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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`MEDTRONIC COREVALVE LLC,
`
`Petitioner,
`
`v.
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`COLIBRI HEART VALVE LLC,
`
`Patent Owner.
`
`____________
`
`Case IPR2020-01454
`
`U.S. Patent No. 9,125,739
`
`____________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`
`TABLE OF CONTENTS
`I.
`INTRODUCTION ........................................................................................... 1
`II. MANDATORY NOTICES (§42.8) ................................................................. 7
`A.
`Real Party-In-Interest ............................................................................ 7
`B.
`Related Matters ...................................................................................... 7
`C.
`Lead and Back-Up Counsel and Service Information .......................... 8
`PAYMENT OF FEES ..................................................................................... 8
`III.
`IV. REQUIREMENTS FOR INTER PARTES REVIEW .................................... 9
`A. Grounds for Standing ............................................................................ 9
`B.
`Identification of Challenge .................................................................... 9
`1.
`The Specific Art on Which the Challenge Is Based ................... 9
`2.
`Statutory Grounds on Which the Challenge Is Based .............. 11
`3.
`How the Claims Are Unpatentable ........................................... 11
`’739 PATENT ................................................................................................ 12
`V.
`’739 PROSECUTION HISTORY ................................................................. 14
`VI.
`VII. THE BOARD SHOULD NOT EXERCISE ITS DISCRETION TO
`DENY INSTITUTION .................................................................................. 16
`A.
`§325(d) ................................................................................................ 16
`B.
`§314(a) ................................................................................................. 22
`VIII. LEVEL OF ORDINARY SKILL .................................................................. 23
`IX. CLAIM CONSTRUCTION .......................................................................... 23
`A.
`“trumpet-like” (claim 1) ...................................................................... 24
`B.
`“valve means” (claim 1) ...................................................................... 24
`C.
`“controlled release mechanism” (claim 5) .......................................... 25
`X. GROUNDS OF UNPATENTABILITY ........................................................ 25
`A. Ground 1: Claims 1-5 Are Rendered Obvious by Garrison ................ 27
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`i
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`C.
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`3.
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`E.
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`F.
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`B.
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`1.
`Overview of Garrison ............................................................... 27
`Claim Chart ............................................................................... 32
`2.
`Ground 2: Claims 1-5 Are Rendered Obvious by Garrison in
`View of Leonhardt ............................................................................... 47
`Ground 5: Claims 1-3 and 5 Are Rendered Obvious by
`Andersen in View of Limon and Gabbay ........................................... 52
`1.
`Overview of Andersen .............................................................. 52
`2.
`Overview of Limon and Motivation to Apply Its
`Teachings to Andersen .............................................................. 54
`Overview of Gabbay and Motivation to Combine with
`Andersen ................................................................................... 57
`Claim Chart ............................................................................... 60
`4.
`D. Ground 6: Claims 1-3 and 5 Are Rendered Obvious by
`Andersen in View of Limon and Phelps ............................................. 74
`Grounds 8-9: Claim 4 Is Rendered Obvious by Andersen in
`View of Limon, Garrison and Gabbay (Ground 8) or Phelps
`(Ground 9) ........................................................................................... 76
`Grounds 3-4, 7, 10: Grounds 1-2, 6 and 9 in further view of
`Nguyen ................................................................................................ 77
`XI. SECONDARY CONSIDERATIONS ........................................................... 78
`XII. CONCLUSION .............................................................................................. 78
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`Exhibit
`(“Ex.”)
