UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,444,696
`
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`
`ANATOMIC BEARING SURFACES
`
`Case IPR2013-00395
`
`DECLARATION OF CHARLES L. BRANCH, JR., M.D.
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`US, Patent and Trademark Officc
`PO. Box 1450
`
`Alexandria, VA
`
`I 3- I
`
`EXHIBIT
`
`IPR2013—00395
`
`Nu\'asive, Inc. Y.
`‘Warsaw Orthopedic, Inc.
`
`

`
`TABLE OF CONTENTS
`
`PAGE
`
`I. 
`
`II. 
`
`ASSIGNMENT. ............................................................................................... 1 
`
`QUALIFICATIONS. ....................................................................................... 2 
`
`III. 
`
`PERSON OF ORDINARY SKILL IN THE ART. ......................................... 5 
`
`IV.  MATERIALS CONSIDERED. ....................................................................... 5 
`
`V. 
`
`BACKGROUND AND SUMMARY OF ’696 PATENT. .............................. 6 
`
`A.  Overview of the human spine. .................................................................. 6 
`
`B.  Interbody spinal fusion procedures and implants. .................................... 9 
`
`C.  The ’696 patent. ....................................................................................... 10 
`
`VI.  CLAIM INTERPRETATION. ...................................................................... 14 
`
`A.  Meaning of the claim recitation “opening.” ............................................ 14 
`
`B.  Meaning of the claim recitation “upper and lower bearing surfaces.” ... 16 
`
`C.  Meaning of the claim recitation “ratchetings.” ....................................... 17 
`
`VII.  NUVASIVE’S PROPOSED GROUNDS OF REJECTION DO NOT
`RENDER THE ’696 PATENT OBVIOUS. .................................................. 18 
`
`A.  Proposed grounds of unpatentability. ...................................................... 18 
`
`1. Claims 1-6 (IPR2013-00395). ............................................................. 18 
`
`2. Claims 7-12 (IPR2013-00396). ........................................................... 19 
`
`B.  Discussion regarding features in the prior art. ........................................ 19 
`
`C.  The cited references of the preliminarily adopted rejections. ................. 20 
`
`1. Senter (WIPO Publication No. WO93/01771). .................................. 20 
`
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`2. Brantigan ’035 (WIPO Publication No. WO89/09035). .................... 24 
`
`2. Brantigan ’O35 (WIPO Publication No. W089/09035) ................... ..242. Brantigan ’O35 (WIPO Publication No. W089/09035) ................... ..24
`
`3. Michelson ’037 (WIPO Publication No. WO90/00037). .................. 26 
`
`3. Michelson ’O37 (WIPO Publication No. W090/00037). ................ ..263. Michelson ’O37 (WIPO Publication No. W090/00037). ................ ..26
`
`4. Wagner (U.S. Patent No. 5,306,309). ................................................ 28 
`
`4. Wagner (U.S. Patent No. 5,306,309). .............................................. ..284. Wagner (U.S. Patent No. 5,306,309). .............................................. ..28
`
`5. Steffee (U.S. Patent No. 5,443,514). .................................................. 30 
`
`5. Steffee (U.S. Patent No. 5,443,514) ................................................. ..3O5. Steffee (U.S. Patent No. 5,443,514) ................................................. ..3O
`
`6. Kim (U.S. Patent No. 5,645,596). ...................................................... 38 
`
`6. Kim (U.S. Patent No. 5,645,596). .................................................... ..386. Kim (U.S. Patent No. 5,645,596). .................................................... ..38
`
`D. Allegedly invalidating obviousness combinations. ................................. 40 
`
`D. Allegedly invalidating obviousness combinations. ............................... ..4OD. Allegedly invalidating obviousness combinations. ............................... ..4O
`
`1. Senter in view of Brantigan ’035. ...................................................... 40 
`
`1. Senter in View of Brantigan ’O35. .................................................... ..4O1. Senter in View of Brantigan ’O35. .................................................... ..4O
`
`2. Michelson ’037 in view of Wagner and Brantigan ’035. .................. 49 
`
`2. Michelson ’O37 in View of Wagner and Brantigan ’O35. ................ ..492. Michelson ’O37 in View of Wagner and Brantigan ’O35. ................ ..49
`
`3. Steffee in view of Michelson ’037 and Kim. ..................................... 55 
`
`
`
`3. Steffee in View of Michelson ’O37 and Kim. ................................... ..553. Steffee in View of Michelson ’O37 and Kim. ................................... ..55
`
`VIII.  APPLICABLE LEGAL PRINCIPLES. ........................................................ 62 
`
`
`
`VIII. APPLICABLE LEGAL PRINCIPLES. ...................................................... ..62VIII. APPLICABLE LEGAL PRINCIPLES. ...................................................... ..62
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`I, Charles L. Branch, Jr., M.D. of Winston-Salem, North Carolina declare that:
`
`I.
