## United States Court of Appeals for the Federal Circuit

2008-1602 PRESSURE PRODUCTS ME DICAL SUPPLIES, INC., Plaintiff-Appellee,

v. GREATBATCH LTD. (doing business as Enpath Medical, Inc.) Defendant-Appellant.

Richard H. Zaitlen , Pillsbury Winthrop Shaw Pittman, LLP, of Los Angeles, California, argued for plaintiff-appell ee. With him on the brief were Caroline S. Lu ; and Andrew B. Grossman , Wilmer Cutler Pickering Ha le & Dorr LLP, of Los Angeles, California. David G. Henry , Patton Boggs LLP, of Dallas, Texas, argued for defendantappellant. With him on the brief were Chris L. Gilbert , and Carolina Cook . Of counsel was Michael J. Schaengold , of Washington, DC. Appealed from: United States District C ourt for the Eastern District of Texas Judge Ron Clark

## United States Court of Appeals for the Federal Circuit

2008-1602 PRESSURE PRODUCTS ME DICAL SUPPLIES, INC., Plaintiff-Appellee,

v. GREATBATCH LTD. (doing business as Enpath Medical, Inc.) Defendant-Appellant.

__________________ _________ DECIDED: March 24, 2010

__________________ _________ Appeal from the United States Dis trict Court for the Eastern Dis trict of Texas in case no. 9:06-CV-121, Judge Ron Clark. Before NEWMAN, LOURIE, RA DER, GAJARSA, and MOORE, Circuit Judges

. Opinion for the court filed by Circuit Judge RADER, in which Judge Lourie, Judge Gajarsa and Judge Moore join. Opinion concu rring in part and dissenting in part filed by Circuit Judge Newman. RADER, Circuit Judge

. The United States District Court for t he Eastern District of Texas construed the claim term “score line” during trial, denied Enpath Medical Inc.’s (“Enpath”) motion for Judgment as a Matter of Law (“JMOL”) that U.S. Pat ent Nos. 5,125,904 (the “’904 patent”) and 5,312,355 (the “’355 patent”) (collectively, the “Lee patents”) are invalid, and denied Enpath’s motion for leave to amend its answer to assert inequitable conduct. Because the record does not support the district court’s claim construction, this court vacates the district court’s findi ng of infringement and remands for furtherproceedings in light of the correct claim construction. As the record supports the district court’s denial of Enpath’s motions for JMOLand leave to amend its answer, this court affirms those denials. I. Pressure Products Medical Supplies, Inc. (“Pressure Products”) is the exclusive licensee of the Lee patents for a medical device known as an introducer. An introducer is a device that permits a surgeon to plac e and remove catheters or pacemaker leads into blood vessels during surgical procedures . The introducer has a sheath that often includes a hemostatic valve that remains in the vein and facilitates regulation of blood flow during an operation. After insertion of the lead, the surgeon must remove the sheath and leave, for example, a pacemaker lead in place. Because the sheath cannot be slipped over the pacemaker end, the prior art included “s plittable” or “peel-away” sheaths. These sheaths also in cluded a hemostatic valve. The prior art, however, had no convenient way to remove the valve along with the sheath. Thus, almost any procedure to remove the valve woul d cause considerable blood loss during a surgical procedure. This invention de vised a way to remove both the valve and the sheath by a splitting proce ss. Figure 1 shows the configuration of the invention. Figure 3 shows a splittable hemostatic valve [14] including a means [34, 36] for splitting or separating the valve and sheath [12].

2008-1602 2Pressure Products licensed the Lee patents from H. L. Medical Inventions, Inc., owned by the inventor of t he ’904 and ’355 patents, Dr. Hongpyo Henry Lee, M.D., a California cardiologist. Then, Pressure Pro ducts sued Enpath in t he Eastern District of Texas, alleging that Enpath’ s FlowGuardTM introducer product (“FlowGuardTM”) and its ViaSealTM prototype introducerproduct (“ViaSealTM”) infringe the Lee patents. Enpath and Pressure Products completed claim construc tion discovery and briefing by July 27, 2007. The magistrate judge held a Markman hearing on August 15, 2007, and entered

a Markman order on March 19, 2008, about th ree months before trial. Claim 1 of each of the ’ 904 and ’355 patents recites the disputed limitation: “means for permitting removal of said hemosta tic valve and introducer sheath from said lead or catheter disposed therethrough without requiring sa id introducer sheath and hemostatic valve to be removed from an end of said lead or catheter.” ’904 patent col.6 l.66–col.7 l.2; ’355 patent col.10 ll.11–15. The magistrate judge ruled that “means for permitting removal” called for a claim construc tion under 35 U.S.C. § 112, paragraph 6. Under that statutory process for construing functional claim terms, the magistrate judge determined that the structur e in the specification that corresponds to the claimed

2008-1602 3function is “score lines defined in the he mostatic valve and introducer sheath, and equivalents thereof.” 1 The term “score line” is reci ted in dependent claims 4 through 8 of the ’904 patent but not in any independent claims. After considering the parties’ arguments and relying on a dicti onary definition, the magist rate judge defined “score line” as “one or more line( s) defined in the hemostatic valve and introducer sheath.” The magistrate judge did not furtherdefine the term “score line.” Depictions of Enpath’s FlowGuardTM and ViaSealTM introducers, made of polytetrafluoroethylene (“PTFE”), are shown below.

