Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15836 Page 1 of
` 11
`
`EXHIBIT 13
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 1 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15837 Page 2 of
` 11
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`NUVASIVE, INC.
`Petitioner
`Petitioner
`
`v.
`v.
`
`WARSAW ORTHOPEDIC, INC.
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`Patent Owner
`
`Patent Number: 8,251,997 B2
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`Issue Date: August 28, 2012
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO
`ADJACENT VERTEBRAE ALONG A CORONAL PLANE
`ADJACENT VERTEBRAE ALONG A CORONAL PLANE
`
`Case IPR2013-00206
`Case I PR2013-00206
`
`PETITIONER'S REPLY TO PATENT OWNER'S RESPONSE
`PETITIONER'S REPLY TO PATENT OWNER'S RESPONSE
`
`NUVA_ATEC0103119
`NUVA_ATEC0103119
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 2 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15838 Page 3 of
` 11
`
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref.13958-01121P2
`Our Ref. 13958-0112IP2
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
`
`I.
`I.
`
`II.
`II.
`
`III.
`ill.
`
`IV.
`IV.
`
`V.
`
`Introduction
` 1
`introduction ............................................................................................................... 1
`
`Claim Interpretations ................................................................................................ 1
`Claim Interpretations
` 1
`
`A "Coronal plane" path to spine (claims 1, 9, 17 and 24) .................................... 1
`A. "Coronal plane" path to spine (claims 1, 9, 17 and 24)
` 1
`
`B. "Elongated portion" (claims 9, 17 and 24) ........................................................ 1
` 1
`B. "Elongated portion" (claims 9, 17 and 24)
`
`C. Implant length/vertebrae width ratio: "Substantially the full traverse width
`C. Implant length/vertebrae width ratio: "Substantially the full traverse width
`(claims 1, 9 and 17) and the "full transverse width" (claim 24) ........................ 2
`(claims 1, 9 and 17) and the "full transverse width" (claim 24)
`2
`
`Jacobson discloses a direct lateral approach that meets the "corona! plane"
`Jacobson discloses a direct lateral approach that meets the "coronal plane"
`path limitation and teaches the insertion of a fusion implant (Claims 9-30:
`path limitation and teaches the insertion of a fusion implant (Claims 9-30:
`Ground 6) ................................................................................................................... 6
`Ground 6)
`6
`
`Brantigan '327 discloses the lateral insertion of an implant, and even if it
`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
`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
`Brantigan '327 meets the "substantially the full transverse width of the
`vertebrae" claim limitation (at least Claims 17-23: Grounds 3-4) ........................ 9
` 9
`vertebrae" claim limitation (at least Claims 17-23: Grounds 3-4)
`
`VI. Michelson '247, when inserted laterally according to the teachings of
`VI. Michelson '247, when inserted laterally according to the teachings of
`Jacobson, would meet the "substantially" or "full" transverse width limitations
`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
`(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
`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
`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
`24 (under Grounds 5-6) or the validity of claims 24-30 under Ground 8 should
` 11
`be considered .......................................................................................................... 11
`be considered
`
`VIII. The claimed "elongated portions"
`VIII. The claimed "elongated portions" ......................................................................... 12
` 12
`
`IX.
`IX.
`
`The "non-combinable" arguments of Warsaw have no merit.. ........................... 12
`The "non-combinable" arguments of Warsaw have no merit
`12
`
`X. Warsaw's secondary considerations arguments for patentability cannot pass
`X. Warsaw's secondary considerations arguments for patentability cannot pass
`scrutiny
` 13
`scrutiny ..................................................................................................................... 13
`
`XI.
`XI.
`
`Conclusion ............................................................................................................... 15
`Conclusion
` 15
`
`i
`
`NUVA_ATEC0103120
`NUVA_ATEC0103120
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 3 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15839 Page 4 of
` 11
`
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-01121P2
`Our Ref.13958-01121P2
`
`NUVASIVE 1001
`NUVASIVE 1001
`
`Declaration of Dr. McAfee, M.D., M.B.A.
`Declaration of Dr. McAfee, M.D., M.B.A.