`
`ASSIGNMENT.
`
`1.
`
`I serve as Professor and Chairman of the Department of Neurosurgery
`
`at Wake Forest University School of Medicine. As illustrated below, my practice,
`
`teaching, and research interests have focused upon the treatment of spinal diseases
`
`and injuries.
`
`2.
`
`I have been retained by counsel for Warsaw Orthopedic, Inc.
`
`(“Warsaw”). I understand that the Patent Trial and Appeal Board (“PTAB”) has
`
`instituted two inter partes reviews of Warsaw’s U.S. Patent No. 8,444,696 (the
`
`“’696 patent”) based upon petitions filed by NuVasive, Inc. (“NuVasive” or
`
`“Petitioner”). The first inter partes review, IPR2013-00395, is directed to claims
`
`1-6 (including independent claims 1 and 4) of the ’696 patent, and the second inter
`
`partes review, IPR2013-00396, is directed to claims 7-12 (including independent
`
`claims 7 and 10) of the ’696 patent.
`
`3.
`
`I have been asked to opine on the subject of the validity of claims
`
`1-12 in light of the grounds of rejection at issue in IPR2013-00395 and
`
`IPR2013-00396. I have also been asked to review and respond to the Declarations
`
`of Dr. John W. Brantigan, M.D. (“’395 Brantigan Declaration” and
`
`“’396 Brantigan Declaration”) submitted in support of NuVasive’s petitions for
`
`inter partes review.
`
`
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`-1-
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`

`
`4.
`
`In forming my opinions as set forth in this Declaration, I have relied
`
`upon my education, research, training, and experience in the area of spinal surgery.
`
`I have also relied upon my review and analysis of the prior art and information
`
`provided to me in connection with this case.
`
`5.
`
`I am being compensated for my work as an expert with respect to this
`
`inter partes review, but my compensation is not contingent in any way on the
`
`content of my opinions or the outcome of this proceeding.
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`II. QUALIFICATIONS.
`
`6.
`
`Presently, I am the Eben Alexander, Jr. Professor and Chair,
`
`Department of Neurosurgery, Wake Forest School of Medicine, and Co-Chair,
`
`Neuroscience Service Line, Wake Forest Baptist Medical Center. I am also
`
`currently serving my second term as a member of the Governing Board of the
`
`School of Biomedical Engineering of Wake Forest University and Virginia
`
`Polytechnic Institute, and my second term as member of the Board of Regents of
`
`Pepperdine University. I also serve as a founding Director of the Collaborative
`
`Spine Research Foundation, a multidisciplinary effort to establish funding
`
`resources for clinical spine research.
`
`7.
`
`I received my Doctorate of Medicine from University of Texas
`
`Southwestern Medical University in 1981. My postdoctoral training included an
`
`internship at the Department of General Surgery at North Carolina Baptist Hospital
`
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`from 1981-1982; a residency, Section on Neurosurgery, North Carolina Baptist
`
`Hospital from 1982-1987, under Dr. David L. Kelly, Jr.; a rotation in Neurosurgery
`
`at the Mayo Clinic in Rochester, Minnesota in January 1985, under Dr. Edward
`
`Laws; a chief residency, Section on Neurosurgery, Bowman Gray School of
`
`Medicine in Winston-Salem, North Carolina from 1985-1986, under Dr. David L.
