Trials@uspto.gov
`571.272.7822
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` Paper No. 8
`April 21, 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 IPR2017-00072
`Patent 6,915,560 B2
`____________
`
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`STACY B. MARGOLIES, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`

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`IPR2017-00072
`Patent 6,915,560 B2
`
`
`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. 1001, “the ’560 patent”). Boston Scientific Scimed,
`Inc. (“Patent Owner”) filed a Corrected 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).
`For the reasons below, based on the circumstances of this case, we
`exercise our discretion under 35 U.S.C. § 325(d) to deny the Petition and,
`therefore, decline to institute inter partes review.
`BACKGROUND
`II.
`A.
`The ’560 Patent
`The ’560 patent, titled “Apparatus for Contracting, Loading or
`Crimping Self-Expanding and Balloon Expandable Stent Devices,” issued
`July 12, 2005, from U.S. Application No. 10/444,807 (the ’807 application),
`filed May 23, 2003. Ex. 1001. 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.”
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`IPR2017-00072
`Patent 6,915,560 B2
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`Ex. 1001, 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. 1001, 3:58.
`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. 8 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).
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`IPR2017-00072
`Patent 6,915,560 B2
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`
`Petitioner further contends (Pet. 36) that the following portion of the
`’560 patent describes the alleged Applicant Admitted Prior Art:
`A cam actuated stent crimper, shown in FIG. 1, employs a
`plurality of arc-shaped or curved slots with semi-circular ends,
`disposed such that each slot or cam engages a cam follower
`bearing 22. The arc-shaped or curved surfaces of the slots are
`inclined to be non-concentric relative to the axis of rotation 26,
`and therefore rotation of the cam plate 28 transmits equal radial
`displacements to the cam follower bearings 22, to simultaneously
`actuate a like number of linear bearings 24, which have their
`corresponding linear tracks or rails mounted on a fixed plate. As
`shown in FIG. 1 the cam plate rotary drive 29 comprises a
`pneumatic cylinder mounted on a pivot or trunnion, arranged
`with the cylinder rod connected rotatably to a short arm fixed
`rigidly to the cam plate. Accordingly, linear motion produced by
`the pneumatic cylinder translates into controllable arcs of motion
`of the circular cam plate, which has a projecting V-shaped profile
`on its outer edge in rolling engagement with three equally spaced
`rollers with mating inverse V-shaped profiles to provide precise
`rotatable support to the cam plate. Depending on the direction
`of rotation, the linear slides which each carry a radially disposed
`crimping blade, are either moved inwards to apply a crimping
`force to the stent, or outwards to release the stent. Also when
`crimping, depending on the degree of rotation of the cam plate,
`a specific radial crimping displacement may be obtained to
`match the diametral reduction required for any particular stent.
`Ex. 1001, 1:62–2:21. The above description of Figure 1 does not state that
`the stent crimper illustrated in Figure 1 was known in the art.
`According to Patent Owner, “[i]mproving upon the then existing
`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 the
`distortion of the stent.” Prelim. Resp. 5 (citing Ex. 1001, 2:26–29,
`2:56–65).
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`IPR2017-00072
`Patent 6,915,560 B2
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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. 1001, 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. 1001] 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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`IPR2017-00072
`Patent 6,915,560 B2
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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.
`
`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. 1001, 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.
`
`Real Parties in Interest
`D.
`Petitioner identifies only itself as a real party in interest. Pet. 14.
`Patent Owner identifies Boston Scientific Scimed, Inc. and Boston Scientific
`Corp. as real parties in interest. Paper 4, 2.
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`IPR2017-00072
`Patent 6,915,560 B2
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`
`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges the patentability of claims 1, 2, 6, 8–11, 14, 15,
`17–19, 23, 25–28, 31, 33–35, 37, 39, and 40 of the ’560 patent on the
`following grounds:
`References
`“Applicant Admitted Prior Art”
`and Sabbaghian1
`“Applicant Admitted Prior Art,”
`Sabbaghian, and Morales2
`“Applicant Admitted Prior Art”
`and Baker3
`“Applicant Admitted Prior Art,”
`Baker, and Morales
`Pet. 29.
