`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`MEDSHAPE, INC.
`Petitioner
`
`v.
`
`CAYENNE MEDICAL, INC.
`Patent Owner
`_______________
`
`Case No. Unassigned
`
`U.S. Patent 8,435,294
`
`Issue Date: May 7, 2013
`
`Title: Devices, Systems and Methods for Material Fixation
`_______________
`
`
`PETITION FOR INTER PARTES REVIEW
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.1 ET SEQ.
`
`
`
`
`
`
`
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`Inter Partes Review Case No. Unassigned
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`U.S. Patent No. 8,435,294
`
`TABLE OF CONTENTS
`THE PETITION ...............................................................................................1
`
`I.
`
`II. MANDATORY NOTICES .............................................................................1
`
`A.
`
`
`
`B.
`
`
`
`C.
`
`
`
`D.
`
`
`
`Real party-in-interest .............................................................................1
`
`Related matters (37 C.F.R. § 42.8(b)(2)) ..............................................2
`
`Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a)) ..................................2
`
`Service information (37 C.F.R. § 42.8(b)(4)) .......................................2
`
`III.
`
`PAYMENT OF FEES ......................................................................................3
`
`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW ............4
`
`
`
` Grounds for Standing (37 C.F.R. § 42.104(a)) .....................................4 A.
`
`B.
`
`
`
`C.
`
`
`
`Level of Ordinary Skill in the Art .........................................................4
`
`Identification of Challenge and Relief Requested (37 C.F.R.
`§ 42.104(b) and 37 C.F.R. § 42.22(a)(1)) .............................................5
`
`1.
`
`
`
`2.
`
`
`
`Claims for which Inter Partes Review is Requested
`(37 C.F.R. § 42.104(b)(2)) ..........................................................5
`
`Specific Statutory Grounds on which the Challenge
`is Based (37 C.F.R. § 42.104(b)(2)) ...........................................5
`
`D.
`
`
`
`Claim Construction - Broadest Reasonable Interpretation
`(“BRI”) (37 C.F.R. § 42.104(b)(3)) ......................................................7
`
`V.
`
`SUMMARY OF THE ‘294 PATENT (EX 1001) ........................................ 10
`
`A.
`
`
`
`B.
`
`
`
`
`
`Background of ‘294 Patent ................................................................ 10
`
`Prosecution History of the ‘294 Patent .............................................. 12
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`Inter Partes Review Case No. Unassigned
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`U.S. Patent No. 8,435,294
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`C.
`
`
`
`Construction of the ‘294 Patent Claim Terms ................................... 18
`
`1.
`
`
`
`2.
`
`
`
`3.
`
`
`
`4.
`
`
`
`5.
`
`
`
`6.
`
`
`
`7.
`
`
`
`8.
`
`
`
`9.
`
`
`
`Claims 6 and 16 - “implant” .................................................... 18
`
`Claims 6 and 16- “a body having a longitudinal axis,
`a distal end, and a proximal end” ............................................ 19
`
`Claims 6 and 16 - “a first member” ......................................... 20
`
`Claim 6 - “moveably expandable outwardly” ......................... 20
`
`Claims 6 and 16 - “a second member on said body
`which is disposed axially from said first member” ................. 21
`
`Claim 6 - “a substantially different construction” ................... 21
`
`Claim 6 - “a distal end of said body comprising
`a space for receiving soft tissue therethrough” ....................... 22
`
`Claim 6 - “surfaces of said body which are oriented both
`generally parallel to said longitudinal axis and generally
`transverse to said longitudinal axis” ........................................ 23
`
`Claim 6 - “a deployment device which is
`moveable in a generally axially direction” .............................. 24
`
`
`
` Claims 6 and 16 - “to deploy” ................................................. 24 10.
`
`
` Claim 9 - “wherein said member first comprises 11.
`an arm which is pivotable outwardly” ..................................... 25
`
`
`
` Claims 9 and 16 - “to engage bone” ........................................ 25 12.
`
`
` Claim 16 - “compresses the soft tissue between said 13.
