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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
`Patent No. 8,361,156
`Claims 1-3, 5, 9, 10, 12-21, 23, 24, and 27
`_____________________________
`
`
`DECLARATION OF JIM A. YOUSSEF, M.D.
`
`
`
`
`
`
`
`
`
`NUVASIVE - EXHIBIT 2055
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
`
`

`

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`
`
`
`TABLE OF CONTENTS
`
`I.
`
`QUALIFICATIONS ........................................................................................ 1
`
`II.
`
`SCOPE OF WORK.......................................................................................... 4
`
`III. LEGAL STANDARDS ................................................................................... 5
`
`IV. BRIEF OVERVIEW OF THE LEVEL OF SKILL ........................................ 7
`
`V.
`
`CLAIM TERMINOLOGY .............................................................................. 8
`
`A.
`
`“Longitudinal Length” and “Longitudinal Aperture Length”............... 9
`
`B.
`
`“Medial Support” ................................................................................ 10
`
`VI. BACKGROUND ........................................................................................... 11
`
`A. Dr. Branch provides an inaccurate description of state of the art
`at the time ............................................................................................ 11
`
`i.
`
`ii.
`
`iii.
`
`iv.
`
`The description of Michelson is inaccurate .............................. 12
`
`The description of Berry is inaccurate ...................................... 16
`
`The description of Brantigan is inaccurate ............................... 17
`
`The description of Baccelli is inaccurate .................................. 22
`
`Development of spinal implants .......................................................... 25
`
`Subsequent innovations in lateral surgery and hindsight .................... 29
`
`B.
`
`C.
`
`D.
`
`State of “modular” implants at the time .............................................. 32
`
`E.
`
`The Petition’s challenge is based on unreasonably sized
`implants ............................................................................................... 35
`
`VII. GROUND 1 – CLAIMS 1-3, 5, 9, 10, 12-21, 23, 24, AND 27 ARE
`NOT OBVIOUS IN VIEW OF BRANTIGAN, BACCELLI, AND
`BERRY .......................................................................................................... 38
`
`-i-
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`

`

`
`
`A.
`
`B.
`
`C.
`
`Brantigan, Baccelli, and Berry do not teach a first and second
`radiopaque marker “proximate to said medial plane” as required
`by all challenged claims ...................................................................... 38
`
`Brantigan, Baccelli, and Berry do not teach an implant with a
`longitudinal aperture length parallel to the longitudinal length
`of the implant ....................................................................................... 42
`
`There is no motivation to combine the teachings of Brantigan,
`Baccelli, and Berry .............................................................................. 45
`
`D. Dependent claims 2, 3, 5, 9, 12-21, 23, 24, and 27 ............................. 45
`
`VIII. GROUND 2 – CLAIM 9 IS NOT OBVIOUS IN VIEW OF
`BRANTIGAN, BACCELLI, MICHELSON, AND BERRY ....................... 50
`
`IX. OBJECTIVE INDICIA OF NONOBVIOUSNESS ...................................... 51
`
`A. NuVasive’s CoRoent® XL Implants are Encompassed by the
`Challenged Claims .............................................................................. 51
`
`B.
`
`Alphatec’s Battalion™ Lateral Spacer copies the claimed
`invention .............................................................................................. 56
`
`CONCLUDING STATEMENTS .................................................................. 61
`
`X.
`
`
`-ii-
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`
`
`I, Jim A. Youssef, M.D., declare as follows:
`
`I.
`
`QUALIFICATIONS
`
`1.
`
`I am an orthopaedic surgeon, board certified by the American Board
`
`of Orthopaedic Surgery, and fellowship trained in spine surgery.
`
`2.
`
`I received an undergraduate degree in Genetics from the University of
`
`California at Berkeley in 1986. I received my medical degree from the University
`
`of California, Irvine School of Medicine, in 1991.
`
`3.
`
`I completed an internship in general surgery at Oregon Health
`
`Sciences University in 1992. I performed my orthopaedic surgery residency at
`
`Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire from 1992-
`
`1996. I was chief resident of orthopaedic surgery at the VA Medical Center in
`
`White River Junction, Vermont from 1995-1996. Subsequently, I did my spine
`
`fellowship training at the University of California, Davis Medical Center in
`
`Sacramento, California from 1996-1997.
`
`4.
