IPR2019-00362
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`Petitioners,
`v.
`NUVASIVE, INC.,
`Patent Owner.
`________________
`Case No. IPR2019-00362
`United States Patent No. 8,361,156
`________________
`
`
`PETITIONERS’ REPLY TO PATENT OWNER’S RESPONSE
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`0
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`

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`TABLE OF CONTENTS
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`I.
`
`INTRODUCTION ........................................................................................1
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`IPR2019-00362
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`STATE-OF-THE-ART .................................................................................3
`II.
`III. CLAIM CONSTRUCTION ..........................................................................5
`IV. GROUND 1 ..................................................................................................6
`A. Motivation to combine Brantigan, Baccelli, and Berry........................6
`B.
`“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” ............................................6
`“first fusion aperture having: a longitudinal aperture length
`extending generally parallel to the longitudinal length” ......................8
`“maximum lateral width of said implant is approximately 18
`mm” ....................................................................................................8
`“medial support” and “second fusion aperture” ...................................9
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`C.
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`D.
`
`E.
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`V. GROUND 2 ................................................................................................10
`A. Motivation to combine Brantigan, Baccelli, and Michelson ..............10
`B.
`“first radiopaque marker” ..................................................................13
`C.
`“maximum lateral width of said implant is approximately 18
`mm” ..................................................................................................14
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`VI. OBJECTIVE INDICIA ...............................................................................16
`VII. CONCLUSION ..........................................................................................19
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`TABLE OF AUTHORITIES
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`IPR2019-00362
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`Page(s)
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`Cases
`
`Agrizap, Inc. v. Woodstream Corp.,
`520 F.3d 1337 (Fed. Cir. 2008) ................................................................................................... 16
`
`In re Applied Materials, Inc.,
`692 F.3d at 1298 ....................................................................................................................... 9, 14
`
`In re Carlson,
`983 F.2d 1032 (Fed. Cir. 1992) ..................................................................................................... 4
`
`Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc.,
`807 F.2d 955 (Fed. Cir. 1986) ....................................................................................................... 4
`
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366 (Fed. Cir. 2019) ................................................................................................... 16
`
`Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324 (Fed. Cir. 2019) ................................................................................................... 16
`
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ................................................................................................... 16
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`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ................................................................................................... 18
`
`In re: NuVasive, Inc.,
`No. 2015-1670, Opinion (Fed. Cir. Dec. 7, 2016)........................................................................ 4
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`Ohio Willow Wood Co. v. Alps S., LLC,
`735 F.3d 1333 (Fed. Cir. 2013) ................................................................................................... 16
`
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019) ..................................................................................................... 4
`
`In re Rouffet,
`149 F.3d 1350 (Fed. Cir. 1998) ..................................................................................................... 4
`
`In re: Warsaw Orhtopedic, Inc.,
`Nos. 2015-1050, 2015-1058 (Fed. Cir. Aug. 9, 2016) ................................................................. 4
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`Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 2013-1576, -1577 .................................................................................................................... 4
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`Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
`No. 3:08-cv-1512 ............................................................................................................................ 4
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`WMS Gaming Inc. v. Int’l Game Tech.,
`184 F.3d 1339 (Fed. Cir. 1999) ................................................................................................... 16
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`Other Authorities
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`37 C.F.R. § 42.6(e) ............................................................................................................................... 5
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`37 C.F.R. § 42.24(d) ............................................................................................................................. 1
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`37 C.F.R. § 42.105(a) ........................................................................................................................... 5
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`Berry et al. “A Morphometric Study of Human Lumbar and Selected Thoracic
`Vertebrae,”
`12 Spine, 362-367 (1987) .............................................................................................................. 4
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`I.
