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-
`Patent 8,992,608
`____________
`
`
`
`SECOND 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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`
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`
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`Edwards Lifesciences Corporation, et al. Exhibit 1136, Page 1/56
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ........................................................................................... 2
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`A.
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`B.
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`Engagement ........................................................................................... 2
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`Background and Qualifications ............................................................ 2
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`II.
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`LEGAL STANDARDS ................................................................................... 3
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`A. Anticipation and Obviousness .............................................................. 3
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`B. Written Description ............................................................................... 3
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`III. ORDINARY SKILL IN THE ART ................................................................ 4
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`IV. BACKGROUND OF THE RELEVANT TECHNOLOGY ........................... 4
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`A.
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`B.
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`C.
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`D.
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`E.
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`Surgical Prosthetic Heart Valves .......................................................... 5
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`Evolution of Stent Technology ............................................................. 6
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`Stent Foreshortening ............................................................................. 6
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`Stent Grafts and Use of Fabric Covering to Prevent Endoleaks .......... 8
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`Transcatheter Heart Valve Technology .............................................. 12
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`V.
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`SUMMARY OF THE ’608 PATENT .......................................................... 15
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`VI. PROSECUTION HISTORY OF THE ’608 PATENT ................................. 20
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`VII. PROPOSED CONSTRUCTIONS OF CLAIM TERMS .............................. 21
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`VIII. INVALIDITY OF CLAIMS 1–9 OF THE ’608 PATENT .......................... 22
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`A. Ground 1: Claims 1–9 Are Invalid Under 35 U.S.C. § 102(b)
`over Haug (Ex. 1135) .......................................................................... 22
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`1.
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`2.
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`3.
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`4.
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`Claim 1 Preamble ..................................................................... 23
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`Element 1.1 ............................................................................... 23
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`Elements 1.2–1.3 ...................................................................... 24
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`Element 1.4 ............................................................................... 24
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`5.
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`6.
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`7.
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`8.
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`9.
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`Element 1.5 ............................................................................... 25
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`Element 1.6 ............................................................................... 25
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`Element 1.7 ............................................................................... 25
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`Element 1.8 ............................................................................... 25
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`Element 1.9 ............................................................................... 26
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`10. Claims 2–3 ................................................................................ 26
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`11. Claim 4...................................................................................... 26
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`12. Claims 5–6 ................................................................................ 27
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`13. Claims 7–9 ................................................................................ 27
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`B. Ground 2: Claims 1-4 Are Invalid Under 35 U.S.C. § 103(a)
`over Seguin (Ex. 1150, 1153) in View of Lazarus (Ex. 1147)
`and Lawrence-Brown (Ex. 1149) ........................................................ 29
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`Claim 1 Preamble ..................................................................... 29
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`Element 1.1 ............................................................................... 29
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`Elements 1.2-1.3 ....................................................................... 30
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`Element 1.4 ............................................................................... 33
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`Element 1.5 ............................................................................... 34
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`Element 1.6 ............................................................................... 34
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`Element 1.7 ............................................................................... 45
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`Element 1.8 ............................................................................... 47
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`Element 1.9 ............................................................................... 48
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`10. Claims 2–3 ................................................................................ 49
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`11. Claim 4...................................................................................... 52
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`IX. CONCLUSION ............................................................................................. 52
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`ii
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`I, Dr. Nigel P. Buller, declare as follows:
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`1.
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`I am over the age of eighteen (18) and otherwise competent to make
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`this Declaration.
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`2.
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`I understand that this Second Declaration is being submitted in
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`connection with Edwards’1 second Petition for inter partes review (“IPR”) of U.S.
`
`Patent No. 8,992,608 (the “’608 Patent”).
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`3.
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`I previously submitted a Declaration in support of Edwards’ first
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`Petition for IPR of the ’608 Patent, IPR2017-00060 (“First Declaration”), which I am
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`informed was instituted by the Patent Trial and Appeal Board on March 29, 2017.
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`4.
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`I understand that my First Declaration, which was Exhibit 1007 to
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`the First Petetion, will be submitted as Exhibit 1107 to Edwards’ second petition.
