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 IPR2017-01294
`Patent 6,371,962
`_______________
`
`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
`
`STATEMENT OF RELIEF REQUESTED ....................................................1
`I.
`INTRODUCTION ...........................................................................................1
`II.
`III. BACKGROUND AND OVERVIEW OF THE ’962 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: Obviousness Of Claims 1-3, 6-8, 11-13, 20-22,
`25, 26, 29, 30, 35, and 36 In View Of Olympus, The
`Knowledge Of A POSITA, Burton, Fischell ’274, and
`Fischell ’507..........................................................................................9
`1.
`The References Fail to Disclose Every Limitation of
`Claims 1-3, 6-8, 11-13, 20-22, 25, 26, 29, 30, 35, and 36..........9
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References.........................................17
`Ground 2: Obviousness Of Claims 1-3, 6, 11-13, 20-22, 25,
`29, 30, 35, and 36 In View Of Fischell ’274 and Burton....................26
`1.
`The References Fail to Disclose Every Limitation of
`Claims 2, 3, 6, 20, 21, and 24 ...................................................26
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine Fischell ’274 and Burton...................27
`Ground 3: Anticipation Of Claims 1-3, 6, 12, 20-22, and 30
`By Ravenscroft....................................................................................30
`Ground 4: Obviousness Of Claims 9, 10, 13, 27, and 28 In
`View Of References In Grounds 1 and 2 and Jendersee.....................39
`
`2.
`
`2.
`
`-i-
`
`V.
`
`VI.
`
`B.
`
`C.
`
`D.
`
`

`

`E.
`
`Ground 5: Obviousness Of Claim 8 in View Of References
`In Grounds 1 Through 3, The Knowledge Of A POSITA,
`Burton, Fischell ’274, Fischell ’507, And/Or Williams......................41
`VII. CONCLUSION..............................................................................................42
`
`-ii-
`
`

`

`TABLE OF AUTHORITIES
`
`CASES
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2016-00727, Paper 13 at 17 (PTAB September 9, 2016).............................21
`
`Page(s)
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) ..........................................................................20
`
`Exacq Technologies, Inc., v. JDS Technologies, Inc.,
`IPR2016-00567, Paper 7 at 23 (PTAB July 15, 2016).......................................22
`
`Exacq Technologies, Inc., v. JDS Technologies, Inc.,
`IPR2016-00567, Paper 7 at 21 (PTAB July 21, 2016).......................................20
`
`Ex parte Levy,
`17 USPQ2d 1461 (B.P.A.I. 1990) ......................................................................36
`
`Grain Processing Corp. v. Am. Maize Prods. Co.,
`840 F.2d 902 (Fed. Cir. 1988) ............................................................................26
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) ..........................................................................34
`
`In re Oelrich,
`666 F.2d 578, 212 USPQ 323 (CCPA 1981)................................................11, 36
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2016-00165, Paper 7 at 17-18 (PTAB Apr. 21, 2016) .................................20
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) .....................................................................21
`
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) ........................................................................12, 36
`
`Seabery N. Am., Inc. v. Lincoln Glob., Inc.,
`IPR2016-00749, Paper 13 at 11-12 (PTAB Sept. 21, 2016) ..............................23
`
`-iii-
`
`