`
`Kelly, Jr.; and a Clinical Fellowship as Chief Resident in the Department of
`
`Neurological Surgery at the University of California in San Francisco, from July
`
`1987-September 1987, under Dr. Charles B. Wilson.
`
`8.
`
`I have been licensed to practice medicine for over 30 years and hold
`
`medical licenses in Texas and North Carolina. I also hold a specialty certification
`
`from the American Board of Neurological Surgery.
`
`9.
`
`I have been teaching spinal surgery since 1987, and have held various
`
`academic appointments during that time at the Wake Forest School of Medicine,
`
`Department of Neurosurgery. In June, 2000, I was appointed to the position of the
`
`Eben Alexander, Jr. Professor and Chair, Department of Neurosurgery, Wake
`
`Forest School of Medicine. Additionally, I have held numerous visiting faculty
`
`positions.
`
`10. My practice and research have focused on the treatment of spinal
`
`diseases and injuries. In particular, I have dedicated much of my career to the
`
`enhancement and education of minimally invasive Posterior Lumbar Interbody
`
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`- 3 -
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`

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`Fusion (PLIF) techniques. These techniques are used by spine surgeons
`
`worldwide.
`
`11.
`
`I have served as Chairman of the American Board of Neurological
`
`Surgery, President of the North American Spine Society, and Chairman of the
`
`AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves.
`
`12.
`
`I am the principal author or co-author of more than 95 journal articles,
`
`chapters, abstracts, and related publications, and have given over 150 lectures and
`
`oral presentations worldwide on various topics related to my practice, teaching,
`
`and research interests.
`
`13.
`
`I have served as Editor-in-Chief of The Spine Journal, and have held
`
`editorial board positions for various other publications including Journal of
`
`Neurosurgery: Spine, Neurosurgery, Clinical Orthopaedics and Related Research,
`
`Journal of Radiosurgery, Neurosurgical Focus, Journal of Spinal Disorders, and
`
`Spinal Surgery: Official Journal of the Japanese Society of Spinal Surgery.
`
`14.
`
`I am a named inventor or co-inventor on U.S. Patent No. 6,174,311
`
`(Interbody Fusion Grafts and Instrumentation); U.S. Patent No. 6,193,757
`
`(Expandable Intervertebral Spacers); U.S. Patent No. 6,200,322 (Minimal
`
`Exposure Posterior Spinal Interbody Instrumentation and Technique); and 37 other
`
`U.S. and European patents related to spinal surgery, spinal implants, and spinal
`
`surgical instrumentation. My inventive and product development activities have
`
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`focused on developing technologies that can be made available for use by myself
`
`and other surgeons in clinical settings to improve patient care and outcomes.
`
`15. A true and correct copy of my curriculum vitae is being submitted
`
`concurrently with this Declaration (EXHIBIT WARSAW2004); it includes a full
`
`list of my qualifications, including past positions and publications.
`
`III. PERSON OF ORDINARY SKILL IN THE ART.
`
`16.
`
`It is my understanding that a person of ordinary skill in the art
`
`(“one of ordinary skill”) at the time of the effective filing date of the application
`
`that lead to the ’696 patent is a surgeon with extensive knowledge of the human
`
`anatomy, the use of devices in the human spine, and the biomechanical,
`
`anatomical, and physiological implications of such use. My opinions are thus
`
`based upon the perspective of one of ordinary skill at the time of the effective
`
`filing date of the application that led to the ’696 patent.
`
`IV. MATERIALS CONSIDERED.
`
`17.