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`5.
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`To avoid repetition in this, my Second Declaration, I hereby adopt
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`and incorporate by reference all of my testimony in my First Declaration, and will refer
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`and cite herein to the First Declaration where appropriate.
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`6.
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`Thus, my opinions provided herein are intended to supplement my
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`First Declaration.
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`1 “Edwards” refers collectively to Edwards Lifesciences Corporation, Edwards
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`Lifesciences LLC, and Edwards Lifesciences AG.
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`1
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`I.
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`INTRODUCTION
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`A. Engagement
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`7.
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`I have been retained on behalf of Edwards to provide my opinion
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`on the state of endovascular prosthetic technology as of June 16, 2004, which is the
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`earliest asserted priority date listed on the face of the ’608 Patent. I also provide my
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`opinion on the scope and content of certain “prior art” patents and printed publications.
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`Further, I provide my opinion regarding the subject matter described and claimed in
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`the ’608 Patent. In particular, I have reviewed and analyzed claims 1–9 of the ’608
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`Patent and concluded, for the reasons set forth below, that each of these claims is
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`invalid as anticipated and/or obvious in view of the prior art.
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`8.
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`I reserve the right to supplement, change, clarify, or modify my
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`opinions should additional information and/or documentation become available to me.
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`I also reserve the right to submit a rebuttal declaration in response to any expert
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`declaration(s) submitted on behalf of the owner of the ’608 Patent, Boston Scientific
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`Scimed, Inc.
`
`B.
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`Background and Qualifications
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`9.
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`For my Background and Qualifications, please refer to paragraphs
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`5–26 of my First Declaration, which I adopt and incorporate herein. Ex. 1107 at ¶¶ 5–
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`26.
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`II. LEGAL STANDARDS
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`A. Anticipation and Obviousness
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`10. For the standards for anticipation and obviousness as it has been
`
`explained to me, please refer to paragraphs 27-33 of my First Declaration, which I
`
`adopt and incorporate herein. Ex. 1107 at ¶¶ 27-33.
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`B. Written Description
`
`11.
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`It has been explained to me that in order to satisfy the written
`
`description requirement, the patent’s description must convey to a person of ordinary
`
`skill in the art that the inventor actually invented and was in possession of what is
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`claimed. The written description requirement, as I understand it, ensures that the scope
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`of a patent owner’s right to exclude, as set forth in the claims, does not overreach the
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`scope of the inventor’s contribution to the field of art as described in the patent as
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`originally filed.
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`12.
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`I understand that in determining the sufficiency of the written
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`description, the knowledge in the relevant field at the time of filing, including the
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`extent of the prior art, the maturity of the field, and the predictability of the art are
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`factors to consider. I understand that it is not required that every nuance of the claimed
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`invention be explicitly described, provided that the person of ordinary skill in the art
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`would understand the inventor had possession of the invention at the time of filing.
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`However, I understand that the written description requirement is not met where the
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`patent’s description only renders an invention obvious.
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`III. ORDINARY SKILL IN THE ART
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`13. For my opinion as to the level of ordinary skill in the art as of the
`
`purported priority date, please refer to paragraphs 34–36 of my First Declaration,
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`which I adopt and incorporate herein. Ex. 1107 at ¶¶ 34–36.
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`14.
`
`I am informed that there is a legal dispute as to whether the ’608
`
`Patent does in fact have a priority date of June 16, 2004, or if there is a break in the
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`priority chain such that the ’608 Patent is afforded a priority date of only November
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`24, 2008. Unless otherwise noted, my opinions and analysis set forth herein apply a
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`June 16, 2004 priority date. These opinions would still apply if the priority date is
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`later, i.e., November 24, 2008.
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`IV. BACKGROUND OF THE RELEVANT TECHNOLOGY
`
`15.
`
`In support of Edwards’ first Inter Partes Review Petition, IPR2017-
`
`00060, my Declaration included an extensive summary of the background of
`
`technology relevant to the claims of the ’608 Patent, which I incorporate herein by
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`reference. Ex. 1107 at ¶¶ 37-87.
