Patent Owner’s Demonstratives
`Alphatec Holdings, Inc. and Alphatec Spine, Inc. v. NuVasive, Inc.
`
`IPR2019-00361, IPR2019-00362, IPR2019-00546
`U.S. Patent Nos. 8,187,334 and 8,361,156
`‐ Representative citations to IPR2019-00361 unless otherwise indicated.
`
`APRIL 3, 2020
`
`
`Alphatec Holdings, Inc. and Alphatec Spine, Inc. v. NuVasive, Inc.
`
`IPR2019-00361, IPR2019-00362, IPR2019-00546
`U.S. Patent Nos. 8,187,334 and 8,361,156
`‐ Representative citations to IPR2019-00361 unless otherwise indicated.
`
`APRIL 3, 2020
`
`
`
`The Challenged Claims
`
`IPR2019-00361: The ’334 Patent
`• Claims 6-9 and 18
`
`IPR2019-00362: The ’156 Patent
`• Claims 1-3, 5, 9-10, 12-21, 23-24, and 27
`
`IPR2019-00546: The ’334 Patent
`• Claim 16
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`2
`
`
`
`Each Challenged Claim Must Be Evaluated As a Whole
`
`‐ EX1001; Paper 28, Patent Owner Response (“POR”), 20-
`24; Paper 41, Patent Owner Sur-Reply, 4-5
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`3
`
`
`
`Challenged Claims of the ’156 Patent
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐
`
`IPR2019-00362 EX1001
`
`4
`
`
`
`Exemplary Lumbar Fusion Implants
`
`‐ EX1001, Fig. 2; Pet. (Paper 2) 7; 362 IPR Pet. 5
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`5
`
`
`
`Burdens of Proof
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`6
`
`
`
`Petitioner Improperly Attempts to Shift Burden of Proof
`
`Petitioner bears the burden for:
`
`• Collateral estoppel
`
`• Claim construction
`
`• Unpatentability over printed
`publication prior art
`
`“In an inter partes review, the
`burden of persuasion is on the
`petitioner to prove ‘unpatentability
`by a preponderance of the evidence,’
`35 U.S.C. § 316(e), and that burden
`never shifts to the patentee.”
`
`-
`
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364, 1375 (Fed. Cir. 2016)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 23; Sur-Reply, 5-6, 13
`7
`
`
`
`Petitioner Attempts to Misuse Estoppel
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`8
`
`
`
`Petitioner Bears the Burden at Final Written Decision
`• “If Patent Owner intends to reassert this argument during trial, Patent Owner should
`explain why it is not estopped from arguing that the limitations of claim 1 incorporated
`into challenged claims 6-9 and 18 demonstrate patentability over Frey, Michelson, and Berry,
`when those same limitations were determined to be unpatentable over Frey and Michelson.”
`
`• “Also, as indicated above, if Patent Owner intends to reassert this argument during trial,
`Patent Owner should explain why it is not estopped from arguing limitations of claim
`1, even if it is in the context of arguing for the challenged dependent claims.”
`
`• “As discussed above for the challenge based on Frey, Michelson, and Berry, if Patent Owner
`intends to assert arguments during trial regarding limitations in cancelled claim 1, Patent
`Owner should explain why it is not estopped from arguing limitations of claim 1, even
`if it is in the context of arguing the dependent claims challenged based on references not
`presented in the previous proceeding.”
`
`• “As discussed above, Patent Owner presents arguments regarding a limitation found in
`cancelled claim 1, and if Patent Owner intends to present arguments during trial regarding
`limitations in cancelled claim 1, Patent Owner should explain why it is not estopped
`from arguing limitations of claim 1, even if it in the context of arguing the dependent claims
`challenged based on references not previously asserted.”
`‐
`Institution Decision, 21-22, 35, 37; POR 1, 20-24, 69
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`9
`
`
`
`Petitioner Misinterprets the Effect of Claim
`Cancellation
`• Petitioner must show the specific
`combination of teachings it asserted in
`its petition renders obvious each
`challenged claim as a whole.
`• Petition’s failure to satisfy its burden
`regarding a claim element is fatal even
`though the element is incorporated by
`dependency from a cancelled claim.
`‐ General Electric Co., IPR2017-00428,
`Paper 38, at 5-7, 16, 31
`‐ MaxLinear, IPR2015-00592, Paper
`87, at 36-37
`• Petitioner failed to establish that claim 1
`may be treated as prior art to cancel the
`challenged claims.
`
`Gillette Co. v. S.C. Johnson & Son, Inc.,
`919 F.2d 720, 724 (Fed. Cir. 1990).
`
`“Focusing on the
`obviousness of
`substitutions and
`differences, instead of on
`the invention as a whole,
`is a legally improper way
`to simplify the often
`difficult determination of
`obviousness.”
