Petitioner’s Demonstrative Slides
`
`Medtronic Corevalve LLC v. Colibri Heart Valve LLC
`Inter Partes Review of
`U.S. Patent No. 9,125,739
`December 8, 2021
`
`IPR2020-01454
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`1
`
`Medtronic Exhibit 1045
`Medtronic Corevalve v. Colibri Heart Valve
`IPR2020-01454
`Page 00001
`
`

`

`Introduction
`
`Table of Abbreviations
`
`Description
`Ex. 1001, U.S. Patent No. 9,125,739
`Ex. 1002, Declaration of Dr. Drasler
`Ex. 1041, Reply Declaration of Dr. Drasler
`Ex. 2020, Deposition Transcript of Dr. Drasler
`Ex. 1005, U.S. Patent No. 6,425,916
`Ex. 1006, U.S. Patent No. 5,957,949
`Ex. 1008, U.S. Patent No. 6,077,295
`Ex. 1009, U.S. Patent No. 7,025,780
`Ex. 1010, WO0015147
`Ex. 1012, WO9829057
`Ex. 1013, U.S. Patent No. 5,840,081
`Ex. 1020, U.S. Patent No. 5,961,549
`Ex. 1021, U.S. Patent No. 5,713,950
`Paper 2 (Petition)
`Paper 6 (Patent Owner’s Preliminary Response)
`Paper 11 (Decision on Institution)
`Paper 14 (Patent Owner’s Response)
`Paper 18 (Reply)
`Paper 19 (Patent Owner’s Sur-Reply)
`Patent Owner (Colibri Heart Valve LLC)
`
`Abbreviation
`’739
`Drasler
`Drasler Reply
`DraslerTr
`Garrison
`Leonhardt
`Limon
`Gabbay
`Phelps
`Letac
`Andersen
`Nguyen
`Cox
`Pet.
`POPR
`DI
`POR
`Reply
`POSR
`PO
`
`All citations within quotations omitted herein, and emphasis added unless otherwise indicated
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`2
`
`IPR2020-01454 Page 00002
`
`

`

`Introduction
`Claim 1 of the ’739 patent:
`[1.pre] An assembly to treat a native heart valve in a patient, the assembly for use in combination with a guidewire,
`the assembly comprising:
`
`[1.1] a prosthetic heart valve including: a stent member having an inner channel, the stent member collapsible,
`expandable and configured for transluminal percutaneous delivery, wherein
`
`[1.2] the stent member includes a tubular structure away from a central portion that flares at both ends in a
`trumpet-like configuration; and
`
`[1.3] 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;
`
`[1.4] 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
`
`[1.5] 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
`
`[1.6] the valve means 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.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`3
`
`IPR2020-01454 Page 00003
`
`

`

`Claim Construction
`
`The Board need not construe the terms PO disputes
`
`• PO’s Construction of “valve” and “valve means” ([1.pre], [1.1], [1.3], [1.5], [1.6]): “portions of the
`replacement heart valve 8 device that allow the one-way flow of blood” (POR 7-8)
`– PO does not contest that Garrison and Andersen each disclose “valve means.” See POR 10-14; Reply 1.
`• PO’s Construction of “flares at both ends in a trumpet-like configuration” ([1.2]): “having, at each
`end, a widening that resembles the bell of a conventional musical trumpet” (POR 7)
`– PO concedes Garrison and Leonhardt disclose “trumpet-like” structures (and does not raise the issue
`vis-à-vis the Andersen grounds). See POR 27, 45; DI 25; Reply 1.
`• PO’s Construction of “controlled release mechanism” ([5]): “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.” (POR 8)
`– PO’s subjective construction should be rejected, but nevertheless does not impact whether the
`limitation is met (see Slides 28-29)
`– PO’s construction relies solely on and omits the key highlighted portions of Dr. Drasler’s testimony
`
`Drasler:
`Q. And so I think you -- you sort of set forth a meaning of that in paragraph 69, and so I wanted to see if I
`understand what you’re saying. Is it the case that, to one of ordinary skill in the art, you would view controlled
`release meaning that the operator can control when the valve of Garrison is released from the sheath?
`A. Control when it's released, and control it so that it doesn't just arbitrarily pop out, so it has some frictional
`aspect to it so that it doesn't want to just go outwards and -- when you don’t want it to, yes.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`DraslerTr. 87:7-18; see also Reply 2.
`
`4
`
`IPR2020-01454 Page 00004
`
`

