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 IPR2017-01296
`Patent 6,007,543
`_______________
`
`
`Before JAMES A. TARTAL, ROBERT L. KINDER,
`and AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`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 IPR2017-01296
`Patent 6,007,543
`_______________
`
`
`Before JAMES A. TARTAL, ROBERT L. KINDER,
`and AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2017-01296
`Patent 6,007,543
`
`
`A. Background
`
`I.
`
`INTRODUCTION
`
`Edwards Lifesciences Corporation (“Petitioner”) filed a Petition
`requesting an inter partes review of claims 1–3, 6–12, 19–21, and 24–29
`(“the challenged claims”) of U.S. Patent No. 6,007,543 (Ex. 1001, “the ’543
`patent”). Paper 2 (“Pet”). Boston Scientific Scimed, Inc. (“Patent Owner”)
`filed a Preliminary Response. Paper 7 (“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314(a), which provides that an
`inter partes review may not be instituted unless the information presented in
`the Petition shows that “there is a reasonable likelihood that the petitioner
`would prevail with respect to at least 1 of the claims challenged in the
`petition.” See also 37 C.F.R § 42.4(a) (delegating authority to the Board).
`After considering the Petition and Preliminary Response, for the reasons
`discussed below, we do not institute an inter partes review.
`
`B. Related Proceeding
`
`The parties represent that the ’543 patent is at issue in Boston
`Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences
`Corp., No. 16-cv-730 (C.D. Cal.). Pet. 85; Paper 4, 2.
`
`C. The ’543 Patent
`
`The ’543 patent, titled “Stent Delivery System with Stent Securement
`Means,” issued December 28, 1999, from U.S. Patent Application No.
`08/702,150, which was filed August 23, 1996. Ex. 1001, [45], [54], [21],
`[22].
`
`
`
`2
`
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`IPR2017-01296
`Patent 6,007,543
`
`
`Figure 1 of the ’543 patent is reproduced below.
`
`
`Figure 1 depicts an isometric view of a balloon catheter and stent. Ex. 1001,
`2:12–15. As shown in Figure 1, catheter 12 includes balloon 14 at distal end
`12b, to which stent 18 is fixed. Id. at 2:40–42, 50–51. In use, catheter 12 is
`advanced through a patient’s vasculature to a desired location and, once
`reached, balloon 14 and stent 18 are expanded. Id. at 2:51–55. After
`expansion, the balloon is deflated and the catheter and balloon are
`withdrawn, while the stent remains in place to maintain the vessel in an
`expanded state. Id. at 1:10–15, 2:55–58.
`Figure 3 of the ’543 patent is reproduced below.
`
`
`Figure 3 depicts an enlarged cross-sectional view of the distal end of
`catheter 12, with balloon 14 and stent 18 in expanded states. Id. at 2:20–23.
`As shown in Figure 3, “a mounting body 30 . . . is included inside balloon 14
`to provide a cushion and/or substrate of enlarged diameter relative to the
`stent shaft to support and hold the stent and secure it during crimping and
`
`
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`IPR2017-01296
`Patent 6,007,543
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`the delivery procedure.” Id. at 3:26–30. In Figure 3, mounting body 30 is a
`cylindrical sleeve carried on inner lumen 26 of the catheter. Id. at 3:35–37.
`However, the ’543 patent also discloses alternate mounting bodies, including
`a spiral cut mounting body (id. at Fig. 4), a cylindrical body comprising
`separate, adjacent rings 30a (id. at Fig. 5), a two-piece interlocked body 30a,
`30b (id. at Fig. 6), or a body comprising a plurality of separate, spaced
`bodies 30a, 30b, 30c (id. at Fig. 8). See id. at 3:66–4:38.
`
`D. Illustrative Claim
`
`Of the challenged claims, claims 1 and 19 are independent.
`Independent claim 1 is illustrative, and is reproduced below:
`1.
