Trials@uspto.gov
`571.272.7822
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` Paper No. 42
`June 28, 2018
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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.
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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`571.272.7822
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` Paper No. 42
`June 28, 2018
`
`
`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.
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
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`IPR2017-00444
`Patent 6,915,560 B2
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`
`INTRODUCTION
`I.
`We have jurisdiction to hear this inter partes review under 35 U.S.C.
`§ 6(c). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. Having considered the record before us and for the
`reasons discussed below, we determine Petitioner has shown by a
`preponderance of the evidence that claims 10, 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”) are unpatentable. See 35 U.S.C. § 316(e). We also deny
`Patent Owner’s Motion to Exclude.
`PROCEDURAL HISTORY
`A.
`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 the ’560
`patent (the “challenged claims”). Boston Scientific Scimed, Inc. (“Patent
`Owner”) filed a Preliminary Response (Paper 7, “Prelim. Resp.”).
`Pursuant to 35 U.S.C. § 314(a), we determined the Petition showed a
`reasonable likelihood that Petitioner would prevail in establishing the
`unpatentability of the challenged claims and instituted inter partes review of
`the ’560 patent on all of the challenged claims. Paper 9 (“Inst. Dec.”). After
`institution, Patent Owner filed a Patent Owner Response. Paper 15
`(“PO Resp.”). Petitioner filed a Reply to Patent Owner’s Response.
`Paper 17; Paper 18 (publicly available redacted version of the Petitioner
`Reply) (“Pet. Reply”).
`Patent Owner also filed a Motion to Exclude expert testimony and
`reply arguments (Paper 25, “PO Mot.”), to which Petitioner provided a
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`Response in opposition (Paper 31, “Pet. Resp.”), further to which Patent
`Owner provided a reply in support (Paper 32, “PO Reply”).
`Oral argument was held before the Board on March 15, 2018.
`Paper 37 (“Tr.”).1 On April 24, 2018, the Supreme Court held in SAS Inst.,
`Inc. v. Iancu that a decision to institute under 35 U.S.C. § 314 may not
`institute on fewer than all claims challenged in the petition. 138 S. Ct. 1348
`(2018). As noted above, prior to SAS we had instituted review on all of the
`challenged claims. Inst. Dec. at 31. Further, after SAS, we issued an order
`directing the parties to meet and confer to determine whether any additional
`briefing and modification of the schedule was desired in light of SAS.
`Paper 38. We also stated that “[t]he parties should discuss whether they
`seek to include the institution of additional grounds from the Petition into
`this proceeding.” Id. at 3. In response, the parties informed the Board that
`“[n]either party seeks to include the institution of additional grounds from
`the Petition” and that “the parties agree that no further briefing or changes to
`the schedule are necessary.” Paper 39; Ex. 3001.
`We issue this Final Written Decision pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73.
`
`
`1 Prior to the oral argument, Patent Owner filed Objections (Paper 34) to the
`demonstrative exhibit filed by Petitioner. The objections of Patent Owner
`generally relate to allegations that certain demonstrative exhibits improperly
`contain new evidence and argument. See id. Demonstrative exhibits are not
`evidence. In this Final Written Decision, we rely directly on the arguments
`presented properly in the briefs of the parties and the evidence of record, not
`on demonstrative exhibits; therefore, the objections of Patent Owner are
`overruled.
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`RELATED MATTERS
`B.
`According to the parties 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
`C.
`Petitioner Edwards Lifesciences Corporation is identified as a real
`party in interest in this case. Pet. 14. Patent Owner Boston Scientific
`Scimed, Inc. and Boston Scientific Corp. are also identified as real parties in
`interest. Paper 4, 2.
`
`BACKGROUND
`II.
`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. 1101. As background information, below we
`provide a summary of the ’560 patent, along with an illustrative claim from
`the ’560 patent, and we identify the instituted grounds of unpatentability and
`the proffered expert testimony. We also address our reasons for denying the
`Motion to Exclude.
`SUMMARY OF THE ’560 PATENT
`A.
`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 the crimping.” Ex. 1101, 2:26–29.
