Function Media, L.L.C. v. Google, Inc. et al

Filing 146

MOTION for Judgment on the Pleadings Regarding Google's Inequitable Conduct Allegations by Function Media, L.L.C.. (Attachments: # 1 Exhibit, # 2 Exhibit, # 3 Exhibit, # 4 Exhibit, # 5 Text of Proposed Order)(Grinstein, Joseph)

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EXHIBIT A WeÉtLaw Page 1 --- F. 3 d ----, 2009 WL 23 6653 5 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. QMass.))) HOnty the Westlaw citation is currently available. West Headnotes United States Court of Appeals, Federal Circuit. EXERGEN CORPORATION, Plaintiff-Cross Appellant, f[f Courts 106 æ96(7) 106 Courts I WAL-MART STORES, INC. Hana Microelecfronics Co., Ltd., and CVS Corporation, Defendants, and 06II Establishment, Organization, and Procedure 106I(G) Rules of Decision 106k88 Previous Decisions as Controlling or as Precedents S.A.A.T. Systems Application Of Advanced Technology, Ltd. and Daiwa Products, Inc., DefendantsAppellants. Nos. 2006-1491. 2007-1 180. 106k96 Decisions of United States Aug4,2009. Background: Owner of three patents relating to infrared thermometers for measuring human body temperature brought infringement action against competitor. Competitor asserted affirmative defenses and counterclaims of both noninfringement and invalidiry. After denying competitor's motion to amend, the United States District Court for the District of Massachusetts, Reginald C. Lindsay, J., upon a jury verdict, found willful infringement and awarded lost profit damages to patent owner, and then subsequently denied competitor's motion for judgment as a matter of law (JMOL), and patent owner's motion to alter or amend judgment for an award of enhanced damages and prejudgment interest. Both parties appealed. Courts as Authority in Other United States Courts 106k96(7\ k. Particular Questions or Subject Matter. Most Cited Cases Court of Appeals for the Federal Circuit reviews the denial of a motion for judgment as a matter of law (JMOL) under the law of the regional circuit. lll Federat Courts l70Bæ776 1708 Federal Courts lT0BVIII Courts of Appeals lT0BVIII(K) Scope, Standards, and Extent lTOBVIIIß)l In General 170B.k776 k. Trial De Novo. Most Cited Cases In the First Circuit, the district court's decision to grant or deny a motion for judgment as a matter law (JMOL) is reviewed de novo. of lf[ Patents 291 æ314(5) Holdings: The Court Judge, held that: of Appeals, Linn, Circuit 291 Patents fl) first patent was invalid as anticipated by a prior aftpafeît; (2) accused device did not directly infringe second 29lXIl Infringement 29IXII(C) Suits in Equrty 29lk314 Hearing 291k314r5\ k. Questions Fact. Most Cited Cases of Law or patent; (1) competitor did not actively induce infringement of third patent; and Parents conduct 2glæ324.55(4) (4) competitor failed to plead inequitable with requisite particularity. Affirmed in part, and reversed in pan. 291 Patents 291XIl Infringement 29IXII(C) Suits in Equity @2009 Thomson Reuters. No Claim to Orig. US Gov. Works. Page2 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) 291k324 Appeal 291k324.55 Questions of Fact, Ver- f6ì Courts 106 ÇÞ96(7) 106 Courts I dicts, and Findings 291k324.55(T Issues of ValidifY 29 1k324.55ø) k. Noveþ, Invention, Anticipation, and Obviousness. Most Cited Cases 06II Establishment, Organization, and Procedure 106II(G) Rules of Decision 106k88 Previous Decisions as Controlling Patents 29tcæt o.tt t, or as Precedents Courts as 29l Patents 106k96 Decisions of United States Authorþ in Other United States Courts 106k96{Ú\ k. Particular Questions or 29l){If Infringement 29lXIi(C) Suits in Equity 291k324 Appeal Subiect Matter. Most Cited Cases 291k324.55 Questions of Fact, Ver- dicts, and Findings 291k324.55(5\ k. Issues of Infringement. Most Cited Cases Anticipation and infringement of a patent are both questions of fact, which, when found by a jury, are generally reviewed for substantial evidence. Whether inequitable conduct in a patent infringement action has been pleaded with requisite particularþ is Federal Circuit law. question govemed 9ft). 28 U.S.C.A. Fed.Rules Civ.Proc.Rule a by l7] Patents 29t æ66G.20) 291 Patents !!l Courts 106 Cã96(7) 29lII Patentability 29lII(D) Anticipation 29Ik63 Prior Patents 291k66 Operation and Effect 291k66(1.20) k. Measuring, Testing, and Indicating-Devices. Most Cited Cases Patent relatingto aradiation detector probe for meas- 106 Courts 1 06II Establishment, Organization, and Procedure l06I(G) Rules of Decision 106k88 Previous Decisions as Controlling or as Precedents 106k96 Decisions of United States Authority in Other United States Courts Courts as 106k96(7) k. Particular Questions or Subject Matter. Most Cited Cases The denial of a motion to amend a pleading is a pro- uring human body temperature was invalid as anticipated by prior art patent disclosing a method and apparatus for measuring the internal temperature of a patient's body by sensing infrared emissions in the external ear canal, despite patent owner's arguments cedural matter governed by the law of the regional circuit. Fed.Rules Civ.Proc.Rule l5(a). 28 U.S.C.A. [5ì Federat Courts 17gg 170B Federal Courts æStZ 170BVIII Courts of Appeals 170BVII(K) Scope, Standards, and Extent 170BVII(K)4 Discretion of Lower Court 1708k817 Cited Cases k. Parties; Pleading. Most that prior art patent detected radiation from probe unit in addition to radiation detected from the patient, and that prior art patent detected radiation only from a single spot, not from "multiple areas"; in reciting its claim limitations, patent relating to the radiation detector probe used the term "comprising," which meant including but not limited to, and thus prior art patent was not required to detect radiation solely from biological tissue, and prior art patent inherently disclosed detection of radiation from "multiple areas," since a user would necessarily detect radiation from the patient's face, outer ear, and ear canal while probe was inserted into the ear canal. The First Circuit reviews the denial of a motion to amend for a\ abuse of discretion. Fed.Rules lË]Patents 29ræ72{o) Civ.Proc.Rule 15(a). 28 U.S.C.A. @ 2009 Thomson Reuters. No Claim to Orig. US Gov. Works. Page 3 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) 291 Patents 29lIl Patentabilify 291 Patents 29III(D) Anticipation 291k72 Identþ of Invention 291k72(l\ k. In General. Most Cited Cases zglxll tures Infringement 29 I XIi(A) What Constitutes Infringement 291k233 Patents for Machines or Manufac291k235 Identity of Principle or Mode of Operation 291k235Q], Devices. Most Cited Cases To anticipate a patent claim, a single prior art reference must expressly or inherently disclose each claim Iimitation. k. Particular Patents or llf Patents 291@226.6 291 Patents 291XIJ Infringement 29 I XII(A) What Constitutes Infringement 291lA265 Substantial Identity of Subject Matter 291k226.6 k. Comparison with Claims of Patent. Most Cited Cases Patents Accused device, which targeted a patient's forehead area for measurement, possessed a display for providing a reading of oral temperature rather than the temperature of the temporal artery beneath the skin of the forehead, and thus the device did not possess "a display for providing an indication of the internal temperature," as required to directly infringe patent relating to a radiation detector measuring tympanic temperature with improved accuracy. 