UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`GLOBUS MEDICAL, INC.,
`Petitioner
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`v.
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`BONUTTI SKELETAL INNOVATIONS LLC,
`Patent Owner
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`
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`Case No.: IPR2015-01346
`U.S. Patent No. 6,099,531
`Issued: August 8, 2000
`Application No: 09/137,443
`Filed: August 20, 1998
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`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,099,531
`
`[CORRECTED]
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`
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`Exhibit 2001 Page 1
`
`Globus Medical, Inc. v.
`Bonutti Skeletal Innovations LLC
`Case IPR2015-00417
`Bonutti Skeletal Innovations LLC - Ex. 2001
`
`

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`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ................................................................................... iii
`LIST OF EXHIBITS .................................................................................................. v
`I.
`INTRODUCTION ........................................................................................... 1
`II.
`FORMALITIES ............................................................................................... 2
`A. Mandatory Notices ................................................................................... 2
`1. Real Party in Interest (37 C.F.R. § 42.8(b)(1)) ................................... 2
`2. Designation of Lead and Backup Counsel (37 C.F.R.§
`42.8(b)(3)) ........................................................................................... 2
`3. Notice of Service (37 C.F.R. § 42.8(b)(4)) ......................................... 2
`4. Related Matters (37 C.F.R. § 42.8(b)(2)) ........................................... 2
`B. Grounds for Standing (37 C.F.R. § 42.104(a)) ........................................ 3
`C.
` Procedural Statements ............................................................................. 4
`III. U.S. PATENT NO. 6,099,531 (“THE ‘531 PATENT”) (EX1001) ................ 4
`A. The ‘531 Patent Specification and Claims ............................................... 4
`B.
` The ‘531 Patent Prosecution History (EX1003) ..................................... 6
`IV. THE PERSON HAVING ORDINARY SKILL IN THE ART AND
`THE STATE OF THE ART ............................................................................ 7
`CLAIM CONSTRUCTION ............................................................................ 8
`V.
`VI. THE PRIOR ART RELIED UPON IN THIS PETITION .............................. 9
`A. U.S. Patent No. 5,306,309 to Wagner et al. (“the ‘309 patent” or
`“Wagner”) (EX1004) ............................................................................... 9
`B. U.S. Patent No. 4,904,261 to Dove et al. (“the ‘261 patent” or
`“Dove”) (EX1005) ................................................................................... 9
`C. French Patent Application No. FR 2,747,034 to Benezech et al.
`(“the FR’034 application” or “Benezech”) (EX1006) ............................. 9
`D. U.S. Patent No. 5,192,327 to Brantigan (“the ‘327 patent” or
`“Brantigan”) (EX1008) .......................................................................... 10
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`i
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`Exhibit 2001 Page 2
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`

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`
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`E. U.S. Patent No. 6,008,433 to Stone (“the ‘433 patent” or “Stone”)
`(EX1009) ................................................................................................ 10
`F. U.S. Patent No. 5,298,254 to Prewett et al. (“the ‘254 patent or
`“Prewett”) (EX1010) ............................................................................. 11
`VII. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. §42.22(a)) ........................................... 11
`VIII. IDENTIFICATION OF GROUNDS FOR UNPATENTABILITY
`(37C.F.R. § 42.104(b)) .................................................................................. 12
`A. Ground 1: Claims 8, 9, 107, 109, and 111 are unpatentable under
`35 U.S.C. § 103(a) as obvious by Wagner (EX1004) ........................... 12
`1. Claim 8 .............................................................................................. 13
`2. Claim 9 .............................................................................................. 20
`3. Claim 107 .......................................................................................... 22
`4. Claim 109 .......................................................................................... 27
`5. Claim 111 .......................................................................................... 28
`B. Ground 2: Claims 46 and 49 are unpatentable under 35 U.S.C. §
`103(a) as obvious over Wagner (the ‘309 patent) (EX1004) in
`view of Dove (the ‘261 patent) (EX1005) ............................................. 30
`1. Claim 46 ............................................................................................ 30
`2. Claim 49 ............................................................................................ 38
`C. Ground 3: Claim 105 is unpatentable under 35 U.S.C. § 103(a)
`as obvious over FR 2,747,034 (the FR’034 application)
`(EX1006) in view Brantigan (the ‘327 patent ) (EX1008) .................... 41
`D. Ground 4: Claim 105 is unpatentable under 35 U.S.C. § 103(a)
`as obvious over Stone (EX1009) in view Prewett (EX1010) ................ 51
`IX. CONCLUSION .............................................................................................. 59
`
`
`
`ii
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`Exhibit 2001 Page 3
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`

