IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In the Inter Partes Review of:
`
`
`
`U.S. Patent No. 8,092,454
`
`Filed: March 11, 2005
`
`Issued: January 10, 2012
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`
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`Trial Number: To Be Assigned
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`Named Inventor: Gary W. Sohngen
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`Panel: To Be Assigned
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`
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`Recorded Assignee: Advanced
`Orthopaedic Solutions, Inc.
`
`Title: Fixation Instrument for Treating
`a Bone Fracture
`
`Mail Stop Inter Partes Review
`Commissions for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,092,454
`UNDER 35 U.S.C. § 311 AND 37 C.F.R. § 42.100
`
`
`
`

`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Compliance with Requirements for Inter Partes Review ............................... 1
`
`A. Mandatory Notices (37 C.F.R. § 42.8(a)(1)) ......................................... 1
`
`a.
`
`b.
`
`c.
`
`Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) .......................... 1
`
`Related Matters (37 C.F.R. § 42.8(b)(2)) ................................... 1
`
`Designation of Lead and Backup Counsel and Service
`Information (37 C.F.R. §§ 42.8(b)(3)-(4)) .................................. 2
`
`Fee for Inter Partes Review (37 C.F.R. § 42.103) ................................ 2
`
`Grounds for Standing (37 C.F.R. § 42.104(a)) ..................................... 3
`
`B.
`
`C.
`
`III.
`
`Identification of Challenge (37 C.F.R. § 42.104(b)) ....................................... 3
`
`IV. Relevant Background of the ’454 Patent ......................................................... 5
`
`A.
`
`B.
`
`C.
`
`Level of Ordinary Skill ......................................................................... 5
`
`Description of the Alleged Invention of the ’454 Patent ...................... 5
`
`Summary of the Prosecution History of the ’454 Patent ...................... 6
`
`V.
`
`Claim Construction .......................................................................................... 9
`
`A.
`
`B.
`
`“a plurality of longitudinal extending grooves” .................................... 9
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`“cap” .................................................................................................... 10
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`VI. Reasonable Likelihood that Claims 6-11, 13-15, and 19-20 Are
`Unpatentable .................................................................................................. 12
`
`A.
`
`B.
`
`Summary of Prior Art .......................................................................... 12
`
`GROUND 1: Claims 6, 7, 9, 10, and 13 are anticipated by
`Shavit under 35 U.S.C. § 102 .............................................................. 14
`
`a.
`
`Claim 6 Is Anticipated by Shavit .............................................. 14
`
`
`
`

`
`
`
`b.
`
`c.
`
`d.
`
`e.
`
`Claim 7 Is Anticipated By Shavit ............................................. 20
`
`Claim 9 Is Anticipated By Shavit ............................................. 21
`
`Claim 10 Is Anticipated By Shavit ........................................... 22
`
`Claim 13 Is Anticipated by Shavit ............................................ 24
`
`C.
`
`GROUND 2: Claims 8 is rendered obvious by Shavit in view of
`Kilpela under 35 U.S.C. § 103(a) ........................................................ 27
`
`D. Ground 3: Claims 14, 15, 19 and 20 are rendered obvious by
`Shavit in view of Kilpela under 35 U.S.C. § 103(a) ........................... 31
`
`a.
`
`b.
`
`c.
`
`d.
`
`Claim 14 Is Rendered Obvious by Shavit in View of Kilpela .. 31
`
`Claim 15 Is Rendered Obvious by Shavit in View of Kilpela .. 33
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`Claim 19 Is Rendered Obvious by Shavit in View of Kilpela .. 34
`
`Claim 20 Is Rendered Obvious by Shavit in View of Kilpela .. 39
`
`E.
`
`GROUND 4: Claims 14, 15, 19 and 20 are rendered obvious by
`Shavit in view of Kilpela and Bramlet under 35 U.S.C. § 103(a) ...... 40
`
`a.
`
`b.
`
`c.
`
`d.
`
`Claim 14 Is Rendered Obvious by Shavit in View of Kilpela
`and Bramlet ............................................................................... 40
`
`Claim 15 Is Rendered Obvious by Shavit in View of Kilpela
`and Bramlet ............................................................................... 45
`
`Claim 19 Is Rendered Obvious by Shavit in View of Kilpela
`and Bramlet under 35 U.S.C. § 103(a) ..................................... 45
`
`Claim 20 Is Rendered Obvious by Shavit in View of Kilpela
`and Bramlet ............................................................................... 47
`
`F.
`
`GROUND 5: Claim 11 is rendered obvious by Shavit in view of
`Bramlet under 35 U.S.C. § 103(a) ....................................................... 47
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`VII. Conclusion ..................................................................................................... 48
`
`ii
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`
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`