`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`1017
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`1018
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`LIST OF EXHIBITS
`Description
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`U.S. Patent No. 9,125,739 (“’739”)
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`Declaration of William J. Drasler, Ph.D. (“Drasler”)
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`File History of U.S. Patent No. 9,125,739
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`Reserved
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`U.S. Patent No. 6,425,916 to Garrison
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`U.S. Patent No. 5,957,949 to Leonhardt
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`Reserved
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`U.S. Patent No. 6,077,295 to Limon
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`U.S. Patent No. 7,025,780 to Gabbay
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`International Patent No. WO 00/15147 to Phelps
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`File History of U.S. Patent 8,900,294
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`International Patent No. WO 98/29057 to Letac
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`U.S. Patent No. 5,840,081 to Andersen
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`Reserved
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`File History of U.S. Patent Application No. 09/659,882
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`File History of U.S. Patent Application No. 10/887,688
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`File History of U.S. Patent Application No. 13/675,665
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`File History of U.S. Patent Application No. 10/037,266
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`iii
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`AneuRX Stent Graft System.pdf available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf/P990020c.pdf
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`U.S. Patent No. 5,961,549 to Nguyen
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`U.S. Patent No. 5,713,950 to Cox
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`Screenshot of Docket Navigator Time-to-Milestone Report for the
`United States District Court of the Central District of California
`Stipulation Regarding IPRs, dated September 1, 2020
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`Declaration of Crena Pacheco
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`
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`
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`iv
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`Pursuant to §§311-319 and §42.1, Medtronic CoreValve LLC (“Petitioner”)
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`petitions for inter partes review (“IPR”) of claims 1-5 (“Claims”) of U.S. Patent
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`9,125,739 (“’739”) (Ex. 1001), assigned to Colibri Heart Valve LLC (“PO”).1 There
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`is a reasonable likelihood that at least one challenged claim is unpatentable as
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`explained herein. Petitioner requests review of the Claims, and judgment finding
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`them unpatentable under §103.
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`I.
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`INTRODUCTION
`The ’739’s purported invention is a replacement heart valve formed by a valve
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`inside of a self-expanding stent, which is delivered to the heart via a vein or artery.
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`For delivery, the valve/stent is collapsed over a pusher member and kept in place
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`with a moveable outer sheath. The valve/stent is deployed by pushing the pusher
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`member out of the sheath. ’739, 5:16-21. The stent has a tubular structure that flares
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`at both ends in a trumpet-like configuration when expanded, but no additional valve
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`reinforcing members exist inside the stent. Id., cl. 1. Drasler ¶34.
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`1 Section cites are to 35 U.S.C. or 37 C.F.R. as context indicates. All
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`emphasis/annotations added unless noted. Annotations added to the figures herein
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`generally quote the language of the Claims for reference. All citations herein are
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`exemplary and not meant to be limiting.
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`1
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`’739 concedes that prosthetic heart valves, e.g., formed of three leaflets of
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`fixed pericardium tissue, were known prior to the alleged invention. The AAPA also
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`makes clear that the claimed delivery system (percutaneous, transluminal,
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`transcatheter delivery systems) for insertion of prosthetic heart valves was also
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`known prior to the invention. ’739, 3:1-10, 3:41-44, 4:21-25, 4:51-53; Drasler ¶¶35-
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`37.
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`The only purportedly novel element of the Claims is requiring “no reinforcing
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`members reside within the inner channel of the stent member.” ’739, cl. 1; see §VI
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`(discussing the prosecution history). Drasler ¶59. But, as discussed herein, it was
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`already well known to construct and deploy a valve without additional reinforcing
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`members within the stent structure in the claimed manner. Drasler ¶¶38, 70.
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`For example, Garrison (Ex. 1005) teaches a known prosthetic valve 6A
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`comprising a valve portion 38 (annotated blue) that does not have any reinforcing
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`members and resides entirely within support structure 26/26A (annotated red) both
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`axially and radially.
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`2
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`Garrison, 5:19-46, 8:13-16, Figs. 10-11 (annotated), 9:64-66. Garrison further
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`discloses that the support structure 26/26A can have the same features as the valve
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`displacer 8, which flares at both ends in a trumpet-like configuration.
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`
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`Garrison, 2:8-11, 4:54-57, 4:66-5:1, Fig. 9. Furthermore, Garrison teaches a
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`delivery assembly in which the prosthetic valve 6A (annotated green) is collapsed
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`onto inner rod 78/pusher element 80 (annotated purple) and held in place by the
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`3
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`distal end of moveable sheath 74 (outer wall of catheter 4A). Furthermore, Garrison
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`teaches a delivery assembly in which the prosthetic valve 6A (annotated yellow).
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`Garrison, 8:24-28, 8:45-47, Fig. 14 (annotated). Leonhardt (Ex. 1006) further
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`discloses a prosthetic heart valve in which the valve resides entirely within a stent
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`with flared ends, without reinforcing members.
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`
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`Leonhardt, Fig. 4, 6:23-31. As a further example, Andersen (Ex. 1013) teaches a
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`prosthetic cardiac valve that includes a valve (annotated blue) mounted entirely
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`within a self-expanding “cylindrical support” stent (annotated red), such that the
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`valve and stent fold and expand together.
