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 IPR2017-01297
`Patent 6,712,827
`_______________
`
`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
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORP.,
`
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-01297
`Patent 6,712,827
`_______________
`
`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 ............................................................iii
`
`V.
`
`VI.
`
`B.
`
`C.
`
`STATEMENT OF RELIEF REQUESTED ....................................................1
`I.
`INTRODUCTION ...........................................................................................1
`II.
`III. BACKGROUND AND OVERVIEW OF THE ’827 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..............................................7
`A.
`Ground 1: Obviousness Of Claims 1–3, 5–14, and 16–20 In
`View Of Olympus, The Knowledge Of A POSITA, Burton,
`Fischell ’274, Fischell ’507, And Williams ..........................................7
`1.
`The References Fail To Disclose Every Limitation Of
`Claims 1–3, 5–14, and 16–20 .....................................................8
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................15
`Ground 2: Obviousness Of Claims 1–3, 5, 7–9, 11–14, and
`16–20 In View Of Fischell ’274, Burton, The Knowledge Of
`A POSITA And/Or Williams ..............................................................25
`1.
`The References Fail To Disclose Every Limitation of
`Claims 3, 5, 7–9, 11–14, and 16 ...............................................25
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................26
`Ground 3: Obviousness Of Claims 13 And 15 In View Of
`References In Grounds 1 And 2 And Jendersee .................................30
`VII. CONCLUSION..............................................................................................31
`
`2.
`
`2.
`
`-i-
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`
`
`TABLE OF AUTHORITIES
`
`CASES
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .....................................................................18
`
`Page(s)
`
`Grain Processing Corp. v. Am. Maize-Prods. Co.,
`840 F.2d 902 (Fed. Cir. 1988) .......................................................................25
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015)................................................................19
`
`DOCKETED CASES
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-00727, Paper 13 at 17 (PTAB Sept. 9, 2016) ................................19
`
`Exacq Techs., Inc., v. JDS Techs., Inc.,
`IPR2016-00567, Paper 7 at 21 (July 15, 2016) .......................................18, 19
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2016-00165, Paper 7 at 17-18 (P.T.A.B. Apr. 21, 2016)........................18
`
`Seabery N. Am., Inc. v. Lincoln Global, Inc.,
`IPR2016-00749, Paper 13 at 11–12 (P.T.A.B. Sept. 21, 2016) ....................23
`
`STATUTES, RULES AND REGULATIONS
`
`37 C.F.R. § 42.107(a).................................................................................................1
`
`-ii-
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`Patent Owner’s Preliminary Response
`IPR2017-01297
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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
`
`-iii-
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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 and 5–20 of U.S. Patent No. 6,712,827 (“the ’827 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—an “intermediate layer” under a
`
`balloon—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 an “intermediate layer” 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 “intermediate layer”—not a single word on
`
`its structure, material, or function. Despite this near-zero disclosure on the alleged
`
`“intermediate layer” in Olympus, Petitioner wants to convince this Board that a
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`person of ordinary skill in the art would somehow have divined this completely
`
`unknown feature in Olympus as an “intermediate layer.” 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.
`
`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 ’827 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,
`
`Scimed Life Systems, Inc.) introduced a series of innovative NIR stent delivery
`
`systems. (Ex. 2001 at 283.)
`
`The invention of the ’827 Patent (one in 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 ’827 Patent relates to a stent delivery
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`system having a catheter with a balloon over which a stent is crimped. A crimped
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`stent is a stent where its diameter has been reduced. A crimped stent and balloon
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`at the end of the catheter are passed through the patient’s body to the treatment
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`site, where the crimped stent is then expanded with the balloon to the diameter of
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`the vessel. The expanded stent acts as a scaffold to maintain an open, unobstructed
`
`vessel. (E.g., Ex. 1001 at 1:65–2:11.) The delivery system further includes an
`
`innovative stent securement structure (an “intermediate layer”), which is an
`
`enlarged body carried by the catheter shaft within the balloon. The intermediate
`
`layer serves to facilitate the mounting and retaining of a crimped stent prior to its
`
`deployment via expansion of the balloon. (E.g., id. at 2:11–17.)
`
`One of the innovative designs of the ’827 Patent is shown in Figure 3, where
`
`a mounting body 30 (an embodiment of an “intermediate layer”) is located inside
`
`the balloon 14 and provides a cushion to support and hold the stent 18 and secure it
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`during the stent delivery procedure. (Ex. 1001 at 3:34–38.)
