Case 3:12-cv-02738-CAB-MDD Document 83 Filed 07/24/13 PageID.2859 Page 1 of 102
`
`Luke L. Dauchot (S.B.N. 229829)
`luke.dauchot@kirkland.com
`Alexander F. MacKinnon (S.B.N. 146883)
`alexander.mackinnon@kirkland.com
`Nimalka R. Wickramasekera (S.B.N. 268518)
`nimalka.wickramasekera@kirkland.com
`Kirkland & Ellis LLP
`333 South Hope Street
`Los Angeles, California 90071
`Telephone: (213) 680-8400
`Facsimile: (213) 680-8500
`
`Attorneys for Plaintiffs/Counterclaim Defendants,
`WARSAW ORTHOPEDIC, INC.; MEDTRONIC
`SOFAMOR DANEK U.S.A., INC.; MEDTRONIC
`PUERTO RICO OPERATIONS CO.; OSTEOTECH,
`INC.; MEDTRONIC, INC.; and MEDTRONIC
`SOFAMOR DANEK DEGGENDORF, GMBH
`
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`WARSAW ORTHOPEDIC, INC.;
`CASE NO. 3:12-cv-02738-CAB (MDD)
`MEDTRONIC SOFAMOR DANEK
`
`
`U.S.A., INC.; MEDTRONIC PUERTO
`SECOND AMENDED AND
`RICO OPERATIONS CO.; and
`SUPPLEMENTAL COMPLAINT FOR
`OSTEOTECH, INC.,
`PATENT INFRINGEMENT
`
`Plaintiffs,
`JURY TRIAL DEMANDED
`
`
`
`
`
`
`vs.
`NUVASIVE, INC.,
`Defendant.
`
`AND RELATED COUNTERCLAIMS.
`
`
`
`
`
`)))))))))))))
`
`))
`
`
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 1
`
`

`

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`Plaintiffs Warsaw Orthopedic, Inc. (“Warsaw”), Medtronic Sofamor Danek
`U.S.A., Inc. (“Sofamor Danek USA”), Medtronic Puerto Rico Operations Co.
`(“MPROC”), and Osteotech, Inc. (“Osteotech”) (collectively “Plaintiffs”) bring this
`First Amended Complaint for Patent Infringement and Jury Demand against
`Defendant NuVasive, Inc. (“NuVasive”), alleging as follows:
`PARTIES, JURISDICTION, AND VENUE
`Plaintiff Warsaw is an Indiana corporation, with its principal place of
`1.
`business in Warsaw, Indiana.
`2.
`Plaintiff Sofamor Danek USA is a Tennessee corporation, with its
`principal place of business in Memphis, Tennessee. Sofamor Danek USA researches,
`develops, and distributes medical devices and instruments for use in connection with
`spine surgery.
`3.
`Plaintiff MPROC is a Cayman Islands corporation, with its principal
`place of business in Humacao, Puerto Rico. MPROC manufactures and sells medical
`devices and instruments for use in connection with spine surgery.
`4.
`Plaintiff Osteotech is a Delaware corporation, with its principal place of
`business in Eatontown, New Jersey. Osteotech makes and sells biologic and
`regenerative therapy products for use in the repair of the musculoskeletal system.
`5.
`Defendant NuVasive is a Delaware corporation, with its principal place
`of business in San Diego, California. NuVasive manufactures and sells various
`medical devices and instruments for use in the spine, including spinal implants and
`bone graft products.
`6.
`This action arises under the patent laws of the United States, 35 U.S.C. §
`1 et seq., and seeks damages and injunctive relief pursuant to 35 U.S.C. §§ 271, 281,
`283–285.
`This Court has subject matter jurisdiction over the action pursuant to 28
`7.
`U.S.C. §§ 1331 and 1338(a) because this action arises under the Acts of Congress
`relating to patents.
`
`1
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 2
`
`