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`INTRODUCTION
`Patent Owner argues the following: (1) most interbody implants available in
`the late-1990’s were allograft bone; (2) Petitioner “asserts a POSA would have
`wanted a 38 mm-wide implant;” (3) “a POSA would not have made the modular
`implant proposed by Petitioner because it would have been less safe and would
`increase invasiveness;” and (4) implementing a “marker configuration [that would]
`‘allow[] surgeons to align the markers with the spinous process during and after the
`implant is inserted laterally” fails because Baccelli does not teach the configuration
`and it is impermissibly based on hindsight. Response, 13, 1–2, 25, 38.1 None of
`this is true. Moreover, Patent Owner’s arguments concerning the orientation of four
`radiopaque markers disclosed in Baccelli (EX1008) and combined with a Brantigan
`(EX1007) implant that otherwise has no markers overlooks the undisputed teaching
`that the Brantigan implant can be inserted using different approaches, including
`lateral.
`Patent Owner argues there is no motivation to combine the cited references
`based on a strawman—Patent Owner’s assertion that Petitioner “theorized sequential
`insertion of pieces into the disc space, moving the pieces around, and assembling
`them within the disc space”—that Patent Owner contends “increase risks to patients
`and make the procedure more invasive, not less invasive.” Response, 12. Petitioner
`never makes this argument.
`It is undisputed that Michelson (EX1032), and Brantigan teach modular
`implants. Neither requires assembly. Indeed, Patent Owner’s suggested assembly
`of modular implants conflicts with the cited art and fact that insertion of modular
`non-bone spinal implants from a lateral approach to the spine was known and widely
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`1 Unless otherwise noted, all emphasis is added and internal citations and quotations
`are omitted.
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`published before the ’156 patent. Contrary to Patent Owner’s assertions2 here,
`Patent Owner cited prior art from 1998 demonstrating such use in another
`proceeding before the Board: McAfee et al., “Minimally Invasive Anterior
`Retroperitoneal Approach to the Lumbar Spine Emphasis on the Lateral BAK,” 23
`Spine, 1476–1484 (1998) (EX1054).3
`In 1998, McAfee described “the first clinical series investigating the use of
`the lateral retroperitoneal minimally invasive approach for lumbar fusions” using
`“two parallel transverse interbody cages” made of non-bone material after “240
`laprascopic BAK interbody fusions and stablizations.” EX1054, 2, 9. “Ten patients
`underwent [minimally invasive lumbar] fusion surgery with custom BAK interbody
`fusion cages. The long axes of the cages were in the transverse direction.” Id., 2, 5.
`Using the lateral approach, a “surgeon can use two longer cages in the transverse
`axis, with a larger-diameter cage anterior and a smaller-diameter cage posterior, thus
`‘customizing’ or ‘dialing-in’ the optimal degree of intervertebral lordosis.” Id., 6.
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`Id., Fig. 5; Fig. 4 (radiographs after BAK interbody fusion in a two-cage). The
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`2 Patent Owner’s expert Dr. Youssef is akin to an employee. Unrelated to work on
`the Petition, Patent Owner will pay Dr. Youssef $1.25 million over the next five
`years plus shares. EX1063. Dr. Youssef has already received $3.5 million,
`including royalties for XLIF. EX1059, 11:23–12:4; EX1064.
`3 Patent Owner cited this as Exhibit 2065 in IPR2014-00075, but did not provide it
`to its experts. EX1050, 34:6–17.
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`reported lateral (C) and antero-posterior (D) radiographs of a transversely oriented
`BAK cage show that POSAs knew the benefits of “aligning markers with the spinous
`process and the lateral ends of the vertebrae” before the ’156 patent without
`“impermissible hindsight.”
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` Id., Fig. 1. These radiographs show the BAK cage emitting stronger signals at its
`center and lateral ends (thereby serving as markers). Id. Patent Owner fails to even
`acknowledge—let alone address—the relevant state-of-the-art.
`Petitioner has shown that challenged claims of the ’156 patent are obvious in
`view of the prior art and, therefore, should be canceled.
`STATE-OF-THE-ART
`II.
`It is well-settled that a POSA is presumed to have knowledge of the relevant
`prior art. “Obviousness is determined from the vantage point of a hypothetical
`person having ordinary skill in the art to which the patent pertains. This legal
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`construct is akin to the ‘reasonable person’ used as a reference in negligence
`determinations. The legal construct also presumes that all prior art references in
`the field of the invention are available to this hypothetical skilled artisan.” In re
`Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). Indeed, a POSA “is a hypothetical
`person who is presumed to be aware of all the pertinent prior art.” Custom
`Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986); In re Carlson, 983 F.2d 1032, 1038 (Fed. Cir. 1992) (“To determine
`patentability, a hypothetical person is presumed to know all the pertinent prior art,
`whether or not the applicant is actually aware of its existence.”).