291Ç229 flll Patenrs 291 q;p314(5) 291 Patents 291 Patents 2glxlf Infringement 29 IXI(A) What Constitutes 291k229 Cited Cases Infringement 291k228 Patents for Processes k. Identity in General. Most 291XIl Infringement 29IXII(C) Suits in Equity 29lk314 Hearing 291k314(5) k. Questions of Law or Fact. Most Cited Cases Once a district court has construed the relevant claim Direct infringement of a patent requires a parfy to perform each and every step or element of a claimed method or product. f terms of a patent, and unless altered by the district court, then that legal determination governs for purposes of trial; no party may contradict the court's construction to a jury. 10l Patents 291 æ259(l') 291 Patents l13ì Patents 291 291 Patents æ259(l) 29IXII Infringement 29 I XI(A) What Constitutes Infringement 291k259 Contributory Infringement; Inducement 29lXI 29 Infringement 291k259(1\ k. In General. Most Cited Cases IXII(A) What Constitutes Infringement 29flA59 Contributory Infringement; In291k259(l\ k. In General. Most Cited ducement Cases Active inducement of a patent requires the patentee to prove first that there has been direct infringement, and second that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another's infr ingement. Scanning within an oval pattern in the temple region fllì Patents 291æß5Q) on one side of the forehead, as directed by instructions of accused thermometer, did not meet literal requirement of claim of patent relating to infrared thermometer that detected temperature of the fore- @2009 Thomson Reuters. No Claim to Orie. US Gov. Works. Page 4 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) head directly over the superficial temporal artery of scanning "across a forehead," so as to support patent owner's claim that manufacturer of accused thermometer actively induced infringement of that patent claim. 291k97 k. Patent Office and Proceedings Therein in General. Most Cited Cases The substantive elements of inequitable conduct in a patent case are: (l) an individual associated with the filing and prosecution of a patent application made an ft[f Patents 291ÞzSS(t) affirmative misrepresentation of a material fact, failed to disclose material information, or submitted 291Patents 291XII Infringement 29 I XI(A) What Constitutes Infringement false material information; and (2) the individual did so with a specific intent to deceive the Patent and Trademark Office (PTO). 291k259 Conhibutory Infringement; Inducement lll Federal Civil Procedure 1704 æ636 291k259(l\ k. In General. Most Cited Cases Accused thermometer measured the surface temperature of the skin covering the temporal artery, rather than the temperature of the temporal artery beneath the skin, as required by claim of patent relating to infrared thermometer that detected temperature of the forehead directly over the superficial temporal artery, and thus, in the absence of direct infringement, manufacturer of accused thermometer was not liable for actively inducing infringement of that claim. patent l70A Federal Civil Procedure ITOAVII Pleadings and Motions 17OAVII(A) Pleadings in General 1704k633 Certainty, Defmiteness and Particularity 1704k636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases The relevant "conditions of mind" for pleading inequitable conduct in patent cases with requisite particular include: (l) knowledge of the withheld material information or of the falsity of the material misrepresentation, and (2) specific intent to deceive the Patent and Trademark Office (PTO). Civ.Proc.Rule 9G). 28 U.S.C.A. Fed.Rules fl5l Federal Civil Procedure 1704 QeSe 1704 Federal Civil Procedure f!l!l Federal Civil Procedure 1704 Ç-636 lT0AVII Pleadings and Motions 170AVII(A) Pleadings in General 1704k633 Certainty, Defmiteness and Particularity 1704k636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases Inequitable conduct in patent cases, while a broader concept than fraud, must be pled with particularity under the Federal Rules of Civil Procedure; a pleading that simply avers the substantive elements of inequitable conduct, without setting forth the particularized factual bases for the allegation, does not satisfu this requirement. Fed.Rules Civ.Proc.Rule 9(b). 28 U.S.C.A. l70A Federal Civil Procedure 170AVII Pleadings and Motions 17OAVII(ê) Pleadings in General 1704k633 Certainty, Def,miteness and Par- ticularity 170Ak636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases To plead the "circumstances" of inequitable conduct in patent cases with the requisite particularity under Federal Rules of Civil Procedure, the pleading must identiff the specific who, what, when, where, and how of the material misrepresentation or omission committed before the Patent and Trademark Office (PTO); moreover, although "knowledge" and "intent'' may be averred generally, the pleading must include sufficient allegations of underlying facts from which a court may reasonably infer that a specific individual (l) knew of the withheld material information or of the falsity of the material misrepresentation, and (2) lL¡llPatents 291 Patents 29 zgtæ97 and Proceedings Thereon lMpplications @2009 Thomson Reuters. No Claim to Oris. US Gov. Works. Page 5 --- F.3 d - - - -, 2009 WL 23 6653 5 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) withheld or misrepresented this information with a specific intent to deceive the PTO. Fed.Rules Civ.Proc.Rule 9(b). 28 U.S.C.A. l70A Federal Civil Procedure 17OAVII Pleadings and Motions lTOAVII(A) Pleadings in General 1704k633 Certainty, Definiteness and Par- [!!l 1 Federal Civil Procedure l70A FO¡O ticularity 1704k636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases Alleged infringer of patent relating to infrared thermometer that detected temperature of the forehead directly over the superficial temporal artery failed to name a specifrc individual associated with the hling of the patent application, who both knew of material 70A Federal Civil Procedure 17OAVII Pleadings and Motions lTOAVII(A) Pleadings in General 1704k633 Certainty, Defmiteness and Par- ticularity 1704k636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases A "reasonable inference" that a specific individual (1) knew of the withheld material information or of the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO, as required to plead inequitable conduct in a patent case with requisite particularity, is one that is plausible and that flows logically from the facts alleged, including any information and deliberately withheld or misrepresented it, and identi$z which claims, and which limitations in those claims, the withheld references were relevant to, and where in those references the material information was found, and the particular claim limitations, or combination of claim limitations, that were supposedly absent from the information of record, as required to plead inequitable conduct with requisite particularþ in patent owner's infringement action. Fed.Rules Civ.Proc.Rule 9(b). 28 U.S.C.A. objective indications of candor and good faith. Fed.Rules Civ.Proc.Rule 9Lb). 28 U.S.C.A. l22l Federal Civil Procedure 170.4. fu636 pQl Federal Civil Procedure 1704 FOSO l70A Federal Civil Procedure 170AVII Pleadings and Motions IT0AVII(A) Pleadings in General 1704k633 Certainty, Definiteness and Par- 170A Federal Civil Procedure 17OAVII Pleadings and Motions ITOAVII(A) Pleadings in General 1704k633 Certainty, Definiteness and Par- ticularity 1704k636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases Records ticularity 1704k636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases In contrast to the pleading stage, to prevail on the merits of an inequitable conduct claim in a paterfi case, the accused infringer must prove both material- 326æ32 326 Records ity and intent by clear and convincing evidence; whereas an inference of deceptive intent must be rea- 326II Public Access 326II(A) In General sonable and drawn from a pleading's allegations of underlying fact to satis$ the Federal Rules of Civil Procedure's heightened pleading requirement, this inference must be the single most reasonable inference able to be drawn from the evidence to meet the 326k32 Cases k. Court Records. Most Cited Because one of the purposes of the Federal Rule of Civil Procedure's heightened pleading requirements for fraud is to protect those whose reputation would clear and convincing standard. Fed.Rules Civ.Proc.Rule 9(b). 