`

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`Upon information and belief, NuVasive transacts business in this judicial
`8.
`District by manufacturing, selling, or offering to sell products that infringe, by
`contributing to the infringement of the patents at issue in this action, or by conducting
`other business within this judicial District.
`9.
`Venue is proper in this judicial District pursuant to 28 U.S.C. §§ 1391(b),
`1391(c), 1391(d) and/or 1400(b).
`
`COUNT I
`10. Paragraphs 1–9 are incorporated into this count by reference.
`11. United States Patent No. 8,021,430 (the “’430 patent,” a copy of which is
`attached hereto as Exhibit A), entitled “Anatomic Spinal Implant Having Anatomic
`Bearing Surfaces,” issued on September 20, 2011. Plaintiff Warsaw is the owner of
`the ’430 patent by written assignment. Warsaw has granted to Plaintiff MPROC, via
`written agreements, the exclusive license under the ’430 patent to use, make, have
`made, import, offer for sale, and sell. MPROC has granted to Plaintiff Sofamor
`Danek USA, via written agreements, the exclusive sub-license under the ’430 patent
`to import, offer for sale, and sell. As a result of these agreements and Warsaw’s
`ownership of the ’430 patent, Plaintiffs Warsaw, MPROC, and Sofamor Danek USA
`have standing to bring suit for infringement of the ’430 patent.
`12. NuVasive is infringing and has infringed the ’430 patent by making,
`using, offering for sale, and selling infringing products, including but not limited to its
`CoRoent XL family of spinal implants (e.g., CoRoent XL Thoracic, CoRoent XL
`Standard, CoRoent XL Lordotic, CoRoent XL Wide Lordotic, CoRoent XL Wide
`Standard, CoRoent XL Coronal Tapered Lordotic, CoRoent XL Coronal Tapered
`Standard, and CoRoent Keeled) for use in its eXtreme Lateral Interbody Fusion
`(“XLIF”) surgical procedure, as well as its CoRoent Large family of spinal implants
`(e.g., CoRoent Large Wide and Narrow) for use in transforaminal or posterior surgical
`approaches, within the United States.
`13. NuVasive’s infringement of the ’430 patent has been without permission,
`
`2
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 3
`
`

`

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`consent, authorization, or license of Plaintiffs.
`14. NuVasive’s infringement of the ’430 patent has caused and will continue
`to cause Plaintiffs substantial damages, and has caused and will continue to cause
`Plaintiffs irreparable harm for which there is no adequate remedy at law.
`COUNT II
`15. Paragraphs 1–9 are incorporated into this count by reference.
`16. United States Patent No. 5,676,146 C2 (the “’146 patent,” a copy of
`which is attached hereto as Exhibit B), entitled “Surgical Implant Containing A
`Resorbable Radiopaque Marker And Method Of Locating Such Within A Body,”
`issued on December 25, 2007. The original application issued as a patent on October
`14, 1997, and reexamination certificates for the ’146 patent issued on April 18, 2000
`and December 25, 2007.
`17. Plaintiff Osteotech was the owner of the ’146 patent from original
`issuance until April 15, 2011. Osteotech obtained its ownership by written
`assignment. As owner of the ’146 patent during this time period, Osteotech has
`standing to sue for infringement of the ’146 patent that occurred between original
`issuance of the patent and April 15, 2011.
`18. Plaintiff Warsaw is the current owner of the ’146 patent by written
`assignment from Osteotech. As a result of this assignment, Warsaw has been the
`owner of the ’146 patent since April 15, 2011. The April 15, 2011 assignment from
`Osteotech to Warsaw did not transfer to Warsaw the right to sue for damages for
`infringement that took place before the assignment.
`19. Warsaw has granted to Plaintiff Sofamor Danek USA, via written
`agreements, an exclusive license under the ’146 patent to import, offer for sale, and
`sell. As a result of these agreements and Warsaw’s ownership of the ’146 patent,
`Plaintiffs Warsaw and Sofamor Danek USA have standing to bring suit for
`infringement of the ’146 patent that occurred from April 15, 2011 to the present, and
`going forward.
`
`3
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 4
`
`