`
`In preparing this Declaration, I have read the claims, specification,
`
`and prosecution history of the ’696 patent. I also have considered NuVasive’s two
`
`Petitions for Inter Partes Review regarding the ’696 patent (IPR2013-00395 and
`
`IPR2013-00396), the PTAB’s Decisions Instituting Inter Partes Review, the prior
`
`art references of the rejections preliminarily adopted by the PTAB, and the ’395
`
`and ’396 Brantigan Declarations. In addition, I have considered the deposition
`
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`transcript (Ex. 2009) of Dr. John W. Brantigan, M.D. taken April 7, 20014. My
`
`opinions also are based on the knowledge I have accumulated over my years of
`
`experience as outlined above.
`
`
`V.
`
`BACKGROUND AND SUMMARY OF THE ’696 PATENT.
`
`18. This section provides an overview of the relevant anatomy,
`
`pathologies, technological background, and the ’696 patented technology. The
`
`’696 patent, entitled “Anatomic Spinal Implant Having Anatomic Bearing
`
`Surfaces,” issued on May 21, 2013 from an application filed on September 19,
`
`2011. I understand that the application that issued as the ’696 patent is a
`
`continuation of an application filed on September 7, 2010, which is a continuation
`
`of an application filed on August 26, 2004, which is a continuation of an
`
`application filed on September 9, 2002, which is a continuation of an application
`
`filed on October 4, 1999, which is a continuation of an application filed on
`
`March 10, 1997, which is a division of an application filed on June 7, 1995.
`
`A. Overview of the human spine.
`19. The ’696 patent relates to interbody spinal fusion implants. In order
`
`to discuss the disclosure of the ’696 patent, it is first useful to present an
`
`anatomical summary of the human spine.
`
`20. The human spine, also called the vertebral column, is made up of 26
`
`bones, which include 24 vertebrae, the sacrum, and coccyx. The vertebrae form a
`
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`support column that carries the overall weight of the trunk, neck, and head,
`
`distributing their weight to the lower limbs of the skeleton. In addition, the spine
`
`functions to protect the spinal cord.
`
`
`
`21. Each individual vertebra is composed of three principal elements: (1)
`
`a body, (2) a vertebral arch, and (3) articular processes. The vertebral body
`
`distributes weight along the vertebral column’s axis and is separated from adjacent
`
`vertebrae by the intervertebral discs. The vertebral body includes upper and lower
`
`endplates in contact with the intervertebral discs.
`
`22. The intervertebral disc is made up of collagen ligament material,
`
`mucinous material (disc material), articular cartilage, fibrocartilage, and adheres to
`
`the bony endplate. The intervertebral discs serve to absorb shock imparted to the
`
`spinal column and afford a degree of movement between adjacent vertebrae.
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`Degeneration of the intervertebral discs can diminish stability of the spine, cause
`
`trauma to surrounding structures, and reduce lordosis between adjacent vertebrae.
`
`When healthy, the intervertebral discs have bi-convex appearances, and the
`
`corresponding upper and lower endplates of the adjacent vertebrae have bi-concave
`
`appearances that complement the bi-convex appearances of the healthy
`
`intervertebral discs. Furthermore, depending on the location of an intervertebral
`
`disc, degeneration thereof may or may not cause disfiguring anatomical changes.
`
`For example, degeneration of intervertebral discs in the cervical region of the spine
`
`is unlikely to cause disfigurement of the bi-convex appearance thereof or the
`
`disfigurement of the bi-concave appearances of the corresponding endplates. In
`
`contrast, when intervertebral discs in the lumbar region of the spine degenerate,
`
`such degeneration can result in disfigurement of the intervertebral disc and the
`
`corresponding upper and lower endplates. To illustrate, the disfigurement of the
`
`intervertebral discs will likely cause loss of their bi-convex appearances, and the
`
`disfigurement of the corresponding upper and lower endplates will likely cause
`
`loss of their bi-concave appearances. These anatomical changes result in a
`
`flattening of the intervertebral disc itself and a flattening of the corresponding
`
`upper and lower endplates. In doing so, the endplates can become parallel with
`
`one another.
