UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
`
`MEDTRONIC COREVALVE LLC, EDWARDS LIFESCIENCES
`CORPORATION, AND
`EDWARDS LIFESCIENCES LLC,
`Petitioner,
`
`v.
`
`COLIBRI HEART VALVE, LLC,
`
`Patent Owner.
`
`____________
`
`Case IPR2020-014541
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`U.S. Patent No. 9,125,739
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`____________
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`DECLARATION OF DR. WILLIAM J. DRASLER IN SUPPORT OF
`PETITIONER’S REPLY TO PATENT OWNER RESPONSE
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`1 Edwards Lifesciences Corporation and Edwards Lifesciences LLC filed a petition
`in IPR2021-00775, and have been joined as petitioners in this proceeding.
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`Medtronic Exhibit 1041
`Medtronic Corevalve v. Colibri Heart Valve
`IPR2020-01454
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`U.S. Patent No. 9,125,739
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`B.
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`2.
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`TABLE OF CONTENTS
`I.
`INTRODUCTION ......................................................................................1
`LEVEL OF ORDINARY SKILL IN THE ART .......................................3
`II.
`III. CLAIM CONSTRUCTION .......................................................................4
`A.
`Flares at both ends in a trumpet-like configuration .............................4
`B.
`Valve means .......................................................................................5
`C.
`Controlled release mechanism ............................................................5
`IV. GARRISON RENDERS OBVIOUS CLAIMS 1-5 (GROUND 1) ............8
`A. Garrison renders obvious “a valve means including…leaflets
`made of fixed pericardial tissue” [1.3] ..............................................11
`Garrison Discloses, and at Minimum Renders Obvious, “the
`stent member…flares at both ends in a trumpet-like
`configuration” [1.2] ..........................................................................15
`1.
`Implementing Garrison’s Features was Within the Skill
`of a Person of Ordinary Skill in the Art ..................................16
`A Person of Ordinary Skill in the Art Would Have Had a
`Reasonable Expectation of Success Implementing
`Garrison’s Features .................................................................24
`Garrison Discloses or Renders Obvious a “controlled release
`mechanism that can be activated” (claim 5) ......................................32
`V. GARRISON IN FURTHER VIEW OF LEONHARDT RENDERS
`OBVIOUS CLAIMS 1-5 (GROUND 2) ...................................................36
`A. A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Apply Leonhardt’s Teachings to Garrison....................37
`Garrison in View of Leonhardt Renders Obvious “the stent
`member includes a tubular structure away from a central
`portion that flares at both ends in a trumpet-like configuration”
`[1.2] ..................................................................................................45
`VI. GARRISON (OR GARRISON IN VIEW OF LEONHARDT) IN
`FURTHER VIEW OF NGUYEN RENDERS OBVIOUS CLAIMS
`1-5 (GROUNDS 3-4) .................................................................................47
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`C.
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`B.
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`B.
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`VII. ANDERSEN AND LIMON, IN FURTHER VIEW OF GABBAY,
`PHELPS, GARRISON AND/OR NGUYEN (GROUNDS 5-10) ............49
`A. A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Apply Limon’s Teachings to Andersen ........................50
`Andersen, Gabbay, and Nguyen Disclose or Render Obvious “a
`Valve Means Including Two to Four Individual Leaflets Made
`of Fixed Pericardial Tissue” ..............................................................61
`A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Apply the Flared Stents of Gabbay or Phelps in
`Implementing Andersen’s Valve Prosthesis ......................................64
`D. A Person of Ordinary Skill in the Art Would Combine
`Andersen’s Prosthesis with Limon’s Delivery System to
`Achieve a “Controlled Release Mechanism” .....................................71
`VIII. CONCLUSION .........................................................................................72
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`C.
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`ii
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`I, Dr. William J. Drasler, have previously been asked to testify as an expert
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`witness in this action. As part of my work in this action, I have been asked by
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`Petitioner to respond to certain assertions by Patent Owner and assertions and
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`opinions from Dr. Lakshmi Prasad Dasi regarding obviousness, including secondary
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`considerations. I hereby declare under penalty of perjury under the laws of the
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`United States as follows:2
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`I.
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`INTRODUCTION
`I am the same William J. Drasler who provided a declaration for this
`1.