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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.
`“In use, as actuation plate 142 is rotated in a clockwise direction, the
`clockwise motion of the actuation plate is translated into linear motion of
`each of linear slide 154 and blade 106 via bearing 150.” Id. at 5:46–49.
`“Each blade 106 moves outward in a direction parallel to the radius 126 on
`which the radial point 122 of the blade 106 lies, resulting in the opening of
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`aperture 118.” Id. at 5:49–52. Conversely, as actuation plate 142 is rotated
`in a counterclockwise direction, each blade 106 moves inward, resulting in
`the closing of aperture 118.” Id. at 5:52–56. “As aperture 118 closes, a
`radially inward force is applied to a medical device disposed in the
`aperture.” Id. at 5:56–57.
`
`Figures 8a and 8b are reproduced below.
`
`
`
`Figures 8a and 8b “are partial side elevational views of an embodiment of
`the inventive apparatus taken along a radial plane during the size reduction
`process.” Id. at 4:14–16. In this embodiment, non-rotating plates 156 are at
`each end. Id. at 7:10–12. First end 174 of each blade 106 is connected to
`linear slide 154a via connecting link 130a and second end 178 is connected
`to linear slide 154b via connecting link 130b. Id. at 7:12–14. “Linear slide
`154a is mounted on non-rotating plate 156a and linear slide 154b is mounted
`on non-rotating plate 156b.” Id. at 7:15–16. Figure 8a illustrates stent 180
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`in tubular aperture 162. Id. at 7:23–24. Figure 8b illustrates blades 106
`having moved inward by rotating actuation plate 142, thereby reducing the
`diameter of aperture 162 and, accordingly, the diameter of stent 180. Id. at
`7:25–31.
`
`According to the ’560 patent, the invention is “particularly concerned
`with the crimping and otherwise reducing in size of inflation expandable
`stents, self-expanding stents and other expandable medical devices.” Id. at
`2:31–34; see also id. at 2:50–55 (“[T]he inventive apparatus may also be
`employed with any other suitable, generally tubular medical device which
`must be reduced in size.”). Moreover, according to the ’560 patent, “[t]he
`inventive apparatus may also be incorporated into a blow molding tool to
`provide a variable size balloon mold” and “[t]he invention is also directed to
`a method for molding a medical balloon.” Id. at 8:65–67, 9:10–12.
`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.
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`INSTITUTED GROUNDS OF UNPATENTABILITY
`C.
`We instituted 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 the ’560 patent on the following
`grounds of unpatentability asserted in the Petition:
`References
`Basis
`Claims challenged
`Yasumi2 (Fig. 8 embodiment)
`§ 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
`
`Yasumi (Fig. 8 embodiment)
`and Morales3
`Inst. Dec. 25.
`
`PROFFERED EXPERT DECLARATIONS
`D.
`Petitioner supports its challenge with the Declaration of Neil Sheehan,
`dated December 5, 2016 (Ex. 1105), and the Supplemental Declaration of
`Neil Sheehan, dated December 14, 2017 (Ex. 1127). Mr. Sheehan is a
`“consulting engineer in the field of medical products” and states that he has
`“worked extensively in the areas of catheters, balloons, plastic and metallic
`materials (including nitinol), inferior vena cava filters, vascular access,
`syringes, pumps, tubing, bonding methods and the like.” Ex. 1105 ¶¶ 1–3.
`Mr. Sheehan also states that he has “over 40 years of experience in medical
`device design and development.” Id. at ¶ 5.
`Patent Owner’s opposition relies on the Declaration of Ronald J.
`Solar, Ph.D., dated September 22, 2017 (Ex. 2016). Dr. Solar is the
`President of Renaissance Biomedical, Inc., which he states “performs
`research and consultation in technical, marketing, commercialization, patent,
`clinical, and regulatory issues related to the medical device industry,” and he
`
`
`2 U.S. Patent No. 4,454,657, issued June 19, 1984 (Ex. 1103, “Yasumi”).
`3 U.S. Patent No. 5,893,852, issued April 13, 1999 (Ex. 1104, “Morales”).
