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 B2
`Issue Date: August 28, 2012
`
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO
`ADJACENT VERTEBRAE ALONG A CORONAL PLANE
`
`
`__________________
`
`
`Case IPR2013-00208
`
`
`______________________________________________________
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO
`ADJACENT VERTEBRAE ALONG A CORONAL PLANE
`
`
`__________________
`
`
`Case IPR2013-00208
`
`
`______________________________________________________
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`Introduction ................................................................................................................. 1
`Claim interpretations .................................................................................................. 1
`A. “Coronal plane” path to spine (claims 1, 9, 17 and 24) .......................................... 1
`B. “Non-bone implant” (Claim 1) ................................................................................. 1
`C. Implant length/vertebrae width ratio: “Substantially the full traverse width
`(claims1, 9 and 17 ................................................................................................. 1
`III. Jacobson discloses a direct lateral approach that meets the “coronal plane”
`path limitation and inherently teaches the insertion of a fusion implant ............... 5
`IV. Brantigan ‘327 discloses the lateral insertion of an implant, and even if it didn’t
`that is not necessary for an obviousness finding .................................................... 7
`V. Brantigan ‘327 meets the “substantially the full transverse width of the
`vertebrae” claim limitation .......................................................................................... 9
`VI Michelson ‘247, when inserted laterally according to the teachings of Jacobson,
`would meet the “substantially the full transverse width of the vertebrae”
`limitation ..................................................................................................................... 10
`VII The “non-combinable” arguments of Warsaw have no merit ............................... 11
`VIII Warsaw’s secondary considerations arguments for patentability cannot pass
`scrutiny ....................................................................................................................... 13
`XI Conclusion
`
`
`
`
`
`
`i
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NUVASIVE1001
`
`NUVASIVE1002
`
`NUVASIVE1003
`
`NUVASIVE1004
`
`NUVASIVE1005
`
`NUVASIVE1006
`
`NUVASIVE1007
`
`NUVASIVE1008
`
`NUVASIVE1009
`
`NUVASIVE1010
`
`NUVASIVE1011
`
`NUVASIVE1012
`
`NUVASIVE1013
`
`NUVASIVE1014
`
`
`
`EXHIBITS
`Declaration of Dr. McAfee, M.D., M.B.A.
`
`U.S. Patent No. 8,251,997 to Michelson (“‘997 Patent”)
`
`Select Prosecution History of the ‘997 patent
`
`U.S. Pat. No. 4,545,374 to Jacobson (“Jacobson”)
`
`Leu et al., Percutaneous Fusion of the Lumbar Spine, Spine
`Vol. 6, No. 3, pp. 593-604 (September 1992) (“Leu”)
`
`U.S. Pat. No. 5,192,327 to Brantigan (“Brantigan”)
`
`U.S. Pat. No. 4,917,704 to Frey et al. (“Frey”)
`
`U.S. Pat. No. 5,015,247 to Michelson (“Michelson ‘247”)
`
`European Pub. No. EP 0567424A1 to Alacreu (“Alacreu”)
`
`Baulot et al., Adjuvant Anterior Spinal Fusion Via Thorascopy,
`Lyon Chirurgical Vol. 90, No. 5, pp. 347-51 (1994) (“Baulot”)
`
`English Translation of Baulot and Certificate of Translation
`
`Rosenthal et al., Removal of a Protruded Thoracic Disc Using
`Microsurgical Endoscopy, Spine Vol. 19, No. 9, pp. 1087-91
`(1994) (“Rosenthal”)
`
`U.S. Pat. No. 4,573,448 to Kambin (“Kambin”)
`
`WO 94/28824 to Michelson (“Michelson PCT”)
`
`ii
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`NUVASIVE1015
`
`
`
`U.S. Pat. No. 5,772,661 to Michelson (“Michelson ‘661”)
`
`NUVASIVE1016
`
`
`
`U.S. Pat. No. 8,343,224 to Lynn et al. (“Lynn”)
`
`NUVASIVE 1017
`
`NUVASIVE 1018
`
`NUVASIVE 1019
`
`NUVASIVE 1020
`
`NUVASIVE 1021
`
`NUVASIVE 1022
`
`NUVASIVE 1023
`
`Affidavit of Mr. Frank E. Scherkenbach in support of Petitioner’s
`Motion for Pro Hac Vice Admission
`
`Resume of Mr. Frank E. Scherkenbach, provided as an exhibit
`to Petitioner’s Motion for Pro Hac Vice
`
`Cover page and Affidavit of Henry Vernon Crock, AO, MD, MS,
`FRCS, FRACS, FRCS Ed (Hon), D. Sc (Horaris causa), of
`Melbourne, Australia, made September 11, 2012
`
`Exhibit HVC-1 to Affidavit of Henry Vernon Crock, being a copy
`of Federal Court of Australia Practice Note CM7
`
`Exhibit HVC-2 to Affidavit of Henry Vernon Crock, being a copy
`of the curriculum vitae of Henry Vernon Crock
`
`Exhibit HVC-3 to Affidavit of Henry Vernon Crock, being a copy
`of Crock, “Observations on the Management of Failed Spinal
`Operations,” in The Journal of Bone and Joint Surgery, Vol.
