Trials@uspto.gov
`571-272-7822
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` Paper No. 28
` Entered: October 12, 2018
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORTATION,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01295
`Patent 8,709,062 B2
`____________
`
`
`
`Before JAMES A. TARTAL, ROBERT L. KINDER, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`

`

`IPR2017-01295
`Patent 8,709,062 B2
`
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Edwards Lifesciences Corporation (“Petitioner”) filed a Petition
`
`requesting an inter partes review of claims 1–26 (“the challenged claims”)
`
`of U.S. Patent No. 8,709,062 B2 (Ex. 1001, “the ’062 patent”). Paper 2
`
`(“Pet.”). Boston Scientific Scimed, Inc. (“Patent Owner”) filed a
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`Preliminary Response. Paper 8 (“Prelim. Resp.”). We instituted an inter
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`partes review of challenged claims 1–7, 9–15, 17–21, and 23–26 on one
`
`ground of unpatentability, pursuant to 35 U.S.C. § 314. Paper 9, 33–34
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`(“Dec. on Inst.”).
`
`After institution, Patent Owner filed a Response (Paper 15, “PO
`
`Resp.”) to the Petition. Before the due date for Petitioner’s Reply, however,
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`the U.S. Supreme Court issued its decision in SAS Institute Inc. v. Iancu,
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`138 S. Ct. 1348 (2018). See Paper 17. Pursuant to SAS Institute, a decision
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`to institute an inter partes review under 35 U.S.C. § 314 may not institute
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`trial on fewer than all claims challenged in the petition. SAS Institute, 138 S.
`
`Ct. at 1355–56, 1358. In this proceeding, however, we had denied
`
`institution with respect to challenged claims 8, 16, and 22, on two grounds
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`of unpatentability. See Dec. on Inst. 9–21. Accordingly, we modified our
`
`Decision on Institution to include review of challenged claims 8, 16, and 22,
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`and all grounds presented in the Petition. Paper 17, 2.
`
`Pursuant to Patent Owner’s request, we allowed Patent Owner to
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`incorporate into its Patent Owner Response (Paper 15) the arguments
`
`presented in its Preliminary Response (Paper 8). Paper 18, 3–4.
`
`Additionally, we modified the due date for Petitioner’s Reply and authorized
`
`Petitioner to respond to both the Decision on Institution and Patent Owner’s
`
`
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`2
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`

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`IPR2017-01295
`Patent 8,709,062 B2
`
`Preliminary Response, in its Reply. Id. at 4. Consistent with our Order,
`
`Petitioner filed a Reply to the Patent Owner Response (Paper 20, “Reply”).
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`An oral hearing was held on August 7, 2018, and a transcript of the
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`hearing is included in the record. Paper 27 (“Tr.”).
`
`We issue this Final Written Decision pursuant to 35 U.S.C. § 318(a)
`
`and 37 C.F.R. § 42.73. For the reasons set forth below, Petitioner has shown
`
`by a preponderance of the evidence that challenged claims 1–7, 9–15, 17–
`
`21, and 23–26 of the ’062 patent are unpatentable, but has not met its burden
`
`with respect to claims 8, 16, and 22.
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`B. Related Proceedings
`
`The parties represent that the ’062 patent is at issue in Boston
`
`Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences
`
`Corp., No. 8:16-cv-00730 (C.D. Cal.). Pet. 101; Paper 4, 2.
`
`C. The ’062 Patent
`
`
`
`The ’062 patent, titled “Stent Delivery System Having Stent
`
`Securement Apparatus,” issued April 29, 2014, from U.S. Patent Application
`
`No. 13/619,231, which was filed September 14, 2012. Ex. 1001, (45), (54),
`
`(21), (22).
`
`
`
`Figure 1 of the ’062 patent is reproduced below.
`
`Figure 1 depicts an isometric view of a balloon catheter. Ex. 1001, 5:53–65.
`
`As shown in Figure 1, catheter 12 includes balloon 14 at distal end 16, to
`
`which stent 18 is fixed. Id. at 8:15–18, 26–27 (stent not shown in Figure 1).
