UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NUVASIVE, INC.
`Petitioner
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`v.
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`WARSAW ORTHOPEDICS, INC.
`Patent Owner
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`Case IPR2013-00395
`Patent No. 8,444,696
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`PETITIONER’S MOTION TO EXCLUDE
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`Case No: IPR2013-00395
`Attorney Docket: 13958-0113IP1
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`TABLE OF AUTHORITIES
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`Fed. R. Evid. 401 ......................................................................................... 1, 2
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`Fed. R. Evid. 403 ......................................................................................... 1, 2
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`Fed. R. Evid. 1002 ....................................................................................... 1, 3
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` 
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`i
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`

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`Case No: IPR2013-00395
`Attorney Docket: 13958-0113IP1
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`I.
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`INTRODUCTION
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`Under 37 C.F.R. § 42.64(c), NuVasive, Inc. moves to exclude Exhibits 2007
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`and 2008 submitted by Warsaw Orthopedic, Inc. in the above-captioned inter
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`partes review. Warsaw’s exhibits are inadmissible under Federal Rules of
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`Evidence 401 and 403, and the best evidence rule (FRE 1002). The Exhibits
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`contain Warsaw’s attorneys’ comparison of two claims from the ʼ696 patent to two
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`claims from the parent case of the ʼ696 patent, U.S. Patent No. 8,021,430 (“the
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`’430 patent,” attached hereto as Appendix A). These exhibits are not evidence.
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`These exhibits are also confusing and prejudicial because they compare only a
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`limited number of the independent claims from the ʼ430 and ʼ696 patents, and
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`conveniently ignore the fact that the rejected dependent claims of the ʼ430 patent
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`are strikingly similar to the independent claims of the ʼ696 patent. If Warsaw truly
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`wanted the Board to compare the claims from both patents it would have submitted
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`the best evidence—the ʼ430 patent and its reexamination certificate—for the
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`Board’s review. Warsaw’s improper attempt to submit misleading attorney
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`argument in the guise of evidence should be recognized as such and excluded.
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`II.
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`PROCEDURAL HISTORY
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`NuVasive filed a corrected petition for inter partes review on July 9, 2013
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`(Paper 7), and the Board granted the petition on December 20, 2013 (Paper 12). In
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` 
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`1
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`its Corrected Petition, NuVasive explained the similarity of issues presented in a
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`prior inter partes reexamination proceedings on the parent ʼ430 patent (which
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`eventually led to the issuance of a reexamination certificate canceling all claims of
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`the ʼ430 patent on August 26, 2013), and the issues in the present proceeding on
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`the ‘696 patent. See Corrected Petition, Paper 7, pp. 5-6; Exhibit 1010 (excerpts
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`from the ʼ430 inter partes reexamination prosecution history). Warsaw then filed
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`its Patent Owner response on April 11, 2014 (Paper 24), and NuVasive replied on
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`June 2, 2014 (Paper 25). On April 18, 2014, NuVasive timely served upon
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`Warsaw’s counsel its objections to Warsaw’s evidence that was filed concurrently
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`with its April 11, 2014 response, under 37 C.F.R. § 42.64(b)(1). NuVasive’s
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`objections are attached hereto as Appendix B.
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`III. ARGUMENT
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`Warsaw’s Exhibits 2007 and 2008 are claims comparisons presumably
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`created by Warsaw’s attorney. See Patent Owner Response, Paper 24, p. 10.
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`These Exhibits are not evidence. They are not testimony of a witness. They are
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`not printed publications or other documentary evidence. Accordingly, Exhibits
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`2007 and 2008 are inadmissible under FRE 401 for lack of relevance.
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`Exhibits 2007 and 2008 should also be excluded under FRE 403 because
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`their probative value is substantially outweighed by their prejudice and confusion
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`of the issues. These exhibits are simply attorney argument comparing only a
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`2
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`limited number of the claims from the ʼ430 patent (claims 19 and 26) with claims
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`from the ʼ696 patent (claims 7 and 10). See Patent Owner Response, Paper 24, p.
