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 IPR2017-01298
`Patent 7,749,234
`_______________
`
`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
`
`

`

`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 ’234 PATENT .....................2
`IV.
`THE ART AND GROUNDS OF UNPATENTABILITY RELIED
`ON BY PETITIONER.....................................................................................5
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING................................................................................................6
`PETITIONER HAS FAILED TO DEMONSTRATE A
`REASONABLE LIKELIHOOD OF UNPATENTABILITY IN
`EACH OF ITS GROUNDS OF CHALLENGE..............................................8
`A.
`Ground 1: Patentability Of Claims 1–3, 5–8, 13, 15, And 18–
`20 In View Of Olympus, The Knowledge Of A POSITA,
`And/Or Burton, Fischell ’507, Williams, Or Fischell ’274 ..................9
`1.
`The References Fail To Disclose Every Limitation Of
`Claims 1–3, 5–8, 13, 15, And 18–20 ..........................................9
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................18
`Ground 2: Patentability Of Claims 1–3, 5, 13, 15, And 18–20
`Over Fischell ’274 In View Of Burton, In Further View Of
`The Knowledge Of A POSITA And/Or Williams ..............................28
`1.
`The References Fail To Disclose Every Limitation Of
`Claim 1–3, 5, 13, 15, And 18–20..............................................28
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................29
`Ground 3: Patentability Of Claims 1, 6–8, 13, 15, And 18–20
`Over Sugiyama ’032 In View Of Fischell ’507 And Further
`In View Of The Knowledge Of A POSITA And/Or Williams...........33
`1.
`The References Fail To Disclose Every Limitation Of
`Claims 1, 6–8, 13, 15, and 18–20 .............................................34
`
`2.
`
`2.
`
`-i-
`
`

`

`2.
`
`2.
`
`D.
`
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................37
`Ground 4: Patentability Of Claims 1–3, 5, 13, 15, 19, and 20
`As Anticipated By Ravenscroft And/Or Obvious In View Of
`The Knowledge Of A POSITA And/Or Williams ..............................39
`1.
`Ravenscroft Fails To Disclose Every Limitation Of The
`Challenged Claims ....................................................................39
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................49
`VII. CONCLUSION..............................................................................................50
`
`-ii-
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`

`

`TABLE OF AUTHORITIES
`
`CASES
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-00727, Paper 13 (P.T.A.B. Sept. 9, 2016)...........................................22
`
`Page(s)
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) ..........................................................................21
`
`Exacq Techs., Inc., v. JDS Techs., Inc.,
`IPR2016-00567, Paper 7 (P.T.A.B. July 15, 2016)......................................21, 22
`
`Grain Processing Corp. v. Am. Maize-Prods. Co.,
`840 F.2d 902 (Fed. Cir. 1988) ............................................................................27
`
`Ex parte Levy,
`17 U.S.P.Q.2d 1461 (B.P.A.I. 1990) ..................................................................46
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) ..........................................................................47
`
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981)......................................................................11, 46
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2016-00165, Paper 7 (P.T.A.B. Apr. 21, 2016) ...........................................21
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) .....................................................................22
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) ........................................................................11, 46
`
`Seabery N. Am., Inc. v. Lincoln Global, Inc.,
`IPR2016-00749, Paper 13 (P.T.A.B. Sept. 21, 2016).........................................24
`
`STATUTES, RULES AND REGULATIONS
`
`37 C.F.R. § 1.84(h)(3)..............................................................................................44
`
`37 C.F.R. § 42.65(a).................................................................................................10
`
`-iii-
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`

`

`37 C.F.R. § 42.107(a).................................................................................................1
`37 C.F.R. § 42.107(a) ................................................................................................. 1
`
`35 U.S.C. § 102..........................................................................................................8
`35 U.S.C. § 102 .......................................................................................................... 8
`
`35 U.S.C. § 103........................................................................................................11
`35 U.S.C. § 103 ........................................................................................................ 11
`
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`

`Patent Owner’s Preliminary Response
`IPR2017-01298
`
`PATENT OWNER’S LIST OF EXHIBITS
`
`Exhibit No. Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`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
`
`U.S. Patent No. 5,415,635
`
`-v-
`
`

