Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 9
`Entered: June 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 IPR2017-00444
`Patent 6,915,560 B2
`____________
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`STACY B. MARGOLIES, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
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`IPR2017-00444
`Patent 6,915,560 B2
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`INTRODUCTION
`I.
`Edwards Lifesciences Corporation (“Petitioner”) filed a Petition
`(Paper 1, “Pet.”) requesting institution of inter partes review of claims 1, 2,
`6, 8–11, 14, 15, 17–19, 23, 25–28, 31, 33–35, 37, 39, and 40 of U.S. Patent
`No. 6,915,560 B2 (Ex. 1101, “the ’560 patent”). Boston Scientific Scimed,
`Inc. (“Patent Owner”) filed a Preliminary Response (Paper 7, “Prelim.
`Resp.”). We have jurisdiction under 35 U.S.C. § 314, 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).
`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, 2, 6, 8–11, 14, 15, 17–19, 23, 25–28, 31, 33–35, 37, 39, and 40.
`Accordingly, we authorize an inter partes review to be instituted as to claims
`1, 2, 6, 8–11, 14, 15, 17–19, 23, 25–28, 31, 33–35, 37, 39, and 40 of the ’560
`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.
`BACKGROUND
`II.
`A.
`The ’560 Patent
`The ’560 patent, titled “Apparatus for Contracting, Loading or
`Crimping Self-Expanding and Balloon Expandable Stent Devices,” issued
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`Patent 6,915,560 B2
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`July 12, 2005, from U.S. Application No. 10/444,807 (the ’807 application),
`filed May 23, 2003. Ex. 1101. The ’807 application was a division of U.S.
`Application No. 09/966,686, filed on October 1, 2001 (issued as U.S. Patent
`No. 6,823,576), which was a continuation of U.S. Application
`No. 09/401,218 (the ’218 application), filed on September 22, 1999 (issued
`as U.S. Patent No. 6,360,577). Id. The ’560 patent generally relates to a
`device “capable of crimping a stent uniformly while minimizing the
`distortion of and scoring and marking of the stent due to crimping.”
`Ex. 1101, 2:26–29. Petitioner contends that the alleged “AAPA [Applicant
`Admitted Prior Art] depicted in Figure 1 and described at 1:62–2:21 of the
`’560 patent is prior art.” Pet. 36.
`Figure 1 of the ’560 patent is reproduced below.
`
`
`Figure 1 illustrates a perspective view of a stent crimper, with the words
`“PRIOR ART” appearing under the label “FIG. 1.” Ex. 1101, 3:58. The
`description in the specification of Figure 1 does not state that the stent
`crimper illustrated in Figure 1 was known in the art. See id. at 1:62–2:21.
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`According to Patent Owner, Figure 1 of the ’560 patent was not labeled
`“PRIOR ART” when filed in the parent ’218 application on September 22,
`1999, but rather, the label was added during prosecution of the
`’218 application in a May 23, 2000, filing by the applicant in response to an
`Examiner request dated February 23, 2000. Prelim. Resp. 9 n.1 (citing
`Ex. 2010, 61, 81). Patent Owner also contends that, prior to the date the
`Petition was filed, Patent Owner informed Petitioner, as part of district court
`proceedings concerning the ’560 patent, that the stent crimper illustrated in
`Figure 1 of the ’560 patent was developed by Boston Scientific and was not
`commercialized. Id. at 10 (citing Ex. 2011, 23; Ex. 2012, 3).
`According to Patent Owner, “[i]mproving upon the prior art crimping
`methods and devices, the ’560 Patent discloses and claims an innovative
`crimper that includes both coupled and movable blades forming a variable-
`sized aperture that applies even forces while minimizing distortion of the
`stent.” Prelim. Resp. 5 (citing Ex. 1101, 2:26–29, 2:56–65).
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`
`Figure 4A of the ’560 patent is reproduced below.
