`
`
`
`
`
`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 DR. MCAFEE
`
`
`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
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`
`Warsaw Orthopedic, Inc. (“Patent Owner”) submits this motion for
`
`observation regarding cross-examination of Dr. McAfee, a reply declarant of
`
`Petitioner’s pursuant to the Board’s March 28 order. NuVasive’s reply declarants
`
`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
`
`submits the following observations based on Dr. McAfee’s prior sworn testimony.
`
`Observation # 1
`
`In Exhibit 1040, on pages 38:11–39:1, Dr. McAfee testified that “lateral” is
`
`a “nonspecific term” that could mean posterolateral. That testimony is relevant to
`
`Dr. McAfee’s reply declaration testimony in paragraph 39 of Exhibit 1029, in
`
`which he states that Dr. Jacobson would have used the term “posterolateral” and
`
`not “lateral” if he were disclosing a posterolateral approach. The testimony is
`
`relevant because Dr. McAfee contradicts himself in an attempt to read
`
`Jacobson ’374 to disclose a direct lateral approach to the spine: in his deposition he
`
`testified that “lateral” is a “nonspecific term” that could include “posterolateral,”
`
`whereas he declares in Exhibit 1029 that “any surgeon with ordinary skill in spinal
`
`surgery during the early 1990s would have understood” Dr. Jacobson did not use
`
`“lateral” to mean “posterolateral.”
`
`
`
`
`
`1
`
`
`
`
`
`Observation # 2
`
`In Exhibit 1040, on page 28:2–10, Dr. McAfee testified that “spinal nerves”
`
`are contained in the spinal column and become “nerve roots” when they “exit the
`
`spinal cord.” That testimony is relevant to Dr. McAfee’s reply declaration
`
`testimony in paragraph 42 of Exhibit 1029, in which he states that “spinal nerves”
`
`“extend in/along the psoas muscle before [they] divide into subsequent nerve
`
`branches.” The testimony is relevant because Dr. McAfee again contradicts
`
`himself in an attempt to read Jacobson ’374 to disclose a direct lateral approach to
`
`the spine. Jacobson ’374 discloses a surgical approach that intersects “spinal
`
`nerves” (Jacobson ’374 at 6:32–38), thus the location of these “spinal nerves” is
`
`relevant to the approach taught by Jacobson.
`
`Observation # 3
`
`In Exhibit 1040, on pages 38:20–39:1, Dr. McAfee testified that persons of
`
`ordinary skill in the art used the term “lateral” to mean many things, including
`
`lateral to the midline of a vertebral body. That testimony is relevant to Dr.
`
`McAfee’s reply declaration testimony in paragraph 64 of Exhibit 1029, in which he
`
`states that this definition of “lateral” is not a “general definition applicable to [Dr.
`
`Brantigan’s] later-filed Brantigan ’327 patent.” The testimony is relevant because
`
`Dr. McAfee contradicts himself in an effort to establish that Brantigan ’327
`
`discloses the direct lateral insertion of an implant. If persons of ordinary skill in
`
`
`
`2
`
`
`
`
`
`the art understood the term “lateral” to be lateral to the midline (see Brantigan ’327
`
`at Fig. 12), Brantigan ’327’s disclosure of “lateral” insertion does not disclose a
`
`“direct lateral” insertion.
`
`Observation # 4
`
`In Exhibit 1040, on page 45:6–16, Dr. McAfee testified that there is nothing
`
`in the written disclosure of Michelson ’247 that teaches a person of ordinary skill
`
`in the art to insert an implant to span as much of the length of the intervertebral
`
`disc space as possible. That testimony is relevant to Dr. McAfee’s reply
`
`declaration testimony at paragraph 83 of Exhibit 1029, in which he states that
`
`Michelson ’247 teaches a surgeon to size an implant to span the full or almost the
`
`full disc space in the direction of insertion. Dr. McAfee’s prior testimony directly
`
`contradicts his statements in reply regarding the disclosure of Michelson ’247: Dr.
`
`McAfee agreed in his deposition that there is not “anything in the ’247 patent that
`
`actually states . . . in writing . . . that an implant inserted from an anterior to
`
`posterior direction should, in fact, span as much of the length from an anterior to
`
`posterior direction of the intervertebral space as possible,” whereas Dr. McAfee
`
`now argues that “the text of Michelson ’247 suggests at least the claimed length,
`
`and Figure 5 of Michelson ’247 suggests even more.”
`
`
`
`
`
`
`
`3
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`
`
`Dated: April 22, 2014
`
`/Thomas H. Martin/
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`4
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
