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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.
`Petitioners,
`
`v.
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`NUVASIVE, INC.,
`Patent Owner.
`
`_____________________________
`
`Case No. IPR2019-00362
`Patent No. 8,361,156
`_____________________________
`
`
`DECLARATION OF CARL R. MCMILLIN, PH.D.
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`NUVASIVE - EXHIBIT 2057
`Alphatec Holdings Inc. et al. v. NuVasive, Inc.
`IPR2019-00362
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`
`
`TABLE OF CONTENTS
`
`
`QUALIFICATIONS ........................................................................................ 1
`I.
`SCOPE OF WORK.......................................................................................... 4
`II.
`III. LEVEL OF ORDINARY SKILL .................................................................... 5
`IV. SUMMARY OF OPINIONS ........................................................................... 5
`V. A PERSON OF ORDINARY SKILL IN THE ART WOULD NOT
`HAVE ADOPTED BERRY’S VERTEBRAL BODY DIMENSIONS
`FOR IMPLANT DIMENSIONS ..................................................................... 6
`A.
`Brantigan’s Implants Are Design to Fit Within the Annulus
`Fibrosis .................................................................................................. 8
`B. Michelson Confirms that a Lumbar Implant Width Should Be
`Less Than that of the Vertebral Body ................................................. 11
`Frey’s Implants Are Designed to Fit Within the Annulus
`Fibrosis ................................................................................................ 12
`VI. A PERSON OF ORDINARY SKILL IN THE ART WOULD NOT
`HAVE SEQUENTIALLY INSERTED LATERAL IMPLANTS ................ 13
`A. Michelson Does Not Disclose Sequential Insertion of a Lateral
`Implant or Modular Members ............................................................. 13
`Brantigan Does Not Disclose Sequential Insertion of a Lateral
`Implant or Modular Members ............................................................. 15
`VII. THE PROPOSAL TO INSERT FREY’S IMPLANTS THROUGH A
`HOLLOW TUBE IS NONSENSICAL ......................................................... 20
`VIII. BRANTIGAN’S INTERBODY FUSION IMPLANTS DO NOT
`HAVE A LONGITUDINAL APERTURE LENGTH PARALLEL TO
`THE LONGITUDINAL LENGTH OF THE IMPLANT ............................. 21
`IX. CONCLUDING STATEMENTS .................................................................. 24
`
`
`C.
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`B.
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`-i-
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`I.
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`I, Carl R. McMillin, declare as follows:
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`QUALIFICATIONS
`1.
`I received a B.S. in Mechanical Engineering with a material science
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`major from the General Motors Institute of Technology and a M.S. and a Ph.D. in
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`Macromolecular Science from the Case Western Reserve University.
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`2.
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`I have extensive experience in the field of biomedical engineering.
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`From 1974 to 1975, I served as a visiting scientist at the Artificial Internal Organs
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`Department of the Cleveland Clinic Foundation. From 1983 to 1989, I held an
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`Associate Professor position in the Department of Biomedical Engineering at The
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`University of Akron where I taught MS/PhD level Biomaterials and Artificial
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`Organs courses. I also served as the Director of the Cardiovascular Laboratory and
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`researched accelerated rubber fatigue, blood-materials interactions, implant
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`associated infections, hemodynamics of artificial hearts, and consulted for
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`AcroMed Corporation on the initial development of artificial spinal discs and
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`carbon fiber composite spine fusion plates.
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`3.
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`Between 1989 and 1997 I worked at AcroMed Corporation where I
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`served in various positions including Senior Scientist and Director of R&D. I
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`conducted and directed research, development, evaluation, and commercialization
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`of many metal, polymer, polymer/carbon fiber composite and elastomer-based
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`1
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`
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`orthopedics products. My work and research at AcroMed Corporation was
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`primarily focused on designing orthopedic products for the spine.
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`4.