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`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`In re Am Acad. Of Sci. Tech Ctr.,
` 367 F.3d 1359 (Fed. Cir. 2004) ............................................................................. 8
`In re Schreiber,
` 128 F.3d 1473, 44 U.S.P.Q.2d 1429 (Fed. Cir. 1997) .........................................44
`KSR Int’l Co. v. Teleflex, Inc.,
` 550 U.S. 398 (2007) ................................................................................ 36, 37, 38
`Pitney Bowes, Inc. v. Hewlett-Packard Co.,
` 182 F.3d 1298, 51 U.S.P.Q.2d 1161 (Fed. Cir. 1999) .........................................43
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
` 550 F.3d 1356 (Fed. Cir. 2008) ...........................................................................38
`Statutes
`
`35 U.S.C. § 102(a) ...................................................................................................10
`35 U.S.C. § 102(b) ........................................................................................ 9, 10, 11
`35 U.S.C. § 102(e)(2) ...............................................................................................10
`35 U.S.C. § 103 ................................................................................................. 11, 12
`35 U.S.C. § 103(a) ................................................................................ 12, 29, 41, 51
`35 U.S.C. § 311 .......................................................................................................... 1
`35 U.S.C. § 312 .......................................................................................................... 1
`35 U.S.C. § 313 .......................................................................................................... 1
`35 U.S.C. § 314 .......................................................................................................... 1
`35 U.S.C. § 314(a) ..................................................................................................... 1
`35 U.S.C. § 315 .......................................................................................................... 1
`35 U.S.C. § 316 .......................................................................................................... 1
`35 U.S.C. § 317 .......................................................................................................... 1
`35 U.S.C. § 318 .......................................................................................................... 1
`35 U.S.C. § 319 .......................................................................................................... 1
`Other Authorities
`
`M.P.E.P. § 2111 ......................................................................................................... 8
`M.P.E.P. § 2111.02 ..................................................................................................43
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`
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`iii
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`Exhibit 2001 Page 4
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`
`Rules
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`37 C.F.R. § 42 ............................................................................................................ 1
`37 C.F.R. § 42.10(b) .................................................................................................. 4
`37 C.F.R. § 42.100(b) ................................................................................................ 8
`37 C.F.R. § 42.104(a) ................................................................................................. 3
`37 C.F.R. § 42.104(b) ..............................................................................................12
`37 C.F.R. § 42.106(a) ................................................................................................. 4
`37 C.F.R. § 42.22(a) .................................................................................................11
`37 C.F.R. § 42.63(e) ................................................................................................... 4
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 2
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`iv
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`Exhibit 2001 Page 5
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`
`
`EX1001
`
`U.S. Patent No. 6,099,531
`
`LIST OF EXHIBITS
`
`EX1002
`
`
`EX1003
`
`Bonutti Skeletal Innovations, LLC v. Globus Medical Inc., U.S.
`District Court for the Eastern District of Pennsylvania, Civil Action
`no. 14-cv-6650-WY– Bonutti Skeletal’s Disclosure of Asserted
`Claims and Infringement Contentions
`
`Prosecution History of U.S. Patent No. 6,099,531
`
`EX1004
`
`U.S. Patent No. 5,306,309 to Wagner
`
`EX1005
`
`U.S. Patent No. 4,904,261 to Dove et al.
`
`EX1006
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`French Patent Application No. FR 2,747,034 to Benezech et al.
`
`EX1007
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`Certified translation of French Patent Application No. FR 2,747,034
`to Benezech et al.
`
`EX1008
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`U.S. Patent No. 5,192,327 to Brantigan
`
`EX1009
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`U.S. Patent No. 6,008,433 to Stone
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`
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`EX1010
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`U.S. Patent No. 5,298,254 to Prewett et al.
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`EX1011
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`Declaration of Jorge A. Ochoa, Ph.D., P.E.
`
`EX1012
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`Curriculum Vitae of Jorge A. Ochoa, Ph.D., P.E.
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`EX1013
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`U.S. Patent no. 5,766,252 to Henry
`
`EX1014
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`U.S. Patent no. 5,865,847 to Kohrs
`
`EX1015
`
`EX1016
`
`Cameron HU, Macnab I, Pilliar RM. Evaluation of biodegradable
`ceramic. J Biomed Mater Res. 1977 Mar;11(2):179-86
`
`Chen YJ, Hsu KY, Shih HN, Huang TJ, Hsu RW. Subtalar arthrodesis
`for malunited os calcis fractures. J. Orthop Surg Taiwan. 1996;13:30-
`37
`
`EX1017
`
`Chen YJ, Huang TJ, Hsu KY, Hsu RW, Chen CW. Subtalar
`distractional realignment arthrodesis with wedge bone grafting and
`
`
`
`v
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`Exhibit 2001 Page 6
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`