28 U.S.C.A. be harmed as a result of being subject to fraud charges, a district court may require that filings be made under seal, require redaction of individuals' names, and impose other safeguards under the Federal Rules of Civil Procedure, or other sources of f2lì Federal Civil Procedure 1704 @636 protective authority. Fed.Rules Civ.Proc.Rules O 2009 Thomson Reuters. No Claim to Orie. US Gov. Works. Page 6 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) 5.2(d)-(e), 9(b), 26(c). 28 U.S.C.A. inequiøble conduct. llll I Federal Civil Procedure l70A þ636 Patents 291æ328(2) 704 Federal Civil Procedure lTOAVII Pleadings and Motions ITOAVII(A) Pleadings in General 1704k633 Certainty, Definiteness and Par- 291 Patents 29LXIIf Decisions on the Validity, Construction, and Infringement of Particular Patents 29 1k328 Patents Enumerated ticularity 170Ak636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases For purposes ofalleging facts giving rise to a reasonable inference of scienter, as required in pleading inequitable conduct in a patent case with requisite particularity, one cannot assume that an individual, who generally knew that a patent reference existed, also knew of the specific material information contained in that reference. Fed.Rules Civ.Proc.Rule 9(b).28 U.S.C.A. Cases 291k328Q\ k. Original Utility. Most Cited Parents 291æ328(2) 291 Patents 291xlll Decisions on the Validity, Construction, and Infringement of Particular Patents 29 1k328 Patents Enumerated 291k328(2) k. Original Utility. Most Cited Cases [24ì Federal Civil Procedure 170A' 1704 Federal Civil Procedure @636 Patents 291æ325(2) 17OAVII Pleadings and Motions ITOAVII(.A) Pleadings in General 1704k633 Certainty, Defmiteness and Par- 291 Patents 29LXIIJ Decisions on the Validity, Construction, and Infringement of Particular Patents 29 1k328 Patents Enumerated ticularþ 170Ak636 k. Fraud, Mistake and Condition of Mind. Most Cited Cases Pleading on "information and belief is permitted under the Federal Rules of Civil Procedure's heightened pleading requirements for fraud when essential information lies uniquely within another party's control, but only if the pleading sets forth the specific 291k328(Ð k. Original Utility. Most Cited Cases Patents 291æ328(2) 291 Patents 29lXIII Decisions on the Validity, Construction, and Infringement of Particular Patents 29 1k328 Patents Enumerated 291k328(.2\ k. Original Utility. Most Cited Cases 4,3 17,998, 4,566,808. Cited. facts upon which the belief is reasonably based. Fed.Rules Civ.Proc.Rule 9(b). 28 U.S.C.A. p!]Patents 291 Patents 2glæ97 and Proceedings Thereon Patent Office and Proceedings zglMpplications 291k97 4,602,642.Cited as Prior Art. 5,0 12,813, 6,292,685. k. Therein in General. Most Cited Cases The mere fact that a patent applicant disclosed a reference during prosecution of one application, but did not disclose it during prosecution ofa related application, is insufficient to meet the threshold level of de- Not Infr inged. 6,047,205. Invalid and Not Infringed. Appeals from the United States District Court for the ceptive intent required to support an allegation of District of Massachusetts in case no. 0l-CV-11306. @ 2009 Thomson Reuters. No Claim to Orie. US Gov. Works. Page 7 --- F.3 d ----, 2009 WL 23 6653 5 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) Judge Reginald C. Lindsay.Heidi E. Harvey, Fish & Richardson P.C., of Boston, MA, argued for plaintiffcross appellant. With her on the brief were Gregory A. Madera and Thomas A. Brown. BACKGROUND Exergen's patents relate to infrared thermometers for measuring humm body temperature. The thermometers first detect infrared radiation emitted from a surface of the human body, such as the tympanic membrane (eardrum) or the skin of the forehead, to obtain the surface temperature. The surface temperature is a function of both the internal (core) temperature within the body and the ambient (air) temperature to which the surface is exposed. From the detected sur- M. Midgley. Jr., Zarian Midgley & Johnson PLLC, of Boise, ID, argued for defendantsPeter appellants. With him on the brief was Dana M. Herberholz. Before MICHEL, Chief Judge, LINN, Circuit Judge, and ST. EVE, District Judge.N LINN, Circuit Judge. *1 S.A.A.T. Systems Application of Advanced Technology, Ltd. and Daiwa Products, Inc. (collectively "SAAT") appeal the denial of their motion for judgment as a malter of law ("JMOL") after a jury found that SAAT willfully infringed U.S. Patents No. 5.012.813 ("the '813 patent"), No. 6,047,205 ("the '205 patent"), and No. 6,292,685 ("the '685 patent") and awarded lost profit damages to the patentee, Exergen Corporation ("Exergen"). Exergen Corp. v. Wal-Mart Stores, 1nc., No. 01-CV-11306 (D.Mass. Aug. 4, 2005). SAAT fuither appeals the denial of its motion for leave to amend its answer to allege that the '813 and '685 patents are unenforceable due to inequitable conduct. Exergen cross-appeals the denial of its motion to alter or amend judgment for an award of enhanced damages and prejudgment interest. face temperature, the thermometers calculate the internal temperature in accordance with equations provided in the patents and then display a digital readout thereof. For example, the '813 and'205 patents disclose a thermometer that detects radiation from the tympanic membrane, but the claims of those patents are directed more broadly to detecting radiation from "biological tissue." The '685 patent, by contrast, is directed to a thermometer that detects radiation from the skin that covers the temporal artery in the temple region near the side ofthe forehead. SAAT manufactures thermometers that detect radiation from the skin that covers the temporal artery. After detecting this radiation, SAAT's thermometers convert the measured surface reading to the patient's oral temperature, which is the commonly used temperature measurement in the United States. We conclude that all claims of the '205 patent are anticipated and that no substantial evidence supports the jury's contrary finding. Furthermore, we conclude that Exergen failed to introduce substantial evidence to support the jury's f,urding that the '813 and '685 patents are infringed. Because our invalidity and noninfringement determinations require that we reverse the damages award, we need not address Exergen's cross-appeal regarding enhanced damages and prejudgment interest. Finally, we conclude that the district court did not abuse its discretion in denying SAAT's motion to amend its pleading because it correctly held that SAAT's proposed allegations of inequitable conduct failed to satisry the heightened pleading requirement of Federal Rule of Civil Procedure 9ß). Thus, we affirm-in-part and reverse-in-part. *2 Exergen sued SAAT for infringement of the '813 and '205 patents on July 27,2001. The '685 patent issued on September 18, 2001, and was added to the suit on October 2,2001. SAAT answered by asserting aff,rmative defenses and counterclaims of both noninfringement and invalidity. On September 6, 2002, SAAT sought leave pursuant to Federal Rule of Civil Procedure 15(a) to add inequitable conduct as an affirmative defense and counterclaim against the '813 and '685 patents. Exergen Corp. v. ílal-Mart Stores, 1nc., No. 0l-CV-11306 (D.Mass. Sept. 6, 2002) (Dkt. No. 51) ("Answer "). The district court denied SAAT's motion, stating that the proposed pleading failed to allege inequitable conduct with particularþ under Rule 9(b). The court then conducted a hearing on claim construction and construed two terms in claim 7 of the @2009 Thomson Reuters. No Claim to Oris. US Gov. Works. Page 8 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) '813 patent. First, the court construed "biological surface tissue" to mean "a living layer of external human tissue having a temperature that can be measured." Exergen Corp. v. lVal-Mart Stores, 1nc., No. dentiary basis' for a reasonable jury to find for that party." Mag Jewelry Co. v. Cherokee. Inc.. 496F.3d 0l-CV-11306, slip op. at 10 (D.Mass. JuIy 14,2004) ("Claim Construction Order "). Second, the court construed "internal temperature" to mean "temperature ofthe region existing beneath the surface ofthe biological tissue targeted for measurement." Id. The parties agreed that these terms were the only terms at issue in the case. Moreover, before trial, Exergen waived any argument that SAAT infringed under the doctrine of equivalents. The case then proceeded to ajury trial on a theory of literal infringement only. The jury found that SAAT questions of fact, which, when found by a jury, are 108. 