`

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`20. NuVasive is infringing and has infringed the ’146 patent from 2008 to the
`present by making, using, offering for sale, and selling infringing products, including
`but not limited to its Osteocel Plus bone graft product, within the United States.
`21. NuVasive is inducing and has induced direct infringement of the ’146
`patent by surgeons in violation of 35 U.S.C. § 271(b) by actively taking steps to
`facilitate purchase of Osteocel Plus and instructing surgeons to use Osteocel Plus in
`spine surgery with knowledge that such use infringes one or more claims of the ’146
`patent, and with the specific intent to induce that infringement.
`22. NuVasive is instructing and has instructed surgeons to use Osteocel Plus
`in spine surgery, including in, but not limited to, its anterior cervical discectomy and
`fusion (“ACDF”), XLIF, anterior lumbar interbody fusion (“ALIF”), posterior cervical
`fusion (“PCF”), posterior laminoplasty, transforaminal lumbar interbody fusion
`(“TLIF”), Interlaminar Lumbar Instrumented Fusion (“ILIF”), posterior lumbar
`interbody fusion (“PLIF”), and posterior fixation surgical techniques.
`23. Following NuVasive’s instructions, surgeons have implanted, and
`continue to implant, Osteocel Plus into patients’ bodies during spine surgery, an act
`that constitutes direct infringement of at least one claim of the ’146 patent.
`24. Upon information and belief, NuVasive has had knowledge of the ’146
`patent at least as early as 2008 given that the Grafton and Grafton Plus products that
`compete with Osteocel Plus are marked with the ’146 patent. Upon information and
`belief, NuVasive’s products have been used in spine surgery in conjunction with
`Grafton products with NuVasive sales representatives present during the surgery.
`NuVasive also has had knowledge of the ’146 patent at least as early as August 21,
`2012, when it was served with Plaintiffs’ original Complaint for Patent Infringement
`and Jury Demand.
`25. NuVasive has acted with the specific intent to induce direct infringement
`of the ’146 patent by, among other things, actively continuing to sell Osteocel Plus
`and actively continuing to instruct surgeons to use Osteocel Plus in spine surgery as
`
`4
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 5
`
`

`

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`alleged with knowledge of the ’146 patent.
`26. NuVasive is also contributing and has contributed to the infringement of
`the ’146 patent in violation of 35 U.S.C. § 271(c) by offering for sale, selling,
`promoting, teaching, and encouraging the use of Osteocel Plus in spine surgery.
`NuVasive markets Osteocel Plus as especially made or especially adapted for
`implantation within patients’ bodies during surgery. Osteocel Plus is not a staple
`article of commerce suitable for substantial non-infringing use because it is especially
`designed for surgical implantation and its location and/or orientation is necessarily
`apparent using x-ray or other radiographic techniques. The use of Osteocel Plus in
`surgery necessarily and directly infringes at least one claim of the ’146 patent.
`27. NuVasive’s infringement of the ’146 patent has been without permission,
`consent, authorization, or license of Plaintiffs.
`28. NuVasive’s infringement of the ’146 patent has caused and will continue
`to cause Plaintiffs substantial damages, and has caused and will continue to cause
`Plaintiffs irreparable harm for which there is no adequate remedy at law.
`COUNT III
`29. Paragraphs 1–12 are incorporated into this count by reference.
`30. United States Patent No. 8,251,997 (the “’997 patent,” a copy of which is
`attached hereto as Exhibit C), entitled “A Method For Inserting An Artificial Implant
`Between Two Adjacent Vertebrae Along A Coronal Plane,” issued on August 28,
`2012 from U.S. Application No. 13/306,583 (“the ’583 application”). The ’997 patent
`relates generally to novel methods for performing surgical procedures in the human
`spine. Plaintiff Warsaw is the owner of the ’997 patent by written assignment.
`Warsaw has granted to Plaintiff Sofamor Danek USA, via written agreements, the
`exclusive license under the ’997 patent to use, make, have made, import, offer for
`sale, and sell. As a result of these agreements and Warsaw’s ownership of the ’997
`patent, Plaintiffs Warsaw and Sofamor Danek USA have standing to bring suit for
`infringement of the ’997 patent.
`
`5
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 6
`
`