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`16.
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`In sum, the umbrella of THV technology includes elements from
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`each of surgical prosthetic valve, stent, and stent graft technologies, and thus each of
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`these technologies is relevant to the analysis of the ’608 Patent, and informs a person
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`of ordinary skill in the art of various features incorporated in THV designs, including
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`features of the THV claimed by the ’608 Patent.
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`17.
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`I supplement my Background of the Relevant Technology
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`discussion from my First Declaration below.
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`A.
`
`Surgical Prosthetic Heart Valves
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`18.
`
`In addition to the sealing structures incorporated by the Starr-
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`Edwards and Perimount valves, see Ex. 1107 at ¶¶ 38-39, other variations were known.
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`For example, U.S. Patent No. 5,469,868 (“Reger”) (Ex. 1138) details a surgical valve
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`prosthesis with a dual sewing-ring design (rings 100, 102 below) and an “interfacing
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`portion 104” therebetween:
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`
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`Ex. 1138 at Fig. 1. Each of these elements is covered by a pleated “brim cover 105”
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`that is “made from a material which is permissive to tissue in-growth so that a degree
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`of adhesion improves adhesion of the grafted valve within the native excised valve
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`orifice”:
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`5
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`Id. at Fig. 17 (“each brim cover 105 and 286 is formed from a hollow cylinder 330”)
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`and 10:26-58, 16:19-31. The “interfacing portion 104 . . . is compressible, but which
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`comprises memory which responsively expands to fill space previously vacated and
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`unfilled by the remainder of stent 30 when compressive pressures are relieved.” Id. at
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`10:26-31.
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`19.
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` In my opinion, a person of ordinary skill in the art designing a
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`THV would have been well aware of surgical valve prostheses and the sealing
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`structures that are used to seal those prostheses to the surrounding tissue. The skilled
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`person would also have appreciated the desirability of adopting sealing structures in
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`THV designs that would similarly minimize the risk of blood leaking between the
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`prosthesis and surrounding tissue.
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`B.
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`Evolution of Stent Technology
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`20. For a summary of the evolution of stent technology, please refer to
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`paragraphs 40–46 of my First Declaration, which I adopt and incorporate herein. Ex.
`
`1107 at ¶¶ 40–46.
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`C.
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`Stent Foreshortening
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`21. For a discussion of stent foreshortening, please refer to paragraphs
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`47–51 of my First Declaration. Ex. 1107 at ¶¶ 47–51.
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`22. As noted in my First Declaration, THVs have used stent designs
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`that foreshorten. See, e.g., Ex. 1103 (Cribier WO ’057) at 16:11-16 (disclosing a stent
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`6
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`with an expanded length of 10mm and a collapsed length of 20 mm (i.e., 50%
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`foreshortening)).
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`23. More generally, it was well known that THV stent designs
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`incorporating diamond-like stent patterns naturally exhibit a degree of foreshortening.
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`As pictured in WO 03/003949 (“Seguin,” Ex. 1150), in compressed form, a diamond-
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`shaped cell is elongated, and in expanded form, the diamond-shaped cell expands in
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`width while shortening in length, i.e., it foreshortens:
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`
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`Ex. 1150 at Figs. 5, 7 and at 6 (“Figure 5 is a view of another detail of the stent, on an
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`enlarged scale, in a state of non-expansion of the stent” & “Figure 7 is a view similar
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`to Figure 5, in a state of expansion of the stent”). As explained by Seguin, “[t]he
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`material from which the stent 2 is made is such that these meshes can pass from a
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`contracted configuration, in which the filaments are near one another, giving the
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`meshes an elongate shape, to an expanded configuration, shown in Figure 1 and in
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`detail in Figure 7, in which the filaments are spaced apart from one another.” Ex. 1150
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`at 7.
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`24.
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`It was thus well-known that diamond-celled stent structures like
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`those shown in Cribier and Seguin, in addition to braided-wire stent structures as
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`described more fully in my First Declaration, see, e.g., Ex. 1107 at ¶ 50 (detailing 53%
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`foreshortening of Wallstent), will exhibit a degree of foreshortening between their
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`compressed and expanded states. See also Ex. 1120 (U.S. Patent App. Pub. No.