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`
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`EX1018
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`EX1019
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`EX1020
`
`EX1021
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`EX1022
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`lateral decompression for calcaneal malunion. J Trauma. 1998
`Oct;45(4):729-37
`
`Holte DC, O'Brien JP, Renton P. Anterior lumbar fusion using a
`hybrid interbody graft. A preliminary radiographic report. Eur Spine J.
`1994;3(1):32-8
`
`Kozak JA, Heilman AE, O'Brien JP. Anterior lumbar fusion options.
`Technique and graft materials. Clin Orthop Relat Res. 1994
`Mar;(300):45-51
`
`Lane JD, Jr., Moore ES, Jr. Transperitoneal Approach to the
`Intervertebral Disc in the Lumbar Area. Ann Surg. Mar
`1948;127(3):537-551
`
`Scranton PE Jr. Results of arthrodesis of the tarsus: talocalcaneal,
`midtarsal, and subtalar joints. Foot Ankle. 1991 Dec;12(3):156-64
`
`Troyanovich SJ, Cailliet R, Janik TJ, Harrison DD, Harrison DE.
`Radiographic mensuration characteristics of the sagittal lumbar spine
`from a normal population with a method to synthesize prior studies of
`lordosis. J Spinal Disord. 1997 Oct;10(5):380-6
`
`EX1023
`
`Uchida A, Nade SM, McCartney ER, Ching W. The use of ceramics
`for bone replacement. A comparative study of three different porous
`ceramics. J Bone Joint Surg Br. 1984 Mar;66(2):269-75
`
`EX1024 Wagner PC, Bagby GW, Brant BD, Gallina A, Ratzlaff M, Sande R.
`Surgical stabilization of the equine cervical spine. Vet Surg 1979
`8:7-12
`
`EX1025 Weiner BK, Fraser RD. Spine update lumbar interbody cages. Spine.
`1998 Mar 1; 23(5):634-40
`
`EX1026
`
`EX1027
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`
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`Claim chart – Claims 8 and 9; 46 and 49; and 107, 109 and 111 vs.
`U.S. Patent No. 5,306,309 and U.S. Patent No. 4,904,261
`
`Claim chart – Claim 105 vs. French Patent Application No. 2,747,034
`and U.S. Patent No. 5,192,327
`
`vi
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`Exhibit 2001 Page 7
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`

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`EX1028
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`Claim chart – Claim 105 vs. U.S. Patent No. 6,008,433 and U.S.
`Patent No. 5,298,254
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`
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`
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`vii
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`Exhibit 2001 Page 8
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`