`

`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, 5–8, 13, 15, and 18–20 of U.S. Patent No. 7,749,234 (“the ’234
`
`Patent”). Pursuant to 37 C.F.R. § 42.107(a), Boston Scientific Scimed, Inc.
`
`(“Patent Owner”) submits this Preliminary Response requesting that the Board
`
`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
`
`prevent a stent from slipping off a stent delivery system during the delivery of the
`
`stent to a treatment site. Yet, Petitioner’s primary obviousness reference
`
`(“Olympus”) is directed to the protection of sharp edges of a stent—which has
`
`nothing to do with the stent securement issue of the claimed invention. Indeed, the
`
`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
`
`discusses this alleged “mounting body”—not a single word on its structure,
`
`material, or function. Despite this near-zero disclosure on the alleged “mounting
`
`body” in Olympus, Petitioner wants to convince this Board that a person of
`
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`

`Patent Owner’s Preliminary Response
`IPR2017-01298
`ordinary skill in the art would somehow have divined this completely unknown
`
`feature in Olympus as a “mounting body.” 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 this completely unknown feature in Olympus to arrive at
`
`the claimed invention. There is simply no evidentiary basis to support Petitioner’s
`
`obviousness argument based on Olympus.
`
`Petitioner’s other unpatentability arguments fare no better. In its
`
`anticipation challenge, the prior art reference at issue (“Ravenscroft”) misses at
`
`least two limitations required in each challenged independent claim. It misses even
`
`more limitations in the challenged dependent claims.
`
`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 ’234 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
`
`from collapsing. In the late 1990s, Patent Owner (including its predecessor,
`
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`Scimed Life Systems, Inc.) introduced a series of innovative NIR stent delivery
`
`systems. (Ex. 2001 at 283.)
`
`The invention of the ’234 Patent (which is one of a six-patent family) was
`
`conceived and reduced to practice during the development of the NIR stent
`
`delivery systems. Effectively filed on August 23, 1996, the ’234 Patent relates to a
`
`stent delivery system having a catheter with a balloon, over which a stent is fitted.
`
`The stent and balloon at the end of the catheter are passed through the patient’s
`
`body to the treatment site, where the stent is then expanded with the balloon to the
`
`diameter of the vessel. The expanded stent acts as a scaffold to maintain an open,
`
`unobstructed vessel. (E.g., Ex. 1001 at 2:12–26.) The delivery system further
`
`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
`
`expansion of the balloon. (See, e.g., id. at 2:26–43.) One of the innovative designs
`
`of the ’234 Patent is shown in Figure 3, where a mounting body 30 is located
`
`inside the balloon 14 and provides a cushion to support and hold the stent 18 and
`
`secure it during the stent delivery procedure. (Id. at 4:51–55; see also id. at Fig. 4.)
`
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`
`Figure 5 shows another embodiment of the innovative designs of the ’234
`
`Patent. In Figure 5, the mounting body 30, also located inside the balloon, is a
`
`spirally cut design to improve flexibility of the catheter, allowing more easy
`
`movement (or tracking) around the bends of the vessel. (Ex. 1001 at 5:22–27.)
`
`Claim 1, which is the only independent claim and is representative of the
`
`challenged claims, reads as follows:
`
`1. A stent delivery catheter comprising:
`an inner shaft, the inner shaft having a proximal portion
`and a distal portion and a center axis,
`an inflatable medical balloon positioned about the distal
`portion of the inner shaft, the medical balloon having
`an expanded state, a contracted state, a proximal end
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`and a distal end, wherein the medical balloon can be
`expanded from its contracted state to its expanded
`state, and
`at least one mounting body secured to the inner shaft,
`inside the medical balloon and around the center axis,
`the mounting body having a length, a circumferential
`surface, wherein the circumferential surface is a