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`Through my work, I helped design and optimize the world’s first
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`carbon fiber composite posterior lumbar interbody fusion (PLIF) cages and the
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`world’s first carbon fiber composite anterior lumbar interbody fusion (ALIF)
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`cages. I also helped to design the first functional artificial spinal discs implanted in
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`patients in the U.S.A., as well as stackable implant systems for variable heights of
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`artificial vertebral bodies. My efforts on these devices involved numerous
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`considerations, including material selection and validation, cadaver spine
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`measurements, strength vs. size optimization, etc.
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`5.
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`I have served on numerous committees and/or advisory boards in the
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`biomedical industry. For example, between 1994 and 1998, I served on the
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`Editorial Advisory Board of the Medical Plastics and Biomaterials for Canon
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`Communications. Between 1990 and 1996, I served as an Executive Editor for the
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`international journal, Bio-Medical Materials and Engineering. I also served on the
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`External Advisory Board (1994-1998) at the Center for Cardiovascular
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`Biomaterials and have been on technical review panels for the NIH. I have also
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`served on the Commercialization Cabinet 1997-2002; the Scientific Advisory
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`Council (1992-1994), and the Executive Advisory Committee (1992-1996), at the
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`Edison Biotechnology Center and Omeris.
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`6.
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`I routinely attend key seminars and conferences in the industry
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`including the all of the annual meetings for the Society for Biomaterials and every
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`fourth year World Congress for Biomaterials for the last 30+ years to the present,
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`and other meetings such as the North American Spine Society meeting in 2011. I
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`have also presented at over 75 national and international meetings as an author or
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`co-author.
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`7.
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`Throughout my career, I have published over 100 journal articles,
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`book chapters, theses, etc. I am the inventor on U.S. Patent No. 5,294,391
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`(“Method of Making a Fiber Reinforced Composite Structure Including
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`Randomizing the Reinforcing Fibers”) and U.S. Patent No. 5,429,863 (Fiber
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`Reinforced Composite Structure”) which are the method and device patents on the
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`PEEK/PEKEKK composite structure that was used in the initial Brantigan PLIF
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`and ALIF cages I am also an inventor on other spine and orthopedic patents
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`including U.S. Patent No. 5,824,094 (“Spinal Disc”); U.S. Patent No. 6,669,732
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`(“Spinal Disc”); and U.S. Patent No. 6,162,252 (“Artificial Spinal Disc”).
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`8. My professional curriculum vitae is attached as EX2058. It details my
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`education, experience, and publications, as briefly summarized above, as well as an
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`overview of some of my experience that is relevant to the matters set forth in this
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`declaration.
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`-3-
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`II.
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`SCOPE OF WORK
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`9.
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` I have been retained by Counsel on behalf of NuVasive, Inc. to
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`provide expert opinions in this matter related to spinal fusion implant sizing and
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`modular spinal fusion implants. My opinions are based on my skills, knowledge,
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`training, education, and experience in spinal fusion implant design, and my
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`examination of the materials cited in this declaration.
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`10.
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`I understand that petitions were filed with the United States Patent and
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`Trademark Office for inter partes review of U.S. Patent Nos. 8,187,334 (“the ’334
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`patent”) and 8,361,156 (“the ’156 patent”).
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`11.
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`I further understand that the Patent Trial and Appeal Board (“PTAB”
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`or the “Board”) has decided to institute inter partes review of claims 6-9, 16, and
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`18 of the ’334 patent and claims 1-3, 5, 9–10, 12-21, 23–24, and 27 of the ’156
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`patent.
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`12.
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`I have been specifically asked to provide my expert opinions on the
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`content of the US2002/0165550 (“Frey,” EX1040), U.S. Pat. No. 5,860,973
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`(“Michelson,” EX1032), U.S. Pat. No. 5,192,327 (“Brantigan,” EX1007), and
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`Berry, et al., “A Morphometric Study of Human Lumbar and Thoracic Vertebrae,”
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`(“Berry,” EX1022). In connection with this analysis I have also reviewed the ’334
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`and ’156 patents.
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`-4-
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`13.
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`I am being compensated at a rate of $400 per hour for my work in this
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`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
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`on the outcome of this matter or the specifics of my testimony.
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`III. LEVEL OF ORDINARY SKILL
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`14.
