Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA528951
`ESTTA Tracking number:
`03/27/2013
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`92049418
`Plaintiff
`C. & J. Clark International Limited
`STEPHEN P. MCNAMARA
`ST. ONGE STEWARD JOHNSTON & REENS LLC
`986 BEDFORD STREET
`STAMFORD, CT 06905
`UNITED STATES
`smcnamara@ssjr.com
`Other Motions/Papers
`Stephen P. McNamara
`smcnamara@ssjr.com, litigation@ssjr.com
`/spmcnamara/
`03/27/2013
`0032 Letter.pdf ( 76 pages )(2209504 bytes )
`
`Proceeding
`Party
`
`Correspondence
`Address
`
`Submission
`Filer's Name
`Filer's e-mail
`Signature
`Date
`Attachments
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`EEKE1;}12'fi§E;}}I;}i;}§;i1};{t§{{"""""""""X
`
`Petitioner
`
`vs.
`
`Cancellation No. 92049418
`
`Unity Clothing Inc.,
`
`Registrant
`..........................................................--X
`
`LETTER WITH CASE CITATIONS
`
`During Oral Argument in the above matter on 26 February 2013, Judge Hightower
`
`asked the undersigned Petitioner’s counsel if counsel could refer the Board to any cases
`
`where, applying a clear and convincing evidence standard, an inference of intent to mislead
`
`was found based on evidence of knowing, false statements of fact such as has been
`
`established in the present proceeding.
`
`Counsel was unable to cite any similar cases at the hearing, but has identified the
`
`following cases which may be helpful to the Board’s decision, and according respectfully
`
`requests that this Letter and the attached decisions be considered in the Board’s decision.
`
`The Federal Circuit recently issued a decision in Therasense, Inc. v. Becton,
`
`Dickinson & Company, 649 F.3d 1276, 1287 (Fed. Cir. 2011), a patent case, in which the
`
`Court stated requirements for proving intent to deceive the Patent Office in order to establish
`
`a defense of inequitable conduct to render a patent unenforceable. The Therasense
`
`standards, like the Bose standards, require a substantial evidentiary showing, however, like
`
`

`
`the Bose standards, they do not require an explicit admission of intent to mislead the PTO,
`
`and the inequitable conduct defense is still important and is applied regularly by inferring
`
`intent from knowing false statements.
`
`In the Therasense decision, the Federal Circuit discussed the issue of intent, and
`
`articulated that to prevail on a claim of inequitable conduct, the accused infringer must prove
`
`by clear and convincing evidence that the patentee acted with the specific intent to deceive
`
`the PTO, z'.e., the patentee made a deliberate decision to withhold known material
`
`information. Id. A district court may infer intent from indirect and circumstantial evidence,
`
`but the specific intent to deceive must be the only reasonable inference that can be inferred.
`
`Id. Because the party alleging inequitable conduct bears the burden of proof, the patentee is
`
`not required to offer any good faith explanation unless the accused infringer first proves a
`
`threshold level of intent to deceive by clear and convincing evidence. Id. at 1291. (Copy of
`
`submitted herewith).
`
`Applying this standard, the District Court on remand, 102 U.S.P.Q.2d 1510 (N.D.
`
`Cal. 2012) determined that intent to deceive the PTO had been proven where the evidence
`
`showed that the inventor made a deliberate decision to withhold known material information
`
`from a related European Patent Office proceeding.
`
`(Id. at 1518-1519) (copy submitted
`
`herewith).
`
`More recently, in a different patent case, Caron and Spellbinders Paper A/‘ls
`
`Company, LLC vs. QuicKutz, 1720., 2012 WL 5497869 (D.Ariz.) the District Court applied the
`
`The/‘asense standard and determined that intent to deceive the PTO had been proven where
`
`the evidence showed that the inventor had knowingly made false statements about
`
`inventorship to the USPTO for purposes of the including persons as inventors to suit their
`
`2
`
`

`
`business interests.
`
`(Id. at 3-5 , *6) (copy submitted herewith). (Additional evidence of intent
`
`to deceive was inferred from conduct associated with various declarations filed with the
`
`USPTO. Id. at 5-11).
`
`Petitioner submits that the record in this proceeding presents clear and convincing
`
`evidence of knowing, material, false statements of facts. Petitioner believes that the above
`
`cases confirm that an inference of intent to mislead is justified on the record in the present
`
`case.