`surface of the mounting body that is outermost
`relative to the center axis and that faces radially away
`from the center axis and toward the medical balloon,
`and having at least one separation in the
`circumferential surface, wherein the at least one
`separation is exposed to a portion of the medical
`balloon which is located along a radial line which
`extends from the center axis and through the
`separation, the at least one separation being a
`circumferential separation, wherein the mounting
`body is formed of a material which resiliently deforms
`under radial pressure.
`
`Certain Patent Owner’s NIR stent delivery systems practice claim 1 and
`
`other claims of the ’234 Patent. (See Ex. 2002 at 6–7.)
`
`IV. THE ART AND GROUNDS OF UNPATENTABILITY RELIED ON
`BY PETITIONER
`
`Petitioner relies on an English translation of Japanese Patent Publication
`
`No. H4-64367 (“Olympus”) (Ex. 1015), U.S. Patent No. 5,026,377 (“Burton”)
`
`-5-
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`(Ex. 1014), U.S. Patent No. 5,639,274 (“Fischell ’274”) (Ex. 1013), U.S. Patent
`
`No. 4,768,507 (“Fischell ’507”) (Ex. 1010), U.S. Patent No. 4,994,032 (“Sugiyama
`
`’032”) (Ex. 1009), U.S. Patent No. 5,437,083 (“Williams”) (Ex. 1027), and U.S.
`
`Patent No. 5,702,418 (“Ravenscroft”) (Ex. 1017). (Pet. at 25–26, 47, 61, and 75.)
`
`Petitioner alleges three grounds of obviousness and one ground of
`
`obviousness and/or anticipation.
`
`Ground
`#
`1
`
`Challenged
`Claims
`1–3, 5–8, 13, 15,
`and 18–20
`
`2
`
`3
`
`4
`
`1–3, 5, 13, 15,
`and 18–20
`1, 6–8, 13, 15,
`and 18–20
`
`1–3, 5, 13, 15,
`19, and 20
`
`(Pet. at 26, 47, 61, 75.)
`
`Basis
`
`Unpatentable as Obvious over Olympus,
`Knowledge of a POSITA and/or Burton, Fischell
`’507, Williams, or Fischell ’274
`Unpateantable as Obvious over Fischell ’274,
`Burton, Knowledge of a POSITA, and/or Williams
`Unpatentable as Obvious over Sugiyama ’032,
`Fischell ’507, Knowledge of a POSITA, and/or
`Williams
`Unpatentable as Anticipated by Ravenscroft and/or
`Obvious over Ravenscroft, the Knowledge of a
`POSITA and/or Williams
`
`V.
`
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING
`
`Patent Owner agrees with Petitioner that the ’234 Patent has expired and that
`
`its claim terms should be construed under the Phillips standard. (See Pet. at 23–
`
`24.) Patent Owner further agrees, as Petitioner concedes, that each claim term of
`
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`the ’234 Patent should receive their plain and ordinary meanings.1 (See id. at 23–
`
`24.)
`
`1 It should be noted that the district court has not held a claim construction hearing
`
`on the ’234 Patent and will not do so until 2018 (if at all). It should also be noted
`
`that while Petitioner, in an effort to seek institution of the ’234 Patent, now
`
`concedes that no terms of the ’234 Patent requires construction by the Board under
`
`the Phillips standard (see Pet. at 23–24), it proposed, in the district court litigation,
`
`far narrower constructions than the plain meanings. (See Ex. 2003 at Appendix C
`
`(e.g., “mounting body” means “an enlarged structure to which the stent is
`
`crimped”; “resiliently deforms” means “deforms during crimping and springs back
`
`toward its original shape”; “circumferential separation” means “separation that
`
`forms a circle around the mounting body”).) Having given up on these overly
`
`narrow constructions it proposed in the district court litigation here, Petitioner still
`
`maintains that it “reserves its right” to pursue these narrow constructions before the
`
`Board later in the proceeding and still has not withdrawn its narrow claim
`
`constructions in the district court litigation. (Pet. at 24 n.3.) Petitioner’s attempt to
`
`maintain different claim construction positions before the 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
`IPR2017-01298
`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 (Grounds 1–4), 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 achieve the
`
`claimed invention. Petitioner has failed to meet these requirements with respect to
`
`each ground of obviousness challenge.2
`
`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
`
`present within the prior art reference.
`
`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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`

