IPR2017-0060
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES LLC,
`AND EDWARDS LIFESCIENCES AG
`Petitioners
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`v .
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`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
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`____________
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`Case IPR2017-00060
`Patent 8,992,608
`____________
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`
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`SUPPLEMENTAL DECLARATION OF NIGEL P. BULLER, M.D.
`SUBMITTED ON BEHALF OF PETITIONERS EDWARDS LIFESCIENCES
`CORPORATION, EDWARDS LIFESCIENCES LLC, AND
`EDWARDS LIFESCIENCES AG
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 1 of 7
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
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`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
`____________
`
`
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`SUPPLEMENTAL DECLARATION OF NIGEL P. BULLER, M.D.
`SUBMITTED ON BEHALF OF PETITIONERS EDWARDS LIFESCIENCES
`CORPORATION, EDWARDS LIFESCIENCES LLC, AND
`EDWARDS LIFESCIENCES AG
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 1 of 7
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`IPR2017-00060
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`I, Dr. Nigel P. Buller, declare as follows:
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`1.
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`I have been retained on behalf of Edwards Lifesciences Corporation,
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`Edwards Lifesciences LLC and Edwards Lifesciences AG (“Edwards”), and its
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`counsel, Jeffer Mangels Butler & Mitchell, LLP, as an expert in this proceeding. I am
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`personally knowledgeable about the matters stated herein and am competent to make
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`this declaration.
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`2.
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`I have been informed that the Patent Owner objected to my qualifications
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`as an expert as of the asserted June 2004 priority date of U.S. Patent No. 8,992,608 (the
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`“’608 Patent”) on “any technical matter relevant to transcatheter aortic heart valves,
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`including, engineering devices for sealing spaces formed by native valve leaflets and
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`fluid dynamics associated with paravalvular leakage of transcatheter aort heart valves,”
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`whether the claims of the ’608 Patent are valid, whether a person of ordinary skill
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`would have been motivated to combine prior art references to disclose the inventions
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`claimed in the '608 patent, the construction and application of claim terms from the
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`'608 patent, and whether I have any first-hand knowledge, experience, or perceptions
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`regarding these issues sufficient to render any lay testimony or opinions on these
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`matters. As such, I have been asked to provide additional explanation regarding these
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`topics.
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`3.
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`First, I incorporate by reference herein the discussion of my Background
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`and Qualifications set forth at Paragraphs 5-26 of my Declaration, as well as my
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`1
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 2 of 7
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`IPR2017-00060
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`Curriculum Vitae attached as Exhibit A to my Declaration, which was submitted as
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`Exhibit 1007 to IPR2017-00060.
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`4.
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`As noted in paragraph 23 of my Declaration, throughout the 1990s, I
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`served on scientific advisory boards, including Patent Owner Boston Scientific’s
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`scientific advisory board, where I discussed and debated concepts and development of
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`a variety of medical devices for use in interventional procedures, including stent-based
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`devices.
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`5.
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`In June of 2004, the asserted priority date of the ’608 Patent, only a
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`handful of physicians in the world had hands-on experience with transcatheter heart
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`valve technology, namely interventional cardiologists Dr. Alain Cribier and his team
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`with respect to aortic transcatheter heart valves and Dr. Philipp Bonhoeffer and his
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`team with respect to pulmonary transcatheter heart valves. As such, a person of
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`ordinary skill in the art for purposes of the ’608 Patent would not be limited to
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`interventional cardiologists with hands-on experience with transcatheter heart valves.
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`Instead, as set forth in my Declaration at Paragraph 36, a person of ordinary skill in the
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`art as of June 2004 would be an interventional cardiologist with a working knowledge
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`of heart valve designs and endovascular prostheses, including expandable stents and
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`stent-grafts. My Declaration provides summations of my expertise in the areas of heart
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`valve designs and endovascular prostheses, including expandable stents and stent-
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`grafts. See Ex. 1007 at Paragraphs 5-26.
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`2
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 3 of 7
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`IPR2017-00060
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`6.
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`I further provide that I have been qualified as an expert in a number of
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`matters involving transcatheter heart valve technology, most recently in a matter where
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`I served as an expert on behalf of Petitioner Edwards Lifesciences in litigation against
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`Patent Owner Boston Scientific involving the European counterpart patents to the ’608
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`Patent, the patent subject here to inter partes review. This and other matters in which
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`I’ve both submitted expert reports and testified at trial on transcatheter heart valve
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`technology are provided below:
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`a. Edwards Lifesciences LLC v. Boston Scientific Scimed, Inc., Case No.
