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`EXPERT REPORT OF DR. BRUCE E. VAN DAM REGARDING VALIDITY OF THE
`ASSERTED CLAIMS OF U.S. PATENT NO. 5,860,973
`
`Warsaw Orthopedic, Inc. v. NuVasive, Inc.
`
`
`
`
`
`CONTAINS CONFIDENTIAL INFORMATION
`
`

`

`I.
`
`INTRODUCTION
`
`1.
`
`I have been engaged by NuVasive to review and analyze the evidence in this case
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`and provide opinions relating to the invalidity and non-infringement of the asserted claims of
`
`U.S. Patent No. 5,860,973 (the “‘973 patent”). This report summarizes my analysis and
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`conclusions regarding invalidity.
`
`2.
`
`The opinions I express in this report are based on my background and experience,
`
`along with my review of certain pleadings, documents, products, and deposition testimony. In
`
`performing my analysis, I have reviewed and applied the Court’s April 1, 2010 claim
`
`constructions for certain terms in the ‘973 patent. For other terms, I have applied what I believe
`
`to be the proper meaning; in the alternative, I have also applied the interpretations proposed by
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`Warsaw Orthopedic (“Warsaw”) and/or the interpretations which I infer from Warsaw’s
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`Infringement Contentions. While I do not agree with Warsaw’s proposed or implied
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`interpretations where they differ from my own, if Warsaw’s interpretations are accepted by the
`
`Court or jury for purposes of assessing infringement, then I understand the same interpretations
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`must apply for purposes of assessing invalidity as well.
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`3.
`
`If called to testify in this matter, I expect to offer the opinions expressed in this
`
`report and the basis for those opinions. I may modify or supplement the opinions that I express
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`in this report if additional evidence or information comes to my attention. I may modify or
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`supplement my opinions in view of arguments made by any person retained by Warsaw,
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`including its counsel and anyone it engages to provide opinions. I may also modify or
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`supplement my opinions if the Court provides the litigants with any additional pertinent rulings.
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`4.
`
`If called to testify in this matter, I may use documents and/or devices to help me
`
`explain my opinions. I may also prepare and use graphics, photographs, video recordings, test
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`
`1
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`

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`data and other presentation aids to help me explain my opinions. I may also use graphics and
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`other presentation aids prepared by other witnesses to help me explain my opinions. I may assist
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`in the development of animations, demonstration materials, and in-court demonstrations to
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`support and explain my opinions. At or before trial, I may use any of the materials referred to in
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`this report (e.g., any of the documents, data, and other information reviewed by me or made
`
`available to me) as exhibits to support my opinions. I may also create summaries of documents,
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`data, and other information reviewed by me, or made available to me, to support my opinions.
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`At trial, I may convey my testimony using images, diagrams, animations, or other
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`demonstratives. Finally, with the permission of the Court, I may offer tutorial information at or
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`before trial regarding anterior spinal implants (e.g., the history of spinal implants and
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`procedures).
`
`5.
`
`I am being compensated for my time spent as an expert on this case at my
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`standard consulting rate of $500 per hour. My compensation as an expert in this matter is in no
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`way dependent upon the results of any investigations I undertake, the substance of any opinion I
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`express, or the ultimate outcome of this case.
`
`II.
`
`SUMMARY OF CONCLUSIONS
`
`6.
`
`My opinions here are based on my understanding of United States patent laws, as
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`provided to me by NuVasive’s attorneys, on my examination and consideration of the materials I
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`reviewed (listed in “Materials Considered” section below), and on my personal knowledge of
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`and experience with spinal implants. In my opinion, the subject matter of the asserted claims of
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`the ‘973 patent (claims 24, 25, 35, 41, 42, 50, 52, 57, 59, and 61) is disclosed in the prior art
`
`references identified below, and, therefore, these asserted claims are invalid as either anticipated
`
`or obvious. Specifically, it is my opinion that:
`
`
`
`2
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`

`

`a.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
`
`taught by U.S. Patent No. 5,192,327 issued to Brantigan (the “Brantgan ‘327 patent”)
`
`either alone or in combination with U.S. Patent No. 5,397,364 to Kozak, U.S. Patent No.