`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .................................................................................................. 28
`
`KSR Int'l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ................................................................................. 29, 35, 42
`
`Nano-Second Tech. Co. v. Dynaflex Int'l,
`944 F. Supp. 2d 855 (C.D. Cal. 2013) .................................................................. 35
`
`Nuvasive, Inc. v. Warsaw Orthopedic, Inc.,
`IPR2013-00206 (PTAB Sept. 23, 2013) ................................................................. 9
`
`Pharmatech Solutions, Inc., v. Lifescan Scotland,
`IPR2013-00247 (Aug. 6, 2014) ............................................................................ 35
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................ 11
`
`Statutes
`
`35 U.S.C. § 102 ............................................................................................... 3, 4, 14
`
`35 U.S.C. § 102(a) ..................................................................................................... 3
`
`35 U.S.C. § 102(b) ..................................................................................................... 4
`
`35 U.S.C. § 102(e) ..................................................................................................... 3
`
`35 U.S.C. § 103 .......................................................................................................... 3
`
`35 U.S.C. § 103(a) ........................................................................................... passim
`
`35 U.S.C. § 112 .......................................................................................................... 3
`
`35 U.S.C. § 311 .......................................................................................................... 1
`
`35 U.S.C. § 315 .......................................................................................................... 3
`
`37 C.F.R. § 1.68 ......................................................................................................... 5
`
`37 C.F.R. § 42.10(b) .................................................................................................. 2
`
`iii
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`

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`
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`37 C.F.R. § 42.100 ..................................................................................................... 1
`37 C.F.R. § 42.100 ................................................................................................... ..1
`
`37 C.F.R. § 42.100(b) ................................................................................................ 9
`37 C.F.R. § 42.100(b) .............................................................................................. ..9
`
`37 C.F.R. § 42.103 ..................................................................................................... 2
`37 C.F.R. § 42.103 ................................................................................................... ..2
`
`37 C.F.R. § 42.104(a) ................................................................................................. 3
`37 C.F.R. § 42.104(a) ............................................................................................... ..3
`
`37 C.F.R. § 42.104(b) ................................................................................................ 3
`37 C.F.R. § 42.104(b) .............................................................................................. ..3
`
`37 C.F.R. § 42.15(a) ................................................................................................... 2
`37 C.F.R. § 42.15(a) ................................................................................................. ..2
`
`37 C.F.R. § 42.8(a)(1) ................................................................................................ 1
`37 C.F.R. § 42.8(a)(1) .............................................................................................. ..1
`
`37 C.F.R. § 42.8(b) .................................................................................................... 1
`37 C.F.R. § 42.8(b) .................................................................................................. ..1
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 1
`37 C.F.R. § 42.8(b)(2) .............................................................................................. ..1
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`37 C.F.R. §§ 42.8(b)(3)-(4) ........................................................................................ 2
`37 C.F.R. §§ 42.8(b)(3)—(4) ...................................................................................... ..2
`
`iv
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`iv
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`