`
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`B. Interbody spinal fusion procedures and implants.
`23. The ultimate objective of spinal implant fusion procedures is to
`
`facilitate the promotion of bone growth between adjacent vertebrae in an
`
`anatomically satisfactory configuration. Such bone growth serves in joining or
`
`fusing adjacent vertebrae together and can occur in the spaces formerly occupied
`
`by the intervertebral discs. By joining or fusing adjacent vertebrae to one another,
`
`the vertebrae can be immobilized with respect to one another to improve stability
`
`of the spine, lessen trauma to surrounding structures, and restore lordosis between
`
`adjacent vertebrae.
`
`24. Today, spinal fusion is performed predominantly using spinal fusion
`
`implants. Such spinal fusion implants can be positioned between adjacent
`
`vertebrae in the spaces formerly occupied by the intervertebral discs. Bone growth
`
`between the adjacent vertebrae into and through the spinal fusion implants serves
`
`to join or fuse the vertebrae to one another. Thus, as commonly understood, a
`
`spinal fusion implant participates in bony fusion of adjacent vertebrae via bone
`
`growth between the adjacent vertebrae into and through the spinal fusion implant.
`
`Generally speaking, Dr. Michelson’s spinal fusion implants, including those
`
`disclosed in the ’696 patent, are the preferred implants of choice for many
`
`surgeons performing spinal fusion surgeries.
`
`
`
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`25. Dr. Brantigan indicates that “[s]pinal fusion is a surgical procedure
`
`that fuses adjacent vertebrae to one another or to an intermediate implant (e.g., via
`
`bone ingrowth) so that the adjacent vertebrae act as a single construct with no
`
`relative motion.” (‘395 Brantigan Declaration (Ex. 1001) at ¶ 6; and ‘396
`
`Brantigan Declaration (Ex. 1101) at ¶ 6.) Generally speaking, Dr. Brantigan’s
`
`definition of “spinal fusion” is accurate as far at it goes. However, I note that Dr.
`
`Brantigan’s definition of “spinal fusion” does not go far enough to also provide an
`
`accurate definition of a “spinal fusion implant.” As discussed above, a spinal
`
`fusion implant participates in bony fusion of adjacent vertebrae via bone growth
`
`between the adjacent vertebrae into and through the spinal fusion implant. Mere
`
`bone ingrowth is not enough to be considered a spinal fusion implant.
`
`C. The ’696 patent.
`
`26.
`
`I note that the ’696 patent relates generally to interbody spinal fusion
`
`implants for use in interbody spinal fusion surgery. More particularly, the ‘696
`
`patent is directed to “spinal fusion implants configured to restore and maintain two
`
`adjacent vertebrae of the spine in correct anatomical angular relationship.” (‘696
`
`patent at col. 1, ll. 21-23.) Furthermore, according to the ‘696 patent, “[t]he spinal
`
`fusion implants of the present invention are sized to fit within the disc space
`
`created by the removal of disc material between two adjacent vertebrae and
`
`conform wholly or in part to the disc space created.” (’696 patent at col. 1, ll. 61-
`
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`64.) To that end, objects of the ‘696 patent include providing “a spinal fusion
`
`implant that fits between [two] adjacent vertebrae and preserves the end [plates] of
`
`those vertebrae,” and “a spinal fusion implant having a shape which conforms to
`
`the endplates of the adjacent vertebrae.” (‘696 patent at col. 4, ll. 27-31.)
`
`27.
`
`It is noted that in order to facilitate spinal fusion, create and maintain
`
`the normal anatomic angular relationship of the adjacent vertebrae, and preserve
`
`the endplates of the adjacent vertebrae, the spinal fusion implants disclosed in the
`
`’696 patent have various features. These features include (1) upper and lower
`
`bearing surfaces of the spinal fusion implants being convex; (2) openings provided
`
`through the spinal fusion implants from proximate the top to proximate the bottom
`
`thereof affording the occurrence of bone growth between the adjacent vertebrae
`
`into and through the spinal fusion implants; and (3) ratchetings provided on the
`
`upper and lower bearing surfaces of the spinal fusion implants that afford forward
`
`movement of the spinal fusion implant in one direction and prevent the spinal
`
`fusion implant from backing out in the opposite direction.
