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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`_____________________________
`
`Case IPR2013-00206
`Patent No. 8,251,997
`_____________________________
`
`
`
`MOTION FOR OBSERVATION REGARDING CROSS-EXAMINATION
`OF MR. MILES
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibits
`
`Exhibit No.
`
`Description
`
`WARSAW2001
`
`Excerpts from Deposition of Dr. Michelson, dated November 19,
`2010
`
`WARSAW2002
`
`Letter to Dr. Michelson from J. Pafford, dated March 28, 1994.
`
`WARSAW2003 Memorandum from Larry Boyd re: Michelson Devices -
`Interbody Fusion Devices, dated January 26, 1994
`
`WARSAW2004
`
`Dezider Imre Invoice, dated December 26, 1993
`
`WARSAW2005 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.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD)
`
`WARSAW2009
`
`License Agreement between Sofamor Danek Group, Inc. and
`Karlin Technology, Inc., dated December 31, 1993
`
`WARSAW2010
`
`U.S. Patent No. 5,860,973
`
`i
`
`
`
`
`
`
`
`WARSAW2011 Memorandum of Decision Following Bench Trial on Inequitable
`Conduct, Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No.
`08-CV-1512 MMA (MDD), dated February 14, 2012
`
`WARSAW2012
`
`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. NuVasive, Inc., Case No. 08-CV-
`1512 MMA (MDD), dated December 23, 2011
`
`WARSAW2013
`
`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.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD), dated
`October 27, 2011
`
`WARSAW2014
`
`Excerpts from NuVasive's Closing Argument Regarding
`Inequitable Conduct Committed During the Prosecution of
`the ’973 Patent, Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case
`No. 08-CV-1512 MMA (MDD), dated December 23, 2011
`
`WARSAW2015
`
`Excerpts from NuVasive's Proposed Findings of Fact and
`Conclusions of Law Regarding the Unenforceability of U.S.
`Patent No. 5,860,973 for Inequitable Conduct, Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-1512 MMA
`(MDD), dated December 23, 2011
`
`WARSAW2016
`
`Letter to R. Jansen from P. McAfee, M.D., dated January 16,
`1995
`
`WARSAW2017
`
`Excerpts from Deposition of Dr. Bruce E. Van Dam, dated
`January 27, 2011
`
`ii
`
`
`
`
`
`
`
`WARSAW2018
`
`U.S. Patent No. 4,573,448
`
`WARSAW2019
`
`Excerpts from Deposition of L. Boyd, dated February 18, 1999
`from Sofamor Danek Holdings, Inc. v. U.S. Surgical Corp., Case
`No. 98-2369 GA (JSG) (W.D. Tenn.)
`
`WARSAW2020
`
`Excerpts from Deposition of L. Boyd, dated December 3, 2010
`from Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-
`CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2021
`
`Excerpts from Deposition of D. Imre, dated October 5, 2001
`from Medtronic 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 Medtronic 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. NuVasive, Inc., Case No.
`08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2024
`
`Excerpts from Deposition of J. Pafford, dated April 3, 2003 from
`Medtronic Sofamor Danek, Inc. v. Karlin Technology, Inc., Case
`No. 01-2373-JPM (W.D. Tenn.)
`
`WARSAW2025
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2026
`
`Stipulation dated November 2, 2010 from Warsaw Orthopedic,
`Inc. v. NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD)
`
`iii
`
`
`
`
`
`
`
`(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.
`NuVasive, 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 11, 2011
`
`WARSAW2030
`
`Declaration of Dr. Paul McAfee. M.D . M.B.A (206)
`
`WARSAW2031
`
`Declaration of Dr. Paul McAfee. M.D . M.B.A (208)
`
`WARSAW2032
`
`U.S. Patent 8,251,997 (annotated)
`
`WARSAW2033
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`(annotated)
`
`WARSAW2034
`
`U.S. Patent 5,015,247 (annotated)
`
`WARSAW2035
`
`Ortho SuperSite entitled Migrated XLIF Cage: Case Report and
`Discussion of Surgical Technique, dated September 11, 2011
`
`WARSAW2036
`
`Dr. McAfee’s Handwritten notes made during his deposition of
`December 7, 2013 and December 8, 2013
`
`iv
`
`
`
`
`
`
`
`WARSAW2037
`
`Reserved
`
`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
`
`WARSAW2040
`
`Dkt 613 ”Order Closing Case” from Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD), dated
`August 20, 2011
`
`WARSAW2041
`
`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2042
`
`U.S. Patent 4,834,757
`
`WARSAW2043
`
`Declaration of Mark Peterson M.D, dated January 19, 2011 in
`U.S. Court of Appeals, case No. 11-55120
`
`WARSAW2044
`
`Declaration of William D. Smith M.D, dated January 19, 2011 in
`U.S. Court of Appeals, case No. 11-55120
`
`WARSAW2045
`
`NuVasive’s Supplemental Responses to Interrogatory 11 -
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-
`1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2046
`
`NuVasive Revenues by (Medtronic, Inc.) Fiscal Year
`
`WARSAW2047
`
`NuVasive Units by (Medtronic, Inc.) Fiscal Year
`
`v
`
`
`
`
`
`
`
`WARSAW2048
`
`Sales Data produced by Warsaw bearing Bates No.
