IPR2017-00060
`
`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.
`
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S MOTION TO
`
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S MOTION TO
`
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`IPR2017-00060
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`PAGE
`
`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
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`PETITIONERS AND DR. BULLER ADDRESSED PATENT
`OWNER’S SECONDARY CONSIDERATIONS ONCE THEY
`WERE ASSERTED ......................................................................................... 1
`
`III. DR. BULLER’S TESTIMONY SHOULD NOT BE EXCLUDED ............... 3
`
`A.
`
`There is No Requirement That Petitioner or Its Expert Must
`Preemptively Address Secondary Considerations ................................ 3
`
`B. Once Dr. Buller Determined That There Was a Lack of Nexus,
`There Was No Need to Further Address the Secondary
`Considerations ....................................................................................... 4
`
`C. Disputes Regarding an Expert’s Analysis of Secondary
`Considerations Go to the Weight Accorded Such Testimony
`and Not Its Exclusion ............................................................................ 8
`
`D.
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`There Is No Basis to Exclude Dr. Buller’s Testimony Based
`PO’s Trial-Within-A-Trial Approach to Secondary
`Considerations ....................................................................................... 9
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`IV. CONCLUSION .............................................................................................. 15
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`
`
`
`
`
`i
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`TABLE OF AUTHORITIES
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`IPR2017-00060
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`CASES
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`PAGE
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`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-00724, Paper 53 (PTAB Sept. 15, 2017)................................... 8, 10, 14
`
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-1953, Paper 107 (PTAB Mar. 23, 2017) ............................................... 3
`
`Baker Hughes, a GE Company, LLC v. Liquidpower Speciality
`Products Inc.,IPR2016-00734, Paper 85 (PTAB Nov. 1, 2017) ...................... 6, 7
`
`Demaco Corp. v. F. Von Langsdorff Licensing Ltd.,
`851 F.2d 1387 (Fed. Cir. 1988) ............................................................................ 5
`
`Festo Crop. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) ............................................................................................ 13
`
`Gnosis S.P.A. v. S. Ala. Med. Sci. Found,
`IPR 2013-116, Paper No. 68 (PTAB June 20, 2014) ........................................... 6
`
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ............................................................................ 5
`
`InTouch Techs., Inc. v. VGo Commc’ns., Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ............................................................................ 9
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .......................................................................... 10
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ........................................................................ 8, 9
`
`Petroleum Geo-Servs. Inc. v. WesternGeco LLC,
`IPR2014-1475, Paper 18 (PTAB Mar. 17, 2015) ............................................. 3, 4
`
`Prometheus Labs., Inc. v. Roxane Labs., Inc.,
`805 F.3d 1092 (Fed. Cir. 2015) ............................................................................ 4
`
`
`
`
`
`ii
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`
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`TABLE OF CONTENTS
`(CONTINUED)
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`PAGE
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`Sight Sound Techs., LLC v. Apple, Inc.,
`809 F.3d 1307 (Fed. Cir. 2015) ............................................................................ 5
`
`Smith & Nephew, Inc. v. Arthrex, Inc.,
`IPR2016-00918, Paper 42 (PTAB Oct. 16, 2017) ................................................ 9
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................ 5
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................ 5
`
`OTHER AUTHORITIES
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`37 C.F.R. § 42.20(c) ................................................................................................... 1
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`
`
`
`
`iii
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`
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`I.
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`INTRODUCTION
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`Patent Owner’s Motion to Exclude should be denied in its entirety. Instead
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`of carrying its burden to show that exclusion is proper, see 37 C.F.R. § 42.20(c),
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`the Motion attacks Petitioners’ expert, Dr. Buller, solely on the unsupported
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`assertion that his original declaration (Ex. 1007) and reply declaration (Ex. 1045)
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`should be excluded for allegedly failing to consider PO’s supposed evidence of
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`secondary considerations. Even if true (it isn’t), PO is wrong that this would
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`warrant exclusion of Dr. Buller’s testimony. At most, such criticisms go to the
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`weight that should be given to Dr. Buller’s testimony. For these reasons, PO’s
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`Motion should be denied.
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`II.