`
`28. The upper and lower bearing surfaces of the spinal fusion implants of
`
`the ’696 patent serve in supporting the adjacent vertebrae. (’696 patent at col. 1,
`
`ll. 65-67.) The ’696 patent indicates that “[t]he spinal fusion implants of the
`
`present invention have upper and lower surfaces that form a support structure for
`
`bearing against the [endplates] of the adjacent vertebrae” and “[t]he implants of the
`
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`present invention have various faces which may be curved so as to conform to the
`
`shape of the vertebral surfaces adjacent to the area of the disc removal.” (’696
`
`patent at col. 1, ll. 65-67; and col. 2, ll. 23-25.) To provide such a conforming
`
`support structure, the upper and lower bearing surfaces can be convex. (’696
`
`patent at col. 2, l. 26; and col. 9, ll. 9-11 and 37-39.) Thus, I note that the upper
`
`and lower bearing surfaces of the spinal fusion implants of the ’696 patent can be
`
`convexly curved to conform to the anatomic endplates of the adjacent vertebrae.
`
`29. The openings through the spinal fusion implants of the ’696 patent
`
`serve in facilitating spinal fusion between the adjacent vertebrae. (’696 patent at
`
`Figs. 1 and 8; and col. 6, ll. 38-43.) For example, the spinal fusion implant 200
`
`depicted in Figs. 8-12 of the ‘696 patent includes a plurality of channels (or
`
`openings) 215 that pass “from the upper surface 212 to the lower surface 214
`
`through the implant 200” (‘696 patent at col. 8, ll. 7 and 8), and the channels (or
`
`openings) 215 “provide for bone ingrowth and facilitate the incorporation of the
`
`implant 200 into the spinal fusion mass” (‘696 patent at col. 8, ll. 8-10). According
`
`to the ’696 patent, once bone growth between the adjacent vertebrae into and
`
`through a spinal fusion implant occurs, the spinal fusion implant “will be a
`
`permanent fixture preventing dislodgement of the implant as well as preventing
`
`any movement between the adjacent vertebrae.” (’696 patent at col. 7, ll. 17-20.)
`
`Thus, I note that the openings provided in the spinal fusion implants of the ’696
`
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`patent are holes provided through the spinal fusion implants, and that the openings
`
`can extend from proximate the top to proximate the bottom of the spinal fusion
`
`implants to afford the occurrence of bone growth between the adjacent vertebrae
`
`into and through the spinal fusion implants.
`
`30. The ratchetings on the upper and lower bearing surfaces of the spinal
`
`fusion implants of the ’696 patent serve to afford forward movement of the spinal
`
`fusion implant in one direction and thereafter prevent the spinal fusion implant
`
`from backing out in the opposite direction. (’696 patent at Fig. 9; and col. 8, ll. 42-
`
`47.) As such, when contacted to two adjacent vertebrae, properly-oriented
`
`ratchetings provide “one-way insertion” of the spinal fusion implants between the
`
`adjacent vertebrae. (’696 patent at col. 8, ll. 42-47.) For example, the implant 200
`
`depicted in Figs. 8-12 of the ‘696 patent includes a plurality of ratchetings 250.
`
`The ‘696 patent indicates that “[t]he ratchetings 250 comprise a bone engaging
`
`edge 252 and angled segment 254” (‘696 patent at col. 8, ll. 38 and 39), and that
`
`“[t]he plurality of ratchetings 250 are oriented in the direction of the insertion end
`
`220 to provide for a one-way insertion of the implant 200 as the bone engaging
`
`edge 252, or ridge, engages the vertebrae and prevents the implant from backing
`
`out once implanted” (‘696 patent at col. 8, ll. 42-47). Thus, I note that the
`
`ratchetings do not prevent movement in two directions, but instead the ratchetings
`
`provided on each of the upper and lower bearing surfaces of the spinal fusion
`
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`
`implants of the ’696 patent include facets that are angled to afford forward
`
`movement of the spinal fusion implant in one direction and facets that are angled
`
`to prevent the spinal fusion implant from backing out in the opposite direction.