`A.
`
`Patent Owner’s Preliminary Response
`IPR2017-01298
`Ground 1: Patentability Of Claims 1–3, 5–8, 13, 15, And 18–20 In
`View Of Olympus, The Knowledge Of A POSITA, And/Or
`Burton, Fischell ’507, Williams, Or Fischell ’274
`
`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 26–36.) Patent
`
`Owner understands, based on Petitioner’s claim chart (Pet. at 36–47), that
`
`Petitioner’s Ground 1 challenge consists of the following arguments:
`
`(1) obviousness of claims 1–3, 5, 19–20 under Olympus in view of Burton,
`
`(2) obviousness of claims 1–3, 5–8, 19–20 under Olympus in view of Burton and
`
`Fischell ’507, (3) obviousness of claims 13 and 18 under Olympus in view of
`
`Burton or Burton and Fischell ’507 in further view of Williams, and
`
`(4) obviousness of claim 15 under Olympus in view of Burton or Burton and
`
`Fischell ’507 in further view of Williams and Fischell ’274. Patent Owner
`
`responds as follows.
`
`1.
`
`The References Fail To Disclose Every Limitation Of
`Claims 1–3, 5–8, 13, 15, And 18–20
`
`Independent claim 1 (and its dependent claims 2–3, 5–8, 13, 15, and 18–
`
`20). As discussed above, one of the key features of the ’234 Patent is a mounting
`
`body, which serves the function of securing a stent. Specifically, independent
`
`claim 1 requires, inter alia, “at least one mounting body secured to the inner
`
`shaft.” (Ex. 1001 at 8:3–4 (emphasis added).) Petitioner fails to demonstrate that
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`the combination of Olympus and Burton (or the knowledge of a skilled artisan)
`
`discloses this limitation in independent claim 1 (and its dependent claims).
`
`Petitioner alleges that Olympus discloses a “mounting body that aids in
`
`securing the stent….” (Pet. at 27; see also id. at 38 [1.2].)3 It is not even close.
`
`While Petitioner relies on the yellow highlighted region in Figure 31 (and
`
`Figure 30) of Olympus (reproduced below) as the support 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) what it is made of, or
`
`(3) what its function is. Based on this record, Petitioner does not even come close
`
`to establishing that the yellowed highlighted region of Figure 31 in Olympus is a
`
`mounting body, as required in each of the challenged claims. Simply calling it a
`
`“mounting body” (e.g., id. at 26–28) and hiring an expert to say that it “aids in
`
`securing the stent” as petitioner alleges (id. at 27; Ex. 1003 at ¶¶ 112–17)—without
`
`any support in Olympus or any facts or data—is insufficient. See 37 C.F.R.
`
`3 In Ground 1, Petitioner does not allege that Burton discloses a mounting body.
`
`(See Pet. at 38–39 [1.2].) Petitioner relies on Burton solely for the purpose of
`
`establishing a separate (as opposed to an integral) component. (Id.)
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`§ 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on
`
`which the opinion is based in entitled to little or no weight.”)4
`
`4 Even if Petitioner could establish that the yellow highlighted region of Figure 31
`
`has a certain function in Olympus, it still has not established that it serves the
`
`function of a “mounting body” as required in independent claim 1 of the ’234
`
`Patent or that it “aids in securing the stent 1 to the balloon 4 and delivery catheter”
`
`as Petitioner alleges. (Pet. at 27.) First, there can be no dispute that there is no
`
`express teaching of such a 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 disclosed in the prior art reference. Petitioner (or its expert)
`
`has not made the showing that a “thickened section” of the catheter shaft under the
`
`balloon necessarily is “a mounting body that aids in securing the stent 1 to the
`
`balloon 4 and delivery catheter,” as Petitioner alleges. (Pet. at 27; Ex. 1003 at
`
`¶ 112.) See In re Oelrich, 666 F.2d 578, 581 (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.”)
`
`(citation omitted); In re Rijckaert, 9 F.3d 1531, 1533–34 (Fed. Cir. 1993)
`
`(reversing rejection under 35 U.S.C. § 103 because inherency was based on what
`
`Footnote continued on next page
`
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`
`Any cursory reading of Olympus would reveal that Olympus has nothing to
`
`do with securing a stent. (Ex. 1015 at 17 [Problems to Be Resolved by the
`
`Invention].) Instead, it is directed to reducing damage to in-vivo tissues due to the
`
`“very hard and sharp” stent edges. (Id.) Each of the ten embodiments of 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)—none of
`
`Footnote continued from previous page
`would result due to optimization of conditions, not what was necessarily present in
`
`the prior art).
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`which is even remotely relevant to a “mounting body” for a stent in claim 1 (and
`
`its dependent claims) of the ’234 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 secures the stent, but
`
`evidence also suggests that the yellow highlighted region in Figure 31 merely
`
`identifies the lumen of an uninflated balloon. For 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 each instance (including Figure 31),
`
`the hatched region exactly matches with the shape of the balloon. If the hatched
`
`region in these figures is an integral part of the catheter 5 (i.e., solid material filling
`
`the hatched region) as Petitioner alleges, there would be no room to inflate the
`
`balloon because there is no space between the hatched region and the balloon.
`
`Thus, the yellow highlighted region in Figure 31 (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
`
`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`Claim 1 also requires that the mounting body “having at least one separation
`
`in the circumferential surface, wherein the at least one separation is exposed to a
`
`portion of the medical balloon which is located along a radial line which extends
`
`from the center axis and through the separation.” (Ex. 1001 at 8:9–14.) While
`
`Petitioner relies on Olympus, Burton, and Fischell ’507 for the disclosure of this