`one of said first and second members and adjacent bone” ...... 26
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`VI. EACH GROUND PROVIDES MORE THAN A REASONABLE
`LIKELIHOOD THAT EACH CHALLENGED CLAIM OF THE
`‘294 PATENT IS UNPATENTABLE ......................................................... 27
`
`U.S. Patent No. 8,435,294
`
`
` Ground 1: § 102(b) - EP 1 066 805 A2 to Gerke et al. A.
`[Claims 6-11, 13 and 16-18] .............................................................. 27
`
`B.
`
`
`
`Ground 2: § 102(b) – Justin ‘271 patent
`[Claims 6-11, 13 and 16-18] .............................................................. 38
`
`C.
`
`
`
`Ground 3: § 102(b) - WO ‘345 [Claims 6-11, 13 and 16-18] ........... 47
`
`
` Ground 4: § 103(a) - WO ‘345 in View of Either EP ‘805 D.
`or the Justin ‘271 patent [Claims 6-11, 13 and 16-18] ...................... 52
`
`E.
`
`
`
`Claim Chart ........................................................................................ 55
`
`VII. CONCLUSION ............................................................................................. 60
`
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`U.S. Patent No. 8,435,294
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`APPENDIX OF EXHIBITS
`
`
`Exhibit
`Number
`
`1001
`
`
`1002
`
`
`1003
`
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`
`
`
`
`
`
`Exhibit Description
`
`
`
`
`
`“Montgomery- ‘294” – U.S. Patent No. 8,435,294
` to Montgomery et al.
`
`Complaint filed in Cayenne Medical, Inc. v. MedShape, Inc.,
` Case No. 2:14-CV-00451
`
`Affidavit of Service Filed in Cayenne Medical, Inc. v. MedShape,
`Inc., Case No. 2:14-CV-00451
`
`Declaration of Geoffrey Higgs, M.D.
`
`European Patent Application EP 1 066 805 A2 to Gerke et al.
`
`U.S. Patent No. 6,887,271 to Justin et al.
`
`International Publication No. WO 02/32345 A3 to Jacobs et al.
`
`File History of 8,435,294
`
`Patent holder Cayenne Medical Inc.’s Opening
` Claim Construction Brief
`
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`Inter Partes Review Case No. Unassigned
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`I.
`
`THE PETITION
`
`U.S. Patent No. 8,435,294
`
`Petitioner, real party-in-interest MedShape, Inc. hereby petitions the Patent
`
`Trial and Appeal Board (the “Board” or the “PTAB”) of the United States Patent
`
`and Trademark Office (“PTO”), pursuant to 35 U.S.C. §§ 311-319 and 37 C.F.R. §
`
`42.1 et seq., to institute an inter partes review, to find and cancel Claims 6-11, 13
`
`and 16-18 of U.S. Patent No. 8,435,294, entitled “Devices, Systems and Methods
`
`for Material Fixation,” issued May 7, 2013 (Serial No. 12/634,581, filed
`
`December 9, 2010) (“ the ‘294 patent”), assigned to Cayenne Medical, Inc. The
`
`‘294 patent is submitted herewith as Exhibit 1001. There is a reasonable
`
`likelihood that Petitioner will prevail with respect to at least one claim challenged
`
`in this petition.
`
`II. MANDATORY NOTICES
`
`As set forth below and pursuant to 37 C.F.R. § 42.8(a)(1), the following
`
`mandatory notices are provided as part of this petition.
`
` Real party-in-interest
`A.
`
`Pursuant to 37 C.F.R. § 42.8(b)(1) Petitioner, MedShape, Inc.
`
`(“MedShape”), a corporation, organized and existing under the laws of the State of
`
`Georgia, is the sole real party-in-interest.
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` Related matters (37 C.F.R. § 42.8(b)(2)) B.
`
`U.S. Patent No. 8,435,294
`
`Cayenne has asserted two patents – U.S. Patent Nos. 8,435,294 and
`
`7,651,528 in a lawsuit captioned Cayenne Medical, Inc. v. MedShape, Inc. Case
`
`No. 2:14-CV-00451 (HRH) (D. Ariz.). The litigation is presently ongoing. In
`
`addition to the instant Petition relating to the ‘294 patent, Petitioner also
`
`concurrently submits a Petition for Inter Partes Review of 7,651,528 (“the ‘528
`
`patent”) owned by Cayenne Medical, Inc.