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`4
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`Petition for Inter Partes Review - IPR2020-01454
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`Andersen, 1:27-33, 2:28-33, 5:29-30, Fig. 12 (annotated). Andersen discloses that
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`“any prior art technique” can be used to implant the prosthesis. Andersen, 4:36-40.
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`Limon (Ex. 1008) discloses a detailed, transcatheter delivery system for implanting
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`
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`such stents.
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`Limon, 5:41-44, Fig. 8 (annotated). Gabbay and Phelps also disclose a self-
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`expanding stent with flared ends to help secure the replacement to the anatomy. E.g.,
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`Gabbay, 3:64-4:8, Fig. 2; Phelps, 7:57-59, Fig. 8.
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`5
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`As demonstrated herein, the prior art renders obvious the Claims, which are
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`directed to an obvious combination of prior art elements combined according to
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`known methods to yield predictable results. The claimed elements and arrangement
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`of elements are rendered obvious by Garrison (and alternatively in further view of
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`Leonhardt) and are also rendered obvious by Andersen in view of Limon and
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`Gabbay (or alternatively Phelps). And Garrison provides additional teachings for
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`dependent claim 4. At most, the combination amounts to nothing more than a
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`“predictable use of prior art elements according to their established functions.” KSR
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`Intern. Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
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`The USPTO did not consider Leonhardt, Andersen, Limon, Phelps, or any
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`other reference providing analogous disclosures during ’739’s prosecution. The
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`USPTO did not consider the same embodiments of Garrison or substantially the
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`same arguments regarding any of the references relied on herein during prosecution.
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`And even if the Office had considered substantially the same art or arguments, it
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`would have erred in allowing the Claims. See §VII.A.
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`Petitioner requests that the Board institute trial and find the Claims
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`unpatentable.
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`II. MANDATORY NOTICES (§42.8)
`A. Real Party-In-Interest
`Pursuant to §42.8(b)(1), Petitioner identifies Medtronic CoreValve LLC and
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`Medtronic Inc. as real parties-in-interest. No other party had access to or control
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`over the present Petition, and no other party funded or participated in preparation of
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`the present Petition.
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`B. Related Matters
`’739 is currently the subject of a district court litigation: Colibri Heart Valve
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`LLC v. Medtronic CoreValve LLC, No. 8:20-cv-847 (C.D. Cal., filed May 4, 2020).
`
`PO dismissed a prior action against Medtronic involving the same patent: Colibri
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`Heart Valve LLC v. Medtronic CoreValve LLC, et al., No. 8:19-cv-02351 (C.D. Cal.,
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`filed December 5, 2019).
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`C. Lead and Back-Up Counsel and Service Information
`
`Lead Counsel
`James L. Davis, Jr.
`Reg. No. 57,325
`ROPES & GRAY LLP
`1900 University Avenue, 6th Floor
`East Palo Alto, CA 94303-2284
`P: 650-617-4794 / F: 617-235-9492
`james.l.davis@ropesgray.com
`Medtronic-Colibri-IPR-
`Service@ropesgray.com
`
`Customer No. 28120
`
`Mailing address for all PTAB
`correspondence:
`ROPES & GRAY LLP
`IPRM—Floor 43
`Prudential Tower
`800 Boylston Street
`Boston, Massachusetts 02199-3600
`
`
`Backup Counsel
`Scott A. McKeown
`Reg. No. 42,866
`ROPES & GRAY LLP
`2099 Pennsylvania Avenue, NW
`Washington, D.C. 20006-6807
`Phone: 202-508-4740
`Fax: 617-235-9492
`scott.mckeown@ropesgray.com
`
`Cassandra Roth
`Reg. No. 73,747
`ROPES & GRAY LLP
`1211 Avenue of the Americas
`New York, NY 10036-8704
`Phone: (212) 596-9000
`Fax: 617-235-9492
`Cassandra.Roth@ropesgray.com
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`Petitioner consents to electronic service of documents to the email addresses
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`of the counsel identified above.
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`III. PAYMENT OF FEES
`The undersigned authorizes the Office to charge the fee required by §42.15(a)
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`and any additional fees that might be due to Deposit Account No. 18-1945, under
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`Order No. 102760-0210-652.
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`U.S. Patent No. 9,125,739
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`IV. REQUIREMENTS FOR INTER PARTES REVIEW
`A. Grounds for Standing
`Pursuant to §42.104(a), Petitioner certifies ’739 is available for IPR.