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`PETITIONERS AND DR. BULLER ADDRESSED PATENT
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`OWNER’S SECONDARY CONSIDERATIONS ONCE THEY WERE
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`ASSERTED
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`PO presented no secondary considerations in its Preliminary Response
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`(POPR). Paper 6, at 30 n.4 (“PO does not set forth herein its evidence of
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`secondary considerations.”). PO did not raise secondary considerations until its
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`Response (Paper 22). In its response, PO relied on the alleged failure of others,
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`long-felt need, copying, industry praise, and commercial success, which were
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`based on its unsupported claim that Petitioners’ SAPIEN 3 transcatheter heart
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`valve (“S3 THV”) is an embodiment of the Challenged Claims. Paper 22 at 47-72.
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`
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`1
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`
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`Notably, other than the nexus issue, neither of PO’s experts addressed any of the
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`secondary considerations despite offering opinions that the Challenged Claims
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`were not invalid over the instituted prior art.1 See Ex. 2079 [Manganaro] and Ex.
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`2080 [Brecker]. In short, PO’s assertions of secondary considerations are
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`supported only by attorney argument.
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`In their Reply (Paper 33), Petitioners and Dr. Buller squarely addressed PO’s
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`secondary considerations evidence and demonstrated that, not only did PO fail to
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`establish the required nexus between the supposed evidence of secondary
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`considerations and Petitioners’ S3 THV, its assertion that secondary considerations
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`exist was wrong and unsupported. Paper 33 at 17-27. In connection with
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`Petitioners’ Reply, Dr. Buller provided a declaration (Ex. 1045) addressing PO’s
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`secondary considerations, including importantly the lack of nexus between the
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`Challenged Claims and Petitioners’ S3 THV, which cuts across all of PO’s
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`secondary considerations (¶¶ 9-27).
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`Petitioners also submitted the declaration of Larry Wood, Corporate Vice
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`President, Transcatheter Heart Valves, at Edwards Lifesciences, who has had
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`responsibility for a number of projects relating to transcatheter heart valves at
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`Edwards, including R&D, operations, marketing, and commercial and clinical
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`development. Ex. 1046, ¶ 5. Notably, Edwards’ SAPIEN 3 THV was
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`1 PO’s expert Brecker addressed only the nexus requirement.
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`
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`2
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`
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`commercialized and marketed during his tenure and under his leadership. Id. In
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`his declaration, Mr. Wood further addressed the secondary considerations of
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`failure of others (¶¶ 18-28), long-felt need (¶¶ 29-33), copying (¶¶ 34-35), industry
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`praise (¶ 36), unexpected results (¶ 37), and commercial success (¶¶ 38-45).2
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`III. DR. BULLER’S TESTIMONY SHOULD NOT BE EXCLUDED
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`A. There is No Requirement That Petitioner or Its Expert Must
`Preemptively Address Secondary Considerations
`
`Regarding PO’s attempt to exclude Dr. Buller’s opening declaration (Ex.
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`1007), as Petitioners explained in their Reply, the Federal Circuit and the Board
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`repeatedly have rejected PO’s argument that a petitioner or its expert must
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`preemptively predict and address a PO’s secondary considerations before they are
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`made. Paper 33 (citing Activision Blizzard, Inc. v. Acceleration Bay, LLC,
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`IPR2015-1953, Pap. 107 at 36 n.15 (PTAB Mar. 23, 2017) (“We disagree that Dr.
`
`Karger’s opening obviousness analysis…is deficient for failure to consider
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`secondary considerations, as Patent Owner alleges... Patent Owner directs us to no
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`authority for the proposition that Dr. Karger’s opening declaration, submitted at the
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`time of the Petition, was required to anticipate and address secondary
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`considerations that had not yet been articulated by Patent Owner and submitted for
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`the record.”). See also Petroleum Geo-Servs. Inc. v. WesternGeco LLC, IPR2014-
`
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`2 PO does not challenge Mr. Wood’s declaration.
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`
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`3
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`
`
`
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`1475, Pap. 18 at 27-28 (PTAB Mar. 17, 2015). Prometheus Labs., Inc. v. Roxane
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`Labs., Inc., 805 F.3d 1092, 1101-02 (Fed. Cir. 2015).
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`Even though Petitioners addressed this issue in their Reply and cited the
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`foregoing authority demonstrating that PO’s contention was wrong, in its motion
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`PO simply ignores this authority and fails to explain how Petitioners could have
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`addressed secondary considerations that had not yet been asserted by PO. Indeed,
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`PO merely cites the same authority cited its Response (See Paper 21 at 72-73) and
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`disregards that these cases do not require a petitioner to anticipate and pre-
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`emptively rebut secondary considerations evidence before it is raised by a PO.