`58-B, No. 2, pp. 193-199, May 1976
`
`Exhibit HVC-4 to Affidavit of Henry Vernon Crock, being a copy
`of Crock, “Anterior Lumbar Interbody Fusion – Indications for its
`Use and Notes on Surgical Technique,” in Clinical Orthopedics
`and Related Research, No. 165, May 1982
`
`
`
`iii
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`NUVASIVE 1024
`
`NUVASIVE 1025
`
`NUVASIVE 1026
`
`NUVASIVE 1027
`
`NUVASIVE 1028
`
`Exhibit HVC-5 to Affidavit of Henry Vernon Crock, being a copy
`of Fujimaki et al., “The Results of 150 Anterior Lumbar
`Interbody Fusion Operations Performed by Two Surgeons in
`Australia,” in in Clinical Orthopedics and Related Research, No.
`165, May 1982
`
`Exhibit HVC-5 to Affidavit of Henry Vernon Crock, being a copy
`of Crock, A Practice of Spinal Surgery, Springer-Verlag, Wein,
`New York, Revised 1st Edition, 1983
`
`Exhibit to HVC-5 Affidavit of Henry Vernon Crock, being a copy
`of Crock, A Short Practice of Spinal Surgery, Springer-Verlag,
`Wein, New York, Revised 2nd Edition, 1993
`
`Page 29 of NUVASIVE 1003, hand-annotated by Dr. Sachs
`during Feb. 25, 2014 Deposition
`
`Transcript of Deposition of Dr. Barton Sachs, Conducted Feb.
`25, 2014
`
`NUVASIVE 1029
`
`Second Declaration of Dr. Paul McAfee, M.D., M.B.A.
`
`NUVASIVE 1030
`
`Declaration of Dr. Robert Jacobson, M.D.
`
`NUVASIVE 1031
`
`Declaration of Dr. John Brantigan, M.D.
`
`NUVASIVE 1032
`
`Declaration of Patrick Miles
`
`NUVASIVE 1033
`
`U.S. Patent No. 6,241,770 to Michelson
`
`NUVASIVE 1034
`
`
`
`U.S. Patent No. 5,397,364 to Kozak et al.
`iv
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`NUVASIVE 1035
`
`NUVASIVE 1036
`
`U.S. Patent No. 5,792,044 to Foley et al.
`
`Friedman, Percutaneous Discectomy: An Alternative to
`Chemonucleolysis?, Neurosurgery, Vol. 13, No. 5 (1983)
`
`NUVASIVE 1037
`
`Kanter and Friedman, Percutaneous Discectomy: An
`Anatomical Study, Neurosurgery, Vol. 16, No. 2, (1985)
`
`NUVASIVE 1038
`
`U.S. Patent No. 7,198,598 to Smith et al.
`
`NUVASIVE 1039
`
`U.S. Patent No. 7,993,378 to Foley et al.
`
`NUVASIVE 1040
`
`NUVASIVE 1041
`
`NUVASIVE 1042
`
`NUVASIVE 1043
`
`NUVASIVE 1044
`
`Transcript of Deposition of Dr. Paul McAfee, Conducted Dec. 6-
`7, 2013
`
`Transcript of Trial Testimony of Dr. John Brantigan, Conducted
`Sept. 11, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`Order Granting Joint Motion for Dismissal, Jul. 12, 2013, from
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 08-CV-1512
`MMA (MDD) (S.D. Cal.)
`
`Transcript of Trial Testimony of Dr. Gary Michelson, Conducted
`Aug. 30, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`Transcript of Trial Testimony of Alexis Lukianov, Conducted
`Sept. 1, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`
`
`v
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`NUVASIVE 1045
`
`NUVASIVE 1046
`
`Transcript of Trial Testimony of Patrick Miles, Conducted Aug.
`31, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc., No.
