Trials@uspto.gov
`571.272.7822
`
`
`Paper No. 10
`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 IPR2017-01294
`Patent 6,371,962 B1
`_______________
`
`
`Before JAMES T. MOORE, JAMES A. TARTAL,
`and AMANDA F.WIEKER, Administrative Patent Judges.
`
`MOORE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571.272.7822
`
`
`Paper No. 10
`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 IPR2017-01294
`Patent 6,371,962 B1
`_______________
`
`
`Before JAMES T. MOORE, JAMES A. TARTAL,
`and AMANDA F.WIEKER, Administrative Patent Judges.
`
`MOORE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2017-01294
`Patent 6,371,962 B1
`
`
`A. Background
`
`I.
`
`INTRODUCTION
`
`Edwards Lifesciences Corporation (“Petitioner”) filed a corrected
`Petition requesting an inter partes review of claims 1–3, 6–13, 20–22, 25–
`30, 35, and 36 (“the challenged claims”) of U.S. Patent No. 6,371,962 B1
`(Ex. 1001, “the ’962 patent”). Paper 8 (“Pet”), 1. Boston Scientific Scimed,
`Inc. (“Patent Owner”) filed a Preliminary Response. Paper 9 (“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 ’962 patent is at issue in Boston
`Scientific Corp. & Boston Scientific SciMed Inc. v. Edwards Lifesciences
`Corp., No. 16-cv-730 (C.D. Cal.). Pet. 88; Paper 4, 2.
`
`C. The ’962 Patent
`
`The ’962 patent, titled “Stent Delivery System With Stent Securement
`Means,” issued April 16, 2002, from U.S. Patent Application No.
`09/420,294, which was filed October 19, 1999. Ex. 1001, [45], [54], [21],
`[22].
`
`
`
`2
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`IPR2017-01294
`Patent 6,371,962 B1
`
`
`Figure 1 of the ’962 patent is reproduced below.
`
`
`Figure 1 depicts an isometric view of a balloon catheter. Ex. 1001, 2:19–22.
`As shown in Figure 1, catheter 12 includes balloon 14 at distal end 16, to
`which stent 18 is fixed. Id. at 2:47–50. 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 3:65–4:7. 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.
`Figure 3 of the ’962 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 2:27–30.
`As shown in Figure 3, “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
`
`
`
`3
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`IPR2017-01294
`Patent 6,371,962 B1
`
`the delivery procedure.” Id. at 3:33–38. In Figure 3, mounting body 30 is a
`cylindrical sleeve carried on inner lumen 26 of the catheter. Id. at 3:42–47.
`However, the ’962 patent also discloses alternate mounting bodies including,
`for example, 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 4:6–4:45.
`
`D. Illustrative Claim
`
`Of the challenged claims, claims 1, 20, and 35 are independent.
`Claims 1 and 20 are reproduced below:
`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:
`a catheter having a shaft having a diameter and
`expandable inflation 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.
`Ex. 1001, 4:56–5:8. (Emphasis added).
`
`
`
`
`4
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`IPR2017-01294
`Patent 6,371,962 B1
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`
`20. A balloon catheter for intraluminal delivery of a stent, the
`catheter comprising a shaft having a diameter, a balloon associated
`with a distal portion of the shaft for receiving a stent, the stent having
`a first end and a second end and a contracted state and an expanded
`state, and means for inflating the balloon, the shaft including at least
`one mounting body radially carried on the shaft inside the balloon,
`whereby the diameter of the shaft is increased inside the balloon to
`facilitate mounting and retaining of a stent to the catheter over the
`balloon, the at least one mounting body 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, the at least one mounting body having a length and
`an outer surface diameter, wherein the outer surface diameter is
`substantially constant along the length.
`
`Id. at 6:14–30. (Emphasis added)
`
`
`E. Prior Art Relied Upon
`
`Fischell ’274
`
`US 5,639,274
`
`Burton
`
`US 5,026,377
`
`Exhibit No.
`Ex. 1010
`
`Ex. 1013
`
`Ex. 1014
`
`Petitioner relies upon the following prior art references, as well as the
`Declaration of Thomas Trotta (Ex. 1003). Pet. 26.
`Reference
`Patent No.