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`Instead they concern the failure to address secondary considerations at trial. See
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`infra, at 8 n.6. Accordingly, there is no basis to exclude Dr. Buller’s opening
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`declaration (Ex. 1007) and PO’s motion should be denied.
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`B. Once Dr. Buller Determined That There Was a Lack of Nexus,
`There Was No Need to Further Address the Secondary
`Considerations
`
`Contrary to PO’s assertion, Dr. Buller did not disregard secondary
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`considerations in his reply declaration (Ex. 1045). Dr. Buller expressly states that
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`“[i]n response to Patent Owner’s purported evidence of secondary considerations, I
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`include here additional points of law that have been explained to me and that I
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`applied in forming my opinions for this declaration.” Ex. 1045, ¶ 5 (emphasis
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`added).
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`
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`4
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`In his reply declaration, Dr. Buller addressed the threshold issue of whether
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`PO had shown there was a nexus between the Challenged Claims and Petitioners’
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`S3 THV. “For objective evidence of secondary considerations to be accorded
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`substantial weight,” however, “its proponent must establish a nexus between the
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`evidence and the merits of the claimed invention.” In re Huai-Hung Kao, 639 F.3d
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`1057, 1068 (Fed. Cir. 2011) (quoting Wyers v. Master Lock Co., 616 F.3d 1231,
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`1246 (Fed. Cir. 2010)). “[N]exus” is a legally and factually sufficient connection
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`between the objective evidence and the claimed invention, such that the objective
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`evidence should be considered in determining nonobviousness. Demaco Corp. v.
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`F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). “[A]
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`presumption of nexus for objective considerations when the patentee shows that
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`the asserted objective evidence is tied to a specific product and that product ‘is the
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`invention disclosed and claimed in the patent.’” WBIP, LLC v. Kohler Co., 829
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`F.3d 1317, 1329 (Fed. Cir. 2016) (citations omitted). PO bears the burden of
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`showing that the product “is the invention disclosed and claimed in the patent.” See
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`Demaco, 851 F.2d at 1392. That is, a nexus is presumed when the product “both
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`‘embodies the claimed features’ and is ‘coextensive’ with the claims at issue.”
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`Sight Sound Techs., LLC v. Apple Inc., 809 F.3d 1307, 1319 (Fed. Cir. 2015).
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`Where, as here, neither PO nor Petitioner produces a commercial product
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`that is coextensive with the challenged claims, the PO is not entitled to a
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`
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`5
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`
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`presumption of nexus “for any of its proffered secondary considerations.” Baker
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`Hughes, a GE Company, LLC v. Liquidpower Speciality Products Inc., Case
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`IPR2016-00734, Paper 85 at 60 (PTAB Nov. 1, 2017) (holding that a failure to
`
`establish a nexus precluded consideration of evidence of long-felt need, failure of
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`others, skepticism and unexpected results, praise, commercial success, copying,
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`and acquiescence); Gnosis S.P.A. v. S. Ala. Med. Sci. Found., IPR 2013-116, Paper
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`No. 68 at 38 (PTAB June 20, 2014) (“All types of objective evidence of
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`nonobviousness must be shown to have a nexus.”).
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`In a detailed analysis, Dr. Buller demonstrated that PO failed to establish the
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`required nexus because, among other things, Petitioners’ S3 THV lacks a fabric
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`skirt that “extends from the distal end of the replacement valve and back
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`proximally over the expandable anchor” and a “a replacement valve commissure
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`support element attached to the expandable anchor.” Ex. 1045, ¶¶ 9-16; see infra,
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`at Section III(D) at 10-14. Once Dr. Buller determined that there was no nexus
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`between Petitioners’ S3 THV and the Challenged Claims, there was no need for
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`him to further address specific evidence of secondary considerations, which PO
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`tied to Petitioners’ S3 THV.3 See Baker Hughes, Case IPR2016-00734, Paper 85 at
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`3 See Paper 22 at 62 (“Petitioner and others [failed] to solve the problem of PVL
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`until the launch of its SAPIEN 3 in 2014”), 64 (“These publications demonstrate
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`that the TAVR community recognized the need for a solution to PVL from 2004
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`6
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`
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`60; Paper 22 at 47-74. Nonetheless, as PO acknowledges, Dr. Buller further
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`addressed, and refuted, PO’s contention that there was copying. Id., ¶¶ 17-27.4 In
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`short, Dr. Buller addressed secondary considerations and disagreed with PO’s
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`until 2014, when Petitioner launched SAPIEN 3 with a fabric seal”), 64 (asserting
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`that Petitioners SAPIEN 3 copied PO’s Lotus device, which PO claims is an
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`embodiment of the challenged claims), 66 (“The industry has widely praised the
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`reduction in PVL achieved by SAPIEN 3”), 69 (relying on the development of the
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`SAPIEN 3 to show unexpected results), 70 (“SAPIEN 3…has enjoyed enormous
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`commercial success”).