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`Figure 4 shows another embodiment of the innovative designs of the ’827
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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
`
`movement (or tracking) around the bends of the vessel. (Ex. 1001 at 4:6–11.)
`
`Claim 1, which is representative of the challenged claims, reads:
`
`1. A balloon catheter for dilating vascular
`constrictions and for simultaneously introducing a
`deformable stent into a vessel to be dilated in order to
`stabilize the vessel in the dilated condition, wherein a
`distal region of the catheter, which is intended to receive
`the deformable stent, comprises: an inner tube that is
`surrounded and crimped onto by the deformable stent; a
`balloon arranged between the deformable stent and the
`inner tube; a pair of longitudinally spaced image
`sensitive marking sleeves carried on the inner tube within
`the balloon such that there is a longitudinal space on the
`inner tube extending between the pair of marking sleeves
`and such that the deformable stent is substantially
`centered there-between; an outer tube disposed between
`the inner tube and the balloon as an intermediate layer,
`wherein the intermediate layer substantially covers the
`longitudinal space on the inner tube between the image
`sensitive marking sleeves, the intermediate layer having
`an outer diameter, wherein the outer diameter of the
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`intermediate layer is substantially constant between the
`pair of marking sleeves.
`Certain Patent Owner’s NIR stent delivery systems practice claim 1 and
`
`other claims of the ’827 Patent. (See Ex. 2002 at 7-9.)
`
`IV. THE ART AND GROUNDS OF UNPATENTABILITY RELIED ON
`BY PETITIONER
`
`Petitioner relies on Japanese Publication No. H4-64367 (“Olympus”) (Ex.
`
`1015), with an English translation provided by Petitioner. Petitioner also relies on
`
`U.S. Patent Nos. 5,026,377 (“Burton”) (Ex. 1014), 5,639,274 (“Fischell ’274”)
`
`(Ex. 1013), 4,768,507 (“Fischell ’507) (Ex. 1010), 5,836,965 (“Jendersee”) (Ex.
`
`1016), and 5,437,083 (“Williams”) (Ex. 1024).1
`
`Petitioner raises three grounds of obviousness arguments:
`
`Ground #
`1
`
`Challenged Claims
`1–3, 5–14, and 16–20
`
`2
`
`1–3, 5, 7–9, 11–14 and 16–
`20
`
`Basis
`Obviousness over Olympus in View
`of the Knowledge of a POSITA
`and/or Burton, Fischell ’274, Fischell
`’507, and/or Williams
`Obviousness over Fischell ’274 in
`View of Burton, the Knowledge of a
`POSITA, and/or Williams
`
`1 Petitioner also asserts that it relies on Sugiyama ’032 (Pet. at 30), but Petitioner
`
`does not set forth any argument or analysis regarding Sugiyama ’032 in any of its
`
`Grounds and thus has not set forth its reliance on Sugiyama ’032 with the requisite
`
`specificity. Accordingly, this reference should be ignored.
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`-5-
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`
`
`3
`
`13 and 15
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`(Pet. at 31, 59, 79.)
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`Obviousness over References in
`Grounds 1 and 2 in Further View of
`Jendersee
`
`V.
`
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING
`
`Patent Owner agrees with Petitioner that the ’827 Patent has expired and that
`
`its claim terms should be construed under the Phillips standard. (See Pet. at 28–
`
`29.) Patent Owner further agrees, as Petitioner concedes, that under the Phillips
`
`standard, the claim terms should be given their plain and ordinary meanings. (See
`
`Pet. at 29.)2
`
`2 It should be noted that the district court has not held a claim construction hearing
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`on the ’827 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 ’827 Patent, now
`
`concedes that no claim term of the ’827 Patent requires construction by the Board
`
`under the Phillips standard (Pet. at 28–29), it proposed, in the district court
`
`litigation, a narrower construction than the plain meaning. (See Ex. 2003 at
`
`Appendix B (“intermediate layer” means “a ‘mounting body’ i.e., an enlarged
`
`structure to which the stent is crimped, that lies on the inner tube”).) Having given
`
`up on this narrow construction it proposed in the district court litigation here,
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`Petitioner still has not withdrawn its narrow claim construction in the district court
`
`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`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, 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.3
`
`A.
