Patent Owner’s Preliminary Response
`IPR2017-01296
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01296
`Patent 6,007,543
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`IPR2017-01296
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01296
`Patent 6,007,543
`_______________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Patent Owner’s Preliminary Response
`IPR2017-01296
`
`TABLE OF CONTENTS
`
`Page
`
`PATENT OWNER’S LIST OF EXHIBITS ............................................................iv
`
`V.
`
`VI.
`
`B.
`
`C.
`
`STATEMENT OF RELIEF REQUESTED ....................................................1
`I.
`INTRODUCTION ...........................................................................................1
`II.
`III. BACKGROUND AND OVERVIEW OF THE ’543 PATENT .....................2
`IV.
`THE ART AND GROUNDS OF UNPATENTABILITY RELIED
`ON BY PETITIONER.....................................................................................6
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING................................................................................................7
`PETITIONER HAS FAILED TO DEMONSTRATE A
`REASONABLE LIKELIHOOD OF UNPATENTABILITY IN
`EACH OF ITS GROUNDS OF CHALLENGE..............................................8
`A.
`Ground 1: Obviousness Of Claims 1–3, 6, 7, 11, 12, 19–21,
`24, 25, 28, And 29 In View Of Olympus, The Knowledge Of
`A POSITA, Burton, Fischell ’274, And Fischell ’507..........................9
`1.
`The References Fail To Disclose Every Limitation Of
`Claims 1–3, 6, 7, 11, 12, 19–21, 24, 25, 28, And 29 ................10
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................18
`Ground 2: Obviousness Of Claims 1–3, 6, 11, 12, 19–21, 24,
`28, And 29 In View Of Fischell ’274 And Burton..............................28
`1.
`The References Fail To Disclose Every Limitation Of
`Claims 2, 3, 6, 20, 21, and 24 ...................................................28
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine Fischell ’274 And Burton .................29
`Ground 3: Obviousness Of Claims 1, 2, 6, 7, 11, 19, 20, 24,
`25, 28, And 29 In View Of Sugiyama ’032 And Fischell ’507 ..........32
`1.
`The References Fail To Disclose Every Limitation Of
`Any Challenged Claim..............................................................32
`
`2.
`
`2.
`
`-i-
`
`
`
`D.
`
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine Sugiyama ’032 And Fischell
`’507 ...........................................................................................34
`Ground 4: Anticipation Of Claims 1–3, 11, 19–21, And 28–
`29 By Pathak .......................................................................................36
`Ground 5: Obviousness Of Claims 9, 10, 12, 26, And 27 In
`View Of References In Grounds 1 Through 3 and Jendersee.............38
`Ground 6: Obviousness Of Claim 8 In View Of References
`In Grounds 1 Through 3, The Knowledge Of A POSITA And
`Williams ..............................................................................................40
`VII. CONCLUSION..............................................................................................41
`
`E.
`
`F.
`
`2.
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`
`TABLE OF AUTHORITIES
`
`CASES
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .....................................................................21
`
`Page(s)
`
`Grain Processing Corp. v. Am. Maize-Prods. Co.,
`840 F.2d 902 (Fed. Cir. 1988) .......................................................................27
`
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981).......................................................................12
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015)................................................................23
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) .........................................................................12
`
`DOCKETED CASES
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-00727, Paper 13 (P.T.A.B. Sept. 9, 2016) .....................................23
`
`Exacq Techs., Inc., v. JDS Techs., Inc.,
`IPR2016-00567, Paper 7 (P.T.A.B. July 15, 2016).................................22, 23
`
`Seabery N. Am., Inc. v. Lincoln Glob., Inc.,
`IPR2016-00749, Paper 13 (P.T.A.B. Sept. 21, 2016) ...................................24
`
`STATUTES, RULES AND REGULATIONS
`
`35 U.S.C. § 102..........................................................................................................9
`
`35 U.S.C. § 103........................................................................................................12
`
`37 C.F.R. § 42.107(a).................................................................................................1
`
`37 C.F.R. § 42.65(a).................................................................................................11
`
`-iii-
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`Patent Owner’s Preliminary Response
`IPR2017-01296
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`PATENT OWNER’S LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`2001
`
`2002
`
`2003
`
`Handbook of Coronary Stents, 2000 Ed.