`

`STATUTES, RULES AND REGULATIONS
`
`37 C.F.R. § 1.84(h)(3)..............................................................................................38
`
`37 C.F.R. § 42.65(a).................................................................................................11
`
`37 C.F.R. § 42.107(a).................................................................................................1
`
`35 U.S.C. § 102..........................................................................................................8
`
`35 U.S.C. § 103........................................................................................................12
`
`-iv-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`
`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 1-3, 6-13, 20-22, 25, 26-29, 30, and 35-36 of U.S. Patent No. 6,371,962
`
`(“the ’962 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
`
`-1-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`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 ’962 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,
`
`-2-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`Scimed Life Systems, Inc.) introduced a series of innovative NIR stent delivery
`
`systems. (Ex. 2001 at 283.)
`
`The invention of the ’962 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 ’962 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 1:64-2:10.) 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 2:10-16.)
`
`One of the innovative designs of the ’962 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.
`
`(Ex. 1001 at 3:33-37.).
`
`-3-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`
`Figure 4 shows another embodiment of the innovative designs of the ’962
`
`Patent. In Figure 4, 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 4:6-11.)
`
`Claim 1, which is representative of the challenged claims, reads:
`
`1. A stent delivery system for carrying and delivering a
`stent having a first end and a second end and a
`contracted state and an expanded state, the system
`comprising:
`
`-4-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`
`a catheter having a shaft having a diameter and
`expandable inflatable means associated therewith at a
`distal part of the shaft and including mounting and
`retaining means for receiving the stent on the
`expandable inflatable means whereby the stent is
`radially expanded upon inflation of the inflatable
`means, the mounting and retaining means including at
`least one mounting body, the at least one mounting
`body having a length and an outer surface diameter
`and being carried on and surrounding the shaft inside
`the inflatable means whereby the diameter of the shaft
`is increased at the distal part for facilitating the
`mounting and retaining of the stent and wherein, when
`the stent is mounted on the catheter, the at least one
`mounting body is between the stent and the shaft, the
`outer surface diameter of the at least one mounting
`body being substantially constant along its length.
`Certain Patent Owner’s NIR stent delivery systems practice claim 1 and
`
`other claims of the ’962 Patent. (See Ex. 2002 at 6-7.)
`
`IV. THE ART AND GROUNDS OF UNPATENTABILITY RELIED ON
`BY PETITIONER
`
`Petitioner relies on Japanese Publication No. H4-64367 (“Olympus”), with
`
`an English translation provided by Petitioner. (See Ex. 1015.) Petitioner also
`
`relies on U.S. Patent Nos. 5,026,377 (“Burton”) (Ex. 1014), 5,639,274 (“Fischell
`
`’274”) (Ex. 1013), 5,702,418 (“Ravenscroft”) (Ex. 1017), 4,768,507 (“Fischell
`
`’507) (Ex. 1010), 5,836,965 (“Jendersee”) (Ex. 1016), and 5,437,083 (“Williams”)
`
`(Ex. 1028).
`
`Petitioner raises four grounds of obviousness arguments and one ground of
`
`anticipation argument:
`
`-5-
`
`

