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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper No. 11
`Filed: November 22, 2017
`
`
`
`
`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
`
`
`
`PETITIONER’S REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71
`ON THE DECISION NOT TO INSTITUTE INTER PARTES REVIEW
`
`

`

`TABLE OF CONTENTS
`
`IPR2017-01294
`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`RELIEF REQUESTED ................................................................................... 2
`
`III.
`
`STANDARD OF REVIEW ............................................................................. 2
`
`IV. ARGUMENT ................................................................................................... 2
`
`B.
`
`A.
`
`The Board Overlooked the Petition’s Construction of the
`“means for inflating the balloon” Limitation ........................................ 3
`
`Since the Petition Provides a Proper Construction of “means for
`inflating the balloon,” Ground 3 States a Sound Basis for
`Invalidating Claim 20 and its Dependent Claims ................................. 7
`CONCLUSION ................................................................................................ 9
`
`V.
`
`
`
`
`
`- i -
`
`

`

`IPR2017-01294
`
`
`I.
`
`INTRODUCTION
`Petitioner Edwards Lifesciences Corporation requests partial reconsideration
`
`of the Board’s Decision in Paper 10 (“Decision”) to deny its petition for inter
`
`partes review of US Pat. No. 6,371,962 B1 (the “’962 Patent”).1
`
`The basis of Edwards’ request is straightforward. The Board rested its
`
`determination on the failure of the Petition to set forth structures in the
`
`specification that correspond to the functions recited in three claim limitations that
`
`the Board reads to be stated in means-plus-function format. With respect to two of
`
`those three terms, the Board is correct – the Petition does not set forth
`
`corresponding structure. But with respect to the third limitation, a “means for
`
`inflating the balloon,” the Petition clearly does state the corresponding structure.
`
`Edwards respectfully submits that the Board may have inadvertently overlooked
`
`Edwards’ submission in this regard. Since this third limitation is the only means-
`
`plus-function limitation of independent claim 20, and since Ground 3 of the
`
`Petition provides compelling evidence that claim 20 and certain of its dependent
`
`claims are invalid over the Ravenscroft reference, Edwards further submits that but
`
`for this oversight, the Board would have granted institution of review claim 20 and
`
`its dependents.
`
`
`
`1 Prior art and other abbreviations are those used in the Petition and the Decision.
`- 1 -
`
`
`
`

`

`II. RELIEF REQUESTED
`Petitioner requests a rehearing of the Decision and institution of an Inter
`
`Partes Review (“IPR”) with respect to Ground 3 and challenged claims 20 through
`
`IPR2017-01294
`
`
`22 and 30.
`
`III. STANDARD OF REVIEW
`
`Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a
`
`panel will review the decision for an abuse of discretion.” An abuse of discretion
`
`occurs when a “decision was based on an erroneous conclusion of law or clearly
`
`erroneous factual findings, or … a clear error of judgment.” PPG Indus. Inc. v
`
`Celanese Polymer Specialties Co. Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988)
`
`(citations omitted). The request must “specifically identify all matters the party
`
`believes the Board misapprehended or overlooked and the place where each matter
`
`was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R.
`
`§ 42.71(d).
`
`IV. ARGUMENT
`The ’962 patent is directed to a delivery system for a balloon-expandable
`
`stent. In its petition, Edwards states five grounds for inter partes review. Edwards
`
`here does not revisit any of Grounds 1, 2, 4 or 5.
`
`Ground 3 asserts that the Ravenscroft reference, U.S. Patent No. 5,702,418
`
`(Ex. 1017) anticipates independent claims 1 and 20, plus various dependent claims.
`
`
`
`- 2 -
`
`

`

`IPR2017-01294
`
`
`This request for rehearing is directed to the application of Ravenscroft solely to
`
`claim 20 and its dependent claims 21, 22, and 30.
`
`A. The Board Overlooked the Petition’s Construction of the “means
`for inflating the balloon” Limitation
`As the Board notes, the claims of the ’962 patent together encompass three
`
`limitations that incorporate the word “means”: “expandable inflatable means,”
`
`“mounting and retaining means,” and “means for inflating the balloon.”
`
`As to the first two terms, Edwards adopted Patent Owner’s litigation
`
`position that section 112(f) did not apply. Accordingly, Edwards did not identify
`
`in its Petition the specification structures that correspond to these limitations. The
`
`Board declined to accept the parties’ position that section 112(f) did not apply.
`
`Accordingly, the Board determined that it lacked the analysis required in order to
`
`assess the applicability of the art to the claims and review of the claims in which
`
`these terms appear, claim 1 and its dependents, was impossible. Edwards does not
`
`seek reconsideration of this portion of the Board’s decision.
`
`The final term, “ means for inflating the balloon,” appears only in claim 20,
`
`reproduced below:
`
`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
`- 3 -
`
`
`
`

