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Therasense, Inc. v. Becton, Dickinson and Co.
649 F.3d 1276
Fed. Cir.
2011
Check Treatment
Docket

*1 (now THERASENSE, known as INC. Inc.) Care, and Ab

Abbott Diabetes Laboratories, Plaintiffs-Appel

bott

lants,

BECTON, AND COMPA DICKINSON Corpora

NY, and Nova Biomedical

tion, Defendants-Appellees,

Bayer LLC, Defendant- Healthcare

Appellee. 2008-1511, 2008-1512, 2008-

Nos.

1513, 2008-1514, 2008-1595. Appeals,

United States Court of

Federal Circuit.

May *3 Whealan, of Spring,

Jоhn M. Silver MD argued plaintiffs-appellants on rehear- ing en banc. With him on the brief were Detre, Singla K. and Peter A. Mun- Rohit LLP, ger, Tolies & Olson of San Francis- co, CA; Jeffrey Weinberger, I. of Los CA; Angeles, Jeffrey A. Lamken and Mi- Jr., LLP, Pattillo, chael G. MoloLamken Washington, were DC. Of counsel Chan- *4 Jr., D’Apuzzo, Rowley, tal Fred A. M. Ward, Song Andrew W. and Donald W. LLP, of An- Munger, Tolies & Olson Los geles, CA. Badke, LLP, Ropes Gray

Bradford J. & York, NY, argued of New for defendants- Becton, appellees Company, Dickinson and rehearing et al. on en him banc. With on the brief was counsel Sona De. Of was Gabrielle M. Ciuffreda. Krevans,

Rachel Morrison & Foerster LLP, Francisco, CA, argued of San defendant-appellee Bayer Healthcare rehearing LLC on en banc. her on With Brian Greg- the brief were M. Kramer and CA; Reilly, ory Diego, W. of San Casino, P. George Joseph Kenneth M. LLP, Amster Rothstein & Ebenstein of York, NY. R. New Of counsel were Jason Bartlett, Jorjani, Wesley E. Parisa Overson. Chen, Solicitor,

Raymond T. Office of Solicitor, Patent and United States Office, Alexandria, ar- Trademark of VA gued for amicus curiae the Director of the Patent Trademark United States Of- rehearing on banc. him on fice en With Jr., Knight, the brief were Bernard J. Counsel, Johnson, Sydney 0. Jr. General A. Gongola, and Janet Associate Solicitors. on the was R. McIn- Of counsel brief Scott tosh, Staff, Attorney, Appellate Civil Divi- Justice, sion, Department of United States Washington, DC. Lamm, Bar Asso- Carolyn B. American IL, ciation, curiae Chicago, for amicus rehear- The American Bar Association on P.C., Sawyer counsel on the brief were ing Spinola, Group, en banc. Of Law of Palo Lafuze, Michael A. and William L. Alto, Valek CA. LLP, Houston, TX.

Vinson & Elkins Mammen, Christian E. University of L. Farella Braun & Martel Cooper, John Law, Hastings California College of the Francisco, CA, LLP, of for amicus San Francisco, CA, San for amici curiae Intel- Laboratories, Dolby Inc. on rehear- curiae Property lectual Law Professors on re- ing en banc. hearing en banc. Taranto, Taranto, Richard G. Farr & Hutchinson, Jr., Leland W. Freeborn & DC, Washington, for amicus curiae Veri- LLP, IL, Chicago, Peters for amici curi- Communications, Inc. on rehearing zon en Foundation, ae Ole K. Nilssen and Geo on the brief were banc. Of counsel John Ltd. rehearing on en banc. himWith Levine, F. Thorne and Gail Verizon Com- the brief were Jonathan Hill and Matthew Inc., Arlington, munications VA. Kramer. J. Hricik, University David Mercer School Gibson, Perry, Mark A. Dunn & Crutch- Law, Macon, GA, for amicus curiae *5 LLP, DC, Washington, er of for amici Professor Hricik on rehearing David en curiae Sanofi-Aventis and Microsoft Cor- banc. poration on rehearing en banc. himWith McDonnell, Boehnen, Paul H. Berghoff, on the brief were Matthew D. McGill and LLP, IL, Berghoff, Chicago, Hulbert & of William G. Jenks. for Property amicus curiae Intellectual Owners on rehearing Association en banc. Robert A. Armitage, Lilly Eli and Com- himWith on the brief was Kurt W. Rohde. IN, pany, of Indianapolis, for amici curiae Of counsel on the brief were Douglas K. 43 Patent Employed by Practitioners Eli Rhodes, Norman H. and Kevin Intellectual Lilly Company rehearing on en banc. Association, Property Washing- Owners of himWith on the brief were James J. Kel- ton, counsel DC. Of was Herbert C. ley and Mark J. Stewart. Wamsley, Property Intellectual Owners Chalsen, Christopher Milbank, E. Association, of Washington, DC. Tweed, LLP, Hadley McCloy & of New Greenspoon, Robert P. Flaehsbart & NY, York for amicus curiae The American LLC, IL, Greenspoon, of Chicago, for ami- Intellectual Property Law Association on ci curiae Acacia Research Corporation and rehearing en banc. With him on the brief Media, 1st rehearing LLC on en banc. were Lawrence T. Kass and Nathaniel T. Scott, LLP, Ian Duane Morris of New Browand. Of counsel on the brief was York, NY, for amicus Apotex, curiae Inc. Alan Kasper, J. American Intellectual on rehearing en banc. him With on the Property Association, Law Arlington, of BennetL-Paris, brief M. Joseph were of VA. Atlanta, GA; Robert Gould and Elese Sauer, Hansjorg Biotechnology Industry Hanson, IL; Chicago, of and Matthew C. DC, Organization, Washington, of for ami- Mousley, Philadelphia, of PA. Of counsel cus curiae Biotechnology Industry The Or- on the Upadhye, brief was Shashank Apo- ganization on rehearing en banc. tex, Inc., Toronto, of CA. Johnston, Timothy D. Nutter McClen- Hadidi,

Frederick F. Chao Hadidi Stark LLP, Boston, MA, nen & Fish LLP, of for ami- Park, & Barker of Menlo for CA Association, amici cus curiae Boston Patent curiae Patent Law Prosecution Firms rehearing Practitioners on on en him rehearing en banc. banc. With on the Of counsel on Rory the brief was Julie Y. Mar- brief was P. Pheiffer. Owens; Sereboff, IP A. C. Shumsky SoCal Law and James C.

Steven LLP, CA, Village, Trela, Jr., for IL. Group Chicago, Westlake Constantine L. Bar Conejo Valley Associa- Korn, amicus curiae was E. Of counsel on the brief David With him on rehearing on en banc. tion Pharmaceutical Research and Manufactur- M. were Mark A. Goldstein and the brief America, Washington, ers of DC. Sarvaiya. Kala Batchelder, LLP, Howrey James R. Obion, Nissen, Spivak, C. Robert CA, Alto, East Palo for curiae SAP amicus McClelland, Neustadt, LLP, of &Maier America, rehearing en Inc. on banc. Alexandria, VA, curiae for amicus Ecore Inc., Respess, Wiliam L. Nanogen International, rehearing en banc. Inc. on CA, Diego, San for amicus Die- curiae San Paul, Wexler, Hastings, Bruce M. Janof- go Property Intellectual Association Law York, LLP, NY, New for sky & Walker on banc. Of on the rehearing en counsel al. curiae Ltd. et on re- amici Eisai Olson, brief was E. Douglas Hastings, Paul him on hearing en banc. the brief With Janofsky Walker, of San Diego, CA. & Stephen Igor B. Kinnaird V. were Witcoff, Shifley, Charles Banner & W. DC. Timofeyev, Washington, Ltd., IL, Chicago, curiae The amicus Stronski, K. Frommer Lawrence James Property Intellectual Law Association NY, LLP, York, ami- Haug of New & Chicago rehearing on en banc. Bar Circuit Associ- cus curiae Federal banc. Of counsel on rehearing ation en Popeo, Daniel Washington Legal J. Stewart, was P. Stewart the brief Terence DC, Washington, Foundation of for amicus *6 Stewart, Washington, of DC. & Washington Legal curiae on Foundation rehearing With him brief en banc. on the Jr., Lord McAughan,

Robert J. Locke Samp. was A. Richard TX, Liddell, LLP, Houston, Bissell & for amicus curiae Houston Intellectual Lehman, Bruce A. International Intel- rehearing Law on en Property Association Institute, of Property Washington, lectual banc. DC, for curiae Intel- amicus International Diskant, L.

Gregory Belknap Patterson Institute, Property rehearing lectual on en York, LLP, NY, Tyler for & of New Webb banc. curiae The amici Johnson & Johnson and Samuels, Jeffrey University of Akron M. Company rehearing Procter & on Gamble Law, Akron, OH, amicus School of for en banc. With him on brief were University curiae of Akron School M. and Charles D. Hoff- Eugene Gelernter rehearing Law on en banc. him on With

mann; Johnson, Eric Philip and S. I. Har- the brief C. Kahrl. was Robert Hadad, Henry ris and of New Bruns- S. Mills, LLP, Jeffrey King & Spalding D. wick, NJ. TX, Austin, for amicus Associa- curiae Pedersen, Brad D. Patterson Thuente tion of Citizens for Patent Protection P.A., Pedersen, Christensen Minne- on en rehearing the Public Interest banc. MN, apolis, for amicus curiae Patterson him the brief was Brian C. Ban- With on Pedersen, P.A. re- Thuente Christensen on ner. hearing en bane. Henry Procter Dinger, Goodwin C. LLP, Sidley Austin Phillips, Carter G. LLP, MA, Boston, for Teva amici curiae DC, amicus curiae Phar- Washington, for USA, Inc., et al. Cisco Pharmaceuticals and maceutical Research Manufacturers Inc., Systems, and Generic Pharmaceutical rehearing on en banc. With him America Kushan, rehearing en Jeffrey P. Eric Association on banc. With on the brief were strip, glucose on the brief were Elaine Herrmann test him contacts a in the blood Blais, K. and An- Nicholas Mitrokostas enzyme an on result- strip, reacts with M. Batchelor. drew ing in transfer of electrons from the glucose enzyme. A mediator trans- Bagatell, L. Brown & Dan Perkins Coie on Bain, Phoenix, AZ, fers these electrons to an electrode P.A., amicus Then, Corporation rehearing strip. Intel en curiae electrons flow from counsel on the brief was Tina M. meter, banc. Of glucose strip to which calculates Chandler, Corporation, Intel Chappell, glucose concentration on the based AZ. electrical current. RADER, strip The '551 claims a

Before test Judge, Chief NEWMAN, LOURIE, BRYSON, an electrochemical sensor for whole testing GAJARSA, LINN, DYK, PROST, blood without a membrane over the elec- MOORE, O’MALLEY, REYNA, trode: Judges.

Circuit single disposable 1. A use electrode strip attachment signal read- Opinion for the court filed Chief circuitry of a out sensor to detect RADER, Judges Judge which Circuit representative current of the concentra- NEWMAN, LOURIE, LINN, MOORE, compound tion of a in a drop of a whole full, join REYNA in which sample comprising: blood Judge joins O’MALLEY in part Circuit V. a) elongated support having sub- Concurring-in-part dissenting-in- flat, stantially surface, planar adapted

part opinion Judge filed Circuit for releasable attachment to said read- O’MALLEY. circuitry; out Dissenting opinion filed by Circuit b) a conductor extending along first said BRYSON, Judge in which Judges Circuit surface and comprising a conductive ele- GAJARSA, DYK, join. and PROST ment for connection to cir- said readout RADER, Judge. Chief *7 cuitry; The United States District for Court c) an strip active electrode on said Northern District of California found U.S. electrical contact with said first conduc- 5,820,551 ‍‌​​​‌​‌‌​​‌‌​‌‌‌​​​‌​‌‌‌​​​‌‌​​​​​‌​‌‌‌‌‌​​​​​​‌‍(“the No. patent”) Patent '551 positioned tor and to contact whole said unenforceable due to inequitable conduct. sample; blood Therasense, Becton, Inc. v. Dickinson & (N.D.Cal.2008) F.Supp.2d d) a along second conductor extending (“Trial ”). (now Opinion Therasense, Inc. comprising said surface a ele- conductive Inc.) Care, Abbott Diabetes and Abbott ment for connection to said read out “Abbott”) (collectively, Laboratories ap- circuitry; and peal judgment. This court vacates e) a reference in elec- counterelectrode and remands for proceedings further con- trical contact said second conductor opinion. sistent with this positioned and to contact said whole sample, blood

I said config- wherein active electrode is patent The '551 disposable involves exposed ured to said whole blood glucose blood test strips for diabetes man- sample without an mem- agement. intervening These strips employ electro- chemical sensors other filtering to measure the level of brane or whole blood glucose a sample of blood. When .... blood member whole at the (empha- brane for blood time of 13 1.29-col. 1.3 patent col. '551 added). blood,” important an invention. “Whole sis claim, con- means blood that

term evidentiary request, To meet Dr. including red components, all of tains submitted a to the Sanghera declaration cells. blood (“PTO”) U.S. Patent Trademark Office art, employed prior In the some sensors stating: the flow tive membranes tive membranes could not deal with diffusion-limiting membranes Fouling thirteen leading cose. Other cause terms: being protective membranes patent”), the mediator membrane surrounds “Live obviousness, electron transfer saw over U.S. Patent Abbott pass, multiple rejections glucose molecules.” Col.4 11.63-66. '382 blood” used active but not red “Optionally, occurs another years, Lawrence filed the the '551 slower patent specification glucose refers including electrode layers, when red blood cells stick permit live to the electrode. Protec- No. art sensors used mediators of blood to blood within a patent but Pope, both permeable to water blood, original application 4,545,382 original application rapid repeated rejections prevent and interfere with glucose molecules in the owned cells. preferably anticipation Abbott’s in 1984. Over electrode be- influx of enzyme to control by Abbott. protective (“the “fouling.” discussed the time following protec- body. when '382 glu- J.A. 7637. affidavit, represented: that an active eleсtrode used protective membrane was protective membrane lines [O]ne enzyme No. the '382 The membrane with whole blood sample read in view of the [O]ne sary. technical read as One guage ent [a] teaching phraseology. 4,545,382 to teach that whole blood optional. art skilled in the art would have not 63 to 65 ... with a whole blood skilled in the skilled in the art would not read at line 63 of column and mediator would patent] “optionally, continued Pope, disclosure of teaching optionally merely that the use a He would working examples, column of submitting but sample to believe [following art would but with a if it rather barrier preferably” of a comprising not, ['382 the use were was neces- whole blood U.S. sample.... Sanghera’s preferred. mere protective especially require have felt layer [4] samples patent] Patent to be of a pat- lan- a *8 Ab- attorney, Sanghera, Dr. Gordon and teaching suggestion is no There Develop- of Research and bott’s Director for use unprotected active electrodes ment, their the novel features of studied specimens with whole blood in '382 [the present to a new application and decided patent].... Pope presented for a new patent. reason J.A. 7645-46. a new to examiner based on claims the earlier, years prosecuting while require protective a Several sensor did pat- to European counterpart the '382 Pope for whole blood. asserted the membrane (“EP ent, 0 078 European the Patent EP would overcome distinction '636”), representations to the whose al- Abbott made patent, art '382 electrodes prior (“EPO”) regard- European Patent Office required protective membrane. legedly preferably” but “optionally, to the same requested ing an affidavit The examiner specification. language European required art a mem- the that the show said, distinguish a Ger- sor. Furthermore January On said Dl, required man reference labeled protective should prevent membrane membrane, diffusion-limiting Abbott’s glucose penetration, the molecules from argued counsel that their European patent “permeable” glucose the membrane is require a invention did not diffusion-limit- molecules. This teaches the skilled arti- ing membrane: that, san the [Dl membrane] whereas semipermeable the mem- Contrary to ... permeability must control the of the Dl, protective brane the membrane ... glucose purpose protec- the of the optionally glucose with the sen- utilized patent tive membrane in suit is patent sor suit is not [sic] not to control permeation controlling permeability sub- glucose very molecules. For this reason Rather, strate .... accordance with the sensor electrode as claimed does not patent column lines 30 33 of the (and have) must not a semiperme- suit: able membrane sense in the ofDl. “Optionally, preferably being when but (first added). emphases J.A. 6585 and third blood, protective used on mem- live enzyme brane surrounds both the and II layers, permeable mediator water 2004, Becton, In March Dickinson and glucose molecules.” (“Becton”) Co. sued Abbott the District See also claim of the in suit as seeking declaratory of Massachusetts granted according to which the sensor judgment noninfringement U.S. Pat- protective electrode has outermost (“the 6,143,164 ent patent”) Nos. '164 (11) permeable membrane to water and (“the 6,592,745 patent”). '745 Becton’s glucose Accordingly, molecules.... product was a glucose strip, blood test purpose protective membrane BD Strip. Test Abbott countersued Bec- suit, preferably used ton in the Northern District of California measurements, with in safety vivo is a alleging strip infringed Becton’s prevent measurement any course '164, '745, patents. and '551 The District of particles coming during [sic] use but off Massachusetts then transferred its case to not a permeability control the sub- the Northern District of California. Ab- strate. bott then sued Nova Biomedical Corp. added). J.A. 6530-31 (emphases (“Nova”), supplier, Becton’s in- alleging 23, 1995, May On European Abbott’s fringement of the patents asserted in Ab- patent counsel explana- submitted another suit against bott’s In August Becton. tion about Dl reference and EP '636. 2005, Abbott Bayer also sued Healthcare “Optionally, preferably being but when (“Bayer”), LLC that its alleging Microfill blood, used on a protective live mem- and Autodisc glucose strips blood infringed brane both enzyme surrounds the '551 and '745 patents. The Northern layers, permeable mediator to water District California consolidated all of the glucose molecules.” *9 cases. It is that this submitted disclosure is The district court granted summary unequivocally clear. The protective judgment of noninfringement of all however, assert- optional, membrane is ed claims in the and preferred patents. '164 '745 when used on live blood Therasense, Becton, order Inc. v. prevent larger to the Dickinson constituents & blood, Co., (N.D.Cal. 835, 854, particular the erythrocytes F.Supp.2d 560 880 2008). interfering with the electrode sen- The district also nearly court found from