`

`Garrison Grounds
`
`Ground
`1
`2
`3
`4
`
`Basis
`§103
`§103
`§103
`§103
`
`Garrison Grounds
`Claim(s) Prior Art
`Garrison
`1-5
`Garrison in view of Leonhardt
`1-5
`Garrison in view of Nguyen
`1-5
`Garrison in view of Leonhardt and Nguyen
`1-5
`
`Disputed Issues
`
`PO’s Arguments
`“a valve means including … leaflets made of fixed pericardial tissue;”
`(’739, [1.3])
`Grounds 1-2: Garrison renders obvious
`Grounds 3-4: Nguyen and motivation to apply its teachings to
`Garrison (and Leonhardt)
`“the stent member includes a tubular structure away from a central
`portion that flares at both ends in a trumpet-like configuration” (’739,
`[1.2])
`Grounds 1, 3: Garrison
`Grounds 2, 4: Leonhardt, motivation to apply its teachings to
`Garrison
`“controlled release mechanism that can be activated” (’739, [5])
`Grounds 1-4: Garrison
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`Pet. at 11.
`
`POR/POSR
`
`Slides
`
`POR 21-25;
`POSR 1-12
`
`POR 46-48;
`POSR 9-10
`
`Slides 6-10
`
`Slides 11-12
`
`POR 10-21, 26-
`33; POSR 22-24
`
`Slides 13-21
`
`POR 37-46
`
`Slides 22-26
`
`POR 33-37;
`POSR 24-25
`
`Slides 27-30
`
`5
`
`IPR2020-01454 Page 00005
`
`

`

`Garrison Grounds
`
`PO’s Arguments
`“a valve means including … leaflets made of fixed
`pericardial tissue;” (’739, [1.3])
`Grounds 1-2: Garrison renders obvious
`
`Grounds 3-4: Nguyen and motivation to apply
`its teachings to Garrison (and Leonhardt)
`
`POR/POSR Slides
`
`POR 21-25;
`POSR 1-12
`POR 46-48;
`POSR 9-10
`
`Slides 6-10
`
`Slides 11-12
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`6
`
`IPR2020-01454 Page 00006
`
`

`

`“a valve means including … leaflets made of fixed pericardial tissue;” (’739, [1.3])
`Garrison in view of a POSITA’s knowledge discloses, and at minimum renders
`obvious, “leaflets made of fixed pericardial tissue”
`• As the ’739 patent admits, valves constructed of fixed pericardial tissue were well-
`known:
`’739 patent: “Most tissue valves are constructed by sewing the leaflets of pig aortic
`valves to a stent to hold the leaflets in proper position, or by constructing valve
`leaflets from the pericardial sac of cows or pigs and sewing them to a stent. The
`porcine or bovine tissue is chemically treated to alleviate any antigenicity.”
`’739 patent, 3:41-46; see also Drasler ¶¶86-88, 105-106; Pet. 31, 38-39, 77-78.
`
`•
`
`Pet. 31-32.
`
`• The Petition identified multiple motivations to apply these teachings in implementing
`Garrison’s device:
`– “strong for its relatively low profile”
`– “relatively easy to manipulate to the desired shape” / “achieve properly
`sized/configured valves”
`– “durability”
`– “one of the most readily available valve construction materials,” “one of the most
`common ways of creating a tissue valve”
`
`•
`
`•
`
`Pet. 31-32; DraslerTr 90:16-92:7; see also Reply 4-5; Pet. 33.
`
`Pet. 77-78; see also DraslerTr 90:16-92:7; Drasler Reply ¶¶59-60.
`
`•
`
`Pet. 31-32, 39, 59, 65; Drasler ¶¶87, 106, 153, 156, 170, 191; see also Nguyen, 1:28-39; Gabbay 3:38-42, 7:4-7; Cox, 4:35-50.
`
`See also Drasler ¶¶105-106, 86-88; Garrison 5:42-48, Figs. 10-11; ’739 patent, 3:41-46.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`7
`
`IPR2020-01454 Page 00007
`
`