`
`I have been a practicing spine surgeon for over two decades. Since
`
`2000, I have been the Medical Director of the Spine Service at the Mercy Regional
`
`Medical Center in Durango, Colorado.
`
`5.
`
`I am the founder of Spine Colorado, P.C., a multidisciplinary
`
`comprehensive center focused on spine care. There, I have an active surgical
`
`practice focused on the treatment of degenerative spine diseases, complex adult
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`1
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`spinal deformity, and spinal injuries, which includes, among other things, spine
`
`surgery.
`
`6.
`
`I have received Achievement Awards from the American Academy of
`
`Orthopaedic Surgeons in 2010, 2011 and 2018.
`
`7.
`
`I am a board member and the Past President for the Society of Lateral
`
`Access Surgery. I am a founding member of the Society of Minimally Invasive
`
`Surgery. I am a member of the American Orthopedic Association, a prestigious
`
`leadership society in orthopedic surgery. I am also a fellow of the American
`
`Academy of Orthopaedic Surgeons. I am a member of the North American Spine
`
`Society, the Cervical Spine Research Society, and the Lumbar Spine Research
`
`Society, and the Scoliosis Research Society.
`
`8.
`
`I have an active research department and have participated not only in
`
`my own original research, but in several clinical trials involving new technology. I
`
`have founded a non-profit organization focused on resources for medical
`
`collaboration. As a result of my academic interests and publications, I have been
`
`invited to speak and participate in Grand Rounds at a number of different hospitals
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`throughout the United States and internationally. I have given over 190
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`presentations at various spine or orthopedic societies related to spine maladies,
`
`spine treatments, spine surgery, and my own research.
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`9.
`
`I have written forty-seven peer reviewed articles related to spine
`
`maladies, treatments, surgery and my own research. I have written numerous book
`
`chapters related to spine maladies and treatments. I have co-edited a textbook,
`
`Global Spinal Alignment: Principles, Pathologies, and Procedures, in 2014.
`
`10.
`
`I have served as a course founder and course director at the Annual
`
`Emerging Technologies Spine Education Summit since 2005. I have served as
`
`faculty teaching Minimally Invasive Techniques for the Treatment of
`
`Thoracolumbar Spine Disorders in St. Louis, Missouri, along with numerous other
`
`courses. I have participated as faculty and course chairman for the annual AAOS
`
`Spine Surgery: State-of-the-Art Techniques and Science since 2005.
`
`11.
`
`I currently serve on several editorial boards and review committees,
`
`including the editorial board for Spine and The Journal of the American Academy
`
`of Orthopaedic Surgeons.
`
`12.
`
`I am a named inventor on over ten patents, which relate to spine
`
`implants and fixation systems.
`
`13.
`
`I receive royalties from NuVasive from some of my inventing
`
`activities. I also have a consulting relationship with NuVasive.
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`
`II.
`
`SCOPE OF WORK
`
`14.
`
`I understand that a petition was filed with the United States Patent and
`
`Trademark Office for inter partes review of U.S. Patent No. 8,361,156 (“the ’156
`
`patent,” EX1001).
`
`15.
`
`I further understand that the Patent Trial and Appeal Board (“PTAB”
`
`or the “Board”) has decided to institute inter partes review of claims 1-3, 5, 9, 10,
`
`12-21, 23, 24, and 27 of the ’156 patent under 35 U.S.C. § 103 based on the
`
`disclosures of US2002/0165550 (“Frey” EX1040), U.S. Pat. No. 5,860,973
`
`(“Michelson” EX1032), U.S. Pat. No. 5,192,327 (“Brantigan,” EX1007),
`
`US2003/0028249 (“Baccelli,” EX1008), and Berry, et. al., “A Morphometric Study
`
`of Human Lumbar and Thoracic Vertebrae,” (“Berry,” EX1022).
`
`16.
`
`I have been specifically asked to provide my expert opinions on the
`
`patentability of the claims of the ’156 patent in view of the asserted grounds in the
`
`petition. In connection with this analysis, I have reviewed the ’156 patent and the
`
`prior art cited against the patentability of claims 1-3, 5, 9, 10, 12-21, 23, 24, and
`
`27. I have also reviewed and considered the petition, Dr. Branch’s declaration, and
`
`the Board’s Decision on Institution of Inter Partes Review.
`
`17.
`
`I am being compensated at a rate of $1,500 per hour for my work in
`
`this matter. I am also being reimbursed for reasonable and customary expenses
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`associated with my work in this investigation. My compensation is not contingent
`
`on the outcome of this matter or the specifics of my testimony.