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`I understand that Dr. Branch asserts that a person of ordinary skill in
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`the art could be a medical doctor with 2-3 years of experience performing
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`interbody spinal fusion surgeries or a mechanical or biomechanical engineer with 2
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`years of experience developing implants and access to orthopedic or
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`neurosurgeons. This is the standard for a person of ordinary skill in the art I have
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`applied throughout this declaration. I understand that the relevant time for
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`consideration is on or before March 29, 2004.
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`IV. SUMMARY OF OPINIONS
`15. A person of ordinary skill in the art would not have designed a spinal
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`fusion implant to have a width as wide or wider than the average depth of the
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`intervertebral space. A person of ordinary skill in the art would not have designed
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`such a spinal fusion implant to be wider than 32 mm and certainly would not have
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`designed a spinal fusion implant to have a width as wide as 37.9 mm. Making an
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`implant wider than 32 mm contradicts how a person of ordinary skill in the art
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`-5-
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`
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`would understand Berry and ignores the teachings of Brantigan, Michelson, and
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`Frey.
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`16. A person of ordinary skill in the art would not have modified the Frey
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`or Brantigan implants for serial insertion of modular members into the disc space.
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`Attempting to move a first implant to make room for a second implant would be
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`quite difficult and would increase the risk of breaking the implant and injuring the
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`patient. In sum, the proposed modification of the Frey and Brantigan implants and
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`insertion method would have been unsafe and more invasive.
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`V. A PERSON OF ORDINARY SKILL IN THE ART WOULD NOT
`HAVE ADOPTED BERRY’S VERTEBRAL BODY DIMENSIONS
`FOR IMPLANT DIMENSIONS
`17. Berry discloses dimensional data obtained from skeletons for lumbar
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`and three thoracic vertebrae. EX1022 at 1, 3. That is, Berry measures bones that
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`completely lack the soft tissue found on the vertebral bodies of patients.
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`18. Figure 1 of Berry (reproduced below) describes the measurements
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`taken of the skeletal vertebrae. For example, the line DEF (D = superior surface, E
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`= middle, and F = inferior surface) defines the measurements made along the mid-
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`sagittal plane of the vertebral body. EX1022, Figure 1. The D and F measurements
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`are sometimes referred to as the anterior-posterior (“A-P”) dimensions or the depth
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`of the vertebral body. E.g., EX1032, 2:5-7 (“[T]he depth of a vertebrae being the
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`dimension of the vertebrae measured from the anterior end to the posterior end of
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`-6-
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`
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`the vertebrae.”); EX2029 at 8. The line ABC (A = superior surface, B = middle,
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`and C = inferior surface) defines the measurements made along the mid-coronal
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`plane of the vertebral body. EX1022, Figure 1. The A and C measurements are
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`sometimes referred to as the medial-lateral (“M-L”) dimensions or the transverse
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`width of the vertebral body. EX1032, 3:7-9 (“The transverse width of a vertebra is
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`measured from one lateral aspect of the spine to the opposite lateral aspect.”);
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`EX2029 at 7 (“Morphometric studies of lumbar vertebrae [citing Berry] indicate
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`that at L5, the ratio of A-P width to M-L width of vertebrae averages 0.66.”).
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`
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`19.
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`I understand that Dr. Branch equates the size of vertebral bodies with
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`the size of lumbar implants. E.g., EX1002, ¶¶152, 153. A person of ordinary skill
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`in the art would not have designed a spinal fusion implant to be wider than the
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`-7-
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`
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`depth of vertebral bodies. To the contrary, a person of ordinary skill in the art at
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`the relevant time would have been familiar with vertebral body dimensions, such
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`as those disclosed in Berry, and would have designed the width of the implant to
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`be significantly narrower than the A-P dimension as measured at the sagittal
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`midplane of the smaller of the two vertebral body endplates that define the
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`intervertebral space. Certainly, following the actual teachings of Berry, one of
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`ordinary skill would not have arrived at the absurdly sized spinal fusion implant
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`(up to 37.9 mm wide) that I understand has been proposed by Petitioner. This is
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`true regardless of whether one is considering sizing for Brantigan, Michelson, or
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`Frey implants.