`
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`3
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`IPR2017-01295
`Patent 8,709,062 B2
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`In use, catheter 12 is advanced through a patient’s vasculature to a desired
`
`location and, once reached, balloon 14 and stent 18 are expanded. Id. at
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`8:49–55. After expansion, the balloon is deflated and the catheter and
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`balloon are withdrawn, while the stent remains in place to maintain the
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`vessel in an expanded state. Id. at 8:55–57.
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`
`
`Figure 4 of the ’062 patent is reproduced below.
`
`
`
`Figure 4 depicts an enlarged cross-sectional view of the distal end of
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`catheter 12, with balloon 14 and stent 18 in expanded states. Id. at 6:3–6.
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`
`
`As shown in Figure 4, “mounting body 30 . . . is included inside
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`balloon 14 to provide a cushion and/or substrate of enlarged diameter
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`relative to the stent to support and hold the stent and secure it during
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`crimping and the delivery procedure.” Id. at 9:28–32. In Figure 4, mounting
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`body 30 is a cylindrical sleeve carried on inner lumen 26 of the catheter. Id.
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`at 9:35–37. However, the ’062 patent also discloses alternate mounting
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`bodies including, for example, a spiral cut mounting body (id. at Fig. 5),
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`a cylindrical body comprising separate, adjacent rings 30a (id. at Fig. 6),
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`a two-piece interlocked body 30a, 30b (id. at Fig. 7), a body comprising a
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`plurality of separate, spaced bodies 30a, 30b, 30c (id. at Fig. 9), a rigid coil
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`mounting body (id. at Fig. 10), or an enlargeable and collapsible mounting
`
`body (id. at Figs. 11–12, 17–21). See id. at 9:66–11:17.
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`
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`IPR2017-01295
`Patent 8,709,062 B2
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`
`D.
`
`Illustrative Claim
`
`Challenged claims 1, 13, 21, and 26 are independent. Claim 1 is
`
`illustrative, and is reproduced below.
`
`1.
`
`A medical device, comprising:
`an elongate shaft including a first tubular member and a
`second tubular member;
`a balloon coupled to the shaft;
`a first member coupled to the first tubular member and
`positioned within the balloon, the first member including a distal
`stop with a tapered distal portion;
`wherein the distal stop includes a proximal end face
`extending substantially perpendicular to a longitudinal axis of
`the elongate shaft;
`a second member coupled to the first tubular member and
`positioned within the balloon, the second member having a distal
`end disposed proximal of the distal stop; and
`a medical implant coupled to the shaft and positioned
`adjacent to the balloon.
`
`Ex. 1001, 25:30–44.
`
`E. Applied References
`
`Petitioner relies upon the following references, and the Declaration of
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`Thomas Trotta (“the Trotta Declaration,” Ex. 1003). Pet. 20–21; see also
`
`Ex. 1026 (correction to the Trotta Declaration).
`
`Reference
`Sugiyama
`
`Patent No.
`US 4,994,032
`
`Fischell ’507
`
`US 4,768,507
`
`Fischell ’274
`
`US 5,639,274
`
`Burton
`
`US 5,026,377
`
`
`
`Exhibit No.
`Ex. 1009
`
`Ex. 1010
`
`Ex. 1013
`
`Ex. 1014
`
`Relevant Dates
`Filed Nov. 29, 1988
`Issued Feb. 19, 1991
`
`Filed Aug. 31, 1987
`Issued Sept. 6, 1988
`
`Filed June 2, 1995
`Issued June 17, 1997
`
`Filed Aug. 17, 1990
`Issued June 25, 1991
`
`5
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`IPR2017-01295
`Patent 8,709,062 B2
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`
`Reference
`Jendersee
`
`Patent No.
`US 5,836,965
`
`Rupp
`
`US 5,653,691
`
`Relevant Dates
`Filed June 7, 1995
`Issued Nov. 17, 1998
`
`Filed Apr. 25, 1996
`Issued Aug. 5, 1997
`
`Exhibit No.
`Ex. 1016
`
`Ex. 1023
`
`Patent Owner relies upon the Declaration of Dr. Ronald J. Solar,
`
`Ph.D. (“the Solar Declaration,” Ex. 2004).
`
`Additionally, the parties rely upon the January 17, 2018, deposition of
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`Mr. Trotta (Ex. 2008), and the April 4, 2018, deposition of Dr. Solar
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`(Ex. 1027 (annotations made during deposition); Ex. 1028 (transcript)).