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`Petitioner is not barred or estopped from requesting IPR challenging the ’739 claims
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`on the grounds identified herein.
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`B.
`Identification of Challenge
`Pursuant to §42.104(b), Petitioner requests IPR of the Claims, and that the
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`Board cancel the same as unpatentable. ’739 matured from 14/253,650 (“’650
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`Application”), filed 04/15/2014, and claims priority through continuations and a
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`continuation-in-part to Application 10/037,266 (Ex. 1018), filed on Jan. 4, 2002.2
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`1.
`The Specific Art on Which the Challenge Is Based
`Petitioner’s grounds rely upon the following prior art:
`
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`2 Petitioner takes no position as to the propriety of the priority claims as the art
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`presented herein pre-dates the earliest possible filing date. Petitioner reserves the
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`right to challenge these priority claims.
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`9
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`Patent /
`Publication
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`Priority Date
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`Issued /
`Published
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`U.S. Patent No. 9,125,739
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`Prior Art
`Under at
`Least
`§1023
`(a), (e)
`
`2/10/1999
`
`7/30/2002
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`5/1/1997
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`9/28/1999
`
`(b)
`
`U.S.
`6,425,916
`U.S.
`5,957,949
`U.S.
`5,840,081
`U.S.
`6,077,295
`U.S.
`7,025,780
`WO
`00/15147
`U.S.
`5,961,549
`
`3 Although PO threatened to swear behind art during prosecution, it did not attempt
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`
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`Name
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`Exhibit
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`Garrison
`
`1005
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`Leonhardt 1006
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`Andersen
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`1013
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`Limon
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`Gabbay
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`Phelps
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`Nguyen
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`1008
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`1009
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`1010
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`1020
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`2/19/1997
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`11/24/1998
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`7/15/1996
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`6/20/2000
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`9/12/20004
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`4/11/2006
`
`9/10/1999
`
`3/23/2000
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`4/3/1997
`
`10/5/1999
`
`(b),
`
`(b),
`
`(a),
`(e)
`(a),
`(e)
`(e)
`
`(a), (b)
`
`(a), (b),
`(e)
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`to do so, nor can it swear behind the art here. During prosecution of ’739’s parent,
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`PO submitted documentation indicating the first alleged conception of any delivery
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`system was 3/24/2001, and even then the assembly identified did not include critical
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`concepts (e.g., pusher member, flared ends and trumpet-like configuration). Ex.
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`1016, 149, 152-236; Ex. 1019, 6. Further, PO failed to show diligence in reduction
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`to practice.
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`4 Gabbay is entitled to an effective filing date of 9/12/2000 as its earlier application
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`has the same disclosures as those cited herein. See Ex. 1015 (file history of App. No.
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`09/659,882), 15-29; MPEP 2136; Drasler ¶166.
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`2.
`Statutory Grounds on Which the Challenge Is Based
`Petitioner respectfully requests cancellation of the Claims on the following
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`grounds:
`
`§103
`Ground Claim(s)
`1
`
`Garrison
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`Prior Art
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`2
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`3
`
`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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`10
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`Garrison in view of Leonhardt
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`1-5
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`Garrison in view of Nguyen
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`1-3, 5
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`Garrison in view of Leonhardt and
`Nguyen
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`Andersen in view of Limon and Gabbay
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`Andersen in view of Limon and Phelps
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`Andersen in view of Limon, Phelps and
`Nguyen
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`Andersen in view of Limon, Gabbay and
`Garrison
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`4
`
`Andersen in view of Limon, Phelps and
`Garrison
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`Andersen in view of Limon, Phelps,
`Nguyen, and Garrison
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`
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`3. How the Claims Are Unpatentable
`Petitioner provides the information required under §§42.104(b)(4)-(5) in §X.
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`V.
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`’739 PATENT
`’739 generally refers to an implantable replacement heart valve and delivery
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`system for treating a native heart valve in a patient. ’739, Abstract, 6:49-51, 11:55-
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`59. The claimed prosthetic heart valve is generally directed to: (1) a collapsible stent
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`that flares at both ends; (2) a valve made of fixed pericardial tissue that does not
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`have any reinforcing members and resides entirely within the stent. The delivery
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`system is generally directed to a multi-catheter assembly, with an internal pusher
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`member that the valve is collapsed onto, and an outer moveable sheath that restrains
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`the collapsed valve onto the pusher member. Drasler ¶41.