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`2001/0021872 (“Bailey”)) at ¶ [0021] (disclosing laser-cut diamond-cell and woven-
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`wire stent structures); Ex. 1139 (U.S. Patent No. 7,731,742 (“Schlick”)) at 4:30-
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`51(“the stent 40 can be lengthened in the direction of arrows 47 and subsequently be
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`expanded in a radial direction and shortened in a longitudinal direction”).
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`D.
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`Stent Grafts and Use of Fabric Covering to Prevent Endoleaks
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`25. For background on stent grafts and the use of fabric coverings to
`
`prevent endoleaks, please refer to paragraphs 52–69 of my First Declaration, which I
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`adopt and incorporate herein. Ex. 1107 at ¶¶ 52–69.
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`26.
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`I provide the following additional examples of graft designs known
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`prior to June 2004 that further enhance the external seal to prevent blood from flowing
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`between the seal and surrounding tissue. In my opinion, a person of skill in the art
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`would appreciate that any of the enhanced sealing structures detailed below, as well as
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`those detailed in my First Declaration, could readily be adopted in THV designs to
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`reduce the risk of paravalvular leak. Ex. 1107 at ¶¶ 62-69.
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`27. U.S. Patent No. 5,693,088 (“Lazarus,” Ex. 1147) discloses a sealing
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`structure enhanced with inflatable “toroidal collars”:
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`Ex. 1147 at Fig. 5 (“toroidal collars 50”). A prosthesis incorporating “toroidal collars”
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`“is designed to mold and adhere to calcification within the vessel and to heal to
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`irregular aortic surfaces,” such that the inflatable chamber of the “toroidal collar”
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`“adjust[s] to the unique internal dimension or shape of the vessel.” Ex. 1147 at 6:39-
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`58, 10:5-8; see also id. at Fig. 5. “The toroidal collars . . . contact the inner vessel wall
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`to assure a comprehensive seal between the graft 10 and the vessel wall.” Id. at 14:20-
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`30. “At a minimum, a toroidal collar is positioned about the proximal end of the
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`biocompatible tube. However, additional toroidal collars may be positioned about the
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`distal end of the tube and/or about the extremity of each leg portion in embodiments
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`configured with leg portions.” Id. at 6:53-58.
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`28. The “toroidal collars” can be inflated by the introduction of a fluid
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`into the collars, or they can be filled with the flow of blood when fenestrations are
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`provided in the wall of the graft structure:
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`Following deployment of the graft 10 within the vessel . . . the toroidal
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`collars 50 may be enlarged or inflated by the introduction of, for example, a
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`fluid into the internal space 52 of each toroidal collar 50. The toroidal
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`collars 50 may be inflated in any number of suitable ways. For example,
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`fenestrations (not shown) may be formed through the wall of the tubular
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`body 12, in alignment with a toroidal collar 50, thereby providing means
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`for flow of blood into the internal space 52 of the toroidal collar 50 to fill or
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`inflate the toroidal collar 50 with blood.
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`Ex. 1147 at 15:5-14.
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`29. U.S. Patent No. 5,476,506 (“Lunn,” Ex. 1134) discloses another
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`enhanced graft structure. The graft structure of Lunn has “ridges 26” and “troughs 28”
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`that the Patent Office previously relied on as a teaching of a fabric seal with “pleats” in
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`rejecting pending claims in a related Boston Scientific THV application:
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`Ex. 1142 at pp. 4-5 of March 5, 2009 Final Rejection in related prosecution history of
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`U.S. Patent Application No. 10/972,287.
