UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ZIMMER BIOMET HOLDINGS, INC., ZIMMER, INC., AND BIOMET, INC.
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`Petitioner,
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`v.
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`ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
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`Patent Owner
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`Case IPR2016-00311
`Patent No. 8,092,454 B2
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`PATENT OWNER ADVANCED ORTHOPAEDIC SOLUTIONS, INC.’S
`PRELIMINARY RESPONSE PURSUANT TO 37 C.F.R. § 42.107
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`    
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`

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`Table of Contents
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`TABLE OF AUTHORITIES .............................................................................................. iv
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`I.
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`Introduction .................................................................................................................... 1
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`II. Claim Construction ........................................................................................................ 1
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`A. Overview of U.S. Patent No. 8,092,454 ..................................................................... 1
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`B. Level of Ordinary Skill in the Art ............................................................................... 3
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`C. The Broadest Reasonable Interpretation Must Consider the Specification. ............... 3
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`D. Zimmer Biomet’s Proposed Claim Construction Is Flawed and
`Should Be Rejected. .......................................................................................................... 4
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`i. Longitudinally Extending Grooves ......................................................................... 4
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`ii. Zimmer Biomet’s Proposed Constructions Are Unreasonable Based on the
`Ordinary Meaning of the Term “Groove.” .................................................................... 5
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`iii. Cap ......................................................................................................................... 10
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`II. Ground 1 – Claims 6, 7, 9, 10, and 13 Are Not Anticipated by Shavit under
`35 U.S.C. §102. .................................................................................................................. 12
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`A. The Same or Substantially the Same Art Was Previously Considered by the Patent
`Office. .............................................................................................................................. 12
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`B. Overview of Shavit. .................................................................................................. 13
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`C. Shavit Does Not Disclose a Lower Surface Operative to Contact a Bone Screw. ... 15
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`i. Claim 6 Is Not Anticipated by Shavit .................................................................... 15
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`ii. Claim 13 Is Not Anticipated by Shavit .................................................................. 19
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`IV. Ground 2 – The Combination of Shavit in View of Kilpela Does Not Render Obvious
`Claim 8. .............................................................................................................................. 20
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`A. Additional Disclosure of Shavit. ............................................................................... 21
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`ii 
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`

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`B. Overview of Kilpela .................................................................................................. 24
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`C. Shavit Teaches Away from the Combination Advocated by Petitioner ................... 24
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`IV. Ground 3 – The Combination of Shavit in View of Kilpela Does Not Render Obvious
`Claims 14, 15, 19, and 20 ................................................................................................... 28
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`A. Claim 14 Is Not Rendered Obvious by Shavit in View of Kilpela .......................... 29
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`B. Claim 19 Is Not Rendered Obvious by Shavit in View of Kilpela .......................... 30
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`IV. Ground 4 – The Combination of Shavit in View of Kilpela and Bramlet Does Not
`Render Obvious Claims 14, 15, 19, and 20 ........................................................................ 31
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`A. Overview of Bramlet ................................................................................................ 31
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`B. Claim 14 Is Not Rendered Obvious by Shavit in View of Kilpela and Bramlet ...... 31
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`C. Claim 19 Is Not Rendered Obvious by Shavit in View of Kilpela and Bramlet ...... 35
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`IV. Ground 5 – The Combination of Shavit in View of Bramlet Does Not Render Obvious
`Claim 11. ............................................................................................................................ 38
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`V. Conclusion ................................................................................................................... 39
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`iii 
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`TABLE OF AUTHORITIES
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`CASES
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`Hoganas AB v Dresser Indus., Inc., 9 F.3d 948, 950 (Fed. Cir. 1993) .......................... 6, 11
`
`In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 (Fed. Cir. 2015) ............................ 3
`
`In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) ................................................................. 27
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`In re Gurley, 27 F.3d 551, 553 (Fed.Cir.1994) .................................................................. 21
`
`In re Mouttet, 686 F.3d 1322, 1333–34 (Fed. Cir. 2012) ................................................... 21
`
`In re NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011) ........................................................ 4
