Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3390 Page 1 of 24
`
`APPENDIX F
`TO DECLARATION OF JIM A. YOUSSEF, M.D.
`
`IN SUPPORT OF NUVASIVE'S MOTION FOR
`PRELIMINARY INJUNCTION
`
`NUVASIVE - EXHIBIT 2014
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`
`
`APPENDIX F
`TO DECLARATION OF JIM A. YOUSSEF, M.D.
`
`IN SUPPORT OF NUVASIVE'S MOTION FOR
`PRELIMINARY INJUNCTION
`
`NUVASIVE - EXHIBIT 2014
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3391 Page 2 of 24
`
`APPENDIX F
`
`8,361,156 Infringement Chart
`
`
`Claim
`[1A] A spinal fusion implant
`of non-bone construction
`positionable within an
`interbody space between a
`first vertebra and a second
`vertebra, said implant
`comprising:
`
`Accused Instrumentality
`The Battalion™ Lateral Spacer is a spinal fusion implant of non-bone construction positionable within an
`interbody space between a first vertebra and a second vertebra.
`
`In particular, the Battalion™ Lateral Spacer is manufactured from PEEK Optima LT1 with/without titanium
`coated endplates and tantalum markers. The Battalion™ Lateral Spacer is configured to be placed into an
`interbody space between a first and second vertebra.
`
`
`[Exhibit U to Complaint (Battalion™ Lateral Thoracolumbar Surgical Technique Guide) at 28]
`
`
`
`
`
`
`
`APPENDIX F
`PAGE 501
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3392 Page 3 of 24
`
`Claim
`
`Accused Instrumentality
`
`
`
`[Exhibit U to Complaint at 28]
`
`The Battalion™ Lateral Spacer includes an upper surface including anti-migration elements to contact said
`first vertebra when said implant is positioned within the interbody space, a lower surface including anti-
`migration elements to contact said second vertebra when said implant is positioned within the interbody
`space, a distal wall, a proximal wall, a first sidewall, and a second sidewall generally opposite from the first
`sidewall, wherein said distal wall, proximal wall, first sidewall, and second sidewall comprise a radiolucent
`material.
`
`The upper surface and lower surface of the Battalion™ Lateral Spacer include anti-migration elements to
`contact a first and second vertebra, respectively, when the Battalion™ Lateral Spacer is positioned within
`the interbody space.
`
`
`[1B] an upper surface
`including anti-migration
`elements to contact said first
`vertebra when said implant is
`positioned within the
`interbody space, a lower
`surface including anti-
`migration elements to contact
`said second vertebra when
`said implant is positioned
`within the interbody space, a
`distal wall, a proximal wall, a
`first sidewall, and a second
`sidewall generally opposite
`from the first sidewall,
`wherein said distal wall,
`proximal wall. first sidewall,
`and second sidewall comprise
`
`
`
`-2-
`
`APPENDIX F
`PAGE 502
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3393 Page 4 of 24
`
`Claim
`a radiolucent material;
`
`Accused Instrumentality
`
`
`[Exhibit V to Complaint (Alphatec’s webpage advertising the Battalion™ Lateral Spancer)]
`
`
`The Battalion™ Lateral Spacer comprises a distal wall, a proximal wall, a first sidewall, and a second
`sidewall generally opposite from the first sidewall. The first sidewall is located anterior (toward the front of
`the patient), while the second sidewall is located posterior (toward the back of the patient). The proximal
`wall is the side in which the surgeon attaches the implant to the inserter for insertion, whereas the distal wall
`is the opposing side of the insertion point. The definition of the proximal wall and distal wall will depend
`on whether the implant is inserted on the left or right side of the patient. The annotated figure shows the
`situation where the implant is inserted from the right side of the patient.
`
`
`
`
`-3-
`
`APPENDIX F
`PAGE 503
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3394 Page 5 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Exhibit V to Complaint]
`
`
`
`
`The distal wall, the proximal wall, the first sidewall, and the second sidewall are manufactured from PEEK
`Optima LT1, a radiolucent material.
