*1 military disability death, as a assignment his technician rather than whether it monkeys. likely was more not administering radiation tests to than to have caused disability the the death. This standard best attempted The witnesses estimate implements legislative policy. the I exposure, would extent his radiation offered remand for redetermination on this basis. opinions as to the that various likelihood cancer, rare exposure this led to this such
acknowledged the uncertainties of
views.
If proper legal the standard for deter-
mining connection is whether this service exposure “more than likely
radiation was cancer,
not” have this rare I caused
agree sparse evidence and specu- opinions do not that satisfy
lative medical However, suggest
standard. I that
correct for rare diseases in such standard
situations, application statutory on benefits, policy governing veterans’ is not PRESSURE PRODUCTS MEDICAL preponderance whether evidence es- INC., SUPPLIES, Plaintiff- that likely tablishes causation was more Appellee, not, medically than but whether it is possi- activity ble that the in-service caused appropriate cancer. Such a standard is (doing GREATBATCH LTD. business sufficiently
when the disease is rare Enpath Medical, Inc.), adequate prove data to or disprove causa- Defendant-Appellant. case, tion do not exist. In such when No. 2008-1602. qualified specific witnesses state exposure disease, “possibly” caused the United Appeals, States Court of cause, and no suggests any evidence other Federal Circuit. policy national deeming served burden to have been met. March precedent on which the Board the Veterans Court relied arose dis- from
eases for which there is sufficient medical
knowledge that a likely “more than not” of proof However,
standard is reasonable.
the statute governing veterans’ claims ad-
justs the burdens so that doubt is resolved favor Applying veteran.
guidance to rare diseases where there is experience
insufficient data and to estab-
lish disease, a reliable etiology
reasonable standard is whether the service
activity could “possibly” have caused
13H “ pat- “Lee patent”) (collectively, ents”) invalid, Enpath’s are denied motion leave to amend its answer Because the inequitable assert conduct. support record not does construction, this vacates the finding of infringement district court’s light proceedings for further remands As the rec- claim construction. correct *4 denial of ord the district court’s supports for and leave to Enpath’s motions JMOL answer, this those amend court affirms its denials.
I. Zaitlen, Pillsbury Winthrop H. Richard Supplies, Products Pressure Medical CA, Pittman, LLP, Angeles, of Los Shaw (“Pressure Products”) Inc. exclusive With him on plaintiff-appellee. for argued a of the Lee for medical licensee Lu; and An- were Caroline S. the brief an An intro- device known as introducer. Grossman, Cutler Picker- Wilmer B. drew that permits surgeon a device a ducer is LLP, Angeles, Dorr of Los CA. Hale & ing pacemaker place and remove catheters during surgical leads into blood vessels LLP, Boggs Henry, Patton David G. The introducer has a sheath procedures. TX, Dallas, argued defendant-appel- for includes a valve that often hemostatic were L. him on the brief Chris lant. With regula- in the vein and facilitates remains was Gilbert, Of counsel and Caroline Cook. during operation. tion of flow an blood Washington, DC. Schaengold, J. Michael lead, surgeon After insertion leave, for must the sheath and remove LOURIE, RADER, NEWMAN, Before Be- example, pacemaker place. lead GAJARSA, MOORE, Judges. Circuit over slipped cause sheath cannot be end, the art included pacemaker prior by for the filed Circuit Opinion “peel-away” sheaths. These “splittable” or LOURIE, RADER, Judge in which Judge valve. also included hemostatic sheaths Judge join. MOORE Judge GAJARSA art, however, had no conve- prior dissenting part Opinion concurring along with way nient to remove the valve by Judge Circuit NEWMAN. filed part Thus, any procedure almost sheath. the valve would cause considera- to remove RADER, Judge. Circuit during procedure. a surgical loss ble blood District Court for the States The United way to This devised a remove invention construed the District of Texas Eastern split- valve and sheath both the trial, during line” denied term “score configu- ting process. Figure shows (“Enpath”) motion Medical Ine.’s 3 shows a Figure ration the invention. Judgment a Matter of Law splittable hemostatic valve [14] including (“JMOL”) 5,125,904 [34, splitting separating Nos. means 36] Patent U.S. “ [12], (the 5,312,355 and sheath (the the valve patent”) and *5 pat-
