Inter Partes Review Case No. IPR2015-00848
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`U.S. Patent No. 8,435,294
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`MEDSHAPE, INC.
`Petitioner
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`v.
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`CAYENNE MEDICAL, INC.
`Patent Owner
`_______________
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`Case No. IPR2015-00848
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`U.S. Patent 8,435,294
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`Issue Date: May 7, 2013
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`Title: Devices, Systems and Methods for Material Fixation
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`_______________
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`PETITIONER’S REPLY BRIEF PURSUANT TO 37 C.F.R. § 42.23(b)
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`U.S. Patent No. 8,435,294
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`MEDSHAPE, INC.
`Petitioner
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`v.
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`CAYENNE MEDICAL, INC.
`Patent Owner
`_______________
`
`Case No. IPR2015-00848
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`U.S. Patent 8,435,294
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`Issue Date: May 7, 2013
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`Title: Devices, Systems and Methods for Material Fixation
`
`_______________
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`PETITIONER’S REPLY BRIEF PURSUANT TO 37 C.F.R. § 42.23(b)
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`
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`Inter Partes Review Case No. IPR2015-00848
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`U.S. Patent No. 8,435,294
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
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`THE CLAIM CONSTRUCTION TESTIMONY PROFFERED BY
`KEVIN OHASHI HAS LITTLE, IF ANY, PROBATIVE VALUE............... 3
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`I.
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`II.
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`III. THE BOARD’S CONSTRUCTION OF THE TERM “MEMBER” IS
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`FULLY SUPPORTED BY THE PATENT SPECIFICATION ...................... 5
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`IV. CMI’S CONSTRUCTION SHOULD BE REJECTED .................................. 8
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`V.
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`THE FILE HISTORY SUPPORTS THE BOARD’S CONSTRUCTION ...13
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`A.
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`B.
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`The ‘528 Patent File History ...............................................................13
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`The ‘294 Patent File History ...............................................................16
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`VI. CHALLENGED CLAIMS 16-18 ARE ANTICIPATED BY GERKE ........18
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`VII. CHALLENGED CLAIMS 16-18 ARE ANTICIPATED BY JUSTIN ........22
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`VIII. CONCLUSION ..............................................................................................25
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`Inter Partes Review Case No. IPR2015-00848
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`U.S. Patent No. 8,435,294
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`TABLE OF AUTHORITIES
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`
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`Cases
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`Google Inc. v. Whitserve LLC
`IPR2013-00249, Paper 32 2014 Pat. App.
`LEXIS 6000 (P.T.A.B. Sept. 9, 2014) ................................................................... 9
`
`Howmedica Osteonics v. Wright Med. Tech. Inc.,
`540 F.3d 1337 (Fed. Cir. 2008) .............................................................................. 4
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`In re Translogic Tech., Inc.
`504 F.3d 1249 (Fed. Cir. 2007) .............................................................................. 5
`
`In re Van Geuns
`988 F.2d 1181 (Fed. Cir. 1993) .............................................................................. 9
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`Johnson Worldwide Assocs., Inc. v. Zebco Corp.
`175 F.3d 985 (Fed. Cir. 1999) ..............................................................................10
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`Purdue Pharma L.P. v. Endo Pharms. Inc.
`438 F.3d 1123 (Fed. Cir. 2006) ............................................................................13
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`Solomon v. Kimberly-Clark Corp.
`216 F.3d 1372 (Fed. Cir. 2000) .............................................................................. 4
`
`SuperGuide Corp. v. DirecTV Enters., Inc.
`358 F.3d 870 (Fed. Cir. 2004) ..............................................................................10
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`Wireless Seismic, Co. v. Fairfield Indus., Inc.
`IPR2014-01113 (P.T.A.B. Oct. 28, 2014) .............................................................. 4
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`Statutes
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`35 U.S.C. § 102 ....................................................................................................3, 25
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`35 U.S.C. § 325(d) ...................................................................................................22
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`Inter Partes Review Case No. IPR2015-00848
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`U.S. Patent No. 8,435,294
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`Other Authorities
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`Office Patent Trial Practice Guide
`77 Fed. Reg. 48756 (Aug. 14, 2012) ...................................................................... 2
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`Regulations
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`37 C.F.R. § 42.121 ...................................................................................................13
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`37 C.F.R. § 42.23(e) ................................................................................................... 2
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`Inter Partes Review Case No. IPR2015-00848
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`U.S. Patent No. 8,435,294
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`APPENDIX OF EXHIBITS
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`Description
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`Previously
`Submitted
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`Montgomery- ‘294” – U.S. Patent No. 8,435,294 to
`Montgomery et al.