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`
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`I.
`
`INTRODUCTION
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`Pursuant to 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42, the undersigned, on
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`behalf of and representing Petitioner Globus Medical, Inc. (“Globus” or
`
`“Petitioner”) hereby petitions for inter partes review of claims 8, 9, 46, 49, 105,
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`107, 109, and 111 of U.S. Patent No. 6,099,531, entitled “Changing Relationship
`
`Between Bones” (“the ‘531 patent), issued to Peter M. Bonutti and assigned to
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`Bonutti Skeletal Innovations LLC (“Bonutti”). The ‘531 patent is attached as
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`EX1001.
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`For the reasons set forth herein, Petitioner asserts that all of the challenged
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`claims are unpatentable. The grounds for unpatentability presented in detail, below,
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`demonstrate how each of the challenged claims is anticipated and/or rendered
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`obvious in view of the prior art. Evidentiary support for Petitioner’s conclusions is
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`provided in the Declaration of Jorge A. Ochoa, Ph.D., P.E. EX1011. Dr. Ochoa is
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`an expert with over 25 years of experience in the area of design and development
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`of orthopedic medical devices, surgical instruments and techniques, as well as
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`biomechanics, and engineering biomaterials. Dr. Ochoa’s declaration establishes
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`that each of the challenged claims is rendered obvious in view of the prior art and
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`confirms all of Petitioner’s assertions of unpatentability. Petitioner submits that
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`this Petition demonstrates a reasonable likelihood that it would prevail with respect
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`to at least one of the claims challenged in the Petition. 35 U.S.C. §314(a).
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`
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`1
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`Exhibit 2001 Page 9
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`

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`
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`Accordingly, Petitioner respectfully requests that this Petition be granted and that
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`claims 8, 9, 46, 49, 105, 107, 109, and 111 of the ‘531 patent be reviewed and held
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`unpatentable.
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`II.
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`FORMALITIES
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`A. Mandatory Notices
`
`1.
`
`Real Party in Interest (37 C.F.R. § 42.8(b)(1))
`
`Globus Medical, Inc. (“Globus”) is the real party-in-interest.
`
`2.
`
`Designation of Lead and Backup Counsel (37 C.F.R.§
`42.8(b)(3))
`
`Backup Counsel
`David P. Utykanski (Reg. No. 39,052)
`HARNESS, DICKEY & PIERCE, P.L.C.
`5445 Corporate Dr., Suite 200
`Troy, MI 48098
`248-641-1600 (telephone)
`248-641-0270 (facsimile)
`dutykanski@hdp.com
`
`
`
`Lead Counsel
`George D. Moustakas (Reg. No. 44,425)
`HARNESS, DICKEY & PIERCE, P.L.C.
`5445 Corporate Dr., Suite 200
`Troy, MI 48098
`248-641-1600 (telephone)
`248-641-0270 (facsimile)
`gdmoustakas@hdp.com
`
`3.
`
`Notice of Service (37 C.F.R. § 42.8(b)(4))
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`Please direct all correspondence to lead counsel at the above address.
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`Petitioner consents to email service at the above-referenced email addresses.
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`4.
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`Related Matters (37 C.F.R. § 42.8(b)(2))
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`Petitioner states that the ‘531 patent is asserted in Bonutti Skeletal
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`Innovations, LLC v. Globus Medical Inc., U.S. District Court for the Eastern
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`District of Pennsylvania, Civil Action no. 14-cv-6650-WY (“the Pending
`
`
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`2
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`Exhibit 2001 Page 10
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`

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`
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`Litigation”). Petitioner is a party to the Pending Litigation. Notably, in the Pending
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`Litigation, Bonutti has accused certain of Globus’s spinal implant devices of
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`infringing the challenged claims of the ‘531 patent. See EX1002.
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`Concurrently with this Petition, Petitioner is also filing a Petition for inter
`
`partes review of U.S. Patent No. 7,001,385 (“the ‘385 patent”). The ‘385 patent is
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`related to the ‘531 patent through continuation practice. Also concurrently with
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`this Petition, Petitioner is filing a Petition for inter partes review of U.S. Patent
`
`No. 6,423,063 (“the ‘063 patent”). The ‘063 patent is also related to the ‘531 patent
`
`through continuation practice. Petitioner understands that the ‘531 patent, the ‘385
`
`patent, and the ‘063 patent are all commonly owned by Bonutti Skeletal
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`Innovations LLC. Moreover, Petitioner is concurrently filing Petitions for inter
`
`partes review of U.S. Patent Nos. 8,486,066 (“the ‘066 patent”) and 8,795,363
`
`(“the ‘363 patent”). The ‘066 and ‘363 patents are related to each other through
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`continuation practice and, although not formally related to the ‘063 patent, they are
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`directed to subject matter similar to that of the ‘063 patent. Petitioner understands
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`that the ‘066 and ‘363 patents are likewise commonly owned by Bonutti Skeletal
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`Innovations LLC.
`
`B. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Petitioner certifies that (1) the ‘531 patent is available for inter partes
`
`review; and (2) Petitioner is not barred or estopped from requesting inter partes
`
`
`
`3
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`Exhibit 2001 Page 11
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`