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`10. The Exhibits ignore the fact that the rejected dependent claims of the ʼ430
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`patent have strong similarities to the independent claims of the ʼ696 patent. See,
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`e.g., claims 20-21, 24-25, 27-28, 31-32 of the ʼ430 patent. Warsaw likely
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`submitted these misleading comparisons, rather than the ʼ430 patent itself, because
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`the similar dependent claims from the ʼ430 patent were all rejected during the inter
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`partes reexamination of that patent. See Corrected Petition, Paper 7, pp. 5-6.; see
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`also Exhibit 1010 (ʼ430 reexamination file history), pp. 92-108. In fact, the CRU
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`rejected those claims on seven separate and independent grounds, including four
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`anticipation grounds based on prior art that was of record in the original
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`prosecution and thus presumably considered by the original examiner. Id. Indeed,
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`even further amended versions of the original claims were rejected. See Exhibit
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`1010, pp. 8-64.
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`Finally, Exhibits 2007 and 2008 also violate the best evidence rule (FRE
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`1002). A copy of the ʼ430 patent (and its reexamination certificate) are printed
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`publications and therefore were readily available to Warsaw as of August 26, 2013,
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`the date the reexamination certificate issued. See ʼ430 patent with reexamination
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`certificate, attached hereto as Appendix A. Thus, the ʼ696 patent and the ʼ430
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`3
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`patent with its reexamination certificate are the best evidence of the differences
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`between the claims of the ʼ430 and ʼ696 patents.
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`IV. CONCLUSION
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`For the reasons set forth above, NuVasive respectfully requests that the
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`Board exclude Warsaw’s Exhibits 2007 and 2008.
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`Respectfully submitted,
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` /Stephen R. Schaefer, Reg. No. 37,927/
`Stephen R. Schaefer
`Reg. No. 37,927
`Counsel for Petitioner
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`4
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`Date: June 26, 2014
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`
`Customer Number 26171
`Fish & Richardson P.C.
`Telephone: (612) 337-2508
`Facsimile: (877) 769-7945
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`CERTIFICATE OF SERVICE
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
`that on June 26, 2014, a complete and entire copy of this Petitioner’s Motion to
`Exclude, was provided via email to the Petitioner by serving the correspondence
`email addresses of record as follows:
`
`
`Thomas H. Martin
`Wesley C. Meinerding
`Martin & Ferraro, LLP
`1557 Lake O’Pines Street, NE
`Hartville, OH
`
`Nimalka Wickramasekera
`333 South Hope Street
`Los Angeles, CA 90071
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`Email: tmartin@martinferraro.com
`Email: docketing@martinferraro.com
`Email: nwickramasekera@kirkland.com
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`5
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`/Edward G. Faeth/
`Edward G. Faeth
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(202) 626-6420
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`

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`APPENDIX A
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`
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`APPENDIX AAPPENDIX A
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`

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`US008021430B2
`
`(12) United States Patent
`Michelson
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,021,430 B2
`*Sep. 20, 2011
`
`(54) ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`(75)
`
`Inventor: Gary Karlin Michelson, Venice, CA
`(US)
`
`(73) Assignee: Warsaw Orthopedic, Inc., Warsaw, IN
`(US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 0 days.
`
`2,372,622 A
`2,677,369 A
`3,298,372 A
`3,605,123 A
`3,848,601 A
`3,867,728 A
`3,875,595 A
`3,905,047 A
`3,948,262 A
`
`3/1945 Fassio
`5/1954 Knowles
`1/1967 Feinberg
`9/1971 Halm
`11/1974 Maet al.
`2/1975 Stubstad et al.
`4/1975 Froning
`9/1975 Long
`4/1976 Zaffaroni
`
`(Continued)
`
`This patent is subject to a terminal dis-
`claimer.
`
`CA
`
`FOREIGN PATENT DOCUMENTS
`1 328 957
`5/1994
`
`(21) Appl.No.: 12/807,489
`
`(22)
`
`Filed:
`
`Sep. 7, 2010
`
`(65)
`
`Prior Publication Data
`
`US 2011/0004310A1
`
`Jan. 6,2011
`
`Related U.S. Application Data
`
`(60) Continuation of application No. 10/926,766, filed on
`Aug. 26, 2004, now Pat. No. 7,789,914, which is a
`continuation of application No. 10/237,751, filed on
`Sep. 9, 2002, now Pat. No. 7,503,933, which is a
`continuation of application No. 09/412,090, filed on
`Oct. 4, 1999, now Pat. No. 6,447,544, which is a
`continuation of application No. 08/813,283, filed on
`Mar. 10, 1997, now Pat. No. 6,302,914, which is a
`division ofapplicationNo. 08/482,146, filed on Jun. 7,
`1995, now Pat. No. 5,609,635.
