IPR2020-01649
`Paper No. 18
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`EDWARDS LIFESCIENCES CORPORATION and
`EDWARDS LIFESCIENCES LLC,
`Petitioners,
`
`v.
`
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`
`____________
`
`Case IPR2020-01649
`Patent 9,125,739
`____________
`
`Before the Honorable ERICA A. FRANKLIN, JAMES A. TARTAL,
`and ERIC C. JESCHKE,
`Administrative Patent Judges.
`
`
`PETITIONERS’ REPLY
`
`IN SUPPORT OF INTER PARTES REVIEW OF
`
`U.S. PATENT NO. 9,125,739
`
`
`
`
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`IPR2020-01649
`Paper No. 18
`
`Page
`
`I.
`
`GROUNDS 2-5 OF THE PETITION EACH RENDER CLAIMS 1-5
`OF THE ’739 UNPATENTABLE .................................................................. 1
`
`A. Grounds 2-5: Bessler Teaches Nearly All Claimed Limitations
`of the ’739 and Would Be Relied Upon by a POSITA as a Base
`Reference in an Obviousness Analysis ................................................. 1
`
`B. Grounds 2-5: It Would Have Been Obvious to Modify Bessler
`to Include a Trumpet-Like Configuration in View of the Teachings of
`Leonhardt and Teitelbaum .................................................................... 4
`
`C. Grounds 2-5: Under Any Interpretation of “Onto the Pusher
`Member,” It Would Have Been Obvious to Modify the Delivery
`System of Bessler to Include a Pusher Member as Claimed ................ 8
`
`D. Grounds 4-5: Claim 5’s “Controlled Release Mechanism”
`Limitation is Obvious .......................................................................... 15
`
`II. GROUND 1: PANIAGUA IS PRIOR ART AND ANTICIPATES
`CLAIMS 1-5 .................................................................................................. 17
`
`In the ’739, “the leaflet portion of the valve itself” must be
`A.
`“formed from a single piece of biocompatible material” in order to
`attain “the novel and improved qualities of the present invention” .... 17
`
`III. CLAIM CONSTRUCTION .......................................................................... 19
`
`“wherein the prosthetic heart valve is collapsed onto the pusher
`A.
`member” .............................................................................................. 19
`
`“flares at both ends in a trumpet-like configuration” & “valve
`B.
`means” ................................................................................................. 23
`
`IV.
`
`IN JANUARY 2002, PETITIONERS’ EXPERT, DR. GOLDBERG,
`WAS A PERSON OF ORDINARY SKILL IN THE ART; PO’S
`EXPERT, DR. DASI, WAS NOT ................................................................. 24
`
`
`
`ii
`
`

`

`IPR2020-01649
`Paper No. 18
`V. A DECISION BY THE BOARD IS CONSTITUTIONALLY VALID ....... 27
`
`VI. CONCLUSION .............................................................................................. 27
`
`
`
`
`
`
`
`
`iii
`
`

`

`IPR2020-01649
`Paper No. 18
`
`TABLE OF AUTHORITIES
`
`
`Cases
`Apogee Lighting Holdings, LLC v. Autronic Plastics, Inc.,
`IPR2020-01024, Paper 11 (PTAB Dec. 1, 2020) ............................................... 25
`Chung v. Bed Bath & Beyond, Inc.,
`No. EP-09-330-FM, 2011 WL 6967991 (W.D. Tex. Dec. 20, 2011) .......... 21, 22
`ClassCo, Inc. v. Apple, Inc.,
`838 F.3d 1214 (Fed. Cir. 2016) .......................................................................... 16
`Edwards Lifesciences Corp. v. Boston Scientific SciMed, Inc.,
`IPR2017-00060, Paper 64 (PTAB Mar. 23, 2018) ............................................. 24
`In re Antor Media Corp.,
`689 F.3d 1282 (Fed. Cir. 2012) ............................................................................ 7
`In re Etter,
`756 F.2d 852 (Fed. Cir. 1985) ............................................................................ 15
`In re Mouttet,
`686 F.3d 1322 (Fed. Cir. 2012) ............................................................................ 2
`In re Nordt Dev. Co.,
`881 F.3d 1371 (Fed. Cir. 2018) .......................................................................... 23
`Infineum USA L.P. v. Chevron Oronite Co.,
`844 F. App’x 297 (Fed. Cir. 2021) ....................................................................... 2
`Microsoft Corp. v. Parallel Networks Licensing, LLC,
`715 F. App’x 1013 (Fed. Cir. 2017) ..................................................................... 7
`Neutrino Dev. Corp. v. Sonosite, Inc.,
`410 F. Supp. 2d 529 (S.D. Tex. 2006) .......................................................... 25, 26
`Norgren Inc. v. ITC,
`699 F.3d 1317 (Fed. Cir. 2012) .......................................................................... 25
`Rivera v. ITC,
`857 F.3d 1315 (Fed. Cir. 2017) .......................................................................... 19
`
`
`
`iv
`
`

