Trials@uspto.gov
`571.272.7822
`
`
`
`Paper No. 8
`Filed: October 25, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01298
`Patent 7,749,234 B2
`____________
`
`
`
`Before JAMES A. TARTAL, MICHAEL L. WOODS, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`WOODS, Administrative Patent Judge.
`
`
`
`DECISION
`
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`

`

`IPR2017-01298
`Patent 7,749,234 B2
`
`
`I.
`
`INTRODUCTION
`
`Edwards Lifesciences Corporation (“Petitioner”) filed a Petition
`
`(Paper 2, “Pet.”) requesting inter partes review of claims 1–3, 5–8, 13, 15,
`
`and 18–20 of U.S. Patent No. 7,749,234 B2 (“the ’234 patent”). Pet. 1.
`
`Boston Scientific Scimed, Inc. (“Patent Owner”) filed a Preliminary
`
`Response (Paper 7, “Prelim. Resp.”) in response to the Petition, contending
`
`that the Petition should be denied as to all challenged claims. Prelim. Resp.
`
`1.
`
`We have jurisdiction under 37 C.F.R. § 42.4(a) and 35 U.S.C. § 314,
`
`which provides that an inter partes review may not be instituted unless the
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`information presented in the Petition “shows that there is a reasonable
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`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.” Having considered the arguments and the
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`evidence presented, for the reasons described below, we do not institute an
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`inter partes review of any of the challenged claims.
`
`A. Related Proceedings
`
`Petitioner represents that the ’234 patent is at issue in Boston
`
`Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences
`
`Corp., No. 16-cv-730 (C.D. Cal.). Pet. 87.
`
`B. The ’234 Patent (Ex. 1001)
`
`The ’234 patent, titled “Catheter Support for Stent Delivery,” is
`
`“directed to improved arrangements for catheters of reduced profile for
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`performing angioplasty and for releasably attaching the stent to the catheter
`
`to facilitate delivery thereof.” Ex. 1001, 1:64–67. The ’234 patent describes
`
`that the “stent is held in place on [a] catheter by means of an enlarged
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`IPR2017-01298
`Patent 7,749,234 B2
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`mounting body carried within the balloon by the catheter shaft to which the
`
`stent and balloon are fitted.” Id. at 2:29–32.
`
`During prosecution of the ’234 patent, the applicant elected the
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`species of Figure 6. Ex. 1002, 97 (“Applicant hereby elects Species 3
`
`(Figure 6).”). To illustrate the elected catheter, we reproduce Figure 6 of the
`
`’234 patent, below:
`
`
`
`According to the ’234 patent, Figure 6 depicts an “embodiment of the
`
`invention with a mounting body positioned to receive a stent but with a stent
`
`not yet mounted.” Ex. 1001, 3:8–10. In particular, the ’234 patent describes
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`“a cylindrical mounting body 30 made up of a plurality of separate adjacent
`
`rings 30a held together by wire 31 which extends therethrough as shown
`
`with stops 29 to secure the rings together.” Id. at 5:32–36. The ’234 patent
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`further describes mounting body 30 as preferably being made of an
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`elastomer material, and more preferably, a resilient elastomer material, such
`
`as lower durometer silicone. Id. at 5:4–8. In operation, the catheter is
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`advanced and positioned through a patient’s vasculature until the stent is
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`adjacent to the portion of the vessel where treatment is desired. Id. at 5:15–
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`18. Once positioned, balloon 14 is inflated to expand the stent to a desired
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`IPR2017-01298
`Patent 7,749,234 B2
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`diameter, after which balloon 14 is deflated and the catheter is removed,
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`leaving the stent (not shown) in place. Id. at 5:18–22.