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`Complaint filed in Cayenne Medical, Inc. v.
`MedShape, Inc., Case No. 2:14-CV-00451
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`Affidavit of Service Filed in Cayenne Medical, Inc. v.
`MedShape, Inc., Case No. 2:14-CV-00451
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`Declaration of Geoffrey Higgs, M.D.
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`European Patent Application EP 1 066 805 A2 to
`Gerke et al.
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`U.S. Patent No. 6,887,271 to Justin et al.
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`International Publication No. WO 02/32345 A3 to
`Jacobs et al.
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`File History of 8,435,294
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`Patent holder Cayenne Medical Inc.’s Opening Claim
`Construction Brief
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`X
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`Exhibit
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`Reply Declaration of Geoffrey Higgs, M.D.
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`iv
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`U.S. Patent No. 8,435,294
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`Inter Partes Review Case No. IPR2015-00848
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`I.
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`INTRODUCTION
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`In the Decision Instituting Inter Partes Review, the Board rejected the
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`construction of “first member” and “second member” proposed by Petitioner,
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`MedShape, Inc. (“MedShape”), and interpreted these terms as encompassing
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`“discernably different portions of an anchor even if these portions are part of a one
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`piece anchor.” Paper 9 at 10-11. For purposes of this proceeding, MedShape does
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`not contest and expressly adopts the Board’s construction of the term “member.”
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`Patent Owner, Cayenne Medical, Inc. (“CMI”) contests the Board’s broadest
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`reasonable interpretation of the term “member,” arguing that it “broadens the term
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`to an unreasonable scope,” and expressly urging for the first time that one skilled
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`in the art would have understood that “member” means “a functional unit of an
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`implant consisting of one or more movable parts, even if there are multiple units on
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`a one-piece implant.” See, e.g., Patent Owner Response (Paper 12 “PO Resp.”) 3,
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`38. In criticizing the Board’s interpretation and framing its own freshly-minted
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`construction, CMI relies upon the testimony of one of the patent’s seven (7) named
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`inventors and extensive attorney argument, while at the same time attempting to
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`limit the intrinsic record upon which its proposed construction is grounded to a
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`single disclosed embodiment and a few disparate excerpts from the prosecution
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`history. See, e.g., PO Resp. 35-46. CMI’s proposed construction, predicated upon
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`self-serving inventor testimony, unsupported attorney argument and a constrained
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`view of the Specification (e.g., PO Resp. 32-36, 38-43, 44-46), is insufficient to
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`disturb the Board’s construction, and should therefore be rejected.
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`With the exception of the terms “member,” CMI does not dispute that all
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`other elements of the challenged claims are described in Gerke and Justin. PO
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`Resp. 31 (“no additional express construction of any other term is necessary to
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`decide the anticipation issues before the Board”); see, e.g., 37 C.F.R. § 42.23(e)
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`(“material fact[s] not specifically denied may be considered admitted”); Office
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`Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) (Patent
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`Owner’s Response “should identify all the involved claims that are believed to be
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`patentable and state the basis for that belief.”). MedShape will therefore not
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`address these uncontested terms in its Reply. Apart from the terms first and second
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`“member,” the record now contains unrebutted arguments and evidence regarding
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`the disclosures found in Gerke and Justin. Petition For Inter Partes Review (Paper
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`1 “Pet”) 27-46. Consistent with the Board’s interpretation of “member,”
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`challenged Claims 16-18 of the ‘294 patent are unpatentable under 35 U.S.C. § 102
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`as anticipated by both Gerke and Justin.
