U.S. Patent No. 9,125,739
`
`-_______
`
`Petition for Inter Partes Review - IPR2020-014542021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC COREVALVE LLC,
`Petitioner,
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC
`
`Petitioners
`
`v.
`
`COLIBRI HEART VALVE LLC,
`
`Patent Owner.
`
`________
`
`Case IPR2020-014542021-
`
`U.S. Patent No. 9,125,739
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. Patent No. 9,125,739
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 1 of 103
`
`
`
`-_______
`
`Petition for Inter Partes Review - IPR2020-014542021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC COREVALVE LLC,
`Petitioner,
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC
`
`Petitioners
`
`v.
`
`COLIBRI HEART VALVE LLC,
`
`Patent Owner.
`
`________
`
`Case IPR2020-014542021-
`
`U.S. Patent No. 9,125,739
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. Patent No. 9,125,739
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 1 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`INTRODUCTION
`1
`II. MANDATORY NOTICES (§42.8)
`7
`A. A. Real Party-In-Interest
`7
`7
`B. B. Related Matters
`8
`Lead and Back-Up Counsel and Service Information
`C.
`8
`PAYMENT OF FEES
`III.
`IV. REQUIREMENTS FOR INTER PARTES REVIEW
`98
`98
`A. A. Grounds for Standing
`98
`B. B. Identification of Challenge
`9
`1.
`The Specific Art on Which the Challenge Is Based
`11
`2.
`Statutory Grounds on Which the Challenge Is Based
`11
`3.
`How the Claims Are Unpatentable
`1211
`’739 PATENT
`V.
`14
`’739 PROSECUTION HISTORY
`VI.
`VII.
`THE BOARD SHOULD NOT EXERCISE ITS DISCRETION
`TO
` DENY INSTITUTION
`16
`B.
`§314(a)
`VIII. LEVEL OF ORDINARY SKILL
`IX. CLAIM CONSTRUCTION
`A. A. “trumpet-like” (claim 1)
`B. B. “valve means” (claim 1)
`
`22
`2321
`23
`2423
`2423
`
`16A. UNDER §325(d)
`
` i
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`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 2 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`C.
`
`“controlled release mechanism” (claim 5)
`
`25
`
`25
`
`46
`
`77
`
` ii
`
`X
`
`3.
`
`IX. GROUNDS OF UNPATENTABILITY
`A.
`Ground 1: Claims 1-5 Are Rendered Obvious by Garrison
`2726
`Overview of Garrison ............................................................. 27
`1.
`Claim Chart ............................................................................. 32
`2.
`Ground 2: Claims 1-5 Are Rendered Obvious by Garrison in
`B.
`View of Leonhardt
`.......................................................................................... 47
`C.
`Ground 5: Claims 1-3 and 5 Are Rendered Obvious by
`Andersen in View of Limon and Gabbay
`51
`.............................................................. 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.
`Ground 6: Claims 1-3 and 5 Are Rendered Obvious by
`D.
`Andersen in View of Limon and Phelps
`................................................................ 74 73
`E.
`Grounds 8-9: Claim 4 Is Rendered Obvious by Andersen in
`View of Limon, Garrison and Gabbay (Ground 8) or Phelps (Ground
`9) ....................................................................................................... 76
`75
`Grounds 3-4, 7, 10: Grounds 1-2, 6 and 9 in further view of
`F.
`Nguyen
`............................................................................................................ 77
`76
`XIX. SECONDARY CONSIDERATIONS
`......................................................... 78
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 3 of 103
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`CONCLUSION
`XIIXI.
`........................................................................................... 78
`77
`
`iii
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`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 4 of 103
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`LIST OF EXHIBITS
`Description
`
`U.S. Patent No. 9,125,739 (“’739”)
`
`Exhibit
`(“Ex.”)