`
`EXHIBITS
`EXHIBITS
`
`NUVASIVE 1002
`NUVASIVE 1002
`
`U.S. Patent No. 8,251,997 to Michelson ("997 patent")
`U.S. Patent No. 8,251,997 to Michelson ("'997 patent")
`
`NUVASIVE 1003
`NUVASIVE 1003
`
`Select Prosecution History of the '997 patent
`Select Prosecution History of the '997 patent
`
`NUVASIVE 1004
`NUVASIVE 1004
`
`U.S. Pat. No. 4,545,374 to Jacobson ("Jacobson")
`U.S. Pat. No. 4,545,37 4 to Jacobson ("Jacobson")
`
`NUVASIVE 1005
`NUVASIVE 1005
`
`Leu et al., Percutaneous Fusion of the Lumbar Spine, Spine
`Leu et al., Percutaneous Fusion of the Lumbar Spine, Spine
`Vol. 6, No. 3, pp. 593-604 (September 1992) ("Leu")
`Vol. 6, No. 3, pp. 593-604 (September 1992) ("Leu")
`
`NUVASIVE 1006
`NUVASIVE 1006
`
`U.S. Pat. No. 5,192,327 to Brantigan ("Brantigan")
`U.S. Pat. No. 5,192,327 to Brantigan ("Brantigan")
`
`NUVASIVE 1007
`NUVASIVE 1007
`
`U.S. Pat. No. 4,917,704 to Frey et al. ("Frey")
`U.S. Pat. No. 4,917,704 to Frey et al. ("Frey")
`
`NUVASIVE 1008
`NUVASIVE 1008
`
`U.S. Pat. No. 5,015,247 to Michelson ("Michelson '247")
`U.S. Pat. No. 5,015,247 to Michelson ("Michelson '247")
`
`NUVASIVE 1009
`NUVASIVE 1009
`
`U.S. Pat. No. 5,569,290 to McAfee ("McAfee")
`U.S. Pat. No. 5,569,290 to McAfee ("McAfee")
`
`NUVASIVE 1010
`NUVASIVE 1010
`
`U.S. Pat. No. 5,772,661 to Michelson ("Michelson '661")
`U.S. Pat. No. 5,772,661 to Michelson ("Michelson '661")
`
`NUVASIVE 1011
`NUVASIVE 1011
`
`U.S. Pat. No. 8,343,224 to Lynn et al. ("Lynn")
`U.S. Pat. No. 8,343,224 to Lynn et al. ("Lynn")
`
`NUVASIVE 1012
`NUVASIVE 1012
`
`NUVASIVE 1013
`NUVASIVE 1013
`
`Affidavit of Mr. Frank E. Scherkenbach in support of Petitioner's
`Affidavit of Mr. Frank E. Scherkenbach in support of Petitioner's
`Motion for Pro Hac Vice Admission
`Motion for Pro Hac Vice Admission
`
`Resume of Mr. Frank E. Scherkenbach, provided as an exhibit
`Resume of Mr. Frank E. Scherkenbach, provided as an exhibit
`to Petitioner's Motion for Pro Hac Vice
`to Petitioner's Motion for Pro Hac Vice
`
`ii
`II
`
`NUVA_ATEC0103121
`NUVA_ATEC0103121
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 4 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15840 Page 5 of
` 11
`
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-01121P2
`Our Ref.13958-01121P2
`
`NUVASIVE 1014
`NUVASIVE 1014
`
`NUVASIVE 1015
`NUVASIVE 1015
`
`NUVASIVE 1016
`NUVASIVE 1016
`
`NUVASIVE 1017
`NUVASIVE 1017
`
`NUVASIVE 1018
`NUVASIVE 1018
`
`NUVASIVE 1019
`NUVASIVE 1019
`
`NUVASIVE 1020
`NUVASIVE 1020
`
`Cover page and Affidavit of Henry Vernon Crock, AO, MD, MS,
`Cover page and Affidavit of Henry Vernon Crock, AO, MD, MS,
`FRCS, FRACS, FRCS Ed (Hon), D. Sc (Horaris causa), of
`FRCS, FRACS, FRCS Ed (Han), D. Sc (Horaris causa), of
`Melbourne, Australia, made September 11, 2012
`Melbourne, Australia, made September 11, 2012
`
`Exhibit HVC-1 to Affidavit of Henry Vernon Crock, being a copy
`Exhibit HVC-1 to Affidavit of Henry Vernon Crock, being a copy
`of Federal Court of Australia Practice Note CM7
`of Federal Court of Australia Practice Note CM7
`
`Exhibit HVC-2 to Affidavit of Henry Vernon Crock, being a copy
`Exhibit HVC-2 to Affidavit of Henry Vernon Crock, being a copy
`of the curriculum vitae of Henry Vernon Crock
`of the curriculum vitae of Henry Vernon Crock
`
`Exhibit HVC-3 to Affidavit of Henry Vernon Crock, being a copy
`Exhibit HVC-3 to Affidavit of Henry Vernon Crock, being a copy
`of Crock, "Observations on the Management of Failed Spinal
`of Crock, "Observations on the Management of Failed Spinal
`Operations," in The Journal of Bone and Joint Surgery, Vol.
