`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES
`LLC, AND EDWARDS LIFESCIENCES AG
`
`Petitioners
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`_______________
`
`Case IPR2017-0060
`Patent 8,992,608
`_______________
`
`JOINT REVISED MOTION TO FILE CONFIDENTIAL DOCUMENTS
`UNDER SEAL
`
`
`
`Pursuant to the Board’s Order (Paper 57) and 37 C.F.R. §§ 42.14 and 42.54,
`
`Petitioners and Patent Owner respectfully submit this Joint Motion to Seal Portions
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`of Exhibits 1049, 1050, 1062, 1063, 2031, 2034, 2036, 2039, 2041, 2042, 2043,
`
`2044, 2045, 2046, 2055, 2056, 2057, 2063, 2077, 2085, 2086, 2088, 2089, 2090,
`
`and 2091.1
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`I.
`
`BACKGROUND
`
`On October 12, 2016, Petitioners filed their petition for inter partes review
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`and various prior art and expert declarations as Exhibits 1001-1034, all of which
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`were publicly filed. On June 23, 2017, Patent Owner filed its Response, and
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`Exhibits 2014-2091, many of which are highly confidential documents. None of
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`these confidential documents contain Patent Owner’s confidential information;
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`these documents include only Petitioners’ confidential information. Patent Owner
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`had access to these documents only via discovery in the co-pending litigation in the
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`District of Delaware (the “Delaware Litigation”). In the Delaware Litigation, the
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`parties are subject to a protective order, which the parties are bound to follow
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`regarding treatment of the other party’s Confidential and Highly Confidential
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`information. Thus, unlike the more typical IPR proceeding where all or nearly all
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`of the documents are publicly available prior art documents or the patent owner’s
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`1 Pursuant to 37 C.F.R. § 42.54(a), Petitioners and Patent Owner hereby certify
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`that they have conferred in good faith on this Joint Motion.
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`1
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`
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`own internal materials to support secondary considerations of nonobviousness,
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`here Patent Owner has alleged (and Petitioners dispute) that it is Petitioners’
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`products that provide evidence of secondary considerations. Although many
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`hundreds of pages of Petitioners’ Highly Confidential information have been filed
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`with the Board, only a few dozen pages from the documents identified in this
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`Motion have been cited and relied on by either party.
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`On August 10, 2017, the Board granted the parties’ Joint Motion for Entry of
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`Stipulated Protective Order. Pap. 29; see also Pap. 26, Ex. 2092.
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`On July 28, 2017, the Parties filed a Joint Motion to File Confidential
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`Documents Under Seal (Pap. 25) (the “First Motion to Seal”) requesting
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`authorization to file under seal portions of Exhibits 2031, 2034, 2036, 2039, 2041,
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`2042, 2043, 2044, 2045, 2046, 2055, 2056, 2057, 2063, 2077, 2080, 2085, 2086,
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`2087, 2088, 2089, 2090, and 2091. On September 22, 2017, Petitioners filed a
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`Motion to File Confidential Documents Under Seal (Pap. 32) (the “Second Motion
`
`to Seal”) requesting authorization to file under seal Petitioners’ Reply (Pap. 33)
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`and Exhibits 1045, 1046, 1049, 1050, 1061, 1062, and 1063.
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`On February 9, 2018, the Board granted-in-part and denied-in-part the First
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`and Second Motions to Seal. Paper 57. In its Decision, the Board granted the
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`Parties’ request to file under seal the redacted portions of Ex. 2080 and all of Ex.
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`2087 as requested in the First Motion to Seal. The Board also granted Petitioner’s
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`2
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`
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`request to file under seal the redacted portions of Ex. 1045, the redacted portions of
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`Ex. 1046, all of Ex. 1061, and the redacted portions of Petitioners’ Reply (Pap. 33)
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`as requested in the Second Motion to Seal. The Board denied the remainder of the
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`motions subject to the Patent Owner or Petitioner filing a revised Motion to Seal
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`directed to these exhibits or a request that the exhibit be expunged by the party that
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`filed the exhibit. Paper 57 at 16.
