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`EXHIBIT 9
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`TO THE DECLARATION OF BRIAN J.
`NISBET IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO NUVASIVE’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE
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`NIMALKA R. WICKREAMASEKERA (SBN: 268518)
`nwickramasekera@winston.com
`DAVID P. DALKE (SBN: 218161)
`ddalke@winston.com
`WINSTON & STRAWN LLP
`333 S. Grand Avenue
`Los Angeles, CA 90071-1543
`Telephone: (213) 615-1700
`Facsimile:
`(213) 615-1750
`
`Attorneys of record continued on next page
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA – SAN DIEGO DIVISION
`
`Plaintiff,
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`NUVASIVE, INC., a Delaware
`corporation
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`v.
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`ALPHATEC HOLDINGS, INC., a
`Delaware corporation and
`ALPHATEC SPINE, INC., a
`California corporation,
`
`Defendants.
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`
`
`
`
`Case No. 3:18-CV-00347-CAB-MDD
`
`[Assigned to Courtroom 4C – Honorable
`Cathy Ann Bencivengo]
`
`[Magistrate: Hon. Mitchell D. Dembin]
`
`HIGHLY CONFIDENTIAL –
`ATTORNEYS’ EYES ONLY
`
`SUBJECT TO PROTECTIVE ORDER
`
`
`OPENING REPORT OF BARTON L.
`SACHS, M.D., M.B.A., F.A.C.P.E.,
`F.A.C.H.E.
`
`
`Complaint Filed: February 13, 2018
`Jury Trial Demanded
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`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 222
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`provisional application; and (4) the later-filed non-provisional application contains a
`reference to the provisional application.
`I understand that to comply with the written description requirement of 35
`50.
`U.S.C. § 112(a), the provisional application must contain a written description that
`includes the manner and process of making and using each invention claimed in the non-
`provisional application in full, clear, and exact terms, to allow an ordinarily skilled
`artisan to practice the invention claimed in the non-provisional application:
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`The specification shall contain a written description of the invention, and
`of the manner and process of making and using it, in such full, clear,
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`concise, and exact terms as to enable any person skilled in the art to which
`it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor or
`joint inventor of carrying out his invention.
`
`(35 U.S.C. § 112(a).)
`I understand that the written description requirement can be met by figures,
`51.
`diagrams, or drawings. I understand, however, that a person of ordinary skill in the art
`must be able to derive the claimed dimensions of the invention from the written
`description.
`I also understand that the provisional application must describe each
`52.
`invention claimed in the non-provisional application sufficiently to convey to a person
`of ordinary skill in the art that the applicant possessed the claimed invention at the time
`the provisional application was filed. In other words, the provisional application must
`demonstrate that the applicant invented what is claimed in the non-provisional
`application on a claim-by-claim basis.
`Further, I understand while the provisional application need not provide
`53.
`verbatim support for the claims in the non-provisional application, one skilled in the art
`reading the earlier application must be able to immediately discern the limitations in the
`claims as of the date of the provisional application.
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`15
`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 223
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`“entitled to a priority date at least as early as March 29, 2004, which is the filing date of
`U.S. Provisional Application No. 60/557,536.” (Infringement Contentions dated June
`29, 2018 at 36.)
`I disagree. None of the asserted claims of the ’334 patent is entitled to
`150.
`March 29, 2004, as a priority date based on the disclosures in the Provisional
`Application.
`In my opinion, the Provisional Application does not provide sufficient
`151.
`written description support for at least the following limitations:
`Radiopaque Marker Limitations Not Supported by Provisional Application
`
`Claim Limitation
`Claim
`“… at least three radiopaque markers;
`Claim 1 (from which claims 16 and 18
`wherein a first of the at least three
`depend)
`radiopaque markers is at least partially
`positioned in said distal wall, a second of
`said at least three radiopaque markers is
`at least partially positioned in said
`proximal wall, and a third of said at least
`three radiopaque markers is at least
`partially positioned
`in said central
`region.”
`fourth
`a
`comprising
`“…
`further
`radiopaque marker situated within said
`implant, said fourth radiopaque marker
`positioned in said central region at a
`position spaced apart from said third
`radiopaque marker.”