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`is also the President and CEO of ThermopeutiX, Inc., which he states is “a
`company which designs, develops, manufactures, and sells vascular catheter
`technology and devices, including coronary, peripheral and neuro-vascular
`catheters and related medical devices.” Id. at ¶ 1. Dr. Solar states that he
`has over thirty years of experience working in “researching and developing
`coronary and peripheral vascular medical devices including balloon
`catheters and stents.” Id. at ¶ 3.
`In our consideration of the expert testimony, Patent Owner argues that
`Mr. Sheehan’s declaration is “entitled to little or no weight because he lacks
`experience in the relevant technologies.” PO Resp. 13–16. Patent Owner
`states that Mr. Sheehan “has never developed a stent,” “has no relevant
`publications,” and no “relevant experience in stent crimping.” Id. at 13–14.
`In comparison, Patent Owner asserts that its expert has at least twenty
`“patents, publications, and presentations specifically relate[d] to stents or
`stent crimpers.” Id. at 15. Patent Owner argues that “to the extent that there
`is any disagreement between Mr. Sheehan and [Patent Owner’s expert], the
`Board should give less or no weight to Mr. Sheehan’s opinions.” Id.
`Patent Owner fails to provide a persuasive justification for why the
`fact that Mr. Sheehan has never developed a stent or personally crimped a
`stent requires that Mr. Sheehan’s testimony be given “little or no weight.”
`Patent Owner also has not shown that Mr. Sheehan lacks credibility or that
`his opinions are not based on relevant evidence. We, therefore, determine
`that Patent Owner has not shown that Mr. Sheehan’s opinions are entitled to
`little or no weight relative to the opinions of Dr. Solar.
`Patent Owner also argues that Mr. Sheehan’s declaration is entitled to
`little or no weight because he “repeatedly relies on unsupported, conclusory
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`assertions—rather than credible evidence.” PO Resp. 16. We have
`considered the opinions expressed by both of the experts in this case and
`accord the appropriate weight to each of their opinions based on whether the
`opinion is credible and whether it is supported by credible evidence.
`E. MOTION TO EXCLUDE
`Patent Owner filed a Motion to Exclude the Supplemental Declaration
`of Neil Sheehan (Ex. 1127) and Petitioner’s Reply (Papers 17 and 18) “for
`including new claim construction issues and arguments raised for the first
`time in Petitioner’s [R]eply.” Paper 25, 2. According to Patent Owner, the
`Supplemental Declaration of Neil Sheehan includes the construction of the
`claim terms “operatively engaged” and “distinct connection locations,” both
`raised for the first time in Petitioner’s Reply. Id. at 4. Patent Owner asserts
`that the Declaration and Reply “make new arguments on how the elements
`of the instituted claims of the ’560 patent are found in the prior art
`reference.” Id. at 4–5. Patent Owner also contends that by waiting to raise
`the new claim constructions and arguments in its Reply for the first time,
`Petitioner denied “Patent Owner the opportunity to respond.” Id. at 5–6.
`Patent Owner, however, did not request an opportunity to either file a
`Surreply to Petitioner’s Reply or to provide additional briefing concerning
`the alleged new claim constructions. Tr. 23:21–24:1.
`In opposition to the Motion, Petitioner argues that a motion to exclude
`is an improper mechanism to argue that a reply brief contains new
`arguments and evidence, that the arguments in the reply are directly
`responsive to issues first presented in the Patent Owner Response, and that
`Petitioner did not apply “new” claim constructions. Paper 31, 1.
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`In reply to the opposition, Patent Owner argues that in one non-
`precedential case a panel of the Board found a motion to exclude moot, and
`in another non-precedential case a panel of the Board granted a motion to
`exclude an expert declaration for exceeding the scope of a reply. Paper 32,
`1–2. Patent Owner further argues that it did not propose constructions for
`“operatively engaged” or “distinct connection locations” in its Patent Owner
`Response, but instead argued the asserted art does not disclose the claimed
`features. Id. at 2–3. Patent Owner further argues that Mr. Sheehan stated in
`his first declaration that claim terms were given their plain and ordinary
`meaning, but did not provide the constructions for “operatively engaged” or
`“distinct connection locations” given in his Supplemental Declaration. Id. at
`3–4. Patent Owner also argues for the first time in its Reply that the brief
`and declaration it seeks to exclude amounts to a “new invalidity theory.”
