Trials@uspto.gov
`571.272.7822
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` Paper No. 7
`March 29, 2017
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00060
`Patent 8,992,608 B2
`____________
`
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 7
`March 29, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00060
`Patent 8,992,608 B2
`____________
`
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`IPR2017-00060
`Patent 8,992,608 B2
`
`
`I.
`INTRODUCTION
`Edwards Lifesciences Corporation (“Petitioner”) filed a Petition
`(Paper 1, “Pet.”) requesting institution of inter partes review of claims 1–4
`of U.S. Patent No. 8,992,608 B2 (Ex. 1001, “the ’608 patent”). Boston
`Scientific Scimed, Inc. (“Patent Owner”) filed a Preliminary Response
`(Paper 6, “Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314(a),
`which provides that an inter partes review may not be instituted “unless . . .
`the information presented in the petition . . . shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.”
`Upon consideration of the Petition and the Preliminary Response, we
`conclude the information presented shows there is a reasonable likelihood
`that Petitioner would prevail in showing the unpatentability of challenged
`claims 1–4. Accordingly, we authorize an inter partes review to be instituted
`as to claims 1–4 of the ’608 patent. Our factual findings and conclusions at
`this stage of the proceeding are based on the evidentiary record developed
`thus far (prior to Patent Owner’s Response). This is not a final decision as
`to patentability of claims for which inter partes review is instituted. Any
`final decision will be based on the record, as fully developed during trial.
`II.
`BACKGROUND
`A.
`The ’608 Patent
`The ’608 patent, titled “Everting Heart Valve,” issued March 31,
`2015, from U.S. Application No. 12/492,512 (the ’512 application), filed
`June 26, 2009. Ex. 1001. The ’512 application was a divisional of U.S.
`Application No. 12/269,213, filed on November 12, 2008 (issued as U.S.
`Patent No. 8,668,733), which was a continuation of U.S. Application
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`No. 10/870,340, filed on June 16, 2004 (issued as U.S. Patent No.
`7,780,725). Id. The ’608 patent generally relates to “methods and apparatus
`for endovascularly replacing a patient’s heart valve.” Ex. 1001, Abstract.
`Figures 32, 33, and 34 of the ’608 patent are reproduced below.
`
`
`
`
`An embodiment of the replacement heart valve and anchor is illustrated in
`Figure 32 in an undeployed configuration, and in Figure 33 in a deployed
`configuration. Ex. 1001 4:38–42. Figure 34 illustrates the replacement
`heart valve deployed in a patient’s heart valve. Id. at 4:43–44. The ’608
`patent further explains:
`FIGS. 32–34 show another way to seal the replacement
`valve against leakage. A fabric seal 380 extends from the distal
`end of valve 20 and back proximally over anchor 30 during
`delivery. When deployed, as shown in FIGS. 33 and 34, fabric
`seal 380 bunches up to create fabric flaps and pockets that extend
`into spaces formed by the native valve leaflets 382, particularly
`when the pockets are filled with blood in response to backflow
`blood pressure. This arrangement creates a seal around the
`replacement valve.
`Id. at 14:21–29.
`Figure 3B of the ’608 patent is reproduced below.
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`Figure 3 B illustrates the deployment of a replacement heart valve. Of
`particular note for purposes of this Decision, “[a]nnular 60 base 22 of
`replacement valve 20 preferably is coupled to skirt region 34 of
`anchor 30, while commissures 24 of replacement valve leaflets 26 are
`coupled to and supported by posts 38.” Ex. 1001, 5:60–63.
`“Replacement valve 20 is preferably made from biologic tissues, e.g.
`porcine valve leaflets or bovine or equine pericardium tissues or
`human cadaver tissue.” Id. at 5:51–53.
`B.