`

`“a valve means including … leaflets made of fixed pericardial tissue;” (’739, [1.3])
`Contrary to PO’s arguments, Petitioner does not rely on bodily incorporation
`
`PO argues: “Nothing in the ’739 patent—or any other reference that Petitioner cites—discusses adding fixed
`pericardium leaflets to a valve device like Garrison’s, which … already has leaflets attached…”
`
`POR 21-25; POSR 1-4.
`
`• But PO mischaracterizes the trial grounds:
`Petition:
`“…’739 admits the use of fixed pericardial tissue was well-known general knowledge for a POSITA…. [¶] A
`POSITA had a reasonable expectation of success in applying these teachings to Garrison’s porcine tissue valve
`to advantageously alleviate antigenicity…using one of the most common ways of creating a tissue valve and to
`use a material with known benefits—strong for its relatively low profile and relatively easy to manipulate to the
`desired shape.”
`“…[A] POSITA would have been motivated to apply the known design teachings of a valve made of fixed pericardial
`tissue to Garrison’s valve with the predictable result of improving Garrison’s device by using one of the most readily
`available valve construction materials to reduce antigenicity.”
`Pet. 31-32, 38-39 (internal citations omitted); see also ’739, 3:41-46; Drasler ¶¶86-88, 104-106; Drasler Reply ¶¶18-20; Reply 3-5;
`KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
`
`Federal Circuit: “The test for obviousness is not whether the features of a secondary reference may be bodily
`incorporated into the structure of the primary reference…the test for obviousness is what the combined teachings of the
`references would have suggested to those having ordinary skill in the art.”
`
`In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012); Reply 4.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`8
`
`IPR2020-01454 Page 00008
`
`

`

`“a valve means including … leaflets made of fixed pericardial tissue;” (’739, [1.3])
`A POSITA would have been motivated to apply common knowledge of
`pericardial leaflets to improve Garrison’s device
`
`PO argues: “Petitioner ignores the disadvantages of using fixed pericardial leaflets, such as introducing a vulnerable
`suture line, and the fact that ‘pericardium is [] thin and very slippery, which makes it difficult for suturing in a millimetricly
`precise way.’”
`
`POR 21-25 (internal citations omitted) (alteration in original); POSR 4-12.
`
`• But as Dr. Drasler testified, even with PO’s alleged disadvantages, POSITAs were motivated to use
`pericardial leaflets due to their benefits:
`
`Dr. Drasler: “[T]here are both advantages and disadvantages to each approach—I explained that a person of
`ordinary skill in the art would have been motivated to apply the known and most-common approach of using
`pericardial tissue instead of a natural valve to advantageously, e.g., “form [the valve] into whatever shape”
`needed; “when you make a pericardial valve” you have the “control” to “pick a strong pericardial tissue” and “form
`the leaflets into the size you want … to suit[] the various patients.”
`
`Federal Circuit: “The fact that the motivating benefit comes at the expense of another benefit, however, should
`not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the
`benefits, both lost and gained, should be weighed against one another.”
`
`Drasler Reply ¶22; see also DraslerTr. 90:16-92:7; Drasler Decl., ¶¶87, 106; Pet. 31-32, 38-39; Reply 3-5.
`
`Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349-50 n.8 (Fed. Cir. 2000); POSR 5.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`9
`
`IPR2020-01454 Page 00009
`
`