Pressure Products licensed the Lee “means for permitting removal said he- Inventions, Inc., ents from H.L. Medical mostatic valve and sheath introducer from owned the inventor the '904 and '355 disposed said lead catheter there- M.D., patents, Hongpyo Henry Lee, Dr. through without said requiring introducer Then, cardiologist. California Pressure sheath and hemostatic to be valve removed Products sued in the Eastern Dis- from an end of said lead catheter.” Texas, trict alleging Enpath’s that 1.2; patent '904 col.6 patent 1.66-col.7 '355 (“Flow- FlowGuard™ introducer product judge col. 10 11.11-15.The magistrate ruled Guard™”) and its in- prototype ViaSeai™ that “means for removal” permitting called (“ViaSeai™”) product troducer infringe for a claim construction under 35 U.S.C. patents. Enpath Lee and Pressure § paragraph statutory 6. Under completed Products claim construction dis- process for construing functional claim covery briefing by July 2007. The terms, magistrate judge determined magistrate judge held a Markman hearing that the structure in the specification 15, 2007, on August and entered a Mark- corresponds to the claimed function is man order on March 19, 2008, three about “score lines defined in the hemostatic valve months before trial. sheath, equivalents and introducer
Claim 1 of of the each '904 and '355 thereof.”1 term “score line” is recit- limitation: disputed recites the dependent through ed in claims 4 8 of the structure, i.e., Although independent appears patent specific claim 1 '355 to recite not further de- magistrate judge did any independent not in but line.” fine the term “score ar- parties’ considering the After claims. dictionary defini- relying on
guments FlowGuard™ Enpath’s Depictions “score judge introducers, defined tion, poly- made of and ViaSeai™ line(s) (“PTFE”), in the are shown tetrafluoroethylene defined or more “one line” as below. introducer sheath.” valve hemostatic
FlowGuard* *6 Indeed, manufacturing procedure Enpath’s that include a feature These introducers (or proximal at the creating a slit what describes “slit” a “cut” or Enpath calls trial, Pressure During end of the sheath. to as score Products refers Pressure Thomas, Joseph tes- expert, Mr. line) tube or Products’ the PTFE top at the procedure manufacturing tified that The trial for removal. to allow sheath in the device so slit or score placed the testimony Enpath’s that included record could be PTFE tube or sheath removing that splitting facilitates cut or slit to Mr. According apart. or torn tube; few, any, peeled PTFE if very PTFE Thomas, composition the molecular feature. include this did not introducers affects the recited structure permitting removal ment "wherein said means construction, two-part comprises a valve of said hemostatic any argu- body parties did not raise ..the make the sheath split evenly PTFE would inequitable defense of conduct. Enpath trial, along length. its entire premised Also Pres- its motion on allegedly new evi- presented X-rays sure Products of En- dence concerning a declaration submitted path’s during FlowGuard™ ViaSeai™ intro- the reexamination of the pat- ducers indicated sheath ends are ent. The district court denied Enpath’s contrast, cut or scored. In the record motion as untimely. Enpath filed its mo- showed that introducers not made of tion eighteen months after Pressure Prod- require scoring PTFE along the complaint entire ucts filed its and over year one length of the sheath bodies to after permit their filed its answer and counter- splitting even papers Moreover, and removal. In claims. Enpath’s motion came submitted Drug to the Food and ten Adminis- months join after the deadline to addi- tration, Enpath described its tional parties FlowGuard™ original under the scheduling- order, device as having in- eight “[a] scored/splittable months after the deadline troducer sheath.” to amend the pleadings under the amend- scheduling ed order. jury
The trial began on June At close trial, of Pressure proof, Products’ After the district court En- denied court, the district sponte, sua path’s defined JMOL motion that the Lee patents perforation; slit; “score line” as a “linear are invalid and permanently enjoined En- slot; tab; line; severing; path’s weakening; or sales of FlowGuard™ and ViaSeai™ tear partial that can be or complete.” products. court, however, stayed the supplemented its definition injunction sales, as to FlowGuard™ condi- response term Enpath’s cross-exami- tioned Enpath’s on deposit into an escrow nation of Pressure Products’ witnesses account or the court registry of an ongoing- over a two-day period. any royalty. To avoid confusion about the meaning of “score Enpath timely appeals line,” the court supplement decided to judgment, final its construction of *7 definition of that term. In the words of line,” “score and the denial of Enpath’s court, the trial “it seems fairly obvious it’s motions for JMOL and leave to amend its that, fact, something in does need to be answer. This court jurisdiction has over defined because defendants are pushing on 1295(a)(1). this case § under 28 U.S.C.