`
`III. LEGAL STANDARDS
`
`18.
`
`I have been advised that a claimed invention is not patentable under
`
`35 U.S.C. § 103 if it is obvious. A patent claim is unpatentable if the claimed
`
`invention would have been obvious to a person of ordinary skill in the field at the
`
`time the claimed invention was made. This means that even if all of the
`
`requirements of the claim cannot be found in a single prior art reference that would
`
`anticipate the claim, a person of ordinary skill in the relevant field who knew about
`
`all this prior art would have come up with the claimed invention.
`
`19.
`
`I have further been advised that the ultimate conclusion of whether a
`
`claim is obvious should be based upon several factual determinations. That is, a
`
`determination of obviousness requires inquiries into: (1) the level of ordinary skill
`
`in the field; (2) the scope and content of the prior art; (3) what difference, if any,
`
`existed between the claimed invention and the prior art; and (4) any objective
`
`indicia of nonobviousness.
`
`20.
`
`I have been advised that, in determining the level of ordinary skill in
`
`the field that someone would have had at the time the claimed invention was made,
`
`I should consider: (1) the levels of education and experience of persons working in
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`the field; (2) the types of problems encountered in the field; and (3) the
`
`sophistication of the technology.
`
`21.
`
`I have been advised that a patent claim composed of several elements
`
`is not proved obvious merely by demonstrating that each of its elements was
`
`independently known in the prior art. In evaluating whether such a claim would
`
`have been obvious, I may consider whether there is a reason that would have
`
`prompted a person of ordinary skill in the field to combine the elements or
`
`concepts from the prior art in the same way as in the claimed invention.
`
`22.
`
`I have also been advised, however, that I must be careful not to
`
`determine obviousness using the benefit of hindsight; many true inventions might
`
`seem obvious after the fact. I should put myself in the position of a person of
`
`ordinary skill in the field at the time the claimed invention was made and I should
`
`not consider what is known today or what is learned from the teaching of the
`
`patent. Hindsight is particularly pertinent here where non-bone implants were a
`
`nascent technology and the claimed implants were made for a surgery developed
`
`concurrently with those implants.
`
`23. Finally, I have been advised that any obviousness rationale for
`
`modifying or combining prior art must include a showing that a person of ordinary
`
`skill would have had a reasonable expectation of success.
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`-6-
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`24. With regard to objective indicia of nonobviousness, I have been
`
`advised that any objective evidence may be considered as an indication that the
`
`claimed invention would not have been obvious at the time the claimed invention
`
`was made. I understand that the purpose of objective indicia is to prevent a
`
`hindsight analysis of the obviousness of the claims.
`
`25.
`
`I have been advised that there are several factors that may be
`
`considered as objective indicia. These factors include the long-felt need,
`
`skepticism, unexpected results and commercial success of the invention.
`
`26.
`
`I have been further advised that in order for objective indicia to be
`
`significant, there must be a sufficient nexus between the claimed invention and the
`
`evidence of objective indicia. I understand that this nexus serves to provide a link
`
`between the merits of the claimed invention and the evidence of objective indicia
`
`provided.
`
`IV. BRIEF OVERVIEW OF THE LEVEL OF SKILL
`
`27.
`
`I have been advised that, in determining the level of ordinary skill in
`
`the art that someone would have had at the time the claimed invention was made, I
`
`should consider: (1) the levels of education and experience of persons working in
`
`the field; (2) the types of problems encountered in the field; and (3) the
`
`sophistication of the technology. I have been advised that an invention must be
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`-7-
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`
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`evaluated not through the eyes of the inventor, who may have been of exceptional
`
`skill, but as by one of ordinary skill in the art.
`
`28. According to Dr. Branch, a person of ordinary skill in the art could be
`
`a medical doctor with 2-3 years of experience performing interbody spinal fusion
`
`surgeries or a mechanical or biomechanical engineer with 2 years of experience
`
`developing implants and access to orthopedic or neurosurgeons. EX1002, ¶18.
`
`29.
`
`I have generally adopted Dr. Branch’s description of a person of
`
`ordinary skill in the art in providing my opinions except that I would add that a
`
`person of ordinary skill in the art would not be familiar with developments in the
`
`art that came after the relevant timeframe. This is an important distinction because,
`
`as discussed below, Dr. Branch’s characterization of the state of the art is
`
`inaccurate and unreliable. It is my impression that the analysis that was conducted
`
`started with the challenged patents and sought to work backward from there as
`
`illustrated by inaccurate descriptions of references, unconventional use of
`
`terminology, lack of supporting evidence, and illogical suggestions.
