UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`V.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,251,997 BZ
`Issue Date: August 28, 2012
`
`Case IPR2013—00206
`
`NOTICE OF SUPPLEMENTAL EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(2)
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`US. Patent and Trademark Office
`PO. Box 1450
`
`Alexandria, VA 22313—1450
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`V.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,251,997 BZ
`Issue Date: August 28, 2012
`
`Case IPR2013—00206
`
`NOTICE OF SUPPLEMENTAL EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(2)
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`US. Patent and Trademark Office
`PO. Box 1450
`
`Alexandria, VA 22313—1450
`
`
`
`IPR2013-00206
`
`US. Patent No. 8,251,997 B2
`Our Ref. 102.0010-041PR
`
`In response to Petitioner’s Objection to Evidence filed on December 30,
`
`2013, Warsaw submits the following items of supplemental evidence pursuant to
`
`37 C.F.R. § 42.64(b)(2).
`
`WARSAW2057
`
`Excerpts from “Axial Skeleton: Osteoiogy and Anthrology”;
`Kinesiology of the Musculoskeletal System, Foundations
`for Rehabilitation, Second Edition
`
`WARSAW2058
`
`Article titled “Clinical Presentation of Disc Degeneration”;
`The Lumbar Intervertebral Disc
`
`WARSAW2059
`
`Declaration of Thomas H. Martin, Esq.
`
`WARSAW2060
`
`Excerpts from Trial Testimony — Warsaw Orthopedic, Inc.
`v. Nu Vasive, Inc, Case No. 08-CV-1512 MMA (MDD)
`(S.D. Cal.)
`
`WARSAW2061
`
`WARSAW2062
`
`NuVasive Financial Data, NuVasive Revenues by Fiscal
`Year, Plaintiff’ 5 Exhibit No. PX2077 - Warsaw Orthopedic,
`Inc. v. Nu Vasive, Inc, Case No. 08—CV-1512 MMA (MDD)
`(S.D. Cal.)
`
`NuVasive Financial Data, NuVasive Units by Fiscai Year,
`Plaintiff‘s Exhibit No. PX2078 - Warsaw Orthopedic, Inc.
`v. Nu Vasive, Inc, Case No. 08-CV-1512 MMA (MDD)
`(SD. Cal.)
`
`
`
`The Patent Trial and Appeal Board is hereby authorized to charge any fees
`
`associated with this proceeding to Deposit Account No. 50-3726 (Customer ID
`
`22882}
`
`Dated: January 14, 2014
`
`Respectfully Submitted,
`
`
`
`w?
`a
`,4,
`
`
`Thomas H. Martin
`
`‘
`
`Registration No. 34,383
`Attorney for Patent Owner
`MARTIN & FERRARO, LLP
`
`1557 Lake O’Pines Street, NE
`
`Hartville, Ohio 44632
`
`Telephone: (330) 877-0700
`Facsimile: (330) 877-2030
`
`
`
`EXHIBIT APPENDIX
`
`Exhibit No.
`
`Qessflntiga
`
`WARSAWZOO l
`
`Excerpts from Deposition of Dr. Michelson, dated November
`19, 2010
`
`WARSAW2002
`
`Letter to Dr. Michelson from J. Pafford, dated March 28, I994.