`1001
`
`10021
`
`Declaration of William J. Drasler, Ph.D. (“Drasler”)
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`File History of U.S. Patent No. 9,125,739
`
`Reserved
`
`U.S. Patent No. 6,425,916 to Garrison
`
`U.S. Patent No. 5,957,949 to Leonhardt
`
`Reserved
`
`U.S. Patent No. 6,077,295 to Limon
`
`U.S. Patent No. 7,025,780 to Gabbay
`
`International Patent No. WO 00/15147 to Phelps
`
`File History of U.S. Patent No. 8,900,294
`
`International PatentApplication Publication No. WO 98/29057 to
`Letac
`U.S. Patent No. 5,840,081 to Andersen
`
`Reserved
`
`File History of U.S. Patent Application No. 09/659,882
`
`File History of U.S. Patent Application No. 10/887,688
`
`File History of U.S. Patent Application No. 13/675,665
`
`1 Exhibit 1002 is a verbatim copy of the Declaration of William J. Drasler, Ph.D.,
`submitted in IPR2020-01454.
`
` iv
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 5 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`File History of U.S. Patent Application No. 10/037,266
`
`AneuRX Stent Graft System.pdf available at
`https://www.accessdata.fda.gov/cdrh_docs/pdf/P990020c.pdf
`
`U.S. Patent No. 5,961,549 to Nguyen
`
`U.S. Patent No. 5,713,950 to Cox
`
`Screenshot of Docket Navigator Time-to-Milestone Report for
`theReserved
`
`United States District Court of the Central District of California
`Stipulation Regarding IPRs, dated September 1, 2020Reserved
`
`Declaration of Crena PachecoBrian P. Egan
`
`Redline Comparison of this Petition and Petition filed in
`IPR2020-01454 (the “Medtronic IPR”)
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
` v
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 6 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`Pursuant to §§311-319 and §42.1, Medtronic CoreValve LLC (“Petitioner”)
`
`petitions forEdwards Lifesciences Corporation and Edwards Lifesciences LLC
`
`(“Petitioners” or “Edwards”) respectfully request inter partes review (“IPR”) of
`
`claims 1-5 (“Claims”) of U.S. Patent 9,125,739 (“’739”) (Ex. 1001), assigned to
`
`Colibri Heart Valve LLC (“PO”).12 There is a reasonable likelihood that at least
`
`one challenged claim is unpatentable as explained herein. Petitioner requests
`
`review of the Claims, and judgment finding them unpatentable under §103.
`
`I. This petition is being submitted concurrently with a motion for joinder.
`
`Specifically, Petitioners request institution and joinder with Medtronic CoreValve
`
`LLC v. Colibri Heart Valve LLC, IPR2020-01454 (the “Medtronic IPR”), which
`
`the Board instituted on March 10, 2021. This petition is substantially identical to
`
`the petition in the Medtronic IPR; it contains the same grounds (based on the same
`
`prior art combinations and supporting evidence) against the same claims. (See Ex.
`
`1025, illustrating changes between the instant petition and the petition in
`
`IPR2020-01454).
`
`I.
`
`INTRODUCTION
`The ’739’s purported invention is a replacement heart valve formed by a
`
`valve inside of a self-expanding stent, which is delivered to the heart via a vein or
`12 Section cites are to 35 U.S.C. or 37 C.F.R. as context indicates. All
`emphasis/annotations added unless noted. Annotations added to the figures
`herein generally quote the language of the Claims for reference. All citations
`herein are exemplary and not meant to be limiting.
`
` 1
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`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 7 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`artery. For delivery, the valve/stent is collapsed over a pusher member and kept in
`
`place with a moveable outer sheath. The valve/stent is deployed by pushing the
`
`pusher member out of the sheath. ’739, 5:16-21. The stent has a tubular structure
`
`that flares at both ends in a trumpet-like configuration when expanded, but no
`
`additional valve reinforcing members exist inside the stent. Id., cl. 1. Drasler ¶34.