`
`Respectfully submitted,
`
`/Stephen P. McNamara/
`
`Stephen P. McNamara
`ST. ONGE STEWARD JOHNSTON & REENS LLC
`986 Bedford Street
`
`Stamford, CT 06905-5619
`Tel. 203-324-6155
`
`Email smcnamara@ssjr. com
`
`Attorneys for Petitioner
`
`

`
`CERTIFICATE OF SERVICE
`
`This is to certify that a true and correct copy of the foregoing
`
`LETTER WITH CASE CITATION
`
`is being served on the Registrant on the date stated below, by electronic mail to:
`
`sshaw@,calljensen.com
`
`and
`
`Vchristenson@calljensen.com
`
`of
`
`CALL & JENSEN
`
`610 NEWPORT CENTER DRIVE , SUITE 700
`NEWPORT BEACH, CA 92660
`
`March 27, 2013
`
`/Stephen P. McNamara/
`
`Stephen P. McNamara
`
`

`
`1276
`
`649 FEDERAL REPORTER, 3d SERIES
`
`(now known as
`INC.
`THERASENSE,
`Abbott Diabetes Care, Inc.) and Ab-
`bott Laboratories, Plaintiffs-Appel-
`lants,
`
`V.
`
`BECTON, DICKINSON AND COMPA-
`
`NY, and Nova Biomedical Corpora-
`tion, Defendants—Appellees,
`and
`
`Bayer Healtl1Care LLC, Defendant-
`Appellee.
`
`Nos. 2008-1511, 2008-1512, 2008-
`1513, 2008—1514, 2008-1595.
`
`United States Court of Appeals,
`Federal Circuit.
`
`May 25, 2011.
`
`action
`Background: Patentee brought
`against competitors alleging infringement
`of patent directed toward disposable blood
`glucose test strips for diabetes manage-
`ment. The United States District Court for
`
`the Northern District of California, Martin
`J. Jenkins, J., 560 F.Supp.2d 835, granted
`summary judgment of noninfringement
`and anticipation in part. The District
`Court, William H. Alsup, J., 565 F.Supp.2d
`1088, following bench trial, granted judg-
`ment of obviousness and inequitable con-
`duct. Patentee appealed. Panel unanimous-
`ly upheld district court’s judgments of
`noninfringement and invalidity, 593 F.3d
`1289. Patentee petitioned for rehearing en
`banc. Petition was granted and judgment
`of panel vacated, 374 Fed.AppX. 35.
`
`Holdings: The Court of Appeals, Rader,
`Chief Judge, held that:
`
`(1) a finding that a misrepresentation or
`omission amounts to gross negligence
`or negligence under a “should have
`known” standard does not satisfy the
`inequitable
`conduct
`intent
`require-
`ment, abrogating Driscoll
`72. Cebalo,
`731 F.2d 878, 885 and Orthopedic
`
`12. All Orthopedic Ap-
`Equip. Co., Inc.
`pliances, Inc, 707 F.2d 1376;
`
`(2) a district court should not use a “slid-
`
`ing scale,” where a weak showing of
`intent may be found sufficient for ineq-
`uitable conduct based on a strong
`showing of materiality, and vice versa,
`abrogating Am. Hoist & Derrick Co. 1).
`Sowa & Sons,
`Inc, 725 F.2d 1350;
`
`(3) a district court may not infer intent
`solely from materiality, but, instead, a
`court must weigh the evidence of in-
`tent to deceive independent of its anal-
`ysis of materiality;
`
`(4) to meet the clear and convincing evi-
`dence standard, the specific intent to
`deceive must be the single most rea-
`sonable inference able to be drawn
`
`from the evidence;
`
`(5) when there are multiple reasonable in-
`ferences that may be drawn, intent to
`deceive cannot be found;
`
`(6) the patentee need not offer any good
`faith explanation unless the accused
`infringer first proves a threshold level
`of intent to deceive by clear and con-
`vincing evidence;
`
`(7) the materiality required to establish
`inequitable conduct is but—for material-
`ity; and
`
`(8) remand was required.
`
`Affirmed in part, vacated in part, and re-
`manded.
`
`O’Malley, Circuit Judge, filed opinion con-
`curring in part and dissenting in part.
`
`filed dissenting
`Bryson, Circuit Judge,
`opinion, in which Gajarsa, Dyk, and Prost,
`Circuit Judges, joined.
`
`Reinstating Parts I, III, and IV of panel
`decision reported at 593 F.3d 1289, which
`affirmed district court’s judgment of obvi-
`ousness, noninfringement, and anticipation,
`respectively.
`
`

`
`THERASENSE, INC. v. BECTON, DICKINSON AND CO.
`Cite as 649 F.3d 1276 (Fed. Cir. 2011)
`
`1277
`
`1. Patents ®=’97.8
`
`is an equitable
`Inequitable conduct
`defense to patent
`infringement
`that,
`if
`proved, bars enforcement of a patent.
`2. Patents @397.8
`
`regarding any
`Inequitable conduct
`single claim renders the entire patent un-
`enforceable.