`

`Schott Gemtron Corp. v. SSW Holding Company, Inc.,
`IPR2013-00358, Paper No. 106 (PTAB Aug. 20, 2014) .................................... 26
`Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355 (Fed. Cir. 2011) .......................................................................... 23
`
`IPR2020-01649
`Paper No. 18
`
`
`
`
`
`
`
`
`v
`
`

`

`EXHIBIT LIST
`
`IPR2020-01649
`Paper No. 18
`
`EXHIBIT 1001 U.S. Patent No. 9,125,739 (Paniagua et al.)
`EXHIBIT 1002
`File History for U.S. Patent No. 9,125,739 (Paniagua et al.)
`EXHIBIT 1003 Andersen et al., Transluminal Implantation of Artificial Heart
`Valves. Description of a New Expandable Aortic Valve and
`Initial Results with Implantation by Catheter Technique in
`Closed Chest Pigs, European Heart Journal 13:704-708 (1992)
`EXHIBIT 1004 U.S. Patent No. 5,411,552 (Andersen et al.)
`EXHIBIT 1005 Bailey, Percutaneous Expandable Prosthetic Valves, Textbook
`of Interventional Cardiology, Chapter 75 (1994)
`EXHIBIT 1006 U.S. Patent No. 5,855,601 (Bessler et al.)
`EXHIBIT 1007 U.S. Patent No. 5,332,402 (Teitelbaum)
`EXHIBIT 1008 Moazami et al., Transluminal Aortic Valve Placement A
`Feasibility Study with a Newly Designed Collapsible Aortic
`Valve, ASAIO J., M381-385 (Sept.-Oct. 1996)
`EXHIBIT 1009 U.S. Patent Application Publication No. 2002/0032481 (Gabbay)
`EXHIBIT 1010 U.S. Patent No. 6,425,916 (Garrison et al.)
`EXHIBIT 1011 U.S. Patent No. 6,652,578 (Bailey et al.)
`EXHIBIT 1012 U.S. Patent No. 5,957,949 (Leonhardt et al.)
`EXHIBIT 1013
`Ebeid et al., Use of Balloon-Expandable Stents for Coarctation
`of the Aorta: Initial Results and Intermediate-Term Follow-Up,
`30 J. Am. C. Cardiology 7, 1847-52 (Dec. 1997)
`Edwards Receives European Approval for Advanced SAPIEN 3
`Valve (Jan. 27, 2014)
`EXHIBIT 1015 U.S. Patent Application Publication No. 2005/0113910
`(Paniagua et al.)
`EXHIBIT 1016 Rösch et al., The Birth, Early Years, and Future of
`Interventional Radiology, J. Vasc. Interv. Radiol., 14:841-853
`(2003)
`EXHIBIT 1017 U.S. Patent No. 6,908,481 (Cribier)
`EXHIBIT 1018
`File History for U.S. Patent No. 8,308,797 (Paniagua et al.)
`EXHIBIT 1019 U.S. Patent Application Publication No. 2001/0044633 (Klint)
`EXHIBIT 1020 Declaration of Steven L. Goldberg, M.D.
`
`EXHIBIT 1014
`
`
`
`vi
`
`