it.” Enpath initially agreed with the dis- trict court’s decision to supplement the but objected
definition later II. to the amend- ed 12, 2006, construction. On June the This court reviews claim con jury returned a verdict for Pressure Prod- struction without Cybor deference. Corp. ucts, finding that Enpath’s FlowGuard™ Techs., Inc., v. FAS 1448, 138 F.3d 1456 and ViaSeai™ introducers literally infring- (Fed.Cir.1998) (en banc). Claim construc ed the patents. Lee jury The found the tion, though dependent on language the Lee patents valid and infringed and themselves, the claims see v. Phillips awarded million damages. $1.1 The (Fed.Cir. 1303, AWH Corp., 415 F.3d 1314 jury also determined that infringement the 2005) (en banc), requires this court to read was not willful. “in language view of the specification, trial,
Before Enpath had moved for they of which part.” are a Id. at 1315 (internal leave to amend its answer to omitted). assert the quotation marks
1315 15(a) apply to the district will to of Rule guide “single best is the specification (ci- to amend.” Sw. Bell of leave court’s denial Id. term.” disputed meaning of the Paso, 541, 346 F.3d City El Tel. Co. v. omitted). con- should also A court tation Cir.2003). (5th history, id. 546 patent’s prosecution the sider dictionary defini- rely on may at dictionary definition the
tions, long as “so III. found any definition not contradict does trial, During de reading of the by a or ascertained corresponding “score line”—the fined at 1322-23. Id. documents.” limi means-plus-function structure of of a the denial patent. This court reviews 1 the '904 tation in claim of of the the law largely under the term for JMOL court defined district motion Murex Inc. v. Adept, 800 cross-examination of Enpath’s circuit. to response regional (Fed.Cir. Ltd., Sec., Enpath’s F.3d Products’ witnesses. Pressure Ap 2008). Court strategy The United States revealed dis cross examination a dis Fifth reviews Circuit trial court’s definition of the pute over the peals for JMOL of motion denial line” its Markman order. term “score trict Dep’t Tex. v. potential Thomas for sur recognizing without deference. While (5th Justice, adjustment in a late prejudice prise Criminal Cir.2000). Thus, uphold terms, must this court this court also meaning of claim unless jury verdict trial court is in in favor acknowledges JMOL evidentiary legally gamesmanship no sufficient position prevent “there best jury to advantage during [reach a reasonable trial. More unfair basis Group USA Bryant Compass over, that a trial court understands result].” Cir.2005) (5th (citing may more about technolo judge learn 50(a)). necessitates some during the trial that gy Fed.R.Civ.P. terms before the of claim
clarification to amend of a motion The denial Indeed, before the district deliberates. 15(a) procedural is a under Rule a pleading line,” acknowledged it “score court defined law of the by the governed also matter than position in a better that it was Phar Admixture circuit. Cent. regional hearing judge the Markman Servs., Cardiac v. Advanced macy Inc. of sheaths operation due to understand *8 (Fed. 1347, Solutions, P.C., F.3d 1357 482 from both testimony expert to extensive 16(b) Cir.2007). that once a Rule provides parties. entered, “may it has
scheduling order been that the posits with trial cause and only good for modified be its de adjustment prejudiced party judge’s late requires It consent.” judge’s the ability its to re compromised reason fense and cannot that the deadlines show “to sympathetic to somewhat spond. the While diligence of despite the ably be met this court is not general, in those concerns & W the S needing extension.” party Ala., judgment its prepared to substitute Enters., Bank LLC v. Southtrust Cir.2003). judge, who understood (5th the district As that of 533, NA, 535 F.3d 315 beyond the limita context far amendments, the entire party post-deadline to in on review record of the written meeting the tions for not cause good show “must Moreover, proceeding. this standard liberal before the more deadline 1316 case, adjustment early enough
court made the In this magistrate judge de give Enpath opportunity line(s) the trial to an to fined “score line” as “one or more adjust consider the new construction and defined the hemostatic valve and intro arguments change. its to account for the ducer sheath” in dependent the context of Thus, this court does not consider the trial 4 through claims patent. 8 the '904 supplemental definition of a claim words “score line” do not appear inde during present term trial to a fundamental pendent claim 1 of patents. the Lee In procedural jeopardizes jury’s flaw that stead, independent that claim includes a recognized, verdict. As court has this mean-plus-function limitation “means for may engage rolling “district courts in a (i.e., permitting removal” “score lines de construction, claim in which the court re fined the hemostatic valve and introduc interpretation visits and alters its sheath, thereof’). er equivalents claim understanding terms as its of the magistrate judge then determined that the technology Pfizer, evolves.” Inc. v. Teva structure in the specification that corre Pharm., Inc., 1364, 429 F.3d 1377 USA sponded to this functional limitation was a (Fed.Cir.2005); Prods., see also Utah Med. score magistrate line. The judge did not Graphic Inc. v. Corp., Controls 350 F.3d define “score line” in the context of the (Fed.Cir.2003) 1376, (holding 1381-82 structure corresponding to independent the district court did not in amending err 1 claim of the patents. Lee Without during its construction oral argu definition of “score line” in the Markman pretrial nearly ments for motions two order structure, corresponding construction). years original after trial judge observed that proceed the trial Moreover, parties “[w]hen raise an ings jury invited the to define this term on dispute actual regarding proper scope its own in a manner this court ques has claims, court, of these not the jury, Micro, tioned in 1360, F.3d must resolve that dispute.” 02 Micro Instruments, Markman v. Westview Co., Int’l Beyond Ltd. v. Innovation Tech. (Fed.Cir.1995) (en banc), 1351, 1360(Fed.Cir.2008). aff'd, 517 U.S. 116 S.Ct.