`
`I.
`
`Introduction
`
`
`
`Pursuant to 35 U.S.C. § 311 and 37 C.F.R. § 42.100, Petitioner Zimmer
`
`Biomet Holdings, Inc. (“Zimmer Biomet”) respectfully requests inter partes
`
`review (“IPR”) of claims 6-11, 13-15, and 19-20 of U.S. Patent No. 8,092,454
`
`(“the ’454 Patent”), which is attached to this Petition as Exhibit 1004.1 The
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`USPTO assignment records indicate that the applicants of the ’454 Patent assigned
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`their rights to Advanced Orthopaedic Solutions, Inc. (“AOS”). (Ex. 1013.)
`
`II. Compliance with Requirements for Inter Partes Review
`A. Mandatory Notices (37 C.F.R. § 42.8(a)(1))
`Pursuant to 37 C.F.R. § 42.8(a)(1), the mandatory notices identified in 37
`
`C.F.R. § 42.8(b) are provided below as part of this Petition.
`
`a. Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
`Zimmer Biomet Holdings, Inc., Zimmer, Inc., and Biomet, Inc. are the real
`
`parties-in-interest. Zimmer Biomet Holdings, Inc. acquired Biomet, Inc. in June
`
`2015.
`
`b. Related Matters (37 C.F.R. § 42.8(b)(2))
`The ’454 Patent is the subject of the civil action Advanced Orthopaedic
`
`Solutions, Inc. v. Biomet, Inc. et al., Case No. 2:14-cv-06354 ODW-(MANx), filed
`
`on August 13, 2014 in the U.S. District Court for the Central District of California.
`
`
`1 Citations throughout this Petition refer to the original page numbers of exhibits.
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`
`
`

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`
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`Advanced Orthopaedic Solutions
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`filed an amended complaint alleging
`
`infringement of the ’454 Patent on July 27, 2015. (Ex. 1010, Amended
`
`Complaint.) The July 27, 2015 amended complaint was the first complaint to
`
`assert infringement of the ’454 Patent. This case is currently pending and may
`
`affect, or be affected by, decisions in this proceeding.
`
`c. Designation of Lead and Backup Counsel and Service Information (37
`C.F.R. §§ 42.8(b)(3)-(4))
`
`Lead Counsel
`Eric Hayes (Reg. No. 53,004)
`eric.hayes@kirkland.com
`Postal and Hand-Delivery Address:
`KIRKLAND & ELLIS LLP
`300 North LaSalle Street
`Chicago, Illinois 60654
`Telephone: (312) 862-2000
`Fax: (312) 862-2200
`
`Pursuant to 37 C.F.R. § 42.10(b), a Power of Attorney accompanies this
`
`Backup Counsel
`Xun (Michael) Liu (Reg. No. 68,815)
`michael.liu@kirkland.com
`Postal and Hand-Delivery Address:
`KIRKLAND & ELLIS LLP
`300 North LaSalle Street
`Chicago, Illinois 60654
`Telephone: (312) 862-2000
`Fax: (312) 862-2200
`
`Petition. Please address all correspondence to lead and back-up counsel. Zimmer
`
`Biomet consents to electronic service by electronic mail.
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`Fee for Inter Partes Review (37 C.F.R. § 42.103)
`
`B.
`Review of eleven (11) claims is requested. Zimmer Biomet authorizes the
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`PTO to charge Deposit Account No. 506092 for the fee set forth in 37 C.F.R.
`
`§ 42.15(a) for this Petition. Zimmer Biomet also authorizes the PTO to charge to
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`this Deposit Account for any additional fees that may be due in connection with
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`this Petition.
`
`2
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`

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`
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`C. Grounds for Standing (37 C.F.R. § 42.104(a))
`Zimmer Biomet certifies that it has standing to request, and is not barred
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`from requesting, an IPR of the ’454 Patent pursuant to 35 U.S.C. § 315. Neither
`
`Zimmer Biomet nor any privy of Zimmer Biomet has filed any civil actions
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`challenging the validity of any claim of the ’454 Patent. Neither Zimmer Biomet
`
`nor any privy of Zimmer Biomet has previously requested IPR of the ’454 Patent.
`
`Zimmer Biomet further certifies that it files this petition for IPR less than one year
`
`after the date on which Zimmer Biomet or any privy of Zimmer Biomet was first
`
`served with a complaint alleging infringement of the ’454 Patent.
`
`III.
`
`Identification of Challenge (37 C.F.R. § 42.104(b))
`Zimmer Biomet requests institution of an IPR and cancellation of claims 6-
`
`11, 13-15, and 19-20 of the ’454 Patent based on the following prior art
`
`references:2
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`Shavit. World Int’l Appl. Pub. No. WO 03/061495 to Shavit et al.
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`(“Shavit”) is attached as Ex. 1005. Shavit was filed on January 22, 2003,
`
`published on July 31, 2003, and is prior art under at least 35 U.S.C. § 102(a) and
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`35 U.S.C. § 102(e). Shavit was not cited or discussed in the prosecution history of
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`the ’454 Patent.
`
`
`2
`References to 35 U.S.C. §§ 102, 103, and 112 throughout this Petition are to
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`the pre-AIA versions of those provisions, which are applicable to the ’454 Patent.
`
`3
`
`