`
`In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010) ........................................ 3
`
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) .................................... 4
`
`KSR Intern.l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ........................................ 26, 27
`
`KSR Internat′l Co. v. Teleflex Inc., 550 U.S. 398, 416, 127 S.Ct. 1727, 167 L.Ed.2d 705
`(2007). ............................................................................................................................. 21
`
`Microsoft Corp. v. Proxyconn, Inc., 789 F.3d, 1292, 1298 (Fed. Cir. 2015) ...................... 3
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`Microsoft, 789 F.3d at 1298 (quoting Suitco, 603 F.3d at 1260) ......................................... 4
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`Nystrom v. TREX Co., Inc., 424 F.3d 1136, 1149 (Fed. Cir. 2005) ................................... 16
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`Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005) ..................... 15
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`Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998) 6, 11
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`Symantec Corp. v. Computer Assocs. Int’l, Inc., 522 F.3d 1279, 1289 n. 3 (Fed. Cir. 2008)
` ..................................................................................................................................... 7, 11
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`Unilever, Inc. v. The Procter & Gamble Co., IPR2015-00506, Paper 17 at 6 (PTAB July 7,
`2014) ................................................................................................................................ 12
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`STATUTES
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`iv 
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`35 U.S.C. § 314 .................................................................................................................... 1
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`35 U.S.C. § 325(d) .............................................................................................................. 12
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`37 C.F.R. § 42.107(a) ........................................................................................................... 1
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`37 C.F.R. § 42.108(c) ........................................................................................................... 1
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`37 C.F.R. §42.65(a) ...................................................................................... 7, 11, 17, 25, 30
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`OTHER AUTHORITIES
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`Oxford Dictionary .......................................................................................................... 6, 10
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`Random House College Dictionary ............................................................................... 5, 10
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`Webster’s New Universal Unabridged Dictionary ........................................................ 4, 10
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`v 
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`I.
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`
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`Introduction
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`Pursuant to 37 C.F.R. § 42.107(a) Patent Owner, Advanced Orthopedic Solutions,
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`Inc. (“AOS”) submits the following preliminary response to the Petition, setting forth
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`reasons why no inter partes review (IPR) should be instituted under 35 U.S.C. § 314.
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`Stated briefly, the Board should not institute an IPR because Petitioner, Zimmer Biomet
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`Holdings, Inc., Zimmer, Inc., and Biomet, Inc. (“Zimmer Biomet”), failed to demonstrate a
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`reasonable likelihood that at least one of the claims challenged in the Petition is
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`unpatentable. 37 C.F.R. § 42.108(c).
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`
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`First, the Petition, and the expert declaration rely upon an improper claim
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`construction. The cited references do not show the elements of the claims 6-11, 13-15, and
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`19-20 as properly construed. Second, the cited references teach away
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`from a combination of elements as advocated by Petitioner.
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`II. Claim Construction
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`A. Overview of U.S. Patent No. 8,092,454
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`U.S. Patent No. 8,092,454 (the “‘454 patent”) (Ex. 1004)
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`discloses a fixation instrument for treating a bone fracture including a
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`bone nail and a bone screw combination. (Ex. 1004, 1:47-49). The
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`fixation instrument includes a nail member 22 having a proximal end 24
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`with an aperture 30 extending through the proximal end 24. (Ex. 1004,
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`1 
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`2:45-47, 2:60-63).
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`A bone screw 32 having a threaded portion
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`34 extends through the aperture 30 in the
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`proximal end 24 of the nail 22. (Ex. 1004,
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`2:63-67). The bone screw 32 includes a plurality
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`of longitudinally extending grooves 56 located on
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`the outer surface 58. (Ex. 1004. 3:25-27).
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`
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`An insert 36 is disposed within a chamber
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`42 in the proximal end of the nail 22. The insert
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`36 has a distal end 38 and a proximal end 40. (Ex.
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`1004, 3:1-3). A locking ring controls the position
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`of the insert 36 within the chamber 42. (Ex. 1004,
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`3:43-44). The insert 36 includes a lower surface
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`52 having locking projections 54 extending longitudinally
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`downward from the lower surface 52. (Ex. 1004, 3:12-14).