`
`Patent Owner’s June 2, 2017 Supplemental Responses To
`Petitioner’s Interrogatory Nos. 8, 10, 14
`
`April 21, 2017 Joint Claim Construction Statement Submitted by
`Patent Owner and Petitioner
`
`2004
`
`U.S. Patent No. 5,415,635
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`Patent Owner’s Preliminary Response
`IPR2017-01296
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`I.
`
`STATEMENT OF RELIEF REQUESTED
`
`On April 19, 2017, Edwards Lifesciences Corporation (“Petitioner”)
`
`submitted a Petition for Inter Partes Review (the “Petition” or “Pet.”) challenging
`
`claims 1–3, 6–12, 19–21, and 24–29 of U.S. Patent No. 6,007,543 (“the ’543
`
`Patent”). Pursuant to 37 C.F.R. § 42.107(a), Boston Scientific Scimed, Inc.
`
`(“Patent Owner”) submits this Preliminary Response requesting that the Board
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`deny the Petition because Petitioner has not demonstrated a reasonable likelihood
`
`of unpatentability of any challenged claim.
`
`II.
`
`INTRODUCTION
`
`The salient feature of the invention at issue relates to the structure, material,
`
`and function of a distinct mechanical component (called a “mounting body”) to
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`prevent a stent from slipping off a stent delivery system during the delivery of the
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`stent to a treatment site. Yet, Petitioner’s primary obviousness reference
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`(“Olympus”) is directed to the protection of sharp edges of a stent—which has
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`nothing to do with the stent securement issue of the claimed invention. Indeed, the
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`feature Petitioner calls a “mounting body” in Olympus appears only in the figures
`
`of Olympus. There is not a single word in the entire disclosure of Olympus that
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`discusses this alleged “mounting body”—not a single word on its structure,
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`material, or function. Despite this near-zero disclosure on the alleged “mounting
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`body” in Olympus, Petitioner wants to convince this Board that a person of
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`ordinary skill in the art would somehow have divined this completely unknown
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`feature in Olympus as a “mounting body,” serving the function of mounting and
`
`retaining the stent. Petitioner also wants to convince this Board, based on almost
`
`nothing in Olympus, that a person of ordinary skill in the art would have modified
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`this completely unknown feature in Olympus to arrive at the claimed invention.
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`There is simply no evidentiary basis to support Petitioner’s obviousness argument
`
`based on Olympus.
`
`Petitioner’s other unpatentability arguments fare no better. In arguing that
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`every limitation of the claimed invention is disclosed in the anticipation reference
`
`(“Pathak”), Petitioner wants to persuade the Board that a light emitter that heats a
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`stent is a “mounting body” that secures the stent. Again, such a wild assertion is
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`not supported by any facts or data.
`
`Accordingly, as discussed in more detail below, the Board should reject each
`
`ground of challenge because Petitioner has not met its burden of demonstrating a
`
`reasonable likelihood of unpatentability of any challenged claim. The Petition
`
`should be denied.
`
`III. BACKGROUND AND OVERVIEW OF THE ’543 PATENT
`
`Patent Owner has been a pioneer in stent delivery systems since the 1990s.
`
`A stent is a tiny tube made of metal or alloy that is placed in an artery (or other
`
`body lumen) to keep the artery open, improve blood flow, and prevent the artery
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`from collapsing. In the late 1990s, Patent Owner (including its predecessor,
`
`Scimed Life Systems, Inc.) introduced a series of innovative NIR stent delivery
`
`systems. (Ex. 2001 at 283.)