`
`
`
`C. Illustrative Claim
`
`Claim 1 is the sole independent claim. Ex. 1001, 7:61–10:7. Claim 1
`
`is also illustrative of the subject matter at issue and is reproduced below,
`
`with emphases added to particular limitations addressed in our Decision:
`
`1. A stent delivery catheter comprising:
`an inner shaft, the inner shaft having a proximal portion
`and a distal portion and a center axis,
`an inflatable medical balloon positioned about the distal
`portion of the inner shaft, the medical balloon having an
`expanded state, a contracted state, a proximal end and a distal
`end, wherein the medical balloon can be expanded from its
`contracted state to its expanded state, and
`at least one mounting body secured to the inner shaft,
`inside the medical balloon and around the center axis, the
`mounting body having a length, a circumferential surface,
`wherein the circumferential surface is a surface of the mounting
`body that is outermost relative to the center axis and that faces
`radially away from the center axis and toward the medical
`balloon, and having at least one separation in the circumferential
`surface, wherein the at least one separation is exposed to a
`portion of the medical balloon which is located along a radial line
`which extends from the center axis and through the separation,
`the at least one separation being a circumferential separation,
`wherein the mounting body is formed of a material which
`resiliently deforms under radial pressure.
`
`Id. at 7:61–8:17 (emphases added).
`
`
`
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`4
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`IPR2017-01298
`Patent 7,749,234 B2
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`
`D. References Relied Upon
`
`The Petitioner relies in relevant part on the following references:
`
`Name
`Olympus
`
`Reference
`Japanese Pub. No. H4-64367, published Feb.
`28, 1992, including its English translation
`US 5,026,377, issued June 25, 1991
`Burton
`Fischell ’507 US 4,768,507, issued Sept. 6, 1998
`Fischell ’274 US 5,639,274, issued June 17, 1997
`Williams
`US 5,437,083, issued Aug. 1, 1995
`Sugiyama
`US 4,994,032, issued Feb. 19, 1991
`Ravenscroft US 5,702,418, issued Dec. 30, 1997
`
`Ex. No.
`Ex. 1015
`
`Ex. 1014
`Ex. 1010
`Ex. 1013
`Ex. 1027
`Ex. 1009
`Ex. 1017
`
`
`
`E. Alleged Grounds of Unpatentability
`
`Petitioner contends that claims 1–3, 5–8, 13, 15, and 18–20 of the
`
`’234 patent are unpatentable under the following grounds:
`
`References
`Olympus, Burton, Fischell ’507, Fischell ’274,
`Williams, and knowledge of a person of ordinary
`skill in the art
`Fischell ’274, Burton, Williams, and knowledge
`of a person of ordinary skill in the art
`Sugiyama, Fischell ’507, Williams, and
`knowledge of a person of ordinary skill in the art
`Ravenscroft, Williams, and knowledge of a
`person of ordinary skill in the art
`
`Basis
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`Claims
`1–3, 5–8, 13,
`15, and 18–20
`
`1–3, 5, 13, 15,
`and 18–20
`1, 6–8, 13, 15,
`and 18–20
`1–3, 5, 13, 15,
`19, and 20
`
`Pet. i.1
`
`
`1 The Petition appears to lack the particularity and specificity required by
`35 U.S.C § 312(a)(3) and 37 C.F.R. § 42.104(b)(2). Petitioner’s allegation
`that the challenged “claims are taught by the following references, alone or
`in combination with each other” (see Pet. 24–25) and Petitioner’s
`identification of the grounds as outlined above, amounts to multiple distinct
`combinations of references. See also id. at 26 (the ground based on
`Olympus, Burton, Fischell ’507, Fischell ’274, Williams, and knowledge of
`a person of ordinary skill in the art), 47 (the ground based on Fischell ’274,
`
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`Patent 7,749,234 B2
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`
`Petitioner also relies on the declaration testimony of Thomas Trotta
`
`(Ex. 1003) in support of its Petition.
`
`II. ANALYSIS
`
`A. Claim Construction
`
`The parties agree that the ’234 patent has expired. Pet. 23 (“the ’234
`
`patent has expired”); Prelim. Resp. 6 (agreeing that the patent has expired).
`
`“[T]he Board’s review of the claims of an expired patent is similar to that of
`
`a district court’s review.” In re Rambus, Inc., 694 F.3d 42, 46 (Fed. Cir.