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`20. A-P implant dimensions should be significantly narrower than the
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`vertebral body dimensions reported in Berry because the available disc space for a
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`spinal fusion implant is limited by soft tissue, such as the annulus fibrosis. The
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`annulus fibrosis is about 5 mm thick, extends around the intervertebral space, and
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`attaches to the apophyseal ring of adjacent vertebral bodies. EX2040 at Fig. 2. Dr.
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`Branch’s use of Berry for sizing implants overlooks that a portion of the disc space
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`is occupied by the annulus fibrosis.
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`A. Brantigan’s Implants Are Design to Fit Within the Annulus Fibrosis
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`-8-
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`21. Brantigan’s implants are designed to fit within the annulus fibrosis
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`(55a) and, as such, are smaller than vertebral bodies. EX1007, Fig. 11 (reproduced
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`below).
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`
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`22. Brantigan expressly instructs that implants should fit within the
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`annulus fibrosis. E.g., EX1007, 2:26-28 (“[T]he device stretches the disc tissue
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`creating a tension which will cause the vertebrae to tightly grip the ring on which it
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`is 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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`-9-
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`23.
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`I worked with Dr. Brantigan during my employment at AcroMed and
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`I had a role in defining the sizing and other physical properties of the implants
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`disclosed in the Brantigan patent. I know from firsthand experience that making
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`implants as large or larger than the vertebral body dimensions reported in Berry is
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`something that would not make sense to a person of ordinary skill in the art at the
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`relevant time.
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`24. Dr. Brantigan and I were well aware of the Berry reference when we
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`were determining sizing for the lumbar interbody fusion implants. EX2029 at 7
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`(citing Berry and relying on its disclosure of “the ratio of A-P width to M-L width
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`of vertebrae”). However, we were also well aware that the space occupied by soft
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`tissue must be accounted for when sizing implants.
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`25. For example, lumbar spinal fusion surgeries had been performed prior
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`to Brantigan’s patent and these earlier surgeries typically used tricortical bone from
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`the patient’s iliac crest, processed allograft bone, or bovine bone. As a result,
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`persons of ordinary skill in the art knew that a portion of the disc space is occupied
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`by soft tissue such as the annulus fibrosis. See also EX2040, Figure 2A (describing
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`the average width of the annulus as 5 mm).
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`26. Given the known sizes of vertebral bodies, such as disclosed by Berry,
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`and the known size of the annulus—the largest Brantigan implant was sized for the
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`lumbar region to be 28 mm in width (A-P dimension) by 42 mm in length (M-L
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`dimension). EX2029 at 7; EX2030 at 3.
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`27.
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`I understand that the Petition asserts, based on Berry, that a skilled
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`artisan would have wanted to increase the width of Brantigan’s implant to be as
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`wide as 37.9 mm for insertion at L4-L5. This width is about 10 mm wider than the
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`widest Brantigan implant and as such, it would not fit within the annulus. That is,
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`the implant Dr. Branch proposes is contrary to Brantigan’s instructions to size an
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`implant to fit within the annulus. An implant width of approximately 38 mm as
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`proposed by the Petition is absurdly wide and would not have been made.
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`B. Michelson Confirms that a Lumbar Implant Width Should Be Less
`Than that of the Vertebral Body
`28. The Michelson reference discloses that the maximum width of even
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`an oversized lateral lumbar spinal fusion implant is 32 mm. EX1032, Abstract,
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`-11-
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`
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`10:33-59. Michelson teaches that this dimension “approximates the depth of the
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`vertebrae.” Id. Michelson is evidence that persons of ordinary skill in the art would
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`have designed implants with dimensions significantly narrower than the depth of
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`the vertebrae.
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`29. Michelson repeatedly discloses that the implant width should not be as
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`wide as the depth of the vertebrae. For example, Michelson discloses that the
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`widths of the implants “need” to be “less than the depth of the vertebrae.” Id.,
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`Abstract, 3:27-32. Michelson also explains that using an implant that exceeds the
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`depth of the vertebrae is not “possible” and results in “great harm” to the patient:
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`[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., 2:3-12. For a lateral implant, as taught by Michelson, this means that the width
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`of the implant needs to be narrower than the depth of the vertebrae. Id., 3:11-17
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`(“[S]uch implants are necessarily limited by the depth, measured from front to
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`back of the vertebrae”).