Although originally agreeing with the (1996) L.Ed.2d 577 (holding that claim con district supplement court’s decision to its court). struction ais matter of law for the line,” definition of “score Enpath now con- Therefore, the trial court undertook to tends that the district by rely- court erred supplement the Markman order clari ing on 02 Micro for its decision. Accord- fying meaning of “score line” as the ing Enpath, to “the district court inwas no structure corresponding independent way faced with the interpreting the claim 1. ‘means for permitting removal’ or ‘score Although concludes that it was line’ limitations because the proper for the trial court supplement judge had already construed those terms.” line,” the definition of “score this court Enpath cites to a non-binding district *9 must now evaluate the merits of Micro, court the trial decision distinguishing 02 as court’s definition of In Qualcomm Inc., well as “score line.” the Corp. Broadcom v. (Fed.Cir.2008). context of corresponding the structure In to both cases, independent the district court claim 1 of supple- patents, declined to the Lee ment the definition of claim the trial court erred in expanding terms that had the defi- already been construed in earlier claim nition of “score line” to include structures construction orders. not disclosed in specifications the to indicate to one skilled in requires sufficient the Section patents.
Lee precise structure of the must be “de- art the means structure corresponding in specification.” recited the Id. specification.” in the scribed testimony essentially His was unrebutted. laundry give a list The Lee If, hand, Id. on the other the title did not patent See '904 col.l art references. prior structure, prior the art the struc- disclose 11.41-61; col.l 11.45-63. The patent prior in the art could not tures reference dis- included the structures trial court to corresponding be a structure the art refer- prior that list of closed within means-plus-function claim element. Id. corresponding structures ences as that (holding properly “the district court including them in its definition by claim 1 [prior held the Dickson article art so, In trial court doing line.” the of “score patent] may place cited the not take the corresponding- impermissibly expanded appear of structure that does not in the 1 to include structures structure of claim specification”). specification. described not judge construed “score Trial courts cannot look to the specification line” consistent with the art, by nothing more than prior identified “one or more lines defined in the hemo- patent, provide in a to valve its title and citation static and introducer sheath.” The means-plus- magistrate judge, citing dictionary, for a a corresponding structure ex- case, In plained function limitation. this these ref that “‘score’ has been to defined scratch, scoring. ‘any alternatives to mean provide groove’ erences line that is many by scoring process.” of the disclosed alterna formed Although The trial court went on to may supplement magis- tives well be determined be struc by equivalents permitted tural section trate’s construction and defined “score lines,” question of fact for the the structure for paragraph permitting 6—a remov- al, slit; slot; tab; split perforation; alternative methods of as “linear —these line; ting peeling severing; weakening; cannot be treated as the or tear that partial or complete.” disclosed structures removal can be Simply mentioning prior art refer means. argues Pressure Products that the trial patent ences does not suffice as correctly court construed the term “score specification description give paten according lines” to the doctrine of claim outright claim to all of the structures tee differentiation. Claim 1 claims “means for in those references. disclosed permitting removal of said hemostatic Devices, Corp. Storage In Atmel valve and introducer sheath.” Claims 4 Info. (Fed.Cir.1999), through 8 of the '904 claim “a score concept to utilize the line defined in said this court refused hemostatic valve and permit- reference to include a introduce sheath” as the means for incorporation such, prior correspond- ting structure in the art as removal. As Pressure Products ing means-plus-function argues means-plus-function structure for a ele- Atmel, encompass In ment of claim 1 must claim element. held struc- lines, namely, art reference could tures other than score those prior that the title of mean-plus-func- prior for a structures disclosed in the art refer- provide the structure expert, patent. argu- “Atmel’s ences mentioned This tion element because Cal- *10 fails, however, lahan, means-plus- because a testified that this title alone was ment already appropriate includes low measures to also ascertain function claim element corresponding equivalents express than the the structural of the structures other speci- specification correspond- described in the structure explicitly structure fication, namely, equivalents ing of the corre- to the claimed function. §
