UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`______________
`
`Case IPR2017-00060
`Patent 8,992,608
`______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`PATENT OWNER’S MOTION TO EXCLUDE
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`______________
`
`Case IPR2017-00060
`Patent 8,992,608
`______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`PATENT OWNER’S MOTION TO EXCLUDE
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION AND RELIEF REQUESTED ..........................................1
`
`BACKGROUND .............................................................................................1
`
`III. ARGUMENT...................................................................................................2
`
`A.
`
`B.
`
`C.
`
`Legal Standards .....................................................................................2
`
`Dr. Buller Has Not Considered The Evidence Regarding
`The Objective Indicia Of Nonobviousness ...........................................4
`
`Petitioner’s Attorney Arguments Do Not Cure Dr. Buller’s
`Failure To Consider The Evidence Of Objective Indicia .....................5
`
`1.
`
`2.
`
`Petitioner Fails To Show Lack Of Nexus ...................................5
`
`Petitioner Fails to Negate The Evidence Regarding
`The Objective Indicia..................................................................8
`
`IV. CONCLUSION................................................................................................8
`
`-i-
`
`
`
`I.
`
`INTRODUCTION AND RELIEF REQUESTED
`
`Pursuant to 37 C.F.R. § 42.64(c), the Trial Practice Guide (77 Fed.
`
`Reg. 48767), and the Scheduling Order (Paper 8), Patent Owner Boston Scientific
`
`Scimed, Inc. (“Patent Owner”) respectfully moves to exclude the following
`
`evidence submitted by Petitioner: Declaration of Nigel P. Buller, M.D. (Ex. 1007)
`
`and Reply Declaration of Nigel P. Buller, M.D. (Ex. 1045).
`
`II.
`
`BACKGROUND
`
`With the Petition, Petitioner submitted an expert declaration of Dr. Nigel P.
`
`Buller setting forth his opinion that U.S. Patent No. 8,992,608 (the “‘608 patent”)
`
`was invalid under 35 U.S.C. § 103. Trial was partially instituted on March 29,
`
`2017, and Patent Owner timely served Petitioner with objections to the
`
`admissibility of Dr. Buller’s declaration on April 12, 2017 (Paper 9). In its
`
`Response (Paper 22), Patent Owner presented extensive evidence of objective
`
`indicia or secondary considerations of nonobviousness and showed that, because
`
`Dr. Buller failed to consider this evidence, his opinion could not support a finding
`
`of obviousness. (Paper 22 at 47-74.) Dr. Buller thereafter submitted a reply
`
`declaration that still failed to address the objective indicia, an omission to which
`
`Patent Owner further timely objected on September 29, 2017. (Paper 35 at 8.)
`
`Because “[e]vidence of secondary considerations of nonobviousness, when
`
`present, must always be considered en route to a determination of obviousness,”
`
`-1-
`
`
`
`Intri-plex Tech., Inc. v. Saint-Gobain Performance Plastics Rencol Ltd., IPR2014-
`
`00309, Paper 83 at 35 (P.T.A.B. Mar. 23, 2014) (emphasis added), reliance on Dr.
`
`Buller’s opinions would constitute error. Those opinions should therefore be
`
`excluded.
`
`III. ARGUMENT
`
`The admissibility of exhibits submitted in a PTAB proceeding is governed
`
`by the Federal Rules of Evidence. See 37 C.F.R. § 42.62(a); Trial Practice Guide,
`
`77 Fed. Reg. 48755. Petitioner, as the proponent, carries the burden of establishing
`
`the admissibility of the challenged evidence by a preponderance of the evidence.
`
`Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592 n.10 (1993).
`
`A.
`
`Legal Standards
`
`In its analysis under § 103(a), the Board must consider any evidence of the
`
`objective indicia of nonobviousness. Evidence of secondary considerations plays a
`
`critical role in the obviousness analysis because it serves as objective indicia of
`
`nonobviousness and “may often be the most probative and cogent evidence in the
`
`record. It may often establish that an invention appearing to have been obvious in
`
`light of the prior art was not.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530,
`
`1538–39 (Fed.Cir.1983). In fact, the Federal Circuit has expressly stated that
`
`“when secondary considerations are present ... it is error not to consider them.” In
`
`re Kao, 639 F.3d 1057, 1067 (Fed.Cir.2011) (emphasis added). The objective
`
`-2-
`
`
`
`indicia may “serve to guard against slipping into use of hindsight, and to resist the
`
`temptation to read into the prior art the teachings of the invention in issue.” Apple
`
`Inc. v. Samsung Elec. Co., Ltd., 839 F.3d 1034, 1052 (Fed. Cir. 2016), petition for
`
`cert. filed (U.S. Mar. 10, 2017) (No. 16-1102) (quoting Graham v. John Deere Co.,
`
`383 U.S. 1, 36 (1966)); see WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed.
