

Q. Did you find anything in the 8551patent that specially adapted thatsensor disclosed? And we’ve lookedat Claim 1, but claims 1 through 4,is there anything in those claimsthat shows that these sensors arespecially adapted for use withblood?

A. No. The 8551 describes the samestructures and approach, effectively,as here. So the 8551 could be usedwith and without a membrane; the8382 could be used with and withouta membrane.

Accordingly, this order finds that the 8551specification adequately disclosed the con-tested limitation.

That said, it is certainly true that the8382 specification had already announced adescription of a glucose sensor without amembrane for use in blood that was asgood or better. After all, the 8382 specifi-cation expressly recited, ‘‘[o]ptionally, butpreferably when being used on live blood,a protective membrane surrounds both theenzyme and the mediator layers TTT’’(col.4:63–65). The only affirmative pas-sage in the 8551 specification on this specif-ic point stated (col.6:66–7:2):

Although the enzyme electrode shouldbe in electrical contact with the liquid, itmay be found valuable to exclude the

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1127MAD DOGG ATHLETICS, INC. v. NYC HOLDINGCite as 565 F.Supp.2d 1127 (C.D.Cal. 2008)

sensor from interfering contact withlarger molecules or tissue fluid compo-nents. This can be done by a covering orsurrounding membrane, depending onthe electrode geometry.

As such, while the 8551 patent adequatelydisclosed the membraneless limitation, itonly did so after such disclosure in the8382 patent.

CONCLUSION

For the foregoing reasons, claims 1–4are invalid as obvious and U.S. Patent No.5,820,551 is unenforceable by reason ofinequitable conduct in procuring its allow-ance. This order concludes all proceed-ings in the district court on the merits ofthe 8551 claims. Before a Rule 54(b) judg-ment is entered, counsel shall advise theCourt whether any further proceedingsare needed. Please do so by NOON ON JULY

2, 2008.

IT IS SO ORDERED.

,

MAD DOGG ATHLETICS, INC.

v.

NYC HOLDING, et al.

No. CV 07–1074–RGK (SHx).

United States District Court,C.D. California.

Feb. 20, 2008.

Background: Trademark owner broughtaction against competitor alleging cyberpi-racy, trademark infringement, unfair com-petition and false designation of origin, andtrademark dilution under Lanham Act, andstate statutory unfair competition, and

constructive trust. Court granted defaultjudgment in favor of owner. Ownerbrought motion to amend judgment in or-der to add nonparty as judgment-debtorbased on alter ego theory of liability.

Holdings: The District Court, R. GaryKlausner, J., held that:

(1) non-party natural person was legallyidentical to corporation;

(2) Court had personal jurisdiction overnon-resident non-party;

(3) non-party had received full and fairopportunity to defend himself; and

(4) procedural arguments of non-partywere untimely.

Motion granted.

1. Judgment O306, 310California courts consider post-judg-

ment amendments, in cases concerning fic-titious business entities, as acts similar tocorrections of clerical errors. West’s Ann.Cal.C.C.P. § 116.560; West’s Ann.Cal.Bus.& Prof.Code § 17900.

2. Federal Civil Procedure O2651.1Federal courts sitting in California

may amend a judgment to add additionaljudgment debtors. Fed.Rules Civ.Proc.Rule 69(a), 28 U.S.C.A.; West’s Ann.Cal.C.C.P. § 187.

3. Federal Civil Procedure O2651.1 Judgment O310

Non-party natural person was legallyidentical to corporation, and thus goodcause existed for amending default judg-ment under California law that had beenentered against corporation, in action al-leging cyberpiracy, trademark infringe-ment, unfair competition and false desig-nation of origin, and trademark dilutionunder Lanham Act, and state statutory un-fair competition, and constructive trust,where natural person owned infringing In-ternet websites that had been registered