`
`
`Figure 4A illustrates “a partial front view of an embodiment of the inventive
`apparatus.” Ex. 1101, 4:1–2. Actuation device 138 includes rotatable
`actuation plate 142 and eight coupled blades 106 disposed about reference
`circle 114 to form aperture 118. See id. at 4:46–49. “Each blade 106 is
`engaged to actuation plate 142 via a cam follower bearing 150 disposed in
`radial slot 146 and attached to mounting means in slotted end 134.” Id. at
`5:19–21. “Each bearing 150 extends from a linear slide 154.” Id. at 5:22.
`Patent Owner further explains:
`In use, as an actuation plate 142 is rotated in a clockwise
`direction, the clockwise motion of the actuation plate is
`translated into linear motion of each linear slide 154 and blade
`106 via bearing 150. ([Ex. 1101] at 5:46–62.) Each blade 106
`moves outward in a direction parallel to the radial line 126,
`resulting in the opening of aperture 118. Conversely, as the
`actuation plate 142 is rotated in a counterclockwise direction,
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`each blade 106 moves inward in a direction parallel to the radial
`line 126, resulting in the closing of aperture 118.
`Prelim. Resp. 6–7.
`
`Illustrative Claim
`B.
`Challenged claims 1, 10, 18, 27, 37, 39, and 40 are independent.
`Claim 1 is illustrative of the claimed subject matter and is reproduced below:
`1. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris having a
`longitudinal axis, the iris defining an aperture, the dies
`disposed about the aperture and between stationary end-walls
`which are disposed about the longitudinal axis, at least one of
`the stationary end-walls operatively engaged to the dies at
`distinct connection locations such that the number of distinct
`connection locations and the number of dies are the same;
`each die having a first straight side and a second straight side, the
`first straight side and the second straight side conver[g]ing to
`form a tip; wherein a portion of the first straight side of each
`die faces the aperture, each first straight side parallel to the
`second side of an adjacent die.
`Ex. 1101, 10:8–22.
`
`Related Proceedings
`C.
`The parties indicate that the ’560 patent is asserted in the United
`States District Court for the Central District of California, in a case
`captioned Boston Scientific Corp. and Boston Scientific Scimed, Inc. v.
`Edwards Lifesciences Corp., Civil Action No. 8:16-cv-0730 (C.D. Cal.).
`Pet. 14; Paper 4, 2. Petitioner also filed petitions challenging claims of the
`’560 patent on other grounds in IPR2017-00072 and IPR2017-01301.
`Real Parties in Interest
`D.
`Petitioner identifies only itself as a real party in interest. Pet. 14.
`Patent Owner identifies itself and Boston Scientific Corp. as real parties in
`interest. Paper 3, 2.
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`Claims challenged
`Basis
`§ 103 1, 2, 6, 8–10, 14, 15, 18, 23,
`25, 27, 28, 31, 33, 37, and 40
`§ 103 11, 17, 19, 26, 34, 35, and 39
`
`The Asserted Grounds of Unpatentability
`E.
`Petitioner identifies the following as the two grounds on which it
`challenges claims 1, 2, 6, 8–11, 14, 15, 17–19, 23, 25–28, 31, 33–35, 37, 39,
`and 40 of the ’560 patent:
`References
`Yasumi1 and “Applicant
`Admitted Prior Art”
`Yasumi, “Applicant Admitted
`Prior Art,” and Morales2
`Pet. 30. Petitioner’s identification of the grounds it asserts, however, fails
`to properly summarize the full range of arguments and grounds asserted by
`Petitioner in the Petition. In particular, Petitioner relies on Yasumi as
`disclosing all of the elements of the challenged claims, and refers to alleged
`Applicant Admitted Prior Art and Morales in the alternative. See, e.g., Pet.
