# Petition for Writ of Certiorari — R.J. Reynolds Tobacco Co. v. Star Scientific, Inc. (No. 08-918) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386017_0071%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 2008 ## Text Soames a 06-918 JAN 16 2009 \\ \\\ y OFFICE OF THE CLERK No. 08-___ IN THE Supreme Court of the Anited States R.J. REYNOLDS TOBACCO COMPANY, Petitioner, Vv. STAR SCIENTIFIC, INC., Respondent. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit PETITION FOR A WRIT OF CERTIORARI RICHARD A. KAPLAN DONALD B. AYER RALPH J. GABRIC Counsel of Record K. SHANNON MRKSICH MICHAEL S. FRIED CYNTHIA A. HOMAN SUSAN M. GERBER JEROLD A. JACOVER RACHAEL A. REAM BRINKS HOFER GILSON CHRISTOPHER J. SMITH & LIONE JONES DAY 455 N. Cityfront Plaza Dr. 51 Louisiana Ave., NW NBC Tower — Suite 3600 Washington, DC 20001 Chicago, IL 60611 (202) 879-3939 (312) 321-4227 January 16, 2009 Counsel for Petitioner i QUESTION PRESENTED The Federal Circuit in this case reversed a district court ruling that two patents were unenforceable due to inequitable conduct. It thus overturned as clearly erroneous district court findings made after a week-long trial, which relied expressly on credibility findings. The district court found that the applicant, Jonnie Williams, had made affirmative misstate- ments to the Patent Office—which the Federal Cir- cuit acknowledged—and never over several years disclosed known prior art that the district court ruled, and the Federal Circuit did not dispute, was highly material. The district court expressly found that this pattern of conduct demonstrated intent to deceive the Patent Examiner. In reversing, the Federal Circuit substantially ig- nored this reasoning, and focused instead on a single incident that was peripheral to the district court’s analysis. The court below never mentioned the dis- trict court's finding that the prolonged non- disclosure of known highly material information showed an intent to deceive and, contrary to its own precedents, strongly suggested that the materiality of concealed information should not be considered in assessing intent for purposes of inequitable conduct. The Question Presented is whether the decision below unduly narrows the duty of candor owed by a patent applicant to the Patent Office and violates fundamental principles of appellate review of trial court fact-finding. il PARTIES TO THE PROCEEDING AND CORPORATE DISCLOSURE STATEMENT The parties to the proceeding below were Peti- tioner R.J. Reynolds Tobacco Company (a North Carolina Corporation), R.J. Reynolds Tobacco Com- pany (a New Jersey Corporation), and Star Scien- tific, Inc., the Respondent. R.J. Reynolds Tobacco Company (a North Carolina Corporation) is succes- sor by merger of R.J. Reynolds Tobacco Company (a New Jersey Corporation), which ceased to exist as of July 30, 2004. Petitioner R.J. Reynolds Tobacco Company is di- rectly and wholly owned by R.J. Reynolds Tobacco Holdings, Inc. (a Delaware Corporation). R.J. Rey- nolds Tobacco Holdings, Inc. is an indirect wholly- owned subsidiary of Reynolds American, Inc., a pub- licly traded corporation. Brown & Williamson Hold- ings, Inc. owns more than 10% of the common stock of Reynolds American, Inc. and is an indirect, wholly-owned subsidiary of British American To- bacco, ple., a publicly traded corporation. ili TABLE OF CONTENTS Page QUES EIN FRE ET BID sv occcsscsessncsnsuvensesvsevesceossseces 1 PARTIES TO THE PROCEEDING AND CORPORATE DISCLOSURE Be Ee BNI E eiciiithnicas s thvcltnnaokeneddncavobenestacktxues li TAs CIE AUTOR 0 BIG ie cccocccsecscccsesvesasessssessosss vi CR Oe MEINE TY eitscsississetnvisasdosedisneanessnenctauarenays 1 Fe BE iret ckiiiettssttsmccistin ronan, 1 STATUTORY PROVISIONS INVOLVED ................ 1 eR EE, wakincieh ncicd sr retanioedixds auouneranaees 2 A. Legal FYAMeCWOPK.....0.....cssccacsecsssesecsreees 2 B. IPI cance on eccenadadcumsialahaveacauassuaal cea enare: 3 C. The District Court’s Inequitable Coratanet TO Cem nsciseiscccssncecsbiesssecnsss 10 D. The Federal Circuit’s Inequitable COMUAOE TROGIR cosicssncasscossvecncsssnvesnes 13 REASONS FOR GRANTING THE WRIT.............. 15 I. THE DECISION BELOW MARKEDLY NARROWS THE INEQUITABLE CONDUCT DEFENSE IN A MANNER AT ODDS WITH PREVIOUS FEDERAL CIRCUIT DECISIONS AND WITH DECISIONS OF OTHER CIRCUITS .......... II. If. iv IN REVERSING THE DISTRICT COURT'S FINDINGS OF INEQUITABLE CONDUCT, THE FEDERAL CIRCUIT VIOLATED THIS COURT’S PRECEDENTS REGARDING THE USE OF CIRCUMSTANTIAL EVIDENCE AND THE PROPER ROLE OF APPELLATE COURTS ............ccceccseees A. The Decision Below Offends Basic Principles Governing Trial Court Factfinding Based on Circumstantial Evidence ................. B. The Decision Below Also Violates This Court’s Clear Directives Concerning the Role of Appellate Courts in Reviewing Trial Court | REE: ee EE Ne C. The Federal Circuit’s Approach to Appellate Review and Trial Court Assessment of Circumstantial Evidence Cannot Be Defended on the Basis that a Different Approach is Appropriate in Patent Cases............ THE DECISION BELOW CREATES GREAT CONFUSION AND WEAKENS THE DUTY OF CANDOR BY PLACING A VERY HIGH THRESHOLD ON PROOF OF INEQUITABLE CONDUCT .... 30 Vv IV. THE FEDERAL CIRCUIT'S DECISION REVERSING THE TRIAL COURT'S FINDINGS OF INEQUITABLE CONDUCT ON BOTH PATENTS IS WRONG ON THE MERITS ......................04. 32 8 | __RERED I renee ONCE D EE DOR oE me NRO ORE 35 APPENDIX Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 637 F.3G 1967 (Ped. Civ. 20GB) .......cccrccsorccssreess la Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. MJG-01-1504 (D. Md. June 26, 2007) PU NOTNE CIUTIOPD osinesscicvecaceccnseceevenisescontorsceeees 30a Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 2007 WL 1890709 (D. Md. June 26, 2007) (Memorandum of Decision Re: Inequitable ei as apa a a caer dla Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. MJG-01-1504 (D. Md. June 22, 2007) (Corrected Memorandum and Order Re: IN i siiccscpcentctsiciacecuamebaauvae T7Ta Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. MJG-01-1504 (D. Md. Dec. 2, 2004) (Memorandum and Order Re: Crime-Fraud Teo ke SRE ENE, WY Aaa NRE Oe 90a Disposition Sheet, Order Denying Petition for Rehearing and Rehearing En Banc (Fed. Cir. Oct. 22, 2008) ..............000.000. 106a U7. Comet... PGE. ©, BG, CL. Biicvcciccsnccasnesocsicssecseness BOTM 2 t 2 oS Seer openeeee sens Guise edamame 108a vl TABLE OF AUTHORITIES Page CASES A.H. Emery Co. v. Marcan Products Corp., Oe We EL COE Cb, LOGB) on... cccscsscssocsensevesccsoneses 23 Abbott Laboratories v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008) .......cccccccccssesseseseseseeees 27 Anderson v. City of Bessemer, 470 U.S. 564 ee cepanun 26 Aventis Pharma S.A. v. Amphastar Phar- maceuticals, Inc., 525 F.3d 1334 (Fed. age a aa as snsbanansnneen’ 20 Batson v. Kentucky, 476 U.S. 79 (1986)................. 25 Blonder-Tongue Laboratories, Inc. v. Uni- versity of Illinois Foundation, 402 U.S. aaa 39 Bonito Boats, Inc. v. Thunder Craft Boats, Be OF a BOE © LUI svcicncnnsskctecsecdecscsseveceseases 17 Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226 (Fed. Cir. ais sgnleponansbeanenes 19 Cardinal Chemical Co. v. Morton Interna- tional, Inc., 28 U.S. 83 (1998) .............. Re eens 17 Cargill, Inc. v. Canbra Foods, Ltd., 476 ee Re CG, FUR, BF TP bia sncccsscseccccnscesecvcccecsces 19 vli Consolidated Aluminum Corp. v. Foseco International Ltd., 910 F.2d 804 (Fed. Ci III ua itt tia cucuaceesediveevauuidlasonsstiimmensouseetaanuune 35 Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253 (Fed. Cir. 1997)....... 19 Dayco Products, Inc. v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir. 2003) ......... iamaneabaa 3 Dennison Manufacturing Co. v. Panduit Cs Be Crees te CD ci catrshessecsrtetsasscnesasencsan 29 Desert Palace, Inc. v. Costa, 539 U.S. 90 RIPE tic cosiedieucdraeeksstasatdneriacensdebeamiadisaiabuenmion 23, 24 Dickinson v. Petroleum Conversion Corp., BE WE CPE CINE sexocscndesccncndenctcdmredeindotuasditosnens 18 Digital Control, Inc. v. Charles Machine Works, 437 F.3d 1309 (Fed. Cir. 2006)...... iiiaainaian 3 Digital Equip. Corp. v. Diamond, 653 F.2d Pe Tc ciscubienkoten 22 Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337 (Fed. Cir. 2007), cert. denied, 128 S.Ct. 375 (2007), and 128 S.Ct. 391 (2007)............ 19, 20 Ebay Inc. v. MercExchange, L.L.C., 547 re ME oa a 28 Ferring B.V. v. Barr Laboratories, I[nc., 437 F.3d 1181 (Fed. Cir. 2006) ................. 18, 19, 20, 27 General Electro Music Corp. v. Samick Mu- sic Corp., 19 F.3d 1405 (Fed. Cir. 1994)............... 8 Vill Graham v. John Deere Co., 383 U.S. 1 RIES Sa es RMR pore ior ee Pon Ne ie ee 2, 30, 31 Holland v. United States, 348 U.S. 121 ia aa aaa ea 24 Holmes Group, Inc. v. Vornado Air Circula- tion Systems, Inc., 535 U.S. 826 (2002) ...... 22, 28 Honeywell International Inc. v. Universal Avionics System Corp., 488 F.3d 982 a ssavecddaavinds 19 Huddleston v. United States, 485 U.S. 681 aah EARL aah oh erry Po SEDO EN to 24, 25 International Telephone & Telegraph Corp. v. Raychem Corp., 538 F.2d 453 (1st Cir. SERRE RIE TON ROU RRR EEE ON ARE | ERNST San 22 Inwood Laboratories, Inc. v. Ives Laborato- 108, Inc., 466 U.S. 844 (1982) ..........c.c.cccccccoceseces 26 Jackson v. Virginia, 443 U.S. 307 (1979) ......... 24, 25 KSR International Co. v. Teleflex Inc., 550 Fs es BT he BF I ED ic evesosensiscecahsscesss 28 Kendall v. Winsor, 62 U.S. 322 (1858)...............0000 3] Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. a Rs Ase SERS LTS RPS Ee Oe aa, Si Kingsiand v. Dorsey, 338 U.S. 318 (1949).....2, 15, 31 Lear, Inc. v. Adkins, 395 U.S. 653 (1969)............... 31 ix li Second Family Ltd. Partnership v. To- shiba Corp., 231 F.3d 1373 (Fed. Cir. yt) Al 7 19 MOSAID Technologies Inc., v. Samsung Electronics Co., 362 F. Supp. 2d 526 CD, Sines evssessesecescess0. 35 McKessor Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cin, BOBF) vcchccoctaeitbaeateennecesacceccccsccese 20, 21 Miller-El v. Cockrell, 537 U.S. 322 (2008).............. 25 Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1868 Ged. Cir, BOB) ...cccccsescccsccssscccccevcsecees 19 Pope Manufacturing Co. v. Gormully, 144 US Bo Be Ce oat ecetccdateasscossescocsccnecees OL Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306 (Pred, Gist, Sie katerssaacnccovesscccccccccces. 19 Precision Instrument Manufacturing Co. v. Automobile Maintenance Machine Co., 324 U.S. SOG CR cermeicescecesscsscessee 2, 16, 28, 29, 31 Schinzing v. Mid-States Stainless, Inc., 415 F.3d SOT CGE Go, Be rcatensccccccesccsccccccsccscsccces: 22 Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945) .c.cccccccsccscsssscesesssseecees 31 True Temper Corp. v. CF&I Steel Corp., 601 F.2d 495 (TOG Car. EO TB) ..........00.0.0..00cc0ccc00 23 x Turzillo v. P&Z Mergentime, 532 F.2d 1393 Pa ane MNEs, - UE cisiucicens soaeinkaandatseibandoubueneenimekdcenents 23 United States v. Yellow Cab Co., 338 U.S. SE TL SS LAIST 26 United States Postal Service Board Of Governors v. Alkens, 460 U.S. 711 (1983).......... 23 Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997) .............cccceeeeee 17 Zenith Radio Corp. v. Hazeltine Research, Pa. GS VF tic Fe Ue a tave nt nckdathescecstcessvetenivsvens 29 CONSTITUTIONS, STATUTES AND REGULATIONS UF OE, BR: 0.8 Bietiincictintcmnnsinusn 2, 15, 30 BD Sr ied Oe I cas scuhrsuscekscecntaieséncaseenddaamanauan l BE UBC. © UDB ecccesissssorcosoverescscosesossccscessecosesene 1 OR TIR SO 1006 ccc 1 ee res Oe EU Tak cnsdsscudacessesecinvcntuesataceaesapcdunteaseieds | ee i eae aeiani 5,11 Be ee ie EE Sodasatsdaschndkctsdscsaeeteaasiasaaeaneua 1 ee Seis cis We Re) 5 WE EA ccssndcsnccsicvacoussocsanouatorenteens 3 Oe GecW cies BD COD overs sccnécsccccsnenccnsccsséecseranscun 3 xl LEGISLATIVE MATERIALS Bee BA, DOD Wee Chee decsccnnsccsesconevscesessesisecesess 17 OTHER AUTHORITIES Scott D. Anderson, Jncquitahle Conduct: Persistent Problems and Recommended Resolutions, 82 Marg. L. Rev. 845 (1999)........... 21 Jon W. Dudas, The Patent System: Today and Tomorrow, at www.uspto.gov/web/ offices/com/speeches/2005apr21.pdf (Apr. 21, 2005) (visited Jan. 4, 2009)................00 31, 32 Kevin F. O’Malley, et al, Federal Jury Practice and Instructions § 17:07 (6th ed. EU TAR ERECT ana RR Dre PROTEC Cen aR 23, 24 Michael A. Weidinger, Note, Jnequitable Pleading: Defendants’ Particular Burden in Patent Infringement Suits, 62 Geo. PEGG. Ea, BOOU. TTT COD cvcccccsdciaccaccesscnccscsscscsss 21 The Doctrine of Inequitable Conduct and the Duty of Candor in Patentrocurement, Ad Hoc Committee on Rule 56 and Ineq- uitable Conduct American Intellectual Property Law Association, 16 AIPLA Be i EE isicscidatrinhtentsdustasucdisnandcdeciseiescessocans 30 Manual of Patent Examining Procedure eg gt hk | Re eee 8 PETITION FOR A WRIT OF CERTIORARI R.J. Reynolds Tobacco Company (“Reynolds”) re- spectfully petitions for a writ of certiorari to review the judgment of the United States Court of Appeals for the Federal Circuit in this case. OPINIONS BELOW The opinion of the court of appeals (Pet. App. 1a) is reported at 537 F.3d 1357. The district court’s deci- sion finding the patents-in-suit unenforceable based on inequitable conduct (Pet. App. 31a) and its opin- ion granting summary judgment for Reynolds based on indefiniteness (Pet. App. 77a) are unreported. JURISDICTION The district court had jurisdiction over Respon- dent’s claims under 28 U.S.C. §$§ 1331 and 1338(a). The Court of Appeals had jurisdiciion to review the district court’s final judgment under 28 U.S.C. § 1295(a)(1). The United States Court of Appeals for the Federal Circuit entered its judgment and opinion on August 25, 2008, and denied Reynolds’s petition for rehearing or rehearing en banc on October 22, 2008. This Court has jurisdiction under 28 U.S.C. § 1254(1). STATUTORY PROVISIONS INVOLVED Section 282 of 35 U.S.C. provides, in relevant part: The following shall be defenses in any action in- volving the validity or infringement of a patent and shall be pleaded: (1) Noninfringement, ab- sence of liability for infringement or unenforce- ability. | 2 STATEMENT A. Legal Framework The Patent Clause of the Constitution autaorizes the Congress “To promote the Progress of. . . useful Arts, by securing for limited Times to .. . Inventors the exclusive Right to their . . . Discoveries.” Art. I, § 8, cl. 8. It “is both a grant of power and a limita- tion.” Graham vy. John Deere Co., 383 U.S. 1, 5 (1966). Congress may neither “enlarge the patent monopoly without regard to the innovation, ad- vancement or social benefit gained thereby,” nor “au- thorize the issuance of patents whose effects are to remove existent knowledge from the public domain.” Id. at 6. The primary responsibility for drawing this consti- tutional distinction between patentable and “unpat- entable material lies in the Patent Office,” and it is “a most difficult task.” Jd. at 18. Those pursuing applications before the Patent and Trademark Office (“PTO”) must act with the “highest degree of candor and good faith,” so that the Office can “rely upon their integrity and deal with them in a spirit of trust and confidence.” Aings/land v. Dorsey, 338 U.S. 318, 319 (1949). Patent applicants and their representa- tives “have an uncompromising duty to report to [the PTQ] all facts concerning possible fraud or inequita- bleness underlying the applications in issue.” Preci- sion Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 818 (1945). The inequitable conduct doctrine is a principal way the duty of candor is enforced. Inequitable conduct exists where clear and convincing evidence shows that the applicant withheld or misstated information in its submissions to the PTO, that information was 3 “material” to patentability,! and the misstatement or omission was made with “intent to deceive” the PTO. Dayco Prods., Inc. v. Total Containment, Inc. 329 F.3d 1358, 1362-63 (Fed. Cir. 2003). Where material information has thus been intentionally misstated or withheld, a court must “weigh[ ] . . . the materiality and intent in light of all the circumstances to deter- mine whether the applicant’s conduct is so culpable that the patent should be held unenforceable.” Jd. (internal quotation marks and emphasis omitted). B. Facts This petition arises from a suit brought by Re- spondent Star Scientific, Inc. (“Star”) against Rey- nolds, alleging infringement of two patents, United States Patents No. 6,202,649 (the “649 patent”) and No. 6,425,401 (the “401 patent’). Pet. App. 32a. Jonnie Williams is the named inventor of both pat- ents. App. A281-82.? ' Information is material to patentability when it is not cumu- lative, and “(1) [i]t establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or (2) {ijt refutes, or is inconsistent with, a position the applicant takes in: (4) [o]pposing an argument of unpatentabil- ity relied on by the Office, or (ii) [ajsserting an argument of pat- entability.” 