Trials@uspto.gov
`571.272.7822
`
`
`Paper No. 9
`Filed: October 25, 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 IPR2017-01295
`Patent 8,709,062 B2
`_______________
`
`
`Before JAMES A. TARTAL, ROBERT L. KINDER,
`and AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571.272.7822
`
`
`Paper No. 9
`Filed: October 25, 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 IPR2017-01295
`Patent 8,709,062 B2
`_______________
`
`
`Before JAMES A. TARTAL, ROBERT L. KINDER,
`and AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
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`IPR2017-01295
`Patent 8,709,062 B2
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`
`A. Background
`
`I.
`
`INTRODUCTION
`
`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 Preliminary
`Response. Paper 8 (“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.” See also 37 C.F.R § 42.4(a) (“The Board institutes the trial on
`behalf of the Director.”). Taking into account the arguments presented in
`the Preliminary Response, we conclude that the information presented in the
`Petition establishes a reasonable likelihood that Petitioner would prevail
`with respect to challenged claims 1–7, 9–15, 17–21, and 23–26, but not with
`respect to challenged claims 8, 16, and 22.
`
`B. Related Proceeding
`
`The parties represent that the ’062 patent is at issue in Boston
`Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences
`Corp., No. 16-cv-730 (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
`2
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`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).
`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
`8:49–55. After expansion, the balloon is deflated and the catheter and
`balloon are withdrawn, while the stent remains in place to maintain the
`vessel in an expanded state. Id. at 8:55–57.
`Figure 4 of the ’062 patent is reproduced below.
`
`
`Figure 4 depicts an enlarged cross-sectional view of the distal end of
`catheter 12, with balloon 14 and stent 18 in expanded states. Id. at 6:3–6.
`As shown in Figure 4, “mounting body 30 . . . is included inside balloon 14
`to provide a cushion and/or substrate of enlarged diameter relative to the
`stent to support and hold the stent and secure it during crimping and the
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`delivery procedure.” Id. at 9:28–32. In Figure 4, mounting body 30 is a
`cylindrical sleeve carried on inner lumen 26 of the catheter. Id. at 9:35–37.
`However, the ’062 patent also discloses alternate mounting bodies including,
`for example, a spiral cut mounting body (id. at Fig. 5), a cylindrical body
`comprising separate, adjacent rings 30a (id. at Fig. 6), a two-piece
`interlocked body 30a, 30b (id. at Fig. 7), a body comprising a plurality of
`separate, spaced bodies 30a, 30b, 30c (id. at Fig. 9), a rigid coil 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.
`
`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.
`
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`E. Applied References
`
`Fischell ’507
`
`US 4,768,507
`
`Fischell ’274
`
`US 5,639,274
`
`Petitioner relies upon the following references, and the Declaration of
`Thomas Trotta (“Trotta Declaration,” Ex. 1003). Pet. 20–21, 46, 78.
`Reference
`Patent No.
`Relevant Dates
`Exhibit No.