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`
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`review of any claim of the ‘531 patent on the grounds identified in this Petition. It
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`should be noted that, in this regard, service of the Summons and Complaint issued
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`in the Pending Litigation was made on Petitioner on December 30, 2014.
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`Consequently, Petitioner is not time barred by the Pending Litigation to bring this
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`Petition.
`
`C.
`
` Procedural Statements
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`This Petition is filed in accordance with 37 C.F.R. § 42.106(a). A Power of
`
`Attorney (37 C.F.R. § 42.10(b)) and Exhibit List (37 C.F.R. § 42.63(e)) are filed
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`concurrently with this Petition. The fee is being paid via Deposit Acct. No. 08-
`
`0750. The United States Patent and Trademark Office is authorized to charge any
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`fee deficiency, or credit any overpayment, to Deposit Acct. No. 08-0750.
`
`III. U.S. PATENT NO. 6,099,531 (“THE ‘531 PATENT”) (EX1001)
`
`The ‘531 patent issued on August 8, 2000, on an application filed on August
`
`20, 1998. The earliest priority date for the ‘531 patent is its filing date.
`
`A.
`
`The ‘531 Patent Specification and Claims
`
`
`
`The ‘531 Patent is directed to changing a spatial relationship between two or
`
`more bones in a patient’s body. The challenged claims, however, encompass
`
`known implantable orthopedic devices and methods for their use in association
`
`with and affecting the spatial relationship of bones in a patient’s body and are
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`unpatentable. The ‘531 Patent issued with 129 claims, of which only claims 8, 9,
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`
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`4
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`Exhibit 2001 Page 12
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`

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`
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`46, 49, 105, 107, 109, and 111 are at issue in this Petition. Claims 8, 46, 105, and
`
`107 are independent, and each of claims 9, 49, 109, and 111 is dependent either
`
`directly or indirectly from one of claims 8, 46, 105, and 107.
`
`The written description and drawings of the ‘531 Patent describe various
`
`embodiments of an implantable spacer device and various embodiments of
`
`methods for changing a spatial relationship between two or more bones in a
`
`patient’s body using the implantable spacer device. Claims 8, 9, 46, 49, 107, 109,
`
`and 11 of the ‘531 Patent are directed to a method for inserting the wedge member
`
`44 into the joint 34 by applying force to the upper and lower bones 30,32 to expand
`
`the joint 34. The wedge member 44 is used to apply force to the bones 30, 32 and
`
`pivot the upper bone 30 about an axis extending through the joint 34 such that the
`
`wedge member 44 can be inserted between the bones 30, 32 with a thin end portion
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`52 of the wedge member 44 leading and a thick end portion 50 of the wedge
`
`member 44 trailing. An upper surface 54 on the wedge member 44 slides along an
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`outer surface 88 of the upper bone 30 and a lower surface 56 on the wedge member
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`44 slides along an outer surface 90 of the lower bone 32 while the wedge member
`
`44 moves into the joint 34. The wedge member 44 is not rotated relative to the
`
`joint 34. A fastener member 70, 72 may be used to fix the wedge member 44 to at
`
`least one of the bones 30, 32. The force between the wedge member 44 and each
`
`of the bones 30, 32 maintains the joint 34 in the expanded condition.
`
`
`
`5
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`Exhibit 2001 Page 13
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`