37 C.F.R. § 1.56(b) (2000) (“Rule 56”). Before 1992 the test was formulated as whether there was a substantial likelihood that a reasonable examiner would con- sider it important. 37 C.F.R. § 1.56(a) (1991). The Federal Cir- cuit has held that the 1992 rule change to “an arguably nar- rower standard of materiality does not supplant or replace our case law. Rather, it merely provides an additional test of mate- riality.” Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1316 (Fed. Cir. 2006). * App. A _ refers to the Federal Circuit Appendix. Star brought suit on the ‘649 patent on May 23, 2001, while the ‘401 patent 4 The patents relate to methods for treating tobacco plants to purportedly prevent formation of chemi- cals called tobacco specific nitrosamines (“TSNAs’). Pet. App. 33a-35a. These TSNAs, which may be car- cinogenic, can form in the tobacco plants during the curing process, and the tobacco industry has looked for curing techniques that minimize or eliminate their formation. Jd. at 34a-35a. There are several ways to cure tobacco. The old- est, “air curing,” simply relies on the exposure of to- bacco leaves to untreated air to dry and cure them. Pet. App. at 34a. To accelerate the curing process, heated air is commonly used in several ways. In “radiant heat indirect-fired curing,” zd. at 3a, (some- times called “flue-curing”), pipes conduct heated air through a curing barn and the exhaust from the burned fuel is discharged outside. Roughly since the 1970s, in the United States, it has become much more common to pack the tobacco more closely to- gether and blow hot air through it (“bulk-curing” methods). One method, “forced air indirect-fired curing,” blows air warmed by a heat exchanger into the curing barn with a fan, and the resultant ex- haust is expelled outside the barn. /d Another method—the most popular one in recent decades—is “direct-fired curing,” where heated air produced by combustion of clean-burning fuels like propane is application was still pending. On July 30, 2002, the same da, that the ‘401 patent issued, Star brought a second lawsuit al- leging violation of that patent, and the two cases were merged for trial. Pet. App. 3la-32a. 9) blown through the curing barn, thus exposing the tobacco to exhaust gases during curing. /d. The patents-in-suit claim curing methods applied to prevent the formation of TSNAs during curing. The patents theorize that TSNAs form “by the action of the micro flora on the surface of the leaf under an- aerobic conditions,” which can be greatly curtailed or stopped by controlling certain conditions, including “humidity, rate of temperature change, temperature, the time of treatment of the tobacco, the airflow (through the curing apparatus or barn), CO level, CO: level, O2 level, and the arrangement of the to- bacco leaves.” App. A5837 (coi. 1, ll. 57-59), A5838 (col. 4, ll. 25-29). The ‘649 patent pertuins to tobacco generally, while the ‘401 patent applies specifically to Virginia flue-cured tobacco. See, e.g., App. A5846 (col. 20, ll. 4-14) and A6022 (col. 20, Il. 8-19). After a seven-day bench trial regarding Reynolds’ inequitable conduct defense, the district court held both patents unenforceable. It held that “Williams and others kept critical information from the PTO so as to give the false impression that .. . there had been no curing processes used in the United States . . . capable of producing tobacco with low levels of TSNA.” Pet. App. 71a, 31a-76a. Evidence of low TSNA levels being achieved by longstanding curing methods, without employing applicant’s techniques, bears on whether the patents identify a patentable innovation. 35 U.S.C. § 102. Some such evidence is summarized in a letter, dated August 28, 1998, prepared for Star’s patent counsel by Star’s technical consultant, Dr. Harold Burton, on the direct request of inventor Jonnie Williams, App. A281-82: 6 I was in China for two weeks during 1997 and I was given commercial Chinese cigarettes. . . Yo my surprise I could not detect TSNA or when I did they were very low. ... Since China is a developing country, they are still usfing] the old curing technology that was abandoned in the US during the sixties. It seemed to me that the probable cause for the absence of TSNA was their use of the old flue- curing techniques. App. A6238 (emphasis added); see also Pet. App. 47a-49a. Dr. Burton testified that ke told Williams that he “had analyzed cigarettes from China” and found that “they were low in nitrosamines.” App. A523; see also App. A288 (Williams testimony). And Williams ac- knowledged knowing, “by September 15, 1998,” that the existing indirect fire curing barns could produce low TSNA tobacco, indeed sometimes tobacco “as low as [he was] endeavor|ing] to claim with [his] own in- vention.” App. A290. Williams’ first patent counsel, Romulo Delmendo, likewise discussed with Williams “the Chinese com- mercial cigarettes and also the radiant curing proc- ess,” while trying to understand what the TSNA lev- els in U.S. tobacco would be if you “just heated [the tobacco] up” without the controls reflected in the pat- ent. App. A216. Williams told Delmendo that, in that circumstance, “you'll get high TSNA levels.” App. A289 (Williams testimony); A217 (Delmendo testimony). Based on that information, the provisional appli- cation which led to the ‘649 patent, filed on Septem- ber 15, 1998, contained the concededly false state- 7 ment, Pet. App. 17a n.7, that flue-curing practiced in China and other countries—where “radiant heat emanating from the flue pipes is used to cure the to- bacco leaves ... Aas been determined... [when] ap- plied to tobacco grown in the United States [to] yield{ ] tobacco products with high levels of TSNA.” See Pet. App. 49a-50a; App. A290. “[G]reat portions of the [Burton] let*er” were included in the provi- sional application. App. A82. The language of the letter reporting “the TSNA results for the Chinese commercial cigarettes” was almost the only part of the letter omitted. App. A225. After filing the provisional application, Williams personally visited a farm in Virginia and secured samples of tobacco cured using another prior art method—forced air indirect-fired curing—coupled with microwave at the end of the process—and, after testing, learned that “very low” TSNA levels had been achieved. App. A292. (“Curran data.”) Wil- liams withheld that data both from the PTO and from his patent counsel Delmendo. App. A292 (Wil- liams testimony); App. A216 (Delmendo testimony); Pet. App. 6a. This occurred at a time when Del- mendo “had concerns about whether the information in the Burton letter should be disclosed to the PTO.” Pet. App. 20a, 51a-52a; App. A219-20. The non-provisional (“final”) ‘649 application that was filed on September 15, 1999 also failed to dis- close the Burton letter, the Curran data, or, more generally, the fact that low TSNA levels had been produced using longstanding curing methods, with- out using applicant’s claimed innovation. The provi- sional application’s false statement regarding radi- ant heat curing was cmitted from the final applica- tion, which instead acknowledged that the method is 8 still used commercially outside the United States, in China and elsewhere, App. A5837 (col. 2, ll. 54-60), but said nothing about the TSNA levels produced us- ing that method. After filing the final ‘649 application, Williams and Star changed legal counsel. Star’s initial coun- sel, Delmendo, who had concerns about whether the Burton letter should be disclosed, Pet. App. 20a, was replaced by Paul Rivard and the firm of Banner & Witcoff. Pet. App. 7a, 54a. The files were trans- ferred to Banner & Witcoff through an intermediary attorney from a third law firm. /d@ Rivard testified that neither Williams nor their predecessor counsel called the Burton letter or the Curran data to his at- tention. App. A228-29. Thereafter, on February 15, 2000, Star’s new counsel filed a “Petition to Make Special” to acceler- ate the processing of the ‘649 application. App. A10327-40. Notwithstanding the heightened disclo- sure obligations under such a petition,’ and even though Rivard asked Williams to provide relevant information about vhe prior art, Williams did not provide him with the Burton letter, the Curran data, or the essential fact that low TSNA levels had been produced with conventional curing methods. App. A228 (Rivard testimony); App. A294 (Williams > A Petition to Make Special requires the applicant to certify “that the applicant or assignee has made or caused to be made a careful and thorough search of the prior art, or has good knowledge of the pertinent prior art.” Manual of Patent Exam- ining Procedure (“MPEP”) § 708.02. Such a petition requires “an extra effort to look for and produce all relevant prior art.” General Electro Music Corp. v. Samick Music Corp., 19 F.3d 1405, 1411 (Fed. Cir. 1994) (emphasis omitted). testimony). Williams had another opportunity to disclose the withheld information at an interview with the pat- ent examiner in August 2000, but again failed to do so. App. A295-296 (Williams testimony); App. A234 (Rivard testimony). Indeed, at no point before the issuance of the ‘649 patent on March 20, 2001 did Williams or his lawyers share with the PTO the Burton letter, the Curran data, or the fact that con- ventional curing methods had produced low TSNA tobacco. See Pet. App. 4a-7a. Eleven days after the PTO allowed the ‘649 patent on September 14, 2000, Williams filed the continua- tion application that led to the ‘401 patent.4 Again, Star’s lawyers filed a Petition to Make Special that expedited the examination of the ‘401 patent, and at that time again failed to disclose the relevant prior art. App. A10327-40. Nor was that information ever disclosed to the PTO during the ‘401 patent prosecu- tion. The ‘401 patent application had been pending nearly seventeen months when the Burton letter came to the attention of Star’s trial counsel. App. A275 (Attorney McMillan testified he had read the Burton letter by February 11, 2002). Following its allowance, on June 10, 2002 trial counsel brought it to the attention of Star’s patent counsel, Rivard, id, who immediately drafted a supplemental informa- tion disclosure statement including the Burton letter and the Curran data, and circulated it among four * In a continuation application, applicant seeks a new “child” patent (here, the ‘401) with an identical specification but differ- ent claims than the “parent” patent (here, the ‘649). 10 Star lawyers. Star’s trial counsel and patent counsel from the Banner firm discussed whether the infor- mation contained in the Burton letter should be dis- closed to the PTO, and all but one (who said that others should decide) agreed that it should be. Pet. App. 66a-68a. Nonetheless, the information was never disclosed. App. A240, A253-54. The ‘401 pat- ent issued on July 30, 2002. C. The District Court’s Inequitable Conduct Decision In a 47-page opinion, the district court ruled that both patents-in-suit were unenforceable based on in- equitable conduct. Pet. App. 3la-76a.5 The district court concluded that “Williams and others deliber- ately misled the PTO in a material manner by keep- ing from the PTO the critical fact known to Williams and others that the claimed beneficial result— tobacco with low to undetectable TSNA levels—Aad been achieved in the United States prior to the ap- plication that led to the Patents-in-Suit.” Jd. at 43a (emphasis in original). In its “Inequitable Conduct Determination” at the end of its opinion, the district court first stated: ® Even if one could argue that the Burton Let- ter per se need not have been disclosed, the 5 In a previous order addressing many of the same facts, the trial court had ordered disclosure of certain documents over Star’s attorney-client privilege claims, based on the crime/fraud exception. Pet. App. 90a. ° The district court noted several times that certain of its con- clusions rested in part on assessments of witness credibility. Pet. App. 54a-55a, 59a-60a, 69a-70a. The district court also included a section in its decision addressing “Particular Credi- bility Concerns.” /d. at 68a-70a. 11 essential fact revealed therein—that a curing method previously used in the United States was capable of, and indeed was the probable cause for, the production of tobacco with low to undetectable levels of TSNA—should not have been kept from the PTO. Id. at 71a. The district court characterized as “criti- cal” the prior art information showing low TSNA levels achieved with established curing methods, :d. at 7la-72a, and quoted in support an October 25, 2000 letter written by Star’s lead trial lawyer: “The fact that the traditional heat exchange curing proc- ess might have produced low-TSNA leaf some of the time, raises the issue of whether the product claimed [by the applications for the Patents-in-Suit] are novel, as required by 35 U.S.C. § 102.” Jd. at 72a. Having found the withheld information material, the district court focused on the extended period of non-disclosure—nearly four years—in concluding “that RJR has established the intent to deceive by Williams and others by clear and convincing evi- dence.” Pet. App. 72a. They engaged in a consistent scheme to avoid informing the Patent Office that the prior art could produce low TSNA tobacco. The scheme started with the false statement [in the provi- sional application that led to the ‘649 patent] that “[iJt has been determined that this process as applied to tobacco grown in the United State[s] yiclds tobacco products with high lev- els of TSNA,” and proceeded through the entire course of prosecution in the PTO. Id. 12 The district court also noted that the prior art in- formation continued to be withheld after the ‘649 patent had issued and the ‘401 patent was still pend- ing, even though a discussion among Star’s lawyers suggested disclosure. Pet. App. 74a-75a; see also id. at 68a. The district court rejected the alleged non- deceptive explanation—a desire to avoid cost and de- lay—offered by patent counsel Rivard for failing to disclose the Burton letter and Curran data when he finally became aware of them in June 2002, after the notice of allowance of the ‘401 patent had issued. /d. at 75a. It found such reasoning to be inconsistent with “a purported practice of erring on the side of disclosure,” zd, at 73a, and with Rivard’s statement that he would have disclosed the information had he known about it earlier. /d. at 74a; App. A258. See App. A239-240. Nowhere in the section of the decision that the court labeled its “Determination” did the district court even mention the shift of law firms that oc- curred in the middle of the patent prosecution.’ In- stead, it relied on the conduct over several years, in- cluding the fact that the disputed prior art was highly material, and the persistent unexplained fail- ure to disclose throughout the extended patent proc- ess. Pet. App. 7la-72a. After weighing the equities based on “a strong showing of materiality and in- tent,” the court held the patents unenforceable. /d. at 76a. 7 The court discussed the change of law firms earlier, during its discussion of all the background facts. Pet. App. 54a. 13 D. The Federal Circuit’s Inequitable Conduct Decision The Federal Circuit reversed the trial court’s ineq- uitable conduct ruling as to both patents. With re- gard to the ‘649 patent, the panel reversed as clearly erroneous the finding of intent to deceive, but left undisturbed the finding that the undisclosed infor- mation was material. Pet. App. 12a, 18a n.8. With regard to the ‘401 patent, the panel left standing the finding of intent to deceive, but re- versed on materiality because immediately prior to the issuance of that patent in 2002, Star submitted Reynolds’ interrogatory responses that the Federal Circuit said rendered the undisclosed information cumulative. Pet. App. 22a-25a. The panel noted the need to “be vigilant in not per- mitting the defense [of inequitable conduct] to be ap- plied too lightly.” Pet. App. 14a. It described intent to deceive as “a separate and essentia! component of inequitable conduct,” zd, and stated that withhold- ing material information “cannot, by itself, satisfy the deceptive intent clement,” zd. at 15a. In assess- ing the evidence of intent, the Federal Circuit never acknowledged the trial court’s actual rationale that persistent failure to disclose over an extended period is itself powerful evidence of such intent, zd. at 72a- 75a, and instead asserted: Here, the district court’s finding of deceptive intent as to both patents-in-suit was based primarily on its acceptance of RJR’s theory that Williams and Star conspired to deliberately prevent Delmendo and his colleagues at the Sughrue firm from disclosing the Burton letter to the PTO by replacing them with the Banner 14 firm and purposely keeping the Banner firm ignorant of the Burton letter. We hold that this “quarantine” theory was not supported by clear and convincing evidence. Pet. App. 17a; 7d. n.7 (acknowledging false state- ments in the provisional application). The panel found that Star had offered reasons (re- lating to personnel changes) for the change in firms. Pet. App. 18a. Noting that the trial court found this testimony not credible, and that “this credibility de- termination was a major basis for its finding of de- ceptive intent,” the panel responded that Reynolds had the burden of proof and the “patentee need not offer any good faith explanation unless the accused infringer first carried his burden to prove a thresh- old level of intent to deceive by clear and convincing evidence.” /d. at 18a-19a. The panel found that Rey- nolds had failed to present evidence sufficient to show a deceitful purpose behind the firm change, /d. at 19a, and on this basis, held the finding of decep- tive intent as to the ‘649 patent clearly erroneous. With respect to the ‘401 patent, the panel noted that “the district court also relied on additional evi- dence to find inequitable conduct”—primarily the decision to continue withholding the prior art even though communications among Star’s lawyers sug- gested a contrary course. Pet. App. 22a, 66a-68a. Noting that the “district court’s finding of deceptive intent ... may [still] be flawed,” the pancl left that issue unresolved and instead reversed on material- ity. Id. at 22a. The panel explained that, following issuance of the ‘649 patent, in the course of the patent infringement litigation, Reynolds had given interrogatory re- 15 sponses stating that “Reynolds recognized in or about 1994 that tobacco . . . cured in the indirect fired barns Aad significantly reduced levels of TSNAs as compared to the commercial, direct-fired, bulk curing barns ....” Pet. App. 24a (emphasis in original). These were disclosed to the PTO during 2002, after the ‘401 patent had already been allowed, and shortly before it issued in July 2002, zd. at 8a- 9a, with an accompanying notation that Star dis- agreed with the assertion. App. Al0419. The Fed- eral Circuit concluded that these responses con- tained the essential information that existing curing methods had achieved low TSNA levels, thus render- ing the withheld information cumulative with regard to the ‘401 prosecution by the time “the Banner law- yers were made aware of [it] in June 2002.” Pet. App. 24a. Reynolds filed a petition for rehearing and rehear- ing en banc, which was denied on October 22, 2008. REASONS FOR GRANTING THE WRIT The Federal Circuit’s contortions to overturn the trial court’s considered fact-finding based cn a full- trial record, articulated credibility concerns, and rea- sonable inferences drawn from applicant’s mislead- ing statements and prolonged non-disclosure of ma- terial information require the attention of this Court. The functioning of the patent system within the constitutional limitation that patent monopolies must “[p]romote the progress of . . . useful [a]rts,” U.S. Const. art. J, § 8, cl. 8, means that patent appli- cants must conduct themselves with the “highest de- gree of candor and good faith,” Aings/and v. Dorsey, 338 U.S. at 319. “Public interest demands that all 16 facts relevant to such matters be submitted formally or informally to the Patent Office, which can then pass upon the sufficiency of the evidence. Only in this way can that agency act to safeguard the public in the first instance against fraudulent patent mo- nopolies.” Precision Instrument, 324 U.S. at 818. The inequitable conduct doctrine, which allows patents to be held unenforceable when there is an intentional breach of the duty of candor, is an essen- tial bulwark in confining patent monopolies to their constitutional hmits. Apparently influenced by “the severity of the penalty” of unenforceability, Pet. App. 14a, the Federal Circuit decision here departs from common sense and the mainstream of its own deci- sions to announce an approach that greatly under- mines the duty of candor by making proof of intent to deceive a difficult scholastic exercise. In setting aside the trial court’s well-grounded findings without discussing its actual reasoning, the decision is also a gross affront to this Court’s principles governing ap- pellate review of trial court fact-finding. I. THE DECISION BELOW MARKEDLY NARROWS THE INEQUITABLE CONDUCT DEFENSE IN A MANNER AT ODDS WITH PREVIOUS FEDERAL CIRCUIT DECISIONS AND WITH DECISIONS OF OTHER CIRCUITS The decision below reversed the trial court’s find- ing of deceptive intent as to the ‘649 patent, even though that finding rested on express misrepresen- tations to the PTO and a carefully-analyzed pattern of conduct revealing “a consistent scheme to avoid informing the Patent Office that the prior art could produce low TSNA tobacco.” Pet. App. 72a. The Federal Circuit did not dispute the materiality of the 17 withheld information, and also did not even discuss the trial court’s reasoning that prolonged non- disclosure of such information in the face of a clear duty to disclose supports an inference of intent to mislead. See Pet. App. 17a. Instead, the Federal Circuit focused on events sur- rounding a change of law firms, wrongly asserting that these events were the primary basis for the finding of deceptive intent. Pet. App. 17a-18a. It fol- lowed this course after commenting at some length about the “separate” nature of the elements of mate- riality and intent to deceive, id. at 14a, and the “need to strictly enforce the .. . elevated standard of proof... because the penalty ...is so severe.” Jd. at 13a. In reversing on this record, the decision below is «¢ odds with many Federal Circuit decisions and those of regional courts of appeals reviewing inequitable conduct findings, which take a more conventional approach to appellate review. As such, it evidences a sharp divide in thinking among the judges of the Federal Circuit, and threatens the special need rec- ognized by Congress for “nationwide uniformity in patent law,” Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 162 (1989) (quoting H.R. Rep. No. 97-312, at 20 (1981)) (internal quotation marks omitted). If uncorrected, it is likely to result in unpredictable and irreconcilable decisions. See, e.g. Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 21 (1997) (noting that divi- sions within the Federal Circuit warrant review by this Court); Cardinal Chem. Co. v. Morton Int’, Inc., 508 U.S. 83, 89 (1993) (noting that uniformity of patent law “is a matter of special importance to the 18 entire Nation”); see also, e.g., Dickinson v. Petroleum Conversion Corp., 338 U.S. 507, 508 (1950) (finding that an “intracircuit conflict” can support certiorari). The decision below directs that the inequitable conduct defense not be “applied too lightly,” and that intent to deceive is an “essential component of ineq- uitable conduct” “separate” from materiality. Pet. App. 14a. Perhaps on that account, the panel failed even to discuss the actual rationale of the trial court’s inference of intent, based in substantial part on the prolonged failure to disclose known, conced- edly material prior art. In that regard, the decision here departs sharply from prior decisions of the Federal Circuit, which view the materiality of withheld information as rele- vant in assessing intent. Indeed, some cases have held that the requirement of actual intent may be replaced by a lesser requirement that the applicant merely should have known of the materiality of a withheld reference if the materiality of the reference is sufficiently significant. This line of cases is exemplified by Ferring B.V. v. Barr Laboratories, Inc., 437 F.3d 1181 (Fed. Cir. 2006), which held that, where an applicant offers no credible explanation for withholding known highly material information, no proof of actual intent is re- quired and it is enough that the applicant “should have known of the materiality of the information.” Id. at 1191 (emphasis added). In evaluating whether this “should have known” intent standard is applicable, Ferring considered the full range of circumstantial evidence, including evi- dence related to materiality. See id. Panels of the 19 Federal Circuit have reiterated this “knew or should have known” standard in a number of other cases. See, e.g., Praxair, Inc. v. ATMT, Inc., 543 F.3d 1306, 1313-15, 1318 (Fed. Cir. 2008); Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1367 (Fed. Cir. 2008); Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1366 (Fed. Cir. 2007). Other Federal Circuit decisions conflict with the decision below by permitting the consideration of materiality as evidence of intent, even where actual intent continues to be required. Thus, in Li Second Family “Ltd. Partnership v. Toshiba Corp., 231 F.3d 1373 (Fed. Cir. 2000), the panel held that “[t]he more material the information misrepresented or withheld by the applicant, the less evidence of intent will be required in order to find that inequitable conduct has occurred.” Jd. at 1378. Panels in other cases have held similarly. See, e.g., Honeywell Int] Inc. v. Universal Avionics Sys. Corp., 488 F.3d 982, 999 (Fed. Cir. 2007) (“The more material the information misrepresented or withheld by the applicant, the less evidence of intent will be required in order to find inequitable conduct.”); Critikon, Inc. v. Becton Dick- inson Vascular Access, Inc., 120 F.3d 1253, 1257 (Fed. Cir. 1997) (holding that “a patentee facing a high level of materiality and ¢lear proof that it knew or should have known of that materiality, can expect to find it difficult to establish ‘subjective good faith’ sufficient to prevent the drawing of an inference of intent to mislead” (internal quotation omitted)); see also Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1239 (Fed. Cir. 2003). For instance, the panel in Dippin’ Dots, Inc. v. Mo- sey, 476 F.3d 1337 (Fed. Cir. 2007), cert. denied, 128 S.Ct. 375 (2007), and 128 S.Ct. 391 (2007), con- 20 cluded that, while “the evidence reveal[ed] less than an egregiously willful intent to deceive” the PTO, an inequitable conduct determination was proper “in light of the high materiality of the nondisclosure.” Id. at 1346 n.4. The Federal Circuit's ordinary consideration of materiality evidence in evaluating intent is illus- trated by McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007), which affirmed a finding of inequitable conduct based significantly on the principle that intent may be inferred from “[t]he high materiality of the with- held prior art coupled with the lack of a credible ex- planation for the nondisclosure.” Jd. at 916 (internal quotation omitted). Similarly, Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., 525 F.3d 1334 (Fed. Cir. 2008), held that an inventor’s failure to disclose information about certain data constituted inequitable conduct, concluding that the denials of one involved in the process “did not outweigh the cumulative evidence evincing an intent to deceive.” Id. at 1348. The decision below was foreshadowed by dissent- ing opinions in several previous cases. For example, in Aventis, Judge Rader in dissent characterized in- equitable conduct as an “atomic bomb” remedy, and argued that the case furthered a trend in “empha- siz[ing] materiality almost to the exclusion of any analysis of the lofty intent requirement for inequita- ble conduct,” and of “[mJerging intent and material- ity.” /d. at 1349-50. Judge Newman similarly dis- sented in Ferring, noting the inconsistency in the Federal Circuit’s inequitable conduct cases, and claiming that the panel majority had “replac[{ed] the 21 need for evidence with a ‘should have known’ stan- dard” in alleged contravention of Federal Circuit precedent. 