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`The parties now move pursuant to the Board’s February 9, 2018 Order and
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`the Stipulated Protective Order to file under seal portions of Exhibits 1049, 1050,
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`1062, 1063, 2031, 2034, 2036, 2039, 2041, 2042, 2043, 2044, 2045, 2046, 2055,
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`2056, 2057, 2063, 2077, 2085, 2086, 2088, 2089, 2090, and 2091. As instructed
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`by the Board (Pap. 57 at 14–15), Petitioners include herein case law that supports
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`its efforts to distinguish what is “confidential and properly redacted from material
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`that is not confidential and must be publicly disclosed.” Pursuant to the Board’s
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`guidance that even amidst much Highly Confidential information, there may be
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`non-confidential information that may help the public to discern at a basic level
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`what the document addresses (Paper 57 at 10), Petitioners have also prepared and
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`respectfully submit simultaneously herewith proposed redacted public versions to
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`replace the fully sealed exhibits previously submitted by both Patent Owner and
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`Petitioner. See Samsung Elec. Co. v. Nvidia Corp., IPR2015-01028, Paper 11 at 3
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`(PTAB Oct. 14, 2015) ( “with any renewed motion to seal, [p]atent [o]wner should
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`3
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`
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`provide a redacted version demonstrating those portions of its [p]reliminary
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`[r]esponse and [e]xhibits that it believes contain confidential information.”). In the
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`below summary, infra § III, Petitioners have also revised their previously-
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`submitted descriptions of the confidential information in these exhibits to more
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`thoroughly explain why the information is confidential. Petitioners have also
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`included the specific page numbers of each exhibit that are explicitly relied upon in
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`any party submission, which further delineates the relevant portions of each exhibit
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`for purposes of this proceeding from the large number of highly confidential pages
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`in each exhibit that are not cited or relied upon by either party in this proceeding
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`(and are thus generally of limited or no relevance to this proceeding).
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`II.
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`LEGAL STANDARD
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`“[T]here is a strong public policy for making all information filed in an inter
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`partes review open to the public. Factual evidence submitted in a trial to support a
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`party’s case for patentability must be made available to the public, unless there is
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`good cause for protecting the evidence.” Garmin Int’l, Inc. v. Cuozzo Speed Techs.
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`LLC, IPR2012-00001, Pap. 36 at 7–8 (PTAB Apr. 5, 2013). As provided by Fed.
`
`R. Civ. P. 26(c)(1)(G), the types of information likely to be confidential and
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`competitively sensitive are “trade secret or other confidential research,
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`development, or commercial information.” See Garmin, IPR2012-00001, Pap. 36
`
`at 4; see also Illumina, Inc. v. Columbia Univ., IPR2012-00007, Pap. 74 at 5–6
`
`4
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`
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`(PTAB Aug. 12, 2013) (granting motion to seal “sensitive proprietary [] technical
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`and business information, internal [] business communications, . . . or [] product
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`development information”); Apple Inc. v. SightSound Techs., LLC, CBM2013-
`
`00020, Paper 105 at 64–65 (PTAB Oct. 14, 2015) (granting motion to seal
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`competitively sensitive sales, marketing, and industry analysis).
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`The Board has recognized that the determination of whether or not to seal
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`particular information involves a balancing of the public interest in the information
`
`at issue against the harm from the disclosure of the confidential information.
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`Office Trial Practice Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012); Samsung,
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`IPR2015-01028, Pap. 11 at 4 (“The renewed motion [to seal] should be specific as
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`to why each document or redacted portion of a document is confidential such that
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`it outweighs the public interest in an open record.”); MasterImage 3D, Inc. v.
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`RealD Inc., IPR2015-00040, Pap. 85 at 75–76 (PTAB Apr. 14, 2016); Illumina,
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`IPR2012-00007, Pap. 74 at 6; Garmin, IPR2012-00001, Pap. 36 at 6–9. When the
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`information sought to be redacted is of no or little relevance to the merits of the
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`IPR proceedings (such that it does not affect “the patentability of claims in an
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`issued patent and therefore the rights of the public,” Garmin, IPR2012-00002, Pap.