`
`
`[1C] wherein said implant has
`a longitudinal length
`extending from a proximal
`end of said proximal wall to a
`distal end of said distal wall,
`said implant has a maximum
`lateral width extending from
`said first sidewall to said
`
`[Exhibit U to Complaint at 28]
`
`The Battalion™ Lateral Spacer has a longitudinal length extending from a proximal end of said proximal
`wall to a distal end of said distal wall, said implant has a maximum lateral width extending from said first
`sidewall to said second sidewall along a medial plane that is generally perpendicular to said longitudinal
`length, and said longitudinal length is greater than said maximum lateral width.
`
`The Battalion™ Lateral Spacer has a longitudinal length and a maximum lateral width. The maximum
`lateral width extends from the first sidewall to the second sidewall along a medial plane that is generally
`perpendicular to the longitudinal length. The longitudinal length is greater than the maximum lateral width.
`
`
`
`
`
`-4-
`
`APPENDIX F
`PAGE 504
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3395 Page 6 of 24
`
`Accused Instrumentality
`All versions of the Battalion™ Lateral Spacer have the features described in this paragraph.
`
`
`Claim
`second sidewall along a
`medial plane that is generally
`perpendicular to said
`longitudinal length, and said
`longitudinal length is greater
`than said maximum lateral
`width;
`
`[Exhibit V to Complaint]
`
`
`
`
`For example, one version of the Battalion™ Lateral Spacer has a maximum lateral width of 18mm and a
`longitudinal width of 60mm.
`
`
`[1D] at least a first fusion
`aperture extending through
`
`[Ex. AM to Complaint (FDA Access GUDID Database search results for “Battalion Lateral”) at 1]
`
`The Battalion™ Lateral Spacer includes at least a first fusion aperture extending through said upper surface
`and lower surface and configured to permit bone growth between the first vertebra and the second vertebra
`
`
`
`
`
`-5-
`
`APPENDIX F
`PAGE 505
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3396 Page 7 of 24
`
`Claim
`said upper surface and lower
`surface and configured to
`permit bone growth between
`the first vertebra and the
`second vertebra when said
`implant is positioned within
`the interbody
`space, said first fusion
`aperture having: a
`longitudinal aperture length
`extending generally parallel to
`the longitudinal length of said
`implant, and a lateral aperture
`width extending between said
`first sidewall to said second
`sidewall, wherein the
`longitudinal aperture length is
`greater than the lateral
`aperture width; and
`
`Accused Instrumentality
`when said implant is positioned within the interbody space, said first fusion aperture having: a longitudinal
`aperture length extending generally parallel to the longitudinal length of said implant, and a lateral aperture
`width extending between said first sidewall to said second sidewall, wherein the longitudinal aperture length
`is greater than the lateral aperture width.
`
`The Battalion™ Lateral Spacer has a fusion aperture extending through the upper surface and the lower
`surface of the implant to allow a surgeon to pack the implant with the appropriate biologics, allograft or
`autograft to permit bone growth.
`
`
`
`[Exhibit U to Complaint at 28]
`
`
`
`
`[Exhibit U to Complaint at 28]
`
`The fusion aperture of the Battalion™ Lateral Spacer has a longitudinal aperture length generally parallel to
`the implant longitudinal length. The fusion aperture has a lateral aperture width extending between the first
`sidewall to the second sidewall. The longitudinal aperture length is greater than the lateral aperture width.
`
`
`
`
`
`
`-6-
`
`
`
`APPENDIX F
`PAGE 506
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3397 Page 8 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Exhibit V to Complaint]
`
`The Battalion™ Lateral Spacer includes at least first and second radiopaque markers oriented generally
`parallel to a height of the implant, wherein said first radiopaque marker extends into said first sidewall at a
`position proximate to said medial plane, and said second radiopaque marker extends into said second
`sidewall at a position proximate to said medial plane.
`
`The Battalion™ Lateral Spacer has first and second markers made of tantalum (i.e., radiopaque material)
`oriented generally parallel to the height of the implant. The first radiopaque marker extends into the first
`sidewall at a position proximate to the medial plane. The second radiopaque marker extends into the second
`sidewall at a position proximate to the medial plane.