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`
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`
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`Claim 105 is directed to the wedge member 44 used in the method recited in
`
`Claims 8, 9, 46, 49, 107, 109, and 11 of the ‘531 Patent. The wedge member 44a
`
`includes a thin end portion 52a and a thick end portion 50a. A first major side
`
`surface (or upper surface) 54a and a second major side surface (or lower surface)
`
`56a each extend from the thin end portion 52a to the thick end portion 50a. A
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`minor surface (or outer surface) 60a extends between the first and second major
`
`side surfaces 54a, 56a. The wedge member 44a tapers from the minor surface 60a
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`and thick end portion 50a to the thin end portion 52a. The wedge member 44a is
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`porous so that bone can grow through the wedge member 44a. The porous
`
`construction is provided by having passages that extend through the wedge
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`member 44a between the first and second major side surfaces 54a, 56a.
`
`B.
`
` The ‘531 Patent Prosecution History (EX1003)
`
`Application No. 09/137,443, now the ‘531 Patent, was filed on August 20,
`
`1998. Only a single office action issued during the prosecution history of the ‘531
`
`Patent. See ‘531 Patent File History, Office Action mailed August 20, 1999. An
`
`Amendment was then filed responding to the Office Action on October 26, 1999.
`
`In the Amendment, Claims 1-32 and 40-51 were cancelled and no other
`
`amendments were made.
`
`It appears that the Applicant successfully argued that Claim 8 (formerly
`
`Claim 52) was allowable over Pavlov et al. (U.S. Pat. No. 5,906,616), Michelson
`
`
`
`6
`
`Exhibit 2001 Page 14
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`

`
`
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`(U.S. Pat. No. 5,609,635), and Salib et al. (U.S. Pat. No. 5,258,031) based on the
`
`method step of “pivoting the first bone about an axis which extends through the
`
`joint interconnecting the first and second bones.” Exhibit EX1003, ‘531 Patent
`
`File History, Amendment dated October 26, 1999, page 41. It appears that the
`
`Applicant successfully argued that Claim 46 (formerly Claim 90) was allowable
`
`over the prior art based on the method step of “moving the wedge member into the
`
`joint between the first and second bones without rotating the wedge member.” Id.,
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`page 56. It appears that the Applicant successfully argued that Claim 105
`
`(formerly Claim 149) was allowable over the prior art based on the following
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`features of the wedge member: “a wedge member having first and second major
`
`side surfaces which intersect to form an edge at a thin end portion of the wedge
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`member” and “a minor side surface which extends between the first and second
`
`major side surfaces and extends from the thick end portion to the thin end portion
`
`of the wedge member.” Id., page 74. Lastly, it appears that the Applicant
`
`successfully argued that Claim 107 (formerly Claim 151) was allowable over the
`
`prior art based on the method step of “moving a leading end portion of a wedge
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`member through the longitudinal central axis of the first bone and through the
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`longitudinal central axis of the second bone.” Id., page 75. The Examiner
`
`accepted these arguments and issued a Notice of Allowance on February 4, 2000.
`
`IV. THE PERSON HAVING ORDINARY SKILL IN THE ART AND THE
`STATE OF THE ART
`
`
`
`7
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`Exhibit 2001 Page 15
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`

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`
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`
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`As established in the Declaration of Dr. Ochoa (EX1011 at ¶ 18), a person
`
`having ordinary skill in the art (PHOSITA) of the ‘531 patent would have a
`
`Bachelor's or equivalent degree in Mechanical Engineering or a related discipline
`
`(e.g. biomechanics or biomedical engineering), and at least five years of
`
`experience. The experience would consist of a) designing, developing, evaluating
`
`and/or using prosthetic devices, b) anatomy, physiology and biology of soft and
`
`calcified tissues including bone healing and fusion, and c) biomechanical and
`
`functional loading of orthopedic implants. Alternatively, a PHOSITA could have
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`an advanced degree, in the technical disciplines provided above, or a Doctor of
`
`Medicine, and at least two years of experience in the subject areas provided above.
`
`V. CLAIM CONSTRUCTION
`
`The claims of the ‘531 patent are to be given their broadest reasonable
`
`construction in light of the ‘531 patent’s specification as understood by a person
`
`having ordinary skill in the art. 37 C.F.R. § 42.100(b).
`
`The standard for claim construction in the United States Patent and
`
`Trademark Office is different than the standard used in litigation in the U.S.
`
`District Courts. In re Am Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1364, 1369 (Fed.
`
`Cir. 2004); M.P.E.P. § 2111. Petitioner, therefore, expressly reserves the right to
`
`argue a different claim construction in a different forum for any term in the ‘531
`
`patent, as appropriate in that proceeding.
`
`
`
`8
`
`Exhibit 2001 Page 16
`
`