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`C. Frey’s Implants Are Designed to Fit Within the Annulus Fibrosis
`30.
`I understand that the Petition asserts that Frey’s implants should be
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`long enough to span the entire bony surface of the midline of the vertebral body as
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`-12-
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`
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`measured by Berry. I disagree. Frey itself discloses that its implants are smaller
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`than the vertebral body and that they are designed to fit within the annulus fibrosis.
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`EX1040, Figs. 47, 53, 65.
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`
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`31. The commercial embodiment of Frey’s implant is consistent with
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`Frey’s disclosure, describing the largest boomerang implant as 36 mm in length
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`(M-L dimension) and 13 mm wide (A-P dimension). EX2031 at 2.
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`
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`VI. A PERSON OF ORDINARY SKILL IN THE ART WOULD NOT
`HAVE SEQUENTIALLY INSERTED LATERAL IMPLANTS
`A. Michelson Does Not Disclose Sequential Insertion of a Lateral Implant
`or Modular Members
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`32.
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`I understand that Dr. Branch asserts that Michelson teaches a modular
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`approach where components are inserted piece-by-piece into the interbody space
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`and assembled together following insertion. I disagree. Michelson has no such
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`teaching.
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`33. Michelson does not disclose inserting implants into the disc space
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`piece-by-piece. In fact, such an insertion method would be contrary to what
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`Michelson describes as a benefit of the inventive implants—that is, the invention
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`permits using a single implant inserted in a single procedure. EX1032, 3:46-49
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`(“The dimensions of the translateral spinal fusion implant of the present invention
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`permits a single implant to be inserted by a single procedure into the spine and to
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`engage more of the adjacent vertebrae.”).
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`34. Michelson describes the modular and non-modular embodiments as
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`similar and discloses that the modular implant is assembled prior to insertion.
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`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 (emphasis added). A person of ordinary skill in the art would
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`not have understood Michelson as teaching serial insertion of modular members.
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`Instead, a skilled artisan would have understood Michelson to disclose what is
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`stated expressly—the implant is assembled prior to insertion thereby retaining the
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`benefits of using a single implant inserted through a single procedure.
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`-14-
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`
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`B. Brantigan Does Not Disclose Sequential Insertion of a Lateral Implant
`or Modular Members
`35.
`I understand that Dr. Branch asserts that Brantigan discloses the same
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`modularity concept as Michelson. This statement is true to the extent that both
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`Michelson and Brantigan disclose modular embodiments that are assembled prior
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`to insertion into the patient. However, as I explain above, Dr. Branch incorrectly
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`describes the “modularity concept” of Michelson as comprising sequential
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`insertion of modular members in the disc space. As with Michelson, Brantigan has
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`no such disclosure. Furthermore, I understand that Dr. Branch conflates
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`Brantigan’s disclosure regarding the vertically stacked modular embodiment with
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`the non-modular posterior insertion embodiment.
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`36. 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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`-15-
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`37.
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`I have firsthand knowledge of the development of Brantigan’s
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`vertebral body replacement embodiments, as I was involved in their development.
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`These stacked devices are assembled and held together by connecting bar 15 that
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`conforms to the height of the stack and locks the pieces of the stack together via
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`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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`-16-
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`
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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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`the time of the operation to match the stack.”).
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`38. A person of ordinary skill in the art would have understood that the
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`stacked device of Brantigan are assembled prior to insertion in the patient. It would
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`be physically impossible to insert the connecting bar 15 into slot 14 after placing
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`the individual pieces into the patient.
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`39.
`
`I understand that Dr. Branch also points to the posterior lumbar
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`implant embodiment of Brantigan as being similar to the modular embodiment of
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`Michelson. Brantigan discloses “[t]wo such hemi-oval rings can be used in the
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`posterior lumbar area in side-by-side relation since the dural sac and nerve roots
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`must be retracted to each side in turn as the implant is placed on the opposite side.”