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61F 2/44
`(52) U.S.Cl.
`.................................................. .. 623/17.16
`(58) Field of Classification Search
`623/17.11—17.16
`See application file for complete search history.
`
`(Continued)
`
`OTHER PUBLICATIONS
`
`Brandt, L., et al.; A Dowell Inserter for Anterior Cervical Interbody
`Fusion; J. Neurosurg. 611793-794 (Oct. 1984).
`
`(Continued)
`
`Primary Examiner — Alvin J Stewart
`(74) Attorney, Agent, or Firm — Martin & Ferraro, LLP
`
`(57)
`
`ABSTRACT
`
`The present application is directed to an interbody spinal
`implant having a structural configuration that provides for
`maintaining the normal anatomic relationship oftwo adjacent
`vertebrae ofthe spine. The spinal implant is sized to fit within
`the disc space created by the removal ofdisc material between
`two adjacent vertebrae and conform wholly, or in part, to the
`disc space created. The spinal implant ofthe present invention
`has first and second sides with upper and lower bearing sur-
`faces that form a support structure for bearing against the end
`plates of the adjacent vertebrae. The upper and lower bearing
`surfaces of the first and second sides are shaped to create an
`anatomic fit with the endplates of the adjacent vertebrae.
`
`32 Claims, 11 Drawing Sheets
`
`
`
`r
`.,.., ...',,_ /~>._-:
`
` C?:J:‘§f‘_t‘IL-.L.
`
`

`
`U.S. PATENT DOCUMENTS
`3,952,334 A
`4/1976 Bokorosetal.
`3,987,499 A
`10/1976 Scharbach et al.
`132451259 S
`8/1977 Snen
`4,070,514 A
`1/1978 Entllerlyetal.
`4,168,326 A
`9/1979 Broemer etal.
`413091777 A
`1/1982 Pet“
`413491921 A
`9/1982 Knntz
`414011112 A
`8/1983 Rezninn
`414051319 A
`9/1983 Ceeennne
`414391152 A
`3/1984 Snn“
`415011259 A
`2/1985 Bngby
`4,507,115 A
`3/1985 Kambaraetal.
`415351485 A
`8/1985 Aenmnn e”n‘
`4,542,539 A
`9/1985 Rowe, Jr. etal.
`415451374 A
`10/1985 Jneebsen
`415471390 A
`10/1985 Aenmnn e”n‘
`415531273 A
`“/1985 W“
`4,554,914 A
`11/1985 Kappetal.
`415991499 A
`1/1989 R1,pp1ee”n~
`415991085 A
`7/1985 Dety
`4504995 A
`8/1985 Stephens
`415081052 A
`8/1985 Vnn Knmpen etnl‘
`4,634,720 A
`1/1987 Dormanetal.
`4,636,217 A
`1/1987 Ogilvieetal.
`4 636 526 A
`1/1987 Dorman et al.
`4’645’503 A
`2/1987 Llnelal
`4,655,777 A
`4/1987 Dunn
`415511535 A
`4/1987 D°nn1nne”n~
`419931721 A
`9/1987 Dneneyne
`419981375 A
`10/1987 Dennnn etnl‘
`417141459 A
`12/1987 Kennn
`417211103 A
`1/1988 Fneenlnnn
`417431259 A
`5/1988 Bnnnngnn
`4,759,766 A
`7/1988 Buettner-Janz et al.
`4759759 A
`7/1988 Hennnn e‘ n1
`417931944 A
`8/1988 Webb
`418201305 A
`4/1989 Hnnnnetnl
`4834757 A
`5/1989 Bnnnngnn
`4,863,476 A
`9/1989 Shepperd
`4,863,477 A
`9/1989 M0_ns0n
`4,865,603 A
`9/1989 Noiles
`4,877,020 A
`10/1989 Vich
`4,878,915 A
`11/1989 Brantigan
`4,904,261 A
`2/1990 Dove etal.
`4,911,718 A
`3/1990 Lee etal.
`4,936,848 A
`6/1990 Bagby
`4,955,908 A
`9/1990 Frey etal.