`Id. at 4–5.
`Patent Owner fails to demonstrate that it is entitled to the relief it
`seeks. See 37 C.F.R. 42.20(c) (“The moving party has the burden of proof to
`establish that it is entitled to the requested relief.”). First, a motion to
`exclude deals with the admissibility of evidence under the Federal Rules of
`Evidence. See 37 C.F.R. §§ 42.62 (applying the Federal Rules of Evidence
`to inter partes reviews), 42.64; Office Patent Trial Practice Guide, 77 Fed.
`Reg. 48,756, 48,758 (August 14, 2012) (“Admissibility of evidence is
`generally governed by the Federal Rules of Evidence.”). As stated in the
`Office Patent Trial Practice Guide, the parties may submit motions to
`exclude regarding evidence “believed to be inadmissible.” Office Patent
`Trial Practice Guide, 77 Fed. Reg. at 48,758. Further, a motion to exclude
`“must explain why the evidence is not admissible (e.g., relevance or
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`hearsay).” Id. at 48,767. Patent Owner has made no showing that the
`Supplemental Declaration or Petitioner’s Reply are inadmissible. We
`further agree with prior panels of the Board, which have determined under
`similar circumstances that a “motion to exclude evidence filed for the
`purpose of striking or excluding an opponent’s brief and/or evidence that a
`party believes goes beyond what is permitted under 37 CFR § 42.23 is
`improper.” Palo Alto Networks, Inc. v. Finjan Inc., Case IPR2015-01979,
`Paper 62, 66 (PTAB Mar. 15, 2017) (stating that an “allegation that evidence
`does not comply with 37 CFR § 42.23 is not a sufficient reason under the
`Federal Rules of Evidence for making an objection and requesting exclusion
`of such evidence”); see also Blackberry Corp. v. Zipit Wireless, Inc., Case
`IPR2014-01508, Paper 49, 40 (PTAB Mar. 29, 2016) (“a motion to exclude
`is not a proper vehicle for a party to raise the issue of arguments exceeding
`the permissible scope of a reply”).
`Second, even if the motion were proper, under Patent Owner’s line of
`reasoning Petitioner should be precluded from providing a reply or
`supplemental declaration that addressed the meaning of the claim terms at
`issue even though Patent Owner argued the corresponding element is not
`disclosed in the prior art, because (1) Patent Owner declined to expressly
`construe the term at issue in the Patent Owner Response, and (2) Petitioner
`did not expressly construe the term in the Petition, but instead relied on its
`“plain and ordinary meaning.” Thus, Patent Owner could select any claim
`term not expressly construed in the Petition, provide no meaning for the
`term, assert it is not disclosed in the asserted reference, and, thereafter,
`exclude virtually any reply from Petitioner addressing the meaning of the
`term. We find such an approach untenable as there is no requirement that
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`every claim term be defined expressly in the Petition. Nor are we persuaded
`that Petitioner’s further explanation of the plain and ordinary meaning of a
`claim term through a reply amounts to a new invalidity theory. Even if the
`Patent Owner declined to provide an express definition of a claim term in the
`Patent Owner Response, by arguing the feature was missing from the prior
`art, Patent Owner was necessarily applying an implicit meaning to the claim
`term in this case, and Petitioner was entitled to reply to this implicit
`construction in its Reply, with the support of a supplemental declaration.
`Thus, we find the Supplemental Declaration of Mr. Sheehan and Petitioner’s
`Reply do not exceed the proper scope provided by our rules. See 37 CFR
`§ 42.23. Patent Owner’s Motion to Exclude is denied.
