`
`
`Filed: June 2, 2021
`
`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 No. IPR2020-01454
`U.S. Patent No. 9,125,739
`___________________
`
`
`PATENT OWNER’S RESPONSE
`UNDER 37 C.F.R. § 42.120
`
`
`

`

`TABLE OF CONTENTS
`INTRODUCTION .......................................................................................... 1 
`I. 
`LEVEL OF ORDINARY SKILL ................................................................... 2 
`II. 
`OVERVIEW OF THE ’739 INVENTION .................................................... 2 
`III. 
`CHALLENGED CLAIMS ............................................................................. 5 
`IV. 
`PROSECUTION HISTORY .......................................................................... 6 
`V. 
`CLAIM CONSTRUCTION ........................................................................... 7 
`VI. 
`A.  “trumpet-like” (claim 1) ................................................................................. 7 
`B.  “valve means” (claim 1) ................................................................................. 7 
`C.  “controlled release mechanism” (claim 5) ..................................................... 8 
`VII.  PETITIONER HAS FAILED TO DEMONSTRATE THAT THE
`CHALLENGED CLAIMS ARE OBVIOUS ............................................................. 8 
`A.  Ground 1: The Challenged Claims are Not Obvious in View of Garrison
`Alone .............................................................................................................. 9 
`1.  A POSA Would Not Know How to Implement the Embodiment of
`Garrison on Which Petitioner Relies .......................................................... 10 
`2.  Garrison Does Not Disclose “a valve means including…leaflets made of
`fixed pericardial tissue,” and Does Not Motivate A POSA to Use Such a
`Valve with Any Reasonable Expectation of Success ................................. 21 
`3.  Garrison Does Not Disclose “the stent member…flares at both ends in a
`trumpet-like configuration” and Does Not Motivate a POSA to Use
`Such a Member with Any Reasonable Expectation of Success ................. 26 
`4.  A POSA Would Understand that Garrison Does Not Disclose a
`Functioning “controlled release mechanism that can be activated” ........... 33 
`B.  Grounds 2, 4: The Challenged Claims are Not Obvious in View of
`Garrison and Leonhardt ................................................................................ 37 
`1.  A POSA Would Not Have Combined Garrison with Leonhardt ................ 37 
`
`
`
`i
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`

`

`2.  Garrison in View of Leonhardt Does Not Disclose “the stent member
`includes a tubular structure away from a central portion that flares at
`both ends in a trumpet-like configuration” ................................................. 44 
`C.  Grounds 3-4: The Challenged Claims are Not Obvious in View of
`Garrison, Leonhardt, and Nguyen ................................................................ 46 
`D.  Grounds 5-10: The Challenged Claims are Not Obvious in View of
`Andersen, Limon, Garrison, Nguyen, and Gabbay or Phelps ...................... 48 
`1.  A POSA Would Not be Motivated to Combine Andersen with Limon ..... 48 
`2.  Andersen, Gabbay, and Nguyen Do Not Disclose “a valve means
`including two to four individual leaflets made of fixed pericardial
`tissue” .......................................................................................................... 58 
`3.  A POSA Would Not Implement the Flared Stents of Gabbay or Phelps
`in Andersen’s Valve Prosthesis .................................................................. 62 
`4.  A POSA Would Not Have Had a Reasonable Expectation of Success in
`Combining Andersen’s Figure 12 Long Valve Prosthesis with Limon’s
`Stent Delivery System to Achieve “a controlled release mechanism that
`can be activated” ......................................................................................... 67 
`VIII.  ADJUDICATION OF THE CHALLENGED PATENTS MAY VIOLATE
`THE U.S. CONSTITUTION ................................................................................... 68 
`IX. 
`CONCLUSION ............................................................................................ 68 
`
`
`
`
`
`
`
`
`ii
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`