`
`Cir. 2016) (“The objective indicia … play an important role as a guard against the
`
`statutorily proscribed hindsight reasoning in the obviousness analysis”); Mintz v.
`
`Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir. 2012) (“These objective
`
`guideposts are powerful tools for courts faced with the difficult task of avoiding
`
`subconscious reliance on hindsight”). Failure to consider the objective indicia
`
`before finding obviousness is error. See, e.g., In re Cyclobenzaprine
`
`Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1079 (Fed.
`
`Cir. 2012) (“[F]act finders must withhold judgment on an obviousness challenge
`
`until it considers all relevant evidence, including that relating to the objective
`
`considerations”).
`
`The Federal Circuit has criticized obviousness experts for failing to consider
`
`the objective indicia. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688
`
`F.3d 1342, 1368 (Fed. Cir. 2012) (reversing obviousness finding where invalidity
`
`expert “admitted that he did not consider the objective indicia of nonobviousness
`
`in reaching his conclusions regarding … invalidity”); InTouch Techs., Inc. v. VGo
`
`-3-
`
`
`
`Commc’ns., Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014) (reversing finding of
`
`invalidity because expert’s testimony “did not even come close” to being
`
`“substantial enough to support an obviousness finding” where “[t]here was … no
`
`effort by [the expert] to guard against this hindsight bias by appropriately
`
`considering all objective evidence of nonobviousness”).
`
`Dr. Buller’s opinions should be excluded under Rule 702 because—absent
`
`consideration of objective indicia—they will not “help the trier of fact to
`
`understand the evidence or to determine a fact in issue,” are not “based on
`
`sufficient facts,” and are not “the product of reliable principles and methods …
`
`reliably applied … to the facts of the case.”
`
`B.
`
`Dr. Buller Has Not Considered The Evidence Regarding
`The Objective Indicia Of Nonobviousness
`
`In its Reply, Petitioner does not dispute Patent Owner’s showing that
`
`Dr. Buller disregarded the objective indicia of nonobviousness in forming his
`
`opinions in this case. (Paper 22 at 72-74.) Petitioner argues instead that it had no
`
`duty to address the objective indicia until after Patent Owner’s Response.
`
`(Paper 34 at 18-19.) Even if that is an accurate statement of the law (it is not),
`
`Dr. Buller’s reply declaration still failed to address all but one of the objective
`
`indicia raised in Patent Owner’s Response—failure of others, long-felt need,
`
`unexpected results, industry praise, and commercial success. (Ex. 2094 at 52:1-5
`
`(“Q. And you didn’t consider any secondary considerations in your reply
`
`-4-
`
`
`
`declaration other than copying; is that right? A. That’s correct.”).) Petitioner’s
`
`own authority requires an expert to address the objective indicia in his rebuttal
`
`declaration. Activision Blizzard, Inc. v. Acceleration Bay, LLC, IPR2015-01953,
`
`Paper 107, at 36 n.15 (P.T.A.B. Mar. 23, 2017) (“once Patent Owner presented its
`
`evidence and arguments, in the Response, Dr. Karger submitted a rebuttal
`
`declaration addressing Patent Owner’s evidence”). Dr. Buller’s failure to do so
`
`renders his methodology unreliable and compels exclusion of his declaration under
`
`Rule 702.
`
`C.
`
`Petitioner’s Attorney Arguments Do Not Cure Dr. Buller’s
`Failure To Consider The Evidence Of Objective Indicia
`
`Petitioner attempts to excuse Dr. Buller’s failure to consider the objective
`
`indicia by (i) disputing Patent Owner’s showing of nexus and (ii) offering attorney
`
`argument and the declaration of Larry Wood to dispute the evidence of the
`
`objective indicia. Neither attempt is successful.
`
`1.
`
`Petitioner Fails To Show Lack Of Nexus
`
`Petitioner’s assertion that “there is no nexus because S3 has separate inner
`
`and outer skirts that are sewn together” (Paper 34 at 20) is based on an improper
`
`claim construction. Specifically, Dr. Buller improperly assumes a requirement that
`
`appears nowhere in the ‘608 patent’s claims or specification—that the seal must be
`
`constructed from a single piece of fabric and cannot be made of two or more pieces
`
`sewn together. Petitioner did not seek such a construction of the claims in its
`
`-5-
`
`
`
`Petition or in the related District Court litigation; such a construction would not, in
`
`any event, be the broadest reasonable interpretation of the claims in view of the
`
`specification. The challenged claims are not methods of manufacture; they are
`
`device claims, and the construction that Petitioner advocates would allow an
`
`infringer to avoid liability simply by manufacturing any element of a device claim
`
`as two or more subcomponents to be combined upon final assembly.