`III. ANALYSIS
`In our analysis of whether Petitioner has sufficiently shown that the
`subject matter of the challenged claims of the ’560 patent would have been
`obvious over the asserted prior art, we next address the applicable principles
`of law; the construction of certain claim terms; the scope and content of the
`asserted prior art of Yasumi and Morales; the differences between the
`claimed subject matter and the asserted prior art; the level of ordinary skill in
`the art; the objective evidence of nonobviousness; and, finally, the reasons
`supporting obviousness.
`
`PRINCIPLES OF LAW
`A.
`To prevail in its challenge to 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,
`Petitioner must prove unpatentability by a preponderance of the evidence.
`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). In an inter partes review, “[a]
`claim in an unexpired patent . . . shall be given its broadest reasonable
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`construction in light of the specification of the patent in which it appears.”
`37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`2142 (2016) (upholding the use of the broadest reasonable interpretation
`standard). In determining the broadest reasonable construction, we presume
`that claim terms carry their ordinary and customary meaning. See In re
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A patentee
`may define a claim term in a manner that differs from its ordinary meaning;
`however, any special definitions must be set forth in the specification with
`reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`A patent claim is unpatentable as obvious under 35 U.S.C. § 103(a) if
`“the differences between” the claimed subject matter “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.” 35 U.S.C. § 103(a). An invention “composed
`of several elements is not proved obvious merely by demonstrating that each
`of its elements was, independently, known in the prior art.” KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398, 418 (2007). Rather, “it can be important to
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine the elements in the way the claimed new invention
`does.” Id.
`An obviousness determination “cannot be sustained by mere
`conclusory statements; instead, there must be some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.” Id. (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006));
`see In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir.
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`2016). 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.
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).
`CLAIM CONSTRUCTION
`B.
`“A stent crimper comprising”
`1.
`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 Mktg.
`Int’l, 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 “the
`inventor of the ’560 patent was working on the particular problem of
`crimping a stent,” the word “stent” appears in the title of the patent, the
`invention is directed to “a device capable of crimping a stent,” and the
`specification states that “‘crimping’ refers to a reduction in size or profile of
`a stent.” PO Resp. 17–23 (citing, e.g., Ex. 1101, 1:48–56, 2:26–29, 2:6–38).
`Thus, according to Patent Owner, the preamble breathes “life and meaning”
`into the claimed invention and is, therefore, limiting. PO Resp. 20 (citing
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257
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`(Fed. Cir. 1989); Gen. Elec. Co. v. Nintendo Co., Ltd., 179 F.3d 1350, 1361
`(Fed. Cir. 1999)).
`We agree with Petitioner that the preamble recitation of “[a] stent
`crimper comprising” is not 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.
`Because “the preamble offers no distinct definition of any of the claimed
`invention’s limitations, but rather merely states . . . the purpose or intended
`use of the invention, . . . the preamble is of no significance to claim
`construction.” Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298,
`1305 (Fed. Cir. 1999), citing Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir.
`1997); Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251,
`1257 (Fed. Cir. 1989); Kropa v. Robie, 187 F.2d 150, 152 (CCPA 1951).
`Moreover, contrary to Patent Owner’s arguments, the ’560 patent
`makes clear that the claimed invention is not intended to be limited to a stent
`crimper. As Petitioner notes, “the specification provides broad disclosure of
`multiple alternative applications for the invention,” including manipulating
`other medical devices and as a balloon mold. Pet. Reply. 7–8 (citing
`Ex. 1101, 2:48–55, 3:14–22, 3:36–37, 8:65–9:62, Figs. 12, 13); Ex. 1101,
`2:48–55, 3:16–21, 3:36–37, 8:65–9:62, Figs. 12, 13.
`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
`“stent crimper” in the preamble for antecedent basis, such that the preamble
`“stent crimper” is limiting. PO Resp. 21 n.3. Further, Patent Owner argues
`that if the preamble is limiting in unchallenged claim 36, “it should be the
`
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`IPR2017-00444
`Patent 6,915,560 B2
`
`same for all claims of the ’560 patent.” Id. Petitioner contends in reply that
`Patent Owner’s argument is contrary to Catalina Marketing because in that
`case preamble language was limiting where it appeared in both the preamble
`and body of the claim, but not limiting for other claims where it appeared
`only in the preamble. Pet. Reply 8–9 (citing Catalina Mktg., 289 F.3d at
`808–11).