`
`’739 concedes that prosthetic heart valves, e.g., formed of three leaflets of
`
`fixed pericardium tissue, were known prior to the alleged invention. The AAPA
`
`also makes clear that the claimed delivery system (percutaneous, transluminal,
`
`transcatheter delivery systems) for insertion of prosthetic heart valves was also
`
`known prior to the invention. ’739, 3:1-10, 3:41-44, 4:21-25, 4:51-53; Drasler
`
`¶¶3537.
`
`The only purportedly novel element of the Claims is requiring “no reinforcing
`
`members reside within the inner channel of the stent member.” ’739, cl. 1; see §VI
`
`(discussing the prosecution history). Drasler ¶59. But, as discussed herein, it was
`
`already well known to construct and deploy a valve without additional reinforcing
`
`members within the stent structure in the claimed manner. Drasler ¶¶38, 70.
`
` 2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 8 of 103
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`For example, Garrison (Ex. 1005) teaches a known prosthetic valve 6A
`
`comprising a valve portion 38 (annotated blue) that does not have any reinforcing
`
`members and resides entirely within support structure 26/26A (annotated red) both
`
`axially and radially.
`
`Garrison, 5:19-46, 8:13-16, Figs. 10-11 (annotated), 9:64-66. Garrison further
`
`discloses that the support structure 26/26A can have the same features as the valve
`
`displacer 8, which flares at both ends in a trumpet-like configuration.
`
` 3
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`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 9 of 103
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`U.S. Patent No. 9,125,739
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`Garrison, 2:8-11, 4:54-57, 4:66-5:1, Fig. 9. Furthermore, Garrison teaches a
`
`delivery assembly in which the prosthetic valve 6A (annotated green) is collapsed
`
`onto inner rod 78/pusher element 80 (annotated purple) and held in place by the
`
`distal end of moveable sheath 74 (outer wall of catheter 4A). Furthermore, Garrison
`
`teaches a delivery assembly in which the prosthetic valve 6A (annotated yellow).
`
`Garrison, 8:24-28, 8:45-47, Fig. 14 (annotated). Leonhardt (Ex. 1006) further
`
`discloses a prosthetic heart valve in which the valve resides entirely within a
`
`stent with flared ends, without reinforcing members.
`
` 4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 10 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`Leonhardt, Fig. 4, 6:23-31. As a further example, Andersen (Ex. 1013) teaches a
`
`prosthetic cardiac valve that includes a valve (annotated blue) mounted entirely
`
`within a self-expanding “cylindrical support” stent (annotated red), such that the
`
`valve and stent fold and expand together.
`
`Andersen, 1:27-33, 2:28-33, 5:29-30, Fig. 12 (annotated). Andersen discloses that
`
`“any prior art technique” can be used to implant the prosthesis. Andersen, 4:36-40.
`
` 5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 11 of 103
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`U.S. Patent No. 9,125,739
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`Limon (Ex. 1008) discloses a detailed, transcatheter delivery system for
`
`implanting such stents.
`
`Limon, 5:41-44, Fig. 8 (annotated). Gabbay and Phelps also disclose a
`
`self-expanding stent with flared ends to help secure the replacement to the
`
`anatomy. E.g., Gabbay, 3:64-4:8, Fig. 2; Phelps, 7:57-59, Fig. 8.
`
`As demonstrated herein, the prior art renders obvious the Claims, which are
`
`directed to an obvious combination of prior art elements combined according to
`
`known methods
`
`to yield predictable results. The claimed elements and
`
`arrangement of elements are rendered obvious by Garrison (and alternatively in
`
`further view of Leonhardt) and are also rendered obvious by Andersen in view of
`
`Limon and Gabbay (or alternatively Phelps). And Garrison provides additional
`
`teachings for dependent claim 4. At most, the combination amounts to nothing
`
`more than a “predictable use of prior art elements according to their established
`
`functions.” KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
`
` 6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 12 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`The USPTO did not consider Leonhardt, Andersen, Limon, Phelps, or
`
`any other reference providing analogous disclosures during ’739’s prosecution.