`08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`Medtronic Corporate Structure, DTX-5651 from Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
`
`NUVASIVE 1047
`
`U.S. Patent No. 8,414,907 to Molz et al.
`
`NUVASIVE 1048
`
`U.S. Patent No. 5,395,317 to Kambin
`
`NUVASIVE 1049
`
`NUVASIVE 1050
`
`NUVASIVE 1051
`
`NUVASIVE 1052
`
`NUVASIVE 1053
`
`Malham, Clinical Outcome and Fusion Rates after the First 30
`Extreme Lateral Interbody Fusions, The Scientific World
`Journal, Volume 2012
`
`Deukmedjian, Bowel and Vascular Injury Following 13,000
`Lateral Interbody Fusions, SMISS 2013 Annual Conference
`
`Pieper, Bending the Paradigm, A White Paper on the Spine,
`Thomas Weisel Partners, Jul. 12, 2005
`
`Ehrhardt, Lateral Interbody Fusion Training Comes to
`Birmingham, Birmingham Medical News, accessed April 24,
`2013
`
`Medtronic, DLIF Marketing Plan, DLIF Is For Every Surgeon,
`2009, PX1056 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`
`
`vi
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`NUVASIVE 1054
`
`Rodgers, Experience and Early Results with a Minimally
`Invasive Technique for Anterior Column Support Through
`eXtreme Lateral Interbody Fusion, US Musculoskeletal Review,
`2007
`
`NUVASIVE 1055
`
`Medtronic, DIRECT LATERAL Interbody Fusion, DLIF Surgical
`Technique, brochure excerpt
`
`NUVASIVE 1056
`
`U.S. Patent No. 8,613,769 to Sears et al.
`
`NUVASIVE 1057
`
`EP Patent App. No. EP2108341A1 to FRÜH et al.
`
`NUVASIVE 1058
`
`U.S. Patent No. 4,222,128 to Tomonaga et al.
`
`NUVASIVE 1059
`
`U.S. Patent No. 7,905,840 to Pimenta et al.
`
`NUVASIVE 1060
`
`U.S. Patent No. 8,591,432 to Pimenta et al.
`
`NUVASIVE 1061
`
`U.S. Patent No. 8,000,782 to Gharib et al.
`
`NUVASIVE 1062
`
`U.S. Patent No. 8,005,535 to Gharib et al.
`
`NUVASIVE 1063
`
`U.S. Patent No. 8,016,767 to Miles et al.
`
`NUVASIVE 1064
`
`U.S. Patent No. D652,922 to Miles et al.
`
`NUVASIVE 1065
`
`U.S. Patent No. 8,187,334 to Curran et al.
`
`NUVASIVE 1066
`
`U.S. Patent No. 8,361,156 to Curran et al.
`
`NUVASIVE 1067
`
`McAfee, Minimally Invasive Anterior Retroperitoneal Approach
`to the Lumbar Spine, SPINE, Vol. 23 (1998)
`
`
`
`vii
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`NUVASIVE 1068
`
`Brief of Plaintiff/Counterclaim Defendant-Appellant Warsaw
`Orthopedic, Inc. and Counterclaim Defendant Appellant
`Medtronic Sofamor Danek USA, Inc., from Warsaw Orthopedic,
`Inc. v. NuVasive, Inc., No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`NUVASIVE 1069
`
`NuVasive’s Opening Brief, from Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`NUVASIVE 1070
`
`U.S. Patent No. 8,192,356 to Miles et al.
`
`NUVASIVE 1071
`
`Reserved – no exhibit
`
`NUVASIVE 1072
`
`Reserved – no exhibit
`
`NUVASIVE 1073
`
`Moro et al., An Anatomic Study of the Lumbar Plexus With
`Respect to Retroperitoneal Endoscopic Surgery, SPINE Vol. 28
`(2003)
`
`
`
`
`
`
`
`
`viii
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`
`TABLE OF AUTHORITIES
`Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983) ............................... 13
`
`
`
`
`
`ix
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`I.
`Introduction
`
`Warsaw’s arguments for patentability of claims 1-8 rely upon improper claim
`
`interpretations and misinterpretations of the prior art. Thus, all claims 1-8 are invalid upon
`
`the grounds 1-4 for which this Board has instituted review.
`
`II.
`
`Claim interpretations
`
`A. “Coronal plane” path to spine (claims 1, 9, 17 and 24)
`
`
`
`Warsaw’s claim interpretation is an attempt to distinguish Jacobson’s approach path
`
`(see PO Resp., pp. 10-12), but Jacobson discloses a direct lateral approach, not a postero-
`
`lateral approach. See infra Part IV; Ex. 1029, ¶ 23. Because Warsaw contends a direct
`
`lateral approach meets the claim (see PO Resp., p. 11), this claim limitation is not at issue.