`

`IPR2017-01294
`
`
`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.
`See Decision at 5; Ex. 1001 6:14-30.
`
`The Decision denied institution with respect to claim 20 and its dependent
`
`claims because it contended that the Petition failed to describe “structure, material,
`
`or acts that correspond to the functions recited” in the means-plus-function
`
`limitation in those claims. Decision at 12. Edwards respectfully submits that this
`
`is factually erroneous.
`
`As seen above, claim 20 does not contain the limitations “expandable
`
`inflatable means” or “mounting and retaining means” that Edwards and Patent
`
`Owner contended are not subject to 35 U.S.C. § 112(f). Petition at 24-25;
`
`Preliminary Response at 6; Decision at 8. Instead, the only limitation in this claim
`
`that could be subject to means-plus-function analysis is the “means for inflating the
`
`
`
`- 4 -
`
`

`

`IPR2017-01294
`
`
`balloon.” 2 Edwards and Patent Owner agree that means-plus-function analysis is
`
`appropriate for this term. Petition at 25; Preliminary Response at 6; Decision at 8.
`
`Furthermore, Edwards did provide that analysis.
`
`In the Petition, Edwards offered a description of the structure that
`
`corresponds to “means for inflating the balloon” function. Petition, p. 25;
`
`Decision, p. 8. What the Board may not have appreciated is that this structure is
`
`taken directly from Patent Owner’s claim construction position which, in turn, rests
`
`expressly on specific language of the specification. Edwards submitted Exhibit
`
`1007, Patent Owner’s correspondence, in support of this point. In Exhibit 1007,
`
`the Patent Owner identifies lines 2:66 to 3:12 of the ’962 Patent as describing the
`
`structures that correspond to the “means for inflating the balloon.” The passage
`
`reads (in part):
`
`The catheter balloon may be inflated by fluid (gas or
`liquid) from an inflation port extending from a lumen 28
`contained in the catheter shaft and opening into the
`
`
`2 While claim 20 does recite an “inflatable means,” this appears to be a claim
`drafting error. There is no antecedent basis for the “inflatable means” in the claim
`language. Instead, in the context of the preceding claim language referencing “a
`balloon…for receiving the stent,” it is obvious that “inflatable means” should read
`“balloon.” See, e.g., CBT Flint Partners, LLC v. Return Path, Inc., 654 F.3d 1353,
`1358 (Fed. Cir. 2011) (holding under the Phillips standard “a district court may
`correct an obvious error in a patent claim”). Taken in context, this limitation
`should therefore read “when the stent is loaded onto the [balloon],” which should
`be given its plain and ordinary meaning.
`
`
`
`
`- 5 -
`
`

`

`IPR2017-01294
`
`
`balloon as shown, or by other known arrangements,
`depending on the design of the catheter. The details and
`mechanics of balloon inflation and specific overall
`catheter construction will vary according to the particular
`design involved in any given instance, and are known in
`the art per se.
`
`Exh. 1001, 3:3-11. The Patent Owner summarized this structure in its claim
`
`construction correspondence as:
`
`The corresponding structure: fluid (gas or liquid) from an
`inflation port and equivalents thereof.
`
`Exh. 1007, pp. 2, 4. 3 And this, of course, is the exact construction that Edwards
`
`offered in the Petition. Petition, p. 25; Decision, p. 8.
`
`Thus, there can be no doubt that a) the Petition treats the “means for
`
`inflating the balloon” limitation of claim 20 as a “means-plus-function” claim, b)
`
`the Petition provides a structure that corresponds to this function, and c) the
`
`structure described in the Petition is drawn from the specification.
`
`Edwards provided no justification in the Petition for treating the “means for
`
`inflating the balloon” limitation as subject to means-plus-function analysis.
`
`Edwards respectfully submits that no such justification is required. As the Board
`
`
`
`3 In its preliminary response to the Petition, the Patent Owner acknowledged
`that it continues to adhere to this construction, stating: “Patent Owner further
`agrees, as Petitioner concedes, that Patent Owner’s proposed constructions for …
`“means for inflating the balloon” in the district court litigation are the proper
`constructions under the Phillips standard.” Patent Owner’s Preliminary Response
`dated August 4, 2017, pp. 6-7.
`
`
`
`- 6 -
`
`

`

`IPR2017-01294
`
`
`notes, use of “means” or “means for” language triggers a presumption that the
`
`claim limitation is subject to section 112(f) analysis. Decision, p. 9 (citing
`
`Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348-49 (Fed. Cir. 2015);
`
`Personalized Media Commc’ns, LLC v. Int’l Trade Comm’n, 161 F.3d 696, 703
`
`(Fed. Cir. 1996); Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1584
`
`(Fed. Cir. 1996)). Argument to the effect that the presumption should be applied
`
`would be superfluous. Accordingly, Edwards respectfully submits that the Petition
`
`provides a proper construction of the claim term “means for inflating the balloon.”
`
`B.
`
`Since the Petition Provides a Proper Construction of “means for
`inflating the balloon,” Ground 3 States a Sound Basis for
`Invalidating Claim 20 and its Dependent Claims
`Once the Board concluded that the Petition failed to identify the structure
`
`corresponding to the means-plus-function element of claim 20, denial of the
`
`Petition became automatic. As the Board notes, if there is no identification of the
`
`structure corresponding to the means element, then the Petition cannot show that
`
`the same or equivalent structures are found in the prior art. Decision at 12.
`
`There is no dispute regarding the function of “means for inflating the
`
`balloon” term. It is simply the plain meaning of inflating the balloon. In Ground
`
`3, the Petition notes that Ravenscroft discloses an “expansible balloon” that is
`
`connected by a lumen such that it can be inflated. Ex. 1017, 7:10-16; Ex. 1003, ¶
`
`153; Petition, p. 79. As Mr. Trotta notes, a person of skill in the art would
`
`
`
`- 7 -
`
`

