`
`IPR2020-01454
`U.S. Patent No. 9,125,739
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC COREVALVE LLC, EDWARDS LIFESCIENCES
`CORPORATION, AND
`EDWARDS LIFESCIENCES LLC,
`
`Petitioner,
`v.
`
`COLIBRI HEART VALVE, LLC,
`
`Patent Owner.
`
`____________
`
`Case IPR2020-014541
`
`U.S. Patent No. 9,125,739
`
`____________
`
`
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`1 Edwards Lifesciences Corporation and Edwards Lifesciences LLC filed a petition
`in IPR2021-00775, and have been joined as petitioners in this proceeding.
`
`

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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`B. 
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`2. 
`
`TABLE OF CONTENTS
`I. 
`INTRODUCTION ......................................................................................... 1 
`II.  CLAIM CONSTRUCTION .......................................................................... 1 
`III.  GARRISON RENDERS OBVIOUS CLAIMS 1-5 (GROUND 1) ............ 3 
`A.  Garrison renders obvious “a valve means including…leaflets
`made of fixed pericardial tissue” [1.3] .................................................. 3 
`Garrison Discloses, and at Minimum Renders Obvious, “the
`stent member…flares at both ends in a trumpet-like
`configuration” [1.2] ............................................................................... 5 
`1. 
`A POSITA Would Have Known How to Implement
`Garrison’s Features ..................................................................... 6 
`A POSITA Would Have Had a Reasonable Expectation
`of Success Implementing Garrison’s Features.......................... 10 
`Garrison Discloses or Renders Obvious a “controlled release
`mechanism that can be activated” (claim 5) ....................................... 13 
`IV.  GARRISON IN FURTHER VIEW OF LEONHARDT RENDERS
`OBVIOUS CLAIMS 1-5 (GROUND 2) ..................................................... 15 
`A.  A POSITA Would Have Been Motivated to Apply Leonhardt’s
`Teachings to Garrison ......................................................................... 15 
`Garrison in View of Leonhardt Renders Obvious “the stent
`member includes a tubular structure away from a central
`portion that flares at both ends in a trumpet-like configuration”
`[1.2] ..................................................................................................... 18 
`V.  GARRISON (AND GARRISON IN VIEW OF LEONHARDT) IN
`FURTHER VIEW OF NGUYEN RENDERS OBVIOUS CLAIMS
`1-5 (GROUNDS 3-4) .................................................................................... 18 
`VI.  ANDERSEN IN VIEW OF LIMON, IN FURTHER VIEW OF
`GABBAY, PHELPS, GARRISON AND/OR NGUYEN
`(GROUNDS 5-10) ........................................................................................ 19 
`A.  A POSITA Would Have Been Motivated to Apply Limon’s
`Teachings to Andersen ........................................................................ 20 
`
`C. 
`
`B. 
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`B. 
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`C. 
`
`Andersen, Gabbay, and Nguyen Disclose or Render Obvious “a
`Valve Means Including Two to Four Individual Leaflets Made
`of Fixed Pericardial Tissue” ................................................................ 24 
`A POSITA Would Have Implemented the Flared Stents of
`Gabbay or Phelps in Andersen’s Valve Prosthesis ............................. 25 
`D.  A POSITA Would Have Been Motivated to Apply Limon’s
`Delivery System Teachings to Andersen’s Prosthesis to
`Achieve a “Controlled Release Mechanism That Can Be
`Activated” ............................................................................................ 27 
`VII.  PO MISCHARACTERIZES DR. DRASLER’S TESTIMONY ............. 28 
`VIII.  DIRECTOR REVIEW IS AVAILABLE .................................................. 29 
`
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`ii
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`
`
`LIST OF EXHIBITS
`U.S. Patent No. 9,125,739 (“’739”)
`
`Ex. 1001
`
`Ex. 1002
`
`Declaration of William J. Drasler, Ph.D. (“Drasler”)
`
`Ex. 1003
`
`File History of U.S. Patent No. 9,125,739
`
`Ex. 1004
`
`Reserved
`
`Ex. 1005
`
`U.S. Patent No. 6,425,916 to Garrison
`
`Ex. 1006
`Ex. 1007
`Ex. 1008
`Ex. 1009
`Ex. 1010
`Ex. 1011
`Ex. 1012
`Ex. 1013
`Ex. 1014
`Ex. 1015
`Ex. 1016
`Ex. 1017
`Ex. 1018
`Ex. 1019
`
`Ex. 1020
`Ex. 1021
`Ex. 1022
`
`Ex. 1023
`Ex. 1024
`Ex. 1025
`Ex. 1026
`
`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
`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
`Stipulation Regarding IPRs, dated December 22, 2020
`Jane Doe et al. v. Xavier Becerra et al., No. 8:19-cv-02105, U.S.