`

`TABLE OF AUTHORITIES
`
`Cases 
`
`Apple Inc. v. Uniloc Luxembourg S.A.,
`IPR2017-02041 (PTAB Mar. 8, 2018) (Paper 10) ............................................... 61
`Belden Inc. v. Berk–Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................................................................ 60
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ............................................................................ 50
`Envtl. Designs, Ltd. v. Union Oil Co. of California,
`713 F.2d 693 (Fed. Cir. 1983) ................................................................................ 9
`G.B.T. Inc. v. Walletex Microelectronics Ltd.,
`IPR2018-00326 (PTAB June 25, 2019) (Paper 60) ............................................. 31
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ....................................................................... 58, 61
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) ..................................................................... 20, 34
`Innogenetics, N.V. v. Abbott Labs,
`512 F.3d 1363 (Fed. Cir. 2008) ..................................................................... 30, 65
`McGinley v. Franklin Sports, Inc.,
`262 F.3d 1339 (Fed. Cir. 2001) ..................................................................... 55, 56
`Metalcraft of Mayville, Inc. v. The Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) ............................................................................ 25
`Neutrino Dev. Corp. v. Sonosite, Inc.,
`410 F. Supp. 2d 529 (S.D. Tex. 2006) ................................................................... 9
`Raytheon Techs. Corp. v. Gen. Elec. Co.,
`993 F.3d 1374 (Fed. Cir. 2021) ..................................................................... 21, 36
`U.S. v. Arthrex, Inc., et al.,
`No. 19-1434, cert. granted, (Oct. 13, 2020) ........................................................ 68
`
`
`
`iii
`
`

`

`Univ. of Maryland Biotechnology Inst. v. Presens Precision Sensing
`GmbH,
`711 F. App’x 1007 (Fed. Cir. 2017) .................................................................... 58
`Winner Int’l Royalty Corp. v. Wang,
`202 F.3d 1340 (Fed. Cir. 2000) ............................................................................ 23
`ZTE (USA) Inc. v. Fundamental Innovation Sys. Int’l LLC,
`IPR2018-00274 (PTAB Aug. 29, 2018) (Paper 17) ............................................ 26
`
`
`
`
`
`
`iv
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`

`

`I.
`
`INTRODUCTION
`Petitioner, challenging claims 1-5 of the ’739 patent, takes a scatter-shot
`
`approach to obviousness without attempting to explain how a POSA would
`
`approach the problems in the art solved by the ’739 patent. Petitioner attempts to
`
`combine prior art references without regard for their field of study, but makes no
`
`mention of the significant hurdles to be overcome by doing so. And even on a
`
`ground that purportedly requires only one reference, Petitioner has created an
`
`embodiment never discussed in that reference and not adequately described or
`
`explained in the Petition. Petitioner fails to set forth even the most basic
`
`requirements to meet its burden of showing unpatentability due to obviousness:
`
`that a POSA would have been motivated to combine two or more references with a
`
`reasonable expectation of success. Petitioner’s arguments must fail.
`
`Additionally, Petitioner has failed to demonstrate that the cited references
`
`render obvious every element of the Challenged Claims, including the
`
`requirements for “a valve means including…leaflets made of fixed pericardial
`
`tissue,” a “stent member…that flares at both ends in a trumpet-like configuration,”
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`and “a controlled release mechanism that can be activated.”
`
`Accordingly, PO requests that the Board find Petitioner has failed to
`
`demonstrate that the Challenged Claims are unpatentable.
`
`
`
`1
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`

`

`II. LEVEL OF ORDINARY SKILL
`For purposes of this Response, PO does not dispute Petitioner’s POSA
`
`definition. (Petition, 23; Dasi ¶¶21-23.)
`
`III. OVERVIEW OF THE ’739 INVENTION
`Heart disease is the leading cause of death in the United States. In severe
`
`cases, the heart valve is so diseased that it cannot be treated by medication or
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`repaired, and must be replaced with an artificial heart valve. Over 100,000
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`defective heart valves are replaced in the U.S. each year. The ’739 patent is
`
`directed to a percutaneous replacement heart valve and a delivery and implantation
`
`system. (’739, Cover.)
`
`PO Colibri was co-founded by Drs. David Paniagua and R. David Fish—the
`
`inventors of the ’739 patent. Drs. Paniagua and Fish, leading interventional
`
`cardiologists and innovators in the field of cardiovascular intervention, were
`
`responsible for one of the first percutaneous heart valve implants, and Dr. Paniagua
`
`performed the world’s first retrograde TAVI procedure on a human in 2003. (Ex.
`
`2001, 2-4.) Their work has resulted in the discovery and development of artificial
`
`heart valves and treatment methodologies that could offer patients an opportunity
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`to receive a less invasive heart valve therapy, and became the basis for Colibri’s
`
`patented inventions.
`
`
`
`2
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`