`
`-
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 20-25; Sur-Reply, 4-5
`10
`
`
`
`Petitioner Failed to Establish Elements of Estoppel
`
`• Petitioner has the burden to demonstrate its assertions are the same as those
`previously, actually and fully litigated and necessary for judgment.
`
`• Petitioner not only failed to establish the Petitions assert, with particularity, the
`same theory of unpatentability as prior IPRs, it argued the opposite was true:
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Pet. 25; POR, 20-21, 24-30
`11
`
`
`
`Petitioner Concedes Different Theories of Unpatentability
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Pet. 26; POR, 20-21, 25-29
`12
`
`
`
`Petitioner Failed to Establish Identity of Issues
`
`• Whether the features relied upon in
`the Petition as first and second fusion
`apertures satisfy the claim
`requirements in combination with the
`remaining requirements of each claim
`as a whole has never been litigated.
`
`• NuVasive does not seek to recapture
`claim 1 of the ’334 patent.
`
`“[T]he Board did not make
`findings as to whether any
`of the other claimed
`limitations (such as fusion
`apertures or anti-migration
`teeth) are disclosed in the
`prior art.”
`
`• The Federal Circuit vacated the
`decision against claim 16 and the
`Board terminated.
`
`EX1005 (In re: NuVasive, Inc., No. 2015-1670,
`-
`Opinion (Fed. Cir. Dec. 7, 2016)), 15; see also id., 16
`(noting that motivation and reasonable expectation of
`success for modular implants also never addressed)
`
`‐ POR, 25-29; Sur-Reply, 4-5; EX1023 (In re: NuVasive, Inc., Nos. 2015-1672 & 2015-1673, Opinion (Nov. 9, 2016)), 2, 21
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`13
`
`
`
`Petitioner Admits that the Patentability of Claims 6-9
`Has Never Been Litigated
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Pet. 25; POR, 26
`14
`
`
`
`Patentability of Claim 18 Over Michelson Modularity
`Has Been Litigated and Confirmed
`The Board Previously Found Claim 18 Patentable over Michelson:
`• “[W]e determine that Petitioner . . . has not shown by a preponderance of the evidence that
`claim 18 of the ’334 patent is unpatentable.”
`• “Petitioner argues that Michelson discloses an implant that ‘would have a . . . Maximum
`lateral width in the range of 14 to 26.’ Patent Owner, however, points out that, ‘Michelson
`discloses no implant that is longer than 40 mm and has a width of 18 mm.’”
`• “Michelson discloses an implant with a preferred width of 26 mm (or between 24 mm and 32
`mm) would approximate the depth of the vertebrae . . . For example, if the total width of at
`least two spinal fusion implants measures 26 mm (i.e., the depth of the vertebrae), then each
`implant would measure 26 mm/2 implants = 13 mm.”
`• “[T]he Board…found that if one combined (1) Michelson’s teaching that the preferred overall
`width of the implant was 26 mm with (2) Michelson’s teachings that at least two ‘narrower’
`implants could be combined to fit that space then at least one of the ‘narrower’ implants
`would be at most 13 mm wide[.]”
`
`‐ POR 27, 29, 32, 36; Sur-Reply 5; EX1004 (IPR2013-00507, Paper 43, Final Written Decision), 2, 4, 9-10; EX1005
`(In re: NuVasive, Inc., No. 2015-1670, Opinion (Fed. Cir. Dec. 7, 2016)), 7-8, 10-12, 14-19; EX1023 (In re: NuVasive,
`Inc., Nos. 2015-1672 & 2015-1673, Opinion (Fed. Cir. Nov. 9, 2016)), 21; EX1023 (IPR2013-00507, Paper 43, Final
`Written Decision), 97, 99, 104-05; EX1023 (IPR2013-00508, Final Written Decision), 113, 117, 125
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`15
`
`
`
`Intervening Changes in Law and Procedure
`
`• Patent Owner Sur-Reply as of right
`
`• Changed claim construction standard
`
`• PPC Broadband forbids the Board from ignoring nexus presumption
`
`• SAS binds Petitioner to the case made out in the Petition
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 33-39; Sur-Reply, 3-6
`16
`
`
`
`Intervening Changes in Law: Claim Construction
`
`“[A] significant change in the
`‘legal atmosphere’–whether in
`the form of new legislation, a new
`court decision, or even a new
`administrative ruling—can justify
`a later court’s refusal to give
`collateral estoppel effect to an
`earlier decision.”