`

`IPR2020-01649
`Paper No. 18
`
`EXHIBIT 1028
`
`EXHIBIT 1029
`
`EXHIBIT 1021 U.S. Patent No. 8,308,797 (Paniagua et al.)
`EXHIBIT 1022
`Infringement Chart from Colibri Heart Valve LLC v. Medtronic
`CoreValve LLC, No. 8:20-cv-847-DOC-JDE, D.I. 30-3 (C.D.
`Cal. June 12, 2020) (Exhibit A to First Amended Complaint).
`EXHIBIT 1023 U.S. Patent No. 6,730,118 (Spenser et al.)
`EXHIBIT 1024
`Press Release, Edwards Lifesciences Receives CE Mark for
`Edwards SAPIEN Transcatheter Heart Valve Edwards
`Lifesciences (Sept. 5, 2007)
`EXHIBIT 1025 Colibri’s Opposition to Medtronic’s Motion to Dismiss First
`Amended Complaint [DKT. 38], Colibri Heart Valve LLC v.
`Medtronic CoreValve LLC, No. 8:20-cv-847-DOC-JDE, D.I. 46
`(C.D. Cal. Aug. 14, 2020)
`EXHIBIT 1026 U.S. Patent No. 8,900,294 (Paniagua et al.)
`EXHIBIT 1027 CoreValve Receives CE Mark Approval for its ReValving™
`System and Announces Plans to Initiate Expanded Clinical
`Evaluation, Business Wire (May 16, 2007)
`Edwards SAPIEN XT Transcatheter Valve and Delivery Systems
`Receive CE Mark (Mar. 2, 2010)
`for First
`Edwards Lifesciences Receives FDA Approval
`Catheter-Based Aortic Heart Valve in the U.S. (Nov. 2, 2011)
`EXHIBIT 1030 Medtronic CoreValve® System Obtains Early FDA Approval on
`Exceptional Clinical Performance (Jan. 17, 2014)
`EXHIBIT 1031 Bonhoeffer et al., Percutaneous Replacement of Pulmonary
`Valve in a Right-Ventricle to Pulmonary-Artery Prosthetic
`Conduit with Valve Dysfunction, Lancet 356:1403-05 (2000)
`Pavcnik et al., Aortic and Venous Valve for Percutaneous
`Insertion, Min Invas Ther & Allied Technol 9(3/4) 287-92
`(2000)
`EXHIBIT 1033 Declaration of Megan E. Dellinger in Support of Petitioners’
`Motion for Admission Pro Hac Vice of Megan E. Dellinger
`Pursuant to 37 C.F.R. § 42.10
`Final Written Decision from Edwards Lifesciences Corp. et al. v.
`Boston Scientific Scimed, Inc., IPR2017-00060, Paper 64 (PTAB
`March 23, 2018)
`EXHIBIT 1035 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
`
`EXHIBIT 1032
`
`EXHIBIT 1034
`
`
`
`vii
`
`

`

`IPR2020-01649
`Paper No. 18
`
`EXHIBIT 1038
`
`(last accessed Sept. 9, 2021)
`EXHIBIT 1036 Reply Declaration of Steven L. Goldberg, M.D.
`EXHIBIT 1037 Cribier, The Development of Transcatheter Aortic Valve
`Replacement (TAVR), Glob Cardiol Sci Pract., Dec. 30, 2016
`FDA Clears Aortic, Mitral Valve-In-Valve Procedures for
`Sapien 3 TAVR Valve, available at
`https://www.dicardiology.com/article/fda-clears-aortic-mitral-
`valve-valve-procedures-sapien-3-tavr-valve (last accessed
`Sept. 9, 2021)
`EXHIBIT 1039 Deposition Transcript of Dr. Lakshmi Prasad Dasi (Aug. 25,
`2021)
`
`
`
`
`
`
`
`
`
`viii
`
`

`

`IPR2017-00060
`Paper No. 18
`PO’s attempt to salvage Claims 1-5 of the ’739 should be rejected. PO’s
`
`arguments mischaracterize the prior art, misapply the law, and rely heavily upon
`
`conclusory and unsupported assertions by its declarant that are contradicted by the
`
`underlying record. The Challenged Claims are unpatentable.
`
`I.
`
`GROUNDS 2-5 EACH RENDER CLAIMS 1-5 OF THE ’739
`UNPATENTABLE
`A. Grounds 2-5: Bessler Teaches Nearly All Claimed Limitations
`of the ’739 and Would Be Relied Upon by a POSITA as a Base
`Reference in an Obviousness Analysis
`
`
`
`PO does not dispute that Bessler teaches nearly all claimed limitations of the
`
`’739. It argues that a POSITA would not have relied on Bessler as a starting point,
`
`when the ’739 copied heavily from Bessler’s teachings (Petition, 4-11, 47-66). PO
`
`and its expert argue without support that a POSITA “would have recognized that
`
`Bessler’s valve device design was inferior to the state of the art in January 2002.”
`
`(Patent Owner Response (“POR”), 25). This, according to PO, is because “a sine-
`
`wave or zig-zag configuration stent design … was not a desirable design” as
`
`compared to a stent with “a network pattern.” (Id.). But PO’s arguments are
`
`contrary to the law and the express teachings of Bessler and otherwise unsupported
`
`by the record.
`
`First, PO’s argument is legally wrong because the Federal Circuit has
`
`“rejected the notion that a patent challenger seeking to demonstrate obviousness
`
`must prove that a [POSITA] would have been motivated to select one prior art
`
`
`
`1
`
`