`31 (arguing that the preamble of each challenged claim is not limiting), 82
`(stating that the press tool of Yasumi is a stent crimper and “to the extent
`necessary, it would have been obvious to a [skilled artisan] to modify
`Yasumi for use as a stent crimper in view of the AAPA”), 85–86 (stating
`that the limitations of claim 39 “are disclosed in or obvious over Yasumi
`alone or in view of the [alleged Applicant Admitted Prior Art],” and that
`“[t]o the extent these limitations are not viewed as disclosed in or obvious in
`view of Yasumi or the [alleged Applicant Admitted Prior Art], Morales also
`discloses the limitations”), 92 (stating that the limitation added by claims 11,
`19, and 35 is “disclosed in or obvious over Yasumi either alone or in view of
`the AAPA” and that “[t]o the extent this limitation is viewed as not disclosed
`
`
`1 U.S. Patent No. 4,454,657, issued June 19, 1984 (Ex. 1103, “Yasumi”).
`2 U.S. Patent No. 5,893,852, issued April 13, 1999 (Ex. 1104, “Morales”).
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`in or obvious in view of Yasumi or the AAPA, Morales” discloses the
`limitation), 94 (same with respect to the limitation added by claims 17, 26,
`and 34). Further, Petitioner relies on two embodiments of the invention
`disclosed by Yasumi, the first shown in Figure 8 of Yasumi and the second
`in Figure 9(a) of Yasumi, but fails to provide any explanation of their
`relationship, if any, to one another.
`Based on our review of the Petition, we understand Petitioner to have
`asserted the following grounds:
`References
`Yasumi (Figure 8 embodiment)
`
`Claims challenged
`Basis
`§ 103 1, 2, 6, 8–11, 14, 15, 17–19,
`23, 25–28, 31, 33–35, 37,
`39, and 40
`§ 103 11, 17, 19, 26, 34, 35, and 39
`
`§ 103 1, 2, 6, 8–11, 14, 15, 17–19,
`23, 25–28, 31, 33–35, 37,
`39, and 40
`§ 103 1, 2, 6, 8–11, 14, 15, 17–19,
`23, 25–28, 31, 33–35, 37,
`39, and 40
`§ 103 1, 2, 6, 8–11, 14, 15, 17–19,
`23, 25–28, 31, 33–35, 37,
`39, and 40
`
`Yasumi (Figure 8 embodiment)
`and Morales
`Yasumi (Figure 8 embodiment)
`and alleged “Applicant Admitted
`Prior Art”
`Yasumi (Figure 8 embodiment)
`and Yasumi (Figure 9(a)
`embodiment)
`Yasumi (Figure 8 embodiment),
`Yasumi (Figure 9(a) embodiment),
`and alleged “Applicant Admitted
`Prior Art”
`Yasumi (Figure 8 embodiment),
`Yasumi (Figure 9(a) embodiment),
`and Morales
`Petitioner supports its challenge with a Declaration of Neil Sheehan, dated
`December 5, 2016 (Ex. 1105).
`
`§ 103 11, 17, 19, 26, 34, 35, and 39
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`
`III. ANALYSIS
`Claim Construction
`A.
`Claims in an inter partes review are given the “broadest reasonable
`construction in light of the specification of the patent in which [they]
`appear[].” 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S.
`Ct. 2131, 2136 (2016).
`1.
`“A stent crimper comprising”
`Each of the challenged claims recites “[a] stent crimper comprising”
`in the preamble. Petitioner contends this preamble language is not limiting
`because the body of each challenged claim describes a structurally complete
`invention, and the preamble does not recite additional structure or provide
`antecedent basis for a claim limitation. Pet. 31–32 (citing Catalina
`Marketing International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808–
`09 (Fed. Cir. 2002)). Petitioner further argues that during examination the
`preamble was not treated as limiting and that the specification acknowledges
`additional uses of the invention beyond stent crimping. Id. at 32 (citing
`Ex. 1101, 2:52–55, 8:65–66; Ex. 1102, 19, 45–47, 49, 72).