`
`36 at 3), the public interest in access to the information is given little or no weight.
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`MasterImage, IPR2015-00040, Pap. 85 at 75 (“the burden to the public from
`
`sealing the limited material identified in [p]atent [o]wner’s [a]mended [m]otion is
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`5
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`
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`minimal, particularly because we need not identify those portions of [the]
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`testimony to address the issues in this case”); Garmin, IPR2012-00001, Pap. 36 at
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`6–9 (sealing business confidential information the details of which “are
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`unimportant to the merits of this case,” as well as personal confidential information
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`that “has little relevance to the merits of any substantive issue”); cf. Lumentum
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`Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00731, Paper 32 at 3–4 (PTAB
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`Feb. 5, 2016) (granting motion to compel production of a copy of a certain
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`schedule of an agreement that contained highly confidential business information
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`but noting that “[t]here is no obligation on a party to produce non-relevant
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`information” and permitting petitioner to “redact any content from [the filed
`
`exhibit] not relevant to this proceeding”).
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`III. GOOD CAUSE EXISTS FOR SEALING CERTAIN CONFIDENTIAL
`INFORMATION
`
`Petitioners submit that each of the proposed Exhibits summarized below
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`contains Petitioners’ confidential engineering, design, business, or commercial
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`information. Indeed, all pages of these Exhibits were designated by Petitioners as
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`“Highly Confidential” pursuant to the terms of the Delaware protective order.
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`Patent Owner has not challenged those designations. Petitioners provide detailed
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`good cause reasons for redacting portions of each of the exhibits, particularly
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`focusing on the redacted materials on those pages of each Exhibit that are cited in
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`any party submission. Although Petitioners contend a large number of uncited
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`6
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`
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`pages of each of the below exhibits are of little or no relevance to this proceeding,
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`see Lumentum Holdings, IPR2015-00731, Paper 32 at 3–4, they have nonetheless
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`endeavored to redact as necessary each page of each Exhibit, and make publicly
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`available non-confidential information so that the public can discern at least a basic
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`level of understanding of what each Exhibit addresses. Paper 57 at 10.
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`Ex. 1049 (pp.2 30-31, 39, 41, and 75-77 (Ex. 1046, ¶¶ 22-23, 29))
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`This 103-page document is an internal Edwards presentation regarding a
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`confidential development project and contains competitively sensitive information
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`about Edwards’ THV prototypes. Redactions on pp. 30-31 concern confidential
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`images of THV prototypes and design parameters related thereto. Redactions on p.
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`39 concern confidential testing related images of THV prototypes and observations
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`related thereto. Redactions on p. 41 concern a confidential summary of
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`observations of THV prototype testing. Redactions on pp. 75-77 concern
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`confidential testing related images of THV prototypes and observations of studies
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`related thereto.
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`Ex. 1050 (p. 32 (Ex. 1046, ¶ 24))
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`This 69-page document is an internal Edwards presentation discussing highly
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`confidential THV research and development, including THV prototypes developed
`
`2
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`Page cites refer to the pages of each Exhibit cited in any party submission
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`and refer to the page number of the IPR Exhibit stamp.
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`7
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`
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`by PVT. The redacted portions of p. 32 concern confidential images of THV
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`prototypes and summary points of prototype development and testing.
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`Exs. 1062 and 1063 (cited pages: all (Ex. 1045, ¶ 14; Pap. 33, 21))
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`Each of these Exhibits are 9-page documents containing a set of highly
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`confidential engineering drawings with precise details of the design and assembly
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`of Petitioners’ product. Indeed, the cover page to each Exhibit notes that “this
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`document contains confidential and proprietary information of Edwards
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`Lifesciences, LLC.” Each drawing has been redacted, along with certain
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`confidential and/or proprietary textual information, including the internal numbers
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`and letters assigned to the drawings and their respective revision numbers and
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`revision history, the identification of the person responsible for the drawings, and
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`particulars of the material used for the illustrated components.