`
`4,834,757 to Brantigan, WO 92/14423 to Pisharodi, WO 90/00037 to Michelson and/or
`
`U.S. Patent No. 5,015,247 to Michelson, rendering each of the claims invalid as
`
`anticipated or obvious.
`
`b.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
`
`taught by the Brantigan Anterior I/F Cage either alone or in combination with U.S. Patent
`
`No. 5,015,247 to Michelson, WO 90/00037 to Michelson and/or U.S. Patent No.
`
`5,397,364 to Kozak, rendering each of the claims invalid as anticipated or obvious.
`
`c.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by U.S. Patent No. 4,834,757 to Brantigan (the “Brantigan ‘757 patent”) either
`
`alone or in combination with U.S. Patent No. 5,015,247 to Michelson, U.S. Patent No.
`
`5,192,327 to Brantigan and/or U.S. Patent No. 5,397,364 to Kozak, rendering each of the
`
`claims invalid as anticipated or obvious.
`
`d.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
`
`taught by the Brantigan I/F Cage either alone or in combination with U.S. Patent No.
`
`5,015,247 to Michelson and/or U.S. Patent No. 5,397,364 to Kozak, rendering each of
`
`the claims invalid as anticipated or obvious.
`
`e.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
`
`taught by U.S. Patent No. 5,015,247 to Michelson (the “Michelson ‘247 patent”) either
`
`alone or in combination with U.S. Patent No. 4,834,757 to Brantigan, U.S. Patent No.
`
`
`
`3
`
`

`

`5,397,364 to Kozak and/or WO 92/14423 to Pisharodi, rendering each of the claims
`
`invalid as anticipated or obvious.
`
`f.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by the BAK Cage either alone or in combination with U.S. Patent No. 4,834,757 to
`
`Brantigan, U.S. Patent No. 5,015,247 to Michelson, U.S. Patent No. 5,397,364 to Kozak
`
`and/or WO 92/14423 to Pisharodi, rendering each of the claims invalid as anticipated or
`
`obvious.
`
`g.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by the implants offered for sale and sold by Dezider Imre to Dr. Michelson on or
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`before January 4, 1994, either alone or in combination with U.S. Patent No. 4,834,757 to
`
`Brantigan, U.S. Patent No. 5,397,364 to Kozak and/or WO 92/14423 to Pisharodi,
`
`rendering each of the claims invalid as anticipated or obvious.
`
`h.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by WO 90/00037 to Michelson (the “Michelson PCT publication”) either alone or
`
`in combination with WO 92/14423 to Pisharodi, rendering each of the claims invalid as
`
`anticipated or obvious.
`
`i.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by U.S. Patent No. 4,501,269 to Bagby (the “Bagby patent”) either alone or in
`
`combination with U.S. Patent No. 4,834,757 to Brantigan, U.S. Patent No. 5,192,327 to
`
`Brantigan, U.S. Patent No. 5,397,364 to Kozak and/or WO 92/14423 to Pisharodi,
`
`rendering each of the claims invalid as anticipated or obvious.
`
`j.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by the article titled “Some Additional Suggestions for an Intervertebral Disc
`
`
`
`4
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`

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`Prosthesis,” H.G. Edeland, Journal of Biomedical Engineering, Vol. 7, 57-62 (1985) (the
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`“Edeland article”) either alone or in combination with U.S. Patent No. 4,501,269 to
`
`Bagby, U.S. Patent No. 4,834,757 to Brantigan, U.S. Patent No. 5,397,364 to Kozak
`
`and/or WO 92/14423 to Pisharodi, rendering each of the claims invalid as anticipated or
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`obvious.
`
`k.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by the article titled “Anterior Lumbar Interbody Fusion, Indications for its Use and
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`Notes on Surgical Technique,” H.V. Crock, Clinical Orthopedics and Related Research,
`
`J.B. Lipincott Co. (1982) (the “Crock article”) either alone or in combination with U.S.
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`Patent No. 4,501,269 to Bagby, U.S. Patent No. 4,834,757 to Brantigan, U.S. Patent No.,
`
`5,192,327 to Brantigan, U.S. Patent No. 5,397,364 to Kozak and/or WO 92/14423 to
`
`Pisharodi, rendering each of the claims invalid as anticipated or obvious.