`

`Colibri’s life-saving inventions include a patented, self-expanding heart
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`valve device that includes cross-linked biological tissue and a delivery system that
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`can be guided through a patient’s artery to the heart where it is positioned and used
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`to replace diseased valves. The patented device and mechanism of controlled
`
`release, which includes making a small incision through which a thin, flexible tube
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`is inserted into the artery, is far less invasive than open heart surgery. The
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`controlled release capability permits a surgeon to recover the patented heart valve
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`device during deployment. For this innovative replacement heart valve and system
`
`of delivery and implantation, Colibri was awarded the ’739 patent.
`
`Specifically, the claimed system of the ’739 patent is first directed to a
`
`prosthetic heart valve, which includes:
`
` A stent member that is collapsible, self-expanding, formed from
`
`nitinol, configured for transluminal percutaneous delivery, and
`
`includes a tubular structure away from a central portion that flares at
`
`both ends in a trumpet-like configuration; and
`
` A valve means that has two to four individual leaflets made of fixed
`
`pericardial tissue, resides entirely within an inner channel of the stent
`
`member, and has no reinforcing members residing within this inner
`
`channel. (’739, 14:5-15.)
`
`
`
`3
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`

`

`Next, the claimed system of the ’739 patent is directed to a delivery system
`
`(shown below), which includes:
`
`(Petition, 14 (citing ’739, Fig. 8).)
`
` A pusher member with a guide wire lumen;
`
`
`
` The prosthetic valve collapsed onto the pusher member to reside (1)
`
`entirely within the inner channel of the stent member in a collapsed
`
`configuration on the pusher member, or (2), upon deployment in the
`
`patient, to continue to reside in entirely within the inner channel of the
`
`stent member; and
`
` A moveable sheath (1) that has a lumen configured for the pusher
`
`member, (2) that restrains the valve in its collapsed configuration on
`
`the pusher member, and (3) that has the distal end of the valve located
`
`at its distal end. (’739, 14:16-29.)
`
`
`
`4
`
`

`

`IV. CHALLENGED CLAIMS
`Petitioner challenges claims 1-5 of the ’739 Patent, of which claim 1 is
`
`independent.
`
`Claim 1 recites:
`
`An assembly to treat a native heart valve in a patient, the
`assembly for use in combination with a guidewire, the assembly
`comprising:
`a prosthetic heart valve including:
`a stent member having an inner channel, the stent
`member collapsible, expandable and configured for
`transluminal percutaneous delivery, wherein the stent member
`includes a tubular structure away from a central portion that
`flares at both ends in a trumpet-like configuration; and
`a valve means including two to four individual leaflets
`made of fixed pericardial tissue, wherein the valve means
`resides entirely within the inner channel of the stent member,
`and wherein no reinforcing members reside within the inner
`channel of the stent member;
`a delivery system including a pusher member and a moveable
`sheath, the pusher member including a guidewire lumen, wherein the
`pusher member is disposed within a lumen of the moveable sheath,
`wherein the prosthetic heart valve is collapsed onto the pusher
`member to reside in a collapsed configuration on the pusher member
`and is restrained in the collapsed configuration by the moveable
`sheath, wherein a distal end of the prosthetic heart valve is located at a
`distal end of the moveable sheath, and wherein the valve means
`
`
`
`5
`
`