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`The insert travels in the chamber 42 until the lower surface 52
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`of the insert 36 engages the outer surface 58 of the bone screw
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`32 and the locking projections 54 of the insert 36 extend into
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`the grooves 56 of the bone screw 32. (Ex. 1004, 3:37-42).
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`2 
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`B.
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`Level of Ordinary Skill in the Art
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`Zimmer Biomet submits that a person of ordinary skill in the art for the ‘454 patent is
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`a person having either (1) a Bachelor’s degree in biomedical engineering, (2) a Bachelor’s
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`degree in mechanical engineering with coursework in biomechanics or orthopedics, or (3)
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`at least three years of experience designing orthopedic implants. (Petition, 5). AOS agrees
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`that item (1) should form part of the level of ordinary skill. AOS disagrees with item (2) as
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`too limiting and submits a person of ordinary skill in the art may have a Bachelor’s degree
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`in engineering with experience designing orthopedic implants. AOS agrees that experience
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`designing orthopedic implants may be included in the skill level.
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`
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`C.
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`The Broadest Reasonable Interpretation Must Consider the
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`Specification.
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`
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`The claims of a patent undergoing an IPR proceeding are to be given their broadest
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`reasonable interpretation. In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 (Fed. Cir.
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`2015) ("We conclude that Congress implicitly approved the broadest reasonable
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`interpretation standard in enacting the AIA."). However, as the Court of Appeals for the
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`Federal Circuit noted, the claims of a patent must always be read in light of the
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`specification and the teachings of the underlying patent. Microsoft Corp. v. Proxyconn,
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`Inc., 789 F.3d, 1292, 1298 (Fed. Cir. 2015); In re Suitco Surface, Inc., 603 F.3d 1255, 1260
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`(Fed. Cir. 2010). Even under the broadest reasonable interpretation, the Board's
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`construction "cannot be divorced from the specification and the record evidence." In re
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`3 
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`NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011). "A construction that is 'unreasonably
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`broad' and which does not 'reasonably reflect the plain language and disclosure' will not
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`pass muster." Microsoft, 789 F.3d at 1298 (quoting Suitco, 603 F.3d at 1260). Claim terms
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`are generally given their ordinary and customary meaning. In re Translogic Tech., Inc., 504
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`F.3d 1249, 1257 (Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning
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`that the term would have to a person of ordinary skill in the art in question.”) (internal
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`quotation marks omitted).
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`
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`D.
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`Zimmer Biomet’s Proposed Claim Construction Is Flawed and Should
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`Be Rejected.
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`
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`Zimmer Biomet proposes constructions that are incorrect and unreasonable – i.e.,
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`not the ordinary and customary meaning.
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`i.
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`Longitudinally Extending Grooves
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`Independent claim 6 of the ‘454 patent recites “said bone screw having a
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`longitudinally 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 outer
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`surface of said bone screw . . ..” (emphasis added).
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`
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`The term “grooves” is clear and does not need construction. The plain and ordinary
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`meaning of the term “groove” may be determined by reference to Webster’s New Universal
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`Unabridged Dictionary as “1. a long, narrow furrow or hollow such as is cut by a tool; also,
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`any rut or furrow like this, … 4. in anatomy, any narrow furrow, depression, or slot
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`4 
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`occurring on the surface of an organ, especially of bone.”(Ex. 2001) or Random House
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`College Dictionary as “1. a long, narrow cut or indentation in a surface.” (Ex. 2002).
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`
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`The plain and ordinary meaning finds support in the specification and drawings of
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`the ‘454 patent describing “a plurality of longitudinally extending grooves 56 located on
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`the outer surface 58 of the bone screw 32.” (Ex. 1004, 3:25-27). As illustrated in FIGS. 2
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`and 3, the grooves 56 are long, narrow furrows, cuts, or indentations in the outer surface 58
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`of the bone screw 32.