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`matter executed on September 1, 2020 (Ex. 1002 (“Drasler Decl.,” “Declaration”)).
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`2. My experience, qualifications, and compensation are provided in my
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`September 1, 2020 Declaration and my curriculum vitae. Drasler Decl., ¶¶7-19,
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`Appendix B. In this Declaration, I have been asked to respond to certain assertions
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`raised by Patent Owner in its Patent Owner’s Response (“POR”) (Paper 14) and by
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`Dr. Lakshmi Prasad Dasi in his supporting declaration (Ex. 2019 (“Dasi”)).
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`3.
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`I understand that, in this proceeding, the Board has instituted Inter
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`Partes Review proceedings based on the following grounds as set forth in my
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`Declaration (Drasler Decl., ¶¶70-226):
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` Throughout this Declaration, all emphasis and annotations are added unless noted.
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` 2
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`1
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`Ground
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`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
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`Claim(s)
`Challenged
`1–5
`1–5
`1–5
`1–5
`1–3, 5
`1–3, 5
`1–3, 5
`4
`4
`4
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`Reference(s)/Basis
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`Garrison
`Garrison, Leonhardt
`Garrison, Nguyen
`Garrison, Leonhardt, Nguyen
`Andersen, Limon, Gabbay
`Andersen, Limon, Phelps
`Andersen, Limon, Phelps, Nguyen
`Andersen, Limon, Gabbay, Garrison
`Andersen, Limon, Phelps, Garrison
`Andersen, Limon, Phelps, Nguyen, Garrison
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`4.
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`In reaching the conclusions described in this Declaration, I have relied
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`on the documents and materials cited herein as well as those cited within and
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`identified in my prior Declaration (see Drasler Decl., Appendix A). I have also
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`considered the documents and materials cited in the POR and the documents cited
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`by Dr. Dasi. A complete listing of all materials upon which I have relied upon in
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`formulating my opinion are included in Appendix C attached hereto.
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`5.
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`As further discussed below, Dr. Dasi’s opinions generally repeat the
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`arguments made by Patent Owner in the POR and vice-versa. I disagree with Dr.
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`Dasi’s opinions for the same reasons that I disagree with the corresponding
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`assertions in the POR and vice-versa.
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`6. My opinions are also based upon my education, training, research,
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`knowledge, and personal and professional experience.
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`7.
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`I hereby declare that all statements made herein of my own knowledge
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`are true and that all statements made on information and belief are believed to be
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`true; and further that these statements were made with the knowledge that willful
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`false statements and the like so made are punishable by fine or imprisonment, or
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`both, under 18 U.S.C. §1001. If called to testify as to the truth of the matters stated
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`herein, I could and would testify competently.
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`II. LEVEL OF ORDINARY SKILL IN THE ART
`In my September 1, 2020 Declaration I opined that “on or before
`8.
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`January 4, 2002, a person of ordinary skill in the art relating to the technology of the
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`’739 patent would have had a minimum of either a medical degree and experience
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`working as an interventional cardiologist or a Bachelor’s degree in bioengineering
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`or mechanical engineering (or a related field) and approximately two years of
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`professional experience in the field of percutaneously, transluminally implantable
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`cardiac prosthetic devices. Additional graduate education could substitute for
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`professional experience, or significant experience in the field could substitute for
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`formal education.” Drasler Decl., ¶31. I have reviewed Dr. Dasi’s opinion regarding
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`the level of ordinary skill in the art with respect to the ’739 patent and his definition
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`is the same. Under my and Dr. Dasi’s definition of the level of ordinary skill in the
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`art I met or exceeded the level of skill required as of January 4, 2002. See, e.g.,
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`Drasler Decl., ¶¶31-32, Appendix B.
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`9. My experience, qualifications, and compensation are provided in my
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`September 1, 2020 Declaration and my curriculum vitae. Drasler Decl., ¶¶7-19,
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`III. CLAIM CONSTRUCTION
`10. As in my September 1, 2020 Declaration, I have interpreted the claims
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`according to their plain and ordinary meaning consistent with the specification. I
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`understand that claim terms should be construed to the extent necessary to resolve
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`the controversy between the parties. However, claim construction is unnecessary
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`here because the Garrison grounds (1-4) and the Andersen grounds (5-10) meet the
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`limitations under the plain and ordinary meaning and Patent Owner’s proposed
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`constructions as further explained in Sections IV-VII and in my September 1, 2020
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`Declaration in Section VIII.
