CPLRG™ 0036 - Pressure Products Medical Supplies v. Greatbatch Ltd. - Mar. 24, 2010

Pressure Products Medical Supplies v. Greatbatch Ltd., 599 F.3d 1308 (Fed. Cir. 2010) (RADER, Lourie, Gajarsa & Moore; NEWMAN, concurring- in- part & dissenting-in-part) PressureProducts03242010

MAJOR ISSUES: supplementing Markman claim construction order during trial; means-plus-function limitations; corresponding structure in prior art incorporated by reference not sufficiently described; obviousness; support for jury verdict; expert testimony that prior art lacked a claim limitation; secondary considerations; prior art considered by PTO during examination and reexamination; inequitable conduct: untimely motion to amend answer to add a defense

COMMENT.  This case was unusual procedurally by having five rather than three judges on the panel.  From its beginning in 1982, the Federal Circuit has been statutorily authorized to use expanded panels.  It has rarely done so.
     The opinion in this case addresses four issues.  First was whether evidence supported a jury’s verdict that a patent’s claims had not been shown to be invalid for obviousness.  The accused infringer’s challenge was based on a German reference.  The court found that there was substantial evidence in the form of expert testimony that a claim limitation was missing from the reference.  Also supportive of the verdict was (a) the action of the PTO in allowing the claims after considering the German reference in both original examination and a reexamination, and (b) secondary considerations, such as the initial skepticism of experts.
     Second was whether the district court erred by not allowing the accused infringer to amend its complaint to add an inequitable conduct defense.  The court sustained that action, referring to a trend in the case law to stiffen the standards for alleging and proving inequitable conduct.
      Third was the propriety of a district court supplementing the construction of a means-plus-function limitation during trial.  The court found no impropriety; there was a risk of surprise and prejudice, but a dispute that arose at trial created another risk:  that the jury would improperly be left to construe the claim.
     Finally was the correctness of the supplementing construction.  The majority held that the district court erred by expanding the definition of the structures that correspond to the means to include structures that were not disclosed in the patent’s specification but, rather, merely in the references that were incorporated by reference.  Such incorporation by reference was barred by Atmel Corp. v. Info. Storage Devices, Inc., 198 F.3d 1374, 1381 (Fed. Cir. 1999).
     On the incorporation issue, Judge Newman dissented, arguing:  “No blanket rule prohibits reliance on prior art for known information.”  Judge Newman predicted dire consequences:  “This 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.”

1. “INTRODUCER”: PLACING AND REMOVING CATHETER LEADS IN BLOOD VESSSELS.  Two patents concerned a medical device known as an “introducer.”  U.S. Pat. No. 5,125,904  USPatNo5125904; U.S. Pat. No. 5,312,355  USPatNo5312355 .  An “introducer” is a surgical  device for placing and removing catheter and pacemaker leads in blood vessels.  The introducer includes a sheath and a valve.  The sheath is splittable for removal.  The patent addressed a problem in the prior art in removing the valve by providing a splittable sheath and a splittable valve.

2. OBVIOUSNESS; JURY VERDICT.  An accused infringer presented an expert’s testimony purporting to show that each limitation of the patent’s asserted claims was presented in a prior art reference, the German “Haindal” patent.  In response, the patent owner presented an opposing expert’s testimony that the reference lacked a “critical component,” to wit, a combination of a splittable valve and a splittable sheath.  A jury rendered a verdict that the claims were neither anticipated by nor obvious in light of the prior art.  The Federal Circuit held that substantial evidence supported the jury’s verdict, including the expert’s testimony.  The patent owner also presented “secondary evidence of non-obviousness. including skepticism of experts.  Finally, the PTO had considered the German Haindal reference in the course of allowing  the patent claims during both examination and reexamination.  This enhanced the presumption of validity.