`4,961,740 A
`10/1990 Ray etal.
`5,015,247 A
`5/1991 Michelson
`5,026,373 A
`6/1991 Ray etal.
`5,055,104 A
`10/1991 Ray
`5,062,845 A
`11/1991 Kuslich et al.
`5,071,437 A
`12/1991 Steffee
`5,122,130 A
`6/1992 Keller
`5,123,926 A
`6/1992 Pisharodi
`5,171,278 A
`12/1992 Pisharodi
`5,190,548 A
`3/1993 Davis
`5,192,327 A
`3/1993 Brantigan
`5,246,458 A
`9/1993 Graham
`5,250,061 A
`10/1993 Michelson
`5,258,031 A
`11/1993 Salib etal.
`5,258,043 A
`11/1993 Stone
`5,304,191 A
`4/1994 Gosselin
`2
`S/1°55 et al1~l
`,
`,
`agner 6 3.
`5,360,430 A
`ll/1994 Lin
`5,370,697 A
`12/1994 Baumgartner
`5,397,364 A
`3/1995 Kozak el all
`5,425,772 A
`5/1995 Bmntigan
`5,443,514 A
`8/ 1995 Steffee
`5,445,639 A
`8/1995 Kuslich et al.
`5,458,638 A
`10/1995 Kuslich et al.
`5,458,643 A
`10/1995 Oka et al.
`
`.
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`'
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`,
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`'
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`US 8,021,430 B2
`Page 2
`
`5,484,437 A
`§’:l4§g’§g; A
`5-’499’984 A
`5,522,899 A
`5-’534’028 A
`5-’5-5-4’l9l A
`5,571,109 A
`5,571,190 A
`5,607,424 A
`5,609,635 A
`5,609,636 A
`5,609,637 A
`5658335 A
`5,658,337 A
`5’665’l22 A
`5,669,909 A
`5,683,463 A
`5,766,252 A
`5’769’897 A
`5,776,199 A
`5,782,919 A
`5,800,547 A
`5,824,094 A
`5’86l’04l A
`5’888’223 A
`’
`’
`5,888,224 A
`§’§§3’§33:‘
`5,984,967 A
`6,059,829 A
`6,149,686 A
`6,159,214 A
`6,302,914 B1
`6,447,544 B1
`6’5-5-8’423 Bl
`6,613,091 B1
`7,056,342 B2
`7,503,933 B2
`7,789,914 B2
`’
`’
`
`1/1996 Michelson
`$332
`:3
`3/l996 Steiner el al,
`6/1996 Michelson ,
`7/l996 Bao elal
`9/l996 Lahllle el al
`11/1996 Bertagnoli
`11/1996 Ulrich etal
`3/1997 Tropiano
`3/1997 Michelson
`3/1997 Kohrsetal
`3/1997 Biedermann etal
`8/l997 Allen
`8/1997 Kohrsetal
`'
`9/l997 Kambln
`9/1997 Zdeblick etal
`11/1997 Godefroy etal
`6/1998 Henryetal
`6/l998 Hlllle
`7/1998 Michelson
`7/1998 Zdeblick etal
`9/1998 Schaferetal
`10/1998 Serhan etal,
`l/l999 Tlenboon
`,
`3/l999 Bray
`3/1999 Beckersetal.
`$1333 E§i‘é‘:‘;i"n
`11/1999 Zdeblick etal
`5/2000 Schlapferetal
`11/2000 Kuslich etal
`12/2000 Michelson ,
`10/2001 Michelson
`9/2002 Michelson
`5/2003 Michelson
`9/2003 Zdeblick etal
`6/2006 Michelson
`3/2009 Michelson
`9/2010 Michelson
`
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`
`FOREIGN PATENT DOCUMENTS
`
`CA
`DE
`DE
`DE
`E1’
`E1’
`E1’
`E1’
`E1’
`E1’
`E1’
`ER
`11’
`11’
`11’
`11’
`SU
`W0
`W0
`W0
`
`2151481
`2910627
`3608163 A1
`36 20 549
`0179695
`0 260 044
`0493 698 A1
`0599 419 A2
`0627 204 A2
`0425 542
`0 646 366
`2 703 580
`60-31706
`60-43984
`62-155846
`5-208029
`1107854
`WO 90/00037
`W0 93/01771
`W0 96/22747
`
`3/1995
`9/1980
`9/1987
`12/1987
`4/1986
`8/ 1988
`7/1992
`6/1994
`12/1994
`3/1995
`4/ 1995
`10/1994
`11/1979
`10/1985
`7/1987
`8/1993
`8/1984
`1/1990
`2/1993
`8/1996
`
`OTHER PUBLICATIONS
`The Oflicial Communication fromthe Canadian Intellectual Property
`'
`'
`Oflice dated Jan. 31, 2002 from corresponding Canadian Patent
`App11enn°nN°~2a223a954~
`European Search Report dated Jan. 12, 2000 for European Patent
`Appl1cat1onNo.969180011ntl1enameofGaryKarl1nM1chelson.