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`F. Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–26 of the ’062 patent
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`based on the following grounds. Pet. 20–21, 46, 78; see also Dec. 6, n.1.
`
`References
`“Fischell ’274 in View of Burton, in
`Further View of Knowledge of a
`POSITA [person of ordinary skill in
`the art] and/or Sugiyama”
`
`“Sugiyama ’032 in View of Fischell
`’507, and in Further View of
`Jendersee”
`
`“Rupp in View of the Knowledge of a
`POSITA and/or Sugiyama ’032 and
`in Further View of Jendersee”
`
`
`
`
`Claims Challenged
`Basis
`§ 103(a) 1–26
`
`§ 103(a) 1–26
`
`§ 103(a) 1–7, 9–15, 17–21, and
`23–26
`
`
`
`6
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`IPR2017-01295
`Patent 8,709,062 B2
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`
`II. DISCUSSION
`
`A. Claim Construction
`
`“The Board construes claims of an expired patent in accordance with
`
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).” Wasica
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`Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1279 (Fed. Cir. 2017).
`
`Accordingly, the “words of a claim ‘are generally given their ordinary and
`
`customary meaning’” as understood by a POSITA at the time of the
`
`invention. Phillips, 415 F.3d at 1312 (quoting Vitronics Corp. v.
`
`Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “In determining
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`the meaning of the disputed claim limitation[s], we look principally to the
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`intrinsic evidence of record, examining the claim language itself, the written
`
`description, and the prosecution history, if in evidence.” DePuy Spine, Inc.
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`v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006).
`
`“[T]he specification ‘is always highly relevant to the claim construction
`
`analysis. Usually, it is dispositive; it is the single best guide to the meaning
`
`of a disputed term.’” Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d
`
`at 1582). Extrinsic evidence is “less significant than the intrinsic record in
`
`determining the legally operative meaning of claim language.” Id. at 1317
`
`(internal quotation marks omitted).
`
`The parties agree that the ’062 patent has expired and, at least for this
`
`proceeding, agree that each claim term should receive its plain and ordinary
`
`meaning. Pet. 18–20; Prelim. Resp. 6; see generally PO Resp. (not directly
`
`addressing claim construction); Tr. 8:9–12 (claim 7), 29:11–12 (same),
`
`30:23–25 (same).
`
`
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`7
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`IPR2017-01295
`Patent 8,709,062 B2
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`
`Upon review of the record before us, we determine that we need not
`
`construe expressly any claim limitation. See Vivid Techs., Inc. v. Am. Sci. &
`
`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`
`B. Principles of Law
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
`
`between the subject matter sought to be patented and the prior art are such
`
`that the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which said
`
`subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
`
`factual determinations, including (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art;
`
`(3) the level of skill in the art; and (4) when in evidence, objective evidence
`
`of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`When evaluating a combination of teachings, we must also “determine
`
`whether there was an apparent reason to combine the known elements in the
`
`fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re
`
`Kahn, 441, F.3d 977, 988 (Fed. Cir. 2006)). Whether a combination of
`
`elements produced a predictable result weighs in the ultimate determination
`
`of obviousness. Id. at 416–417.
`
`“In an [inter partes review], the petitioner has the burden from the
`
`onset to show with particularity why the patent it challenges is
`
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`
`Cir. 2016). The burden of persuasion never shifts to Patent Owner.
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`
`
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`IPR2017-01295
`Patent 8,709,062 B2
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`(Fed. Cir. 2015). To prevail, Petitioner must support its challenge by a
`
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`
`We analyze the challenges presented in the Petition in accordance
`
`with the above-stated principles.
`
`C. Level of Ordinary Skill in the Art
`
`In determining whether an invention would have been obvious at the
`
`time it was made, we consider the level of ordinary skill in the pertinent art
`
`at the time of the invention. Graham, 383 U.S. at 17.
`
`Petitioner relies upon the Trotta Declaration and contends that a
`
`POSITA would have “an undergraduate degree in science in mechanical,
`
`manufacturing, or material science engineering, as well as at least five years’
`
`experience in designing minimally invasive catheter-based interventions,” or
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`“an undergraduate degree in a different subject matter . . . [and] five to ten
`
`years of experience in the industry in designing minimally invasive catheter-
`
`based interventions.” Pet. 18 (citing Ex. 1003 ¶ 80).