`Sugiyama
`US 4,994,032
`Filed Nov. 29, 1988
`Ex. 1009
`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
`Filed June 7, 1995
`Issued Nov. 17, 1998
`Filed Apr. 25, 1996
`Issued Aug. 5, 1997
`
`Ex. 1010
`
`Ex. 1013
`
`Ex. 1014
`
`Ex. 1016
`
`Ex. 1023
`
`Burton
`
`US 5,026,377
`
`Jendersee
`
`US 5,836,965
`
`Rupp
`
`US 5,653,691
`
`
`
`
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`F. Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–10 and 13 of the
`’040 patent based on the following grounds. Pet. 20, 21, 46, 78.1
`References
`Basis
`Claims Challenged
`Fischell ’274 in View of Burton in
`§ 103(a) 1–26
`Further View of the Knowledge of a
`Person of Ordinary Skill in the Art
`and/or Sugiyama
`Sugiyama in View of Fischell ’507
`and in Further View of Jendersee
`Rupp in View of the Knowledge of a
`Person of Ordinary Skill in the Art
`and/or Sugiyama and in Further View
`of Jendersee
`
`§ 103(a) 1–7, 9–15, 17–21, and
`23–26
`
`§ 103(a) 1–26
`
`
`1 Petitioner’s allegation that the challenged claims are unpatentable over “the
`references identified below, alone or in combination with each other” (see
`Pet. 20) lacks the particularity and specificity required by 35 U.S.C
`§ 312(a)(3) and 37 C.F.R. § 42.104(b)(2). Furthermore, Petitioner’s
`identification of the grounds as outlined above, through the use of “and/or”
`expands what is identified as three grounds of unpatentability into several
`distinct combinations of references. The function of the Board is not to
`comb through Petitioner’s arguments in order to decipher the strongest
`argument or to determine the strongest combination of references to
`challenge the claims. See generally LG Elecs., Inc. v. Rosetta-Wireless
`Corp., Case IPR2016-01516 (PTAB Apr. 3, 2017) (Paper 25). As such, for
`each identified ground, we exercise our discretion and consider all of the
`references in combination as one ground of unpatentability, as this is the
`most consistent reading of the Petition and claim charts.
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`II. DISCUSSION
`
`A. Claim Construction
`
`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.
`Based on the record before us, at this stage of the proceeding, we need
`not provide express constructions for 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) objective evidence of nonobviousness,
`i.e., secondary considerations.2 Graham v. John Deere Co., 383 U.S. 1, 17–
`18 (1966).
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`
`
`2 The Preliminary Response does not identify any secondary considerations.
`Prelim. Resp. 8 n.2.
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`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016). This burden never shifts to Patent Owner. Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`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
`person of ordinary skill in the art (“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 “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 a relevant skill level. See generally Prelim. Resp.
`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, we apply Petitioner’s assessment for purposes of
`this Decision. Further, the applied prior art reflects the appropriate level of
`skill at the time of the claimed invention. See Okajima v. Bourdeau, 261
`F.3d 1350, 1355 (Fed. Cir. 2001).
`
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`D. Obviousness over the Combined Teachings of Fischell ’274,
`Burton, Sugiyama, and the Knowledge of a POSITA
`
`Petitioner contends that challenged claims 1–26 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. Patent
`Owner disputes Petitioner’s contentions. Prelim. Resp. 8–21. For reasons
`that follow, we determine Petitioner has not demonstrated a reasonable
`likelihood of prevailing as to the challenged claims.
`
`1. 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
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`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.
`
`2. 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), or with a surface material that takes a set and
`10
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`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.
`
`3. Overview of Sugiyama (Ex. 1009)
`
`Sugiyama is a U.S. Patent titled “Balloon Catheter.” Ex. 1009, [54].
`Sugiyama’s Figure 1 is reproduced below.
`
`
`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.
`
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`4. Analysis of Applied Art
`
`a. Independent Claim 1
`Petitioner contends that Fischell ’274 discloses a medical device
`substantially as claimed including, inter alia, 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 ’273 “lacks any
`under-balloon securement mechanism,” akin to the claimed “second member
`. . . positioned within the balloon,” but notes that Fischell ’274 “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 over the
`balloon while the sheath was being withdrawn.” Id. at 22 (citing Ex. 1013,
`6:34–38).
`Accordingly, Petitioner contends that the stent delivery system of
`Fischell ’274 “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” 9. Pet. 22–23, 25–26.
`According to Petitioner, “[t]his modification 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);
`see also id. at 28–29.3
`
`
`3 Regarding dependent claims 5 and 6, Petitioner also relies on Sugiyama’s
`teachings of adhesive bonding of catheter balloons to catheter shafts. Id. at
`26–27, 32.
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`Patent Owner argues that Petitioner has not shown sufficiently that a
`person of ordinary skill in the art would have modified Fischell ’274 to
`arrive at the claimed invention. Prelim. Resp. 18. We agree.