`
`Ground 1: Obviousness Of Claims 1–3, 5–14, And 16–20 In View
`Of Olympus, The Knowledge Of A POSITA, Burton, Fischell
`’274, Fischell ’507, And Williams
`
`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 31–40.) Patent
`
`Footnote continued from previous page
`litigation. 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.
`
`3 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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`IPR2017-01297
`Owner understands, based on Petitioner’s claim chart (Pet. at 40–58), that
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`Petitioner’s Ground 1 challenge consists of the following arguments: (1)
`
`obviousness of claims 1–3, 13, 14, and 16–20 under Olympus in view of Williams,
`
`Burton, Fischell ’274, and the knowledge of a POSITA, and (2) obviousness of
`
`claims 5–12 under Olympus in view of Williams, Burton, Fischell ’274, the
`
`knowledge of a POSITA, and Fischell ’507. Patent Owner responds as follows.
`
`1.
`
`The References Fail To Disclose Every Limitation Of
`Claims 1–3, 5–14, and 16–20
`
`Independent claims 1, 16, and 17 (and their dependent claims 2, 3, 5–14,
`
`and 18–20). As discussed above, one of the key features of the ’827 Patent is an
`
`intermediate layer disposed between the inner tube and the balloon (which secures
`
`a stent). Specifically, independent claim 1 requires, inter alia, “an outer tube
`
`disposed between the inner tube and the balloon as an intermediate layer”;
`
`independent claim 16 requires, inter alia, an “intermediate tube . . . provided
`
`between interior tube and exterior balloon as an intermediate layer”; and
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`independent claim 17 requires, inter alia, “an intermediate layer disposed between
`
`the inner tube and the balloon” wherein the intermediate layer “covers the inner
`
`tube.” (Ex. 1001 at 5:1–2, 6:7–10, 6:28–30 (emphases added).) Petitioner relies
`
`on the yellow highlighted region in Figure 31 (and Figure 30) of Olympus
`
`(reproduced below) as the support for an “intermediate layer [or tube].” (Pet. at
`
`43–44.) Petitioner fails to demonstrate that the yellow highlighted region in Figure
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`-8-
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`31 of Olympus is an actual layer of material, much less an intermediate layer or
`
`tube required in each challenged claim of the ’827 Patent.
`
`Specifically, 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. Instead, based on the figures of
`
`Olympus, it appears that the yellow highlighted region merely identifies the lumen
`
`of an uninflated balloon, not a layer of material of catheter 5 of Olympus. 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 actual layer of
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`material of the catheter 5 (i.e., solid material filling the hatched region) as
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`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–
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`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.)
`
`Because of the lack of sufficient description in Olympus, Petitioner has not
`
`established that the yellowed highlighted region of Figure 31 in Olympus is a layer
`
`of material between catheter 5 and balloon 4 that could constitute an intermediate
`
`layer or tube required in each challenged claim of the ’827 Patent.
`
`Independent claim 16. In addition to the above, independent claim 16 of
`
`the ’827 Patent further requires that the intermediate tube “is composed of a
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`Patent Owner’s Preliminary Response
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`flexible material.” Petitioner merely relies on the same alleged evidentiary support
`
`for claim 1 of the ’827 Patent. (Pet. at 53 [16.3].) However, Petitioner fails to
`
`point to any support for a “flexible material” in its combination of references for
`
`claim 1 of the ’827 Patent. (Pet. at 43–45 [1.3].) Therefore, Petitioner has not met
`
`its burden of proof in establishing the presence of a flexible material required in
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`claim 16 of the ’827 Patent in the combination of references.
`
`Dependent claim 3. Claim 3 requires that “the outer tube comprises an
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`elastic material into which the deformable stent is pressed in the crimping
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`operation.” The cited portion of Olympus relied on by Petitioner states that a
`
`stent—not the alleged intermediate layer (i.e., the yellow highlighted region in
`
`Figure 31)—can be covered with a polyurethane thermoplastic elastomer. (See
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`Pet. at 46 (citing Ex. 1015 at 24 (Polyurethane thermoplastic elastomer can be used
`
`“as the protective material, to cover the sharp edges at both ends of the stent 1, and
`
`is affixed on the outer periphery of both ends of the stent 1.”)).) Thus, there is no
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`evidence in Olympus to support the limitation required in claim 3 that relates to the
`
`material of the intermediate layer. Further, the cited portions of Burton relied on
`
`by Petitioner relate to materials for the grip member without any reference to any
`
`“crimping operation” required in claim 3. (Pet. at 46.) Petitioner fails to even
`
`attempt to establish that the cited portions of Burton have anything to do with a
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`crimping operation. (Id.) Therefore, Petitioner has not met its burden of proof in
`
`establishing the limitations required in claim 3 in the combination of references.