`The state-of-the-art before the alleged inventions of the ’156 patent is critical
`to a proper obviousness analysis regarding motivation to combine. The Federal
`Circuit recently stressed: “A motivation to combine may be found ‘explicitly or
`implicitly in market forces; design incentives; the ‘interrelated teachings of multiple
`patents’; ‘any need or problem known in the field of endeavor at the time of
`invention and addressed by the patent’; and the background knowledge, creativity,
`and common sense of the person of ordinary skill.’” Realtime Data, LLC v. Iancu,
`912 F.3d 1368, 1374 (Fed. Cir. 2019).
`Patent Owner criticizes “Dr. Branch’s characterization of the state of the art
`[as] inaccurate and unreliable,” while ignoring the relevant art. Response, 9, 13. For
`example, Patent Owner argues that “most interbody implants that were available in
`and around the late-1990’s were made of allograft bone,” and that “use of non-bone
`interbody spinal fusion implants ‘was still fairly nascent’ at the time of the
`invention.” Response, 13. This ignores Michelson’s express disclosure in 1999 that
`“Michelson, Ray, Bagby, Kuslich, and others have taught the use of hollow, threaded
`perforated cylinders to be placed across a disc space between adjacent vertebrae in
`the human spine to encourage interbody spinal fusion by the growth of bone from
`one vertebra adjacent a disc to the other vertebra adjacent that disc through such
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`implants. Michelson, Zdeblick and others have also taught the use of similar devices
`. . . . Such implants now in common use throughout the spine, may be used
`individually or inserted across the disc space in side-by-side pairs, and may be
`insertable from a variety of directions.” EX1053, 2:20–37. McAfee’s “threaded
`perforated cylinders” are not made of allograft bone. EX1054, 2, 9.
`Further, Patent Owner ignores the testimony it elicited from Dr. Brantigan on
`its behalf regarding public availability of Brantigan cages in a prior jury trial.
`Response, 14; EX2055, ¶¶38–40; see EX2029, 2; 2030, 2; EX1035, 1; EX1056, 3–
`7. Patent Owner did not make Dr. Youssef aware of such testimony. EX1050,
`37:12–21. Patent Owner relied on this testimony, and the trial exhibits that
`accompanied it, along with Brantigan (EX1007) to argue that Michelson’s claims
`(EX1032) were invalid. EX1035, 20. Patent Owner stated that “[b]y 1990, years
`before the earliest possible priority date [1995], spine surgeon Dr. John Brantigan
`had developed and used implants with the same dimensions and structures” claimed
`in Michelson. Id. Patent Owner also told the Federal Circuit that “Dr. Brantigan
`inserted an implant in a patient named ‘JC’ on July, 9, 1990 to address a burst
`fracture at the L1 vertebrae.” Id. The results of this and other surgeries were
`published in Spine in 1993. EX1056, 8; EX1055.
`Accordingly, Patent Owner’s criticisms of Dr. Branch, including the charge
`that Dr. Branch “mistakes private product development activities for information
`generally known and available to a POSA,” are baseless.
`III. CLAIM CONSTRUCTION
`In the Institution Decision, the Board construed “longitudinal length” in
`accordance with claim 1 such that “a longitudinal length” “extend[s] from a proximal
`end of said proximal wall to a distal end of said distal wall” where “said longitudinal
`length is greater than said maximum lateral width.” Paper 18, 13.
`The Board also construed “medial plane” in accordance with claim 1 such that
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`a “medial plane” “is located approximately at the midpoint of the longitudinal
`length.” Id., 14. Additionally, the Board construed “proximate” to mean “near.” Id.