`
`The USPTO did not consider the same embodiments of Garrison or substantially
`
`the same arguments regarding any of the references relied on herein during
`
`prosecution. And even if the Office had considered substantially the same art or
`
`arguments, it would have erred in allowing the Claims. See §VII.A.
`
`PetitionerPetitioners requests that the Board institute trial, join this petition
`
`with the Medtronic IPR, and find the Claims unpatentable.
`
`II.
`
`II. MANDATORY NOTICES (§42.8)
`A.
`Real Party-In-Interest
`Pursuant to §42.8(b)(1), Petitioner identifies Medtronic CoreValve LLC and
`
`Medtronic Inc.Petitioners identify Edwards Lifesciences Corporation and Edwards
`
`Lifesciences LLC as real parties-in-interest. No other party had access to or
`
`control over the present Petition, and no other party funded or participated in
`
`preparation of the present Petition.
`
`B.
`
`Related Matters
`
` 7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 13 of 103
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`’739 is currently the subject of a district court litigation: Colibri Heart
`
`Valve 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 Heart Valve LLC v. Medtronic CoreValve LLC, et al., No. 8:19-cv-02351
`
`(C.D. Cal., filed December 5, 2019). Petitioners are not a party to those actions.
`
`’739 is currently also at issue in two other IPR proceedings: (1) the
`
`Medtronic IPR, which was instituted on March 10, 2021; and (2) IPR2020-01649.
`
`IPR2020-01649 is the first petition Edwards Lifesciences filed concerning claims
`
`1-5 of the ’739 patent; the instant petition is Edwards Lifesciences second petition
`
`concerning claims 1-5 of the ’739 patent. The Board instituted IPR2020-01649 on
`
`March 26, 2021. See IPR2020-01649, Paper No. 8.
`
` 8
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 14 of 103
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`C.
`
`Lead and Back-Up Counsel and Service Information
`
`Lead Counsel
`James L. Davis, Jr.
`Brian P. Egan (Reg. No. 57,32554,866)
`ROPESMorris, Nichols, Arsht &
`GRAYTunnell 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-IPRService@
`ropesgray.com
`
`Customer No. 28120
`
`Mailing address for all PTAB
`correspondence:
`ROPES & GRAY LLP
`IPRM—Floor 43
`Prudential Tower
`800 Boylston
`1201 North Market Street
`Boston, Massachusetts 02199-3600
`
`P.O. Box 1347
`Wilmington, DE 19899-1347
`Email: began@morrisnichols.com
`Telephone: 302-351-9454
`Facsimile: 302-498-6216
`
`Backup Counsel
`Scott A. McKeownGregory S. Cordrey
`(Reg. No. 44,089)
`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
`
`Jefffer Mangels Butler & Mitchell, LLP
`3 Park Plaza, Suite 1100
`Irvine, CA 92614
`Email: gcordrey@jmbm.com
`Telephone: 949-623-7200
`Facsimile: 949-623-7201
`
`Petitioner consentsPetitioners consent to electronic service of documents to
`
`the email addresses of the counsel identified above.
`
`III.
`
`III. PAYMENT OF FEES
`
` 9
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 15 of 103
`
`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`The undersigned authorizes the Office to charge the fee required by
`
`§42.15(a) and any additional fees that might be due to Deposit Account No.
`
`18-1945, under Order No. 102760-0210-652100440.
`
`IV.
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW
`A.
`Grounds for Standing
`Pursuant to §42.104(a), Petitioner certifiesPetitioners certify ’739
`
`is available for IPR. Petitioner isPetitioners are not barred or estopped from
`
`requesting IPR challenging the ’739 claims on the grounds identified herein.
`
`B.
`Identification of Challenge
`Pursuant to §42.104(b), Petitioner requestsPetitioners request IPR of
`
`the Claims, and that the Board cancel the same as unpatentable. ’739 matured
`
`from 14/253,650 (“’650 Application”), filed 04/15/2014, and claims priority
`
`through continuations and a continuation-in-part to Application 10/037,266 (Ex.