`

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`31. NuVasive is inducing and has induced direct infringement of the ’997
`patent by surgeons in violation of 35 U.S.C. § 271(b) by actively taking steps to
`facilitate purchase of its CoRoent XL family of implants and at least its MaXcess 4
`Retractor and instructing and training surgeons to use the CoRoent XL family of
`implants and at least the MaXcess 4 Retractor in NuVasive’s minimally invasive
`spinal surgical procedure, XLIF, that is performed through the side of patients’ bodies
`with knowledge that such use infringes one or more claims of the ’997 patent, and
`with the specific intent to induce that infringement.
`32. NuVasive is instructing and training and has instructed and trained
`surgeons to use its CoRoent XL family of implants and at least its MaXcess 4
`Retractor in its XLIF surgical technique. NuVasive includes such instruction in, for
`example, published surgical techniques and CoRoent XL and MaXcess 4 Retractor
`marketing literature, and on its website, available at http://www.nuvasive.com/patient-
`solutions/indications/lumbar-degenerative-disc-disease. NuVasive also provides such
`instruction during training courses.
`33. Following NuVasive’s instructions, surgeons have implanted, and
`continue to implant, the CoRoent XL family of implants into patients’ bodies using at
`least the MaXcess 4 Retractor while performing NuVasive’s XLIF surgical technique,
`an act that constitutes direct infringement of at least one claim of the ’997 patent.
`34. NuVasive has had knowledge of the claims of the ’997 patent at least as
`early as August 3, 2012, when notice was provided to NuVasive of a filing with the
`United States Patent & Trademark Office of an Opposition and Petition Under 37
`C.F.R. § 1.183 in the inter partes reexamination of U.S. Patent 7,207,949 (Control No.
`95/001,202), which noted that the claims of the ’583 application were allowed and the
`patent would issue shortly.
`35. Upon information and belief, NuVasive has been monitoring patents in
`the ’997 patent family at least as early as 2008.
`36. NuVasive has acted with the specific intent to induce direct infringement
`
`6
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 7
`
`

`

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`of the ’997 patent by, among other things, actively marketing, selling, supporting, and
`warranting the CoRoent XL family of implants and at least the MaXcess 4 Retractor
`and actively continuing to instruct surgeons to use the CoRoent XL family of implants
`and at least the MaXcess 4 Retractor while performing NuVasive’s XLIF surgical
`technique as alleged with knowledge of the ’997 patent.
`37. NuVasive is also contributing and has contributed to the infringement of
`the ’997 patent in violation of 35 U.S.C. § 271(c) by offering for sale, selling,
`promoting, teaching, and encouraging the use of its CoRoent XL family of implants
`and at least its MaXcess 4 Retractor in its XLIF surgical technique. NuVasive
`markets its CoRoent XL family of implants and MaXcess 4 Retractor as especially
`made or especially adapted for use in its XLIF surgical technique.
`38. The CoRoent XL family of implants is not a staple article of commerce
`suitable for substantial non-infringing use. The CoRoent XL family of implants is
`especially designed for use in NuVasive’s XLIF surgical technique, a procedure
`performed from the lateral aspect of the spine. For example, NuVasive markets “the
`CoRoent® XL family of implants [as] [d]esigned specifically for the eXtreme Lateral
`Interbody Fusion (XLIF®) procedure.” The structural configurations of the CoRoent
`XL family of implants render them unsuitable for insertion from the anterior or
`posterior aspect of the spine. These structural configurations include at least the
`dimensions, surface configurations, and insertion mechanisms. The use of the
`CoRoent XL family of implants in NuVasive’s XLIF surgical technique necessarily
`and directly infringes at least one claim of the ’997 patent.
`39. The MaXcess 4 Retractor is not a staple article of commerce suitable for
`substantial non-infringing use. The MaXcess 4 retractor is especially designed for use
`in NuVasive’s XLIF surgical technique, a procedure performed from the lateral aspect
`of the spine. For example, NuVasive markets its MaXcess 4 Retractor as the “fourth
`generation XLIF access system” “designed to deliver reproducible XLIF outcomes.”
`The structural configurations of the MaXcess 4 Retractor render it unsuitable for use
`
`7
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 8
`
`