`
`Dependent claims 5–12. Claim 5 requires that the intermediate layer
`
`includes “at least one separation whereby the flexibility of the body and catheter is
`
`increased.” Claim 6 requires “a spiral separation”; claim 7 requires “a plurality of
`
`separations”; and claim 8 requires “the plurality of separations are substantially
`
`parallel.” Claim 9 requires that “the intermediate layer includes at least one cut in
`
`its surface.” Claim 10 requires that “the cut is a spiral separation”; claim 11
`
`requires “a plurality of cuts”; and claim 12 requires that “the plurality of cuts are
`
`circumferential cuts and are substantially parallel.” While Petitioner relies on
`
`Olympus, Burton, and Fischell ’507 for the disclosure of those limitations in
`
`claims 5–12 (Pet. at 46–50), none of them actually disclose those limitations.
`
`First, while Petition asserts that Olympus “teaches the use of spiral-shaped
`
`coil stents” (Pet. at 47), such an assertion is irrelevant because the claims at issue
`
`that require a spiral separation or spiral cut require that the separation or cut be in
`
`the intermediate layer, not the stent.
`
`Second, contrary to Petitioner’s assertion (Pet. at 46–47), the circumferential
`
`gaps 12 and 13 in Figure 3 of Burton (reproduced below) are merely dents to “tuck
`
`in” the stent for “protecting them [the ends of the stent] and preventing exposed
`
`filaments from snagging.” (Ex. 1014 at 4:30–37, 5:48–52) Therefore, the dents in
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`Figure 13 of Burton are not “separation[s]” or “cuts” and their function is to
`
`prevent snagging, not to increase the flexibility of the catheter as required in claims
`
`5, 7, and 8 of the ’827 Patent.
`
`Third, contrary to Petitioner’s suggestion (Pet. at 47–48), Fischell ’507
`
`teaches that the “grooves 26” are formed on the inner core itself (i.e., the catheter),
`
`not on an intermediate layer. (Ex. 1010 at 3:47–55) (“Fig. 3 shows the distal end
`
`of the insertion catheter 20 which consists of an inner core 22…. The core 22
`
`has … spiral grooves 26….”) Further, contrary to Petitioner’s suggestion (Pet. at
`
`47), the purpose of the grooves of Fischell ’507 is to provide a location into which
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`a stent can be placed, not to increase the flexibility of the catheter. (Ex. 1010 at
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`3:47–55 (“spiral grooves 26 into which the coil spring IS [Intravascular Stent] 10 is
`
`placed”).) Petitioner’s assertion that Fischell ’507 teaches separations in the
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`Patent Owner’s Preliminary Response
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`alleged intermediate layer to “improve flexibility” (Pet. at 48) again lacks merits
`
`and is contradicted by the express teachings of Fischell ’507.
`
`Dependent claim 13. Claim 13 requires “a stop carried by the inner tube
`
`inside the balloon.” Petitioner alleges that the structure 7 in Burton discloses a
`
`stop. (Pet. at 50.) Contrary to Petitioner’s allegation (see Pet. at 50), the structure
`
`“7” in Figure 1 of Burton (reproduced below) is to provide “a smooth transition
`
`from said end of the outer sleeve.”(Ex. 1014 at 5:32–35; Pet. at 50.) It is not a
`
`“stop.”
`
`Dependent claim 14. Claim 14 requires that “the intermediate layer is
`
`generally cylindrical.” Petitioner argues that “this would be an obvious design
`
`choice and a minor modification to Olympus’s substantially cylindrical
`
`intermediate layer.” (Pet. at 51.) As discussed above, Olympus does not disclose
`
`any intermediate layer. As such, Olympus could not have disclosed a generally
`
`cylindrical intermediate layer.
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`IPR2017-01297
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References
`
`2.
`
`Even if Petitioner could demonstrate that the combinations of references
`
`teach each limitation of claims 1–3, 5–14, and 16–20 of the ’827 Patent, Petitioner
`
`still fails to demonstrate a motivation to combine the references.