`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 that the preambles of all other claims are limiting
`in the same manner that the preamble of claim 36 may be. We, therefore,
`need not resolve whether the preamble of claim 36 is limiting, and reject
`Patent Owner’s contention that the same preamble of all claims of the ’560
`patent are limiting based on the preamble of claim 36. Accordingly, “[a]
`stent crimper comprising,” as 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.
`2.
`“dies” and “blades”
`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 agrees the terms are used interchangeably and do not require
`express construction. PO Resp. 24n.5. We agree that the terms “dies” and
`“blades” are used interchangeably in the ’560 patent and determine no
`further express construction is required.
`
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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 agrees the terms are used interchangeably and contends they
`do not require express construction. PO Resp. 24 n.5.
`We agree that the terms are used interchangeably in the ’560 patent.
`We further find Petitioner’s proposed construction duplicative to the claim
`language and, therefore, unhelpful. See, e.g., Ex. 1101, 10:9–13 (claim 1
`reciting “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”).
`4.
`“operatively engaged”
`Claim 1 recites “at least one of the stationary end-walls operatively
`engaged to the dies.” Claims 18, 37, and 40 contain similar recitations.
`“Operatively engaged” does not appear in the specification of the
`’560 patent outside of the claims.
`In the Petition, Petitioner identifies how it contends Yasumi discloses
`the “operatively engaged” limitation, but does not offer an express definition
`of the term. Pet. 56, 57, 69, 76, and 79. Patent Owner argues in its response
`that Yasumi does not disclose the “operatively engaged” limitations. PO
`Resp. 25–27. Patent Owner does not provide an express construction for
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`IPR2017-00444
`Patent 6,915,560 B2
`
`“operatively engaged,” but instead argues: “there is no evidence that the
`movable pieces, the support discs, or the setting piece is affixed to any side
`plate.” Id. at 27. During oral argument, Patent Owner similarly explained
`that it had not proposed a definition for “operatively engaged,” but that
`“[a]ffixing is one example of operatively engaged,” but “not the only
`example,” as “[y]ou could have an indirect connection.” Tr. 24:18–25:12.
`In its Reply, Petitioner contends the claims do not require dies
`“directly engaged or affixed to a stationary end-wall.” Pet. Reply 2.
`Petitioner does not propose an express definition of “operatively engaged” in
`its Reply, but suggests that if certain elements relied on from Yasumi “were
`not operatively engaged,” then the device would not work. Pet. Reply 14.
`In support of Petitioner’s contentions, Mr. Sheehan explains in his
`supplemental declaration that applying “the ordinary and customary
`meaning,” “[o]peratively engaged simply means engaged in a way that
`furthers the operation, or that the engagement produces the intended effect.”
`Ex. 1127 ¶ 32. Patent Owner asserted at oral argument that the construction
`provided by Petitioner was “way too broad” because it would lead to
`everything in Figure 8 of Yasumi being “operatively engaged with each
`other.” Tr. 24:2–14.
`To the extent Petitioner’s proposal divorces the recited “engaged”
`from the “operation” of the apparatus, we agree the meaning would be too
`broad. However, we discern little substantive difference in the arguments
`made by both parties with regard to what “operatively engaged”
`encompasses, even if they dispute the full scope of the meaning of the term.
`There is no reasonable dispute that an element is “operatively engaged” if it
`is engaged, directly or indirectly, in the operation of the device. See, e.g.,
`
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`Tr. 24:13–25:12; see also Ex. 1126, 60:18–25 (Dr. Solar equating operative
`engagement to “whether it’s fixed or connected in some manner that
`explains how that part works”). No further express construction is
`necessary.
`“distinct connection locations”
`5.
`Claim 1 recites “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.”
`“Distinct connection locations” does not appear in the specification of the
`’560 patent outside of the claims. The featur
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