`Tech. Mitt. Krupp, Nickel-Titanium Spacers for Partial Stiffening of
`the Spinal C0lumn—Pr0blems Involved, Manufacture, Pretesting,
`and Clinical Use; Vol. 42 (1984), N0. 1, pp. 24-38; including trans-
`lation pp. 5-27.
`
`

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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 1 of 11
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`US 8,021,430 B2
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`

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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 2 of 11
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`US 8,021,430 B2
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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 3 of 11
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`US 8,021,430 B2
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`FIG 7A
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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 4 of 11
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`US 8,021,430 B2
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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 5 of 11
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`US 8,021,430 B2
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`U.S. Patent
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`Sep. 20, 2011
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`Sheet 11 of 11
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`US 8,021,430 B2
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`US 8,021,430 B2
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`1
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
`
`This application is a continuation of application Ser. No.
`10/926,766, filed Aug. 26, 2004, now U.S. Pat. No. 7,789,
`914; which is a continuation of application Ser. No. 10/237,
`751, filed Sep. 9, 2002 now U.S. Pat. No. 7,503,933; which is
`a continuation of application Ser. No. 09/412,090, filed Oct.
`4, 1999, now U.S. Pat. No. 6,447,544; which is a continuation
`of application Ser. No. 08/813,283, filed Mar. 10, 1997, now
`U.S. Pat. No. 6,302,914; which is a divisional of application
`Ser. No. 08/482,146, filed Jun. 7, 1995, now U.S. Pat. No.
`5,609,635; all of which are incorporated herein by reference.
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`The present invention relates generally to interbody spinal
`fusion implants, and in particular to spinal fusion implants
`configured to restore and maintain two adjacent vertebrae of
`the spine in correct anatomical angular relationship.
`2. Description of the PriorArt
`Both the cervical and lunbar areas of the human spine are,
`in a healthy state, lordotic such that they are curved convex
`forward. It is not uncommon that in degenerative conditions
`of the spine that lordosis is lost. This effectively shortens the
`spinal canal which decreases its capacity. Further, the absence
`of lordosis moves the spinal cord anteriorly where it may be
`compressed against the posterior portions of the vertebral
`bodies and discs. Finally, such a loss of lordosis disturbs the
`overall mechanics of the spine which may cause cascading
`degenerative changes throughout the adjacent spinal seg-
`ments.
`
`The surgical treatment of those degenerative conditions of
`the spine in which the spinal discs are in various states of
`collapse, and out of lordosis, commonly involves spinal
`fusion. That is the joining together of adjacent vertebrae
`through an area of shared bone. When the sharedbone is in the
`area previously occupied by the intervertebral disc that is
`referred to as an interbody fusion. Further history in this
`regard is provided in application Ser. No. 08/263,952 entitled
`Artificial Spinal Fusion Implants (“Parent Application”)
`incorporated herein by reference.
`The Parent Application taught the use of artificial spinal
`fusion implants that were capable of being placed between
`adjacent vertebrae, and which implants were capable of con-
`taining and providing fusion promoting substances including
`bone at the fusion site. These devices were further capable of
`restoring the height of the disc space and of supporting the
`spine, and were self-stabilizing as well as being stabilizing to
`the spinal area where implanted.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to interbody spinal fusion
`implants having a structural configuration that provides for
`the maintaining and creating of the normal anatomic angular
`relationship oftwo adjacent vertebrae ofthe spine to maintain
`and create spinal lordosis. The spinal fusion implants of the
`present invention are sized to fit within the disc space created
`by the removal of disc material between two adjacent verte-
`brae and conform wholly or in part to the disc space created.