`
`B. “Non-bone implant” (claim 1)
`
`Warsaw does not disagree that the Brantigan ‘327 and Michelson ‘247 implants – the
`
`implants of NuVasive’s invalidity grounds – meet the “non-bone” limitation of claim 1. See
`
`PO Resp., pp. 12-13, 26-40, 40-46; see also Pet., pp. 19, 28. Although Warsaw’s proposed
`
`interpretation would exclude implants that include a non-bone construct loaded with “fusion
`
`promoting material” such as bone chips, Warsaw concedes such implants qualify as the
`
`claimed non-bone implants. See PO Resp., pp. 12-13, 26-40, 40-46; see also ‘997 patent,
`
`15:46-50, cl. 9; Michelson ‘247, 10:7-12; Brantigan ‘327, 4:50-56; Ex. 1029, ¶ 32.
`
`C. Implant length / vertebrae width ratio: “Substantially the full transverse
`width” (claims 1, 9 and 17)
`
`
`
`1
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`
`This Board, in its Institution Decision, stated: “One of skill in the art would have
`
`understood that, if the length [of the implant] occupies ‘substantially’ the full transverse width
`
`[of the vertebrae], the length may occupy the full transverse width but also may occupy only
`
`a length that is less than the full transverse width of the vertebral bodies by an insubstantial
`
`amount.” Inst. Dec., p. 8. This Board did not define what an “insubstantial amount” was.
`
`Warsaw contends that “substantially the full transverse width of the vertebrae” requires that
`
`the implant be long enough so that both ends of the implant rest upon the “apophyseal ring”
`
`of the vertebrae. See PO Response, p. 7 (“sized to rest on the apophyseal ring”) and pp. 6-
`
`7, 31-38, 42-46; see also Sachs Decl. (Ex. 2038), ¶¶ 112, 121, 127, and 131; Sachs Depo.,
`
`Ex. 1028, 142:19-23; but see Second McAfee Decl., Ex. 1029, ¶ 25. The lower limit that
`
`Warsaw is attempting to impose upon the claimed implant length/vertebrae width ratio is
`
`improper for the following reasons.
`
`First, Warsaw’s lower length limit has no support in the ‘997 specification. The ‘997
`
`specification shows only examples that are less than the full transverse width, and has no
`
`example implant lengths, no example ratios of implant size versus vertebrae transverse
`
`width, and nowhere mentions the “apophyseal ring.” See Pet., pp. 5-7; First McAfee Decl.,
`
`Ex. 1001, ¶¶ 17-19. The vague references in the ‘997 specification to “optimal fit” and the
`
`like upon which Warsaw relies— refer to PO Resp., pp. 45-46, quoting 3:26-30, 11:3-8,
`
`21:4-11 and 33-38 of the ‘997 specification—do not support a claim interpretation that the
`
`
`
`2
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`implant ends must rest upon the apophyseal ring. The patent figures showing an implant
`
`and vertebrae (Figs. 23, 30, 30A) also do not support the narrow claim interpretation. See
`
`Ex. 1001, ¶¶ 17-19. Warsaw does not disagree that FIG. 30 (the figure in which the implant
`
`appears longer than others) is anatomically inaccurate (see Ex. 1001, ¶ 19). Warsaw also
`
`does not disagree that FIG. 23 shows a length of only about 73% of the full transverse width
`
`of the vertebrae. See PO Resp., p. 36-37 fn. 6; compare Ex. 1001, ¶ 18. Although Warsaw
`
`accuses NuVasive of improperly limiting the claims to FIG. 23 (Resp., pp. 36-37, fn. 6), that
`
`is not correct. NuVasive contends a broadest reasonable interpretation would include both
`
`examples, FIGs. 23 and 30, not one at the exclusion of the other. See Ex. 1029, ¶ 27.
`
`Also, Warsaw cannot, on the one hand, rely on the ‘997 specification language of
`
`“maximum possible length across the transverse width W of the vertebrae T7 and T8” (11:3-
`
`8) as support for an implant spanning the full transverse width (Resp., p. 7 fn. 1), but then
`
`ignore that the thoracic (T7/T8) example that language is referring to is shown in FIG. 23,
`
`which shows only 73%. The written specification and the figures support a broader
`
`interpretation than Warsaw is trying to impose. See Ex. 1029, ¶¶ 25-30.