`

`Ground #
`1
`
`Challenged Claims
`1-3, 6-8, 11-13, 20-22, 25,
`26, 29, 30, 35, and 36
`
`2
`
`3
`4
`
`5
`
`1-3, 6, 11-13, 20-22, 25, 29,
`30, 35, and 36
`1-3, 6, 12, 20-22, and 30
`9, 10, 13, 27, and 28
`
`8
`
`Patent Owner’s Preliminary Response
`IPR2017-01294
`
`Basis
`Obviousness over Olympus in View
`of the Knowledge of a POSITA
`and/or Burton, Fischell ’274 and/or
`Fischell ’507
`Obviousness over Fischell ’274 in
`View of Burton
`Anticipation by Ravenscroft
`Obviousness over References in
`Grounds 1 and 2 in Further View of
`Jendersee
`Obviousness over References in
`Grounds 1 through 3 in Further View
`of the Knowledge of a POSITA
`and/or Burton, Fischell ’274, Fischell
`’507 and/or Williams
`
`(Pet. at 27, 52, 71, 82, 84.)
`
`V.
`
`CLAIM CONSTRUCTION AND THE DISTRICT COURT
`PROCEEDING
`
`Patent Owner agrees with Petitioner that the ’962 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 Patent Owner’s
`
`proposed constructions for “expandable inflatable means,” “mounting and
`
`retaining means,” and “means for inflating the balloon” in the district court
`
`-6-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`litigation are the proper constructions under the Phillips standard.1 (See Pet. at 24-
`
`25.)
`
`1 It should be noted that the district court has not held a claim construction hearing
`
`on the ’962 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 ’962 Patent, now
`
`concedes that (1) the three 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 ’962 Patent require construction by the Board under the Phillips standard (Pet.
`
`at 25), it proposed, in the district court litigation, far narrower constructions than
`
`the plain meanings. (See Ex. 2003 at Appendix B (e.g., “contracted state” means
`
`“state that the stent is left in by the crimper”); (“mounting and retaining means for
`
`receiving” is a means-plus-function-term where the function is “for holding the
`
`stent in place during crimping and the delivery procedure” and the structure is “a
`
`mounting body as pictured and described in Figs. 1-8” and the accompanying
`
`disclosures); (“mounting body” means “an enlarged structure to which the stent is
`
`crimped”); (mounted/mounting [in reference to the stent]” means
`
`“crimped/crimping”); (“loaded” means “crimped”).) Having given up on these
`
`overly narrow constructions it proposed in the district court litigation here,
`
`Petitioner still maintains that it “reserves its right” to pursue these narrow
`
`Footnote continued on next page
`
`-7-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`VI. PETITIONER HAS FAILED TO DEMONSTRATE A REASONABLE
`LIKELIHOOD OF UNPATENTABILITY IN EACH OF ITS
`GROUNDS OF CHALLENGE
`
`To carry its burden of an obviousness challenge (Ground 1-2 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
`
`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
`
`Footnote continued from previous page
`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 fn. 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.
`
`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.
`
`-8-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`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 1-3, 6-8, 11-13, 20-22, 25, 26,
`29, 30, 35, and 36 In View Of Olympus, The Knowledge Of A
`POSITA, Burton, Fischell ’274, and Fischell ’507
`
`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 27-35.) Patent Owner
`
`understands, based on Petitioner’s claim chart (Pet. at 35-52), that Petitioner’s
`
`Ground 1 challenge consists of the following arguments: (1) obviousness of
`
`claims 1-3, 12, 13, 20-22, 30, 35, and 36 under Olympus in view of Burton or the
`
`knowledge of a POSITA, (2) obviousness of claims 6, 7, 25, and 26 under
`
`Olympus in view of Burton or Fischell ’507, and (3) obviousness of claims 11 and
`
`29 under Olympus in view of Burton or Fischell ’274. Patent Owner responds as
`
`follows.
`
`1.
`
`The References Fail to Disclose Every Limitation of Claims
`1-3, 6-8, 11-13, 20-22, 25, 26, 29, 30, 35, and 36
`
`Independent claims 1, 20 and 35 (and their dependent claims 2, 3, 6-8,
`
`11-13, 21, 22, 25, 26, 29, 30, and 36). As discussed above, one of the key features
`
`of the ’962 Patent is a mounting body, which serves the functions of mounting and
`
`retaining a stent. Specifically, independent claims 1 and 20 require, inter alia,
`
`(1) a “mounting and retaining means including at least one mounting body,” and
`
`-9-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`(2) “whereby the diameter of the shaft and inflatable portion are increased at the
`
`distal part for facilitating the mounting and retaining of the stent.” (Ex. 1001 at
`
`4:64-5:3; 7:7-8:5.) (emphases added.) Similarly, independent claim 20 requires “a
`
`mounting body” and the diameter of the shaft being increased to “facilitate
`
`mounting and retaining of a stent.” (Id. at 6:19-23.) Petitioner fails to demonstrate
`
`that the combination of Olympus and Burton (or the knowledge of a skilled artisan)
`
`discloses these limitations in independent claims 1 and 20 (and their dependent
`
`claims).
`
`Petitioner alleges that Olympus discloses a “mounting body.” (Pet. at 38
`
`[1.3].)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
`
`3 In Ground 1, Petitioner does not allege that Burton discloses a mounting body.
`
`(See Pet. at 38-39 [1.3].) Petitioner relies on Burton solely for the purpose of
`
`establishing a separate (as opposed to an integral) component. (Id.)
