Case 3:18-cv-00347-CAB-MDD Document 304-17 Filed 01/26/21 PageID.28776 Page 1 of
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`EXHIBIT 7
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`TO THE DECLARATION OF
`BRIAN J. NISBET IN SUPPORT OF
`DEFENDANTS’ MOTION FOR
`SUMMARY JUDGMENT
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`Case 3:18-cv-00347-CAB-MDD Document 304-17 Filed 01/26/21 PageID.28777 Page 2 of
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
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`NUVASIVE, INC., a Delaware corporation,
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` Plaintiff,
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`v.
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`ALPHATEC HOLDINGS, INC., a Delaware
`corporation, and ALPHATEC SPINE, INC., a
`California corporation,
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` Defendants.
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`Case No. 18-cv-00347-MDD-CAB
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`REBUTTAL EXPERT REPORT OF JIM YOUSSEF, MD
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`EXHIBIT 7 - PAGE 902
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`does not cite any information that supports his opinions regarding what he believes is reflected in
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`these documents.
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`182. Also, February 2004 is less than one year before March 29, 2004 so this sales
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`spreadsheet does not indicate a sale more than one year prior to the priority date.
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`xii. May 21, 2004 Email
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`183. Dr. Sachs cites to a May 21, 2004 email (NUVA_ATEC0341150) and an
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`attachment (NUVA_ATEC0341153) and concludes they show a prior sale. Sachs Implant
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`Opening Report at ¶ 314. I disagree.
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`184. As stated above (¶ 89), these documents do not provide a description of the
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`relevant features of the referenced devices, nor do they contain any description of the
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`circumstances surrounding what Dr. Sachs opines was their use or sale. Moreover, Dr. Sachs
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`does not cite any information that supports his opinions regarding what he believes is reflected in
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`these documents.
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`185. Also, February 2004 and March 2004 are less than one year before March 29,
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`2004 so the May 21, 2004 email (NUVA_ATEC0341150) and accompanying attachment
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`(NUVA_ATEC0341153) do not indicate a sale more than one year prior to the priority date.
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`XII. THE ASSERTED CLAIMS ARE NOT INDEFINITE
`A.
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`Claims 1 and 16 of the ’334 Patent are not Indefinite—“central region” and
`“generally parallel”
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`186. Dr. Sachs contends that claims 1 and 16 of the ’334 patent are indefinite because
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`the claim language “central region” would not inform a POSA of the scope of the claims. Sachs
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`Implant Opening Report at ¶ 329. I disagree. For the reasons set forth below, a POSA reading
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`the claim language “central region” in the context of the claims and the specification would
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`understand the scope of the claims.
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`EXHIBIT 7 - PAGE 903
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`187. Dr. Sachs also contends that claim 1 is indefinite because claim 1 requires a
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`longitudinal aperture length extending “generally parallel” to the longitudinal length of the
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`implant. Sachs Implant Opening Report at ¶ 329. I disagree. For the reasons set forth below, a
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`POSA reading the claim language “generally parallel” in the context of the claims and the
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`specification would understand the scope of the claims.6
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`188. Specifically, Dr. Sachs states “the claims, specification, and file history fail to
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`provide guidance regarding how to determine the size, shape, or bounds of the claimed ‘central
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`region,’ or how to determine whether the first and second sidewalls, medial support, and/or
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`radiopaque markers are positioned ‘generally centrally’ or within the ‘central region.’ Moreover,
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`the specification of the ’334 patent fails to provide any guidance regarding how to determine
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`whether a longitudinal aperture length extends ‘generally parallel’ to the longitudinal length of
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`the implant.” Sachs Implant Opening Report at ¶ 329.
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`189.
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`I note that Alphatec identified the central region of Figure 2 of the ’334 patent
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`during inter partes review and made the below, annotated, diagram:
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`6 I understand from counsel that Alphatec did not include any indefiniteness arguments in
`its Final Invalidity Contentions regarding “generally parallel,” and thus Dr. Sachs’s opinions
`are improper. Regardless, I address them in this report.
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`EXHIBIT 7 - PAGE 904
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`upper surface anti-migration elements
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`.,
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`proximal wan---
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`longitudinal length
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`IPR2019-00546, Pet. at 7.
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`190.
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`I am also informed by counsel that the Patent Trial and Appeal Board did not note
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`any ambiguity in the scope of the claim limitation “central region” during inter partes review.