`

`resides entirely within the inner channel of the stent member in said
`collapsed configuration and is configured to continue to reside
`entirely within the inner channel of the stent member upon
`deployment in the patient.
`
`(Id., 14:2-29.)
`
`Claim 2 recites:
`
`The assembly of claim 1, wherein the stent member is self-expanding.
`
`(Id., 14:30-31.)
`
`Claim 3 recites:
`
`The assembly of claim 2, wherein the stent member comprises nitinol.
`
`(Id., 14:32-33.)
`
`Claim 4 recites:
`
`4. The assembly of claim 1, wherein the stent member includes two
`circles of barbs on an outer surface of the stent member.
`
`(Id., 14:34-36.)
`
`Claim 5 recites:
`
`The assembly of claim 1, wherein the pusher member includes a
`controlled release mechanism that can be activated.
`
`(Id., 14:37-38.)
`
`V.
`
`PROSECUTION HISTORY
`The ’739 Patent was filed on April 15, 2014, and claims priority to
`
`application No. 10/887,688, filed on July 10, 2004, as well as to application No.
`
`
`
`6
`
`

`

`10/037,266, filed on January 4, 2002, of which the ’688 application is a
`
`continuation-in-part. (’739, Cover.) The ’739 patent’s application was examined by
`
`Cheryl Miller, as was its sister application, which matured into U.S. Patent No.
`
`8,900,294. (Compare Ex. 1003, 1797 with Ex. 1011, 1820.) During prosecution of
`
`the ’294 patent, Applicants overcame rejections over Garrison and Leonhardt, and
`
`during prosecution of the ’739 patent, Applicants overcame rejections over
`
`Garrison alone and in combination with other references. (Ex. 1011, 1816-20; Ex.
`
`1003, 1794.) The ’739 patent issued on September 8, 2015. (’739, Cover.)
`
`VI. CLAIM CONSTRUCTION
`PO agrees with Petitioner that, for purposes of this Response, all terms of the
`
`’739 patent, other than those specified below, have their plain and ordinary
`
`meaning.
`
`A.
`
`“trumpet-like” (claim 1)
`In related district court litigation, the Technical Special Master construed
`
`“flares at both ends in a trumpet-like configuration” to mean “having, at each end,
`
`a widening that resembles the bell of a conventional musical trumpet.” (Ex. 2025,
`
`46.) Judge Carter adopted this construction. (Ex. 2026.) PO applies this definition
`
`to this proceeding. (Dasi ¶¶72-73.)
`
`B.
`
`“valve means” (claim 1)
`In related district court litigation, the Technical Special Master construed
`
`“valve” and “valve means” to mean “portions of the replacement heart valve
`
`
`
`7
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`

`

`device that allow the one-way flow of blood.” (Ex. 2025, 15.). Judge Carter
`
`adopted this construction. (Ex. 2026.) PO applies this definition to this proceeding.
`
`(Dasi ¶¶74-75.)
`
`C.
`
`“controlled release mechanism” (claim 5)
`Petitioner’s expert defined “controlled release” as meaning that “the operator
`
`can control when the valve…is released,” including “control [of the valve’s
`
`release] so that [the valve] doesn’t just arbitrarily pop out…when [the operator]
`
`do[es]n’t want it to.” (Ex. 2020, 87:7-18.) PO applies this definition here. (Dasi
`
`¶¶76-78.)
`
`VII. PETITIONER HAS FAILED TO DEMONSTRATE THAT THE
`CHALLENGED CLAIMS ARE OBVIOUS
`During deposition, Petitioner’s expert admitted to applying an incorrect
`
`standard to his obviousness analysis. Specifically, he required a combination to
`
`produce unexpected results in order to be non-obvious. (Ex. 2020, 19:13-20:16,
`
`24:5-17.)
`
`Additionally, Petitioner’s expert also admitted to opining based on his own
`
`perspective, rather than from the perspective of a POSA. For example, although he
`
`had been practicing in the relevant field for approximately 20 years by the relevant
`
`2002/2004 date at issue here, in contrast to the two years of experience required by
`
`his POSA definition, Petitioner’s expert stated that in reaching his opinions he
`
`“would use anything and everything [he] knew up to that point in 2002.” (Ex.
`
`
`
`8
`
`