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`The prosthetic heart valve comprises a cylindrical “stent member 100” (red
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`annotation below), preferably “self-expanding” and formed from nitinol and having
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`flared ends in a “trumpet-like configuration” (not shown), with a “valve means
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`200…disposed within the cylindrical stent member” (blue annotation). ’739, 5:27-
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`28, 6:57-67, 7:55-63. ’739 concedes that a POSITA would have known that most
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`tissue valves were leaflets constructed from “the pericardial sac of cows or pigs and
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`sew[n]…to a stent.” ’739, 3:41-46. The valve does not have any reinforcing
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`members and resides entirely within the stent.
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`’739, 5:64-67, 6:57-67, cl. 1, Fig. 5 (annotated). Additionally, the “stent member
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`100” preferably “carries a plurality of barbs” that extend from the outer surface,
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`allowing it to be fixed in a desired position. ’739, 8:11-20; Drasler ¶¶42-44.
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`Prior to introduction into the patient, the valve device (green annotation
`
`below) is collapsed over pusher member 420 (purple annotation), and held in that
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`collapsed position by a moveable sheath (orange annotation). ’739, 5:16-20, 11:40-
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`51, 12:11-15, 14:10-23, Fig. 8. In the collapsed position, the prosthetic valve’s distal
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`end is located at the moveable sheath’s distal end when loaded into the delivery
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`system. ’739, Fig. 8.5 The pusher member and moveable sheath are coaxial, and
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`move relative to each other.
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`5 Distal refers to the portion away from the user of the device, whereas proximal
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`refers to the portion near the user. ’739, 11:40-55, cl. 1.
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`’739, 5:16-20. 12:11-15, 14:19-23; Drasler ¶45.
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`The loaded delivery system is introduced percutaneously and transluminally
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`into the patient, in some embodiments over guidewire 450 (annotated red), to the
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`native heart valve. ’739, 11:44-58, 12:15-24. Then, pusher member 420 is pushed
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`out of the moveable sheath, deploying the valve. ’739, 11:51-59; Drasler ¶¶46-53.
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`VI.
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`’739 PROSECUTION HISTORY
`In Application 14/253,650, which matured into ’739, the originally filed
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`claims were generally directed to a “percutaneous bioprosthetic heart valve and a
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`delivery and implantation system” with “a stent member…and a valve means,” and
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`a catheter including a “pusher member and a moveable sheath.” Ex. 1003, 44-50,
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`69-70. The prosthetic heart valve resides “in a collapsed configuration on the pusher
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`member and is restrained in a collapsed configuration by the moveable sheath.” Id.,
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`69-70. Drasler ¶¶39-40, 54-55.
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`The Examiner rejected the issued claims (prosecution claims 34-38) over
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`Garrison alone and U.S. Publication 2002/0032481A1 (“’481 Gabbay”) in view of
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`Garrison. Ex. 1003, 1793-1797. Applicant amended prosecution claim 34 to be
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`directed towards “[a]n assembly for treating a native heart valve in a patient…for
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`use in combination with a guidewire” and specified the valve means is “made of
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`fixed pericardial tissue…attached to a proximal and wider part of the stent member”
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`and the pusher member “includ[es] a guidewire lumen.” Id., 1867-1879. After an
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`Examiner Interview, Applicant amended prosecution claim 34 to specify that the
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`“distal end of the prosthetic heart valve is located at a distal end of the moveable
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`sheath” when loaded in the delivery system. Id., 1913-1916, 1923. In a final
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`rejection, the Examiner rejected prosecution claims 34-38 over multiple grounds,
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`including Garrison in view of Cribier and ’481 Gabbay. Id., 1941-1951.
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`Specifically, the Examiner relied on the embodiment of Garrison with an inverted
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`valve 6D, depicted in Figs. 31-38.” Id. In response, Applicant distinguished this
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`embodiment of Garrison by amending to require the valve means be attached “closer
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`to the proximal and wider part of the stent” (a limitation not in the issued claims)
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`and reside entirely within the inner channel of the stent member in both “collapsed”
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`and “unrestrained” configurations. Id., 1968-1984. Applicant separately addressed
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`Garrison’s support structure 26 (depicted in Fig. 10) despite it not being part of the
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`rejection. Id., 1978-1979. Applicant never disputed that support structure 26 of
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`Garrison discloses a valve entirely within the inner channel of the stent member, but
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`instead argued that it failed to have a “trumpet-like” configuration because this was
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`only a feature of a separate “valve displacer 8”—ignoring Garrison’s disclosure that
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`“all features of any valve displacer…may also form part of any of the cardiac valves
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`described.” Id; Garrison 4:52-57. Drasler ¶¶56-58.