`
` Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a))
`C.
`
`Petitioner designates the following individuals as its lead counsel and back-
`
`up lead counsel:
`
`
`
`
`
` Back-up Lead Counsel
`
`
`Lead Counsel
`
`James F. Harrington
`Anthony E. Bennett
`
`Reg. No. 44,741
`Reg. No. 40,910
`
`Hoffmann & Baron, LLP
`Hoffmann & Baron, LLP
`aebdocket@hbiplaw.com
`jfhdocket@hbiplaw.com
` (516) 822-3550
`
`
` (516) 822-3550
`
`
`D.
`
`Service information (37 C.F.R. § 42.8(b)(4))
`
`Service on Petitioner may be made electronically by using all the following
`
`two email addresses together in providing service: aebdocket@hbiplaw.com and
`
`jfhdocket@hbiplaw.com. Service on Petitioner may be made by Postal Mailing or
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`or Hand-delivery addressed to Lead and Back-up Lead Counsel at the following
`
`U.S. Patent No. 8,435,294
`
`address, but electronic service above is requested:
`
`
`
`
`
`
`
`
`
`
`Hoffmann & Baron, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
`
`
`
`
`
`
`This document, together with all exhibits referenced herein, has been served
`
`on the patent owner at its principal place of business at 16597 North 92nd Street,
`
`Suite 101, Scottsdale, Arizona 85260 as well as the correspondence address of
`
`record for the ‘294 patent: Donald E. Stout, Esq., Stout, Axa & Buyan, LLP, 4
`
`Venture, Suite 300, Irvine, CA 92618.
`
`III. PAYMENT OF FEES
`
`Pursuant to 37 C.F.R. §§ 42.103 and 42.15(a), the requisite filing fee of
`
`$23,000 (request fee of $9,000 and post-institution fee of $14,000) for this Petition
`
`for Inter Partes Review is submitted herewith. Claims 6-9, 11, 13, and 16-18 of
`
`the ‘294 patent are being reviewed as part of this Petition. The undersigned
`
`further authorizes payment from Deposit Account No. 08-2461 for any additional
`
`fees or refund that may be due in connection with the Petition.
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`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW
`
`U.S. Patent No. 8,435,294
`
`
`
` Grounds for Standing (37 C.F.R. § 42.104(a)) A.
`
`Petitioner hereby certifies that the ‘294 patent is available for Inter Partes
`
`Review and that Petitioner is not barred or estopped from requesting Inter Partes
`
`Review challenging the claims of the ‘294 patent on the grounds identified herein.
`
`This Petition is timely filed under 35 U.S.C. § 315(b) because it is filed within one
`
`year of the service of the Complaint alleging infringement of the ‘294 patent by
`
`Cayenne. See Exs. 1002-1003.
`
`
`B.
`
`Level of Ordinary Skill in the Art
`
`The ‘294 patent claims priority to a provisional application filed on
`
`November 18, 2004. A person of ordinary skill in the art in November 2004
`
`would be a person with a Bachelor of Science degree in mechanical engineering
`
`with at least two years of practical or post-graduate work in the area of
`
`implantable orthopaedic medical devices, or a person having graduated with a
`
`medical degree from an accredited medical school with experience in using anchor
`
`devices for attaching soft tissue to bone.
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`U.S. Patent No. 8,435,294
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`
`C.
`
`Identification of Challenge and Relief Requested
`(37 C.F.R. § 42.104(b) and 37 C.F.R. § 42.22(a)(1))
`
`The precise relief requested by Petitioner is that Claims 6-11, 13, and 16-18
`
`are found unpatentable and cancelled from the ‘294 patent.
`
`
`1.
`
`Claims for which Inter Partes Review is Requested (37 C.F.R.
`§ 42.104(b)(2))
`
`Petitioner requests Inter Partes Review of Claims 6-11, 13 and 16-18 of
`
`U.S. Patent No. 8,435,294 to Montgomery et al. (“the ‘294 patent”).
`
`
`2.
