Pressure Products Medical Supplies v. Greatbatch (dba Enpath Medical) (CAFC 2008-1602r) precedential

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.

Claim Construction

The onset of a moving definition of "score line" -

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."1 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."

At the close of Pressure Products trial presentation -

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.

Claim construction case law this episode -

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.

To the "score line": the CAFC leniently looks upon claim construction redefinition.

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 the 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 trial court is in the best position to prevent gamesmanship and unfair advantage during trial. Moreover, this court understands that a trial judge may learn more about the technology during the trial that necessitates some clarification of claim terms before the jury 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 operation of sheaths due to extensive expert testimony from both parties.

Enpath posits that the trial judge's late adjustment prejudiced its defense and compromised its ability to respond. While somewhat sympathetic to those concerns in general, this court is not prepared to substitute its judgment for that of the district judge, who understood the entire context far beyond the 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 opportunity 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 claim 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 its understanding of the technology 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 regarding 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).

In this case, the magistrate judge defined "score line" as "one or more line(s) defined in the hemostatic valve and introducer sheath" in the context of dependent claims 4 through 8 of the '904 patent. The 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 specification that corresponded to this functional limitation was a score line. The magistrate 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 judge observed that the trial proceedings invited the jury to define this term on its own in a manner this 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.

A judge changing his mind on claim term definition is passable, but only if the change is passable.

In the context of the corresponding structure to independent claim 1 of the Lee patents, the trial court erred in expanding the definition of "score line" to include structures not disclosed in the specifications of the Lee patents. Section 112 requires that the corresponding structure must be "described in the specification."

Relying upon the prior art as specification support for a means-plus-function limitation is on the wrong side of the score line of acceptability.

Trial courts cannot look to the prior art, identified by nothing more than its title and citation in a patent, to provide corresponding structure for a means-plus-function limitation. In this case, these references provide alternatives to scoring. Although many of the disclosed alternatives may well be determined to be structural equivalents permitted by section 112, paragraph 6--a question of fact for the jury--these alternative methods of splitting or peeling cannot be treated as the disclosed structures for the removal means. Simply mentioning prior art references in a patent does not suffice as a specification description to give 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.

The magistrate judge construed "score line" consistent with the specification as "one or more lines defined in the hemostatic valve and introducer sheath." The magistrate judge, citing a dictionary, explained 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 construction and defined "score lines," the structure for permitting removal, as "linear perforation; slit; slot; tab; line; severing; weakening; or tear that can be partial or complete."

The trial court erroneously used structures from the prior art references listed in the patent to provide a definition for score lines encompassing structures not disclosed expressly in the patent specification. 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 specification. This court remands for further proceedings in light of the proper construction of the term "score lines." Those further proceedings will allow appropriate measures to also ascertain the structural equivalents of the express structure in the specification corresponding to the claimed function.

The error in claim construction required rectification, the majority ruled. The majority in this case comprised opinion writer Judge Rader, joined by judges Lourie, Gajarsa and Moore.

Because the district court erred by including structures not described in the specification in the definition 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.

Judge Newman dissented on the claim construction error call by the majority. Quite rightly so.

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 became manifest in the examination and cross-examination of the witnesses, for, as the district court observed, it was "fairly obvious it's something 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 claim construction by the judge was appropriate. Claim construction is a matter of law, and it is essential that the jury be correctly instructed on the law, lest the entire trial be tainted. See O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360, 1362 (Fed. Cir. 2008) ("When 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 court revisits and alters its interpretation 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 specification and equivalents thereof:

§112 ¶6. An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

The district court construed the "means for permitting removal" clause with reference to the patents' specifications and the prior art cited in the specifications... 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.

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 error to have considered the references.

It cannot be error for the district court to have recognized that splittable sheaths were well known, and to have construed the "means for permitting removal" clause in light of this knowledge. The only error that my colleagues ascribe to the district court's claim construction is that the court included equivalent structure from the prior art set forth in the specifications 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 permitting removal" clause, for this construction of law was the responsibility of the judge, not the jury.

No blanket rule prohibits reliance on prior 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 reference' into a host document, such as a patent, the referenced document becomes effectively part of the host document as if it were explicitly contained therein."). This expedient is not without logical limitations, but incorporated material is viewed as it would be treated by a person experienced 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 skill in the field of the invention through whose eyes the claims are construed."). Information 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 statements of what is new, not cumbersome repetitions of what 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, incorporate 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 invention begins, and describe what he has made that is new and what it replaces of the old. That which 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 technologic content of the district 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 non-infringing, and does not argue that the jury verdict is not supported by substantial evidence. The record states that Enpath told the Food and Drug Administration that its device has "a scored/splittable introducer sheath." The record also contains evidence that the Enpath manufacturing process creates a slit at the proximal end of the 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 there was not substantial evidence of infringement on the magistrate judge's definition of "score" as a "'scratch, line or groove' that is formed by the 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 explaining terms to judges who are unfamiliar with technical terminology, dictionaries are not superior to clear definitions in technological references on the same subject matter.¹

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

Enpath now challenges the propriety of the 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 prejudiced 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 evidence at trial. The district court construed the claims to include the structure set forth 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.

Prior Art Validity

Enpath had argued anticipation as a matter of law, which wasn't granted. There was a missing element in the cited prior art.

Furthermore, Pressure Products offered secondary evidence of non-obviousness including evidence of commercial success, long felt need, skepticism of experts, and unexpected results of the commercial embodiment of the Lee patents. This court "has repeatedly explained, [that secondary 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 skepticism of experts and unexpected results, the record confirms that other medical device companies initially turned down the opportunity to license the Lee patents because they did not believe that the invention would work. Enpath did not offer any evidence that rebutted or challenged Pressure Products' secondary evidence of non-obviousness.

Validity affirmed.

Amending Pleadings

Enpath had motioned "for leave to amend its answer to assert the defense of inequitable conduct," based upon an engineer not recalling signing declarations supporting the patentee during reexam. The district court denied the motion.

Two different standards exist for the denial of a motion for leave to amend the pleadings. The more rigid standard of Rule 16(b) is applicable 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. Southtrust Bank of Ala., NA, 315 F.3d 533, 536 (5th Cir. 2003). Under the more liberal standard of Rule 15(a), the trial court should grant leave to file absent a substantial 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.").

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. 2001). 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 have fundamentally altered the nature of the case and imposed additional discovery requirements and undue prejudice on the nonmoving party).

Denial affirmed.