`
`WARSAW2003
`
`Memorandum from Larry Boyd re: Michelson Devices -
`Interbody Fusion Devices, dated January 26, 1994
`
`WARSAW2004
`
`Dezider Imre Invoice, dated December 26, 1993
`
`WARSAWZOOS
`
`Memorandum from Larry Boyd re: Meeting with Dr. Gary
`Karlin Michelson, dated January 11, 1994
`
`WARSAW2006
`
`Memorandum from Larry Boyd re: Notes on Threaded Dowel
`Concepts of Dr. Michelson, dated January 11, 1994
`
`WARSAW2007
`
`Letter to Dr. Michelson from L. Boyd, dated January 13, 1994
`
`WARSAW2008
`
`Excerpts from Trial Testimony — Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc, Case No. 08—CV—l 512 MMA (MDD)
`
`WARSAW2009
`
`License Agreement between Sofamor Danek Group, Inc. and
`Karlin Technology, Inc, dated December 31, 1993
`
`WARSAW20 l 0
`
`US. Patent No. 5,860,973
`
`WARSAW201 1
`
`Memorandum of Decision Following Bench Trial on
`Inequitable Conduct, Warsaw Orthopedic, Inc. v. Nu Vasive,
`Inc, Case No. 08—CV—l 5 12 MMA (MDD), dated February 14,
`2012
`
`
`
`WARSAW2012
`
`WARSAW2013
`
`WARSAW20 14
`
`WARSAW201 5
`
`Excerpts from NuVasive’s Reply in Support of Its Renewed
`Motion for Judgment as a Matter of Law or A New Trial,
`Warsaw Orthopedic, Inc. v. Nu Vasive, Inc, Case No. 08-CV-
`1512 MMA (MDD), dated December 23, 2011
`
`Excerpts from NuVasive‘s Memorandum of Points and
`Authorities in Support of Its Renewed Motion for Judgment as
`a Matter of Law or a New Trial, Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc., Case No. 08-CV-1512 MMA (MDD), dated
`October 27, 201 l
`
`Excerpts from NuVasive's Closing Argument Regarding
`Inequitable Conduct Committed During the Prosecution of the
`’973 Patent, Warsaw Orthopedic, Inc. v. Nu Vasive, Inc, Case
`No. 08-CV-1512 MMA (MDD), dated December 23, 2011
`
`Excerpts from NuVasive's Proposed Findings of Fact and
`Conclusions of Law Regarding the Uuenforceability of US.
`Patent No. 5,860,973 for Inequitable Conduct, Warsaw
`Orthopedic, Inc. v. Nu Vasive, Inc, Case No. 08-CV-1512
`MMA (MDD), dated December 23, 201 1
`
`WARSAWZO 1 6
`
`Letter to R. Jansen from P. McAfee, M.D., dated January 16,
`1995
`
`WARSAW2O 1 7
`
`Excerpts from Deposition of Dr. Bruce E. Van Dam, dated
`January 27, 2011
`
`WARSAW201 8
`
`US. Patent No. 4,573,448
`
`WARSAW2019
`
`Excerpts from Deposition of L. Boyd, dated February 18, 1999
`from Sofamor Danek Holdings, inc. v. US. Surgical Corp.,
`Case No. 98—2369 GA (JSG) (WI). Tenn.)
`
`WARSAW2020
`
`Excerpts from Deposition of L. Boyd, dated December 3, 2010
`from Warsaw Orthopedic, Inc. 12. Na Vasive, Inc, Case No. 08-
`CV-1512 MMA (MDD) (so. Cal.)
`
`
`
`WARSAWZOZ l
`
`Excerpts from Deposition of D. lmre, dated October 5, 2001
`from Medtrom'c Sofamor Danek, Inc. v. Osteotech, Inc., Case
`No. 99-2656~GN (W.D. Tenn.)
`
`WARSAW2022
`
`Excerpts from Deposition of B. Estes, dated November 10,
`2003 from Medtrom'c Sofamor Danek, Inc. v. Karlin
`Technology, Inc., Case No. 01—2373-JPM (W.D. Tenn.)
`
`WARSAW2023
`
`Excerpts from Deposition of G. Michelson, dated November
`19, 2010 from Warsaw Orthopedic, Inc. v. Nu Vasive, Inc.,
`Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2024
`
`Excerpts from Deposition of J. Pafford, dated April 3, 2003
`from Medrronic Sofamor Danek, Inc. v. Karlin Technology,
`Inc., Case No. 01—2373—JPM (W.D. Tenn.)
`
`WARSAW2025
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc., Case No. 08-CV—1512 MMA (MDD) (S.D.