`
`V. CLAIM TERMINOLOGY
`
`30. The petition asserts that “the challenged claims should be given their
`
`plain and ordinary meaning” and “submits that no express construction is needed
`
`to resolve the issues in this Petition.” Pet. 26. As discussed in detail below, the
`
`petition departs from the plain and ordinary meaning of the claims in several
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`-8-
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`important respects. Below, I address several claim terms where the Petition departs
`
`from and contradicts the plain and ordinary meaning of the claims.
`
`A. “Longitudinal Length” and “Longitudinal Aperture Length”
`
`31. All challenged claims require that the implant have a “longitudinal
`
`length” and that the first fusion aperture have a “longitudinal aperture length.” I
`
`have reviewed the language of the claims and the specification of the ’156 patent.
`
`Based upon the claim language and patent specification, and my knowledge and
`
`experience as a spine surgeon, I understand the plain and ordinary meaning of the
`
`terms longitudinal length and longitudinal aperture length.
`
`32. Based on my knowledge and years of experience, it is my opinion that
`
`the plain and ordinary meaning of the term longitudinal length is the longest
`
`dimension of the object. For the implant, the longitudinal length is the longest
`
`dimension of the implant. For the fusion aperture, the longitudinal aperture length
`
`is the longest dimension of the aperture. The claim uses additional language to
`
`specify that the longitudinal (longest) length of the implant must extend between
`
`the distal and proximal ends, that the longitudinal (longest) aperture length must be
`
`generally parallel to the longitudinal (longest) length of the implant, and that the
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`lateral widths of each of the implant and the aperture must extend between the
`
`sidewalls of the implant. EX1001, 12:44-64. The claim thus requires that the
`
`longest dimension of the first fusion aperture be generally parallel to the longest
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`-9-
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`dimension of the implant. This is how a person of ordinary skill in the art would
`
`have understand each of those terms at the time of the invention. It is also how the
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`terms are used in the claims and in the description of the ’156 patent.
`
`33. That the ordinary meaning of longitudinal length is the longest
`
`dimension is confirmed by the references asserted in the petition. For example, the
`
`Frey reference describes the long axis of the implant as extending through the
`
`implant at its center “longitudinally.” EX1040, Figures 55 and 63, ¶¶147, 159.
`
`34. As another example, the Brantigan reference discloses that “[r]idges
`
`12 are formed longitudinally across the end faces 11c.” EX1007, 4:15-16. As
`
`depicted in Fig. 1, the longitudinal ridges 12 run in the direction of the longest
`
`dimension of the implant (its longitudinal length). Id., 4:20-22.
`
`
`
`B. “Medial Support”
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`-10-
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`35.
`
` Claims 15-18 each require that the implant have “a medial support.”
`
`Based on my knowledge and years of experience as a spine surgeon, it is my
`
`opinion that the plain and ordinary meaning of term “medial” refers to the middle
`
`or midpoint of an object. In the context of claims 15-18 of the ’156 patent, the
`
`medial support is “located approximately at the midpoint of the longitudinal length
`
`of the implant.”
`
`VI. BACKGROUND
`
`A. Dr. Branch provides an inaccurate description of state of the art
`at the time
`
`36. Dr. Branch provides an inaccurate and unreliable description of the
`
`state of the art at the time. As illustrated below, Dr. Branch incorrectly describes
`
`the cited references and developments in the field, and critically omits information
`
`a skilled artisan would have considered important to the analysis in this case.
`
`37. Dr. Branch mischaracterizes the maturity of the field and the timing of
`
`developments with respect to non-bone spinal fusion implants. See, e.g., EX1002,
`
`¶¶39-49. For example, Dr. Branch says that “[b]y the 1990s, the use of non-bone
`
`interbody spinal fusion implants had become common place.” EX1002, ¶39. This
`
`is incorrect. In fact, most interbody implants that were available in and around the
`
`late-1990’s were made of allograft bone. By 2004, the field was still fairly nascent,
`
`with few examples of non-bone spinal fusion implants. In fact, the only devices Dr.