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`191. Dr. Sachs notes that the specification of the ’334 patent does not contain a
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`definition of “central region,” implying that one is necessary. Sachs Implant Opening Report at
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`¶ 329. I disagree. A person of skill in the art can readily understand the meaning of “central
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`region” as recited in the claims of the ’334 patent in the context of the specification and
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`prosecution history.
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`192. Dr. Sachs further states “the claims, specification, and file history fail to provide
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`guidance regarding how to determine the size, shape, or bounds of the claimed ‘central region,’
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`or how to determine whether the first and second sidewalls, medial support, and/or radiopaque
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`markers are positioned ‘generally centrally’ or within the ‘central region.’” Sachs Implant
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`Opening Report at ¶ 329. Again, I disagree. As exemplified by Alphatec’s annotation of Figure
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`2 of the ’334 patent, a person of skill in the art can readily determine the central region of the
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`claimed implant that (1) “includes portions of the first and second sidewalls;” (2) is “positioned
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`generally centrally between the proximal wall and the distal wall;” and (3) contains at least a
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`portion that defines the “maximum lateral width of the implant extending from [the] first
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`sidewall to [the] second sidewall” as recited in the claims.
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`193. Dr. Sachs further states “[t]he patent does not specify any structure, function,
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`purpose, import, or benefit of these limitations, including over the prior art” and “because neither
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`the claims nor the intrinsic record describes any function, purpose, import, or benefit of these
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`terms, there is no benchmark or baseline by which to discern the boundaries of these terms
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`relative to any intended purpose.” Sachs Implant Opening Report at ¶ 329. I disagree. As noted
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`above, the claims themselves recite several structural elements related to these limitations.
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`Moreover, a person of skill in the art reading the patent would recognize that the central region
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`of the implant and the longitudinal aperture generally parallel to the longitudinal length of the
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`implant are important features of the invention at least in that those structures enable a surgeon to
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`confirm proper placement of a laterally inserted spinal implant. These limitations also allow the
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`implant to span the apophyseal ring, further adding benefit to the claimed implant in ways not
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`present in pre-existing implants.
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`194. Dr. Sachs further states “[b]ecause the terms are highly subjective and lack any
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`objective boundaries, they lack reasonable certainty to a POSA.” Sachs Implant Opening Report
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`at ¶ 329. I disagree. In the context of the specification, neither “central region” nor “generally
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`parallel” are “highly subjective” from the perspective of a person of skill in the art. Instead,
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`these are well-understood terms to a POSA.
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`195. Dr. Sachs further states “while some meaning may be ascribed to the terms, there
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`is not a single, discernable meaning, and multiple meanings are equally as reasonable in view of
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`EXHIBIT 7 - PAGE 906
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`the specification” and “[b]ecause the patent and file history fail to disclose a single known
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`approach or establish that, where multiple known approaches exist, a POSA would not know
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`which approach to select to arrive at these claim limitations.” Sachs Implant Opening Report at
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`¶ 329.7 I disagree, and I note that Dr. Sachs does not identify or describe any of these supposed
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`“multiple meanings.” As discussed above, the meaning of both “central region” and “generally
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`parallel” as recited in the claims and in the context of the specification of the ’334 patent are
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`readily apparent to a person of skill in the art.
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`196. Dr. Sachs’ complaint about the language of the ’334 patent appears to be a
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`general complaint about claim language that includes terms of approximation. A person of skill
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`in the art, however, would have no difficulty interpreting terms of approximation such as “central
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`region” and “generally parallel.” Moreover, I note that Dr. Sachs provides no support for his
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`opinion that such terms of approximation are outside of the understanding of a person of skill in
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`the art. Also, I am informed by counsel that claims containing terms of degree or approximation
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`are not inherently indefinite and that an invention does not need to be defined with mathematical
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`precision to be valid.
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`B.
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`Claim 1 of the ’156 Patent is not Indefinite—“medial plane” and “at a
`position proximate to the medial plane”
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`197. Dr. Sachs contends that claim 1 of the ’156 patent is indefinite because the terms
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`“medial plane” and “at a position proximate to the medial plane” would not reasonably inform a
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`7 My reading of Dr. Sachs’s statements regarding “approaches” is that he was referring to
`multiple “meanings” rather than multiple approaches to the spine. To extent Dr. Sachs did
`intend to refer to multiple approaches to the spine, it is my opinion that a POSA reviewing the
`Implant Patents would understand them to refer to spinal implants for a lateral, trans-psoas
`approach, as explained in detail in my Opening Implant Report. Youssef Implant Opening
`Report at ¶ 44; Access Patent Opening Report at ¶¶ 65-70.