`
`1018), filed on Jan. 4, 2002.23
`
`1.
`
`The Specific Art on Which the Challenge Is Based
`
`PetitionerPetitioners’s grounds rely upon the following prior art:
`
`2 Petitioner takes3 For purposes of this petition only, Petitioners take no position
`as to the propriety of the priority claims as the art presented herein pre-dates the
`earliest possible filing date. Petitioner reservesPetitioners reserve the right to
`challenge these priority claims.
`
` 10
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`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 16 of 103
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`U.S. Patent No. 9,125,739
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`Name
`
`Exhibit
`
`Patent /
`Publication
`
`Priority Date
`
`Issued /
`Published
`
`Garrison
`
`1005
`
`Leonhardt 1006
`
`Andersen
`
`Limon
`
`Gabbay
`
`Phelps
`
`Nguyen
`
`1013
`
`1008
`
`1009
`
`1010
`
`1020
`
`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
`
`Prior Art
`Under at
`Least
`§10234
`(a), (e)
`
`2/10/1999
`
`7/30/2002
`
`5/1/1997
`
`9/28/1999
`
`(b)
`
`2/19/1997
`
`7/15/1996
`
`9/12/200045
`
`11/24/1998 (a), (b),
` (e)
`(a),
` (e)
`(e)
`
`6/20/2000
`
`4/11/2006
`
`(b),
`
`9/10/1999
`
`3/23/2000
`
`(a), (b)
`
`4/3/1997
`
`10/5/1999 (a), (b), (e)
`
`3 4 Although PO threatened to swear behind art during prosecution, it did not
`attempt to do so, nor can it swear behind the art here. During prosecution of
`’739’s parent, PO submitted documentation indicating the first alleged
`conception of any delivery system was 3/24/2001, and even then the assembly
`identified did not include critical concepts (e.g., pusher member, flared ends and
`trumpet-like configuration). Ex. 1016, 149, 152-236; Ex. 1019, 6. Further, PO
`failed to show diligence in reduction to practice.
`4 5 Gabbay is entitled to an effective filing date of 9/12/2000 as its earlier
`application has the same disclosures as those cited herein. See Ex. 1015 (file
`history of App. No. 09/659,882), 15-29; MPEP 2136; Drasler ¶166.10166.
`
` 11
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 17 of 103
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
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`2.
`
`Statutory Grounds on Which the Challenge Is Based
`
`PetitionerPetitioners respectfully requestsrequest cancellation of the Claims
`
`on the following grounds:
`
`§103
`Ground Claim(s)
`1
`
`Garrison
`
`Prior Art
`
`Garrison in view of Leonhardt
`
`1-5
`
`Garrison in view of Nguyen
`
`Garrison in view of Leonhardt and Nguyen
`
`Andersen in view of Limon and Gabbay
`
`1-3, 5
`
`Andersen in view of Limon and Phelps
`
`Andersen in view of Limon, Phelps and Nguyen
`
`Andersen in view of Limon, Gabbay and Garrison
`
`Andersen in view of Limon, Phelps and Garrison
`
`4
`
`Andersen in view of Limon, Phelps, Nguyen, and
`Garrison
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
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`10
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`3.
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`3.
`
`How the Claims Are Unpatentable
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` 12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 18 of 103
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`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`Petitioner providesPetitioners provide the information required under
`
`§§42.104(b)(4)-(5) in §X.
`
` 13
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 19 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`V.
`
`V. ’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,
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`11:5559. The claimed prosthetic heart valve is generally directed to: (1) a
`
`collapsible stent that flares at both ends; (2) a valve made of fixed pericardial
`
`tissue that does not have any reinforcing members and resides entirely within the
`
`stent. The delivery system is generally directed to a multi-catheter assembly, with
`
`an internal pusher member that the valve is collapsed onto, and an outer moveable
`
`sheath that restrains the collapsed valve onto the pusher member. Drasler ¶41.