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`EX1007, 2:7-11. This portion of Brantigan is describing implants for posterior
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`insertion—not a “modular” assembly. Because posterior access to the center of the
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`-17-
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`
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`disc space is blocked by the spinal canal typically two smaller implants are used.
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`This concept is well illustrated in the Telamon Guide. See generally EX1011; see
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`also id., 8 (reproduced below, showing the arrangement of two smaller implants).
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`40. That is, Brantigan is not here disclosing a modular implant, but rather
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`disclosing that two implants should be inserted along two posterior surgical paths
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`into the disc space.
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`41.
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`I was further asked to comment on the hypothetical placement of two
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`Brantigan implants side-by-side in the disc space. Brantigan does not teach placing
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`two oval implants side-by-side and doing so would run contrary to Brantigan’s
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`teaching.
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`42. The shape of the Brantigan implant is poorly suited for side-by-side
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`placement in the interbody space. Brantigan instructs that the implant should have
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`-18-
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`“dimensions in the same ratio as normal vertebral bodies” and should “conform
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`with the general outline perimeter of the vertebrae.” EX1007, 1:18-21, 2:2-4. The
`
`proposed side-by-side placement would leave unsupported gaps on the lateral
`
`aspects of the two implants, as shown below.
`
`
`
`The gaps on the lateral aspects of the two implants would be expected to result in
`
`an unstable platform for the spinal column. Moreover, such an arrangement would
`
`fundamentally alter the implant design such that it no longer conforms to the
`
`general outline perimeter of the vertebrae. In sum, such a configuration would
`
`result in a less stable platform versus retaining Brantigan’s original implant design.
`
`43. This modification also would disregard Brantigan’s instruction to
`
`make implants with the same width-to-length ratio as normal lumbar vertebral
`
`bodies. Brantigan specifically used “the ratio of A-P width to M-L width of
`
`-19-
`
`
`
`
`
`vertebrae” reported by Berry in sizing his implants. EX2029 at 8; see also id.
`
`(disclosing using the average width to length ratio for L5 (0.66) as reported by
`
`Berry). Brantigan believed, as did I, that “the ratio of dimension of the cages
`
`should duplicate the known average dimensions of lumbar vertebrae” and that “the
`
`different sizes should maintain about the same ratio.” EX2029 at 8; EX1007, 1:18-
`
`21 (“The rings are bottomed on the opposing end faces of adjoining vertebrae, are
`
`preferably oval shaped with medial-lateral and anterior-posterior dimensions in the
`
`same ratio as normal vertebral bodies…”). Our implants were “oval shaped to
`
`conform with the general outline perimeter of the vertebrae.” EX1007, 2:2-4.
`
`Placing two Brantigan implants side by side would abandon this ratio and shape,
`
`contradict the teachings of Brantigan and Berry, and result in an inferior implant.
`
`VII. THE PROPOSAL TO INSERT FREY’S IMPLANTS THROUGH A
`HOLLOW TUBE IS NONSENSICAL
`44.
`I understand that Dr. Branch proposes inserting Frey’s implants
`
`through a hollow tube. Inserting Frey’s implants through a hollow tube would be
`
`disfavored at least because it (1) disregards the surgical approach for which Frey
`
`was specifically designed, and (2) would have increased the risk of damage to the
`
`implant.
`
`45. The Frey implant is designed for insertion in a transforaminal lumbar
`
`interbody fusion (i.e., TLIF) surgery. Spinal fusion implants are made to fit tightly
`
`in the disc space and to withstand the force needed to push the implant into
`
`-20-
`
`
`
`
`
`position. E.g., EX1032, 8:20-22 (“The implant driver instrument may then be
`
`impacted by a mallet, or similar device…”); EX1040, ¶139 (“[T]he surgeon
`
`controls inserter 1100 with one hand while the other hand provides a pushing or
`
`impaction force on implant 1000 with pusher 1200.”). As such, Frey’s implants
`
`were designed to withstand the forces associated with a curved path through the
`
`disc space.
`
`46.