`Patent Owner argues that the preamble is limiting because “stent”
`appears in the title of the patent and throughout the specification, including
`all of the claims, and, therefore, “stent crimper” is “an important
`characteristic” of the patent and should be limiting. Prelim. Resp. 27–28
`(citing, inter alia, Poly-America, L.P. v. GSE Lining Tech., Inc., 383 F.3d
`1303, 1310 (Fed. Cir. 2004); Catalina Mktg., 289 F.3d at 808; Rotatable
`Techs. LLC v. Motorola Mobility LLC, 567 Fed. App’x 941, 943 (Fed. Cir.
`2014)). Patent Owner also argues that in unchallenged claim 36 of the ’560
`patent, the body of the claim recites “the stent crimper” and refers back to
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`“stent crimper” in the preamble for antecedent basis, such that the preamble
`“stent crimper” is limiting. Further, Patent Owner argues that if the
`preamble is limiting in unchallenged claim 36, “it should be construed the
`same in other claims” of the ’560 patent. Prelim. Resp. 29. We agree with
`Patent Owner that, as a general matter, claim terms should be construed
`consistently across claims in a patent. However, that principle does not
`dictate, on the current record, that the preambles of other claims are limiting
`in the same manner that the preamble of claim 36 may be.
`For purposes of this decision, we are not persuaded that the preamble
`recitation of “[a] stent crimper comprising” is limiting as to any of the
`challenged claims. The preamble language merely provides a name to the
`claimed invention that describes a use for the invention, whereas the body of
`each claim describes a structurally complete invention. See Catalina Mktg.,
`289 F.3d at 809. Accordingly, for purposes of this decision, “[a] stent
`crimper comprising” recited in the preamble of the challenged claims does
`not limit the claims beyond the complete structure set forth in the body of
`the claims.
`“dies” and “blades”
`2.
`Petitioner contends the term “dies” (appearing in claims 1, 10, 18, 37,
`39, and 40) and the term “blades” (appearing in claim 27 and throughout the
`specification) mean the same thing and are interchangeable. Pet. 33 (noting
`that during examination “dies” were treated and corresponding to “blades).
`Patent Owner has not disputed Petitioner’s contention. Prelim. Resp. 27 n.5.
`For purposes of this decision, we agree that the terms “dies” and “blades”
`are used interchangeably in the ’560 patent, and determine no further
`express construction is required for purposes of this decision.
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`“stationary end-walls” and “stationary plates”
`3.
`Petitioner contends the term “stationary end-walls” (appearing in
`claims 1, 10, 18, 27, and 37) and the term “stationary plates” (appearing in
`claim 40) both describe “stationary elements disposed about the longitudinal
`axis of an aperture formed by a plurality of movable dies or blades.” Pet.
`34. Petitioner further contends that, outside of the claims, the specification
`does not use either term or distinguish between them. Id. Patent Owner has
`not disputed that the terms are interchangeable. Prelim. Resp. 30 n.6. Patent
`Owner does, however, argue that Petitioner fails to provide any basis for
`equating claim terms “end-walls” and “plates” with the nonce word
`“elements.” Id. at 29–30. We agree with Patent Owner that Petitioner fails
`to provide a sufficient explanation in support of its proposed construction
`and further determine that the term “stationary end-walls” and the term
`“stationary plates” are used interchangeably in the ’560 patent but require no
`further express construction for purposes of this decision.
`B.
`Asserted Obviousness Over Yasumi (Figure 8 Embodiment)
`We understand Petitioner to contend that challenged claims 1, 2, 6, 8–
`11, 14, 15, 17–19, 23, 25–28, 31, 33–35, 37, 39, and 40 of the ’560 patent
`would have been obvious over Yasumi, as taught in the embodiment of
`Figure 8. Pet. 44–100. Under this ground we do not view Petitioner’s
`arguments as limited to the discussion of Figure 8 in Yasumi, but rather to
`encompass all that Yasumi discloses other than any disclosure pertaining
`only to another embodiment. Accordingly, we consider Petitioner’s
`contentions based on Yasumi’s explanation of features shown in Figures 3
`and 10 as they relate to the Figure 8 embodiment, but we do not consider
`arguments asserted by Petitioner based on the embodiment of Figure 9(a).