`
`mation, clear and convincing evidence must
`show that the applicant made a deliberate
`decision to withhold a known material ref-
`
`erence;
`
`in other words,
`
`the accused in-
`
`fringer must prove by clear and convincing
`evidence that the applicant knew of the
`reference, knew that it was material, and
`made a deliberate decision to withhold it.
`
`3. Patents <9=>97.8
`
`9. Patents @997. 14
`
`inequitable
`Unlike other deficiencies,
`conduct cannot be cured by patent reissue
`or reexamination.
`
`4. Patents <9=>97.8
`
`The taint of a finding of inequitable
`conduct can spread from a single patent to
`render unenforceable other related patents
`and applications in the same technology
`family.
`
`5. Patents <9=’325.11(2.1)
`
`Prevailing on a claim of inequitable
`conduct often makes a patent case “excep-
`tional,” leading potentially to an award of
`attorney fees. 35 U.S.C.A. § 285.
`
`6. Privileged Communications and Con-
`fidentiality (35154
`
`In a patent case, a finding of inequita-
`ble conduct may prove the crime or fraud
`exception to the attorney~client privilege.
`7. Patents €397.10
`
`To prevail on a claim of inequitable
`conduct, the accused infringer must prove
`that the patentee acted with the specific
`intent to deceive the Patent and Trade-
`
`mark Office (PTO); a finding that the mis-
`representation or omission amounts
`to
`gross negligence or negligence under a
`“should have known” standard does not
`
`satisfy this intent requirement; abrogating
`Driscoll 7). Cebalo, 731 F.2d 878, 885 and
`Orthopedic Eqmjp. Co., Inc. 11. All Orthope—
`dic Appliances, Inc, 707 F.2d 1376.
`
`8. Patents €397.10, 97.13
`
`In a patent case alleging inequitable
`conduct, a district court should not use a
`
`“sliding scale,” where a weak showing of
`intent may be found sufficient based on a
`strong showing of materiality, and vice
`versa; abrogating Am. Hoist &: Derrick
`Co.
`72. Sowa &: Sons, Inc, 725 F.2d 1350.
`
`10. Patents <>=>97.13
`
`In a patent case alleging inequitable
`conduct, a district court may not
`infer
`intent solely from materiality, but, instead,
`a court must weigh the evidence of intent
`to deceive independent of its analysis of
`materiality.
`
`11. Patents <=3=>97.10
`
`In a patent case alleging inequitable
`conduct, proving that the applicant knew
`of a reference, should have known of its
`materiality, and decided not to submit it to
`the Patent and Trademark Office (PTO)
`does not prove specific intent to deceive.
`
`12. Patents €797.13
`
`In a patent case alleging inequitable
`conduct, a district court may infer intent
`from indirect and circumstantial evidence;
`however, to meet the clear and convincing
`evidence standard, the specific intent
`to
`deceive must be the single most reasonable
`inference able to be drawn from the evi-
`
`dence, in that the evidence must be suffi-
`
`In a patent case alleging inequitable
`conduct
`involving nondisclosure of infor-
`
`cient to require a finding of deceitful intent
`in the light of all the circumstances.
`
`

`
`1278
`
`649 FEDERAL REPORTER, 3d SERIES
`
`13. Patents $97.13
`
`In a patent case alleging inequitable
`conduct, when there are multiple reason-
`able inferences that may be drawn, intent
`to deceive cannot be found.
`
`invalidate a claim based on a deliberately
`withheld reference, the reference may be
`material if it would have blocked patent
`issuance under the different evidentiary
`standards of the Patent and Trademark
`
`14. Federal Courts $870.1
`
`Office (PTO).
`
`findings re-
`District court’s factual
`garding what reasonable inferences may
`be drawn from the evidence are reviewed
`for clear error.
`
`15. Patents $97.13
`
`In a patent case alleging inequitable
`conduct, because the party alleging inequi-
`table conduct bears the burden of proof,
`the patentee need not offer any good faith
`explanation unless the accused infringer
`first proves a threshold level of intent to
`deceive by clear and convincing evidence;
`the absence of a good faith explanation for
`withholding a material reference does not,
`by itself, prove intent to deceive.
`16. Patents $97.9
`
`As a general matter, in a patent case,
`the materiality required to establish ineq-
`uitable conduct is but-for materiality; when
`an applicant fails to disclose prior art to
`the Patent and Trademark Office (PTO),
`that prior art is but-for material
`if the
`PTO would not have allowed a claim had it
`
`been aware of the undisclosed prior art.