`District Court Docket (C.D. Cal.)
`
`iii
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`Shuthima Pongsai V. Am. Express Co., No. 8:19cv1628, U.S.
`District Court Docket (C.D. Cal.)
`C.D. Cal. General Order 20-12 dated September 14, 2020
`C.D. Cal. General Order 20-15 dated November 25, 2020
`C.D. Cal. General Order 20-05 dated April 13, 2020
`C.D. Cal. General Order 20-08 dated May 28, 2020
`C.D. Cal. General Order 20-09 dated August 6, 2020
`C.D. Cal. Order of the Chief Judge 20-042 dated March 19, 2020
`Activation of Continuity of Operations Plan dated December 7,
`2020
`Press Release - Activation of Continuity of Operations Plan dated
`December 7, 2020
`Colibri Heart Valve LLC v Medtronic Corevalve LLC, No. 8:20-
`cv-00847, U.S. District Court Docket (C.D. Cal.)
`Extension of Continuity of Operations Plan dated January 6, 2021
`Colibri Heart Valve LLC v Medtronic Corevalve LLC, No. 8:20-
`cv-00847-DOC-JDE, Dkt. 73, Scheduling Order (C.D. Cal.
`November 24, 2020)
`Medtronic, Inc. v. Axonics Modulation Techns., Inc., No. 8:19-cv-
`02115-DOC-JDE, Dkt. 55, Order Granting Defendant’s Motion to
`Stay Litigation Pending Inter Partes Review (C.D. Cal. May 8,
`2020)
`Declaration of Crena Pacheco
`Reply Declaration of William J. Drasler, Ph.D. (“DraslerReply”)
`USPTO implementation of an interim Director review process
`following Arthrex, available
`at https://www.uspto.gov/patents/patent-trial-and-appeal-
`board/procedures/uspto-implementation-interim-director-review
`(last accessed August 24, 2021)
`U.S. Patent Application Publication No. 2021/0145572
`Declaration of Jonathan Bradford
`
`Ex. 1027
`
`Ex. 1028
`Ex. 1029
`Ex. 1030
`Ex. 1031
`Ex. 1032
`Ex. 1033
`Ex. 1034
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`Ex. 1035
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`Ex. 1036
`
`Ex. 1037
`Ex. 1038
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`Ex. 1039
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`Ex. 1040
`Ex. 1041
`Ex. 1042
`
`Ex. 1043
`Ex. 1044
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`I.
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`INTRODUCTION
`Unable to rebut the Trial Grounds, Patent Owner (“PO”) instead repeats failed
`
`arguments from its Preliminary Response, mischaracterizes the references,
`
`misrepresents expert testimony, and misapplies the law. The Challenged Claims are
`
`unpatentable.
`
`II. CLAIM CONSTRUCTION
`Claim construction is unnecessary because the Garrison grounds (1-4) and the
`
`Andersen grounds (5-10) meet the limitations under either party’s proposed
`
`construction, and the prior art discloses the claimed features regardless of the terms’
`
`precise bounds. See §§III-VI infra; Pet. §X; Pap. 11 (“DI”) 25; DraslerReply ¶¶10-
`
`14.
`
`PO’s proposed “trumpet-like” and “valve means” constructions are
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`unnecessary. The prior art discloses the “trumpet-like” and “valve means”
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`limitations under either the plain and ordinary meaning or PO’s constructions for the
`
`reasons set forth in the Petition. Moreover, the limitations are not disputed. PO
`
`concedes Garrison and Leonhardt disclose “trumpet-like” structures (and does not
`
`raise the issue vis-à-vis the Andersen grounds). POR 27, 45; DI 25. Similarly, PO
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`does not contest that Garrison and Andersen each disclose “valve means.” POR 10-
`
`14.