`A stent delivery system comprising:
`a radially expandable stent of generally cylindrical
`configuration, having a first end and a second end and a
`contracted state and an expanded state, and
`a catheter having a shaft having a diameter and
`expandable inflatable means associated therewith at a
`distal part of the shaft, wherein the inflatable means
`including mounting and
`comprises a balloon, and
`retaining means for receiving the stent on the expandable
`inflatable means for radial expansion of the stent upon
`inflation of the inflatable means, the mounting and
`retaining means including at least one mounting body
`carried on and surrounding the shaft inside the inflatable
`means, the at least one mounting body being substantially
`the same length as the stent and being positioned on the
`shaft such that when the stent is loaded onto the inflatable
`means and the shaft in the stent's contracted state at least a
`portion of the at least one mounting body is under the stent
`and between the first and second ends of the stent,
`whereby the diameter of the shaft and inflatable portion
`are increased at the distal part for facilitating the mounting
`and retaining of the stent.
`
`4
`
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`IPR2017-01296
`Patent 6,007,543
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`Ex. 1001, 4:49–5:4 (emphasis added). Independent claim 19 recites a
`“balloon catheter” comprising, inter alia, “means for inflating the balloon.”
`Id. at 6:13, 6:17–18.
`
`E. Prior Art Relied Upon
`
`Petitioner relies upon the following prior art references, as well as the
`Declaration of Thomas Trotta (Ex. 1003). Pet. 20–21.
`Reference
`Patent No.
`Relevant Dates
`Sugiyama ’032 US 4,994,032
`Filed Nov. 29, 1988
`Issued Feb. 19, 1991
`Filed Aug. 31, 1987
`Issued Sept. 6, 1988
`Filed June 2, 1995
`Issued June 17, 1997
`Filed Aug. 17, 1990
`Issued June 25, 1991
`Filed July 3, 1990
`Published Feb. 28, 1992
`Filed June 7, 1995
`Issued Nov. 17, 1998
`Filed June 7, 1995
`Issued Apr. 21, 1998
`Filed May 24, 1993
`Issued Aug. 1, 1995
`
`Exhibit No.
`Ex. 1009
`
`Ex. 1010
`
`Ex. 1013
`
`Ex. 1014
`
`Ex. 10151
`
`Ex. 1016
`
`Ex. 1026
`
`Ex. 1027
`
`Fischell ’507
`
`US 4,768,507
`
`Fischell ’274
`
`US 5,639,274
`
`Burton
`
`US 5,026,377
`
`Olympus
`
`JP 1992-64367
`
`Jendersee
`
`US 5,836,965
`
`Pathak
`
`US 5,741,323
`
`Williams
`
`US 5,437,083
`
`
`
`
`1 Exhibit 1015 includes a Japanese-language version of the reference, at
`exhibit pages 1–15, an English translation of the reference, at exhibit pages
`16–35, and a notarized Certificate of Translation, at exhibit pages 36–37.
`
`
`
`5
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`IPR2017-01296
`Patent 6,007,543
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`
`F. Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–3, 6–12, 19–21, and
`24–29 of the ’543 patent based on the following grounds. Pet. 22–83.2
`References
`Basis
`Claim(s)
`Challenged
`§ 103(a) 1–3, 6, 7, 11, 12, 19–21,
`24, 25, 28, and 29
`
`[1] Olympus in View of the
`Knowledge of a POSITA and/or
`Burton, Fischell ’274, and/or
`Fischell ’507
`[2] Fischell ’274 and Burton
`
`§ 103(a) 1–3, 6, 11, 12, 19–21,
`24, 28, and 29
`[3] Sugiyama ’032 and Fischell ’507 § 103(a) 1, 2, 6, 7, 11, 19, 20, 24,
`25, 28, and 29
`§ 102(e) 1–3, 11, 19–21, 28,
`and 29
`§ 103(a) 9, 10, 12, 26, 27
`
`[4] Pathak
`
`[5] The References in Ground 1–3,
`and Jendersee
`[6] The References in Ground 1–3,
`and the Knowledge of a POSITA or
`Williams
`
`§ 103(a) 8
`
`
`2 Although we need not address in depth the asserted grounds of
`unpatentability in this case, see infra, 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
`unpatentable over “the references identified below, alone or in combination
`with each other” (see Pet. 20), and Petitioner’s identification of the grounds
`as outlined above, amounts to many distinct combinations of references.