`
`-10-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`Figure 31 in Olympus is a mounting body or that it serves function of stent
`
`mounting or retention, as required in each of the challenged claims. Simply calling
`
`it a “mounting body” (e.g., Pet. at 27-28) and hiring an expert to say that it meets
`
`the stent mounting and retention functions (Ex. 1003 at ¶¶ 118-124)—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 in entitled to little or no weight.”)4
`
`4 Even if Petitioner could establish that the yellow highlighted region of Figure 31
`
`has certain function in Olympus, it still has not established that it serves the
`
`function of stent mounting or retention required in independent claims 1, 20 and 35
`
`of the ’962 Patent. First, there can be no dispute that there is no express teaching
`
`of such functions 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 ¶ 121) necessarily serves the function of stent mounting or retention.
`
`See In re Oelrich, 666 F.2d 578, 581–82, 212 USPQ 323, 326 (CCPA 1981) (“The
`
`fact that a certain result or characteristic may occur or be present in the prior art is
`
`not sufficient to establish the inherency of that result or characteristic.”); In re
`
`Footnote continued on next page
`
`-11-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`
`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 Solved By
`
`The Invention].) Instead, it is directed to reducing damages to in-vivo tissues due
`
`to the “very hard and sharp” stent edges. (Ex. 1015 at 17.) 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 which is even remotely relevant to facilitating stent
`
`Footnote continued from previous page
`Rijckaert, 9 F.3d 1531, 1534 (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).
`
`-12-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`mounting and retention required in each of the challenged claims of the ’962 Patent
`
`in Ground 1.5
`
`5 As to what the yellow highlighted region of Figure 31 is, not only is there no
`
`evidence demonstrating that it is a mounting body or that it serves the stent
`
`mounting and retention functions, evidence 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
`
`Footnote continued on next page
`
`-13-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`Dependent claims 2-3 and 21-22. In addition to the above, Petitioner also
`
`fails to demonstrate that the combination of Olympus and Burton discloses specific
`
`limitations in dependent claims 2-3 and 20-21. In particular, claims 2 and 21
`
`require that a mounting body be “of a material which resiliently deforms under
`
`radial pressure.” Claims 3 and 22 further require that “the material is elastomeric.”
`
`The cited portion of Olympus relied on by Petitioner states that a stent—not the
`
`alleged mounting body (i.e., the yellow highlighted region in Figure 31)—can be
`
`covered with a polyurethane thermoplastic elastomer. (See Pet. at 41 (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.”).) Further, the cited portions of Burton
`
`relied on by Petitioner relate to “a high friction material.” (See Pet. at 40-41 (citing
`
`Footnote continued from previous page
`hatched regions “50” and “51”); 6:49-62 (“the first and second inflatable working
`
`sections 50 and 51”); see also Figure 1, 3-4.)
`
`-14-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`Ex. 1014 at 3:48-61, 4:3-7, 5:46-51, 5:56-64).) Petitioner has not explained why
`
`“a high friction material” disclosed in Burton necessarily “resiliently deforms
`
`under radial pressure” or is “elastomeric” as required in claims 2-3 and 21-22.
`
`Dependent claims 6-7 and 25-26. In addition, claim 6 requires that the
`
`mounting body include “at least one separation whereby the flexibility of the body
`
`and catheter is increased.” Claim 25 requires that the mounting body include “at
`
`least one separation whereby trackability of the catheter is improved.” Claims 7
`
`and 26 further require that the recited separation is in the form of a spiral. While
`
`Petitioner relies on Olympus, Burton and Fischell ’507 for the disclosure of the
`
`limitations in claims 6-7 and 25-26 (Pet. at 41-43, 48), none of them actually
`
`disclose those limitations.
`
`First, while Petition asserts that Olympus “teaches the use of spiral-shaped
`
`coil stents” (Pet. at 42), 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 (Pet. at 41), 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 4:35-37, 5:48-52.) Therefore, the dents in
`
`Figure 13 of Burton are not “separation[s]” and their functions are to prevent
`
`snagging, not increasing the “flexibility of the [mounting] body and catheter” or to
`
`-15-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`“improve” the “trackability of the catheter” required in claims 6-7 and 25-26.
`
`Indeed, Burton does not teach anything close to increasing flexibility or
`
`trackability. Petitioner’s assertion that the circumferential gaps in Burton are
`
`separations to “enhance the flexibility of the body of the Burton device” is
`
`unsupported and is contradicted by the express teachings of Burton. (Pet. at 41.)
`
`Third, contrary to Petitioner’s suggestion (Pet. at 42), Fischell ’507 teaches
`
`that the “grooves 26” are formed on the inner core itself (i.e., the catheter), not on a
`
`mounting body. (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 42), the
`
`purpose of the groves of Fischell ’507 is to provide a location into which a stent