1 Although independent claim 1 of the ’355 patent appears to recite specific structure, i.e. , “wherein said means for permitting removal of said hemostatic valve co mprises a two-part body . . . ,” the parties did not raise any argument that the recited st ructure affects the claim construction.

2008-1602 4These introducers include a fe ature that Enpath calls a “cut” or “slit” (or what Pressure Products refers to as a score line) at the top of the PTFE tube or sheath to allow for removal. The trial record included te stimony that Enpath’s cut or slit facilitates splitting and removing the PTFE tube; very fe w, if any, PTFE intr oducers did not include this feature. Indeed, Enpath’s manufacturing procedure describes cr eating a slit at the proximal end of the sheath. During trial, Pressure Products’ expert, Mr. Joseph Thomas, testified that this manufacturing proc edure placed the slit or score in the device so that the PTFE tube or sheath could be peeled or torn apart. According to Mr. Thomas, the molecular composition of the PTFE would make the sheath split evenly along its entire length. Also at trial, Pressure Products presented X-rays of Enpath’s FlowGuardTM and ViaSealTM introducers that indicated the sheath ends are cut or scored. In contrast, the record showed th at introducers not made of PTFE require scoring along the entire length of the sheat h bodies to permit their even splitting and removal. In papers submitted to the Food and Drug Administration, Enpath described its FlowGuardTM device as having “[a] sco red/splittable introducer sheath.” The jury trial began on June 6, 2008. At the close of Pressure Products’ proof, the district court, sua sponte , defined “score line” as a “linear perforati on; slit; slot; tab; line; severing; weakening; or tear that can be partial or complete.” The court supplemented its definition of the term in response to Enpath’s cross-examination of Pressure Products’ witnesses over a two-day period. To avoid any jury confusion about the meaning of “score line,” the court decided to supplement the definit ion of that term. In the words of the trial court, “it seems fairly obvious it’s somethi ng that, in fact, does need to be defined because defendants are pushing on it.” Enpath init ially agreed with

2008-1602 5the district court’s decision to supplemen t the definition but later objected to the amended construction. On June 12, 2006, t he jury returned a verdict for Pressure Products, finding that Enpath’s FlowGuar dTM and ViaSealTM introducers literally infringed the Lee patents. The jury f ound the Lee patents valid and infringed and awarded $1.1 million in damages. The jury also determined that the infringement was not willful. Before trial, Enpath had moved for l eave to amend its answer to assert the defense of inequitable conduct. Enpath premised its motion on allegedly new evidence concerning a declaration submitted during the reexamination of the ’904 patent. The district court denied Enpath’s motion as untim ely. Enpath filed it s motion eighteen months after Pressure Products filed its comp laint and over one year after Enpath filed its answer and counterclaims. Moreover, E npath’s motion came ten months after the deadline to join additional parties under the original scheduling order, and eight months after the deadline to amend the pleadings under the amended scheduli ng order. After trial, the district court denied Enpath’s JMOL motion that the Lee patents are invalid and permanently enjoined Enpath’s sales of FlowGuardTM and ViaSealTM products. The court, however, stayed the in junction as to FlowGuardTM sales, conditioned on Enpath’s deposit into an escrow account or the cour t registry of an ongoing royalty. Enpath timely appeals the dist rict court’s final judgment, its construction of “score line,” and the denial of Enpath’s motions for JMOL and leave to amend its answer. This court has jurisdiction over this case under 28 U.S.C. § 1295(a)(1).

2008-1602 6II. This court reviews claim cons truction without deference. Cybor Corp. v. FAS Techs., Inc. , 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc). Claim construction, though dependent on the language of the claims themselves, see Phillips v. AWH Corp. , 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc), requires this court to read that language “in view of the specificati on, of which they are a part.” Id. at 1315 (internal quotation marks omitted). The s pecification is the “single bes t guide to the meaning of a disputed term.” Id. (citation omitted). A court s hould also consider the patent’s prosecution history, id. at 1317, and may rely on dictionary definitions, “so long as the dictionary definition d oes not contradict any definitio n found in or ascertained by a reading of the patent documents.” Id. at 1322–23. This court reviews the denial of a motion for JMOL under the law of the regional circuit. 800 Adept, Inc. v. Murex Sec., Ltd. , 539 F.3d 1354, 1366 (F ed. Cir. 2008). The United States Court of Appeals for the Fifth Circuit revi ews a district court’s denial of a motion for JMOL without deference. Thomas v. Tex. Dep’t of Criminal Justice , 220 F.3d 389, 392 (5th Cir. 2000). Thus, this court must uphold a JMOL in favor of the jury verdict unless “there is no legally sufficient evidentiary basis for a reasonable jury to [reach that result].” Bryant v. Compass Group USA Inc. , 413 F.3d 471 (5th Cir. 2005) (citing Fed. R. Civ . P. 50(a)). The denial of a motion to amend a plead ing under Rule 15(a) is a procedural matter also governed by the la w of the regional circuit. Cent. Admixture Pharmacy Servs., Inc. v. Advanced Cardiac Solutions, P.C. , 482 F.3d 1347, 1357 (Fed. Cir. 2007). Rule 16(b) provides that onc e a scheduling order has been ent ered, it “may be modified