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`A.
`11.
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`Flares at both ends in a trumpet-like configuration
`I understand that Patent Owner proposes to construe the term “flares at
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`both ends in a trumpet-like configuration” means “having, at each end, a widening
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`that resembles the bell of a conventional musical trumpet” (Pap. 14 (“POR”) 7).
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`Such a construction is unnecessary. First, as put forth in my Declaration, the prior
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`art discloses a “trumpet-like” structure. Moreover, Patent Owner admits Garrison
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`and Leonhardt disclose “trumpet-like” structures (and does not raise the issue with
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`respect to the Andersen grounds). POR 27, 45. As I discuss in Section IV.B, Patent
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`Owner and Dr. Dasi wrongly argue that these disclosed features could not be
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`incorporated into Garrison’s valve device. POR 27, 45; Dasi ¶¶130-132, 135, 137,
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`177,. No construction is necessary here and adopting PO’s construction does not
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`impact the result of the IPR.
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`B. Valve means
`12. Similarly unnecessary, is Patent Owner’s proposed construction for
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`“valve means” as “portions of the replacement heart valve device that allow the one-
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`way flow of blood” (POR 7-8). Neither Patent Owner nor Dr. Dasi contest that
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`Garrison discloses “valve means.” POR 10-14; Dasi ¶¶98-126. Regardless, under
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`the plain and ordinary meaning of the term or under Patent Owner’s construction,
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`the limitation is met by all grounds as I discuss Sections IVA and VII.B. As such,
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`no construction is necessary here and adopting PO’s construction does not impact
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`the result of the IPR.
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`C. Controlled release mechanism
`13. Regarding the term “controlled release mechanism,” it is my opinion
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`that its plain and ordinary meaning should apply. This is consistent with how I
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`applied the term in my first Declaration. Drasler Decl., ¶¶68-69, 130-131. Patent
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`Owner and Dr. Dasi purport to show that I applied a different construction (“‘the
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`operator can control when the valve…is released’ including ‘control [of the valve’s
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`release] so that [the valve] doesn’t just arbitrarily pop out…when [the operator]
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`do[es]n’t want it to.’”). POR 8 (citing Ex. 2020 (“DraslerTr.”), 87:14-18); Dasi ¶77
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`(citing DraslerTr., 87:7-18). However, Patent Owner and Dr. Dasi mischaracterize
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`my testimony by omitting my explanation that demonstrates there needs to be some
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`mechanism to control the release of the valve—which is simply the term’s plain and
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`ordinary meaning. Specifically, they omitted the underlined portion:
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`Q. And so I think you -- you sort of set forth a meaning of that in
`paragraph 69, and so I wanted to see if I understand what you’re
`saying. Is it the case that, to one of ordinary skill in the art, you would
`view controlled release meaning that the operator can control when
`the valve of Garrison is released from the sheath?
`A. Control when it’s released, and control it so that it doesn’t just
`arbitrarily pop out, so it has some frictional aspect to it so that it
`doesn’t want to just go outwards and – when you don’t want it to,
`yes.
`Ex. 2020 (“DraslerTr.”), 87:14-18.
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`14. Neither Patent Owner nor Dr. Dasi cite any evidence other than my
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`misrepresented testimony in their attempt to exclude friction as a mechanism to
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`control the release of the valve and modify the term to require that “‘the operator
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`can control when the valve…is released’ including ‘control [of the valve’s release]
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`so that [the valve] doesn’t just arbitrarily pop out…when [the operator] do[es]n’t
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`want it to.’” Regardless of whether the term’s plain and ordinary meaning or Patent
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`Owner’s construction applies, the limitation is met by each of the Grounds put for
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`in my Declaration. With respect to the Garrison grounds, the omitted portion of my
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`testimony underlined above ties back to my testimony on the prior page that this
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`frictional aspect is precisely the mechanism used by Garrison for the controlled
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`release mechanism—demonstrating the limitation is met. DraslerTr. 85:21-86:22.
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`As I testified:
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`Q. Okay. I want to look at the delivery mechanism in Garrison. For
`that, we are looking primarily, I believe, at figure 14. So would you
`agree that there is no attachment mechanism between the valve
`device here and the delivery system?