`
`limitation (Pet. at 39–41), none of them actually disclose such a separation.
`
`First, while Petitioner asserts that Olympus teaches the use of “spiral or coil-
`
`shaped stents” (Id. at 32; see also id. at 40–41), such an assertion is irrelevant
`
`because the claims at issue require a separation in the mounting body, not the stent.
`
`Second, contrary to Petitioner’s assertion (Id. at 39–40), the circumferential
`
`gaps 12 and 13 in Figure 3 of Burton (reproduced below) are merely dents to “tuck
`
`into” the stent for “protecting them [the ends of the stent] and preventing exposed
`
`Footnote continued from previous page
`“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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`Patent Owner’s Preliminary Response
`IPR2017-01298
`filaments from snagging.” (Ex. 1014 at 4:37–39, 5:48–52) As can be seen in
`
`Figure 3, no radial line can extend from the center axis through the separation.
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`Therefore, the dents in Figure 13 of Burton are not “separation[s].” Petitioner’s
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`assertion that the circumferential gaps in Burton are separations is unsupported and
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`is contradicted by the express teachings of Burton. (Pet. at 39–40.)
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`Third, contrary to Petitioner’s suggestion (Pet. at 40), 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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`mounting body. (Ex. 1010 at 3:47–55 (“Fig. 3 shows the distal end of the insertion
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`catheter 20 which consists of an inner core 22…. The core 22 has … spiral
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`grooves 26….”).) Thus, there is no separation for any radial line to extend through
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`as required in claim 1. Even if “core 22” could be a mounting body, Fischell ’507
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`discloses only a surface groove of sufficient depth to accommodate a wire, and it
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`does not even suggest the claimed separation through which a radial line from the
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`central axis could pass. (Id. (“spiral grooves 26 into which the coil spring IS
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`[Intravascular Stent] 10 is placed”).) Petitioner’s assertion that Fischell ’507
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`teaches separations again lacks merit and is contradicted by the express teachings
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`of Fischell ’507.
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`Claim 1 also requires that “the mounting body is formed of a material which
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`resiliently deforms under radial pressure.” (Ex. 1001 at 8:15–17.) But Petitioner
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`relies on the combination of Olympus and Burton, which fails to disclose this
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`limitation. (Pet. at 41 [1.4].) The cited portion of Olympus relied on by Petitioner
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`states that a stent—not the alleged mounting body (i.e., the yellow highlighted
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`region in Figure 31)—can be covered with a polyurethane thermoplastic elastomer.
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`(See id. (citing Ex. 1015 at 7 [Page 24] (Polyurethane thermoplastic elastomer can
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`be used “as the protective material, to cover the sharp edges at both ends of the
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`stent 1, and is affixed on the outer periphery of both ends of the stent 1.”)).)
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`Further, the cited portions of Burton relied on by Petitioner relate to “a high
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`friction material.” (See id. (citing Ex. 1014 at 3:48–61, 4:3–7, 5:46–51, 5:56–64).)
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`Petitioner has not explained why “a high friction material” disclosed in Burton
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`necessarily “resiliently deforms under radial pressure” as required in claim 1.
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`Dependent claims 2, 3, and 5. In addition, claims 2, 3, and 5 require that
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`the mounting body has “a plurality of separations.” Petitioner relies on Burton to
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`disclose the “plurality of separations.” (Pet. at 41–43.) As discussed above,
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`Burton does not disclose a single separation, and therefore does not disclose a
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`“plurality of separations” as required in claims 2, 3, and 5 of the ’234 Patent.
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`Dependent claims 6–8. Further, claims 6 and 8 require that “the separation
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`is substantially along the entire length of the mounting body” and claim 7 requires
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`that the “separation is in the form of a spiral.” Petitioner relies on Fischell ’507 to
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`disclose a spiral separation that extends substantially the length of a mounting
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`body. (Pet. at 43–44.) As discussed above, Fischell ’507 does not disclose
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`separations in a mounting body but a surface groove in the catheter that does not