2008-1602 7only for good cause and with the judge’s consen t.” It requires a party “to show that the deadlines cannot reasonably be met despite the diligence of the party needing the extension.” S&W Enters., LLC v. Southtrust Bank of Ala., NA , 315 F.3d 533, 535 (5th Cir. 2003). As to post-deadline amendments, a party “must show good cause for not meeting the deadline before the more liberal standard of Rule 15(a ) will apply to the district court’s denial of leave to amend.” Sw. Bell Tel. Co. v. City of El Paso , 346 F.3d 541, 546 (5th Cir. 2003). III. During trial, the district court defined “ score line”— the corresponding structure of the means-plus-function limitation in claim 1 of the ’904 patent. The district court defined the term largely in response to Enpath’s cross- examination of Pressure Products’ witnesses. Enpath’s cross examination strategy revealed a dispute over the trial court’s definition of t he term “score line” in its Markman order. While recognizing the potential for surprise and prejudice in a late adjustment to the meaning of claim terms, this court also acknowledges that the tr ial court is in the best position to prevent gamesmanship and unfair advant age during trial. Moreover, this court understands that a trial judge may learn more about the te chnology during the trial that necessitates some clarification of claim terms before the ju ry deliberates. Indeed, before the district court defined “score line,” it acknowledged that it was in a better position than the magistrate judge at the Markman hearing to understand the oper ation of sheaths due to extensive expert testimony from both parties. Enpath posits that the tria l judge’s late adjustment prejudiced its defense and compromised its ability to respond. While so mewhat sympathetic to those concerns in

2008-1602 8general, this court is not prepared to substitute its judgment for that of the district judge, who understood the entire context far beyond t he limitations of the written record on review in this proceeding. Moreover, the district court made the adjustment early enough in the trial to give Enpath an opportuni ty to consider the new construction and adjust its arguments to account for the change. Thus, this court does not consider the trial court’s supplemental definition of a clai m term during trial to present a fundamental procedural flaw that jeopardizes the jury’s verdict. As this court has recognized, “district courts may engage in a rolling claim construction, in which the court revisits and alters its interpretation of the claim terms as it s understanding of the te chnology evolves.” Pfizer, Inc. v. Teva Pharm., USA, Inc. , 429 F.3d 1364, 1377 (Fed. Cir. 2005); see also Utah Med. Prods., Inc. v. Graphic Controls Corp. , 350 F.3d 1376, 1381–82 (Fed. Cir. 2003) (holding that the district court did not err in amending its claim construction during oral arguments for pretrial motions nearly two years after the original construction). Moreover, “[w]hen the parties raise an actual dispute r egarding the proper scope of these claims, the court, not the jury , must resolve that dispute.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co. , 521 F.3d 1351, 1360 (Fed. Cir. 2008). Although originally agreeing with the district court’s decision to supplement its definition of “score line,” Enpat h now contends that the distri ct court erred by relying on O2 Micro for its decision. According to Enpath, “the district court was in no way faced with the jury interpreting the ‘means for permi tting removal’ or ‘sco re line’ limitations because the magistrate judge ha d already construed those terms.” Enpath cites to a non-binding district court decision distinguishing O2 Micro , as well as Broadcom Corp. v. Qualcomm Inc. , 543 F.3d 683, 694 (Fed. Cir. 2008). In both cases, the district court

2008-1602 9declined to supplement the definition of cl aim terms that had al ready been construed in earlier claim construction orders. In this case, the magistrate judge defined “score line” as “one or more line(s) defined in the hemostatic valve and introducersheath” in the context of dependent claims 4 through 8 of the ’904 patent. T he words “score line” do not appear in independent claim 1 of the Lee patents. Instead, that independent claim includes a mean-plus-function limitation “means for permitting removal” (i.e., “score lines defined in the hemostatic valve and introducer sheath, and equivalents thereof”). The magistrate judge then determined that the structure in the specificat ion that corresponded to this functional limitation was a score line. The m agistrate judge did not define “score line” in the context of the structure corresponding to independent claim 1 of the Lee patents. Without a definition of “score line” in the Markman order for that corresponding structure, the trial jud ge observed that the tria l proceedings invited the jury to define this term on its own in a manner th is court has questioned in O2 Micro , 521 F.3d at 1360, and Markman v. Westview Instruments, Inc. , 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd , 517 U.S. 370 (1996) (holding that claim construction is a matter of law for the court). Therefore, the trial court undertook to supplement the Markman order by clarifying the meaning of “score line” as the structure corresponding to independent claim 1. Although this court concludes that it was proper for the trial court to supplement the definition of “score line,” th is court must now evaluate t he merits of the trial court’s definition of “score line.” In the context of the correspondi ng structure to independent claim 1 of the Lee patents, the tr ial court erred in expanding th e definition of “score line”