`
`The Petition failed to address the
`change in claim construction
`standard:
`• Undisputed the prior IPRs were
`governed by BRI
`
`• Undisputed the present petitions
`are governed by Phillips
`
`-
`
`Bingaman v. Dep’t of Treasury, 127 F.3d 1431,
`1438 (Fed. Cir. 1997)
`
`• This intervening change warrants a
`new determination
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 35-36; Sur-Reply, 5
`17
`
`
`
`Intervening Changes in Law: Claim Construction
`
`• Cancellation of claim 1 was predicated on an assumption that each of Michelson’s modular
`members qualifies as the implant required by claim 1
`
`• Michelson discloses that its narrower implants 1000 are modular members that are
`“combined in a modular fashion for insertion” between the vertebrae.
`
`• Dr. Youssef explains: “narrower” implants 1000 are combined together to form a single
`modular spinal implant before being inserted between the vertebrae.
`
`• Under Phillips, a single Michelson modular member (implant 1000) thus does not by itself
`constitute a “spinal fusion implant” as required by the claims.
`
`‐ The results would have been different under the changed claim construction standard.
`
`• Dow Chemical Co. v. Nova Chemicals Corp., 803 F.3d 620, 624 (Fed. Cir. 2015)
`(intervening change in law provides an exception to issue preclusion)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 35-36
`18
`
`
`
`Intervening Changes in Law: Objective Indica Nexus
`• Petitioner admits PPC Broadband forbids the Board from ignoring nexus
`presumption, implicitly conceding objective indicia must be relitigated.
`
`“When the patentee has presented undisputed evidence that its
`product is the invention disclosed in the challenged claims, it is error
`for the Board to find the contrary without further explanation. . . .
`[W]e presume that any commercial success of these products is due
`to the patented invention. This is true even when the product has
`additional, unclaimed features.”
`
`-
`
`PPC Broadband v. Corning Optical Commc’ns RF, 815 F.3d 734, 746-47 (Fed. Cir. 2016).
`
`‐ POR, 33, 37-38; Paper 35 (Reply), 8; Sur-Reply, 3-6
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`19
`
`
`
`Intervening Changes in Law: SAS
`
`SAS dictates that the scope of the
`present proceeding “is limited by
`the prior art and the arguments in
`the petition.”
`• SAS is an intervening change in
`law reflected in intervening Trial
`Practice Guide Updates that
`precludes application of collateral
`estoppel.
`‐ MaxLinear, Inv. v. Cresta
`Tech. Corp., IPR2015-00592,
`Paper 87, at 36-37
`
`“Congress told the Director what
`he must say yes or no to: an
`inter partes review that
`proceeds ‘in accordance with’
`or ‘in conformance to’ the
`petition.”
`
`SAS Inst., Inc. v. Iancu,
`-
`584 U.S. --- , 138 S. Ct. 1355-56 (2018)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR 23-24, 38-39
`20
`
`
`
`Collateral Estoppel Is An Equitable Doctrine
`
`Application of collateral
`estoppel here would be
`inequitable
`• NuVasive would be barred from
`defending different claims
`against different grounds
`• Petitioner would still be
`permitted to relitigate issues
`where Board improperly placed
`burden on NuVasive in prior IPR
`
`“[I]t’s often the case that you have
`multiple cases raising allegations of
`invalidity against . . . The same patent.
`It doesn’t mean that I’m going to
`import the arguments made by one
`petitioner in one case into arguments
`made by a different petitioner in a
`different case, right. Clearly I wouldn’t
`do that.”
`
`-
`
`EX2045, 28:8-14; see also id., 32:16-22
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 30-31
`21
`
`
`
`Petitioner Failed to Establish Board Power to Cancel
`Claims Based on Common Law Estoppel
`Petitioner failed to show the Board has any authority to cancel
`challenged claims based on estoppel
`• Petitioner failed to address any cases cited in the PORs showing that the
`Board lacks common law authority
`
`‐ Michigan v. EPA, 268 F.3d 1075, 1081 (D.C. Cir. 2001)
`
`‐ Louisiana Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 374 (1986)
`
`‐ CAB v. Delta Air Lines, Inc., 367 U.S. 316, 322 (1961)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 21-24, 39-41; Sur-Reply, 2-6
`22
`
`
`
`Petitioner Failed to Establish Board Power to Cancel
`Claims Based on Common Law Estoppel
`Petitioner failed to show the Board has any authority to cancel
`challenged claims based on estoppel
`• The Board may not apply even a well-settled common law doctrine as a rule
`of decision when Congress has addressed the subject matter at issue without
`expressly authorizing the doctrine for the Board’s use.
`‐ Arista Networks, Inc. v. Cisco Systems, Inc., 908 F.3d 792, 802-04 (Fed.
`Cir. 2018) (Board lacks authority to apply common law doctrine because
`Congress unambiguously addressed who may file a petition without
`providing for assignor estoppel for AIA trials).