`MR. DAVIS: Objection; form.
`A. Garrison teaches that the pusher pushes the stent – or valve stent
`out of the sheath such that those projections are extending out of the
`sheath. Then he mentions the word “coupled,” that the stent is
`coupled to the catheter while he manipulates the catheter to allow
`those projections to attach to the displacer. And then – then he
`continues on to allow the stent to be pushed out of the sheath.
`The word “coupled” is a word that I had tried to consider what it
`meant. “Connected” was one of the definitions that I found. My – my
`interpretation, as described in the declaration, is that there is a – a
`frictional force between the stent and the outer sheath that’s holding
`it and that there’s no description that I could find in the specification
`about them being attached.
`DraslerTr. 85:21-86:22. Indeed, Garrison discloses a “controlled release mechanism”
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`under any reasonable construction and PO’s as explained in Section IV.C. And
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`regarding the Andersen grounds, neither Patent Owner nor Dr. Dasi contest that
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`Limon discloses a controlled release mechanism. Rather, as I discuss in Sections
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`VII.A and VII.D, they wrongly argue that Limon’s teaching of this mechanism could
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`not be applied to Andersen’s valve prosthesis. POR 57-58; Dasi ¶¶218-220.
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`IV. GARRISON RENDERS OBVIOUS CLAIMS 1-5 (GROUND 1)
`15. As I set forth in my Declaration, Garrison renders obvious the
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`Challenged Claims. Drasler Decl., ¶¶73-131.
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`16. Patent Owner alleges that “Petitioner’s expert admitted to applying an
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`incorrect standard to his obviousness analysis” and “admitted to opining based on
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`his own perspective, rather than from the perspective of a POSA.” POR 8-9 (citing
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`DraslerTr., 19:13-20:16, 24:5-17, 22:18-23:4). I disagree. Patent Owner is
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`mischaracterizing my testimony concerning obviousness and my experience.
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`Regarding the obviousness standard I applied, Patent Owner omits the very next
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`question following my purported admission, which reveals that unexpected results
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`were not the only way I considered something could be non-obvious. DraslerTr.
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`20:17-21:14. Rather, I was answering Patent Owner’s questions regarding hindsight:
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`Q. Do you have an understanding as to whether hindsight can ever
`be used in deciding whether a claimed invention would have been
`obvious?
`MR. DAVIS: Objection; form.
`A. I believe that if you had hindsight about combining different
`elements that were available to you in a manner that was not
`expected, did not provide an expected result, then it would not be
`obvious.
`Q. Okay. I want to make sure I understood what you said. Are you
`saying that hindsight is related to whether combining -- strike that.
`What do you mean by if you had hindsight about combining different
`elements in a manner that was not expected?
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`A. Okay. Hindsight, I believe, would mean that you’re aware of
`something that is already out there, as opposed to foresight. You’re
`looking back at something that is already out there, something that’s
`available. Okay. So if you merely took that item that was available
`to you and try to write a patent on your -- on that, that would be
`considered obvious and would not be patentable.
`DraslerTr. 19:13-20:16. I testified that if something was known in the art it would
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`have been obvious. DraslerTr. 24:5-17 (“Q. It would just be in the real-time. What
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`you said just a second ago, just reading your answer, you said, ‘If components are
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`brought together in a manner that does not provide any unexpected result and would
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`be obvious to someone skilled in the art at the time, then it would not be a patentable
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`device. It would be considered obvious.’ A. Yeah. Let’s just say, the second half of
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`that, if it was known to an ordinary person skilled in the art, plus does not provide
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`an unexpected result, then it would not be unobvious -- it would be obvious. …”).
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`To the extent Patent Owner’s question instead meant to ask whether it was
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`appropriate to use hindsight in an obviousness analysis, I understand that it is not
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`appropriate, and I have not used hindsight in forming my opinions here. Rather, I
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`offered my opinions from the perspective of a person of ordinary skill in the 2002
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`timeframe. I set forth the standard that I applied for obviousness in my original
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`declaration. Drasler Decl., ¶¶24-29.