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`The prosthetic heart valve comprises a cylindrical “stent member 100” (red
`
`annotation below), preferably “self-expanding” and formed from nitinol and
`
`having flared ends in a “trumpet-like configuration” (not shown), with a “valve
`
`means 200...disposed within the cylindrical stent member” (blue annotation). ’739,
`
`5:2728, 6:57-67, 7:55-63. ’739 concedes that a POSITA would have known that
`
`most tissue valves were leaflets constructed from “the pericardial sac of cows or
`
`pigs and sew[n]...to a stent.” ’739, 3:41-46. The valve does not have any
`
`reinforcing members and resides entirely within the stent.
`
` 14
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 20 of 103
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`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`’739, 5:64-67, 6:57-67, cl. 1, Fig. 5 (annotated). Additionally, the “stent member
`
`100” preferably “carries a plurality of barbs” that extend from the outer surface,
`
`allowing it to be fixed in a desired position. ’739, 8:11-20; Drasler ¶¶42-44.
`
`Prior to introduction into the patient, the valve device (green annotation
`
`below) is collapsed over pusher member 420 (purple annotation), and held in that
`
`collapsed position by a moveable sheath (orange annotation). ’739, 5:16-20,
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`11:4051, 12:11-15, 14:10-23, Fig. 8.6 In the collapsed position, the prosthetic
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`valve’s distal end is located at the moveable sheath’s distal end when loaded into
`
`6 Petitioners reserve the right to dispute whether Figure 8 accurately depicts a
`“pusher member” as it is described in the ’739 specification. See, e.g.,
`IPR2020-01649, Paper 2 at 40 n.8. Any inconsistency between the ’739’s
`specification and Figure 8 is, however, immaterial for purposes of the instant
`petition.
`
` 15
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 21 of 103
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`
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`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`the delivery system. ’739, Fig. 8.57 The pusher member and moveable sheath are
`
`coaxial, and move relative to each other.
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`5 7 Distal refers to the portion away from the user of the device, whereas proximal
`refers to the portion near the user. ’739, 11:40-55, cl. 1.
`
` 16
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 22 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`’739, 5:16-20. 12:11-15, 14:19-23; Drasler ¶45.
`
`The
`
`loaded delivery
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`system
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`is
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`introduced percutaneously and
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`transluminally into the patient, in some embodiments over guidewire 450
`
`(annotated red), to the native heart valve. ’739, 11:44-58, 12:15-24. Then,
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`pusher member 420 is pushed out of the moveable sheath, deploying the valve.
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`’739, 11:51-59; Drasler ¶¶46-53.
`
`VI.
`
`VI. ’739 PROSECUTION HISTORY
`In Application 14/253,650, which matured into ’739, the originally filed
`
`claims were generally directed to a “percutaneous bioprosthetic heart valve and a
`
`delivery and implantation system” with “a stent member...and a valve means,”
`
`and a catheter including a “pusher member and a moveable sheath.” Ex. 1003,
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`44-50, 69-70. The prosthetic heart valve resides “in a collapsed configuration on
`
`the pusher member and is restrained in a collapsed configuration by the
`
`moveable sheath.” Id., 69-70. Drasler ¶¶39-40, 54-55.
`
` 17
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 23 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`The Examiner rejected the issued claims (prosecution claims 34-38) over
`
`Garrison alone and U.S. Publication 2002/0032481A1 (“’481 Gabbay”) in view
`
`of Garrison. Ex. 1003, 1793-1797. Applicant amended prosecution claim 34 to
`
`be directed towards “[a]n assembly for treating a native heart valve in a
`
`patient...for use in combination with a guidewire” and specified the valve means is
`
`“made of fixed pericardial tissue...attached to a proximal and wider part of the
`
`stent member” and the pusher member “includ[es] a guidewire lumen.” Id.,
`
`1867-1879. After an Examiner Interview, Applicant amended prosecution claim
`
`34 to specify that the “distal end of the prosthetic heart valve is located at a distal
`
`end of the moveable sheath” when loaded in the delivery system. Id., 1913-1916,
`
`1923. In a final rejection, the Examiner rejected prosecution claims 34-38 over
`
`multiple grounds, including Garrison in view of Cribier and ’481 Gabbay.