`
`17. Patents $97.9, 97.13
`
`In a patent case alleging inequitable
`conduct, when assessing the materiality of
`a withheld reference, a court must deter-
`mine whether the Patent and Trademark
`Office (PTO) would have allowed the claim
`if it had been aware of the undisclosed
`
`reference; in making this patentability de-
`termination,
`the court should apply the
`preponderance of the evidence standard
`and give claims their broadest reasonable
`construction.
`
`18. Patents $97.9
`
`In a patent case alleging inequitable
`conduct, even if a district court does not
`
`19. Patents $97.8
`
`As an equitable doctrine, inequitable
`conduct hinges on basic fairness; the reme-
`dy imposed by a court of equity should be
`commensurate with the violation.
`
`20. Patents $97.8
`
`Because inequitable conduct renders
`an entire patent, or even a patent family,
`unenforceable, as a general rule, this doc-
`trine should only be applied in instances
`where the patentee’s misconduct resulted
`in the unfair benefit of receiving an unwar-
`ranted claim; enforcement of an otherwise
`
`injure the public
`valid patent does not
`merely because of misconduct,
`lurking
`somewhere in patent prosecution, that was
`immaterial to the patent’s issuance, and a
`patentee obtains no advantage from mis-
`conduct if the patent would have issued
`anyway.
`
`21. Patents $97.9
`
`In a patent case alleging inequitable
`conduct, when the patentee has engaged in
`affirmative acts of egregious misconduct,
`such as the filing of an unmistakably false
`affidavit, the misconduct is material.
`
`22. Patents $97.9
`
`Because neither mere nondisclosure of
`
`prior art references to the Patent and
`Trademark Office (PTO) nor failure to
`mention prior art references in an affidavit
`constitutes affirmative egregious miscon-
`duct, claims of inequitable conduct that are
`based on such omissions require proof of
`but-for materiality.
`
`

`
`THERASENSE, INC. V. BECTON, DICKINSON AND CO.
`Cite as 649 F.3d 1276 (Fed. Cir. 2011)
`
`1279
`
`23. Patents ($997.9
`
`In a patent case alleging inequitable
`conduct, a court is not bound by the defini-
`tion of materiality in Patent and Trade-
`mark Office (PTO) rules, which lack but-
`for materiality. 37 C.F.R. § 1.56.
`
`24. Patents @997.14
`
`In patent case alleging inequitable
`conduct, remand was required for district
`court
`to determine whether Patent and
`Trademark Office (PTO) would not have
`
`granted patent but for patentee’s failure
`to disclose briefs to European Patent Of-
`fice (EPO); in particular, district court had
`to determine whether PTO would have
`
`found declaration by patentee’s director of
`research and development, and accompa-
`nying submission by patent attorney, un-
`persuasive in overcoming obviousness re-
`jection over patentee’s prior patent if it
`had disclosed EPO briefs.
`
`25. Patents 6997.14
`
`In patent case alleging inequitable
`conduct, remand was required for district
`court
`to determine whether
`there was
`
`clear and convincing evidence demonstrat-
`ing that patentee’s director of research
`and development
`and patent attorney
`knew of briefs to European Patent Office
`(EPO), knew of
`their materiality, and
`made conscious decision to not disclose
`them in order
`to deceive Patent and
`
`Trademark Office (PTO), since court had
`found intent to deceive based on absence
`
`of good faith explanation for failing to
`disclose EPO briefs and court had relied
`
`upon “should have known” negligence
`standard in reaching its finding of intent.
`
`Patents <9=’328(2)
`
`4,225,410, 4,545,382. Cited as Prior
`
`Art.
`
`Patents <%=’328(2)
`
`5,820,551, 6,143,164, 6,592,745. Cited.
`
`John M. Whealan, of Silver Spring, MD
`argued for plaintiffs-appellants on rehear-
`ing en banc. With him on the brief were
`Rohit K. Singla and Peter A. Detre, Mun-
`ger, Tolles & Olson LLP, of San Francis-
`co, CA; and Jeffrey I. Weinberger, of Los
`Angeles, CA; Jeffrey A. Lamken and Mi-
`chael G. Pattillo, Jr., MoloLamken LLP, of
`Washington, DC. Of counsel were Chan-
`tal M. D’Apuzzo, Fred A. Rowley, Jr.,
`Andrew W. Song and Donald W. Ward,
`Munger, Tolles & Olson LLP, of Los An-
`geles, CA.
`
`Bradford J. Badke, Ropes & Gray LLP,
`of New York, NY, argued for defendants-
`appellees Becton, Dickinson and Company,
`et al. on rehearing en banc. With him on
`the brief was Sona De. Of counsel was
`Gabrielle M. Ciuffreda.