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`II. THE CLAIM CONSTRUCTION TESTIMONY PROFFERED BY
`KEVIN OHASHI HAS LITTLE, IF ANY, PROBATIVE VALUE
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`In a flawed attempt to legitimize its new construction of the term “member,”
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`CMI relies upon the testimony of Kevin Ohashi, one of the seven (7) named
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`inventors of the ‘294 patent. See generally Ex. 2001; see, e.g., PO Resp. 44-46. In
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`particular, Dr. Ohashi avers that one of ordinary skill in the art would have
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`understood that the generic term “member,” recited in each of the challenged
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`claims, means “a functional unit of an implant consisting of one or more movably
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`parts, even if these are multiple units on a one-piece implant.” See, e.g., Ex. 2001,
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`¶ 54. Not only does Dr. Ohashi try to justify his post-hoc construction of the term
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`“member” recited in the claims of his own patent (Ex. 2001, ¶¶ 44-55), he proffers
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`his opinion regarding the particular embodiment he believes was intended to fall
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`within the scope of that construction (e.g., Ex. 2001, ¶¶ 35-41, 43), and then opines
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`why, under his construction, Gerke and Justin do not describe the first and second
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`“members” of the challenged claims. Ex. 2001, ¶¶ 59-64, 66-73.
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`Post-hoc, litigation-induced inventor testimony, like that relied upon by
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`CMI, has little or no probative value on issues relating to claim construction. See,
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`e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379 (Fed. Cir. 2000)
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`(“litigation-derived inventor testimony in the context of claim construction . . . is
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`entitled to little, if any, prohibitive value”); Wireless Seismic, Co. v. Fairfield
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`Indus., Inc., IPR2014-01113, Paper 8 at 3, (P.T.A.B. Oct. 28, 2014) (“claim
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`construction depends heavily on the understanding of one with ordinary skill in the
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`art . . . and not so much, if at all, on what an inventor himself thinks of the meaning
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`of a claim term”); see Howmedica Osteonics v. Wright Med. Tech. Inc., 540 F.3d
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`1337, 1346-47 (Fed. Cir. 2008) (“[w]hether an inventor’s testimony is consistent
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`with a broader or narrower claim scope, that testimony is still limited by the fact
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`that an inventor understands the invention but may not understand the claims,
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`which are typically drafted by the attorney prosecuting the patent application”).
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`Dr. Ohashi’s testimony regarding his current belief regarding how one
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`skilled in the art would have understood the term “member,” his opinion as to the
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`single embodiment of his patent arguably encompassed by his proposed
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`construction, and his litigation-induced opinion how, under his interpretation of his
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`own patent, Gerke and Justin do not describe first and second “members” is no
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`exception. Dr. Ohashi’s claim construction testimony and opinions lack probative
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`value and should be given no weight by the Board. Stripped of this irrelevant
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`opinion testimony, CMI is relegated to unsupported attorney argument which is
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`insufficient to disturb the Board’s construction of the generic term “member.”
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`III. THE BOARD’S CONSTRUCTION OF THE TERM “MEMBER”
`IS FULLY SUPPORTED BY THE PATENT SPECIFICATION
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`The terms “first member” and “second member” are recited in each of the
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`four independent claims of the ‘294 patent. Ex. 1001 (Claims 1, 6, 14, 16). These
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`terms are given their ordinary and customary meaning, as would be understood by
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`one of ordinary skill in the art in the context of the entire patent disclosure. In re
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`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). While Dr. Ohashi
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`and the other six named inventors could have acted as lexicographer by providing a
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`special definition for the generic term “member,” the word “member” appears once
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`in the specification, and then only in relation to Figures 23 to 26 (“non-cylindrical
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`direct anchor 231 (in this case fabricated from a resilient elastic member”)). Ex.
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`1001, 18:31-32 (italics added). Nevertheless, the Specification expressly describes
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`numerous implant and anchor embodiments having “members” of different
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`structures, shapes, and geometries allowing the respective members to possibly
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`operate in different ways within the bone tunnel. These different structural and
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`operational features exhibited by the members of the anchor embodiments recited
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`in the Specification provide significant support for the Board’s construction of
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`“member.”
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`For example as Dr. Higgs detailed, Figure 3 describes first anchor members
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`(i.e., the “mid-section 33 between these ‘clover leaf’ extensions are not flared”)
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`that, when expanded compresses soft tissue, and second members of the anchor
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`that are “flared at the ‘clover leaf’ extension” that partially penetrate into the bone.
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`Ex. 1001, 13:35-14:2. These different anchor members clearly possess different
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`shapes and behave differently, and would therefore be considered “discernably
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`different portions” of the anchor consistent with the Board’s construction. Ex.
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`1010, ¶ 32 (Reply Declaration of Geoffrey Higgs, M.D.).