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`Ex. 2031 (pp. 18, 35-39 (Pap. 21, 13; Ex. 2080, 106, 112; Pap. 33, 22))
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`This 100-page document is a highly confidential internal presentation that includes
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`competitively sensitive information concerning the development and testing of the
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`Sapien product line. Redactions on p. 18 concern confidential drawings of a
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`SAPIEN 3 frame. Pages 35-36 are left unredacted in their entirety. Redactions on
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`p. 37 concern confidential SAPIEN 3 design requirements and considerations for
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`the reduction of PVL. Redactions on p. 38 concern confidential drawings of the
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`8
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`
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`SAPIEN 3 external skirt. Redactions on p. 39 concern a confidential description of
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`key features of SAPIEN 3 and analysis of pros and cons of its design.
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`Ex. 2034 (p. 6 (Pap. 21, 52, 55; Ex. 2080, 101, 102, 110))
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`This 172-page document is a highly confidential presentation disclosed to a limited
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`number of physicians who participate in Edwards’ THV training and contains
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`competitively sensitive information regarding Edwards’ training strategy. No
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`redactions have been applied to p. 6, the only page cited in this Exhibit.
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`Ex. 2036 (pp. 3, 5, 7 (Pap. 21, 54, 55; Ex. 2080, 107, 109)
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`This 9-page document is a highly confidential internal manufacturing specification
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`for the SAPIEN 3 product, which, as noted on the document, “contains confidential
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`and proprietary information of Edwards Lifesciences, LLC.” Redactions on each
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`of pages 3, 5, and 7 include highly confidential images of the SAPIEN 3 at various
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`stages of manufacture, and assembly instructions related thereto.
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`Ex. 2039 (pp. 1, 5 (Pap. 21, 58))
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`This 5-page document is a highly confidential internal report regarding physician
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`preferences related to THVs. The redacted material on each of pages 1 and 5
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`concerns summary meeting notes from a confidential meeting between PVT
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`employees and practicing physicians concerning THV sizing and paravalvular
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`leak. As noted on the bottom of each page, these notes are “company proprietary
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`and confidential” information.
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`9
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`
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`Exs. 2041 (pp. 6-7 (Pap. 21, 59)) and 2042 (pp. 11-12 (Pap. 21, 59))
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` These 20-page and 44-page documents are highly confidential internal notes
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`regarding competitively sensitive business and marketing decisions and progress of
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`Edwards’ THV program. The redacted information on each of pp. 6-7 of Ex. 2041
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`and pp. 11-12 of Ex. 2042 concerns highly confidential design considerations and
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`improvements of Edwards’ PHV2 next-generation THV product.
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`Ex. 2043 (pp. 1, 23, 24, 28 (Pap. 21, 59; Ex, 2100, 36))
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`This 43-page document is highly confidential internal notes regarding
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`competitively sensitive business and marketing decisions and progress of Edwards’
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`THV program. Redactions on p. 1 concern confidential notes from an internal
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`Edwards meeting involving design reviews of various THV-related projects.
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`Redactions on pp. 23-24 concern a confidential slide presentation on paravalvular
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`leak prevention and preliminary design review, including project objectives,
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`specifications, and testing information. Redactions on p. 28 concern a confidential
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`slide presentation on Edwards’ PHV2 next-generation THV product relating to
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`design inputs and assumptions, and marketing considerations.
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`Ex. 2044 (pp. 12, 25 (Pap. 21, 59, 65))
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`This 42-page document is a highly confidential internal design review of Edwards’
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`THV products. Redactions on p. 12 concern confidential information related to the
`
`10
`
`
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`status of a THV project involving Biomerix foam, and p. 25 concerns confidential
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`information related to an FMEA risk analysis of that same project.
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`Ex. 2045 (p. 4 (Pap. 21, 60))
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`This 26-page document is a highly confidential internal presentation containing
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`competitively sensitive marketing, testing, and product development information
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`on Edwards’ SAPIEN products. Redactions on p. 4 concern confidential
`
`information on Edwards’ PHV2 THV product, including confidential design
`
`characteristics of certain THV designs.