2008-1602 10to include structures not disclosed in the spec ifications of the Lee patents. Section 112 requires that the corresponding structure must be “described in the specification.” The Lee patents give a laundry list of prior art references. See ’904 patent col.1 ll.41–61; ’355 patent col.1 ll.45–63. The trial court included the structures disclosed within that list of prior art references as co rresponding structures fo r claim 1 by including them in its definition of “score line.” In doing so, t he trial court impermissibly expanded the corresponding structure of claim 1 to include structures not described in the specification. Trial courts cannot look to the prior art, identified by nothing more than its title and citation in a patent, to provide corres ponding structure for a means-plus-function limitation. In this case, these references pr ovide alternatives to scoring. Although many of the disclosed alternatives may well be determined to be structural equivalents permitted by section 112, paragraph 6—a questi on of fact for the jury—these alternative methods of splitting or peelin g cannot be treated as the di sclosed structures for the removal means. Simply mentioning prior art references in a patent does not suffice as a specification description to gi ve the patentee outright claim to all of the structures disclosed in those references. In Atmel Corp. v. Info. Storage Devices, Inc. , 198 F.3d 1374, 1381 (Fed. Cir. 1999), this court refused to utilize the concept of incorporation by reference to include a structure in the prior art as a corresponding structure for a means-plus-function claim element. In Atmel , this court held that the title of a prior art reference could provide the structure for a mean-plus-function element be cause “Atmel’s expert, Callahan, testified that this title alone was sufficient to indicate to one skilled in the ar t the precise structure

2008-1602 11of the means recited in the specification.” Id. at 1382. His testimony was essentially unrebutted. Id. If, on the other hand, the title did not disclose the prior art structure, the structures in the prior ar t reference could not be a co rresponding structure to the means-plus-function claim element. Id. (holding that “the district court properly held that the Dickson article [prior art ci ted in the patent] may not take the place of structure that does not appear in the specification”). The magistrate judge construed “score line” consistent with th e specification as “one or more lines defined in the hemosta tic valve and introducer sheath.” The magistrate judge, citing a dictionary, expl ained that “‘score’ has been defined to mean ‘any scratch, line or groove’ that is formed by the scoring process.” The trial court went on to supplement the magistrate’s construc tion and defined “score lines,” the structure for permitting removal, as “li near perforation; slit; slot; tab; line; severing; weakening; or tear that can be partial or complete.” Pressure Products argues that the trial court correctly construed the term “score lines” according to the doctrin e of claim differentiation. Claim 1 claims “means for permitting removal of said hem ostatic valve and introducer sheath.” Claims 4 through 8 of the ’904 patent claim “a score line defi ned in said hemostatic valve and introduce sheath” as the means for permitting removal. As such, Pressure Products argues that the means-plus-function element of claim 1 must encompass structures other than score lines, namely, those structures disclos ed in the prior art re ferences mentioned in the patent. This argument fails, however, be cause a means-plus-function claim element already includes structures other than the co rresponding structure exp licitly described in the specification, name ly, equivalents of the co rresponding structure. See 35 U.S.C.

2008-1602 12§ 112, ¶ 6. Therefore, as the means-plus-function claim elem ent of claim 1 includes the equivalents of score lines, the magistrate j udge’s claim construction does not violate the doctrine of claim differentiation. The specification does not expressly descri be use of a cut or a slit or a tear for removal. The specification explains, “[t]he score line comprises a pair of lines defined in the hemostatic valve and introduc er sheath. The pair of sco re lines are diametrically opposed from each other on the hemostatic valve and introduc er sheath.” ’904 patent col.3 ll.14–18. The patent fu rther explains, “score lines 34 and 36 are shown as having a V-shaped cross section but have such a shape and depth as to permit the entire length of introducer sheath 10 to be manually separated.” Id. col.6 ll.7–10. The specification recognizes a differenc e between score lines and slots. Id. col.6 ll.28–32 (”However, it is entirely possible that score lines 34 and 36 will be continued through flanges 38 and 40 to provide deep scores instead of open slots 44 and 46.” (emphasis added)). The trial court erroneously used structures from the prior art references listed in the patent to provide a definition for score lines encom passing structures not disclosed expressly in the patent specificat ion. As such, this court detects error in the trial court’s definition. Score lines are “one or more lines defined in the hemostatic valve and introducer sheath” as supported by the specif ication. This court remands for further proceedings in light of the proper construction of the term “score lines.” Those further proceedings will allow appr opriate measures to also ascertain the structural equivalents of the express structure in the specification correspondi ng to the claimed function.