`
`Second, Warsaw’s narrow claim interpretation is built upon a factually incorrect
`
`premise that the apophyseal ring is the only hard part of the vertebrae end face that will
`
`support an implant. But the apophyseal ring is confluent with hard cortical bone within
`
`(inside) the apophyseal ring, and that hard cortical bone within the apophyseal ring will also
`
`
`
`3
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`support an implant without subsidence. See Ex. 1029, ¶ 3; see also Ex. 1034, Fig. 2A
`
`(showing a region of “stronger bone” between the apophyseal ring and weak cancellous
`
`bone in center). Also, the width of the apophyseal ring varies from patient to patient within a
`
`relatively wide range of almost nothing in some older patients with a progressed spinal
`
`disease state to about 15% of the transverse width on each side (thus, up to 30% of the
`
`total transverse width adding both sides). See Ex. 1029, ¶ 77; Ex. 1028, 147:1-7. As such,
`
`an ordinary surgeon would not know whether the implants shown in FIGs. 23 and 30 are
`
`resting upon the “apophyseal ring” or other hard bony surfaces entirely within the
`
`apophyseal ring. See Ex. 1029, ¶¶ 3, 77.
`
`Third, Warsaw’s narrow claim interpretation is contrary to important extrinsic
`
`evidence. Dr. Michelson’s own ‘770 patent filed in 1999 characterizes the “prior art” ‘997
`
`patent implant as having ends that do not rest upon the apophyseal ring. See Ex. 1029, ¶
`
`26; Ex. 1033, FIGS. 1, 11 (“prior art” ‘997 implant) & 3:57-4:12; Ex. 1001, ¶ 19. Also,
`
`Warsaw’s “swear behind” evidence relies upon a 42 mm implant for the lower lumbar
`
`lumber (L3 to L5), but a 42 mm implant length would be well short of the average full
`
`transverse vertebrae widths there of 51-53 mm. See Ex. 1029, ¶¶ 13 and 78. Also, Dr.
`
`Michelson’s ‘973 implant patent (a CIP of the ‘661 patent, which has near the same
`
`specification as the ‘997 patent) provided example implant lengths (12-30 mm for thoracic,
`
`and 35-50 mm for lumbar), and those implant lengths are also well short of the vertebrae full
`
`
`
`4
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`transverse widths (29.8-43.8 mm for thoracic, and 45.2-53.4 mm for lumbar). See Ex. 2010,
`
`7:21-30; Ex. 1001, Berry paper, p. 92, Table 1.
`
`Fourth, Warsaw’s narrow interpretation ignores that in the ‘997 patent the
`
`apophyseal ring is removed in the drilling process before the cylindrical implant is inserted.
`
`See Ex. 1002, Figs. 24 and 29; see also Ex. 1029, ¶ 28. As such, Warsaw’s narrow
`
`interpretation ignores Dr. Michelson’s preferred embodiments in which all or most of the
`
`apophyseal ring and the cortical rim is drilled/cut/removed in the targeted implant location
`
`prior to inserting the implant.
`
`Therefore, the proper broadest reasonable interpretation of the “substantially full
`
`transverse” claim limitation does not require that both ends of the implant rest upon the
`
`vertebrae apophyseal ring. Ex. 1029, ¶¶ 25-31. It is sufficient that the implant rest upon
`
`hard bone surfaces even within (inside) the apophyseal ring, because to one of skill in the
`
`art in early 1995 such an implant positioning would also have been viewed as stable.
`
`III.
`
`Jacobson discloses a direct lateral approach that meets the “coronal
`plane” path limitation and inherently teaches the insertion of a fusion
`implant.
`Warsaw first contends Jacobson discloses a posterolateral approach, not a direct
`
`lateral approach. PO Resp., pp. 18-24. Warsaw is wrong. See Ex. 1029, ¶¶ 36-47. That
`
`Jacobson is direct lateral is not only crystal clear from the reference itself (see Ex. 1001, ¶¶
`
`22-23; Ex. 1029, ¶ 38), it is well corroborated. First, two published peer-reviewed journal
`
`
`
`5
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`articles from the 1980’s describe Dr. Jacobson’s procedure, and illustrate views Dr. Sachs
`
`says are needed to distinguish between lateral and posterolateral; they clearly show direct
`
`lateral. See Ex. 1036, FIGS. 3-6; Ex. 1037, FIG. 1; Ex. 1029, ¶ 38. Second, Dr. Jacobson
`
`provides testimony confirming his approach was direct lateral. Ex. 1030, ¶¶ 4-10. Third,
`
`numerous Warsaw patents call Jacobson’s approach “lateral,” and distinguish it from
`
`“posterolateral.” See, e.g., Ex. 1039, 2:28-47; see also Ex. 1029, ¶ 41 (providing long list of
`
`Warsaw patents making this distinction).