`
`Claim 16
`
`I refer to these limitations as the “radiopaque marker limitations.”
`152.
`153. Additionally, it is my opinion that the asserted claims of the ’334 patent
`are not entitled to a priority date of March 29, 2004, because the Provisional Application
`does not provide sufficient written description support for at least the following
`limitations:
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`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 224
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`Dimension Limitations Not Supported by Provisional Application
`Claim Limitation
`Claim
`“… wherein
`said
`implant has a
`Claim 1 (from which claims 16 and 18
`longitudinal length greater than 40 mm
`depend)
`extending from a proximal end of said
`proximal wall to a distal end of said distal
`wall …”
`“… wherein said longitudinal length is at
`least two and half times greater than said
`maximum lateral width …”
`“… wherein said maximum lateral width
`of said implant is approximately 18 mm.”
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`Claim 1 (from which claims 16 and 18
`depend)
`Claim 18
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`154. Collectively, I refer to these limitations as the “dimension” limitations.
`(a) The asserted claims are not entitled to a March 29, 2004
`because the Provisional Application does not support the
`“radiopaque marker” limitations
`155. As noted above, there is nothing in the Provisional Application that
`discloses the radiopaque marker limitations in the claimed spinal implants.
`156. Rather, support for the “radiopaque markers” limitations did not appear
`until March 29, 2005 when applicants filed U.S. Patent Application Serial No.
`11/093,409 (the “’409 application”) (NUVA_ATEC0020856–910), which ultimately
`issued as U.S. Patent No. 7,918,891 (the “’891 patent”). The ’334 patent is a
`continuation of the ’891 patent, and these patents substantively share the same
`specification, aside from minor changes describing related applications. (See, e.g., ’334
`patent at cover page, 1:4–13.)
`In the ’409 application filed on March 29, 2005, the applicants added
`157.
`several paragraphs and statements that were not part of the Provisional Application,
`including multiple passages and figures describing how radiopaque markers could be
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`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 225
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`In my opinion, the radiopaque marker limitations are not described in the
`163.
`Provisional Application. As discussed above, the ’409 application expressly discloses
`that the “spinal fusion implant of the present invention may be provided with any number
`of features for enhancing the visualization of the implant during and/or after implantation
`into a spinal target site.” (’409 application at 5:20–22; ’334 patent at 2:53–56.) And
`that “such visualization enhancement features may take the form of the spike elements
`used for anti-migration, which may be manufactured from any of a variety of suitable
`materials, including but not limited to a metal, ceramic, and/or polymer material,
`preferably having radiopaque characteristics.” (’409 application at 5:23–6:2; ’334 patent
`
`at 2:57–62.) The ’409 application also provides several figures illustrating how the
`radiopaque markers can be used to enhance visualization. (’409 application at Fig. 18–
`23.) But, these passages and figures, definitively disclosing that “spike elements” can
`serve as radiopaque “visualization enhancement features,” are missing from the
`Provisional Application.
`164. Unlike the ’409 application, there is nothing in the Provisional Application
`that describes “spike elements” as being “radiopaque markers” or being used to enhance
`visualization. Instead, the Provisional Application describes “spike elements” as
`exclusively being anti-migration elements, which are not the same as “radiopaque
`markers” and do not serve
`the same purpose as “radiopaque markers.”
`(NUVA_ATEC0020805 at 810–811 (Provisional Application).)
`165. As the name suggests, anti-migration features are used to prevent the
`implant from moving after implantation in the vertebrae. The anti-migration features
`bear the mechanical burden of preventing movement. Antimigration features for
`interbody implants are important to stabilize the implants securely within the intradiscal
`space. The stability serves to both: (1) prevent gross dislodgement occurring with
`possible damage to adjacent spinal soft-tissue structures; and (2) to enhance solid
`interbody bone fusion. Continued motion of the implant within the intradiscal space
`may often lead to pseudoarthrosis (non-boney fusion or fibrous non-union.) In contrast,
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`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 226
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`radiopaque markers are used for visualization, both during implantation to ensure the
`implant is correctly positioned and after implantation to ensure the implant is not
`migrating. The function of radiopaque markers differs from anti-migration features
`because the radiopaque markers act as a visual check to ensure that the anti-migration
`features are indeed preventing movement of the implant.