`

`IPR2020-01649
`Paper No. 18
`disclosure over another.” Infineum USA L.P. v. Chevron Oronite Co., 844 F.
`
`App’x 297, 305 (Fed. Cir. 2021); see also In re Mouttet, 686 F.3d 1322, 1334 (Fed.
`
`Cir. 2012) (“just because better alternatives exist in the prior art does not mean that
`
`an inferior combination is inapt for obviousness purposes.”). A challenger just
`
`needs to show a POSITA would have been motivated to modify Bessler’s
`
`teachings with a reasonable expectation of success to arrive at the claimed
`
`invention.
`
`Second, PO’s arguments are at best a criticism of Bessler’s preferred
`
`embodiment. Not once in the 67-page Response or 105-page Dasi Declaration is it
`
`acknowledged that Bessler is not limited to a sine-wave or zig-zag configuration,
`
`and that Bessler, as an alternative, expressly teaches a “mesh configuration or a
`
`similar configuration which will allow the stent to be readily collapsible and self-
`
`expandable.” (EX1006, 6:7-11 (emphasis added)). Dr. Dasi ignored this express
`
`teaching—“[t]o my knowledge, there’s no mesh pattern stent disclosed in Bessler.”
`
`(EX1039, 35:15-36:6.) This disclosure couldn’t have been lost on PO as it cherry-
`
`picks the sine-wave and zig-zag configurations from the same portion of Bessler.
`
`(POR, 25 (citing Bessler, 5:15-6:18)). And Bessler’s description of the various
`
`stent forms that can be adopted was copied word-for-word into the ’739’s
`
`specification. (See Petition, 5-6). It is this copied “mesh” disclosure that supports
`
`
`
`2
`
`

`

`IPR2020-01649
`Paper No. 18
`the “network pattern” Dr. Dasi touts as the most-preferred stent design in January
`
`2002. EX1039, 29:2-30:5.1
`
`Third, Dr. Dasi opines that “Bessler’s single-wire designs would not have
`
`been expected to supply the uniform radial force needed to force the native aortic
`
`leaflets out of place.” (EX2019, ¶108). In addition to ignoring Bessler’s
`
`alternative teaching of a mesh-type stent, Dr. Dasi also ignores Bessler’s teaching
`
`that the diseased native valve can be removed prior to implantation. (EX1006,
`
`2:63-67, 4:27-52, 6:32-50, 7:1-25).2 Any suggestion that the zig-zag and sine-
`
`wave embodiments of Bessler lack sufficient radial force to withstand calcified,
`
`native aortic leaflets is a red herring because (1) the leaflets can be removed prior
`
`to implantation, and (2) the ’739’s claims are not limited to the treatment of aortic
`
`“Network pattern” is not a term used to describe any stent pattern in the
`
`1
`
`’739. “Mesh” is the term that appears in the specification, which Dr. Dasi agrees is
`
`a type of “network pattern.” (See, e.g., EX2019, ¶51; EX1039, 30:1-31:22.) The
`
`references Dr. Dasi cites for the proposition that a “network pattern” was the
`
`“most-preferred stent design” in January 2002 actually take no position on
`
`preferred stent designs. (See EX2019, ¶51 (citing EX2023, EX2024)).
`
`2
`
`Largely copying the disclosure of Bessler, the ’739 also discloses that “[t]he
`
`defective heart valve is removed by a suitable modality ….” (EX1001, 10:60-66;
`
`see EX1006, 4:30-36; Petition, 11).
`
`
`
`3
`
`

`

`IPR2020-01649
`Paper No. 18
`stenosis, and more broadly encompass treatment of insufficient (i.e., regurgitant)
`
`valves where no calcification is present. (EX1039, 10:10-12:5, 95:5-96:15; see
`
`also EX1034, 31 (“Patent Owner’s argument is premised on the false notion that
`
`claim 1 is directed to an aortic replacement valve that may only be placed where
`
`there is a ‘hard, calcified aortic annulus.’”)). Moreover, PO ignores that Dr.
`
`Bessler successfully implanted a wireform stent structure in the aortic position in
`
`animal studies, and that other wireform structures, including Andersen and
`
`Pavcnik, were successfully implanted in the aortic position. (EX1008 at 1, 4-5
`
`(Bessler) (Petition, 14-15), EX1032 (Pavcnik); EX2021 (Andersen)). PO’s bald
`
`assertions to the contrary should be rejected.
`
`B. Grounds 2-5: It Would Have Been Obvious to Modify Bessler
`to Include a Trumpet-Like Configuration in View of the
`Teachings of Leonhardt and Teitelbaum
`
`
`
`PO does not dispute that both Leonhardt and Teitelbaum teach stents with
`
`trumpet-like configurations. (POR, 51-63). PO argues only that a POSITA would
`
`not have been motivated to modify the stent structure of Bessler in view of the
`
`teachings of Leonhardt and Teitelbaum. (Id.). But PO rests its argument on the
`
`false premise that Bessler is limited to a sine-wave or zig-zag stent structure, and
`
`on the erroneous assertion that this prior art would not be combined by a POSITA
`
`because Bessler is limited to an aortic valve prosthesis and Leonhardt and
`
`Teitelbaum are limited to mitral valve prostheses.
`
`
`
`4
`
`