`

`2020, 22:18-23:4; compare Ex. 1002 ¶31 with Ex. 1002 ¶¶13-19.) Thus,
`
`Petitioner’s expert’s declaration is improper. See Neutrino Dev. Corp. v. Sonosite,
`
`Inc., 410 F. Supp. 2d 529, 550 (S.D. Tex. 2006) (“[I]f [the expert] testified based
`
`on his own perspective and that he possesses ‘extraordinary,’ not ordinary, skill in
`
`the art, then his conclusions are improper.” (citing Envtl. Designs, Ltd. v. Union
`
`Oil Co. of California, 713 F.2d 693, 697 (Fed. Cir. 1983) (“The important
`
`consideration lies in the need to adhere to the statute, i.e., to hold that an invention
`
`would or would not have been obvious, as a whole, when it was made, to a person
`
`of ‘ordinary skill in the art’—not to the judge, or to a layman, or to those skilled in
`
`remote arts, or to geniuses in the art at hand.”)).)
`
`As such, the opinions of Petitioner’s expert—which provide the only
`
`purported support for Petitioner’s allegations—should be entitled to little, if any,
`
`weight.
`
`A. Ground 1: The Challenged Claims are Not Obvious in View of
`Garrison Alone
`Petitioner argues that Garrison alone renders the Challenged Claims
`
`obvious. (Petition, 11.) To the contrary, a POSA would not know how to
`
`implement the purported integrated heart valve device upon which Petitioner relies
`
`into Garrison’s delivery system. (Dasi ¶¶121-124.) Further, Garrison does not
`
`teach or render obvious all the limitations of the ’739 patent claims. (Dasi ¶129.)
`
`
`
`9
`
`

`

`1.
`
`A POSA Would Not Know How to Implement the Embodiment of
`Garrison on Which Petitioner Relies
`Petitioner presents four sets of obviousness grounds that each contend that a
`
`POSA would have begun with Garrison as the primary reference. (See Petition,
`
`11.) But a POSA in 2002/20041 trying to make a heart valve device as claimed in
`
`the ’739 patent would not have considered the embodiment of Garrison (upon
`
`which Petitioner purports to rely)—simply put, this is because a POSA would not
`
`know how to implement this embodiment. (Dasi ¶¶98-99.)
`
`Garrison discloses a system and method for cardiac valve replacement to
`
`purportedly avoid “median sternotomy or major thoracotomy,” i.e., open-heart
`
`surgery. (Garrison, 1:55-65.) In Garrison’s first embodiment, Garrison describes
`
`implanting two components: “a valve displacer [] used to hold the native valve
`
`leaflets open so that the native valve does not need to be removed” and a
`
`replacement cardiac valve device. (Garrison, 1:66-2:22.) Despite the fact that
`
`
`1 January 2002 is the priority date for the ’739 patent and the filing date of the
`
`earliest application to which the ’739 patent claims priority as a continuation-in-
`
`part. (’739, Cover). However, PO’s arguments do not change if a July 2004 date is
`
`used—which is the filing date of the earliest application to which the ’739 patent
`
`claims priority as a continuation. Petitioner took “no position as to the propriety of
`
`the priority claims” to January 4, 2002. (Petition, 9, n.2.)
`
`
`
`10
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`