`

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`in surgery performed from the anterior or posterior aspect of the spine. These
`structural configurations include at least the blade length that is especially adapted for
`use in lateral spine surgery. The use of the MaXcess 4 Retractor in NuVasive’s XLIF
`surgical technique necessarily and directly infringes at least one claim of the ’997
`patent.
`40. NuVasive’s infringement of the ’997 patent has been without permission,
`consent, authorization, or license of Plaintiffs.
`41. NuVasive’s infringement of the ’997 patent has caused and will continue
`to cause Plaintiffs substantial damages, and has caused and will continue to cause
`Plaintiffs irreparable harm for which there is no adequate remedy at law.
`COUNT IV
`42. Paragraphs 1–9 are incorporated into this count by reference.
`43. United States Patent No. 8,444,696 (the “’696 patent,” a copy of which is
`attached hereto as Exhibit D), entitled “Anatomic Spinal Implant Having Anatomic
`Bearing Surfaces,” issued on May 21, 2013. Plaintiff Warsaw is the owner of the ’696
`patent by written assignment. Warsaw has granted to Plaintiff MPROC, via written
`agreements, the exclusive license under the ’696 patent to use, make, have made,
`import, offer for sale, and sell. MPROC has granted to Plaintiff Sofamor Danek USA,
`via written agreements, the exclusive sub-license under the ’696 patent to import,
`offer for sale, and sell. As a result of these agreements and Warsaw’s ownership of
`the ’696 patent, Plaintiffs Warsaw, MPROC, and Sofamor Danek USA have standing
`to bring suit for infringement of the ’696 patent.
`44. NuVasive is infringing and has infringed the ’696 patent by making,
`using, offering for sale, and selling infringing products, including but not limited to its
`CoRoent XL family of spinal implants (e.g., CoRoent XL Thoracic, CoRoent XL
`Standard, CoRoent XL Lordotic, CoRoent XL Wide Lordotic, CoRoent XL Wide
`Standard, CoRoent XL Coronal Tapered Lordotic, CoRoent XL Coronal Tapered
`Standard, CoRoent XL Keeled, and CoRoent XL Fixation ) for use in its eXtreme
`
`8
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 9
`
`

`

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`Lateral Interbody Fusion (“XLIF”) surgical procedure, as well as its CoRoent Large
`family of spinal implants (e.g., CoRoent Large Wide, CoRoent Large Narrow, and
`CoRoent Large Tapered) for use in transforaminal or posterior surgical approaches,
`within the United States.
`45. NuVasive’s infringement of the ’696 patent has been without permission,
`consent, authorization, or license of Plaintiffs.
`46. NuVasive’s infringement of the ’696 patent has caused and will continue
`to cause Plaintiffs substantial damages, and has caused and will continue to cause
`Plaintiffs irreparable harm for which there is no adequate remedy at law.
`PRAYER FOR RELIEF
`WHEREFORE, Plaintiffs request that the Court:
`1.
`Adjudge that NuVasive has infringed and is infringing the ’430 patent;
`2.
`Adjudge that NuVasive has directly infringed and is directly infringing
`and has induced and contributed to and is inducing and contributing to the
`infringement of the ’146 patent;
`3.
`Adjudge that NuVasive has induced and contributed to and is inducing
`and contributing to the infringement of the ’997 patent;
`4. Adjudge that NuVasive has infringed and is infringing the ’696 patent;
`5.
`Preliminarily and permanently enjoin NuVasive and its affiliates,
`subsidiaries, officers, directors, employees, agents, representatives, licensees,
`successors, and assigns, and all of those acting for it and on its behalf, or acting in
`concert with it, from further infringement of the ’430, ’146, ’997, and ’696 patents;
`6.
`Award compensatory damages to Plaintiffs, together with interest;
`7.
`Order an accounting to the extent necessary to provide complete
`monetary relief to Plaintiffs;
`8.
`Award Plaintiffs their costs and, where appropriate, reasonable attorney
`fees under 35 U.S.C. § 285; and
`
`9
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 10
`
`