`Illustrative Claim
`Challenged claim 1 is the sole independent claim challenged, from
`which challenged claims 2–4 depend. Claim 1 is illustrative of the claimed
`subject matter and is reproduced below:
`1. A system for replacing a heart valve, comprising:
`an expandable anchor having a collapsed delivery configuration
`and an expanded configuration, the expandable anchor
`comprising a distal end;
`a replacement valve commissure support element attached to the
`expandable anchor;
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`a commissure portion of a replacement valve leaflet attached to
`the commissure support element; and
`a fabric seal at least partially disposed around an exterior portion
`of the expandable anchor when the anchor is in the expanded
`configuration, the fabric seal having an undeployed state and
`a deployed state, wherein in the deployed state the fabric seal
`comprises flaps that extend into spaces formed by native
`valve leaflets;
`wherein a distal end of the replacement valve leaflet is attached
`to the fabric seal and when the expandable anchor is in the
`collapsed delivery configuration, the fabric seal extends from
`the distal end of the replacement valve and back proximally
`over the expandable anchor, the fabric seal being adapted to
`prevent blood from flowing between the fabric seal and heart
`tissue.
`Ex. 1001, 22:22–42.
`
`Related Proceedings
`C.
`According to the parties the ’608 patent is a subject of a case
`captioned Boston Scientific Corp. et al. v. Edwards Lifesciences Corp., Case
`No. 1:16-cv-00275 (D. Del.). Pet. 25; Paper 4, 2. Petitioner also states that
`“there is at least one pending U.S. patent application, serial number
`14/873,462, that claims priority to the ’608 patent.” Id. at 26.
`D.
`Real Parties in Interest
`Petitioner identifies Edwards Lifesciences Corporation, Edwards
`Lifesciences LLC, and Edwards Lifesciences AG as real parties in interest.
`Pet. 25. Patent Owner identifies Boston Scientific Scimed, Inc. and Boston
`Scientific Corp. as real parties in interest. Paper 4, 2.
`
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`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges the patentability of claims 1–4 of the ’608 patent
`on the following grounds:
`Reference(s)
`
`Claims challenged
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`Spenser1
`Spenser and Elliot2
`Spenser and Thornton3
`Spenser and Cook4
`Spenser and De Paulis5
`Cribier6
`Cribier and Spiridigliozzi7
`Cribier and Elliot
`Cribier and Thornton
`Cribier and Cook
`Cribier and De Paulis
`
`Basis
`§ 102 1–4
`§ 103 1–4
`§ 103 1–4
`§ 103 1–4
`§ 103 1–4
`§ 102 1–4
`§ 103 1–4
`§ 103 1–4
`§ 103 1–4
`§ 103 1–4
`§ 103 1–4
`
`Petitioner supports its challenge with a Declaration by Nigel P. Buller,
`M.D., dated October 10, 2016 (Ex. 1007).
`
`
`1 WO 03/047468 A1, published June 12, 2003 (Ex. 1004, “Spenser”).
`Citations to Spenser are to the original pagination.
`2 U.S. Patent App. Pub. No. 2003/0236567 A1, published
`December 25, 2003 (Ex. 1005, “Elliot”).
`3 U.S. Patent No. 6,015,431, issued January 18, 2000
`(Ex. 1019, “Thornton”).
`4 U.S. Patent App. Pub. No. 2004/0082989 A1, published April 29, 2004
`(Ex. 1006, “Cook”).
`5 U.S. Patent No. 6,352,554 B2, issued March 5, 2002
`(Ex. 1021, “De Paulis”).
`6 WO 98/29057, published July 9, 1998 (Ex. 1003, “Cribier”). Citations to
`Cribier are to the original pagination.
`7 U.S. Patent App. Pub. No. 2004/0033364 A1, published February 19, 2004
`(Exhibit 1010, “Spiridigliozzi”).
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`III. ANALYSIS
`Claim Construction
`A.
`Claim 1 recites “the fabric seal comprises flaps.” Ex. 1001, 22:34.