`

`Petitioner repeatedly cites to and relies upon Garrison’s two-component
`
`embodiment, Petitioner’s expert has specifically disclaimed any reliance on
`
`Garrison’s two-component valve replacement system. Specifically, Petitioner’s
`
`expert testified:
`
`[T]he two-component system that you are referring to here, namely
`support--valve support inside of a displacer, is not what we’re
`proposing here in this declaration as[] the device structure that[]
`could be used as taught by Garrison.” (Ex. 2020, 74:11-17.) Upon
`further questioning, Petitioner’s expert confirmed his non-reliance on
`Garrison’s two-component embodiment: “Q. Okay. And you said that
`you’re not proposing in your declaration…using the two-
`component device taught by Garrison with Leonhardt; is that
`right?... A. That’s right…”
`(Ex. 2020, 75:10-76:4.) For this reason, every argument in which Petitioner relies
`
`on Garrison’s two-component system—including those arguments upon which the
`
`PTAB relied in instituting IPR—should be disregarded. (See, e.g., Petition, 4, 29-
`
`32 (“this [flared] support stent structure was well-known and a POSITA and would
`
`have been motivated to implement it to better hold the valve in the valve
`
`displacer…”), 34, 39-41 (relying on Figure 14 embodiment for delivery of two-
`
`component system and controlled release where “After the valve displacer 8 has
`
`been expanding, the catheter 4A is retraced [sic] a predetermined amount…The
`
`catheter 4A may then be manipulated as necessary so that the protrusions 34
`
`
`
`11
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`

`

`engage the openings 14 in the valve displacer 8.”), 42, 45, 47 (“The valve 6A
`
`preferably remains coupled to the catheter 4A while the protrusions 34 are exposed
`
`for manipulation of the valve 6A until the valve 6A engages the valve displacer
`
`8…The rod 78 is then advanced far enough to completely release the cardiac valve
`
`6A.”), 51-52 (“A POSITA would have been motivated to apply Leonhardt’s
`
`teachings…to Garrison’s support structure…increasing the surface area over which
`
`the support structure presses and seals against the valve displacer to better secure
`
`the prosthesis.”).)
`
`Garrison also discloses two types of alternative embodiments in addition to
`
`its two-component system. First, Garrison contemplates using a valve device
`
`without a displacer. However, Garrison describes only one scenario in which that
`
`would be appropriate: if the native valve leaflets are removed. (Garrison, 4:49-52.)
`
`A POSA would have understood that, in 2002/2004, removal of native leaflets was
`
`not possible during a TAVR procedure but instead required the invasive surgical
`
`procedures Garrison sought to avoid. (Dasi ¶¶113-114; see Ex. 2020, 30:15-31:13;
`
`Garrison, 4:47-49.) Petitioner’s expert made clear that Petitioner is not relying on
`
`this embodiment of Garrison, either. (See Ex. 2020, 75:10-76:4.)
`
`
`
`12
`
`

`

`Second, Garrison considers a displacer that is integrated with the valve
`
`device. (See Garrison, 10:38-11:45, Figures 31-33.) Garrison discloses that this
`
`integrated device, rather than using the percutaneous delivery system for the two-
`
`component system shown in Figure 14, is delivered via direct access into the aorta
`
`as shown in Figure 31 below. This is a much more invasive and complicated
`
`procedure than percutaneous delivery that a POSA would not have favored over
`
`Garrison’s two-component system. (Dasi ¶¶115-116; see Garrison, Figures 31-33;
`
`Ex. 2020, 45:5-46:12.)
`
`Despite the fact that Petitioner repeatedly cites to Garrison’s integrated
`
`embodiment (see Petition, 29, 35-36), during deposition, Petitioner’s expert
`
`specifically disclaimed any reliance on Garrison’s integrated embodiment as
`
`depicted in Figures 31-33. Specifically, Petitioner’s expert’s testified:
`
`
`
`13
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`

`

`Q. So focusing instead on the integrated device of Garrison, if I
`understand it correctly, Garrison describes inverting the valve so that
`it’s not damaged during delivery and then pulling it back into its
`intended position by sutures that pull the valve device into place. Is
`that right for the integrated device in Garrison?…
`A. No. It—[]that is incorrect. So Garrison does indeed describe an
`embodiment of an integrated device that has the features that you just
`described and is shown in, for example, figures 31, 32, and perhaps
`others as well. That--that is not the form of the integrated device
`that is being proposed here in the declaration…”
`(Ex. 2020, 76:5-78:4).) For this reason, every argument in which Petitioner relies
`
`on Garrison’s integrated embodiment—including those arguments upon which the
`
`PTAB relied in instituting IPR—should also be disregarded. (See, e.g., Petition, 29,
`
`35 (“Alternatively, a POSITA would have understood…that Garrison also
`
`discloses an integrated valve displacer and cardiac valve…and the other
`
`discussions regarding the support structure in claim 1 similarly apply to the
`
`embodiment integrated with the valve displacer. Garrison 2:5-10, 4:52-57.”), 36
`
`(“Valve displacer 8 and cardiac valve 6 may be integrated into a single structure
`
`and delivered together rather than separately.”).)
`
`Instead, Petitioner’s expert has taken the position that he is relying solely on
`
`a purported fourth embodiment from Garrison in which Garrison’s “valve
`
`(including its support structure)” has “the same features of the valve displacer.”
`
`(Petition, 29; Ex. 2020, 74:11-17, 75:10-76:4.) Specifically, Petitioner’s expert
`
`
`
`14
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`