`
`Patent Owner does not provide an assessment of the relevant skill
`
`level. See generally PO Resp. However, Dr. Solar, Patent Owner’s
`
`declarant, “generally agree[s]” with the definition offered by Mr. Trotta. See
`
`Ex. 2004 ¶ 23; Ex. 1028, 23:12–15 (“essentially concur[ring]”).
`
`Based on our review of the ’062 patent, the types of problems and
`
`solutions described in the ’062 patent and applied prior art, and the
`
`testimony of Mr. Trotta and Dr. Solar, we adopt Petitioner’s identification of
`
`the credentials of a POSITA.
`
`Patent Owner argues that the Board should afford Mr. Trotta’s
`
`testimony little or no weight “because he lacks experience in the relevant
`
`technologies.” PO Resp. 12–15. According to Patent Owner, Mr. Trotta
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`
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`IPR2017-01295
`Patent 8,709,062 B2
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`“has no actual experience in stent crimping” and “the first time [he] worked
`
`on any stent securement issue was in 1997,” after the ’062 patent was filed.
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`Id. at 12, 13 n.2.
`
`We disagree with Patent Owner because, as just discussed, the
`
`relevant level of skill in the art does not require experience with stent
`
`crimping or stent securement. Indeed, the challenged claims of the ’062
`
`patent do not include any limitations directed to stent crimping or stent
`
`securement. Ex. 1001, 25:30–28:32; see also Ex. 1028, 32:3–6 (Dr. Solar
`
`testifying that claim 1 does not recite “secure”), 49:20–23 (Dr. Solar
`
`testifying that claim 1 does not recite “crimping”); see also infra Section
`
`II.F.2.a.vi. Moreover, Dr. Solar testified that he considers Mr. Trotta to have
`
`been a POSITA in 1996. Ex. 1028, 23:16–25. Further, Patent Owner has
`
`not cited any persuasive authority for the proposition that a witness being
`
`offered as an expert must also have acquired the knowledge and skill set of a
`
`POSITA as of the critical date. As such, Patent Owner has not persuaded us
`
`that Mr. Trotta’s testimony should be discounted.
`
`D. Obviousness over the Combined Teachings of
`“Fischell ’274 in View of Burton, in Further View of
`Knowledge of a POSITA and/or Sugiyama”
`
`Petitioner contends that claims 1–26 of the ’062 patent are
`
`unpatentable under 35 U.S.C. § 103(a), over the combined teachings of
`
`Fischell ’274, Burton, Sugiyama, and the knowledge of a POSITA. Pet. 21–
`
`46; Reply 20–26. For reasons that follow, we determine Petitioner has not
`
`demonstrated that the challenged claims are unpatentable by a
`
`preponderance of the evidence.
`
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`10
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`

`IPR2017-01295
`Patent 8,709,062 B2
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`
` Overview of Fischell ’274 (Ex. 1013)
`
`Fischell ’274 is a U.S. Patent titled “Integrated Catheter System for
`
`Balloon Angioplasty and Stent Delivery.” Ex. 1013, [54]. Figure 2A of
`
`Fischell ’274 is reproduced below.
`
`
`
`Figure 2A depicts a longitudinal cross-section of preferred integrated
`
`catheter system 60, which includes balloon angioplasty catheter 20 with
`
`inflatable balloon 23, and stent catheter 65 with stent 15 retained in
`
`containment cavity 69. Id. at 3:29–30, 4:50–57; see also id. at Fig. 1
`
`(depicting a “simplified form of the integrated catheter system”).
`
`Integrated catheter system 60 is used as follows: (1) system 60 is
`
`advanced through an artery until balloon 23 lies within an arterial stenosis
`
`(id. at Fig. 7A); (2) balloon 23 is inflated and stent catheter 65 passes
`
`therethrough (id. at Fig. 7B); (3) balloon 23 is deflated (id. at Fig. 7C);
`
`(4) stent 15 is positioned over balloon 23 (id. at Fig. 7D); (5) balloon 23 is
`
`inflated minimally, which causes stent 15 to be retained on balloon 23, and
`
`the stent catheter is pulled back (id. at Fig. 7E); (6) stent 15 deploys, either
`
`through self-expansion (id. at Fig. 7E') or through inflation of the balloon to
`
`high pressure (id. at Fig. 7F); and (7) balloon 23 is deflated and retracted
`
`from the artery (id. at Fig. 7G). See also id. at 6:3–50.