`Petitioner’s proposed modification to Fischell ’274 places Burton’s
`grip member 9 underneath Fischell 274’s balloon 23 and stent 15,
`purportedly to “ensure stent securement.” Pet 25 (also contending such a
`combination would simplify delivery system operation and decrease the
`catheter profile) (citing Ex. 1003 ¶¶ 108–109), 28–29. However, Burton
`explains that grip member 9 retains stent 10 due to physical contact between
`the grip member and the stent, for example, through a high-friction,
`adhesive, or settable contact surface between the grip member and the stent.
`See, e.g., Ex. 1014, 5:46–64; see also id. at 3:48–56 (“[A]n important
`characteristic of the grip member is that it should be capable of gripping or
`holding a stent . . . it is necessary when the grip member is a sleeve of
`material, that said material has a surface which offers high resistance to
`sliding motion.”). Neither Petitioner nor Mr. Trotta explain sufficiently
`how, in the proposed modification, the grip member would serve to retain
`Fischell 274’s stent when Fischell 274’s balloon 23 is located between the
`grip member and the stent, precluding the physical contact relied upon by
`Burton. See Pet. 25–26; Ex. 1003 ¶¶ 107–111. In particular, we find
`nothing in the cited portion of Mr. Trotta’s declaration that addresses how
`Burton’s grip member would secure a stent under the proposed modified
`structure, namely, in the absence of direct contact between the stent and grip
`member. See, e.g., Ex. 1003 ¶¶ 107–111; see also In re Acad. of Sci. Tech
`Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to
`weigh the declarations and conclude that the lack of factual corroboration
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`warrants discounting the opinions expressed in the declarations.”); see also
`37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the
`underlying facts or data on which the opinion is based is entitled to little or
`no weight.”).
`We agree with Patent Owner that, in the proposed combination, the
`grip member seemingly “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.” Prelim. Resp. 20.
`As such, we are not persuaded that Petitioner presents a sufficient rationale
`to show that it would have been obvious for a person of ordinary skill in the
`art to have combined Fischell ’274 and Burton to ensure stent securement,
`simplify delivery system operation, or decrease the catheter profile, as
`Petitioner contends. Pet. 25–26.
`Based on the record before us, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its contention that the
`combined teachings of Fischell ’274, Burton, Sugiyama, and the knowledge
`of a POSITA render obvious independent claim 1, or claims 2–12, which
`depend from claim 1.
`
`b. Independent Claims 13, 21, and 26
`
`We have reviewed carefully the evidence presented by Petitioner
`regarding independent claims 13, 21, and 26. Pet. 35–46. Importantly,
`independent claims 13, 21, and 26 include limitations concerning a
`“proximal member,” for which Petitioner relies on the combined teachings
`of Fischell ’274 and Burton, as discussed above regarding claim 1. Id. at 36,
`41, 45.
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`Based on the record before us, and for the same reasons discussed
`above regarding claim 1, we determine that Petitioner has not established a
`reasonable likelihood of prevailing on its contention that the combined
`teachings of Fischell ’274, Burton, Sugiyama, and the knowledge of a
`POSITA render obvious independent claims 13, 21, or 26. For the same
`reasons, we determine that Petitioner has not established a reasonable
`likelihood of prevailing with respect to claims 14–20, which depend from
`claim 13 or claims 22–25, which depend from claim 21.
`
`E. Alleged Obviousness over the Combined Teachings of Sugiyama,
`Fischell ’507, and Jendersee
`
`Petitioner contends that challenged claims 1–26 are unpatentable
`under 35 U.S.C. § 103(a) over the combined teachings of Sugiyama, Fischell
`’507, and Jendersee. Pet. 46–78. Patent Owner disputes Petitioner’s
`contentions. Prelim. Resp. 22–26. For reasons that follow, we determine
`Petitioner has not demonstrated a reasonable likelihood of prevailing as to
`the challenged claims.