`
`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
`
`§ 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
`
`Petitioner supports its challenge with a Declaration by Neil Sheehan,
`dated October 12, 2016 (Ex. 1011). Petitioner’s reliance on alleged
`Applicant Admitted Prior Art is not merely incidental to Petitioner’s
`contentions, but instead forms the basis of each ground asserted by
`Petitioner. According to Petitioner, “[t]he only distinction between the
`AAPA and the challenged claims is the shape and arrangement of the blades
`that form the claimed ‘polygonal aperture.’” Pet. 37 (citing Ex. 1011 ¶ 94).
`Sabbaghian is directed to “an adjustable socket for a socket wrench.”
`Ex. 1006, Abstract. Baker is directed to “[a] tube pointer for compressing
`metal tubes.” Ex. 1008, Abstract. Morales is directed to “[a] stent crimping
`
`
`1 U.S. Patent No. 5,918,511, issued July 6, 1999 (Ex. 1006, “Sabbaghian).
`2 U.S. Patent No. 5,893,852, issued April 13, 1999 (Ex. 1007, “Morales”).
`3 U.S. Patent No. 4,308,744, issued January 5, 1982 (Ex. 1008, “Baker”).
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`IPR2017-00072
`Patent 6,915,560 B2
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`tool for firmly and uniformly crimping a conventional or radioactive stent
`onto a balloon catheter.” Ex. 1007, Abstract.
`III. ANALYSIS
`Asserted Obviousness over Alleged Applicant Admitted Prior Art
`Petitioner contends that the challenged claims of the ’560 patent
`would have been obvious over alleged Applicant Admitted Prior Art in
`combination with additional prior art. Pet. 44–100. The scope of inter
`partes review is limited, as is made clear by 35 U.S.C. § 311(b) (“Section
`311(b)”), which states:
`(b) Scope. A petitioner in an inter partes review may request to
`cancel as unpatentable 1 or more claims of a patent only on a
`ground that could be raised under section 102 or 103 and only on
`the basis of prior art consisting of patents or printed publications.
`According to the Petition, “[t]he ’560 patent also illustrates and discusses an
`admitted prior art stent crimper (‘Applicant Admitted Prior Art’ or
`‘AAPA’).” Pet. 16. More particularly, the Petition states that “[t]he AAPA
`is a stent crimper.” Id. at 17. The Petition also states that “[t]he AAPA
`depicted in Figure 1 and described at 1:62–2:21 of the ’560 patent is prior
`art.” Pet. 36–37.
`Patent Owner argues that “Petitioner has not established that any
`aspect of the alleged AAPA constitutes a prior art patent or printed
`publication.” Prelim. Resp. 7–8. Patent Owner further asserts that
`“Petitioner presents no evidence demonstrating that Figure 1 was publicly
`available prior to the critical date of September 22, 1999.” Id. at 8–9.
`In this case, Petitioner’s grounds of unpatentability rely on alleged
`Applicant Admitted Prior Art to address a substantial proportion of the
`limitations of the challenged claims. For example, Petitioner relies
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`IPR2017-00072
`Patent 6,915,560 B2
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`pointedly on alleged Applicant Admitted Prior Art as disclosing, with
`respect to claim 1 of the ’560 patent: “a stent crimper,” “dies disposed about
`the aperture and between stationary end-walls which are disposed about the
`longitudinal axis,” and “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.”
`Pet. 45–48. For other claim limitations, Petitioner asserts claim elements
`would have been “inherent” in the alleged Applicant Admitted Prior Art.
`See Pet. 77, 81, 82, 93. We need not resolve whether the alleged AAPA
`constitutes a prior art patent or printed publication as required by 35 U.S.C.
`§ 311(b) because, even assuming it is available as prior art, we decline to
`institute inter partes review for the following reasons.
`In determining whether to institute inter partes review, we may “deny
`some or all grounds for unpatentability for some or all of the challenged
`claims.” 37 C.F.R. § 42.108(b); see 35 U.S.C. § 314(a). Our discretionary
`determination of whether to institute review is guided by 35 U.S.C. § 325(d),
`which states, in relevant part, that “[i]n determining whether to institute or
`order a proceeding under this chapter, chapter 30, or chapter 31, the Director
`may take into account whether, and reject the petition or request because, the
`same or substantially the same prior art or arguments previously were
`presented to the Office.” 35 U.S.C. § 325(d) (emphasis added).4
`Indisputably the alleged Applicant Admitted Prior Art, appearing on
`the face of the challenged patent, was previously presented to the Office
`
`
`4 Chapter 31 of the Patent Act covers inter partes review proceedings. Thus,
`although § 325(d) appears in Chapter 32, which is directed to post-grant
`reviews, it is applicable to inter partes reviews.