`IV. GROUND 1
`A. Motivation to combine Brantigan, Baccelli, and Berry
`Petitioner explained that a POSA would have been motivated to position
`markers arranged as in Baccelli in the sidewalls of Brantigan’s implant to allow a
`surgeon to align the markers with the spinous process during and after lateral
`insertion of the implant. Petition, 31–33. Patent Owner advances multiple
`arguments challenging the motivation to combine Ground 1 references. Each is
`incorrect.
`Petitioner and Dr. Branch explain the motivation to add the markers of
`Baccelli’s marker to the modified implant of Brantigan in view of Berry. Petition,
`30–33, EX1002, ¶¶123–126. Patent Owner argues that Petitioner’s motivation to
`combine was allegedly previously
`rejected by
`the Federal Circuit as
`hindsight. Response, 25–26. Patent Owner’s argument is based on impermissible
`ignorance of the relevant state-of-the-art. Indeed, as Patent Owner’s own
`reference—McAfee—explained, in 1988, surgeons knew to use a lateral approach
`to implant “two longer cages in the transverse axis, with a larger-diameter cage
`anterior and a smaller-diameter cage posterior.” EX1054, 6. McAfee also reported
`lateral and antero-posterior radiographs of the transversely-oriented BAK cages to
`illustrate the benefits of “aligning makers with the spinous process and lateral ends
`of the vertebrae.” Id., Fig. 4. Accordingly, contrary to Patent Owner’s
`representations to the Board, it was within the general knowledge of a POSA—and
`not “impermissible hindsight”—to incorporate markers into translateral implants to
`assist with alignment.
`“first radiopaque marker extends into said first sidewall at a
`B.
`position proximate to said medial plane, and said second radiopaque
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`marker extends into said second sidewall at a position proximate to said
`medial plane”
`Petitioner demonstrated how Brantigan, Berry, and Baccelli disclose this
`limitation. Petition, 49–52. As the Board noted in the Institution Decision, “medial
`plane” should be construed in accordance with the express language of claim 1.
`Paper 18, 13. Claim 1 expressly defines various coordinates of the claimed implant.
`The longitudinal length “extend[s] from a proximal end of said proximal wall to a
`distal end of said distal wall.” EX1001, cl. 1. Similarly, the maximum lateral width
`“extend[s] from said first sidewall to said second sidewall along a medial plane that
`is generally perpendicular to said longitudinal length.” Id. Given these coordinates,
`Baccelli discloses a first radiopaque marker that extends into said first sidewall at a
`position proximate—or near—to said medial plane, and said second radiopaque
`marker extends into said second sidewall at a position proximate to said medial
`plane, just as depicted in the annotated images in the Petition. Petition, 50–51.
`Notably, Petitioner is not asserting that the Baccelli implant has a “longitudinal
`length that is greater than its maximum lateral width.” Instead, Petitioner relies on
`Brantigan and Berry to disclose the dimensional limitations.
`Patent Owner essentially argues that the length, width, and medial plane can
`only be understood in the context of an implant that has a longitudinal length that is
`greater than said maximal lateral width. Response, 20–23. But that argument is
`incorrect because the language describing the length, width, and medial plane
`coordinates is separate from the language explaining how those coordinates
`interrelate.
`Patent Owner also argues that a POSA applying Baccelli’s marker
`configuration to Brantigan would not arrive at the claimed implant. Response, 24.
`Not so. Patent Owner’s argument overlooks that Brantigan’s implants are “suitable
`for anterior, posterior or lateral placement in any area of the spine requiring
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`replacement of disc or vertebral body.” EX1007, 2:57–59.
`As shown in the Petition, annotated Brantigan figures 8 and 10 illustrate the
`requisite coordinates when the implant is laterally inserted, which does “not require
`mounting apertures in the end faces of the plugs.” Petition, 42–44; EX1007, 7:5–6.
`In this configuration, the red arrows depicted in Patent Owner’s annotated image
`would be located in the sidewalls where the dotted lines are located—that is,
`proximate to the medial plane. Response, 24. Accordingly, Baccelli discloses this
`limitation.
`“first fusion aperture having: a longitudinal aperture length
`C.
`extending generally parallel to the longitudinal length”
`Petitioner demonstrated that Brantigan’s central aperture 11d disclosed this
`limitation, as illustrated, for example, in Figures 1 and 6. Petition, 47–48.