`
`2012). Therefore, we apply the principles set forth by the Court of Appeals
`
`for the Federal Circuit in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.
`
`2005) (en banc). Under this approach, claim terms are given their ordinary
`
`and customary meaning, as would be understood by a person of ordinary
`
`skill in the art, at the time of the invention, in light of the language of the
`
`claims, the specification, and the prosecution history of record. Id. at 1312–
`
`19.
`
`Although neither Patent Owner nor Petitioner proffer any particular
`
`construction for any claimed limitation (see Pet. 24; see also Prelim. Resp.
`
`
`Burton, Williams, and knowledge of a person of ordinary skill in the art), 61
`(the ground based on Sugiyama, Fischell ’507, Williams, and knowledge of
`a person of ordinary skill in the art), 61 (the ground based on Sugiyama,
`Fischell ’507, Williams, and knowledge of a person of ordinary skill in the
`art), and 75 (the ground based on Ravenscroft, Williams, and knowledge of a
`person of ordinary skill in the art). The function of the Board is not to comb
`through Petitioner’s arguments in order to decipher the strongest argument
`or to determine the strongest combination of references to challenge the
`claims. See generally LG Elecs., Inc. v. Rosetta-Wireless Corp., Case
`IPR2016-01516 (PTAB Apr. 3, 2017) (Paper 25). As such, for each
`identified ground, we exercise our discretion and consider all of the
`references in combination as one ground of unpatentability, as this is the
`most consistent reading of the Petition and claim charts.
`
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`IPR2017-01298
`Patent 7,749,234 B2
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`6–7), we determine that the claimed limitation, “wherein the mounting body
`
`is formed of a material which resiliently deforms under radial pressure,”
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`requires express construction for purposes of this Decision, namely, to
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`analyze Petitioner’s challenge under Ravenscroft, Williams, and the
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`knowledge of a person of ordinary skill in the art. In particular, Petitioner
`
`appears to interpret “resiliently deformable” as being analogous to
`
`flexibility. See Pet. 81–82 (“a POSITA would have understood that flexible
`
`thin portion 17 would be made of a material even more flexible (and
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`resiliently deformable) than PEBAX”).
`
`1.
`“wherein the mounting body is formed of a material which
`resiliently deforms under radial pressure”
`
`The parties agree that the claimed limitation should be given its plain
`
`and ordinary meaning. Pet. 23–24; Prelim. Resp. 6–7. As discussed above,
`
`for an expired patent, we give claim terms their ordinary and customary
`
`meaning, as would be understood by a person of ordinary skill in the art, at
`
`the time of the invention, in light of the language of the claims, the
`
`specification, and the prosecution history of record. Phillips, 415 F.3d at
`
`1312–19.
`
`We first focus on the language of the claimed limitation. Here, the
`
`claim requires the mounting body to be formed of a material that resiliently
`
`deforms under radial pressure. “[I]n determining the ordinary and customary
`
`meaning of the claim term as viewed by a person of ordinary skill in the art,
`
`it is appropriate to consult a general dictionary definition of the word for
`
`guidance.” See Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed.
`
`Cir. 2010) (citation omitted). In consulting general dictionary definitions,
`
`we find “resiliently” to be the adverb of the adjective “resilient,” which can
`
`be defined as “returning to the original form or position after being bent,
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`IPR2017-01298
`Patent 7,749,234 B2
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`compressed, or stretched” and “capable of withstanding shock without
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`permanent deformation or rupture.” Dictionary.com definition of “resilient,”
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`http://www.dictionary.com/browse/resilient (last visited on Sept. 21, 2017);
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`Merriam-Webster definition of “resilient,” https://www.merriam-
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`webster.com/dictionary/resilient (last visited on Sept. 21, 2017). We further
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`note that these definitions were relied on by Petitioner in the related district
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`court proceeding. See Ex. 2003, 18–19.