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`IPR2017-00072
`Patent 6,915,560 B2
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`during prosecution of the ’560 patent. Petitioner concedes that during
`examination the alleged Applicant Admitted Prior Art was applied “to reject
`the claims during prosecution.” Pet. 36; see also Prelim. Resp. 13–16
`(discussing application of alleged Applicant Admitted Prior Art during
`prosecution of the ’560 patent).
`Morales also was previously presented to the Office as it was
`identified on an Information Disclosure Statement considered during
`prosecution of the ’560 patent. See id. at 17 (citing Ex. 1002, 160).
`Moreover, Petitioner argues that Morales is essentially duplicative of the
`alleged Applicant Admitted Prior Art. See, e.g., Pet. 78 (stating that to the
`extent certain limitations “are not viewed as inherent in or obvious in view”
`of the alleged Applicant Admitted Prior Art, “Morales also discloses these
`limitations”).
`Sabbaghian, disclosing an adjustable socket wrench, and Baker,
`disclosing a tube pointer, were not considered during prosecution. See Pet.
`37, 41. Petitioner relies on Sabbaghian and Baker as disclosing dies
`arranged to form a variable-sized polygonal aperture, the only claimed
`feature Petitioner argues is missing from the alleged Applicant Admitted
`Prior Art. Pet. 3–4, 37–43. According to Petitioner, “the polygonal-shaped
`die configuration is nothing new,” and “[f]or more than a century, skilled
`artisans have used such a configuration.” Id. at 4. Petitioner concedes that
`“[t]he die configuration disclosed in Sabbaghian and Baker is not unique.
`Such a die configuration is common in the prior art.” Id. at 93 (under the
`heading “The Claimed Die Configuration Was Ubiquitous In The Prior
`Art”). Although Sabbaghian and Baker were not considered, Petitioner
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`IPR2017-00072
`Patent 6,915,560 B2
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`notes that during examination Whitesell5 was applied as disclosing a crimper
`with a “substantially regular polygonal shape.” Pet. 22. Similarly,
`Tuberman6 was considered during prosecution as teaching a device with “an
`aperture of a substantially regular polygonal shape.” See Prelim. Resp. 19
`(quoting Ex. 1002, 45).
`For the foregoing reasons we determine that the alleged Applicant
`Admitted Prior Art and Morales were previously presented to the Office.
`Additionally, the Petition further presents information from Sabbaghian and
`Baker, generally described by Petitioner as “ubiquitous” in the prior art,
`which we find to be the same or substantially the same as information
`considered during prosecution in the context of other references, including
`Whitesell and Tuberman.
`
`III. CONCLUSION
`Based on the arguments in the Petition and Preliminary Response, and
`the evidence of record, we conclude that the instant Petition raises the same
`or substantially the same prior art or arguments as those previously
`presented to the Office. In light of the circumstances of the present case, we
`exercise our discretion not to institute inter partes review of the ’560 patent
`pursuant to our authority arising under 35 U.S.C. §§ 314 and 325(d), and
`37 C.F.R. §§ 42.4 and 42.108.
`
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’560 patent.
`
`
`5 U.S. Patent No. 5,261,263 (Ex. 1003, “Whitesell”).
`6 U.S. Patent No. 3,695,087 (Ex. 1002, “Tuberman”).
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`IPR2017-00072
`Patent 6,915,560 B2
`
`For PETITIONER:
`
`Craig Summers
`Brenton Babcock
`Christy Lea
`Cheryl Burgess
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2css@knobbe.com
`2brb@knobbe.com
`2cgl@knobbe.com
`2ctb@knobbe.com
`
`For PATENT OWNER:
`
`Wallace Wu
`Jennifer Sklenar
`Nicholas Nyemah
`ARNOLD & PORTER LLP
`wallace.wu@aporter.com
`jennifer.sklenar@aporter.com
`nicholas.nyemah@aporter.com
`
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