`• Petitioner never addressed statutory argument that 35 U.S.C. § 315(e) limits
`estoppel to petitioners
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 21-24, 39-41; Sur-Reply, 2-6
`23
`
`
`
`Petitioner’s Belated and
`Unsupported Claim Constructions
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`24
`
`
`
`Petitioner Failed to Satisfy its
`Burden on Claim Construction
`
`Petitioner chose not to construe any terms in the
`Petitions
`
`The petition must
`set forth: . . .
`how the
`challenged claim
`is to be construed.
`
`-
`
`37 C.F.R. §42.104(b)(3)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Pet. 26
`25
`
`
`
`Petitioner Attempts to Rewrite the Challenged Claims
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX1001; POR, 20-24; Sur-Reply, 4-5
`26
`
`
`
`Petitioner’s Belated Attempt at Claim Construction is
`Not Supported by Evidence
`
`Central Region
`• Claim 1 specifies that the central region defines the maximum lateral width
`of the implant, which is not the same dimensions as the longitudinal length
`of the implant.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Pet. 7; POR, 10-20; 546 IPR POR, 8
`27
`
`
`
`Petitioner Incorrectly Read “Longitudinal” Out of the
`Patent Claims
`
`Longitudinal Length
`• Petitioner relied on Baccelli’s shorter A-P dimension as the longitudinal
`length to mislabel the spikes 24 as being in the central region and along the
`medial plane of Baccelli’s implant
`
`‐ Pet. 16, 44-48, 68-70; POR, 4-9, 19-20; EX2055, ¶¶31-35, 66-71, 117-20; 362 IPR Pet. 10,
`31, 50-53; 362 IPR POR, 4-9, 20-23, 36-38; 362 IPR EX2055, ¶¶31-34, 60-66, 101-09
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`28
`
`
`
`Petitioner Confuses “Longitudinal Length” with
`“Maximum Lateral Width”
`
`Claim 1 of the ’334 patent states “a portion of the central region
`defin[es] a maximum lateral width of said implant.”
`• Petitioner instead erroneously points to the longitudinal length of the
`implant.
`
`t
`
`t
`
`‐ POR, 19-20; EX1001, claim 1; EX1008, Fig. 2; EX2055, ¶¶66-71
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`29
`
`
`
`Petitioner Confuses “Longitudinal Length” with
`“Maximum Lateral Width”
`
`Claim 1 of the ’156 patent requires the maximum lateral width of the
`implant extend along the “medial plane”
`• Petitioner erroneously points to the longitudinal length, not maximum
`lateral width.
`
`t
`
`t
`
`362 IPR POR, 14; EX1001, claim 1; EX2055, ¶¶60-66; EX1008, Fig. 2
`
`‐
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`30
`
`
`
`The Board Called Petitioner Out for the ’156 Patent
`
`Longitudinal Length
`• The Board correctly recognized that “Petitioner needs to show Baccelli
`teaches or suggests the recited radiopaque markers proximate the medial
`plane, which is (a) generally perpendicular to the longitudinal length and (b)
`along where the maximum lateral width extends as claim 1 recites.”
`
`362 IPR Inst. Decision, 27 n.12; 362 IPR EX2055, ¶¶31-34, 60-66, 101-09
`
`‐
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`31
`
`
`
`Petitioner Incorrectly Read “Longitudinal”
`Out of the Patent Claims
`Longitudinal Length
`• The longitudinal aperture length by very definition is the longest dimension
`of the aperture.
`‐ The longest dimension of the aperture must be parallel or close to parallel
`to the longest dimension of the implant, which must extend between the
`distal and proximal ends.
`
`• Reading “longitudinal” out of the claim is disfavored.
`‐ Akzo Nobel Coatings, Inc. v. Dow Chemical Co., 811 F.3d 1334, 1340 (Fed.