2008-1602 13IV. The district court denied Enpath’s JMOL motion for invalidity of the Lee patents. Enpath asserts it presented clear and convinci ng evidence that Haindl’s German Patent Number 3834600 (“the Haindl ’600 patent”) anticipates and renders obvious the Lee patents. It further asserts that Pressure Products did not ov ercome its prima facie case of invalidity. To demonstrate anticipation, Enpath’s expert witness, Dr. Ethan Podet, provided for the jury claim construction charts compari ng every element of the claims at issue to the Haindl ’600 patent. Pre ssure Products’ expert witness, Dr. Eli Gang, rebutted Dr. Podet’s testimony by testifyi ng that the Haindl ’600 patent does not teach or suggest a critical component of the Lee patents, i.e., the combinat ion of both a splittable hemostatic valve and a splittable introducer sheath. Dr. Gang al so examined each of the other prior art references cited in Dr . Podet’s expert report and gave reasons why they did not show anticipati on or obviousness. Anticipati on requires “a single prior art reference [that] discloses each and every limitation of the claimed invention.” Schering Corp. v. Geneva Pharm. , 339 F.3d 1373, 1377 (Fed. Cir. 2003) . Moreover, the Patent and Trademark Office (“PTO”) examined the Haindl ’600 patent twice during the examination and re-examination of the ’904 patent. The PTO, nevertheless, allowed the ’904 patent, instilling the statutor y presumption of validity into the Lee patents. To rebut Dr. Podet’s obviousness testim ony, Pressure Products used Dr. HansGuenter Haindl’s declaration f iled during the reexam ination of the ’904 patent. In the declaration, Dr. Haindl states that his invention, the Hain dl ’600 patent, lacks a hemostatic, splittable valve as claimed by the ’904 and ’355 patents. Dr. Haindl’s

2008-1602 14declaration also states that the Haindl ’600 patent does not include an “enabling disclosure” of a splittable assembly. Furthermore, Pressure Products offer ed secondary evidence of non-obviousness including evidence of commercial success, l ong felt need, skepticism of experts, and unexpected results of the comm ercial embodiment of the Lee patents. This court “has repeatedly explained, [that secondar y consideration evidence] is not just a cumulative or confirmatory part of the obviousness calculus but constitutes independent evidence of nonobviousness.” Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc. , 520 F.3d 1358, 1365 (Fed. Cir. 2008). In terms of the skeptic ism of experts and unexpected results, the record confirms that other medical dev ice companies initially turned down the opportunity to license the Lee patents because t hey did not believe that the invention would work. Enpath did not offer any evi dence that rebutted or challenged Pressure Products’ secondary evidence of non-obviousness. In sum, the trial record shows ample s upport for the jury’s judgment that the claimed invention would not have been antici pated or rendered obvious by prior art at the time of invention. Enpath has not shown that the jury’s verdict on these points was unreasonable or based on insubs tantial evidence. Becaus e substantial evidence supports the jury’s verdict, the district cour t did not err in denying Enpath’s motion for JMOL on invalidity. V. The district court denied Enpath’s motion for leave to amend its answer to assert the defense of inequitable conduct. Enpath based its defense on a November 5, 2007 declaration of Mr. Steven Kont os, a biomedical engineer and designer of catheters and

2008-1602 15devices used with catheters. Mr. Kontos stated in his declaration that although he recognized his signature, he did not re member signing two 1995 declarations supporting the patentee during re -examination of the ’904 pa tent. Enpath contends the district court’s denial was an abuse of discretion. Two different standards exist for the deni al of a motion for leave to amend the pleadings. The more rigid stand ard of Rule 16(b) is applic able to motions filed after a scheduling order deadline has expired and requires a showing of good cause to file outside the deadline. See S&W Enters., L.L.C. v. Sout htrust Bank of Ala., NA , 315 F.3d 533, 536 (5th Cir. 2003). Under the more liber al standard of Rule 15(a), the trial court should grant leave to file absent a substantia l reason for denial, such as undue delay, bad faith, dilatory motive, repeated failure to cure deficiencies with other amendments, futility of the amendment, or undue prejudice to the opposing party. See Foman v. Davis , 371 U.S. 178, 182 (1962); see also Stripling v. Jordan Prod. Co., LLC , 234 F.3d 863, 872–73 (5th Cir. 2000) (“[Rule 15(a)] evinces a bias in favor of granting leave to amend.”). Enpath contends that Rule 15(a) applies in this case because the district court set a “Final Amended Pleadi ngs” deadline of April 5, 2007 fo r the plaintiff but not for Enpath. The district court’ s scheduling order further set a deadline of April 26, 2007 to “Respond to Amended Pleadings” but did not set an explicit deadline to file motions for leave to amend the pleadings. Thus, when Enpath filed its motion on December 7, 2007, no scheduling orderdeadline had passed as applied to Enpath. However, even under the more liberal standard of Rule 15(a), leave to amend is not automatic. See