sponding structure. See 35 U.S.C. ¶ Therefore, means-plus-function as the IV. claim 1 includes the element of lines, The court equivalents Enpath’s of score district denied not judge’s invalidity claim construction does violate JMOL motion for of the Lee the doctrine of claim differentiation. patents. Enpath presented asserts it clear convincing evidence that Haindl’s Ger expressly not specification The does de- (“the man Patent Number 3834600 Haindl of a cut or a slit a tear for scribe use patent”) anticipates '600 and renders obvi specification explains, removal. The “[t]he patents. ous the Lee It further asserts comprises pair score line of lines defined that Pressure Products did not overcome in the hemostatic valve and introducer prima invalidity. its facie case sheath; pair of score lines are dia- metrically opposed from each other on the anticipation, To demonstrate En- hemostatic valve and introducer sheath.” witness, Podet, path’s expert Dr. Ethan patent patent '904 col.3 11.14-18.The fur- provided for the claim construction explains, ther “score lines 34 and 36 are comparing every charts element of the having V-shaped shown as cross section claims at issue to the patent. Haindl '600 a shape depth but have such as to witness, expert Pressure Products’ Dr. Eli permit length the entire of introducer Gang, rebutted Dr. testimony by Podet’s manually separated.” sheath 10 to be Id. testifying that patent the Haindl '600 does recognizes col.6 11.7-10.The specification suggest not teach or a critical component difference between score lines and slots. i.e., patents, Lee the combination of (“However, entirely Id. col.6 11.28-32 it is splittable both a hemostatic valve possible that score lines 34 and 36 will be splittable Gang introducer sheath. Dr. through flanges continued and 40 also examined each of the prior other art provide deep open scores instead slots references cited in Dr. expert Podet’s re added)). (emphasis and 46.” port gave why they reasons did not
The trial erroneously used struc- anticipation show or obviousness. Antici prior tures from the art pation requires references listed “a single prior art refer patent in the provide a definition for every ence discloses each and [that] limita score encompassing lines structures not tion of the claimed invention.” Schering expressly Pharm., disclosed in the patent specifica- Corp. v. Geneva such, (Fed.Cir.2003). tion. As Moreover, this court detects error in the Pat (“PTO”) the trial court’s definition. Score lines are ent and Trademark Office exam “one or more lines defined in the hemo- ined the Haindl '600 during twice static valve sup- and introducer sheath” as the examination and re-examination of the ported specification. PTO, patent. nevertheless, This court al remands for proceedings light further patent, instilling lowed the '904 the statu the proper tory construction of the term presumption validity “score into the Lee lines.” Those proceedings patents. further will al-
1319 testi- Dr. Podet’s obviousness To rebut V. Dr. Hans-
mony, Pressure Products used Enpath’s The district court denied during filed Haindl’s declaration Guenter motion for leave to amend its answer to In patent. of the '904 the reexamination the defense of inequitable assert conduct. declaration, Dr. Haindl states that his Enpath based its defense on a November invention, patent, lacks a the Haindl '600 5, Kontos, 2007 declaration of Mr. Steven hemostatic, valve as claimed splittable engineer designer biomedical cathe patents. Dr. Haindl’s the '904 and '355 ters and devices used with catheters. Mr. that the Haindl '600 declaration also states Kontos stated his declaration that al “enabling dis- does not include an though recognized signature, he his he did splittable assembly. of a closure” signing not remember two 1995 declara supporting patentee during tions re Furthermore, Pressure Products patent. examination of the Enpath of non-obvious secondary offered evidence contends the district court’s denial was an including evidence of commercial suc ness abuse of discretion. need, cess, long skepticism experts, felt unexpected results of the commercial Two different exist for the standards patents. of the Lee This embodiment denial of a motion for leave to amend the explained, sec repeatedly [that court “has pleadings. rigid The more standard of ondary just is not evidence] consideration 16(b) applicable Rule to motions filed confirmatory of the part a cumulative or after a scheduling order deadline has ex- obviousness calculus but constitutes inde pired requires showing of good pendent evidence of nonobviousness.” Or cause to file outside the deadline. See S & Labs., Pharm., Mylan Inc. v. tho-McNeil Enters., v. W L.L.C. Southtrust Bank of (Fed.Gir.2008). 1358, 520 F.3d 1365 Ala., NA, (5th 533, Cir.2003). skepticism experts In terms of the the more standard of Under liberal Rule results, unexpected the record confirms 15(a), grant the trial court should leave to ini companies that other medical device denial, file absent substantial reason li tially opportunity turned down the faith, delay, dilatory undue bad such as they because did not cense the Lee motive, repeated failure to cure deficien- work. believe that the invention would amendments, futility cies with other any did not offer evidence Enpath amendment, prejudice op- or undue to the challenged Pressure Products’ rebutted Davis, posing party. See Foman secondary evidence of non-obviousness. 