`
`l.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by the article titled “Anterior Fusion of the Spine for Infective Lesions in Adults,”
`
`H.B.S. Kemp et al., 55B Journal of Bone & Joint Surgery 715 (1973) (the “Kemp
`
`article”) either alone or in combination with U.S. Patent No. 4,834,757 to Brantigan, U.S.
`
`Patent No. 5,015,247 to Michelson and/or U.S. Patent No. 5,192,327 to Brantigan,
`
`rendering each of the claims invalid as anticipated or obvious.
`
`m.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
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`taught by an U.S. Patent No. 5,489,307 to Kuslich et al. (the “Kuslich patent”) either
`
`alone or in combination with U.S. Patent No. 4,834,757 to Brantigan, U.S. Patent No.
`
`5,397,364 to Kozak and/or WO 92/14423 to Pisharodi, rendering each of the claims
`
`invalid as anticipated or obvious.
`
`
`
`5
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`

`

`n.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
`
`taught by WO 92/14423 to Pisharodi Madhavan (the “Pisharodi PCT publication”) either
`
`alone or in combination with U.S. Patent No. 4,501,269 to Bagby, U.S. Patent No.
`
`4,834,757 to Brantigan and/or U.S. Patent No. 5,397,364 to Kozak, rendering each of the
`
`claims invalid as anticipated or obvious.
`
`o.
`
`Each of the limitations found in the asserted claims of the ‘973 patent is
`
`taught by U.S. Patent No. 5,397,364 to Kozak (the “Kozak patent”) either alone or in
`
`combination with U.S. Patent No. 4,501,269 to Bagby, U.S. Patent No. 4,834,757 to
`
`Brantigan, U.S. Patent No. 5,192,327 to Brantigan and/or WO 92/14423 to Pisharodi,
`
`rendering each of the claims invalid as anticipated or obvious.
`
`III.
`
`SUMMARY OF MY BACKGROUND AND QUALIFICATIONS
`
`7.
`
`I am an orthopaedic surgeon board certified by the American Board of
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`Orthopaedic Surgery and fellowship trained in spinal surgery. After twenty years of service in
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`the U.S. Army Medical Corps and seventeen years of private practice in La Jolla, CA, I retired
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`from clinical practice in September 2009. Presently I teach surgical technique to visiting
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`surgeons, teach anatomy and diagnostic imaging, and consult with engineers on behalf of
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`NuVasive.
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`8.
`
`I received my medical degree from the University of Southern California, Los
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`Angeles, in 1976. My internship and orthopaedic residency training were completed at Letterman
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`Army Medical Center, San Francisco, in 1981. I received one year of spine fellowship training in
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`1984-1985 as a John H. Moe Fellow at the Twin Cities Scoliosis Center, Minneapolis. Following
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`fellowship training I was assigned to Walter Reed Army Medical Center, Washington, DC, as
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`6
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`chief of orthopaedic spine surgery until my retirement from the Army in 1992. Thereafter I was
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`in private practice as an orthopaedic spine surgeon in San Diego until 2009.
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`9.
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`During my service in the Medical Corps I received awards as outlined in my
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`curriculum vitae. During my assignment at Walter Reed Army Medical Center, I was selected to
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`serve on a Department of Defense-Department of State team sent to Vietnam in 1988 concerning
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`the Missing in Action/Prisoner of War issue. During the First Gulf War, I served as chief of
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`orthopaedics at Walter Reed. Concerning other matters, then-General Colin Powell commended
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`me in his autobiography published in 1997 for caring for his son, an active-duty lieutenant who
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`had sustained serious spinal and pelvic injuries.
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`10. While in private practice, I served as chief of the orthopaedic service at Sharp-
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`Grossmont Medical Center, La Mesa, a board member of the Orthopaedic Surgery Center of La
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`Jolla and a member of the board of directors of the California Orthopaedic Association. I am an
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`emeritus member of the American Academy of Orthopaedic Surgeons, the Scoliosis Research
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`Society, the North American Spine Society and the California Orthopaedic Association. While in
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`private practice, I was designated a Top Surgeon by the Consumers’ Research Council of
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`America.
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`11. My curriculum vitae is attached hereto as Exhibit A.
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`12.
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`I have served as an expert witness in the cases listed in Exhibit B.