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`Further, the Figure 30 anchor shows first members (i.e., upper tabs that
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`compress tendon directly against the surface of the bone) and second anchor
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`members (i.e., lower tabs 322 that expand outwardly into engagement with bone).
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`Ex. 1001, 19:64-20:21. Again, the different members of the Figure 32 anchor
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`embodiment are both visibly and operationally different, and therefore provide
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`further support for the Board’s construction of “member.” Ex. 1010, ¶ 34.
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`“Discernably different portions,” consistent with the Board’s construction,
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`are also clearly depicted by the anchor of Figure 20. In particular, this
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`embodiment describes first members (i.e., lower groves 208) that expand
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`outwardly and compress tendon directly against the surface of the bone and second
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`members (i.e., extensions 209 located on the upper portion of the anchor that
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`expand outwardly into engagement with bone). Ex. 1001, 17:35-61. This
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`embodiment clearly illustrates “first members” and “second members” of an
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`anchor that are “discernably different” that comports with the Board’s
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`construction. Ex. 1010, ¶ 35.
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`Figure 32 details an anchor embodiment having first and second “members”
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`that are “discernably different.” Specifically, first members (i.e., lower tabs 322
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`expand outwardly into engagement with bone, while second members (i.e., upper
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`tabs compress tendon directly against the surface of the bone). Ex. 1001, 20:27-36.
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`These “discernably different portions” of the Figure 32 anchor are both visibly and
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`operationally different, and therefore consistent with Board’s construction of the
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`term “member.” Ex. 1010, ¶ 36. Likewise, the anchors depicted in Figures 22 and
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`49 also illustrate first and second members that are “discernably different portions”
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`of the described embodiments consistent with the Board’s construction. Ex. 1001,
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`18:7-24; 23:14-26; Ex. 1010, ¶¶ 33, 37.
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`Contrary to CMI’s assertions, these described embodiments strongly align
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`with and fully support the Board’s construction of the generic term “member.”
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`IV. CMI’S CONSTRUCTION SHOULD BE REJECTED
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`CMI proposes a construction for “member” that is too narrow by importing
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`functional limitations from a single embodiment while broader embodiments, such
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`as the ones discussed above, are ignored. In contrast, the Board’s construction as
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`covering “discernably different portions of an anchor,” properly focuses on the
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`structure of the anchor - - whether one skilled in the art, observing the anchor,
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`would perceive boundaries separating one portion of the anchor from the other.
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`The way individual members operate can provide additional grounds for
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`distinguishing the members, but requiring separate, independent mechanisms for
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`these members, as proposed by CMI, is simply not described in the Specification.
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`Ex. 1010, ¶¶ 13-14 and 63.
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`Central to CMI’s claim construction argument is an improper attempt to
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`restrict its construction of the term “member” to the functional features of the
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`particular device depicted in Figure 48. See, e.g., PO Resp. 7, 8-10, 32-33, 35-36,
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`45-46. However, the Board must reject CMI’s invitation to import features of one
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`of the numerous described embodiments into the challenged claims when the claim
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`language, as there, is broader than any single embodiment. See In re Van Geuns,
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`988 F.2d 1181, 1184 (Fed. Cir. 1993) (“limitations are not to be read into the
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`claims from the specification”).
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`While Applicants chose to claim their purported invention broadly using the
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`generic term “member,” CMI fails to provide any persuasive argument as to why
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`the claims can be construed as narrowly as now proposed. Further, CMI offers no
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`credible explanation why one skilled in the art would completely ignore express
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`directives in the Specification that the embodiments are non-limiting, and instead
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`focus exclusively on the single embodiment depicted by Figure 48 to ascertain the
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`scope and meaning of the term “member.” Ex. 1010, ¶¶ 24-27.