437 F.3d at 1196. Judge Newman also dissented in McKesson, contending that the panel majority had improperly weakened the standard for proving intent. See 487 F.3d at 926. The decision below, in its sharp departure from prior Circuit precedent, thus brings to a head a sim- mering dispute among the judges of the Federal Cir- cuit regarding the propriety of relying on the mate- riality of misstatements or )missions in assessing deceptive intent. By offering guidance on the “sepa- rate” character of the materiality and intent inquir- ies, and then wholly ignoring the trial court’s reli- ance on the materiality of the undisclosed prior art, see Pet. App. 17a—which the Federal Circuit did not dispute—the court here compounded a confusion in Federal Circuit inequitable conduct law that was al- ready well recognized.® In addition tc being out of step with other Federal Circuit decisions, the decision below is in even sharper conflict with decisions of the regional courts 8 See, e.g., Scott D. Anderson, Jnequitable Conduct: Persistent Problems and Recommended Resolutions, 82 Marq. L. Rev. 845, 848-49 (1999) (noting the Federal Circuit’s “narrow and incon- sistent interpretations” of inequitable conduct standards, “which confuses patent applicants, complicates patent prosecu- tion, and misleads district court judges”); Michael A. Weid- inger, Note, Jnequitable Pleading: Defendants’ Particular Bur- den in Patent Infringement Suits, 62 Geo. Wash. L. Rev. 1178, 1188 (1994) (noting that the Federal Circuit standards “have changed rapidly,” “causing confusion in the patent bar,” and producing “confused standards”). 22 of appeals.? Indeed, there is a stark and longstand- ing circuit split over whether the “intent” prong of the inequitable conduct test requires, as a general matter, actual intent or merely recklessness or gross negligence. In the decision below, the Federal Circuit followed its own precedent in expressly requiring a finding of specific intent to deceive. Pet. App. 13a; see also Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 873-74 (Fed. Cir. 1988) (en banc) (re- jecting gross negligence standard). The First Cir- cuit, however, has held, to the contrary, that “reck- less, or grossly negligent conduct” can suffice to sat- isfy the mental state prong of the inequitable con- duct analysis. Digital Equip. Corp. v. Diamond, 653 F.2d 701, 709 (1st Cir. 1981); see also Int] Tel. & Tel. Corp. v. Raychem Corp., 538 F.2d 453, 461 (1st Cir. 1976) (same). The Tenth Circuit has similarly held that intent is not required, and that reckless- ness or gross negligence may be enough. See True 8 The Federal Circuit’s nationwide patent jurisdiction does not render this circuit split inert or irrelevant, because the regional circuits continue to decide issues of patent law in some cases, such as where patent issues are raised in counterclaims under Holmes Group, Inc. v. Vornado Air Circulation Systems, Inc., 535 U.S. 826, 834 (2002). See, e.g., Schinzing v. Mid-States Stainless, Inc., 415 F.3d 807 (8th Cir. 2005) (regional circuit deciding inequitable conduct issue). Justice Stevens’s separate opinion in Holmes Group specifically noted that because “other circuits will have some role to play in the development of” pat- ent law, “[a]n occasional conflict in decisions [could] be useful in identifying questions that merit this Court’s attention.” 535 U.S. at 839 (Stevens, J., concurring in part and concurring in the judgment). 23 Temper Corp. v. CF&I Steel Corp., 601 F.2d 495, 501, 504-05 (10th Cir. 1979). See also A.H. Emery Co. v. Marcan Prods. Corp., 389 F.2d 11, 18 (2d Cir. 1968). The D.C. Circuit has noted the division over whether something less than actual intent may suf- fice, but reserved the question. See Turzillo v. P&Z Mergentime, 532 F.2d 1393, 1400 (D.C. Cir. 1976). These cases present a sharp and irreconcilable split over the requisite mental state under the ineq- uitable conduct doctrine. They also serve more gen- erally to highlight how greatly the Federal Circuit here has departed from traditional approaches to proving intent, and to show the extent of the confu- sion that the decision here is likely to sow. Il. IN REVERSING THE DISTRICT COURT’S FINDINGS OF INEQUITABLE CONDUCT, THE FEDERAL CIRCUIT VIOLATED THIS COURT'S PRECEDENTS REGARDING THE USE OF CIRCUMSTANTIAL EVIDENCE AND THE PROPER ROLE OF APPELLATE COURTS A. The Decision Below Offends Basic Principles Governing Trial Court Factfinding Based on Circumstantial Evidence The law “makes no distinction between the weight or value to be given to either direct or circumstantial evidence,” Desert Palace, Inc. v. Costa, 539 U.S. 90, 100 (20038) (quotation omitted), and “[t]he trier of fact should consider all the evidence, giving it what- ever weight and credence it deserves.” U.S. Postal Serv. Bd. Of Governors v. Aikens, 460 U.S. 711, 714 n.3 (1983). Indeed, “[t]he intent . . . that a person possesses at any given time may not ordinarily be proved directly,” and thus usually must be shown by circumstantial evidence. Kevin F. O’Malley, et a/, 24 Federal Jury Practice and Instructions § 17:07 (6th ed. 2008) (treatise cited at 539 U.S. at 100). Many of this Court’s cases uphold proof of specific intent—including as an element of a crime where proof beyond a reasonable doubt is required—based on circumstantial evidence less compelling than that rejected sub silentio by the Federal Circuit. Indeed, this Court has approved inferences based on circum- stantial evidence much like the one relied upon by the trial court—that improper conduct is more likely done with culpable intent where it is done repeateaiy or over an extended period of time. In Jackson vy. Virginia, 443 U.S. 307, 325 (1979), for example, the Court found sufficient the proof of premeditated intent to kill based on circumstantial evidence including the facts that the “petitioner shot the victim not once but twice.” In Holland v. United States, 348 U.S. 121, 139-140 (1954), in affirming a conviction for tax evasion, the Court concluded that the jury could have found spe- cific intent based on “a consistent pattern of under- reporting large amounts of income, and... failure. . . to include all of their income in their books and re- cords.” /d, at 139. Likewise, in Huddleston v. United States, 485 U.S. 681 (1988), the Court affirmed a district court’s al- lowance of evidence that a defendant had twice be- fore dealt in goods under suspicious circumstances to prove that the defendant knew certain goods were stolen. The Court explained that “[e]xtrinsic acts evidence may be critical to the establishment of the truth as to a disputed issue, especially when that is- sue involves the actor’s state of mind and the only 25 means of ascertaining that mental state is by draw- ing inferences from conduct.” Jd. at 685. Similarly, this Court has made clear that a prose- cutor’s conduct in making peremptory challenges can support discriminatory intent under Batson v. Ken- tucky, 476 U.S. 79 (1986). In Miller-E/ v. Cockrell, 537 U.S. 322 (2003), the Court found that the dis- proportionate use of peremptory challenges and dif- ferential questioning with regard to African- American jurors was probative of discriminatory in- tent. See id. at 342, 344. Certainly, the inference of intent to deceive drawn by the district court in this case, based on a patent applicant who claims an invention to produce low TSNA tobacco and fails over several years to disclose known evidence of such tobacco being produced by existing methods, is no less reasonable than the in- ferences drawn in these cases. Yet the Federal Cir- cuit here apparently deemed that inference unwor- thy even of discussion. See Pet. App. 17a. B. The Decision Below Also Violates This Court’s Clear Directives Concerning the Role of Appellate Courts in Reviewing Trial Court Factfinding The Federal Circuit also ignored this Court’s ad- monitions about the proper role of appellate courts in reviewing trial court factfinding. While the court claimed to review for clear error, Pet. App. 12a, it did not reference the relevant question such review raises—“whether, after viewing the evidence in the light most favorable to the [facts found below], any rational trier of fact” could have found intent. Jack- son, 443 U.S. at 319. 26 Determining the weight of the evidence “is the spe- cial province of the trier of fact,” Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982), and a “reviewing court oversteps the bounds of its duty under Rule 52(a) if it undertakes to duplicate the role of the lower court.” Anderson v. City of Besse- mer, 470 U.S. 564, 573 (1985). “There is no excep- tion which permits [a party] . . . to come to this Court for what virtually amounts to a trial de novo on the record of such findings as intent, motive and design.” United States v. Yellow Cab Co., 338 U.S. 338, 341- 42 (1949). Thus, “[w]here there are two permissible views of the evidence, the factfinder’s choice between them cannot be clearly erroneous.” Anderson, 470 U.S. at 574. This point has a heightened importance where, as here, trial court factfinding is premised upon deter- minations of witness credibility. See Pet. App. 54a, 59a-60a, 68a-70a, 74a. “When findings are based on determinations regarding the credibility of wit- nesses, Rule 52(a) demands even greater deference to the trial court’s findings ... .” Anderson, 470 U.S. at 575. Yet the Federal Circuit gave no deference to the several credibility judgments by the trial judge who heard the witnesses, including inventor Wil- liams whose intent to deceive is most centrally at is- sue. Pet. App. 54a-55a, 59a, 69a-70a. Ultimately, the Federal Circuit did not even ac- knowledge the trial court’s explicit rationale that in- tent to deceive was shown in part by the prolonged and repeated failure to disclose known, highly mate- rial information, in the face of a legal duty to do so. Pet. App. 7la-72a. Far from deferring to the trial court findings if reasonable, the Federal Circuit here 27 simply ignored them, and reversed based on a lengthy discussion of a minor piece of the overall evidentiary record.!° C. The Federal Circuit’s Approach to Appellate Review and Trial Court Assessment of Circumstantial Evidence Cannot Be Defended on the Basis that a Different Approach is Appropriate in Patent Cases The decision below warns that courts must “be vigilant in not permitting the defense to be applied too lightly.” Pet. App. 14a. In this statement the court mirrors sentiments that have appeared from time-to-time in Federal Circuit cases.'!' Whatever the relevance of those sentiments, they cannot mean that well-established principles governing appellate review of trial court factfinding are somehow less applicable where inequitable conduct is in issue. This Court has recently noted that “familiar prin- ciples apply with equal force to disputes arising un- 10 Moreover, the Federal Circuit held that a finding of intent “must ... be the single most reasonable inference able to be drawn from the evidence... .” Pet. App. 15a-16a. To the ex tent this statement is intended to govern appellate review of trial court findings, it is obviously unsound in that it substi- tutes the judgment of appellate court for that of the initial fact- finder. "' See, e.g., Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1358 (Fed. Cir. 2008) (referring to inequitable conduct as a “plague”); Ferring B.V. v. Barr Labs., Inc., 437 F.3d 1181, 1195 (Fed. Cir. 2006) (opining that the inequitable conduct doctrine was “grossly misused,” leading to “disproportionally pernicious” consequences) (Newman, J., dissenting); Kingsdown Med. Con- sultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 n.15 (Fed. Cir. 1988) (referring to inequitable conduct claims as “an absolute plague”). 28 der the Patent Act.” Hbay Jnc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006). It has also recog- nized the risk that a specialized patent court “may develop an institutional bias.” Ho/mes Group, Inc. v. Vornado Air Circulation Sys., Inc., 585 U.S. 826, 839 (2002) (Stevens, J., concurring in part and concur- ring in the judgment). In Ebay, this Court rejected a special departure from the “well-established princi- ples of equity” governing the issuance of injunctions in patent cases. 547 U.S. at 391. In ASR Jnterna- tional Co. v. Teleflex Inc., 550 U.S. 398, 127 S.Ct. 1727, 1742-43 (2007), the Court similarly rejected a novel approach to obviousness, referring to a Federal Circuit approach there as “rigid” and denying “fact- finders recourse to common sense.” The Federal Circuit’s reversal of the trial court's exercise of common sense in this case is no more ac- ceptable. Indeed, it is at odds with decisions of this Court addressing factfinding and appellate review in patent cases. In Precision Instrument Manufactur- ing Co., this Court rejected an appellate reversal of a district court finding of inequitable conduct following a trial “on the sole issue of .. . alleged inequitable conduct.” 