`

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`Award Plaintiffs any other such relief as the Court deems just and proper.
`9.
`DATED: May 23, 2013
`Respectfully submitted,
`KIRKLAND & ELLIS LLP
`
`
`
`/s/ Nimalka R. Wickramasekera
`Luke L. Dauchot
`Alexander F. MacKinnon
`Nimalka R. Wickramasekera
`
`Attorneys for Plaintiffs/Counterclaim
`Defendants, WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK U.S.A.,
`INC.; MEDTRONIC PUERTO RICO
`OPERATIONS CO.; OSTEOTECH, INC.;
`MEDTRONIC, INC.; and MEDTRONIC
`SOFAMOR DANEK DEGGENDORF, GMBH
`
`
`10
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 11
`
`

`

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`22
`23
`24
`25
`26
`27
`28
`
`JURY TRIAL DEMAND
`PLAINTIFFS DEMAND A TRIAL BY JURY ON ALL ISSUES SO
`TRIABLE.
`DATED: May 23, 2013
`
`Respectfully submitted,
`KIRKLAND & ELLIS LLP
`
`
`
`/s/ Nimalka R. Wickramasekera
`Luke L. Dauchot
`Alexander F. MacKinnon
`Nimalka R. Wickramasekera
`
`Attorneys for Plaintiffs/Counterclaim
`Defendants, WARSAW ORTHOPEDIC, INC.;
`MEDTRONIC SOFAMOR DANEK U.S.A.,
`INC.; MEDTRONIC PUERTO RICO
`OPERATIONS CO.; OSTEOTECH, INC.;
`MEDTRONIC, INC.; and MEDTRONIC
`SOFAMOR DANEK DEGGENDORF, GMB
`
`
`
`
`11
`SECOND AMENDED AND SUPP. COMPLAINT FOR PATENT INFRINGEMENT
`
`CASE NO: 3:12-cv-02738
`
`Exhibit 1 - Page 12
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 83 Filed 07/24/13 PageID.2871 Page 13 of 102
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`EXHIBIT A
`
`
`
`Exhibit 1 - Page 13
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 83 Filed 07/24/13 PageID.2872 Page 14 of 102
`111111
`1111111111111111111111111111111111111111111111111111111111111
`US008021430B2
`
`c12) 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
`
`(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. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 12/807,489
`
`(22) Filed:
`
`Sep.7,2010
`
`(65)
`
`Prior Publication Data
`
`US 2011/0004310Al
`
`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 of application No. 08/482,146, filed on Jun. 7,
`1995, now Pat. No. 5,609,635.
`
`(51)
`
`Int. Cl.
`A61F 2144
`(2006.01)
`(52) U.S. Cl. .................................................... 623/17.16
`(58) Field of Classification Search . ... . 623/17.11-17.16
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`2,372,622 A
`3/1945 Fassio
`2,677,369 A
`5/1954 Knowles
`3,298,372 A
`111967 Feinberg
`9/1971 Hahn
`3,605,123 A
`3,848,601 A
`1111974 Ma eta!.
`3,867,728 A
`21197 5 Stubstad et a!.
`3,875,595 A
`4/1975 Froning
`9/1975 Long
`3,905,047 A
`4/1976 Zaffaroni
`3,948,262 A
`(Continued)
`
`CA
`
`FOREIGN PATENT DOCUMENTS
`1 328 957
`5/1994
`(Continued)
`
`OTHER PUBLICATIONS
`
`Brandt, L., et a!.; A Dowell Inserter for Anterior Cervical Interbody
`Fusion; J. Neurosurg. 61:793-794 (Oct. 1984).
`
`(Continued)
`
`Primary Examiner- Alvin J Stewart
`(74) Attorney, Agent, or Firm- Martin & Ferraro, LLP
`
`ABSTRACT