`
`Olympus in view of Burton (and the knowledge of a POSITA). The
`
`primary combination of references in Ground 1 is the combination of Olympus and
`
`Burton. Petitioner argues that one of ordinary skill in the art would have replaced
`
`“an integral intermediate layer” in Olympus with a separate one because a separate
`
`intermediate layer would improve manufacturability as suggested by Burton. (Pet.
`
`at 35.) Petitioner’s argument fails for a number of reasons. First, as discussed
`
`above, the fundamental premise that Olympus teaches an intermediate layer or
`
`outer tube is unsupported. Moreover, as discussed above, Petitioner cannot find a
`
`single word in Olympus that describes the structure, material, or function of the
`
`yellow highlighted region of Figure 31. Certainly there is no disclosure
`
`whatsoever in Olympus that the alleged intermediate layer (i.e., the yellow
`
`highlighted region of Figure 31) facilitates the securement of a stent, which is a
`
`key objective of the claimed invention of the ’827 Patent.
`
`Any cursory reading of Olympus would reveal that Olympus has nothing to
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`do with securing a stent. (Ex. 1015 at 17 [Problems to Be Resolved by the
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`Invention].) Instead, it is directed to reducing damages to in-vivo tissues due to the
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`“very hard and sharp” stent edges. (Ex. 1015 at 17.) Each of the ten embodiments
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`of Olympus deals with various stent edge protective materials on the outer
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`periphery of the stent (and the prevention of the protective materials from coming
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`loose)—none of which is even remotely relevant to stent securement issues
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`addressed in the ’827 Patent. Not surprisingly, Petitioner fails to identify any
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`disclosure in Olympus that remotely suggests an issue with stent securement.
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`There is no rational reason for a person skilled in the art to choose Olympus in an
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`effort to address the issue of stent securement issue identified in the ’827 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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`that the alleged “integral intermediate layer” needs to be improved, suffers any
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`shortcoming, or is difficult to make. (Pet. at 33.) In other words, to the extent that
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`one could believe that the alleged intermediate layer in Olympus secures a stent,
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`there would be no reason to modify it as suggested by Petitioner. Petitioner’s
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`assertion that “a POSITA would have been motivated to modify the Olympus
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`device to have a separate intermediate layer because the modification would
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`improve the manufacturability of the device” (Pet. at 35) has no support in
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`Olympus. For example, Petitioner cannot point to any teaching or suggestion in
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`Olympus that indicates any manufacturability issues associated with the alleged
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`“integral intermediate layer.” The conclusory opinion of Petitioner’s expert
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`suggesting such manufacturability issues—without any support in Olympus or any
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`facts or data—lacks probative value. (Ex. 1003 at ¶ 127.4)
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`Third, even if a skilled artisan would elect to modify the alleged “integral
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`intermediate layer [or tube]” in Olympus, there would be no rational reason to
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`combine it with Burton as suggested by Petitioner. As an initial matter, contrary to
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`Petitioner’s suggestion (Pet. at 33), Burton merely states that a gripping member
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`could be “an integral portion of the core” or “attached around the periphery of the
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`core” without hinting any preference for the latter choice or that the former choice
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`would have any manufacturability issues. (Ex. 1014 at 2:21–23.) And contrary to
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`Petitioner’s assertion (Pet. at 34), the structure “7” in Figure 1 of Burton is to
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`provide “a smooth transition from said end of the outer sleeve.” It is not a “conical
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`stop” to “secure the stent.” (Ex. 1014 at 5:32–35; Pet. at 35.) Thus, there is no
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`evidence in Burton that supports a motivation to combine as Petitioner suggests.
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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 involvement of any balloon. (E.g., Ex. 1014
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`4 Without seeking Patent Owner’s consent or the Board’s approval, Petitioner
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`submitted an entirely new expert declaration on May 11, 2017, nearly a month
`
`after the initial filing of the Petition on April 19, 2017. While Patent Owner
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`hereby refers to the new declaration, it objects to its filing as improper.
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`at 2:13–15.) Olympus, on the other hand, is directed to a stent delivery system
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`using a balloon. (See, e.g., Ex. 1015 at Fig. 30–31.) Moreover, Olympus and
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`Burton address entirely different problems. While Olympus is directed to
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`protecting in-vivo tissues or endoscope channels from the sharp edges of a balloon-
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`expandable stent (Ex. 1015 at 17), Burton is directed to a structure for releasably
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`holding a self-expanding stent (Ex. 1014 at 2:13–32). See Broadcom Corp. v.