`
`
`[1E] at least first and second
`radiopaque markers oriented
`generally parallel to a height
`of the implant. wherein said
`first radiopaque marker
`extends into said first sidewall
`at a position proximate to said
`medial plane, and said second
`radiopaque marker extends
`into said second sidewall at a
`position proximate to said
`medial plane.
`
`
`
`[Exhibit U to Complaint at 28]
`
`
`
`
`
`-7-
`
`[Exhibit V to Complaint]
`
`
`
`APPENDIX F
`PAGE 507
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3398 Page 9 of 24
`
`Claim
`
`Accused Instrumentality
`
`[2A] The spinal fusion
`implant of claim 1, wherein
`the first and second
`radiopaque markers are
`substantially equally spaced
`apart from said proximal end
`of said proximal wall by a
`first longitudinal distance.
`
`[Exhibit U to Complaint at 25]
`
`
`
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein the first and second
`radiopaque markers are substantially equally spaced apart from said proximal end of said proximal wall by
`a first longitudinal distance.
`
`The two radiopaque markers of the Battalion™ Lateral Spacer are spaced such that they are substantially
`equal from the proximal wall along a longitudinal distance.
`
`
`
`
`-8-
`
`APPENDIX F
`PAGE 508
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3399 Page 10 of 24
`
`Claim
`
`Accused Instrumentality
`
`[5A] The spinal fusion
`implant of claim 1, further
`including at least one
`receiving aperture position at
`said proximal wall wherein
`said longitudinal length is
`greater than 40 mm.
`
`[Exhibit V to Complaint]
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, further including at least one
`receiving aperture position at said proximal wall wherein said longitudinal length is greater than 40 mm.
`
`The Battalion™ Lateral Spacer has at least one receiving aperture at its proximal wall in order to engage the
`Battalion™ LLIF Inserter. For example, the Alphatec Surgical Guide instructs a surgeon to “[a]ttach the
`implant to the Inserter by lining up the implant’s lateral notches with the tangs of the Battalion LLIF
`Inserter.” The lateral notches are placed along the proximal wall.
`
`
`
`
`
`
`-9-
`
`APPENDIX F
`PAGE 509
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3400 Page 11 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Exhibit V to Complaint]
`
`
`
`
`[Ex. U to Complaint at 24]
`
`
`
`
`
`
`-10-
`
`APPENDIX F
`PAGE 510
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3401 Page 12 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Ex. U to Complaint at 24]
`
`
`
`
`The Battalion™ Lateral Spacer has a longitudinal length greater than 40 mm. For example, one version of
`the Battalion™ Lateral Spacer has a longitudinal length of 60 mm, and another version has a longitudinal
`length of 50 mm.
`
`
`[Ex. AM to Complaint at 1]
`
`
`
`
`
`-11-
`
`APPENDIX F
`PAGE 511
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3402 Page 13 of 24
`
`Claim
`
`Accused Instrumentality
`
`[9A] The spinal fusion
`implant of claim 1, wherein
`said maximum lateral width of
`said implant is approximately
`18 mm.
`
`
`Exhibit W to Declaration of Jim A. Youssef, M.D. in support of NuVasive’s Motion for Preliminary Injunction (FDA Access
`GUDID Database search results for “Battalion Lateral Spinal Spacer System 00190376040301”) at 2]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said maximum lateral width
`of said implant is approximately 18 mm.
`
`For example, at least two versions of the Battalion™ Lateral Spacer have a maximum lateral width of 18
`mm.
`
`
`
`-12-
`
`APPENDIX F
`PAGE 512
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3403 Page 14 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Ex. AM to Complaint at 1]
`
`
`
`
`Exhibit W to Declaration of Jim A. Youssef, M.D. in support of NuVasive’s Motion for Preliminary Injunction (FDA Access
`GUDID Database search results for “Battalion Lateral Spinal Spacer System 00190376040301”) at 1]
`
`As another example, Alphatec offers a version of the Battalion™ Lateral Spacer that is 22mm wide.
`
`
`
`
`-13-
`
`APPENDIX F
`PAGE 513
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3404 Page 15 of 24
`
`Claim
`
`Accused Instrumentality
`
`[10A] The spinal fusion
`implant of claim 1, wherein
`said radiolucent material
`comprises PEEK.