`
`
`
`VI. THE PRIOR ART RELIED UPON IN THIS PETITION
`
`A. U.S. Patent No. 5,306,309 to Wagner et al. (“the ‘309 patent” or
`“Wagner”) (EX1004)
`
`U.S. Patent No. 5,306,309 to Wagner et al., entitled “Spinal Disk Implant
`
`
`
`and Implantation Kit,” issued April 26, 1994. Wagner is prior art to the ‘531 patent
`
`under 35 U.S.C. § 102(b) because it is a patent more than one year prior to the date
`
`of the application for the ‘531 patent in the United States. Wagner was neither
`
`disclosed by the patent applicant nor cited, referred to, or relied on by the
`
`Examiner during the prosecution of the application leading to the ‘531 patent.
`
`B. U.S. Patent No. 4,904,261 to Dove et al. (“the ‘261 patent” or
`“Dove”) (EX1005)
`
`U.S. Patent No. 4,904,261 to Dove et al., entitled “Spinal Implants,” issued
`
`
`
`February 27, 1990. Dove is prior art to the ‘531 patent under 35 U.S.C. § 102(b)
`
`because it is a patent more than one year prior to the date of the application for the
`
`‘531 patent in the United States. Dove was neither disclosed by the patent
`
`applicant nor cited, referred to, or relied on by the Examiner during the prosecution
`
`of the application leading to the ‘531 patent.
`
`C.
`
`French Patent Application No. FR 2,747,034 to Benezech et al.
`(“the FR’034 application” or “Benezech”) (EX1006)1
`
`
`French Patent Application No. FR 2,747,034 to Benezech et al., entitled
`
`
`1A certified English translation of the specification of the FR’034 application is
`attached as EX1007.
`
`
`
`9
`
`Exhibit 2001 Page 17
`
`

`
`
`
`“Intersomatic Setting and Fusion System,” published October 10, 1997. The
`
`FR’034 application is prior art to the ‘531 patent under 35 U.S.C. § 102(a) because
`
`it is a printed publication in the U.S. or a foreign country before the invention of
`
`the ‘531 patent. The FR’034 application was neither disclosed by the patent
`
`applicant nor cited, referred to, or relied on by the Examiner during the prosecution
`
`of the application leading to the ‘531 patent.
`
`D. U.S. Patent No. 5,192,327 to Brantigan (“the ‘327 patent” or
`“Brantigan”) (EX1008)
`
`U.S. Patent No. 5,192,327, entitled “Surgical Prosthetic Implant for
`
`
`
`Vertebrae,” issued March 9, 1993. Brantigan is prior art to the ‘531 patent under 35
`
`U.S.C. § 102(b) because it is a patent more than one year prior to the date of the
`
`application for the ‘531 patent in the United States. Brantigan was neither
`
`disclosed by the patent applicant nor cited, referred to, or relied on by the
`
`Examiner during the prosecution of the application leading to the ‘531 patent.
`
`E. U.S. Patent No. 6,008,433 to Stone (“the ‘433 patent” or “Stone”)
`(EX1009)
`
`U.S. Patent No. 6,008,433, entitled “Osteotomy Wedge Device, Kit and
`
`
`
`Methods for Realignment of a Varus Angulated Knee,” issued December 28, 1999
`
`from an application filed in the United States on April 23, 1998. Stone is prior art
`
`to the ‘531 patent under 35 U.S.C. § 102(e)(2) because it is a patent granted on an
`
`application for patent by another filed in the United States before the invention by
`
`
`
`10
`
`Exhibit 2001 Page 18
`
`