`
`
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`Kilpela. U. S. Patent No. 6,123,708 to Kilpela et al. (“Kilpela”) is attached
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`as Ex. 1006. Kilpela issued on September 26, 2000 and is prior art under at least
`
`35 U.S.C. § 102(b). Kilpela was not cited or discussed during the prosecution
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`history of the ’454 Patent.
`
`Bramlet. U.S. Patent No. 6,443,954 to Bramlet et al. (“Bramlet”) is
`
`attached as Exhibit 1007. Bramlet issued on September 3, 2002 and is prior art
`
`under at least 35 U.S.C. § 102(b).
`
`The Board should find claims 6-11, 13-15, and 19-20 of the ’454 Patent
`
`unpatentable based on the following proposed statutory grounds.
`
` More
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`specifically, the Board should institute an IPR trial on Grounds 1, 2, and 5
`
`irrespective of how the term “cap” is construed. Additionally, the Board should
`
`institute trial on Ground 3 if the Board construes the term “cap” as a “barrier or
`
`cover,” (See infra Section V.B.) or Ground 4 if the Board adopts a narrower
`
`construction of “cap.”
`
`(1) Claims 6, 7, 9, 10, and 13 are anticipated by Shavit under 35 U.S.C.
`
`§ 102.
`
`(2) Claims 8 is rendered obvious by Shavit in view of Kilpela under 35
`
`U.S.C. § 103(a).
`
`(3) Claims 14, 15, 19 and 20 are rendered obvious by Shavit in view of
`
`Kilpela under 35 U.S.C. § 103(a).
`
`4
`
`

`
`
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`(4) Claims 14, 15, 19 and 20 are rendered obvious by Shavit in view of
`
`Kilpela and Bramlet under 35 U.S.C. § 103(a).
`
`(5) Claim 11 is rendered obvious by Shavit in view of Bramlet under 35
`
`U.S.C. § 103(a).
`
`Zimmer Biomet sets forth below the relevant background of the ’454 Patent
`
`(Section IV), how the contested claims are to be construed (Section V), and how
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`the construed claims are unpatentable under the statutory grounds specified above
`
`(Section VI). Attached is an Appendix of Exhibits setting forth numbered exhibits
`
`supporting this Petition. Under 37 C.F.R. § 1.68, Zimmer Biomet also submits a
`
`declaration by Dr. Richard F. Kyle in support of this Petition. (Ex. 1001.)
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`IV. Relevant Background of the ’454 Patent
`
`A. Level of Ordinary Skill
`A person of ordinary skill in the art at the time of the alleged invention
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`would have a bachelor’s degree in biomedical engineering, a bachelor’s degree in
`
`mechanical engineering with coursework in biomechanics or orthopaedics, or at
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`least 3 years of experience designing orthopaedic implants. (Ex. 1001 at ¶¶ 16-17.)
`
`B. Description of the Alleged Invention of the ’454 Patent
`The ’454 Patent describes “a nail and bone screw combination used to treat a
`
`fracture of the femur.” (Ex. 1004, ’454 Patent, at 1:13-20.) The nail 22 has a
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`chamber 42 in the proximal end, which contains an insert 36 to engage the bone
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`5
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`