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`IV. ANALYTIC FRAMEWORK USED TO REACH MY CONCLUSIONS
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`Materials Considered
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`13.
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`In reaching the conclusions expressed in this report, I reviewed and examined the
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`documents and things listed in Exhibit C to this report.
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`7
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`14.
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`It is my understanding that the Court has, in this case, interpreted certain terms in
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`the asserted claims of the ‘973 patent. Accordingly, in the preparation of this report, and for
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`those terms, I have adhered to the constructions set forth in the Court’s “Order Construing
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`Disputed Claim Terms of United States Patent Nos. 5,860,973; 6,945,933; 6,592,586; and
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`7,470,236,” signed on April 1, 2010. A copy of this Order is attached to this report as Exhibit D.
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`15.
`
`In addition to the materials listed in Exhibit C and the Court’s claim construction
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`opinion in Exhibit D, I relied on my own knowledge, training, and experience with spinal
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`implants to reach the conclusions expressed in this report. Should additional information
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`become available in this case that is relevant to this report, I may supplement this report or the
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`opinions I have expressed.
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`Legal Standards
`
`16.
`
`I am not an attorney. In preparing my analysis, I have applied the legal standards
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`described below, which were provided to me by counsel for NuVasive.
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`17.
`
`Initially, it is my understanding that in order for a U.S. patent to be valid, the
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`specification of the patent must contain a written description of the invention and of the manner
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`and process of making and using it, in such full, clear, concise, and exact terms as to enable a
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`person of ordinary skill in the art to which it pertains to make it and use it without undue
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`experimentation. I also understand that the patent “claims” must particularly point out and
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`distinctly claim the subject matter the patentee regards as his invention. In understand that
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`assessing the written description provided in the specification and claims, the “definiteness” of
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`the claims, and the question of enablement, these assessments should be done from the point of
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`view of one of ordinary skill in the art.
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`8
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`18.
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`It is also my understanding that assessing the validity of a U.S. Patent based on a
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`prior art analysis requires two essential steps. First, one must construe the terms of the patent
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`claims to understand what meaning they would have to one of ordinary skill in the art. I have
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`reviewed the Court’s Order Construing Disputed Claim Terms of United States Patent Nos.
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`5,860,973; 6,945,933; 6,592,586; and 7,470,236, which is dated April 1, 2010 (“Order”) and will
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`adhere to these determinations throughout this report. I will use the plain and ordinary meaning
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`for claim terms relevant to my analysis that were not addressed by the Court.
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`19.
`
`After the claim terms have been construed, one may then assess validity by
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`comparing a patent claim to the “prior art.” A prior art “reference” is considered prior art for all
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`that it discloses or teaches to one of ordinary skill. A reference will be prior art if it satisfies the
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`rules set out in 35 U.S.C. § 102, including, for example, the requirement that the reference has an
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`effective date either more than one year before the patent was filed, or before the date of
`
`invention. I also understand that reference is prior art if it was available to the extent that
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`persons interested and ordinarily skilled in the art, exercising reasonable diligence, could have
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`located it. The reference need not have been distributed or indexed, but must otherwise have
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`been made sufficiently publicly accessible to persons interested and ordinarily skilled in the art.
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`20.
`
`To assess the level of ordinary skill in the art, I understand one can consider the
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`types of problems encountered in the art, the prior solutions to those problems found in prior art
`
`references, the rapidity with which innovations are made, the sophistication of the technology,
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`and the level of education of active workers in the field. My assessment of the level of ordinary
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`skill in art is set forth below.
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`
`
`9
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`21.
`
`It is also my understanding that once issued by the Patent Office, a patent is
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`presumed to be valid. In order to prove a patent invalid, the challenger must present what is
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`referred to as “clear and convincing” evidence of invalidity.1
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`22.
`
`It is my understanding that a patent claim is invalid if the claimed invention is not
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`new. For the claim to be invalid as not new, all of its requirements must have existed or been
`
`described in a single prior art reference. If a patent claim is not new, it said to be “anticipated” by
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`a prior art reference. The description in the prior art reference does not have to be in the same
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`words as the claim, but all of the requirements of the claim must be there, either stated or
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`necessarily implied, so that someone of ordinary skill in the subject matter or art looking at that
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`one reference would be able to make and use the claimed invention.
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`23.