117 (1st Cir.200î (quoting Fed.R.Civ.P. 50(a)(l). Anticipation and infringement are both generally reviewed for substantial evidence. See Cordis Corp. v. Boston Scientilìc Coro.. 561 F.3d 1319. 1330. 1335 lFed.Cir.2009). [4][5ll-61 The denial of a motion to amend a pleading under Rule 15(a) is a procedural matter governed by the law of the regional circuit. See Cent. Admixture Pharmaq Servs., Inc. v. Advanced Cardiac Solutions. P.C.. 482 F.3d 1347. 1357 (.Fed.Cir.2007). The First Circuit reviews the denial of a Rule 15(a) motion for an abuse of discretion. See Trans-Spec Truck Serv.. Inc. v. Caterpillar Inc., 524 F.3d 315. 326 (lst Cir.2008). Whether inequitable conduct has been pleaded with particularity under Rule 9(b) is a question governed by Federal Circuit law. See Cent. Admixture, 482 F.3d at 1356. *3 directly infringed claim 7 of the 'E_1_3__patgnt and claims I and 3-5 of the '205 patent, and that SAAT actively induced infringement of claims I and27-30 of the '685 patent. Infringement of each patent was found to be willful. The jury also found in favor of Exergen on SAAT's invalidity defenses. Finally, the jury awarded lost profit damages totaling more than $2.5 million. IL Anticipation [7][8] SAAT challenges the jury's finding that claims l-5 of the '205 patent are not anticipated by U.S. Patent No. 4.602.642 ("O'Hara"). "To anticipate a claim, a single prior art reference must expressly or inherently disclose each claim limitation." Finisar Corp. v. SAAT moved for JMOL on the grounds of noninfringement, invalidity, and absence of lost profits. These motions were denied on March 24,2006. Exergen moved to alter or amend judgment for an award of enhanced damages and prejudgment interest. This motion was denied on January 12.2007. DirecTV Group. (Fed.Cir.2008). lnc.,523 F.3d 1323. 1334 SAAT and Exergen appeal. We have jurisdiction under23 U.S.C. { 1295(aXl). DISCUSSION Claim I is the sole independent claim of the '205 patent. It recites: l. A method of detecting tissue comprising: temperature of biological L Standard ofReview We review the denial of a motion for JMOL under the law of the regional circuit. See 800 Adept. lllt2lt3l providing a radiation detector for sensing infrared radiation from an extemal target; sensing radiation from multiple areas of the biological tissue with the radiation detector; and electronically detecting the peak radiation from the multiple areas to obtain a peak temperature signal. '205 patent col.20 11.46-54. Inc. v. Murex Sec.. Ltd.. 539 F.3d 1354. 1366 (Fed.Cir.2008). In the First Circuit, "[t]he district court's decision to grant or deny a motion for judgment as a matter of law is reviewed de novo." ,So/oLebron v. Fed. Express Corp., 538 F.3d 45. 56 (lst Cir.2008). JMOL is appropriate if "the presentation of the parfy's case reveals no 'legally sufficient evi- O 2009 Thomson Reuters. No Claim to Orie. US Gov. Works. Page 9 --- F.3d ----,2009 WL 2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) O'Hara issued more than two years before the earliest priority date of the ' 205 patent. O'Hara discloses "a method and apparatus for measuring the internal temperature of a patient's body by sensing infrared emissions in the external ear canal." O'Hara col.3 ll.8-10. This apparatus includes a handheld "probe unit" containing "an infrared sensitive thermopile detector," id. col.3 11.37-40, and a base or "chopper unit" that mates with and heats the probe unit to 98oF open-ended and allows for additional steps."). The fact thal O'Hara detects radiation from the heated probe, in addition to detecting the peak radiation from multiple areas of the biological tissue to obøin a peak temperature signal, does not prevent O'Hara from anticipating claim 1. Moreover, Exergen does not argue that a heated probe is incapable ofdetecting for calibration immediately prior to use, id. 11.32-36. When a user removes the probe coI.3 unit from the chopper unit, the system begins taking radiation measurements at a rate of seven times per second and radiation from sources having a lower temperature. To the contrary, Exergen concedes that the detection of radiation is an additive process that allows radiation to be detected from both the heated probe and the biological tissue. Pl.-Cross Appellant's Br. 3l (stating that O'Hara's "own radiation is always ødded stores the maximum reading. Id. col.l2 11.37-47. to the radiation it is detecting from random targets that it encounters along the way" (emphasis added)). Second, Exergen's contention that O'Hara detects radiation only from a single spot, not from "multiple areas," is unsupported by substantial evidence. In fact, Exergen's expert, Dr. Pompei, testified that O'Hara inherently discloses this limitation: From the time that the probe unit is removed from the chopper unit, the user has ten seconds to insert the probe into the external ear canal and press the SCAN key. Id. col.l2 11.61-65. When the SCAN key is pressed, "[t]he maximum reading from the beginning of the removal of the probe unit from the chopper unit is displayed as the tympanic temperature." Id. col.l3 ll.7-9. Exergen's expert, Dr. Pompei, admitted at trial that O'Hara discloses all limitations of claim I except the third step, namely, "electronically detecting the peak Q. While you're moving this probe unit from the chopper unit, is it-what is it measuring? A. It's measuring infrared radiation. radiation from the multiple areas to obtain a peak temperature signal." J.A. 6502-03 (39:14-40:12). On appeal, Exergen also focuses only on this third step distinguishing O'Hara. First, Exergen argues that O'Hara heats the probe unit to 98oF and detects this radiation in addition to the radiation detected from the patient. Second, Exergen argues that O'Hara detects radiation only from a single spot, not from "multiple areas," in the ear canal after the SCAN key is pressed. Neither of these arguments, however, provides a plausible basis for distinguishing O'Hara. and presents two arguments for Q. And yon hove to move it along the side of the patient's face to get to the ear, don't you? A. Yes. Q. During the period that you're moving along the side of the patient's face, what's it measuring? What's it doing? A. It's measuring radiation. *4 First, nothing in claim I of the '205 patent requires the detector to detect radiation solely from the bioIogical tissue. The claim uses the term "comprising," which is well understood in patent law to mean "including but not limited to." CIAS. .lnc. v. Alliance Gaming Corp.. 504 F.3d 1356. 1360 (led.Cir.2007); see Invitrogen Corp. v. Biocrest M-fç., L.P.,327 F.3d 1 3 64. 1 3 68 (Fed.Cir.2003 ) ("The transition' comprising' itr a method claim indicates that the claim is I.A. 6495-96 (32:25-33:12 (emphasis added)). Beof O'Hara's method would necessarily detect radiation from the patient's face, outer ear, and ear canal at a rate of seven times per second while inserting the probe unit into the ear canal, O'Hara inherently discloses the detection of radiation from "multiple areas" of biological tissue. See cause a user Trintec Indus., Inc. v. Top-U.S.A. Corp.,295 F.3d O 2009 Thomson Reuters. No Claim to Oris. US Gov. Works. Page l0 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) 1292. 129 5 (F ed.Ctr.2002\ ("Inherent anticipation requires that the missing descriptive material is 'necessarily present,' not merely probably or possibly present, in the prior art." (quotng In re Robertson. 169 F.3d 743. 