`Cal.)
`
`WARSAW2026
`
`Stipulation dated November 2, 2010 from Warsaw Orthopedic,
`Inc. v. Nu Vasive, Inc., Case No. 08-CV-1512 MMA (MDD)
`(S.D. Cal.)
`
`WARSAW2027
`
`Excerpts from Deposition of L. Boyd, dated November 13,
`2003 from Medtronic Sofamor Danek, Inc. v. Karlin
`Technology, Inc., Case No. 01-2373—JPM (W.D. Tenn.)
`
`WARSAW2028
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc., Case No. 08-CV-1512 MMA (MDD) (S.D.
`Cal.)
`
`WARSAW2029
`
`Ortho SuperSite entitled Migrated XLIF Cage: Case Report
`and Discussion of Surgical Technique, dated September 1 1,
`2011
`
`WARSAW203 0
`
`Declaration of Dr. Paul McAfee. M.D . M.B.A (206)
`
`WARSAW203 1
`
`Declaration of Dr. Paul McAfee. MD . M.B.A (208)
`
`
`
`WARSAW2032
`
`US. Patent 8,251,997
`
`WARSAW2033
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc, Case No. 08-CV-1512 MMA (MDD) (S.D.
`Cal.) (with annotations)
`
`WARSAW2034
`
`US. Patent 5,015,247
`
`WARSAW203 5
`
`Ortho SuperSite entitled Migrated XLIF Cage: Case Report
`and Discussion of Surgicai Technique, dated September 11,
`2011
`
`WARSAW203 6
`
`Dr. McAfee’s Handwritten notes made during his deposition of
`December 7, 2013 and December 8, 2013
`
`WARSAW203 7
`
`[RESERVED] This exhibit has not been filed with the Board
`
`WARSAW2038
`
`Declaration of Dr. Barton L. Sachs, M.D., M.B.A.
`
`WARSAW2039
`
`Excerpts from Deposition of Dr. Paul McAfee, dated
`December 6, 2013 and December 7, 2013 in matters IPR2013-
`00206 and IPR2013-00208
`
`WARSAW204O
`
`Dkt 613 ”Order Closing Case” from Warsaw Orthopedic, Inc.
`v. Nu Vasive, Inc, Case No. 08-CV-1512 MMA (MDD), dated
`August 20, 2011
`
`WARSAW204I
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`Nu Vasive, Inc, Case No. 08—CV—lSl2 MMA (MDD) (SD.
`Cal.)
`
`WARSAW2042
`
`US. Patent 4,834,757
`
`WARSAW2043
`
`Declaration of Mark Peterson MD, dated January 19, 2011 in
`US. Court oprpeals, case No. 11—55120
`
`
`
`WARSAW2044
`
`Declaration of William D. Smith MD, dated January 19, 2011
`in U.S. Court oprpeals, case No. l 1-55120
`
`WARSAW2045
`
`NuVasive’s Supplemental Responses to Interrogatory 11 -
`Warsaw Orthopedic, Inc. v. Nu Vasive, Inc., Case No. 08-CV-
`1512 MMA (MDD) (SD. Cal.)
`
`WARSAW2046
`
`Sales Data produced by NuVasive bearing Bates Nos.
`N0978712— N0979l29- Warsaw Orthopedic, Inc. v. Nu Vasive,
`Inc, Case No. 08-CV-1512 MMA (MDD) (SD. Cal.)
`
`WARSAW2047
`
`Sales Data produced by NuVasive bearing Bates Nos.
`N0980704— N0980720- Warsaw Orthopedic, Inc. v. Nu Vasive,
`Inc., Case No. 08—CV-1512 MMA (MDD) (SD. Cal.)
`
`WARSAW2048
`
`Sales Data produced by Warsaw bearing Bates No.
`MNUV5009816- Warsaw Orthopedic, Inc. v. Nu Vasive, Inc,
`Case No. 08-CV~1512 MMA (MDD) (SD. Cal.)