`
`Branch points to—the SVS and Telamon PLIF spacers—are identified as
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`becoming available in the 2003 timeframe at the earliest. EX1002, ¶45; see also
`
`EX1009; EX1010. And I understand that the public availability of these materials
`
`at the relevant time has been a disputed issue.
`
`38.
`
`Indeed, Dr. Branch also seems to repeatedly confuse non-public
`
`development activities with prior art publications. For example, Dr. Branch states
`
`that AcroMed began developing radiolucent spinal fusion implants, such as those
`
`made of PEEK, “at least as early as the late 1990s.” EX1002, ¶44. Dr. Branch does
`
`not specify whether the referenced AcroMed activities were known to the public at
`
`the relevant time. Dr. Branch also relies on his own “development” activities with
`
`Medtronic prior to the commercial release of the Telamon spacers. EX1002, ¶45.
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`However, as with his statements regarding AcroMed, there is no evidence that his
`
`development activities were known to the public.
`
`39. As illustrated in further detail below, Dr. Branch also provides
`
`inaccurate and unreliable descriptions when it comes to the cited references.
`
`i. The description of Michelson is inaccurate
`
`40. Michelson discloses “oversized” translateral spinal fusion implants
`
`that are inserted into the interbody space using a hollow tube. EX1032, Abstract
`
`(“An oversized spinal implant for translateral insertion…”), 3:60-63 (“The
`
`translateral spinal fusion implant of the present invention may be inserted into the
`
`-12-
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`disc space through a hollow tube which is engaged to the lateral aspect of the
`
`spine…”).
`
`41. Michelson specifically provides instruction for the sizing for his
`
`oversized lumbar spinal fusion implants. EX1032, 7:22-26 (“[T]he present
`
`invention has an overall length in the range of 35 mm to 50 mm, with 38-44 mm
`
`being preferred, and a maximum diameter in the range of 22 mm to 30 mm, with
`
`24-26 mm being preferred when inserted in the lumbar spine.”), 10:41-47 (“[T]he
`
`spinal fusion implant 900 has a … a width in the range of 24 mm to 32 mm, with
`
`the preferred width being 26 mm; and a length in the range of 32 mm to 50 mm,
`
`with 42 mm being the preferred length.”). Michelson further discloses that these
`
`spinal fusion implants have “a width that approximates the depth of the vertebrae.”
`
`EX1032, 10:32-47. That is, Michelson discloses that the widest lumbar implant is
`
`32 mm, with a 26 mm wide implant being preferred in his oversized implants.
`
`42. Despite express description of implant sizing in Michelson, Dr.
`
`Branch falsely states that one would need to turn different literature (i.e., Berry) to
`
`determine the appropriate width of an implant for the L4-L5 interbody space.
`
`EX1002, ¶281 (“Michelson ’973 … does not specify what region of the lumbar
`
`spine those dimensions pertain to. Therefore, a POSA designing an implant for
`
`fusion between L4 and L5, for example, would have been motivated to further rely
`
`on Berry’s dimensional data.”). This is wrong for several reasons. First, the Berry
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`reference was published more than a decade prior to Michelson. Second, the L4-L5
`
`interbody space is perhaps the most common site of instability in patients requiring
`
`lumber fusion surgery. A person of ordinary skill in the art would have understood
`
`that Dr. Michelson’s lumbar implant dimensions already accounted for vertebral
`
`body dimensions (including those published in Berry) when describing the
`
`appropriate sizing of his lumbar fusion implants.
`
`43. Moreover, Michelson teaches that the widths of the implants “need”
`
`to be “less than the depth of the vertebrae.” Id., Abstract, 3:27-32. As Michelson
`
`explains, the aorta and vena cava “lie anterior to the spine and the dural sac and
`
`nerves [lie] posteriorly” to the spine. EX1032, 3:56-59. Michelson further explains
`
`that using an implant that exceeds the depth of the vertebrae is not “possible” and
`
`results in “great harm” to the patient:
`
`[T]he maximum possible length for an implant that is inserted from
`either the front or the back of the patient is limited to the depth of the
`vertebrae, the depth of a vertebrae being the dimension of the
`vertebrae measured from the anterior end to the posterior end of the
`vertebrae. It was not previously possible to insert an implant that had
`a length that was greater than the depth of the vertebrae from front to
`back as such an implant would protrude from either the anterior or
`posterior aspect of the spine resulting in great harm to the patient.