`
`Rachel Krevans, Morrison & Foerster
`LLP, of San Francisco, CA, argued for
`defendant-appellee
`Bayer HealthCare
`LLC on rehearing en banc. With her on
`the brief were Brian M. Kramer and Greg-
`ory W. Reilly, of San Diego, CA;
`and
`Kenneth P. George and Joseph M. Casino,
`Amster Rothstein & Ebenstein LLP, of
`New York, NY. Of counsel were Jason R.
`
`Bartlett, Parisa Jorjani, and Wesley E.
`Overson.
`
`Raymond T. Chen, Solicitor, Office of
`the Solicitor, United States Patent and
`Trademark Office, of Alexandria, VA ar-
`gued for amicus curiae the Director of the
`United States Patent and Trademark Of-
`
`fice on rehearing en banc. With him on
`the brief were Bernard J. Knight, Jr.,
`General Counsel, Sydney O. Johnson, Jr.
`and Janet A. Gongola, Associate Solicitors.
`Of counsel on the brief was Scott R. McIn-
`
`tosh, Attorney, Appellate Staff, Civil Divi-
`sion, United States Department of Justice,
`of Washington, DC.
`
`Carolyn B. Lamm, American Bar Asso-
`ciation, of Chicago, IL, for amicus curiae
`The American Bar Association on rehear-
`
`

`
`1280
`
`649 FEDERAL REPORTER, 3d SERIES
`
`ing en banc. Of counsel on the brief were
`Michael A. Valek and William L. Lafuze,
`Vinson & Elkins LLP, of Houston, TX.
`
`John L. Cooper, Farella Braun & Martel
`LLP, of San Francisco, CA, for amicus
`curiae Dolby Laboratories, Inc. on rehear-
`ing en banc.
`
`Richard G. Taranto, Farr & Taranto, of
`Washington, DC, for amicus curiae Veri-
`zon Communications, Inc. on rehearing en
`banc. Of counsel on the brief were John
`
`Thorne and Gail F. Levine, Verizon Com-
`munications Inc., of Arlington, VA.
`
`David Hricik, Mercer University School
`of Law, of Macon, GA, for amicus curiae
`Professor David Hricik on rehearing en
`banc.
`
`Paul H. Berghoff, McDonnell, Boehnen,
`Hulbert & Berghoff, LLP, of Chicago, IL,
`for amicus curiae Intellectual Property
`Owners Association on rehearing en banc.
`With him on the brief was Kurt W. Rohde.
`
`Of counsel on the brief were Douglas K.
`Norman and Kevin H. Rhodes, Intellectual
`Property Owners Association, of Washing-
`ton, DC. Of counsel was Herbert C.
`
`Intellectual Property Owners
`Wamsley,
`Association, of Washington, DC.
`
`Robert P. Greenspoon, Flachsbart &
`Greenspoon, LLC, of Chicago, IL, for ami-
`ci curiae Acacia Research Corporation and
`1st Media, LLC on rehearing en banc.
`
`Ian Scott, Duane Morris LLP, of New
`York, NY, for amicus curiae Apotex, Inc.
`on rehearing en banc. With him on the
`brief were Joseph M. Bennett—Paris, of
`Atlanta, GA; Robert Gould and Elese
`Hanson, of Chicago, IL; and Matthew C.
`Mousley, of Philadelphia, PA. Of counsel
`on the brief was Shashank Upadhye, Apo-
`tex, Inc., of Toronto, CA.
`
`Frederick F. Hadidi, Chao Hadidi Stark
`& Barker LLP, of Menlo Park, CA for
`amici curiae 22 Patent Prosecution Firms
`
`and Practitioners on rehearing en banc.
`Of counsel on the brief was Julie Y. Mar-
`
`Spinola, Sawyer Law Group, P.C., of Palo
`Alto, CA.
`
`Christian E. Mammen, University of
`California Hastings College of the Law, of
`San Francisco, CA, for amici curiae Intel-
`lectual Property Law Professors on re-
`hearing en banc.
`
`Leland W. Hutchinson, Jr., Freeborn &
`Peters LLP, of Chicago, IL, for amici curi-
`ae Ole K. Nilssen and Geo Foundation,
`Ltd. on rehearing en banc. With him on
`the brief were Jonathan Hill and Matthew
`J. Kramer.
`
`Mark A. Perry, Gibson, Dunn & Crutch-
`er LLP, of Washington, DC,
`for amici
`curiae Sanofi—Aventis and Microsoft Cor-
`
`poration on rehearing en banc. With him
`on the brief were Matthew D. McGill and
`William G. Jenks.
`
`Robert A. Armitage, Eli Lilly and Com-
`pany, of Indianapolis, IN, for amici curiae
`43 Patent Practitioners Employed by Eli
`Lilly and Company on rehearing en banc.
`With him on the brief were James J. Kel-
`
`ley and Mark J. Stewart.
`
`Chalsen, Milbank,
`E.