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`1
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`U.S. Patent No. 9,125,739
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`PO’s proposed construction of “controlled release mechanism” as “the
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`operator can control when the valve…is released,” including “control [of the valve’s
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`release] so that [the valve] doesn’t just arbitrarily pop out…when [the operator]
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`do[es]n’t want it to” relies exclusively on mischaracterized expert testimony. PO
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`(POR 8) cites the following, but omits the underlined portion: “control when it’s
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`released, and control it so that it doesn’t just arbitrarily pop out, so it has some
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`frictional aspect to it so that it doesn’t want to just go outwards…when you don't
`
`want it to.” Ex. 2020 (“DraslerTr.”), 87:14-18.2 As Dr. Drasler testified, there must
`
`be some mechanism to control the valve’s release—which is simply the term’s plain
`
`and ordinary meaning. Ex. 1041 (“DraslerReply”), ¶¶13-14. PO cites no basis in
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`the intrinsic record to further require the operator’s subjective intent or excerpt only
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`portions of Dr. Drasler’s testimony; its proposed construction should be rejected.
`
`Nevertheless, PO’s construction is unnecessary. Garrison discloses a “controlled
`
`release mechanism” under the plain and ordinary meaning, any reasonable
`
`construction and PO’s construction. §III.C. And PO does not contest that Limon
`
`discloses a controlled release mechanism—instead wrongly arguing Limon’s
`
`teachings could not be applied to Andersen. POR 57-58; §§VI.A, VI.D infra.
`
`Accordingly, no construction is necessary. DraslerReply ¶¶13-14.
`
`
`2 All emphasis added unless otherwise noted.
`
`2
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`U.S. Patent No. 9,125,739
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`III. GARRISON RENDERS OBVIOUS CLAIMS 1-5 (GROUND 1)
`As the Petition explains, Garrison renders obvious the Challenged Claims.
`
`Pet. 27-47; Ex. 1002 (“Drasler”), ¶¶73-131; DraslerReply ¶¶15-17. PO’s specific
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`Ground 1 arguments mischaracterize the prior art and Dr. Drasler’s testimony and
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`misapply the law.
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`A. Garrison renders obvious “a valve means including…leaflets
`made of fixed pericardial tissue” [1.3]
`PO does not dispute that Garrison’s “valve portion 38” is a “valve means.”
`
`As the Petition explains, ’739 admits “[m]ost tissue valves are constructed” with
`
`fixed pericardial tissue. Pet. 12; ’739 3:41-46. A POSITA would have been
`
`motivated to and had a reasonable expectation of success in implementing
`
`Garrison’s valves using fixed pericardial tissue—a material with known benefits:
`
`readily available, reduces antigenicity, strong for its relatively low profile, and easily
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`manipulated. Pet. 31-32, 36-37; Drasler ¶¶87-88, 104-106.
`
`PO misconstrues the Grounds as requiring bodily incorporation of pericardial
`
`tissue leaflets onto Garrison’s existing leaflets, but the Grounds do not propose
`
`adding “additional or replacement leaflets” as PO asserts. POR 21-22. Rather, the
`
`Petition demonstrated a POSITA would have been motivated to apply known
`
`teachings having known benefits (advantageous construction from fixed pericardial
`
`tissue) to implement—not replace—Garrison’s valve. Pet. 31-32, 36-37; ’739 3:41-
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`3
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`46; Drasler ¶¶87-88, 104-106; DraslerReply ¶¶18-20; In re Mouttet, 686 F.3d 1322,
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`1332 (Fed. Cir. 2012).
`
`PO’s alleged tradeoffs between using natural valves or ones formed of
`
`pericardial tissue (POR 22-25) do not mean a POSITA would not have been
`
`motivated to apply the admitted prior art’s teachings in implementing Garrison’s
`
`valve. D Randall Mfg. v. Rea, 733 F.3d 1355, 1363 (Fed. Cir. 2013) (“it is hard to
`
`see why a [POSITA] would not have thought to modify [the prior art] to include this
`
`[prevalent] feature” in the art); Mouttet, 686 F.3d at 1330 (finding “engineering
`
`tradeoff[s]” between advantages/disadvantages were “well within” a POSITA’s skill
`
`level). Despite potentially requiring additional sutures with known risks (DraslerTr.