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`
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`The ‘454 patent also uses the term “groove” in an identical fashion to refer to the
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`structure identified by reference numeral 46, see FIG. 2. “The tabs or guide/locating
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`members 44 cooperate with a pair of grooves or channels 46 that extend longitudinally
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`along the sidewalls 48 of the chamber 42.” (Ex. 1004, 3:5-8). The tabs 44 of the insert 36
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`are received in the grooves or channels 46 in the sidewalls 48 wherein the insert 36 is
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`slidably received and prevented from rotating in the chamber 42. (Ex. 1004, 3:14-19). As
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`illustrated in FIG. 2, the grooves or channels 46 are long, narrow furrows, cuts, or
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`indentations in the sidewalls 48 of the chamber 42.
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`
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`ii.
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`Zimmer Biomet’s Proposed Constructions Are Unreasonable Based on
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`the Ordinary Meaning of the Term “Groove.”
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`
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`Without explanation, Zimmer Biomet proposes three different constructions of the
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`term “grooves.” First, Zimmer Biomet proposes, based on the testimony of Dr. Kyle, “a
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`person of ordinary skill in the art would understand that ‘grooves’ refers to cuts or
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`5 
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`

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`depressions on the bone screw.” (Petition, 9:13-14, Kyle Declaration, Ex. 1001 at ¶¶36-37).
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`Second, Zimmer Biomet proposes “a person of ordinary skill in the art would interpret
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`‘grooves’ as cuts or depressions to fit a locking projection or insert.” (Petition, 9:20 –
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`10:1-2). Third, Zimmer Biomet proposes “a person of ordinary skill would understand that
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`‘grooves’ refers to cuts or depressions that form a space for positioning an insert.”
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`(Petition, 10:7-9).
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`
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`Both the second and third proposed constructions contradict the construction offered
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`by their expert Dr. Kyle. Further, the proposed construction contradicts the plain and
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`ordinary meaning of the term cited in the Oxford Dictionary definition provided by
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`Zimmer Biomet.
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`
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`Zimmer Biomet’s second and third proposed constructions add an extraneous
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`limitation to the claim. The second construction adds, “to fit a locking projection or insert”
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`and the third construction adds, “that form a space for positioning an insert.” It is
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`“improper to add ‘extraneous’ limitations to a claim, that is, limitations added ‘wholly
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`apart from any need to interpret what the patentee meant by particular words or phrases in
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`the claim.’” Hoganas AB v Dresser Indus., Inc., 9 F.3d 948, 950 (Fed. Cir. 1993). It is well
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`settled that if a feature is not necessary to give meaning to a claim term, it is “extraneous”
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`and should not be read into the claim. Renishaw PLC v. Marposs Societa' per Azioni, 158
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`F.3d 1243, 1249 (Fed. Cir. 1998). Zimmer Biomet offers no evidence supporting its
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`contention these terms are necessary to give meaning to the term “groove.”
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`6 
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`
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`Zimmer Biomet’s first proposed construction is based on the testimony of Dr. Kyle.
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`However, Dr. Kyle testifies as to his opinion, not the opinion of a person of ordinary skill in
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`the art, “[i]n my opinion….” (Kyle Declaration, Ex. 1001, ¶36). “In forming my opinions
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`on how to interpret the claims…” (Ex. 1001, ¶35, ll. 5). Dr. Kyle states, “Therefore, it is my
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`opinion that the broadest reasonable interpretation of ‘a plurality of longitudinally
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`extending groove’ is ‘a plurality of longitudinally extending cuts or depressions.’” (Ex.
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`1001 at ¶37) (emphasis added).
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`
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`Dr. Kyle does not explain or provide specifics regarding why a person of ordinary
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`skill in the art would construe the term in the manner he proposes. “Expert testimony that
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`does not disclose the underlying facts or data on which the opinion is based is entitled to
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`little or no weight.” 37 C.F.R. §42.65(a). Dr. Kyle merely gives his opinion on claim
`
`construction; it is entitled to no weight. Symantec Corp. v. Computer Assocs. Int’l, Inc.,
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`522 F.3d 1279, 1289 n. 3 (Fed. Cir. 2008) (“To the extent that the testimony merely gives
`
`the expert’s opinion as to claim construction, we attribute it no weight.”).