1285 of a patent proved, patent. claims '745 bars enforcement the of the all of asserted Id. at anticipation. 880. This judge-made invalid due to doctrine evolved from a Supreme applied trio Court cases trial, the a bench district Following the doctrine of unclean hands to dismiss 1-4 of that claims the determined court patent egregious involving cases miscon- invalid due obvious- patent '551 were Keystone duct: Driller v.Co. General Ex- patent the '382 and light of U.S. ness Co., 240, 146, (“the cavator 290 U.S. 54 S.Ct. 78 4,225,410 patent”). '410 Patent No. (1933), L.Ed. v. 1127. 293 Hazel-Atlas Glass Co. Opinion at The central issue Trial Co., 238, prior Hartford-Empire was the art for obviousness whether 322 U.S. 64 glucose 997, (1944), disclosed a sensor would have L.Ed. S.Ct. 88 1250 overruled for blood to a without mеmbrane whole by grounds on other Oil Co. v. Standard ordinary skill in the art. The person States, 17, 31, 429 United U.S. 97 S.Ct. 50 found that the '382 district court (1976), L.Ed.2d 21 and Precision Instru- protective “a disclosed sensors Manufacturing ment v. Co. Automotive optional except was in all cases membrane Co., 806, 324 Machinery Maintenance U.S. blood, case case live in which the the (1945). 65 S.Ct. 89 L.Ed. 1381 preferred was protective membrane —but Keystone involved the manufacture and at required.” primary Id. 1103. Of not suppression of evidence. 290 U.S. at here, the court held the relevance district patentee 54 S.Ct. 146. The of “a knew '551 unenforceable possible prior party prior use” a third Abbott conduct because did disclose filing patent application but did PTO briefs the EPO filed on the inform Id. the PTO. at 54 146. S.Ct. January 12,1994 and 1995. at May Id. patent, After issuance of the the paten- the 1127. paid prior sign tee the user a false judgments Abbott inval- appealed stating that was affidavit his use an aban- unenforceability, idity, noninfringe- and bought doned his experiment agree- and Therasense, Becton, Inc. ment. Dickin- ment keep prior secret the details (Fed.Cir.2010), F.3d son & 1289 suppress use and to evidence. Id. With vacated, (Fed.Cir.2010). Fed.Appx. patentee preparations place, these unanimously upheld A this court panel of patent, along then asserted this with two judgments the district court’s of nonin- against Byers other Machine Co. patents, at fringement invalidity. and Id. 1311. (“Byers”). Keystone Byers Driller Co. v. unenforceability, also af- panel On (N.D.Ohio 1929). Co., F.Supp. Mach. firmed, but with a dissent. Id. at 1312-25 and of cover- Unaware of use (Linn, J., dissenting). up, patents held and the court valid Recognizing problems created infringed granted injunction. an Id. expansion inequita- and overuse of the at 160. doctrine, granted ble conduct this court then patentee asserted the same rehearing en petition Abbott’s banc patents against General Excavator Co. panel. judgment vacated in- Osgood sought temporary Co. Therasense, Fed.Appx. at This junction previ- based on the decree court’s ineq- court now vacates district Keystone, ous case. Byers U.S. judgment uitable conduct and remands. 146. The court de- 54 S.Ct. district Ill injunctions nied but made defen- dis- post dants bonds. Id. The defendants equitable Inequitable conduct is *10 that, if introduced evidence of the infringement covered and defense to 1286

corrupt patentee investiga between the before and after transaction Hazel-Atlas’s 243-44, prior 242-43, at S.Ct. spoke and the user. Id. 54 him. tors Id. at 64 S.Ct. court 146. The district declined dismiss 997. After Hazel-Atlas settled with the hands. these cases for unclean Id. On patentee, patentee paid the Clarke total Circuit reversed and re- appeal, the Sixth $8,000. These Id. facts surfaced the manded with instructions dismiss suit, later United States Hartford-Em The af- complaints. Supreme Id. Court (N.D.Ohio 1942). pire F.Supp. 46 541 247, firmed. Id. at 146. S.Ct. Hazel-Atlas, 243, 322 U.S. at 997. S.Ct. if Supreme explained The Court the newly-discovered On thе basis of these corrupt patentee between the transaction facts, petitioned Hazel-Atlas Third the the had and user been discovered judgment, to vacate its Circuit but the Byers case, previous “the court un- the 243-44, Id. court refused. at 997. S.Ct. doubtedly would have been warranted Supreme 251, The Court at reversed. Id. holding it require sufficient to dismissal Supreme 64 S.Ct. 997. The ex- Court 246, at the cause of action.” Id. 54 S.Ct. plained if the district court had patentee Byers 146. Because the used the patentee’s deception learned the before injunction an decree to seek the cases PTO, it the would have been warranted in against Osgood General Co. Excavator dismissing patentee’s case under the Co., it did not come to court clean 250, doctrine of unclean hands. Id. at hands, and dismissal these cases was Likewise, 997. S.Ct. had Third Circuit appropriate. at Id. 54 S.Ct. 146. patentee’s learned of the suppression of Keystone, Like Hazel-Atlas involved evidence, it also could have dismissed both the manufacture suppression appeal. Accordingly, Supreme Id. evidence. 322 U.S. at 997. S.Ct. judgment against Court vacated the Ha- with “apparently Faced insurmountable zel-Atlas and reinstated the original judg- opposition,” patentee’s Patent Office dismissing patentee’s ment case. Id. attorneys describing wrote article at 64 S.Ct. 997. invention as a remarkable advance in the Precision, patentee suppressed Clarke, art had well-known William perjury evidence of before the PTO and expert, sign publish it as his own and it in attempted to enforce the perjury-tainted journal. a trade Id. After the patentee 816-20, patent. 324 at U.S. 993. S.Ct. submitted the Clarke article to the PTO The PTO had declared an interference be- support of its application, the PTO allowed tween two applications, one filed 240A11, a patent to issue. Id. at 64 S.Ct. Larson and the other Zimmerman. Id. 997. 65 S.Ct. 993. Mainte- Automotive patentee brought against Ha- suit (“Automotive”) Machinery nance Co. (“Hazel-Atlas”), zel-Atlas Co. alleg- Glass application. owned the Zimmerman Id. ing infringement patent. Id. at preliminary Larson filed his statement 64 S.Ct. 997. The district court no found proceedings the PTO with false dates of infringement. appeal, Id. On paten- conception, disclosure, drawing, descrip- attorneys emphasized tee’s arti- Clarke tion, Later, practice. reduction to he cle, and the Third Circuit reversed the in support testified of these false dates in district judgment, holding pat- court’s proceeding. 809-10, an interference Id. at ent infringed. valid and patentee Id. The S.Ct. then went great lengths conceal false authorship article, perjury con- Automotive discovered this but Clarke tacting times, multiple including Clarke did not reveal this information to the PTO.

1287 Instead, also di- Inequitable conduct 818, Automo- PTO. 65 S.Ct. 993. Id. at settlement with hands private verged into from the doctrine unclean tive entered rights the to gave that Automotive potent Larson more by adopting a different and suppressed and evi- application Larson the remedy unenforceability of the entire — 813-14, at Id. perjury. of Larson’s dence mere of the patent rather than dismissal eventually re- 993. Automotive 65 S.Ct. Precision, at instant suit. See 324 U.S. Larson the and patents both ceived suit); 819, (dismissing 65 993 Hazel- S.Ct. 814, at applications. Id. Zimmerman Atlas, 251, (noting at S.Ct. 997 U.S. Despite knowing that the Lar- 993. S.Ct. remedy the dismissal that was limited to perjury, with Auto- patent was tainted son and the unenforcea- did not render against to others. sought motive enforce ble); Keystone, 247, 290 U.S. at 54 S.Ct. 807, at 65 S.Ct. 993. Id. suit). (affirming dismissal court found Automotive The district strong- scope line with this wider and unclean hands and dismissed the suit. had remedy, inequitable er conduct came The Seventh 65 S.Ct. 993. Id. at require finding of both intent to deceive Supreme reversed. Id. The Court Circuit materiality. and Star Inc. v. Scientific decision, ex- the Seventh Circuit’s reversed Reynolds R.J. Tobacco that dismissal was warranted be- plaining (Fed.Cir.2008). To on the prevail only patentee failed cause not had conduct, inequitable defense of the accused knowledge perjury its disclose infringer applicant prove must PTO, actively suppressed it had evidence infor- misrepresented or omitted material its effects. perjury magnified and specific mation with the intent to deceive 818-19, at 65 S.Ct. 993. Id. infringer the PTO. The accused must Id. prove both and materiali- elements—intent IV ty by convincing evidence. Id. clear — Keystone, unclean hands cases burden, infringer If the accused meets Hazel-Atlas, formed and Precision the ba- weigh court then district must inequitable a new con- sis for doctrine appli- whether the equities to determine developed over time. and evolved duct warrants cant’s conduct before PTO cases these hands before Each of unclean entire unenforceable. rendering the particularly Supreme Court dealt misconduct, including perjury, Id. egregious evidence, manufacture of false early un- recognizes This that the court Precision, of evidence. See suppression present any not stan- clean hands cases do 993; 816-20, at S.Ct. Hazel- 324 U.S. materiality. say, dard for Needless 997;

Atlas, Key- at 322 U.S. 64 S.Ct. re- development court’s stone, at 290 U.S. 54 S.Ct. More- does not quirement inequitable conduct over, “deliberately they all involved cannot) (and Court supplant Supreme carefully scheme[s] executed planned inequitable conduct precedent. Though but only the PTO also to defraud” cases, unclean developed these from Hazel-Atlas, courts. 322 U.S. supply hands remains available to doctrine As the conduct doc- S.Ct. 997. like egregious misconduct remedy from unclean hands trine evolved these Court cases. Supreme cases, scope a broader it came embrace emerged from As misconduct, only including egregious hands, intent to unclean the standards for acts of misconduct intended affirmative fluctuated deceive and courts but deceive both PTO has past, In the this court of information over time. the mere nondisclosure also *12 1288 meeting low

espoused prosecuting attorney patentee’s standards for from the requirement, finding intent it satisfied litigation Stephen team. See A. Merrill et gross negligence negli based on or even al., Nat’l Research Council of the Nat’l Cebalo, See gence. Driscoll 731 F.2d Academies, System A Patent the 21st for (Fed.Cir.1984) (“Where 878, they 885 (2004). Moreover, Century 122 inequita- knew, known, should with or that the ble conduct cast charges a dark cloud over be to the held reference would material patent’s validity paint paten- and consideration, their PTO’s failure dis as a tee bad actor. Because doctrine proof close the reference is sufficient turpitude pat- focuses the moral the existence of an intent to mislead consequences entee with ruinous for the PTO.”); Orthopedic Equip. v. All Inc. reputation patent attorney, his dis- Inc., Orthopedic Appliances, F.2d 707 courages settlement and deflects attention (Fed.Cir.1983) 1376, (requiring 1383-84 from the of validity infringe- merits and only gross negligence to sustain finding a ment issues. Paper, Committee Position intent). This court has previously also Inequitable The Doctrine Conduct and adopted using broad view of materiality, Duty Candor Patent Prosecu- a “reasonable examiner” based standard tion: Its Impact Current Adverse on the on the PTO’s 1977 amendment to Rule 56. Operation the United States Patent See Am. Hoist & Derrick Co. v. Sowa & 74, (1988). System, Q.J. 16 AIPLA In- 75 Inc., Sons, 1350, (Fed.Cir. 725 F.2d 1362 equitable disputes conduct also “inereas[e] (1977) (a 1984); § see also 37 C.F.R. 1.56 complexity, duration cost of pat- and reference material if “there ais substan infringement litigation ent is already tial likelihood that a reasonable examiner complexity notorious for and high important deciding would consider it Appendix cost.” Brief and of the Ameri- application whether allow the to issue patent”). can Bar weakening Further show Ass’n as Amicus Curiae ing inequitable needed establish con most Perhaps importantly, duct, placed this court then intent remedy for inequitable conduct is the together on scale.” “sliding patent “atomic bomb” of law. Aventis Hoist, Am. 725 F.2d at 1362. modifi This Pharm., Amphastar Inc., Pharma S.A. v. cation conduct doctrine (Fed.Cir.2008) (Rader, 525 F.3d patents held unenforceable a re based on J., dissenting). defenses, validity Unlike if showing duced of intent con record are specific, claim see U.S.C. strong showing materiality, tained a § inequitable conduct regarding any effect, vice this change versa. conflat claim single renders the un entire ed, diluted, the standards both Kingsdown enforceable. Med. Consul materiality. intent and tants, Inc., Ltd. v. Hollister F.2d This court embraced these reduced (Fed.Cir.1988). Unlike other deficien standards intent and cies, inequitable conduct cannot cured fostеr full disclosure to the id. PTO. See Aventis, reissue, 1341, 6, 525 F.3d at n. at 1363. This encouraging new focus on reexamination, Textron, Molins PLC v. disclosure has had numerous unforeseen Inc., (Fed.Cir.1995). 48 F.3d consequences. and unintended Most Moreover, the taint of a finding inequi prominently, inequitable conduct has be- spread single table conduct can from significant litigation come a A strategy. patent to render unenforceable other relat charge conveniently expands discovery patents ed corporate applications into in the same practices See, filing before and disqualifies technology family. e.g., Consol. Alu- Ltd., dus., Dayco Inc. v. Corp., F.2d v. Foseco Int’l Corp. minum Labs, (Fed.Cir.1988); (Fed.Cir.1990). Thus, also a find- 1422 see Abbott 804, 808-12 *13 Sandoz, (Fed. Inc., 1341, 544 may endanger conduct v. F.3d 1358 inequitable ing of Cir.2008); Desiccants, company’s patent of a Inc. v. portion substantial Multiform (Fed. Medzam, Ltd., 1473, 133 1482 F.3d portfolio. Cir.1998); Magnivision, Inc. v. Bonneau inequitable of conduct finding A Co., 956, (Fed.Cir.1997); 960 115 F.3d Al and unfair com may spawn also antitrust Cyanamid Inc. v. Am. 64 lied Colloids claims. v. See Chemical Co. petition Dow 1570, 1578(Fed.Cir.1995); Molins, 48 F.3d (Fed.Cir. 1470, 1471 139 F.3d Corp., Exxon at 1182. F.3d (unfair claim); 1998) competition Walker unfettered, inequitable Left conduct Inc. Food Mach. & Equip., v. Process only the plagued doctrine has courts 178, S.Ct. Corp., 382 U.S. 86 Chem. patent system. but also the entire Be- (1965) (antitrust 347, 15 247 action L.Ed.2d allegations inequitable of cause conduct Further, prevailing damages). treble for brought “the routinely are on slenderest often inequitable a claim of conduct Indus., Burlington grounds,” 849 F.2d at “exceptional,” poten leading makes a case 1422, patent prosecutors constantly con- attorneys’ of under tially to award fees Brasseler, I, of specter inequitable front conduct § U.S.A. L.P. U.S.C. 35 inequitable charges. casting With conduct Stryker Corp., 267 F.3d 1380 Sales (Fed.Cir.2001). hangman’s noose, inequitable A of the shadow of it is finding patent may prove unsurprising prosecutors regu- the crime or fraud also bury exception attorney-client privilege. larly deluge PTO examiners with Worldwide, references, re Spalding Sports prior of art most of See (Fed.Cir.2000). Inc., marginal 807 value. Brief have See for the United States as Amicus Curiae at 17 consequences, it far-reaching these With (submission nine of hundred references charging inequitable is no wonder any indication without which ones were litigation conduct has become a common relevant); Biotechnology most Brief of the study eighty tactic. One estimated Industry Organization as Amicus Curiae of in- patent infringement cases percent (submission eighteen of pages at 7 of cited conduct. allegations cluded references, including pages listing five ref- 75; Paper Position at see also Committee claims, actions, office erences declara- Mammen, Controlling Christian tions, amendments, summaries, interview In- “Plague”: Reforming Doctrine appli- other and communications related Conduct, Berkeley 24 Tech. L.J. equitable cаtions). “Applicants too much disclose (2009). Inequitable conduct 1358 prior meaningfully art for the PTO to con- overplayed, appearing “has been sider, explain significance, and do suit, cluttering nearly every patent and all out of fear that do otherwise risks a patent system.” Kimberly-Clark up ABA claim conduct.” Sec- Johnson, F.2d Corp. v. & 745 Johnson Law, A Property tion Intellectual Sec- (Fed.Cir.1984). 1437, 1454 “[T]he habit Agenda Paper: 21st Centu- tion White charging inequitable conduct almost ev- (2009). 2 ry Patent This tidal major case become an abso- ery has Reform identifying of disclosure makes wave lawyers plague. Reputable lute seem prior more difficult. most relevant art charge against compelled feel make the Brief Amicus See United States reputable lawyers on slenderest other (submission “large 1at numbers represent their client’s inter- Curiae grounds, to questionable art references of ma- adequately, Burlington In- perhaps.” ests 1290 Precision,