`Christopher
`Tweed, Hadley & McCloy LLP, of New
`York NY, for amicus curiae The American
`
`Intellectual Property Law Association on
`rehearing en banc. With him on the brief
`were Lawrence T. Kass and Nathaniel T.
`Browand. Of counsel on the brief was
`
`Alan J. Kasper, American Intellectual
`Property Law Association, of Arlington,
`VA.
`
`Hansjorg Sauer, Biotechnology Industry
`Organization, of Washington, DC, for ami-
`cus curiae The Biotechnology Industry Or-
`ganization on rehearing en banc.
`
`Timothy D. Johnston, Nutter McClen-
`nen & Fish LLP, of Boston, MA, for ami-
`cus curiae Boston Patent Law Association,
`on rehearing en banc. With him on the
`brief was Rory P. Pheiffer.
`
`

`
`THERASENSE, INC. V. BECTON, DICKINSON AND CO.
`Cite as 649 F.3d 1276 (Fed. Cir. 2011)
`
`1281
`
`IP Law
`Steven C. Sereboff, SoCal
`Group LLP, of Westlake Village, CA, for
`amicus curiae Conejo Valley Bar Associa-
`tion on rehearing en banc. With him on
`the brief were Mark A. Goldstein and M.
`
`Kala Sarvaiya.
`
`Spivak,
`Robert C. Nissen, Oblon,
`McClelland, Maier & Neustadt, LLP, of
`Alexandria, VA, for amicus curiae Ecore
`
`International, Inc. on rehearing en banc.
`
`Bruce M. Wexler, Paul, Hastings, Janof-
`sky & Walker LLP, of New York, NY, for
`amici curiae Eisai Co., Ltd. et al. on re-
`hearing en banc. With him on the brief
`were Stephen B. Kinnaird and Igor V.
`Timofeyev, of Washington, DC.
`
`James K. Stronski, Frommer Lawrence
`& Haug LLP, of New York, NY, for ami-
`cus curiae The Federal Circuit Bar Associ-
`
`ation on rehearing en banc. Of counsel on
`the brief was Terence P. Stewart, Stewart
`& Stewart, of Washington, DC.
`
`Robert J. McAughan, Jr., Locke Lord
`Bissell & Liddell, LLP, of Houston, TX,
`for amicus curiae Houston Intellectual
`
`Property Law Association on rehearing en
`banc.
`
`Gregory L. Diskant, Patterson Belknap
`Webb & Tyler LLP, of New York, NY, for
`amici curiae Johnson & Johnson and The
`
`Procter & Gamble Company on rehearing
`en banc. With him on the brief were
`
`Eugene M. Gelernter and Charles D. Hoff-
`mann; and Philip S. Johnson, Eric I. Har-
`ris and Henry S. Hadad, of New Bruns-
`wick, NJ.
`
`Brad D. Pedersen, Patterson Thuente
`Christensen Pedersen, P.A., of Minne-
`apolis, MN, for amicus curiae Patterson
`Thuente Christensen Pedersen, P.A. on re-
`hearing en banc.
`
`A. Shumsky and James C. Owens; and
`Constantine L. Trela, Jr., of Chicago, IL.
`Of counsel on the brief was David E. Korn,
`Pharmaceutical Research and Manufactur-
`
`ers of America, of Washington, DC.
`
`James R. Batchelder, Howrey LLP, of
`East Palo Alto, CA, for amicus curiae SAP
`America, Inc. on rehearing en banc.
`
`Wiliam L. Respess, Nanogen Inc., of
`San Diego, CA, for amicus curiae San Die-
`go Intellectual Property Law Association
`on rehearing en banc. Of counsel on the
`brief was Douglas E. Olson, Paul Hastings,
`Janofsky & Walker, of San Diego, CA.
`
`Charles W. Shifley, Banner & Witcoff,
`Ltd., of Chicago, IL, for anxious curiae The
`Intellectual Property Law Association of
`Chicago on rehearing en banc.
`
`J. Popeo, Washington Legal
`Daniel
`Foundation of Washington, DC, for amicus
`curiae Washington Legal Foundation on
`rehearing en banc. With him on the brief
`was Richard A. Samp.
`
`Bruce A. Lehman, International Intel-
`
`lectual Property Institute, of Washington,
`DC, for amicus curiae International Intel-
`
`lectual Property Institute, on rehearing en
`banc.
`
`Jeffrey M. Samuels, University of Akron
`School of Law, Akron, OH,
`for amicus
`curiae The University of Akron School of
`Law on rehearing en banc. With him on
`the brief was Robert C. Kahrl.
`
`Jeffrey D. Mills, King & Spalding LLP,
`of Austin, TX, for amicus curiae Associa-
`tion of Citizens for Patent Protection in
`
`the Public Interest on rehearing en banc.