`166. The Provisional Application focuses on fixation and “anti-migration” of
`the interbody implant as its key features. Much of the patent explanation is directed at
`the term anti-migration. For example, the Provisional Application specification recites
`that “Suitable anti-migration features may include, but are not necessarily limited to,
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`angled teeth formed along the upper and/or lower surfaces of the spinal fusion implant
`and/or spike elements disposed partially within and partially outside the upper and/or
`lower surfaces of the spinal fusion implant. Such anti-migration features provide the
`additional benefit of increasing the overall surface area between the spinal fusion implant
`of the present invention and the adjacent vertebrae, which promotes overall bone fusion
`rates.” (NUVA_ATEC0020805 at 810–811 (Provisional Application), 0020819
`(describing the anti-migration features of an “exemplary spinal fusion implant” in
`additional depth), 0020827 (stating that a cervical fusion implant of the present invention
`“also preferably includes anti-migration features” such as anti-migration teeth and
`spikes).) The Provisional Application does not, however, provide, let alone focus on,
`any explanation of using a radiopaque marker for determining implant position. In fact,
`the term radiopaque is only mentioned once in the entirety of the Provisional
`Application, and only to describe a “suitable material” that the anti-migration spike
`elements may be manufactured from. (NUVA_ATEC0020805 at 819 (Provisional
`Application).) Therefore, based on the overwhelming disclosures of the spikes as anti-
`migration features, the limited mention of radiopacity or radio-opaqueness, and the total
`lack of mention of visibility in reference to the spikes in the Provisional Application, a
`POSA would not understand the Provisional Application to be enabling or to be
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`68
`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 227
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`providing written description to support that the anti-migration spikes are also to be used
`as radiopaque markers for determining position.
`In summary, in my opinion, “spike elements” as disclosed in the
`167.
`Provisional Application would not have been understood by a POSA to be “radiopaque
`markers,” as that term is used in the asserted claims of the ’334 patent. In other words,
`a POSA reading the Provisional Application would not immediately discern that “spike
`elements” are the “radiopaque markers” recited in the claims. To the contrary, a POSA
`would have understood “spike elements” to be one of several “anti-migration features
`designed to increase the friction between the spinal fusion implant 10 and the adjacent
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`contacting surfaces of the vertebral bodies so as to prohibit migration of the spinal fusion
`implant 10 after
`implantation.”
` (NUVA_ATEC0020805 at 819 (Provisional
`Application).)
`It is also immaterial that the Provisional Application discloses that “spike
`168.
`elements 7, 8, [and] 9 may be manufactured from any of a variety of suitable materials,
`including but not limited to a metal, ceramic, and/or polymer material, preferably having
`radiopaque characteristics.” (NUVA_ATEC0020805 at 819 (Provisional Application).)
`This disclosure—that “spike elements” can optionally have radiopaque characteristics,
`again, in the context of the “spike elements” being only anti-migration features—does
`not provide a POSA with an adequate written description to teach the use of “spike
`elements” as radiopaque markers to enhance visualization.
`169. This disclosure is insufficient for the same reasons articulated above.
`170. Similarly, Figure 2 in the Provisional Application does not sufficiently
`disclose the radiopaque marker limitations. (NUVA_ATEC0020805 at 836 (Fig. 2 of
`Provisional Application).) Figure 2 of the Provisional Application contains a drawing
`with numbers 7, 8 and 9, which are the anti-migration spikes. In its Description of
`Drawings, the Provisional Application describes Figure 2 as “a perspective view of the
`lumbar fusion implant of FIG. 1, illustrating (among other things) fusion apertures
`extending between top and bottom surfaces, a plurality of visualization apertures
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`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 228
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`(NUVA_ATEC0252711–728 at 712 (CoRoent System December 2004 510(k)—Device
`Description).)