`Claim 2 depends from claim 1 and further recites “the fabric seal defines a
`plurality of pockets.” Id. at 22:43–44. Petitioner contends that “flaps”
`should be construed to mean “circumferentially oriented folds or unattached
`ends.” Pet. 43. Petitioner further contends that “pockets” should be
`construed to mean “open spaces or cavities formed by flaps of the fabric
`seal.” Id. at 45. Patent Owner argues that Petitioner’s proposed
`constructions are not the broadest reasonable, but proposes no alternative.
`Prelim. Resp. 4. Instead, Patent Owner contends that the Petition should be
`denied under Petitioner’s proposed constructions. Id. We determine no
`terms require express construction for purposes of this Decision. Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999):
`“only those terms need be construed that are in controversy, and only to the
`extent necessary to resolve the controversy.”
`B.
`Asserted Anticipation by Spenser
`Petitioner contends that the challenged claims of the ’608 patent are
`anticipated by Spenser. Pet. 74–75. Spenser, titled “Implantable Prosthetic
`Valve,” describes a valve prosthesis comprised of a support stent and valve
`assembly. Ex. 1004, Abstract.
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`Figure 1 of Spenser is reproduced below.
`
`
`Figure 1 illustrates an implantable prosthetic tricuspid valve suitable for
`deployment by a stent. Ex. 1004, 14. Tricuspid implantable prosthetic valve
`20 includes valve assembly 28, with inlet 24, outlet 26, and outer walls
`consisting of collapsible pliant material 29. Id. at 22. Valve assembly 28 is
`attached to annular support stent 22 at bores 25 on support beams 23. Id.
`“[C]uff portion 21 of the valve assembly 28 is wrapped around support stent
`22 at inlet 24 to enhance the stability.” Id. “Preferably cuff portion 21 of
`valve material 28 is attached to support beams 23.” Id. Spenser describes as
`an “important feature” the constant length of the support beams 23 such that
`“there is no need for slack material as the attachment points (25) remain at
`constant distance regardless of the position of the valve device (crimped or
`deployed).” Id. at 23.
`
`First, Petitioner argues that if claim 1 is not construed to be limited to
`“circumferential ‘flaps’,” then Spenser discloses “flaps” because “excess
`fabric would surround the prosthesis,” forming longitudinal pleats if
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`deployed short of its “maximum diameter.” Pet. 74. The only support
`Petitioner cites is an ambiguous reference to “See supra Section II.D” of the
`Petition, which spans eleven pages. Presumably of particular note in that
`portion of the Petition, Petitioner contends (apparently with respect to stents
`in general) that under certain conditions “unless the covering is completely
`elastic,” if a stent is deployed “short of its maximum diameter,” it “typically
`results in the formation of longitudinally oriented pleats.” Pet. 10–11, citing,
`inter alia, Lawrence,8 358).
`
`As Patent Owner notes, Spenser depicts a cuff portion of the
`prosthesis that is taught with no flaps. Prelim. Resp. 23–24 (citing Ex. 1004
`Fig. 1). Indeed, Petitioner appears to acknowledge that “Spenser does not
`explicitly disclose whether the fabric seal, in the deployed state, comprises
`circumferential ‘flaps’ . . . as claimed by the ’608 patent.” Pet. 71. Thus,
`Petitioner’s argument is premised on an alleged inherent disclosure by
`Spenser of “flaps,” as required by claim 1 of the ’608 patent.
`To establish inherency, the extrinsic evidence must make clear
`that the missing descriptive matter is necessarily present in the
`thing described in the reference, and that it would be so
`recognized by persons of ordinary skill. Inherency, however,
`may not be established by probabilities or possibilities. The mere
`fact that a certain thing may result from a given set of
`circumstances is not sufficient.