`
`Further, I understand that a patent claim is invalid if the claimed invention would
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`have been “obvious” to a person of ordinary skill in the field at the time the application was
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`filed. This means that even if all of the requirements of the claim cannot be found in a single
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`prior art reference that would anticipate the claim, a person of ordinary skill in the field who
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`knew about all this prior art would have come up with the claimed invention.
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`24.
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`However, I understand that a patent claim composed of several elements is not
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`proved obvious merely by demonstrating that each of its elements was independently known in
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`the prior art. In evaluating whether such a claim would have been obvious, I may consider
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`
`1 However, I also understand that the United States Supreme Court is considering whether to
`lower the standard for proving invalidity based on art not cited to or considered on the merits by
`the Patent Office during prosecution, from a “clear and convincing” standard to a
`“preponderance of the evidence” standard. Microsoft Corp. v. I4I Ltd. P’ship, 60 U.S.L.W. 3128
`(U.S. Nov. 29, 2010) (No. 10-290). Given the opinions expressed in this report, which are based
`on the presently applicable clear and convincing standard, it follows that I am of the opinion that
`all the same art anticipates and/or renders obvious the asserted claims for all the same reasons,
`but even more clearly, should the applicable standard become the “preponderance of evidence.”
`I reserve the right to amend or supplement this report if, and as necessary in view of, any
`subsequent changes to the applicable law.
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`10
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`whether I find a reason that would have prompted a person of ordinary skill in the field to
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`combine the elements or concepts from the prior art in the same way as in the claimed invention.
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`I understand there is no single way to define the line between true inventiveness on one hand
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`(which is patentable) and the application of common sense and ordinary skill to solve a problem
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`on the other hand (which is not patentable). For example, market forces or other design
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`incentives may be what produced a change, rather than true inventiveness. It is my understanding
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`that I may consider whether the change was merely the predictable result of using prior art
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`elements according to their known functions, or whether it was the result of true inventiveness.
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`And, I may also consider whether there is some teaching or suggestion in the prior art to make
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`the modification or combination of elements claimed in the patent. Also, I should consider
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`whether the innovation applies a known technique that had been used to improve a similar device
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`or method in a similar way. I may also consider whether the claimed invention would have been
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`obvious to try, meaning that the claimed innovation was one of a relatively small number of
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`possible approaches to the problem with a reasonable expectation of success by those skilled in
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`the art. However, I understand that I must be careful not to determine obviousness using the
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`benefit of hindsight and that many true inventions might seem obvious after the fact. I
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`understand that I should consider obviousness from the position of a person of ordinary skill in
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`the field at the time the claimed invention was made and that I should not consider what is
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`known today or what is learned from the teaching of the patent.
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`25.
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`I understand the ultimate conclusion of whether a claim is obvious should be
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`based upon my determination of several factual decisions. First, I must decide the level of
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`ordinary skill in the field that someone would have had at the time the claimed invention was
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`11
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`made. Second, I must decide the scope and content of the prior art. Third, I must decide what
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`difference, if any, existed between the claimed invention and the prior art.
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`26.
`
`It is my understanding that to rebut a showing of obviousness based on prior art,
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`Warsaw may attempt to show the existence of one or more secondary considerations of non-
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`obviousness, including:
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
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`f.
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`g.
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`h.
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`Commercial success of a product due to the merits of the claimed invention
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`A long felt need for the solution provided by the claimed invention
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`Unsuccessful attempts by others to find the solution provided by the claimed
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`invention
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`Copying of the claimed invention by others
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`Unexpected and superior results from the claimed invention
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`Acceptance by others of the claimed invention as shown by praise from others in
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`the field or from the licensing of the claimed invention
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`Other evidence tending to show nonobviousness
`
`Independent invention of the claimed invention by others before or at about the
`
`same time as the named inventor thought of it
`
`27.
`
`It is my understanding that, in order to establish a secondary consideration of non-
`
`obviousness, Warsaw must show a nexus between that secondary consideration and the claimed
`
`invention. I have not included opinions regarding secondary considerations of non-obviousness
`
`in this report because I understand that the secondary considerations must first be shown to exist.
`
`If Warsaw asserts the presence of any secondary considerations of non-obviousness, I reserve the
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`right to supplement this report to address those secondary considerations.