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`30. U.S. Patent Application Publication No. 2003/0093145
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`(“Lawrence-Brown,” Ex. 1149) discloses another sealing structure with an inflatable
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`chamber that includes “annular flanges or ridges 7”:
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`Ex. 1149 at ¶ [0068] and Figs. 2, 9. “At each end of the graft are a series of annular
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`flanges or ridges 7 which are in effect continuations of the outer wall 2 and when the
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`body is inflated with the settable or filler material, the annular flanges or ridges 7 are
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`also inflated. In use these annular flanges, when inflated, engage against the walls of
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`the body lumen to provide a seal so that blood flow will not occur on the outside of the
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`graft.” Id. Lawrence-Brown further notes that “[a] clear advantage of the graft and
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`deployment system of the present invention over the prior art is that the graft can
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`mould itself to the walls of the artery and/or the laminated thrombus” and thereby
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`“deform to fit the small irregularities” in the surrounding tissue, thereby preventing
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`“endoleaks.” Id. at ¶ [0102]. “In use these annular flanges, when inflated, engage
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`against the walls of the body lumen to provide a seal so that blood flow will not occur
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`on the outside of the graft.” Id. at ¶ [0068].
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`31. Schlick discloses multiple embodiments, including (1) a stent graft
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`incorporating a valve structure; and (2) a bare stent graft. Each embodiment includes a
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`contoured outer surface resulting from stent foreshortening:
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`
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`Ex. 1139 at Fig. 4 and 4:30-51. The contoured seal of Schlick “can adjust to the
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`surface contour in a hollow organ without forming gaps.” Id. at 3:58-4:3.
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`E.
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`Transcatheter Heart Valve Technology
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`32. For a background description of transcatheter heart valve
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`technology, please refer to paragraphs 70–87 of my First Declaration, which I adopt
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`and incorporate herein. Ex. 1107 at ¶¶ 70–87. I supplement this background
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`description below.
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`12
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`(a)
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`Textbook of Interventional Cardiology
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`33.
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`In 1994, Steven Bailey published a chapter in The Textbook of
`
`Interventional Cardiology titled Percutaneous Expandable Prosthetic Valves, and
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`recognized the early work of Dr. Andersen:
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`The most exciting published work in this area to date is the investigations
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`by Andersen et al. from Denmark published in 1992. They reported on
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`their work on developing a transluminal implantable heart valve. They
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`began their investigations in 1987 and have developed an exciting catheter-
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`based technique that has been initially evaluated in a porcine model.
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`See Ex. 1137 (Textbook of Interventional Cardiology) at 1276.
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`34. Bailey further recognized, however, that:
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`Current mechanical and prosthetic valves suffer from a number of problems
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`. . . including the predisposition to thrombus formation and embolization,
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`perivalvular leak, infection, difficulty sizing valve to annulus, valve
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`degeneration, and pannus formation. The designer of any percutaneously
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`placed valve will need to consider these issues during its design and
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`development in order to minimize these problems.
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`Id. at 1271.
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`35. The Textbook design considerations outlined by Bailey in 1994
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`were taken into account in THV development following Andersen’s work. Well before
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`any ’608 Patent priority date, the THV field already yielded design improvements that
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`addressed these considerations, which became state of the art. For example, stent
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`designs were better sized for the target annulus in order to reduce the risk of
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`embolization, valve designs and valve support structures (e.g., support structures for
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`the commissures of the valve) were designed to reduce the risk of valve degeneration,
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`and external seals were designed to reduce the risk of paravalvular leak. See, e.g., Ex.
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`1103 (WO 98/29057 (“Cribier”)), Ex. 1104 (WO 03/047468 (“Spenser”)), Ex. 1150
`
`(Seguin),2 Ex. 1109 (U.S. Patent App. Pub. No. 2001/0039450 (“Pavcnik”)), Ex. 1120
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`(Bailey), Ex. 1133 (U.S. Patent No. 5,855,601 (“Bessler”)). By June 2004, these
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`features were well-understood implementation choices for any THV and would have
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`been obvious to a person of ordinary skill in the art to be predictably, beneficially, and
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`straightforwardly applied together in the combinations claimed by Patent Owner.
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`(b)
`
`Seguin
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`36. As explained in detail, infra Section VIII.B., Seguin details a THV
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`with an anchor (“stent”), a valve structure, commissure support elements, and a fabric
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`seal (“sheath 3” with “flaps” 40 and 42 comprising “peripheral inflatable chambers” 41
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`and 43) that extends from the distal end of the valve structure and back proximally
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`over the anchor:
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`
`2
`I understand that Exhibit 1150 is a certified English translation of WO 03/003949,
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`which was originally published in French. See Ex. 1153. All of my citations and
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`references to “Seguin” are to the English translation (Ex. 1150).