`Operations," in The Journal of Bone and Joint Surgery, Vol.
`58-B, No. 2, pp. 193-199, May 1976
`58-B, No. 2, pp. 193-199, May 1976
`
`Exhibit HVC-4 to Affidavit of Henry Vernon Crock, being a copy
`Exhibit HVC-4 to Affidavit of Henry Vernon Crock, being a copy
`of Crock, "Anterior Lumbar Interbody Fusion — Indications for its
`of Crock, "Anterior Lumbar lnterbody Fusion - Indications for its
`Use and Notes on Surgical Technique," in Clinical Orthopedics
`Use and Notes on Surgical Technique," in Clinical Orthopedics
`and Related Research, No. 165, May 1982
`and Related Research, No. 165, May 1982
`
`Exhibit HVC-5 to Affidavit of Henry Vernon Crock, being a copy
`Exhibit HVC-5 to Affidavit of Henry Vernon Crock, being a copy
`of Fujimaki et al., "The Results of 150 Anterior Lumbar
`of Fujimaki et al., "The Results of 150 Anterior Lumbar
`Interbody Fusion Operations Performed by Two Surgeons in
`lnterbody Fusion Operations Performed by Two Surgeons in
`Australia," in in Clinical Orthopedics and Related Research, No.
`Australia," in in Clinical Orthopedics and Related Research, No.
`165, May 1982
`165, May 1982
`
`Exhibit HVC-6 to Affidavit of Henry Vernon Crock, being a copy
`Exhibit HVC-6 to Affidavit of Henry Vernon Crock, being a copy
`of Crock, A Practice of Spinal Surgery, Springer-Verlag, Wein,
`of Crock, A Practice of Spinal Surgery, Springer-Verlag, Wein,
`New York, Revised 1st Edition, 1983
`New York, Revised 151 Edition, 1983
`iii
`Ill
`
`NUVA_ATEC0103122
`NUVA_ATEC0103122
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 5 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15841 Page 6 of
` 11
`
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-0112lP2
`Our Ref.13958-01121P2
`
`NUVASIVE 1021
`NUVASIVE 1021
`
`Exhibit to HVC-7 Affidavit of Henry Vernon Crock, being a copy
`Exhibit to HVC-7 Affidavit of Henry Vernon Crock, being a copy
`of Crock, A Short Practice of Spinal Surgery, Springer-Verlag,
`of Crock, A Short Practice of Spinal Surgery, Springer-Verlag,
`Wein, New York, Revised 2nd Edition, 1993
`Wein, New York, Revised 2nd Edition, 1993
`
`NUVASIVE 1022
`NUVASIVE 1022
`
`Reserved — no exhibit
`Reserved - no exhibit
`
`NUVASIVE 1023
`NUVASIVE 1023
`
`Reserved — no exhibit
`Reserved - no exhibit
`
`NUVASIVE 1024
`NUVASIVE 1024
`
`Reserved — no exhibit
`Reserved - no exhibit
`
`NUVASIVE 1025
`NUVASIVE 1025
`
`Reserved — no exhibit
`Reserved - no exhibit
`
`NUVASIVE 1026
`NUVASIVE 1026
`
`Reserved — no exhibit
`Reserved - no exhibit
`
`NUVASIVE 1027
`NUVASIVE 1027
`
`NUVASIVE 1028
`NUVASIVE 1028
`
`Page 29 of NUVASIVE 1003, hand-annotated by Dr. Sachs
`Page 29 of NUVASIVE 1003, hand-annotated by Dr. Sachs
`during Feb. 25, 2014 Deposition
`during Feb. 25, 2014 Deposition
`
`Transcript of Deposition of Dr. Barton Sachs, Conducted Feb.
`Transcript of Deposition of Dr. Barton Sachs, Conducted Feb.