teriality ... harms the effectiveness and the courts. See 324 U.S. at 815-16, (assertion of in- process”). “This flood examination 993 S.Ct. agency’s examining formation strains by perjury); known to tainted Hazel- directly the Atlas, (a resources and contributes to at U.S. S.Ct. backlog.” at Id. 17-18. planned “deliberately carefully execut- ed scheme to defraud” the involving PTO essential, at honesty the PTO is

While bribery perjury); Keystone, both low standards for intent 246-47, ‍‌​​​‌​‌‌​​‌‌​‌‌‌​​​‌​‌‌‌​​​‌‌​​​​​‌​‌‌‌‌‌​​​​​​‌‍(bribery U.S. S.Ct. inadvertently many led to unintended *14 evidence). suppression of them, consequences, among ad- increased judication complexity, cost and reduced Intent sepa and are settlement, courts, likelihood of burdened Roche, requirements. rate Hoffmann-La resources, strained PTO increased PTO Promega Inc. v. Corp., 323 F.3d 1359 backlog, impaired patent and quality. (Fed.Cir.2003). A district court should not tightens court This now the standards scale,” a “sliding use where a weak show finding both intent and in or- may of ing intent be found sufficient based der to redirect doctrine that has been a strong materiality, showing of public. overused to the detriment of the Moreover, vice versa. may a district court solely not infer intent from materiality. V Instead, a weigh court must the evidence prevail To on a claim of inequita of intent to its independent deceive of anal conduct, ble infringer the accused must ysis materiality. of Proving that the appli prove patentee the acted with the reference, cant knew of should have Star, specific intent to deceive the PTO. known of materiality, and decided not Kingsdown, 537 F.3d at (citing 1366 863 submit to prove it the PTO does not 876). at finding F.2d A that the misrepre Star, specific intent deceive. See 537 sentation or gross omission amounts to (“the at F.3d 1366 fact that information negligence negligence under a “should later found material was disclosed can have known” satisfy standard does not not, itself, satisfy deceptive the intent requirement. intent Kingsdown, 863 F.2d conduct”). element of involving at “In a 876. case nondisclosure information, clear and evi convincing Because direct evidence of de must applicant rare, dence show that the ceptive made intent is may a district court a deliberate decision to withhold a known infer intent from indirect and circumstan Molins, material reference.” 48 at F.3d S.D., Mfg. tial evidence. Larson Co. of added). (emphases words, 1181 In other Ltd., Inc. Aluminart Prods. infringer the prove accused must clear (Fed.Cir.2009). However, 1340 convincing evidence applicant that the meet the convincing clear and evidence reference, knew the knew that it was standard, specific the intent to deceive material, and made deliberate decision to single must be “the most infer reasonable withhold it. ence able to be drawn from the evidence.” Star, Indeed, at F.3d the evi requirement This of knowledge de- dence require “must be sufficient to a find origins liberate action has in the trio of ing deceitful intent in the all Supreme light Court cases that set in motion development Kingsdown, circumstances.” F.2d added). cases, Hence, (emphasis doctrine. In each of pat- those when there entee acted knowingly deliberately are multiple reasonable inferences that purpose defrauding drawn, the PTO bemay intent to deceive cannot be affidavits, patentee had submitted two Corp. v. ICOS See Techs. found. Scanner F.3d Sys. Corp., falsely claiming the invention had Vision (“Whenever (Fed.Cir.2008) prof- evidence production used in the of rubber been materiality or intent either fered show goods only in fact test slabs of when rub- multiple reasonable infer- susceptible of been produced. ber had Id. Because ences, clearly court errs in over- a district was misrepresentation but-for in favor another looking one inference issuance, patent’s cause of Court inference.”). This equally reasonable held that was immaterial and refused court’s factual the district court reviews extinguish patent’s presumption of va- reasonable infer- findings regarding what lidity: the evidence for may be drawn from ences goods Production of rubber use or Star, F.3d at 1365. error. See clear indispensable grant- sale was not party alleging inequi affidavits, Because the ing patent. Hence proof, reckless, conduct bears the burden table though perhaps were not *15 any good not faith “patentee need offer the essentially basis for it or material to its infringer the accused explanation unless presumption issue. The reasonable of in provefs] ... a threshold level of first by validity grant furnished the convincing by tent to deceive clear therefore, seem to patent, would not Star, at 1368. F.3d evidence.” destroyed. for good explanation of a faith absence Although at Id. 48 S.Ct. Corona not, withholding does a material reference hands, does address unclean the Cord not itself, prоve intent to deceive. conduct, it inequitable to demon- precursor unwillingness the extin- strates Court’s to VI statutory validity the of guish presumption past, the this court has tried to ad- In patentee misrepresenta- the a where made inequitable con- proliferation the of dress the not the tion to PTO did affect charges the intent stan- by raising duct patent. of thus issuance the Corona Cord In this court Kingsdown, dard alone. supports materiality a but-for standard gross negligence alone made clear that conduct, particularly given that inequitable justify not an inference enough was unenforceability remedy the severe F.2d at 876. intent deceive. far mere inequitable conduct exceeds the that “the involved Kingsdown established validity. of presumption removal a culpa- sufficient conduct ... must indicate that, gen This court holds as a a bility finding of intent require matter, required added). eral the (emphasis This Id. deceive.” is but-for ma standard, alone, inequitable establish standing did higher intent teriality., an fails to dis applicant number of con- When not reduce the PTO, prior prior duct cases before courts did art to the art close problem of mar- cure overdisclosure if the have but-for material PTO would not To ginally prior relevant art to PTO. a had it aware of the allowed claim been concerns, adjusts these this court address Hence, assessing art. undisclosed materiality. as well the standard for reference, the materiality of a withheld must whether the PTO court determine In Corona Cord Tire Co. Dovan have if it would allowed claim had been Court con- Corp., Supreme Chemical reference. of the undisclosed aware patentee’s mis- sidered determination, 358, making patentability this to the PTO. 276 U.S. representation (1928). 373-74, apply preponderance L.Ed. the court should S.Ct. ... give standard and claims exerted behalf one who deceit of the evidence broadest reasonable construction. any gained their unfair means has an advan- Examining Patent Proce- added) (internal See Manual of tage.”) (emphasis citations (8th (“MPEP”) §§ ed. dure omitted). Moreover, enforcement an 2010). Rev.8, patentability July Often injure otherwise valid does not validi- congruent of a will claim be misconduct, merely public because of lurk- ty properly a claim is determination —if ing prosecution, in patent somewhere court based on the invalidated district patent’s was immaterial to the issuance. reference, deliberately withheld then Although but-for materiality necessarily material reference is because generally proved satisfy must be finding invalidity in a district court re- evidence, convincing conduct, quires materiality prong clear and evidentiary higher burden than that used recognizes exception court However, prosecution even PTO. egregious cases of affirmative misconduct. if a district court doеs invalidate exception general requir This rule deliberately claim based on a withheld ref- ing proof but-for incorporates elements of erence, may the reference be material if it early unclean hands cases before the would blocked issuance under Court, Supreme which dealt with “delib evidentiary the PTO’s different standards. erately planned carefully executed §§ See MPEP 706 (preponderance of the scheme[s]” to defraud the and the PTO (broadest evidence), 2111 con- reasonable *16 Hazel-Atlas, 245, courts. 322 U.S. at 64 struction). patentee S.Ct. 997. When the has en doctrine, equitable

As an ineq gaged in acts egregious affirmative of hinges uitable conduct basic fairness. misconduct, such an filing as the of un remedy imposed by equi a court “[T]he affidavit, mistakably false the misconduct ty should be with viola commensurate material. See is Rohm & Haas Co. v. Penick, tion.” Columbus Bd. Educ. v. Crystal 1556, Chem. 722 F.2d 1571 465, 449, 2941, 443 S.Ct. U.S. 99 61 (“there (Fed.Cir.1983) is no room to ar (1979). L.Ed.2d 666 Because gue that submission of false affidavits is (or patent an renders entire even material”); Int’l, see also Ltd. Refac unenforceable, a patent family) as gener 1576, Corp., v. Lotus Dev. 1583 rule, only al this doctrine should applied be (Fed.Cir.1996) (finding the intentional in instances the patentee’s where miscon employment omission of declarant’s duct resulted in the unfair benefit re company inventor’s rendered the affidavit Star, an ceiving unwarranted claim. See inherently false and that are “[a]ffidavits (“[j]ust 537 F.3d at it 1366 is inequitable material”). all, patentee After is un permit to a patentee who his obtained likely go great lengths to to to deceive through misrepresenta deliberate the PTO with a it falsehood unless be tions or omissions material information lieves the falsehood will affect issu patent against others, enforce the it is patent. 247, ance of the See id. at 64 also to strike down an entire (pointing patentee’s S.Ct. 997 out patentee only where the committed lawyers “went considerable trouble and missteps minor or acted with cul minimal expense” to manufacture false evidence all, pability”). After patentee obtains they it because believed was needed to advantage no pat from misconduct if the patent). obtain issuance of the Because ent would have issued anyway. Key See stone, 245, (“The neither mere nondisclosure of art U.S. at 54 S.Ct. 146 equitable powers of the court can never references to PTO nor failure men- in an defined as such Al [under test].” references affidavit be prior art tion affirmative egregious though equitable require miscon- doctrines some constitutes duct, inequitable conduct that abandoning flexibility, claims the use measure require proof such omissions are based on entirely contrary long tests to both materiality. By creating an ex- of but-for standing practice Supreme Court egregious affirmative punish ception prеcedent. long applied have rules Courts the failure to dis- penalizing without acts determining partic and tests whether information that would not close scope ular factual situation falls within the decision, changed issuance this court See, e.g., equitable an doctrine. Winter necessary en- balance between strikes Council, Inc., v. Natural Res. Def. honesty before the PTO and couraging 365, 172 L.Ed.2d 249 U.S. S.Ct. ineq- unfounded accusations of preventing (four-factor (2008) preliminary test for in uitable conduct. junctions); eBay MercExchange, Inc. v. this mischaraeterizes L.L.C., The concurrence 126 S.Ct. U.S. egregious acts exception for affirmative (2006)(four-factor L.Ed.2d 641 test provided limiting example permanent injunctions); Gutierrez —the unmistakably false affidavit. filing of an 206, 215, Corp., Waterman S.S. 373 U.S. misunderstanding, the con- Based on this (1963)(“the 1185, 10L.Ed.2d 297 test S.Ct. court’s test for currence asserts this requires of laches” both de unreasonable unduly contrary rigid Moreover, prejudice). lay consequent precedent. actuality, Supreme Court Supreme Court has made clear that however, materiality standard forth set important purpose such tests serve opinion exception includes an limiting the discretion of district courts. misconduct, affirmative egregious acts of governed by equity must be [C]ourts Ac- just filing of false affidavits. precedents rules and no less than the requiring rule but- cordingly, general courts of law ... the alterna- [because] *17 guidance to materiality provides clear for to equity tive is use each chancellor’s courts, practitioners and while equity, conscience as measure which exception gives misconduct egregious arbitrary alternative would capture extraor- flexibility test sufficient measuring by uncertain as distance Thus, only not dinary circumstances. length of chancellor’s foot.... each sensitive to varied approach this court’s all, guide low- equitable After rules considerations, it is facts and equitable uncertainty, un- er courts reduce avoid early unclean with the also consistent surprise, disparate fair minimize treat- egre- of which dealt with hands cases—all cases, thereby help ment of similar Precision, See 324 U.S. gious misconduct. litigants.... all 816-20, (perjury sup- S.Ct. 993 at 65 Thomas, 314, 323, 116 Lonchar v. 517 U.S. Hazel-Atlas, evidence); pression of (1996) (inter- L.Ed.2d 440 S.Ct. (manufacture at 64 S.Ct. 997 U.S. omitted). nal This court there- quotations evidence); Keystone, 290 suppression rejects fore the view that its test —albeit (bribery and at 54 S.Ct. 146 U.S. capture varying man- enough flexible evidence). suppression of egregious and abusive con- ifestations of appears to eschew The concurrence in the context of inappropriate duct—is definition, because, un- any by test use inequitable conduct has metastasized. way materiality, a district court any test for der adopt the defi This court does in cases inequitable conduct could find Rule As PTO question would not nition “where the conduct matter, by against an this court is not bound counsels this court abdicating initial its materiality in rules. the definition PTO responsibility to determine the boundaries Kessler, Inc. F.3d See Merck & inequitable conduct. (“[T]he (Fed.Cir.1996) 1543, 1549-50 This court adopt declines to the current rulemaking powers of the PTO’s broadest defining inequitable version of 56 in Rule grant ... NOT does Commissioner reliance this because on standard rules.”); see authority issue substantive very in the problems has resulted this (Jan. 1992) (The Fed.Reg.2021 also 57 sought court taking to address this case PTO Rule 56 not define “do[es] stated provides en banc. Rule informa- conduct.”). fraud or While tion is material if it is not cumulative and: court the PTO’s respects knowledge (1) establishes, It or in itself combi- expertise, area of the routine invocation of information, nation with other a prima patent litigation conduct in has unpatentability claim; facie case of of a beyond had adverse ramifications its effect or above, patent PTO. As discussed (2) refutes, with, It or is inconsistent inventors, courts, prosecutors, and the position the in: applicant takes public large at reining an interest in (i) in inequitable Notably, conduct. both the Opposing argument of unpa- Bar American Association and Ameri- tentability Office, relied on by the or Association, Property can Intellectual Law (ii) Asserting an argument patenta- which represent spectrum a wide inter- bility. ests, support requiring but-for § 37 C.F.R. provides 1.56. Rule 56 further (which 56). Rule is absent from a “prima facie case of unpatentability This has court looked the PTO’s Rule is established when the information com- 56 in past as a starting point pels that a unpatent- conclusion claim is Hoist, determining materiality. See Am. ... any able given consideration is before gone F.2d 1363. Rule 56 has may evidence which be submitted in an revisions, through several from the “fraud” attempt to contrary establish a conclusion in its original promulgation standard added). Id. patentability.” (emphasis 1949 to the “reasonable examiner” stan prong The first Rule overly 56 is broad version, dard in the current because information is considered material any includes information that “refutes if even the information would be rendered position with” any appli inconsistent *18 in light subsequent argument irrelevant of cant regarding took patentability. See 37 explanation by or patentee. the Under (1950); § § C.F.R. 1.56 37 C.F.R. 1.56 standard, inequitable conduct could be (1992). (1977); § 37 C.F.R. Tying 1.56 the found an applicant’s based on failure to for inequitable standard con patent disclose information that a examin- rules, duct to PTO understandably agree er readily would was not relevant to change time, from time to has led to uncer prosecution considering the after pat- the tainty inconsistency in develop and the Likewise, argument. entee’s the second ment conduct doctrine. prong broadly of Rule 56 encompasses See, Control, e.g., Digital Inc. v. Charles anything that margin- could considered Works, (Fed. 1309, Mach. 437 F.3d 1316 ally relevant If an patentability. appli- Cir.2006) (applying 1977 version Rule of cant were to assert that his 56); invention Aids, Independent Living Bruno Inc. non-obvious, Servs., would have Ltd., example, v. been Mobility Acorn 1348, (Fed.Cir.2005) anything any bearing 1352-53 relation to (applying obvious- 56). 1992 Experience version of Rule thus could ness be found material under the