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`4 Although not expressly captioned as “secondary considerations” because they had
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`not yet been asserted, Dr. Buller also addressed the long felt need for a solution to
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`PVL in his original declaration when describing certain known solutions. Ex.
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`1007, ¶ 38 (noting the use of sealing ring to address PVL because “paravalvular
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`leak was a well-recognized complication of surgical valve replacement as early as
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`the 1960s”); ¶ 59 (noting the use of external fabric to address PVL because “stent
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`designers and physicians also recognized the risk of blood leaking between the
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`stent graft prosthesis and the surrounding tissue”); ¶ 83 (noting that the cuff portion
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`of Spenser’s THV helps prevent leakage).
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`
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`7
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`
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`contention that they were present and supported the non-obviousness of the
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`Challenged Claims.5
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`C. Disputes Regarding an Expert’s Analysis of Secondary
`Considerations Go to the Weight Accorded Such Testimony
`and Not Its Exclusion
`
`
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`PO wrongly asserts that Dr. Buller’s testimony can be excluded merely
`
`because, as it alleges (and Petitioners dispute), he did not respond to every alleged
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`secondary consideration. Notwithstanding that Dr. Buller addressed the secondary
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`considerations when he concluded that there was no nexus between Petitioners’ S3
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`THV and the Challenged Claims, even where an expert has not performed a nexus
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`analysis or addressed any of the secondary considerations, the Board has rejected
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`this argument. See Activision Blizzard, Inc. v. Acceleration Bay, LLC, IPR2016-
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`00724, Paper 53 at 57 (PTAB Sept. 15, 2017) (denying motion to exclude based on
`
`PO’s argument that Petitioner’s expert “failed to consider secondary considerations
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`in forming his obviousness analysis”). Indeed, the Board has held that whether to
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`give an expert’s failure to discuss secondary considerations any weight “is not the
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`proper subject matter of a motion to exclude evidence under the Federal Rules of
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`Evidence.” Id.6
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`5 Dr. Buller’s testimony is in stark contrast to PO’s experts who neither addressed
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`secondary considerations nor adopted PO’s position regarding them.
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`6 PO’s authority also does not support such a rule. In Kinetic Concepts, Inc. v.
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`8
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`
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`It also is well recognized that the Board, sitting as a non-jury tribunal with
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`administrative expertise, is well-positioned to determine and assign the appropriate
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`weight to be accorded to the evidence presented by the parties without the need for
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`formal exclusion. See e.g., Smith & Nephew, Inc. v. Arthrex, Inc., IPR2016-00918,
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`Paper 42 at 79-80 (PTAB Oct. 16, 2017). This is yet another reason to deny PO’s
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`Motion. Finally, as the Board explained, “the better course is to have a complete
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`record of the evidence to facilitate public access as well as appellate review.” Id.
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`D. There Is No Basis to Exclude Dr. Buller’s Testimony Based
`PO’s Trial-Within-A-Trial Approach to Secondary
`Considerations
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`Confronted with the fact that Dr. Buller considered PO’s “evidence” of
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`secondary considerations and determined there was a lack of nexus (which defeats
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`all of PO’s secondary considerations arguments), PO attacks the substance of Dr.
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`Buller’s opinion that Petitioners’ S3 THV is covered by the Challenged Claims. In
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`Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012), the Court noted that
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`the accused infringer offered no rebuttal evidence in the face of significant
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`evidence of secondary considerations, including that its own expert did not
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`consider this evidence. Notably, the Court did not preclude the defendant’s expert
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`from testifying on the obviousness of the asserted claims because he did not
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`consider evidence of secondary considerations. Id.; InTouch Techs., Inc. v. VGo
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`Commc’ns., Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014) (same).
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`
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`9
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`
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`doing so, PO has created an improper trial-within-a-trial based on infringement
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`allegations that are not appropriately or adequately presented here by relying on its
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`self-serving allegations as evidence of secondary considerations. Paper 33, at 19 &
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`n.13. The Federal Circuit has criticized this approach to secondary considerations.