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`After another examiner interview, the Examiner entered an Examiner
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`Amendment and issued a Notice of Allowance. Ex. 1003, 2148-2150. The
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`Amendment specified that the “no reinforcing members reside within the inner
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`channel of the stent member” limitation was added to more clearly overcome a
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`previous rejection in view of Bailey, but the Examiner did not provide additional
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`reasons for allowance. Id.; Drasler ¶59.
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`VII. THE BOARD SHOULD NOT EXERCISE ITS DISCRETION TO
`DENY INSTITUTION
`A.
`§325(d)
`Considering the two-part framework discussed in Advanced Bionics, LLC v.
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`Med-El Elektromedizinische Gerate GMBH, IPR2019-01469, Pap. 6, *8-9, the
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`Office has not previously considered the same or substantially the same art or
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`arguments presented herein, and even if it had, the Office would have erred “in a
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`manner material to the patentability of challenged claims.” The Board therefore
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`should not exercise its §325(d) discretion to deny institution.
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`Grounds 3-6 do not rely on the same or substantially the same art and
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`arguments raised during ’739’s prosecution. Andersen and Limon were not
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`previously considered; and no considered reference is substantially similar to them.
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`For example, Andersen teaches at least one limitation that the Examiner erroneously
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`believed was not found in the prior art: valve means wherein no reinforcing members
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`reside within the inner channel of the stent member (see §X.C.4[1.3]). Andersen
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`also teaches that its valve is implanted via any prior art technique, and Limon
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`teaches the techniques claimed (see §X.C.4[1.4]-[1.5]).6 The Office also has not
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`previously considered the expert testimony submitted herewith. Ex. 1002.
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`Moreover, where the “Examiner did not expressly consider” at least
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`Andersen, Limon, and Phelps, it is difficult, if not impossible, to explain “why the
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`Examiner allowed the claims” or “how the Examiner might have considered the
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`arguments presented in the Petition.” Bowtech, Inc. v. MCP IP, LLC, IPR2019-
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`00379, Pap. 14, *20 (declining to exercise §325(d) discretion). Thus, for this further
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`reason, an exercise of §325(d) discretion is not appropriate here.
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`Grounds 1-2 do not rely on the same or substantially the same art and
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`arguments raised during ’739’s prosecution. Leonhardt (Ground 2) was not
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`cited by the Examiner during ’739’s prosecution. And while the Examiner rejected
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`claims over Garrison alone and ’481 Gabbay in view of Garrison (Ex. 1003, 1794-
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`6 Gabbay and Phelps are relied on for only the well-known stent shape with flared
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`ends and pericardial tissue limitations (Grounds 3-6) and Garrison is relied on only
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`for its teachings of stent barbs as required in dependent claim 4 (Grounds 5-6).
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`1797), the Examiner relied on different components in Garrison. The Examiner
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`relied on an inverted valve attached only at its base to a circumferential ring 111 as
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`shown in Fig. 38 (below). Ex. 1003, 1794-1795; Garrison, 10:51-62; see also Ex.
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`1003, 1795-97 (not relying on Garrison’s non-inverted valve/stent disclosure).
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`Grounds 1-2 instead rely on another embodiment, e.g., Fig. 9 (annotated below).
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`E.g., Garrison, 4:66-5:3, 5:42-48. The Examiner does not appear to have considered
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`Garrison’s separate disclosure that the support structure 26 (a stent member) can
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`have the same features as the valve displacer 8, which would include its increasingly
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`flared ends. E.g., Garrison, 4:52-57. See §VI.
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`Because Grounds 1-2 present argument based on different embodiment
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`disclosures than those considered by the Office, the art and arguments are not
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`substantially the same as those previously considered. NFL Enters. LLC v. OpenTV,
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`Inc., IPR2017-02092, Pap. 7, *16 (finding arguments and evidence were not before
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`the Office where the Examiner focused on one embodiment, overlooking another);
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`Limelight Networks, Inc. v. Akamai Techs., Inc., IPR2016-01711, Pap. 10, *21
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`(finding arguments not the same where there was “no indication” that Examiner
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`considered whether reference’s preferred embodiment taught certain limitations).