`
`1. Overview of Fischell ’507 (Ex. 1010)
`
`Fischell ’507 is a U.S. Patent titled “Intravascular Stent and
`Percutaneous Insertion Catheter System for the Dilation of an Arterial
`Stenosis and the Prevention of Arterial Restenosis.” Ex. 1010, [54]. 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
`inserting an intravascular stent. Id. at 3:11–12. As shown in Figure 3,
`catheter 20 includes inner core 22 and outer cylinder 24. Id. at 3:47–49.
`Inner core 22 includes spiral grooves 26 and back groove 28, into which
`stent 10 is placed, such that flange 30 retains the proximal end of stent 10
`within back groove 28. Id. at 3:49–51, 3:66–4:27 (explaining that pliers
`hold distal portion of stent 10 into distal-most groove 26; the center of stent
`10 is forced into spiral grooves 26 extending along the length of core 22 by
`pulling and twisting with pliers; the most proximal turn of stent 10 is forced
`into groove 28 with needle-nose pliers; and outer cylinder 24 is moved to
`cover the entire stent 10).
`
`2. Overview of Jendersee (Ex. 1016)
`
`Jendersee is a U.S. Patent titled “Stent Delivery and Deployment
`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 balloon
`36, positioned with interior and exterior sheaths 42, 44, during a process of
`encapsulation. Id. at 4:62–64. Jendersee explains that by encapsulating the
`stent with the catheter’s balloon, the “balloon may expand part way around
`the stent and adhere thereto,” such that a “smoother transition” is provided
`between the catheter and the ends of the stent. Id. at 3:21–31; see also id. at
`6:41–33 (explaining that the encapsulation process includes steps of
`compressing stent 10 on balloon 36; placing sheaths 42, 44 over the catheter;
`partially expanding balloon 36; elevating the temperature such that balloon
`36 expands partially outwardly around stent 10; and cooling the assembly to
`set the shape of balloon 36 and adhere it to stent 10).
`
`Jendersee’s Figure 8 is reproduced below.
`
`
`Figure 8 depicts a longitudinal cross sectional view of the stent assembly
`with “conventional retainers 54” located within the balloon to secure the
`stent to the balloon and to create a smooth transition across the assembly.
`Id. at 5:9–11, 7:36–40, 7:46–52.
`
`3. Analysis of Applied Art
`
`a. Independent Claim 1
`Petitioner contends that Sugiyama discloses a medical device
`substantially as claimed including, inter alia, a catheter having first inner
`tubular member 1, second tubular member 2, and balloon 3, wherein coil-
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`shaped reinforcement 9 is positioned within balloon 3. Pet. 46–49, 56–59.
`Petitioner does not contend that Sugiyama discloses a stent, but instead
`contends that it would have been obvious “to adapt Sugiyama’s catheter for
`use as a stent delivery system because its balloon catheter is a vascular
`dilatation catheter . . . capable of exerting sufficient force to perform direct
`stenting, simultaneously expanding the stenosis and deploying a mounted
`stent.” Id. at 49–50.
`According to Petitioner, the “spiral coil shape [of Sugiyama’s
`reinforcement 9] would make it particularly suitable for securely holding
`and delivering a spiral-shaped stent such as that taught by Fischell ’507.”