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`HC-2015-004574 (High Court of Justice Chancery Division, United
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`Kingdom). The Approved Judgment in this matter, attached as Exhibit
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`1036 hereto, confirms that I was qualified as an expert witness on
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`transcatheter heart valve technology. See, e.g., Exhibit 1036 at ¶¶ 47-48.
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`b. CoreValve Inc. v. Edwards Lifesciences AG, Case No. HC-07-C01243
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`(High Court of Justice Chancery Division, United Kingdom). The
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`Judgment in this matter, attached as Exhibit 1037 hereto, confirms that I
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`was qualified as an expert witness on transcatheter heart valve technology.
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`See, e.g., Exhibit 1037 at ¶¶ 40-44.
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`c. Edwards Lifesciences AG v. Cook Biotech Inc., Case No. HC08-00934
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`(High Court of Justice Chancery Division, United Kingdom). The
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`Approved Judgment in this matter, attached as Exhibit 1038 hereto,
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`3
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 4 of 7
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`IPR2017-00060
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`confirms that I was qualified as an expert witness on transcatheter heart
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`valve technology. See, e.g., Exhibit 1038 at ¶¶ 5-6.
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`d. Edwards Lifesciences AG v. CoreValve, Inc., C.A. No. 08-091 (GMS) (D.
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`Del.). The Court’s post-trial memorandum opinion in this matter,
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`attached as Exhibit 1039 hereto, confirms that I was qualified as an expert
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`witness on transcatheter heart valve technology. See, e.g., Exhibit 1039 at
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`7.
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`e. Edwards Lifesciences LLC v. Medtronic CoreValve LLC, C.A. No. 12-023
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`(GMS) (D. Del.). There is no post-trial opinion in this matter as it settled
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`prior to issuance of any such opinion, but Edwards’ post-trial brief in
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`support of its motion for enhanced damages, attached hereto as Exhibit
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`1040, confirms that I was qualified as an expert witness on transcatheter
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`heart valve technology. See, e.g., Exhibit 1040 at 12-13.
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`7.
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`I have been informed that the Patent Owner also objected to Exhibit 1015,
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`Excerpts from Vossoughi et al., Stent Graft Update (2000), submitted on October 12,
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`2016 in the Petition for Inter Partes Review, and I have been asked to provide
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`additional information regarding this Exhibit. This textbook is accepted by those of
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`ordinary skill in the art and in the field of interventional cardiology generally as a
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`reliable authority and it also is relied on by persons of ordinary skill in the art and in
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`the field of interventional cardiology. Exhibit 1041 is a true and correct copy of the
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`complete Stent Graft Update textbook.
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`4
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 5 of 7
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`IPR2017—0006O
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` L
` accepted bythose ofordinary Skillin the art andIn the field 0f interventlonal
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`{1:-_ 8 I have been informedthatthe Patent Owner objected to Ex 1016,
`IExcerptsfrornDolmatch et al., Stent Grafts: Current Clinical Practice (1999),
`E‘s‘} submitted on Qctober12, 2016111 the Petition for Inter Partes Review, and I have been
`i asked to prov1de additional information regarding this Exhibit This textbook1S
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`1' cardiologygenerally as a reliable authority and it also15 relied on by persons of
`“
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`’7 r _
`skillin,the art and-in the field ofinterventional cardiolOgy. Exhibit 1042 is a
`trueand correctcobyioi‘ithe complete’SLtent Grafts: Current Clinical Practice textbook.
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`V
`911,11" 1I havebeeninformedthatthe Patent Owner objected to Ex. 1026,
`:1 GoreExcluderInstructions for Use (2002), submitted on October 12, 2016m the
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`Petitlon for Inter Partes Review, and I have been asked to provide additional
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`15.,JApri125, 2017
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`J ,1' authority and1talso13relied on bypersons ofordinary skill1n the art and1nthe field
`I . {of Interventmnal cardiology.
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`.15;
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`' Edwards Lifescience Corporation, et a1. Exhiblt 1035, p. 6 of 7
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 6 of 7
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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 April 26,
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`2017, a complete and entire copy of DECLARATION OF NIGEL P.
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`BUELLER, M.D. 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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`
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`/s/ Gregory Cordrey
`Gregory S. Cordrey
`Attorney for Petitioners
`Registration No. 44,089
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`Edwards Lifescience Corporation, et al. Exhibit 1035, p. 7 of 7
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