`
`
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`IPR2017-01295
`Patent 8,709,062 B2
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`
` Overview of Burton (Ex. 1014)
`
`Burton is a U.S. Patent titled “Stent Placement Instrument and
`
`Method.” Ex. 1014, [54]. Figures 1 and 3 of Burton are reproduced below.
`
`
`
`Figure 1 depicts an instrument for holding and deploying self-expanding
`
`stent 10, wherein the instrument includes grip member 9, one embodiment of
`
`which is depicted in greater detail in Figure 3. Id. at Abstract, 5:11–12,
`
`5:15–16. Burton explains that grip member 9 engages stent 10 with a high-
`
`friction surface material (id. at Figs. 3–3A), with a coating of releasable
`
`adhesive (id. at Fig. 4), and/or with a surface material that takes a set and
`
`deforms due to compression of the stent against the settable material (id. at
`
`Fig. 5). See, e.g., id. at 3:29–4:22, 5:46–64.
`
` Overview of Sugiyama (Ex. 1009)
`
`Sugiyama is a U.S. Patent titled “Balloon Catheter.” Ex. 1009, [54].
`
`Sugiyama’s Figure 1 is reproduced below.
`
`
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`12
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`
`
`Figure 1 depicts an enlarged sectional view of the distal end of a balloon
`
`catheter. Id. at 2:47–48. As reflected in Figure 1, “reinforcement 9 is
`
`wound about a predetermined portion of the outer surface of the inner tube 1
`
`which is enclosed within the balloon 3 . . . . [Accordingly], the inner tube is
`
`rendered more resistant against buckling.” Id. at 4:58–65. Sugiyama
`
`specifies that reinforcement 9 may “have turns [thereof] so wound that they
`
`be in intimate contact with each other” or “may alternatively be so wound
`
`that its turns are thick for example in intimate contact with each other in
`
`both end parts and thin or sparse in the intermediate part of the coil spring.”
`
`Id. at 7:53–63, Figs. 12–13.
`
`
`
`Sugiyama also discloses that the ends of balloon 3 may be secured to
`
`inner and outer tubes 1, 2 with adhesive. Id. at 4:13–17.
`
` Analysis of Applied Art
`
`
`
`Petitioner contends that the combined teachings of Fischell ’274,
`
`Burton, Sugiyama, and the knowledge of a POSITA render obvious
`
`claims 1–26 of the ’062 patent. Pet. 21–46; Reply 20–26. Patent Owner
`
`disputes Petitioner’s contentions. Prelim. Resp. 8–21; see also Paper 18, 3–
`
`4. Patent Owner argues, inter alia, that a POSITA would not have modified
`
`Fischell ’274 to arrive at the claimed invention. Prelim. Resp. 18.
`
`
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`After considering the parties’ arguments and evidence, we determine
`
`Petitioner has not demonstrated that the challenged claims are unpatentable
`
`by a preponderance of the evidence.
`
`a. Independent Claim 1
`
`Petitioner contends that Fischell ’274 discloses a medical device
`
`substantially as claimed including a catheter having balloon 23 and first
`
`distal stop member 7, wherein stent 15 is positioned adjacent the balloon.
`
`Pet. 21–22, 27–30. Petitioner states that Fischell ’274 “lacks any under-
`
`balloon securement mechanism” akin to the claimed “second member . . .
`
`positioned within the balloon,” but, nonetheless, “teaches that the balloon
`
`itself had some ability to retain the stent . . . [by] inflating the balloon to a
`
`low pressure [to] temporarily hold the stent in place.” Id. at 22 (citing
`
`Ex. 1013, 6:34–38). Thus, Petitioner contends that the Fischell ’274 stent
`
`delivery system “could be improved by increasing the balloon’s ability to
`
`retain the stent,” including by “adding securement structures under the
`
`balloon,” such as Burton’s “soft, elastomeric grip member.” Pet. 22–23, 25–
`
`26. According to Petitioner, this “would allow the stent to be securely
`
`carried on the balloon during delivery,” and “would ensure stent securement,
`
`simplify delivery system operation, and decrease the overall profile of the
`
`delivery catheter.” Id. at 25–26 (citing Ex. 1003 ¶¶ 108–111), 28–29.