3. SUPPLEMENTING CONSTRUCTION OF MEANS-PLUS-FUNCTION LIMITATION; ERROR TO INCLUDE CORRESPONDING STRUCTURE INCORPORATED BY REFERENCE FROM PRIOR ART.  The patent’s asserted claims required, inter alia, “means for permitting removal” of a valve and a sheath.
      a. MARKMAN ORDER CONSTRUCTION: CORRESPONDING STRUCTURE AS “SCORE LINES” DISCLOSED IN SPECIFICATION; DEFINITION AS LINES IN VALVE AND SHEATH.  In a pre-trial Markman order, a magistrate ruled that a claim phrase, “means for permitting removal,” in the claims of two asserted patents was a Section 112/6 means clause.  The magistrate further ruled that the specification structure corresponding to the means was “score lines,” and that “score lines” meant “one or more lines” in a valve and sheath.
     b. ACCUSED PRODUCTS: “SLIT.”  In an accused infringer’s products, the sheath had a slit at the top and was a material that would split evenly along the sheath’s length.
     c. TRIAL: DISPUTE ON DEFINITION OF “SCORE LINES”; SUPPLEMENTING DEFINITION AS INCLUDING “SLIT”; SLITS SHOWN IN PRIOR ART PATENTS INCORPORATED BY REFERENCE.  At trial, in response to a dispute arising from an accused infringer’s cross-examination of a patent owner’s witnesses, a district court supplemented the definition of “score lines.”  It defined “score lines” as “a `linear perforation; slit; slot; tab; line; severing; weakening; or tear that can be partial or complete.’ ”  It relied on a “laundry list” of prior art references that the patents incorporated by reference.  The incorporated patents disclosed various ways to split or peel apart a sheath.
    d. NO ERROR IN SUPPLEMENTING DEFINITION; RISK OF SURPRISE AND PREJUDICE; RISK THAT JURY WOULD DEFINE TERM.  The Federal Circuit held that the district court did not err in supplementing the definition.  There was potential for surprise and prejudice to the accused infringer in the “late adjustment to the meaning of claim terms.”  However, the adjustment was early in the trial and the district court was in the best position to prevent unfairness.  The district court did not err in finding that the parties’ dispute at trial create a risk that the jury would define at term on its own, contrary to O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351 (Fed. Cir. 2008), and Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996).
     e. SUPPLEMENTAL DEFINITION: ERRONEOUS.  Though supplementation was proper, the district court’s definition was erroneous.
          i. NO EXPANSION OF MEANS BY INCORPORATION BY REFERENCE.  The district court erred in by expanding the definition to include structures that were not disclosed in the patents’ specification but merely in the references that were incorporated by reference.  See Atmel Corp. v. Info. Storage Devices, Inc., 198 F.3d 1374, 1381 (Fed. Cir. 1999).
          ii. The magistrate’s definition of the “score lines” corresponding structure as “one or more lines defined” in the valve and sheath was proper.
          iii. DISTRICT COURT ERROR IN INCLUDING “SLOTS”; SPECIFICATION DISTINGUISHES “SCORE LINES” AND “SLOTS.”   The district court erred in using the incorporated references to include “slots.”  The patents’ specification recognized “a difference between score lines and slots.”  It stated the score lines could be continued “to provide deep scores instead of open slots.”
          iv. CLAIM DIFFERENTIATION.  The definition did not violate the principle of claim differentiation even though dependent claims expressly provided that the “means” of the independent claim should be “score lines.”
     f. EQUIVALENCY TO “SCORE LINES”: FACT QUESTIONS FOR JURY.  Whether the accused products’ slot was a Section 112/6 equivalent of the patent specification “score lines” structure was a fact question for the jury.

4. UNTIMELY ADDITION OF INEQUITABLE CONDUCT DEFENSE; RECENT FEDERAL CIRCUIT DECISIONS; HIGHER STANDARDS ON PLEADING AND PROVING INEQUITABLE CONDUCT. A district court did not abuse its discretion in denying as untimely and potentially prejudicial an accused infringer’s motion to amend its answer to add an inequitable conduct defense.  Further support for the district court’s action could be found in recent Federal Circuit decisions that impose “higher standards of proof to invoke” inequitable conduct as a bar to a patent’s enforceability. See Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008); Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1329 n.5 (Fed. Cir. 2009).

1. On jury verdicts regarding obviousness, see Chisum Patent Law Digest 1565; Chisum on Patents 5.04[3][d][xiv][B].
2. On construing “means-plus-function” limitations and determining the “corresponding structure” that measures equivalency of means, Chisum Patent Law Digest 5253; Chisum on Patents 18.03[5].
3. On the need to construe claims and accordingly instruct juries, see Chisum Patent Law Digest 5262.40; Chisum on Patents 18.06[2][a][iv].
4. On pleading and proving inequitable conduct, see Chisum Patent Law Digest 4730; Chisum on Patents 19.03[5].

©2010 Donald S. Chisum - All Rights Reserved

Website design by Bluegrass Internet Services