`With him on the brief was Brian C. Ban-
`ner.
`
`Carter G. Phillips, Sidley Austin LLP, of
`Washington, DC, for amicus curiae Phar-
`maceutical Research and Manufacturers of
`
`America on rehearing en banc. With him
`on the brief were Jeffrey P. Kushan, Eric
`
`Henry C. Dinger, Goodwin Procter
`LLP, of Boston, MA, for amici curiae Teva
`Pharmaceuticals USA, Inc., et al. Cisco
`Systems, Inc., and Generic Pharmaceutical
`Association on rehearing en banc. With
`
`

`
`1282
`
`649 FEDERAL REPORTER, 3d SERIES
`
`him on the brief were Elaine Herrmann
`Blais, Nicholas K. Mitrokostas and An-
`drew M. Batchelor.
`
`Dan L. Bagatell, Perkins Coie Brown &
`Bain, P.A., of Phoenix, AZ,
`for amicus
`curiae Intel Corporation on rehearing en
`banc. Of counsel on the brief was Tina M.
`
`Chappell, Intel Corporation, of Chandler,
`AZ.
`
`Before RADER, Chief Judge,
`NEWMAN, LOURIE, BRYSON,
`GAJARSA, LINN, DYK, PROST,
`MOORE, O’MALLEY, and REYNA,
`Circuit Judges.
`
`Opinion for the court filed by Chief
`Judge RADE R, in which Circuit Judges
`NEWMAN, LOURIE, LINN, MOORE,
`and REYNA join in full, and in which
`Circuit Judge O’MALLEY joins in part V.
`
`Concurring-in-part and dissenting-in-
`part opinion filed by Circuit Judge
`O’MALLEY.
`
`Dissenting opinion filed by Circuit
`Judge BRYSON, in which Circuit Judges
`GAJARSA, DYK, and PROST join.
`
`RADER, Chief Judge.
`The United States District Court for the
`Northern District of California found U.S.
`
`Patent No. 5,820,551 (“the ’551 patent”)
`unenforceable due to inequitable conduct.
`Therasense, Inc. v. Becton, Dickinson &
`Co., 565 F.Supp.2d 1088 (N.D.Cal.2008)
`(“Trial Opinion”). Therasense, Inc. (now
`Abbott Diabetes Care,
`Inc.) and Abbott
`Laboratories
`(collectively, “Abbott”) ap-
`peal
`that judgment. This court vacates
`and remands for further proceedings con-
`sistent with this opinion.
`
`I
`
`involves disposable
`’551 patent
`The
`blood glucose test strips for diabetes man-
`agement. These strips employ electro-
`chemical sensors to measure the level of
`
`glucose in a sample of blood. When blood
`
`contacts a test strip, glucose in the blood
`reacts with an enzyme on the strip, result-
`ing in the transfer of electrons from the
`glucose to the enzyme. A mediator trans-
`fers these electrons to an electrode on the
`
`strip. Then, the electrons flow from the
`strip to a glucose meter, which calculates
`the glucose concentration based on the
`electrical current.
`
`The ’551 patent claims a test strip with
`an electrochemical sensor for testing whole
`blood Without a membrane over the elec-
`trode:
`
`1. A single use disposable electrode
`strip for attachment to the signal read-
`out circuitry of a sensor to detect a
`current representative of the concentra-
`tion of a compound in a drop of a whole
`blood sample comprising:
`
`a) an elongated support having a sub-
`stantially flat, planar surface, adapted
`for releasable attachment to said read-
`
`out circuitry;
`
`b) a first conductor extending along said
`surface and comprising a conductive ele-
`ment for connection to said readout cir-
`
`cuitry;
`
`c) an active electrode on said strip in
`electrical contact with said first conduc-
`
`tor and positioned to contact said whole
`blood sample;
`
`d) a second conductor extending along
`said surface comprising a conductive ele-
`ment for connection to said read out
`
`circuitry; and
`
`e) a reference counterelectrode in elec-
`trical contact with said second conductor
`
`and positioned to contact said whole
`blood sample,
`
`wherein said active electrode is config-
`ured to be exposed to said whole blood
`sample without an intervening mem-
`brane or other whole blood filtering
`member .
`.
`.
`.
`
`

`
`THERASENSE, INC. V. BECTON, DICKINSON AND CO.
`Citeas649 F.3d 1276 (Fed. Cir. 2011)
`
`1283
`
`’551 patent col. 13 l.29—-col. 14 1.3 (empha-
`sis added).
`“VVhole blood,” an important
`term in the claim, means blood that con-
`
`tains all of its components, including red
`blood cells.