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`Ex. 1108 at Figs. 2, 3, 9, 14 and 2:1-9, 4:4-6, 4:33-37, 5:14-33, 10:22-24, 11:29-31,
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`12:14-21, 15:5-14, 15:22-27, 16:20-36, 17:16-18:3, 18:28-32, 19:1-3, Claims 15-16.
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`V.
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`SUMMARY OF THE ’608 PATENT
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`37. For a summary of the ’608 Patent, please refer to paragraphs 88–
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`106 of my First Declaration. Ex. 1107 at ¶¶ 88–106. I supplement this summary with
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`respect to the ’608 Patent’s claimed features of “a commissure support element” and a
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`valve “commissure portion.”
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`38. Every claim of the ’608 Patent requires “a replacement valve
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`commissure support element attached to the expandable anchor” and “a commissure
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`portion of a replacement valve leaflet attached to the commissure support element.”
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`Ex. 1101, Claim 1 (emphasis added). And every claim of the ’608 Patent uses the
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`transition “comprising.” Id. It has been explained to me that in interpreting patent
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`claims, when a claim uses the “comprising” transition, the use of the article “a” is
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`commonly interpreted as “one or more.” Thus, all claims of the ’608 Patent include
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`both THVs with a plurality of commissure support elements and commissures and
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`THVs with only a single commissure support element or a single commissure.
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`39. Additionally, I note that claims 5, 6, and 8 include further
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`limitations regarding “the commissure support element.” It has been explained to me
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`that in interpreting patent claims, when a claim uses the “comprising” transition, the
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`use of the article “the” is also commonly interpreted as “one or more.”
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`40.
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`I have reviewed the specification of U.S. Patent Application No.
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`10/870,340 (Ex. 1143) (the “Haug application”), which I understand is purported to
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`be the grandparent application of the ’608 Patent. I further understand that the Haug
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`application has the same specification as the ’608 Patent. I find no disclosure in the
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`Haug application of an embodiment having only a single commissure support element
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`or a single commissure.
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`41. Starting with the Figures of the Haug application, the pictured
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`embodiments relate to trileaflet valves with three commissure support elements for
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`each of three commissure portions of the valve:
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`See, e.g., Ex. 1143 at Figs. 3B (cross section of THV depicting two of three
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`commissure support elements and two of three valve commissures), 12B (three-
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`dimensional representation of THV having three commissure support elements and
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`three valve commissures).
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`42. As to the specification of the Haug application, a person of ordinary
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`skill in the art would understand every use of the word “commissure” in this
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`specification to be plural. Ex. 1143 at ¶ [0065] (“Annular base 22 of replacement
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`valve 20 preferably is coupled to skirt region 34 of anchor 30, while commissures 24
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`of replacement valve leaflets 26 are coupled to and supported by posts 38.”);
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`¶ [00104] (“Valve commissures 24 are connected to male interlocking elements 302
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`along their length.”); ¶ [00127] (“Everting valve 520 is similar to previously described
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`valve 20, in that commissures 524 of replacement valve leaflets 526 are coupled to and
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`supported by posts 38 of anchor 30ʹ.”); and ¶ [00145] (“Everting valve 720 further
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`comprises posts 722 to which valve leaflets 726 are attached to provide commissure
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`support.”) (all emphases added). Further, every reference to the “post” element that
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`the specification of the Haug application describes as providing support for the
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`commissures clearly describes a plurality of posts. See Ex. 1143 at ¶¶ [0064], [0065],
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`[0067], [0074], [0077], [0093], [0096], [0097], [00106], [00126], [00127], [00129],
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`[00139], [00140], [00145], [00147], [00149], [00150], [00152], [00153], [00154].