`
`VI. CLAIM INTERPRETATION.
`
`31.
`
`In inter partes reviews, I understand claim terms are given their
`
`broadest reasonable construction in light of the specification of the patent in which
`
`they appear. I understand that under the broadest reasonable interpretation
`
`standard, claims are given their ordinary and customary meaning in view of the
`
`specification as would be understood by one of ordinary skill. I also understand
`
`that the prosecution history of a patent, and the prosecution histories of its parent
`
`applications, may be considered in determining the scope and meaning of the claim
`
`terms. Keeping these principles in mind, I have considered the following claim
`
`language when reviewing the claims of the ’696 patent.
`
`A. Meaning of the claim recitation “opening.”
`
`32.
`
`Independent claims 1, 4, 7, and 10 each recite “an opening between
`
`said trailing face and said insertion face and between said first and second sides to
`
`permit for the growth of bone through said implant from the first vertebra to the
`
`second vertebra.”
`
`33. From my above-discussed reading of the specification and drawings
`
`of the ’696 patent, and in my opinion as a skilled artisan, the ordinary meaning of
`
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`the claim term “opening” is a hole through the spinal fusion implant. Thus, one of
`
`ordinary skill would understand the “opening” recitation in light of the
`
`specification and drawings of the ‘696 patent to require a hole that extends through
`
`the spinal fusion implant further limited in two ways: (1) the hole is located
`
`between the trailing face and the insertion face and between the first and second
`
`sides of the spinal fusion implant, and (2) the hole permits for the growth of bone
`
`through the spinal fusion implant from the first vertebra to the second vertebra. As
`
`such, to afford both (1) and (2), the hole must necessarily extend through the spinal
`
`fusion implant from proximate the top to proximate the bottom thereof in the space
`
`between the trailing face, the insertion face, and the first and second sides of the
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`spinal fusion implant. Accordingly, the “opening” recitation of independent claims
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`1, 4, 7, and 10 in pertinent part requires a hole extending through the spinal fusion
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`implant from proximate the top to proximate the bottom thereof in the space
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`between the trailing face, the insertion face, and the first and second sides of the
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`spinal fusion implant. Furthermore, because the “opening” recitation requires “an
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`opening…to permit for the growth of bone through said implant from the first
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`vertebra to the second vertebra,” this recitation makes clear that the implants
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`claimed in independent claims 1, 4, 7, and 10 are spinal fusion implants.
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`B. Meaning of the claim recitation “upper and lower bearing surfaces.”
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`34.
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`Independent claims 1, 4, 7, and 10 each recite “upper and lower
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`bearing surfaces each having a length measured parallel to the longitudinal axis of
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`said implant, said upper and lower bearing surfaces having portions proximate
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`each of said first and second sides and being convex along the entire length of said
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`upper and lower bearing surfaces relative to the second plane and in a direction
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`parallel to the longitudinal axis.”
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`35. From my above-discussed reading of the specification and drawings
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`of the ’696 patent, and in my opinion as a skilled artisan, the ordinary meaning of
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`the claim term “upper and lower bearing surfaces” is upper and lower surfaces for
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`bearing against the anatomic endplates of the adjacent vertebrae. Because the
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`upper and lower bearing surfaces bear against the anatomic endplates of the
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`adjacent vertebrae, the convexity thereof must necessarily conform to the anotomic
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`endplates. Thus, one of ordinary skill would understand the “upper and lower
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`bearing surfaces” recitation in light of the specification and drawings of the ‘696
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`patent to require upper and lower bearing surfaces for bearing against the anatomic
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`endplates of the adjacent vertebrae, further limited to require the upper and lower
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`bearing surfaces have a length measured parallel to the longitudinal axis of the
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`spinal fusion implant, have portions proximate each of the first and second sides,
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`and are convexly curved along the entire length thereof relative to the second plane
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`in a direction parallel to the longitudinal axis, the convex curvatures conforming to
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`the anatomic endplates of the adjacent vertebrae along the entire length thereof.