`Cir. 2016)
`
`‐ POR, 4-5; EX1001, 12:44-64; EX2055, ¶¶31-32; EX2023, 1204; EX2057, ¶¶50-53
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`32
`
`
`
`The Specification Confirms “Longitudinal Length” is
`the Longest Dimension
`
`Longitudinal Length
`• The specification confirms that “longitudinal length” is the longest
`dimension
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX1001, 2:17-21, Fig. 2; POR, 5
`33
`
`
`
`Dr. Branch Confirms “Longitudinal Length” is the
`Longest Dimension
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX2022, 51:11-17; POR, 5
`34
`
`
`
`Dr. Branch Confirms “Longitudinal Length” is the
`Longest Dimension
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX2022, 76:7-12; POR, 5
`35
`
`
`
`Petitioner Incorrectly Read “Longitudinal” Out of the
`’334 Patent Claims
`
`Longitudinal Length
`• Dr. Branch confirmed the plain meaning of “longitudinal length” as the
`longest dimension, sketching how “the mid-coronal plane cuts the vertebral
`body in half longitudinally” at deposition:
`
`‐ POR, 6-7; EX2021; EX2022, 37:10-14, 43:11-44:23, 117:18-118:8
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`36
`
`
`
`Brantigan Confirms NuVasive’s Construction of
`“Longitudinal Length”
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 5-6; EX1007, 4:15-22, Fig. 1
`37
`
`
`
`Frey Confirms NuVasive’s Construction of
`“Longitudinal Length”
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 5-6; EX1040, Fig. 55, ¶0147
`38
`
`
`
`Frey Confirms NuVasive’s Construction of
`“Longitudinal Length”
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 5-6; EX1040, Fig. 63, ¶ 0159
`39
`
`
`
`Dr. Branch Confirms Frey’s Support of Patent Owner’s
`Construction of “Longitudinal Length”
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX2022, 88:5-13; POR, 5-6
`40
`
`
`
`Dr. Branch Confirms Frey’s Support of Patent Owner’s
`Construction of “Longitudinal Length”
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX2022, 89:15-22; POR, 5-6
`41
`
`
`
`Drs. Youssef and McMillin Confirm NuVasive’s
`Construction of “Longitudinal Length”
`
`‐ POR, 5-6; EX2055, ¶¶31-35, 66-71, 117-20; see also EX2057, ¶¶50-53
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`42
`
`
`
`The Board Previously Determined that the “Medial
`Plane” is at the Midpoint of the Longitudinal Length
`
`‐ POR, 8-9; EX1013 (IPR2013-00504, Paper 8, Institution Decision), 130-33
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`43
`
`
`
`Dr. Youssef Confirms “Medial” Refers to the Middle or
`Midpoint of an Object
`
`Medial Support
`
`‐ POR, 8-9; EX2055, ¶¶36-37; EX1001, claim 6
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`44
`
`
`
`Petitioner Failed To Establish Baccelli
`“Instructs” Using the Claimed Marker
`Configuration
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`45
`
`
`
`Missing Elements: Two Radiopaque Markers in the
`Central Region/Medial Plane
`The ’156 Patent: Claim 1
`The ’334 Patent: Claim 16
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ EX1001
`46
`
`
`
`Missing Elements: Two Radiopaque Markers in the
`Central Region/Medial Plane
`• Petitioner relied on Baccelli’s shorter A-P dimension as the longitudinal
`length to mislabel the spikes 24 as being in the central region and along the
`medial plane of Baccelli’s implant
`
`‐ Pet. 16, 44-48, 68-70; POR, 4-9, 19-20; EX2055, ¶¶31-35, 66-71, 117-20; 362 Pet. 10, 31,
`50-53; 362 IPR POR, 4-9, 20-23, 36-38; 362 IPR EX2055, ¶¶31-34, 60-66, 101-09; 546
`IPR Pet. 16, 30, 34, 50; 546 IPR POR, 4-8, 18-19; 546 IPR EX2055, ¶¶69-70, 108-13
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`47
`
`
`
`Missing Elements: Two Radiopaque Markers in the
`Central Region/Medial Plane
`Baccelli’s implant includes two spikes 24 on the sidewalls and two
`markers 47 on the front and rear.
`• Baccelli discloses that spikes 24 are “disposed symmetrically to each other
`about the sagittal midplane.”
`
`‐ POR, 58-60; EX1008, ¶¶24, 30, 34, 41-43, Figs. 1-4, 8-9; 362 IPR POR, 14-16, 20-24, 36-38; 546 IPR POR, 19-23
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`48
`
`
`
`Petitioner Mischaracterized the Sagittal Midplane as
`Depending on Direction of Implant Insertion
`
`The sagittal midplane:
`
`• Divides the body into right
`and left halves
`
`• Is agnostic to the direction
`of insertion of any implant
`
`‐ POR, 7, 59-62; Sur-Reply, 10-11; EX1002, ¶¶29-30; 362 IPR POR, 7, 24; 546 IPR POR, 7, 19-23; 546 IPR Sur-Reply, 17
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`49
`
`
`
`Missing Elements: Two Radiopaque Markers in the
`Central Region/Medial Plane
`
`Placing radiopaque markers on the proximal and distal ends of the
`Brantigan implant, as taught by Baccelli, results in no radiopaque
`markers in the central region or proximate the medial plane of the
`implant
`
`‐ POR, 7, 59-62; Sur-Reply, 10-11; EX1002, ¶¶29-30; 362 IPR POR, 7, 24; 546 IPR POR, 7, 19-23; 546 IPR Sur-Reply, 17
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`50
`
`
`
`Missing Elements: Two Radiopaque Markers in the
`Central Region/Medial Plane
`
`Placing radiopaque markers on the proximal and distal ends of
`the Frey implant, as taught by Baccelli, results in no radiopaque
`markers in the central region/medial plane of the implant
`
`‐ POR, 7, 59-62; Sur-Reply, 10-11; EX1002, ¶¶29-30; 362 IPR POR, 7, 24; 546 IPR POR, 7, 19-23; 546 IPR Sur-Reply, 28-30
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`51
`
`
`
`Petitioner Relied on Nothing More Than Ipse Dixit
`
`The Petition Contains No Support For Alignment with the Spinous
`Process
`• Dr. Branch’s ipse dixit simply copied from the rationale rejected by the
`Federal Circuit as being based wholly on hindsight.