`

`testified: “When Garrison says in his specification somewhere--I think it’s in
`
`column 4. I can’t remember the line.…That[] you can indeed use any of the aspects
`
`of the displacer in the valve support structure and[] you can integrate them.
`
`Integrate would mean to me that you can take, for example, the valve leaflets of the
`
`valve support structure and put it into the displacer, which then becomes your new
`
`valve support structure.” (Ex. 2020, 76:5-78:4.)
`
`However, a POSA would not have read Garrison as disclosing a fourth
`
`embodiment beyond the disclosed two-component device, valve-only device, or
`
`integrated device as depicted in Figures 31-38 (Dasi ¶¶117-118; Garrison, 4:52-
`
`54.) Particularly, the complete paragraph of Garrison upon which Petitioner’s
`
`expert relies states:
`
`[embodiment 1] The valve displacer 8 is expanded within the native
`valve to hold the native cardiac valve leaflets 6 open. An advantage of
`the system 2 and method of the present invention is that the native
`valve does not need to be removed. [embodiment 2] The replacement
`cardiac valves described herein may, of course, also be used when
`removing the native valve rather than using the valve displacer 8.
`[embodiment 3] Furthermore, the valve displacer 8 and cardiac valve
`6 may be integrated into a single structure and delivered together
`rather than separately. Thus, all features of any valve displacer
`described herein may also form part of any of the cardiac valves
`described.
`
`
`
`15
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`

`(Garrison, 4:46-57.) The fact that Garrison’s disclosure that “all features of any
`
`valve displacer described herein may also form part of any of the cardiac valves
`
`described” follows the word “Thus,” would indicate to a POSA that this disclosure
`
`relates to what comes before it—namely, the immediately-proceeding disclosure of
`
`a third embodiment in which “the valve displacer 8 and cardiac valve 6 may be
`
`integrated into a single structure and delivered together rather than separately.”
`
`(Dasi ¶118; see Garrison, 4:52-57.) It follows that a POSA would properly
`
`understand Garrison to be disclosing only three embodiments—(1) a two-
`
`component device, (2) a valve-only device (inserted after removal of native
`
`leaflets), and (3) an integrated device, in which “the valve displacer 8 and cardiac
`
`valve 6 may be integrated into a single structure and delivered together rather than
`
`separately.” (Dasi ¶118.) A POSA would understand that for this disclosed
`
`integrated device, “all features of any valve displacer described herein may also
`
`form part of any of the cardiac valves described.” (Id.; see Garrison, 4:52-57.)
`
`A POSA would find further confirmation of this reading in the fact that
`
`Garrison proceeds to provide detailed descriptions and figures relating to three
`
`embodiments: (1) a two-component device, (2) a valve-only device, and (3) an
`
`integrated device in which “the valve displacer 8 and cardiac valve 6 may be
`
`integrated into a single structure and delivered together rather than separately,” but
`
`does not contain any disclosure of a fourth embodiment of an integrated structure.
`
`
`
`16
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`

