`
`U.S. Patent No. 9,125,739
`
`Petition for Inter Partes Review - IPR2020-01454
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC COREVALVE LLC,
`
`Petitioner,
`
`v.
`
`COLIBRI HEART VALVE LLC,
`
`Patent Owner.
`
`____________
`
`Case IPR2020-01454
`
`U.S. Patent No. 9,125,739
`
`____________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`

`

`
`
`U.S. Patent No. 9,125,739
`
`Petition for Inter Partes Review - IPR2020-01454
`
`
`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 
`
`i
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`C. 
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`3. 
`
`E. 
`
`F. 
`
`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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`ii
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`

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`
`
`
`
`Exhibit
`(“Ex.”)
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
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`1016
`
`1017
`
`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
`
`U.S. Patent No. 9,125,739 (“’739”)
`
`Declaration of William J. Drasler, Ph.D. (“Drasler”)
`
`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 8,900,294
`
`International Patent 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
`
`File History of U.S. Patent Application No. 10/037,266
`
`iii
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`

`

`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
`
`
`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 the
`United States District Court of the Central District of California
`Stipulation Regarding IPRs, dated September 1, 2020
`
`Declaration of Crena Pacheco
`
`
`
`
`
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`iv
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`U.S. Patent No. 9,125,739
`
`Petition for Inter Partes Review - IPR2020-01454
`
`Pursuant to §§311-319 and §42.1, Medtronic CoreValve LLC (“Petitioner”)
`
`petitions for 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”).1 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.
`
`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 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.
`
`
`1 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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`’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 ¶¶35-
`
`37.
`
`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.
`
`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.
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`2
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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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`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.
`
`
`
`
`
`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
`
`3
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`

`

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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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`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.
`
`
`
`
`
`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.
`
`4
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`

`

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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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`
`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.
`
`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.
`
`
`
`5
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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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`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).
`
`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.
`
`Petitioner requests that the Board institute trial and find the Claims
`
`unpatentable.
`
`6
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
`
`
`II. MANDATORY NOTICES (§42.8)
`A. Real Party-In-Interest
`Pursuant to §42.8(b)(1), Petitioner identifies Medtronic CoreValve LLC and
`
`Medtronic Inc. 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
`’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).
`
`7
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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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`
`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
`
`Petitioner consents to electronic service of documents to the email addresses
`
`of the counsel identified above.
`
`III. PAYMENT OF FEES
`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. 102760-0210-652.
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`8
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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
`
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW
`A. Grounds for Standing
`Pursuant to §42.104(a), Petitioner certifies ’739 is available for IPR.
`
`Petitioner is 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 requests 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, 2002.2
`
`1.
`The Specific Art on Which the Challenge Is Based
`Petitioner’s grounds rely upon the following prior art:
`
`
`2 Petitioner takes no position as to the propriety of the priority claims as the art
`
`presented herein pre-dates the earliest possible filing date. Petitioner reserves the
`
`right to challenge these priority claims.
`
`9
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`

`

`Patent /
`Publication
`
`Priority Date
`
`Issued /
`Published
`
`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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`Prior Art
`Under at
`Least
`§1023
`(a), (e)
`
`2/10/1999
`
`7/30/2002
`
`5/1/1997
`
`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
`
`
`
`Name
`
`Exhibit
`
`Garrison
`
`1005
`
`Leonhardt 1006
`
`Andersen
`
`1013
`
`Limon
`
`Gabbay
`
`Phelps
`
`Nguyen
`
`1008
`
`1009
`
`1010
`
`1020
`
`2/19/1997
`
`11/24/1998
`
`7/15/1996
`
`6/20/2000
`
`9/12/20004
`
`4/11/2006
`
`9/10/1999
`
`3/23/2000
`
`4/3/1997
`
`10/5/1999
`
`(b),
`
`(b),
`
`(a),
`(e)
`(a),
`(e)
`(e)
`
`(a), (b)
`
`(a), (b),
`(e)
`
`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 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.
`
`10
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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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`2.
`Statutory Grounds on Which the Challenge Is Based
`Petitioner respectfully requests cancellation of the Claims on the following
`
`grounds:
`
`§103
`Ground Claim(s)
`1
`
`Garrison
`
`Prior Art
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`Garrison in view of Leonhardt
`
`1-5
`
`Garrison in view of Nguyen
`
`1-3, 5
`
`Garrison in view of Leonhardt and
`Nguyen
`
`Andersen in view of Limon and Gabbay
`
`Andersen in view of Limon and Phelps
`
`Andersen in view of Limon, Phelps and
`Nguyen
`
`Andersen in view of Limon, Gabbay and
`Garrison
`
`4
`
`Andersen in view of Limon, Phelps and
`Garrison
`
`Andersen in view of Limon, Phelps,
`Nguyen, and Garrison
`
`
`
`3. How the Claims Are Unpatentable
`Petitioner provides the information required under §§42.104(b)(4)-(5) in §X.
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`11
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`V.
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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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`
`’739 PATENT
`’739 generally refers to an implantable replacement heart valve and delivery
`
`system for treating a native heart valve in a patient. ’739, Abstract, 6:49-51, 11:55-
`
`59. 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.
`
`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, 5:27-
`
`28, 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.
`
`12
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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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`
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`’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, 11:40-
`
`51, 12:11-15, 14:10-23, Fig. 8. In the collapsed position, the prosthetic valve’s distal
`
`end is located at the moveable sheath’s distal end when loaded into the delivery
`
`system. ’739, Fig. 8.5 The pusher member and moveable sheath are coaxial, and
`
`move relative to each other.
`
`
`5 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.
`
`13
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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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`’739, 5:16-20. 12:11-15, 14:19-23; Drasler ¶45.
`
`The loaded delivery system is introduced percutaneously and 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, pusher member 420 is pushed
`
`out of the moveable sheath, deploying the valve. ’739, 11:51-59; Drasler ¶¶46-53.
`
`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, 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.
`
`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
`
`14
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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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`U.S. Patent No. 9,125,739
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`Petition for Inter Partes Review - IPR2020-01454
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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