`
`
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`Dr. Kyle’s testimony regarding the prior art supports the plain and ordinary meaning
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`of the term “groove” as used in the ‘454 patent. Dr. Kyle initially refers to the Zickel Nail
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`as having “slots” across the surface of the femoral neck nail. (Kyle Declaration, Ex. 1001,
`
`¶24).
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`7 
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`

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`
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`When Dr. Kyle discusses the Zickel Nail, Exhibit 1041,
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`Browner at 129, he indicates the femoral neck nail (bone
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`screw) includes “slots” extending perpendicular to the
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`longitudinal axis of the bone screw. The shoulders or sides of
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`the “slots” prevent longitudinal movement of the neck nail
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`(bone screw.) Dr. Kyle explains these “slots” fix the bone
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`screw in the longitudinal direction. (Kyle Declaration, Ex.
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`1001, ¶24)
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`
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`Dr. Kyle explains this technology has a shortcoming;
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`specifically, fixing the bone screw in the longitudinal direction
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`may cause bone screw cut-out (the tip of the screw may “cut out”
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`of the femoral head and protrude into the hip joint. (Kyle
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`Declaration, Ex. 1001, ¶24).
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`
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`Dr. Kyle acknowledges that the Zickel Nail contains
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`grooves by pointing out “one solution was to simply change the
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`orientation of the grooves on the bone screw. Medical technology
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`companies designed bone screws with grooves that extend
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`longitudinally rather than circumferentially.” (Kyle Declaration,
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`Ex. 1001, ¶25) (emphasis added). Dr. Kyle identifies Ex. 1043,
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`Halder at 34, as illustrating a bone screw having a groove
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` 
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`8 
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`

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`extending longitudinally. Dr. Kyle explains that “in these designs, a portion of the set
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`screw engages the longitudinal groove and prevents the bone screw from rotating while
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`still allowing some sliding motion.” (Kyle Declaration, Ex. 1001, ¶25) (emphasis added).
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`Dr. Kyle specifically uses the term “groove” and does not refer to it as a cut or depression.
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`
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`The prior art cited by the examiner during prosecution also supports the plain and
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`ordinary meaning of the term “groove.” Roth et al. (Ex. 2003) discloses that the nail 22
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`includes a channel 64 having a pair of grooves 65 formed on the channel. (Ex. 2003, 6:
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`43-45). Roth uses the term “groove” to define the structure; i.e., the long, narrow furrow on
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`the surface shown in Fig. 7. (Ex.
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`2003, 7:8-12).
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`
`
`
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`Zimmer Biomet’s
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`AFFiXUS Hip Fracture Nail
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`Surgical Technique brochure also
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`identifies the “grooves” in the lag
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`(bone) screw. As shown, the
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`pre-loaded set screw is rotated
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`until “the set screw contacts the lag
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`screw in one of the four lag screw
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`grooves (Figure 22A & 22B).”
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`(Exhibit 1040, pp. 84).
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`9 
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`
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`The term “grooves” in claim 6 should be accorded its plain and ordinary meaning.
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`iii. Cap
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`Independent claim 19 and dependent claims 11 and 14 recite “a cap.” The term “cap”
`
`is clear and does not need construction. The plain and ordinary meaning of the term “cap”
`
`may be determined by reference to Webster’s New Universal Unabridged Dictionary as “
`
`6. Anything resembling a cap in appearance, position, or use; as,… (i) a cover for a jar,
`
`lens, etc.” (Ex. 2001)(emphasis in original) or Random House College Dictionary as “5.
`
`Anything resembling a covering for the head in shape, use, or position: a cap on a bottle.”
`
`(Ex. 2002)(emphasis in original).
`
`
`
`The ordinary meaning finds support in the specification and drawings of the ‘454
`
`patent describing “the opening 50 at the trailing or rear edge 26 of the nail member 22 is
`
`closed by a cap 82 threadably received in the chamber 42.” (Ex. 1004, 4: 46-53). As
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`illustrated in FIGS. 2 and 6, the cap 82 is at the trailing or rear edge 26 of the nail member
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`22.