1295 Corp. v. Sony 56 See Am. right. Rule Because Rule Univ. prong of second of Studios, Inc., 417, materiality, adopt- 439, 464 104 City low bar U.S. sets such inevitably (1984) 774, result (finding this standard would 78 L.Ed.2d 574 ing S.Ct. existing continuing prosecutors patent analogy to draw an between appropriate of disclosing much art too practice patents “because of the copyrights litigators marginal relevance between kinship historic law charge inequitable conduct continuing to law”). But-for copyright proof required litigation strategy. as a nearly every case copyrights invalidate both trade- materi- critique applicant of but-for based misconduct. See The dissent’s marks on 411(b)(1) of materi- heavily on definitions ality (copyright); § relies 17 U.S.C. Citi- Contrary to the ality in contexts. bank, Inc., other Group, N.A. 724 v. Citibanc dissent, however, Cir.1984) made implication (11th (trade- 1540, F.2d 1544 required to com- proof is establish but-for marks). The dissent concedes that “but law fraud re- law fraud. Common mon materiality is to cancel a required for” reliance, equiva- which is quires proof of that it is re- trademark but contends not test for set but-for lent quired registration to invalidate federal C.J.S. Fraud opinion. in this See 37 forth copyright. Various courts have held oth- (“the fraud § element 51 reliance 2 B. Nimmer & erwise. See Melville requires misrepresentation claim Nimmer, David on Copyright Nimmer injured party actually induced (rev. ed.2010) (“plaintiffs § fail- 7.20[B][1] action”); Restatement change course to inform the Copyright given ure Office of (fraud (1977) (Second) § re- Torts 525 substance, facts is without extent misrep- on the party that the “relies quires registered that the Office would have acting from refraining or resentation subject work even had it known those action”); see, Corp. Mobil v. e.g., Exxon facts”). Moreover, the has Copyright Act Dept. Conservation & Natural Ala. for” mak- requirement, codified this “but (Ala.2007) (reli Res., 1093, 1116 986 So.2d copyright registration clear suf- ing if only of fraud “can be met ance element permit suit, infringement ficient to even does, do, or some plaintiff does if the certificate of registration contains thing plaintiff that the would would information, “the inaccurate unless inaccu- misrepresentation have done but for information, known, if racy of would fact”); v. Mortgage material Alliance Co. Register Copyrights have caused the Rothwell, 1239, 44 Cal. 10 Cal.4th 17 registration.” refuse U.S.C. (Cal.1995) 352, 900 P.2d 601 Rptr.2d 411(b)(1); Copy- § also Nimmer see (same); Empkey, Neb. Luscher § ma- right (explaining 7.20[B][2] (Neb.1980) (same); 293 N.W.2d teriality [set “standard forth Ellis, P.2d Spencer v. Or. Copyright amendment to the is well Act] (same). (Or.1959) remaining ex Act in line with the construction dissent, mate where but-for amples *19 amendment”). prior to this rele riality required, is have limited but- conduct. While vance VII may in materiality required not be for context, inequi for every appropriate it is case, held this the district court light the numerous table patent inequita '551 unenforceable for consequences of a looser standard. adverse did not dis conduct because Abbott ble briefs it submitted to the EPO re close Moreover, if this court were consider counterpart contexts, European garding the in other materiality standards Opinion Trial at 1127. Be- copy- patent. law '382 analogous most area of is proceedings opinion. district court found statements cause the consistent with this I, in the EPO briefs material under the III, made court This also reinstates Parts and standard, PTO’s Rule 56 panel decision reported IV at 593 set under the but-for standard 1289, affirming F.3d the district court’s opinion, forth in this this court vacates the obviousness, judgment noninfringement, materiality. Id. findings district court’s anticipation, respectively. and The judg- remand, 1115. the district On ment below is court determine whether the PTO should AFFIRMED-IN-PART, VACATED- but granted would not have IN-PART, and REMANDED-IN-PART. Abbott’s failure to disclose EPO briefs. In particular, the district court must deter- Costs PTO found mine whether the would have party Each shall bear costs. its own Sanghera’s Pope’s declaration and accom- unpersuasive panying submission in over- O’MALLEY, Judge, concurring Circuit rejection

coming the obviousness over the dissenting and part part. if had '382 Abbott disclosed the EPO briefs. Patent practitioners call regularly court provide guidelines. this clear

The district court intent found They seek to know under good precisely deceive based on the absence what of a failing faith explanation governing principles to disclose the circumstances will be However, EPO briefs. Id. at 1113-16. applied, precisely they how will be “patentee any good need not offer faith applied. precision While may be in the explanation infringer unless accused patent practitioners do, nature of what prove[s] first ... a threshold of in level defining the desire for rules in the scienti- tent convincing to deceive clear and understandable, fic world the law does not Star, evidence.” 537 F.3d at always lend itself to such precision. In- upon district court also relied the “should deed, dealing when application negligence known” in reach standard remedies, equitable principles and the law ing finding Opin intent. See Trial imprecise by design. ion (“Attorney at 1113 Pope knew or I understand and admire majority’s should have known that the withheld infor to respond practitioners’ desire calls for highly mation would have been material to precision clarity. I also understand examiner”). Because the court district perceived its concern with litigation abuses did not find intent to deceive under the surrounding assertions of con- knowing and deliberate standard forth set believe, however, I duct. mаjority that the opinion, this court vacates the dis call responds to that and addresses those trict court’s findings intent. Id. at ways concerns fail to acknowledge remand, 1113-16. On the district court and remain true the equitable nature of should determine whether there clear doctrine seeks to cabin. convincing demonstrating evidence that Sanghera Pope knew of the EPO respectfully I dissent from those por- briefs, knew of materiality, their and made majority opinion tions which de- the conscious decision not to them disclose scribe the test it directs lower courts to in order to deceive the PTO. apply assessing materiality and which *20 reasons,

For the vacates and foregoing court remands for further inquiry this the district finding ineq- materiality vacates court’s the of determinations made uitable conduct and remands for further district the court this case. As ex-

1297 below, jority I in the of and the other dissenters. This is so remainder concur plained because, addressing types when the of con- judgment. and majority’s decision that duct should be deemed of sufficient

I. a finding inequita- concern allow for of conduct, majority’s majority decision ble both the and dissent I concur judgment impose strain too hard to hard and fast of vacate and remand rules. court with instructions reconsid- district Spe- of conduct. finding inequitable

er its jurisdiction equity “The of has essence court under- cifically, because the district been the of the Chancellor to do power governing standably referred to standards to mould each decree to the equity and from determination drawn our intent its particular case.” necessities of Wein law, court district should be prior case Romero-Barcelo, 305, berger v. 456 U.S. assess, in first opportunity to given (1982) 1798, 312, 102 72 91 S.Ct. L.Ed.2d evidence, instance, and its whether the Bowles, 321, (quoting v. Hecht Co. 321 U.S. determinations, support a find- credibility (1944)). 329, 587, 64 S.Ct. 88 L.Ed. 754 to deceive. In this ing specific of a intent equity governed While of “must be courts dissenters, I agree regard, like other rules no precedents less than the that, Thomas, majority’s holding pre- law,” v. a courts of Lonchar 517 with 314, 323, 1293, inequitable a con- U.S. 116 S.Ct. 134 L.Ed.2d requisite finding (1996), “[flexibility rigidi 440 rather than duct, must find that a district court equitable ty distinguished” jurisdic has culpability at issue “sufficient tion, 312, 102 at Weinberger, 456 U.S. S.Ct. intent to finding a deceive.” require rules; “Equity eschews mechanical Consultants, Med. Ltd. v. Hol- Kingsdown depends flexibility.” Holmberg it (Fed.Cir. on Inc., 867, 876 863 F.2d lister Armbrecht, 582, U.S. 66 S.Ct. 1988). determination, in- this making (1946). 90 L.Ed. 743 materiality must be tent to deceive and courts may District separately. found equitable ap- notions of relief Traditional scale,” may they nor employ “sliding pat- force in the context of ply equal materiality from alone.1 Fi- LLC, infer intent eBay MercExchange, ents. Inc. v. agree may 393-94, I a district court nally, 547 U.S. S.Ct. (2006)(holding categor- intent from indirect and circumstan- infer L.Ed.2d 641 evidence, only granting injunction where is “the ical rule tial but a dis- abrogates inference able to be holder prevailing patent most reasonable single Maj. granting equita- trict discretion Op. from the at court’s drawn evidence.” prin- Inc. ble relief and runs afoul traditional Star v. R.J. (quoting Scientific long recognized ciples equity). We F.3d Reynolds Tobacco (Fed.Cir.2008)). that the conduct is doctrine Kingsdown, based equity. II. (“[T]he question ultimate of whether views, equitable point my respect- It is at this conduct occurred nature.”). this Despite longstanding of both ma- fully, diverge from those may rely majority the same items of evidence in join portion I of the on 1. While V), (Part materiality inquiries. A its with the both intent opinion I do so understand- however, must, separate district reach ing majority does not hold that it is court materiality may consider level of intent impermissible a court to conclusions specific finding base intent to deceive evidence as circumstantial alone, regardless level of legal inquiries analysis. other intent As in all elements, multiple materiality. involving the district court *21 Int’l, Ltd., Corp. num Foseco majority dissenting the principle, both (Fed.Cir.1990) (“Indeed, opinions flexibility rigid- in favor of eschew what we ity. suggest for mate- opinions ‘inequitable Both tests termed conduct’ is no respec- in all cases. riality apply to Their more than the unclean hands ap- doctrine materiality inquiries tive are black or to plied particular conduct before the white, equity (citations requires judicial PTO.”) omitted). while con- There is no gray. sideration of of shades support the cites majority none—for —and proposition the that inequitable conduct is majority The defines under a independent somehow the of unclean test, with an exception but-for for inten- principles hands the Supreme Court de- tionally affidavits filed with the PTO.2 false and explained trilogy scribed in its of dissent, Maj. Op. at 1291-93. The on the majority cases. remainder of the hand, materiality according other defines clear, moreover, opinion makes the provide to Both Rule 56. tests fail to majority’s purpose, and that the test it with flexibility ineq- district courts to find adopts, is to delimit and narrow the con- extraordinary uitable in an conduct case the tours of unclean doctrine hands when question where the conduct would not applied application process before such defined as under either test. This PTO, the not to acknowledge flexibility in contrary result to very nature of it.4 equity and centuries of Supreme Court precedent. cannot, accordingly, I lend adopt that provides We should a test as support to of the either immutable tests guidance much pat- district courts and my

proposed by colleagues. but, applicants possible, so, ent in doing that, may disregard we majority equitable

While despite states nature inquiry Thus, of the at adopts, hand. we must strictures test it “the that, clear unclean make while we believe hands doctrine the test remains available remedy encompasses virtually we offer all supply а for forms of egregious miscon- duct conduct sufficient to a finding like that warrant Supreme Court cases,” conduct, inequitable open we pos- statement does not address leave express Maj. sibility some Op. concerns I here.3 form of intentional mis- Since, painstak- currently 1287-88. as the conduct we do majority envision ingly explains, the inequitable equitable doctrine of could warrant relief. ap- This conduct we are defining grew, proach respects Supreme out those Court’s rec- cases, “unclean hands” ognition asserted dichot- equity courts of “exercise See omy is a one. Consol Alumi- false judgment light prior precedent, but majority responds 2. The supplant this characteriza- simply very unclean hands could tion, general opin- criticism in this allegations inequitable majori- conduct ion, defining broadly its test more ty seeks curb. acknowledging degree flexibility within that, applaud four corners. For I spectrum, 4.At other end of the the dis- think, however, majority. I do not that this acknowledgement sent’s that a district court explanation additional sufficient address inequita- retains discretion to to find decline expressed opinion. all of the concerns in this ble conduct even in the face of evidence of I propose remain of the view that I the test similarly and intent is insufficient here is the consistent most with the doctrine’s the unyielding to undercut nature of the test origins. adopts. clearly conduct It allow, instance, Indeed, language finding does not for a raises some additional concerns. If "unclean hands” remains avail- for conduct not encom- misconduct, charges able passed by in cases PTO Rule 56.