2008-1602 16Parish v. Frazier , 195 F.3d 761, 763 (5th Cir. 1999); Avatar Exploration, Inc. v. Chevron, U.S.A., Inc. , 933 F.2d 314, 320 (5th Cir. 1991). Prejudice is the “touchstone of the inquiry under rule 15(a).” Lone Star Ladies Invest. Club v. Schlotzsky’s Inc. , 238 F.3d 363, 368 (5th Cir. 20 01). Thus, prejudice to the nonmoving party may be sufficient to deny leave to amend. See Mayeaux v. La. Health Servs. & Indem. Co. , 376 F.3d 420, 427 (5th Cir. 2004) (denying a motion to amend a pleading that would ha ve fundamentally altered the nature of the case and imposed additional discovery requirem ents and undue prejudice on the nonmoving party). Enpath raised its inequit able conduct defense in two motions on November 16, 2007 and December 7, 2007. To plead ineq uitable conduct with particularity as required under Rule 9(b), Enpat h contends that it could not file these motions until it received the November 5, 2007 Kontos declaration. The district court reasoned that allowing Enpath to amend its pl eadings “almost certainly” would have resulted in undue delay and would have “very likely” resulted in undue prejudice to Pressure Products. The district court also considered the leng th of time that the Kontos declarations were available to Enpath before bringing it s motions to amend. The 1995 declarations were publicly available at least since Nove mber 19, 1996, the date the PTO reissued the ’904 patent. Moreover, Enpath received a copy of the ’904 pat ent’s file wrapper as early as January 16, 2007. Nothing prevent ed Enpath from conducting discovery on the two 1995 Kontos declarations shortly following this date. Accordingly, because Enpath has not met its high burden of showing that the district court abused its discretion in

2008-1602 17denying Enpath’s motions for leave to amend its answer, this court affirms the district court’s denial. Since the trial court’s ruling on this motion to amend, this court has issued significant opinions requiring specific and demanding showings of evidence before a party may assert the defense of inequitable conduct. See, e.g. , Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. , 537 F.3d 1357, 1365 (Fed. Cir. 2008) (“We review the district court's inequitable conduct determinat ion under a two-tier standard; we review the underlying factual determinations for clear e rror, but we review the ultimate decision as to inequitable conduct for an abus e of discretion.”). Moreover, The burden of proving i nequitable conduct lies with the accused infringer . . . . To successfully prove inequi table conduct, the accused infringer must present “evidence that t he applicant (1) made an affirmative misrepresentation of material fact, fa iled to disclose material information, or submitted false material information, and (2) intended to deceive the [PTO].” . . . Further, at least a thres hold level of each element–i.e., both materiality and intent to deceive-mus t be proven by clear and convincing evidence. . . . And even if this elevated evidentiary burden is met as to both elements, the distri ct court must still balan ce the equities to determine whether the applicant's c onduct before the PTO was egregious enough to warrant holding the entire pat ent unenforceable. . . . Thus, even if a threshold level of both materiality and intent to deceive are proven by clear and convincing evidence, the c ourt may still decline to render the patent unenforceable. Id. (internal citations omitted); see also Exergen Corp. v. Wal-Mart Stores, Inc. , 575 F.3d 1312, 1329 n.5 (Fed. Cir. 2009) (“Whereas an inference of deceptive intent must be reasonable and drawn from a pl eading's allegations of underlying fact to satisfy Rule 9(b), this inference must be “the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard.” (emphasis added, internal citations omitted)).

2008-1602 182008-1602 19 Based on these cases, this court doubts that the motion to amend would even satisfy these higher standards of proof to invo ke the doctrine in the first place. These subsequent cases further support the trial c ourt’s action to deny the motion to amend. VI. Because the district court erred by in cluding structures not described in the specification in the definiti on of the corresponding structure to the means-plus-function claim element, this court vacates and remands for a determination of infringement using the correct claim construction. Because the reco rd supports the district court’s denial of Enpath’s motions for JMOL and leave to am end its answer, this court affirms those denials. AFFIRMED-IN-PART, REVER SED-IN-PART, AND REMANDED COSTS Each party shall bear its own costs.

## United States Court of Appeals for the Federal Circuit

2008-1602

PRESSURE PRODUCTS MEDICAL SUPPLIES, INC., Plaintiff-Appellee,

v. GREATBATCH LTD. (doing business as Enpath Medical, Inc.) Defendant-Appellant.

Appeal from the United States District Court fo r the Eastern District of Texas in Case No. 9:06-CV-121, Judge Ron Clark.