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`17. Further, Patent Owner mischaracterizes my testimony concerning
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`whether I considered what I knew in 2002 in performing my analysis; I said that I
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`would consider this information: “Q. Fair. I’ll clarify the question. So in reaching
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`the opinions you set forth in your declaration, did you apply all of the experience
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`that you set forth in your CV up to the January 4th, 2002, date? [¶] A. I have a -- I
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`believe the answer is yes. I -- I would use anything and everything I knew up to that
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`point in 2002.” DraslerTr. 22:18-23:4. However, as I repeatedly testified, I then
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`analyzed the question of obviousness from the perspective of a person of ordinary
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`skill taking into account what that person would have known and understood at the
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`time. E.g., DraslerTr. 23:10-24:17 (explaining that if “somebody…skilled in the art
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`at the time,” would find that the claims simply brought well-known components
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`together without providing unexpected results, then it would be considered obvious),
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`58:13-59:10 (explaining the “considerations…somebody skilled in the art would
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`make…[and] know” in anchoring an aortic valve versus a mitral valve”); Drasler
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`Decl., ¶¶24 (“I understand that obviousness is determined from the perspective of a
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`hypothetical person of ordinary skill in the art and that the asserted claims of the
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`patent should be read from the point of view of such a person at the time the claimed
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`invention was made.”), 40 (“I … consider the patent and the prior art from the
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`perspective of a person of ordinary skill in the art as of January 4, 2002.”).
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`A. Garrison renders obvious “a valve means including…leaflets
`made of fixed pericardial tissue” [1.3]
`18. As I set forth in my Declaration, the ’739 admits that “[m]ost tissue
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`valves are constructed” with fixed pericardial tissue, and a person of ordinary skill
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`in the art would have thus been motivated to and had a reasonable expectation of
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`success implementing Garrison’s valves using fixed pericardial tissue. Drasler Decl.,
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`¶¶87-88, 104-106; ’739 3:41-46. Fixed pericardial tissue was a readily available
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`material that was known to advantageously reduce antigenicity and to be strong for
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`its relatively low profile and easy to manipulate to the desired shape—motivating a
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`person of ordinary skill to use this material. ’739 patent, 3:41-46, 4:51-53; Cox,
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`4:35-45 (“Most tissue valves are constructed … by constructing valve leaflets from
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`the pericardial sac…of cows or pigs and … is chemically treated to alleviate any
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`antigenicity (i.e., to reduce the risk that the patient’s body will reject the foreign
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`tissue[.]”); Nguyen, 1:28-39 (“…pericardium is first harvested … then chemically
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`fixed to crosslink collagen and elastin molecules in the tissue and increase the tissue
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`durability”).
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`19. Despite these motivations, however, Patent Owner argues and Dr. Dasi
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`opines that it would not have been obvious to construct Garrison’s valve from fixed
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`pericardial tissue because it “already has leaflets attached” and therefore “has no
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`need for additional or replacement leaflets.” POR 22; Dasi ¶¶143-144. I disagree
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`for the reasons discussed below.
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`20. Patent Owner also argues “a POSA would not modify a valve device
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`like Garrison’s—with functioning leaflets—to replace the existing leaflets with
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`those of another material” (POR 22). Dr. Dasi’s opinion mirrors this argument. Dasi
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`¶¶140-145. I disagree. Patent Owner’s argument and Dr. Dasi’s opinion
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`misconstrue the grounds as requiring bodily incorporation of pericardial tissue into
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`Garrison rather than applying the well-known teaching of using pericardial tissue in
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`implementing Garrison’s valve. Drasler Decl., ¶¶87-88, 104-106. As I explained in
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`my Declaration, however, a person of ordinary skill in the art would have been
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`motivated to apply known prior-art teachings to implement—not replace—the
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`Garrison valve. Drasler Decl., ¶¶87, 104-105; ’739 3:41-46. Garrison already
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`discloses the shape and design of a valve, and it was known to advantageously
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`construct a valve from fixed pericardial tissue. Drasler Decl., ¶¶87, 104-105.
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`Moreover, given that fixed pericardial tissue was the most common tissue used for
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`prosthetic valves, a person of ordinary skill in the art would have had a reasonable
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`expectation of success in applying these known teachings. Drasler Decl., ¶¶88, 106.