`
`[Ex. AM to Complaint at 1]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said radiolucent material
`comprises PEEK.
`
`In particular, the Battalion™ Lateral Spacer is manufactured from PEEK Optima LT1, a radiolucent
`material.
`
`
`
`
`[12A] The spinal fusion
`implant of claim 1, wherein
`said upper and lower surfaces
`are generally parallel to one
`
`[Exhibit U to Complaint at 28]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said upper and lower
`surfaces are generally parallel to one another.
`
`Alphatec offers a version of the Battalion™ Lateral Spacer at 0°, meaning that the implant is not tapered
`
`
`
`
`
`-14-
`
`APPENDIX F
`PAGE 514
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3405 Page 16 of 24
`
`Claim
`another.
`
`Accused Instrumentality
`and its upper and lower surfaces are generally parallel to one another. See also [Exhibit V to Complaint at
`1] noting that the Battalion™ Lateral Spacer is “available in Parallel. . . with a variety of width and height
`options for the lumbar and thoracic spine.”).
`
`
`[Ex. AM to Complaint at 1]
`
`
`
`[13A] The spinal fusion
`implant of claim 1, wherein
`said upper and lower surfaces
`are generally angled relative
`to one another to
`approximately correspond to
`lordosis of a lumbar spine
`when said implant is
`positioned within the
`interbody space.
`
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said upper and lower
`surfaces are generally angled relative to one another to approximately correspond to lordosis of a lumbar
`spine when said implant is positioned within the interbody space.
`
`Alphatec offers versions of the Battalion™ Lateral Spacer to be tapered according to at least 6° or 15°
`lordosis configurations. When inserted into the interbody space of the patient’s lumbar spine, the implant’s
`upper and lower surfaces will correspond to the degree lordosis of the implant. See also Exhibit V to
`Complaint at 1 (noting that the Battalion™ Lateral Spacer is “available in. . . Lordotic with a variety of
`width and height options for the lumbar and thoracic spine.”).
`
`
`
`
`-15-
`
`APPENDIX F
`PAGE 515
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3406 Page 17 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Ex. AM to Complaint at 1]
`
`
`
`
`[14A] The spinal fusion
`implant of claim 1, wherein
`
`[Ex. AM to Complaint at 1]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said first fusion aperture is
`one of generally rectangular and generally oblong in shape.
`
`
`
`
`
`-16-
`
`APPENDIX F
`PAGE 516
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3407 Page 18 of 24
`
`Claim
`said first fusion aperture is
`one of generally rectangular
`and generally oblong in shape.
`
`Accused Instrumentality
`The apertures of the Battalion™ Lateral Spacer are generally rectangular and oblong in shape.
`
`
`[Exhibit V to Complaint]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, further comprising a medial support
`extending between the first and second sidewalls.
`
`
`
`[15A] The spinal fusion
`implant of claim 1, further
`comprising a medial support
`extending between the first
`and second sidewalls.
`
`
`
`-17-
`
`[Exhibit V to Complaint]
`
`
`
`APPENDIX F
`PAGE 517
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3408 Page 19 of 24
`
`Claim
`[16A] The spinal fusion
`implant of claim 15, wherein
`said medial support is
`positioned along said medial
`plane.
`
`Accused Instrumentality
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 15, wherein said medial support is
`positioned along said medial plane.
`
`The Battalion™ Lateral Spacer contains first and second sidewalls bisected by a medial support. The
`medial support extending between the first and second sidewalls is positioned along a medial plane.
`
`
`[Exhibit V to Complaint]
`
`
`
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, further including a second fusion
`aperture extending through said upper surface and lower surface and configured to permit bone growth
`between the first vertebra and the second vertebra when said implant is positioned within the interbody
`space.
`
`The Battalion™ Lateral Spacer includes a second fusion aperture extending from the upper and lower
`surface of the implant.
`
`
`[17A] The spinal fusion
`implant of claim 1, further
`including a second fusion
`aperture extending through
`said upper surface and lower
`surface and configured to
`permit bone growth between
`the first vertebra and the
`second vertebra when said
`implant is positioned within
`the interbody space.
