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Pressure Products Medical Supplies, Inc. v. Greatbatch Ltd.

March 24, 2010


Appeal from the United States District Court for the Eastern District of Texas in case no. 9:06-CV-121, Judge Ron Clark.

The opinion of the court was delivered by: Rader, Circuit Judge

Published opinion

Revised March 31, 2010*fn1

Before NEWMAN, LOURIE, RADER, 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 concurring in part and dissenting in part filed by Circuit Judge Newman.

The United States District Court for the 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. Patent 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 finding of infringement and remands for further proceedings in light of the correct claim construction. As the record supports the district court's denial of Enpath's motions for JMOL and leave to amend its answer, this court affirms those denials.


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 place 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 "splittable" or "peel-away" sheaths. These sheaths also included 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 would cause considerable blood loss during a surgical procedure. This invention devised a way to remove both the valve and the sheath by a splitting process. 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].

Pressure Products licensed the Lee patents from H. L. Medical Inventions, Inc., owned by the inventor of the '904 and '355 patents, Dr. Hongpyo Henry Lee, M.D., a California cardiologist. Then, Pressure Products sued Enpath in the Eastern District of Texas, alleging that Enpath's FlowGuardTM introducer product ("FlowGuardTM") and its ViaSealTM prototype introducer product ("ViaSealTM") infringe the Lee patents. Enpath and Pressure Products completed claim construction 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 three months before trial.

Claim 1 of each of the '904 and '355 patents recites the disputed limitation: "means for permitting removal of said hemostatic valve and introducer sheath from said lead or catheter disposed therethrough without requiring said 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 construction under 35 U.S.C. § 112, paragraph 6. Under that statutory process for construing functional claim terms, the magistrate judge determined that the structure in the specification that corresponds to the claimed function is "score lines defined in the hemostatic valve and introducer sheath, and equivalents thereof."*fn2 The term "score line" is recited 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 dictionary definition, the magistrate judge defined "score line" as "one or more line(s) defined in the hemostatic valve and introducer sheath." The magistrate judge did not further define the term "score line."

Depictions of Enpath's FlowGuardTM and ViaSealTM introducers, made of polytetrafluoroethylene ("PTFE"), are shown below.

These introducers include a feature 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 testimony that Enpath's cut or slit facilitates splitting and removing the PTFE tube; very few, if any, PTFE introducers did not include this feature. Indeed, Enpath's manufacturing procedure describes creating a slit at the proximal end of the sheath. During trial, Pressure Products' expert, Mr. Joseph Thomas, testified that this manufacturing procedure 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 that introducers not made of PTFE require scoring along the entire length of the sheath 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] scored/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 perforation; 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 definition of that term. In the words of the trial court, "it seems fairly obvious it's something that, in fact, does need to be defined because defendants are pushing on it." Enpath initially agreed with the district court's decision to supplement the definition but later objected to the amended construction. On June 12, 2006, the jury returned a verdict for Pressure Products, finding that Enpath's FlowGuardTM and ViaSealTM introducers literally infringed the Lee patents. The jury found 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 leave 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 untimely. Enpath filed its motion eighteen months after Pressure Products filed its complaint and over one year after Enpath filed its answer and counterclaims. Moreover, Enpath'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 scheduling 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 injunction as to FlowGuardTM sales, conditioned on Enpath's deposit into an escrow account or the court registry of an ongoing royalty.

Enpath timely appeals the district 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).


This court reviews claim construction 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 specification, of which they are a part." Id. at 1315 (internal quotation marks omitted). The specification is the "single best guide to the meaning of a disputed term." Id. (citation omitted). A court should also consider the patent's prosecution history, id. at 1317, and may rely on dictionary definitions, "so long as the dictionary definition does not contradict any definition 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 (Fed. Cir. 2008). The United States Court of Appeals for the Fifth Circuit reviews 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 pleading under Rule 15(a) is a procedural matter also governed by the law 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 once a scheduling order has been entered, it "may be modified only for good cause and with the judge's consent." 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 ...

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