182, 227, 178, 83 S.Ct. 9 L.Ed.2d U.S. (1962); Stripling see also v. Jordan Prod. sum, ample In the trial record shows Co., LLC, (5th 872-73 Cir. jury’s support judgment for the 2000) (“[Rule 15(a) evinces a bias in favor ] invention would not have been an- claimed amend.”). granting leave to by prior obvious art ticipated or rendered 15(a) Enpath at the time of invention. has not applies contends that Rule jury’s shown that verdict on these the district court set a this case because in- points Pleadings” was unreasonable or based on “Final Amended deadline of plaintiff evidence. Because substantial 2007 for the but not for April substantial verdict, jury’s scheduling The district court’s supports Enpath. evidence April En- further set a deadline of denying district court did not err order “Respond Pleadings” to Amended invalidity. on path’s motion JMOL *12 1320 Moreover, explicit patent. an deadline to file sued the '904 Enpath
but did not set pleadings. copy patent’s to amend the received of the '904 file motions leave 16, Thus, wrapper early January as as Enpath when filed its motion on 2007. 7, 2007, Nothing prevented Enpath from scheduling no order conduct- December ing discovery on the two 1995 Kontos dec- passed applied Enpath. had as deadline shortly larations However, following this date. Ac- even under more liberal cordingly, Enpath because 15(a), has not met its standard of Rule leave to amend is high showing burden of Frazier, district not automatic. See Parish v. 195 court abused its discretion in En- (5th Cir.1999); denying 761, F.3d 763 Avatar Ex path’s motions for leave to an- Chevron, U.S.A., amend its Inc., ploration, Inc. swer, this court affirms the district court’s (5th Cir.1991). 314, 933 F.2d 320
denial.
Prejudice “touchstone of the Since the trial ruling on 15(a).” inquiry under rule Lone Star La amend, this motion to this court has issued Schlotzsky’s dies Invest. Club v. 238 significant opinions requiring specific and (5th Cir.2001). 363, Thus, preju F.3d demanding showings of evidence before nonmoving party may dice to the be suffi party may assert the inequita defense of deny May cient to leave to amend. See See, ble conduct. e.g., Scientific, Star Inc. Co., eaux v. La. Health Servs. & Indem. Co., Reynolds v. R.J. Tobacco (5th Cir.2004) 420, (denying (“We 1357, (Fed.Cir.2008) review the motion amend a pleading that would inequitable district court’s conduct deter fundamentally have altered the nature standard; mination under a two-tier we imposed discovery the ease and additional underlying review the factual determina requirements prejudice and undue on the error, tions for clear but we review the nonmoving party). ultimate inequitable decision as to conduct Enpath raised its inequitable conduct discretion.”). Moreover, for an abuse of defense two motions on November proving inequitable The burden of con- 2007 and plead December To duct infringer lies with the accused .... inequitable conduct particularity with successfully prove To inequitable con- required 9(b), under Rule Enpath contends duct, the accused infringer present must that it could not file these motions until it (1) “evidence that applicant made an received the November 2007 Kontos affirmative misrepresentation of materi- declaration. The district court reasoned fact, al failed to disclose material infor- that allowing Enpath to plead- amend its mation, or submitted false material in- ings certainly” “almost would have result- (2) formation, and intended to deceive delay “very ed undue and would have Further, ... [PTO].” least likely” prejudice resulted in undue to Pres- i.e., threshold level of each element — sure Products. materiality both and intent to deceive- The district court also considered the proven by must be clear and convincing length of time that the Kontos declarations evidence.... if And even this elevated were available to bringing before evidentiary burden is met as to both its motions to elements, amend. The 1995 declara- the district court must still tions publicly were available at least since equities balance the to determine wheth- 19, 1996, November the date the PTO reis- er applicant’s conduct before the NEWMAN, enough Judge, concurring to warrant Circuit egregious was PTO dissenting part. the entire unenforcea- holding part, Thus, if a threshold level ble.... even *13 join I the court’s affirmance of the dis- and intent to deceive materiality both judgment trict court’s on the issues of convincing and evi- proven by are clear validity inequitable and conduct. Howev- dence, may still decline to the court er, I affirm judg- would also the court’s unenforceable. render the ment on of infringement, the issue for (internal omitted); see also Id. citations error has not been shown in the reversible Stores, Inc., Exergen Corp. v. Wal-Mart construction, district court’s claim and the (Fed.Cir.2009) n. 5 jury’s by verdict is supported substantial (“Whereas deceptive an inference of intent evidence. and drawn from a must be reasonable underlying fact to The claim clause at issue pleading’s allegations is means- 9(b), clause, inference must be satisfy Rule this plus-function presented in both single ‘the most reasonable able 5,125,904 5,312,355, U.S. Patent Nos. and inference drawn from the evidence to meet the to be patents starting claim of both with the ” (emphasis standard.’ convincing clear and clauses, same as follows: omitted)). added, internal citations A assembly sheath for with use eases, on this court doubts Based these comprising: lead or catheter an intro- motion amend would even satis- to sheath; ducer in- fy higher proof these standards of coupled hemostatic valve to said intro- in place. voke the doctrine the first These sheath, ducer said hemostatic valve and support further the trial subsequent cases being arranged introducer sheath deny motion to court’s action to configured permit introduction of at amend. lead or therethrough; least one catheter permitting removal of means said VI. hemostatic valve and introducer sheath Because the district court erred in- disposed from said lead or catheter in cluding structures not described therethrough in- requiring without said specification in the definition of the corre- troducer sheath and hemostatic valve to sponding means-plus-func- structure to the be removed from an end of said lead or element, claim court tion this vacates catheter, ... infringe- for a remands determination judge construed the using ment the correct construction. permitting “means for removal” as supports the Because the record district line,” primary “score which is the struc- Enpath’s motions for court’s denial of in specification, ture shown answer, JMOL and leave to amend its dictionary adopted the definition of “score” affirms those denials. “ scratch, line, ‘any groove’ as or that is AFFIRMED-IN-PART, REVERSED- scoring process,” formed in the from the IN-PART, AND REMANDED Dictionary Academic Press: Science (1992). Technology COSTS presentation plaintiffs After case chief, the district court further con- party Each shall bear its own costs. The district court construed the “means clause means-plus-function strued the removal” clause with refer- permitting manifest that became view of the debate patents’ specifications to the and the and cross-examination ence the examination witnesses, for, specifications. the district court art cited in the prior “fairly some- observed, prior obvious it’s state that “the art has de- it was fact, that, away need to be defined thing splittable peel does vised a number of it. pushing are on defendants so that it because sheaths. The sheath is scored agree with gather I defendants by splitting peeling And would it off withdrawn analysis. Is that correct?” Counsel pat- catheter.” pacemaker from *14 defendant, responded: Enpath, 11.41-44; for the patent col.l 11.45- ent col.l '335 “Yes, My A3769. col- your Honor.” patents way also state that the the 48. The panel this confirm this leagues on implemented is or the splittable structure by judge the additional claim construction peel-away feature is realized is not critical construction is a appropriate. was Claim to the invention: law, it and is essential matter of by nature which such detailed [T]he law, correctly instructed on the jury be is or splittable implemented structure entire trial be tainted. See 02 lest the peel-away how feature is realized is [the] Beyond Micro Int’l Ltd. v. Innovation Any not critical to the invention. meth- (Fed. 1360, Co., 1351, F.3d 1362 Tech. 521 by od now known or later devised which Cir.2008) (“When parties the raise an actu- such sheaths 12 and valve assemblies 14 regarding proper scope the dispute al may split separated may be or be em- claims, court, jury, not these the the must contemplated being are ployed and as dispute.... is the court’s [I]t resolve the scope within the of the invention. it.”). procedure duty to resolve This is not in explained Pfizer, unusual. As this court 11.59-66; patent patent '904 col.5 '355 col.7 Pharmaceuticals, v. Teva Inc. USA patents 11.37-44.Both the '904 and the '355 (Fed.Cir.2005), “dis- F.3d prior publications showing sep- cite various may engage rolling trict courts in a claim methods, aration as included the court’s construction, the court which revisits in- Referring claim construction. to this interpretation of claim and alters its the trial, at testimony formation and the the understanding of the terms as its technolo- for district court construed the “means gy evolves.” permitting removal the valve and [of slit, slot, perforation, as “linear sheath]” statute, provided by means-plus-func- As tab, line, severing, weakening, or tear that claim in light tion terms are construed partial complete.” can or This elabo- be specifica- the structures described the presented, rated claim construction was equivalents tion thereof: and quoting majority opinion, any the “to avoid ¶ § 112 An in a 6. element claim for a meaning confusion about the of ‘score may expressed combination be as a ” Maj. My colleagues atOp. line.’ step performing specified means or assign procedure. no