`
`Id.,
`
`1941-1951. Specifically, the Examiner relied on the embodiment of Garrison with
`
`an inverted valve 6D, depicted in Figs. 31-38.” Id. In response, Applicant
`
`distinguished this embodiment of Garrison by amending to require the valve
`
`means be attached “closer to the proximal and wider part of the stent” (a limitation
`
`not in the issued claims) and reside entirely within the inner channel of the stent
`
`member in both “collapsed” and “unrestrained” configurations. Id., 1968-1984.
`
`Applicant separately addressed Garrison’s support structure 26 (depicted in Fig.
`
`10) despite it not being part of the rejection. Id., 1978-1979. Applicant never
`
` 18
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 24 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`disputed that support structure 26 of Garrison discloses a valve entirely within the
`
`inner channel of the stent member, but instead argued that it failed to have a
`
`“trumpet-like” configuration because this was only a feature of a separate “valve
`
`displacer 8”—ignoring Garrison’s disclosure that “all features of any valve
`
`displacer...may also form part of any of the cardiac valves described.” Id;
`
`Garrison 4:52-57. Drasler ¶¶56-58.
`
`After another examiner interview, the Examiner entered an Examiner
`
`Amendment and issued a Notice of Allowance. Ex. 1003, 2148-2150. The
`
`Amendment specified that the “no reinforcing members reside within the inner
`
`channel of the stent member” limitation was added to more clearly overcome a
`
`previous rejection in view of Bailey, but the Examiner did not provide additional
`
`reasons for allowance. Id.; Drasler ¶59.
`
`VII.
`
`VII. THE BOARD SHOULD NOT EXERCISE ITS DISCRETION
`TO DENY INSTITUTION
`A. UNDER §325(d)
`Considering the two-part framework discussed in Advanced Bionics, LLC
`
`v. Med-El Elektromedizinische Gerate GMBH, IPR2019-01469, Pap. 6, *8-9, other
`
`than in the Medtronic IPR, which this petition seeks to join, the Office has not
`
`previously considered the same or substantially the same art or arguments
`
`presented herein, and even if it had, the Office would have erred “in a manner
`
` 19
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 25 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`material to the patentability of challenged claims.” The Board therefore should not
`
`exercise its §325(d) discretion to deny institution.
`
`Grounds 3-6 do not rely on the same or substantially the same art and
`
`arguments raised during ’739’s prosecution. Andersen and Limon were not
`
`previously considered; and no considered reference is substantially similar to
`
`them. For example, Andersen teaches at least one limitation that the Examiner
`
`erroneously believed was not found in the prior art: valve means wherein no
`
`reinforcing members reside within the inner channel of the stent member (see
`
`§X.C.4[1.3]). Andersen also teaches that its valve is implanted via any prior art
`
`technique, and Limon teaches the techniques claimed (see §X.C.4[1.4]-[1.5]).68
`
`The Office also has not previously considered the expert testimony submitted
`
`herewith. Ex. 1002.
`
`Moreover, where the “Examiner did not expressly consider” at least
`
`Andersen, Limon, and Phelps, it is difficult, if not impossible, to explain “why
`
`the Examiner allowed the claims” or “how the Examiner might have considered
`
`the arguments presented in the Petition.” Bowtech, Inc. v. MCP IP, LLC,
`
`6 8 Gabbay and Phelps are relied on for only the well-known stent shape with
`flared ends and pericardial tissue limitations (Grounds 3-6) and Garrison is
`relied on only for its teachings of stent barbs as required in dependent claim 4
`(Grounds 5-6).