NEWMAN, Circuit Judge , concurring in part, dissenting in part. I join the court’s affirmance of the district court’s judgment on t he issues of validity and inequitable conduct. However, I would also affirm the court’s judgment on the issue of infringement, for reversible error has not been shown in the district court’s claim construction, and the jury’s verdict is supported by substantial evidence. The claim clause at issue is a means-plus- function clause, pres ented in both U.S. Patent Nos. 5,125,904 and 5,312, 355, claim 1 of both patent s starting with the same clauses, as follows:
1. A sheath assembly for use with a lead or catheter comprising: an introducer sheath;a hemostatic valve coupled to said in troducer sheath, said hemostatic valve and introducer sheath being arranged and configured to permit introduction of at least one lead or catheter therethrough; means for permitting removal of said hemostatic valve and introducer sheath from said lead or cat heter disposed therethrough without requiring said introducer sheath and hemostatic valve to be removed from an end of said lead or catheter, . . . The magistrate judge construed t he “means for permitting removal” as a “score line,” which is the primary structur e shown in the specification, and adopted the dictionary definition of “score” as “‘any scratch, line, or groove’ that is formed in the scoring process,” from the Academic Press: Dictionary of Science and Technology(1992). After presentation of the plaintiff’s case in chief, the district court further construed the means-plus-function clause in view of the debate that becam e manifest in the examination and cross-examination of the witnesses, for, as the district court observed, it was “fairly obvious it’s someth ing that, in fact, does need to be defined because defendants are pushing on it. And I would gather defendants agree with that analysis. Is that correct?” Counsel for the defendant, Enpath , responded: “Yes, your Honor.” A3769. My colleagues on this panel confirm that this additional clai m construction by the judge was appropriate. Claim construction is a matter of law, and it is essential that t he jury be correctly instructed on the law, lest the ent ire trial be tainted. See O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co. , 521 F.3d 1351, 1360, 1362 (Fed. Cir. 2008) (“W hen the parties raise an actual dispute regarding the proper scope of these claims, the court, not the jury, must resolve the dispute. . . . [I]t is the court’s duty to resolve it.”). This procedure is not unusual. As this court explained in Pfizer, Inc. v. Teva Pharmaceuticals, USA, Inc. , 429 F.3d 1364, 1377 (Fed. Cir. 2005), “district courts may engage in a rolling claim construction, in which the

2008-1602 2court revisits and alters its in terpretation of the claim terms as its understanding of the technology evolves.” As provided by statute, means -plus-function claim terms are construed in light of the structures described in the spec ification and equivalents thereof: §112 ¶6. An element in a claim fo r a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or ac ts in support thereof, and such claim shall be construed to cover the corre sponding structure, material, or acts described in the specification and equivalents thereof. The district court construed the “means fo r permitting removal” clause with reference to the patents’ specifications and the prior art cited in the specificat ions. The patents state that “the prior art has devised a number of splittable or peel away sheaths. The sheath is scored so that it is withdrawn by splitting or peeling it off fr om the pacemaker catheter.” ’904 patent col.1 ll.41-44; ’335 patent col.1 ll.45-48. The patents also state that the way the splittable structure is implemented or the peel-away feature is rea lized is not critical to the invention: [T]he detailed nature by which such sp littable structure is implemented or how [the] peel-away feature is realized is not critical to the invention. Any method now known or later devised by which such sheaths 12 and valve assemblies 14 may be split or s eparated may be employed and are contemplated as being within t he scope of the invention. ’904 patent col.5 ll.59–66; ’355 pat ent col.7 ll.37–44. Both the ’904 and the ’355 patents cite prior publications showing various separatio n methods, as included in the court’s claim construction. Referring to this information and the testimony at trial, the district court construed the “means for permitting removal [of the valve and sheath]” as a “linear perforation, slit, slot, tab, line, severing, weakeni ng, or tear that can be partial or complete.” This elaborated claim construction was present ed, quoting the majority opinion, “to avoid

2008-1602 3any jury confusion about the meaning of ‘score li ne.’” Maj. Op. at 5. My colleagues assign no error to this procedure. The references were incorporated to show the prior art, not to define what was new. The splitting and separation of the sheath was not what was new; what was new was the combination with removal of the hemostatic valve. Thus for the splitti ng of the plastic, the cited references showed various ways in wh ich that had been done in the past, and the patents stated that “any method now known or later devised by whic h such sheaths 12 and valve assemblies 14 may be split or separat ed may be employed and are contemplated as being within the scope of the in vention.” ’904 patent col.5 ll.62–66; ’355 patent col.7 ll.41–
44. My colleagues rule that the district court should have ignored these cited references, and should not have recognized their content, or even their titles, in construing the “means” portion of the claim. Although this objection was not raised to the district court, my colleagues now deem it to be reversible erro r to have considered the references, which include Littleford, “Split Sleeve Introducers fo r Pacemaker Electrodes and the Like,” U.S. Pat. No. 4,243,050 (1981); Osborne, “Tear A part Cannula,” U.S. Pat. No. RE 31,955 (1985); Boarini et al., “Peelabl e Catheter with Securing Ring and Suture Sleeve,” U.S. Pat. No. 4,411,654 (1983); and Moorehead, “Medical Lay ered Peel Away Sheath and Methods,” U.S. Pat. No. 4,983,168 (1991). It cannot be error for the district court to have recognized that splittable sheaths were well known, and to have c onstrued the “means for permitting removal” clause in light of this knowledge. The only error that my co lleagues ascribe to the district court’s claim construction is that the court included equivalent structure from the prior art set forth in the