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`43. Similarly, the original claims of the Haug application refer only to
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`commissures in plural form. Ex. 1143 at Claims 18, 64 (“18. The apparatus of claim
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`17, wherein the supporting connection is adapted to support replacement valve
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`commissures.”; “64. The apparatus of claim 63, wherein the supporting connection is
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`adapted to support replacement valve commissures.” (emphases added)).
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`44. The original claims of the Haug application do include a limitation
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`for “a replacement valve support.” However, this refers to a support for the valve as a
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`whole, not a valve commissure. Moreover, the only reference I have located to “a
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`replacement valve support” in the specification of the Haug application incorporates
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`reference to a plurality of commissure support elements: “[a] replacement valve 354
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`[that] is disposed within anchor 350 and supported by a replacement valve support,
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`such as the posts described in earlier embodiments.” Ex. 1143 at ¶ [00106]
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`(emphasis added)).
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`45.
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`In my opinion, a valve with only a single commissure support and
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`a single commissure portion requires a completely different and unique design, which
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`is wholly unsupported in the grandparent application. By comparison, WO
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`1998/029057 (“Cribier,” Ex. 1103) includes embodiments that, at a minimum,
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`suggest to a person of ordinary skill in the art how a THV could be designed with
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`only a single commissure support element and a single commissure portion attached
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`thereto:
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`See Ex. 1103 at Figs. 11c-e. As pictured, the valve structure in this Cribier
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`embodiment includes a semi-rigid part 24’ akin to a commissure support element and a
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`foldable part 23’ that collapses into the semi-rigid part during diastole. Id. This
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`embodiment would, at a minimum, conceptually provides a person of ordinary skill in
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`the art a THV design with only one commissure support element and one commissure
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`portion. Nothing in the Haug application contemplates or suggests in any way a single
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`commissure support element design as suggested by Cribier or otherwise.
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`46. Thus, in my opinion, the Haug application does not provide written
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`description support for a THV comprising a single “commissure support element” or a
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`single valve “commissure portion.”
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`47. The first reference to a singular valve commissure portion and
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`commissure support element in the family of the ’608 Patent is in a preliminary
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`amendment to the ’213 Application, which I understand to be the parent of the ’608
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`Patent, on November 24, 2008. Ex. 1144 at 117 (Nov. 24, 2008 Preliminary
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`Amendment). Like the claims of the ’608 Patent, these claims included “a replacement
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`valve commissure support element attached to the expandable anchor” and “a
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`commissure portion of a replacement valve leaflet attached to the commissure support
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`element.” Id.
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`VI. PROSECUTION HISTORY OF THE ’608 PATENT
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`48. For a summary of the prosecution history of the ’608 Patent, please
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`refer to paragraphs 108–17 of my First Declaration, which I incorporate herein by
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`reference. Ex. 1107 at ¶¶ 108–17.
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`VII. PROPOSED CONSTRUCTIONS OF CLAIM TERMS
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`49. For my opinions on construction of claim terms of the ’608 Patent,
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`please refer to paragraphs 118–29 of my First Declaration, which I incorporate herein
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`by reference. Ex. 1107 at ¶¶ 118–29.
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`50.
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`In addition, I note that I acted as an expert witness on behalf of
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`Edwards Lifesciences in the UK proceeding captioned Edwards Lifesciences LLC v.
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`Boston Sci. SciMed, Inc., Claim No. HC-2015-004574, including at trial in January
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`2017. That trial involved invalidity and infringement issues concerning EP 2 749 254
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`(Ex. 1122) and EP 2 926 766 (Ex. 1130), which are European counterpart patents to
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`the ’608 Patent.
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`51. At that trial, Boston Scientific argued that certain embodiments
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`detailed in EP 254 and EP 766, which are similarly disclosed in the ’608 Patent, are not
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`mutually exclusive. Specifically, Boston Scientific argued that the “sacs” embodiment,
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`which is detailed at Figures 14-16 of the ’608 Patent, and the “flaps and pockets”
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`embodiment, which is detailed at Figures 32-34 of the ’608 Patent, are not mutually
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`exclusive. See Ex. 1145 (Boston’s Closing Statement) at ¶¶ 137–38 (e.g., “[I]t is
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`difficult to draw any c