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 IPR2017-01304
`Patent 6,203,558
`_______________
`
`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 ............................................................. v
`
`V.
`
`VI.
`
`B.
`
`C.
`D.
`
`STATEMENT OF RELIEF REQUESTED ....................................................1
`I.
`INTRODUCTION ...........................................................................................1
`II.
`III. BACKGROUND AND OVERVIEW OF THE ’558 PATENT .....................2
`IV.
`THE ART AND GROUNDS OF UNPATENTABILITY ON
`WHICH PETITIONER RELIES.....................................................................6
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING................................................................................................7
`PETITIONER HAS FAILED TO CARRY ITS BURDEON OF A
`REASONABLE LIKELIHOOD OF SUCCESS.............................................8
`A.
`Ground 1: Obviousness Of Claims 1, 2, 9, 14, 20, And 21 In
`View Of Olympus, Burton, Fischell ’274, Fischell ’507, And
`The Knowledge Of A POSITA .............................................................9
`1.
`The References Fail To Disclose Every Limitation Of
`Claims 1, 2, 9, 14, 20, and 21 ...................................................10
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................16
`Ground 2: Obviousness Of Claims 1, 2, 9, 20, And 21 In
`View Of Sugiyama ’032 And Fischell ’507........................................23
`1.
`The References Fail To Disclose Every Limitation Of
`Any Challenged Claim..............................................................23
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine Sugiyama ’032 And Fischell
`’507 ...........................................................................................25
`Ground 3: Anticipation Of Claim 1 By Ravenscroft ..........................28
`Ground 4: Obviousness Of Claim 14 In View Of References
`In Grounds 1 And 2 In Further View Of Jendersee ............................33
`1.
`The References Fail To Disclose Each Limitation Of
`Claim 14....................................................................................33
`
`2.
`
`2.
`
`-i-
`
`

`

`2.
`
`2.
`
`E.
`
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine The References Of Grounds 1
`And 2 With Jendersee ...............................................................33
`Ground 5: Obviousness Of Claim 22 In View Of References
`In Ground 4 In Further View Of The Knowledge Of A
`POSITA Or Fischell ’274....................................................................36
`1.
`The References Fail To Disclose Every Limitation Of
`Claim 22....................................................................................36
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine Fischell ’274 With The
`References In Ground 4 ............................................................37
`VII. CONCLUSION..............................................................................................38
`
`-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) .....................................20
`
`Page(s)
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .....................................................................18
`
`Exacq Techs., Inc., v. JDS Techs., Inc.,
`IPR2016-00567, Paper 7 (P.T.A.B. July 15, 2016).................................19, 20
`
`Grain Processing Corp. v. Am. Maize-Prods. Co.,
`840 F.2d 902 (Fed. Cir. 1988) .......................................................................23
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .......................................................................37
`
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981).......................................................................11
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2016-00165, Paper 7 (P.T.A.B. Apr. 21, 2016) ......................................18
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015)................................................................20
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) .........................................................................12
`
`Seabery N. Am., Inc. v. Lincoln Glob., Inc.,
`IPR2016-00749, Paper 13 (P.T.A.B. Sept. 21, 2016) ...................................21
`
`STATUTES, RULES AND REGULATIONS
`
`35 U.S.C. § 102..........................................................................................................9
`
`35 U.S.C. § 103........................................................................................................12
`
`35 U.S.C. § 112..........................................................................................................8
`
`-iii-
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`

`

`37 C.F.R. § 1.84(h)(3)..............................................................................................32
`37 C.F.R. § 1.84(h)(3) .............................................................................................. 32
`
`37 C.F.R. § 42.107(a).................................................................................................1
`37 C.F.R. § 42.107(a) ................................................................................................. 1
`
`37 C.F.R. § 42.65(a).................................................................................................11
`37 C.F.R. § 42.65(a) ................................................................................................. 11
`
`-iv-
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`
`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
`
`-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, 2, 9, 14, and 20–22 of U.S. Patent No. 6,203,558 (“the ’558 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
`IPR2017-01304
`ordinary skill in the art would somehow have divined this completely unknown
`
`feature in Olympus as a “mounting body,” serving the functions 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
`
`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 ’558 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
`IPR2017-01304
`Scimed Life Systems, Inc.) introduced a series of innovative NIR stent delivery
`
`systems. (Ex. 2001 at 283.)
`
`The invention of the ’558 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 ’558 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 3:28–42.) 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. (E.g., id. at 3:43–49.) One of the innovative designs of
`
`the ’558 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 9:36–40; see also id. at Fig. 4.)