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`Additionally, the expert declaration submitted herewith was not previously
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`considered. Ex. 1002.
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`Even if the Examiner had considered substantially the same art or
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`arguments including the embodiments of Garrison on which Grounds 1-2 rely,
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`the Examiner also committed multiple errors material to patentability. Despite
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`initially rejecting the claims over Garrison alone and/or ’481 Gabbay in view of
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`Garrison (Ex. 1003, 1794-1797), the Examiner subsequently and erroneously failed
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`to maintain the Garrison rejections after the claims were amended to require the
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`valve be “made of fixed pericardial tissue” and that “no reinforcing members reside
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`within the inner channel of the stent member.” See §VI. ’739 concedes that a
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`POSITA would have known that “[m]ost tissue valves are constructed” using fixed
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`pericardial tissue. ’739, 3:41-46. And while the Examiner’s earlier rejections
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`focused on Garrison’s valve displacer 8 as the stent, Garrison’s support structure
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`26A is also a stent, which does not have any reinforcing members within its inner
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`chamber, and is disclosed as potentially having the same features of the valve
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`displacer, which would include its flared-ends in a trumpet-like configuration as
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`further discussed in §X.A and illustrated in Fig. 9 (annotated). And to the extent
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`that Applicant attempted to argue that the “inverted” embodiment in Fig. 35 did not
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`reside entirely within the stent member, Applicant never disputed that these features
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`are disclosed by the other embodiments of Garrison, including the embodiments
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`relied on in this petition.
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`Moreover, Leonhardt, which was not cited during ’739’s prosecution, further
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`provides these same teachings that would have been obvious to apply to Garrison as
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`discussed in §X.B and illustrated in Figures 4 and 2 (annotated and excerpted).
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`The Examiner erred in failing to reject the claims over Garrison in view of
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`the AAPA and alternatively in further view of Leonhardt. See Versa Prods. v.
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`Varidesk, LLC, IPR2020-00387, Pap. 13, *15-17 (finding Examiner erred in failing
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`to cite to “better component” and again by failing to adjust mapping of a claim in
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`response to amendment); Arrows Up, LLC v. Oren Techs., LLC, IPR2018-01231,
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`Pap. 7, *11-12 (finding Examiner erred in misunderstanding prior art reference);
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`NFL Enters., IPR2017-02092, Pap. 7, *16 (declining to exercise discretion where
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`Office reached different conclusions on the same evidence); Power Integrations, Inc.
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`v. Semiconductor Components Indus., LLC, IPR2018-01539, Pap. 13, *28-29
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`(finding error where Examiner failed to substantively analyze potential contributions
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`of prior art of record or identify purported “deleterious effects” counseling against
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`combination).
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`B.
`§314(a)
`Co-pending district court proceedings also do not warrant the exercise of
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`discretion under §314(a) based on the six Apple/Fintiv factors. 1: Petitioner intends
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`to seek a stay of the related district court litigation pending the outcome of this IPR
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`and IPR2020-01453 concerning the other asserted patent. 2: While the parties have
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`proposed a February 2022 trial date, Petitioner will be moving for a stay promptly
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`and does not believe a trial date should be set. Moreover, in practice, the median
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`time to trial for a patent case in this district is 2 years 6 months, putting the trial date
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`in November 2022—approximately seven months or more after the Final Written
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`Decision would issue in this proceeding. Ex. 1022. 3: To date, the court has not
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`issued any substantive orders related to ’739 and Petitioner has moved to dismiss
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`pending claims. 4: Contentions have not been served in the litigation and Petitioner
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`has stipulated that it will not pursue the same grounds raised herein in the litigation
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`if this Petition is instituted (Ex. 1023). 5: The litigation and PTAB parties are the
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`same. 6: The merits of this Petition are particularly strong as shown herein,
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`particularly in light of ’739’s admissions that the majority of the limitations were
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`known in the art (see §I).
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`The Board should not exercise its discretion to deny institution.
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`VIII. LEVEL OF ORDINARY SKILL
`A person of ordinary skill in the art (“POSITA”), at the time ’739 or its parent
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`ap