2008-1602 4specifications and brought out in the testimony of witnesses, instead of relying solely on a dictionary definition. No flaw has been ascribed to the district court’s action to explain to the jury what is included in the “means for permi tting removal” clause, for this construction of law was the responsibility of the judge, not the jury. The majority opinion states that Atmel Corp. v. Information Storage Devices, Inc. , 198 F.3d 1374, 1381 (Fed. Cir. 1999) prohibits a patentee from relying on an “incorporated” reference to describe a corresponding struct ure under §112, ¶6. That is an incorrect generalization. In Atmel , the flaw was that no structure at all was described to perform the claimed function apart from the incorporated reference, and that this description could not come solely from the incorporated reference. See id. at 1382 (“Fulfillment of the §112, ¶6 tradeoff cannot be satisfied when there is a total omission of structur e. There must be structure in the specification.”). However, that is far remov ed from the situat ion here. The ’904 and ’355 patents fully describe structures that perform the cl aimed function of removal of the valve and sheath, describing splittable s heaths of various forms , and explaining that there are many known ways of splitting or peeling plastic. No blanket rule prohibits reliance on prio r art for known information. Precedent is contrary. See Telemac Cellular Corp. v. Topp Telecom, Inc. , 247 F.3d 1316, 1329 (Fed. Cir. 2001) (“When a document is ‘incorporated by re ference’ into a host document, such as a patent, the referenced document becomes effect ively part of the host document as if it were explicitly contained therei n.”). This expedient is not without logical limitations, but incorporated material is viewed as it would be treated by a person ex perienced in the field of the invention. See Multiform Desiccants, Inc. v. Medzam, Ltd. , 133 F.3d 1473, 1477 (Fed. Cir. 1998) (“It is the person of ordinary sk ill in the field of the invention through whose

2008-1602 5eyes the claims are construed.”). Informati on is incorporated by reference into patent specifications for various purposes, and known information may usefully be incorporated by reference, to illustrate known structures that are known alternatives or equivalents to those in the specification. This enables patents to remain concise statement s of what is new, not cumbersome repetitions of w hat is already known and readily provided by reference. In re Howarth , 654 F.2d 103, 106 (CCPA 1981) (“[A]n applicant may, in the interests of economy of time and space, incorporat e certain types of documents by specific reference in his application to such source materials.”); see Loom Co. v. Higgins , 105 U.S. (Otto.) 580, 586 (1881) (“[A patentee] may begin at the point where his invent ion begins, and describe what he has made that is new and what it replaces of the old. That wh ich is common and well known is as if it were written out in the patent and delineated in the drawings.”). My colleagues assign no error to the technologi c content of the dist rict court’s claim construction, no unfairness to the procedure, and no absence of support for the jury verdict. Enpath does not argue that its devices’ means for removing the sheath and valve are noninfringing, and does not argue that the jury verdict is not supported by substantial evidence. The record states that Enpat h told the Food and Drug Administration that its device has “a scored/splittable introducer sheath.” The record also contains evi dence that the Enpath manufacturing process creates a s lit at the proximal end of th e sheath. There is no basis for suspecting that substantial evidence does not support the jury verdict, whether on the magistrate judge’s initial claim construction, or on the district court’s elaborated claim construction. Enpath has not argued that t here was not substantial ev idence of infringement on the magistrate judge’s definition of “score” as a “‘scratch, line or groov e’ that is formed by

2008-1602 6the scoring process.” Indeed, one wonders why a general definition in a dictionary is preferable to the definitions in specific technological references in the specification. While this court in Phillips v. AWH Corp. , 415 F.3d 1303 (Fed. Cir. 2005) (en banc), recognized that dictionaries can be useful in explai ning terms to judges who are unfamiliar with technical terminology, dictionaries are not super ior to clear definitions in technological references on the same subject matter. 1 Enpath now challenges the propriety of t he district court’s reworking the claim construction during the trial, although at the time Enpath encouraged the court to do so. Enpath states that it was pr ejudiced because it prepared for trial based on the magistrate judge’s claim construction, but Enpath does not state that it requested and was denied additional time to adjust its defense. See Newell Companies, Inc. v. Kenney Mfg. Co. , 864 F.2d 757, 765 (Fed. Cir. 1988) (“Trials must be fair, not perfect.”); Devices for Medicine, Inc. v. Boehl , 822 F.2d 1062, 1066 (Fed. Cir. 1987) (same) . This attack on the district court’s procedure is as unwarranted as it is tardy. I would affirm the district court’s claim construction, for it conforms to the specification, the prosecution history, and the ev idence at trial. The district court construed the claims to include the structure set fort h in the specification and equivalents thereof, drawing on the subject matter incorporated by reference in the specification, and on the evidence at trial. Neither procedural flaw, nor harmful error, has been shown. Respectfully, I dissent.

1 This ruling negating reliance on informa tion incorporated by reference can have far-reaching consequences, in prohibiting reliance on incorporated published material, thereby requiring the applicant to reproduce po ssibly large amounts of published text, even if only to show variants known in the prior art, as here.

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