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`For example, neither CMI nor Dr. Ohashi identify any portion of the
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`Specification suggesting that Applicants intended to limit the claimed first or
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`second “members” exclusively to the use or operation of the particular anchor
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`depicted by Figure 48. See, e.g., Google Inc. v. Whitserve LLC, IPR2013-00249,
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`Paper 32, 2014 Pat. App. LEXIS 6000, *17 (P.T.A.B. Sept. 9, 2014) (“[a]bsent a
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`clear disclaimer in the specification, the broadest reasonable interpretation of a
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`claim should not be limited to any particular embodiment”). To the contrary, the
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`Specification is replete with express statements that the patent claims are not
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`limited by any single embodiment. See, e.g., Ex 1001, 3:29-32 (the “full scope of
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`the present invention covers all concepts and designs that function in the same
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`manner as the exemplary embodiments described herein and throughout this
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`disclosure”); 24:43-46 (the “foregoing disclosure of the preferred embodiments of
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`the present invention has been presented for purposed of illustration and
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`description [and] is not intended . . . to limit the invention to the precise forms
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`disclosed”); see 13:3-338. In fact, CMI conceded that the particular anchor device
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`depicted by Figure 48 is “representative” and not limiting. CMI’s Preliminary
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`Response (Paper 8 “Prelim. Resp.”) 5 (Figure 48 is merely a “representative
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`embodiment”). These statements evidence Applicants’ intent not to limit the scope
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`of the term “member” to any single embodiment as now proposed by CMI.
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`CMI’s attempt to construe the term “member” by importing functional and
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`structural features arguably possessed by a single illustrative embodiment is also
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`legally improper. See, e.g., PO Resp. 6-7, 32-36. Specifically, “a particular
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`embodiment appearing in the written description may not be read into a claim
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`when the claim language is broader than the embodiment.” SuperGuide Corp. v.
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`DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004); see, e.g., Johnson
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`Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 992 (Fed. Cir. 1999)
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`(“[J]ust as the preferred embodiment itself does not limit claim terms, mere
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`inferences drawn from the description of an embodiment of the invention cannot
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`serve to limit claim terms, as they are insufficient to require a narrower definition
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`of a disputed term.”). Accordingly, CMI’s attempt to limit the construction of
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`“member” to the functional and/or structural features exhibited by the Figure 48
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`anchor should be rejected.
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`CMI’s assertion that independent Claim 6 and dependent Claims 9, 11 and
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`12 arguably may cover the anchor depicted in Figure 48 is equally unavailing. PO
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`Resp. 8-9. In particular, CMI offers no persuasive explanation why the method
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`recited in challenged Claims 16-18 must be restricted exclusively to how the
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`particular device depicted in Figure 48 may possibly operate.
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`CMI’s effort to redefine and clarify what its construction of the term
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`“member” actually means further exposes the flaws in its construction. For
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`example, after urging that the term “member” should be construed to mean “a
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`functional unit of an implant consisting of one or more moveable parts, even if
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`there are multiple limits on a one-piece implant,” CMI then tries to import
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`additional functional and structural limitations into the term “functional unit.” For
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`example, CMI alternatively proposes that that the term “functional unit,” in the
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`context of the ‘294 patent, must either operate in the “same manner” or through the
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`use of the “same mechanism.” PO Resp. 34. CMI also asserts that its “functional
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`unit” “must function independently and discretely from one another.” PO Resp.
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`33. In yet a further variation, CMI proposes that its definitional term “functional
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`unit” must be “deployed through a separate, independent mechanism.” PO Resp.
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`35. Based upon this shifting construction, one skilled in the art would have no
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`clear understanding as to the scope and meaning of term “member” under CMI’s
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`proposed construction. Ex. 1010, ¶¶15-17. CMI’s self-professed need to clarify
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`and explain what is meant by the very construction it proffered for the term
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`“member” is sufficient reason for the Board to reject CMI’s proposed construction.
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`Finally, CMI’s strained claim construction is belied by the actions of
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`Applicants during prosecution and CMI during this proceeding. Specifically, had
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`Applicants desired claims limited to a method of anchoring soft tissue to bone
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`using an implant or anchor having first and second “functional units consisting of
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`one or more movable parts, even if there are multiple limits on a one-piece
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`implant,” they would have not used the broad and generic term “member” in the
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`claims. Further, CMI could have sought to amend the challenged claims so that
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`the terms first and second “member” were structurally and functionally limited to
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`the features of the Figure 48 anchor embodiment. However, Applicants and CMI
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`followed neither course. Rather, CMI and one of the named inventors seek to
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`avoid the requirements of, inter alia, 37 C.F.R. § 42.121, and now attempt to
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`impermissibly amend the challenged claims in an effort to avoid Gerke and Justin.