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`
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`Zimmer Biomet’s proposes that the term “cap” should be construed as “barrier or
`
`cover.” (Petition, 10:14-15, Kyle Declaration, Ex. 1001, ¶39). The proposed construction
`
`contradicts the plain and ordinary meaning of the term cited in the Oxford Dictionary
`
`definition provided by Zimmer Biomet – “defining ‘cap’ as ‘something designed to cover
`
`and to protect, preserve, or close’).” (Petition, 11:1-2).
`
`Zimmer Biomet’s proposed construction is based on the testimony of Dr. Kyle.
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`10 
`
`
`
` 
`
`

`
`However, Dr. Kyle testifies as to his opinion, not the opinion of a person of ordinary skill in
`
`the art, “[i]n my opinion….” (Kyle Declaration, Ex. 1001, ¶38). “In forming my opinions
`
`on how to interpret the claims….” (Ex. 1001, ¶35, ll. 5). Dr. Kyle states, “it is my opinion
`
`that ‘cap’ should be interpreted as a ‘barrier or cover.’” (Ex. 1001, ¶39).
`
`
`
`Dr. Kyle does not explain or provide specifics regarding why a person of ordinary
`
`skill in the art would construe the term in the manner he proposes. “Expert testimony that
`
`does not disclose the underlying facts or data on which the opinion is based is entitled to
`
`little or no weight.” 37 C.F.R. §42.65(a). Dr. Kyle merely gives his opinion on claim
`
`construction; it is entitled to no weight. Symantec Corp. v. Computer Assocs. Int’l, Inc.,
`
`522 F.3d 1279, 1289 n. 3 (Fed. Cir. 2008) (“To the extent that the testimony merely gives
`
`the expert’s opinion as to claim construction, we attribute it no weight.”).
`
`
`
`Again, it is “improper to add ‘extraneous’ limitations to a claim, that is, limitations
`
`added ‘wholly apart from any need to interpret what the patentee meant by particular words
`
`or phrases in the claim.’” Hoganas AB v Dresser Indus., Inc., 9 F.3d 948, 950 (Fed. Cir.
`
`1993). It is well settled that if a feature is not necessary to give meaning to a claim term, it
`
`is “extraneous” and should not be read into the claim. Renishaw PLC v. Marposs Societa'
`
`per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). Zimmer Biomet offers no evidence
`
`supporting its contention that the term “cap” should include structural and functional
`
`limitations wherein it acts as a barrier to impede bone formation and soft tissue growth
`
`inside the nail. Such additional language “is not necessary to give meaning to the term
`
` 
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`11 
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`

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`“cap.”
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`
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`The term “cap” in claims 11, 14, and 19 should be accorded its plain and ordinary
`
`meaning.
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`II. Ground 1 – Claims 6, 7, 9, 10, and 13 Are Not Anticipated by Shavit under 35
`
`U.S.C. §102.
`
`
`
`Zimmer Biomet asserts as Ground 1 that claims 6, 7, 9, 10, and 13 are anticipated by
`
`Shavit, International Publication No. WO 03/061495 (‘Shavit”)(Ex. 1007). Shavit cannot
`
`anticipate these claims – of which claims 6 and 13 are independent claims.
`
`
`
`A.
`
`The Same or Substantially the Same Art Was Previously Considered by
`
`the Patent Office.
`
`
`
`A decision to decline Zimmer Biomet’s Petition is supported by the Patent Office
`
`previously considering Roth ‘197 (Ex. 2003). Unilever, Inc. v. The Procter & Gamble
`
`Co., IPR2015-00506, Paper 17 at 6 (PTAB July 7, 2014) (Institution of Proceeding denied
`
`because “’the same or substantially the same prior art’ previously was ‘presented to the
`
`Office’ in the [earlier] proceeding.”), citing 35 U.S.C. § 325(d). During the prosecution of
`
`the ‘454 patent Primary Examiner Nicholas Woodall cited both Roth, U.S. Patent
`
`Publication No. 2003/0074000 which issued as Roth ‘197 (Ex. 2003) and Roth, U.S. Patent
`
`No. 7,306,600.