`185. The fact that FDA reviewers did not understand the device to have
`radiopaque markers based on NuVasive’s description concerning anti-migration spikes
`supports my opinion that the Provisional Application, which only discloses anti-
`migration spikes and does not in any way tie those anti-migration spikes to serving as
`radiopaque markers, does not enable or provide sufficient written description to the
`POSA to support the radiopaque marker limitations. This exchange is further evidence
`that the POSA would not have understood the Provisional Application to enable and/or
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`provide sufficient written description to support the radiopaque marker limitations.
`186. Notably, following its fall 2004 exchange with the FDA, NuVasive
`submitted the ’409 application on March 24, 2005 to the Patent Office, which finally
`included sufficient disclosures to notify a POSA about the radiopaque marker limitation.
`187. Accordingly, it is my opinion that asserted claims of the ’334 patent are
`not entitled to a priority date earlier than March 29, 2005, at least because the
`“radiopaque marker” limitations were not disclosed in any earlier application.
`(b) The asserted claims are also not entitled to a March 29,
`2004 priority date because the “dimension” limitations are
`not described in the Provisional Application.
`188. As discussed, the asserted claims of the ’334 patent require that the claimed
`implant have certain dimensions—i.e., 40 mm long, have a length that is two and a half
`times more than the width, and a maximum width that is 18 mm.
`189. As discussed above, the ’409 application changed the disclosed
`dimensions of the spinal implant otherwise described in the Provisional Application.
`These changes enable and provide written description support of the dimension
`limitations in the asserted claims of the ’334 patent.
`In Exhibit 8, I highlighted these differences (i.e., the dimension disclosures
`190.
`not disclosed in the Provisional Application but later included in the ’409 application),
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`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 229
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`using the ’334 patent as a proxy for the specification of the ’409 application because the
`specifications are substantively identical. (See, e.g., ’334 patent at 2:17–25, 5:15–19,
`11:48–12:11, and Figs. 18–23.) Exhibit 9 highlights these limitations in the ’409
`application.
`In my opinion, the dimension limitations are not described in the
`191.
`Provisional Application. The ’409 application states that “[f]or lumbar fusion, the spinal
`fusion implant of the present invention may be dimensioned, by way of example only,
`having a width ranging between 9 and 18 mm, a height ranging between 8 and 16 mm,
`and a length ranging between 25 and 45 mm. For cervical fusion, the spinal fusion
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`implant of the present invention may be dimensioned, by way of example only, having
`a width about 11 mm, a height ranging between 5 and 12 mm, and a length about 14
`mm.” (’409 application at 11:16–19 (emphasis added).)
`In contrast, the Provisional Application states that “[f]or lumbar fusion, the
`192.
`spinal fusion implant of the present invention may be dimensioned, by way of example
`only, having a length ranging between 9 and 18 mm, a height ranging between 8 and 16
`mm, and a width ranging between 25 and 45 mm. (NUVA_ATEC0020805 at 809
`(Provisional Application).) For cervical fusion, the spinal fusion implant of the present
`invention may be dimensioned, by way of example only, having a length about 11 mm,
`a height ranging between 5 and 12 mm, and a width about 14 mm.”
`(NUVA_ATEC0020805 at 809–810 (Provisional Application) (emphasis added).)
`In my opinion, an implant for lumbar fusion “having a length ranging
`193.
`between 9 and 18 mm” would not have been understood by a POSA to be an implant
`“wherein said maximum lateral width of said implant is approximately 18 mm,” as
`required by claim 18. Further, an implant for cervical fusion “having a length about 11
`mm” would not have been understood by a POSA to be an implant “wherein said
`maximum lateral width of said implant is approximately 18 mm,” as required by
`claim 18.
`
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`F.A.C.P.E., F.A.C.H.E.
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`EXHIBIT 9 - PAGE 230
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`194. Additionally, in my opinion, an implant for lumbar fusion having “a width
`ranging between 25 and 45 mm” would not have been understood by a POSA to be an
`implant “wherein said implant has a longitudinal length greater than 40 mm extending
`from a proximal end of said proximal wall to a distal end of said distal wall,” as required
`by claim 1. Further, an implant for cervical fusion having “a width about 14 mm” would
`not have been understood by a POSA to be an implant “wherein said implant has a
`longitudinal length greater than 40 mm extending from a proximal end of said proximal
`wall to a distal end of said distal wall,” as required by claim 1.