1299 statute, equita nor with the consistent specific the fact that of with awareness Accordingly, of I ble nature the doctrine.5 circumstances, predict in ad- hard to often that, cases would overrule those and hold in vance, special warrant treatment could discretion, a in the exercise of its district Florida, Holland v. an case.” appropriate — may render than all choose to fewer court 2549, -, 2563, 177 130 S.Ct. U.S. unenforceable, may simply claims dismiss (2010). L.Ed.2d 130 it, may action before or fashion some flexible nature of with the Consistent remedy, so long other reasonable as moreover, should jurisdiction, we equity court remedy imposed by the is “commen determining proper that recognize Bd. surate with violation.” Columbus of given a instance remedy for Penick, 449, 465, 99 Educ. v. 443 U.S. of the discretion of district is within conduct 2941, (1979); also 61 L.Ed.2d 666 see 5.Ct. course, courts, subject, statutory con- of (“The Hecht, 329, 321 U.S. at 64 S.Ct. 587 Driller Co. Ex- Keystone v. Gen. straints. jurisdiction of equity essence has been Co., 240, 245-46, 290 54 S.Ct. cavator U.S. power equity of the Chancellor to and do (“[Courts (1933) 146, equi- of L.Ed. 293 each to the to mould decree necessities ty] by formula restrained are not bound case.”); French, particular Miller v. tends trammel by any limitation that 327, 360, 120 S.Ct. 530 U.S. discretion.”); just frеe and exercise (2000) (“These recog L.Ed.2d 326 cases Elec. Auto-Lite 396 U.S. Mills v. importance permitting nize the courts (1970) 616, 24 L.Ed.2d 593 90 S.Ct. cases tailor relief ... equity (“In selecting remedy a the lower courts particular exigencies of cases and individu exercise the sound discretion should so, doing they recog al In circumstances. eq- guides the determinations courts nize the fact that in certain circumstances role keeping equity mind the uity, justice requires flexibility necessary adjustment nice the instrument treat cases ratio differently different —the public interest reconciliation between equity itself.”) (Brey that underlies nale well as between com- private needs as added). J., er, (emphasis Al dissenting) (internal claims”) private quota- peting remedy lowing flexibility would omitted). we tions and citations While the incentive to use reduce ineq- a previously finding held tactic litigation conduct as and address unenforceable ‍‌​​​‌​‌‌​​‌‌​‌‌‌​​​‌​‌‌‌​​​‌‌​​​​​‌​‌‌‌‌‌​​​​​​‌‍all uitable renders many my of the concerns that trouble col and, wrongly procured patent claims of the leagues expressed by and were Abbott circumstances, patents, proceedi certain related certain amici in these en banc remedy compelled neither singular ngs.6 this proposition inequi- codified defense of from a treatise for the While 1952 Act (1) patent's claims paragraph hands in of 35 U.S.C. table conduct renders all of unclean remedy. specify § did See 35 of those unenforceable. Id. 1561. None and, cases, however, (providing binding § "unenforceabili- on court U.S.C. are this action); above, infringement ty” propo- defense an is a reasons I for the stated find Federico, "Commentary on Pat- the New power P.J. with the of the sition inconsistent Act,” 75 J. ent each Chancellor "mould” decree to Soc’y & Trademark Off. Pat. (1) (1993) (explaining paragraph in- particular case. necessities laches, "equitable defenses such as es- cludes statute, hands”). described Abbott 6. One evils toppel and unclean whether, thus, barring possibility provides guidance as to amici is the order no discretion, misrepre- may based on equitable a court render enforcement of some, all, applicant’s entity sta- of an "small claims unenforceable. sentation but Tex, Ltd., may unenforceability F.2d To the extent & v. Lex tus.” J.P. Stevens Co. (Fed.Cir.1984), point we cited harsh such circumstances —a cases collected too

III. firm integrity conviction that the of the process application PTO as to the at issue provide guidance To district courts to wholly was In adopting undermined. such aid in the their discretion in exercise test, confirm, I also we should believe as inquiries beyond inequitable conduct — above, explained equitable nature “any Supreme Court’s direction willful of the doctrine demands that this pro- test concerning act the cause of action which firm guidance only guidancе— vide rightfully transgress equita can be said —albeit respect to district courts with to the exer- is sufficient ble standards of conduct cause cise of their in the by ineq- for the of the maxim discretion face of invocation chancellor,” Mfg. Instrument uitable conduct Precision claims. Co., Co. v. Auto. Maint. Mach. 324 U.S. ably For the by reasons articulated 806, 814-16, 65 S.Ct. 89 L.Ed. 1381 majority, I do not we believe should direct (1945) guidance believe such should re —I district Rule 56 courts to use as the meas- expressed by flect the concerns Su materiality ure of this context. As the preme trilogy Court in the case from majority points out, among things, other it emerged. which the As doctrine the Court is both too too vague and leaving broad — Precision, minimum, said in equity at re room for findings conduct in that, quires seeking public when bene sufficiently circumstances egregious sponsored fit of a government monopoly, fall within Supreme the bounds of the “fairly applicants must act and without trilogy Court from the doctrine Similarly, fraud or Id. deceit.” Hazel- emerged. agree I also cannot completely Hartford-Empire Atlas Glass Co. v. proposed by the test the majority. 322 U.S. S.Ct. L.Ed. 1250 Given the scope complexity of PTO (1944), that, regardless the Court found proceedings, misconduct can and does oc- impact patentabili of such conduct on cur outside the context written affida- ty, the equity doors of should be closed to circumstances, vits. In certain regardless a patentee presented who impact issuance, such office, impartial, as an article it authored. sufficiently egregious that, misconduct is Id. at 64 S.Ct. 997. accompanied requisite when intent general guidance mind, With this I deceive, support it a finding could believe conduct should be deemed material Indeed, conduct. Hazel-At- (1) (whether

where: but for conduct las, the article in question present- was not the form an affirmative act or through ed to the PTO affidavit. 322 non-disclosure), intentional the patent 240-41, tests, U.S. 64 S.Ct. Both (as would not have issued Chief Judge moreover, fail to allow room to address Rader explains concept majori- in the beyond conduct their contours which equi- (2) ty opinion); constitutes a ty ignore. should not representation false or misleading of fact (rendered so either because the statement IV. made is false on face or information is Applying propose, I any the test or rea- which, known, omitted if would render the sonable test for representation (3) comports or misleading); false with Supreme precedent, district court finds that I the behavior Court would is so offensive that court is left with a affirm the finding district court’s that the opine

which I do not deception. courts would to address that of intentional form —district remedy have discretion to fashion some lesser case This unlike the situation where a ref- of information nondisclosure Indeed, already I the omis- erence before an believe examiner was material. as material under the who can his or her own qualify here draw conclusions sions plus” standard and as to it teaches majority’s “but-for what and is able to that, accepting gov- that test spin even discount offered counsel. See standard, Labs., on the Innogenetics, a remand issue erning N.V. v. Abbott necessary (Fed.Cir.2008). nor appro- is neither F.3d Al- *24 priate. though in- key sentence itself was Shay, inquiry deed before Examiner note, As the other dissenters whether point had shifted to a extrinsic evi- glucose art that sensors prior taught is, Shay dence. That Examiner had ac- used to whole blood without could be test quiesced Attorney Pope’s request to to key a was focus protective membrane resort evidence to extrinsic to show patentability inquiry. PTO examiner’s sentence would been under- to submit ex- requesting permission After by differently stood skilled artisans than response rejection to trinsic evidence suggested. its Having words received PTO, submitted sworn from the Abbott evidence, permission supply to extrinsic Dr. expert from its Gordon declaration duty-bound Attorney Pope pres- was Sanghera accompanied statements any ent inconsistent extrinsic informa- Pope. counsel Lawrence Both from its tion him. known to the arena of representations to the examiner contained evidence, extrinsic un- examiner was to be regarding they alleged ap- what able to way fend for himself. He had no understanding pri- of the critical propriate what, any, contrary if extrin- knowing reference which the examiner or art with things, they Among concerned. other sic information had been left out of the was unequivocally Sanghera that one skilled asserted declaration. He was com- prior art would have read the art pletely dependent Attorney Pope on say protective that use membrane Sanghera fully any Dr. ex- disclose was samples optional. information, con, whole blood pro with trinsic known from these declarations was the point Omitted them on the factual covered contrary rep- made fact Abbott had the submission. on matter

resentations this same Id. The district court’s conclu- (“EPO”) in con- European Patent Office thorough They sions were and correct. prosecution nection with the earlier of a should be affirmed. There, Ab- European application. V. represented “unequivocal- it was bott prior language art ly clear” the same I do weigh policy debate was, that the membrane protective meant majority between the and the dissenters. fact, optional. There are merits to concerns ex- each, they pressed by may be rele- The district court concluded that these vant, in varying degrees, to the exercise “highly nondisclosures were material” be particular a court’s in a case. discretion “they precise on the cause centered sen cannot, however, Policy justify concerns question prior art tence refer [in adopting legal that di- ence], broad standards taught.” what meaning Therasense, Becton, verge explicated by from the Su- doctrines Inc. v. Dickinson & (N.D.Cal. provide A immut- preme Court. desire F.Supp.2d 2008). guidance parties able to lower courts and specifically, More the district court similarly justify is not sufficient to found: equitable an doc- disclosure” in order to avoid attempt court’s to corral the risk trine with neat tests. of an rendering all claims otherwise valid patent unenforceable because of the omis- are To the extent there concerns with sion marginally of some relevant reference. litigation surrounding improper abuses result, As a have frequently examiners doctrine, important use of this otherwise been an art swamped excess of there are vehicles available the district references little having relevance to court to address those concerns. Careful applications them. application before pleading requirements Exergen Corp. forth in v. Wal-Mart set traced, can problems These at least Stores, Inc., (Fed.Cir.2009), in part, uncertainty to doctrinal on three early management techniques case de points: First, what standard of intent signed unsupported to ferret out and test in assessing allega- should be applied claims, stay orders to *25 tion applicant rep- that an has made false discovery or consideration of such claims or failed to resentations disclose material pending all other determinations in the Second, facts to the PTO. what standard sanctions, case, or even are all tools dis be applied should to such trict employ appropriate. courts can where misrepresentations or nondisclosures. reasons, I For these concur in in part Third, “sliding whether there should be a part and dissent in from decision the scale” a strong showing under which today. majority announces I would leave either materiality or intent should be able to district courts the discretion apply to make weaker up showing for a on the equitable doctrine to the unique cir- other element. they cumstances with presented, are agreement There is substantial as to while them to in encouraging keep sight proper resolution two of those three obligation guard against their abuses of First, parties issues. to this and case it. agree

most of the that proof ineq- amici BRYSON, Judge, Circuit with whom require showing uitable conduct should a GAJARSA, DYK, PROST, Circuit specific PTO; neg- intent to deceive the Judges, join, dissenting. ligence, negligence, gross even should Second, enough. parties be I agree most of party the amici that a invok- There is broad consensus that the law of ing inequitable defense conduct in inequitable conduct an unsatisfactory prove required should be both specific adjustment. state needs In recent materiality by intent and clear and con- years, differing ap- standards have been evidence; vincing there should be no “slid- in plied determining particular whether ing scale” a whereby strong showing toas conduct inequitable rises to the level of one up element can make for proof weaker patent conduct sufficient to render a unen- as to the other. forceable. That uncertainty doctrinal has However, remaining on the issue—the had consequences adverse both for proper apply determining standard litigation for In litigation, the PTO. whether sufficiently the conduct issue is counterclaims of inequitable conduct have material to render suit unen- many been raised too cases and have sharp disagreement. forceable—there is PTO, proved difficult to resolve. In the disagreement That is what divides the lack a clear and uniform standard majority court in The inequitable this case. pat- conduct has led some takes prosecutors position ent to err the side of “over- nondisclosures should a culpability require indicate sufficient sufficiently trigger material to deemed if, intent to deceive.” Id. at 876. only finding had inequitable defense disclosed, the question been matter court Kingsdown did not find pat- not have obtained would applicant necessary proper to address the standard however, sig- marks position, That ent. determining materiality, because that and, believe, departure I unwise nificant addressed in earlier cases. issue had been Since its precedents. court’s from this Kingsdown, five-judge years Four before has looked to the days, this court first & v. Lex panel opinion J.P. Stevens Co. rule, 56, 37 C.F.R. Rule PTO’s disclosure (Fed.Cir.1984), Ltd., 747 F.2d 1553 Tex 1.56, defining mate- § the standard for materiality requirement had addressed involv- conduct cases riality observations, following and made the material infor- the failure to disclose ing today: the law until which have remained form, that rule In its current mation. First, principle, endorsed the the court material not that information is provides predecessor our previously adopted case of prima facie only if it establishes court, conduct is broader if it refutes or is but also unpatentability, (cit than common law fraud. Id. at 1559 applicant position with a inconsistent Curtiss, ing Norton pat- respect before the PTO takes (CCPA 1970)). Second, the court ex the material- I would adhere to entability. *26 could plained inequitable conduct disclo- forth in the PTO’s ity standard set on the failure to disclose material based First, the for two basic reasons: sure rule well as the submission of information as know what position in best to PTO is Third, information. false material Id. ef- need to conduct information examiners require court stated that disclosure еxaminations, i.e., and efficient fective in Rule 37 C.F.R. ment set forth PTO material to the exami- what information is (1984), appropriate § established “the 1.56 Second, higher stan- process. nation standard starting point” because majori- materiality adopted by the dard of ought to closely aligns “most with how one incentives provide appropriate ty will with the PTO.” J.P. Ste conduct business with the comply to patent applicants for vens, doing, F.2d at 1559. In so upon obligations places the PTO disclosure in opinion to its earlier court referred them. (Fed. Cebalo, 878, 884 v. 731 F.2d Driscoll years ago, Kingsdown in Twenty-three Cir.1984), court had stated that where the Hollister, Inc., Medical Consultants “essentially represents a cod PTO Rule 56 conflicting precedents court was faced with maxim as ification of the ‘clean hands’ requirement the “intent” regarding Moreover, patent applicants.” applied inequitable conduct. The court doctrine of Kings- just year the decision before conflicts in an en banc deci- resolved those down, Manufacturing, the court Gardco joined. all of the court sion that members Lighting Inc. v. Herst (en banc). (Fed.Cir.1988) 863 F.2d 867 (Fed.Cir.1987), had reiterated that “gross proof held that even The court appropriate forth the standard Rule 56 set satisfy not sufficient to negligence” is undis determining the for Instead, requirement. intent to deceive con inequitable in an closed information par- concluded that in order for the court duct case. justify holding ticular conduct occa- time there have been unenforceable, Since question, the conduct holding in evidence, from the departures sional includ- light of all the “viewed level of faith, requisite as to the Kingsdown must good indicative of ing evidence intent to establish conduct. applicant attorney As intended to mislead however, materiality, the court respect has con- the PTO with to a material matter. sistently held that the PTO’s Rule 56 sets 2. Materiality by is measured what the proper determining baseline mate- PTO demands of apply who those riality, although there has been some vari- prosecute patent applications. The disclo- regard ation in our decisions to which sure standard that expects the PTO those applies version of the PTO’s rule in partic- parties comply with is set forth in the ular’cases. current version the PTO’s Rule 56. Un- standard, der that inequitable conduct appropriate departures cure for re- quires proof that the information at from issue principles conduct established, either itself or in combina- place that were at put time of information, tion with other prima facie Kingsdown would be to reaffirm those case of unpatentability, or was summarized inconsistent principles, as above. The ma- position with a applicant taken however, be- jority, a far has taken more radi- fore respect the PTO with pаtentability. approach. cal respect With to the issue of materiality, majority has adopted a Intent mislead and test support has no this court’s must be separately proved. There is no cases and is with a long inconsistent line of “sliding scale” degree under precedents dating early years back to the intent that must be proved depends on the of this court. The effect of the majority’s strength of the showing as to the material- test, moreover, new merely does not re- ity of the information issue.1 form inequitable conduct, the doctrine of These principles only are consistent but comes abolishing altogether. close to with our law on inequitable but, if I respectfully from that aspect dissent implemented consistently, should be suffi- *27 view, the court’s In my decision. what is cient to practical address the problems jettison needed is not to the doctrine of that have arisen under the current regime. conduct, inequitable simply but to reaffirm majority While the correct inequita- is that the principles set early years down ble conduct claims have been raised too of this court in light provisions of the of often in past, are there less Draconian rule, the current PTO disclosure re- means of addressing problem than quire adherence principles. to those As proposed by First, those majority. applied duty to the applicant of an refinements to the suggested doctrine here attorney to material disclose information in likely would be to significantly reduce the the course of prosecuting patent applica- frequency with which defense is raised. tion, those principles can be summarized Second, recently this court has held that as follows: the strict pleading requirements of Fed.