`
`Specific Statutory Grounds on which the Challenge is Based
`(37 C.F.R. § 42.104(b)(2))
`
`The specific statutory grounds for the challenge are as follows:
`
`Ground Reference(s)
`
`Basis
`
`Claims Challenged
`
`1
`
`2
`
`3
`
`4
`
`EP 1 066 805 A2
`
`U.S. Patent No. 6,887,271
`
`WO 02/32345 A3
`
`WO 02/32345 A3 in view
`of EP 1 066 805 A2 or U.S.
`Patent No. 6,887,271
`
`6-11, 13, and 16-18
`35 U.S.C. § 102(b)
`
`
`35 U.S.C. § 102(b) 6-11, 13, and 16-18
`
`35 U.S.C. § 102(b)
`
`35 U.S.C. § 103(a) 6-11, 13 and 16-18
`
`6-11, 13, and 16-18
`
`Petitioner contends that Claims 6-11, 13, and 16-18 are unpatentable under
`
`35 U.S.C. §§ 102 and/or 103, with the following prior art references being cited in
`
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`support of the challenge: EP 1 066 805 A2 (EP ‘805), U.S. Patent No. 6,887,271
`
`U.S. Patent No. 8,435,294
`
`(“the Justin ‘271 patent”), and WO 02/32345 A3 (WO ‘345). All the foregoing art
`
`art qualify as prior art against the ‘294 patent under 35 U.S.C. § 102.
`
`The references set forth in the table below were all published before
`
`November 18, 2003, which is more than one year prior to the earliest possible
`
`priority date of November 18, 2004 of the ‘294 patent.
`
`§102(b) Reference
`
`Publication Date
`
`Exhibit No.
`
`EP 1 066 805 A2
`
`January 10, 2001
`
`U.S. Patent No. 6,887,271
`
`April 3, 2003
`
`WO 02/32345
`
`April 25, 2002
`
`1005
`
`1006
`
`1007
`
`While the Justin ‘271 patent was of record during prosecution of the
`
`application that issued as the ‘294 patent, neither EP ‘805, nor WO ‘345 was of
`
`record. The Justin ‘271 patent was relied upon by the examiner as a secondary
`
`reference in a rejection during prosecution of the application that issued as the
`
`‘294 patent.
`
`The arguments made herein regarding any art mentioned in the prosecution
`
`history of the ‘294 patent were not made during the prosecution of the patent
`
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`application. The Justin ‘271 patent is being applied in a different manner than
`
`U.S. Patent No. 8,435,294
`
`utilized by the Examiner.
`
`
` Claim Construction - Broadest Reasonable D.
`Interpretation (“BRI”) (37 C.F.R. § 42.104(b)(3))
`
`In an inter partes review, claim terms are interpreted according to their
`
`broadest reasonable construction in light of the specification of the patent in which
`
`they appear. 37 C.F.R. § 42.100(b); Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48756, 48766 (Aug. 14, 2012). The patent claim terms are also given their
`
`ordinary and customary meaning as would be understood by one of ordinary skill
`
`in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504
`
`F.3d 1249, 1257 (Fed. Cir. 2007). Therefore, the claim terms in the ‘294 patent
`
`should be interpreted according to their broadest reasonable construction in light
`
`of the specification and should also be given their ordinary and customary
`
`meaning as would be understood by one of ordinary skill in the art in the context
`
`of the entire disclosure.
`
`The following discussion proposes constructions of terms in the challenged
`
`claims under the broadest reasonable construction standard. Any claim terms not
`
`included in the following discussion are to be given their broadest reasonable
`
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`interpretation in light of the specification as commonly understood by those of
`
`U.S. Patent No. 8,435,294
`
`ordinary skill in the art. (M.P.E.P. § 2111.01(I)). Should the patent owner, in
`
`order to avoid the prior art, contend that the claims have a construction different
`
`from their broadest reasonable interpretation, the appropriate course is for the
`
`patent owner to seek to amend the claims to expressly correspond to its
`
`contentions in this proceeding. See 77 Fed. Reg. 48764 (Aug. 14, 2012). Any
`
`such amendment would only be permissible if the proposed amended claims
`
`comply with 35 U.S.C. § 112.