`

`IPR2020-01649
`Paper No. 18
`First, PO argues that a POSITA would not flare the ends of Bessler’s single-
`
`
`
`wire embodiment because it “would increase paravalvular leakage.” (POR at 51
`
`(citing EX2019, ¶¶124, 131)). But Paragraphs 124 and 131 of the Dasi Declaration
`
`are entirely conclusory, cite no support, and blatantly ignore the “mesh”-type stent
`
`structure explicitly taught by Bessler. See supra 2-3. PO concedes that a
`
`“preferred” mesh stent would increase sealing and decrease leakage. (POR at 53
`
`(“selecting Bessler’s [sine-wave or zig-zag] stent design would have decreased
`
`sealing and increased leakage of blood around the valve device—in contrast with
`
`the preferable network pattern a POSA would have chosen.” (emphasis in bold
`
`added))). Moreover, no matter which Bessler stent structure is adopted, PO
`
`ignores that Bessler teaches the use of a cuff that may cover at least a portion of the
`
`stent frame to aid in sealing the prosthesis against the surrounding tissue, thus
`
`undermining any argument that an increase in spacing between adjacent struts
`
`necessarily leads to an increase in paravalvular leaks. (See, e.g., EX1006, Claim 1
`
`(“wherein the cuff portion is configured to position the valve snugly and sealingly
`
`at a valve site”); Petition, 13).
`
`
`
`5
`
`

`

`IPR2020-01649
`Paper No. 18
`Second, PO’s argument that a POSITA would not combine teachings of an
`
`
`
`aortic valve prosthesis with teachings of a mitral valve prosthesis (or vice versa)3
`
`are erroneously based on the preferred embodiments of Bessler, Leonhardt, and
`
`Teitelbaum. None of these prior art references is limited to a prosthesis for a
`
`particular heart valve, which Dr. Dasi does not dispute. (See, e.g., EX1006, 2:26-
`
`29 and Claim 1; EX1012, 4:56-65, 9:64-67; EX1007, 4:38-44 and Claims 1, 5;
`
`EX1039, 98:5-108:13; EX1036, ¶7). Thus, any suggestion that a POSITA would
`
`not combine Bessler with either Leonhardt or Teitelbaum because they are directed
`
`at prostheses for different heart valves is belied by the broad disclosures of each of
`
`these prior art references. (EX1036, ¶7). Even if so-limited, the prior art
`
`recognizes that a prosthesis can be readily adapted for use in multiple valve
`
`locations (see, e.g., EX1012, 4:55-65 (Leonhardt recognizing that “one basic stent
`
`shape” could be adopted, which “may be manufactured with more or less outward
`
`force to accommodate other placement positions”)), and a POSITA looking to
`
`Contrary to Dr. Dasi’s opinion that “[e]ven today,” a POSITA “would not
`
`3
`
`take a transcatheter prosthetic mitral valve device and implant it in the aortic
`
`valve” or vice versa (which implies hindsight), (EX2019, ¶43), it is, in fact, done
`
`today: Edwards’ SAPIEN 3—the only FDA approved THV for mitral valve-in-
`
`valve procedures—is also approved for use in the aortic valve. (EX1036, ¶7 n.1;
`
`EX1038).
`
`
`
`6
`
`

`

`IPR2020-01649
`Paper No. 18
`make improvements to these just-emerging technologies4 would have considered
`
`any potentially beneficial features in prosthetic valves designed for any location
`
`(EX1036, ¶6).5
`
`
`
`Third, PO argues that “a POSA would be concerned that the flared portion
`
`of the stent would push the calcified, native leaflets into the sinus in a way that
`
`occludes the coronary arteries.” (POR, 57). But PO again ignores that Bessler
`
`teaches that the diseased native valve leaflets may be excised prior to implantation
`
`of the prosthesis, thus alleviating any purported concern of blocking the coronaries
`
`with the native valve leaflets. Supra 3; see also EX1039, 95:19-96:2. Even if the
`
`native leaflets are not removed, PO ignores Dr. Goldberg’s testimony that a
`
`Teitelbaum-like stent design “might actually reduce the risk of coronary
`
`Neither an aortic or mitral THV had been successfully implanted in a patient
`
`4
`
`as of January 2002; the first-in-human aortic THV implant was not until April
`
`2002. (EX1037).
`
`5
`
`Dr. Dasi’s cursory, unsupported assertions that certain teachings would not
`
`be a starting point for a POSITA or would not work in certain valve locations
`
`(EX2019, ¶¶42-44, 102-112, 119-22, 124, 128, 130-31, 133-35), cannot overcome
`
`the presumption that these teachings are enabled. Microsoft Corp. v. Parallel
`
`Networks Licensing, LLC, 715 F. App’x 1013, 1021 (Fed. Cir. 2017) (citing In re
`
`Antor Media Corp., 689 F.3d 1282, 1289, 1292 (Fed. Cir. 2012)).
`
`
`
`7
`
`