`
`We also examine the Specification to determine how the claim term is
`
`used throughout the ’234 patent. Upon reviewing the Specification, we find
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`the following disclosure helpful in our interpretation of the claimed
`
`limitation:
`
`Although, the material of the mounting body may be hard,
`it is preferably of any deformable thermoplastic material,
`preferably an elastomer material and more preferably of a
`relatively resilient elastomer material, e.g., lower durometer
`silicone. A preferred deformable thermoplastic material is high
`density polyethylene (HDPE). A preferred lower durometer
`silicone is in the form of tubing. The deformation of the resilient
`material of the mounting body when the stent/balloon is crimped
`to it causes a radial outward force on the stent/balloon
`increasing the friction therebetween despite any recoil of the
`stent.
`
`Ex. 1001, 5:4–14 (emphases added). We further note that the parties each
`
`cite to this portion of the Specification in support of their respective district
`
`court claim constructions. See Ex. 2003, 18–19.
`
`We now focus on the prosecution history of record. In an amendment
`
`dated September 30, 2008, the applicant amended independent claim 1 to
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`recite, “wherein the mounting body is formed of a material which resiliently
`
`deforms under radial pressure.” Ex. 1002, 577. Along with the amendment,
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`the applicant distinguished over other cited art as failing to “address what
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`Patent 7,749,234 B2
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`material the ‘mounting body’ is made of” and, for at least this reason, argued
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`that an Examiner’s particular rejection was improper. Id. at 581–582.
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`Upon reviewing the language of the claims, the specification, and the
`
`prosecution history of record, we conclude that the claimed limitation,
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`“wherein the mounting body is formed of a material which resiliently
`
`deforms under radial pressure,” requires the mounting body to be formed of
`
`a material that returns to its original form, and without permanent
`
`deformation, after being compressed by some radial pressure, such as, but
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`not limited to, the radial pressure resulting from crimping a stent on a
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`balloon positioned outside and around the mounting body.
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`2.
`
`Other Claimed Limitations
`
`We determine that no other terms require express construction for the
`
`purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642
`
`F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to
`
`the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc.
`
`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`B. Principles of Law
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
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`between the subject matter sought to be patented and the prior art are such
`
`that the subject matter as a whole would have been obvious at the time the
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`invention was made to a person having ordinary skill in the art to which said
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`subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
`
`factual determinations, including (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art; (3)
`
`the level of skill in the art; and (4) objective evidence of nonobviousness,
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`i.e., secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–
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`18 (1966).
`
`“In an [inter partes review], the petitioner has the burden from the
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`onset to show with particularity why the patent it challenges is
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`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`
`Cir. 2016). This burden never shifts to Patent Owner. Dynamic Drinkware,
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`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`C. Level of Ordinary Skill in the Art
`
`In determining whether an invention would have been obvious at the
`
`time it was made, we consider the level of ordinary skill in the pertinent art
`
`at the time of the invention. Graham, 383 U.S. at 17.
`
`Petitioner relies upon the Trotta Declaration (Ex. 1003) and contends
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`that a person of ordinary skill in the art (“POSITA”) would have “an
`
`undergraduate degree in science in mechanical, manufacturing, or material
`
`science engineering, as well as at least five years’ experience in designing
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`minimally invasive catheter-based interventions,” or “an undergraduate
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`degree in a different subject matter . . . [and] five to ten years of experience
`
`in the industry in designing minimally invasive catheter-based
`
`interventions.” Pet. 22–23 (citing Ex. 1003 ¶¶ 87–89). Patent Owner does
`
`not provide an assessment of a relevant skill level. See generally Prelim.
`
`Resp.
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`Based on our review of the ’234 patent, the types of problems and
`
`solutions described in the ’234 patent and applied prior art, and the
`
`testimony of Mr. Trotta, we apply Petitioner’s assessment for purposes of
`
`this Decision. Further, the applied prior art reflects the appropriate level of
`
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`skill at the time of the claimed invention. See Okajima v. Bourdeau, 261
`
`F.3d 1350, 1355 (Fed. Cir. 2001).
`
`D. Cited Art
`
`1.