1.Inequitable 9(b) requires proof, conduct apply R.Civ.P. to counterclaims in- by evidence, clear convincing conduct, equitable requiring detailed factu- important 1359, 1. distinguish It is (Fed.Cir.2007); between relax- Ferring 1366 B.V. v. ing required proof proof Labs., of intent Inc., if 1181, Barr F.3d 437 1190-91 strong, impermissible, which is (Fed.Cir.2006); GFI, Corp., Inc. v. Franklin opposed considering degree of mate- 1268, (Fed.Cir.2001); 265 F.3d Paragon 1274 intent, riality as relevant issue of Lab., Labs., Inc., Podiatry Inc. v. KLM 984 appropriate, particularly given that direct 1182, (Fed.Cir.1993); F.2d 1189 Merck & Co. intent, evidence of such as an admission of Pharmacal, Inc., Danbury v. 873 F.2d deceptive purpose, is seldom available. See (Fed.Cir.1989). Foods, Ltd., Cargill, Inc. v. Canbra 476 F.3d merely plead unpatent claims would have been found and not notice al averments claims. Such respect to such able. This is not a tweak to the doctrine ing with likely to dis requirements conduct; are pleading inequitable it is fundamental Ex counterclaims. See courage baseless change would have the effect elimi Stores, Inc., 575 Corp. v. ergen Wal-Mart nating independent role of the doctrine (Fed.Cir.2009). Third, 1312, 1326-29 F.3d inequitable conduct as to disclosure obli that lack inequitable conduct assertions in limited gations except circumstances. can controlled legal support be factual and rejected repeatedly This court has the “but of-the through application courts by trial in light for” test as too restrictive provided by Fed.R.Civ.P. sanctions inequitable conduct policies served held, repeatedly this court Finally, as has Danbury doctrine. See Merck & Co. v. inequitable conduct is an the doctrine of Pharmacal, Inc., (Fed. 1418, 1421 F.2d doctrine, and even when the ele equitable Cir.1989); L.P. see also Purdue Pharma v. of intent and are satis ments Inc., Endo Pharms. 438 F.3d fied, court to it remains for the district (Fed.Cir.2006); Hoffmann-LaRoche, Inc. determine, equitable in the exercise of its Promega Corp., v. 323 F.3d whether, “in all the judgment, light of (Fed.Cir.2003); Textron, Molins PLC circumstances, the conduct of particular Inc., (Fed.Cir.1995); 48 F.3d 1179-80 culpable that its patentee is so Burroughs Corp., A.B. Dick Co. v. LaBounty Mfg., enforced.” should (Fed.Cir.1986). F.2d Those Comm’n, Trade Inc. v. U.S. Int’l policies dictate that it should continue to (Fed.Cir.1992). 1066, 1070 do so. problem of “over- regard With persuasively argues As the PTO in its marginally numbers of large disclosure” of brief, amicus the “but for” standard for relevant references the course materiality is too restrictive to serve the in its amicus brief prosecution, the PTO purposes that the doctrine of judicial confidence that strict expresses designed promote. conduct was If a convincing” “clear and adherence to the failure to disclose constitutes infringers which accused must standard only a proper when disclosure prove specific intent to deceive the PTO claim, rejection result in of a there would largely problem. Since the will solve applicants little to be *28 will be incentive directly problem of over-disclosure affects PTO, with the because in most candid PTO, there is no reason not to credit the inequitable instances the sanction of con- tightening that a the PTO’s assertion apply only will if the claims that issue duct inequitable the intent element of the con- anyway. example, are invalid For under duct doctrine should be sufficient to ad- materiality, appli- the “but for” test of that a problem dress the drastic modi- considering cant whether to disclose facts only element not fication possible prior about a use of the invention contrary required, but would be is not little reason to disclose those would have in the interest efficient examina- PTO’s applicant the PTO. If the re- facts to tions. use, prior pat- mained silent about the the II issued, prior ent and the use was never discovered, applicant would benefit majority The holds that a failure to dis- But even if the from the nondisclosure. pur- information is “material” for close litigation, prior during use was discovered only conduct if it satis- poses inequitable failure to disclose would be held to test; i.e., for” the conduct fies the “but conduct, if that, only for the constitute must be such but addition, period relevant within that of time. rendered the prior use otherwise applicant rarely would thus that it explains claims invalid. the PTO has access concealing prior use nothing by lose regarding inequitable to relevant facts con- PTO, he would not be at because from duct, investigative it lacks re- because enforce an other- right losing risk of result, sources. As a the PTO has con- patent. wise valid cluded that a court is the best forum alleged which to consider breaches of the situation, if particularly op- In that duty inequi- disclosure the context of an patent a valuable is at to obtain portunity table conduct defense. See Patent and stake, be no inducement there will Implementation Office forthcoming. appli- If the Trademark applicant to be 1.56,1095 misleadingly § art or Gaz. Pat. & cant withholds C.F.R. Off. Trade- succeeds, (Oct. 11,1988). matters and particular discloses mark Office that would not have he obtains Ill Even if the nondisclo-

issued otherwise. dis- misleading sure or disclosure later infirmities, practical from its Aside covered, majority’s ap- under the rule the adopted by majority “but for” standard off, as the will plicant is no worse duty is inconsistent with the that the Su- only lost if the claims would otherwise be preme Court and the PTO have both de- be held invalid. So there is little lose applying pat- scribed as who seek those of deceit. It no by following course ex parte application process. ents profes- uprightness indictment of the patent applicants prosecu- sionalism of A group say they as a should not tors The doctrine conduct has subjected system an incentive be such origins trilogy Supreme in a Court all, long recog- that. been After has dating decisions back to the 1930s. The may open tempt nized that “an door cases, Keystone first of the three Driller large saint.” stakes sometimes Given Co. v. General Excavator 290 U.S. patent prosecutions, regime issue (1933), 54 S.Ct. 78 L.Ed. 293 that a potential- that ensures dishonest but applied equitable principle of “unclean ly can profitable pur- course of action patentee’s hands” a case which a essentially marginal sued with no added representative had obtained a false affida- regime risk is an unwise no matter how vit and taken other steps to avoid the subjects. virtuous its possibly invalidating prior disclosure of a It expect is unrealistic to that other patented use of the paten- invention. The provide will an effective deterrent means tee obtained a favorable decree in an in- to ensure that material information will fringement against action a different de- during patent prosecu- not be withheld *29 fendant and then relied on that in decree that pros- tions. The PTO advises us the obtaining preliminary injunctions against duty pect enforcing the of disclosure in the defendants the cases the before through inequita- other than the threat of Court. prac- ble conduct possible claims is Supreme The the connec- Court found tical. The prospect agency disciplinary tion between earlier to be and later cases action for disclosure violations is unrealis- “to that did not tic, plaintiff sufficient show explains, the PTO because the Office is come with clean hands” in the later cases. by any required charges statute file 2462, concluded finding, § Based on that the Court years, within five see 28 U.S.C. justified previous it seldom learns of conduct that the misconduct the

1307 244, in rule.” 322 at complaints the those cases. U.S. S.Ct. 997. The dismissal of determination, the Court reaching In Court found standard to be satisfied necessary find it to decide whether did not on the facts before it. plaintiff that the evidence of use the response argument have had the effect suppressed had would in question article was not “basic” to the patent. enough It was invalidating in litigation, Supreme issues Court conduct had “immediate improper that the stated that the circumstances did not “call necessary equity relation to the [that attempted appraisal.” for such an patentee sought] respect of the mat- U.S. at 997. S.Ct. The Court litigation.” ter in 290 U.S. 54 S.Ct. explained: “Hartford’s officials and law- yers thought the article material. They later, in A decade Hazel-Atlas Glass Co. persuade conceived it in an effort to Hartford-Empire U.S. grant hostile Patent Office to their patent (1944), L.Ed. 1250 the Su- S.Ct. application, and went to considerable trou- preme again Court held unen- expense get published.” ble and it Id. forceable, in part this time because of mis- The Court added Hartford’s fraud Patent by patentee before the “had its genesis plan publish an obtaining patent. paten- The Office in article purpose for the deliberate of deceiv- tee, to issuance of encountering resistance ing the Patent Office.... Had the Dis- Office, arranged the Patent trict Court learned of the fraud on the an publication for the article a trade original infringement Patent Office at the publication that described the invention as trial, it would have been warranted in dis- in the The a remarkable advance field. missing Hartford’s case.” Id. at product to be the of a purported article Significantly, S.Ct. 997. the Court did not party, though disinterested even was regard the issue of Hartford’s conduct as actually patentee’s written one of the turning on whether the fraudulent conduct lawyers. patent ultimately The issued. was the for” cause of the issuance “but court, was also used in where it The article patent. The Court stated that it would patentee obtaining a favor- assisted have come if to the same conclusion even judgment appellate able from court. fraudulently pro- the statements from the patentee subsequently went to consid- actually cured article were true. Id. at lengths erable to ensure that the truth 247, 64 S.Ct. 997. “But for” causation was regarding authorship of the article necessary finding materiality. In- emerge.

would not The efforts at conceal- stead, the Court focused on the patentee’s failed, however, in- ment and the accused deceiving purpose “deliberate the Pat- sought fringer relief the lower court refusing ent Office” as the core reason for on the misconduct. based patentee’s rights pat- to enforce the in the Because the misconduct was discovered ent. expiration after the of the term of court later, A year Supreme again Court during judgment question which the was addressed the issue of the effect of miscon- entered, Supreme invoked the Court during proceedings duct before the Patent fraud, of after-discovered doctrine subsequent patent Office on enforcement judgment permitted court revisit *30 case, actions in court. That In- Precision even after the end of the term in which it entered, Manufacturing strument Co. v. Automo- if was the circumstances “are Machinery tive Maintenance 324 U.S. sufficiently gross deemed to demand a de- (1945), 89 L.Ed. 1381 parture rigid from adherence to the term S.Ct. in sequence brought way some to the attention following an involved arose events, of which was that Auto- at upshot the the Patent Office.” U.S. knowing to a rights patent explained, motive obtained The “Those S.Ct. 993. Court false applicant had made original that the the applications pending who have to the dates of con- pertaining statements parties Patent Office or who are to Patent practice of the ception and reduction proceedings uncompromis- Office Supreme The Court claimed invention. duty report concerning to it all ing facts unenforceable, applying patent the held possible inequitableness underly- fraud or against unclean hands the doctrine of in ing applications issue.... Public knowledge on its patent owner based that interest demands all facts relevant to during that occurred the misconduct formally in- such matters be submitted prosecution patent. Office, formally to the Patent which can explained that the sort of The Court pass upon sufficiency then of the evi- necessary trigger misconduct court’s Only way agency dence. in this can that litigant” refusal to aid “the unclean need act to safeguard public the first punisha- “of a nature as to be not be such against patent monop- instance fraudulent justify legal pro- ble as a crime or as to prosecut- olies.” Because Automotive had any Any character. willful act ceedings patent application ed the and obtained the concerning right- the cause of action which patent attempting “without ever to reveal transgress fully equitable can be said to anyone to the Patent Office or to else the standards of conduct is sufficient cause for possessed concerning applica- facts it the chan- the invocation of maxim ancestry,” tion’s fraudulent con- Court cellor.” 324 at 65 S.Ct. 993. U.S. displayed cluded that Automotive “has not that “where a suit in The Court added requisite that standard of conduct equity public concerns the interest as well equity.” maintenance of this suit in at Id. litigants private as the interests of the 819, 65 993. S.Ct. doctrine assumes even wider and more Keystone As in the and Hazel-Atlas significant proportions.” Id. The enforce- cases, Supreme Court the Precision stated, patent, ment of a the Court is a Instrument case did look to whether “concerning matter far more than in- the conduct in question would have ren- parties. pos- terests of the adverse The plaintiffs application unpatent- dered the patent session and assertion of rights are ” holding pat- able. all of Automotive’s great public.’ ‘issues moment to the Id. unenforceable, ents to be the Court found In a statement that has served as the basis enough plaintiff was that the had inten- subsequent development for the of the doc- tionally withheld information from the Pat- conduct, trine of inequitable the Court ent that Office should have been submitted far-reaching added social and “[t]he so the Patent Office could consider it. consequences patent economic of a ... suggestion There was no the Court’s give public paramount interest opinion that the dismissal of the action seeing patent monopolies spring from if, appropriate only would be for the but backgrounds free from fraud or other in- conduct, would not have issued. equitable conduct.” Id. at 65 S.Ct. principles set down the Court Hazel-Atlas, In- Keystone, and Precision The Court refused to enforce Automo- can be summarized as follows: strument tive’s because it concluded that Au- (1) that, public special has a interest suppressed tomotive “knew and facts least, very seeing patent monopolies “spring should have been *31 attorneys responsibilities appli or other the free from fraud backgrounds from (2) conduct”; the corollary appear as a cants who before PTO. inequitable interest, that, patent applicants “By endorsed the statement Court public that duty report uncompromising application reason of the nature of an “have an concerning all facts patent, relationship attorneys Office] Patent the to the [the inequitableness underly- requires highest fraud or the possible degree Patent Office (3) all facts relevant the ing applications”; good of candor and faith. In its relation to matters must be submitted to such ... applicants, rely upon the Office must Office, upon pass “which can thеn Patent and deal with them in a integrity their ” (4) evidence”; sufficiency of the spirit Kings of trust and confidence.... failure to disclose to the Patent intentional 318, 319, Dorsey, land v. 338 U.S. 70 S.Ct. application is tainted Office that a (1949). 123, 94 L.Ed. 123 Because the justify not by fraud is sufficient cause investigative PTO lacks the and research (5) miscon- enforcing patent; representations resources to look behind need not constitute action- question duct counsel, by applicants and their it neces fraud; if the conduct able is sufficient sarily representations ‍‌​​​‌​‌‌​​‌‌​‌‌‌​​​‌​‌‌‌​​​‌‌​​​​​‌​‌‌‌‌‌​​​​​​‌‍relies on those as to act that violates stan- constitutes a willful many during prosecu facts that arise dealing conduct in equitable dards of of patent applications, including tion ex the Patent Office.2 perimental by appli results obtained cants, art, the state of the and the

Shortly Key- after the decisions in the Hazel-Atlas, stone, knowledge persons of skill the art and Precision Instru- cases, Supreme question. made a the field Some these facts ment Court directly uniquely on will be in the hands of the appli- further observation bears Keystone-Hazel-Pre ground. asserted claims on that Id. at 2. Two decades before trilogy, Supreme cision Court considered S.Ct. 380. during pros misstatements made Although majority sup- the effect of cites Corona as validity on the of a on a meth port ecution interpretation for its narrow of the mate- vulcanizing conduct, Corona Cord Tire od for rubber. riality requirement Corp., Co. v. Dovan Chem. 276 U.S. little Corona is of relevance to that issue. (1928). 72 L.Ed. 610 S.Ct. predates inequita- Corona the creation of the ble conduct doctrine and has never been cited Office, the Patent the inventor at- Before Supreme any addressing Court in case tempted behind a reference sub- to swear Apart unclean hands or conduct. averring mitting affidavits date of earlier from the fact that the decision addressed the conception practice for his reduction validity, enforceability, rather than issue of had invention. The inventor asserted that he the Court's decision was based on its conclu- successfully method "in the used the claimed question affidavit in not sion that the was goods,” vulcanization of rubber and one of material because what mattered was that the his fellow chemists stated that the method rubber, method had been used to vulcanize vulcanization of had been used "in the actual that it been used vulcanize rubber not had hose, tires, belts, goods, valves rubber such as particular was in turn used to make goods.” and other mechanical Id. at goods. Given that the nature of the rubber fact, In at the time referred to in S.Ct. objects the inventor vulcanized was not the inventor had used his meth- the affidavits Office, before the Patent relevant to issues only od on test slabs of rubber. The Court surprising it is not that the Court found the that whether the claimed method was noted event, any material. error to be production in the of useful articles was used claims, language stating Court’s choice of relevant to the asserted and it — affidavit, "were not the basis for issuance [the affidavits that the false while therefore held reckless, essentially patent] material to its not "the basis for” or "essential- was test, issue,” but patent. is not restricted to a "but for” ly material to” the issuance of the materiality. suggests a standard for therefore declined to invalidate the broader The Court *32 matter, language paralleling Supreme In and, practical undiscover- cant in Kingsland Dorsey, at the PTO. For discussion an examiner Court’s able reasons, imposed PTO has “a relation- recognized the Norton court those examiners provide duty applicants on of trust between the Patent Office and ship patent- that is material with information wishing those to avail themselves of the ability. governmental grants agency which that authority to given has been issue.” 433