` Patent Owner’s argument that Brantigan “Fig. 1 depicts an unassembled
`precursor to the implant that is designed to received connecting bar 15” and thus,
`there is no “first fusion aperture unbounded by a medial support in the form of central
`aperture 11d” is incorrect. Response, 27–28. First, Brantigan Figure 1 illustrates
`“a top and side perspective view of a full oval prosthetic device according to this
`invention.” EX1007, 3:19–22. Contrary to Patent Owner’s argument, Brantigan
`does not identify the implant illustrated in Figure 1 as “unassembled.” Second, to
`the extent Patent Owner contends that Brantigan’s devices always have either a
`connecting bar or a reinforcing bar dividing side-by-side apertures, the argument is
`inconsistent with the plain language of the claims. For example, claims 12 and 13
`recite an implant having a central aperture, while other claims, like 10 and 11, recite
`an implant having “a bar intersecting the interior of the plug.”
`Accordingly, Brantigan discloses this limitation.
`“maximum lateral width of said implant is approximately 18 mm”
`D.
`Petitioner demonstrated that Brantigan disclosed this limitation in view of
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`Berry at T2. Petition, 56.
`Patent Owner’s argument that “[n]o asserted reference teaches implant
`dimensions should be as large as adjacent vertebral bodies” contradicts express
`teachings in Brantigan. Indeed, Brantigan states that its implants are “generally
`shaped and sized to conform with the disc space” and which are “dimensionally
`similar to normal vertebral bodies.” EX1007, 4:6–7, abstract.
`Further, Dr. McMillin’s opinion is inconsistent with arguments Patent Owner
`made to the Federal Circuit. Specifically, Patent Owner relied on Berry’s data to
`argue that “the 42 mm Brantigan implant” had length, width, and height dimensions
`that were recited in the claims of the ’973. EX1035, 42–43. Importantly, Patent
`Owner never argued that Berry’s data should be modified because Brantigan’s
`implants were designed to fit within the annulus fibrosis, as Dr. McMillin now
`opines. EX2057, ¶¶20–22. Indeed, the opposite was true—NuVasive argued that
`because Brantigan’s “implants are dimensionally similar to normal vertebral bodies,’
`are ‘shaped to conform with the general outline perimeter of the vertebrae,’
`“Brantigan ’327 thus discloses the same dimensions claimed in the ’973 patent.”
`EX1035, 22. Accordingly, Brantigan discloses this limitation.
`“medial support” and “second fusion aperture”
`E.
`Petitioner demonstrated that Brantigan in view of Berry and Baccelli discloses
`this limitation. Petition, 60–63.
`Patent Owner argues that, based on Brantigan Fig. 6, the longitudinal aperture
`length of the first fusion aperture is perpendicular to the longitudinal length of the
`aperture. Response, 31. Patent Owner’s argument is incorrect because it disregards
`a basic tenet of patent law—a reference is available for all that it teaches, not simply
`a preferred or illustrated embodiment. In re Applied Materials, Inc., 692 F.3d at
`1298. Indeed, Brantigan states that its implants are “dimensionally similar to normal
`vertebral bodies.” EX1007, abstract; see also EX1035, 22. Accordingly, implants
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`designed for the lumbar region would include a medial support such that the requisite
`dimensions for the second fusion aperture are met. Accordingly, this limitation is
`disclosed.
`V. GROUND 2
`A. Motivation to combine Brantigan, Baccelli, and Michelson
`ignore
`Patent Owner’s arguments regarding motivation
`to combine
`Petitioner’s actual evidence and the relevant state-of-the-art. Patent Owner argues
`that “Brantigan does not disclose sequential insertion of modular members into the
`disc space but instead teaches assembly prior to insertion.” Response, 34. The
`argument conflates Brantigan’s vertically stacked and modular, hemi-oval implants.
`Petitioner does not suggest stacking modular implants. Instead, Petitioner states
`accurately that a POSA would have been motivated to apply Michelson’s “long and
`narrow” modularity to Brantigan, which is “generally shaped and sized to conform
`with the disc space” and are “dimensionally similar to normal vertebral bodies.