`
`Inserting Frey’s implants through a hollow tube would require
`
`substituting a linear insertion pathway into the disc space instead of the curved
`
`path Frey was designed for. The curved insertion path requires radial movement of
`
`the insertion tool (EX1040, ¶¶148,149) and this movement is not possible if the
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`insertion tool must fit within the hollow tube described by Michelson. The
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`insertion pathway would thus have to be linear.
`
`47. Applying an impaction force on the boomerang implant of Frey in a
`
`linear direction would subject the implant to forces that it was not designed to
`
`withstand. Specifically, applying force linearly would place a great deal of stress at
`
`the center of the implant which would increase the risk of implant failure.
`
`VIII. BRANTIGAN’S INTERBODY FUSION IMPLANTS DO NOT HAVE A
`LONGITUDINAL APERTURE LENGTH PARALLEL TO THE
`LONGITUDINAL LENGTH OF THE IMPLANT
`48. The petition materials allege that the first fusion aperture limitation is
`
`met by the implants exemplified in Figures 1 (implant 11) and 6 (implant 30).
`
`-21-
`
`
`
`
`
`However, neither implant 11 nor 30 has a longitudinal aperture length parallel to
`
`the longitudinal length of the implant.
`
`
`
`49. The difference between implants 11 and 30 is whether the reinforcing
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`bar 32 is integral to the implant. As shown above, the reinforcing bar 32 separates
`
`the interior portion of the implant 30 into two side-by-side apertures. EX1007,
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`5:40-44 (“The hollow interior 23 of the plug 31 is thus bisected by an integral
`
`internal partition 32 forming a pair of side-by-side apertures through the plug
`
`adapted to receive bone graft material.”). Likewise, the connecting bar 15 separates
`
`the interior portion of implant 11 into two side-by-side apertures. EX1007, 4:38-41
`
`(“The connecting bar 15 has a height conforming with the total height of a stack 17
`
`of plugs 11 shown in FIG. 4 or with only a single plug 11 if a stack of plugs is not
`
`necessary.”), 4:50-54 (“The central aperture 11d of each plug 11 is separated by
`
`the bar 15 into two side-by-side chambers which are easily packed with bone graft
`
`-22-
`
`
`
`
`
`material…”), (“Instead of providing a separate bar or plate 15, as shown in FIG. 6,
`
`a modified device 30 of this invention is a plug 31 of the same oval shape as the
`
`plug 11 of FIGS. 1 and 4 but the reinforcing bar 32 of this plug is integral with its
`
`side walls 31a.”).
`
`50. The “longitudinal length” is the longest dimension of the implant. The
`
`challenged claims require that the “longitudinal length [of the implant]…extend[s]
`
`from a proximal end of said proximal wall to a distal end of said distal wall.” That
`
`is, the longest dimension of the implant must be the length between the proximal
`
`and distal walls. Furthermore, the longitudinal length of the aperture must also
`
`“extend[] generally parallel to the longitudinal length of said implant.” Therefore,
`
`the longitudinal length of the aperture must be generally parallel to the longest
`
`dimension of the implant.
`
`51.
`
` The first fusion aperture of implant 30 does not have a “longitudinal
`
`aperture length extending generally parallel to the longitudinal length of said
`
`implant, and a lateral aperture width extending between said first sidewall to said
`
`second sidewall, wherein the longitudinal aperture length is greater than the lateral
`
`aperture width.” The longest dimension of the first aperture is not parallel to the
`
`long axis of the implant—it is orthogonal.
`
`52.
`
`Implant 11 also does not have a “longitudinal aperture length
`
`extending generally parallel to the longitudinal length of said implant, and a lateral
`
`-23-
`
`
`
`
`
`aperture width extending between said first sidewall to said second sidewall,
`
`wherein the longitudinal aperture length is greater than the lateral aperture width.”
`
`Figure 1 depicts an unassembled implant 11 lacking connecting bar 15. When
`
`connecting bar 15 is inserted into slot 14, two side-by-side apertures are created in
`
`implant 11 with the same dimensions as the apertures of implant 30.
`
`53. Accordingly, as with implant
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