`In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations omitted)
`(internal quotation marks omitted). By merely asserting what “typically”
`occurs under certain conditions with stents in general, Petitioner fails to
`
`
`8 Lawrence et al., “Percutaneous Endovascular Graft: Experimental
`Evaluation,” Radiology, 163(2): 357–60 (May 1987) (Ex. 1029,
`“Lawrence”).
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`adequately contend, much less show that “flaps” are “necessarily present” in
`the prosthetic described by Spenser to support Petitioner’s inherency
`argument.
`Second, Petitioner argues that Spenser applies a crimping device to
`the prosthetic to compress the valve for delivery, which “[a]s Patent Owner
`asserts, . . . will form a pleated structure that remains pleated after re-
`expansion.” Pet. 74. Petitioner identifies no persuasive support for its
`contention that pleats forming flaps are “necessarily present” in the
`prosthetic described by Spenser. Instead, Petitioner’s argument is largely
`premised on Patent Owner’s alleged infringement contentions in another
`proceeding. See Ex. 1007 ¶¶ 106, 195 (rather than unambiguously stating
`his own opinion, Petitioner’s Declarant instead states that “[a]s Boston
`Scientific asserts, this will form a pleated structure that remains pleated after
`re-expansion.”).
`As further support, Petitioner ambiguously provides a citation to “see
`also supra Section V” of the Petition, which spans nineteen pages. Pet. 75.
`Presumably of particular note in that portion of the Petition, Petitioner
`contends U.S Patent No. 5,855,601 (Ex. 1033, “Bessler”) “details a
`compressed, self-expanding THV with a pleated seal.” See id. at 33–34.
`Petitioner, however, does not adequately explain the significance of Bessler
`to Spenser. To the contrary, as Petitioner makes clear, Bessler explicitly
`illustrates a device with pleating and Spenser does not. Id. at 33–34, 66.
`Petitioner directs us to no sufficient disclosure in Spencer, or elsewhere, to
`support its contention that pleats, and therefore “flaps,” are necessarily
`present in the prosthetic described by Spenser. Petitioner’s reliance on
`Bessler (or Lawrence), suggests, at most, a possibility that pleats might be
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`formed by the prosthetic of Spenser under some conditions, which is an
`insufficient showing to demonstrate anticipation. See Robertson, 169 F.3d at
`745. Accordingly, the information provided by Petitioner does not show a
`reasonable likelihood of prevailing in showing that claim 1 of the ’608
`patent, or any of claims 2–4 which depend from claim 1, is anticipated by
`Spenser.
`Asserted Obviousness over Spenser and Other Prior Art
`C.
`Petitioner contends claims 1–4 of the ’608 patent would have been
`obvious over the combination of Spenser and either Elliot, Thornton, Cook,
`or De Paulis. Pet. 66–74. In each ground, we determine that Petitioner
`sufficiently asserts that Spenser discloses the claimed features other than
`“flaps” and “pockets” based on the current record, and focus our discussion
`on the additional references and the rational for the combinations. See id.
`
`1.
`Elliot
`Elliot, titled “Implantable Prosthesis with Displaceable Skirt,” relates
`to “tubular prostheses, including, but not limited to, endovascular grafts and
`stent-grafts, for maintaining patency of blood vessels and treating aneurysms
`(e.g., aortic aneurysms), and tubular conduits for maintaining patency in
`other bodily passageways.” Ex. 1005 ¶ 1. Elliot describes the use of “at
`least one skirt” that extends from a tubular body. Id. ¶ 24. The skirt has a
`peripheral edge that is free and displaceable to a greater diameter than the
`diameter of the tubular body, such that it “can be displaced to contact, and
`form a seal with a surrounding wall.” Id. “Irregularities and/or wall
`displacement . . . can be responded to by the skirt [] in minimizing endoleaks
`about the prosthesis.” Id.
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`Figure 7 of Elliot is reproduced below.