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`Roth ‘197 discloses a nail 22 having a body member 60 and the drive member 62
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`disposed in an interior channel 64. (Ex. 2003, 6:21-23). Cooperation between the body
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`member 60, drive member 62, and channel 64 substantially prevent the implant 20 from
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`rotating about its longitudinal axis 30 within bore 66 and also limit sliding of the implant
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`20 within bore 66 to a predetermined distance. (Ex. 2003, 6:26-32). Cooperation between
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`the tabs 85 on the body member 60 and the grooves 65 in the interior channel 64 maintain
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`the surface 79 of the body member 60 at a distance from the implant 20 when the coupling
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`mechanism is assembled and locked, thus allowing the implant 20 to freely slide in the bore
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`66. (Ex. 2003, 7:14-18).The surface 79, shown in FIG. 9, does not contact the implant 20.
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`(Ex. 2003, 7:21-23).
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`Shavit discloses the same art. Specifically, a nail-stopping screw 28, extending
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`through the hole in the nail 12 and engaging a slot 34 in the stem 26, limiting axial
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`movement of the stem 26 and corresponding tab 20. (Ex. 1005, 12:19-20). As illustrated in
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`FIGS. 3A and 4 only the tab 20 engages the hip peg 10, specifically the slot 18, whereby the
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`hip peg 10 freely moves back and forth along its longitudinal axis.
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`Like the tabs 85 and the grooves 65 of Roth ‘197 keep the surface 79 of the body
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`member 60 at a distance from the implant 20 enabling the implant 20 to freely slide in the
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`bore 66, Shavit uses the nail-stopping screw 28 and groove 34 in the stem 26 to keep
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`surface of the stem 26 from contacting the hip peg 10, enabling the hip peg 10 to freely
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`slide in the hole 16.
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`B. Overview of Shavit.
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`Shavit discloses a nail 12 with holes 14, 16. (Ex. 1005, 7:29-30). A hip peg or larger
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`screw 10 extends through the hole 16 and a pin or smaller screw extends through the hole
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`14. (Ex. 1005, 8:3-5). Although not expressly referred to, the drawings, FIGS. 3A, 3B and
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`4, illustrate the hole 16 having an inner circumferential or peripheral surface defining the
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`outer boundary of the hole 16. For the hip peg or larger screw number 10 to extend through
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`and slide in or move back and forth along the axis of the hip peg 10 there must be clearance
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`between the outer circumferential or peripheral surface of the hip peg 10 and the inner
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`circumferential or peripheral surface of the hole 16. Shavit expressly discloses relative
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`movement between the hip peg 10 and the nail 12. (Ex. 1005, 8:10-12).
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`To control relative movement between the nail 12 and the hip peg 10, Shavit
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`discloses a locking mechanism 22, in an opening 27 at the proximal end of the nail 12,
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`illustrated in FIGS. 2 and 3A-3B. As illustrated, the hip peg 10, FIG. 1B, has a slot 18. A
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`tab 20 at the end of the locking mechanism 22 fits into the slot 18 preventing the hip peg 10
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`from coming out of the hole 16 in the nail 12. (Ex. 1005, 8:7-8.) Because the slot 18 is a
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`longer than the tab 20, in a direction along the axis of the hip peg 10, the hip peg 10 moves
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`back and forth along its axis. (Ex. 1005, 8:10-12.) Further, the slot 18 may be wider than
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`the tab 20 so the hip peg 10 freely rotates about a limited angle when the tab is inserted into
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`the slot 18 besides being free to move along its axis. (Ex. 1005, 8: 12-14.)
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`Shavit discloses the locking mechanism 22 accessible from a proximal end of the
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`nail 12. (Ex. 1005, 7:30-31). FIG. 2 illustrates the locking mechanism 22 including a linear
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`adapter 24 and a stem 26. FIGS. 3A and 3B illustrate side cross-sectional views of the nail
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`showing the details of the locking mechanism 22. (Ex. 1005, 7:18-20.)