`
`Also, for the ‘294 patent inventors to act as their own lexicographer, the
`
`definition must be set forth in the specification with reasonable clarity,
`
`deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per Azioni, 158
`
`F.3d 1243, 1249 (Fed. Cir. 1998). If a feature is not necessary to give meaning to
`
`what the ‘294 patent inventors mean by a claim term, it would be “extraneous” and
`
`should not be read into the claim. Renishaw PLC, 158 F.3d at 1249; E.I. du Pont
`
`de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir.
`
`1988). The construction that stays true to the claim language and most naturally
`
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`aligns with the inventors’ description is likely the correct interpretation. See
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`U.S. Patent No. 8,435,294
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`Renishaw PLC, 158 F.3d at 1250.
`
`Petitioner’s position regarding the scope of ‘294 patent claims should not be
`
`taken as an assertion regarding the appropriate claim scope in other adjudicative
`
`forums where a different claim interpretation standard may apply, e.g., in a patent
`
`infringement action. Moreover, Petitioner reserves all of its rights to further
`
`challenge any of the claim terms herein under 35 U.S.C. § 112, including by
`
`arguing that the terms are not definite, supported by the written description, and/or
`
`enabled. Further, as Petitioner is precluded from presenting challenges under 35
`
`U.S.C. § 112 in an inter partes review, Petitioner’s arguments in this Petition, or
`
`lack of arguments on any of these grounds, should not be interpreted as waiving or
`
`conflicting with arguments available in other forums under 35 U.S.C. § 112.
`
`Petitioner notes that the interpretation recommended in Section V
`
`subsection C is at times similar to the construction the patent holder Cayenne
`
`proposed in its Opening Claim Construction Brief in the corresponding litigation.
`
`(Exhibit 1009). The claim construction in a litigation can be narrower than in an
`
`inter partes review because it is performed in view of both the intrinsic and
`
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`extrinsic record. Philips v. AWH Corp., 415 F.3d, 1303 (Fed. Cir. 2005). In
`
`U.S. Patent No. 8,435,294
`
`addition, if the claim is still ambiguous in view of the relevant evidence during a
`
`litigation, it should construed to preserve the validity. Id. at 1327. This standard
`
`does not apply to the inter partes review. See generally In re Cuozzo Speed Techs,
`
`Techs, LLC, No. 2014-1301 (Fed. Cir. Feb. 4, 2015). Thus, while Petitioner’s
`
`proposed claim construction in the corresponding litigation can be more narrow
`
`than recommended herein, Cayenne’s proposed claim construction in connection
`
`with this Petition should not be more narrow than what is proposed in its Opening
`
`Claim Construction Brief. (Exhibit 1009).
`
`V.
`
`SUMMARY OF THE ‘294 PATENT (EX 1001)
`
`
`
` Background of ‘294 Patent A.
`
`The ‘294 patent generally relates to devices, systems and methods for
`
`material fixation (Ex. 1001). (Col. 1, lines 18-19). More specifically, the
`
`purported invention relates to techniques that can be used to firmly hold a soft
`
`tissue or graft against bone tissue within a bone tunnel. (Col. 1, lines 19-22). In
`
`the specification of the ‘294 patent, Patentees expressly state that, although the
`
`tendon to bone example is used throughout the disclosure for the sake of
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`simplicity, the invention is applicable to any soft material to hard material fixation.
`
`U.S. Patent No. 8,435,294
`
`(Col. 3, lines 2-16). The various embodiments disclosed in the ‘294 patent include
`
`include a substantially non-cylindrical shape having a substantially non-circular
`
`cross-section to enable compression of the graft directly against the bone and
`
`securing the anchor within the bone tunnel. The substantially non-cylindrical
`
`shape applies differential forces to compress the graft against the bone tissue. In
`
`addition, the substantially non-cylindrical anchor embodiments urge the graft
`
`directly against the bone tissue while engaging the bone tissue directly to prevent
`
`dislodgment of the anchor relevant to the bone. (Col. 3, lines 45-57).