`
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`
`Figure 5 shows another embodiment of the innovative designs of the ’558
`
`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 10:8–13.)
`
`Claim 1, which is the lone independent claim and is representative of the
`
`challenged claims, reads as follows:
`
`1. A system/assembly for delivery and deployment of
`an inflation expandable stent within a vessel, comprising:
`a catheter having proximal and distal ends;
`a stent, inflation expandable from a delivery diameter
`to a deployment diameter, such that the delivery
`diameter is reduced from the deployment diameter
`
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`for conforming the stent to the catheter, such that
`the stent, in its delivery diameter, is coaxially
`mounted on the catheter near the catheter distal
`end;
`an expandable inflation means coaxially mounted on
`the catheter within the stent, for expansion of the
`stent from the delivery diameter to the deployment
`diameter upon application of deployment pressure
`to the expandable inflation means; and
`a mounting and retaining means coaxially mounted on
`the catheter within the expandable inflation means,
`the mounting and retaining means designed and
`adapted to provide a securement for the stent in the
`delivery diameter to maintain the stent in position
`on the catheter during delivery to the deployment
`site,
`the catheter having a shaft and the expandable
`inflation means being positioned at a distal part of
`the shaft, the mounting and retaining means being
`positioned for receiving the stent on the
`expandable inflation means for radial expansion of
`the stent upon expansion of the expandable
`inflation means, the mounting and retaining means
`including at least one mounting body carried by
`the shaft inside the expandable inflation means
`whereby the diameter of the shaft and expandable
`inflation means are increased at the distal part for
`
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`
`facilitating the mounting and retaining of the
`s[t]ent, the mounting body including at least one
`separation, whereby the flexibility of the body and
`catheter is increased.
`
`Certain of Patent Owner’s NIR stent delivery systems practice claim 1 and
`
`other claims of the ’558 Patent. (See Ex. 2002 at 6–7.)
`
`IV. THE ART AND GROUNDS OF UNPATENTABILITY ON WHICH
`PETITIONER RELIES
`
`Petitioner relies on an English translation of Japanese Patent Publication No.
`
`H4-64637 (“Olympus”) (Ex. 1015), U.S. Patent Nos. 5,026,377 (“Burton”) (Ex.
`
`1014), 5,639,274 (“Fischell ’274”) (Ex. 1013), 4,994,032 (“Sugiyama ’032”) (Ex.
`
`1009), 5,702,418 (“Ravenscroft”) (Ex. 1017), 4,768,507 (“Fischell ’507) (Ex.
`
`1010), and 5,836,965 (“Jendersee”) (Ex. 1016). (Pet. at 23; see also id. at 24, 38,
`
`52, 58, 61.)
`
`Petitioner raises four grounds of obviousness and one ground of anticipation
`
`arguments:
`
`Ground #
`1
`
`Challenged Claims
`1, 2, 9, 13, 20, and 21
`
`2
`
`3
`
`1, 2, 9, 20, and 21
`
`1
`
`Basis
`Unpatentable as Obvious over
`Olympus in View of the Knowledge
`of a POSITA and/or Burton, Fischell
`’274, and/or Fischell ’507
`Unpatentable as Obvious over
`Sugiyama ’032 in view of Fischell
`’507
`Unpatentable as Anticipated by
`Ravenscroft
`
`-6-
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`

`

`4
`
`5
`
`14
`
`22
`
`Patent Owner’s Preliminary Response
`IPR2017-01304
`Unpatentable as Obvious over
`References in Grounds 1 and 2 in
`Further View of Jendersee
`Unpatentable as Obvious over
`Ground 4, in Further View of the
`Knowledge of a POSITA or Fischell
`’274
`
`(Pet. at 24, 38, 52, 58, 61.)
`
`V.
`
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING
`
`Patent Owner agrees with Petitioner that the ’558 Patent has expired and that
`
`its claim terms should be construed under the Phillips standard. (See Pet. at 20–
`
`21.) Patent Owner further agrees, as Petitioner concedes, that Patent Owner’s
`
`proposed constructions for “expandable inflatable means” and “mounting and
`
`retaining means” in the district court litigation are the proper constructions under
`
`the Phillips standard.1 (See Pet. at 21–22.)