`
`‐ POR, 55-56, 61; EX1013, 18 (In re NuVasive, Inc., 842 F.3d 1376, 1384 (Fed. Cir. 2016));
`EX2017, 7:9-8:13; EX2028, ¶60; 362 IPR POR, 24-26, 38-39; 546 IPR POR, 30-31
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`52
`
`
`
`Petitioner Abandoned the
`Petitions and Grounds References
`
`Petitioner Abandoned Baccelli Marker Positioning
`• Petitioner later asserted in the 546 Reply that it “does not rely on Baccelli for
`the ‘central region’ limitation,” yet Petitioner’s case hinges on these
`mischaracterizations of Baccelli teaching placing two radiopaque markers in
`the claimed central region.
`
`‐
`
`546 IPR Sur-Reply, 16-17; 546 IPR Pet. 34-35; 546 IPR POR, 18-23, 28; 546 IPR Reply, 10
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`53
`
`
`
`Petitioner Abandoned the
`Petitions and Grounds References
`Petitioner’s introduction of McAfee in
`Reply is a belated attempt to fill a
`void in its prima facie case
`• McAfee is irrelevant to the Petition’s
`argument, which was that Baccelli
`“instructs” the claimed marker
`placement.
`• McAfee’s BAK cage is radiopaque, has
`no radiopaque markers, and does not
`teach placement of markers in the
`central region or medial plane.
`• The image relied upon is a post-
`operative image that was not used to
`position the implant; it does not
`demonstrate alignment with the
`spinous process.
`
`‐ POR, 11; EX1054, 3; Pet. 45; 362 IPR Pet. 31; 546 IPR Pet. 30, 40
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`54
`
`
`
`Petitioner Failed to Prove a POSA Would
`Size Implants For a 36+ mm (A-P) Disc
`Space
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`55
`
`
`
`Petitioner Conflates Implant Dimensions with
`Vertebral Body Dimensions
`
`• Berry discloses dimensional data obtained from skeletons, i.e., vertebra
`lacking soft tissue (e.g., the annulus).
`• Dr. Youssef confirms that the annulus is about 5 mm wide and attaches to
`the apophyseal ring of the vertebral body around the vertebral body.
`• Petitioner fails to prove a POSA would have been motivated to size the
`implant to extend beyond the annulus fibrosis:
`‐ Frey implants did not
`‐ Brantigan implants did not
`‐ Michelson implants did not
`‐ Telamon and SVS-Synthes implants did not
`• Petitioner’s case ignores soft tissue, location in the spine, and adjacent
`anatomical structures (e.g., vena cava, aorta, etc.).
`
`‐ POR, 10-11, 14-18, 42-43, 51, 62-65; Pet. 30-31, 40-43, 47-48, 62-64, 73-
`74; EX1022, 1; EX2040, Fig. 2; EX2055, ¶¶53-55; EX2057, ¶¶17-20
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`56
`
`
`
`Frey Implants 1000 and 1400 Fit Within the Annulus
`
`Fit within the annulus fibrosis
`• Frey does not disclose or suggest an
`implant that extends beyond the annulus.
`• To account for the annulus fibrosis,
`implants are at least about 10 mm smaller
`than the vertebral body in each direction.
`‐ As they are designed to fit at the
`anterior-most portion of the disc space,
`they must be even smaller.
`‐ Undisputed the largest Boomerang
`implant was 36 mm long x 13 mm wide.
`
`‐ POR, 16-17; EX1040, ¶¶116, 130, 134-39, 148-49, 156, Figs. 29, 47, 53; EX2022, 78:12-
`80:20, 81:18-82:23, 85:6-87:11; EX2031, 2; EX2055, ¶¶49-52; EX2057, ¶¶30-31
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`57
`
`
`
`Brantigan Teaches Implants that Fit within the
`Annulus Fibrosis
`
`‐ EX1007, 6:23-32
`
`‐ POR, 17-19; Pet. 15, 44; EX1007, Abstract, 1:7-11, 1:59-61, 2:7-11, 2:26-28, 2:34-43, 2:63-64, 3:25-31, 4:23-27,
`4:38-39, 5:18-21, 6:23-32, 6:61, Figs. 1, 3-4, 11; EX1011, 8; EX2022,; EX2055, ¶¶56-65; EX2057, ¶¶21-27, 35-40
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`58
`
`
`
`Dr. Brantigan Confirms the Implants Fit Within Annulus
`
`Brantigan used Berry but accounted for the annulus fibrosis.