B light parte at In of the ex F.2d 793. defined the disclosure obli- The PTO has patent prosecution, nature of number patent prose- in those involved gation for filed, capaci- and the limited applications of the PTO has in its Rule cutions ty of the PTO “to ascertain the facts nec- statutory authority under its promulgated essary adjudge patentable merits of “govern that regulations to establish that application,” each the court stated proceedings the Office.” 35 conduct of honesty “highest standards of and candor 2(b). § Rule 56 was first U.S.C. When part applicants presenting on the of such portion promulgated necessary ... facts to the office are ele- inequitable conduct rule that addressed working patent system.” ments in a Id. at fraudulently provided “any application reason, approved 794. the court For any filed or in connection with which fraud expansion types of the “the miscon- practiced attempted on Patent applicants penal- duct for which will be Office, § may be stricken.” 37 C.F.R. 1.56 ized.” Id. (1950). light policies, In of those the court ex- Ap- of Customs and Patent Court plained that the test for “can- construed the PTO’s disclosure rule peals applied narrowly not be too if the rela- Curtiss, in Norton v. its 1970 decision tionship of confidence and trust between F.2d at 779. The court that case applicants and Patent Office is to have authority upheld the Commissioner’s any meaning,” findings real and that for fraud on the patent application strike materiality should not be limited to those in violation of the PTO’s Rule 56. PTO facts, they cases in which the true if had Interpreting the term “fraud” Rule known, likely pre- been “would most began by noting the court the term particular vented the allowance of the should not be limited to the kind fraud claims at issue.” 433 F.2d at In 795. independently would be actionable as cases, such the claims at issue “would (whiсh a tort or crime the court referred to invalid, event,” any probably be and the fraud”). Instead, as “technical the court question whether was unen- explained that “fraud” as used in the Rule really secondary “would forceable ‘inequitable’ “a range included wider importance.” Accordingly, Id. the court justify holding pat- conduct” that would proper interpretation concluded that a Defining ent at unenforceable. Id. element must include fac- broadly purpose fraud more for the patentability tors other than the of the ruled, justified, Rule 56 was the court be- issue, including subjective “the claims “applicants cause before the Patent Office considerations of the examiner and the being relationship are held to a of confi- applicant.” Id. agency. dence and trust to that The indi- substantially the PTO revised expansion concept cated of ‘fraud’ the disclo- explicit Rule 56 to make more attempt manifests the courts to relationship meaningful.” obligations imposed patent appli- make this Id. sure *33 Examining Appeal patent.”); to issue as a cants. Patent Halliburton Co. v. 43,729, 43,730 Procedures, Fed.Reg. 41 1435, Schlumberger Corp., Tech. 925 F.2d 1976). 4, The 1977 ver- (proposed Oct. (Fed.Cir.1991) (“Information 1440 is mate- imposed “duty rule of can- sion of the rial if there is ‘substantial likelihood that a faith” on those involved in good dor and reasonable examiner would consider it im- prosecution patent or preparation portant deciding whether to allow required them “to applications dis- ”) application patent.’ (citing to issue as a they information are close to the Office 56). the 1977version of PTO Rule is material to the exami- aware of which ensuing years, In the reg court has application.” nation of the The rule de- ularly referred to the “reasonable examin fined information as “material” if there er” test as the standard for measuring “a likelihood that a rea- was substantial raising in cases ineq claims of would consider it im- sonable examiner See, e.g., uitable conduct. Golden Hour portant deciding whether to allow the emsCharts, Inc., Sys., Data Inc. v. 614 application patent.” to issue as a 1367, (Fed.Cir.2010); F.3d 1373-74 Levi creation, Shortly after this court’s Mfg. ton Co. v. Universal Sec. Instru began addressing inequitable con court ments, Inc., (Fed. 1353, 606 F.3d 1358-59 claims raised in the course of duct Cir.2010); Astrazeneca LP Pharms. outset, litigation. From the infringement Inc., 766, Teva Pharm. 583 F.3d 773 USA to the PTO’s Rule 56 as the court looked (Fed.Cir.2009); Prods., Dayco Inc. v. Total standard for the setting appropriate Inc., Containment, 1358, 329 F.3d 1363 inequi doctrine of materiality prong of the (Fed.Cir.2003) cases). (citing Under that Am. Hoist table conduct. See & Derrick test, Inc., consistently the court has Sons, 1350, ruled that a 725 Co. v. Sowa & F.2d (Fed.Cir.1984) (“The false statement or may PTO ‘standard’ nondisclosure for appropriate starting point any is an material purposes for of an materiality”; discussion of failurе to satis conduct determination even if the inven fy obligation, that disclosure combined question tion in would patent otherwise be PTO, with an intent to deceive the can See, Control, e.g., Digital able. Inc. v. unenforceable); render a J.P. Ste Works, 1309, Charles Mach. 437 F.3d vens, (adopting 747 F.2d at 1559 the mate (Fed.Cir.2006); Li Family Second Ltd. 56); Gardco, riality requirement from Rule 1373, P’ship Corp., v. Toshiba 231 F.3d (Rule at 1214 “appropriate 820 F.2d (Fed.Cir.2000); PerSeptive 1380-81 Bios starting point determining materiali Biotech, Inc., ystems, Inc. v. Pharmacia omitted); Indus., ty”) (quotation Fox Inc. (Fed.Cir.2000); 225 F.3d A.B. Sys., 922 v. Structural Pres. F.2d 803 Dick, 798 F.2d at 1397. (Fed.Cir.1990) (adopting Rule 56 standard 56, adopt- In the PTO Rule revised materiality). particular, the court ing what it called a “clearer and more endorsed the of that standard use as the objective definition of what information the proper appro test for when an patentability.” Office considers material to level of intent was shown. priate Spe See Disclosure, Duty of Fed.Reg.2021, cialty Composites Corp., v. Cabot (Jan. 1992). As revised (Fed.Cir.1988) (“Nondisclosed 981, 992 or imposes duty current version of Rule 56 false information is material if there is a filing individuals associated with the likelihood that a ex substantial reasonable prosecution application of an to dis- aminer would have considered the omitted all close to the Office information known to important reference or false information deciding application patentability whether to allow the be material to as defined 56(a). in the pending to render the claims invalid The rule then states Rule the rule. explanation. of further “material” if it is “not absence that information already of rec- information cumulative to rule, Rule part It is the second in the applica- of record being made ord 56(b)(2), object. appellants to which the tion” and requires applicant of the rule part That *34 itself, (1) establishes, in by or combi- It that provide information is inconsistent information, prima with other

nation by the position with or refutes a taken claim; of a unpatentability 56(b)(2) facie case Rule applicant before the office. or clearly beyond a “but for” test and is goes (2) with, refutes, dispute inconsistent in this It or is therefore the focus takes in: position applicant case. (i) argument unpa- Opposing an adopted At the time it the 1992 revision Office, by

tentability relied possi- to Rule the PTO considered (ii) Asserting argument patenta- an bility adopting a “but for” test of mate- bility. majority that riality of the sort has today. rejected The that adopted Office 56(b) requires Rule part The first test, a nar- concluding adopting such that, information at applicant provide row standard “would not cause the Office supple- or further explanation least absent to obtain the information it needs to evalu- mentation, compel would the conclusion patentability may decisions ate so unpatentable. Thе the invention presumed by correct the courts.” The explains “prima rule that a facie case if PTO added that it did not have the “when the unpatentability” is established information, “meaningful examina- needed that a compels information a conclusion patent applications place tion of will take unpatentable prepon- claim is under the infringement for the first time case evidence, burden-of-proof derance of the Duty before a district court.” of Disclo- standard, giving each term its broadest sure, Fed.Reg. at 2023. consistent with the reasonable construction any consideration specification, before change, In the aftermath of that this may given to evidence which be submit- frequently court has treated the PTO’s contrary attempt ted in an to establish a setting of the rule as forth the new version patentability.” adopting conclusion of proper materiality, standard for cases rule, explained that it intend- PTO of failure to disclose mate- involving claims references, applicants ed for to submit information, applications rial at least for aware, they were that would render processed Indepen- after 1992. In Bruno pending unpatentable claims over the Aids, Living Mobility dent Inc. v. Acorn Rules, Proposed Fed.Reg. references. (Fed.Cir. Services, Ltd., 394 F.3d 1348 1991). 37,321, 37,324 (Aug. PTO 2005), the the 1992 version of quoted court examiner, added that it is the role of the patents prosecut- Rule 56 and held that for applicant, analyze sufficiency not the ed while that version of the rule was weight argument. of a rebuttal See effect, materiality of the “we evaluate the imposed id. The intent standard Rule under the standard [undisclosed matter] adopted by 56 and court answers the applicable set forth in the amended rule.” majority’s regarding 1352-53; concerns the breadth at also Id. see Hoffinann-La- 56(b). Roche, part provi- of the first of Rule That 323 F.3d at 1368 n. 2. The court act applies only applicants give sion who with added that “we deference to the applica- at the time an specific intent to deceive the PTO PTO’s formulation being an examin- withholding prior powerful prosecuted art that is so tion is before expects explained it The PTO has the 1992 of conduct er of the standard proposed in the Office.” amendment was “to address crit- proceedings be followed 1353; Bruno, concerning perceived also Bd. icism lack of cer- F.3d at see Bioscience, Inc., tainty 333 F.3d standard.” v. Am. Educ. (Fed.Cir.2003); § Purdue Phar- M.P.E.P. 2001.04. The revised rule was L.P., 1129; provide greater clarity Monsanto Co. intended “to ma 438 F.3d N.V., 1229, hopefully litigation 514 F.3d minimize the burden of Bayer Bioscience (Fed.Cir.2008); Esqu- question Taltech Ltd. v. on the conduct be- (Fed. Office, Ltd., providing fore the while the Office el Enters. Cir.2010). necessary As it did before the court with the information for effec- to make clear that does tive and efficient examination of hаs continued Moreover, materiality. Id. apply applications.” a “but for” test for its brief in *35 Sys., urged Data 614 F.3d at this case the PTO has this court to Hour See Golden 1374; Hoffmann-LaRoche, adopt 323 F.3d at the standard set forth in the current PLC, 1368; Molins 48 F.3d 1179-80. PTO Rule 56 as the standard for material nondisclosures rather than referring to occasion, addressing the issue On when both the 1992 standard and the “reason- court referred to materiality, of has able examiner” standard from the 1977 both the 1977 standard and the 1992 stan of version the Rule. pertinent it as to the supplanted dard that See, materiality. e.g., Digital judge definition of Because the PTO is the best Control, 437 F.3d at 1316. The court has what information its examiners need to that, examinations, light of the fact as the conduct effective done so the PTO’s explained, materiality the 1992 standard was definition of is PTO has entitled to def- signal sharp departure determining not meant a erence in whether the failure particular Yet while the two to disclose during from the 1977 standard. information patent prosecution standards were not meant to be dramati constitutes different, Moreover, recognized the court conduct. cally has because PTO has regards materiality that the the 1992 standard as refined the standard in setting PTO setting precise expects applicants forth a clearer and more forth what and necessary representatives, of the disclosure to their there is no need for statement a conducting apply efficient examinations. See courts to broader test of materiali- 1310, Target Corp., ty adjudicating inequitable Rothman v. 556 F.3d (Fed.Cir.2009); claims, doing Purdue Pharma as so could at least theoreti- L.P., 1129; Corp. cally imposition 438 F.3d at Pharmacia result in the of sanctions Pharm., Inc., 1369, a v. Par F.3d 1373 for failure to disclose matters that the (Fed.Cir.2005). require PTO does not to be disclosed.3 “duty asserting patentability opposing with the 3. The PTO’s Rule 56 deals takes" patentability” argument disclose information material to unpatentability relied on explicitly and does not address affirmative 56(b)(2). the PTO. Rule An affirmative false by parties to the PTO made false statements separately violate the statement does not prosecuting patent application. a In some may contrary disclosure nonetheless be rules case, instances, as in this a false or mislead- "duty good broader of candor ing affirmative statement also violates the dis- (a) paragraph faith” referred to in of Rule party requirement, because when a closure imposed which is on “each individual associ makes a statement is inconsistent with filing prosecution pat ated with the statement, party’s prior own the failure to application.” Sylva ent See Nilssen v. Osram statement constitutes a fail- disclose Inc., nia, (Fed.Cir 1231-32 “refutes, ure to disclose information that or is . Prods., 2007); Dayco F.3d at 1363-64. with, position applicant inconsistent any disclоsure C suggest that This not to is might have de- that the PTO requirement forth in materiality standard set for an predicate serve as vised would adopted as in 1977 and refined Rule ineq- charge. Because inequitable conduct idiosyncratic is not an contrivance doctrine equitable is an uitable conduct PTO; contrary, it quite is consis- courts, simply a mecha- and not applied with the standard that is tent of PTO judicial enforcement nism for variety in a of other analo- applied wide rules, of the court-made doctrine scope Although relationship contexts. gous inseparably tied breadth is patent applicants between the PTO and However, the rules. the PTO’s disclosure law, appro- unusual our it is nonetheless con- of both the purposes basic way priate concept to look to the same, Rule are the duct doctrine and areas, in other applied the PTO and the disclosure duties obligations requirements disclosure are defined imposes applicants, on imposed parties are in a wide candor reasonably are calculated to by Rule variety settings. necessary pro- produce the disclosure in- provides particularly Securities law mote efficient conduct of examinations *36 analogy, proxy and structive as issuers and discourage types of omissions (if in- corporate that made intention- insiders often have access to misrepresentations formation relevant to a stockholder’s deci- ally) equitable raise concerns. these circumstances, efficiency diligent of sion that even the most investor considerations economy encourage Similarly, us to embrace the could not discover. in a than approach. long reasonably applicant position So as it is often better PTO’s calculus, the examiner to know art or aligns equitable our own we of relevant with circumstances, potentially invalidating of should defer to the PTO’s assessment prior Notably, treat intentional breaches of such as use. in the securi- its needs and context, typical- providing rules as ties law a nondisclosure is PTO’s disclosure ly regarded material without the need finding basis for a of conduct. as Living, Thus, Indep. See Bruno prove example, reliance. 394 F.3d an the case of those who have affirmative majority question actually The holds that the "but for” test that the article in was writ- apply egre- does not to "affirmative acts of attorney patentee. ten an for the The gious misconduct.” It then adds that neither "affirmative distinction between acts” prior "nondisclosure of art references to the apt "nondisclosure” is thus to become fertile prior art PTO nor failure to mention refer- future, ground litigation in the not to ences in affidavit constitutes affirmative "egregious” mention the distinction between egregious any misconduct” under circum- assertedly misconduct and misconduct that is illustrates, it often stances. As this case "egregious.” less than difficult to draw a line between nondisclosure Contrary Judge O’Mal- statement misrepresentation. and affirmative For ex- ley's separate opinion, nothing opinion in this ample, pur- is a submission to the PTO that rejects application ineq- of the doctrine of prior ports to the state of the art but describe (or hands”) ap- uitable conduct "unclean knowingly an “af- omits the closest art misconduct, litiga- plied of to other forms merely firmative act” of misconduct or tion or otherwise. This case deals with the "non-disclosure of information”? Even the consequences of nondisclosure in violation of case, majority de- which the Hazel-Atlas duty imposed by of disclosure the PTO's example egregious scribes as an duct, miscon- solely opinion Rule and this is directed regarded could be as an instance of nondisclosure, the role of the doctrine problem as the identified Supreme in that context. Court was the failure to disclose circumstances, duty of disclosure to investors under the the omitted fact fail to comply securities laws and who significance would assumed actual duty, Supreme that Court has held in the deliberations the reasonable not a “positive proof reliance is shareholder. recovery. All that is neces prerequisite to Id. facts material sary is withheld be proceedings Even criminal that re that a the sense reasonable investor quire proof materiality, prosecu such as might important have considered them tions under the federal mail and wire fraud making decision.” [the investment] statutes, 1341, 1343, §§ 18 U.S.C. a “but States, Ute Citizens v. United Affiliated applied. for” test of is not 128, 153-54, 406 U.S. 92 S.Ct. penalize only Those laws affirmative (1972). Supreme L.Ed.2d 741 Court misrepresentations, but also the conceal recently reaffirmed that standard in Ma ment of material facts. United States v. — Initiatives, Siracusano, Inc. v. trixx (3d Olatunji 872 F.2d Cir. U.S. -, 179 L.Ed.2d 398 S.Ct. 1989); v. O’Malley, United States (2011). passage In a that addressed con (11th 1240, 1247 Cir.1983). a charge When case, cerns similar to those raised in this mail or wire fraud is based on the explained adopted the Court it had nondisclosure of material information in the “reasonable investor” standard to en duty disclose, violation of a proof sure that investors would have access to require showing does not important information to their investment victim; part actual reliance on the decisions, being while “careful to set required proof all that is that the non materiality, too low a standard of for fear disclosure or concealment be capable of management bury would the share influencing the intended victim. See Ned *37 holders in an avalanche of trivial informa States, 1, 16, 24-25, er v. United 527 U.S. (quotations tion.” Id. at citations (1999). 1827, 119 S.Ct. 144 L.Ed.2d 35 See omitted). Riley, 312, also United States v. 621 F.3d Supreme adopted The Court has a sim- (3d Cir.2010) (nondisclosed 332-33 rela rejected materiality ilar standard —and tionship mayor purchaser between materiality “but for” test for the con- —in city property was material “even if the 14(a) Ex- text of section of the Securities relationship per would not have se barred 1934, change regarding proxy Act of so- Szur, purchase].”); [the United States v. Indus., licitations. See TSC Inc. v. (2d (securi 200, Cir.2002) 211-12 289 F.3d Inc., 438, Northway, 426 U.S. 96 S.Ct. duty ties broker owed to customers to (1976). 2126, There, 48 L.Ed.2d 757 disclose broker would earn “exorbi stated that an fact Court omitted is mate- trades; tant” commission on such informa “if rial there is a substantial likelihood purpose tion was material for the of the that a reasonable shareholder would con- it wire fraud statute because would have important deciding sider it how to been “relevant to a customer’s decision 449, Signifi- vote.” Id. 96 S.Ct. 2126. stock”); purchase the United States v. cantly, purposes, for our added Court (2d Bronston, Cir.1981) 920, proper that the standard (concealment of information that defendant require proof does not of a substantial duty is under a is material if disclose likelihood that of the disclosure omitted the nondisclosure “could or does result in fact would have caused the reasonable victim). harm” to the change investor his vote. What the The same have contemplate showing principles applied standard does is a been that, of a substantial likelihood under all to nondisclosures of material information a matter is explains, statement of Torts matters, civil matters that even in civil man would attach per- material if “a reasonable having grave as regarded have been existence or nonexistence importance In a denaturalization to its consequences. sonal action,” or if example, determining a “concealment or his choice of proceeding, in the course of “knows or representation made the maker of the misrepresentation” process recipient is considered that its re- the naturalization has reason to know 1427(a) § if it under 8 U.S.C. the matter as gards likely regard “material” or is tendency influence the “a natural ac- determining has his choice of important Immigration (Second) and Natural- decisions Restatement Torts tion.” Service”; necessary to States, it is not (1977); ization § Neder v. United see misrepre- or 1827, that the nondisclosure 1, 5, show 22 & n. 119 S.Ct. U.S. an question actually had such (1999) sentation (citing the Restatement L.Ed.2d 35 States, 485 Kungys v. United effect. See materiality require- setting as forth 1537, 99 L.Ed.2d 108 S.Ct. fraud). U.S. In order for ment for common-law (1988). noted in Supreme Court satisfy misrepresentation a material it never been the test that case that “has needed for an requirement causation misrepresentation necessary it for the damages, award of likely would more than not or concealment plaintiff misrepre- reliance on the to show decision, an erroneous produced have However, sentation. the “but for” test likely more than not even that would tort actions for apply does not even to investigation.” Id. at triggered necessary damages, as it is not for the (emphasis original). 108 S.Ct. 1537 “that he would not have plaintiff to show acting or refrained from' as he did acted to the common law respect Even with representa- had relied on the unless he fraud, deceit, misrepresen- action for (Second) tion.” Restatement Torts tation, than exacting which is more § settings cmt. In none of these conduct, b. see doctrine of J.P. been set at the has test 747 F.2d at the “but Stevens & majori- high adopted by “but for” level to the element of apply for” test does setting, ty the Re- in this case.4 materiality. *38 remedies, heightened § majority argues 17 U.S.C.