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`
`Summary of Yasumi (Figure 8 Embodiment)
`1.
`Yasumi, titled “Aperture Setting Device,” issued June 19, 1984,
`generally describes a device “in which the size of a predetermined polygonal
`aperture can be changed, retaining the polygonal configuration,” and is
`“made of a plurality of movable pieces each of which has a triangular
`section in a plane which includes an aperture and perpendicular to the axis
`thereof.” Ex. 1103, 1:10–13, 1:46–49. According to Yasumi, the device
`described “would be of great utility when employed in such devices as a
`chuck, a press tool, an electric wire guide device, a drawing die, a control
`valve, and so forth.” Id. at 1:35–39.
`Figure 8 of Yasumi is reproduced below.
`
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`Yasumi Figure 8 illustrates an exploded perspective view of a manual
`forming and pressing tool embodying the invention described. Id. at 2:30–
`32. Fixed handle 26 is composed of parallel side plates 27-1 and 27-2 with
`circular holes 28-1 and 28-2. Id. at 7:39–46. Movable handle 37 includes
`frame 20 with mounted movable pieces 12 to 17. Id. at 7:46–52.
`
`Frame 20 is illustrated in additional detail in Figures 3 and 10,
`reproduced below.
`
`
`Figure 3 is a plan view illustrating the aperture setting device and Figure 10
`is a sectional view of the same. Ex. 1103, 2:1–3, 2:39–40. As shown in
`Figures 3 and 10, guide groove 39 is cut in the inner peripheral surface of
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`frame 20, and each movable piece 12 to 193 has elongated projection 40
`which moves along guide groove 39 and prevents the movable pieces from
`getting out of frame 20. Id. at 5:39–57. Drive pins 22-1 to 22-8 are inserted
`in elongated holes 23-1 to 23-8 such that the drive pins drive the movable
`pieces 12 to 19 along frame 20 a distance “d” when frame 20 rotates relative
`to guide base 21, thereby varying the size of the regular polygon that forms
`aperture 11. Id. at 5:59–6:19.
`With regard again to Figure 8, “movable handle 37 and the fixed
`handle 26 are designed so that they can turn about the axis of frame 20
`relative to each other, and the movable pieces 12 to 17 are moved by the
`relative rotational movement of the handles 37 and 26.” Id. at 7:63–68.
`Setting piece 32 for setting the opening of the apertures is interposed
`between frame 20 and side plate 27-1. Id. at 8:10–12. Support disks 41 and
`42 are placed outside of side plates 27-2 and 27-1, respectively. Id. at 8:1–5.
`Screw 46 is screwed into the threaded hole of each pin 45 such that “the
`fixed handle 26, the movable handle 37 and the setting pi[e]ce 32 are
`coupled together, but the movable handle 37 is rotatable relative to the fixed
`handle 26.” Id. at 8:38–45. In operation:
`Bringing the grips of the fixed handle 26 and the movable handle
`27 close to each other, the setting piece 32 also turns but butts
`against the fixed handle 26 when a set angle is reached, and
`further rotational movement of the setting piece 32 is limited, and
`consequently the pins 45 are fixed. Bringing the grips of the
`handles 26 and 37 closer to each other, the pins 45 move in the
`elongated holes 23-1 to 23-6 to move the movable pieces 12 to
`
`
`3 In Figure 8, frame 20 includes only 6 movable pieces, 12 to 17, but the
`operation of the device appears to be substantially the same as that depicted
`in Figures 3 and 10, which illustrate 8 movable pieces.
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`17 in the frame 20, reducing the aperture defined by the movable
`pieces 12 to 17.
`Id. at 8:45–54.
`2.