745 (.Fed.Ctr.l999\)). Exergen also contends, with respect to the "multiple areas" limitation, that O'Hara's probe unit employs a detector with a wide field of view, which, once inserted into the ear canal, measures radiation from only one spot of the ear canal after the SCAN key is pressed. Exergen's argument overlooks the We therefore reverse the jury's finding that all claims of the'205 patent are not invalid. Moreover, because "invalid claim[s] cannot give rise to liability for infringement," Medtronic. Inc. v. Cardiac Pacemakers. Inc.. 721 F.2d 1563. 1583 Ged.Cir.l983), SAAT cannot be liable for infringement of this patent. III.Infringement the jury's ltndings that SAAT directly infringed the '813 patent and actively induced infringement of the '685 patent. "Direct infringement requires a parly to perform each and every step or element of a claimed method or product." BMC Res., Inc. v. Pq¡mentech. L.P.. 498 F3d 1373. 1378 (Fed.Cir.2007). Active inducement requires the patentee to prove "first that there has been direct infringement, and second that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another's infringement." Minn. Mining & Mfg. Co. v. Chemque. Inc.. 303 F.3d 1294. 1304-05 (Fed.Cir.2002\ (cita' fact that the term "biological tissue" in claim I is not limited to "ear canal," and the fact that O'Hara detects radiation from multiple areas of the body during the entire time that the probe unit is being inserted into the ear canal, even beþre the SCAN l9l[l0] SAAT challenges key is pressed. O'Hara unambiguously states that "[t]he maximum readingy'om the beginning of the removal of the probe unit from the chopper unit is displayed as the tympanic temperature." O'Hara col. l3 ll.7-9 (emphasis added). The record also reflects that as the probe unit is moved into position in the ear canal, it necessarily passes over-and detects radiation from-the face, outer ear, and ear canal along the way. Because O'Hara obtains a peak tions omitted). temperature signal corresponding to a peak radiation detected over the patient's face, outer eat, and ear canal-i.e., multiple areas of the biological tissue-O'Hara anticipates claim l. A. The'813 Patent F ll Claim 7 is the sole claim of the'813 patent found infringed. It recites, with key term emphasized: 7. A radiation detector comprising: a thermopile mounted to *5 Exergen presents no separate argument as to the validþ of dependent claims 2-5. The limitations of those claims are readily found in O'Hara. Compare '205 patent claim 2 ("a temperature display for displaying the peak temperature"), with O'Hara col.4 11.25-26 ("The internal body temperature ... is displayed on the LCD."); compare'205 patent claim 3 ("the radiation sensor is a thermopil'), with O'Hara col.3 11.39-40 ("an infrared sensitive thermopile detector"); compare'205 patent claim 4 ("sounding an audible tone from the radiation detector to indicate detection of peak radiation"), with O'Hara coI.l3 ll.l1-13 ("the audio indicator is energized to signal completion of the temperature reading process"); compare'205 patent claim 5 ("the biological tissue is scanned with movement of the radiation detector"), with O'Hara col.12 11.59-61 ("The user then inserts the speculum covered probe into the external ear canal using moderate pressure."). view atarget of biological surface tissue; a temperature sensor ambient temperature; for sensing an electronic circuit coupled to the thermopile and temperature sensor and responsive to the voltage across the thermopile and the temperature sensed by the sensor to provide an indication ofan internal temperature within the biological tissue adjusted for the ambient temperature to which the surface tissue is exposed; and a dßpløyfor providing an indication of the internal temperature. '813 patent col. 14 11.50-63. O 2009 Thomson Reuters. No Claim to Orig. US Gov. Vy'orks. Page 11 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) SAAT argues that its device does not possess "a display for providing an indication of the internal temperature" as recited in the claim. The district court construed "intemal temperature" to mean "temperature of the region existing beneath the surface of the biological tissue targeted for measurement." Claim Construction Order at 10. Neither SAAT nor Exergen challenges the construction of "internal temperature." Moreover, because SAAT's device targets the patient's forehead area for measurement, it is undisputed that the relevant "internal temperature" here is the temperature of the temporal artery beneath the skin of the forehead. SAAT's device, however, measures infrared radiation from the patient's forehead to calculate and display a digital readout of the patient's oral temperafitre, which is different from (and typically lower than) the patient's temporal artery temperature. Although Exergen told thejury that "an oral temperature is an internal temperature," J.A. 188 (ll9:21-22), Exergen now retracts that statement and acknowledges that the "intemal temperature" here is "the temperature of the temporal artery beneafh the skin of the forehead that is targeted," Pl.-Cross Appellant's Br. 35 (emphasis added). For these reasons, SAAT argues that its device does not infringe. *6 Exergen responds that oral temperature, while not itself an internal temperature, is nevertheless an "indication" of internal temperature because the two temperatures can be compared and correlated to one another in a clinical lookup table. Exergen further argues that SAAT did not seek any particular construction of the term "indication" and thus SAAT has waived its attempt to construe "indication" to mean "reading." arriving at the internal temperature. Id. 6346 (184:8l0 (Dr. Pompei testifring with respect to claim 7 that "[w]hen scanning the surface of the skin, then the temperature that I display here is the temperature underneath, somewhere inside that tissue")). We further decline to find waiver against SAAT in view of Exergen's misleading statement to the jury that "an oral temperature is an internal temperature" in the context of a forehead thermometer-a statement that directly contradicts the district court's earlier construction of "internal temperature." See Claim Construction Order at 10. Once a district court has [l2] construed the relevant claim terms, and unless altered by the district court, then that legal determination governs for purposes of trial. No party may contradict the court's construction to a iurv. Because it is undisputed that SAAT's device possesses a display for providing a reading of oral temperature rather than the temperature of the temporal artery beneath the skin of the forehead, the device cannot infringe claim 7 of the '813 patent. We therefore reverse the jury's finding that this patent is infringed. B. The'685 Patent The jury found that SAAT actively fringement of claims We observe that it is Exergen, not SAAT, which seeks to change the ordinary meaning of "indication" that was given to the jury. Exergen's own expert and co-inventor on the '813 patent, Dr. Pompei, testified on direct examination that the phrase "a display for providing an indication" in claim 7 means that "[o]n the display it reads a temperature that is-you know, is the internal temperature." J.A. 6346 (184:13-14 (em- phasis added)). His testimony made clear that the number shown on the display must itself be the value of the internal temperature; it cannot be some other value requiring fuither (mental) computation before Inducement requires a threshold finding of direct infringement. Because Exergen presented no evidence of any "specific instance of direct infringement," Exergen was required to show that "the accused device necessarily infringes the patent in suit." ACCO Brands. Inc. v. ABA Locl<s Mfrs. Co.. 501F.3d 1307. 1313 (Fed.Cir.2007) (citing Qvnacore Holdings Corp. v. U.S. Philips Corp.. 363 F.3d 1263. 1275-76 (Fed.Cir.2004\). Exergen relied on instructions and drawings accompanying SAAT's infrared thermometers as circumstantial evidence that customers would necessarily infringe the '685 patent. See Moleculon Research Corp. v. CBS. Inc.. 793 F.Zd 1261. 