`
`Ex. 2046 (pp. 4, 10, 28 (Pap. 21, 60; Pap. 48, 4; Ex. 2100, 96))
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`This 62-page document is a highly confidential internal presentation regarding a
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`competitively sensitive design review for Edwards’ Sapien 3 product. Page 4 has
`
`been left unredacted in its entirety. Redactions on p. 10 concern a confidential
`
`comparison between the SAPIEN XT and SAPIEN 3 products. Redactions on p.
`
`28 concern a confidential cross-sectional drawing of the SAPIEN 3 device and a
`
`description of the components related thereto.
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`Ex. 2055 (pp. 1-6, 19, 32-38 (Pap. 21, 17 n.3, 64))
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`This 56-page document is a highly confidential presentation regarding competition
`
`in the THV industry that includes competitively sensitive information, including
`
`survey results. Pages 1-2 have been left unredacted in their entirety, which identify
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`the document as a confidential marketing analysis prepared by Marketech Group
`
`11
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`
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`for Edwards Lifesciences. Redactions on p. 3 concern confidential marketing
`
`research steps performed in the Marketech analysis. Redactions on p. 4 concern a
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`confidential overview of THV procedures and demographics. Redactions on p. 5
`
`concern confidential analysis of THV attributes needed to succeed in the market.
`
`Redactions on p. 6 concern confidential analysis of marketing research results
`
`concerning THVs. Redactions on p. 19 concern confidential analysis of marketing
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`research results concerning THV purchase drivers and behavior. Redactions on pp.
`
`32-38 concern confidential analysis of marketing research results related to a
`
`conjoint analysis, as described on slide 35, which has been left unredacted.
`
`Ex. 2056 (pp. 56-58 (Pap. 21, 65))
`
`This 117-page document is a highly confidential document containing assessments
`
`of competition in the THV industry and contains competitively sensitive
`
`information. Redactions on p. 56 concern confidential competitive analysis of
`
`Boston Scientific’s Lotus valve product. Publicly available images on this page
`
`were left unredacted. Pages 57-58 were left unredacted in their entirety.
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`Ex. 2057 (pp. 13, 14 (Pap. 21, 66; Ex. 2100, 90))
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`This 132-page document is a highly confidential internal presentation regarding
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`competitively sensitive Edwards’ messaging and marketing strategy for its THV
`
`products. Redactions on pp. 13-14 concern confidential internal marketing
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`materials on the development of positioning, messaging, and concepts related to
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`12
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`
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`the SAPIEN 3 device, including the messaging pillars adopted for the SAPIEN 3
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`device. Pictures of the SAPIEN 3 device on these slides have been left unredacted.
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`Ex. 2063 (pp. 1, 3, 4 (Pap. 21, 69; Ex. 1046, ¶ 37; Ex. 2100, 110))
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`This is a 5-page, highly confidential draft of a script purportedly prepared for an
`
`internal video about the development of the SAPIEN 3 product. This document
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`contains competitively sensitive information regarding the development,
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`marketing, and messaging surrounding the SAPIEN 3 product. The redacted
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`information on each of pp. 1, 3, and 4 relates to the confidential development
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`commentary prepared for the purported video.
`
`Ex. 2077 (p. 11 (Pap. 21, 52; Ex. 2080, 102, 103; Pap. 33, 22; Ex. 1045, ¶ 16))
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`This is a 48-page highly confidential internal marketing presentation regarding
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`Edwards’ THV products and competitively sensitive messaging, design trade-offs
`
`and choices, and summaries of testing results related to these products. The only
`
`page cited, p. 11, is left unredacted in its entirety, which includes an annotated
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`picture of the SAPIEN 3 and its frame design.
`
`Ex. 2085 (p. 4 (Pap. 21, 53, 56))
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`This is a 5-page document containing highly confidential internal meeting notes
`
`and an internal presentation regarding Edwards’ SAPIEN 3 product, including
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`competitively sensitive testing, testing results, and proposed studies. Redactions
`
`on p. 4 concern confidential analysis of the SAPIEN 3’s PVL skirt performance.