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`In FIGS. 3A and 4 Shavit discloses a mechanism for controlling the axial travel of
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`the locking mechanism 22 including a nail-stopping screw 28 extending through a hole 30
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`in the nail 12 engaging a slot 34 in the stem 26. The length of the slot 34 limits the axial
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`travel of the locking mechanism 22 in the opening 27. As explained in Shavit the “[s]lot 34
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`is long enough axially so that, when nail-stopping screw 28 engages slot 34, stem 26 is free
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`to move axially from a position where tab 20 is not engaged at all in slot 18 (but adapter 24
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`is still screwed part of the way into opening 27) to the position were tab 20 is completely
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`engaged in slot 18.” (Ex. 1005, 12:22-26.)
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`As illustrated in FIGS. 3A and 4 when proximal end of the slot 34 engages the
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`nail-stopping screw 28, preventing further axial travel of the locking mechanism 22, only
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`the tab 20 extends inwardly past the inner circumferential or peripheral surface of the hole
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`16.
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`C.
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`Shavit Does Not Disclose a Lower Surface Operative to Contact a Bone
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`Screw.
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`A claim is unpatentable under 35 U.S.C. §102 only if a single prior art reference
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`expressly or inherently describes each and every limitation set forth in the claim. Perricone
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`v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005).
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`i.
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`Claim 6 Is Not Anticipated by Shavit
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`Claim 6 recites the following elements: “an insert… having a lower surface, said
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`lower surface operative to contact a bone screw extending through said aperture;” “a
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`locking projection located on said lower surface of said insert;’ and “said bone screw…
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`having a plurality of longitudinal extending grooves,… wherein said locking projection is
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`located in one of said grooves when said lower surface contacts said bone screw.”
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`Shavit expressly discloses the purpose of the tab 20 fitting in slot 18 allows the hip
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`peg 10 to move in the aperture 16. Nothing in Shavit cites or refers to a lower surface of
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`stem 26 contacting the hip peg 10.
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`Because Shavit does not expressly describe this structure, Petitioner attempts to
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`show that FIG.1B of Shavit illustrates it. Petitioner’s argument hinges on an inference
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`drawn from FIG. 1B about the relationship between the hip peg 10 and stem 26. However,
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`arguments based on patent drawings not explicitly made to scale are unavailing. Nystrom v.
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`TREX Co., Inc., 424 F.3d 1136, 1149 (Fed. Cir. 2005). Shavit explicitly acknowledges,
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`“some of the drawings may not be drawn to scale.” (Ex. 1005, 7:12)(emphasis added).
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`Petitioner cites Dr. Kyle’s declaration for support that Shavit describes the above-
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`identified elements of claim 6. Dr. Kyle opines that the stem 26 of Shavit includes a lower
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`surface and a locking projection on the lower surface. (Kyle Declaration, Ex. 1001, ¶53).
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`Dr. Kyle opines that the insert of Shavit includes a “lower surface” and annotates FIG. 4 of
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`Shavit to identify the purported “lower surface.” (Kyle Declaration, Ex. 1001, ¶53). Dr.
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`Kyle provides no specific explanation or identifies evidence supporting his opinion.
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`“Expert testimony that does not disclose the underlying facts or data on which the opinion
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`is based iss entitled too little or nno weight.”” 37 C.F.RR. §42.65(aa).
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`As illustrated in FIGS. 33A and 3BB below, noo portion oof the stem
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`26, other tthan the
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`the red
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`tab 20, exxtends past the inner ccircumfereential or peeripheral suurface, illuustrated by
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`line, definning the ouuter boundaary of the hhole 16. (EEx. 1005 att FIGS. 3AA and 3B
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`(annotatedd)).
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`Further, ccontrary to Dr. Kyle’ss opinion, tthe area annnotated byy Dr. Kyle
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` as being aa “lower
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`surface,” is instead aa portion oof the longiitudinal axxial bore exxtending innwardly froom the
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`opening 227 at the prroximal endd of the na
`ail. (Ex. 10
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`05, 9:2-5.)) Both FIGGS. 3A and d 3B