`
`
`
`-18-
`
`APPENDIX F
`PAGE 518
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3409 Page 20 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Exhibit V to Complaint]
`
`The second aperture of the Battalion™ Lateral Spacer is intended to be packed with osteoinductive (i.e.,
`bone growth) material such as biologics, allograft of autograft to allow for fusion between two vertebra
`when positioned in the interbody space.
`
`
`
`
`[Exhibit U to Complaint at 28]
`
`
`[18A] The spinal fusion
`implant of claim 17, wherein
`said second fusion aperture is
`
`[Exhibit U to Complaint at 28]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said second fusion aperture
`is separated from said first fusion aperture by a medial support.
`
`
`
`
`
`
`-19-
`
`APPENDIX F
`PAGE 519
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3410 Page 21 of 24
`
`Claim
`separated from said first
`fusion aperture by a medial
`support.
`
`Accused Instrumentality
`
`[19A] The spinal fusion
`implant of claim 1, wherein
`said anti-migration elements
`of said upper surface comprise
`a plurality of ridges.
`
`[Exhibit V to Complaint]
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said anti-migration elements
`of said upper surface comprise a plurality of ridges.
`
`The Battalion™ Lateral Spacer contains a plurality of ridges on its upper surface.
`
`
`
`
`
`-20-
`
`[Exhibit V to Complaint]
`
`
`
`APPENDIX F
`PAGE 520
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3411 Page 22 of 24
`
`Claim
`[20A] The spinal fusion
`implant of claim 19, wherein
`said plurality of ridges extend
`generally perpendicular to
`said longitudinal length.
`
`Accused Instrumentality
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said plurality of ridges
`extend generally perpendicular to said longitudinal length.
`
`The Battalion™ Lateral Spacer contains anti-migration ridge elements on the upper surface of the implant.
`A portion of these ridges extend generally perpendicular to the longitudinal length of the implant.
`
`
`[Exhibit V to Complaint]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, wherein said implant has a height
`extending from said upper surface to said lower surface, wherein said maximum lateral width is greater than
`said height.
`
`
`
`
`[24A] The implant of claim 1,
`wherein said implant has a
`height extending from said
`upper surface to said lower
`surface, wherein said
`maximum lateral width is
`greater than said height.
`
`
`
`-21-
`
`APPENDIX F
`PAGE 521
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3412 Page 23 of 24
`
`Claim
`
`Accused Instrumentality
`
`[Exhibit V to Complaint]
`
`
`
`
`For example, in one version of the Battalion™ Lateral Spacer, the height is 16 mm, which is less than the
`maximum lateral width of 18 mm.
`
`
`[Ex. AM to Complaint at 1]
`
`In another version of the Battalion™ Lateral Spacer, the height is 14 mm, which is less than the maximum
`lateral width of 18 mm.
`
`
`
`
`
`-22-
`
`APPENDIX F
`PAGE 522
`
`
`
`Case 3:18-cv-00347-CAB-MDD Document 37-74 Filed 04/05/18 PageID.3413 Page 24 of 24
`
`Claim
`
`Accused Instrumentality
`
`[27A] The spinal fusion
`implant of claim 1, further
`comprising an osteoinductive
`material positioned with said
`first fusion aperture.
`
`
`Exhibit W to Declaration of Jim A. Youssef, M.D. in support of NuVasive’s Motion for Preliminary Injunction (FDA Access
`GUDID Database search results for “Battalion Lateral Spinal Spacer System 00190376040301”) at 2]
`
`The Battalion™ Lateral Spacer is the spinal fusion implant of claim 1, further comprising an osteoinductive
`material positioned with said first fusion aperture.
`
`The Battalion™ Lateral Spacer contains a first fusion aperture that is intended to be packed with
`osteoinductive (i.e., bone growth) material such as biologics, allograft of autograft.
`
` [Exhibit U to Complaint at 28]
`
`
`[Exhibit U to Complaint at 28]
`
`
`
`
`
`
`
`-23-
`
`APPENDIX F
`PAGE 523
`
`
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