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`Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004)
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`(“Not every competing product that arguably fails within the scope of a patent is
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`evidence of copying. Otherwise every infringement suit would automatically
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`confirm the nonobviousness of the patent.”)
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`More importantly, PO’s criticisms of Dr. Buller’s analysis go to the weight
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`his opinion should be afforded, rather than exclusion under the Federal Rules of
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`Evidence. Activision Blizzard, Inc., IPR2016-00724, Paper 53 at 57. PO cites no
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`rule or authority that, even assuming Dr. Buller is incorrect (he isn’t), his opinion
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`should be excluded under the Federal Rules of Evidence.
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`The case for excluding Dr. Buller’s testimony based on PO’s disagreement
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`is even more unjustified given that PO’s Motion is nothing more than attorney
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`argument that belatedly attempts to cure deficiencies in, and improperly expand
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`upon, its Response. Paper 41 at 5-7. Because of the concurrent litigation, PO long
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`has known of Petitioners’ non-infringement contentions and could have had its
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`experts address them in PO’s Response, but chose not to. Now is too late. PO’s
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`10
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`re-casted infringement arguments are not the proper subject matter of a motion to
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`exclude, should be disregarded, and the motion should be denied.
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`PO also is wrong on the merits, which is another reason to deny its motion.
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`First, in its response PO never sought to construe any claim terms to cover a
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`seal made with two separate skirts attached with discrete thread structures, despite
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`knowing that it would be relying on Petitioners’ S3 THV, which it knew to have a
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`two-skirt construction. Paper 21 at 20. Because a motion to exclude is not the
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`proper time to raise new claim construction arguments, PO’s arguments should be
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`disregarded.
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`Second, PO ignores that during the prosecution of the Challenged Claims it
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`distinguished over the prior art its alleged invention having a single-piece
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`construction of its fabric seal by requiring the fabric seal extends from the distal
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`end of the valve back over the anchor. As highlighted in the Petition, PO added
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`the following language in order to distinguish over prior art fabric seals:
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`a distal end of the replacement valve leaflet is attached to the fabric
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`seal and when the expandable anchor is in the collapsed delivery
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`configuration, the fabric seal extends from the distal end of the
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`replacement valve and back proximally over the expandable anchor,
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`the fabric seal being adapted to prevent blood from flowing between
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`the fabric seal and heart tissue.
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`
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`11
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`
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`Petition at 38 (citing July 9, 2014 Amendment at 2, Ex. 1002).
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`By adding this claim language, PO expressly argued that “[a]s shown for
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`example in FIG. 32 of the immediate Application ... the fabric seal doubles over
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`the distal end of the expandable anchor. . . . In contrast, neither Leonhardt nor De
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`Paulis, whether considered independently or in combination, teaches, suggests, or
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`otherwise renders obvious a ‘when the expandable anchor is in the collapsed
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`delivery configuration, the fabric seal extends from the distal end of the
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`replacement valve and back proximally over the expandable anchor.’” Id. at 39
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`(citing July 9, 2014 Amendment at 4-5). Based on this amendment and argument,
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`the examiner allowed the claims. Id. (citing October 6, 2014 notice of allowance).
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`Nowhere in PO’s Response, in its experts’ declarations, or even in its motion
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`to exclude did it address the differences between this claim limitation in light of
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`the prosecution history and Petitioners’ S3 THV two-skirt construction, which Dr.
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`Buller explained does not extend from the distal end of the valve and back
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`proximally over the anchor. The only evidence of record on this issue establishes
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`that these differences are significant because the S3 THV was intentionally
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`designed to use a two-skirt construction having different thread structures to deal
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`with the increase in its length in its compressed, delivery configuration. Ex. 1045
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`at ¶ 14 (“[T]he difference between SAPIEN 3’s two-skirt design and the ’608
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`Patent’s one-skirt design is significant. In SAPIEN 3, the threads making up the
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`
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`12
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`
`
`
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`fabric of the inner skirt are oriented at a 45-degree angle to the longitudinal axis of
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`the valve in order to accommodate the elongation of the structure when it is in its
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`collapsed configuration.”) (internal citations omitted). PO’s attempt to use a
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`motion to exclude to address deficiencies in its nexus argument, and thus salvage
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`its alleged evidence of secondary considerations, is improper and insufficient. As
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`such, these arguments should be disregarded.7
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`Similarly, PO’s belated attempt to rebut Dr. Buller’s analysis that the S3
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`THV lacks “a replacement valve commissure support element attached to the
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`expandable anchor” fares no better. Contrary to PO’s assertion that this is a straw
`
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`7 PO’s attempt to parse the claim language to support its litigation-driven “two-
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`piece” fabric seal construction is unsupported. The only embodiments depicted
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`and described in the ’608 patent show a single-piece construction of the fabric seal.