`
`1 It should be noted that the district court has not held a claim construction hearing
`
`on the ’558 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 ’558 Patent, now
`
`concedes that (1) the two terms proposed by Patent Owner in the district court
`
`litigation are the plain meanings of these terms and (2) there are no other terms of
`
`the ’558 Patent that require construction by the Board under the Phillips standard
`
`(Pet. at 22), it proposed, in the district court litigation, far narrower constructions
`
`Footnote continued on next page
`
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`VI. PETITIONER HAS FAILED TO CARRY ITS BURDEON OF A
`REASONABLE LIKELIHOOD OF SUCCESS
`
`To carry its burden of an obviousness challenge (Grounds 1–2 and 4–5),
`
`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
`than the plain meanings. (See Ex. 2003 at Appendix D (e.g., “expandable inflation
`
`means” and “mounting and retaining means” are subject to 35 U.S.C. § 112, ¶ 6;
`
`“mounting body” means “an enlarged structure to which the stent is crimped”;
`
`“mounted” means “crimped”; “mounting” means “crimping”).) 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 21 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
`IPR2017-01304
`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 3), 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.
`
`A.
`
`Ground 1: Obviousness Of Claims 1, 2, 9, 14, 20, And 21 In View
`Of Olympus, Burton, Fischell ’274, Fischell ’507, And The
`Knowledge Of A POSITA
`
`In its Ground 1 argument, Petitioner merely lists the challenged claims and
`
`its cited references, but without identifying which specific claims are allegedly
`
`obvious in view of what specific combinations of references. (Pet. at 24–31.)
`
`Patent Owner understands, based on Petitioner’s claim chart (Pet. at 31–38), that
`
`Petitioner’s Ground 1 challenge consists of the following arguments:
`
`(1) obviousness of claims 1 and 2 over Olympus in view of Burton and the
`
`knowledge of a POSITA; (2) obviousness of claim 1, 2, 9, 20, and 21 over
`
`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
`IPR2017-01304
`Olympus in view of Fischell ’507 and the knowledge of a POSITA; and
`
`(3) obviousness of claims 9, 14, 20, and 21 over Olympus in view of the
`
`knowledge of a POSITA, Burton, and Fischell ’507. Patent Owner responds as
`
`follows.
`
`1.
`
`The References Fail To Disclose Every Limitation Of
`Claims 1, 2, 9, 14, 20, and 21
`Independent claim1 (and its dependent claims 2, 9, 14, 20, and 21). As
`
`discussed above, one of the key features of the ’558 Patent is a mounting body,
`
`which serves the functions of mounting and retaining a stent. Specifically,
`
`independent claim 1 requires, inter alia, (1) a “mounting and retaining means
`
`including at least one mounting body,” and (2) “whereby the diameter of the shaft
`
`and inflatable portion are increased at the distal part for facilitating the mounting
`
`and retaining of the s[t]ent.” (Ex. 1001 at 25:63–26:28 (emphases added).)
`
`Petitioner fails to demonstrate that the combination of Olympus, Burton, Fischell
`
`’507 and/or the knowledge of a skilled artisan discloses these limitations in
`
`independent claim 1 (and their dependent claims).
`
`Petitioner alleges that Olympus discloses a “mounting body.” (Pet. at 34–35
`
`[1.4]–[1.5].) 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
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`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 yellow highlighted region of
`
`Figure 31 in Olympus is a mounting body or that it serves the function of stent
`
`mounting or retention, as required in each of the challenged claims. Simply calling
`
`it a “mounting body” (e.g., Pet. at 24–25) and hiring an expert to say that it meets
`
`the stent mounting and retention functions (Ex. 1003 at ¶¶ 117–19)—without any
`
`support in Olympus or any facts or data—is insufficient. See 37 C.F.R. § 42.65(a)
`
`(“Expert testimony that does not disclose the underlying facts or data on which the
`
`opinion is based is entitled to little or no weight.”).3
`
`3 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
`
`function of stent mounting or retention required in independent claim 1 of the ’558
`
`Patent. 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 an “increased diameter” of the shaft under the balloon (Ex. 1003 at
`
`¶ 118) necessarily serves the function of stent mounting or retention. See In re
`
`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`
`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
`
`Olympus deals with various stent edge protective materials on the outer periphery
`
`Footnote continued from previous page
`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 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
`IPR2017-01304
`of the stent (and the prevention of the protective materials from coming loose)—
`
`none of which is even remotely relevant to facilitating stent mounting and retention
`
`required in each of the challenged claims of the ’558 Patent in Ground 1.4
`
`4 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, 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
`
`Footnote continued on next page
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`In addition, claim 1 (and its dependent claims 2, 9, 14, 20, and 21) requires
`
`that the mounting body include “at least one separation, whereby the flexibility of
`
`the body and catheter is increased.” (Ex. 1001 at 26:26–28.) Dependent claim 9
`
`(and claims 14, 20, and 21, which depend on claim 9) further require that the
`
`recited separation is in the form of a spiral. (Id. at 26:51–52.) While Petitioner
`
`relies on Olympus, Burton, and Fischell ’507 for the disclosure of the limitations in
`
`claims 1 and 9 (Pet. at 36–37), none of them actually disclose these limitations.