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`36.
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`In short, the recitation of “upper and lower bearing surfaces…being
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`convex” of independent claims 1, 4, 7, and 10 in pertinent part requires upper and
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`lower surfaces of the spinal fusion implant for bearing against the anatomic
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`endplates of the adjacent vertebrae, where the upper and lower bearing surfaces
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`have convex curvatures conforming to the anatomic endplates of the adjacent
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`vertebrae along the entire length thereof.
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`C. Meaning of the claim recitation “ratchetings.”
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`37.
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`Independent claims 1, 4, 7, and 10 each recite “ratchetings on each of
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`said upper and lower bearing surfaces adapted to engage the first vertebra and the
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`second vertebra, respectively, each of said ratchetings having a ridge oriented in a
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`direction generally parallel to the width of said implant, said ratchetings on each of
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`said upper and lower bearing surfaces facing one direction.”
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`38. From my above-discussed reading of the specification and drawings
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`of the ’696 patent, and in my opinion as a skilled artisan, the ordinary and
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`customary meaning of the claim term “ratchetings” is facets that are angled to
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`afford forward movement of the spinal fusion implant in one direction and facets
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`that are angled to prevent the spinal fusion implant from backing out in the
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`opposite direction. Thus, one of ordinary skill would understand the “ratchetings”
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`recitation in light of the specification and drawings of the ‘696 patent to require
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`facets that are angled to afford forward movement of the spinal fusion implant in
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`one direction and facets that are angled to prevent the spinal fusion implant from
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`backing out in the opposite direction provided on each of the upper and lower
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`bearing surfaces, further limited to require that the ratchetings on the upper and
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`lower bearing surfaces are adapted to engage the first vertebra and the second
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`vertebra, respectively, and the ratchetings on the upper and lower bearing surfaces
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`each have a ridge oriented in a direction generally parallel to the width of the
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`spinal fusion implant and face one direction.
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`39.
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`In short, the “ratchetings” recitation of independent claims 1, 4, 7, and
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`10 in pertinent part requires facets that are angled to afford forward movement of
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`the spinal fusion implant in one direction and facets that are angled to prevent the
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`spinal fusion implant from backing out in the opposite direction.
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`VII. NUVASIVE’S PROPOSED GROUNDS OF REJECTION DO NOT
`RENDER THE ’696 PATENT OBVIOUS.
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`A. Proposed grounds of unpatentability.
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`1. Claims 1-6 (IPR2013-00395).
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`40.
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`I understand that in IPR2013-00395 the PTAB has preliminarily
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`adopted the following rejections: (1) rejection of claims 1, 3, 4, and 6 under 35
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`U.S.C. § 103(a) based on WIPO Publication No. WO93/01771 to Senter et al.
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`(“Senter”) in view of WIPO Publication No. WO89/09035 to Brantigan
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`(“Brantigan ’035”); (2) rejection of claims 2 and 5 under 35 U.S.C. § 103(a) based
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`on Senter in view of Brantigan ’035 and U.S. Patent No. 5,192,327 to Brantigan
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`(“Brantigan ’327”); and (3) rejection of claims 1-6 under 35 U.S.C. § 103(a) based
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`on WIPO Publication No. WO90/00037 to Michelson (“Michelson ’037”) in view
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`of U.S. Patent No. 5,306,309 to Wagner et al. (“Wagner”) and Brantigan ’035.
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`The cited references, NuVasive’s and Dr. Brantigan’s interpretations of these
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`references, and the prior art combinations