`Claim 1
`Petitioner provides a claim chart identifying how it contends Yasumi
`teaches each limitation of claim 1 based on the embodiment shown in Figure
`8 of Yasumi. Pet. 51–58. With regard to the preamble of claim 1, Petitioner
`states that it is not limiting, as discussed above, but also contends that
`Yasumi discloses “a manual forming and pressing tool” which is capable of
`crimping a stent illustrated in Figure 8 of Yasumi. Id. at 51; Ex. 1103 2:30–
`32. According to Petitioner, Yasumi movable pieces 12-19 correspond to
`the claimed “plurality of movable dies” disposed about an aperture, and side
`plates 27-1 and 27-2 correspond to the claimed “stationary end-walls.” Id. at
`51–53. Petitioner asserts that the movable pieces of Yasumi also correspond
`to the claimed converging first and second straight sides. Id. 57–58.
`Having reviewed the record, we determine that the information
`presented establishes a reasonable likelihood that Petitioner would prevail in
`showing that the subject matter of claim 1 of the ’560 patent would have
`been obvious over Yasumi based on the embodiment shown in Figure 8 of
`Yasumi. At this stage of the proceeding, the primary issue over whether
`Petitioner has sufficiently shown how Yasumi discloses each feature of
`claim 1 focuses on the limitation: “at least one of the stationary end-walls
`operatively engaged to the dies at distinct connection locations such that the
`number of distinct connection locations and the number of dies are the
`same.” According to Petitioner:
`In Figure 8, each movable piece has one elongated hole that
`engages the piece to the wide-end portions of the fixed handle
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`side plates 27-1 and 27-2 via support disks 42 & 43, drive pins
`45, screws 46, and setting piece 32. The six elongated holes are
`the six distinct connection locations that operatively engage the
`six dies to the stationary end-walls.
`Pet. 55–56 (citing Ex. 1103, 8:1–54). Petitioner’s contentions are supported
`by Mr. Sheehan, though with little additional elaboration beyond what is
`provided in the Petition. See Ex. 1105 ¶¶ 122, 125.
`
`Patent Owner argues that:
`Petitioner has not demonstrated that the alleged stationary end-
`walls are “operatively engaged” to the dies as the claims require.
`For example, contrary to Petitioner’s assertion, there is no
`evidence that, in Figure 8, the side plates 27-1 and 27-2 are
`operatively engaged to the moving pieces 12 to 17 (or operatively
`engaged to these moving pieces through the frame 20, the
`support discs 41 and 42, or the setting piece 32). (Ex. 1103 at
`7:52–57, 8:28–54.)
`Prelim. Resp. 32–33. Patent Owner’s argument is not persuasive on the
`present record because Petitioner does provide evidence supporting its
`contentions, including citations to Yasumi and Mr. Sheehan’s declaration.
`Moreover, as noted above, Yasumi states that “the movable pieces 12 to 17
`are moved by the relative rotational movement of the handles 37 and 26,”
`and handle 26 is comprised of side plates 27-1 and 27-2. Ex. 1103, 7:66–68.
`From this, Yasumi appears to support Petitioner’s contention that the side
`plates are “operatively engaged” to the movable pieces as required by
`claim 1. On the present record we are persuaded that Petitioner has
`sufficiently shown how it contends Yasumi teaches the “operatively
`engaged” limitation of claim 1 to support institution.
`
`In support of its assertion that Yasumi renders claim 1 obvious,
`Petitioner contends, inter alia, that the aperture setting device it discloses, if
`not specifically directed to “a stent crimper,” was not limited to certain
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`applications and was expressly directed to a manual forming and pressing
`tool. Pet. 82. According to Petitioner, as supported by Mr. Sheehan, a
`person of ordinary skill would recognize that a manual forming and pressing
`tool is another term for a crimper, and that such a device could be applied to
`suitable crimping applications, including to stents. Id. at 82–83; Ex. 1105
`¶¶ 109, 126. Petitioner further contends that benefits associated with the
`device of Yasumi, such as uniformity of crimping, would have motivated its
`use in applications including stent crimping. Id. at 83–84.