error to this structure, function without the recital of incorporated The references were material, thereof, in support or acts art, prior the not to define what was show such shall be construed to cover structure, material, splitting separation of the new. corresponding new; in the sheath was not what was what was specification acts described with removal of equivalents thereof. new was the combination of law was the split- responsibility valve. Thus struction the hemostatic jury. not plastic, judge, the cited references ting of ways various in which that had showed majority opinion states that Atmel and the past, done been Devices, Inc., Corp. Storage v. Information now known or “any stated that method (Fed.Cir.1999) prohib- 12 and later devised which such sheaths a patentee relying “incorpo- its from on an may split sepa- assemblies 14 be valve correspond- rated” reference to describe a may employed be and are contem- rated ¶ ing § structure under 6. That an scope plated being within Atmel, In generalization. incorrect 11.62-66; invention.” '904 eol.5 flaw was that no structure all was de- patent col.711.41-44. perform scribed to the claimed function reference, My colleagues apart incorporated rule that from the ignored description solely court should have these cited ref- could not come erences, recognized incorporated not have from the and should reference. See id. *15 ¶ (“Fulfillment titles, content, 112, § in or even their con- at 1382 their 6 of the claim. tradeoff cannot struing portion the “means” be satisfied when there is a objection was not raised to total omission of structure. There Although this must court, in my colleagues specification.”). now deem be structure the How- the district ever, to have considered that is far from it to be reversible error removed the situa- Littleford, references, patents fully which include tion here. The '904 and '355 that “Split perform Sleeve Introducers for Pacemaker describe structures Like,” Pat. claimed function Electrodes and the U.S. No. of removal of the valve Osborne, sheath, 4,243,050 (1981); Apart describing splittable “Tear sheaths of Cannula,” 31,955 (1985); forms, explaining RE various U.S. Pat. No. that there ah, many ways splitting peel- Boarini et “Peelable Catheter with Se- are known Sleeve,” eming Ring ing plastic. and Suture U.S. Pat. Moorehead, 4,411,654 (1983); and No. prohibits No blanket rule reliance on Layered Away “Medical Peel Sheath prior art for information. known Prece- (1991).
Methods,”
4,983,168
Pat. No.
U.S.
contrary.
dent is
See Telemac Cellular
Telecom, Inc.,
Corp.
Topp
It cannot be error for the district court
v.
247 F.3d
(Fed.Cir.2001) (“When
a
recognized
splittable
to have
that
sheaths
1329
docu-
known,
‘incorporated by
well
and to have construed ment is
reference’ into a
were
document,
permitting
patent,
the “means for
removal” clause host
such as a
the refer-
light
knowledge.
only
effectively part
in
of this
error
enced document becomes
if it
my colleagues
explicitly
that
ascribe to the district
of the host document as
were
therein.”).
expedient
claim
is that the court
contained
This
is not
construction
limitations,
pri-
logical
incorporat-
but
equivalent
included
structure from the
without
it
specifications
or art set forth in the
ed material is viewed as would be treat-
witnesses,
testimony
by
person experienced
out in
ed
in the field of
brought
Desiccants,
solely
dictionary
the invention.
relying
instead of
on
See Multiform
Medzam, Ltd.,
No
been ascribed to Inc. v.
definition.
flaw has
(Fed.Cir.1998) (“It
explain
person
court’s action to
to the
is the
of ordi-
nary
in
skill in the field of the invention
jury what is included
the “means
clause,
through
eyes
for this con-
whose
the claims are con-
permitting removal”
strued.”).
verdict,
incorporated by
magistrate judge’s
Information is
whether on the
construction,
specifications
into
for var-
initial claim
or on the district
reference
may
information
purposes, and known
court’s elaborated
construction.
ious
reference,
by
usefully
incorporated
be
Enpath
argued
has not
that there was
known structures
are known
illustrate
infringement
not substantial evidence of
on
to those in the
equivalents
alternatives or
magistrate judge’s
definition
“score”
This enables
to re-
specification.
“ ‘scratch,
line
groove’
is
new,
of what
main concise statements
is
Indeed,
by
scoring process.”
formed
repetitions of what is al-
not cumbersome
why general
one wonders
definition in a
ready
readily provided by ref-
known and
dictionary
preferable
to the definitions
Howarth,
In re
erence.
specific technological references
(CCPA 1981) (“[A]n
applicant may,
specification.
Phillips
While this court
economy of time and space,
interests of
(Fed.Cir.
Corp.,
v. AWH
set thereof, drawing subject on the mat-
lents speci- reference incorporated
ter
fication, evidence at trial. and on the flaw, harmful procedural nor er-
Neither
ror, Respectfully, I dis- has been shown.
sent. BIOCHEM, INC., Life
ENZO Enzo
Sciences, University, and Yale
Plaintiffs-Appellants, Tropix, Inc.,
APPLERA CORP.
Defendants-Appellees.
No. 2009-1281. Appeals, Court of
United States
Federal Circuit.
March