`
`According to the Patentees, the embodiments of the invention allow direct
`
`fixation of the tendon within the bone tunnel without a pull-through stitch needed
`
`to seat the tendon in the bone tunnel and hold tension during fixation. Patentees
`
`also assert that the invention provides direct tendon to bone compression, which
`
`facilitates healing, and provides a single point of fixation which allows for more
`
`isometric graft positioning. (Col. 4, lines 3-17). Patentees also state that there is
`
`no tendon compromise because there is no cutting of the graft with screw threads,
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`and no cutting of the sutures with screw threads as is seen with methods of the
`
`U.S. Patent No. 8,435,294
`
`prior art. (Col. 4, lines 28-30).
`
`
`B.
`
`Prosecution History of the ‘294 Patent
`
`The file history of the ‘294 patent was obtained by Petitioner from the
`
`USPTO PAIR database and is found at Exhibit 1008.
`
`The ‘294 patent issued from Application No. 12/634,581 (“ the ‘581
`
`application”), filed on December 9, 2009. The ‘581 application is a continuation
`
`of Application No. 11/281,566 filed on November 18, 2005, issued as U.S. Patent
`
`No. 7,651,528. The ‘581 application claims priority to Provisional Application
`
`No. 60/628,774 filed on November 18, 2004 and Provisional Application No.
`
`60/671,510 filed on April 15, 2005. (Exhibit 1008, pp. 10-81)
`
`The ‘581 application was originally filed with 20 claims. The original
`
`claims broadly related to a device for connecting a soft material to a hard material,
`
`the device comprising a substantially non-cylindrical anchor that secures the soft
`
`material thereto, the anchor adapted to stably attach to a hard material.
`
`Corresponding system and method claims were also provided. (Exhibit 1008, pp.
`
`77-80).
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`U.S. Patent No. 8,435,294
`
`By Preliminary Amendment filed on January 30, 2012, Patentees cancelled
`
`all of the original claims, i.e., Claims 10-20 and added new Claims 21-41.
`
`(Exhibit 1008, pp. 199-204). In the remarks section of the Amendment, the
`
`Patentees indicated that the specification was amended to update the priority
`
`claims. No reason was given for the cancellation of Claims 10-20 and
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`replacement with new Claims 21-41. (Exhibit 1008, p. 205).
`
`In the non-final rejection mailed on February 8, 2012, the Examiner rejected
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`all of the pending claims, i.e., Claims 21-41. (Exhibit 1008, pp. 211-220). Claims
`
`Claims 21-41 were first rejected on the ground of non-statutory obviousness-type
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`double patenting as being unpatentable over Claims 1-18 of U.S. Patent No.
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`7,651,528. In addition, Claims 28-36 and 39-41 were rejected on the ground of
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`non-statutory obviousness-type double patenting as being unpatentable over
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`Claims 1-10 of U.S. Patent No. 7,879,094. Claims 21-27 and 37-38 were rejected
`
`under 35 U.S.C. § 102(e) as being anticipated by Martinek (U.S Patent No.
`
`7,037,324). Claims 28-36 and 39-41, which ultimately issued as Claims 6-11, 13
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`and 16-18 of the ‘294 patent being challenged herein, were rejected under 35
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`- 13 -
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`Inter Partes Review Case No. Unassigned
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`U.S.C. § 102(b) as being anticipated by Li U.S. Patent No. 5,702,215 (“the Li ‘215
`
`U.S. Patent No. 8,435,294
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`patent”).
`
`The Examiner asserted that the Li ‘215 patent disclosed a material fixation
`
`system that included an implant placeable in a space defined by bone, the implant
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`comprising a body having a distal end and a proximal end and a first member on
`
`the body which is expandable outwardly; and a second member on the body which
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`is disposed axially from the first member and is expandable outwardly. The
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`Examiner asserted that the method Claims 39-41 would have been inherently
`
`carried out in the operation of the device in Claim 28. Id.