`
` 20
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 26 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`IPR2019-00379, Pap. 14, *20 (declining to exercise §325(d) discretion). Thus,
`
`for this further reason, an exercise of §325(d) discretion is not appropriate here.
`
`Grounds 1-2 do not rely on the same or substantially the same art and
`
`arguments raised during ’739’s prosecution. Leonhardt (Ground 2) was not
`
`cited by the Examiner during ’739’s prosecution. And while the Examiner rejected
`
`claims over Garrison alone and ’481 Gabbay in view of Garrison (Ex. 1003,
`
`1794-1797), the Examiner relied on different components in Garrison. The
`
`Examiner relied on an inverted valve attached only at its base to a
`
`circumferential ring 111 as shown in Fig. 38 (below). Ex. 1003, 1794-1795;
`
`Garrison, 10:51-62; see also Ex. 1003, 1795-97 (not relying on Garrison’s
`
`non-inverted valve/stent disclosure). Grounds 1-2 instead rely on another
`
`embodiment, e.g., Fig. 9 (annotated below). E.g., Garrison, 4:66-5:3, 5:42-48.
`
`The Examiner does not appear to have considered Garrison’s separate
`
`disclosure that the support structure 26 (a stent member) can have the same
`
`features as the valve displacer 8, which would include its increasingly flared
`
`ends. E.g., Garrison, 4:52-57. See §VI.
`
` 21
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 27 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`Because Grounds 1-2 present argument based on different embodiment
`
`disclosures than those considered by the Office, the art and arguments are not
`
`substantially the same as those previously considered. NFL Enters. LLC v.
`
`OpenTV, Inc., IPR2017-02092, Pap. 7, *16 (finding arguments and evidence were
`
`not before the Office where the Examiner focused on one embodiment,
`
`overlooking another); Limelight Networks, Inc. v. Akamai Techs., Inc.,
`
`IPR2016-01711, Pap. 10, *21 (finding arguments not the same where there was
`
`“no
`
`indication”
`
`that Examiner considered whether reference’s preferred
`
`embodiment taught certain limitations). Additionally, the expert declaration
`
`submitted herewith was not previously considered. Ex. 1002.
`
`Even if the Examiner had considered substantially the same art or
`
`arguments including the embodiments of Garrison on which Grounds 1-2
`
`rely, the Examiner also committed multiple errors material to patentability.
`
` 22
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 28 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020-014542021-_______
`
`Despite initially rejecting the claims over Garrison alone and/or ’481 Gabbay in
`
`view of Garrison (Ex. 1003, 1794-1797), the Examiner subsequently and
`
`erroneously failed to maintain the Garrison rejections after the claims were
`
`amended to require the valve be “made of fixed pericardial tissue” and that “no
`
`reinforcing members reside within the inner channel of the stent member.” See
`
`§VI. ’739 concedes that a POSITA would have known that “[m]ost tissue valves
`
`are constructed” using fixed pericardial tissue. ’739, 3:41-46. And while the
`
`Examiner’s earlier rejections focused on Garrison’s valve displacer 8 as the stent,
`
`Garrison’s support structure 26A is also a stent, which does not have any
`
`reinforcing members within its inner chamber, and is disclosed as potentially
`
`having the same features of the valve displacer, which would include its
`
`flared-ends in a trumpet-like configuration as further discussed in §X.A and
`
`illustrated in Fig. 9 (annotated). And to the extent that Applicant attempted to
`
`argue that the “inverted” embodiment in Fig. 35 did not reside entirely within the
`
`stent member, Applicant never disputed that these features are disclosed by the
`
`other embodiments of Garrison, including the embodiments relied on in this
`
`petition.
`
` 23
`
`Edwards Lifesciences Corporation, et al. Exhibit 1025, p. 29 of 103
`
`
`
`U.S. Patent No. 9,125,739
`Petition for Inter Partes Review - IPR2020
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