`
`Petitioner relies upon Mr. Trotta’s testimony that Burton’s “soft,
`
`elastomeric mounting body . . . would be particularly suited to secure the
`
`balloon-expandable stent of Fischell ’274 over the balloon without requiring
`
`an external sheath or other profile-increasing structure,” which would
`
`improve the profile and trackability of the catheter. Ex. 1003 ¶ 110.
`
`Mr. Trotta also testified that Burton’s grip member would be placed under
`
`
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`14
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`IPR2017-01295
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`the balloon of Fischell ’274 and would overlie or be positioned adjacent the
`
`radiopaque markers. Id. ¶¶ 111–112.
`
`Patent Owner argues that a POSITA would not have modified Fischell
`
`’274 as proposed. Prelim. Resp. 18. According to Patent Owner, Fischell
`
`’274 concerns balloon-delivered stents, while Burton concerns self-
`
`expandable stents. Id. at 19–20. Due to these differences, Patent Owner
`
`alleges that Burton’s grip member 9 “would be rendered ineffective if used
`
`under the balloon of Fischell ’274, because the operation of the grip member
`
`requires direct contact between the stent and the grip member.” Id. at 20
`
`(citation omitted). “[P]lacing the grip member under the balloon as in
`
`Fischell ’274 prevents the direct contact.” Id.
`
`In the Reply, Petitioner responds that a POSITA would have modified
`
`the prior art as proposed in order to eliminate the catheter’s sheath and allow
`
`direct stenting, which reduces the time, cost, and complexity of surgery.
`
`Reply 22–23. Petitioner argues that although Burton’s grip member “uses
`
`direct contact” to secure Burton’s stent, it “would also be suitable for
`
`securing a balloon-expandable stent,” as taught by Fischell ’274, because
`
`placing the grip member under the balloon would avoid problems associated
`
`with over-crimping. Id. at 24 (citing Ex. 1003 ¶ 55). According to
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`Petitioner, the grip member’s “material composition would allow it to
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`deform and support a stent and balloon compressed over it.” Id. at 25 (citing
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`Ex. 1003 ¶¶ 109–112). Also, Petitioner argues that by “providing an
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`enlarged diameter from the catheter shaft, Burton’s grip member would
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`serve to better secure a balloon-expandable stent on to the balloon.” Id. at
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`25 (citing Ex. 1003 ¶¶ 55, 109–111; Ex. 1014 at 3:25–28).
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`We are not persuaded by Petitioner’s contentions. The proposed
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`modification to Fischell ’274 places Burton’s grip member 9 underneath
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`Fischell 274’s balloon 23 and stent 15, to “ensure stent securement.” Pet 25
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`(citing Ex. 1003 ¶¶ 108–109), 28–29. However, Burton explains that grip
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`member 9 retains the stent through physical contact, for example, through a
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`high-friction, adhesive, or settable contact surface between the grip member
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`and the stent. See, e.g., Ex. 1014, 5:46–64, 3:29–33 (disclosing a “friction
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`contact surface . . . that will take a set”), 3:48–56 (“[A]n important
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`characteristic of the grip member is that it should be capable of gripping or
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`holding a stent . . . [e.g.,] a surface which offers high resistance to sliding
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`motion.”), 3:62–65 (disclosing a “releasable adhesive”). Neither Petitioner
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`nor Mr. Trotta explains sufficiently how the grip member would retain the
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`Fischell ’274 stent, when balloon 23 is located between the grip member and
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`the stent, precluding the physical contact relied upon by Burton. See
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`Pet. 25–26; Ex. 1003 ¶¶ 107–111.