`
`Olympus (Ex. 1015)
`
`Olympus is a Japanese Publication that discloses an “expansion tool
`
`for biological ducts.” Ex. 1015, 16. In particular, Olympus discloses a
`
`balloon dilator for expanding a blood vessel and deploying a stent. See id. at
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`16–17. To illustrate a particular embodiment of Olympus’s expansion
`
`tool—which Petitioner itself relies upon (Pet. 27)—we reproduce Figures
`
`28–32, below:
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`
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`
`According to Olympus, these figures depict mesh-shaped stent 1
`
`mounted ono the outer periphery of balloon 4 of balloon dilator 3, and
`
`positioned within biological duct 7. Ex. 1015, 24. In order to prevent any
`
`sharp edges from stent 1 from damaging the inner surface of duct 7, a ring-
`
`shaped thermal softening material 21 is provided over stent 1. Id. This
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`thermal softening material 21 may be composed of polyurethane
`
`thermoplastic elastomer. Id.
`
`2.
`
`Burton (Ex. 1014)
`
`Burton is a U.S. Patent titled “Stent Placement Instrument and
`
`Method.” Ex. 1014, [54]. Figures 1 and 3 of Burton are reproduced below:
`
`
`
`
`
`
`
`
`
`According to Burton, Figure 1 depicts an instrument for holding and
`
`deploying self-expanding stent 10, wherein the instrument includes grip
`
`member 9, one embodiment of which is depicted in greater detail in Figure
`
`3. Id. at [57], 5:11–12, 5:15–16. As shown in Figure 3, Burton explains that
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`grip member 9 engages stent 10 with a high-friction surface material. Id. at
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`3:48–56, 5:46–48.
`
`3.
`
`Fischell ’507 (Ex. 1010)
`
`Fischell ’507 is a U.S. Patent titled “Intravascular Stent and
`
`Percutaneous Insertion Catheter System for the Dilation of an Arterial
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`Stenosis and the Prevention of Arterial Restenosis.” Ex. 1010, [54]. To
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`illustrate Fischell ’507’s insertion catheter, we reproduced Figure 3, below:
`
`
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`According to Fischell ’507, Figure 3 depicts the distal end of insertion
`
`catheter 20, including inner core 22 and outer cylinder 24. Id. at 3:47–49.
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`Core 22 includes spiral grooves 26 into which coil spring 10 is placed. Id. at
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`3, 3:49–51. Coil spring 10 is an intravascular stent that is placed at a
`
`dilation site immediately after balloon dilation. Id. at 3:33–35.
`
`4.
`
`Fischell ’274 (Ex. 1013)
`
`Fischell ’274 is a U.S. Patent titled “Integrated Catheter System for
`
`Balloon Angioplasty and Stent Delivery.” Ex. 1013, [54]. Figure 2A of
`
`Fischell ’274 is reproduced below.
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`
`
`Figure 2A depicts a longitudinal cross section of a preferred integrated
`
`catheter system 60, which includes balloon angioplasty catheter 20,
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`inflatable balloon 23, and stent catheter 65 with stent 15 retained in
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`containment cavity 69. Id. at 3:29–30, 4:50–57; see also id. at Fig. 1
`
`(depicting a “simplified form of the integrated catheter system”). Outer tube
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`31 (numbered in Fig. 1) is provided to enclose a self-expanding or balloon
`
`expandable stent 15. Id. at 4:45–47.
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`The integrated catheter system 60 is used as follows: (1) system 60 is
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`advanced through an artery until balloon 23 lies within an arterial stenosis
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`(id. at Fig. 7A); (2) balloon 23 is inflated and stent catheter 65 passes
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`therethrough (id. at Fig. 7B); (3) balloon 23 is deflated (id. at Fig. 7C); (4)
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`stent 15 is positioned over balloon 23 (id. at Fig. 7D); (5) balloon 23 is
`
`inflated minimally, which causes stent 15 to be retained on balloon 23, and
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`the stent catheter is pulled back (id. at Fig. 7E); (6) stent 15 deploys, either
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`through self-expansion (id. at Fig. 7E') or through inflation of the balloon to
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`high pressure (id. at Fig. 7F); and (7) balloon 23 is deflated and retracted
`
`from the artery (id. at Fig. 7G). See also id. at 6:3–50.