`The spinal fusion implants of the present invention have
`upper and lower surfaces that form a support structure for
`bearing against the end plates ofthe adjacent vertebrae. In the
`preferred embodiments, the upper and lower surfaces are
`disposed in a converging angular relationship to each other
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`such that the implants ofthe present invention have an overall
`“wedged-shape” in an elevational side view. The angular
`relationship of the upper and lower surfaces places and main-
`tains the vertebrae adjacent to those surfaces in an angular
`relationship to each other, creating and maintaining the
`desired lordosis.
`
`The implants of the present invention may have surface
`irregularities to increase their surface area, and/or to further
`engage the adjacent vertebrae and to enhance stability. The
`lordotic implants of the present invention may have surface
`irregularities that are uniform in height along the longitudinal
`axis of the upper and lower vertebrae engaging surfaces, or
`may increase in height from one end of the implant to the
`other. That is, the implant body and the surface formed and the
`projections may be similarly wedged. The outer contour of
`the surface projections may be more or less rectangular while
`the underlying implant may be wedge- shaped; or the reverse
`wherein the underlying implant body is more or less rectan-
`gular while the contour of the surface projections are wedge-
`shaped from one end of the implant to the other.
`The implants of the present invention have various faces
`which may be curved so as to conform to the shape of the
`vertebral surfaces adjacent to the area of the disc removal.
`Specifically the upper and/or lower surfaces may be convex,
`and/or the front and/or rear surfaces may be convex. The
`surfaces of the implants of the present invention may have
`openings which may or may not pass all the way through
`them, and a central chamber in communication to the surface
`through holes. The openings may be of random sizes, and/or
`shapes, and/or distributions. The implants themselves may be
`composed of materials, and/or have surface treatments, to
`encourage microscopic bone ingrowth into the implants.
`In the performing of a posterior lumbar interbody fusion, it
`is not possible to replace the removed portions of the disc, if
`a total nuclear discectomy has been performed, with a single
`large implant as the delicate dural sac containing the spinal
`cord, and the nerve roots cover at all times at least some
`portion of the posterior disc space. As set forth in the Parent
`Application, the use of “modular implants” is appropriate in
`such cases. The modular implants being approximately as
`long as the depth of the disc material removed, but being
`considerably narrower, such that they can be introduced into
`the disc space from the posterior aspect to either side of the
`dural sac, and then aligned side to side within the disc space
`so that a number ofthem each having a length consistent with
`the depth of the disc removed in that area would in combina-
`tion have a width equal to the width of the disc material
`removed.
`
`The modular implants of the present invention may be
`generally wedge-shaped and may have upper and lower sur-
`faces conforming to the contours of the vertebral endplates,
`which contours include but are not limited to being relatively
`flat or convex. As the disc spaces in the lumbar spine are
`generally lordotic, said implants in the preferred embodiment
`would be taller anteriorly, that is at the implant’s insertion
`end, and less tall posteriorly, that is at the implant’s trailing
`end. To introduce an implant that is taller at its insertion end
`than the space available at the posterior aspect of the disc
`space, even when that disc space is optimally distracted, is
`problematic.
`The modular implants ofthe present invention provide two
`solutions to the problem. In the first embodiment, the modular
`implants may have a reduced size at their insertion end,
`including but not limited to a bullet nose, a convexity, and a
`chamfer to a smaller front surface. This then provides that the
`implant has an area small enough to be introduced into the
`posterior aspect of the disc space when the disc space is
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`US 8,021,430 B2
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`adequately distracted and the contour ofthat specialized lead-
`ing portion of the implant is such that it then allows for a
`ramping up ofthe adjacent vertebrae relative to the implant as
`the implant is advanced forward into the disc space.