`Relevant Dates
`Fischell ’507
`US 4,768,507
`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
`
`Olympus
`
`JP 1992-64367
`
`Ex. 10151
`
`
`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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`IPR2017-01294
`Patent 6,371,962 B1
`
`
`Reference
`Jendersee
`
`Patent No.
`US 5,836,965
`
`Ravenscroft
`
`US 5,702,418
`
`Williams
`
`US 5,437,083
`
`Relevant Dates
`Filed June 7, 1995
`Issued Nov. 17, 1998
`Filed Sept. 12, 1995
`Issued Dec. 30, 1997
`Filed May 24, 1993
`Issued Aug. 1, 1995
`
`Exhibit No.
`Ex. 1016
`
`Ex. 1017
`
`Ex. 1028
`
`
`
`F. Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–3, 6–13, 20–22, 25–
`30, 35, and 36 of the ’962 patent based on the following grounds. Pet. 27–
`88.2
`
`References
`
`[1] Olympus in View of the
`Knowledge of a POSITA and/or
`Burton, Fischell ’274, and/or
`Fischell ’507
`
`Basis
`
`Claim(s)
`Challenged
`§ 103(a) 1–3, 6–8, 11–13, 20–22,
`25, 26, 29, 30, 35, and
`36
`
`
`2 Although we need not address in depth the asserted grounds of
`unpatentability in this case, 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” (Pet.
`25), 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). Moreover, at
`least Grounds 4 and 5 as stated are repetitive and nonsensical, having
`references considered a plurality of times in view of themselves.
`6
`
`
`
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`IPR2017-01294
`Patent 6,371,962 B1
`
`
`References
`
`[2] Fischell ’274 in View of Burton
`
`[3] Ravenscroft
`
`[4] The References in Grounds 1 and
`2, in Further View of Jendersee
`[5] The References in Grounds 1–3,
`in Further View of the Knowledge of
`a POSITA and/or Burton, Fischell
`’274, Fischell ’507, and/or Williams
`
`Basis
`
`Claim(s)
`Challenged
`§ 103(a) 1–3, 6, 11–13, 20–22,
`25, 29, 30, 35, and 36
`§ 102(b) 1–3, 6, 12, 20–22, and
`30
`§ 103(a) 9, 10, 13, 27, and 28
`
`§ 103(a) 8
`
`II. DISCUSSION
`
`A. Claim Construction
`
`The parties agree that the ’962 patent has expired. Pet. 23; Prelim.
`Resp. 6. “[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.
`
`
`
`7
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`IPR2017-01294
`Patent 6,371,962 B1
`
`
`1. The Parties’ Positions
`For purposes of this proceeding, Petitioner adopts Patent Owner’s
`proposed constructions from co-pending district court litigation. Pet. 24–25.
`Accordingly, Petitioner adopts the following positions:
`
`Claim
`Limitation
`“expandable inflatable
`means” (see claim 1)
`
`“mounting and retaining
`means” (see claim 1)
`
`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”
`“fluid (gas or liquid)
`from an inflation
`port and equivalents
`thereof.”
`See id. at 23–25 (citing Ex. 1007). Patent Owner “agrees . . . that Patent
`Owner’s proposed constructions . . . in the district court litigation are the
`proper constructions.” Prelim. Resp. 6–7.3
`2. Means-Plus-Function Claiming
`Means-plus-function claiming is allowed pursuant to 35 U.S.C. § 112
`
`¶ 6, which provides that:
`
`3 After the Petition was filed, the parties filed a Joint Claim Construction
`Statement in district court, in which both Patent Owner’s and Petitioner’s
`positions differed somewhat from those identified in the Petition. Compare
`Ex. 2003, B1–10 with Pet. 23–25 (citing Ex. 1007). Indeed, Petitioner’s
`interpretations were narrower in some respects in the litigation. See also
`Prelim. Resp. 6–7 (citing Pet. 23–25).
`
`“means for inflating the
`balloon” (see claim 20)
`
`Subject to § 112 ¶ 6
`
`
`
`8
`
`
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`IPR2017-01294
`Patent 6,371,962 B1
`
`
`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.’” (quoting 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) (“[U]se of the term ‘means’ has come to be so closely associated
`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
`
`
`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 ’962 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.
`9
`
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`IPR2017-01294
`Patent 6,371,962 B1
`
`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 ’962 Patent
`In this case, as emphasized in independent claims 1 and 20 above (but
`also applicable to independent claim 35), the challenged claims all recite the
`term “means.”