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`12
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`Level of Ordinary Skill in the Relevant Field
`
`28.
`
`I understand that assessment of anticipation and obviousness must be done
`
`through the eyes of a hypothetical person of ordinary skill in the relevant field. To assess the
`
`level of ordinary skill in the relevant field, I have been instructed to consider the types of
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`problems encountered by those in the relevant fields, the prior solutions to those problems found
`
`in prior art references, the rapidity with which innovations are made, the sophistication of the
`
`technology, and the level of education of active workers in the relevant fields.
`
`29.
`
`The field related to the ‘973 patent is spinal implants. In my opinion, the
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`hypothetical person of ordinary skill in the art would be either (i) someone with a college degree
`
`in bio-medical engineering (or equivalent training) and two to three years of experience in
`
`designing spinal implants or a closely related field; or (ii) a spine surgeon with two to three years
`
`of experience specifically related to the design and use of spinal implants.
`
`30.
`
`I do not understand Warsaw to have expressed a view as to what they believe to
`
`be the relevant field to the claimed invention or the level of ordinary skill within that field. Thus,
`
`I cannot comment in this report on whether I agree or disagree with that position. If I disagree, I
`
`reserve the right to explain the basis of my disagreement at a later date.
`
`V.
`
`BACKGROUND REGARDING SPINAL IMPLANTS AND FUSION
`PROCEDURES
`
`31.
`
`At the time of my surgical training (1977-1981) there were relatively few spinal
`
`implants in common use. For example, the Harrington rod with its modifications was used in
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`posterior fusion procedures and the Dwyer cable was used in anterior fusion procedures. These
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`devices were implanted to obtain and maintain correction of spinal deformity resulting from
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`disease or trauma. Otherwise, the majority of fusion procedures were performed in situ, that is,
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`without the use of implants for spinal alignment and internal fixation. In those instances
`
`
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`13
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`

`correction of spinal deformity as well as postoperative immobilization of the spine were
`
`accomplished with external immobilization using a plaster cast or sometimes a plastic brace.
`
`32.
`
` The concept of interbody fusion dates back at least to the mid-20th century.
`
`Typically, interbody fusion was accomplished with either autogenous bone (bone from the
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`patient) or allograft bone (bone from another human). In order to keep the evacuated disk space
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`open and maintain alignment of the spine it was necessary to use a graft that consisted of tri-
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`cortical bone or cortical bone dowels. However, there were problems. While autogenous bone is
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`the “gold standard” for grafting material the amount is finite. Moreover, there are potential
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`complications with the harvest of bone graft from the surgical patient. For example, harvest of a
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`tri-cortical bone graft leaves a defect in the bone harvested so that for an individual requiring
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`multiple levels of fusion an unacceptable defect may result. Properly processed allograft avoids
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`the potential complications of harvest from the patient but does not have the same capacity to
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`induce fusion. Moreover, there is the possibility of disease transmission. Last, there is the
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`problem of subsidence during healing of an interbody fusion caused by bone resorption in the
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`early phases of bone healing, with the result that the interspace may collapse with loss of spinal
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`alignment and/or failure of the fusion to heal.
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`33.
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`Accordingly, there was a recognized need of a substitute for the tri-cortical or
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`cortical dowel bone graft. During the mid-to-late 1980s, Jurgen Harms and John Brantigan made
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`notable contributions in this regard, Harms with a titanium cage and Brantigan with a carbon
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`fiber cage. In both instances the cage maintained the interbody space and spinal alignment while
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`the graft material contained in the cage promoted fusion. Somewhat later, threaded cylindrical
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`cages were developed, such as the Bagby and Kuslich, or “BAK” cage, but these have been
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`largely abandoned because of an unacceptable incidence of complications. However, the
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`interbody cage in the forms and materials evolved from the designs by Harms and Brantigan
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`remain in wide use to this day. The NuVasive interbody fusion cages are examples of this
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`evolution. As a spine surgeon I have used the above-mentioned implants in my practice as they
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`became available.
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`34.