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`even suggest a separation, a spiral separation, or a separation that runs the length of
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`a mounting body as required in claims 6–8 of the ’234 Patent.
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`Dependent claim 18. Dependent claim 18 adds the requirement that the
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`“mounting body is substantially the same length as the stent.” Petitioner relies on
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`Figure 31 of Olympus to show this limitation and concludes without support that
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`this limitation is met. (Pet. at 46.) Not only is the specification of Olympus
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`completely silent on the issue of a mounting body, Figure 31 (on which Petitioner
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`relies) as well as Figures 3–5, 15–17, 20–22, 25–27, 30–32, 45, 52, and 55 show
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`that the portion of the drawings that Petitioner contends discloses a mounting body
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`(see id. at 26) is not the same length as the stent. Rather, in every drawing of
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`Olympus in which that portion appears, the portion is the same length as the entire
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`balloon 4, including points at which the expanded balloon 4 contacts the catheter 5.
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References
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`2.
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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, 5–8, 13, 15, and 18–20 of the ’234 Patent,
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`Petitioner still fails to demonstrate a motivation to combine the 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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`29–30; Ex. 1003 at ¶ 117.) 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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`mounting body is utterly unsupported. Petitioner cannot find a single word in
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`Olympus suggesting that the yellow highlighted region of Figure 31 is a mounting
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`body (or that it secures a stent). Indeed, as discussed above, the entire disclosure
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`of Olympus relates to stent edge protection. Not surprisingly, Petitioner fails to
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`identify any disclosure in Olympus that remotely suggests an issue with stent
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`securement. There is no rational reason for a person skilled in the art to choose
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`Olympus in an effort to address the stent securement issue identified in the ’234
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`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 securement, there is still no indication in Olympus
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`Patent Owner’s Preliminary Response
`IPR2017-01298
`that the alleged integral mounting body needs to be improved, suffers any
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`shortcoming, or is difficult to make. (Pet. at 29–30.) In other words, to the extent
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`that one could believe that the alleged mounting body in Olympus serves the
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`function of “securing the stent” as asserted by Petitioner (id. at 27), there would be
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`no reason to modify it as suggested by Petitioner. Petitioner’s assertion that “[a]
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`POSITA would therefore consider whether alternatives to an integral mounting
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`body were available and would immediately understand that making the mounting
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`body separately and later attaching it to the shaft might be easier than molding an
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`integral mounting body” has no support in Olympus. (Id. at 29–30.) For example,
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`Petitioner cannot point to any teaching or suggestion in Olympus that indicates any
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`manufacturability issues associated with the alleged “integral mounting body.”
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`(Id.) The conclusory opinion of Petitioner’s expert suggesting such
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`manufacturability issues—without any support in Olympus or any facts or data—
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`lacks probative value. (Ex. 1003 at ¶ 117.)
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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 be no rational reason to combine it with Burton as
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`suggested by Petitioner. As an initial matter, contrary to Petitioner’s suggestion
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`(Pet. at 30), 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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`Patent Owner’s Preliminary Response
`IPR2017-01298
`manufacturability issues. (Ex. 1014 at 2:21–23.) And contrary to Petitioner’s
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`assertion (Pet. at 29–30), the structure “7” in Figure 1 of Burton (reproduced
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`below) is to provide “a smooth tra