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`5.
`
`Sugiyama (Ex. 1009)
`
`Sugiyama is a U.S. Patent titled “Balloon Catheter.” Ex. 1009, [54].
`
`Although Sugiyama describes a “balloon catheter for expanding and thereby
`
`remedying stenosis in a blood vessel” (id. at 1:7–9), Sugiyama does not
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`disclose that its catheter is used for deploying a stent (see generally id.).
`
`Sugiyama’s Figure 13 is reproduced below.
`
`
`
`Figure 13 depicts an enlarged sectional view of the distal end of a
`
`balloon catheter. Id. at 2:47–48, 67–68. As reflected in Figure 13,
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`“reinforcement 9 is wound about a predetermined portion of the outer
`
`surface of the inner tube 1 which is enclosed within the balloon 3. . . .
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`[Accordingly], the inner tube is rendered more resistant against buckling.”
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`Id. at 4:58–68. Sugiyama specifies that reinforcement 9 may “have turns
`
`[thereof] so wound that they be in intimate contact with each other” or “may
`
`alternatively be so wound that its turns are thick for example in intimate
`
`contact with each other in both end parts and thin or sparse in the
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`intermediate part of the coil spring.” Id. at 7:53–63.
`
`6.
`
`Ravenscroft (Ex. 1017)
`
`Ravenscroft is a U.S. Patent titled “Stent Delivery System.” Ex. 1017,
`
`[54]. Ravenscroft discloses different embodiments of a stent delivery
`
`system, including a stent delivery system that (1) deploys a self-expanding
`
`stent without a balloon (id. at Figs. 1, 3), and (2) deploys a non-self-
`
`expanding stent with the aid of a balloon (id. at Fig. 7). See id. at 5:46–62,
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`15
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`7:1–6. To illustrate Ravenscroft’s embodiment of the non-self-expanding
`
`stent that utilizes a balloon, we reproduce Figure 7 of Ravenscroft, below:
`
`
`
`According to Ravenscroft, Figure 7 depicts a stent delivery system for
`
`deploying a non-self-expanding stent. Id. at 4:60–62. In particular, Figure 7
`
`depicts, “expansible balloon 60 that underlies the stent 50 between proximal
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`ends 58 and 59 [and] balloon 60 also underlies between the rings and the
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`stent 50.” Id. at 7:10–14. Ravenscroft also describes stiff portion 15 as
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`extending along catheter 11 and core portions 16, 17 as “relatively flexible
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`radially.” Id. at 5:23–31.
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`7. Williams (Ex. 1027)
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`Williams is a U.S. Patent titled “Stent-Loading Mechanism” and
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`discloses a device for loading a stent onto a catheter assembly. Ex. 1027,
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`[54], 1:48–50. Williams discloses that its device allows for stents to be
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`crimped onto the outside of the catheter. Id. at 2:16–22.
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`E. Olympus, Burton, Fischell ’507, Fischell ’274, Williams, and
`knowledge of a person of ordinary skill in the art
`
`Petitioner contends that claims 1–3, 5–8, 13, 15, and 18–20 are
`
`unpatentable over Olympus, Burton, Fischell ’507, Fischell ’274, Williams,
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`and the knowledge of a person of ordinary skill in the art. Pet. 26; see infra
`
`n.1.
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`Patent 7,749,234 B2
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`1.
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`Petitioner’s Challenge
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`Petitioner submits that Olympus discloses a balloon-expandable stent
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`delivery catheter that utilizes a balloon to simultaneously dilate a blood
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`vessel and deploy a balloon-expandable stent. Pet. 26 (citing Ex. 1015, 1,
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`8). In addressing the claimed “mounting body,” Petitioner submits
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`annotated versions of Olympus’s Figures 30 and 31, which we reproduce
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`below (id. at 26–27):
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`According to Petitioner, Olympus’s “thickened section of catheter 5”
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`forms a “mounting body” under balloon 4, and supports stent 1 (illustrated in
`
`
`
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`17
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`Patent 7,749,234 B2
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`the unannotated version of Figure 30, reproduced supra) while the stent is
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`advanced on the balloon and to implantation site 8. Id. at 26–27 (emphasis
`
`added).