`
`The invention of the ’543 Patent (the first of a six-patent family) was
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`conceived and reduced to practice during the development of the NIR stent
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`delivery systems. Filed on August 23, 1996, the ’543 Patent relates to a stent
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`delivery system having a catheter with a balloon over which a stent is fitted. The
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`stent and balloon at the end of the catheter are passed through the patient’s body to
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`the treatment site, where the stent is then expanded with the balloon to the diameter
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`of the vessel. The expanded stent acts as a scaffold to maintain an open,
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`unobstructed vessel. (E.g., Ex. 1001 at 1:57–2:3.) The delivery system further
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`includes an innovative stent securement structure (a “mounting body”), which is an
`
`enlarged body carried by the catheter shaft within the balloon. The mounting body
`
`serves to facilitate the mounting and retaining of a stent prior to its deployment via
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`expansion of the balloon. (E.g., id. at 2:4–9.)
`
`One of the innovative designs of the ’543 Patent is shown in Figure 3, where
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`a mounting body 30 is located inside the balloon 14 and provides a cushion to
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`support and hold the stent 18 and secure it during the stent delivery procedure.
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`(Ex. 1001 at 3:26–30.)
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`Patent Owner’s Preliminary Response
`IPR2017-01296
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`Figure 4 shows another embodiment of the innovative designs of the ’543
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`Patent. In Figure 4, the mounting body 30, also located inside the balloon, is a
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`spirally cut design to improve flexibility of the catheter, allowing more easy
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`movement (or tracking) around the bends of the vessel. (Ex. 1001 at 3:66–4:4.)
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`Claim 1, which is representative of the challenged claims, reads:
`
`1. A stent delivery system comprising:
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`a radially expandable stent of generally cylindrical
`configuration, having a first end and a second end and
`a contracted state and an expanded state, and
`a catheter having a shaft having a diameter and
`expandable inflatable means associated therewith at a
`distal part of the shaft, wherein the inflatable means
`comprises a balloon, and including mounting and
`retaining means
`for
`receiving the stent on the
`expandable inflatable means for radial expansion of
`the stent upon inflation of the inflatable means, the
`mounting and retaining means including at least one
`mounting body carried on and surrounding the shaft
`inside the inflatable means, the at least one mounting
`body being substantially the same length as the stent
`and being positioned on the shaft such that when the
`stent is loaded onto the inflatable means and the shaft
`in the stent’s contracted state at least a portion of the
`at least one mounting body is under the stent and
`between the first and second ends of
`the stent,
`whereby the diameter of the shaft and inflatable
`portion are increased at the distal part for facilitating
`the mounting and retaining of the stent.
`
`Certain Patent Owner’s NIR stent delivery systems practice claim 1 and
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`other claims of the ’543 Patent. (See Ex. 2002 at 6–7.)
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`IV. THE ART AND GROUNDS OF UNPATENTABILITY RELIED ON
`BY PETITIONER
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`Petitioner relies on Japanese Publication No. H4-64367 (“Olympus”) (Ex.
`
`1015), with an English translation provided by Petitioner. Petitioner also relies on
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`U.S. Patent Nos. 5,026,377 (“Burton”) (Ex. 1014), 5,639,274 (“Fischell ’274”)
`
`(Ex. 2013), 4,768,507 (“Fischell ’507) (Ex. 1010), 4,994,032 (Sugiyama ’032”)
`
`(Ex. 1009), 5,741,323 (“Pathak”) (Ex. 1026), 5,836,965 (“Jendersee”) (Ex. 1016),
`
`and 5,437,083 (“Williams”) (Ex. 1027).
`
`Petitioner raises five grounds of obviousness arguments and one ground of
`
`anticipation argument:
`
`Ground #
`1
`
`Challenged Claims
`1–3, 6, 7, 11, 12, 19–21, 24,
`25, 28, and 29
`
`2
`
`3
`
`4
`5
`
`6
`
`1–3, 6, 11, 12, 19–21, 24,
`28, and 29
`1, 2, 6, 7, 11, 19, 20, 24, 25,
`28, and 29
`1–3, 11, 19–21, 28, and 28
`9, 10, 12, 26, and 27
`
`8
`
`(Pet. at 22, 40, 55, 70, 79, 82.)