`
`
`
`Figure 7 illustrates prosthesis 10, including skirts 16a and 16b, and Figure 8
`illustrates a plurality of skirts 16A, 16B, 16C. Id. ¶ 40. Petitioner contends
`that the structure formed by the skirts disclosed by Elliot corresponds to the
`claimed “flaps” and “pockets.” Pet. 57–59, 71.
`
`Patent Owner argues that Elliot is insufficient because “it has nothing
`to do with valves,” and instead is directed to forming a seal with a
`surrounding wall. Prelim. Resp. 42–43. Petitioner, however, relies on
`Spenser as disclosing a prosthetic valve. Pet. 66. Patent Owner’s argument
`improperly attacks Elliott individually, when Petitioner asserts that Spenser
`in combination with Elliott discloses the claimed features. See In re Merck
`& Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (cautioning against attacking
`references individually when obviousness is predicated upon a combination
`of prior art disclosures). We are persuaded, based on the present record, that
`Petitioner has sufficiently identified how the combination of Elliot and
`Spenser allegedly teaches every claim feature, including those not disclosed
`by Spenser alone.
`Thornton
`
`2.
`Thornton, titled “Endolumenal Stent-Graft with Leak-Resistant Seal,”
`relates to an implantable medical device, including a tubular member and
`one or more sealing members secured to an outer surface of the tubular
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`member, which is expandable to engage an endolumenal wall. Ex. 1019,
`Abstract.
`Figure 1 of Thornton is reproduced below:
`
`
`Figure 1 illustrates tubular member 10, including tubular wall 12 and seal
`member 20. Id. at 7:14–20. Thornton further explains:
`Seal member (20) is shown in FIG. l as an occlusive cuff,
`which has a first cuff end (22) secured to outer surface (18) of
`tubular wall (12), and which also has a second cuff end (24) at
`least a portion which is unsecured to form a flange (26). In this
`configuration, flange (26) forms a one-way valve
`that
`circumferentially surrounds tubular member (10) and occludes
`flow around tubular wall (12) in the direction from the first cuff
`end (22) to the second cuff end (24) when tubular member (10)
`is deployed with in a radially confining endolumenal space.
`Ex. 1019, 7:20–29. Petitioner contends that the structure formed by the seal
`member disclosed by Thornton corresponds to the claimed “flaps” and
`“pockets.” Pet. 60–61, 71.
`Patent Owner argues that Thornton is insufficient because “it has
`nothing to do with valves,” and instead engages the vascular wall. Prelim.
`Resp. 45–47. Petitioner, however, relies on Spenser as disclosing a
`prosthetic valve. Pet. 66. Patent Owner’s argument improperly attacks
`Thornton individually, when Petitioner asserts that Spenser in combination
`with Thornton discloses the claimed features. See In re Merck & Co.,
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`800 F.2d at 1097. We are persuaded, based on the present record, that
`Petitioner has sufficiently identified how the combination of Thornton and
`Spenser allegedly teaches every claim feature, including those not disclosed
`by Spenser alone.
`Cook
`
`3.
`Cook, titled “Stent Graft with Improved Proximal End,” relates to a
`stent graft prosthesis comprising a main body portion and a cuff that
`“comprises an external sealing zone that extends around the outer main body
`portion to help prevent leakage of fluids.” Ex. 1006, Abstract.
`Figures 2 and 6 of Cook are reproduced below.
`
`
`
`Figure 2 illustrates graft prosthesis 10, including cuff portion 15 with frayed
`portion 22. Ex. 1006 ¶¶ 26, 30. As shown in Figure 6, according to Cook,
`sealing zone 21, including frayed portion 22, may be “configured such that
`the free edge 17 of the cuff portion 15 is directed proximally (toward the
`first or folded edge 16), to produce a fold 44 that creates gutter-like pocket
`45 that is able to collect any blood passing around the leading edge 16 of the
`graft 11 to prevent an endoleak and promote thrombus formation.”
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`Ex. 1006 ¶ 36. Petitioner contends that the structure formed by the sealing
`zone disclosed by Cook corresponds to the claimed “flaps” and “pockets.”