`Patent Owner advances arguments challenging the obviousness
`ground over Yasumi based both on a lack of motivation to combine and the
`absence of a reasonable expectation of success. Prelim. Resp. 34–44. For
`example, according to Patent Owner, Petitioner: (1) fails to provide
`evidence that a manual forming and pressing tool is another term for a
`crimper; (2) fails to explain why a skilled artisan would have been
`“motivated to look to Yasumi in the first place”; (3) fails to explain why a
`skilled artisan “attempting to improve crimping an expandable stent” would
`be interested in how to crimp other materials such as an electrical connector
`onto a wire or the end of a tube; (4) fails to explain why a skilled artisan
`“would be interested in the forming and pressing tool [of Yasumi] where a
`solid electric wire is pressed and reshaped with no regard to distortion or
`marking”; and (5) fails to demonstrate that a skilled artisan would have had a
`reasonable expectation of success since Yasumi is designed to operate on an
`electric wire involving large pressures, not a tubular stent. Id.
`We have considered Patent Owner’s arguments but are persuaded that
`Petitioner has provided a sufficient basis for obviousness of claim 1 over
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`Yasumi based on the current record.4 We understand Petitioner’s contention
`to be that Yasumi discloses all of the features of claim 1, and that, although
`the preamble recitation of a “stent crimper” is not limiting, it would have
`been obvious to use the device of Yasumi as a stent crimper based on the
`reasons provided by Petitioner, including the identified benefits of Yasumi.
`Accordingly, the information provided by Petitioner shows a reasonable
`likelihood of prevailing in showing that claim 1 of the ’560 patent would
`have been obvious over Yasumi based on the embodiment shown in Figure 8
`of Yasumi.
`3.
`
`Claims 2, 6, 8–11, 14, 15, 17–19, 23, 25–28, 31, 33–35,
`37, 39, and 40
`Petitioner provides claims charts and argument identifying how it
`contends claims 2, 6, 8–11, 14, 15, 17–19, 23, 25–28, 31, 33–35, 37, 39, and
`40 of the ’560 patent would have been obvious over Yasumi, as taught in the
`embodiment of Figure 8. Pet. 58–100. Patent Owner disputes Petitioner’s
`contentions with regard to these additional claims for the same reasons
`
`
`4 Patent Owner also contends that institution should be declined under
`35 U.S.C. § 325(d) because the same or substantially the same prior art or
`arguments were presented both during prosecution and in a previous petition
`for inter partes review. Prelim. Resp. 13–25. Although alleged Applicant
`Admitted Prior Art would have been before the Office previously, as
`discussed above, in this case not every ground asserted by Petitioner rests on
`alleged Applicant Admitted Prior Art. Petitioner contends that Yasumi was
`not considered during prosecution. Pet. 38. Petitioner also contends that
`Morales was not considered during examination, but Patent Owner argues
`that Morales was submitted on an Information Disclosure Statement and
`initialed by the Examiner. Pet. 47; Prelim. Resp. 25. We have considered
`Patent Owner’s arguments and decline to exercise our discretion under 35
`U.S.C. § 325(d) to deny the Petition under the specific circumstances
`presented.
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`asserted with respect to claim 1. Prelim. Resp. 31–44. For the reasons set
`forth above, Petitioner has demonstrated a reasonable likelihood that claim 1
`of the ’560 patent would have been obvious over Yasumi, as taught in the
`embodiment of Figure 8. Having decided that the asserted obviousness over
`Yasumi supports a reasonable likelihood that at least one of the challenged
`claims is unpatentable, we exercise our discretion under 37 C.F.R. § 42.108
`to proceed with review of all challenged claims 2, 6, 8–11, 14, 15, 17–19,
`23, 25–28, 31, 33–35, 37, 39, and 40 as obvious over Yasumi, as taught in
`the embodiment of Figure 8. See Intex Recreation Corp. v. Bestway
`Inflatables & Material Corp., IPR2016-00180, Paper 13, at 8–11 (PTAB
`June 6, 2016).