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`V. THE FILE HISTORY SUPPORTS THE BOARD’S CONSTRUCTION
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`CMI argues Applicants disclaimed the Board’s construction of the term
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`“member.” PO Resp. 39-44. CMI’s argument is both legally and factually
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`baseless. Applicants failed to make the necessary clear and unmistakable
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`disavowal of scope of the term “member” during prosecution. Purdue Pharma
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`L.P. v. Endo Pharms. Inc., 438 F.3d 1123, 1136 (Fed. Cir. 2006) (disclaimer
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`requires a “clear and unmistakable disavowal of scope during prosecution”).
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`A. The ‘528 Patent File History
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`During prosecution, the Examiner rejected all pending claims, i.e., claims
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`21-41 that included first and second members. Ex. 1008, pp. 199-206. In
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`response, Applicants argued, inter alia, that pending claim 39 (issued as Claim 12
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`of the ‘528 patent) was not anticipated by the cited references (i.e., McDevitt; Lee
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`and Stewart - 7,201,754) because these patents failed to disclose deploying a first
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`member outwardly to engage adjacent bone and deploying a second member
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`disposed axially from the first member outwardly to engage bone. Applicants
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`further urged that the Examiner ignored the limitation that the second member, as
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`well as the first member, is expandable outwardly. As such, there was no clear
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`disavowal of an interpretation that would cover an anchor having discernably
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`different portions. Ex. 1008, pp. 217-224.
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`CMI tries to bolster its meritless disclaimer argument by proposing what
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`“the Examiner could have determined” when considering Stewart (Ex. 2005). PO
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`Resp. 39. However, CMI’s speculation is not relevant to the issue of disclaimer.
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`In particular, the Examiner noted that Stewart describes a first member (10) on the
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`body which is expandable outwardly to engage portions of the bone and a second
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`member (11) on the body which is distal to the first member wherein proximal
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`movement of the second member actuates the first member to expand outwardly to
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`engage bone. Ex. 1008, pp. 199-205. In response, and in contrast to CMI’s current
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`assertions, Applicants did not argue the definition of the term “member,” and
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`merely asserted that the claims were “patentable over” Stewart “for the reasons
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`discussed above with respect to those earlier references.” Ex. 1008, pp. 217-224.
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`Ex. 1010, ¶ 44. Applicants’ statements regarding Stewart do not support CMI’s
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`disclaimer argument.
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`CMI also relies upon prosecution arguments regarding Curtis (Ex. 2006) to
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`prop-up its meritless disclaimer argument. PO Resp. 40-42. CMI contends that
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`Applicants’ response to the Examiner’s rejection of all of the pending claims over
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`Curtis (Ex. 1008, pp. 228-232) emphasized that this reference did not disclose a
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`second axially spaced expandable member. PO Resp. 41. Again, contrary to
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`CMI’s assertion, Applicants did not argue that the Examiner was incorrect in
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`identifying a first and second member, but instead suggested that the second
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`member (14) identified by the Examiner “did not deploy outwardly to engage
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`adjacent material.” Thus, in attempting to distinguish Curtis, Applicants focused
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`on the fact that Curtis does not disclose placing soft tissue on the implant (11, 14).
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`In fact, Applicants stressed that Curtis only disclosed a suture anchoring method,
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`and a suture cannot be construed as “soft tissue.” Ex. 1008, pp. 241-250. Again,
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`there was no discussion, and clearly no specific disavowal of the term “member”
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`or a construction that would include multi-legged anchors. Ex. 1010, ¶¶ 45-46.
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`In response to the final Office Action rejecting pending claims 39-41 and
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`44-46 as anticipated by Adams, Applicants observed that claim 39 had been
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`amended to recite that the outward deployment of one of the first and second
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`members compresses soft tissue between the said one of the first and second
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`members and adjacent bone. Applicants urged that Adams discloses an unrelated
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`implantable fastening system for securing layers of tissue together to treat GERD.
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`There was simply no disavowal of the term “member” or a construction that would
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`include multi-legged anchors. Ex. 1008, pp. 374-380.
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`B.
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`The ‘294 Patent File History
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`Contrary to CMI’s assertion, there was also no clear and unmistakable
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`disavowal of the Board’s interpretation of the term “member” during the
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`prosecution of the ‘294 patent. PO Resp. 42-44.