`

`“a valve means including … leaflets made of fixed pericardial tissue;” (’739, [1.3])
`A POSITA would have been motivated to apply common knowledge of
`pericardial leaflets to improve Garrison’s device
`
`PO argues: “Rygg says that fixed pericardium’s advantages are shared by the Garrison/Andersen natural valves, but
`goes on to state that fixed pericardium valves have a weakness not shared by natural valves….[¶]….Fisher also
`provides no motivation for Petitioner’s proffered combination, and even teaches away from it.”
`POSR 6-7 (internal citations omitted) (italics in original); POR 21-25.
`
`• Petitioner does not rely on Rygg and Fisher
`• Regardless, Rygg and Fisher do not teach away from use of pericardial tissue
`leaflets:
`Fisher: “pericardial bioprosthesis has been used clinically for over 13 years with good clinical follow-up results”
`Fisher, 105; see also Drasler Reply ¶22
`
`Rygg: “porcine pericardium … have the advantages in common that follow from the application of a
`heterologous material, viz. that they remain thin and movable, and that no deposits are formed on the them that
`may get loose and cause thrombi”
`
`Rygg, 2:5-12; see also Drasler Reply ¶22.
`
`Drasler: “Indeed, Patent Owner’s and Dr. Dasi’s own exhibits (relied on to show that using pericardial tissue
`requires sutures that are a point of weakness) acknowledge that using pericardial tissue has advantages.”
`
`Drasler Reply ¶22 (citing Fisher, 105; Rygg, 2:5-12).
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`10
`
`IPR2020-01454 Page 00010
`
`

`

`Garrison Grounds
`
`PO’s Arguments
`“a valve means including … leaflets made of fixed
`pericardial tissue;” (’739, [1.3])
`Grounds 1-2: Garrison renders obvious
`
`Grounds 3-4: Nguyen and motivation to apply
`its teachings to Garrison (and Leonhardt)
`
`POR/POSR Slides
`
`POR 21-25;
`POSR 1-12
`POR 46-48;
`POSR 9-10
`
`Slides 6-10
`
`Slides 11-12
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`11
`
`IPR2020-01454 Page 00011
`
`

`

`“a valve means including … leaflets made of fixed pericardial tissue;” (’739, [1.3])
`Nguyen discloses, and at minimum renders obvious, “leaflets made of fixed
`pericardial tissue” and a POSITA would have been motivated to apply
`Nguyen’s teachings to Garrison
`
`• Nguyen teaches:
`Nguyen: “Bio-prosthetic valves may be formed from an intact, multi-leaflet porcine (pig) heart valve, or by
`shaping a plurality of individual leaflets out of bovine pericardial tissue and combining the leaflets to form the
`valve. …[B]ovine (cow) pericardium is commonly used to make individual leaflets for prosthetic heart valves.”
`Nguyen, 1:28-39; see also Drasler ¶¶86-88, 105-106, 153; Pet. 77-79.
`Nguyen: “Despite the drawbacks of artificial heart valve material, over twenty years of clinical experience
`surrounding implanted artificial heart valves has produced a proven track record of success.”
`Nguyen 1:51-54, 1:28-39; see also Pet. 77-78; Drasler ¶153.
`
`• A POSITA would have been motivated to apply Nguyen’s teachings to Garrison
`(see Slides 7-10)
`• This is consistent with the other art of record, e.g.:
`Gabbay: “The outer sheath 130 may be a sheath of natural tissue pericardium ( e.g., bovine, equine, porcine,
`etc.), another biological tissue material (e.g., collagen), or a synthetic material (e.g., Dacron).”
`Gabbay 7:4-12, 3:38-48; see also Drasler ¶¶86-88, 105-106; Pet. 31, 77-78.
`
`Drasler ¶153; see also Nguyen, 1:28-39; Gabbay 3:38-42, 7:4-7; Cox, 4:35-50; ’739 patent, 3:41-46; Pet. 77-78.
`
`Cox: “Most tissue valves are constructed by sewing the leaflets of pig aortic valves to a stent … or by
`constructing valve leaflets from the pericardial sac (which surrounds the heart) of cows or pigs and sewing them
`to a stent…The only tissue valves currently approved by 1he FDA for implantation in the U.S.A. are the
`Carpentier-Edwards Porcine Valve, the Hancock Porcine Valve, and the Carpentier-Edwards Pericardial Valve.”
`
`• PO repeats the same arguments (e.g., POR 48), which fail for the reasons (see Slides 8-10)
`
`Cox, 4:35-50, 25:39-46; see also Drasler ¶¶86-88, 105-106; Pet. 77-78.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`Nguyen, 1:28-39, 1:51-54; Drasler ¶¶86-88, 105-106, 153; DraslerReply ¶¶58-59; Pet. 77-79; Reply 19;
`see also Gabbay 3:38-42, 7:4-7; Cox 4:35-50; ’739, 3:41-46.
`.
`
`12
`
`IPR2020-01454 Page 00012
`
`