`Pet. 62–64, 71.
`Patent Owner argues that Cook is insufficient because “it has nothing
`to do with valves,” and instead engages the vessel wall. Prelim. Resp. 48–
`49. Petitioner, however, relies on Spenser as disclosing a prosthetic valve.
`Pet. 66. Patent Owner’s argument improperly attacks Cook individually,
`when Petitioner asserts that Spenser in combination with Cook discloses the
`claimed features. See In re Merck & Co., 800 F.2d at 1097. We are
`persuaded, based on the present record, that Petitioner has sufficiently
`identified how the combination of Cook and Spenser allegedly teaches every
`claim feature, including those not disclosed by Spenser alone.
`
`4.
`De Paulis
`De Paulis, titled “Prosthetic Tubular Aortic Conduit and Method for
`Manufacturing the Same,” relates to a prosthetic aortic conduit for replacing
`a root portion of an aorta. Ex. 1021, Abstract.
`Figure 2 of De Paulis is reproduced below.
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`Figure 2 illustrates conduit 10 with upper portion 12 with circumferentially
`extending corrugations 13 and second lower portion 14 with longitudinally
`extending pleats or corrugations 16. Ex. 1021, 4:62–5:6. Petitioner
`contends that the circumferentially extending corrugations or pleats
`disclosed by De Paulis correspond to the claimed “flaps” and “pockets.”
`Pet. 64–65, 73.
`
`5. Motivation for Asserted Combinations
`a.
`Spenser in Combination with Either Elliot,
`Thornton, or Cook
`Petitioner argues that it would have been obvious to modify Spenser
`in view of Elliot, Thornton, or Cook for the same following reasons: (1) to
`further improve the sealing function of the fabric seal to further minimize
`the risk of paravalvular leaks, and (2) because the use of external skirts to
`prevent endoleaks was a known technique from either Elliot, Thornton, or
`Cook that would have improved the similar device of Spenser in the same
`way, yielding predictable results. Pet. 59–62, 64, 71–73.
`Patent Owner argues that there was no motivation to combine Spenser
`and either Elliot, Thornton, or Cook because none of the references
`recognized or solved the problem of paravalvular leakage solved by the
`’608 patent. Prelim. Resp. 53–58. Patent Owner also argues that Spenser
`and either Elliot, Thornton, or Cook are incompatible because Spenser
`discourages slack in the cuff while Elliot, Thornton, and Cook disclose skirts
`or flanges extending outward. Id. at 54, 56, 58. Patent Owner’s arguments
`are insufficiently supported on the present record to persuade us that
`Petitioner’s rationale for the asserted combinations is insufficient for
`purposes of institution. Accordingly, we are persuaded that the information
`provided by Petitioner demonstrates a reasonable likelihood of prevailing in
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`showing that claims 1–4 of the ’608 patent would have been obvious over
`Spenser and either Elliot, Thornton, or Cook.
`a.
`Spenser in Combination with De Paulis
`With regard to De Paulis, Petitioner contends a combination with
`Spenser would have been obvious because the structure of De Paulis would
`have been “an obvious design choice” and would permit “the seal to
`significantly increase in length.” Pet. 73. According to Petitioner,
`“[a]lthough the support beams taught by Spenser preferably remain constant
`in length, the remainder of the stent structure undergoes a degree of
`foreshortening.” Id. (citing Ex. 1004 at 23; Ex. 1007 ¶¶ 83, 191).
`Rather than support Petitioner’s contention, the portion of Spenser
`cited by Petitioner states that:
`The valve assembly is attached to the support stent at the
`support beams, and due to their constant length there is no need
`for slack material as the attachment points (25) remain at
`constant distances regardless of the position of the valve device
`(crimped or deployed).
