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 IPR2013-00206
`
`
`______________________________________________________
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
` 
`
`
`
`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`
`III.
`
`IV.
`
`V.
`
`I.
`II.
`
`
`
`
`TABLE OF CONTENTS
`Introduction ............................................................................................................... 1
`Claim Interpretations ................................................................................................ 1
` A. “Coronal plane” path to spine (claims 1, 9, 17 and 24) .................................... 1
` B. “Elongated portion” (claims 9, 17 and 24) ........................................................ 1
` C. Implant length/vertebrae width ratio: “Substantially the full traverse width
`(claims 1, 9 and 17) and the “full transverse width” (claim 24) ........................ 2
`Jacobson discloses a direct lateral approach that meets the “coronal plane”
`path limitation and teaches the insertion of a fusion implant (Claims 9-30:
`Ground 6) ................................................................................................................... 6
`Brantigan ‘327 discloses the lateral insertion of an implant, and even if it
`didn’t, that is not necessary for obviousness (Claims 17-23: Grounds 3-4) ...... 7
`Brantigan ‘327 meets the “substantially the full transverse width of the
`vertebrae” claim limitation (at least Claims 17-23: Grounds 3-4) ........................ 9
`VI. Michelson ‘247, when inserted laterally according to the teachings of
`Jacobson, would meet the “substantially” or “full” transverse width limitations
`(at least Claims 9-16 and 24-30: Grounds 1-2 and 5-6) ....................................... 10
`VII. Claims 24-30: If this Board interprets the claim 24 limitation of “full transverse
`width” different from claims 9 and 17, then either Michelson ’247 meets claim
`24 (under Grounds 5-6) or the validity of claims 24-30 under Ground 8 should
`be considered .......................................................................................................... 11
`VIII. The claimed “elongated portions” ......................................................................... 12
`IX.
`The “non-combinable” arguments of Warsaw have no merit ............................. 12
`X.
`Warsaw’s secondary considerations arguments for patentability cannot pass
`scrutiny..................................................................................................................... 13
`Conclusion ............................................................................................................... 15
`i 
`
`XI.
`
` 
`
`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`
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`
`
`
`
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`
`
`
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`
`
`NUVASIVE 1001
`
`NUVASIVE 1002
`
`NUVASIVE 1003
`
`NUVASIVE 1004
`
`NUVASIVE 1005
`
`NUVASIVE 1006
`
`NUVASIVE 1007
`
`NUVASIVE 1008
`
`NUVASIVE 1009
`
`NUVASIVE 1010
`
`NUVASIVE 1011
`
`NUVASIVE 1012
`
`NUVASIVE 1013
`
`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”)
`
`U.S. Pat. No. 5,569,290 to McAfee (“McAfee”)
`
`U.S. Pat. No. 5,772,661 to Michelson (“Michelson ‘661”)
`
`U.S. Pat. No. 8,343,224 to Lynn et al. (“Lynn”)
`
`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
`
` 
`
`ii 
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`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
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`NUVASIVE 1014
`
`NUVASIVE 1015
`
`NUVASIVE 1016
`
`NUVASIVE 1017
`
`NUVASIVE 1018
`
`NUVASIVE 1019
`
`NUVASIVE 1020
`
` 
`
`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
`
`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-6 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
`iii 
`
`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`NUVASIVE 1021
`
`Exhibit to HVC-7 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
`
`NUVASIVE 1022
`
`Reserved – no exhibit
`
`NUVASIVE 1023
`
`Reserved – no exhibit
`
`NUVASIVE 1024
`
`Reserved – no exhibit
`
`NUVASIVE 1025
`
`Reserved – no exhibit
`
`NUVASIVE 1026
`
`Reserved – no exhibit
`
`NUVASIVE 1027
`
`NUVASIVE 1028
`
`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.
`
`NUVASIVE 1035
`
` 
`
`U.S. Patent No. 5,792,044 to Foley et al.
`iv 
`
`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`NUVASIVE 1036
`
`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 IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`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 IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`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 IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`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 
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`