`25, 2014
`25, 2014
`
`NUVASIVE 1029
`NUVASIVE 1029
`
`Second Declaration of Dr. Paul McAfee, M.D., M.B.A.
`Second Declaration of Dr. Paul McAfee, M.D., M.B.A.
`
`NUVASIVE 1030
`NUVASIVE 1030
`
`Declaration of Dr. Robert Jacobson, M.D.
`Declaration of Dr. Robert Jacobson, M.D.
`
`NUVASIVE 1031
`NUVASIVE 1031
`
`Declaration of Dr. John Brantigan, M.D.
`Declaration of Dr. John Brantigan, M.D.
`
`NUVASIVE 1032
`NUVASIVE 1032
`
`Declaration of Patrick Miles
`Declaration of Patrick Miles
`
`NUVASIVE 1033
`NUVASIVE 1033
`
`U.S. Patent No. 6,241,770 to Michelson
`U.S. Patent No. 6,241, 770 to Michelson
`
`NUVASIVE 1034
`NUVASIVE 1034
`
`U.S. Patent No. 5,397,364 to Kozak et al.
`U.S. Patent No. 5,397,364 to Kozak et al.
`
`NUVASIVE 1035
`NUVASIVE 1035
`
`U.S. Patent No. 5,792,044 to Foley et al.
`U.S. Patent No. 5,792,044 to Foley et al.
`
`iv
`IV
`
`NUVA_ATEC0103123
`NUVA_ATEC0103123
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 6 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15842 Page 7 of
` 11
`
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-01121P2
`Our Ref.13958-01121P2
`
`NUVASIVE 1036
`NUVASIVE 1036
`
`NUVASIVE 1037
`NUVASIVE 1037
`
`Friedman, Percutaneous Discectomy: An Alternative to
`Friedman, Percutaneous Discectomy: An Alternative to
`Chemonucleolysis?, Neurosurgery, Vol. 13, No. 5 (1983)
`Chemonucleolysis?, Neurosurgery, Vol. 13, No. 5 (1983)
`
`Kanter and Friedman, Percutaneous Discectomy: An
`Kanter and Friedman, Percutaneous Discectomy: An
`Anatomical Study, Neurosurgery, Vol. 16, No. 2, (1985)
`Anatomical Study, Neurosurgery, Vol. 16, No. 2, (1985)
`
`NUVASIVE 1038
`NUVASIVE 1038
`
`U.S. Patent No. 7,198,598 to Smith et al.
`U.S. Patent No. 7,198,598 to Smith et al.
`
`NUVASIVE 1039
`NUVASIVE 1039
`
`U.S. Patent No. 7,993,378 to Foley et al.
`U.S. Patent No. 7,993,378 to Foley et al.
`
`NUVASIVE 1040
`NUVASIVE 1040
`
`NUVASIVE 1041
`NUVASIVE 1041
`
`NUVASIVE 1042
`NUVASIVE 1042
`
`NUVASIVE 1043
`NUVASIVE 1043
`
`NUVASIVE 1044
`NUVASIVE 1044
`
`Transcript of Deposition of Dr. Paul McAfee, Conducted Dec. 6-
`Transcript of Deposition of Dr. Paul McAfee, Conducted Dec. 6-
`7, 2013
`7, 2013
`
`Transcript of Trial Testimony of Dr. John Brantigan, Conducted
`Transcript of Trial Testimony of Dr. John Brantigan, Conducted
`Sept. 11, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`Sept. 11, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`No. 08-CV-1512 MMA (MOD) (S.D. Cal.)
`
`Order Granting Joint Motion for Dismissal, Jul. 12, 2013, from
`Order Granting Joint Motion for Dismissal, Jul. 12, 2013, from
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 08-CV-1512
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 08-CV-1512
`MMA (MDD) (S.D. Cal.)
`MMA (MOD) (S.D. Cal.)
`
`Transcript of Trial Testimony of Dr. Gary Michelson, Conducted
`Transcript of Trial Testimony of Dr. Gary Michelson, Conducted
`Aug. 30, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`Aug. 30, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`No. 08-CV-1512 MMA (MOD) (S.D. Cal.)
`
`Transcript of Trial Testimony of Alexis Lukianov, Conducted
`Transcript of Trial Testimony of Alexis Lukianov, Conducted
`Sept. 1, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`Sept. 1, 2011 from Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`No. 08-CV-1512 MMA (MOD) (S.D. Cal.)