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`In a non-final rejection, the Examiner rejected claims 39-41, as anticipated
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`by Li. In response, claim 39 (issued as independent Claim 16 of the ‘294 patent)
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`was amended to define the implant as “having a longitudinal axis extending from a
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`distal end from the implant to a proximal end of the implant.” The second member
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`was further defined as being disposed on said implant in an axially spaced
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`relationship from the first member. Lastly, claim 39 was amended to include the
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`element “wherein the outward deployment of first of said first and second
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`members compresses the soft tissue between said one of said first and second
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`members and adjacent bone.” Ex. 2003, pp. 255-262. Addressing the claim 39
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`amendments, Applicants argued that Li does not describe anything relating to soft
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`tissue, and therefore the element of the first and second members compressing the
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`soft tissue against adjacent bone was not disclosed. Ex. 2003, p. 262.
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`In the following Office Action, in relevant part, claims 39-41 were rejected
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`as obvious over Levy in view of Justin. Ex. 2003, pp. 273-280. The Examiner
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`relied upon Justin in response to the Applicants’ previous Amendment that the
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`outward deployment of one of said first and second members compresses the soft
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`tissue between one of said first and second members and adjacent bone, and stated
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`“given the teaching of Justin, it would have been obvious to one having ordinary
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`skill in the art at the time the invention was made to modify the device of Levy et
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`al. as taught by Justin et al., to fix the bone engaging elements, as well as the graft
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`material, in bone tunnel.” Ex. 2003, p. 277. In response, Applicants maintained
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`that, since Levy related to securing two fractured pieces of bone together, while
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`Justin is concerned with attaching soft tissue to bone, one skilled in the art would
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`not combine the two types of anchors. Ex. 2003, p. 344. Applicants made no clear
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`disclaimer of an interpretation that would cover multi-legged anchors.
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`CMI’s arguments do not evidence the “clear and unmistakable disavowal”
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`necessary to show Applicants “effectively disclaimed” an interpretation of the term
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`“member” that encompasses the prior art.
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`VI. CHALLENGED CLAIMS 16-18 ARE ANTICIPATED BY GERKE
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`With regard to each of the challenged claims, the only element CMI contests
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`Gerke (Ex. 1006) fails to disclose is first and second axially displaced members.
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`PO Resp. 48-52. Because CMI does not dispute that Gerke discloses the remaining
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`elements recited in Claims 16-18, MedShape will not address these uncontested
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`claim terms. Based upon the current record, Gerke discloses each and every
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`limitation of Claims 16-18 of the ‘294 patent. Ex. 1010, ¶¶ 80-84.
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`The argument advanced by CMI and Dr. Ohashi that Gerke describes a
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`“single functional unit” that “cannot reasonably be divided into multiple
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`‘discernably distinct ‘portions’” can be dismissed in short order by looking at
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`Figure 1 of Gerke. See, e.g., PO Resp. 47-48; Ex 2001, ¶¶ 59, 61, 64. As Dr.
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`Higgs explained, one skilled in the art would have readily observed that Gerke
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`details two discernably different portions of an anchor, consistent with the Board’s
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`construction and therefore discloses first and second axially displaced members as
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`recited in Claim 16. Ex. 1010, ¶¶ 49-62.
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`In particular, the first and second anchor members described in Gerke can be
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`readily distinguished by their different shape, location and function. The Gerke
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`anchor provides clear boundaries delimiting the two members. In particular, the
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`first member of the anchor extends from the anchor proximal end 6 to the first
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`notch formed on the legs as shown in the annotated Figure 1(c). The second
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`member is the portion of the anchor
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`that extends from the first notch to the
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`distally disposed second notch. Ex.
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`1005, Figs. 1(c) and 3; Ex. 1010,
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`¶¶ 49-50. Accordingly, the anchor has
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`definite, distinguishable and
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`observable boundaries that define a beginning and an end of both the first and the
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`second members. Therefore, the first and second members are “discernably
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`different portions” of the anchor consistent with the Board’s construction. Ex.
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`1010, ¶ 51.
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`CMI and Dr. Ohashi also opine that the notches which serve to delimit the
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`first and second members are irrelevant features of the Gerke anchor. See PO
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`Resp. 49-50; Ex 2001, ¶¶ 61-63. This argument is unavailing as one skilled in the
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`art would visibly observe that these notches are thinned areas that enable flexing
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`between the first and second members, allow independent movement and
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`ultimately permit the first and second members to function independently. Ex.
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`19
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`U.S. Patent No. 8,
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