`• The Brantigan implants “stretch the annulus…as high as we could.”
`‐ EX2060, 23:12-18
`• “We do not remove the annulus, no.”
`‐ EX2060, 40:8-23
`
`‐ POR, 11-12; Sur-Reply, 12-13; EX1055, ¶¶80, 97-104; EX2029, 8-9; EX2060,
`19:20-20:8, 24:4-25:4, 26:21-27:3, 34:23-37:21, 41:13-23, 47:15-48:9, 49:10-15
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`59
`
`
`
`Dr. Brantigan Confirms the
`Implants Fit Within Annulus
`
`Brantigan used Berry but accounted for the annulus fibrosis.
`• Petitioner knew that Brantigan implants were sized according to Berry to
`have A-P dimensions between 24 and 28 mm.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Sur-Reply, 12-13; EX2029, 8; EX2061
`60
`
`
`
`Petitioner’s Judicial Estoppel Argument Fails
`
`“Warsaw’s argument assumes that the
`limitation ‘substantially the full
`traverse width’ . . . Means that the
`length of the patented implant must
`extend beyond a vertebra’s endplate to
`include the apophyseal ring. However
`the PTAB properly concluded that
`‘[Warsaw] does not show that claim 1
`also recites an implant being sized to
`extend onto the apophyseal ring[.]”
`
`- In re Warsaw Orthopedic, Inc.,
`832 F.3d 1327, 1331 (Fed. Cir. 2016).
`
`NuVasive’s assertion of
`Brantigan in an earlier
`IPR never depended on
`establishing the
`implant extended
`beyond the annulus
`fibrosis onto the
`apophyseal ring.
`
`‐ POR, 39-40; EX1019 (In re: Warsaw Orthopedic, Inc., Nos. 2015-1050
`& 2015-1058 (Fed. Cir. Aug. 9, 2016)), 6-7; 362 IPR Sur-Reply, 11
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`61
`
`
`
`Michelson’s “Oversized” Implants
`
`Michelson’s maximum A-P implant dimensions is 32 mm.
`
`• Michelson lateral lumbar implant widths of 22-32 mm have “a width that
`approximates the depth of the vertebrae.”
`‐ EX1032, Abstract, 7:22-26, 10:32-47; EX2055, ¶¶42-44; EX2057, ¶¶28-29
`
`• Michelson teaches even these “oversized” implants “need” to be “less than the
`depth of the vertebrae” to avoid “great harm” to the patient and that these
`dangers “necessarily limit” the dimensions of the implant.
`‐ EX1032, Abstract, 2:1-13, 3:11-17, 3:27-32, 3:56-69; EX2055, ¶¶44-45
`
`• Board previously rejected argument re Frey implant that “sufficient to span
`the disc space” means the implant dimensions are equal to vertebral body
`dimensions.
`‐ EX1023 (IPR2013-00507, Paper 7, Institution Decision), 136
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ POR, 11-12, 14-15
`62
`
`
`
`PLIF Implants Account for the Annulus Fibrosis
`Telamon Implant lengths do not exceed 26 mm
`
`‐ POR, 10; EX1010; EX1011; EX1032, 2:3-7; EX2055, ¶¶75-76
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`63
`
`
`
`PLIF Implants Account for the Annulus Fibrosis
`
`SVS-Synthes Implant lengths do not exceed 26 mm
`
`‐ POR, 10; EX1009; EX1032, 2:3-7; EX2055, ¶¶75-76
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`64
`
`
`
`Petitioner Abandons the
`Petitions and Grounds References?
`The Petitions asserted that a POSA would have:
`
`• been motivated to size implants
`according to the “direct dimensional
`measurements” for human vertebrae
`reported in Berry.
`• taken the average width of L5, added the
`standard deviation to obtain an A-P
`dimension of (35.1 mm + 2.8 mm), and
`divided by two to create individual
`pieces having widths up to 18.95 mm,
`which would “nest” together in the disc
`space.
`‐ 18.95 x 2 = 37.9
`
`‐ Pet. 42-43 & n.7-10, 62-64 & n.10-13; 362 IPR Pet. 74-75 & n.9-12; 546 IPR Pet. 56-57 & n.5-8
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`65
`
`
`
`Petitioner Abandons the
`Petitions and Grounds References?