`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).
`
`
`
`6
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`Patent 6,007,543
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`
`II. DISCUSSION
`
`A. Claim Construction
`
`The parties agree that the ’543 patent has expired. Pet. 17; Prelim.
`Resp. 7. “[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). Accordingly, the “words of a claim ‘are
`generally given their ordinary and customary meaning’” as understood by a
`person of ordinary skill in the art at the time of the invention. Id. at 1312.
`1. The Parties’ Positions
`For purposes of this proceeding, Petitioner adopts Patent Owner’s
`proposed constructions from co-pending district court litigation. Pet. 18.
`Accordingly, Petitioner adopts the following positions:
`
`Claim
`Limitation
`“expandable
`inflatable means”
`(see claim 1)
`“mounting and
`retaining means
`for receiving the
`stent”
`(see claim 1)
`“means for
`inflating the
`balloon”
`(see claim 19)
`
`
`
`Construction
`
`Applicability of
`35 U.S.C. § 112 ¶ 6
`Not subject to § 112 ¶ 6 “a structure capable of
`being expanded and
`inflated”
`Not subject to § 112 ¶ 6 “a structure on which
`another structure can be
`mounted and retained”
`
`Subject to § 112 ¶ 6
`
`Corresponding structure is
`“fluid (gas or liquid) from
`an inflation port and
`equivalents thereof”
`
`7
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`IPR2017-01296
`Patent 6,007,543
`
`See id. at 19 (citing Ex. 1007). Patent Owner “agrees . . . that Patent
`Owner’s proposed constructions . . . in the district court litigation are the
`proper constructions.” Prelim. Resp. 7.3
`2. Means-Plus-Function Claiming
`Means-plus-function claiming is allowed pursuant to 35 U.S.C. § 112
`
`¶ 6, which provides that:
`An element in a claim for a combination may be expressed
`as a means or step for performing a specified function without
`the recital of structure, material, or acts in support thereof, and
`such claim shall be construed to cover the corresponding
`structure, material, or acts described in the specification and
`equivalents thereof.4
`Claim limitations that include the term “means” or “means for” are
`presumed to invoke 35 U.S.C. § 112 ¶ 6. See Williamson v. Citrix Online,
`LLC, 792 F.3d 1339, 1348–49 (Fed. Cir. 2015) (en banc in relevant part)
`(“The converse presumption remains unaffected: ‘use of the word ‘means’
`creates a presumption that § 112, ¶ 6 applies.’”); see also Personalized
`Media Commc’ns, LLC v. Int’l Trade Comm’n, 161 F.3d 696, 703 (Fed. Cir.
`1998); Greenberg v. Ethicon Endo–Surgery, Inc., 91 F.3d 1580, 1584 (Fed.
`Cir. 1996) (“[Use] of the term ‘means’ has come to be so closely associated
`
`
`3 After the Petition was filed, the parties filed a Joint Claim Construction
`Statement in district court, in which Patent Owner’s positions differed
`somewhat from those identified in the Petition. Compare Ex. 2003, B1, B3,
`B8, with Pet. 19 (citing Ex. 1007); see also Prelim. Resp. 7 (citing Pet. 19).
`4 Section 4(c) of the Leahy-Smith America Invents Act, Pub. L. No. 112–29,
`125 Stat. 284 (2011) (“AIA”) re-designated 35 U.S.C. § 112 ¶ 6, as
`35 U.S.C. § 112(f). However, because the ’543 Patent has a filing date
`before September 16, 2012, the effective date of § 4(c) of the AIA, we will
`refer to the pre-AIA version of 35 U.S.C. § 112.