`
`In response, Patentees amended Claim 28 (issued as Claim 6) to include a
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`body having “a longitudinal axis” and further define the first and second member
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`to be moveably expandable outwardly. Claim 28 was further amended to include
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`the element “a distal end of said body comprising a space for receiving soft tissue
`
`therethrough, said space being defined by surfaces of said body which are oriented
`
`both generally parallel to said longitudinal axis and generally transverse to said
`
`longitudinal axis.” Claim 28 was further amended to require “a deployment
`
`device which is moveable in a generally axial direction to deploy at least one of
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`- 14 -
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`Inter Partes Review Case No. Unassigned
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`said of first and second members.” The method of Claim 39 (issued as
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`U.S. Patent No. 8,435,294
`
`independent Claim 16) was also amended to define the implant as “having a
`
`longitudinal axis extending from a distal end from the implant to a proximal end of
`
`the implant.” In addition, the second member was further defined as in a axially
`
`space relationship from the first member. Lastly, Claim 39 was amended to
`
`include the element “wherein the outward deployment of one of said first and
`
`second members compresses the soft tissue between said one of said first and
`
`second members and adjacent bone.” (Exhibit 1008, pp. 255-262).
`
`In the Remarks section of the Amendment, Patentees argued that the Li ‘215
`
`patent disclosed a retractable fixation device for securing two portions of a
`
`fractured bone together until the bone has healed. Patentees further argued that,
`
`since the Li ‘215 patent does not contemplate anchoring soft tissue, there is no
`
`disclosure of the element of a distal end of the body of the device having a space
`
`for receiving soft tissue therethrough. Patentees also argued that the Li ‘215
`
`patent failed to disclose or suggest the deployment device. Similarly, with regard
`
`to Claim 39, Patentees maintained that, since the Li ‘215 patent does not disclose
`
`or suggest anything regarding soft tissue, the element of the first and second
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`- 15 -
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`Inter Partes Review Case No. Unassigned
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`members compressing the soft tissue against adjacent bone is not disclosed.
`
`U.S. Patent No. 8,435,294
`
`Patentees also filed a Terminal Disclaimer. Id.
`
`A second non-final Office Action was mailed on July 9, 2012 rejecting all
`
`of the pending claims, i.e., Claims 21-28 and 30-41. (Exhibit 1008, pp. 273-280).
`
`Claim 29 was cancelled in the previous Amendment. More specifically, the
`
`Examiner asserted that Claims 23, 27, 28, and 30-41 were rejected under 35
`
`U.S.C. § 103(a) as being unpatentable over Levy (U.S. Patent No. 6,554,833) in
`
`view of Justin (U.S. Patent No. 6,887,271). The Examiner argued that Levy
`
`discloses all of the claim limitations such as a body, a first member that is
`
`moveably expandable outwardly, a second member that is moveably expandable
`
`outwardly, and a deployment device that is moveable in a generally axial direction
`
`to deploy at least of the first and second members and a plurality of arms that
`
`expand and pivot to engage bones.
`
`The Examiner conceded that Levy did not teach a distal tip about which soft
`
`tissue may be looped, the distal end comprising a space for receiving soft tissue
`
`therethrough, the space being defined by surfaces of the body which are oriented
`
`both generally parallel to the longitudinal axis and generally transverse to the
`
`
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`- 16 -
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`Inter Partes Review Case No. Unassigned
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`longitudinal axis. However, the Examiner asserted that these elements were
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`U.S. Patent No. 8,435,294
`
`disclosed in Justin et al. Id.
`
`Patentees filed an Amendment in response further amending Claim 28 to
`
`include the element, “said second member being of a substantially different
`
`construction then said first member.” In the Remarks portion of the Amendment,
`
`Patentees argued that, since Levy not at all concerned with the attachment of soft
`
`tissue to bone, there would have been no motivation to apply the teachings of
`
`Justin to modify the Levy device. Patentees argued that the only motivation
`
`asserted by the Examiner is that Justin is “similar art.” However, Patentees argued
`
`argued that other than both references being in the field of orthopedics, they are
`
`totally dissimilar because Levy is concerned with securing two fractured pieces of
`
`both together, while Justin is concerned with attaching soft tissue to bone. Thus,
`
`Patentees argued that a practitioner in the field would never use the two types of
`
`anchors together. In addition, regarding independent Claim 28, Patentees urged
`
`that the second member of Levy is of substantially the same construction as the
`
`first member of Levy. Patentees provide no indication for support in the spec for
`
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`- 17 -
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`Inter Partes Review Case No. Unassigned
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`the phrase “substantially different construction” nor does the specification contain
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`U.S. Patent No. 8,435,294
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`any definition. (Exhibit 1008, pp. 334-346).