`
`Petitioner Abandons Implant Sizing According
`to Berry
`
`‐ Pet. 42-43; Reply, 9-10; Sur-Reply, 11-14; Supp. Sur-Reply, 2-3
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`66
`
`
`
`Petitioner Abandons the
`Petitions and Grounds References?
`Petitioner’s proposed A-P dimension of the disc space (37.9 mm) is
`absurdly wide
`‐ POR, 42, 64 (citing EX2057, ¶27 (describing skepticism of large width of the 18 mm CoRoent XL implant)); Sur-Reply, 11-
`12
`
`• Abandoning the arguments made in the Petitions, Petitioner now asserts:
`
`‐ In the 361 Reply that they “never suggested manufacturing or inserting an
`implant that is ‘up to 37.9 mm wide.”
`
`‐ In the 362 Reply that they did not suggest that a “lumbar implant for the
`L4/L5 disc space should have a width of 37.9 mm.”
`
`‐ POR, 41; Reply, 9-10; Sur-Reply, 9-10, 12-14; Supp. Sur-Reply, 3; 362 IPR Pet. 74-75
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`67
`
`
`
`Petitioner Relies on Hindsight
`
`Petitioner’s arguments regarding the individual JC patient do nothing to
`establish motivation to make the implant as proposed in the petition.
`
`• Even if 18 mm wide CoRoent XL implant is inserted without removal of the
`annulus, this does not establish motivation to insert a two-piece modular
`implant as large as 37.9 mm as asserted in the Petition.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐ Sur-Reply, 13-14; Reply, 17
`68
`
`
`
`Petitioner’s Reply in IPR2019-00361
`Abandons Ground 1 for Claim 9
`Ground 1 argued that:
`• A POSA would have been motivated to modify the Brantigan implant
`according to Berry for insertion in the interbody space at T2.
`• Such a modified implant allegedly would have had a “longitudinal length of
`approximately 29.8 mm and a lateral width of approximately 18.1 mm.”
`
`Petitioner failed to demonstrate that:
`• A POSA would have been motivated to insert any implant laterally at T2.
`• The alleged disc space is large enough for an 18 mm implant.
`
`‐ POR, 12, 16-17, 19, 28-31 (citing EX2055, ¶¶120-24; EX2043, 27); Sur-Reply, 9-12; EX2022, 38:5-15; 362 IPR Pet. 56
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`69
`
`
`
`Petitioner Abandons the Modularity of
`Michelson
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`70
`
`
`
`Petitions Relied on Michelson Modularity of Figs. 18-19
`
`• The Petitions propose modifying Frey
`and Brantigan so that the implants may
`be inserted “in a modular fashion as
`taught by Michelson.”
`‐ Pet. 2-3, 5, 12, 30, 41, 61-62; POR, 1-2, 12-13, 15-16, 18-19,
`42-43, 51-53; Sur-Reply, 1, 6-10; Supp. Sur-Reply, 1-4; 362
`IPR Pet. 14, 69, 72, 74; 362 IPR Sur-Reply, 12-13; 546 Pet. 2,
`4-5, 13-14, 41, 54-56; 546 IPR Sur-Reply, 12
`• The proposed motivation for applying
`Michelson modularity to Frey and
`Brantigan was “to increase patient safety
`and minimize invasiveness.”
`‐ Pet. 30, 47-48; POR, 1-2, 12-13, 44-45, 53-55; Sur-Reply, 1,
`6-8; Supp. Sur-Reply, 2-4; 362 IPR Pet. 69; 362 IPR Sur-
`Reply, 12-13; 546 Pet. 41, 54-55; 546 IPR Sur-Reply, 12
`
`“To achieve the benefits of
`Michelson for a lumbar fusion, a
`POSA would have been motivated to
`make Frey’s laterally-inserted spinal
`fusion implants long-and-narrows
`as taught by Michelson for insertion
`in a modular fashion through a
`hollow tube to increase patient
`safety and minimize invasiveness.”
`
`-
`
`Pet. 30; see also id., 47 (Brantigan)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`71
`
`
`
`The Board Instituted Based On Sequential Insertion
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`‐
`
`Inst. Decision, 40
`
`72
`
`
`
`Dr. Branch Undermined Petitioner’s Case
`
`“[M]y concept of
`modular is you put one
`in, you move it in
`position, you put a
`second one in, you
`kind of push it up
`against that other one.”
`
`-
`
`EX2022, 121:15-122:7
`
`Petitioner’s expert
`explained during
`deposition that he
`understands the
`modularity taught by
`Michelson to involve
`sequential insertion of
`modular members.
`
`‐ POR, 12-15, 43-45; Sur-Reply, 1-2, 7-8; Supp. Sur-Reply, 3-4; EX1032, 3:46-46; EX2055, ¶¶42-43; EX2057, ¶¶33-34
`DEMONSTRATIVE EXHIBIT – NOT
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