`Case IPR2013-00206
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`Our Ref. 13958-0112IP2
` 
`
`TABLE OF AUTHORITIES
`See Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983) ....................... 14
`
` 
`
`ix 
`
`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`I.
`Introduction
`
`Warsaw’s arguments for patentability of claims 9-30 rely upon improper claim
`
`interpretations and misinterpretations of the prior art. Thus, all claims 9-30 are invalid upon
`
`the grounds 1-6 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. 10-11), 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. “Elongated portion” (claims 9, 17 and 24)
`
`Claims 9, 17 and 24, for each elongated portion and in slightly varying verbiage,
`
`define “said length of said elongated portion being greater than the width.” Ex. 1002, 24:33-
`
`34 (cl. 9), 25:55-56 (cl. 17), 28:13-14, 19-20 & 22-23 (cl. 24). Warsaw contends each
`
`“elongated portion” must be interpreted to require that the length be substantially greater
`
`than the width. PO Resp., pp. 12-14. Warsaw tries to avoid the definition of “elongate” in
`
`the claims by saying it is not a definition, but rather “the recitation of the length, width, and
`
`thickness is necessary to orient the proper dimension along the height of the disc space.”
`
`PO Resp., pp. 13-14. But Warsaw ignores that the claims not only recite “a length, a
`
` 
`
`1
`
`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
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`thikness, and a width” (thus setting the antecedent basis), but also provides the definition
`
`after the antecedent basis is set. See Ex. 1002, 24:32-34; 25:54-56; 27:11-13. Thus, the
`
`express definition of “elongate” in the claims is not required for antecedent basis purposes.
`
`See Ex. 1029, ¶ 24. And although Warsaw gives examples of “elongated” members, those
`
`elongated members also have lengths that are greater than widths, which is consistent with
`
`the express definition. Id. Thus, the broadest reasonable interpretation of “elongated”
`
`should be no narrower than the express definition in the claims. Id.
`
`C. Implant length / vertebrae width ratio: “Substantially the full transverse
`width” (claims 1, 9 and 17) and “the full transverse width” (claim 24)
`The Board, in its Institution Decisions, interpreted claim 1 (in IPR2013-00208) and
`
`claim 9 (in IPR2013-00206) similarly, but did not address the interpretation of claim 24,
`
`which has a similar phrase but omits the word “substantially.” With respect to claim 9 (and
`
`presumably claim 17), the Board in IPR2013-00206, stated: “One of ordinary skill in the art
`
`would have understood also that if the length occupies ‘substantially’ the full transverse
`
`width, 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. 9; see also Pet., pp. 5-6. Regarding claim 24, NuVasive contended “full
`
`transverse width” should be interpreted the same as claims 9 and 17, given the ‘997 patent
`
`only discloses implants that are less than the full transverse width. See Pet., p. 6-7; Ex.
`
`1001, ¶¶ 18-21; Ex. 1029, ¶ 24. Warsaw does not disagree that the ‘997 specification
`
` 
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`2
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`

`

`Case IPR2013-00206
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`discloses only implants that are less than the full transverse width, and though its Response
`
`is silent on the point, its expert Dr. Sachs confirmed he applied a “substantially the full
`
`transverse width” interpretation to claim 24. Ex. 1028, 152:12-6.
`
`Warsaw contends “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.” 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, 131; Sachs Depo., Ex. 1028,
`
`142:19-23. The lower limit that Warsaw is attempting to impose upon the claimed implant
`
`length / vertebrae width ratio is improper for several reasons. See Ex. 1029, ¶¶ 25-31.
`
`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 of the “apophyseal ring.” See Pet., pp. 5-6; First McAfee
`
`Decl., Ex. 1001, ¶¶ 17-20. The vague references in the ‘997 specification to “optimal fit”
`
`and the like upon which Warsaw relies—PO Resp., p. 46, quoting 3:26-30, 11:3-8, and
`
`21:4-11 of the ‘997 specification—do not support a claim interpretation that the 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 is anatomically inaccurate (see Ex. 1001, ¶
`
` 
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`3
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`19), and does not disagree that FIG. 23 shows a length of only about 73% of the full
`
`transverse width. See PO Resp., p. 36-37 fn. 6; compare Ex. 1001, ¶ 18. Although
`
`Warsaw accuses NuVasive of improperly limiting the claims to FIG. 23 (see PO 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 only one at the exclusion of the other.
`
`See Ex. 1029, ¶ 27. The written specification and the figures support a broader reading of
`
`the claim than Warsaw is trying to impose. 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 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,
`
`144:15-20. 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
`
` 
`
`4
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`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 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 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. 89, 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, the implant, at best, only would rest next
`
`to the apophyseal ring.
`
`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. See 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.
`
` 
`
`5
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`