`195. Additionally, in my opinion, an implant for lumbar fusion having “a width
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`ranging between 25 and 45 mm” would not have been understood by a POSA to be an
`implant “wherein said longitudinal length is at least two and half times greater than said
`maximum lateral width,” as required by claim 1. In particular, a length of 18 mm (as
`disclosed in the Provisional Application) is not 2.5 times greater than a width ranging
`between 25 and 45 mm (as disclosed in the Provisional Application). Further, an implant
`for cervical fusion having “a width about 14 mm” would not have been understood by a
`POSA to be an implant “wherein said longitudinal length is at least two and half times
`greater than said maximum lateral width,” as required by claim 1. In particular, a length
`of about 11 mm (as disclosed in the Provisional Application) is not 2.5 times greater than
`a width of about 14 mm (as disclosed in the Provisional Application).
`196. When reading the Provisional Application, a person of ordinary skill in the
`art would understand that it taught an implant having a width greater than the length. In
`other words, reading the Provisional Application, a person of ordinary skill in the art
`would not be able to immediately discern whether the described dimensions pertain to
`the dimensions of the associated interbody disc space anatomy or the technical direction
`of the placement of the implant. As an example, I note that an airplane has a width (tip
`of wingspan to tip of wingspan) that is often longer that the length (of the airplane
`fuselage body), yet the direction of flight of the plane is along the shorter dimension of
`the plane (from nose to tail).
`
`78
`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
`
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`
`EXHIBIT 9 - PAGE 231
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`

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`197. My opinion is further supported by the disclosure in the ’334 specification
`that the implant “may be introduced in any variety of approaches, such as posterior,
`anterior, antero-lateral, and postero-lateral, without departing from the scope of the
`present invention (depending on the size of the implant 10).” (’334 patent at 5:31–35;
`see also ’409 application at 12:2–5.) A POSA would know that the length of an implant
`is typically determined based on the direction in which the implant is to be inserted into
`a patient. Thus, the dimensions of an implant may be different depending on which
`approach is used. For example, a POSA would understand that due to the anatomy of
`the spine, an implant that is inserted using a lateral approach is longer than it is wide
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`whereas an implant that is inserted using anterior approach is wider than it is long. In
`other words, there is no requirement that an implant’s length be longer than its width.
`Indeed, the width of NuVasive’s CoRoent Small implant is greater than its length due to
`the
`preferred
`approach
`for
`insertion
`(i.e.,
`an
`anterior
`approach).
`(NUVA_ATEC0341114–115 at 115 (2004 CoRoent Sales Sheet).) The same is true for
`traditional lumbar ALIF implants. Thus, a POSA would have understood the dimensions
`disclosed in the Provisional Application to be correct. More specifically, since the
`Provisional Application describes an implant that is wider than long, a POSA would
`have understood this to be an ALIF implant. Indeed, NuVasive specifically added to the
`’409 application that the claimed implant was “particularly suited for introduction into
`the disc space via a lateral (trans-psoas) approach to the spine”—there are no references
`to a lateral approach in the Provisional Application. (’409 application at 12:2–5; see
`also ’334 patent at 5:31–35.) A POSA would therefore have considered the swapping
`of “length” and “width” from the Provisional Application to the ’409 application to be a
`significant change because it describes a lateral implant.
`198. Accordingly, it is my opinion that asserted claims of the ’334 patent are
`not entitled to a priority date earlier than March 29, 2005, at least because the
`“dimension” limitations were not disclosed in any earlier application.
`B. U.S. Patent No. 8,361,156
`
`79
`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
`
`
`
`EXHIBIT 9 - PAGE 232
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`

`

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`Radiopaque Marker Limitations Not Supported by Provisional Application
`Claim Limitation
`Claim
`“… 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 ….”
`
`Claim 1
`
`
`I refer to this limitation as the “radiopaque marker” limitation.
`209.
`210. Additionally, it is my opinion that the asserted claims of the ’156 patent
`are not entitled to a priority date of March 29, 2004, because the Provisional Application
`does not enable or provide sufficient written description support for at least the following
`limitations:
`Dimension Limitations Not Supported by Provisional Application
`Claim Limitation
`Claim
`a
`“… wherein
`said
`implant has
`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.”