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`Emulex Corp., 732 F.3d 1325, 1334 (Fed. Cir. 2013) (“[P]rior art references that
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`address different problems may not . . . support an inference that the skilled artisan
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`would consult both of them simultaneously”); Palo Alto Networks, Inc. v. Finjan,
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`Inc., IPR2016-00165, Paper 7 at 17-18 (P.T.A.B. Apr. 21, 2016) (denying
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`institution because there was no motivation to combine two references where the
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`second reference “addresses a different problem” than the first).
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`There is no suggestion in Olympus that its balloon-expandable stent could be
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`used as a self-expanding stent. Nor is there any suggestion in Burton that its self-
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`expanding stent could be delivered by a balloon-expandable system as in Olympus.
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`See Exacq Techs., Inc., v. JDS Techs., Inc., IPR2016-00567, Paper 7 at 21 (July 15,
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`2016) (It would not have been obvious to modify Acosta’s COVMS to use the
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`MAC address of the AXIS camera server for authorization because “[n]either
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`Acosta nor AXIS suggest[ed] using a MAC address for determining if a computer
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`program is authorized to access the camera element or server.”).
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`-18-
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`In fact, the grip member of Burton, specifically designed for a self-
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`expanding stent where the stent is compressed within an outer sleeve prior to
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`deployment and is deployed by withdrawing the sleeve without the use of a balloon
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`(see Ex. 1014 at 3:18–28) would be rendered ineffective if used in the balloon
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`catheter of Olympus. This is because, in Olympus, the stent is not in direct contact
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`with the alleged intermediate layer (the balloon being between the stent and the
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`alleged intermediate layer), whereas the operation of the grip member in Burton
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`requires direct contact between the stent and the grip member. (See Ex. 1015 at
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`Fig. 31; Ex. 1014 at 5:48–52 (“circumferential gaps ” to accommodate ends of the
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`stent), 3:48–61 (a surface having a “high coefficient of friction” that resists sliding
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`motion of the stent and is “in contact with the stent”; a “roughened or irregular”
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`surface), 3:62–4:2 (a “coating of a releasable adhesive.”).) See Plas-Pak Indus.,
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`Inc. v. Sulzer Mixpac AG, 600 F. App’x 755, 758 (Fed. Cir. 2015) (“combinations
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`that change the ‘basic principles under which the [prior art] was designed to
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`operate,’ or that render the prior art ‘inoperable for its intended purpose,’ may fail
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`to support a conclusion of obviousness”) (citations omitted); Activision Blizzard,
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`Inc. v. Acceleration Bay, LLC, IPR2016-00727, Paper 13 at 17 (PTAB Sept. 9,
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`2016) (finding no motivation to apply Shoubridge’s teaching of constrained
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`flooding to DirectPlay because DirectPlay did not teach the type of network for
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`which Shoubridge described as an effective and reliable routing method.); Exacq
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`-19-
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`Patent Owner’s Preliminary Response
`IPR2017-01297
`Techs., Inc., IPR2016-00567, Paper 7 at 23 (finding Petitioner “d[id] not provide a
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`sufficient reason as to why an ordinarily skilled artisan would have modified
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`Acosta’s non-ARP protocol system to add a router-based ARP command, as
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`described by Nelson”).
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`Indeed, combining Burton with any balloon catheter would render the
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`balloon incapable of inflating to expand the stent. This is because the
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`“circumferential gaps 12, 13” are intended to “accommodate the ends 11 of the
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`stent”—i.e., the ends of the stent are tucked into these recesses such that they do
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`not “snag[] the inner wall of the outer sleeve.” (Ex. 1014 at 5:48–52, Fig. 3.) The
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`ends of the stent would stab any balloon positioned between the stent and the grip
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`member, rendering the balloon inoperative. Thus, not only is there no rational
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`reason to combine Olympus with Burton, but a very clear reason to avoid such a
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`combination.
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`Olympus in view of Williams (and the knowledge of a POSITA).
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`Petitioner alleges that “[c]rimping a stent onto a balloon and catheter were well
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`known to a POSITA” and that Williams “teaches a prior art stent-crimping device
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`f
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