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`
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`screw 32 and a locking ring 60 that secures the insert. (Id. at 1:59-61.) The insert
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`is “rotatably attached” to the locking ring, so that when “the locking ring 60 is
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`rotated by a suitable tool, the locking ring 60 moves the insert 36 longitudinally”
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`within the chamber. (Id. at 4:23-28.) As the insert moves downward, it engages
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`the bone screw to secure it against rotation.
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`Summary of the Prosecution History of the ’454 Patent
`
`C.
`The ’454 Patent issued from U.S. Application No. 11/078/750 (“the ’750
`
`application”), filed on March 11, 2005. (Ex. 1019.) The ’454 Patent also claims
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`priority to U.S. Provisional Application No. 60/552,229. (Ex. 1012.)
`
`On October 26, 2006, the Examiner issued an Office Action that rejected all
`
`pending claims. (Ex. 1020, 10/26/06 Action, at 1.) In particular, the Examiner
`
`rejected claims 7 and 14 as indefinite; claims 1, 3-6, 9, and 11-14 as anticipated by
`
`U.S. Patent 6,406,477 (“Fujiwara I”) or Japanese Patent JP09066061 (“Fujiwara
`
`II”). (Id. at 3-7.) The Examiner also rejected claims 2, 8, and 17-19 as obvious
`
`over Fujiwara I in view of U.S. Patent Pub. 2002/0156473 (“Bramlet”); claim 20
`
`as obvious over Fujiwara I in view of Bramlet and further in view of Fujiwara II;
`
`and claims 7 and 10 as obvious in view of Fujiwara I and U.S. Patent Pub.
`
`2003/0074000 (“Roth Publication”). (Id. at 7-10.)
`
`To overcome the Examiner’s rejections, the Applicant added new limitations
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`and redrafted several dependent claims into independent form. (Ex. 1021, 3/26/07
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`6
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`

`
`
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`Resp., at 3-10.) Among other changes, the Applicant amended claim 6 to recite an
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`insert with “a lower surface [that] … includes a locking projection wherein the
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`lower surface is operative to contact a bone screw.” (Id. at 13.)
`
`In the second Office Action, the Examiner continued to reject claims based
`
`on Fujiwara I, Fujiwara II, Bramlet, and U.S. Patent Pub. 2001/0012939 (“Wahl”).
`
`(Ex. 1022, 6/13/07 Action, at 2-11.) And in a third Office Action, the Examiner
`
`found several claims obvious in view of Fujiwara I and U.S. Patent 7,306,600
`
`(“Roth”),3 among other rejections. (Ex. 1024, 2/4/08 Action at 7.)
`
`Faced with these rejections, the Applicant further amended the pending
`
`claims. (Ex. 1025, 5/29/2008 Resp., at 2-9.) For example, the Applicant amended
`
`claim 6 to recite a bone screw with a “plurality of longitudinal extending grooves
`
`on an outer surface of said bone screw wherein said locking projection is located in
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`one of said grooves when said lower surface contacts said bone screw.” (Id.)
`
`In a final Office Action on August 18, 2008, the Examiner rejected every
`
`pending claim except for claims 15, 16 and 20. (Ex. 1026, 8/18/08 Action, at 1.)
`
`In response, the Applicant filed a Request for Continued Examination (“RCE”),
`
`(Ex. 1027, 12/18/08 RCE, at 11), along with amended claims. (Ex. 1028, 12/18/08
`
`Resp., at 11.) After the RCE, the Examiner issued another final rejection. (Ex.
`
`1029, 3/9/09 Action.) The Applicant filed a pre-appeal brief request, (Ex. 1030,
`
`3 Roth Publication and Roth contain the same disclosure.
`
`7
`
`

`
`
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`06/09/2009 Req.), which prompted the Patent Office to reopen prosecution. (Ex.
`
`1031, 7/27/09 Notice.) In the next Office Action, the Examiner found that U.S.
`
`Patent Pub. 2001/0034523 (“Nelson”) anticipated claims 3-5, 22 and 23, and that
`
`the Roth Publication anticipated claims 6-12, 14, and 17-21. (Ex. 1032, 10/26/09
`
`Action, at 4-5.)
`
`Applicant responded that Nelson discloses a “set screw” that is different
`
`from the insert as claimed, and that Nelson does not disclose a chamber or a
`
`locking ring with threads. (Ex. 1033, 3/26/10 Resp., at 12.) With respect to the
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`Roth Publication, the Applicant argued that it failed to disclose “a locking
`
`projection located on the lower surface” or “a lower surface extending at an angle
`
`substantially the same as the angle of the aperture.” (Id. at 13-15.)
`
`Unpersuaded, the Examiner issued a final rejection, (Ex. 1034, 4/27/10
`
`Action), and the Applicant filed another pre-appeal brief. (Ex. 1035, 8/27/10
`
`Request.) Applicant again argued that Nelson discloses a different set screw than
`
`what claims 3-5, 22 and 23 recite, (id. at 1), and further that the Roth Publication
`
`does not have an insert with a lower surface that contacts the bone screw or a
`
`concave lower surface, (id. at 3-5). In response, the Patent Office reopened
`
`prosecution, (Ex. 1036, 11/26/2010 Notice), and ultimately allowed the claims
`
`based on the Applicant’s arguments. (Ex. 1037, 02/01/11 Action; Ex. 1038,
`
`8
`
`