`EX1007, 4:6–7, abstract.
`Patent Owner also argues that Brantigan’s “antimigration elements would
`make it dangerous and difficult to move the first implant out of the way to insert the
`second implant.” This misstates Petitioner’s argument and the prior art. Response,
`34. The Petition does not state that insertion of modular implants requires moving
`a first implant out of the way. Instead, the first implant is placed, and the second
`implant is placed in its appropriate position without needing to move the first. Real-
`world examples cited above demonstrate that such insertion was not hypothetical.
`Patent Owner also argues that the Petition fails to demonstrate that a POSA
`would have been motivated to make Brantigan into two modular members for
`sequential insertion through a hollow tube to increase patient safety and minimize
`invasiveness. Response, 34. The explanation is straightforward: lateral insertion of
`multiple implants having a width of no more than 18 mm—as opposed to insertion
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`of one implant having a width of 32 mm for example (as disclosed in EX1032,
`10:45)—would lead to increased patient safety and decreased invasiveness because
`the incision would be smaller. Thus, far from “present[ing] more opportunities for
`unwanted iatrogenic injury to the tissues and potential harm to the patient,” as Dr.
`Youssef opines (EX2055, ¶108), the modular “long and narrow” implants proposed
`in the petition could be inserted in a minimally invasive procedure “through a hollow
`tube which is engaged to the lateral aspect of the spine through a lateral, anterior, or
`anterolateral incision making the procedure safe and simple.” EX1032, 3:62–65.
`Indeed, Michelson’s long and narrow “translateral implants of the present invention
`are safer to use than implants inserted from the front or back as the aorta and vena
`cava lie anterior to the spine and the dural sac and nerves posteriorly, all of which
`structures are simply avoided in the lateral approach.” EX1032, 3:55–59.
`Patent Owner argues that “Michelson does not disclose sequential insertion of
`modular members into the disc space but instead teaches assembly prior to
`insertion.” Response, 18. Patent Owner mischaracterizes Michelson in multiple
`ways. In context, Michelson states that “[t]he dimensions of the translateral spinal
`fusion implant of the present invention permits a single implant to inserted by a
`single procedure into the spine and to engage more of the adjacent vertebrae.”
`EX1032, 3:46–49. In other words, Michelson is referring to the dimensions—and
`in particular only the length is consistent throughout his disclosure and
`embodiments—of “the translateral spinal fusion implant of the present invention”
`because “it has a different structural configuration as compared to spinal implants
`for insertion from either the front or back of the patient, as such implants are
`necessarily limited [in length] by the depth, measured from the front to back of the
`vertebrae.” EX1032, 3:11–17. In other words, Michelson claims and discloses a
`“translateral” implant length—as a single length—to span the disc space, as opposed
`to placing two shorter implants in the disc space, one behind the other, to meet the
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`requisite length.
`Patent Owner’s argument that Michelson’s “modular members are combined
`before insertion into the disc space, not after” mischaracterizes Michelson.
`Response, 18. Nowhere does Michelson “teach[] assembly prior to insertion.” Id.
`Indeed, Patent Owner argues that because “more than one spinal fusion implant 1000
`may be combined in a modular fashion for insertion within the disc space,” that
`the modular implants must be assembled before insertion. EX2055, ¶¶47–48;
`EX2057, ¶¶33–34. But this interpretation renders Michelson’s narrow embodiment
`meaningless. If modular components must be assembled before insertion, there is
`no use for implant 1000, which “has a narrower width” than implant 900. EX1032,
`10:52. Indeed, Michelson’s Figure 19 shows “a plurality of the spinal implants of
`FIG 18…inserted from the lateral aspect in a modular fashion in the disc space,”
`which comports with the disclosure that the implants “may be inserted into the disc
`space through a hollow tube which is engaged to the lateral aspect of the spine
`through a lateral…incision.” EX1032, 10:56–59, 3:62–64, see also 5:34–39. Thus,
`Michelson teaches an alternative embodiment of modular, long and narrow implants
`that can be inserted sequentially through a hollow tube and combined in the disc
`space to “a width that approximates the depth of the vertebrae.” EX1032, 10:40–41.