`
`A Notice of Allowance was mailed on January 11, 2013. (Exhibit 1008, pp.
`
`352-356). No explanation was given by the Examiner as to the patentability of the
`
`claims. The Issue Fee was timely paid on April 5, 2013 (Exhibit 1008, pp. 367-
`
`369) and the patent issued on May 7, 2013 as U.S. Patent No. 8,435,294. (Exhibit
`
`1008, pp. 375).
`
`
`
` Construction of the ‘294 Patent Claim Terms C.
`
`As discussed above, a claim in inter partes review is given the “Broadest
`
`reasonable construction in light of the specification. See 37 C.F.R. § 42.100(b).
`
`Petitioner sets forth herein its recommended interpretation of certain claim
`
`terms, the scope of which are unclear on its face.
`
`
`1.
`
`Claims 6 and 16 - “implant”
`
`The term “implant” is used in independent Claims 6 and 16 but is not
`
`expressly defined in the ‘294 patent. However, the ‘294 patent does disclose
`
`“implant embodiments of the present invention.” (Col. 8, line 25). The
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`specification then further describes “[d]irect anchor embodiments [that] include
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`- 18 -
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`Inter Partes Review Case No. Unassigned
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`uniquely shaped implants that hold a tendon or other soft tissue, and fix it directly
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`U.S. Patent No. 8,435,294
`
`to the bone.” (Col. 8, lines 30-32). In addition, Figs. 48A-48D are described as
`
`disclosing an “implant.” (Col. 23, line 7). Thus, the proper construction of
`
`“implant” is “an object surgically placed in the body.”
`
`
`2.
`
`Claims 6 and 16 - “having a longitudinal axis,
`a distal end, and a proximal end”
`
`The element of “having a longitudinal axis, a distal end, and a proximal
`
`end” set forth in Claim 6 of the ‘294 patent is not expressly defined in the
`
`specification. Referring to Figs. 11A-11C, the specification does refer to the ACL
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`ACL graph strands 113 being “looped around the distal end of the direct anchor 71
`
`and inserted through the bone hold 112 of the femur 111.” (Col. 15, lines 37-38).
`
`Thus, the distal end, is generally referred to as the end being inserted into the
`
`bone. Similarly, referring to Figs. 17A-17C, the specification refers to the tendon
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`segment 173 looping around “the distal end of the substantially non-cylindrical
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`direct anchor 71.” (Col. 16, lines 64-66). Thus, the proper construction for
`
`“having a longitudinal axis, a distal end, and a proximal end” is “a structure
`
`having an axis along its length having a first leading end opposed to a second
`
`end.”
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`- 19 -
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`Inter Partes Review Case No. Unassigned
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`3.
`
`Claims 6 and 16 - “a first member”
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`U.S. Patent No. 8,435,294
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`The term “member” is not defined or referred to anywhere in the
`
`specification, only the claims. However, the specification broadly refers to
`
`different portions of the body. For example, referring to Figs. 3A-3C, patentees
`
`describe clover leaf extensions having one end 32 that is flared to engage bone,
`
`and a mid-section 33 that is not flared to ensure the body is able to radially expand
`
`during deployment thereby compressing the tendon against the bone. (Col. 13,
`
`lines 44-53). Thus, “a first member on said body” should be construed as “a
`
`distinct portion of the body.”
`
`
`4.
`
`Claim 6 - “moveably expandable outwardly”
`
`The term “moveably expandable outwardly” is not defined or referred to in
`
`the specification. The term “moveably” was added to Claim 6 in an Amendment
`
`during the prosecution of the application. The specification discloses that “the
`
`direct anchor can incorporate expandable arms that compress the tendon or other
`
`soft tissue directly against the bone while directly contacting the bone to provide
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`anchoring of the implant.” (Col. 8, lines 39-43). Thus, the proper construction of
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`- 20 -
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`Inter Partes Review Case No. Unassigned
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`of the term “moveably expandable outwardly” is “capable of being moved or
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`U.S. Patent No. 8,435,294
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`deformed in an outward direction away from the longitudinal axis of the body.”
`
`
`5.
`
`Claim 6 and 16 - “a second member on said body
`which is di
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