`
`
`
`06/30/11 Resp.) A Notice of Allowability was mailed on September 6, 2011, (Ex.
`
`1039, 9/6/11 Notice) and the ’454 Patent issued on January 10, 2012.
`
`V. Claim Construction
`A.
`“a plurality of longitudinal extending grooves”
`Zimmer Biomet submits, for purposes of this IPR, that the term “a plurality
`
`of longitudinal extending grooves” as recited in the ’454 Patent, should be
`
`construed as “a plurality of longitudinal extending cuts or depressions.” A claim in
`
`IPR is given the broadest reasonable interpretation (“BRI”).
`
` 37 C.F.R.
`
`§ 42.100(b). Under the BRI standard, claim terms are given their “ordinary and
`
`customary meaning as would be understood by one of ordinary skill in the art in
`
`the context of the entire patent disclosure.” Nuvasive, Inc. v. Warsaw Orthopedic,
`
`Inc., IPR 2013-00206, Paper No. 17 at 6 (PTAB Sept. 23, 2013).
`
`In view of the intrinsic evidence, a person of ordinary skill in the art would
`
`understand that “grooves” refers to cuts or depressions on the bone screw. (Ex.
`
`1001 at ¶¶ 36-37.) The ’454 Patent does not expressly define this term, nor limit
`
`“groove” to any particular geometry. Rather, the specification explains that the
`
`grooves are of “a size and shape that are complementary to the locking projections
`
`56 located on the lower surface 52 of the insert 36.” (Ex. 1004 at 3:27-29.) And
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`“the purpose of the locking projections 54 is to engage the grooves 56.” (Id. at
`
`3:33-34.) Based on this description, a person of ordinary skill in the art would
`
`9
`
`

`
`
`
`interpret “grooves” as cuts or depressions to fit a locking projection or insert. (Ex.
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`1001 at ¶ 37.)
`
`The purpose of
`
`the groove also supports such an
`
`interpretation.
`
`Longitudinal grooves help prevent the bone screw from rotating, but allow
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`longitudinal movement. (Ex. 1001 at ¶¶ 24-25.) This facilitates healing by
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`allowing the femur to contract and reduces the risk that the locking screw will
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`“cut-out” of the femoral head as the bone contracts. (Id.) Hence, a person of
`
`ordinary skill would understand that “grooves” refers to cuts or depressions that
`
`form a space for positioning an insert. (Id. at ¶ 37) Zimmer Biomet’s proposed
`
`construction is consistent with the plain and ordinary meaning of the term. (See
`
`e.g. Ex. 1044, Oxford Dictionary at 867 (defining groove as “a channel or hollow,
`
`cut by artificial means, in metal, wood, etc.”).)
`
`“cap”
`
`B.
`Zimmer Biomet further submits, for purposes of this IPR, that the term
`
`“cap” as recited in the ’454 Patent, should be construed as “barrier or cover.” In
`
`accordance with the BRI standard, this interpretation is consistent with the intrinsic
`
`evidence. (Ex. 1004 at 4:46-53, 5:46-51, FIGS. 6, 11, 13-15.) The ’454 Patent
`
`does not expressly define this term, or necessarily limit “cap” to any particular
`
`location. Zimmer Biomet’s proposed construction is consistent with the plain and
`
`ordinary meaning of “cap.” (See e.g. Ex. 1045, Webster’s Dictionary at 330,
`
`10
`
`