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`Ex. 1001, Figs. 32-34; col. 14:21-29 (“A fabric seal 380 extends from the distal
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`end of valve 20 and back proximally over anchor 30 during delivery.”) (emphasis
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`added). Similarly, any attempt to rely on the doctrine of equivalents is
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`unsupported. PO’s expert did not argue equivalence in support of his nexus
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`argument and, even if he had, it would be meritless because PO’s amendment and
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`arguments would have precluded it under the doctrine of prosecution history
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`estoppel. See Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722,
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`740-41 (2002).
`
`
`
`13
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`man, PO’s expert never identified what structure he was relying on as the
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`“commissure support element” beyond circling in red a region of the S3 THV with
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`various components. Ex. 2080, App. B at 4-5. In Dr. Buller’s view, the only
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`component that is supporting the commissure is the commissure window, which is
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`an integral part of the frame, and not separately “attached to” the frame as required
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`by the Challenged Claims. Ex. 1045 at 8-9. Faced with this evidence that the S3
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`THV lacks another claimed feature (and thus is not co-extensive with the
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`Challenged Claims), PO again argues claim construction – asserting for the first
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`time that the broadest reasonable interpretation of “attached to” supports its
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`infringement contentions. However, as PO implicitly concedes, an element, like
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`the commissure window in Petitioners’ S3 THV, that is integral with the anchor
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`cannot be “attached to” the anchor under its plain and ordinary meaning. And, as
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`noted above, it is improper for PO to use its motion to exclude to address
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`deficiencies in its nexus argument. In any event, PO’s criticisms of Dr. Buller’s
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`analysis are not a proper reason for excluding his testimony. At most, such
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`criticisms go to the weight Dr. Buller’s testimony should be given rather than its
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`exclusion. Activision Blizzard, Inc., IPR2016-00724, Paper 53 at 57.
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`Finally, contrary to PO’s assertion, Petitioners did not “fail to negate” PO’s
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`alleged evidence of secondary considerations. As explained above and in
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`Petitioners’ Reply, Dr. Buller addressed the lack of nexus, which is necessary for
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`14
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`all of PO’s secondary considerations arguments.8 See supra, Section II; see also
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`Paper 33 at 17-27; Ex. 1045, ¶¶ 9-27. The evidence shows that PO’s allegations of
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`secondary considerations are unsupported and, in any event, cannot overcome
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`Petitioners’ strong showing that the Challenged Claims are obvious.
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`IV. CONCLUSION
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`For the reasons stated, PO’s motion to exclude the original declaration (Ex.
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`1007) and the reply declaration (Ex. 1045) of Dr. Buller should be denied.
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`Dated: November 17, 2017
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`Respectfully Submitted,
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`
`
`/s/Gregory S. Cordrey
` Gregory S. Cordrey, Esq. (Reg. No. 44,089)
` Brian P. Egan, Esq. (Reg. No. 54,866)
` Catherine Nyarady, Esq. (Reg. No. 42,042)
` Attorney for Petitioners
`Edwards Lifesciences Corporation,
`Edwards Lifesciences LLC, and
`Edwards Lifesciences AG
`
`
`
`
`8 Furthermore, as noted, Mr. Wood also addressed in detail the failure of others,
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`long-felt need, copying, industry praise, unexpected results, and commercial
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`success. Ex. 1046, ¶¶ 18-46.
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`
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`15
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on November
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`17, 2017, a complete and entire copy of PETITIONERS’ OPPOSITION TO
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE PURSUANT TO
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`37 C.F.R. § 42.64 has been served in its entirety by e-mail on the following
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`addresses of record for Patent Owner:
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`jennifer.sklenar@apks.com
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`wallace.wu@apks.com
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`marc.cohn@apks.com
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`matthew.wolf@apks.com
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`edward.han@apks.com
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`
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`Dated: November 17, 2017
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`
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`
`
` /s/Gregory S. Cordrey
`Gregory S. Cordrey, Esq. (Reg. No. 44,089)
`Attorney for Petitioners
`Edwards Lifesciences Corporation,
`Edwards Lifesciences LLC, and
`Edwards Lifesciences AG
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`16
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