`
`In the prior art, some sensors employed
`diffusion-limiting membranes
`to control
`the flow of glucose to the electrode be-
`cause the slower mediators of the time
`
`could not deal with a rapid influx of glu-
`cose. Other prior art sensors used protec-
`tive membranes
`to prevent
`“fouling.”
`Fouling occurs when red blood cells stick
`to the active electrode and interfere with
`electron transfer to the electrode. Protec-
`
`tive membranes permit glucose molecules
`to pass, but not red blood cells.
`
`application
`filed the original
`Abbott
`leading to the ’551 patent in 1984. Over
`thirteen years,
`that original application
`saw multiple rejections for anticipation and
`obviousness, including repeated rejections
`over U.S. Patent No. 4,545,382 (“the ’382
`patent”), another patent owned by Abbott.
`The ’382 patent specification discussed
`protective membranes
`in the following
`terms:
`“Optionally, but preferably when
`being used on live blood, a protective
`membrane surrounds both the enzyme and
`the mediator layers, permeable to water
`and glucose molecules.” Col.4 ll.63—66.
`
`“Live blood” refers to blood within a body.
`
`In 1997, Lawrence Pope, Abbott’s patent
`attorney, and Dr. Gordon Sanghera, Ab-
`bott’s Director of Research and Develop-
`ment, studied the novel features of their
`
`application and decided to present a new
`reason for a patent. Pope presented new
`claims to the examiner based on a new
`
`sensor that did not require a protective
`membrane for whole blood. Pope asserted
`that this distinction would overcome the
`
`prior art ’382 patent, whose electrodes al-
`legedly required a protective membrane.
`The examiner requested an affidavit
`to
`show that the prior art required a mem-
`
`brane for whole blood at the time of the
`invention.
`
`this evidentiary request, Dr.
`To meet
`Sanghera submitted a declaration to the
`U.S. Patent and Trademark Office (“PTO”)
`stating:
`[O]ne skilled in the art would have felt
`
`that an active electrode comprising an
`enzyme and a mediator would require a
`protective membrane if it were to be
`
`.
`.
`used with a whole blood sample. .
`[O]ne skilled in the art would not read
`lines 63 to 65 of column 4 of U.S. Patent
`No. 4,545,382 to teach that the use of a
`protective membrane with a whole blood
`
`sample is optionally or merely preferred.
`
`J.A. 7637. Pope, in submitting Sanghera’s
`affidavit, represented:
`
`The art continued to believe [following
`the '382 patent] that a barrier layer for
`[a] whole blood sample was neces-
`sary. .
`.
`.
`One skilled in the art would not have
`
`read the disclosure of the [’382 patent]
`as teaching that the use of a protective
`membrane with whole blood samples
`was optional. He would not, especially
`in view of the working examples, have
`read the “optionally, but preferably” lan-
`guage at
`line 63 of column [4] as a
`technical teaching but rather mere pat-
`ent phraseology.
`
`There is no teaching or suggestion of
`unprotected active electrodes for use
`with whole blood specimens in [the ’382
`patent]. .
`.
`.
`J.A. 7645~46.
`
`Several years earlier, while prosecuting
`the European counterpart to the ’382 pat-
`ent, European Patent EP 0 078 636 (“EP
`’636”), Abbott made representations to the
`European Patent Office (“EPO”) regard-
`ing the same “optionally, but preferably”
`language in the European specification.
`
`

`
`1284
`
`649 FEDERAL REPORTER, 3d SERIES
`
`On January 12, 1994, to distinguish a Ger-
`man reference labeled D1, which required
`a diffusion-limiting membrane, Abbott’s
`European patent counsel argued that their
`invention did not require a diffusion-limit-
`ing membrane:
`Contrary to the semipermeable mem-
`brane of DI,
`the protective membrane
`optionally utilized with the glucose sen-
`sor of the patent
`is [sic] suit
`is not
`controlling the permeability of the sub-
`strate .
`.
`.
`. Rather, in accordance with
`column 5, lines 30 to 33 of the patent in
`suit:
`
`“Optionally, but preferably when being
`used on live blood, a protective mem-
`brane surrounds both the enzyme and
`the mediator layers, permeable to water
`and glucose molecules.”
`See also claim 10 of the patent in suit as
`granted according to which the sensor
`electrode has an outermost protective
`membrane (11) permeable to water and
`glucose molecules. .
`.
`. Accordingly, the
`purpose of the protective membrane of
`the patent in suit, preferably to be used
`with in vivo measurements, is a safety
`measurement
`to prevent any course
`[sic] particles coming off during use but
`not a permeability control for the sub-
`strate.
`
`J.A. 6530-31 (emphases added).
`
`On May 23, 1995, Abbott’s European
`patent counsel submitted another explana-
`tion about the D1 ref