`
`
`
`(defining “cap” as “something designed to cover and to protect, preserve, or
`
`close”).)
`
`In the field of intramedullary nails, caps provide a physical barrier or act as a
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`cover for the passageway in the nail. (Ex. 1001 at ¶¶ 32, 38.) The presence of a
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`cap reduces bone and soft tissue ingrowth that would otherwise make the nail more
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`difficult to extract, especially if ingrowth adheres to structures such as threads or
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`grooves. (Id. at ¶ 32.)
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`Moreover, based on the plain language of the claims, the term “cap” should
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`not be limited to a barrier or cover positioned only at the rear-edge of the nail. The
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`differences among the ’454 Patent claims suggest that “cap” can be a “barrier or
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`cover” that is offset from the rear edge of the nail. Such “[d]ifferences among
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`claims can . . . be a useful guide in understanding the meaning of particular claim
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`terms.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005). Here, claim
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`11 recites “[a] fixation instrument . . . including a cap, said cap operative to close
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`said opening located at said rear edge of said nail member.” (Ex. 1004 at claim 11
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`(emphasis added).) By contrast, claims 14 and 19 do not require the cap to be
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`located at the rear edge only of the nail. In light of this distinction, a person of
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`ordinary skill in the art would interpret “cap” as a barrier or cover, but not limit the
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`meaning of the term to one that is necessarily located at the rear edge of the nail.
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`11
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`

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`
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`Zimmer Biomet submits, for purposes of this IPR, that the remaining terms
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`be given their plain and ordinary meaning in accordance with the BRI standard.
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`VI. Reasonable Likelihood that Claims 6-11, 13-15, and 19-20 Are
`Unpatentable
`
`As described below, Shavit, Kilpela and Bramlet anticipate or render
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`obvious claims 6-11, 13-15, and 19-20 of the ’454 Patent.
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`Summary of Prior Art
`
`A.
`Shavit discloses a device “used to repair bone fractures, in particular
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`intramedullary nails used for fractures of the proximal femur.” (Ex. 1005 at 1:3-4.)
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`The device includes an intramedullary nail, bone screws, and a locking mechanism
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`for the bone screws. (Id. at 7:29-33; Ex. 1001 at ¶ 41.) The locking mechanism
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`includes a locking ring attached to an insert inside of the bone nail. (Ex. 1005 at
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`9:1-18.) As the locking ring moves downward, it pushes the attached insert
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`towards the bone screw. (Id. at 9:3-9.) The locking ring is tightened until a
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`locking projection on the insert engages a groove on the bone screw, thereby
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`securing the bone screw. (Id. at 8:7-16.)
`
`(Ex. 1005 at Fig. 1A.)
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`
`
`12
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`

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`
`
`
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`(Ex. 1005 at Fig. 4.)
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`Kilpela also discloses an intramedullary nail and bone screws that are
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`connected with a set screw in the proximal end of the nail. (Ex. 1006 at 4:1-44;
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`Ex. 1001 at ¶ 44.) According to Kilpela, the set screw may be preloaded in the
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`nail, and is preferably cannulated so the nail can be implanted over a guide wire.
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`(Ex. 1006 at 3:13-27.)
`
`(Ex. 1006 at Fig. 1.)
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`
`
`13
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`

`
`
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`Bramlet discloses “an intramedullary system for coupling bone portions
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`across a fracture.” (Ex. 1007 at 1:6-12.) The intramedullary system includes a
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`bone nail, a lag screw (which functions as a bone screw), and an end cap. (Id. at
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`5:33-36; Ex. 1001 at ¶ 45.) The end cap covers the proximal opening of the nail,
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`and also includes an elongated projection that engages part of the bone screw. (Ex.
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`1007 at 3:52-54; Fig. 2-3.)
`
`
`
`(Ex. 1007 at Fig. 1.)
`B. GROUND 1: Claims 6, 7, 9, 10, and 13 are anticipated by Shavit
`under 35 U.S.C. § 102
`a. Claim 6 Is Anticipated by Shavit
`Preamble. Shavit discloses “[a] fixation instrument for treating a bone
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`fracture.” For example, Shavit describes an intramedullary nail “used for fractures
`
`14
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`

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`
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`of the proximal femur.” (Ex. 1005, Shavit, at 1.)
`
`Limitation [A]. Shavit discloses “a nail member, having a longitudinal
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`axis, a distal end and a proximal end, said proximal end having a transverse
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`aperture extending therethrough and said nail member having a chamber located in
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`said proximal end.”
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`Shavit discloses a nail member with a transverse aperture extending through
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`the proximal end. (Ex. 1001 at ¶ 51.) Shavit states, for example, that “the
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`proximal portion of nail 12 … [includes] smaller hole 14, closer to the proximal
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`end, and larger hole 16 [transverse aperture] further from the proximal end.” (Ex.
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`1005 at 8:3-4.) The nail member in Shavit also includes a longitudinal axis and
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`distal end. (Id. at FIG. 3A; Ex. 1001 at ¶ 50.)
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`(Ex. 1005 at Figs. 2 (annotated).)
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`15
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`
`
`