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`We recognize Petitioner’s argument, made in its Reply and at the oral
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`hearing, that Burton’s grip member may include material that is deformable,
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`which would secure the stent even with a balloon located between the stent
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`and the grip member. Reply 25 (citing Ex. 1003 ¶¶ 109–112); Tr. 16:19–
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`19:10. However, neither the Petition nor the Trotta Declaration discusses
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`deformation at all; this argument was made for the first time in the Reply
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`and, thus, is improper. Compare Pet. 21–46, and Ex. 1003 ¶¶ 109–112, with
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`Reply 25; see also 37 C.F.R. § 42.23(b).
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`Additionally, Burton explains that deformable materials that “take a
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`set” are inherently high-friction materials. See, e.g., Ex. 1014, 4:13–16
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`(“When the core itself is made from a material that will take a set, such a
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`material being inherently of high friction, the larger diameter may not be
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`necessary.”), 4:16–21, 6:56–64. Neither Petitioner nor Mr. Trotta addresses
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`this disclosure, or explains how Burton’s grip member would secure the
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`stent without contact between the high-friction, settable, deformable material
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`and the stent to be secured. See, e.g., Pet. 21–46; Ex. 1003 ¶¶ 107–111.
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`For example, Mr. Trotta testifies that the proposed modification
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`would secure the stent without requiring an external sheath, which would
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`improve trackability and profile. Ex. 1003 ¶ 110. Although this may be a
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`beneficial result, if the modification were achieved, this testimony does not
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`explain how the grip member would secure the stent in the absence of
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`physical contact with high-friction, settable material or adhesive material.
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`Likewise, Mr. Trotta’s opinion regarding the location of Burton’s grip
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`member, when used with the stent of Fischell ’237, fails to cure this
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`deficiency. Id. ¶¶ 111–112 (located underneath the balloon and either
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`overlying or adjacent radiopaque markers).1 See In re Acad. of Sci. Tech
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`Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004); see also 37 C.F.R. § 42.65(a).
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`Additionally, we are unpersuaded by Petitioner’s Reply argument that,
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`by “providing an enlarged diameter from the catheter shaft, Burton’s grip
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`1 Petitioner’s argument that placing Burton’s grip member under the balloon
`would help avoid problems associated with over-crimping is also
`insufficiently supported. Reply 24 (citing Ex. 1003 ¶ 55). Mr. Trotta opined
`that, generally speaking, mounting a balloon-expandable stent on a catheter
`without a sheath “presented a difficult compromise in how tightly to crimp
`the stent,” because over-crimping could damage the stent, but under-
`crimping might cause the stent to fall off. Ex. 1003 ¶ 55. This testimony,
`however, does not relate to the proposed combination, and does not explain
`how placing Burton’s grip member underneath the Fischell ’274 balloon
`would either retain the stent or avoid over-crimping. See id. ¶¶ 55, 109–112.
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`member would serve to better secure a balloon-expandable stent on to the
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`balloon and catheter shaft.” Reply 25 (citing Ex. 1003 ¶¶ 55, 109–111;
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`Ex. 1014 at 3:25–28); Tr. 16:19–19:10. The Trotta Declaration states that
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`the grip member “would have a larger diameter than the radiopaque
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`markers” of Fischell ’274. Ex. 1003 ¶ 112. This testimony, however, does
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`not explain sufficiently how a diameter larger than certain markers
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`“improve[s] securement for a balloon-expandable stent.” Pet. 25.
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`Petitioner’s analogy to a golf club shaft, provided in the Reply, is new,
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`speculative, and unsupported attorney argument, which cannot take the place
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`of evidence. Id. at 25 n.8 (speculating that “a synthetic grip for a golf club
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`shaft helps a player to have a secure grip by providing an increased diameter
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`and a softer composition than the shaft, and its diameter and firmness can be
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`adjusted to best fit an individual player’s hands”); cf. In re Pearson, 494
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`F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take
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`the place of evidence.”).
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`Petitioner has not demonstrated sufficiently that, in the proposed
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`combination, Burton’s grip member would secure the Fischell ’274 stent, in
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`the absence of physical contact between the stent and the grip member. As
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`such, Petitioner has not demonstrated that a skilled artisan would have made
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`such a modification, whether to ensure stent securement, simplify delivery
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`system operation, or decrease the catheter profile, as Petitioner contends.