`
`Petitioner also relies on Burton in addressing the claimed “mounting
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`body,” providing an annotated version of Burton’s Figure 3, which we
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`reproduce, below (Pet. 28):
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`
`
`Burton describes Figure 3 as depicting grip member 9 “made from a
`
`high friction material” around the periphery of outer hollow core 5 and in
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`direct contact with stent 10. Ex. 1014, 5:46–51. According to Petitioner,
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`Burton teaches that its “grip member” is designed to securely hold a
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`compacted stent during delivery, and prevents the stent from slipping off the
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`grip member. Pet. 28 (citing Ex. 1014, 2:20–32, 4:67–5:2).
`
`In combining Olympus with Burton, Petitioner proposes to modify the
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`Olympus device to have a separate mounting body because the modification
`
`would improve the manufacturability of the device and that a person having
`
`ordinary skill in the art would have considered a mounting body like
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`Burton’s grip member. Pet. 30 (citing Ex. 1014, 2:21–23). Petitioner further
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`reasons that a person having ordinary skill in the art would place Burton’s
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`grip member (the claimed “mounting body”) “underneath the balloon,”
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`Patent 7,749,234 B2
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`because if “it were on top of the balloon, it would impair the expansion of
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`the balloon.” Id. at 30–31 (citing Ex. 1003 ¶ 121).
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`2.
`
`Analysis
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`Patent Owner argues that Petitioner has not shown sufficiently that a
`
`person of ordinary skill in the art would have modified Olympus to arrive at
`
`the claimed invention. See Prelim. Resp. 18–23. We agree.
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`Petitioner’s proposed modification of Olympus places Burton’s grip
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`member 9 underneath Olympus’s balloon, purportedly to arrive at a “stent
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`delivery system in which the stent was well secured to the catheter.” Pet 31
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`(citing Ex. 1003 ¶ 121). However, Burton explains that grip member 9
`
`retains stent 10 due to physical contact between the grip member and the
`
`stent, for example, through a high-friction surface between the grip member
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`and the stent. See, e.g., Ex. 1014, 5:46–47 (“grip member 9 made from a
`
`high friction material”); see also id. at 3:48–56 (“an important characteristic
`
`of the grip member is that it should be capable of gripping or holding a stent
`
`. . . it is necessary when the grip member is a sleeve of material, that said
`
`material has a surface which offers high resistance to sliding motion”); see
`
`also id. at Fig. 3. Neither Petitioner nor Mr. Trotta explain sufficiently how,
`
`in the proposed modification, Burton’s grip member would serve to retain
`
`Olympus’s stent when Olympus’s balloon is located between the grip
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`member and the stent. See Pet. 28–31; Ex. 1003 ¶ 121. In particular, we
`
`find nothing in the cited portion of Mr. Trotta’s declaration that addresses
`
`how Burton’s grip member would secure a stent under the proposed
`
`modification, namely, in the absence of direct contact between the stent and
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`grip member. See, e.g., Ex. 1003 ¶ 121; see also 37 C.F.R. § 42.65(a)
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`(“Expert testimony that does not disclose the underlying facts or data on
`
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`which the opinion is based is entitled to little or no weight.”). Rather, we
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`find persuasive Patent Owner’s argument that Burton’s grip member would
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`seemingly “be rendered ineffective if used in the balloon catheter of
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`Olympus[,] . . . because, in Olympus, the stent is not in direct contact with
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`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 contact between the stent and the grip member.” Prelim.
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`Resp. 22 (citing Ex. 1015, Fig. 31; Ex. 1014, 5:48–52). As such, we are not
`
`persuaded that Petitioner presents a sufficient rationale to show that it would
`
`have been obvious for a person of ordinary skill in the art to have combined
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`Olympus and Burton to secure Olympus’s stent, as Petitioner contends. Pet.