`The implants of the present invention provide a second
`solution to this same problem. In the preferred embodiment of
`the modular implant, the implant is again wedge-shaped in
`the side elevational view and is taller at its insertion end than
`
`at its trailing end. However, the implant incorporates at its
`trailing end a means for engaging insertion instrumentation
`such as the box and threaded opening configuration disclosed
`in the Parent Application. Since in the preferred embodiment
`these implants are wedge-shaped in the side elevational view
`when upright but are generally rectangular when viewed from
`the top plan view, these implants are therefore designed to be
`introduced into the disc space on their side such that the side
`walls of the implants are adjacent to the end plates of the
`adjacent vertebrae. The implants have a side-to-side dimen-
`sion that is less than the dimension through the insertion end
`of the implant when upright. It is possible to easily insert
`these implants with them on their side and then to use the
`insertion instrument engaged to the implant to rotate the
`implants ninety degrees into the fully upright position, once
`they have been fully inserted. Once inserted, the upper and
`lower surfaces are adjacent to the endplates of the adjacent
`vertebrae and create and maintain the desired angular rela-
`tionship ofthe adjacent vertebrae as the upper and lower walls
`are angled with respect to each other.
`In an alternative embodiment of the present invention, a
`mechanical implant which may be inserted in a collapsed
`position and which may then be adjusted to increase in height
`so as to provide for the optimal restoration ofthe height of the
`space between the adjacent vertebrae is disclosed. The
`mechanical implant may be wedge-shaped, and have upper
`and lower surfaces, the contours of which generally conform
`to the contacted areas of the adjacent vertebral endplates and
`which contours may include but are not limited to being
`relatively flat, or convex. Further, the mechanical implant
`may be wedge-shaped or generally rectangular, but capable of
`increasing in both height and the extent of wedging when
`adjusted. This may easily be achieved by having one of the
`two wedge mechanisms employed in the example givenbeing
`larger, or steeper than the other. Alternatively, a single wedge
`may be utilized, and if it is desired to achieved increased
`height at one end of the implant while restricting the height at
`the other, then the end ofthe implant may incorporate a hinge
`means and the height expansion at the other end achieved by
`drawing a wedge member, bar, ball, or other means from the
`far end toward the hinged end so as to drive said upper and
`lower surfaces apart in a wedged fashion.
`In an alternative embodiment of the present invention, an
`implant having a mechanically deployable bone engaging
`means is taught. Such an implant is generally wedge-shaped
`in the side elevational view and has upper and lower surfaces
`generally conforming to the contour of the vertebral end-
`plates where contacted by the implant, and which upper and
`lower surfaces may be but are not limited to being either flat
`or convex. The use of such deployable bone engaging means
`are particularly of value in that the largest possible implant
`may be inserted into a disc space and the vertebral engaging
`means, which if fixed to the surface would have blocked the
`insertion of the implant, may then be deployed after the
`insertion such that the distance from the tip of the upper and
`lower boite engagement means exceeds the height of the
`space available for insertion. Such a feature is of particular
`value when the implant itself is wedge-shaped as the consid-
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`erable compressive loads across the lumbar spine would tend
`to drive a wedge-shaped implants out of the disc space.
`
`OBJECTS OF THE PRESENT INVENTION
`
`It is an object of the present invention to provide a spinal
`fusion implant that is easily inserted into the spine, having a
`tapered leading end;
`It is another object of the present invention to provide a
`spinal fusion implant that tapers in height from one end to the
`other consistent with the taper of a normal spinal disc;
`It is yet another object ofthe present invention to provide a
`spinal fusion implant that is capable of maintaining anatomic
`alignment and lordosis of two adjacent vertebrae during the
`spinal fusion process;
`It is still another object of the present invention to provide
`a spinal fusion implant that is self stabilizing within the spine;
`It is yet another object ofthe present invention to provide a
`spinal fusion implant that is capable of providing stability
`between adjacent vertebrae when inserted;
`It is further another object of the present invention to pro-
`vide a spinal fusion implant that is capable of spacing apart
`and supporting adjacent vertebrae in an angular relationship
`during the spinal fusion process;
`It is still further another object of the present invention to
`provide a spinal fusion implant that fits between to adjacent
`vertebrae and preserves the end plants ofthose vertebrae; and
`It is another object of the present invention to provide a
`spinal fusion implant having a shape which conforms to the
`endplates of the adjacent vertebrae; and
`invention will
`These and other objects of the present
`become apparent from a review of the accompanying draw-
`ings and the detailed description of the drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective view ofthe lordotic interbody spinal
`fusion implant of the present invention with a slidable door
`shown in a partially open position providing access to the
`internal chamber of the implant.
`FIG. 2 is a top plan view of the lordotic interbody spinal
`fusion implant of the present invention.
`FIG. 3 is a left side elevational view of the lordotic inter-
`
`body spinal fusion implant of the present invention.