`8
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`IPR2017-01296
`Patent 6,007,543
`
`with ‘means-plus-function’ claiming that it is fair to say that the use of the
`term ‘means’ (particularly as used in the phrase ‘means for’) generally
`invokes [§ 112 ¶ 6].”).
`This presumption may be rebutted, however, “if the evidence intrinsic
`to the patent and any relevant extrinsic evidence so warrant.” Personalized
`Media Commc’ns, 161 F.3d at 704. For example, the presumption may be
`overcome where the claim specifically identifies structure sufficient to
`perform the recited function. See TriMed, Inc. v. Stryker Corp., 514 F.3d
`1256, 1259–60 (Fed. Cir. 2008) (“Sufficient structure exists when the claim
`language specifies the exact structure that performs the functions in question
`without need to resort to other portions of the specification or extrinsic
`evidence for an adequate understanding of the structure.”); see also Sage
`Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1427–28 (Fed. Cir. 1997).
`3. Means-Plus-Function Limitations in the ’543 Patent
`In this case, as emphasized in claims 1 and 19 above, the challenged
`claims recite the term “means.” See, e.g., Ex. 1001, 4:53–54, 4:56–57, 6:16–
`17 (“expandable inflatable means”; “mounting and retaining means for
`receiving the stent”; “means for inflating the balloon”).
`(a) “expandable inflatable means” and “mounting and
`retaining means for receiving the stent”
`With respect to “expandable inflatable means” and “mounting and
`retaining means for receiving the stent,” Petitioner contends that these
`limitations do not invoke 35 U.S.C. § 112 ¶ 6. Pet. 19. Petitioner, however,
`does not discuss the presumption associated with use of the word “means” in
`these limitations, and does not provide a single citation to intrinsic or
`competent extrinsic evidence to suggest that the presumption is unwarranted
`
`
`
`9
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`IPR2017-01296
`Patent 6,007,543
`
`in this case. Instead, Petitioner simply incorporates by reference a letter
`between counsel in the co-pending district court litigation. Id. (citing
`Ex. 1007). Even if Petitioner’s incorporation by reference were proper, but
`cf. 37 C.F.R. § 42.6(a)(3), the cited letter also fails to explain how or why
`applicable intrinsic or extrinsic evidence warrants deviating from the
`presumption that use of the term “means” invokes 35 U.S.C. § 112 ¶ 6.
`Although this letter suggests that the parties may agree that § 112 ¶ 6 should
`not apply to these limitations, a non-binding agreement between parties does
`not constitute persuasive evidence and does not suspend our Rules. See
`infra Section II.A.3.c. Further, claim construction, and whether § 112 ¶ 6
`applies, is a legal determination made based on a hierarchy of evidence––
`intrinsic evidence being the most persuasive.
`In addition to stating that 35 U.S.C. § 112 ¶ 6 does not apply, the
`Petition also provides constructions for these limitations. Pet. 19. However,
`the proposed constructions simply reiterate the functions recited by the
`claims. For example, Petitioner construes “expandable inflatable means” as
`“a structure capable of being expanded and inflated.” Id. Petitioner’s
`contentions in this regard fail to explain how or why Petitioner believes any
`applicable evidence overcomes the presumption that use of the term
`“means” invokes § 112 ¶ 6. It is not this panel’s charge to divine the
`reasoning or justification for Petitioner’s position, without any guiding
`explanation from Petitioner.
`Accordingly, absent any persuasive rebuttal, we presume that
`“expandable inflatable means” and “mounting and retaining means for
`receiving the stent” invoke 35 U.S.C. § 112 ¶ 6.