1272 (Fed.Cir.1986) (holding that sales of product with instructions to use product in an infringing manner may constitute circumstantial evidence that customers would use the product in the marmer directed). As we shall explain, however, any cus- I induced in- and 27-30 of the '685 patent. tomer who actually followed SAAT's instructions @ 2009 Thomson Reuters. No Claim to Orie. US Gov. Works. Page 12 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) would not have performed the steps recited in the asserted claims of the '685 patent and thus would not have directly infringed the patent. Accordingly, we reverse the jury's fmding that SAAT actively induced infringement of this patent. forehead; and providing a peak temperature reading from plural readings during the step of scanning. l. Claim I *7 [l3] Claim I recites: '685 patent col.9 ll.l5-20. The parties agree that "lat- erally" means "horizontal relative to the body." Pl.-Cross Appellant's Br. 42. human l. A method of detecting comprising: human body temperature Exergen presented evidence of sales of two types of thermometers: ThermoTek and CVS.N Both thermometers were sold with instructions containins the following drawing: laterally scanning a temperature detector across a J.A. 7917 , 7951 (two circles added during trial). The instructions for the ThermoTek thermometer state, "Scan with the thermometer around the temple area (marked as dotted area in the drawing)." Id. at 7917 (emphasis added). The instructions for the CVS thermometer state, "Place the thermometer's soft touch tip just outside the eyebrow (in the temple region of the forehead) and slowly slide upwards to just below the hai¡line." Id. at795l (emphasis added). We agree with SAAT. Even if the term "laterally scanning" captures the minimal horizontal movement envisioned by Exergen (an issue on which we express no opinion), Exergen's argument ignores the claim language requiring the lateral scan to occur "across a forehead," not merely within the temple region located on one side ofthe forehead. In fact, counsel for Exergen told the jury to essentially ignore this requirement: SAAT argues that a user following either set of instructions would not be "laterally scanning ... across a forehead," as recited in the claim, because the two oval patterns (marked as the dotted areas) are located only on the temples and a¡e oriented vertically relative to the human body. Exergen responds that each oval pattern includes at least some horizontal component, which Exergen believes is sufficient to constitute "laterally scanning." whether scan.... [MS. HARVEY:] The only other issue on this is or not, with Claim l, there's a Iateral And I was thinking, you know, dogs go straight to where they're going across, and my cats go around in a circle to get there, but they both end up at the same place. When you go around in a circle, you have gone across. It doesn't matter if I-it would be like saying cross the Charles River going east. Well, you can cross the Charles River going east, west, north and south, depending on which bridge O 2009 Thomson Reuters. No Claim to Oris. US Gov. Works. Page 13 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) you take, right? You crossed the river, you've crossed the river. .... And Doctor Pompei admitted that if you followed strictly their instmctions to start out here at the outside ofthe eyebrow and go straight up to the hairline, that would not be a lateral scan. On the added)). Exergen's reliance on this testimony is misplaced for two reasons. First, Mr. Gerlitz was not referring to the instructions sold with the ThermoTek or CVS thermometers, which instruct only to scan inside the dotted oval patterns in a noninfringing manner. Second, his testimony shows merely that the thermometers "can" be used in an infringing manner by scanning across the forehead from one temple to the other, as opposed to the noninfringing manner disclosed in the ThermoTek or CVS instructions. "Because the accused device can be used at any given time in a noninfringing manner, the accused device other hand, if they're scanning in this direction, they're doing both vertical and lateral. And this is word-snffing to try to hide out from that claim of the pøtent because the point is-and you saw him take the temperature on the front cover of the '685 patent. The point of those instructions is to find the temporal artery. It's to make sure that you cross it, right? And these instructions ensure that you cross the temporal artery. does not necessarily infringe the [patent-in-suit]." ACCO Brqnd.E. 501 F .3d at 1313. *8 J.A. 199-200 (130:8-13l:10 (emphases added)). Thus, Exergen posited to the jury that scanning within one of the oval patterns in the temple region was sufficient to infringe claim I because such a scan would achieve substantially the same result as scanning across the forehead, namely, crossing the temporal artery. The claim recites "across a forehead," not "across a temporal artery." The ThermoTek instruction says to scan "around the temple area (marked as dotted area in the ùawing)"-a motion that is more limited than scanning "across a forehead." Exergen's insistence on the sufficiency of merely crossing the temporal artery, including its criticism of SAAT's alleged "word-sniff,rng," is an argument sounding in the doctrine ofequivalents-a doctrine "designed to do equity" and "to relieve an inventor from a semantic strait jacket," Perkin-Elmer Corp. v. Westinshouse El e c. C orp.. 822 F .2d 1 528. 1532 (F ed.Ctr.l987), but jury could have found that a purchaser of SAAT's thermometers, who actually followed the accompanying instructions, would have performed the steps recited in claim 1, we reverse the jury's frnding that SAAT actively induced infringement of this claim. Because no reasonable 2. Claim2T t14l Claim 27 recites: method of detecting human body temperature comprising measuring temperature of the temporal artery through skin. 27. A '685 patent col. 10 11.58-60. SAAT argues that its device does not measure the "temperature of the temporal artery through skin" as recited in the claim but measures only the surface temperature of the skin that covers the temporal artery. It is undisputed that ambient air causes the skin to be at a lower temperature than the temporal artery. SAAT's device then converts this skin temperature measurement to oral temperature, which again is different from the temperature of the temporal artery. one which Exergen expressly waived before trial. Under a theory of literal infringement, to which Exergen was limited, no reasonable jury could have found that scanning within an oval pattern in the temple region on one side of the forehead meets the literal requirement of scanning "across a forehead." Exergen also points SAAT's president, Mr. Gerlitz, who described the operation of the accused thermometer as follows: "when it shows 'ready ,' yotJ can go to the temple and start to go from the left side of the left eyeball to the right side of the to the testimony of *9 Exergen responds, citing portions of Dr. Pompei's testimony, ostensibly for the proposition that "sensing the temperature of the forehead in the temple area right eyeball." J.A. 7360 (54:14-16 (emphasis as defendants' instructions direct will necessarily measure the temperature of the temporal artery." Pl.Cross Appellant's Br. 45 (citing 1.A.6417-19 (66:6- @ 2009 Thomson Reuters. No Claim to Orig. US Gov. Works. Page 14 --- F.3d ----,2009 WL2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) 68 : I 9), 6420-22 (69 :13 -7 l:14)). uitable conduct with particularity under Rule 9(b). On appeal, SAAT focuses only on its allegations concerning the '685 patent. Exergen overstates the record.w All that Dr. Pompei said in his testimony was that a user scanning within the temple area would necessarily scan over the temporal artery. J.A.6417 (66:21 ("it's scanning over the temporal artery")), 6418 (67:18-20 ("the infrared detector ... is scanned across the temporal artery")), 6419 (68:6-7 ("it crosses over the temporal artery")), 6421(70:21-22 ("iÍ's right at the location of the temporal artery")), 6422 (71:13-14 ("you'd still cross the temporal artery")). He