324 U.S. at 808. In reinstating the district court’s inequitable conduct determination, this Court surveyed the evidence relied upon by the district court in finding inequitable conduct and found it suf- ficient. See id. at 818. The Court held that the pat- entee should have disclosed misstatements to the PTO, despite the fact that “it did not have positive and conclusive knowledge” of them at the time be- cause the misstatements had occurred before it had been assigned the patent application. /d. at 816-17. The Court held that a patent applicant’s duty of dis- closure to the PTO “is not excused by reasonable 29 doubts as to the sufficiency of the proof of the inequi- table conduct.” Jd. at 818. Similarly, in Zenith Radio Corp. v. Hazeltine Re- search, Inc., 395 U.S. 100 (1969), the court of appeals had reversed a finding of patent misuse and anti- trust violation. This Court reversed the court of ap- peals, noting that “Zenith’s evidence, although by no means conclusive, was sufficient to sustain the infer- ence that Zenith had in fact been injured.” Jd. at 114. The opinion emphasized that “appellate courts must constantly have in mind that their function is not to decide factual issues de novo. The authority of an appellate court, when reviewing the findings of a judge as well as those of a jury, is circumscribed by the deference it must give to decisions of the trier of the fact, who is usually in a superior position to ap- praise and weigh the evidence,” /d. at 123. This Court’s more recent GVR decision in Denni- son Manufacturing Co. v. Panduit Corp., 475 U.S. 809 (1986), was premised on the same principles. Dennison vacated a Federal Circuit decision on obvi- ousness. As here, the district court decision under review (there, a finding of obviousness) was made “by clear and convincing evidence,” id. at 810, and the Federal Circuit reversed under a clear error standard of review. This Court vacated the Federal Circuit’s decision in light of the petitioner’s conten- tion that the Federal Circuit had improperly “substi- tuti[ed] its view of factual issues for that of the Dis- trict Court.” Jd. Finding this contention “not insub- stantial,” id., this Court vacated and remanded for further proceedings. Accordingly, this Court should grant review to make clear that there are no special limitations upon 30 the trial court’s assessment of circumstantial evi- dence of intent applicable to ineguitable conduct or to patent cases, and to reaffirm that the Federal Cir- cuit is no different than other circuits in its appellate role. Ill. THE DECISION BELOW CREATES GRLAT CONFUSION AND WEAKENS THE DUTY OF CANDOR BY PLACING A VERY HIGH THRESHOLD ON PROOF OF INEQUITABLE CONDUCT The inequitable conduct defense is raised in more than half of all patent infringement cases. The Doc- trine of Inequitable Conduct and the Duty of Candor in Patent Procurement, Ad Hoc Committee on Rule 56 and Inequitable Conduct American Intellectual Property Law Association, 16 AIPLA Q.J. 74, 75 (1988). The proper standard for its proof, and the way in which trial courts are to assess the evidence, including whether and how the materiality of mis- statements or omissions may be probative of intent, is thus a matter of utmost importance in patent liti- gation. Moreover, the issue is one of constitutional dimen- sion, as the inequitable conduct doctrine plays an important role in policing the constitutional bound- ary on the power to issue temporary patent monopo- hes only for the purpose of encouraging genuine in- novations. See U.S. Const. art. I, § 8; Graham, 383 U.S. at 5. “[T]he limited and temporary monopoly granted to inventors was never designed for their ex- clusive profit or advantage; the benefit to the public or community at large was another and doubtless the primary object in granting and securing that 31 monopoly.” Kendal/ v. Winsor, 62 U.S. 322, 327-28 (1858). Wrongly issued patents obstruct the free inter- change of ideas and technological developments. See, e.g., Lear, Inc. v. Adkins, 395 U.S. 653, 670 (1969). Thus, this Court has long emphasized the public importance of precluding enforcement of wrongfully issued patents. See, e.g., Pope Mfg. Co. v. Gormully, 144 U.S. 224, 234 (1892) (noting that it is “important to the public that competition should not be repressed by worthless patents”). Consequently, issues relating to the propriety of the issuance of a patent are even more important than questions re- lating to infringement. See, e.g., Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 330 (1945). Because the PTO is charged with making the deci- sions regarding patentability in the first instance, and because the task of sorting patentable from un- patentable subject matter is “most difficult”, Gra- ham, 383 U.S. at 18, this Court has emphasized the uncompromising duty of candor owed by “[t]hose who have applications pending with the Patent Office.” Precision Instrument, 324 U.S. at 818. See also, e.g., Kingsland, 338 U.S. at 319. The need for full candor in dealings with the PTO is all the more crucial in light of the “record work- load crisis” that Office faces. Jon W. Dudas, The Patent System: Today and Tomorrow, at 4, at www.uspto.gov/web/offices/com/speeches/2005apr21. pdf (Apr. 21, 2005) (visited Jan. 4, 2009). Applica- tions more than doubled between 1992 and 2005, with the greatest increases in the most complex sub- ject areas, and there is recognized need for patent 32 applicants to share the burden of improving the sys- tem’s functioning. Jd. at 3, 8. The critical nature of the issue here for all of those reasons is compounded further by the greatly ex- panded volume of patent litigation in recent years, the fact that it is a “very costly process,” Blonder- Tongue Labs., Inc. v. Univ. of Illinois Found., 402 U.S. 313, 334 (1971), and the tremendous impor- tance of patents to American commerce and indus- try. For all of these reasons, this case merits the Court’s attention. IV. THE FEDERAL CIRCUIT'S DECISION REVERSING THE TRIAL COURT'S FINDINGS OF INEQUITABLE CONDUCT ON BOTH PATENTS IS WRONG ON THE MERITS The court below should have decided whether the trial court could reasonably have found clear and convincing evidence that Williams and those assist- ing him made material misstatements or omissions with intent to mislead the PTO. After evaluation of the evidence received at a lengthy trial, this was not a difficult question for the trial court, and it should not have been a close one for the Federal Circuit ei- ther. The district court found that Williams failed over a period of years to disclose known evidence that cur- ing methods used in the United States could produce low or undetectable TSNA levels. Pet. App. 71a-72a; App. A290 (Williams admits such knowledge by Sep- tember 15, 1998). The court found this known prior art to be highly material. J/d. It also found flatly false the provisional application’s statement—that came from Williams, App. A217, A289—that the longstanding radiant heating method had been de- 33 termined to produce high TSNA tobacco. The dis- trict court’s several credibility findings, Pet. App. 54a, 59a-60a, 68a-70a, 74a, and other factors, led it to discount various testimony asserting non- materiality or explaining why the information had not been produced. Jd. at 66a-70a, 74a-75a. On all these grounds, the district court concluded that “Wil- liams and others deliberately misled the PTO in a material manner by keeping from [it] the critical fact known to Williams and others that the claimed bene- ficial result—tobacco with low to undetectable TSNA levels—Aad been achieved in the United tates prior to the application that led to the Patents-in-Suit.” Id. at 43a. The Federal Circuit did not disturb the finding that the withheld information was material with re- gard to the ‘649 patent. It further acknowledged that the statement in the provisional application was “inaccurate.” Pet. App. 17a-18a nn.7, 8. Nor did the Federal Circuit ever make reference, see Pet. App. 17a, to the trial court’s essential reasoning that the persistent non-disclosure of known, highly material prior art over a period of several years, in the face of numerous occasions triggering renewed duties to produce it, is probative of deceptive intent. Instead, the Federal Circuit focused on a straw man, the mid- stream change of law firms, stating falsely that the finding of deceptive intent was based primarily upon that series of events. In this respect, the Federal Circuit seems to have been acting on its assertion that in the world of inequitable conduct, materiality and intent must be proven separately, thus prohibit- ing the trial court’s reliance on materiality. 34 Had the Federal Circuit considered the reasoning of the trial court and rejected it as beyond the limits of rationality, it would certainly merit reversal as contrary to decisions of this Court affirming infer- ences of intent on much weaker evidence. The Fed- eral Circuit’s failure even to discuss the actual rea- soning of the trial court, and reversal for the reasons it gave, is an affront to the judicial process. The Federal Circuit’s reversal of the unenforceabil- ity ruling as to the ‘401 patent is also obviously in- correct. The court conceded that even more evidence of deceptive intent existed as to that patent. Pet. App. 22a. The panel nonetheless reversed on the ground that the prior art at issue, whose previous materiality the court had not disputed, became cu- mulative in early 2002, when, after the ‘401 patent had already been allowed, Star submitted to the PTO a Reynolds litigation discovery response assert- ing that, as of 1994, indirect fired barns had pro- duced “significantly reduced levels of TSNAs.” Jd. at 24a. The notion that such a litigation response by an obviously interested party, submitted at the eleventh hour, would render cumulative the well-known but long-concealed, objective evidence that low TSNA levels had long been achieved using traditional cur- ing methods, is at best highly implausible.12. And Star submitted Reynolds’ interrogatory responses to the PTO only with the express disclaimer that “Ap- 12 In addition, the uncontradicted expert testimony was that the Burton letter was not cumulative of the RJR discovery re- sponses for anything else in the record in the prosecution. App. A319, A325-326. plicant respectfully disagrees with R.J. Reynolds’ characterization of the documents.” App. A10419.13 CONCLUSION The petition for a writ of certiorari should be granted. RICHARD A. KAPLAN RALPH J. GABRIC K. SHANNON MRKSICH CYNTHIA A. HOMAN JEROLD A. JACOVER BRINKS HOFER GILSON & LIONE 455 N. Cityfront Plaza Dr. NBC Tower — Suite 3600 Chicago, IL 60611 (312) 321-4227 January 16, 2009 Respectfully submitted, DONALD B. AYER Counsel of Record MICHAEL S. FRIED SUSAN M. GERBER RACHAEL A. REAM CHRISTOPHER J. SMITH JONES DAY 51 Louisiana Ave., NW Washington, DC 20001 (202) 879-3939 Counsel for Petitioner 13 The facts that the two patents have an identical specification and nearly identical claims—with the ‘401 patent being some- what narrower—also strongly suggest that the ‘401 is unen- forceable if the ‘649 is, under the doctrine of “infectious unen- forceability.” See Consol. Aluminum Corp. v. Foseco Inti. Ltd., 910 F.2d 804 (Fed. Cir. 1990); MOSAID Techs. Inc., v. Samsung Elecs. Co., 362 F. Supp. 2d 526, 553-54 (D.N.J. 2005). Ata minimum, a finding of inequitable conduct as to the ‘649 patent would require a remand to assess the continuing enforceability of the ‘401 pa. at. APPENDIX lu STAR SCIENTIFIC, INC., Plaintiff—Appellant, Vv. R.J. REYNOLDS TOBACCO COMPANY (a North Carolina Corporation) and R.J. Reynolds Tobacco Company (a New Jersey Corporation), Defendants—Appellees. No. 2007-1448. United States Court of Appeals, Federal Circuit. Aug. 25, 2008. Rehearing and Rehearing En Banc Denied Oct. 22, 2008. Carter G. Phillips, Sidley Austin LLP, of Washington, DC, argued for plaintiff-appellant. With him on the brief were Eric A. Shumsky and Peter S. Choi. Of counsel on the brief were Richard McMillan, Jr., Clifton S. Elgarten, Mark M. Supko, and Michael I. Coe, Crowell & Moring LLP, of Washington, DC. Richard A. Kaplan, Brinks Hofer Gilson & Lione, of Chicago, Illinois, argued for defendants-appellees. With him on the brief we’ e Jerold A. Jacover, Ralph J. Gabric, K. Shannon Mrksich, Cynthia A. Homan, and Julie L. Leichtman Beiore MICHEL, Chief Judge, SCHALL and DYK, Circuit Judges. MICHEL, Chief Judge. Plaintiff—Appellant Star Srientific, Inc. (“Star”) appeals from a final ju; gment in favor of Defendants—Appellees R.J. Reynolds Tobacco Company (N.C.) and RwJ. Reynolds Tobacco 2a Company (N.J.) (collectively, “RJR”). The district court entered memoranda and orders: (1) holding, after a bench trial, that Star's U.S. Patent Nos. 6,202,649 (“the ‘649 patent”) and 6,425,401 (“the ‘401 patent”) ar: unenforceable due to inequitable conduct; and (2) granting summary judgment of invalidity of all asserted claims of the ‘649 and ‘401 patents due to indefiniteness. See Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 8:01—cv—1504, 2007 WL 1890709, slip op. at 46 (D. Md. June 26, 2007) (“Inequitable Conduct Order’); Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 8:01—cv—1504, slip op. at 12-14 (D. Md. June 22, 2007) (“Indefiniteness Order’). Because the district court’s judgment as to inequitable conduct was based on factual findings that we deem clearly erroneous, we reverse the judgment of unenforceability of the 649 and ‘401 patents. We also reverse the grant of summary judgment as to indefiniteness because we conclude that the claim term at issue, “anaerobic condition,” is not indefinite, and ‘ve remand for further proceedings on infringement and validity. I. BACKGROUND A. Tobacco Curing Technology Fresh tobacco (“green tobacco”) must be dried in a process called “curing” before it is suitable for consumption as cigarettes or other such products. Curing is done in curing “barns,” and commercial tobacco companies like RJR cure their tobacco in bulk-curing barns in which substantial quantities of harvested tobacco are cured together in large stacks. Smaller operations may use the older and long-used 3a technology of “stick barns” in which much smaller quantities of tobacco are cured. Four major mechanisms of curing have been used in the United States: (1) air curing, where the tobacco is air-dried without the application of heat; (2) radiant heat indirect-fired curing (“radiant heat curing”), where fuel (typically oil) is burned and the hot exhaust gases are passed through pipes running through the barn such that the hot pipes radiate heat into the barn to dry the tobacco, but the exhaust gases are then expelled outside the barn; (3) direct-fired curing, where fuel (typically propane) is burned and the hot exhaust gases themselves are blown directly into the barn to dry the tobacco; and (4) forced air indirect-fired curing, where fuel is burned to heat clean air that is then blown into the barn to dry the tobacco, while the exhaust gases from the fuel burning are expelled outside the barn. In the 1960s, the primary method used by American tobacco companies was radiant heat curing. By the 1970s, most companies switched to direct-fired curing, which was the predominant method used until at least the late 1990s. Cured tobacco contains a number of hazardous chemicals, including carcinogens known as tobacco specific nitrosamines (“TSNAs”), which are not present in green tobacco. In the 1990s, researchers began to explore TSNA