`
`
`
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`IPR2017-01296
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`
`
`(b) “means for inflating the balloon”
`With respect to “means for inflating the balloon,” Petitioner contends
`that this limitation invokes 35 U.S.C. § 112 ¶ 6. Pet. 19. Petitioner contends
`that the corresponding structure is “fluid (gas or liquid) from an inflation
`port and equivalents thereof.” Id.
`(c) Identification of Corresponding Structure
`In proceedings before this Board, our Rules require that if a
`challenged claim contains a means-plus-function limitation under 35 U.S.C.
`§ 112 ¶ 6, Petitioner is required to construe the limitation and to “identify
`the specific portions of the specification that describe the structure, material,
`or acts corresponding to each claimed function.” 37 C.F.R. § 42.104(b)(3).
`Here, the Petition fails to identify any portion of the ’543 patent
`Specification that describes the structure, material, or acts that correspond to
`the functions recited in the above-referenced limitations. See Pet. 19; see
`also 37 C.F.R. § 42.6(a)(3). It is not this panel’s responsibility to identify
`the portions of the Specification upon which it believes Petitioner may rely
`to support its positions with respect to 35 U.S.C. § 112 ¶ 6. Our Rules place
`this burden on Petitioner, so that the panel may evaluate effectively the
`challenged claims vis-à-vis the asserted prior art, as discussed below.
`
`B. Asserted Grounds of Unpatentability
`
`To show that a challenged claim containing a means-plus-function
`limitation is unpatentable over the asserted prior art, Petitioner must show
`that the structure that corresponds to a claimed function, or its equivalent, is
`found in, or obvious over, the applied prior art. See Fresenius USA, Inc. v.
`Baxter Int’l, Inc., 582 F.3d 1288, 1299–1300 (Fed. Cir. 2009) (“It is firmly
`
`
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`11
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`IPR2017-01296
`Patent 6,007,543
`
`established in our precedent that a structural analysis is required when
`means-plus-function limitations are at issue; a functional analysis alone will
`not suffice.”) (emphases added). In this case, Petitioner’s failure to construe
`the claims in accordance with our Rules is determinative. By failing to
`identify structure, material, or acts in the ’543 patent Specification that
`correspond to the claimed functions, Petitioner necessarily has not shown
`where that structure, material, acts, or their equivalents are disclosed in the
`applied prior art. Compare Pet. 19, with id. at 32 (discussing “expandable
`inflatable means”), 32–33 (discussing “mounting and retaining means for
`receiving the stent”), 38 (discussing “means for inflating the balloon”), 47–
`48, 52, 61–63, 67, 74, 77.
`For these reasons, Petitioner has not established a reasonable
`likelihood that it would prevail in showing the unpatentability of
`independent claims 1 or 19 based on any of the asserted grounds of
`unpatentability. Petitioner’s challenges to dependent claims 2, 3, 6–12, 20,
`21, and 24–29 similarly fail for the same reasons.
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine Petitioner has not
`demonstrated a reasonable likelihood it would prevail in establishing the
`unpatentability of the challenged claims of the ’543 patent.
`
`IV. ORDER
`
`Upon consideration of the record before us, it is:
`ORDERED that the Petition is denied as to all challenged claims, and
`no trial is instituted.
`
`
`
`
`
`
`12
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`IPR2017-01296
`Patent 6,007,543
`
`PETITIONER:
`
`A. James Isbester
`KILPATRICK TOWNSEND & STOCKTON LLP
`jisbester@kilpatricktownsend.com
`
`Craig S. Summers
`Joshua Stowell
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2css@knobbe.com
`Joshua.Stowell@knobbe.com
`
`
`PATENT OWNER:
`
`Wallace Wu
`Jennifer A. Sklenar
`Nicholas M. Nyemah
`ARNOLD & PORTER KAYE SCHOLER LLP
`Wallace.Wu@apks.com
`Jennifer.Sklenar@apks.com
`Nicholas.Nyemah@apks.com
`
`
`
`
`
`
`
`
`13
`
`
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