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 REPLY IN SUPPORT OF ITS
`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 REPLY IN SUPPORT OF ITS
`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
`
`
`
`In its opposition to Patent Owner’s motion to exclude the declarations of its
`
`expert, Dr. Buller, Petitioner does not dispute Patent Owner’s showing that:
`
` In forming his opinion that U.S. Patent No. 8,992,608 (the “‘608 patent”) is
`
`obvious, Dr. Buller never considered evidence of objective indicia of
`
`nonobviousness even in connection with his reply declaration, which was
`
`submitted after Patent Owner placed such evidence into the record through its
`
`Response (Paper 22 at 47-72);
`
` “There is no authority suggesting that attorney argument or another witness’
`
`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” 1 (Paper 41 at 8); and
`
` “[W]hen secondary considerations are present … it is error not to consider
`
`them” and “[t]he objective indicia … play an important role as a guard against
`
`the statutorily proscribed hindsight reasoning in the obviousness analysis”2
`
`1 Petitioner notes in passing that its Corporate Vice President, Larry Wood,
`
`addresses the objective indicia that Dr. Buller failed to address (Paper 45 at 2-3,
`
`15 n.8), but Mr. Wood is not a person of skill in the art and does not opine that the
`
`‘608 patent is obvious. (See Ex. 2096 at 3-4; Ex. 1046 ¶ 9.)
`
`2 Petitioner’s observation that Patent Owner’s experts do not discuss secondary
`
`considerations (Paper 45 at 2, 8 n.5) misses the point; its experts’ opinion—that the
`
`-1-
`
`
`
`(Paper 41 at 2-3 (quoting Federal Circuit cases)).
`
`Petitioner also incorrectly contends that “[o]nce Dr. Buller determined that
`
`there was no nexus between [its product] and the Challenged Claims, there was no
`
`need for him to further address specific evidence of secondary considerations.”
`
`(Paper 45 at 6.) Because Dr. Buller’s analysis of nexus is incorrect, he is not
`
`relieved of the need to consider the objective evidence of nonobviousness.
`
`I.
`
`PATENT OWNER HAS DEMONSTRATED NEXUS
`
`Petitioner wrongly argues that Patent Owner’s position regarding nexus—
`
`that the two fabric skirts of Sapien 3, which are sutured together to form the fabric
`
`seal of the ‘608 patent—depends on a belated claim construction argument.
`
`(Paper 45 at 11.) In fact, Patent Owner relies on the plain and ordinary meaning—
`
`not a specialized construction—of “attached,” which includes both direct and
`
`indirect attachment. (See Paper 41 at 5-7 (citing cases).) Thus, the claimed fabric
`
`seal may be directly attached to the replacement valve leaflets or, as in Sapien 3,
`
`indirectly attached by means of a second piece of fabric. (See Ex. 2080 at 103-10.)
`
`It is Petitioner that relies on an improper claim construction that it failed to plead;
`
`Dr. Buller assumes that the fabric seal must be made from a single piece of fabric
`
`and cannot be constructed from two or more pieces sewn together, despite the
`
`absence of support for this narrow construction of the ‘608 patent’s claims.
`
`’608 patent is not obvious—is not susceptible to hindsight bias.
`
`-2-
`
`
`
`(See Ex. 1045 ¶¶ 11-13); Baby Trend, Inc. v. Wonderland Nurserygoods Co.,
`
`IPR2015-00841, Paper 77 at 18 (PTAB June 27, 2016) (finding “a fabric member”
`
`to mean either “a single piece of fabric or multiple pieces of fabric” because there
`
`is “no clear intent to limit ‘a fabric member’ to just a unitary construction”).
`
`Indeed, this construction would lead to the absurd result that an infringer may
`
`avoid liability simply by manufacturing any claim element as two or more
`
`subcomponents to be combined upon final assembly.
`
`Petitioner’s argument that Patent Owner distinguished the ‘608 patent over
`
`the prior art during prosecution based on a single-piece construction of the claimed
`
`fabric seal (Paper 45 at 11-13) is also wrong. The amendment on which Petitioner
`
`relies added the requirement that the “fabric seal extends from the distal end of the
`
`replacement valve and back proximally over the expandable anchor” in response to
`
`a rejection over Leonhardt in view of De Paulis. (Ex. 1002 at 7/9/14 Amendment.)
`
`This amendment, however, pertains to the location and orientation of the fabric
`
`seal—not whether it is constructed from one or more pieces of material. Indeed,
`
`the alleged seals of Leonhardt and De Paulis were single-piece constructions:
`
`-3-
`
`
`
`(Ex. 1027 at FIG. 4; Ex. 1021 at FIG. 2.) In the case of Sapien 3, its fabric seal,
`
`formed by two pieces of fabric sutured together, extends from the replacement
`
`valve and back proximally over the expandable anchor as claimed in the ‘608
`
`patent. (Ex. 2080 at 103-110.)
`
`Petitioner’s arguments regarding the “commissure support element” are
`
`equally unavailing. In its Motion (Paper 41 at 7), Patent Owner made clear that the
`
`claimed commissure support element is Sapien 3’s
`
`(Ex. 2077 at 11; Ex. 2046 at 28.) Petitioner ignores this showing.
`
`Even if the commissure support element were Sapien 3’s “windows,” as
`
`Petitioner contends (Paper 45 at 14), that element is “attached” to the anchor, as
`
`the claims require. Petitioner’s argument that the windows are not attached to the
`
`frame because they are “an integral part of the frame” (id.) improperly fails to
`
`-4-
`
`
`
`apply the broadest reasonable interpretation of “attached.” (See, e.g., Webster’s II
`
`(1988) (defining “attach” as “To connect as an adjunct or associated part”).) The
`
`Board should reject Petitioner’s argument, which nonsensically requires the Board
`
`to find that two elements joined by metal struts are not “attached” to one another.
`
`II.
`
`DR. BULLER’S FAILURE TO CONSIDER EVIDENCE OF
`OBJECTIVE INDICIA DOES NOT GO ONLY TO WEIGHT
`
`Petitioner’s argument that “criticisms of Dr. Buller’s analysis go to the
`
`weight his opinion should be afforded, rather than exclusion” (Paper 45 at 10)
`
`misconstrues Activision Blizzard, Inc. v. Acceleration Bay, LLC, IPR2016-00724,
`
`Paper 53 (PTAB Sept. 15, 2017). Although “the amount of weight we should give
`
`evidence is not the proper subject matter of a motion to exclude evidence” (id.
`
`at 57), Patent Owner’s motion here seeks exclusion of Dr. Buller’s declarations
`
`under FRE 702 (Paper 41 at 4)—not a ruling as to the weight they should be given.
`
`In any event, Petitioner offers no response to Patent Owner’s showing that the
`
`expert testimony in Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`
`IPR2015-01953, Paper 107 (PTAB Mar. 23, 2017), was allowed specifically
`
`because the expert addressed the objective evidence in his reply declaration—
`
`which Dr. Buller failed to do here. (Paper 41 at 4-5 (citing Activision,
`
`Paper 107 at 36 n.15).)
`
`III. CONCLUSION
`
`The Panel should exclude Dr. Buller’s opening and reply declarations.
`
`-5-
`
`
`
`Dated: December 1, 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.
`
`-6-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`
`REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE EVIDENCE
`
`PURSUANT TO 37 C.F.R. § 42.64 was served on December 1, 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
`
`-i-
`
`
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