never equated this act with measuring the temperature of the temporal artery. Nor did he state that the temperature of the skin is the same as the temperature of the temporal artery. To The relevant portion states: of SAAT's proposed pleading 40. The '685 patent is unenforceable due to inequitable conduct by Exergen, its agents and/or attorneys during the prosecution of the application for the' 685 patent before the PTO. *10 41. Prior to the frling of the '685 patent application, Exergen filed a patent application that ulti- the contrary, the specification of the '685 patent, which names Dr. Pompei as the sole inventor, makes clear that skin loses heat to the air as a function of the ambient temperature ("Tu") at the same time that the skin is heated by the core arterial blood supply, such as the blood supply in the temporal artery. '685 patent mately issued as U.S. Patent No. 4.566.808 (hereinafter referred to as "the '808 patent") on January 28, 1986. Thus, Exergen was a\ryare of the'808 patent well before the '685 patent issued on September 18, 2001. The '808 patent was material to the patentability of the '685 patent because it discloses a technique of scanning a radiation detector across a target to measure the maximum emitted radiation, and it is not cumulative to the information already of record in the prosecution history of the'685 patent. col.Zll.14-36; col.7 ll.3-38. Skin temperature ("T,") is expressly distinguished from core temperature ("T""). Id. col.1 11.24-25. The specif,rcation then provides an equation to "calculate core temperature Tc when skin temperature Ts and ambient temperature Tu are known." Id. col.1 11.39-41. Simply put, a measurement of the temperature of the skin is not a measurement of the temperature of the temporal artery beneath the skin. It requires a further computation to arrive at the temperature of the temporal artery, a computation that SAAT's device indisputably does not perform. Thus, a customer using SAAT's device would not have infringed independent claim 27 or its dependent claims 28-30. See Muniauction. Inc. v. Thomson Corp.. 532 F.3d 1318. 1329 n. 5 (Fed.Cir.2008) ("4 conclusion of noninfringement as to the independent claims requires a conclusion of noninfringement as to the dependent 42. In addition, U.S. Patent No. 4.317.998 (hereinafter referred to as "the '998 patent") was cited in a Supplemental Information Disclosure Statement filed by Exergen on October 17,1997 in connection with the prosecution of the '205 patent. Thus, Exergen was aware of the '998 patent well before the '685 patent issued on September 18, 2001. The '998 oatent was material to the patentability of the '685 patent because it discloses a technique of swiping a radiation detector across a target, and it is not cumulative to the information already of record in the prosecution history ofthe'685 patent. 43. Because Exergen was aware of the'808 patent and the '998 patent prior to the issuance of the '685 patent, Exergen had an opportunity to disclose each of these patents to the PTO during the prosecution of the'685 patent. Moreover, because the'808 patent and the '998 patent were material to the patentability of the '685 patent, Exergen had an obligation to disclose each of these patents to the PTO. Nevertheless, Exergen failed to cite either of these patents to the PTO during the prosecution of the claims."). In the absence of direct infringement, SAAT cannot be liable for induced infringement. IV. Inequitable Conduct The district court denied SAAT's motion to add inequitable conduct as an affirmative defense and counterclaim against the '813 and '685 patents, holding that SAAT's proposed pleading failed to allege ineq- @2009 Thomson Reuters. No Claim to Orig. US Gov. Works. Page 15 --- F.3 d - - - -, 2009 WL 23 6653 5 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) '685 patent. SAAT is informed and believes, and therefore alleges, that Exergen, its agents and/or attorneys intentionally withheld the '808 patent and the '998 patent from the PTO with the intent to deceive the PTO to issue the'685 patent. 44. In addition, during the prosecution of the '685 patent application, Exergen made a number of arguments to the PTO to overcome rejections of the pending claims based upon various prior art references related to tympanic temperature detectors. For example, in an Amendment filed on July 31, 2000, the following statements were made to the PTO: omission were made with the intent to deceive the PTO to issue the '685 patent. Answer fll40-46. SAAT argues that its allegations pass muster under the First Circuit's "time, place, and content" test for Rule 9ft) pleadings, citrng McGintv v. Beranger Vollrswagen, Inc.. 633 F.2d 226. 228 (lst Cir.l980\. But see Altern.ative Sys. Concepts, Inc. v. SJ)nops))s. Inc., 37 4 F .3 d 23. 29 ( 1 st Cir.2004) (requiring identification of "the who, what, where, and when of the allegedly false or fraudulent representation"). Conhary to SAAT's suggestion, however, we apply our own law, not the law of the regional circuit, to the question of whether inequitable conduct has been pleaded with particularity under Rule 9(b). See Cent. Admixture. 482 F3d at 1356 (stating that whether inequitable conduct has been adequately pleaded is a question of Federal Circuit law because it "pertains to or is unique to patent law"). F5l116l Rule 9ft) requires that "[i]n all averments of What was nonobvious ... was that reliable temperature measurements could be obtained from the forehead by extending techniques initially developed for the tympanic membrane. What had not been generally appreciated by those skilled in the art of temperature measurement was that the superficial temporal artery ... provides an exceptionally reliable temperature reading. 45. These arguments made to the PTO were contradicted by statements from Exergen's own website, such as the following statement which appeared on the website at the time of the July 31, 2000 Amendment: The temporal artery area has a long history of temperature measurement, dating back to the early centuries before Christ with the first recorded references to palpation of the head for fever assessment. 46. Thus, while Exergen acknowledged on its website that the temporal artery has a long history of temperature measurement, Exergen misrepresented to the PTO that no such history existed and omitted any reference to the website. The misrepresentation and omission were material to the patentabilþ of the ' 685 patent because the information was not cumulative to the information already of record in the prosecution history of the '685 patent, and it refutes, or is inconsistent with, a position taken by Exergen in asserting an argument of pat- *ll or mistake shall be stated with particuladty." "[I]nequitable conduct, while a broader concept than fraud, must be pled with particularity" under Rule !þ). Ferguson Beau regard/Logic Controls. Div. of Dover Resources, Jnc. v. Mega S)ts.. LLC. 350 F.3d 1327. 1344 (Fed.Ctr.2003\. A pleading that simply avers the substantive elements of inequitable conduct, without setting forth the particularized factual bases for the allegation, does not satisfr Rule 9(b).N .See King Auto.. Inc. v. Speedv Mufler King. Inc. 667 F.2d 1008. 1010 (CCPA l98l) ("Rule 9(b) requires that the pleadings contain explicit rather than implied expression of the circumstances constituting fraud."). For example, in a case where inequitable conduct was alleged on the basis that an applicant "failed to disclose all the relevant prior art known to it," we found this allegation deficient because it did not identiff the specific prior art that was allegedly known to the applicant and not disclosed. Cent. Admixture. 