`length
`“… a
`longitudinal aperture
`to
`the
`extending generally parallel
`longitudinal length of said implant, and a
`lateral aperture width extending between
`said first sidewall to said second sidewall,
`
`Claim 1
`
`Claim 1
`
`83
`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
`
`
`
`EXHIBIT 9 - PAGE 233
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`

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`wherein the longitudinal aperture length is
`greater than the lateral aperture width.”
`“… a position proximate to said medial
`plane.”
`“… said longitudinal length is greater than
`40 mm.”
`
`Claim 1
`
`Claim 5
`
`211. Collectively, I refer to these limitations as the “dimension” limitations.
`(a) The asserted claims are not entitled to a March 29, 2004
`priority date because the “radiopaque marker” limitations
`
`are not disclosed in the Provisional Application
`212. As noted above with respect to the ’334 patent, there is nothing in the
`Provisional Application that discloses the radiopaque marker limitations in the claimed
`spinal implants.
`213. Rather, support for the “radiopaque markers” limitations did not appear
`until March 29, 2005 when applicants filed U.S. Patent Application Serial No.
`11/093,409 (NUVA_ATEC0020856–910), which ultimately issued as U.S. Patent No.
`7,918,891. The ’156 patent is a continuation of the ’891 patent, and these patents
`substantively share the same specification, aside from minor changes describing related
`applications. (See, e.g., ’156 patent at cover page, 1:4–15.)
`In Section IX.A.3 above, I provide my opinion that the radiopaque marker
`214.
`limitations are not described in the Provisional Application and therefore the asserted
`claims of the ’334 patent are not entitled to a priority date of March 29, 2004. I
`incorporate by reference that section in its entirety as though fully stated herein. For
`the same reasons and based on the same factual information and evidence, the asserted
`claims of the ’156 patent are not entitled to a priority date of March 29, 2004, but rather
`can only claim priority to March 29, 2005, because the Provisional Application does not
`enable or provide written description support for the “radiopaque marker” limitations.
`
`84
`OPENING EXPERT REPORT OF BARTON L. SACHS, M.D., M.B.A.,
`F.A.C.P.E., F.A.C.H.E.
`
`
`
`EXHIBIT 9 - PAGE 234
`
`

`

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`(b) The asserted claims of the ’156 patent are not entitled to a
`March 29, 2004 priority date because the “dimension”
`limitations are not disclosed in the Priority Application
`236. As discussed in Section IX.B, the asserted claims of the ’156 patent require
`that the claimed implant have certain dimensions—i.e., a length that is greater than the
`width, an aperture length greater than the aperture width, 40 mm long, and a width
`greater than the height.
`In Section IX.A.3 above, I provide my opinion that the dimension
`237.
`limitations are not described in the Provisional Application and therefore the asserted
`
`claims of the ’334 patent are not entitled to a priority date of March 29, 2004. I
`incorporate by reference that section in its entirety as though fully stated herein. For
`the same reasons and based on the same factual information and evidence, the asserted
`claims of the ’156 patent are not entitled to a priority date of March 29, 2004, but rather
`can only claim priority to March 29, 2005, because the Provisional Application does not
`enable or provide written description support for the “dimension” limitations.
`In summary, which is stated here for ease of reference and not to be
`238.
`construed as limiting, when the applicants filed the ’409 application on March 29, 2005,
`they modified several paragraphs and added statements that were not part of the
`Provisional Application. The applicants made certain changes that concerned the
`disclosed dimensions of the claimed spinal implants.
`239. As mentioned, in Exhibit 11, I highlighted these differences (i.e., the
`dimension disclosures not disclosed in the Provisional Application but later included in
`the ’409 application), using the ’156 patent as a proxy for the specification of the ’409
`application because the specifications are substantively identical. (See, e.g., ’156 patent
`at 2:17–25, 5:15–19, 11:48–12:11, and Figs. 18–23.) Exhibit 9 highlights these
`disclosures in the ’409 application.
`I incorporate my analysis concerning the priority date of “dimension”
`240.
`limitations of the asserted claims of the ’334 patent here. F