`
`87:19-90:11), ’739 admits “[m]ost tissue valves are constructed” with fixed
`
`pericardial tissue (’739 3:41-46) with recognized benefits (Drasler ¶¶42, 86-88, 104-
`
`106; DraslerReply ¶21; Pet. 31-32, 38-39)—thereby establishing obviousness.
`
`Moreover, Garrison’s natural valves are also sutured—posing similar risks.
`
`Garrison 5:46-48; DraslerReply ¶21. PO’s assertions that Dr. Drasler’s opinions
`
`disregard leaflet damage/durability (POR 24) is belied by testimony that PO omits:
`
`“I did consider that any damage to the leaflet was something that had to be taken
`
`into consideration.” DraslerTr. 36:20-37:9 (explaining those risks are not significant
`
`here); DraslerReply ¶22. As Dr. Drasler explained, each approach has advantages
`
`and disadvantages—a POSITA would have been motivated and been able to apply
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`4
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`U.S. Patent No. 9,125,739
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`the most-common material for forming valves in implementing Garrison’s valves to
`
`advantageously, e.g., achieve properly sized/configured valves, and attach them to
`
`the device as taught by Garrison. DraslerTr. 90:16-92:7; DraslerReply ¶22; Drasler
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`¶¶87, 106; Pet. 31-32, 39.
`
`B. Garrison Discloses, and at Minimum Renders Obvious, “the stent
`member…flares at both ends in a trumpet-like configuration”
`[1.2]
`As the Petition explains, Garrison explicitly teaches two devices that flare in
`
`a trumpet-like configuration: 1) a valve-device separate from the displacer (“valve-
`
`device”), applying Garrison’s
`
`teaching
`
`that “all features of any valve
`
`displacer…may also form part of any…cardiac valves” (Garrison 4:54-57); and 2) a
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`combined displacer/valve-device “integrated into a single structure and delivered
`
`together” (“displacer/valve-device”) (Garrison 4:52-54). Garrison 2:5-10, 4:52-65;
`
`Pet. 29, 35-36; Drasler ¶¶76-79, 96-99. Such flared valve-devices were well-known,
`
`and a POSITA would have understood, or at least found obvious, that Garrison’s
`
`self-expanding cardiac valve 6A would have displacer 8’s flared features to ensure
`
`6A “advantageously conforms” to either the displacer or the vasculature. Drasler
`
`¶¶76-79, 98-99; Pet. 29-30, 35. Accordingly, Garrison discloses, and at minimum
`
`renders obvious, a flared valve-device, or alternately a flared displacer/valve-device.
`
`Pet. 35; Drasler ¶¶98-99; DraslerReply ¶23.
`
`5
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`1.
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`A POSITA Would Have Known How to Implement
`Garrison’s Features
`First, despite Garrison’s teachings of flared valve-devices and flared
`
`displacer/valve-devices, PO wrongly insinuates a POSITA would not have known
`
`how to implement such structures. POR 10-21. But prior art patents are
`
`presumptively enabled and PO must put forward evidence of “nonenablement”—
`
`though it does not even attempt to analyze the Wands factors. Amgen Inc. v. Hoechst
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`Marion Roussel, 314 F.3d 1313, 1355 (Fed. Cir. 2003); Johns Manville Corp. v.
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`Knauf Insulation, Inc., IPR2015-01402, Paper 45, *14-16. Moreover, “as
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`enablement of the prior art is not a requirement to prove invalidity under § 103,”
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`Amgen, 314 F.3d at 1357, PO’s conclusory specters of misaligned valves or invasive
`
`procedures (POR 12, 20) are irrelevant.3,4 Garrison’s disclosures are enabled.
`
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`3 Regardless, Garrison teaches aligning the displacer (and thus the displacer/valve-
`
`device) to “trap[]”the “native leaflets…in the recess” formed by its flared ends.
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`Garrison, 5:1-13; DraslerReply ¶¶24-25. Garrison alternatively discloses using a
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`valve-device sans displacer after “removing the native valve” (no alignment
`
`needed)—despite associated risks. Garrison, 4:49-54; DraslerReply ¶27.
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`4 Indeed, ’739 itself does not provide any such teachings. DraslerReply ¶38.