`
`First, while Petitioner asserts that Olympus teaches the use of “spiral or coil-
`
`shaped stents” (id. at 30), such an assertion is irrelevant because the claims at issue
`
`require a spiral separation in the mounting body, not the stent.
`
`Second, contrary to Petitioner’s assertion (id. at 36), 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
`
`Footnote continued from previous page
`(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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`Patent Owner’s Preliminary Response
`IPR2017-01304
`filaments from snagging.” (Ex. 1014 at 4:37–39, 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” as
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`required in claim 1. Indeed, Burton does not teach anything close to increasing
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`flexibility. Petitioner’s assertion that the circumferential gaps in Burton would be
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`understood to be separations that “improve the flexibility and trackability of the
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`catheter shaft” is unsupported and is contradicted by the express teachings of
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`Burton. (Pet. at 29.)
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`Third, contrary to Petitioner’s suggestion (id. 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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`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….”).) Further, contrary to Petitioner’s suggestion (Pet. at 36), the
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`purpose of the grooves of Fischell ’507 is to provide a location into which a stent
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`can be placed, not increasing the flexibility of the catheter. (Ex. 1010 at 3:47–55
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`(“spiral grooves 26 into which the coil spring IS [Intravascular Stent] 10 is
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`placed”).) Petitioner’s assertion that Fischell ’507 teaches separations in the
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`mounting body to “improve flexibility” (Pet. at 31, 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, 2, 9, 14, 20, and 21 of the ’558 Patent, Petitioner
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`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 modified the
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`“mounting body” in Olympus with the circumferential separations in Burton
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`because the use of such separations would “improve the flexibility and trackability
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`of the catheter shaft.” (Pet. at 29; Ex. 1003 at ¶ 127.) Petitioner’s argument fails
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`for a number of reasons. First, as discussed above, the fundamental premise that
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`Olympus teaches a mounting body for stent mounting and retention is utterly
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`unsupported. Petitioner cannot find a single word in Olympus suggesting that the
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`yellow highlighted region of Figure 31 is a mounting body or that it facilitates the
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`mounting or retaining of a stent. Indeed, as discussed above, the entire disclosure
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`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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`mounting or retention. There is no rational reason for a person skilled in the art to
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`choose Olympus in an effort to address the issue of stent mounting or retention
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`identified in the ’558 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 mounting body needs to be improved, suffers any
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`shortcoming, or is difficult to make. (Pet. at 29.) 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. For example, Petitioner cannot point to any teaching or suggestion
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`in Olympus that indicates any flexibility issues associated with the alleged
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`“mounting body.” (Id. at 29, 36–37.) The opinions of Petitioner’s expert also
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`offer no probative value as he does not suggest that Olympus discloses any such
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`flexibility issues. (E.g., Ex. 1003 at ¶ 127.)
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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. Indeed, combining Burton with any balloon catheter
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`would render the balloon incapable of inflating to expand the stent. This is
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`Patent Owner’s Preliminary Response
`IPR2017-01304
`because the “circumferential gaps 12, 13” are intended to “accommodate the ends
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`11 of the stent”—i.e., the ends of the stent are tucked into these recesses such that
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`they do not “snag[] the inner wall of the outer sleeve.” (Ex. 1014 at 5:48–52, Fig.
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`3.) The ends of the stent would stab any balloon positioned between the stent and
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`the grip member, rendering the balloon inoperative. Thus, not only is there no
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`rational reason to combine Olympus with Burton, but also a very clear reason to
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`avoid such a combination is plainly evident.
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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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`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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`Patent Owner’s Preliminary Response
`IPR2017-01304
`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 in Olympus.
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`See Exacq Techs., Inc., v. JDS Techs., Inc., IPR2016-00567, Paper 7 at 21
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`(P.T.A.B. July 15, 2016) (It would not have been obvious to modify Acosta’s
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`COVMS to use the MAC address of the AXIS camera server for authorization
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`because “[n]either Acosta nor AXIS suggest[ed] using a MAC address for
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`determining if a computer program is authorized to access the camera element or
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`server.”).
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`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 mounting body (the balloon being between the stent and the
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`alleged mounting body), whereas the operation of the grip member in Burton
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`requires direct co