`

`(Dasi ¶119; see Garrison, (1) 2:23-25 (two-component), (2) 11:40-41 (valve-only)
`
`and (3)10:37-51 (“Referring to FIGS. 31-38 another system 2D for introducing a
`
`valve 6D is shown wherein similar or the same reference numbers refer to similar
`
`or the same structure. The valve 6D is coupled to a valve displacer 8D prior to
`
`introduction into the patient….The support structure 26D has protrusions 34D
`
`which engage holes 108 in the valve displacer 8D. The valve 6D and valve
`
`displacer 8D may engage one another in any other suitable manner. The valve 6D
`
`is inverted before being attached to the valve displacer 8D as shown in FIG. 35.”).
`
`Because a POSA would not understand Garrison to even disclose an
`
`embodiment like the one upon which Petitioner’s expert relies, a POSA “would not
`
`view the ’739 patent as obvious in light of Garrison alone, or in light of any of the
`
`combinations with Garrison that the Petition sets forth.” (Dasi ¶120.) In addition,
`
`even if Garrison were viewed as disclosing a fourth embodiment, as Petitioner’s
`
`expert describes, a POSA “would not know how to use Garrison’s disclosures to
`
`make this purported fourth embodiment.” (Dasi ¶121.) Specifically, Petitioner does
`
`not allege how a POSA would make or deploy this purported fourth purported
`
`embodiment of Garrison’s valve device.
`
`For example, Petitioner relies on Garrison’s disclosure of its two-component
`
`delivery system, in which the valve displacer and valve device are designed to fit
`
`together in a particular way, as shown in Figure 9 (annotated below). The valve
`
`
`
`17
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`

`

`displacer has openings (14) in the distal portion and the valve device has
`
`protrusions (34), such as a coil or barbs, that engage with the openings on the valve
`
`displacer. (Dasi ¶103.)
`
`
`
`Figure 14 shows the delivery device of Garrison’s two-component
`
`embodiment. Garrison describes how to use the device of Figure 14 to implant the
`
`valve displacer and valve device. First, the balloon-expandable valve displacer
`
`must be placed in the native aortic annulus to displace the diseased native leaflets.
`
`After the delivery catheter is introduced transfemorally, “[t]he valve displacer 8 is
`
`[] introduced between the valve leaflets as shown in FIG. 3 and the balloon 50 is
`
`inflated to expand the valve displacer as shown in FIG. 4 The valve displacer 8
`
`holds the native valve leaflets open so that the native valve does not have to be
`
`removed.” (Garrison, 7:49-53; 8:51-53.) Then, Petitioner argues that “[t]he valve
`
`6A preferably remains coupled to the catheter 4A while the protrusions 34 are
`
`
`
`18
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`

`exposed for manipulation of the valve 6A until the valve 6A engages the valve
`
`displacer 8.…[T]he rod 78 is then advanced far enough to completely release the
`
`cardiac valve 6A.” (Petition, 47; Dasi ¶¶104-105.)
`
`Although Petitioner relies on Garrison’s Figure 14 delivery system for its
`
`obviousness analysis (see, e.g., Petition, 30-31, 40-41), Petitioner provides no
`
`explanation for how a POSA would have used Garrison’s delivery device
`
`embodiment pictured in Figure 14 without a separate valve displacer, as would be
`
`required in the purported fourth embodiment of Garrison upon which Petitioner
`
`relies. For example, Garrison only describes Figure 14 as being used with valve
`
`displacers that are balloon expandable. Petitioner fails to consider what material its
`
`proposed integrated device embodiment would be composed of, how it would
`
`function, and whether a POSA would have needed to modify the device or delivery
`
`system further for it to work properly. Indeed, the only delivery system that
`
`Garrison discloses for an integrated device embodiment is disclosed with respect to
`
`Garrison’s Figures 31-38, upon which Petitioner’s expert has disclaimed any
`
`
`
`19
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`

`

`reliance, as discussed above. (Dasi ¶¶123, 135; see Garrison, 10:37-51; Ex. 2020,
`
`76:5-78:4.) See In re Stepan Co., 868 F.3d 1342, 1346 n.1 (Fed. Cir. 2017)
`
`(“Whether a rejection is based on combining disclosures from multiple references,
`
`combining multiple embodiments from a single reference, or selecting from large
`
`lists of elements in a single reference, the