482 F.3d at 1356-57 (intemal quotation marks omitted). In that case, the accused infringer also alleged that the applicant "sought to mislead the [PTO] regarding the relationship between the claimed invention and the prior art" "by manipulation of various measurements and units." Id. at 1356 (internal quotation marks omitted). fraud or mistake, the circumstances constituting fraud entability. SAAT is informed and believes, and therefore alleges, that the misrepresentation and @ 2009 Thomson Reuters. No Claim to Orie. US Gov. Works. Page 16 --- F.3d ----, 2009 WL 2366535 (C.A.Fed. (Mass.)) (Cite as: 2009 \üL 2366535 (C.A.Fed. (Mass.))) This pleading, too, was deficient because it failed to identifu "what 'measurements and units' were manipulated, or how that manipulation was meant to mislead the PTO." Id. at 1357 . As the Seventh Circuit has held, the "circumstances" in Rule 9ft) must be at l0 (E.D.Tex. Aug. 14,2000) ("Merely putting the words ... 'inequitable conduct' in a[n] ... Answer will not be sufficient to unleash the mischief' of the defense.). set forth with "particularþ," i.e., they "must be pleaded in detail"r'lt]his means the who, what, when, where, and how" of the alleged fuaud. DiLeo v. Ernst & Young. 901F.2d 624.627 OthCk.l99}),. Based on the foregoing, and following the lead of the Seventh Circuit in fraud cases, we hold that in pleading inequitable conduct in patent cases, Rule 9(b) requires identification of the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO. *12 IITJ Rule 9ft) also states that "[m]alice, intent, knowledge, and other conditions of mind of a person may be averred generally." The relevant "conditions of mind" for inequitable conduct include: (1) knowledge of the withheld material information or of the falsity of the material misrepresentation, and (2) specific intent to deceive the PTO. See Hebert v. Lisle Corp., 99 F.3d 1109. 1116 Ged.Cir.1996); Molins, 48 F.3d at 1181. Although "knowledge" and "intent" may be averred generally, our precedent, like that of several regional circuits, requires that the pleadings allege sufficient underlying facts from which a court may reasonably infer that a pafi acted with the requisite state of mind .N In King Automotive, a trademark registrant filed a petition with the PTO declaring that, to the best of its knowledge, no third party had the right to use the mark "SPEEDY MUFFLER KING" or a confusingly similar mark. 667 F.2d at 1010. A competitor then sought to cancel the mark under $ 38 ofthe Lanham Act alleging, among other things, that the registrant's statement was "known ... to be untrue" and was made with "intent to deceive" the PTO because the registrant had previously obtained a trademark search report showing a third party's use of a confusingly similar mark, namely, "MUFFLER KING." Id. al1009 & n. 3. Our predecessor court, the Court of Customs and Patent Appeals, found this pleading deficient under Rule 9(b). The court held: Even if the disclosures in the trademark search report supported appellant's contention that [the registrantl knew of the alleged third-party use of MUF- FLER KING (and on this point we express no opinion), appellant's conclusory statement that [the registrant] knew its declaration to be untrue is not supported by a pleading of any facts which reflect [the registrant'sl belief that the respective uses of MUFFLER KING and SPEEDY MUFFLER KING would be likely to confuse. *13 Id. at l0ll (emphases added). Thus, the registrant's knowledge of MUFFLER KING, standing alone, was not enough to infer that the registrant also subjectively believed that the mark was confusingly similar ro SPEEDY MUFFLER KING. The pleading thus failed to allege sufñcient underlying facts to support a reasonable inference that the registrant knew its statement to be false or that it intended to deceive the PTO.1d L18ll19]t20] In sum, to plead the "circumstances" of inequitable conduct with the requisite "particularity" under Rule 9(þ), the pleading must identiff the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO. Moreover, although "knowledge" and "intenf' may be averred generally, a pleading of inequi- ln Ferguson Beauregard, an accused infringer al- leged that a patentee had made an aff,trmative misrepresentation to the PTO in a petition under 35 U.S.C. $ 41(c), in which the patentee declared that its late payment of a patent maintenance fee was "unintentional." 350 F.3d at 1343. In its pleadings, the accused infringer averred scienter generally. Id. at 1344 (alleging that the patentee "did not have firsthand knowledge of the facts and ci¡cumstances surrounding the late paymenf' and that the late payment "was not unintentional"). We affirmed the district court's decision to strike the inequitable conduct allegations as failing to provide a factual basis for the assertion that the patentee's late payment was "not unintentional," stating that "we decline to infer facts to support a claim that must be pled with particularity." Id.; Ferguson Beøu regard/Logic Controls Div. of Dover Res., Inc. v. Megø Sys., LLC, No. 99-CV-437, slip op. O 2009 Thomson Reuters. No Claim to Oris. US Gov. Works. Page 17 --- F. 3 d ----, 2009 WL 23 6653 5 (C.A.Fed. (Mass.)) (Cite as: 2009 WL 2366535 (C.A.Fed. (Mass.))) table conduct under Rule 9ft) must include sufftcient allegations of underlying facts from which a court may reasonably infer that a specific individual (l) knew of the withheld material information or of the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO.N the information already of record," Answer nn 4l-42, but does not identiff the particular claim limitations, or combination of claim limitations, that are supposedly absent from the information of record. Such allegations are necessary to explain both "why" the withheld information is material and not cumulative, and "how" an examiner would have used this infor- [2ll Turning now to SAAT's pleading, we agree with the district court that the allegations are deficient with respect to both the particularity of the facts alleged and the reasonableness of the inference of scienter. We begin with the factual deficiencies, of which we note three. mation in assessing the patentabilþ of the claims. See Larson MÍg. Co. v. Aluminart Prods. Ltd., 559 F.3d 1317. 1333 ßed.Cir.2009) (ftnding information cumulative to art of record that taught the "same combination" of claim limitations taught in withheld reference); 37 C.F.R A l.566Xl) (information is material if it "establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim"). l22lFrst, the pleading refers generally to "Exergen, its agents and/or attorneys," Answer'lT'lT 40, 43, but fails to name the specific individual associated with the filing or prosecution of the application issuing as the ' 685 patent, who both knew of the material information and deliberately withheld or misrepresented it. The pleading thus fails to identif, the "who" of the material omissions and misrepresentation. See 37 C.F.R. $ 1.56(a) ("Each individual asso' ciated with the frling and prosecution of a patent application has a duty ofcandor and good faith in dealing with the [PTO] ...." (emphasis added)); id. at Q 1.56(c) (identifring classes of individuals); Manual of Patent Examining Procedures ("MPEP") $ 2001.01 (8th ed., rev.2,Il4ay 2004) (explaining that "the duty applies only to individuals, not to organizations"). Aside from these factual deficiencies, which themselves are fatal under Rule 9(b), the facts that are alleged do not give rise to a reasonable inference of scienter, including both (l) knowledge of the withheld material information or of the falsity of the material misrepresentation, and (2) specific intent to deceive the PTO. t23l With regard to the withheld patent references, the pleading states that "Exergen was aware" of the '808 and'998=p¡fg¡þ in general, and that Exergen had N Second, the pleading fails to identify which claims, and which limitations in those claims, the withheld references are relevant to, and where in those refer- ences the material information is found-i.e., the "whaf' and "where" of the material omissions. See Reeents qf Univ. of Cql. v. Eli Lill), & Co., ll9 F.3d 1559. 1570 (.Fed.Cir.1997) ("Information is material if a reasonable examiner would have considered it important to the patentability of a c

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