`(57)
`The present application is directed to an interbody spinal
`implant having a structural configuration that provides for
`maintaining the normal anatomic relationship of two adjacent
`vertebrae of the spine. The spinal implant is sized to fit within
`the disc space created by the removal of disc material between
`two adjacent vertebrae and conform wholly, or in part, to the
`disc space created. The spinal implant of the present invention
`has first and second sides with upper and lower bearing sur(cid:173)
`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
`
`BE4RDV0?
`
`BEARDVC
`.. SLlHF:.ACE
`
`~SECY..J/VD
`TE:/?/11./VAL
`P4.RT
`
`Bti~R11VCl
`SURFAC~E
`
`SURFACE
`
`Exhibit A - Page 1
`
`Exhibit 1 - Page 14
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 83 Filed 07/24/13 PageID.2873 Page 15 of 102
`
`US 8,021,430 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`4/1976 Bokoros eta!.
`3,952,334 A
`10/1976 Scharbach et a!.
`3,987,499 A
`D245,259 s
`8/1977 Shen
`4,070,514 A
`111978 Entherly et a!.
`4,168,326 A
`9/1979 Broemer et a!.
`4,309,777 A
`111982 Patil
`4,349,921 A
`9/1982 Kuntz
`4,401,112 A
`8/1983 Rezaian
`4,405,319 A
`9/1983 Cosentino
`4,439,152 A
`3/1984 Small
`4,501,269 A
`2/1985 Bagby
`4,507,115 A
`3/1985 Kambara et al.
`4,535,485 A
`8/1985 Ashman et al.
`4,542,539 A
`9/1985 Rowe, Jr. et al.
`4,545,374 A
`10/1985 Jacobson
`4,547,390 A
`10/1985 Ashman et al.
`1111985 Wu
`4,553,273 A
`1111985 Kappet a!.
`4,554,914 A
`4,566,466 A
`111986 Ripple eta!.
`4,599,086 A
`7/1986 Doty
`4,604,995 A
`8/1986 Stephens
`4,608,052 A
`8/1986 Van Kampen et a!.
`4,634,720 A
`111987 Dorman eta!.
`4,636,217 A
`111987 Ogilvie et al.
`111987 Dorman eta!.
`4,636,526 A
`4,645,503 A
`2/1987 Lin eta!.
`4,655,777 A
`4/1987 Dunn
`4,661,536 A
`4/1987 Dorman eta!.
`4,693,721 A
`9/1987 Ducheyne
`4,698,375 A
`10/1987 Dorman eta!.
`4,714,469 A
`12/1987 Kenna
`111988 Freedland
`4,721,103 A
`4,743,256 A
`5/1988 Brantigan
`4,759,766 A
`7/1988 Buettner-Janz et a!.
`7/1988 Hedman eta!.
`4,759,769 A
`4,763,644 A
`8/1988 Webb
`4,820,305 A
`4/1989 Harms eta!.
`4,834,757 A
`5/1989 Brantigan
`4,863,476 A
`9/1989 Shepperd
`4,863,477 A
`9/1989 Monson
`4,865,603 A
`9/1989 Noiles
`4,877,020 A
`10/1989 Vich
`4,878,915 A
`1111989 Brantigan
`2/1990 Dove eta!.
`4,904,261 A
`3/1990 Lee et al.
`4,911,718 A
`6/1990 Bagby
`4,936,848 A
`9/1990 Frey eta!.
`4,955,908 A
`10/1990 Ray eta!.
`4,961,740 A
`5,015,247 A
`5/1991 Michelson
`6/1991 Ray eta!.
`5,026,373 A
`5,055,104 A
`10/1991 Ray
`1111991 Kuslich et al.
`5,062,845 A
`5,071,437 A
`12/1991 Steffee
`5,122,130 A
`6/1992 Keller
`6/1992 Pisharodi
`5,123,926 A
`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
`1111993 Salib eta!.
`5,258,031 A
`5,258,043 A
`1111993 Stone
`5,304,191 A
`4/1994 Gosselin
`5,306,308 A
`4/1994 Grosset a!.
`5,306,309 A
`4/1994 Wagner eta!.
`5,360,430 A
`1111994 Lin
`5,370,697 A
`12/1994 Baumgartner
`5,397,364 A
`3/1995 Kozak eta!.