`
`WARSAW2049
`
`WARSAW2050
`
`The XLIF Approach presentation produced by NuVasive
`bearing Bates Nos. N0017072 - N0017142- Warsaw
`Orthopedic, Inc. v. Nu Vasive, Inc, Case No. 08—CV-1512
`MMA (MDD) (SD. Cal.)
`
`Article titled “Direct Lateral interbody Fusion -- A Minimally
`Invasive Approach to Spinal Stabilization” produced by
`Warsaw bearing Bates No. MNUV5059266 — MNUV5059271-
`Warsaw Orthopedic, Inc. v. Nu Vasive, Inc, Case No. 08—CV-
`1512 MMA (MDD) (SD. Cal.)
`
`WARSAW205 l
`
`Article titled “A New Solution” produced by Warsaw bearing
`Bates No. MNUV505928’7 - MNUV5059290- Warsaw
`
`Orthopedic, Inc. v. Nu Vastve, Inc, Case No. 08-CV~1512
`MMA (MDD) (SD. Cal.)
`
`WARSAW2052
`
`Article titled “26 Technologies Receive 2009 Spine
`Technology Award” produced by Warsaw bearing Bates No.
`MNUV505991 - Warsaw Orthopedic, Inc. v. Nu Vasive, Inc,
`Case No. 08-CV-1512 MMA (MDD) (SD. Cal.)
`
`7
`
`
`
`WARSAW2053
`
`Article titled “Current Concepts Review -- Interbody Fusion
`Cages in Reconstructive Operations on the Spine”
`
`WARSAW2054
`
`Article titled “Spinal Implants: Past, Present, and Future”
`
`WARSAW2055
`
`Excerpt from book titled “intervertebral Fusion —- Using
`Carbon Fiber Reinforced Polymer Implants”
`
`WARSAW2056
`
`Excerpts from Inequitable Conduct Trial Testimony- Warsaw
`Orthopedic, Inc. v. Nu Vasive, Inc., Case No. 08-CV—1512
`MMA (MDD) (SD. Cal.)
`
`WARSAW2057
`
`Excerpts from “Axial Skeleton: Osteology and Anthrology”;
`Kinesiology of the Musculoskeletal System, Foundations for
`Rehabilitation, Second Edition
`
`WARSAW2058
`
`Article titled “Clinical Presentation of Disc Degeneration”;
`The Lumbar Intervertebral Disc
`
`WARSAW2059
`
`Declaration of Thomas H. Martin, Esq.
`
`WARSAW2060
`
`Excerpts from Trial Testimony — Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (SD.
`Cal.)
`
`WARSAW2061
`
`WARSAW2062
`
`NuVasive Financial Data, NuVasive Revenues by Fiscal Year,
`Piaintiff’s Exhibit No. PX2077 ~ Warsaw Orthopedic, Inc. V.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (SI).
`Cal.)
`
`NuVasive Financial Data, NuVasive Units by Fiscal Year,
`Plaintiff’ s Exhibit No. PX2078 — Warsaw Orthopedic, Inc. V.
`NuVasive, Inc., Case No. OS—CV-ISIZ MMA (MDD) (SD.
`Cal.)
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of this NOTICE OF
`
`SUPPLEMENTAL EVIDENCE UNDER 37 CPR. § 42.64(b)(2) was served in its
`
`entirety Via electronic mail to APSI@fr.com (referencing Attorney Docket No.
`
`13958-01121Pl ):
`
`Stephen R. Schaefer
`
`Michael T. Hawkins
`
`3200 RBC Plaza
`
`3200 RBC Plaza
`
`60 South Sixth Street
`
`60 South Sixth Street
`
`Minneapolis, MN 55402
`
`Minneapolis, MN 55402
`
`Date of Service:
`
`J anuary I4, 2014
`
`(”34“
`.
`
`Signature: .,
`-
`
`
`Thomas H. Martin, Reg. No. 34,383
`
`
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