`
`
`
`
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`(Ex. 1005 at Fig. 4 (annotated).) The nail member of Shavit has a chamber located
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`in the proximal end. (Ex. 1001 at ¶ 51.) For example, Shavit depicts “a cross-
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`sectional view of locking mechanism 22 assembled inside the nail,” and the
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`chamber in which the locking mechanism is located. (Ex. 1005 at 9:26-27.)
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`Limitation [B]. Shavit discloses “an insert adapted to be positioned within
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`said chamber and having a lower surface, said lower surface operative to contact a
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`bone screw extending through said aperture.”
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`Shavit discloses an insert, and states that “[l]ocking mechanism 22
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`comprises a linear adapter 24 [locking ring] and a stem 26 [insert].” (Ex. 1005 at
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`9:1-2.) This insert is positioned within the chamber and includes a lower surface
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`as depicted in, for example, Figures 1B and 4. (Id. at Figs. 1B, 4.) Further, Figure
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`1B also shows that the lower surface of the insert is operative to contact the bone
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`screw extending through the aperture. (See also Ex. 1001 at ¶¶ 54-55.)
`
`16
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`

`
`
`
`
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`(Ex. 1005 at Figs. 1B, 4 (annotated).)
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`Limitation [C]. Shavit discloses “a locking ring received in said chamber
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`and engaging said insert, said locking ring operative to secure said insert within
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`said chamber.”
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`Shavit discloses a locking ring, which it refers to as an “adapter.” (Ex. 1001
`
`at ¶ 57.) For example, Shavit states that “[l]ocking mechanism 22 comprises a
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`linear adapter 24 [locking ring] and a stem 26 [insert]. There is an opening 27
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`[chamber] at the proximal end of the nail. Adapter 24 [locking ring] has threads 38
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`which match threads inside opening 27 [chamber].” (Ex. 1005 at 9:1-3.)
`
`
`
`17
`
`

`
`
`
`(Ex. 1005 at Fig. 4 (annotated).) This locking ring is operative to secure an insert
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`within a chamber in the proximal end of the nail member. (Id.) For example,
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`Shavit states that “[a]dapter 24 [locking ring] connects to stem 26 [insert], using
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`coupling mechanism 36.” (Ex. 1005 at 9:5-6.) As such, “[t]he coupling
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`mechanism allows adapter 24 [locking ring] to rotate freely with respect to stem 26
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`[insert] while it is coupled. In particular, the coupling mechanism allows adapter
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`24 [locking ring] to push or pull stem 26 [insert] axially, without requiring stem 26
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`to rotate . . . .” (Id. at 9:7-9.)
`
`Limitation [D]. Shavit discloses “a locking projection located on said lower
`
`surface of said insert.” The insert disclosed in Shavit includes a locking projection,
`
`called a “tab.” For example, Shavit states that “[t]he hip peg [bone screw] has a
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`slot 18 [groove], and there is a tab 20 [locking projection], at the end of locking
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`mechanism 22, which fits into slot 18 [groove].” (Ex. 1005 at 8:7-8.)
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`Limitation [E]. Shavit discloses “said bone screw having a longitudinally
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`[sic] axis and having a plurality of longitudinal extending grooves, said grooves
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`extending substantially parallel to said longitudinal axis of said bone screw on an
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`outer surface of said bone screw wherein said locking projection is located in one
`
`of said grooves when said lower surface contacts said bone screw.”
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`Shavit discloses a bone screw, and describes “an intramedullary nail
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`apparatus comprising . . . a first screw which goes through the first hole [on the
`
`18
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`

`
`
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`nail and] a second screw which goes through the second hole [on the nail].” (Ex.
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`1005 at 3:10-17.) Shavit calls the first bone screw a “hip peg.” (Id. at 3:7-9.) The
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`bone screw has a longitudinal axis and a plurality of longitudinally extending
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`grooves, called “slots.” (Id. at 8:7-8.) For example, Shavit states that “[t]he hip
`
`peg [bone screw] has a slot 18 [groove],