`

`Case IPR2013-00206
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112IP2
` 
`III.
`Jacobson discloses a direct lateral approach that meets the “coronal
`plane” path limitation and teaches the insertion of a fusion implant (Claims
`9-30: Ground 1-6).
`Warsaw first contends Jacobson discloses a posterolateral approach, not a direct
`
`lateral approach. PO Resp., pp. 19-24. 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, ¶¶
`
`23-24; Ex. 1029, ¶ 38), it is well corroborated. First, two published peer-reviewed journal
`
`articles from the 1980s describe Dr. Jacobson’s procedure, and illustrate views Dr. Sachs
`
`says are needed to distinguish between lateral and posterolateral; they 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
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`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.
`
`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 is irrelevant. First,
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`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 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, 4. To be sure, Dr. McAfee at
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`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.
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`In addition, Warsaw’s positions in this regard are based on a flawed view that Jacobson
`
`discloses a posterolateral approach and would involves 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
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`cannula. Ex. 1029, ¶¶ 49-51. That is merely one of several reasons why a skilled artisan
`
`would use the Brantigan ‘327 or Michelson ‘247 implants with Jacobson’s lateral cannula.
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`Pet., pp. 18-20, 27-30, 37-40; Ex. 1001, ¶¶ 28-29, 32-33, 36. Further, even if an “implant”—
`
`in Warsaw’s narrow sense—would not have been necessarily used in Jacobson’s “fusion” in
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`1982, one of skill in the art would have recognized the conventional usage or necessity for
`
`such implants before 1995 given the accepted surgical practices and the state of the art in
`
`the early 1990s. See Ex. 1001, ¶ 28; 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 (Claims 17-23:
`Grounds 3-4).
`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.
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`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,
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`5:30-35, 6:61-69. By contrast, “laterally” in Brantigan ‘757 refers to a posterior approach
`
`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
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`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 the direct
`
`lateral implant insertion (which is not the case), that would be irrelevant because Jacobson
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`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. 22-30; Ex. 1029, ¶¶ 88-90.
`
`V.
`
`Brantigan ‘327 meets the “substantially the full transverse width of the
`vertebrae” claim limitation (at least Claims 17-23: Grounds 3-4).
`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, ¶ 33
`
`(Brantigan ‘327 FIG. 10 spans more of the transverse width than the ‘997 patent FIG. 23
`
`implant). One of skill in the art would recognize that the Brantigan ‘327 oval implants may
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`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 design to be seated on the “spongy center” of the
`
`vertebrae. Compare Ex. 1034, FIG. 2A, with Brantigan ‘327, 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 & 19; Ex. 1029, ¶¶ 64-65 & 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” or “full” transverse width
`limitations (at least Claims 9-16 and 24-30: Grounds 1-2 and 5-6).
`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
`
`“teaches a surgeon to size a posterior implant to span less than substantially the full depth
`
`of the disc space.” See PO Resp., p. 42. Despite all the irrelevant arguments that Warsaw
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`makes in connection with Michelson ‘247, what’s important is what Warsaw does not say.
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`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.
`
`VII. Claims 24-30: If this Board interprets the claim 24 limitation of “full
`transverse width” different from claims 9 and 17, then either Michelson ’247
`meets claim 24 (under Grounds 5-6) or the validity of claims 24-30 under
`Ground 8 should be considered.
`Given the similarity of the Michelson ‘997 and ‘247 implant designs and surgical
`
`tools, to the extent the ‘997 specification is deemed to disclose the “full transverse width”
`
`along the direction of insertion, Michelson ‘247 would have to be interpreted similarly. But if
`
`claim 24 is interpreted even more narrowly and excludes Michelson ‘247 from that
`
`interpretation, then the ‘997 patent is not entitled to its priority date of Feb. 27, 1995. See
`
`Petition, pp. 50-60; see also pp. 44-46. In that case, NuVasive respectfully request that the
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`Board consider the validity of claims 24-30 under Ground 8. See id., pp. 50-60.
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`VIII. The claimed “elongated portions”
`McAfee ‘290 is only relied upon for claims 9-16, for the removable feature recited in
`
`claim 9. See Pet., pp. 16-17. Warsaw’s swear-behind proof for McAfee ‘290 is deficient for
`
`many reasons, including that it does not show the very “removable” feature for which
`
`McAfee ’290 is used. Ex. 1029, ¶¶ 11, 14, 87; also ¶¶ 12-21. Next, for claims 17, 24,
`
`Warsaw says Michelson ‘247’s teeth are not “substantially” elongated, but that is not
`
`required by the claims (see infra Section II.B.), and the Michelson ‘247 teeth are more than
`
`a little bit longer than they are wide so this limitation is met even under Warsaw’s
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`“substantially” language. Ex. 1029, ¶ 86. Finally, for claim 17, Jacobson’s wires are indeed
`
`positioned over the vertebrae. See Pet., p. 30, 5; see also Ex. 1029, ¶¶ 54-55.
`
`IX.
`
`The “non-combinable” arguments of Warsaw have no merit.
`Jacobson, Leu, and Brantigan (claims 17-23): Warsaw’s arguments largely rest upon
`
`errors in Jacobson and Brantigan ‘327 and erroneous claim interpretations refuted above.
`
`See Ex. 1029, ¶¶ 88-90. Warsaw’s argument that the Brantigan implant is not conducive to
`
`a cannula or a minimally invasive procedure (see PO Resp., p. 52-53) is rebutted by
`
`Jacobson cannula 30 being elliptical and thus is able to accommodate “wider ins