`

`IPR2020-01649
`Paper No. 18
`obstruction by pushing the leaflets down and away from the coronary arteries
`
`which are up higher.” (EX2020, 59:6-13). PO also ignores Petitioners’ argument
`
`that Cribier (EX1017), the Wallstent (EX1016, 7; EX1018, 167, 169), Garrison
`
`(EX1010), Gabbay (EX1009), and Bailey (EX1011) each provide additional
`
`motivation to combine Bessler with Leonhardt and Teitelbaum as each teach the
`
`use of trumpet-like stent configurations. Petition, 16-21, 51, 53. Cribier, for
`
`example, explicitly teaches the use of a stent with trumpet-like ends (i.e., “a
`
`concave shape”) “aimed at reinforcing the embedding and the locking of the
`
`implantable valve in the distorted aortic orifice.” (EX1017, 5:64-67; Petition, 20-
`
`21). Thus, any suggestion that a prosthesis with trumpet-like ends would not be
`
`desirable in the aortic position is countered by this volume of uncontested evidence
`
`and contrary to the understanding of a POSITA at the time of the alleged invention.
`
`C. Grounds 2-5: Under Any Interpretation of “Onto the Pusher
`Member,” It Would Have Been Obvious to Modify the
`Delivery System of Bessler to Include a Pusher Member as
`Claimed
`
`As set forth in the Petition, even if “onto” is defined narrowly such that it
`
`requires the pusher member to pass through the interior of the prosthetic valve, it
`
`would have been obvious to a POSITA to modify Bessler in view of the teachings
`
`of Klint, Leonhardt, or Teitelbaum to arrive at the ’739’s claimed delivery system.
`
`Petition, 61-63, 66-70. PO’s arguments mischaracterize the prior art and are wrong
`
`on the law.
`
`
`
`8
`
`

`

`1.
`
`PO Mischaracterizes Klint
`
`IPR2020-01649
`Paper No. 18
`
`PO first argues that “Petitioners’ argument relies on Klint’s Example 6,
`
`which includes two embodiments of pusher members, neither of which includes a
`
`prosthetic heart valve device collapsed on to the pusher member.” (POR, 41). But
`
`Klint explicitly teaches that “[t]he prosthesis may be of the radially compressible,
`
`self-expandable type such as … a valve,” (EX1019, ¶[0091]; Petition, 67; EX1036,
`
`¶11), and that “the engagement means [of the pusher member] can also be
`
`designed as an elongate member that extends coaxially inside the radially
`
`compressed prosthesis and engages the prosthesis at several locations along the
`
`length thereof … ,” (id., ¶[0094]; Petition, 68-69; EX1036, ¶10).
`
`Next, PO argues that “a POSA would understand that Klint’s second pusher
`
`member embodiment is deployed by being pushed through an already collapsed
`
`prosthesis when that prosthesis is in place and ready to be released from its
`
`receptacle” because there is only a “single disclosed method for deploying the
`
`pusher member for Klint’s Example 6.” (POR, 44; EX1036, ¶8). But there is
`
`nothing in Klint that limits its second embodiment of a pusher member to a
`
`particular method of use. (See also EX2020, 66:18-67:2; EX1036, ¶9). Even if
`
`there was, Claims 1-5 of the ’739 are device claims, not method claims, and
`
`require only that the prosthesis is in a collapsed state on the pusher member.
`
`Moreover, PO’s interpretation is at odds with the explicit disclosure of Klint,
`
`
`
`9
`
`