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`21. Patent Owner argues and Dr. Dasi opines that “Petitioner ignores the
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`disadvantages of using fixed pericardial leaflets.” POR 22-25; Dasi ¶¶147-149. But
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`a person of ordinary skill in the art would still have been motivated to apply the
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`admitted prior art’s teachings in implementing Garrison’s valve despite the
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`purported tradeoffs between using a natural valve and a valve formed of pericardial
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`tissue. While a person of ordinary skill would have understood that using pericardial
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`tissue may require some additional sutures, which can have risks (DraslerTr. 87:19-
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`90:11) and that pericardial tissue can be slippery, the ’739 admits “[m]ost tissue
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`valves are constructed” with fixed pericardial tissue because of its other benefits,
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`such as its high strength to weight ratio and because of the ease in “handl[ing] and
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`fold[ing] the material” after it has been dried and compressed. ’739 3:41-46. Thus,
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`a person of ordinary skill would have had an expectation of success in using fixed
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`pericardial tissue and understood that it would have worked. Drasler Decl., ¶¶42, 86-
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`88, 104-106. In fact, Garrison already discloses using sutures for the native pig valve
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`used therein to attach the natural valve—posing the same risk of creating a seam
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`susceptible to tearing that is present when a suture is used to form a fixed pericardial
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`tissue valve. Garrison 5:46-48; Drasler Tr. 88:6-89:5. Dr. Dasi’s assertions that I do
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`not describe how a person of skill would make Garrison’s valve out of fixed
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`pericardial tissue or attach it to the Garrison’s stent (Dasi ¶¶149, 197) are similarly
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`unfounded as it would have been well-within the ability of a person of ordinary skill
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`to use the most-common material for forming valves to create Garrison’s valve and
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`attach it to the stent in the manner taught in Garrison (and admitted to be known in
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`the prior art by the ’739 patent) as I previously testified. Drasler Decl., ¶¶87, 106,
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`152-153; ’739 3:41-46.
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`22. Patent Owner asserts and Dr. Dasi opines that I did not consider the
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`damage to/durability of the leaflet in forming my opinions. POR 24; Dasi ¶145
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`(citing, Ex. 2021 (Fisher), 16(2):105-110, Ex. 2022 (Rygg), 2:45-52, DraslerTr.
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`88:6-90:11). I disagree. Patent Owner’s argument and Dr. Dasi’s opinion are
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`mistaken. As I testified, “I did consider that any damage to the leaflet was something
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`that had to be taken into consideration.” DraslerTr. 36:20-37:9. But, as I further
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`testified, “[t]he damage to the leaflet associated with stretching is…typically not the
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`main focus of the type of damage that could occur.” DraslerTr. 36:20-37:9. Indeed,
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`as I testified, there are both advantages and disadvantages to each approach—I
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`explained that a person of ordinary skill in the art would have been motivated to
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`apply the known and most-common approach of using pericardial tissue instead of
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`a natural valve to advantageously, e.g., “form [the valve] into whatever shape”
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`needed; “when you make a pericardial valve” you have the “control” to “pick a
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`strong pericardial tissue” and “form the leaflets into the size you want … to suite the
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`various patients.” DraslerTr. 90:16-92:7; Drasler Decl., ¶¶87, 106. Indeed, Patent
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`Owner’s and Dr. Dasi’s own exhibits (relied on to show that using pericardial tissue
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`requires sutures that are a point of weakness) acknowledge that using pericardial
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`tissue has advantages. See, e.g., Ex. 2021 (Fisher), 105 (acknowledging that by 1987
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`“pericardial bioprosthesis has been used clinically for over 13 years with good
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`clinical follow-up results”); Ex. 2022 (Rygg), 2:5-12 (acknowledging that fixed
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`“porcine pericardium … have the advantages in common that follow from the
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`application of a heterologous material, viz. that they remain thin and movable, and
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`that no deposits are formed on the them that may get loose and cause thrombi”). This
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`is a significant benefit over trying to find a pig with a native valve of the right size:
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`“[e]verybody would have known that pig valves vary in size, in accordance with the
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`size of the pig.” DraslerTr. 91:21-92:1.