`Id.; see also id. at 52. Petitioner contends that Fischell ’507 discloses a
`catheter for placing coil spring stent 10, wherein the catheter includes spiral
`grooves 26 into which the stent is placed, for deployment after balloon
`dilation of a vessel. Id. at 51, 59. According to Petitioner, a person of
`ordinary skill in the art would have recognized that “the gaps between the
`turns of [Sugiyama’s] spiral reinforcement 9 would create a structure similar
`to the spiral grooves of Fischell ’507, thereby providing a mounting body
`located on the catheter shaft to help secure the stent during delivery.” Id. at
`52 (citing Ex. 1003 ¶¶ 128–130). Petitioner also contends that by
`“modifying the Fischell ’507 stent to be balloon-expandable, it would be
`unnecessary to use the outer sheath cylinder 24, thereby reducing the overall
`profile of the delivery system and improving the flexibility and trackability
`of the delivery catheter. Accordingly, a POSITA would have been
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`motivated to add the coil stent taught by Fischell ’507 to the balloon catheter
`of Sugiyama ’032.” Id. at 52–53 (citing Ex. 1003 ¶¶ 131).4
` Patent Owner argues that Petitioner has not shown sufficiently that a
`person of ordinary skill in the art would have had reason to use Sugiyama’s
`balloon catheter with the stent disclosed by Fischell ’507 to arrive at the
`claimed invention. Prelim. Resp. 22. We agree.
`Petitioner’s proposed modification to Sugiyama places Fischell ’507’s
`coil stent 10 over Sugiyama’s balloon 3 and spiral reinforcement 9,
`purportedly to “help secure the stent during delivery” and to reduce the
`profile of the assembly. Pet. 52–53 (providing annotated version of
`Sugiyama’s Figure 13); Ex. 1003 ¶ 130. We agree with Patent Owner’s
`argument, however, that the fundamental differences between Fischell
`’507’s coil stent and Sugiyama’s catheter shaft and balloon would not have
`led a person of ordinary skill in the art to have combined the references, as
`Petitioner proposes. Prelim. Resp. 22–24. Petitioner provides insufficient
`reasoning as to why a person of ordinary skill in the art would have added
`Fischell ’507’s coil stent to the outside of Sugiyama’s balloon. As discussed
`above, Fischell ’507’s stent is not balloon expandable and Sugiyama does
`not describe its catheter as being used for deploying stents. As such,
`Petitioner’s proposed combination appears to be premised on an
`impermissible use of hindsight, rather than on a rational basis to combine the
`references.
`
`
`4 Petitioner also relies on Jendersee’s teachings of tapered distal stops. Id. at
`53–58.
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`Additionally, Fischell ’507 explains that stent 10 is secured to Fischell
`507’s catheter by forcing the entire length of stent 10 to fit into grooves 26,
`28 along the length of catheter core 22. See, e.g., Ex. 1010, 3:47–55, 3:67–
`4:27 (using pliers to force the stent, including its distal and proximal ends,
`into grooves in the catheter core). Neither Petitioner nor Mr. Trotta explain
`sufficiently how, in the proposed modification, Fischell ’507’s stent would
`be secured on Sugiyama’s catheter when Sugiyama’s balloon 3 would be
`located between the spiral reinforcement and the stent, precluding the force-
`fit relied upon to secure the stent of Fischell ’507. See Pet. 52–53; Ex. 1003
`¶¶ 129–131.
`We agree with Patent Owner that, in the proposed combination, the
`coil-shaped stent disclosed by Fischell ’507 seemingly “would be
`ineffective” if used with Sugiyama’s balloon catheter “because the structures
`holding the self-expanding stent in Fischell ’507 require direct contact with
`the stent. If such structures are placed under [Sugiyama’s] balloon, they lose
`direct contact with the stent, thus fundamentally altering the mechanism of
`action of Fischell ’507.” Prelim. Resp. 23–24 (also persuasively arguing
`that such a modification would puncture Sugiyama’s balloon). As such, we
`are not persuaded that Petitioner presents a sufficient rationale to show that
`it would have been obvious for a person of ordinary skill in the art to have
`combined Sugiyama and Fischell ’507 to help secure the stent during
`delivery, as Petitioner contends. Pet. 52–53.
`Based on the record before us, we determine that Petitioner has not
`established a reasonable likelihood of prevailing on its contention that the
`combined teachings of Sugiyama, Fischell ’507, and Jendersee render
`obvious independent claim 1, or claims 2–12, which depend from claim 1.