`
`v
`v
`
`NUVA_ATEC0103124
`NUVA_ATEC0103124
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 7 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15843 Page 8 of
` 11
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-01121P2
`Our Ref.13958-01121P2
`
`Ill.
`Ill.
`
`Jacobson discloses a direct lateral approach that meets the "coronal
`Jacobson discloses a direct lateral approach that meets the "coronal
`plane" path limitation and teaches the insertion of a fusion implant (Claims
`plane" path limitation and teaches the insertion of a fusion implant (Claims
`9-30: Ground 1-6).
`9-30: Ground 1-6).
`
`Warsaw first contends Jacobson discloses a posterolateral approach, not a direct
`Warsaw first contends Jacobson discloses a posterolateral approach, not a direct
`
`lateral approach. PO Resp., pp. 19-24. Warsaw is wrong. See Ex. 1029, Ilf 36-47. That
`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, I[I[
`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
`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
`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.
`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, 1 38. Second, Dr. Jacobson provides
`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, Ilf 4-10. Third, numerous
`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."
`Warsaw patents call Jacobson's approach "lateral," and distinguish it from "posterolateral."
`
`See, e.g., Ex. 1039, 2:28-47; see also Ex. 1029, 1 41.
`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
`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,
`implant. See PO Resp., p. 24-26. Warsaw's position is incorrect, and is irrelevant. First,
`
`Warsaw gives flawed reliance on Dr. McAfee's testimony that "[a] spine fusion anywhere
`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"
`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
`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
`that is quite different from Jacobson's reference to "fusion" in connection with a cannula
`
`positioned adjacent a spinal disc space. See Ex. 1029, 11 52, 4. To be sure, Dr. McAfee at
`positioned adjacent a spinal disc space. See Ex. 1029, ~~52, 4. To be sure, Dr. McAfee at
`
`6
`6
`
`NUVA_ATEC0103134
`NUVA_ATEC0103134
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 8 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15844 Page 9 of
` 11
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-01121P2
`Our Ref.13958-01121P2
`
`his deposition was not asked whether Jacobson's reference to "fusion" necessarily involved
`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.
`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
`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
`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,
`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
`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
`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
`dependent upon Jacobson necessarily disclosing the introduction of an implant through the
`
`cannula. Ex. 1029, Ilf 49-51. That is merely one of several reasons why a skilled artisan
`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.
`would use the Brantigan '327 or Michelson '247 implants with Jacobson's lateral cannula.
`
`Pet., pp. 18-20, 27-30, 37-40; Ex. 1001, Ilf 28-29, 32-33, 36. Further, even if an "implant"—
`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
`in Warsaw's narrow sense-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
`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
`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, 11149-52 & 4; Ex. 2038, ¶ 91.
`the early 1990s. See Ex. 1001, ~ 28; Ex. 1029, ~~ 49-52 & 4; Ex. 2038, ~ 91.
`
`IV.
`IV.
`
`Brantigan '327 discloses the lateral insertion of an implant, and even if it
`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:
`didn't, that is not necessary for an obviousness finding (Claims 17-23:
`Grounds 3-4).
`Grounds 3-4).
`
`Warsaw is wrong when it contends at pp. 26-31 of its Response that FIG. 10 of
`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, Ilf 7-17; Ex.
`Brantigan '327 does not disclose a laterally inserted implant. See Ex. 1031, ~~ 7 -17; Ex.
`
`7
`7
`
`NUVA_ATEC0103135
`NUVA_ATEC0103135
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 9 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15845 Page 10 of
` 11
`Case I PR2013-00206
`Case I PR2013-00206
`U.S. Patent No. 8,251,997
`U.S. Patent No. 8,251,997
`Our Ref. 13958-01121P2
`Our Ref.13958-01121P2
`
`Copying: Warsaw argues that the patentability of its '997 claims, first presented in
`Copying: Warsaw argues that the patentability of its '997 claims, first presented in
`
`2011, is supported by alleged NuVasive management copying that led to NuVasive's XLIF
`2011, is supported by alleged NuVasive management copying that led to NuVasive's XLIF
`
`solution, released in 2004. See PO Response, p. 59. Warsaw's argument reaches too far.
`solution, released in 2004. See PO Response, p. 59. Warsaw's argument reaches too far.