formation in tobacco and discovered links between TSNAs and direct-fired 4a curing. As a result, some researchers began to investigate how curing methods could be altered to minimize TSNA formation. B. The ‘649 Patent In August 1998, Jonnie Williams of Star engaged attorney Romulo Delmendo of Sughrue, Mion, Zinn, Macpeak & Seas (“the Sughrue firm”) to prosecute a patent application on a tobacco curing process aimed at lowering TSNA levels. Williams, the inventor, believed that TSNAs were formed due to the presence of microbes on the tobacco leaves. According to this theory, ambient oxygen in the vicinity of the drying leaves is reduced during cure by the production of carbon dioxide as the green tobacco leaves degrade and by the oxygen-poor combustion gases blown in during direct-fired curing. The microbes thus must _ operate anaerobically and obtain oxygen through reduction- oxidation reactions involving nitrates also produced from leaf degradation. Those reactions produce nitrites, which in turn form TSNAs through further chemical reactions. Williams’ method sought to prevent TSNA formation by lessening the drop in oxygen levels through control of airflow, humidity and temperature inside the curing barn, thereby reducing the microbes’ need to resort to anaerobic processes. As part of the preparation of Williams’ patent application, Delmendo was sent a letter on August 28, 1998, by scientist and Star consultant Dr. Harold Burton (“the Burton letter”). Burton wrote to relate his recent observation that Chinese tobacco products contain very low TSNA levels. The Burton letter further stated: 5a Since China is a developing country, they are still use [sic] the old curing technology that was abandoned in the U.S. during the sixties. It seemed to me that the probable cause for the absence of TSNA was their use of the old [radiant heat] flue-curing techniques. J.A. at A6237. Delmendo testified that although he was initially concerned about the information, he then spoke with Burton, analyzed the letter, and ultimately concluded that neither it nor its content was material to the contemplated patent application. Delmendo filed with the United States Patent and Trademark Office (“PTO”) a provisional patent application, Application Serial No. 60/100,372 (“the Provisional”), on behalf of Williams on September 15, 1998. The application disclosed that some nations, including China, still utilize radiant heat curing. J.A. at A5808—09. The disclosure also stated: “It has been determined that [the radiant heat] process as applied to tobacco grown in the United States yields tobacco products with high levels of TSNA.” Jd. at A5809. Williams testified that this statement was based on inferences he drew from information he received from Brown & Williamson, another tobacco company, indicating that Brazilian tobacco cured using radiant heat techniques resulted in TSNA levels of 2—3 ppm. Shortly after the Provisional was filed, Williams received samples from two Virginia farms that still used radiant heat curing and forwarded them to Burton for measurements of TSNA content. The first, from the Jennings farm, contained 1.0—1.5 ppm TSNAs (“the Jennings data”). The second, from the Curran farm, contained 0.39 ppm (“the Curran data”). Unlike the Jennings data, however, the 6a Curran data was derived from a partially-cured sample; the sample was partially-cured using radiant heat curing, but Williams’ associate completed the cure using a microwave prior to Burton’s tests.! Williams informed Delmendo of the Jennings data over the phone but never showed him the actual data in document form. He did not inform Delmendo of the Curran data. Delmendo testified that he and Williams considered the Jennings data to be relevant but not a significant concern because Williams’ method produced a significantly greater reduction in TSNAs.? On September 15, 1999, exactly one year after filing the Provisional, Delmendo filed Application Serial No. 09/397,018 (“the ‘018 application”) on behalf of Williams. The ‘018 application’s draft specification adopted most of the Provisional’s disclosure but deleted the statement that radiant heat curing of U.S.-grown tobacco produced “high levels of TSNA.” Instead, it stated: In flue curing processes that utilize a heat exchanger capable of providing relatively low airflow through the curing barn, I have discovered that it is possible to somewhat reduce the TSNA levels by not venting combustive exhaust gases < 1 It is undisputed that microwave curing produces vastly lower TSNA levels than any indirect-fired or direct-fired curing process. 2 According to Delmendo, he understood that direct-fired curing produced TSNA levels ex ceeding 3.0 ppm, thus the 1.0—-1.5 ppm produced by the indirect-fired process on the Jennings farm was “somewhat reduced.” J.A. at A219. By contrast, Williams informed Delmendo that his process reduced TSNA levels much further to the 0.1-0.2 ppm range. 7a into the curing apparatus or barn. The preferred aspects of the present invention are premised on the discovery that other parameters, as identified above (e.g., airflow), can be adjusted to ensure the prevention or reduction of at least one TSNA regardless of the ambient conditions. ‘649 patent col.6 11.22—-30 (emphasis added). Delmendo testified that this new disclosure was based on his discussion of the Jennings data with Williams. Shortly after the filing of the ‘018 application, Williams and Star elected to terminate the Sughrue attorneys’ involvement in the prosecution and replace them with attorneys from Banner & Witcoff (“the Banner firm”), including Paul Rivard and Dale Hoscheit. Hoscheit testified that he met with Delmendo and others from the Sughrue firm to discuss the transfer of files and the status of pending applications. Paul Perito, « partner of the law firm Paul, Hastings, Janofsky & Walker (“Paul Hastings”) who became the chairman of Star, tapped Scott Flicker from Paul Hastings to facilitate the transfer of files from the Sughrue firm to the Banner firm. Upon receiving the files, Rivard searched them for prior art but did not notice the Burton letter. On February 15, 2000, Rivard filed a Petition to Make Special regarding the ‘018 application, including an Information Disclosure Statement (“IDS”) discussing and distinguishing certain prior art. The IDS did not include the Burton letter. The Petition was ultimately granted, and the application was allowed on September 14, 2000, and ultimately issued on March 20, 2001, as the ‘649 patent. 8a C. The ‘401 Patent and the Present Litigation On September 25, 2000, on behalf of Williams, Rivard filed Application Serial No. 09/668,144 (“the ‘144 application”), a continuation of the ‘018 application. Rivard also filed a Petition to Make Special for the ‘144 application with an accompanying IDS listing many of the same references as his earlier IDS for the petition regarding the ‘018 application. This IDS also did not include the Burton letter. Star filed the present suit on May 23, 2001, alleging that RJR infringed claims 4, 12 and 20 of the ‘649 patent. As the litigation proceeded, Rivard periodically filed supplemental IDSs to the ‘144 application to disclose to the PTO some of the additional prior art raised by RJR against the ‘649 patent during discovery. For example, on June 12, 2001, Rivard disclosed RJR’s Application Serial No. 09/735,177, which was published on April 26, 2001. Rivard also disclosed RJR’s interrogatory responses regarding invalidity along with the cited references. These disclosures continued after the ‘144 application was allowed in January 2002. In April 2002, the issue fee for the ‘144 application was paid. In June 2002, while waiting for the ‘144 application to issue as a patent, Rivard became aware of the Burton letter and Curran data when Star’s trial counsel, Crowell & Moring (“Crowell”), informed him that RJR had raised those documents in the litigation. Rivard’s initial reaction was that they should be disclosed out of an abundance of caution. Several Crowell attorneys exchanged e- mails amongst themselves discussing whether they thought the Burton letter and/or Curran data was required to be disclosed to the PTO given that the 9a ‘144 application had yet to be issued; several agreed that it may be best to “err on the side of disclosure.” J.A. at A10998—99. Meanwhile, Rivard and Hoscheit at the Banner firm conferred and ultimately decided that the Burton letter and the Curran data were not material and thus did not need to be disclosed to the PTO. They were never disclosed to the PTO. The ‘144 application thus issued as expected on July 30, 2002, as the ‘401 patent. Star immediately moved to amend its complaint to add allegations that RJR was infringing claim 41 of the ‘401 patent as well. D. Claim Construction, Trial and Summary Judgment Claim 4 of the ‘649 patent is representative of all of the asserted claims: A process of substantially preventing the formation of at least one nitrosamine in a harvested tobacco plant, the process comprising: drying at least a portion of the plant, while said portion is uncured, yellow, and in a state susceptible to having the formation of nitrosamines arrested, in a controlled environment and for a time sufficient to substantially prevent the formation of said at least one nitrosamine; wherein said controlled environment comprises air free of combustion exhaust gases and an airflow sufficient to substantially prevent an anaerobic condition around the vicinity of said plant portion; and wherein said controlled environment is provided by controlling at least one of humidity, temperature, and airflow. 10a The district court construed three terms relevant to this appeal: “substantially prevent the formation of at least one nitrosamine,” “controlled environment,” and “anaerobic condition.” The court construed “substantially prevent the formation of at least one nitrosamine” to mean “the level of at least one of the nitrosamines falls within the following ranges: less than about 0.05 mg/g for NNN, less than about 0.10 mg/g for NAT plus NAG, and less than about 0.05 mg/g for NNK.”3 Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., No. 8:01-cv—1504, slip op. at 2 (D.Md. Mar. 31, 2004) (“Markman Order’). The court then construed “controlled environment” to mean “controlling one or more of humidity, temperature and airflow in the curing barn, in a manner different from conventional curing, in order to substantially prevent the formation of TSNAs.” Jd. Finally, the court construed “anaerobic condition” to mean “an oxygen deficient condition (such as is created by an atmosphere of combustion gases or from the release of carbon dioxide by the plant during cure) which promotes microbial nitrate reductase activity.”4 Jd. at 1-2. These claim constructions are not disputed in this appeal. The district court held a bench trial on RJR’s inequitable conduct defense in January and February of 2005. Star and RJR also filed cross 3 These abbreviations (e.g, NNN, NNK) represent different known TSNAs. These units of measurement, micrograms per gram (mg/g), are equivalent to parts per million (ppm). 4 Nitrate reductase is the enzyme used by the microbes on the surface of curing tobacco leaves to catalyze some of the chemical reactions that ultimately produce TSNAs. lla motions for summary judgment on RJR’s indefiniteness defense, and RJR filed another summary judgment motion on its anticipation and best mode defenses. On January 19, 2007, the district court issued its decisions on the parties’ summary judgment motions. The court granted RJR’s motion for summary judgment that the asserted claims of both patents are invalid for indefiniteness, holding that the term “anaerobic condition” was indefinite. Indefiniteness Order, slip op. at 12—14.5 The court also denied RJR’s motion for summary judgment that the asserted claims are invalid due to anticipation and violations of the best mode requirement, holding that Star raised genuine issues of material fact as to those defenses.§ Star Scieniific, Inc. v. R.J. Reynolds Tobacco Co., No. 8:01—cv—1504, slip op. at 12-15 (D.Md. Jan. 19, 2007) (“Anticipation Order’). On June 26, 2007, the district court issued a decision on RJR’s inequitable conduct defense. The 5 The district court replaced its January 19, 2007 opinion regarding indefiniteness with a corrected opinion on June 22, 2007, to rectify a minor clerical error. 6 The district court purported to grant partial summary judgment to RJR by holding that neither asserted patent could claim priority to the filing date of the Provisional, a predicate to RJR’s invalidity arguments. Anticipation Order, slip op. at 16. Star argues tnat this decision was erroneous and should be reversed. However, this holding is not properly before this court since it did not form the basis of any judgment. Priority date in and of itself is not a claim or defense on which summary judgment can be granted, and the district court denied RJR’s motion for summary judgment on anticipation and best mode, which RJR does not cross-appeal. 12a court held both of Star’s asserted patents unenforceable due to inequitable conduct and entered final judgment in favor of RJR. See Inequitable Conduct Order, slip op. at 46. Star timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(1). Il. DISCUSSION A. Inequitable Conduct a We review the district court’s inequitable conduct determination under a two-tier standard; we review the underlying factual determinations for clear error, but we review the ultimate decision as to inequitable conduct for an abuse of discretion. Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1364-65 (Fed. Cir. 2007). If the district court’s determination of inequitable conduct is based on a clearly erroneous finding of materiality and/or intent, it constitutes an abuse of discretion and must be reversed. Jmpax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 13866 .375 (Fed. Cir. 2006). With respect to the ‘649 pawnt, we hold that the district court clearly erred in finding that RJR had proven that Williams and Star had an intent to deceive the PTO. With respect to the ‘401 patent, we hold that the district court clearly erred in finding that the information contained in the Burton letter and Curran data was material. The burden of proving inequitable conduct les with the accused infringer. Ulead Sys., inc. v. Lex Computer & Mgmt. Corp., 351 F.3d 1139, 1146 (Fed. Cir. 2003). To successfully preve inequitable conduct, the accused infringer must present “evidence that the applicant (1) made an affirmative 13a misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the [PTO].” Cargill, 476 F.3d at 1363 (citing Jmpax Labs., 468 F.3d at 1374). Further, at least a threshold level of each element—-ze., both materiality and intent to deceive—must be proven by clear and convincing evidence. /d.; Digital Control Inc. v. Charles Mach. Works, 437 F.3d 1309, 1313 (Fed. Cir. 2006). And even if this elevated evidentiary burden is met as to both elements, the district court must still balance the equities to determine whether the applicant’s conduct before the PTO was egregious enough to warrant holding the entire patent unenforceable. Monsanto Co. v. Bayer BioScience N.V., 363 F.3d 1235, 1239 (Fed. Cir. 2004). Thus, even if a threshold level of both materiality and intent to deceive are proven by clear and convincing evidence, the court may still decline to render the patent unenforceable. The need to strictly enforce the burden of proof and elevated standard of proof in the inequitable conduct context is paramount because the penalty for inequitable conduct is so severe, the loss of the entire patent even where every claim clearly meets every requirement of patentability. This penalty was originally applied only in cases of “fraud on the Patent Office.” See Hazel—Atlas Glass Co. v-. Hartford—Empire Co., 322 U.S. 238, 250-51, 64 S.Ct. 997, 88 L.Ed. 1250 (1944); see also Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806, 816, 65 S.Ct. 993, 89 L.Ed. 1381 (1945) (“The far-reaching social and economic consequences of a patent, therefore, give the public a paramount interest in seeing that patent [grants] spring from backgrounds free from fraud or other inequitable 14a conduct and that such [grants] are kept within their legitimate scope.”); Digital Control, 437 F.3d at 1315 (discussing the roots of inequitable conduct in common law fraud). Subsequent case law has broadened the doctrine to encompass misconduct less egregious than fraud, see for example Nobelpharma AP v. Implant Innovations, Inc., 141 F.3d 1059, 1069—70 (Fed. Cir. 1998), but the severity of the penalty has not changed, and thus courts must be vigilant in not permitting the defense to be apphed too lightly. Just as it is inequitable to permit a patentee who obtained his patent through deliberate misrepresentations or omissions of material information to enforce the patent against others, it is also inequitable to strike down an entire patent where the patentee only committed minor missteps or acted with minimal culpability or in good faith. As a result, courts must ensure that an accused infringer asserting inequitable conduct has met his burden on materiality and deceptive intent with clear and convincing evidence before exercising its discretion on whether to render a_ patent unenforceable. With regard to the deceptive intent prong, we have emphasized that “materiality does not presume intent, which is a separate and essential component of inequitable conduct.” GFT, Inc. v. Franklin Corp., 265 F.3d 1268, 1274 (Fed. Cir. 2001). Moreover, as we explained in Molins PLC Textron, Inc.: [T]he alleged conduct must not amount merely to the improper performance of, or omission of, an act one ought to have performed. Rather, clear and convincing evidence must prove that an applicant had the specific intent to... mislead[ ] or deceiv[e} the PTO. In a case involving nondisclosure of 15a information, clear and convincing evidence must show that the applicant made a deliberate decision to withhold a known material reference. 48 F.3d 1172, 1181 (Fed. Cir. 1995) (emphases added). Thus, the fact that information later found material was not disclosed cannot, by itself, satisfy the deceptive intent element of inequitable conduct. M. Eagles Tool Warehouse, Inc. v. Fisher Tooling Co., 439 F.3d 1335, 1340 (Fed. Cir. 2006). Rather, to prevail on the defense, the accused infringer must prove by clear and convincing evidence that the material information was withheld with the specific intent to deceive the PTO. Jd; see also Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc) (holding even gross negligence insufficient to prove intent to deceive). We have also held that because dire«* evidence of deceptive intent is rarely available, such intent can be inferred from indirect and _ circumstantial evidence. Cargi/], 476 F.3d at 1364. But such evidence must still be clear and convincing, and inferences drawn from lesser evidence cannot satisfy the deceptive intent requirement. See Ferring, 437 F.3d at 1186 (“The predicate facts must be proven by clear and convincing evidence.”). Further, the inference must not’ only be based on sufficient evidence and be reasonable in light of that evidence, but it must also be the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard. Scanner Techs. Corp. v. ICOS Vision Sys. Corp., 528 F.3d 1365, 1376 (Fed. Cir. 2008) (“Whenever evidence proffered to show either materiality or intent is susceptible of multiple reasonable inferences, a district court 16a clearly errs in overlooking one inference in favor of another equally reasonable inference.”). With respect to the materiality prong, we have held that “information is material when a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent.” Symantec Corp. v. Computer Assocs. Int7, Ine., 522 F.3d 1279, 1297 (Fed. Cir. 2008); see also Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1314 (Fed. Cir. 2006). It is well- established, however, that information is not material if it is cumulative of other information already disclosed to the PTO. Honeywell Int Inc. v. Universal Avionics Sys. Corp., 488 F.8d 982, 1000 (Fed. Cir. 2007) (“Information cumulative of other information already before the Patent Office is not material.”); 37 C.F.R. § 1.56(b) (“[IJnformation is material to patentability when it is not cumulative to information already of record or being made of record in the application... .”). If a threshold level of intent to deceive or materiality is not established by clear and convincing evidence, the district court does not have any discretion to exercise and cannot hold the patent unenforceable regardless of the relative equities or how it might balance them. See Nordberg, Inc. v. Telsmith, Inc., 82 F.3d 394, 398 (Fed. Cir. 1996) (holding that the district court properly refrained from balancing materiality and intent when a threshold showing of intent to deceive was not clearly and convincingly made). Only after adequate showings are made as to both materiality and deceptive intent may the district court look to the equities by weighing the facts underlying those showings. “The more material the omission or the 17a misrepresentation, the lower [the] level of intent [is] required to establish inequitable conduct, and vice versa.” Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1256 (Fed. Cir. 1997). At this second stage, however, the question is no longer whether materiality and/or intent to deceive were proven with evidence that is sufficiently clear and convincing. While the facts of materiality and intent to deceive must be proven by clear and convincing evidence, the district court must balance the substance of those now-proven facts and all the equities of the case to determine whether the severe penalty of unenforceability should be imposed. It is this balancing that is committed to the district court’s discretion. Molins, 48 F.3d at 1178. 2. Here, the district court’s finding of deceptive intent as to both patents-in-suit was based primarily on its acceptance of RJR’s theory that Williams and Star conspired to deliberately prevent Delmendo and his colleagues at the Sughrue firm from disclosing the Burton letter to the PTO by replacing them with the Banner firm and purposely keeping the Banner firm ignorant of the Burton letter. We hold that this “quarantine” theory was not supported by clear and convincing evidence.? As a resuit, we hold that the 7 The district court also inferred intent to deceive from the statement in the Provisional that prior art radiant heat curing produced high levels of TSNAs in American tobacco. There is no dispute that this statement was inaccurate. While we do not hold that inaccurate statements made in_ provisional applications cannot evidence an intent to deceive, we note that provisional applications are not examined and that the alleged misrepresentation here was corrected prior to examination of the non-provisional applications. As such, we hold that this 18a district court’s finding of deceptive intent with regard to the ‘649 patent was clearly erroneous. Star’s witnesses testified that the reasens behind the replacement of the Sughrue firm were that a key partner passed away and that Williams observed a Sughrue attorney perform unsatisfactorily in an unrelated prosecution. The district court indicated that it viewed this testimony as not credible and that this credibility determination was a major basis for its finding of deceptive intent. Certainly, credibility determinations are an aspect of fact-finding that appellate courts should rarely reverse. But even if Star’s explanations are not to be believed, it remained AJF’s burden to prove its allegation regarding the reason for the Sughrue firm’s dismissal. RJR cannot carry its burden simply because Star failed to prove a credible alternative explanation. See M. Eagles Tool Warehouse, 439 F.3d at 1341 (“When the absence of a good faith explanation is the only evidence of intent, however, that evidence alone does not constitute clear and convincing evidence warranting an inference of intent.”). The patentee need not offer any good faith explanation unless the accused infringer first carried statement is not clear and convincing evidence of deceptive intent. 8 Thus, we need not address whether the district court’s finding of materiality as to the ‘649 patent Was clearly crroneous. Regarding the ‘401 patent, the district court’s finding of deceptive intent was in part based on additional evidence concerning events following the issuance of the ‘649 patent. As explained further below, we need not decide whether that deceptive intent finding was also clearly erroneous because we find the district court’s finding of matcriality as to the ‘401 patent clearly erroneous. 19a his burden to prove a threshold level of intent to deceive by clear and convincing evidence. Nordberg, 82 F.3d at 398. Only when the accused infringer has met this burden is it incumbent upon the patentee to rebut the evidence of deceptive intent with a good faith explanation for the alleged misconduct. See /d. In reviewing the affirmative evidence, it becomes clear that RJR’s evidence had a major gap—RJR failed to elicit any testimony or submit any other evidence indicating that Star knew what the Burton letter said prior to replacing the Sughrue firm, or that the letter was a, reason for changing firms. RJR admitted at oral argument that it failed to even ask Wilhams or Star’s other executives about these critical facts, and RJR failed to identify any vestimony or other evidence when specifically asked by us to do so in supplemental briefing. Further, a review of the record shows that Williams actually testified, in response to a different question, that he had never seen the Burton letter prior to his deposition in the present litigation. This statement was never impeached, questioned, or explored by RJR’s counsel. RJR identified Perito, Star’s chairman, as the officer who made the decision to terminate the Sughrue firm, but Perito was never asked whether he had knowledge of the Burton letter or whether it played any role in his decision to change firms. As noted earlier, the district court may infer facts supporting an intent to deceive from indirect evidence. Cargi//, 476 F.3d at 1364. But no inference can be drawn if there is no evidence, direct or indirect, t':at can support the inference. RJR’s lack of any evidence at all on the crux of its theory, let alone clear and _ convincing’- evidence, demonstrates that it failed to carry its burden. 20a Other facts and inferences relied on by the district court do not plug this hole in RJR’s evidence. First, the district court found that Delmendo had concerns about whether the information in the Burton letter should be disclosed to the PTO, the suggested inference being that Star would have been motivated to replace him to ensure he did not disclose the letter to the PTO. Indeed, both Delmendo’s testimony and his written notes provide evidence supporting the finding that he had such concerns. However, he was not asked whether he ever expressed those concerns to Williams or anyone else at Star. No Star witness was asked whether Delmendo expressed his concerns to them cither. This record cannot support an inference that Star was motivated to replace Delmendo due to his concerns about the Burton letter since there is no evidence, let alone clear and convincing evidence, that Star even knew about the letter or his concerns. Again, RJR failed to carry its turden of proof. Second, the district court also found that Perito’s use of an intermediary, Flicker of Paul Hastings, to facilitate the transfer of files from the Sughrue firm to the Banner firm evidenced an intent to prevent any communication between the firms. The inference drawn, therefore, was that Star was deliberately insulating the Banner lawyers from the Sughrue lawyers to prevent the former from learning of Delmendo’s concerns regarding the Burton letter. But RJR’s failure to adduce any evidence that Star knew of Delmendo’s concerns or the Burton letter’s contents renders this inference clearly erroneous as well. Moreover, Hoscheit of the Banner firm specifically testified that he did meet with the Sughrue attorneys, and the district court did not 2la indicate that it found this testimony or Hoscheit in general to not be credible. In fact, it did not address this testimony at all. Furthermore, the district court rejected RJR’s allegation that the Sughrue files, and the Burton letter in particular, were tampered with before being conveyed to the Banner firm. Thus, the Banner firm was clearly given the Burton letter. Yet again, RJR failed to provide clear and convincing evidence to support its allegations. We also question the district court’s reliance on the admitted fact that Star never instructed Rivard or his colleagues at the Banner firm to disclose the Burton letter, nor specifically brought it to their attention prior to June 2002. As already noted, RJR failed to provide evidence that Star knew anything about the Burton letter’s contents or that the letter raised any concerns relevant to the prosecution of its patents. Thus, the evidence does not support an inference that Star’s failure to bring the Burton letter to the Banner firm’s attention was motivated by a deceptive intent to keep it from the examiner. And there is no evidence indicating that Williams, Star or their attorneys at the Banner firm became aware of the Burton letter before June 2002, well after the ‘649 patent issued in March 20, 2001. Given the heavy reliance by the district court on the Burton letter and RJR’s “quarantine” theory, the numerous evidentiary failings relating to this theory gives us a “definite and firm conviction” that the resulting finding of deceptive intent as to the ‘649 patent was clearly erroneous. See Molins, 48 F.3d at 1178. 