`
`Id., 2:1-12. For a lateral implant, as taught by Michelson, this means that the width
`
`of the implant needs to be narrower than the depths of the adjacent vertebrae. Id.,
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`3:11-17 (“[S]uch implants are necessarily limited by the depth, measured from
`
`front to back of the vertebrae”).
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`44. Michelson further discloses that a benefit of the inventive implant is
`
`that only a single implant is needed for stability. EX1032, 3:46-49 (“The
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`dimensions of the translateral spinal fusion implant of the present invention
`
`permits a single implant to be inserted by a single procedure into the spine and to
`
`engage more of the adjacent vertebrae.”).
`
`45. With one exception, all embodiments in Michelson are single piece
`
`implants. Michelson briefly describes an alternate embodiment of his oversized
`
`implant where a modular implant is assembled together prior to insertion into the
`
`disc space.
`
`The spinal fusion implant 1000 is similar to the spinal fusion implant
`900, but has a narrower width such that more than one spinal fusion
`implant 1000 may be combined in a modular fashion for insertion
`within the disc space D between the adjacent vertebrae.
`
`EX1032, 10:50-53.
`
`46.
`
`I understand that Dr. Branch contemplates a modular approach where
`
`components are inserted piece by piece into the interbody space and assembled
`
`together following insertion. As I explained above, that is not reflective of the
`
`modular implant embodiment of Michelson. That is, Michelson only describes
`
`combining modular components for insertion in the disc space—it does not
`
`describe combining components in the disc space after serial insertion. Dr.
`
`Branch’s position is in direct conflict with the express disclosure of Michelson as
`
`well as Michelson’s description of the benefit of the claimed invention—that is, the
`
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`inventive implants allow for insertion of a “single implant” using a “single
`
`procedure.” EX1032, 3:46-49.
`
`ii. The description of Berry is inaccurate
`
`47. Berry discloses dimensional data obtained from skeletons for lumbar
`
`and thoracic vertebra. EX1022 at 1. That is, Berry measures vertebra lacking soft
`
`tissue, such as the annulus.
`
`48. Dr. Branch equates the size of vertebral bodies with the size of lumbar
`
`implants. E.g., EX1002, ¶¶283, 284. But Dr. Branch’s use of Berry for sizing
`
`implants overlooks the portion of the vertebral body that is occupied by soft tissue.
`
`For example, the annulus attaches to the apophyseal ring of the vertebral body and
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`is about 5 mm wide. EX2040, Fig. 2. Sizing of a lateral implant would need to
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`account for such soft tissues remaining on opposing sides (anterior and posterior)
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`of the vertebral body, which would occupy at least about 10mm of the disc space
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`in the anterior/posterior direction.
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`49. The size of the vertebral bodies varies greatly from the upper thoracic
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`to the lower lumbar spine. EX1022 at Table 1. A person of ordinary skill in the art
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`would have taken Berry into consideration and recognized that the sizes available
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`for implantation of a certain implant would not only be limited by soft tissue, but
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`by location in the spine and by adjacent anatomical structures (e.g., vena cava,
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`aorta). As such, a person of ordinary skill in the art would not have chosen to place
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`certain implants at specific spinal intervertebral levels for risk of iatrogenic injury
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`to such structures. That is, the size and shape of an implant prevents placement at
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`certain spinal levels because of specific risk of injury to adjacent anatomical
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`structures.
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`iii. The description of Brantigan is inaccurate
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`50. Brantigan discloses interbody fusion implants and vertebral prosthetic
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`devices. EX1007, 1:7-11. None of Brantigan’s devices include radiopaque
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`markers.
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`51. Brantigan does not disclose sizes of implants but suggests that the
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`length and width ratio of implants should match those of normal vertebral bodies.
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`EX1007, 1:18-21 (“The rings are bottomed on the opposing end faces of adjoining
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`vertebrae, are preferably oval shaped with medial-lateral and anterior-posterior
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`dimensions in the same ratio as normal vertebral bodies…”). Brantigan does not
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`suggest making implant dimensions equal to the dimensions of normal vertebral
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`bodies. Indeed, Brantigan teaches the exact opposite.