`
`Warsaw’s expert Dr. Sachs rendered his flawed opinion that Jacobson discloses
`
`posterolateral without a proper inquiry. See Ex. 1028, 155:5-156:4. Dr. Sachs conduct is
`
`not an isolated incident, but is a continuing pattern of misrepresenting other surgeons’ work.
`
`He’s done it with Dr. Crock’s lateral work, with Dr. Brantigan’s lateral work, and with Dr.
`
`McAfee’s lateral work. Ex. 1029, ¶ 10. Dr. Sachs’ testimony is therefore unreliable, and
`
`biased by the unusually large amount of money he’s received in serving first Dr. Michelson
`
`and now Warsaw in defending Dr. Michelson’s patents. Ex. 1028, 58:5-66:10.
`
`Next, Warsaw argues Jacobson’s mention of fusion would not necessarily involve an
`
`implant. See PO Resp., p. 24-26. Warsaw’s position is incorrect, and in any event is
`
`irrelevant. First, Warsaw gives flawed reliance on Dr. McAfee’s testimony that “[a] spine
`
`fusion anywhere can occur without an implant.” PO Resp., pp. 24-25. That is indeed true
`
`with “auto-fusion” for example where bones in the spine may fuse together without surgical
`
`
`
`6
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`intervention, but that is quite different from Jacobson’s reference to “fusion” in connection
`
`with a cannula positioned adjacent a spinal disc space. See Ex. 1029, ¶¶ 52 and 4. To be
`
`sure, Dr. McAfee at his deposition was not asked whether Jacobson’s reference to “fusion”
`
`necessarily involved an implant, and in fact was asked no questions at all about Jacobson.
`
`Ex. 1040, 26:8-27:1. In addition, Warsaw’s positions in this regard are based on a flawed
`
`view that Jacobson discloses a posterolateral approach and would involve procedures on
`
`the posterior spinal column, which it does not. See Ex. 1029, ¶ 53. Second, Warsaw’s
`
`point is irrelevant, because the obviousness of using the implants of Brantigan ‘327 or
`
`Michelson ‘247 with the access system resulting from the combined teachings of Jacobson
`
`and Leu is not dependent upon Jacobson necessarily disclosing the introduction of an
`
`implant through the access cannula. Ex. 1029, ¶¶ 49-51. That is one of several reasons
`
`why one of skill in the art would use the Brantigan ‘327 or Michelson ‘247 implants with the
`
`combined teachings of Jacobson and Leu. See Pet., pp. 18-20, 27-29; Ex. 1001, ¶¶ 29, 31.
`
`Further, even if an “implant”—in Warsaw’s narrow sense of the term—would not have been
`
`necessarily used in Jacobson’s “fusion” in 1982, one of skill in the art would have
`
`recognized the conventional usage or necessity for such fusion implants before 1995 given
`
`the accepted surgical practices and advancement of spinal implant technology in the early
`
`1990s. Ex. 1001, ¶¶ 29, 31; Ex. 1029, ¶¶ 49-52 & 4; Ex. 2038, ¶ 91.
`
`IV.
`
`Brantigan ‘327 discloses the lateral insertion of an implant, and even if it
`didn’t, that is not necessary for an obviousness finding.
`
`
`
`7
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`
`Warsaw is wrong when it contends at pp. 26-31 of its Response that FIG. 10 of
`
`Brantigan’327 does not disclose a laterally inserted implant. See Ex. 1031, ¶¶ 7-17; Ex.
`
`1029, ¶¶ 59-69. FIG. 10 is a front view of the spine, with two implants 11 resting
`
`translaterally in the upper disc space 54. See Ex. 1006, Fig. 10. The threaded holes
`
`(shown in hidden lines) at the left sides of implants 11 in FIG. 11 are for an implant insertion
`
`tool, indicating insertion was laterally. See Ex. 1006, 4:20-22 & FIG. 13. Warsaw argues
`
`FIG. 10 is unclear, and inconsistent with FIG. 11. Not true. FIG. 11 shows the anterior
`
`example illustrated at the bottom in FIG. 10, not the lateral example shown at the top of FIG.