`

`Garrison Grounds
`
`PO’s Arguments
`“the stent member includes a tubular structure away
`from a central portion that flares at both ends in a
`trumpet-like configuration” (’739, [1.2])
`Grounds 1, 3: Garrison
`
`Grounds 2, 4: Leonhardt, motivation to apply its
`teachings to Garrison
`
`POR/POSR
`
`Slides
`
`POR 10-21,
`26-33; POSR
`22-24
`POR 37-46
`
`Slides
`13-21
`
`Slides
`22-26
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`13
`
`IPR2020-01454 Page 00013
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`Garrison discloses, and at minimum renders obvious, “the stent member…flares at
`both ends in a trumpet-like configuration”
`Garrison: “[T]he valve displacer has a first end, a second end
`and a central section between... The first and second ends
`are preferably flared outwardly to form a circumferential
`recess around the central portion.”
`Garrison, Fig. 8, 2:15-10; see also Pet. 27-32, 35-36.
`
`• Garrison teaches its valve support structure (the
`claimed stent member) may have all the features of
`Garrison’s displacer, including its flared ends:
`Garrison: “Thus, all features of any valve displacer described
`herein may also form part of any of the cardiac valves
`described herein without departing from the scope of the
`invention.”
`Garrison, 4:54-57; see also Pet. 27-32, 35-36.
`
`Drasler: “As discussed in Section VIII.A.1, a [POSITA] thus
`would have understood that Garrison also discloses a
`support structure that “flare[s] outwardly” in a similar manner
`in order to have the same features as the displacer. At a
`minimum…a [POSITA] would have found it obvious and
`would have been motivated to use a valve support having
`this structure…to advantageously conform the valve to the
`valve displacer or the vasculature to help prevent movement
`of the device.”
`
`Drasler ¶¶99 (internal citations omitted), 76-79, 96-98; see also
`Garrison, 2:5-10, 4:52-57, 4:66-5:4; Pet. 27-32, 35-36.
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`• Alternatively, Garrison teaches an integrated
`displacer and valve (collectively including the
`claimed stent member) that has flared ends:
`Garrison: “Furthermore, the valve displacer 8 and cardiac
`valve 6 may be integrated into a single structure and delivered
`together rather than separately.”
`Garrison, 4:52-54; see also Pet. 27-32, 35-36.
`Drasler: “Alternatively, a [POSITA] would have understood,
`and at a minimum found it obvious, that Garrison also
`discloses an integrated valve displacer and cardiac valve such
`that the overall valve support structure ‘flare[s] outwardly.’”
`Drasler ¶¶99 (internal citations omitted), 76-79, 96-98; see also
`Garrison, 2:5-10, 4:52-57, 4:66-5:4; Pet. 27-32, 35-36.
`Drasler: “Indeed, at a minimum, a person of ordinary skill in
`the art would have been motivated to apply these teachings to
`the support structure…to ensure cardiac valve 6A
`advantageously conforms…directly to the vessel wall, and to
`help prevent movement.”
`Drasler ¶¶77, 76, 78-79, 96-99; see also Pet. 29-30, 35-36.
`
`14
`
`IPR2020-01454 Page 00014
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have known how to implement Garrison’s features
`
`PO argues: “Garrison…provide[s] 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. (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….The valve 6D is coupled to a valve
`displacer 8D prior to introduction into the patient….”).”
`
`E.g.., POR 16-17.
`
`• PO’s attempts to limit Garrison’s disclosure to three, siloed embodiments run
`contrary to Garrison’s express teachings…and excludes the vast majority of
`Garrison’s teachings.
`
`Reply 8-9.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`15
`
`IPR2020-01454 Page 00015
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have known how to implement Garrison’s features
`
`PO argues: “[A] POSA would not know how to implement this embodiment [of Garrison]”
`
`POR 10-21.
`
`• But Garrison is presumed enabled:
`Federal Circuit: “[W]e hold a presumption arises that both the claimed and unclaimed disclosures in a prior art
`patent are enabled.”
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003); see also Reply 6.
`
`• Nevertheless, a POSITA would have known how to implement a flared stent in view of
`Garrison’s teachings:
`Drasler: “Moreover, a person of skill in the art would have understood a flared shape to work as expected,
`because that flared shape with a valve entirely inside was well-known as enabling the device to better engage the
`surrounding structure with a similar shape (e.g., the valve displacer and/or the vasculature) and prevent
`movement of the device. For example, Letac confirms that a “concave shape…is aimed at reinforcing the
`embedding and the locking of the implantable valve in the distorted aortic orifice.” Additionally, Gabbay teaches …
`the flared shape allows the device to better engage with the surrounding tissue and “mitigate movement,” thereby
`reducing the risk of displacement. As another example, Leonhardt similarly discloses ends of the stent flare out
`… to help it “conform and seal” to the tissue.... And Phelps similarly teaches … flared ends … to hold a stent with
`a valve in place. In view of these examples, a person of ordinary skill in the art would have had a reasonable
`expectation of success in creating a valve support with flared ends with a valve inside, like the valve displacer
`described by Garrison, and would know that this type of structure would work as expected.”
`
`Drasler ¶76-79 (internal citations omitted) (citing Letac, Figs. 3a-3b, 9:19-21, 9:7-9; Gabbay, Fig. 2, 3:36-4:8,2:5-15,
`8:14-43; Leonhardt, Fig. 2, 6:17-22, 5:45-48, 10:53-64; Phelps, Figs. 7-8, 10:7-17, 10:25-29); see also Garrison 4:46-57,
`5:14-15; Drasler ¶96-99 (citing Garrison, 5:19-21); Pet. 28-30, 35-36; DraslerReply ¶¶23-39; Reply 5-13.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`16
`
`IPR2020-01454 Page 00016
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have known how to implement Garrison’s features
`
`PO argues: “Petitioner’s expert has specifically disclaimed any reliance on Garrison’s two-component valve
`replacement system. … [¶] … Petitioner’s expert made clear that Petitioner is not relying on this embodiment of
`Garrison [using a valve device without a displacer] either.”
`
`• But, PO mischaracterizes Dr. Drasler’s testimony and ignores Garrison’s express
`teachings (see also Slide 14):
`Drasler: “[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.”
`
`Garrison: “[A]ll features of any valve displacer described herein may also form part of any of the cardiac valves
`described herein without departing from the scope of the invention.”
`
`DraslerTr. 75:10-76:4; see also DraslerReply ¶26; Reply 7-9; Pet. 27-32,35-39; Drasler ¶¶77-78.
`
`POR 10-12.
`
`Garrison, 4:54-57; see also Pet. 27-32, 35-36; Reply 7-9.
`
`Drasler: “Garrison teaches a “valve displacer” which “has a first end, a second end and a central section between
`the…ends” with the “first and second ends…flared outwardly to form a circumferential recess around the central
`portion” as shown in Figure 8 below. Garrison further teaches the replacement valve and the displacer may be
`“integrated into a single structure,” and that the valve can have all the same features as the displacer.
`Alternatively, Garrison also teaches that the support structure may be implanted without the valve displacer.”
`
`Drasler ¶¶98-99 (internal citations omitted) (citing Garrison, 2:5-10, 4:49-57, 4:52-57, 4:63-64, Fig. 8); see also Reply, 8;
`Drasler ¶¶77-79; Pet. 29, 35; DraslerReply ¶27.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`17
`
`IPR2020-01454 Page 00017
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have known how to implement Garrison’s features
`
`PO argues: “Petitioner does not allege how a POSA would make or deploy this purported fourth purported embodiment
`of Garrison’s valve device.”