`Ex. 1004, 23. In further support of Petitioner, Dr. Buller states that:
`The support beams (25) for the valve commissures described by
`Spenser are designed such that their length remains constant,
`thereby providing a stable attachment
`region
`for
`the
`commissures of the valve while the remaining portions of the
`THV undergo a degree of foreshortening. [Ex. 1004] at pp. 34–
`35.
`Ex. 1007 ¶ 83. Dr. Buller does not identify what “remaining portions” of the
`Spenser prosthetic “undergo a degree of foreshortening” or otherwise
`provide any explanation for such a conclusion. We are not persuaded that
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`the portion of Spenser cited by Dr. Buller sufficiently supports such a
`contention to show it is not merely conclusory. Spenser states:
`[T]he length of the attaching means (the height of the valve)
`remains at all times constant; thus suitable for serving as the
`pliable valve assembly’s anchorage. The leaflets are attached to
`the support frame at the attaching means, and due to their
`constant length there is no need for slack material as these
`attachment points that remain at constant distances regardless of
`the position of the valve assembly (crimped or deployed). This
`is an important feature for this means that the manufacturer of
`the valve device can make sure the valve assembly is secured and
`fastened to the support frame at all times.
`Ex. 1004, 34–35. No portion of Spenser cited by Petitioner or Dr. Buller
`indicates that foreshortening occurs with the prosthetic. Further, by merely
`arguing a combination is an “obvious design choice,” without further
`explanation, Petitioner has not provided sufficiently the “articulated
`reasoning with some rational underpinning” required to support the legal
`conclusion of obviousness. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`(2007). Accordingly, the information provided by Petitioner does not show
`a reasonable likelihood of prevailing in showing that any of claims 1–4
`would have been obvious over Spenser and De Paulis.
`D.
`Asserted Anticipation by Cribier
`Petitioner contends that the challenged claims of the ’608 patent are
`anticipated by Cribier. Pet. 47–54. Cribier, titled “Valve Prosthesis for
`Implantation in Body Channels,” describes a valve prosthesis comprised of a
`collapsible valvular structure and an expandable frame. Ex. 1003, Abstract.
`
`18
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`Figures 4a and 4b of Cribier are reproduced below.
`
`
`
`Figures 4a and 4b illustrate an implantable valve (“IV”) 13, as disclosed by
`Cribier, in the compressed position and the expanded position, respectively.
`Ex. 1003, 18:1–4. The implantable valve is made of an “expand[a]ble but
`substantially rigid structure made of the frame 10,” and “a soft and mobile
`tissue constituting the valvular structure 14 exhibiting a continuous surface
`truncated between a base 15 and an upper extremity 16.” Id. at 18:13–18.
`The tissue has rectilinear struts 17 to “strengthen it” and “to induce a
`patterned movement between its open and closed state.” Id. at 18:22–25.
`The valvular structure includes internal cover 19 to be fixed on the internal
`wall of frame 10 to prevent “any passage of blood through the spaces
`between the bars 11 of the frame,” and to strengthen the fastening of
`valvular structure 14 to frame 10. Id. at 20:26–21:3.
`
`19
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`Figure 6d of Cribier is reproduced below.
`
`
`Figure 6d illustrates a sectional view of the implantable valve showing the
`internal cover and the external cover of the valvular structure overlapping
`the frame bars. Ex. 1003, 11:18–21. According to Cribier:
`At Figure 6d, the internal cover 19 is extended at its lower
`end 19’ to an external cover 19’’ which is rolled up to be applied
`on the external wall of the stent 10. The internal and external
`cover are molded, glued or soldered to the bars of the stent 10.
`Id. at 22:23–26. Cribier further explains that “[t]he internal cover makes a
`sort of ‘sleeve’ below the fastening of the valvular structure on the internal
`surface of the frame, covering the spaces between the frame bars of the
`frame at this level, thus preventing any regurgitation of blood through these
`spaces.” Id. at 22:17–20.