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`6
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`Second, PO mischaracterizes Petitioner’s expert’s testimony—wrongly
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`attempting to eliminate or miscategorize trial grounds, which alternatively rely on
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`Garrison’s (1) valve-device either in (a) a two-component system or (b) without a
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`displacer, and (2) Garrison’s displacer/valve-device. PO asserts Dr. Drasler
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`disclaimed reliance on a two-component system (i.e., a valve-device separate from
`
`the displacer) (POR 10-11, 26-27). But, consistent with his prior testimony (e.g.,
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`Drasler ¶¶77-78), Dr. Drasler instead explained he relies on Garrison’s flared valve-
`
`device and alternatively Garrison’s flared displacer/valve-device, both of which
`
`meet the claims:
`
`[W]e’re focusing in on the statement made by Garrison…that the
`valve support structure can have…any and all of the properties found
`in the displacer. And that the…two components...–the valve support
`structure and the displacer can be integrated into one device. And that
`then provides the device that has the features that this declaration
`focuses on.
`
`DraslerTr. 75:10-76:4; DraslerReply ¶26.5
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`PO’s assertion (POR 12) that Dr. Drasler is not relying on Garrison’s
`
`disclosure of the valve-device sans displacer (Garrison 4:49-57) is belied by
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`Drasler’s reliance on this very teaching—a unit that meets the claims when a flared-
`
`
`5 PO uses an ellipsis to omit this critical testimony. POR 11.
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`7
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`U.S. Patent No. 9,125,739
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`shape is applied to its stent. Drasler ¶¶77-79, 98; Pet. 29, 35. Garrison
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`acknowledges this teaching requires undesirable leaflet removal but, nonetheless,
`
`teaches this option. Garrison 4:49-57; DraslerReply ¶27.
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`PO incorrectly asserts Dr. Drasler conceded a displacer/valve-device would
`
`be limited to Garrison’s Figures 31-38 embodiments (depicting a sub-variant—
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`“valve 6D” and “displacer 8D” assembled in an inverted configuration). POR 13-
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`14; Garrison 10:37-62. But PO’s question was limited to Garrison’s “inverted”
`
`valve, and Dr. Drasler acknowledged Garrison describes such an embodiment in,
`
`e.g., “figures 31, 32….” DraslerTr. 76:14-77:1. He never agreed with PO’s
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`incorrect premise that Garrison’s only integrated device is the inverted device.
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`DraslerReply ¶28.
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`Moreover, Garrison’s teaching—that “displacer 8 and…valve 6” (a general
`
`class of devices) may be integrated together and/or features of “any” displacer
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`incorporated into “any” valve—applies to all of Garrison’s various embodiments.
`
`Garrison 4:52-65; Pet. 29, 35-36; Drasler ¶¶96-99. For example, “valve 6A” is a
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`self-expanding variant “similar” to “valve 6” and “implanted in substantially the
`
`same manner.” Garrison 8:10-47, 9:64-10:1; DraslerReply ¶29. PO’s insinuation
`
`that this disclosure applies only to Figures 31-38’s valve 6D and displacer 8D is
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`baseless. POR 15-16; DraslerReply ¶30. PO’s attempts to limit Garrison’s
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`disclosure to three, siloed embodiments runs contrary to Garrison’s express
`
`8
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`U.S. Patent No. 9,125,739
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`teachings (POR 17 (citing 2:23-25, 11:40-41, 10:37-51)) and excludes the vast
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`majority of Garrison’s teachings.
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`Third, PO falsely asserts the Petition fails to detail how Figure 14’s system
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`deploys the displacer/valve-device (i.e., Garrison’s integrated unit), or the materials
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`to construct it. POR 17-21. As the Petition explains, Garrison teaches various
`
`delivery mechanisms and materials for valve 6 using “the same or similar reference
`
`numbers [to] refer to the same or similar structures” across teachings—including
`
`operating “delivery catheter 4A” to deploy valve 6A (a self-expanding valve-device
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`made of, e.g., shape-memory alloys such as nitinol). Pet. 28-31, 39-40; Drasler
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`¶¶107-110; Garrison Figs. 13-14, 8:10-34, 8:45-47, 8:65-9:10. Garrison further
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`teaches a self-expanding displacer. Garrison 9:2-10; Pet. 29; Drasler ¶¶74, 78.