`
`
`
`the applicant of the ‘531 patent. Stone was neither disclosed by the patent
`
`applicant nor cited, referred to, or relied on by the Examiner during the prosecution
`
`of the application leading to the ‘531 patent.
`
`F.
`
`U.S. Patent No. 5,298,254 to Prewett et al. (“the ‘254 patent or
`“Prewett”) (EX1010)
`
`
`U.S. Patent No. 5,298,254, entitled “Shaped, Swollen Demineralized Bone
`
`and Its Use in Bone Repair,” issued March 29, 1994. Prewett is prior art to the ‘531
`
`patent under 35 U.S.C. § 102(b) because it is a patent issued more than one year
`
`prior to the date of the application for the ‘531 patent in the United States. Prewett
`
`was neither disclosed by the patent applicant nor cited, referred to, or relied on by
`
`the Examiner during the prosecution of the application leading to the ‘531 patent.
`
`VII. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. §42.22(a))
`
`
`
`Petitioner seeks, by this Petition, a final, written decision that challenged
`
`claims 8, 9, 46, 49, 105, 107, 109 and 11 of the ‘531 patent are unpatentable as
`
`obvious pursuant to 35 U.S.C. § 103. Of these challenged claims, claims 8, 46, 105
`
`and 107 are independent. Claim 9 depends from claim 8; claim 49 depends from
`
`claim 46; and claims 109 and 111 depend from claim 107. In summary, and as
`
`established by the declaration of Dr. Ochoa, Wagner renders claims 8, 9, 107, 109
`
`and 111 unpatentable as obvious under 35 U.S.C. § 103 (EX1011 at ¶¶ 30, 32- 55,
`
`and 61-64); Wagner in view of Dove renders claims 46 and 49 unpatentable as
`
`
`
`11
`
`Exhibit 2001 Page 19
`
`

`
`
`
`obvious under 35 U.S.C. § 103 (Id. at ¶¶ 30- 64); the FR’034 application in view
`
`of Brantigan renders claim 105 unpatentable as obvious under 35 U.S.C. § 103 (Id.
`
`at ¶¶ 65-82); and Stone in view of Prewett renders claim 105 unpatentable as
`
`obvious under 35 U.S.C. § 103 (Id. at ¶¶ 83-97).
`
`VIII. IDENTIFICATION OF GROUNDS FOR UNPATENTABILITY
`(37C.F.R. § 42.104(b))
`
`
`
`This petition presents the following Grounds of unpatentability:
`
`(cid:129) Ground 1: Claims 8, 9, 107, 109, and 111 are unpatentable under 35 U.S.C.
`
`§ 103(a) as obvious over Wagner (EX1004).
`
`(cid:129) Ground 2: Claims 46 and 49 are unpatentable under 35 U.S.C. § 103(a) as
`
`obvious over Wagner (EX1004) in view of Dove (EX1005).
`
`(cid:129) Ground 3: Claim 105 is unpatentable under 35 U.S.C. § 103(a) as obvious
`
`over the FR’034 application (EX1006) in view Brantigan (EX1008).
`
`(cid:129) Ground 4: Claim 105 is unpatentable under 35 U.S.C. § 103(a) as obvious
`
`over Stone (EX1009) in view Prewett (EX1010).
`
`A. Ground 1: Claims 8, 9, 107, 109, and 111 are unpatentable under
`35 U.S.C. § 103(a) as obvious by Wagner (EX1004)
`
`Wagner discloses a spinal implant device for use in spinal fusion surgical
`
`
`
`procedures, EX1004 at Abstract; 1:5-10, 2:47-52 and FIGs. 3, 6 and 8; EX1011
`
`at ¶30, and a method for implanting an interbody cage during spinal fusion.
`
`EX1011 at ¶30. The spinal implant device (“spinal disk implant 50”) of Wagner is
`
`
`
`12
`
`Exhibit 2001 Page 20
`
`

`
`
`
`configured for insertion from the anterior approach, with a substantially wedge-
`
`shaped body having transverse faces (68, 70) that are tapered from the thick
`
`anterior end (52) toward the thin posterior end (54). Id.; EX1004 at 6:63-68, FIGs.
`
`3 and 6. The body may be formed of a biodegradable material, preferably ceramic
`
`calcium hydroxylapatite. EX1011 at ¶30; EX1004 at 6:13-26. The Wagner
`
`implant is impacted into place between the vertebrae using a hammer and
`
`thereafter provides a load-bearing spacer. EX1011 at ¶30; EX1004 at 8:57-9:2,
`
`9:26-34.
`
`1.
`
`Claim 8
`
`‘531 patent Claim 8 vs. Wagner
`Wagner (the ‘309 patent) (EX1004) discloses:
`(cid:129) Wagner discloses a spinal implant device for use in spinal
`fusion surgical procedures that changes the spatial
`relationship (e.g., restores a desired anatomical relationship
`from a degenerated condition) between first and second bones
`(i.e., vertebrae) at an intervertebral joint in a patient’s body.
`EX1011 at ¶30.
`(cid:129) Wagner discloses a spinal disk implant 50 for surgically
`implanting between two v