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`Basis
`Obviousness over Olympus in View
`of the Knowledge of a POSITA
`and/or Burton, Fischell ’274 and/or
`Fischell ’507
`Obviousness over Fischell ’274 in
`View of Burton
`Obviousness over Sugiyama ’032 in
`view of Fischell ’507
`Anticipation by Pathak
`Obviousness over References in
`Grounds 1 through 3 in Further View
`of Jendersee
`Obviousness over References in
`Grounds 1 through 3 in Further View
`of the Knowledge of a POSITA or
`Williams
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING
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`V.
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`Patent Owner agrees with Petitioner that the ’543 Patent has expired and that
`
`its claim terms should be construed under the Phillips standard. (See Pet. at 17–
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`18.) Patent Owner further agrees, as Petitioner concedes, that Patent Owner’s
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`proposed constructions for “expandable inflatable means,” “mounting and
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`retaining means,” and “means for inflating the balloon” in the district court
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`litigation are the proper constructions under the Phillips standard.1 (See Pet. at 19.)
`
`1 It should be noted that the district court has not held a claim construction hearing
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`on the ’543 Patent and will not do so until 2018 (if at all). It should also be noted
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`that while Petitioner, in an effort to seek institution of the ’543 Patent, now
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`concedes that (1) the three terms proposed by Patent Owner in the district court
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`litigation are the plain meanings of these terms and (2) there are no other terms of
`
`the ’543 Patent require construction by the Board under the Phillips standard (Pet.
`
`at 19), it proposed, in the district court litigation, far narrower constructions than
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`the plain meanings. (See Ex. 2003 at Appendix B (e.g., “contracted state” means
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`“state that the stent is left in by the crimper”); (“mounting and retaining means for
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`receiving” is a means-plus-function-term where the function is “for holding the
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`stent in place during crimping and the delivery procedure” and the structure is “a
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`mounting body as pictured and described in Figs. 1–8” and the accompanying
`
`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`VI. PETITIONER HAS FAILED TO DEMONSTRATE A REASONABLE
`LIKELIHOOD OF UNPATENTABILITY IN EACH OF ITS
`GROUNDS OF CHALLENGE
`
`To carry its burden of an obviousness challenge (Ground 1-3 and 5-6),
`
`Petitioner must at least show—with particularity—that (1) the combination of
`
`references teaches every limitation of the challenged claims and (2) a skilled
`
`artisan would have been motivated to combine the teachings of the references to
`
`Footnote continued from previous page
`disclosures); (“mounting body” means “an enlarged structure to which the stent is
`
`crimped”); (“mounted/mounting [in reference to the stent]” means
`
`“crimped/crimping”); (“loaded” means “crimped”).) Having given up on these
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`overly narrow constructions it proposed in the district court litigation here,
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`Petitioner still maintains that it “reserves its right” to pursue these narrow
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`constructions before the Board later in the proceeding and still has not withdrawn
`
`its narrow claim constructions in the district court litigation. (Pet. at 18 n.3.)
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`Petitioner’s attempt to maintain different claim construction positions before the
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`Board and before the district court—when the same Phillips claim construction
`
`standard applies in both jurisdictions—is improper.
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`Patent Owner’s Preliminary Response
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`achieve the claimed invention. Petitioner has failed to meet these requirements
`
`with respect to each ground of obviousness challenge.2
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`In addition, for a claim to be found anticipated under 35 U.S.C. § 102
`
`(Ground 4), each and every element as set forth in the claim must be found, either
`
`expressly or inherently described, in a single prior art reference. Here, Petitioner
`
`has failed to demonstrate that all of the elements of any challenged claim are
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`present within the prior art reference.