`
`can be placed, not increasing the flexibility or trackability of the catheter. (Ex.
`
`1010 at 3:47-55 (“[S]piral groove 26 into which the coil spring IS [Intravascular
`
`-16-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`Stent] 10 is placed.”) Petitioner’s assertion that Fischell ’507 teaches separations
`
`in the mounting body to “improve flexibility” (Pet. at 42) again lacks merits and is
`
`contradicted by the express teachings of Fischell ’507.
`
`2.
`
`Petitioner Has Not Met Its Burden Of Demonstrating A
`Motivation To Combine References
`
`Even if Petitioner could demonstrate that the combinations of references
`
`teach each limitation of claims 1-3, 6-8, 11-13, 20-22, 25, 26, 29, 30, 35, and 36 of
`
`the ’962 Patent, Petitioner still fails to demonstrate a motivation to combine the
`
`references.
`
`Olympus In View Of Burton (And Knowledge Of The Art). Petitioner
`
`argues that one of ordinary skill in the art would have replaced “an integral
`
`mounting body” in Olympus with a separate one because a separate mounting body
`
`would improve manufacturability as suggested by Burton. (Pet. at 31; Ex. 1003 at
`
`¶ 127.) Petitioner’s argument fails for a number of reasons. First, as discussed
`
`above, the fundamental premise that Olympus teaches a mounting body for stent
`
`mounting and retention is utterly unsupported. Petitioner cannot find a single word
`
`in Olympus suggesting that the yellow highlighted region of Figure 31 is a
`
`mounting body or that it facilitates the mounting or retaining of a stent. Indeed, as
`
`discussed above, the entire disclosure of Olympus relates to stent edge protection.
`
`Not surprisingly, Petitioner fails to identify any disclosure in Olympus that
`
`remotely suggests an issue with stent mounting or retention. There is thus no
`
`-17-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`rational reason for a person skilled in the art to choose Olympus in an effort to
`
`address the issue of stent mounting or retention identified in the ’962 Patent.
`
`Second, even assuming one skilled in the art would select Olympus to
`
`modify for purposes of stent mounting and retention, there is still no indication in
`
`Olympus that the alleged integral mounting body needs to be improved, suffers any
`
`shortcoming, or is difficult to make. (Pet. at 31.) In other words, to the extent that
`
`one could believe that the alleged mounting body in Olympus serves the function
`
`of stent mounting or retention, there would be no reason to modify it as suggested
`
`by Petitioner. Petitioner’s assertion that “[a] POSITA would therefore consider
`
`whether alternatives to an integral mounting body were available and would
`
`immediately understand that making the mounting body separately and later
`
`attaching it to the shaft might be easier than forming an integral mounting body”
`
`has no support in Olympus. (Id.) For example, Petitioner cannot point to any
`
`teaching or suggestion in Olympus that indicates any manufacturability issues
`
`associated with the alleged “integral mounting body.” (Id.) The conclusory
`
`opinion of Petitioner’s expert suggesting such manufacturability issues without any
`
`support in Olympus or any facts or data, lacks probative value. (Ex. 1003 at
`
`¶ 127.)
`
`Third, even if a skilled artisan would elect to modify the alleged mounting
`
`body in Olympus, there would not be any rational reason to combine it with Burton
`
`-18-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`as suggested by Petitioner. As an initial matter, contrary to Petitioner’s suggestion
`
`(Pet. at 31), Burton merely states that a gripping member could be “integral portion
`
`of the core” or “attached around the periphery of the core” without hinting any
`
`preference for the latter choice or that the former choice would have any
`
`manufacturability issues. (Ex. 1014 at 2:22-24.) And contrary to Petitioner’s
`
`assertion (Pet. at 31-32), the structure “7” in Figure 1 of Burton (reproduced
`
`below) is to provide “a smooth transition from said end of the outer sleeve,” not a
`
`“conical stop” to “secure the stent.” (Ex. 1014 at 5:32-35; Pet. at 26.) Thus, there
`
`is no evidence in Burton that supports a motivation to combine as Petitioner
`
`suggests.
`
`-19-
`
`

`

`Patent Owner’s Preliminary Response
`IPR2017-01294
`While Burton discusses stent securement issues, such disclosure is directed
`
`to a self-expanding stent, without the involvement of any balloon. Olympus, on
`
`the other hand, is directed to a stent delivery system using a balloon. Moreover,
`
`Olympus and Burton address entirely different problems. While Olympus is
`
`directed to protecting in-vivo tissues or endoscope channels from the sharp edges
`
`of a balloon-expandable stent (Ex. 1015 at 17), Burton is directed to a structure for
`
`releasably holding a self-expanding stent (Ex. 1014 at 2:13-32). See Broadcom
`
`Corp. v. Emulex Corp., 732 F.3d 1325, 1334 (Fed. Cir. 2013) (“[P]rior art
`
`references that address different problems may not . . . support an inference that the
`
`skilled artisan would consult both of them simultaneously.”); Palo Alto Networks,
`
`Inc. v. Finjan, Inc., IPR2016-00165, Paper 7 at 17-18 (PTAB Apr. 21, 2016)
`
`(denying institution because there was no motivation to combine two references
`
`where the second reference “addresses a different problem” than the first).
`
`There is no suggestion in Olympus that its balloon-expandable stent could be
`
`