`

`IPR2020-01649
`Paper No. 18
`which plainly states that the engagement means “extends coaxially inside the
`
`radially compressed prosthesis.” (EX1019, ¶[0094]). Regardless of the method
`
`used with Klint’s second embodiment, Dr. Dasi’s own mock-up confirms a
`
`POSITA would understand that the valve prosthesis is collapsed onto the
`
`engagement means of the pusher member. (EX2019, ¶175; EX1039, 113:21-114:5
`
`(Dr. Dasi agreeing that, even in his interpretation of Klint’s second embodiment,
`
`the outflow end of the valve prosthesis is in a collapsed state on the pusher
`
`member)).
`
`2.
`A POSITA Would Have Been Motivated to Combine
`Bessler’s Heart Valve Device with Klint’s Pusher Member
`
`PO contends that “[e]ven if … Klint’s second embodiment is considered to
`
`disclose a valve device collapsed onto the pusher member before deployment, a
`
`POSA would not have combined Klint’s second embodiment with Bessler’s heart
`
`valve device.” (POR, 45). According to PO, “a POSA would have understood that
`
`the pusher of Klint’s second embodiment would have risked damaging the valve
`
`device’s leaflets.” (POR, 46-50). But PO’s argument is premised on Klint’s
`
`teaching of a pusher member having “‘radial projections, hooks, ridges,’ or the
`
`like” (POR, 47); PO ignores that “another kind of engagement means such as a
`
`high friction material” could be employed in any areas where a POSITA may be
`
`concerned that a radial projection, hook, or ridge may damage the tissue of the
`
`prosthesis (EX1019, ¶[0094]). See EX1036, ¶12.
`
`
`
`10
`
`

`

`IPR2020-01649
`Paper No. 18
`Even if radial projections, hooks, or ridges are used, the fact that Klint
`
`recognized that these projections are located at “several locations along the length”
`
`of the prosthesis teaches the obvious—that a POSITA could simply employ
`
`projections at locations where there is no valve tissue to minimize the risk of
`
`damaging the tissue. EX1036, ¶12. For example, a POSITA employing the
`
`teachings of Klint’s second embodiment of a pusher member with Bessler Figure 5
`
`would position pusher-member projections along the outflow end of the device
`
`where no valve tissue is located:
`
`(EX1006, Figs. 4 & 5 (red annotations added); see EX1036, ¶12). This is exactly
`
`what is depicted in Dr. Dasi’s modified Klint Figure 16, where the pusher member
`
`includes hooks that are engaging the outflow end of the valve prosthesis:
`
`
`
`
`
`11
`
`

`

`IPR2020-01649
`Paper No. 18
`
`
`
`(EX2019, ¶175; EX1039, 112:8-15 (Dr. Dasi agreeing that his drawing includes
`
`hooks along the outflow end of the valve device)).
`
`3.
`Leonhardt Teaches Colibri’s Interpretation of a Delivery
`System “Wherein the Prosthetic Heart Valve Is Collapsed onto
`the Pusher Member”
`According to PO and its expert, the “pusher member 420” in Figure 8 of the
`
`
`
`’739 is not limited to the nose cone feature labelled as 420, but instead includes a
`
`portion of the catheter that passes through the prosthesis. POR, 13-14; EX1039,
`
`46:20-47:6, 49:7-14, 61:14-22, 66:10-68:20. PO relabels this portion of the
`
`catheter “pusher member 420” (POR, 13-14), notwithstanding that Figure 8
`
`identifies this portion as “the catheter lumen 430” and the specification provides
`
`that the prosthesis is “collapsed over the tube,” which refers to “flexible hollow
`
`tube catheter 410” in Figure 8, not pusher member 420. (EX1001, 12:9-12).
`
`According to Dr. Dasi, the pusher member of the ’739 “can include portions [of the
`
`
`
`12
`
`

`

`IPR2020-01649
`Paper No. 18
`delivery system] that are adjacent to the stent structure on either side of the stent”
`
`(EX1039, 68:12-20) and the friction between the valve prosthesis and the tube it is
`
`collapsed onto is part of what supplies the pushing force to deploy the device (id.,
`
`66:20-67:14).
`
`
`
`Reading Leonhardt in light of PO’s interpretation of the ’739, Leonhardt
`
`discloses the same elements that Dr. Dasi identifies as the “pusher member” in
`
`Figure 8 of the ’739. (See also Petition, 61-62.) Leonhardt has a “nose cone”
`
`(“[t]apered head 156” (EX1012, 8:10-14)) and a tube the valve device is collapsed
`
`onto (inner catheter 110 and valve stent 20 (id., 7:11-20), not pictured below, see
`
`Figs. 9A-D of Leonhardt), and another portion of the “pusher member” behind the
`
`stent (visible within the catheter to the left of Leonhardt Figure 5), identified as the
`
`“push rod 112” (id., 6:43-49).
`
`
`
`13
`
`