`
`13
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`
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`Ex. 2086 (p. 11 (Pap. 21, 53))
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`This is a 50-page document concerning a highly confidential internal presentation
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`titled “SAPIEN 3 Product Deep Dive” regarding competitively sensitive marketing
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`strategies, messaging, and design goals for Edwards’ Sapien 3 product and related
`
`systems. Redactions on p. 11 relate to highly confidential information concerning
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`the SAPIEN 3 design, including its external skirt design, the specifications of the
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`SAPIEN 3 skirts, and comparison to certain SAPIEN XT components.
`
`Ex. 2088 (p. 1 (Pap. 21, 56))
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`This is a 1-page document concerning highly confidential internal meeting notes
`
`regarding Edwards’ Sapien 3 product, including competitively sensitive testing,
`
`testing results, and proposed studies. Redactions on p. 1 relate to highly
`
`confidential notes concerning an internal meeting on the SAPIEN 3 PVL skirt.
`
`Ex. 2089 (p. 2 (Pap. 21, 61))
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`This is a 2-page document containing a highly confidential set of internal emails
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`regarding competitively sensitive internal analysis of a clinical trial. Redactions on
`
`p. 2 concern a confidential communication on SAPIEN XT testing and design
`
`issues related to PVL.
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`Ex. 2090 (p. 5 (Pap. 21, 62))
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`This is a 53-page document concerning a highly confidential presentation
`
`regarding Edwards’ competitively sensitive internal sales strategy and messaging
`
`14
`
`
`
`for its products. Redactions on p. 5 relate to highly confidential marketing
`
`information related to the SAPIEN 3 product launch.
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`Ex. 2091 (p. 1 (Pap. 21, 64))
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`This is a one-page, highly confidential set of internal emails regarding Edwards’
`
`employees’ views on competitively sensitive market preferences and design
`
`attributes of THVs. Redactions on p. 1 relate to highly confidential
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`communications concerning a conjoint marketing study analysis.
`
`IV. CONCLUSION
`For the foregoing reasons, the parties respectfully request that the Board
`
`grant their Revised Motion to Seal Portions of Exhibits 1049, 1050, 1062, 1063,
`
`2031, 2034, 2036, 2039, 2041, 2042, 2043, 2044, 2045, 2046, 2055, 2056, 2057,
`
`2063, 2077, 2085, 2086, 2088, 2089, 2090, and 2091.
`
`15
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`
`
`DATED: February 23, 2018
`
`/s/ Jennifer A. Sklenar________
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu (Reg. No. 45,380)
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel: (213) 243-4000
`Fax: (213) 243-4199
`
`Attorneys for Patent Owner Boston
`Scientific Scimed, Inc.
`
`/s/ Gregory S. Cordrey
`Gregory S. Cordrey (Reg. No. 44,089)
`Brian P. Egan (Reg. No. (54,866)
`Catherine Nyarady (Reg. No. 42,042)
`
`Attorneys for Petitioners
`Edwards Lifesciences Corporation,
`Edwards Lifesciences LLC, and
`Edwards Lifesciences AG
`
`16
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on February
`
`23, 2018, a complete and entire copy of PETITIONERS’ REVISED MOTION
`
`TO FILE CONFIDENTIAL DOCUMENTS UNDER SEAL has been served in
`
`its entirety by e-mail on the following addresses of record for Patent Owner:
`
`jennifer.sklenar@apks.com
`
`wallace.wu@apks.com
`
`DATED: February 23, 2018
`
`/s/ Gregory S. Cordrey
`Gregory S. Cordrey (Reg. No. 44,089)
`Brian P. Egan (Reg. No. (54,866)
`Catherine Nyarady (Reg. No. 42,042)
`
`Attorneys for Petitioners
`Edwards Lifesciences Corporation,
`Edwards Lifesciences LLC, and
`Edwards Lifesciences AG
`
`17
`
`