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`B. Garrison Discloses, and at Minimum Renders Obvious, “the stent
`member…flares at both ends in a trumpet-like configuration”
`[1.2]
`23. As I set forth in my Declaration and as I testified, Garrison’s explicit
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`teachings provide two configurations that have a valve-device that flares in the
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`trumpet-like configuration: 1) a two-component configuration applying Garrison’s
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`teaching that “all features of any valve displacer described herein may also form part
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`of any of the cardiac valves described herein” (Garrison 4:54-57); and 2) an
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`integrated structure where a valve (including its support structure) and a valve
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`displacer are “integrated into a single structure and delivered together” (Garrison
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`4:52-54). Garrison 2:5-10, 4:58-65; Drasler Decl., ¶¶77-78, 96-99. I explained that
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`a person of ordinary skill in the art would have understood, or at least found it
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`obvious, that a self-expanding cardiac valve 6A would have the flared features of
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`valve displacer 8 in order to “ensure cardiac valve 6A advantageously conforms to
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`the valve displacer” as part of the two-component system “or [conform] directly to
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`the vessel wall” as part of an integrated embodiment and that such cardiac valves
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`with flared features were well-known. Drasler Decl., ¶¶77-78. Accordingly,
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`Garrison discloses, and at minimum renders obvious, a support structure with a
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`flared shape, or alternately an integrated valve and valve displacer with a flared
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`shape. Drasler Decl., ¶¶77-78, 98-99.
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`1.
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`Implementing Garrison’s Features was Within the Skill of a
`Person of Ordinary Skill in the Art
`24. Patent Owner and Dr. Dasi insinuate that it would be impossible for the
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`valve to have this type of flared structure and that a person of ordinary skill in the
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`art would not have known how to implement it. POR 10-21; Dasi ¶¶98-99, 106-112,
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`134, 137. I disagree. Garrison teaches that the valve device may have the flared
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`structure (e.g., as part of a two-component system, or as part of an “integrated”
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`system where the valve and displacer are combined into a single structure) as
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`discussed above and in my original declaration. Drasler Decl., ¶¶77-78, 98-99. In
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`addition, Patent Owner and Dr. Dasi mischaracterize my expert testimony and
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`miscategorizes the various embodiments described by Garrison.
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`25. First, Patent Owner asserts and Dr. Dasi opines that a person of ordinary
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`skill in the art would not have known how to implement the Garrison system where
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`the valve had a flared structure, and that doing so would have been disadvantageous
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`or dangerous in the 2002-2004 timeframe. POR 10, 12, 17-20; Dasi ¶¶98-99, 106-
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`112, 134, 137. I disagree. Patent Owner’s assertion relies on Dr. Dasi’s conclusory
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`opinions that “a person of skill in the art would not know how to use Garrison’s
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`disclosures to make this purported fourth embodiment,” but such a claim is
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`unfounded. A person of ordinary skill in the art would have understood that
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`Garrison’s teachings would work and provide for an effective valve-replacement
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`system. For example, Dr. Dasi’s discussions of “deformations” in the valve displacer
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`caused by the vasculature (e.g., Dasi ¶¶106-108) ignore that the valve displacer and
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`the valve support (which has the same shape as the valve displacer in the two-
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`component embodiment) are designed to maintain their shape during implantation
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`and any minor deformations due to surrounding tissues would be accommodated by
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`both in the same way; moreover, any such deformations would not impact the
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`integrated embodiment discussed above. Dr. Dasi’s speculative concerns regarding
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`mating issues are unfounded. Dr. Dasi’s comments regarding the unclaimed
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`potential step of pacing the heart during the procedure (Dasi ¶109) are similarly
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`unfounded as Garrison does not teach away from pacing and instead leaves that to a
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`person of ordinary skill in the art. Dr. Dasi also opines that “Garrison does not teach
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`a person of skill how to properly align any integrated valve with the native leaflets,
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`rather than to engage the valve displacer.” Dasi ¶122. But, Dr. Dasi provides no
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`support for such a conclusory statement, and he contradicts the repeated disclosures
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`in the prior art confirming that a person of ordinary skill in the art would have
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`understood that such an arrangement would indeed work. Drasler Decl., ¶¶77-78
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`(citing Garrison, Leonhardt, Gabbay and Phelps). In the two-component
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`arrangement, where the support structure of the valve has the shape of the valve
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`displacer, the valve (and its support structure) are still deployed in the valve displacer
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`such that it is aligned relative to the native leaflets. Garrison, 2:16-19 (explaining
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`the cardiac valve may be “positioned independent from the valve displacer”), 5:1-
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`13 (explaining the alignment relative to the native leaflets such that they are “trapped
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`in the recess” and held “open” by the “flared ends”), Fig. 9 (illustrating