`

`IPR2020-01649
`Paper No. 18
`
`
`
`That Leonhardt also includes this “push rod” element behind the valve device does
`
`not negate its disclosure of a “pusher member” akin to the one that PO has
`
`annotated in Figure 8 of the ’739—per Dr. Dasi, the pusher member is not limited
`
`to the portion of the delivery system under the prosthesis and “can include portions
`
`that are adjacent to the stent structure on either side” (EX1039, 68:12-20), and the
`
`frictional force that is part of the pushing force for deployment can be provided by
`
`
`
`14
`
`

`

`IPR2020-01649
`Paper No. 18
`the portion of the catheter tube on which the prosthesis is collapsed (id., 66:20-
`
`67:14).
`
`D. Grounds 4-5: Claim 5’s “Controlled Release Mechanism”
`Limitation Is Obvious
`
`PO does “not dispute that Bessler discusses a restraining method that would
`
`keep a valve device from popping out and hold it for controlled release using
`
`sutures and threads.” (POR, 65-66; EX2019, ¶188). PO argues only that
`
`physically substituting Klint’s pusher member for Bessler’s pusher member would
`
`require removal of Bessler’s controlled release mechanism. (POR, 65). This is
`
`wrong on the law. It has been long established that the obviousness inquiry does
`
`not ask “whether the references could be physically combined but whether the
`
`claimed inventions are rendered obvious by the teachings of the prior art as a
`
`whole.” In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985). There can be no dispute
`
`that, as a whole, the teachings of Bessler and Klint render the “controlled release
`
`mechanism” requirement obvious. (Petition, 8-9, 66-70).
`
`Even if Klint’s pusher legally had to be physically combined with Bessler’s
`
`delivery system, there is no suggestion that Bessler’s pusher member and
`
`controlled release sutures could not be combined with Klint’s pusher member, or
`
`that the resulting system could not be adapted to include locations to secure the
`
`sutures taught by Bessler if Bessler’s pusher member is replaced by Klint’s pusher
`
`member. (See POR, 65-66.) PO’s entire argument appears to be anchored to Klint
`
`
`
`15
`
`

`

`IPR2020-01649
`Paper No. 18
`not having holes in its pusher member. (POR, 65). But a POSITA in January 2002
`
`wanting to combine Bessler and Klint and to include the advantages of Bessler’s
`
`controlled release mechanism would have used their ordinary creativity to include
`
`holes (or another attachment means) in the pusher member taught by Klint so that
`
`Bessler’s sutures could be looped through. See ClassCo, Inc. v. Apple, Inc., 838
`
`F.3d 1214, 1219 (Fed. Cir. 2016) (“[A POSITA] is also a person of ordinary
`
`creativity, not an automaton…. The rationale of KSR does not support ClassCo’s
`
`theory that a [POSITA] can only perform combinations of a puzzle element A with
`
`a perfectly fitting puzzle element B.” (internal quotation marks, citations omitted));
`
`EX1036, ¶¶13-19. Indeed, Klint itself explains that “projections, hooks, ridges, or
`
`another kind of engagement means such as a high friction material” (EX1019,
`
`¶[0094] (emphases added); EX1036, ¶¶15-16) can be used, and another
`
`embodiment of Klint’s invention (for an embolization device), explicitly describes
`
`use of “two mating parts held together by a thread that can be pulled out for
`
`detachment of the embolization device” and explains that “[t]hese kinds of
`
`connection means are well known in the art, e.g., [collecting patents] ….”
`
`(EX1019, ¶[0113], ¶[0110]; EX1036, ¶¶15-16). Other references known by
`
`January 2002 confirm that a POSITA would know how to use threads or sutures to
`
`temporarily secure a device to a delivery system, and provide additional motivation
`
`
`
`16
`
`

`

`IPR2020-01649
`Paper No. 18
`to combine the teachings of Bessler and Klint. See, e.g., EX1009, ¶[0112];
`
`EX1010, 11:26-34; EX1012, 9:6-24, 11:37-63, Figs. 7a-7b; EX1036, ¶¶17-19.
`
`II. GROUND 1: PANIAGUA IS PRIOR ART AND ANTICIPATES
`CLAIMS 1-5
`
`There is no dispute that if Paniagua is prior art to the ’739, then it anticipates
`
`Claims 1-5. The only dispute is whether the specification as of January 4, 2002
`
`adequately described the full scope of Claims 1-5. It did not. (Petition, 34-37, 42-
`
`43).
`
`A.
`
`In the ’739, “The Leaflet Portion of the Valve Itself” Must Be
`“Formed from a Single Piece of Biocompatible Material” in
`Order to Attain “the Novel and Improved Qualities of the
`Present Invention”
`
`PO’s response relies on portions of t