`The Court of Appeals for the Federal Circuit summarized the
`analytical framework for determining whether prior art anticipates a claim as
`follows:
`To anticipate a claim, a single prior art reference must expressly
`or inherently disclose each claim limitation. Celeritas Techs.,
`Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir.
`1998). But disclosure of each element is not quite enough—this
`court has long held that “[a]nticipation requires the presence in a
`single prior art disclosure of all elements of a claimed invention
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`arranged as in the claim.” Connell v. Sears, Roebuck & Co., 722
`F.2d 1542, 1548 (Fed. Cir. 1983) (citing Soundscriber Corp. v.
`United States, 175 Ct. Cl. 644, 360 F.2d 954, 960 (1966)
`(emphasis added)).
`Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1334–35 (Fed. Cir.
`2008). “Thus, it is not enough that the prior art reference discloses part of
`the claimed invention, which an ordinary artisan might supplement to make
`the whole, or that it includes multiple, distinct teachings that the artisan
`might somehow combine to achieve the claimed invention.” Net MoneyIN,
`Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 n.5 (Fed. Cir. 2008). “The
`requirement that the prior art elements themselves be ‘arranged as in the
`claim’ means that claims cannot be ‘treated . . . as mere catalogs of separate
`parts, in disregard of the part-to-part relationships set forth in the claims and
`that give the claims their meaning.’” Therasense, Inc. v. Becton, Dickinson
`& Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (quoting Lindemann
`Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1459
`(Fed.Cir.1984)).
`Claim 1 requires “a replacement valve commissure support element
`attached to the expandable anchor.” Petitioner contends struts 17 of Cribier
`correspond to this limitation. Pet. 48 (citing Ex. 1003, 18:18–28, Fig. 4a,
`4b). Claim 1 further requires “a commissure portion of a replacement valve
`leaflet attached to the commissure support element.” According to
`Petitioner:
`
`As shown, for example, in Figure 4b above, Cribier
`discloses a commissure portion of a replacement valve leaflet
`attached to the commissure support element. See also [Ex. 1003]
`at 18:18–28. The structure of the valve commissures disclosed
`by Cribier can vary as Cribier discloses the use of “any type of
`valvular structure,” including valvular structures “made with
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`biological tissues such as the pericardium, or with porcine
`leaflets.” See id. at 24:9–10, 26:13–16; Ex. 1007 at ¶ 137. Thus,
`Cribier contemplates various commissure and commissure
`support elements beyond those shown, for example, in Figure 4b.
`Ex. 1007 at ¶ 139.
`Pet. 48–49. Petitioner fails to identify any feature shown in Figure 4b that
`corresponds to the claimed “a commissure portion of a replacement valve
`leaflet.” Moreover, the portion of Cribier cited by Petitioner does not
`address “a commissure portion of a replacement valve leaflet,” and
`Petitioner does not otherwise explain how it contends that disclosure
`corresponds to “a commissure portion of a replacement valve leaflet,” as
`claimed. See Ex. 1003, 18:18–28 (teaching “a valvular structure 14
`exhibiting a continuous surface truncated between a base 15 and an upper
`extremity 16”) (emphasis added).
`Patent Owner argues that although “Cribier discloses ‘several types’
`of valvular structures – as depicted in Figures 4-5 and 9-11 – none of these
`includes any ‘replacement valve leaflets.’” Prelim. Resp. 15. Instead,
`Cribier criticizes a prior art cardiac valve prosthesis that used “a semi-lunar
`leaflet design” as “inherently fragile,” and “not strong enough.” Ex. 1003,
`4:3–13.
`We determine that Cribier’s reference to “any type of valvular
`structure” is not a sufficient disclosure of any specific structure, particularly
`one that expressly includes “a commissure portion of a replacement valve
`leaflet,” as required by claim 1 of the ’608 patent. Similarly, Cribier’s
`statement that “porcine leaflets” may be used to make a valvular structure
`suggests a material
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