`MNUV5009816- Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2049
`
`The XLIF Approach presentation produced by NuVasive bearing
`Bates Nos. N0017072 - N0017142- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`WARSAW2050
`
`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. NuVasive, Inc., Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
`
`WARSAW2051
`
`Article titled “A New Solution” produced by Warsaw bearing
`Bates No. MNUV5059287 - MNUV5059290- Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
`
`WARSAW2052
`
`Article titled “26 Technologies Receive 2009 Spine Technology
`Award” produced by Warsaw bearing Bates No. MNUV505991
`- Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-
`1512 MMA (MDD) (S.D. Cal.)
`
`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”
`
`vi
`
`
`
`
`
`
`
`
`
`
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`WARSAW2056
`
`Excerpts from Inequitable Conduct Trial Testimony- Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
`
`WARSAW2057
`
`Expunged
`
`WARSAW2058
`
`Expunged
`
`WARSAW2059
`
`Expunged
`
`WARSAW2060
`
`Expunged
`
`WARSAW2061
`
`Expunged
`
`WARSAW2062
`
`Expunged
`
`WARSAW2063
`
`Affidavit of Nimalka Wickramasekera
`
`WARSAW2064
`
`Pat Miles Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`vii
`
`
`
`
`
`
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`Warsaw Orthopedic, Inc. (“Patent Owner”) submits this motion for
`
`observation regarding cross-examination of Mr. Miles, a reply declarant of
`
`Petitioner’s pursuant to the Board’s March 28 order. NuVasive’s reply declarants
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`have given sworn testimony on the subject matter of this proceeding multiple times.
`
`In lieu of taking additional depositions, the parties have agreed to Warsaw’s use of
`
`prior sworn testimony of Petitioner’s reply declarants in observations. Warsaw
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`submits the following observations based on Mr. Miles prior sworn testimony.
`
`Observation #1
`
`In Exhibit 2064, on pages 422:21−424:7, Mr. Miles testified that the length
`
`of NuVasive’s CoRoent XL implant spanning the entire transverse width of the
`
`vertebral body was an innovative feature. That testimony is relevant to Mr.
`
`Miles’s reply declaration testimony at paragraph 9 of Exhibit 1032, in which he
`
`lists “[s]ome key factors to XLIF’s success.” The testimony shows that Mr.
`
`Miles’s statements in paragraph 9 of his declaration are incomplete: while in his
`
`declaration Mr. Miles purports to identify the key innovative features of XLIF, he
`
`omits the feature that he testified was innovative at the parties’ 2011 trial before
`
`the judge and the jury—i.e., that the CoRoent XL implant’s length is innovative
`
`because it spans the entire width of the vertebral body.
`
`
`
`
`
`
`
`1
`
`
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`
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`Observation #2
`
`In Exhibit 2064, on pages 432:13−434:10, 472:21–475:5, Mr. Miles testified
`
`that while he was an employee at Medtronic he worked on a procedure with Dr.
`
`Kevin Foley referred to as “ELIF.” At a trial between the parties in 2011, Mr.
`
`Miles was shown a Medtronic memorandum from July 2000, and he testified that
`
`this memorandum stated that “ELIF” stood for “Extreme Lateral Interbody
`
`Fusion.” This testimony is relevant to Mr. Miles’s reply declaration at paragraph
`
`15 of Exhibit 1032 because it undermines Mr. Miles’s assertion that the ELIF
`
`project at Medtronic referred to “Endoscopic Lumbar Interbody Fusion,” not
`
`“Extreme Lateral Interbody Fusion.” This testimony is also relevant to paragraph
`
`16 of Exhibit 1032 because it undermines Mr. Miles’s assertion that he “personally
`
`came up with the name ‘eXtreme Lateral Interbody Fusion’ and the ‘XLIF’
`
`acronym … after [he] came to NuVasive, and came up with that name and
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`acronym with no knowledge of ELIF ever having been an acronym for ‘Extreme
`
`Lateral Interbody Fusion’.”
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`2
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`Respectfully Submitted,
`
`
`
`Dated: April 22, 2014
`
`/Thomas H. Martin/
`
`
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`
`
`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
`
`
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`3
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