9 To the extent the district court also relied on the non- disclosure of the Curran data, we note that even tho district 22a 3. Because the district court’s finding of deceptive intent as to the ‘401 patent was also heavily based on RJR’s “quarantine” theory, that finding is also weakened by the failings in that theory. But the district court also relied on additional evidence to find inequitable conduct as to the ‘401 patent. As Star concecaes, its attorneys at the Banner firm were made aware of the Burton letter and Curran data in June 2002, at which time the ‘401 patent had not yet been issued.!° Although Star had the opportunity to disclose them at that time, it did not disclose either document to the PTO. While the district court’s finding of deceptive intent even with regard to this additional evidence may be flawed in some respects, we reverse the holding of inequitable conduct as to the ‘401 patent because the district court’s finding of materiality was clearly erroneous. The district court found that the Burton letter and Curran data disclosed “the essential fact that the prior art could yield low TSNA tobacco at least some of the time,” and that this fact was “manifestly material.” /nequitable Conduct Order, slip op. at 41-— 42. However, in the course of the prosecution of the ‘401 patent, Star disclosed to the PTO other references that made this information contained in the Burton letter and Curran data _ clearly court acknowledged that the materiality of the Curran data was questionable given that the Curran tobacco was partially cured using a microwave. 10 Tt is clear that the events in June 2002 and the events that followed cannot render the ‘649 patent unenforceable due to inequitable conduct because the ‘649 patent had already issued. 23a cumulative.!! Star points to the disclosure of several references, including RJR’s interrogatory responses from this litigation and the language of the ‘401 patent’s specification. The ‘401 patent’s specification, lke the ‘649 patent’s specification, states: In flue curing processes that utilize a heat exchanger capable of providing relatively low airflow through the curing barn, I have discoverea that it is possible to somewhat reduce the TSNA levels by not venting combustive exhaust gases into the curing apparatus or barn. ‘401 patent, col.6 11.27—31 (emphasis added). Thus, the specification points out that “somewhat reduce[d]” levels of ‘TSNA were previously attainable. This alone may not render cumulative the Burton letter’s disclosure that low to undetectable levels of TSNA _ were previously unattainable, but another disclosure fills this gap. In particular, Star disclosed RJR’s interrogatory responses produced during the ‘649 patent infringement litigation. Of particular relevance is interrogatory question number 1: Describe in detail all research, field tests or other studies that you or others on your behalf have conducted, sponsored, or participated in regarding TSNA formation and/or reduction (including, without limitation, work conducted in Greece, \! These disclosures were made after the ‘649 patent was zssued, thus our analysis of materiality here applies only to the ‘401 patent. As already discussed, we reverse the holding of inequitable conduct as to the ‘649 patent due to the clearly erroneous finding of deceptive tntent with regard to that patent. 24a Turkey or North Carolina), including the results of such research, test or study, and any documents concerning such research, test or study. J.A. at 6303. RJR’s response to that interrogatory provided that: “Reynolds recognized in or about 1994 that tobacco (whether flue-cured or burley) cured in the indirect fired barns Aad significantly reduced levels of TSNNAs as compared to the commercial direct-fired, bulk curing barns at Reynolds’ Avoca facility.” J.A. at 6305 (emphasis added). Also, “[b]y about 1997, Reynolds recognized that it was the absence of combustion exhaust gases in the indirect fired barns that was responsible for the significantly reduced TSNA /evels obtained in flue-cured tobacco cured in those barns.” Jd. (emphasis added). “Reynolds then confirmed that tobacco cured in existing commercial, indirect-fired, bulk curing barns also contained significantly reduced levels of TSNAs as compared to tobacco cured in the commercial, gas-fired, bulk curing barns.” J.A. at 6305-06 (emphasis added). The _interrogatory response also provided a specific example: “Data collected in 1996 from tobacco cured in one of Hassell Brown’s indirect fired barns, which was heated with a heat exchanger, revealed that flue-cured tobacco cured in this barn had undetectable levels of TSNAs.” J.A. at 6306 (emphasis added). We conclude that this interrogatory response, which Star disclosed to the PTO, contained the critical information that the prior art had achieved low to insignificant levels of TSNA, and that the information contained in the Burton letter ana in the Curran data would therefore have been cumulative in the ‘401 prosecution by the time the Banner lawyers were made aware of them in June 2002. 25a Because cumulative information is not material, we hold that the district court clearly erred in finding that the information contained in the Burton letter and in the Curran data was material to the prosecution of the ‘401 patent. Under these circumstances, the finding of inequitable conduct with respect to the ‘401 patent must also be set aside. Therefore, we reverse the judgment of unenforceability of both the ‘649 and ‘401 patents. B. Indefiniteness Though we reverse the district court’s holding of inequitable conduct, its judgment of no lability for infringement may still be affirmed if we uphold the district court’s grant of summary judgment as to claim indefiniteness because it covered all asserted claims of both patents. We review both a district court’s grant of summary judgment and a holding of claim indefiniteness de novo. Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 13842, 1347 (Fed. Cir. 2005). The district court held that the term “anaerobic condition” is indefinite and thus, since it appears in every asserted independent claim, held that all asserted claims are invalid as indefinite. Indefiniteness Order, slip op. at 12—14. However, because the claim term “anaerobic condition” is not indefinite, we also reverse the grant of summary judgment. The requirement of claim definiteness is set ferth in 35 U.S.C. § 112, 4 2, which requires claims “particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” We have held that “lo|]nly claims not amenable to construction or insolubly ambiguous are indefinite.” Datamize, 417 F.3d at 1347 (citations omitted). A claim term is not indefinite just because 26a “it poses a difficult issue of claim construction.” Exxon Research & Engg Co. v. United States, 265 F.3d 1371, 1375 (Fed. Cir. 2001). Rather, the standard is whether “the claims [are] amenable to construction, however difficult that task may be.” /d. “By finding claims indefinite only if reasonable efforts at claim construction prove futile, we accord respect to the statutory presumption of patent validity ....” ld. The parties do not dispute the claim constructions reached by the district court, and the district court did construe all terms relevant to this appeal. In and of itself, a reduction of the meaning of a claim term into words is not dispositive of whether the term is definite. Halliburton Energy Serv., Inc. v. M—I LLC, 514 F.8d 1244, 1251 (Fed. Cir. 2008). And if reasonable efforts at claim construction result in a definition that does not. provide _ sufficient particularity and clarity to inform skilled artisans of the bounds of the claim, the claim is insolubly ambiguous and invalid for indefiniteness. See id. at 1249-51. The district court construed the term “anaerobic condition” to mean “an oxygen deficient condition (such as is created by an atmosphere of combustion gases or from the release of carbon dioxide by the plant during cure) which promotes microbial nitrate reductase activity.” Markman Order, slip op. at 1-2. Thus, a skilled artisan would know that the claim term contemplates only conditions where the dearth of oxygen promotes the activity of the nitrate reductase enzyme. It is undisputed that those of ordinary skill would understand from the patents’ specifications that the significance of nitrate reductase activity to the claimed invention is that it 27a produces nitrites, which then form TSNAs. See ‘649 patent col.7 11.89-55; ‘401 patent col.7 11.43—59. Therefore, from the claim term “anaerobic condition” and the intrinsic record, a skilled artisan would discern that the term delineates those conditions where the shortage of oxygen results in increased TSNA formation. This is further supported by statements to that effect in the _ patents’ speciiications. See, eg., “649 patent col.4 11.36—39 (“For example, it is postulated that if the conditions [contemplated for the present invention] are made aerobic, the microbes will consume oxygen in the atmosphere for their energy source, and therefore no nitrites will form.”). We have stated that “[w]hen a word of degree is used ... the patent’s specification [must] provide[ | some standard for measuring that degree” to be definite. Datamize, 417 F.3d at 1351 (quoting Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed. Cir. 1984)). Here, the term “anaerobic condition” is in effect a term of degree because its bounds depend on the degree of oxygen deficiency. And as the district court determined in its claim construction, the intrinsic record provides a standard for measuring that degree and assessing the bounds of “anaerobic condition” as required by Datamize, namely the level of TSNA formation. In fact, the claims explicitly refer to the standard, requiring that the tobacco be cured in a “controlled environment” that prevents an “anaerobic condition” in order to “substantially prevent the formation of at least one nitrosamine.” See ‘649 patent cl.4. The district court further determined that TSNA formation is itself a well-defined standard as disclosed by the asserted patents. It construed the 28a term “substantially prevent the formation of at least one nitrosamine” to mean “the level of at least one of the nitrosamines falls within the following ranges: less than about 0.05 mg/g for NNN, less than about 0.10 mg/g for NAT plus NAG, and less than about 0.05 mg/g for NNK.” Markman Order, slip op. at 2. In other words, the district court was able to discern from the intrinsic record that TSNA formation, as contemplated by the asserted patents, is tied to highly specific measurements of four very specific chemical compounds. Far from being insolubly ambiguous, a_ skilled artisan could determine whether an “anaerobic condition” was present—or, rather, was prevented—simply by measuring the levels of NNN, NAT, NAG, and NNK. The district court’s contrary conclusion was based on its misunderstanding that claim definiteness requires that a potential infringer be able to determine if a process infringes before practicing the claimed process.!2 But we disclaimed any such approach in =Jnvitrogen Corp. vv. SBiocrest Manufacturing, L.P., 424 F.3d 1374, 1384 (Fed. Cir. 2005). We explained that Stratagene, in making a 12 The district court misunderstood our decision in Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1383-84 (Fed. Cir. 2003). There, we rejected a proposed construction that, if adopted, would have rendered the term indefinite because a given composition could both infringe and not infringe simultaneously. We did not hold the claim term at issue to be indefinite; in fact, after rejecting that proposed construction, we arrived at the correct construction which did not render the term indefinite. /d at 1384. And while we emphasized that a claim is indefinite if a skilled artisan cannot determine if an accused product infringes or not, we did not hold that the infringement determination must be able to be made at any particular time. 29a similar argument, was “really talking about the difficulty of avoiding infringement, not indefiniteness of the claim.” Jd. “The test for indefiniteness does not depend on a _ potential infringer’s ability to ascertain the nature of its own accused product to determine infringement, but instead on whether the claim delineates to a skilled artisan the bounds of the invention.” /d. (citing SmitaKline Beecham Corp. v. Apotex Corp., 403 F.3d 13381, 1341 (Fed. Cir. 2005)); see also Datamize, 417 F.3d at 1354 (holding that “indefiniteness does not depend on the difficulty experienced by a particular person in comparing the claims with the prior art or the claims with allegedly infringing products or acts”). As construed by the district court, the term “anaerobic condition” clearly delineates the bounds of claim scope and thus is not indefinite. The district court’s grant of summary judgment of indefiniteness must therefcre be reversed. CONCLUSION For the reasons provided above, we reverse the district court’s judgment of unenforceability of both asserted patents due to inequitable conduct. We also reverse the district court's grant of summary judgment of invalidity of all asserted claims due to indefiniteness and remand for further proceedings on the infringement complaint consistent with this opinion. REVERSED and REMANDED 30a IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND STAR SCIENTIFIC, INC. * Plaintiff sd vs. * CIVIL ACTION R.J. REYNOLDS TOBACCO’ - * NO. MJG-01-1504 COMPANY, et al. * Defendants ° * * * * * * ME RDE On January 19, 2007, the Court issued its Memorandum and Order Re: Indefiniteness granting summary judgment to Defendants, but withheld the entry of Judgment pending decision of Defendants’ Inequitable Conduct defense. The Court has, this date, issued its Memorandum of Decision Re: Inequitable Conduct. Accordingly: 1. Judgment shall be, and hereby is, entered in favor of Defendants R.J. Reynolds Tobacco Company, et al against Plaintiff Star Scientific, Inc. dismissing all claims, with prejudice, with assessable costs. 3. This Order shall be deemed to be a final judgment within the meaning of Rule 58 of the Federal Rules of Civil Procedure. SO ORDERED, on Tuesday, June 26, 2007. /s/ Marvin J. Garbis United States District Judge 3la United States District Court, D. Maryland. STAR SCIENTIFIC, INC. Plaintiff Vv R.J. REYNOLDS TOBACCO COMPANY, et al. Defendants No. Civ.A. MJG-01-1504. June 26, 2007. Richard McMillan, Jr., Jona [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386017_0071%3A1. Public record. Not legal advice.