`
`10. Ex. 1029, ¶¶ 66-67. Although there is cross-section labeling in FIG. 10 at the location
`
`of the upper disc space 54, a skilled artisan would readily see this as a harmless drafting
`
`error. Id.; Ex. 1031, ¶¶ 16-17. FIG. 11 is clearly not a cross-section of FIG. 10, and the
`
`numbering of the vertebral bodies 52 and 57 in FIGS. 10 and 11 make clear that FIG. 11 is
`
`the anterior example of the lower disc space 56 of FIG. 10, not the lateral example shown in
`
`the upper disc space 54 of FIG. 10. See Ex. 1031, ¶¶ 16-17; Ex. 1029, ¶¶ 66-67.
`
`Warsaw is also wrong when it argues at pp. 29-31 of its Response that “laterally” as
`
`used in Brantigan ‘327 does not mean a lateral approach, but rather means lateral of the
`
`midline as used for example in Brantigan ‘757. “Laterally” in Brantigan ‘327 is used in a list
`
`of approaches that includes “anteriorly, posteriorly or laterally.” See Ex. 1006, 2:64-66,
`
`5:30-35, 6:61-69. By contrast, “laterally” in Brantigan ‘757 refers to a posterior approach
`
`
`
`8
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`where the implants are placed lateral of the midline. If “laterally” in Brantigan ‘327 really
`
`meant lateral of the midline, it would make no sense and would be redundant to include that
`
`in a list that includes a “posterior” approach. Warsaw’s argument just cannot hold water.
`
`See Ex. 1031, ¶¶ 7-14; Ex. 1029, ¶¶ 59-64.
`
`Finally, even if Warsaw were correct that Brantigan ‘327 does not disclose a direct
`
`lateral implant insertion (which is not the case), that would be irrelevant because Jacobson
`
`supplies the teaching of a direct lateral approach such that Brantigan ‘327’s lateral insertion
`
`is not necessary for an obviousness conclusion. See Pet., pp. 14-21; Ex. 1029, ¶¶ 88-90.
`
`V.
`
`Brantigan ‘327 meets the “substantially the full transverse width of the
`vertebrae” claim limitation.
`Warsaw next argues that Brantigan ‘327 does not disclose implants that rest upon
`
`the apophyseal ring, but rather Brantigan ‘327 “teaches an implant that is designed to be
`
`seated on the cancellous, spongy center of the vertebral body.” PO Resp., p. 32. That is
`
`wrong. First, this argument rests upon a claim interpretation that is incorrect, as described
`
`above. See supra Section II.C. Also, Brantigan ‘327 is clear; his oval implants are
`
`“bottomed on the hard bone faces or end plates and are generally oval shaped to conform
`
`with the general outline perimeter of the vertebrae.” See Ex. 1006, 2:1-4; 8:57-59
`
`(“generally conforming in shape and size with opposing hard end plates”). Brantigan ‘327 –
`
`taking into account its figures and textual description – discloses implants spanning no less
`
`of the full transverse width than the ‘997 patent discloses. See, e.g., Ex. 1001, ¶ 29
`
`
`
`9
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`(showing Brantigan ‘327 FIG. 10 spans more of the transverse width than the FIG. 23
`
`implant of the ‘997 patent). One of skill in the art would certainly recognize that the
`
`Brantigan ‘327 oval implants may rest on the apophyseal ring or at least on the hard cortical
`
`bone within the apophyseal ring, depending on the variable factor of how wide the particular
`
`patient’s apophyseal ring actually is. Ex. 1029, ¶ 77; see also Ex. 1029, ¶¶ 70-78; Ex. 1031,
`
`¶¶ 18-21. Warsaw is simply wrong that Brantigan ‘327 is designed to be seated on the
`
`“spongy center” of the vertebrae. Ex. 1029, ¶¶ 71-74; also compare Ex. 1034, FIG. 2A, with
`
`Ex. 1006, FIG. 10. The only way that Warsaw can reach such an illogical conclusion that is
`
`contrary to the plain language of the Brantigan ‘327 patent is by repeatedly misstating Dr.
`
`Brantigan’s testimony. See Ex. 1031, ¶¶ 14-15 and 19; Ex. 1029, ¶¶ 64-65 and 73. But
`
`that cannot change the fact that Brantigan ‘327, under the proper broadest reasonable claim
`
`interpretation, clearly meets the “substantially the full transverse width” claim limitation.
`
`VI. Michelson ‘247, when inserted laterally according to the teachings of
`Jacobson, would meet the “substantially the full transverse width of the
`vertebrae” limitation.
`Michelson ‘247 discloses the same implant design as Michelson ‘997, namely, the
`
`now-obsolete threaded cylindrical cage that is inserted into a drilled hole. See Petition, p.