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`A variety of different approaches have been used to insert interbody cages. A
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`direct posterior or posterior midline approach was used first by surgeons. Notable in this regard
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`is the report of Russell Hibbs in 1911 for the treatment of tuberculosis. In 1953, Ralph Cloward
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`described a posterior lumbar interbody fusion (PLIF) technique, which is still employed by
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`surgeons today. Jurgen Harms described transforaminal lumbar interbody fusion (TLIF), a
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`posterolateral modification of the PLIF, as early as 1982 and over the ensuing decade the
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`technique was widely adopted and is still employed today. Ito of Japan first described an
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`anterior retroperitoneal approach to the lumbar spine for treatment of tuberculosis in 1934. His
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`countryman Iwahara first described an anterior retroperitoneal approach to the lumbar spine for
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`interbody fusion in 1944. Extensive experience with anterior lumbar and thoracolumbar
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`approaches to the spine was reported by A.R. Hodgson in 1956. Hodgson first used his approach
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`technique for treatment of tuberculosis, but later used it for non-tuberculous disease. Hodgson’s
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`experience encouraged surgeons to utilize an anterior or anterolateral approach to the lumbar
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`spine for treatment of spinal deformity, degenerative disease and trauma. In 1982, H.V. Crock
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`reported a twenty-year experience performing lumbar interbody fusions from direct anterior and
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`lateral approaches using bone dowels. In essence, approaching the lumbar spine directly
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`anteriorly, anterolaterally or laterally as the situation dictated was commonplace by the time of
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`my training, and I subsequently employed these approaches in my practice.
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`35.
`
`An appreciation of the vertebral bony anatomy and attached ligament anatomy is
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`necessary when using interbody implants. The bony endplates of the lumbar vertebrae as viewed
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`in the transverse plane are not round but oval, having a greater frontal plane than sagittal plane
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`dimension. Except for the L5 vertebral body, the posterior walls of the lumbar vertebrae are
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`slightly concave, making the bony endplates somewhat kidney-shaped. The surfaces of the bony
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`endplates are also slightly concave. The cortical bone in the central portion of the endplate is
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`thinner and therefore weaker than that of the ring apophysis or rim of the vertebrae. Thus, an
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`interbody implant positioned in the central portion of the endplate has a greater tendency to
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`subside than one resting on the ring apophysis. Stability of an implant in the interbody space is
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`also enhanced by making as much contact with the bony surface of the endplates and restoring as
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`much as possible the original height of the disk space. Restoring the disc height places the disc
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`annulus, thick anterior longitudinal ligament and thinner posterior longitudinal ligament in
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`tension. That tension or ligamentotaxis further stabilizes the interbody implant.
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`VI.
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`THE ‘973 PATENT
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`36.
`
`The ‘973 patent relates to spinal implants that can be inserted from the side of a
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`patient, referred to as a “translateral” approach, across the transverse width of the spine and
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`between two adjacent vertebrae. (‘973 patent, at 1:16-19.)
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`37. When filed, the patent application that eventually became the ‘973 patent claimed
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`priority to an earlier patent application (U.S. patent no. 5,015,247) filed June 13, 1988, which
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`also names Dr. Michelson as an inventor. The ‘247 patent describes spinal implants very similar
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`to those described in the ‘973 patent, as I will discuss in more detail later in this report. I also
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`understand that the ‘247 patent is already expired, and specifically expired on June 13, 2008.
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`The priority claim to the ‘247 patent was dropped toward the end of the proceedings in the U.S.
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`Patent and Trademark Office on the application that became the ‘973 patent. My understanding
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`is that if the priority claim had not been dropped, the ‘973 patent would have also expired on
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`June 13, 2008. Therefore, the dropping of the priority claim not only renders the ‘247 patent
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`(and many other references, as discussed below) prior art to the ‘973 patent, but it lengthened the
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`term of the ‘973 patent from June 13, 2008 to February 27, 2015.
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`38.
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`According to the ‘973 patent, prior art spinal fusion implants were inserted “only
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`from the anterior or posterior direction, from the front or the back of the patient.” (‘973 patent, at
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`1:21-23.) The patent discloses that the prior art anterior or posterior implants were known to
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`have cylindrical, rectangular, and other shapes and were known to be formed from bone (e.g., a
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`bone dowel having threads formed therein) or from artificial materials (e.g., metal). (‘973 patent,
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`at 1:23-45.) According to the ‘973 patent, the spinal implants known in the art were limited to a
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`maximum possible length that w