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`29–31.
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`Based on the record before us, we determine that Petitioner has not
`
`established a reasonable likelihood of prevailing on its contention that the
`
`combined teachings of Olympus, Burton, Fischell ’507, Fischell ’274,
`
`Williams, and the knowledge of a POSITA render obvious claims 1–3, 5–8,
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`13, 15, and 18–20.
`
`F. Fischell ’274, Burton, Williams, and
`knowledge of a person of ordinary skill in the art
`
`Petitioner contends that claims 1–3, 5, 13, 15, and 18–20 are
`
`unpatentable over Fischell ’274, Burton, Williams, and the knowledge of a
`
`person of ordinary skill in the art. Pet. 47; see infra n.1.
`
`1.
`
`Petitioner’s Challenge
`
`Petitioner submits that Fischell ’274 discloses a balloon-expandable
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`stent delivery system substantially as claimed, and as shown in Figure 1,
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`which we reproduce below (Pet. 47–48):
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`According to Petitioner, and as shown above, Fischell ’274 discloses,
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`inter alia, catheter 12 having balloon 23, where stent 15 is “moved over the
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`balloon for deployment by pusher tube 32.” Id. (citing, in part, Ex. 1013,
`
`4:32–49).
`
`Petitioner acknowledges that “[a]lthough Fischell ’274’s delivery
`
`system relies primarily on the outer sheath [31] for securement, it also
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`teaches that the balloon itself has some stent retention ability.” Id. at 48
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`(citing Ex. 1013, 6:34–38). Petitioner argues that this teaching would have
`
`suggested to a person having ordinary skill in the art “to add [a] mounting
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`body under the balloon to help secure the stent, thereby dispensing with the
`
`outer sheath structure, and improving profile, flexibility, and trackability.”
`
`Id. Petitioner further asserts a person having ordinary skill in the art would
`
`have considered and combined Burton’s “grip member,” discussed supra.
`
`See id. at 49.
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`In summary, Petitioner proposes to modify the stent delivery system
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`of Fischell ’274 by (1) dispensing with outer tube structure 31 (id. at 48) and
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`(2) adding Burton’s “grip member” 9 “underneath the balloon” “to secure
`
`the balloon-expandable stent” (id. at 50–51 (citing Ex. 1003 ¶¶ 142–143)).
`
`Petitioner submits that this improved stent delivery system would “ensure
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`stent securement, simplify delivery system operation, and decrease the
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`overall profile of the delivery catheter.” Id. at 51 (citing Ex. 1003 ¶ 141).
`
`2.
`
`Analysis
`
`As with the prior ground, Patent Owner argues that Petitioner has not
`
`shown sufficiently that a person of ordinary skill in the art would have
`
`modified Fischell ’274 to arrive at the claimed invention. Prelim. Resp. 29–
`
`31. We agree.
`
`Petitioner’s proposed modification to Fischell ’274 places Burton’s
`
`grip member 9 underneath Fischell 274’s balloon 23, purportedly to “secure
`
`the balloon-expandable stent.” Pet 51 (citing Ex. 1003 ¶ 142). However,
`
`Burton explains that grip member 9 retains the stent due to physical contact
`
`between the grip member and the stent, for example, through a high-friction
`
`surface between the grip member and the stent. See, e.g., Ex. 1014, 5:46–47
`
`(“grip member 9 made from a high friction material”); see also id. at 3:48–
`
`56 (“an important characteristic of the grip member is that it should be
`
`capable of gripping or holding a stent . . . it is necessary when the grip
`
`member is a sleeve of material, that said material has a surface which offers
`
`high resistance to sliding motion”); id. at Fig. 3. As with the previous
`
`ground, neither Petitioner nor Mr. Trotta explain sufficiently how, in the
`
`proposed modification, Burton’s grip member would serve to retain Fischell
`
`’274’s stent when Fischell ’274’s balloon is located between the grip
`
`member and the stent. See Pet. 49–52; Ex. 1003 ¶¶ 141–143. In particular,
`
`we find nothing in the ci