`FIG. 4 is a right side elevational view of the lordotic inter-
`body spinal fusion implant of the present invention.
`FIG. 5 is a front end view of the lordotic interbody spinal
`fusion implant of the present invention showing the slidable
`door in a partially open position.
`FIG. 6 is a rear end view of the lordotic interbody spinal
`fusion implant ofthe present invention showing the means for
`engaging insertion instrumentation.
`FIG. 7 is an enlarged fragmentary view along line 7 ofFIG.
`2 illustrating the bone engaging surface configuration of the
`lordotic interbody spinal fusion implant of the present inven-
`tion.
`
`FIG. 7A is an elevational side view of a segment of the
`spinal column having the lordotic implant of the present
`invention inserted in the disc space at different disc levels
`between adjacent vertebrae to restore and maintain the cor-
`rect anatomical alignment of the adjacent vertebrae.
`FIG. 8 is a top plan view of an alternative embodiment of
`the lordotic interbody spinal fusion implant of the present
`invention.
`FIG. 9 is a left side elevational view of the lordotic inter-
`
`body spinal fusion implant of FIG. 8.
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`FIG. 10 is a front end View of the lordotic interbody spinal
`fusion implant of FIG. 8.
`FIG. 11 is a rear end View of the lordotic interbody spinal
`fusion implant of FIG. 8 showing the means for engaging
`insertion instrumentation.
`FIG. 12 is an enlarged fragmentary View along line 12 of
`FIG. 8 illustrating the surface configuration the lordotic inter-
`body spinal fusion implant of the present inVention.
`FIG. 13 is a top plan View of an altematiVe embodiment of
`the lordotic interbody spinal fusion implant of the present
`inVention made of a mesh-like material.
`FIG. 14 is a left side eleVational View of the lordotic inter-
`body spinal fusion implant of FIG. 13.
`FIG. 15 is a front end View of the lordotic interbody spinal
`fusion implant of FIG. 13.
`FIG. 16 is a rear end View of the lordotic interbody spinal
`fusion implant of FIG. 13 showing the means for engaging
`insertion instrumentation.
`FIG. 17 is an enlarged fragmentary View along line 17 of
`FIG. 13 illustrating the surface configuration of the lordotic
`interbody spinal fusion implant of the present inVention.
`FIG. 18 is a perspectiVe View of an altematiVe embodiment
`of the lordotic interbody spinal fusion implant of the present
`inVention.
`FIG. 19 is a top plan View of the lordotic interbody spinal
`fusion implant of FIG. 18.
`FIG. 20 is a left side eleVational View of the lordotic inter-
`body spinal fusion implant of FIG. 18.
`FIG. 21 is a rear end View of the lordotic interbody spinal
`fusion implant of FIG. 18.
`FIG. 22 is a front end View of the lordotic interbody spinal
`fusion implant of FIG. 18.
`FIG. 23 is an enlarged fragmentary View along line 23 of
`FIG. 22 illustrating the surface configuration the lordotic
`interbody spinal fusion implant of the present inVention.
`FIG. 24 is a top plan View of an altematiVe embodiment of
`the lordotic interbody spinal fusion implant of the present
`inVention.
`FIG. 25 is a left side eleVational View of the lordotic inter-
`body spinal fusion implant of FIG. 24.
`FIG. 26 is a rear end View of the lordotic interbody spinal
`fusion implant of FIG. 24.
`FIG. 27 is a front end View of the lordotic interbody spinal
`fusion implant of FIG. 24.
`FIG. 28 is an enlarged fragmentary View along line 28 of
`the lordotic interbody spinal fusion implant of FIG. 24 illus-
`trating the surface configuration of the lordotic interbody
`spinal fusion implant of the present inVention.
`FIG. 29 is a sectional View along lines 29--29 ofFIG. 28 the
`lordotic interbody spinal fusion implant of the present inVen-
`tion.
`FIG. 30 is a side eleVational View of a segment of the
`human spinal column shown with an alternatiVe embodiment
`of the lordotic spinal fusion implant of the present inVention
`that is adjustable and expandable shown in sectional View
`inserted in the disc space leVels to restore and maintain the
`correct anatomical alignment of the adjacent Vertebrae.
`FIG. 31 is a side cross sectional View of, an altematiVe
`embodiment of the