`
`POR 10-21.
`
`• But, Garrison teaches how to make and deploy the embodiments:
`
`Garrison: “Referring to FIGS. 13 and 14, another system 2A for implanting a cardiac valve 6A is shown wherein
`the same or similar reference numbers refer to the same or similar structures.…[C]ardiac valve 6A is self-
`expanding….preferred materials are…shape-memory alloys such as nitinol….[¶¶] [C]ardiac valve 6A is implanted
`in substantially the same manner as the cardiac valve 6 and the discussion of implantation of the cardiac valve 6
`is also applicable here…[¶],….[V]alve displacer 8B is similar to the valve displacer 8 described above, however,
`the valve displacer 8B is also self-expanding...”
`
`Garrison 8:10-34, 8:45-47, 8:65-9:10, Figs. 13-14; see also Pet. 28-31, 39-40; Drasler ¶¶74, 78, 107-110.
`
`Drasler: “Where the valve and valve displacer are integrated, the integrated structure is delivered the same way a
`valve displacer is using the self-expanding material. Specifically, Garrison…explains the “cardiac valve 6A” can be
`delivered via “catheter 4A” which has “an expandable member for expanding the valve displacer” (e.g., using a
`balloon). Garrison further explains that the delivery of the valve is accomplished by “advancing a rod 78 having a
`pusher element” to “move the cardiac valve 6A out of the [catheter’s] chamber”.... Separately, Garrison describes
`a delivery method using self-expanding valve displacer which “does not require an independent expansion
`mechanism.” Where the support structure has the flared shape of the valve displacer and is made of the self-
`expanding material, it is either deployed into the previously-deployed valve displacer or directly onto the
`vasculature, e.g., onto the tissues of the native valve.”
`
`DraslerReply ¶31 (internal citations omitted); see also Pet. 29-30, 35; Drasler Decl., ¶¶77, 79, 99;
`Garrison Figs. 13-14, 4:49-57, 8:10-23, 8:24-38, 8:65-9:10.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`18
`
`IPR2020-01454 Page 00018
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have been motivated to implement Garrison’s features with a
`reasonable expectation of success
`PO argues: “[N]one of these references teach a POSA how to successfully implement a flared structure in Garrison,
`where adding a flared shape to Garrison’s winding conformation would result in the bends of the wire being too far apart,
`resulting in an excessive amount of space for blood to leak through.”
`
`• But, Garrison provides sufficient guidance:
`
`POR 26-30.
`
`Garrison: “The support structure 26 is preferably formed with first and second elongate members 28, 30 which
`are wound to form windings 31, preferably about 12-18 windings 31, around the circumference of the valve 6.”
`
`Garrison, 5:19-29, 2:5-10, 4:52-57; see also Reply 10; Pet. 18; DraslerReply ¶32-32; Reply 10-11.
`
`Drasler: “[T]here is nothing inherent about a flared stent that causes leakage. Whether the flared shape would
`have caused the windings in the distal portion to bend…would not change the distance between windings at the
`annular location where the valve tissue is attached to the support structure (element 41 …): If anything, using a
`flared stent would help ensure that the reverse blood flow would be blocked by conforming more closely to the
`vasculature … and/or valve displacer … Garrison’s teachings…show no tissue at the distal portion … [E]ven if it
`was assumed that there was some increased risk of leakage, that risk is already present with the valve displacer
`and Garrison expressly teaches that the two components could be integrated together and the features of the
`displacer can be applied to the valve (including its support structure). …Therefore, a person of ordinary skill in the
`art would have been motivated to conform the valve stent more closely to the valve displacer or the vessel wall in
`order to increase the seal between the two and would have understood that Garrison would work as I described in