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`52. For example, Brantigan instructs that the implant should fit within the
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`annulus. E.g., EX1007, 2:26-28 (“[T]he device stretches the disc tissue creating a
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`tension which will cause the vertebrae to tightly grip the ring on which it is
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`bottomed.”), 2:63-64 (“…stretching the annular fibrosis so that the vertebrae can
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`tightly grip the plug…”), 6:25-32 (“A Z-shaped cut 58 through the tubular fibrous
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`portion of the disc 55 provides access to the interior pulpus portion of the disc
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`permitting its removal to receive a single plug 11 forming a rigid strut inside of the
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`column of disc fibers 55a which remain attached to the bottom face 52b of the
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`upper vertebrae 52 and the top face 57a of the lower vertebrae 57.”), 6:61 (“This
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`stretches the remaining disc tissue …”).
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`53. Dr. Branch incorrectly asserts that “a POSA would have understood
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`that the Brantigan lateral embodiments have a longitudinal length that spans the
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`full transverse width of the vertebra and its sidewalls are located along the anterior
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`and posterior portions of the vertebral body” EX1002, ¶122 (citing EX1007, Figs.
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`8, 10). As explained above, Brantigan describes his implants as fitting within the
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`annulus and occupying less than the entire vertebral body. E.g., EX1007, Figs. 10,
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`11. Furthermore, Dr. Branch’s assertion is contrary to Brantigan’s instruction to
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`leave the annulus intact. E.g., EX1007, 2:26-28, 2:63-64, 6:25-32, 6:61.
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`54. Dr. Branch states that “Michelson discloses the same modularity
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`concept Brantigan describes.” EX1002, ¶280. This statement is correct to the
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`extent that both Michelson and Brantigan disclose modular devices that are
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`assembled prior to insertion such that the assembled modular device is the spinal
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`fusion implant. As I explain above, Dr. Branch incorrectly describes the
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`“modularity concept” of Michelson as comprising sequential insertion of modular
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`members into the disc space. As with Michelson, Brantigan has no such disclosure.
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`Furthermore, Dr. Branch conflates Brantigan’s disclosure regarding the vertically
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`stacked modular embodiment with the non-modular posterior insertion
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`embodiment.
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`55. For example, Brantigan discloses an alternate embodiment for
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`replacement of vertebral bodies—not an interbody fusion implant embodiment—
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`where devices are assembled in a vertically stacked configuration. EX1007,
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`Abstract, 2:34-43. Brantigan discloses that multiple devices may be “stacked to the
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`exact height required.” EX1007, 2:35-38; see also id., 2:41-43 (“An average
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`grafting height is 30 mm after corpectomy and this can be achieved by stacking,
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`for example, three 10 mm high oval implants.”), Figs. 1, 3, 4 (shown below).
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`Brantigan’s stacked plug embodiment (e.g., Figure 4) is not an interbody fusion
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`implant embodiment because the stacked plugs are not positioned within an
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`interbody space but are instead used replace excised vertebral bodies.
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`56. Brantigan’s stacked devices are held together by connecting bar 15
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`that conforms to the height of the stack and locks the pieces of the stack together
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`via slot 14. EX1007, Abstract (“The implants can be provided in sets of different
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`thicknesses and are internally grooved to receive an upstanding connecting bar to
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`bind together the individual stacked implants into a stable unit.”), 1:59-61 (“When
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`stacked, an interior connecting bar can be provided to lock the components in fixed
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`relation and cooperate with interfitting ridges.”), 3:25-28 (“FIG. 3 is a top and side
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`perspective view of a connecting bar fitting the illustrated grooves in the devices of
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`FIGS. 1 and 2 to hold a plurality of the devices in stacked relation”), 3:29-31
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`(“FIG. 4 is a top and side perspective view of a stack of the devices of FIG. 1 with
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`the connecting bar of FIG. 3 in place”), 4:23-27 (describing Fig. 1 as having
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`“vertical grooves 14 … for mounting a rectangular connecting bar 15 shown in
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`FIG. 3.”), 4:38-49 (“The connecting bar 15 has a height conforming with the total
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`height of a stack 17 of plugs 11 shown in FIG. 4 or with only a single plug 11 if a
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`stack of plugs is not necessary. As shown in FIG. 4 three plugs 11 are stacked
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`together with the ridges 12 of the intermediate plug nested in and interdigitating
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`with the ridges of top and bottom plugs. These ridges interfit to provide a stable
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`stack and the connecting bar 15 seated in the aligned grooves 14 of the three plugs
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`will prevent shifting of the stack.”), 5:18-21 (“The lengths or heights of the
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`connecting bars 15 can also be varied to suit conditions or can be ground down at
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`