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`A.
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`Ground 1: Obviousness Of Claims 1–3, 6, 7, 11, 12, 19–21, 24, 25,
`28, And 29 In View Of Olympus, The Knowledge Of A POSITA,
`Burton, Fischell ’274, And Fischell ’507
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`In its Ground 1 argument, Petitioner merely lists all challenged claims and
`
`all references, but without identifying which specific claims are allegedly obvious
`
`in view of what specific combinations of references. (Pet. at 22–30.) Patent
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`Owner understands, based on Petitioner’s claim chart (Pet. at 30–40), that
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`Petitioner’s Ground 1 challenge consists of the following arguments: (1)
`
`obviousness of claims 1–3, 12, 19–21, 28, and 29 under Olympus in view of
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`Burton or the knowledge of a POSITA, (2) obviousness of claims 6–7 and 24–25
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`2 Patent Owner does not provide evidence or argument on the secondary
`
`considerations in this Preliminary Response. Patent Owner reserves the right to do
`
`so should the Board institute this proceeding.
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`Patent Owner’s Preliminary Response
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`under Olympus in view of Burton or Fischell ’507, and (3) obviousness of claims
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`11 and 28 under Olympus in view of Burton or Fischell ’274. Patent Owner
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`responds as follows.
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`1.
`
`The References Fail To Disclose Every Limitation Of
`Claims 1–3, 6, 7, 11, 12, 19–21, 24, 25, 28, And 29
`
`Independent claims 1 and 19 (and their dependent claims 2–3, 6, 7, 11,
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`12, 20–21, 24, 25, 28, and 29). As discussed above, one of the key features of the
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`’543 Patent is a mounting body, which serves the function of mounting and
`
`retaining a stent. Specifically, independent claim 1 requires, inter alia, (1) a
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`“mounting and retaining means including at least one mounting body,” and (2)
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`“whereby the diameter of the shaft and inflatable portion are increased at the distal
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`part for facilitating the mounting and retaining of the stent.” (Ex. 1001 at 4:49–
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`5:4 (emphases added).) Similarly, independent claim 19 requires “a mounting
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`body” and the distal diameter being increased to “facilitate the mounting of the
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`stent.” (Id. at 6:12–27.) Petitioner fails to demonstrate that the combination of
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`Olympus and Burton (or the knowledge of a skilled artisan) discloses these
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`limitations in independent claims 1 and 19 (and their dependent claims).
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`Petitioner alleges that Olympus discloses a “mounting body.” (Pet. at 33
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`[1.3].)3 It is not even close. While Petitioner relies on the yellow highlighted
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`region in Figure 31 (and Figure 30) of Olympus (reproduced below) as the support
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`for a “mounting body,” Petitioner cannot point to a single word in Olympus that
`
`describes this yellow highlighted region. There is absolutely no description—in
`
`the entire disclosure of Olympus—of (1) what the yellow highlighted region is, (2)
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`what it is made of, or (3) what its function is. Based on this record, Petitioner does
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`not even come close to establishing that the yellowed highlighted region of Figure
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`31 in Olympus is a mounting body or that it serves function of stent mounting or
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`retention, as required in each of the challenged claims. Simply calling it a
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`“mounting body” (e.g., Pet. at 22) and hiring an expert to say that it meets the stent
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`mounting and retention functions (Ex. 1003 at ¶¶ 111–13)—without any support in
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`Olympus or any facts or data—is insufficient. See 37 C.F.R. § 42.65(a) (“Expert
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`3 In Ground 1, Petitioner does not allege that Burton discloses a mounting body.
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`(See Pet. at 32 [1.3], 34 [1.5].) Petitioner relies on Burton solely for the purpose of
`
`establishing a separate (as opposed to an integral) component. (Id. at 33 [1.3].)