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`EXHIBIT 7 - PAGE 907
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`POSA with reasonable certainty the scope of the invention. Sachs Implant Opening Report at
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`¶¶ 331-337. I disagree.
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`198.
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`I understand from counsel that NuVasive and Alphatec agreed that “medial plane
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`that is generally perpendicular to said longitudinal length” means “plane that is generally
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`perpendicular to and intersects with said longitudinal length at the middle or midline of the
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`longitudinal length.” Doc. No. 133-2 at 21 (Appendix B4, Joint Claim Construction Worksheet).
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`199. Dr. Sachs interprets this agreed construction to mean that “the ‘medial plane’ is
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`located in the middle of the implant along its length.” Sachs Implant Opening Report at ¶ 333. I
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`disagree. The claim language and the construction state that the medial plane is perpendicular to
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`the length of the implant. Therefore, as recited in the Asserted Claims, the medial plane is along
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`the “width” of the implant, not the “length.” Thus, I disagree with Dr. Sachs’ opinions regarding
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`indefiniteness of the claims of the ’156 patent at least because they are based on this
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`fundamental, basic error.
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`200. Dr. Sachs states that beyond his erroneous interpretation of the agreed upon
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`meaning of “medial plane” “the patent does not specify any structure, function, purpose, import,
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`or benefit of the medial plane, including over the prior art.” Sachs Implant Opening Report at
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`¶¶ 333, 335. I disagree. For example, as Dr. Sachs acknowledges, the claims require radiopaque
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`markers “at a position proximate to said medial plane.” Sachs Implant Opening Report at ¶ 334.
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`That is a structure with an important function and benefit of the invention—it allows a surgeon to
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`accurately determine the position of an implant after it is inserted in a lateral, spinal fusion
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`procedure. Moreover, I note that during inter partes review, the PTAB adopted a construction of
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`medial plane that is similar to the one agreed to by the parties (“medial plane in the context of
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`claim 1 is located approximately at the midpoint of the longitudinal length”) and found that the
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`EXHIBIT 7 - PAGE 908
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`prior art did not teach radiopaque markers proximate to the medial plane. IPR2019-00362
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`(Paper 57), Final Written Decision at 18, 60. Thus, Dr. Sachs’ contention that the medial plane
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`of the claims does not distinguish the prior art is wrong.
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`201. Dr. Sachs acknowledges that, when read in context of the specification,
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`“proximate” means “near” and that therefore “proximate to said medial plane” means “near said
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`medial plane. Sachs Implant Opening Report at ¶ 334. I agree.
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`202. Dr. Sachs further states that, because “near” lacks mathematical precision, a
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`POSA cannot determine the boundaries of the claim with reasonable certainty. Sachs Implant
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`Opening Report at ¶ 334. I disagree. A POSA reading the ’156 patent would understand that the
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`radiopaque markers proximate to, or near, the medial plane allow a surgeon to confirm proper
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`placement of an implant that is inserted via a lateral, trans-psoas lumbar fusion procedure.
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`Specifically, the location of these markers would allow a POSA to identify the location of the
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`implant in the A/P plane and confirm the implant is properly positioned within the interbody
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`space. Thus, to function, the markers need not be directly on the medial plane with mathematical
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`precision, but they do need to be near the medial plane such that the surgeon can recognize and
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`analyze the placement of the implant. Again, Dr. Sachs appears to be taking the position that any
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`term of approximation would prevent a POSA from understanding claims covering a spinal
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`implant. I disagree. The understanding of a POSA is not so limited and rigid as Dr. Sachs
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`suggests.
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`XIII. CONCLUSION
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`203. Ultimately, as explained in detail above, it is my opinion that Dr. Sachs’s report
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`heavily relies upon misstatements, mischaracterizations, and/or speculation regarding his alleged
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`supporting evidence, and further relies on unsubstantiated documentation in providing his
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`opinions. In addition, Dr. Sachs also mischaracterizes the contents and disclosure of the
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`Date: December 18, 2020
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`EXHIBIT 7 - PAGE 910
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