4. The that the "but for” test see 2009), (Supp. provision that was not copyright Ill but applied is in both and trademark applicable presumption copy- the registration. made To law to claims of fraudulent 410(c), context, § right validity U.S.C. set forth in 17 contrary, copyright the in the courts subject pre-2008 which remains to the stan- rejected have the "but for” test in favor of Copyright dards. See 2 Nimmer on registration that a federal will be invali- rule 7.20[B][1], 7-212.4(2) § at n. 25.2. willfully or dated if the claimant misstates that, known, trademarks, “might deciding to state a fact if true that in fails As for is rejection application.” the will occasioned a whether fraud on PTO result the 859, register, Update, the 736 F.2d cancellation of a mark on federal Eckes Card Prices added); (2d Cir.1984) (emphasis apply materiality. see courts a "but for” test of 861-62 See, e.g., Express Trading generally 2 & David Nim- Orient Co. v. Federat- Melville B. Nimmer 7.20[B][1], Stores, Inc., (2d mer, Copyright Dep’t § at 7- ed 842 F.2d Nimmer on (rev. 2010) ("If Cir.1988) 4(1) (defining that ed. the material fact as "one & n. 21 wilfully have affected the action on the or fails to state a would PTO’s claimant misstates that, known, Citibank, applications”); might the N.A. v. Citibanc fact if have caused Inc., (11th reject application, Grp., Cir. Copyright [it] Office to the "false, invalid.") 1984) by (citing (requiring may numerous material statement be ruled cases). Congress adopted plaintiff of a that would have consti- a "but fact In registration govern grounds tuted for denial of the for” test to the effect of errors on known.”). right the author right bring and the had the truth been As a civil action by majority discussing course charted is when the use of sensors with Supreme blood, contrary thus to the Court deci- following: whole stated the rise to the doctrine of gave sions that Optionally, but preferably being when conduct, long to a line of our blood, used on live a protective mem- principles precedent, own and brane surrounds enzyme both the and applied that courts have in oth- layers, permeable the mediator to water rule, this court’s new er contexts. Under glucose and molecules. an who conceals information applicant patent, '382 col. 11.63-66. A central intent to deceive the will be free PTO issue before the examiner was whether the patent his it can to enforce unless be “optionally” pas- use of the term in that convincing proved by clear evidence that sage possible indicated it was to use not have patent would issued but (or live) sensors whole blood without though majority Even for the fraud. protective membrane. justifies part by rule in asserting its new The district court found that the persons prosecution improve pat- that it will in prosecuting involved the '551 applica- PTO, I am ents before the convinced tion, attorney Abbott’s Pope Lawrence likely rule to have an the new adverse expert, Dr. Sanghera, Gordon made and the impact public large, the PTO representations to the examiner that the significantly—is a view shared that — pertinent passage in the patent '382 should the PTO itself. taken at particular, face value. Sanghera Dr. submitted a IV declaration though he stated that even the '382 case, The facts of this as found patent referred to the use of a protective court, why district illustrate the materiali- surrounding membrane enzyme ty standard of Rule 56 is suitable test for layers mediator glucose meter as inequitable conduct claims based on disclo- “optionally, preferably” present, but “one during sure violations. A central issue skilled in the art would have felt that an examination that led to the issuance of the comprising enzyme active electrode patent prior '551 was whether the art had require a mediator would a protective taught glucose sensors could be used if membrane it were to be used awith protective to test blood whole without sample.” reason, whole blood For he membrane. The examiner focused on stated, he was “sure that one skilled in the taught whether the art '382 art patent] would not read '382 [the the use of sensors without membranes. teach that the face, protective use of a mem- On its '382 seemed to sample option- brane with a whole blood teach that sensors could be used without testing ally merely preferred.” Pope, membranes when whole blood be- Mr. *39 specification of the patent, prosecuting attorney, cause the '382 added own his re- PTO, reasons, leading law treatise trademark has would not exist. For those as out, however, pointed McCarthy explained, cancellation of a mark has the "standard of dis- register extinguish procure- from the federal does not closure and hence of ‘fraud’ in the rights registrations the trademark of the mark’s owner or ment federal trademark be, is, right infringers. quite defeat the owner’s sue should different from that in McCarthy, McCarthy patent procurement. stringent J. Thomas on Trade- The stan- (4th Competition applicable § patent ap- marks and 31.60 of disclosure dard[s] Unfair ed.2008). plications appropriate applica- are ... not registration, registration.” Unlike the effect of a trademark tions trademark Id. at which, (internal grants right patent quotation § the issuance of a 31.65 and citation omit- ted). but for examination and allowance at the Pope. Dr. Mr. The Sanghera’s through Sanghera Dr. submitting when marks issue, after a finding in court’s on that made He stated: “One skilled declaration. analysis representations of the not have read disclosure detailed the art would bodies, teaching as that the held to be clear- patent] the two cannot be of the ['382 ly membrane with whole The court also found protective of a erroneous. district use optional. was He would samples that Abbott’s failure to disclose to the ex- blood not, working in view of the ex- especially aminer that it had made inconsistent state- optionally, pref- read the but amples, have regarding teaching ments ‘to the EPO ... as a technical teach- language erably patent highly of the was material. '382 phraseology.” patent rather mere ing but the court found that the failure particular, teaching is no added: “There Pope Mr. in inconsistency to disclose the those state- active unprotected electrodes suggestion of nondisclosure cov- ments was kind specimens in [the with whole blood for use being ered PTO Rule as nondisclo- or the other art of rec- patent '382] with a sure of information “inconsistent Shortly application.” after ord ... position applicant takes in [assert- made, were the examin- those submissions That ing argument patentability.” for a er allowed the claims membraneless too, regarded clearly finding, cannot be sensor. central role of the light erroneous of the portion patent in the pertinent of the '382 found, problem,

The the district court that led to application examination directly made contradicto- that Abbott had patent. of the the issuance '551 ry representations European to the Patent (“EPO”) concerning teaching Office intent, Turning to the issue of the dis- in connection the '382 with the trict court failure to found Abbott’s European patent applica- of a prosecution disclose material information was inten- tion and had not disclosed those contradic- tional, i.e., specific it was made with the tory representations to the PTO. Before intent to deceive the PTO. The district EPO, Eu- represented Abbott that the testimony Pope court heard live from Mr. ropean counterpart '382 re- Sanghera and Dr. and conducted a detailed optional- a “protective ferred to membrane analysis testimony light of their of the ly of the glucose utilized with sensor analysis, record. Based on that the court “pref- patent,” and that the membrane was justify concluded that their efforts to their erably to with in vivo measure- be used unpersuasive. conduct were The court specific ments.” reference to the With Pope Sanghera found that Mr. and Dr. language patent reciting from the use contrary representa- were aware of the protective “optionally, membrane consciously made to the tions EPO preferably being but when used on live from the chose to withhold them PTO. blood,” Abbott told the EPO: “It is sub- carefully expla- The court considered their unequivocally mitted this disclosure is nations for their failure to disclose the clear. protective option- membrane is expla- references and found each witness’s al, however, it preferred when used on lacking. nation to be The court discred- prevent larger live blood order to that he under- Pope’s explanation ited Mr. blood, particular constituents of the er- “unequivocally stood the term clear” *40 ythrocytes interfering from with the elec- permea- submission to relate to the EPO trode sensor.” membrane, bility not to the text “unequiv- immediately following the words

The district court found that Abbott’s clear,” that ocally plainly where it is stated representations to the EPO contradicted PTO, optional. The court was representations its made membrane by Pope’s persuaded Mr. statement PTO did not contradict the statements EPO, made to the the court found that Dr. “optionally, prefera- he but that believed Sanghera representation knew that a had meant, patents, “op- context of bly” made to been the EPO that the '326 pat- always.” tionally, but ent not require did a membrane when used possible then considered alter- The court Noting with whole blood. that Dr. Sangh- Pope’s native reasons for Mr. decision not trial testimony era’s had been impeached contradictory EPO state- to disclose prior- his inconsistent statements on ments, that possibility such as the Mr. points, finding certain that Dr. Sangh- Pope meaning had misunderstood “unconvincing era exhibited an trial de- the terms “whole blood” and “live blood.” meanor,” the district court found that he however, Ultimately, the district court requisite acted with the intent to deceive. identify plausible could no reason for the inAs the case of Mr. Pope, the district nondisclosure and therefore found that Mr. findings court’s Sanghera as Dr. are not Pope deceptive had acted with intent. clearly erroneous. finding,

That based on the court’s consid- Viewed in light of the district court’s Pope’s eration of Mr. demeanor and over- findings, compelling this case is a one for credibility, analy- all as well as the court’s applying principles con- whole, sis of the record as a cannot be said duct. The district court found that Ab- clearly representatives to be bott’s deliberately erroneous. with- held material from the directly PTO that reasons, For similar the court that found refuted Abbott’s contention that one Sanghera Dr. also acted with intent skilled in the art would have believеd that deceive the PTO. The court considered the '382 taught that a membrane rejected the possibility that Dr. required was analysis. whole blood Sanghera Pope, believed that Mr. Abbott’s Abbott’s position inconsistent on the teach- PTO, counsel before the would disclose the ings of this critical reference squarely falls material information. The court began by scope within the of information of the sort that finding Sanghera’s Dr. declaration be- 56(b)(2), i.e., referred to in Rule PTO in- representations fore the PTO contained “refutes, formation that or is inconsistent misleading by that were omission. The with, position the applicant takes in ... explained finding court as follows: [ajsserting argument of patentability.” ‍‌​​​‌​‌‌​​‌‌​‌‌‌​​​‌​‌‌‌​​​‌‌​​​​​‌​‌‌‌‌‌​​​​​​‌‍Given the examiner’s focus on the issue of He step. did not have to take this extra protective whether the membrane so, Having obligated done he was prior not, art patent optional was avoid intentional deception. His sworn importance issue was of critical in the statements to the PTO about the mean- prosecution of the application issued ing of the “optionally preferably” but patent, though as the '551 even the undis- sentence were known him to be in- information, revealed, closed if may not company’s consistent with his own state- rejection resulted of the claims ments to the EPO —statements he had at issue. Accordingly, the district court helped himself craft. made all the findings necessary support Sanghera’s testimony As to Dr. that he holding that the '551 patent was unen- believed statements he made to the forceable for conduct.5 Be- Understandably relying on this court's levels and intent.” Al law, point case district court stated one though suggest those remarks a looser stan Pope that Mr. "knew or should have here, known” they dard than that advocated do not the withheld information would have ruling ineq undermine the district court’s examiner, highly been material to the and at conduct, uitable because the district court point “balancing another the court referred to *41 findings factual court’s the district cause and because clearly erroneous

are not proper with the comports

legal analysis conduct the doctrine

role of law, judgment the district court’s

in patent is unenforceable the '551 affirmed.

inequitable conduct should dissent. respectfully

I GROUP, TECHNOLOGY

ALLIED

INC., Plaintiff-Appellant, STATES, Defendant-Appellee,

UNITED Solutions,

Monster Government

LLC, Defendant-Appellee.

No. 2010-5131. Appeals, States Court of

United

Federal Circuit. 9, 2011.

June Sept.

Rehearing En Banc Denied attorney clearly remarks findings [to satisfied the declaration and the elsewhere made requirements of the more restrictive stan- respect Sanghera, With to Dr. PTO].” set above. dard for forth "consciously that he made sworn court found Pope particular, court found that Mr. deliberately that were [PTO] statements to the specific intent to deceive Examin- "acted with misleading.” respect With to the issue PTO,” Shay Pope er and the that Mr. and Dr. moreover, judge did "balancing,” the district Sanghera and deliberate "made conscious against necessary to balance intent find decision to withhold disclosure to the PTO of explicitly materiality, he found because EPO, and that these statements” strong to both the evidence was materials both of them "knew that the EPO and intent. made affirmative statements inconsistent

Case Details

Case Name: Therasense, Inc. v. Becton, Dickinson and Co.
Court Name: Court of Appeals for the Federal Circuit
Date Published: May 25, 2011
Citation: 649 F.3d 1276
Docket Number: 2008-1511, 2008-1512, 2008-1513, 2008-1514, 2008-1595
Court Abbreviation: Fed. Cir.
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