`my Declaration.”
`
`DraslerReply ¶33 (internal citations omitted); see also Pet. 29-30, 35; Drasler ¶¶77-78, 99;
`Garrison 2:8-11, 5:46-47, Figs. 9-11, 4:52-54; Reply 10-11.
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`19
`
`IPR2020-01454 Page 00019
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have been motivated to implement Garrison’s features with a
`reasonable expectation of success
`PO argues: “[A] POSA would be further concerned that adding a flared shape to the long posts seen in Garrison’s
`Figures 9 and 10 would cause significant increased loads on the commissural attachment points, as well as increased
`deflection of the posts during each heartbeat…[Petitioner’s expert] once again admitted that he did not consider how the
`prior art combinations he utilizes in his analysis would impact the durability of his proposed valve.”
`
`• But, the trial grounds instead rely on the flared shape of the valve displacer, which the
`prior art repeatedly teaches will work (see Slides 14, 16):
`Drasler: “Garrison itself teaches that the valve and its attachment points can be arranged in this manner both
`through an integrated embodiment and by applying features of the valve displacer to the support structure. And as
`I pointed out, Gabbay, Leonhardt and Phelps further demonstrate that it was well-known to attach the valve to a
`stent that is flared in a trumpet-like manner.”
`
`POR 30-31.
`
`DraslerReply ¶34 (internal citations omitted); see also DraslerTr. 36:20-37:19, 36:11-19; Drasler ¶¶78, 138;
`Garrison 2:5-10, 4:52-57; Pet. 29-30; Reply 11-12; Gabbay, 4:67-5:12; Leonhardt 6:25-38; Phelps, 12:19-20.
`
`• And Dr. Drasler did consider leaflet attachment durability:
`Drasler: “Q. So you did not, in forming your opinions, consider whether the stent design would increase a risk of
`tearing or stretching of the commissures; is that right?
`
`A. I -- I did consider that any damage to the leaflet was something that had to be taken into consideration. The
`damage to the leaflet associated with stretching is -- is something that was typically not necessarily the main focus
`of the type of damage that could occur in evaluating the prior art or the -- this patent.
`Q. What about tearing of the leaflets at the commissures, was that something that was considered at the time
`when evaluating stent design?
`A. I would say every design of a -- of a device has to consider how you're going to attach the leaflets to the
`commissures, how you're going to attach the leaflets to the stent In order to provide the most durable function for
`the valve.”
`
`PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`DraslerTr. 36:20-37:19; see also DraslerReply ¶34; Drasler ¶138; Drasler ¶78; Pet. 29-30; Reply 11.
`
`20
`
`IPR2020-01454 Page 00020
`
`

`

`“the stent member…flares at both ends in a trumpet-like configuration” (’739, [1.2])
`A POSITA would have been motivated to implement Garrison’s features with a
`reasonable expectation of success
`PO argues: “[A] POSA would know that improper alignment of a flared device with the native leaflets would
`risk rupture of the aorta. Garrison does not disclose any method to ensure that alignment.”
`POR 30.
`• But, as Dr. Drasler testified, flared valve support structures were known to work in the aortic
`position (i.e., not block the coronary ostia or risk rupture of the aorta) as Garrison itself teaches
`(see also Slides 14, 24):
`
`Drasler: “Moreover, a person of skill in the art would have understood a flared shape to work as
`expected, because that flared shape with a valve entirely inside was well-known as enabling the device
`to better engage the surrounding structure with a similar shape (e.g., the valve displacer and/or the
`vasculature) and prevent movement of the device. For example, Letac (WO 98/29057, Ex. 1012)
`confirms that a “concave shape…is aimed at reinforcing the embedding and the locking of the
`