`
`First, NuVasive's XLIF solution was the result of numerous NuVasive innovations made
`First, NuVasive's XLIF solution was the result of numerous NuVasive innovations made
`
`during the 2001-2004 timeframe. See Ex. 1032, lif 14-16. Further, the only resemblance
`during the 2001-2004 timeframe. See Ex. 1032, ~~ 14-16. Further, the only resemblance
`
`that NuVasive's XLIF solution bears with the solution described and claimed in the '997
`that NuVasive's XLIF solution bears with the solution described and claimed in the '997
`
`patent is that both use a lateral approach and both employ the idea of "sequential dilation."
`patent is that both use a lateral approach and both employ the idea of "sequential dilation."
`
`But both of those concepts pre-date the '997 patent. See Ex. 1004 (disclosing a lateral
`But both of those concepts pre-date the '997 patent. See Ex. 1004 (disclosing a lateral
`
`approach in 1982); Ex. 1001, ¶ 24 (discussing that sequential dilation was already well
`approach in 1982); Ex. 1001, ~ 24 (discussing that sequential dilation was already well
`
`known before 1995). Further, "ELIF" (see Resp., p. 60) is not XLIF, is very different from
`known before 1995). Further, "ELIF" (see Resp., p. 60) is not XLIF, is very different from
`
`the '997 patent and XLIF, and indeed Warsaw does not even contend ELIF embodies the
`the '997 patent and XLIF, and indeed Warsaw does not even contend ELIF embodies the
`
``997 patent claims. Thus, Warsaw's copying arguments also fail. Ex. 1029, Ilf 103-05.
`'997 patent claims. Thus, Warsaw's copying arguments also fail. Ex. 1029, ~~ 103-05.
`
`Xl. Conclusion
`Conclusion
`XI.
`
`Accordingly, NuVasive requests that all claims at issue in this proceeding (claims 9-
`Accordingly, NuVasive requests that all claims at issue in this proceeding (claims 9-
`
`30) be found invalid at least upon the grounds for which this Board has instituted review.
`30) be found invalid at least upon the grounds for which this Board has instituted review.
`
`Dated: Mar. 11, 2014
`Dated: Mar. 11 2014
`
`
`
`Respectfully submitted,
`Respectfully submitted,
`
`/Stephen R. Schaefer, Reg. No. 37,927/
`/Stephen R. Schaefer, Reg. No. 37,927/
`Stephen R. Schaefer, Reg. No. 37,927
`Stephen R. Schaefer, Reg. No. 37,927
`
`/Michael T. Hawkins Reg. No. 57,867/
`/Michael T. Hawkins Reg. No. 57,867/
`Michael T. Hawkins, Reg. No. 57,867
`Michael T. Hawkins, Reg. No. 57,867
`
`(Trial No. IPR2013-00208)
`(Trial No. I PR2013-00208)
`
`Attorneys for Petitioner
`Attorneys for Petitioner
`
`15
`15
`
`NUVA_ATEC0103143
`NUVA_ATEC0103143
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 10 of 11
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 132-15 Filed 12/03/18 PageID.15846 Page 11 of
` 11
`
`CERTIFICATE OF SERVICE
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
`
`that on March 11, 2014, a complete and entire copy of this Petitioner's Reply to
`that on March 11,2014, a complete and entire copy of this Petitioner's Reply to
`
`Patent Owner's Response and its exhibits were provided via email to the Patent
`Patent Owner's Response and its exhibits were provided via email to the Patent
`
`Owner by serving the correspondence email addresses of record as follows:
`Owner by serving the correspondence email addresses of record as follows:
`
`Thomas H. Martin
`Thomas H. Martin
`Wesley C. Meinerding
`Wesley C. Meinerding
`Martin & Ferraro, LLP
`Martin & Ferraro, LLP
`1557 Lake O'Pines Street, NE
`1557 Lake O'Pines Street, NE
`Hartville, OH 44632
`Hartville, OH 44632
`
`Email: tmartin@martinferraro.com
`Email: tmartin@martinferraro.com
`Email: docketing@martinferraro.com
`Email: docketing(m.martinferraro. com
`=
`
`/Edward G. Faeth/
`/Edward G. Faeth/
`Edward G. Faeth
`Edward G. Faeth
`Fish & Richardson P.C.
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`Minneapolis, MN 55402
`(858) 678-5667
`(858) 678-5667
`
`NUVA_ATEC0103144
`NUVA_ATEC0103144
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. v. NUVASIVE INC.
`IPR2019-00362, Ex. 1060, p. 11 of 11
`
`