`Michelson ’770—which reflects the relevant state of the art—“demonstrates a pair
`of implants 500a and 500b…being used in a side-by-side relationship inserted
`generally laterally or anterolaterally into the spine.” EX1053, 10:10–13. Michelson
`’770 also illustrates “two implants 600a and 600b, one anterior, one posterior, [and]
`the anterior one may be of a larger diameter than the posterior one. The posterior
`one may be longer than the anterior one.” Id., 10:13–16.
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`Id., Figs. 13B, 14B. Accordingly, Patent Owner’s theory that a POSA would
`assemble Michelson’s modular implants through a hollow tube is baseless.
`Finally, the Petition and Dr. Branch explain the motivation to add Baccelli’s
`markers to the modified implant of Brantigan in view of Michelson and Berry.
`Petition 30–33, EX1002, ¶¶123–126. Patent Owner argues that Petitioner’s
`motivation to combine was allegedly previously rejected by the Federal Circuit as
`hindsight. Response, 32–33. Patent Owner’s argument is based on ignorance of the
`relevant state-of-the-art. Indeed, as Patent Owner’s own reference—McAfee—
`explained, in 1988, surgeons knew to use a lateral approach to implant “two longer
`cages in the transverse axis, with a larger-diameter cage anterior and a smaller-
`diameter cage posterior.” EX1054, 6. McAfee also reported lateral and antero-
`posterior radiographs of the transversely-oriented BAK cages to illustrate the
`benefits of “aligning makers with the spinous process and lateral ends of the
`vertebrae.” Id., Fig. 4. Accordingly, contrary to Patent Owner’s representations to
`the Board, it was within the general knowledge of a POSA—and not “impermissible
`hindsight”—to incorporate markers into lateral implants to assist with alignment.
`“first radiopaque marker”
`B.
`As explained above in Section IV(B), petitioner demonstrated how
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`Brantigan, Berry, and Baccelli disclose this limitation. That discussion is
`incorporated by reference herein.
`“maximum lateral width of said implant is approximately 18 mm”
`C.
`Petitioner demonstrated how a POSA would have modified the Brantigan
`implant in light of the teachings of Michelson, Baccelli, and Berry to obtain an
`implant having widths in the range of 16.15 mm to 18.95 mm. Petition, 70–75.
`Patent Owner argues Petitioner’s proposal to exceed 32 mm for the total
`implant width in the disc space is simply “absurd.” Response, 33–34. Patent Owner
`also counters that Brantigan’s implants are designed to fit within the annulus fibrosis
`and have smaller dimensions than adjacent vertebral bodies. Response, 62–63.
`Neither of these arguments—even if true—explains why an implant having a width
`in the range of 16.16 m to 18.95 mm would not render the limitation obvious.
`Dr. McMillin (and Youssef) opine that “Brantigan’s implants are designed to
`fit within the annulus fibrosis and, as such, are smaller than vertebral bodies.”
`McMillin Decl., ¶21. This opinion is inconsistent with express teachings of
`Brantigan, stating that its implants are “dimensionally similar to normal vertebral
`bodies.” Brantigan, abstract. While Brantigan may describe an embodiment that
`fits within the annulus fibrosis, the reference is available for all that it teaches and is
`not limited to particular embodiments. In re Applied Materials, Inc., 692 F.3d at
`1298.
`Further, the opinion is inconsistent with Patent Owner’s statements to the
`Federal Circuit. Specifically, Patent Owner relied on Berry to argue that “the 42 mm
`Brantigan implant” had length, width, and height dimensions that were recited in the
`claims of Michelson. EX1035, 7. Patent Owner never argued that Berry should be
`modified because Brantigan was designed to fit within the annulus fibrosis, as Patent
`Owner now argues. EX2057, ¶¶20–22. Indeed, the opposite was true—Patent
`Owner argued that Brantigan’s “implants are dimensionally similar to normal
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`vertebral bodies,’ [and] are ‘shaped to conform with the gen