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`b. Independent Claims 13, 21, and 26
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`Independent claims 13, 21, and 26 include limitations concerning a
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`“proximal member,” for which Petitioner relies on the combined teachings
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`of Fischell ’274 and Burton, as discussed above regarding claim 1. Pet. 36,
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`41, 45. For the same reasons discussed above regarding claim 1, we
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`determine that Petitioner has not met its burden to demonstrate, by a
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`preponderance of the evidence, that the combined teachings of Fischell ’274,
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`Burton, Sugiyama, and the knowledge of a POSITA render obvious
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`independent claims 13, 21, or 26.
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`c. Dependent Claims 2–12, 14–20, and 22–25
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`Claims 2–12 depend directly or indirectly from claim 1; claims 14–20
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`depend directly or indirectly from claim 13; and claims 22–25 depend
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`directly from claim 21. For the same reasons discussed above regarding
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`claims 1, 13, and 21, we determine that Petitioner has not met its burden to
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`demonstrate, by a preponderance of the evidence, that the combined
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`teachings of Fischell ’274, Burton, Sugiyama, and the knowledge of a
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`POSITA render obvious these claims.
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`E. Obviousness over the Combined Teachings of
`“Sugiyama ’032 in View of Fischell ’507, and
`in Further View of Jendersee”
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`Petitioner contends that claims 1–26 of the ’062 patent are unpatentable
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`under 35 U.S.C. § 103(a), over the combined teachings of Sugiyama,
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`Fischell ’507, and Jendersee. Pet. 46–78. For reasons that follow, we
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`determine Petitioner has not demonstrated that the challenged claims are
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`unpatentable by a preponderance of the evidence.
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` Overview of Fischell ’507 (Ex. 1010)
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`Fischell ’507 is a U.S. Patent titled “Intravascular Stent and
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`Percutaneous Insertion Catheter System for the Dilation of an Arterial
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`Stenosis and the Prevention of Arterial Restenosis.” Ex. 1010, [54].
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`Figure 3 of Fischell ’507 is reproduced below.
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`Figure 3 depicts a cross-sectional view of the distal end of a catheter for
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`inserting an intravascular stent. Id. at 3:11–12. As shown in Figure 3,
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`catheter 20 includes inner core 22 and outer cylinder 24. Id. at 3:47–49.
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`Inner core 22 includes spiral grooves 26 and back groove 28, into which
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`stent 10 is placed, such that flange 30 retains the proximal end of stent 10
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`within back groove 28. Id. at 3:49–51, 3:66–4:27 (explaining that pliers
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`hold distal portion of stent 10 into distal-most groove 26; the center of stent
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`10 is forced into spiral grooves 26 extending along the length of core 22 by
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`pulling and twisting with pliers; the most proximal turn of stent 10 is forced
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`into groove 28 with needle-nose pliers; and outer cylinder 24 is moved to
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`cover the entire stent 10).
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` Overview of Jendersee (Ex. 1016)
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`Jendersee is a U.S. Patent titled “Stent Delivery and Deployment
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`Method.” Ex. 1016, [54]. Figure 3 of Jendersee is reproduced below.
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`Figure 3 depicts a longitudinal cross-sectional view of stent 10 and
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`balloon 36, positioned with interior and exterior sheaths 42, 44, during a
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`process of encapsulation. Id. at 4:62–64. Jendersee explains that by
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`encapsulating the stent with the catheter’s balloon, the “balloon may expand
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`part way around the stent and adhere thereto,” such that a “smoother
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`transition” is provided between the catheter and the ends of the stent. Id. at
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`3:21–31; see also id. at 6:41–53 (explaining that the encapsulation process
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`includes steps of compressing stent segment 10 on balloon 36; placing
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`sheaths 42, 44 over the catheter; partially expanding balloon 36; elevating
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`the temperature such that balloon 36 expands partially outwardly around
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`stent 10; and cooling the assembly to set the shape of balloon 36 and adhere
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`it to stent 10).
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`
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`Jendersee’s Figure 8 is reproduced below.
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`Figure 8 depicts a longitudinal cross sectional view of the stent assembly
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`with “conventional retainers 54” located within the balloon to secure the
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`stent to the balloon and to create a smooth transition across the assembly.
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`
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`Id. at 5:9–11, 7:36–40, 7:46–52.
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` Analysis of Applied Art
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`
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`Petitioner contends that the combin