`
`28; also compare Michelson ‘247, FIG. 5 with Michelson ‘997, FIG. 19. FIG. 5 of Michelson
`
`‘247 shows an example where an implant spans the entire depth of the disc space along the
`
`direction of insertion. See Ex. 1029, ¶¶ 82-83. Warsaw argues that Michelson ‘247
`
`
`
`10
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`“teaches a surgeon to size a posterior implant to span less than substantially the full depth
`
`of the disc space.” See PO Response, p. 42. Despite all the irrelevant arguments that
`
`Warsaw makes in connection with Michelson ‘247, what’s important is what Warsaw does
`
`not say. Warsaw does not say that the posteriorly inserted Michelson ‘247 implants would
`
`not rest on the apophyseal ring, and does not say that the Michelson ‘247 implants are
`
`designed to rest only a “spongy” center part of the vertebrae. And although Warsaw argues
`
`that the drill in Michelson ‘247 has a stop limit such that it would stop short of the full
`
`transverse width (see PO Resp., pp. 42-43), Warsaw omits the fact that the ‘997 patent’s
`
`drill has the very same feature (see ‘997 patent, FIGS. 11, 13, col. 13:21-29, 13:58-61).
`
`See also Ex. 1029, ¶¶ 82-83. Here too, it is clear that under a proper interpretation of
`
`“substantially the full width,” Michelson ‘247 discloses insertion of an implant “substantially
`
`the full width” of the vertebrae along the direction of insertion. See Ex. 1029, ¶¶ 79-85.
`
`The “non-combinable” arguments of Warsaw have no merit.
`VII.
`Jacobson, Leu, and Brantigan: Warsaw’s arguments largely rest upon misreadings
`
`of Jacobson and Brantigan ‘327 and narrow claim interpretations refuted above. See Ex.
`
`1029, ¶¶ 88-90. Warsaw also argues that “the Brantigan implant is not conducive to
`
`insertion through a cannula or similar surgical instrument in a minimally invasive procedure.”
`
`See PO Resp., p. 52. But the Jacobson cannula 30 is elliptical and thus is able to
`
`accommodate “wider instruments” (Ex. 1004, 9:17-26) like the non-cylindrical Brantigan ‘327
`
`
`
`11
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`implants; and, the Brantigan ‘327 implant has a tool insertion hole at its trailing edge for an
`
`implant insertion tool that is in line with the implant for advancement through a cannula (Ex.
`
`1006, FIG. 13). See also Ex. 1029, ¶ 90; ‘997 patent, col. 17:51-65. Finally, Warsaw
`
`argues “[n]either Brantigan nor Jacobson nor Leu teaches a method of distracting vertebral
`
`bodies to accommodate the Brantigan implant, which is not bullet-nosed or otherwise self-
`
`distracting.” Petition, pp. 52-53. This ignores that Brantigan ‘327 discloses the disc space
`
`being distracted or “stretched” prior to insertion of the implant (Ex. 1006, at 6:59-68), and
`
`ignores that the lateral decubitus positioning in Jacobson provides distraction for an implant
`
`(see Ex. 1004, FIGS. 3-8). See also Ex. 1029, ¶¶ 90.
`
`Jacobson, Leu, and Michelson ‘247: First, Warsaw’s position that Michelson ‘247
`
`cannot be inserted laterally is inconsistent with Dr. Michelson’s prior testimony that the
`
`implant in Michelson ‘247 can be inserted not only “from the front” or “from the back,” but
`
`also “from the side.” Ex. 1043, 258:16-259:6 (Dr. Michelson testifying in 2011 to reconfirm
`
`his prior testimony from 2004 regarding direction of insertion). Second, the “rocking”
`
`problem that Warsaw describes (PO Resp., pp. 53-54) is a non-issue in view of the
`
`prevalence of fixation systems used with spinal fusion, as even the ‘997 patent
`
`acknowledges. See Ex. 1002, 16:53-58; Ex. 1029, ¶ 80. The other arguments Warsaw
`
`presents all rest upon misinterpretations of the prior art and improperly narrow claim
`
`interpretations already addressed above. Ex. 1029, ¶¶ 91-93.
`
`
`
`12
`
`
`
`Case IPR2013-00208
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP1
`
`VIII. Warsaw’s secondary considerations arguments for patentability cannot
`pass scrutiny.
`Teaching Away: Warsaw’s arguments here too rest primarily upon misreadings of
`
`the prior art and the improperly narrow reading of the “substant
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