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`testimony that does not disclose the underlying facts or data on which the opinion
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`is based is entitled to little or no weight.”).)4
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`4 Even if Petitioner could establish that the yellow highlighted region of Figure 31
`
`has certain functions in Olympus, it still has not established that it serves the
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`function of stent mounting or retention required in independent claims 1 and 19 of
`
`the ’543 Patent. First, there can be no dispute that there is no express teaching of
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`such function in Olympus. Second, to be found inherent, an unstated element must
`
`exist as a matter of scientific fact and flow naturally from the elements expressly
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`disclosed in the prior art reference. Petitioner (or its expert) has not made the
`
`showing that an “increased diameter” of the shaft under the balloon (Ex. 1003 at
`
`¶ 112) necessarily serves the function of stent mounting or retention. See In re
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`Oelrich, 666 F.2d 578, 581–82 (C.C.P.A. 1981) (“Inherency, however, may not be
`
`established by probabilities or possibilities. The mere fact that a certain thing may
`
`result from a given set of circumstances is not sufficient.”); In re Rijckaert, 9 F.3d
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`1531, 1534 (Fed. Cir. 1993) (reversing rejection under 35 U.S.C. § 103 because
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`inherency was based on what would result due to optimization of conditions, not
`
`what was necessarily present in the prior art).
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`Any cursory reading of Olympus would reveal that Olympus has nothing to
`
`do with mounting or retaining a stent. (Ex. 1015 at 17 [Problems to Be Resolved
`
`by the Invention].) Instead, it is directed to reducing damages to in-vivo tissues
`
`due to the “very hard and sharp” stent edges. (Id.) Each of the ten embodiments of
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`Olympus deals with various stent edge protective materials on the outer periphery
`
`of the stent (and the prevention of the protective materials from coming loose)—
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`none of which is even remotely relevant to facilitating stent mounting and retention
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`required in each of the challenged claims of the ’543 Patent in Ground 1.5
`
`5 As to what the yellow highlighted region of Figure 31 is, not only is there no
`
`evidence demonstrating that it is a mounting body or that it serves the stent
`
`mounting and retention function, evidence suggests that the yellow highlighted
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`Footnote continued on next page
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`Footnote continued from previous page
`region in Figure 31 merely identifies the lumen of an uninflated balloon. For
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`example, Figures 3–5, 15–17, 20–22, 25–27, 30–32, 45, 52, and 55 of Olympus
`
`show the same hatched region as the yellow highlighted region in Figure 31. In
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`each instance (including Figure 31), the hatched region exactly matches with the
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`shape of the balloon. If the hatched region in these figures is an integral part of the
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`catheter 5 (i.e., solid material filling the hatched region) as Petitioner alleges, there
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`would be no room to inflate the balloon because there is no space between the
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`hatched region and the balloon. Thus, the yellow highlighted region in Figure 31
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`(and similar hatched regions in Figures 3–5, 15–17, 20–22, 25–27, 30–32, 45, 52,
`
`and 55) appears to indicate the lumen of an uninflated balloon, not a solid material
`
`as Petitioner alleges. Similar diagramming techniques (using a hatched region to
`
`indicate an uninflated balloon) have been used in the balloon catheter art. (See,
`
`e.g., Ex. 2004 [U.S. Patent No. 5,415,635] at Figure 6 (reproduced below showing
`
`hatched regions “50” and “51”), 6:49–62 (“the first and second inflatable working
`
`sections 50 and 51”); see also id. at Figs. 1, 3–4.)
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`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`Moreover, Petitioner does not provide any support for its allegation that
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`Figure 31 of Olympus discloses “the at least one mounting body being
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`substantially the same length as the stent” as required by claims 1 and 19. (See
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`Pet. at 33, 38.) Not only is the specification of Olympus completely silent on the
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`issue of a mounting body, but Figure 31 (on which Petitioner relies) as well as
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`Figures 3–5, 15–17, 20–22, 25–27, 30–32, 45, 52, and 55 show that the portion of
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`the drawings that Petitioner contends discloses a mounting body (see Pet. at 23) is
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`not the same length as the stent. Rather, in every drawing of Olympus in which
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`that portion appears, the portion is the same length as the entire balloon 4,
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`including points at which the expanded balloon 4 contacts the catheter 5.