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`These teachings apply with equal force to Garrison’s valve-device and
`
`displacer/valve-device. Thus, the integrated displacer/valve-device is delivered the
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`same way as Garrison’s self-expanding displacer. Pet. 35; Drasler ¶99;
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`DraslerReply ¶31; Garrison Figs. 13-14, 4:49-57, 8:10-34, 8:44-47, 8:65-9:10. And
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`the self-expanding, flared valve-device is deployed either into the previously-
`
`deployed displacer or directly onto the vasculature. Pet. 29-30, 35; Drasler ¶¶77, 79,
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`99; DraslerReply ¶31.
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`9
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`2.
`
`A POSITA Would Have Had a Reasonable Expectation of
`Success Implementing Garrison’s Features
`PO attempts
`to
`reframe
`its
`flawed enablement arguments as
`
`motivation/“expectation of success” arguments that fail for the same reasons. PO
`
`incorrectly argues a POSITA would not have known how to implement Garrison’s
`
`valve-device with a flared structure nor had a motivation to do so (POR 26-33)—
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`despite Garrison explicitly teaching that a valve-device’s stent may have the flared
`
`features of, or be integrated with, the displacer, and the myriad flared valve-devices
`
`in the prior art. Pet. 29-30, 35-36; Drasler ¶¶96-99; Garrison 4:52-65. PO’s
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`arguments fail.
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`First, PO wrongly argues flaring the valve-device’s windings would increase
`
`“space between the wires in the stent—especially in the distal portion,” purportedly
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`“push[ing] the valve’s tissue inward and away from the vessel wall” and thereby
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`purportedly allowing blood to leak through. POR 28-29, (citing Ex. 2019 (Dasi),
`
`¶¶132-135). PO ignores Garrison’s express teaching of flared displacer/valve-
`
`devices as well as a preferred number of windings— providing sufficient guidance
`
`for a POSITA and an expectation of success. Pet. 18; Garrison, 2:5-10, 4:52-57,
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`5:19-29 (“preferably about 12-18 windings”); DraslerReply ¶¶32-33. Moreover, PO
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`misapprehends Garrison, whose valve-device does not have tissue at its distal end
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`(Pet. 4; Garrison Figs. 8 (openings 14 in displacer’s distal end), 9 (distal ends without
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`tissue)) and Figures 9-11’s valve-device’s proximal-end tissue is designed to push
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`inward—that closes the valve. Garrison Figs. 9-10 (open valve), 11 (closed valve).
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`DraslerReply ¶33. Moreover, Garrison’s valve-device instead seals at valve base 41
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`in valve-device’s middle—further confirming there is no leakage risk. Garrison,
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`Figs. 9-11, 5:42-48; DraslerReply ¶33. But even if there were, trade-offs in a given
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`design choice do not negate the motivation to modify Garrison to conform more
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`closely to the displacer or vasculature, which would further improve the seal and
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`stabilize the device. Pet. 29-30, 35; Drasler ¶¶77-78, 99; DraslerReply ¶33; Garrison
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`2:8-11; In re Fulton, 391 F.3d 1195, 1200-01 (Fed. Cir. 2004).
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`Second, contrary to PO’s assertion that Dr. Drasler did not consider the
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`increased loads on a flared device’s leaflet attachment points, Dr. Drasler testified
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`he “did consider that any damage to the leaflet was something that had to be taken
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`into consideration” and that he did consider leaflet attachment durability and opined
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`a POSITA would have had a reasonable expectation of success. DraslerTr. 36:20-
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`37:19; DraslerReply ¶34; Drasler ¶138. Indeed, the question/answer PO relies on
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`was instead directed to “whether there were any sort of…stent designs that would
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`make tearing or stretching of the commissures more risky.” POR 30-31 (citing
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`DraslerTr. 36:11-19). Even beyond Garrison’s teachings to use a flared
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`displacer/valve-device and valve-device, Gabbay, Leonhardt and Phelps further
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`demonstrate that it was well-known to attach a valve to a flared stent. Drasler ¶78;
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`Pet. 29-30; DraslerReply ¶34.
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`Third, PO wrongly alleges that Dr. Drasler did not consider whether an
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`implant might obstruct coronary arteries, but the cited testimony explains only that
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`he was not asked to opine on the differences between “anchoring an aortic valve
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`versus a mitral valve.” POR 32 (citing DraslerTr. 58:13-59:16). As Dr. Drasler
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`testified, a POSITA would have known to not obstruct coronary arteries (DraslerTr.