`
`In effect, Petitioner contends that the outer skirt must be directly attached to
`
`the distal end of the replacement valve—a requirement that is found nowhere in the
`
`claim or the specification and is contrary to law. See Southco, Inc. v. Fivetech
`
`Tech. Inc., 611 F. App’x 681, 686 (Fed. Cir. 2015) (“the ordinary meaning of
`
`‘attached’ includes both direct and indirect attachment”)1; Repro-Med Sys., Inc. v.
`
`Emed Techs. Corp., IPR2015-01920, Paper 65 at 14-17 (P.T.A.B. Jan. 12, 2017)
`
`(“The ordinary and customary meaning of the term ‘in attachment to’ encompasses
`
`both direct and indirect attachment”). The claim requires that the “fabric seal,”
`
`which is “at least partially disposed around the exterior,” be attached to the distal
`
`end of the replacement valve; a portion of the fabric seal that is not around the
`
`exterior may be attached to the distal end of the replacement valve, as in SAPIEN
`
`1 Although the term “attached” was limited to direct attachment in Southco, the
`
`finding in that case was based on language in the claim at issue clearly limiting
`
`“attached” to direct attachment. See Southco, Inc., 611 F. App’x at 686.
`
`-6-
`
`
`
`3. Moreover, Figure 32 shows an inner portion of the fabric seal attached to the
`
`valve 20. Thus, Petitioner’s unduly narrow construction is contrary to the intrinsic
`
`evidence. In sum, SAPIEN 3’s inner and outer skirts are sewn together to form a
`
`seal attached to the distal end of the replacement valve and extends back
`
`proximally over the anchor, as required by the ‘608 patent.
`
`Petitioner’s other argument regarding nexus—that “the ‘windows’ that
`
`support S3’s commissures are part of the anchor (and thus cannot be ‘attached to’
`
`the anchor as the Challenged Claims require)” (Paper 34 at 21)—is a strawman.
`
`Patent Owner and its expert, Dr. Stephen Brecker (Ex. 2080 at App’x B
`
`Element 1.2), identified SAPIEN 3’s “commissure attachments”—not its frame’s
`
`“windows”—as the “replacement valve commissure support element attached to
`
`the expandable anchor.” (Paper 22 at 51-52.)
`
`In any event, Petitioner again assumes an improperly narrow construction of
`
`the claim term “attached.” Petitioner’s premise—that “attached” means the
`
`commissure support element must be a separate structure that is welded or
`
`otherwise joined to the frame (as opposed to a distinct feature incorporated during
`
`the manufacture of the frame)—finds no support in the ‘608 patent’s claims or
`
`specification. It is readily apparent that the SAPIEN 3’s windows are “attached” to
`
`its frame.
`
`-7-
`
`
`
`2.
`
`Petitioner Fails to Negate The Evidence Regarding
`The Objective Indicia
`There is no authority suggesting that attorney argument or another witness’s
`
`consideration of evidence of objective indicia of nonobviousness—such as that of
`
`Mr. Wood—can compensate for the failure of the obviousness expert to consider
`
`such evidence, and Petitioner cites none. Here, Petitioner relies on Dr. Buller’s
`
`analysis of the prior art but provides no assurance that he did not rely on hindsight
`
`in conducting that analysis.
`
`IV. CONCLUSION
`
`For the reasons stated herein, the Board should exclude the Declaration of
`
`Nigel P. Buller, M.D. (Ex. 1007) and Reply Declaration of Nigel P. Buller, M.D.
`
`(Ex. 1045).
`
`Dated: November 3, 2017
`
`Respectfully submitted
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu (Reg. No. 45,380)
`ARNOLD & PORTER
`KAYE SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax:
`(213) 243-4199
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc.
`
`-8-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`MOTION TO EXCLUDE was served on November 3, 2017 to the following
`Counsel for Petitioner via e-mail:
`
`Gregory S. Cordrey (Reg. No. 44,089)
`Jeffer Mangels Butler & Mitchell, LLP
`3 Park Plaza, Suite 1100
`Irvine, CA 926214
`Email: gcordrey@jmbm.com
`Telephone: 949-623-7200
`Facsimile: 949-623-7201
`
`Brian Egan (Reg. No. 54,866)
`Morris, Nichols, Arsht & Tunnell, LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`Email: began@MNAT.com
`Telephone: 302-351-9454
`Facsimile: 302-498-6216
`
`Catherine Nyarardy (Reg. No. 42,042)
`Paul, Weiss, Rifkind, Wharton &
`Garrison, LLP
`1285 Avenue of the Americas
`New York, NY 10019
`Email: cnyarardy@paulweiss.com
`Telephone: 212-373-3532
`Facsimile: 212-492-0532
`
`Attorneys for Petitioners Edwards LifeSciences Corporation, Edwards Lifesciences
`LLC, and Edwards Lifesciences AG
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`ARNOLD & PORTER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`-9-
`
`
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