`

`IPR2017-01294
`
`
`understand that Ravenscroft thereby discloses a structure that has the function of
`
`inflating the balloon. Furthermore, that structure is a lumen with a port inside the
`
`balloon, just like the lumen with inflation port disclosed in the patent.
`
`The Board also expressed concern that without constructions of the means-
`
`plus-function limitations, ascertaining the “motivation for combining and
`
`modifying the prior art” was difficult. Decision at 13. This should not, however,
`
`be a concern with respect to Ground 3. Ground 3 offers no combinations, but
`
`rather, rests entirely upon the anticipation by Ravenscroft. Petition at 71-73, 78-
`
`82. Accordingly, there is no need to modify Ravenscroft, or combine its
`
`disclosures with another prior art reference. Id.
`
`Finally, while Edwards acknowledges that the Board declined to institute a
`
`trial with respect to Ravenscroft in the Petition for Inter Partes Review of the
`
`related U.S. Patent No. 7,749,234 (the “’234 patent”), IPR2017-01298, the issues
`
`that the Board identified regarding Ravenscroft in that proceeding are not relevant
`
`here. Specifically, the challenged claims of the ’234 patent all recited a mounting
`
`body “formed of a material which resiliently deforms under radial pressure,” and
`
`the Board declined to institute because “Petitioner has not persuasively shown that
`
`[Ravenscroft] discloses a ‘mounting body…formed of a material which resiliently
`
`deforms’ as required by the claims.” IPR2017-01298, Paper 8 at 32. In contrast,
`
`in the instant proceeding, the “resiliently deforms” limitation is absent from claims
`
`
`
`- 8 -
`
`

`

`IPR2017-01294
`
`
`20 through 22 and 30 of the ’962 patent. Thus, the Board’s decision with respect
`
`to IPR2017-01298 does not affect the merits of the Petition’s argument with
`
`respect to claims 20 through 22 and 30 in this proceeding.
`
`V. CONCLUSION
`The Board denied institution because it believed that the Petition failed to
`
`identify the structures in the specification corresponding to the functions of certain
`
`means-plus-function elements. Edwards did, however, provide such an
`
`identification for the only means-plus-function limitation of independent claim 20.
`
`Edwards therefore respectfully submits that Ground 3 of the Petition, to the extent
`
`it is directed against claim 20 and its dependent claims 21, 22, and 30, sets forth a
`
`basis for the institution of inter partes review. Edwards respectfully requests that
`
`the Board grant this request for rehearing.
`
`Dated: November 22, 2017
`
`
`
`
`
`
`
`
`
`Respectfully submitted
`
`By: /s/ A. James Isbester
`A. James Isbester
`Registration No. 36,315
`Lead Counsel for Petitioners
`
`
`
`Back-Up Counsel
`Lead Counsel
`A. James Isbester
`Craig S. Summers
`Registration No. 36,315
`Registration No. 31,430
`jisbester@kilpatricktownsend.com
`2css@knobbe.com
`
`Joshua Stowell
`Postal and Hand-Delivery Address:
`Registration No. 64,096
`Kilpatrick Townsend & Stockton LLP
`Joshua.Stowell@knobbe.com
`- 9 -
`
`
`
`

`

`Two Embarcadero Center, Suite 1900
`San Francisco, CA 94111
`Telephone: (415) 576-0200
`Fax: (415) 576-0300
`
`
`
`
`
`IPR2017-01294
`
`
`
`Postal and Hand-Delivery Address:
`Knobbe, Martens, Olson & Bear,
`LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Telephone: (949) 760-0404
`Fax: (949) 760-9502
`
`
`
`- 10 -
`
`

`

`CERTIFICATE OF SERVICE
`
`IPR2017-01294
`
`
`The undersigned hereby certifies that a copy of this PETITIONER’S
`
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71 ON THE DECISION
`
`NOT TO INSTITUTE INTER PARTES REVIEW, has been served via Electronic
`
`Mail on November 22, 2017, upon the following:
`
`
`
`
`
`
`
`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
`
`
`
`
`
`Dated: November 22, 2017
`
`
`
`
`
`
`
`By: /s/ A. James Isbester
`A. James Isbester
`Registration No. 36,315
`Counsel for Petitioners
`
`
`
`- 11 -
`
`

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