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`Dependent claims 2–3 and 20–21. In addition to the above, Petitioner also
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`fails to demonstrate that the combination of Olympus and Burton discloses specific
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`limitations in dependent claims 2–3 and 20–21. In particular, claims 2 and 20
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`require that a mounting body be “of a material which resiliently deforms under
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`radial pressure.” Claims 3 and 21 further require that “the material is elastomeric.”
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`The cited portion of Olympus relied on by Petitioner states that a stent—not the
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`alleged mounting body (i.e., the yellow highlighted region in Figure 31)—can be
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`covered with a polyurethane thermoplastic elastomer. (See Pet. at 35, 39 (citing
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`Footnote continued from previous page
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`Ex. 1015 at 24 (Polyurethane thermoplastic elastomer can be used “as the
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`protective material, to cover the sharp edges at both ends of the stent 1, and is
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`affixed on the outer periphery of both ends of the stent 1.”)).) Further, the cited
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`portions of Burton relied on by Petitioner relate to “a high friction material.” (See
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`Pet. 35, 39 (citing Ex. 1014 at 3:48–61, 4:3–7, 5:46–51, 5:56–64).) Petitioner has
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`not explained why “a high friction material” disclosed in Burton necessarily
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`“resiliently deforms under radial pressure” or is “elastomeric” as required in claims
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`2–3 and 20–21.
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`Dependent claims 6–7 and 24–25. In addition, claim 6 requires that the
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`mounting body include “at least one separation whereby the flexibility of the body
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`and catheter is increased.” Claim 24 requires that the mounting body include “at
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`least one separation whereby trackability of the catheter is improved.” Claims 7
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`and 25 further require that the recited separation is in the form of a spiral. While
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`Petitioner relies on Olympus, Burton, and Fischell ’507 for the disclosure of the
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`limitations in claims 6–7 and 24–25 (Pet. at 35–36, 40–41), none of them actually
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`disclose those limitations.
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`First, while Petition asserts that Olympus “teaches the use of spiral-shaped
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`coil stent” (Pet. at 35), such assertion is irrelevant because the claims at issue
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`require a spiral separation in the mounting body, not the stent.
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`Second, contrary to Petitioner’s assertion (Pet. at 35), the circumferential
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`gaps 12 and 13 in Figure 3 of Burton (reproduced below) are merely dents to “tuck
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`in” the stent for “protecting them [the ends of the stent] and preventing exposed
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`filaments from snagging.” (Ex. 1014 at 4:35–37, 5:48–52) Therefore, the dents in
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`Figure 13 of Burton are not “separation[s]” and their functions are to prevent
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`snagging, not increasing the “flexibility of the [mounting] body and catheter” or to
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`“improve” the “trackability of the catheter” required in claims 6–7 and 24–25.
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`Indeed, Burton does not teach anything close to increasing flexibility or
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`trackability. Petitioner’s assertion that the circumferential gaps in Burton are
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`separations to “enhance the flexibility of the body of the Burton device” is
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`unsupported and is contradicted by the express teachings of Burton. (Pet. at 35.)
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`Third, contrary to Petitioner’s suggestion (Pet. at 36), Fischell ’507 teaches
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`that the “grooves 26” are formed on the inner core itself (i.e., the catheter), not on a
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`mounting body. (Ex. 1010 at 3:47–55) (“Fig. 3 shows the distal end of the
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`insertion catheter 20 which consists of an inner core 22…. The core 22 has …
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`spiral grooves 26….”) Further, contrary to Petitioner’s suggestion (Pet. at 36), the
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`purpose of the groves of Fischell ’507 is to provide a location into which a stent
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`can be placed, not increasing the flexibility or trackability of the catheter. (Ex.