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`b. Independent Claims 13, 21, and 26
`We have reviewed carefully the evidence presented by Petitioner
`regarding independent claims 13, 21, and 26. Pet. 65–78. Importantly,
`independent claims 13, 21, and 26 include limitations concerning a
`“cardiovascular implant” or an “implantable endoprosthesis,” for which
`Petitioner relies on the combined teachings of Sugiyama and Fischell ’507,
`as discussed above regarding claim 1. Id. at 65–66, 71–72, 78.
`Based on the record before us, and for the same reasons discussed
`above regarding claim 1, we determine that Petitioner has not established a
`reasonable likelihood of prevailing on its contention that the combined
`teachings of Sugiyama, Fischell ’507, and Jendersee render obvious
`independent claims 13, 21, or 26. For the same reasons, we determine that
`Petitioner has not established a reasonable likelihood of prevailing with
`respect to claims 14–20, which depend from claim 13 or claims 22–25,
`which depend from claim 21.
`
`F. Alleged Obviousness over the Combined Teachings of Rupp,
`Sugiyama, Jendersee, and the Knowledge of a POSITA
`
`Petitioner contends that challenged claims 1–7, 9–15, 17–21, and 23–
`26 are unpatentable under 35 U.S.C. § 103(a) over the combined teachings
`of Rupp, Sugiyama, Jendersee, and the knowledge of a POSITA. Pet. 78–
`100. Patent Owner disputes Petitioner’s contentions. Prelim. Resp. 26–32.
`For reasons that follow, we determine Petitioner has demonstrated a
`reasonable likelihood of prevailing as to the challenged claims.
`
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`1. Overview of Rupp (Ex. 1023)
`Rupp is a U.S. Patent titled “Thickened Inner Lumen for Uniform
`Stent Expansion and Method of Making.” Ex. 1023, [54]. Rupp’s Figure 1
`is reproduced below.
`
`
`Figure 1 depicts a longitudinal cross-section of a stent deployment device
`that has multiple built-up layers. Id. at 2:63–65. As shown in Figure 1,
`Rupp discloses a catheter having inner lumen 30, inflation lumen tubing 55,
`and balloon 35, wherein stent 100 is crimped upon balloon 35. Id. at 5:12–
`26, 5:38–40. Rupp discloses that built-up section 20 (comprising layers 40,
`50, 60) is affixed to inner lumen 30 and is centered underneath stent 100. Id.
`at 5:5–7, 5:41–45. Rupp explains that built-up section 20 ensures uniform
`expansion of the balloon and avoids pin-hole leaks. Id. at 4:56–67, 5:38–45.
`2. Analysis of 35 U.S.C. § 325(d)
`As an initial matter, Patent Owner argues that we should exercise our
`discretion under 35 U.S.C. § 325(d) to deny this alleged ground of
`unpatentability because it “is based entirely on the same or substantially the
`same art that was before the examiner during prosecution.” Prelim. Resp.
`27. Patent Owner contends that the Examiner rejected pending claims in
`
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`light of Rupp, and that Jendersee was cited to the Examiner during
`prosecution. Id. at 27–28. Patent Owner also alleges that Sugiyama “is
`substantially similar” to another reference cited by the Examiner during
`prosecution. Id. at 28.
`a. Relevant Prosecution History
`The ’062 patent issued on April 29, 2014, from U.S. Patent
`Application No. 13/619,231 (“the ’231 application”), which was filed on
`September 14, 2012. Ex. 1001, (21), (22), (45). Issued independent claim 1
`of the ’062 patent corresponds to application independent claim 1 of the
`’231 application. Compare Ex. 1001, 25:30–44, with Ex. 1002, 215
`(Nov. 22, 2013, Claim Amendment), 233 (Dec. 6, 2013, Notice of
`Allowability). Further, issued independent claim 13 corresponds with
`application independent claim 15; issued independent claim 21 corresponds
`with application independent claim 24; and issued independent claim 26
`correspo
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