`5,425,772 A
`6/1995 Brantigan
`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.
`10/1995 Oka eta!.
`5,458,643 A
`
`5,484,437 A
`5,489,307 A
`5,489,308 A
`5,499,984 A
`5,522,899 A
`5,534,028 A
`5,554,191 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
`5,658,335 A
`5,658,337 A
`5,665,122 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
`5,861,041 A
`5,888,223 A
`5,888,224 A
`5,893,890 A
`5,980,522 A
`5,984,967 A
`6,059,829 A
`6,149,686 A
`6,159,214 A
`6,302,914 B1
`6,447,544 B1
`6,558,423 B1
`6,613,091 B1
`7,056,342 B2
`7,503,933 B2
`7,789,914 B2
`
`111996 Michelson
`2/1996 Kuslich et al.
`2/1996 Kuslich et al.
`3/1996 Steiner et a!.
`6/1996 Michelson
`7/1996 Bao eta!.
`9/1996 Lahille eta!.
`1111996 Bertagnoli
`1111996 Ulrich et al.
`3/1997 Tropiano
`3/1997 Michelson
`3/1997 Kohrs et al.
`3/1997 Biedermann et a!.
`8/1997 Allen
`8/1997 Kohrs et al.
`9/1997 Kambin
`9/1997 Zdeblick et a!.
`1111997 Godefroy et al.
`6/1998 Henry et al.
`6/1998 Hiirle
`7/1998 Michelson
`7/1998 Zdeblick et a!.
`9/1998 Schafer et a!.
`10/1998 Serhan eta!.
`111999 Tienboon
`3/1999 Bray
`3/1999 Beckers et a!.
`4/1999 Pisharodi
`1111999 Koros et al.
`1111999 Zdeblick et a!.
`5/2000 Schliipfer et a!.
`1112000 Kuslich et al.
`12/2000 Michelson
`10/2001 Michelson
`9/2002 Michelson
`5/2003 Michelson
`9/2003 Zdeblick et a!.
`6/2006 Michelson
`3/2009 Michelson
`9/2010 Michelson
`
`CA
`DE
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`FR
`JP
`JP
`JP
`JP
`su
`wo
`wo
`wo
`
`FOREIGN PATENT DOCUMENTS
`2151481
`3/1995
`29 10 627
`9/1980
`36 08 163 A1
`9/1987
`36 20 549
`12/1987
`0179695
`4/1986
`0 260 044
`8/1988
`0 493 698 A1
`7/1992
`0 599 419 A2
`6/1994
`0 627 204 A2
`12/1994
`0 425 542
`3/1995
`0 646 366
`4/1995
`2 703 580
`10/1994
`60-31706
`1111979
`60-43984
`10/1985
`62-155846
`7/1987
`8/1993
`5-208029
`1107854
`8/1984
`wo 90/00037
`111990
`W093/01771
`2/1993
`wo 96/22747
`8/1996
`OTHER PUBLICATIONS
`
`The Official Communication from the Canadian Intellectual Property
`Office dated Jan. 31, 2002 from corresponding Canadian Patent
`Application No. 2,223,964.
`European Search Report dated Jan. 12, 2000 for European Patent
`Application No. 96918001 in the name of Gary Karlin Michelson.
`Tech. Mitt. Krupp, Nickel-Titanium Spacers for Part1al StJffenmg of
`the Spinal Colunm-Problems Involved, Manufacture, Pretesting,
`and Clinical Use; vol. 42 (1984), No. 1, pp. 24-38; including trans-
`lation pp. 5-27.
`
`Exhibit A - Page 2
`
`Exhibit 1 - Page 15
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 83 Filed 07/24/13 PageID.2874 Page 16 of 102
`
`U.S. Patent
`
`Sep.20,2011
`
`Sheet 1 of 11
`
`US 8,021,430 B2
`
`""'
`()
`k:
`
`0
`
`~
`
`~
`
`~ \
`
`\
`~\ 0
`\~ ::;E
`
`Exhibit A - Page 3
`
`Exhibit 1 - Page 16
`
`

`

`Case 3:12-cv-02738-CAB-MDD Document 83 Filed 07/24/13 PageID.2875 Page 17 of 102
`
`U.S. Patent
`
`Sep.20,2011
`
`Sheet 2 of 11
`
`US 8,021,430 B2
`
`120
`
`7
`
`116
`
`132
`
`;~--=-1
`I 13