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`58:13-59:10) and Dr. Drasler only accepted the prior art’s teachings after
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`considering whether the art can do what it says it can (DraslerTr. 54:14-56:12).
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`DraslerReply ¶35.
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`Fourth, PO and its expert make the conclusory argument that a flared valve-
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`device could not be obvious because it would have been difficult to align and could
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`risk coronary obstruction (POR 30-33), but it is undisputed that Garrison discloses
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`a flared valve displacer, which is aligned appropriately and avoids coronary
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`obstructions. Garrison, 2:16-19, 5:1-13, Fig. 9; DraslerReply ¶¶36-39. The same
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`would apply
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`to Garrison’s flared valve-device and displacer/valve-device
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`embodiments, wherein the valve support either has the features of or is integrated
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`with the flared displacer, respectively. Tellingly, ’739 itself does not provide such a
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`disclosure regarding alignment (nor does it claim this functionality) because it was
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`within a POSITA’s abilities. E.g., Garrison 2:8-11; Leonhardt 10:50-61;
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`DraslerReply ¶38. Moreover, Garrison teaches sizing the valve-device to account
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`for leaflets’ “length and size…and position of the coronary ostia”—to avoid
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`blockage risks. Garrison 7:14-27; DraslerReply ¶38. Indeed, the prior art’s repeated
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`disclosures of flared stents further confirms a POSITA would have understood that
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`such an arrangement would work. Drasler ¶78; Pet. 29-30; DraslerReply ¶38.
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`C. Garrison Discloses or Renders Obvious a “controlled release
`mechanism that can be activated” (claim 5)
`As the Petition explains, Garrison discloses that the valve-device “remains
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`coupled” to a delivery catheter until it is fully deployed using “rod 78 having a
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`pusher element 80”—thereby providing a controlled release mechanism. Pet. 46-
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`47; Drasler ¶¶129-131; Garrison 8:25-64. The delivery catheter includes a
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`retractable “outer wall” that holds the valve-device in place until delivery. Pet. 39-
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`40; Drasler ¶¶107-110; Garrison 8:53-58, 9:51-53. PO’s flawed arguments that a
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`POSITA would be unable to use Garrison’s “delivery catheter” for controlled valve
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`deployment (POR 33-36) fail for the same reasons discussed in §III.B.1.
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`PO wrongly purports that no mechanism prevents Garrison’s valve-device
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`from popping out during delivery (POR 34)—despite Garrison’s disclosure that the
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`valve “remains coupled” to a delivery catheter until it is fully deployed and Dr.
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`Drasler’s explanation that “there is a[] frictional force between the stent and the outer
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`sheath that’s holding it” similar to ’739’s embodiment. Pet. 46-47; Drasler ¶¶129-
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`131; Garrison 8:25-64; DraslerTr. 85:21-86:22; DraslerReply ¶¶40-42. PO’s
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`assertion that friction-based restraints would be insufficient (POR 34-35) is
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`particularly puzzling since ’739 itself fails to depict any additional attachment
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`mechanism. ’739 Fig. 8; DraslerReply ¶42. PO also mischaracterizes Dr. Drasler’s
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`testimony on this point, claiming Garrison fails to meet Dr. Drasler’s purported
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`definition of “controlled release,” when Dr. Drasler explicitly included friction-
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`based mechanisms in the testimony PO relies on as a definition. POR 35;
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`DraslerReply ¶42; see §II.
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`Next, PO’s argument that Garrison’s Figure 14 system 2A would not work
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`with a self-expanding valve-device because “pushing on the posts would initially
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`cause the posts to buckle rather than move” (POR 35-36) contradicts Garrison’s
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`explicit disclosure: Figure 14 depicts “system 2A for implanting…valve 6A,” which
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`“is self-expanding”—demonstrating it works with self-expanding valves. Pet. 39-
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`40; Garrison 8:10-23; DraslerReply ¶43.
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`Finally, PO incorrectly asserts that Figure 14’s 2A would only be used with
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`balloon expandable displacers (POR 36), which is belied by Garrison’s teachings of
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`“self-expanding” displacer/valve-devices. §III.B.1; DraslerReply ¶44; Garrison 7:4-
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`14.