`With respect to these limitations, Petitioner contends that these
`limitations in some instances do and in others do not invoke 35 U.S.C. § 112
`¶ 6. Pet. 24–25. 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 persuasive intrinsic or extrinsic evidence to
`suggest that the presumption is either warranted or unwarranted in any case.
`Instead, Petitioner incorporates by reference a letter between counsel
`in the co-pending district court litigation. Id. (citing Ex. 1007). Even if
`Petitioner’s incorporation of counsel’s positions in litigation by reference
`were proper,5 the cited letter also fails to explain how or why applicable
`intrinsic or extrinsic evidence warrants in selected instances only 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 or should not apply to these limitations, a non-binding agreement
`
`
`5 See 37 C.F.R. § 42.6(a)(3), prohibiting incorporation by reference of
`arguments.
`
`
`
`10
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`IPR2017-01294
`Patent 6,371,962 B1
`
`between parties does not constitute persuasive evidence and does not
`suspend operation of our Rules requiring the Petitioner to identify the
`corresponding structure and function, or explain otherwise. 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. Lawyer argument is among the least persuasive.
`In addition to stating that 35 U.S.C. § 112 ¶ 6 does only occasionally
`apply, the Petition also provides constructions for these limitations. Pet. 24–
`25. 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. at 24. 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,” “mounting and retaining means,” and
`“means for inflating the balloon” invoke 35 U.S.C. § 112 ¶ 6.
`(a) 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 “must 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).
`(Emphasis added). Here, the Petition fails to identify any portion of the ’962
`11
`
`
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`
`
`IPR2017-01294
`Patent 6,371,962 B1
`
`patent Specification that describes the structure, material, or acts that
`correspond to the functions recited in the above-referenced limitations, and
`references a different document. See Pet. 24–25; 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
`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 the structure,
`material, or acts in the ’962 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. 24–25, with id. at 37 (discussing “expandable inflatable
`means”), 37–38 (discussing “mounting and retaining means”), 45–46
`(discussing “means for inflating”).
`
`
`
`12
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`IPR2017-01294
`Patent 6,371,962 B1
`
`
`
`This is not merely an academic exercise. Much of the rationale of the
`Petition depends upon why a person of ordinary skill in the art would be
`motivated to alter the primary references. For example, Petitioner urges for
`Ground 1:
`
`A POSITA would be motivated in light of Fischell ’507’s
`teachings to add spiral grooves corresponding to the spiral stent
`into the mounting body of Olympus in order to improve the
`securement of the compacted stent during delivery, reducing its
`profile while still allowing it to be expanded by the balloon at the
`deployment site. Ex. 1003 (Trotta Decl.) ¶ 125. Likewise, a
`POSITA would understand that the presence of these grooves
`would improve the flexibility and trackability of the portion of
`the catheter containing the mounting body. Id. ¶126; accord Ex.
`1013 (Fischell ’274) at 10:3-6 (teaching that making a helical cut
`in a catheter tube results in “greatly increased flexibility”).
`
`
`Pet. 34.
`
`
`Which parts of which reference pertain to the “mounting and retaining
`means” as used in the claims, for example, becomes critical to understanding
`not only how the elements are found to satisfy the claim elements, but also
`the motivation for combining and modifying the prior art. This deficiency
`affects the rationale throughout the Petition. See also Pet. 45–46. (Claim
`20, incorporating by reference also Petition sections 1.0 – 1.4 pertaining to
`Claim 1).
`While the panel has no doubt it could undertake a form of analysis to
`determine the range of equivalents, under the unique facts of this case, it
`declines to do so on behalf of the Petitioner.
`
`
`
`13
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`IPR2017-01294
`Patent 6,371,962 B1
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`
`For these reasons, Petitioner has not established a reasonable
`likelihood that it would prevail in showing the unpatentability of
`independent claims 1, 20, or 35 based on any of the asserted grounds of
`unpatentability. Petitioner’s challenges to claims which depend therefrom
`fail for the same reasons.
`
`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 ’962 patent.
`
`III. 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.
`
`
`
`
`
`
`14
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`IPR2017-01294
`Patent 6,371,962 B1
`
`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
`
`
`
`15
`
`
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