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`1010 at 3:47–55 (“spiral grooves 26 into which the coil spring IS [Intravascular
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`Stent] 10 is placed”) Petitioner’s assertion that Fischell ’507 teaches separations in
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`the mounting body to “improve flexibility” (Pet. at 36) again lacks merits and is
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`contradicted by the express teachings of Fischell ’507.
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`2.
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`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References
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`Even if Petitioner could demonstrate that the combinations of references
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`teach each limitation of claims 1–3, 6, 7, 11, 12, 19–21, 24, 25, 28, and 29 of the
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`’543 Patent, Petitioner still fails to demonstrate a motivation to combine the
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`references.
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`Olympus in view of Burton (and the knowledge of a POSITA).
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`Petitioner argues that one of ordinary skill in the art would have replaced “an
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`integral mounting body” in Olympus with a separate one because a separate
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`mounting body would improve manufacturability as suggested by Burton. (Pet. at
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`25–26; Ex. 1003 at ¶ 114.) Petitioner’s argument fails for a number of reasons.
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`First, as discussed above, the fundamental premise that Olympus teaches a
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`mounting body for stent mounting and retention is utterly unsupported. Petitioner
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`cannot find a single word in Olympus suggesting that the yellow highlighted
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`region of Figure 31 is a mounting body or that it facilitates the mounting or
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`retaining of a stent. Indeed, as discussed above, the entire disclosure of Olympus
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`relates to stent edge protection. Not surprisingly, Petitioner fails to identify any
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`disclosure in Olympus that remotely suggests an issue with stent mounting or
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`retention. There is thus no rational reason for a person skilled in the art to choose
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`Olympus in an effort to address the issue of stent mounting or retention identified
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`in the ’543 Patent.
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`Second, even assuming one skilled in the art would select Olympus to
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`modify for purposes of stent mounting and retention, there is still no indication in
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`Olympus that the alleged integral mounting body needs to be improved, suffers any
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`shortcoming, or is difficult to make. (Pet. at 25.) In other words, to the extent that
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`one could believe that the alleged mounting body in Olympus serves the function
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`of stent mounting or retention, there would be no reason to modify it as suggested
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`by Petitioner. Petitioner’s assertion that “[a] POSITA would therefore consider
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`whether alternatives to an integral mounting body were available and would
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`immediately understand that making the mounting body separately and later
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`attaching it to the shaft might be easier than forming an integral mounting body”
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`has no support in Olympus. For example, Petitioner cannot point to any teaching
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`Patent Owner’s Preliminary Response
`IPR2017-01296
`or suggestion in Olympus that indicates any manufacturability issues associated
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`with the alleged “integral mounting body.” (Id.) The conclusory opinion of
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`Petitioner’s expert suggesting such manufacturability issues without any support in
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`Olympus or any facts or data, lacks probative value. (Ex. 1003 at ¶ 114.)
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`Third, even if a skilled artisan would elect to modify the alleged mounting
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`body in Olympus, there would not be any rational reason to combine it with Burton
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`as suggested by Petitioner. As an initial matter, contrary to Petitioner’s suggestion
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`(Pet. at 26), Burton merely states that a gripping member could be “integral portion
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`of the core” or “attached around the periphery of the core” without hinting any
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`preference for the latter choice or that the former choice would have any
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`manufacturability issues. (Ex. 1014 at 2:22–24.) And contrary to Petitioner’s
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`assertion (Pet. at 25), the structure “7” in Figure 1 of Burton (reproduced below) is
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`to provide “a smooth transition from said end of the outer sleeve,” not a “conical
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`stop” to “secure the stent.” (Ex. 1014 at 5:32–35; Pet. at 26.) Thus, there is no
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`evidence in Burton that supports a motivation to combine as Petitioner suggests.
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`Patent Owner’s Preliminary Response
`IPR2017-01296
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`While Burton discusses stent securement issues, such disclosure is directed
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`to a self-expanding stent, without the involvem
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