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`IV. GARRISON IN FURTHER VIEW OF LEONHARDT RENDERS
`OBVIOUS CLAIMS 1-5 (GROUND 2)
`As the Petition explains, Garrison in view of Leonhardt renders obvious the
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`Challenged Claims. Pet. 47-52; Drasler ¶¶132-150. Specifically, to the extent
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`disclosure beyond Garrison is required, Leonhardt expressly teaches that the stent
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`member includes a tubular structure away from a central portion that flares at both
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`ends in a trumpet-like configuration (element [1.2]), as well as a valve residing
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`entirely within an inner channel of the stent member (elements [1.3] and [1.6]). Pet.
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`50-51; Drasler ¶¶141-150.
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`A. A POSITA Would Have Been Motivated to Apply Leonhardt’s
`Teachings to Garrison
`As the Petition explains, a POSITA would have been motivated to apply (1)
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`Leonhardt’s teachings of a trumpet-like configuration to Garrison to advantageously
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`conform and seal support structure 26a to the displacer or vasculature (Pet. 50-51)
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`and (2) Leonhardt’s teachings of placing the valve within the support structure to
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`advantageously protect the valve and increase the seal’s quality (Pet. 51-52).
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`PO incorrectly argues a POSITA would not have been motivated to combine
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`Garrison’s and Leonhardt’s teachings because Leonhardt purportedly relates to
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`mitral valve replacements while Garrison relates to aortic valve replacements (POR
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`37), but PO does not dispute that both references relate to cardiac valve replacement
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`and ’739 does not distinguish between the two valves or claim replacement of a
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`particular valve. Nevertheless, even PO’s expert concedes Garrison’s teachings also
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`apply to “mitral…valves” (Garrison 7:10-14) and Leonhardt’s teachings also apply
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`to aortic valves (Leonhardt 9:63-10:30, 4:49-60, Figs. 2-3). Dasi ¶164; see Drasler
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`¶¶82, 132, 139, 144; Ex. 1043 ¶49; DraslerReply ¶¶45-49.
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`PO also mischaracterizes Dr. Drasler’s testimony, incorrectly arguing that he
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`failed to account for differences between mitral and aortic valves. POR 38-39 (citing
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`testimony regarding “anchoring” mitral/aortic valves), 44 (citing testimony
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`regarding patent “claims”). Dr. Drasler testified that he evaluated the prior art’s
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`entirety “for what it says that it can do,” and “assess[ed] whether…what they’re
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`teaching is correct” before accepting prior art teachings as applicable to both aortic
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`and mitral valves. §III.B.2; DraslerTr. 50:18-53:16 (explaining how the prior art
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`works for mitral and aortic), 54:4-13, 55:14-56:12; Drasler ¶¶82, 132, 139, 144;
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`DraslerReply ¶50.
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`Regarding applying Garrison’s teachings to mitral valves, PO concedes the
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`valve could either be loaded into the delivery catheter backwards or delivered
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`transapically (without reversing the valve). POR 39-40; DraslerReply ¶52. Even if
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`transapical were not an option (it is) for a displacer/valve-device, the valve’s
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`direction would not impact its release and, for a flared valve-device, the stent would
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`conform to the displacer upon implantation. Pet. 29, 35; Drasler ¶¶77, 99;
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`DraslerReply ¶¶51-52. Moreover, PO’s insistence that a POSITA would “not be
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`motivated” to pursue mitral valve replacements fails given Garrison’s explicit
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`disclosure that its teachings “may also be applied to other cardiac valves such as the
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`mitral....” Garrison 7:10-14; DraslerReply ¶51.
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`PO erroneously argues a POSITA would not have been motivated to apply
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`Leonhardt’s teachings to aortic valves because the device would need to be
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`positioned differently, would be unable to form a proper seal, and would risk
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`leakage. POR 41-43.6 But once again, these conclusory arguments fail given
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`Leonhardt’s explicit disclosure that its valve-stent may be used as an aortic valve
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`replacement. Leonhardt 3:15-30 (“…placed…directly over an existing…cardiac
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`valve…”), 4:49-60, 9:63-67 (“placement site is in the…aortic valve.”); Pet. 48, 50;
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`Drasler ¶¶132, 137; DraslerReply ¶55. Moreover, as Dr. Drasler repeatedly testified,
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`a POSITA would have the skill to use Leonhardt’s teachings to implement the valve
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`“over an