`C.
`Asserted Obviousness Over Yasumi (Figure 8 Embodiment)
`and Morales
`Petitioner contends claims 11, 17, 19, 26, 34, 35, and 39 would have
`been obvious over Yasumi, as taught in the embodiment of Figure 8, and
`Morales. Pet. 85–95. Patent Owner has not separately disputed Petitioner’s
`contentions based on Morales, but instead argues that because Petitioner’s
`contentions based on Yasumi are insufficient, Petitioner’s asserted
`combination with Morales fails for the same reasons. Prelim. Resp. 44.
`1.
`Summary of Morales
`Morales, titled “Stent Crimping Tool and Method of Use,” issued
`
`April 13, 1999, and describes a “stent crimping tool for firmly and uniformly
`crimping a conventional or radioactive stent onto a balloon catheter.” Ex.
`1104, Abstract.
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`Figure 1 of Morales is reproduced below.
`
`
`Figure 1 illustrates intravascular stent 10, comprised of radially expandable
`cylindrical elements 12 interconnected by members 13, mounted onto
`deliver catheter 11 with balloon 14 for expanding stent 10 within coronary
`artery 15. Ex. 1104, 5:60–67. “Stent 10 is crimped down onto balloon 14 to
`ensure a low profile,” and the invention of Morales “addresses this crimping
`procedure.” Id. at 6:24–25.
`
`Figure 2 of Morales is reproduced below.
`
`
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`Figure 2 illustrates a sectional view of stent crimping tool 22 comprised of
`proximal section 24, teeth 30, collar 32, screw feed 28, and distal section 26.
`Id. at 6:67–7:3. Morales further explains that:
`As screw feed 28 advances toward proximal section 24, it carries
`forward teeth 30 so that angular proximal edges 58 of each tooth
`30 encounters tapered end 42, which in turn forces teeth 30 to
`converge radially inward. As this convergence occurs, radius
`edges 62 of teeth 30 engage and crimp the underlying stent 10
`onto balloon catheter 11. Teeth 30 thus act as jaws closing down
`on stent 10. The mandrel optionally loaded into delivery catheter
`11 prevents the crimping process from overly compressing stent
`10 onto catheter 11.
`Ex. 1104, 8:58–67.
`2.
`Claims 11, 19, and 35
`Claims 11, 19, and 35 each recite “wherein a stent is disposed about a
`medical balloon, the medical balloon disposed about a catheter.” Ex. 1101
`10:58–60, 11:27–29, 12:7–9. Petitioner contends that Morales discloses
`stent 10 disposed about balloon 14, the balloon disposed about a delivery
`catheter 11. Pet. 92–93 (citing Ex. 1104 Fig. 1).
`3.
`Claims 17, 26, and 34
`Claims 17, 26,5 and 34 each recite “wherein an entire stent is disposed
`in the aperture.” Ex. 1101 11:5–6, 11:42–43, 12:5–6. Petitioner contends
`that Morales discloses an entire stent 10 disposed within an aperture formed
`by dies 30. Pet. 94.
`4.
`Claim 39
`Petitioner contends that “[c]laim 39 recites limitations substantially
`similar to those previously recited in [c]laim 1, but adds limitations directed
`
`
`5 We understand the recitation in claim 26 of an “entire stout” is intended to
`instead recite an “entire stent.”
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`to an aperture ‘having a center and a first opening and a second opening,’
`and ‘the dies constructed and arranged to have a length exceeding the length
`of a stent with a longitudinal axis passing through both the first opening and
`the second opening.’” Pet. 85. Petitioner further contends that Morales
`“discloses an aperture (between teeth 30) having a center and a first opening
`and a second opening,” as well as “dies (teeth 30) constructed and arranged
`to have a length exceeding the length of a stent,” as required by claim 39.
`Id. at 88–90.
`Petitioner further argues that the combination of Morales with Yasumi
`would have been obvious because the device of Yasumi was capable of
`