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`In re Patent of: Curran et al.
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`U.S. Patent No.: 8,361,156
`Issue Date:
`January 29, 2013
`Appl. Ser. No.: 13/441,092
`Filing Date: April 6, 2012
`Title:
`SYSTEMS AND METHODS FOR SPINAL FUSION
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`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Attorney Docket No.: 108136.00029
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`DECLARATION OF RICHARD A. HYNES, M.D.
`REGARDING U.S. PATENT NO. 8,361,156
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION AND SCOPE OF WORK .................................................................... 1
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`II. PROFESSIONAL BACKGROUND ................................................................................... 2
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`III.
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`BASIS FOR OPINION ..................................................................................................... 3
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`IV.
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`THE FIELD OF SPINAL FUSION IMPLANTS .......................................................... 5
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`V. THE LAW OF OBVIOUSNESS.......................................................................................... 8
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`A.
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` Distal Wall / Proximal Wall ........................................................................................................................... 11
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`B. Releasably Mate ............................................................................................................................................... 12
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`C. Extend Generally Perpendicular to Said Longitudinal Length ................................................................... 13
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`D. Elongate Body ................................................................................................................................................... 14
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`E. Generally Rectangular and Generally Oblong in Shape .............................................................................. 14
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`H. Oriented Generally Parallel to a Height of the Implant ............................................................................... 15
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`VIII. LEVEL OF ORDINARY SKILL IN THE ART .......................................................... 16
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`IX.
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`THE SCOPE AND CONTENT OF THE PRIOR ART .............................................. 16
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`A. U.S. Patent Appl. Pub. No. 2002/0165550 (“Frey”) ....................................................................................... 16
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`B. U.S. Patent Appl. Pub. No. 2003/0028249 (“Baccelli”) .................................................................................. 18
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`C. U.S. Patent Appl. Pub. No. 2003/0139813 (“Messerli”)................................................................................. 20
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`D. U.S. Patent No. 5,860,973 (“Michelson”) ........................................................................................................ 20
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`E. U.S. Patent Appl. Pub. No. 2003/0100950 (“Moret”) .................................................................................... 21
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`F.
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`Synthes Vertebral Spacer-PR Brochure (“SVS-PR” or “SVS-PR Brochure”) .......................................... 22
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`G. Telamon Verte-Stack PEEK Vertebral Body Spacer Brochures (“Telamon”) .......................................... 23
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`X. DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE PRIOR ART
`AND THE OBVIOUSNESS OF THE ASSERTED CLAIMS ................................................ 25
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`A. Claim 1 .............................................................................................................................................................. 27
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`B. Claim 2 .............................................................................................................................................................. 36
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`C. Claim 3 .............................................................................................................................................................. 37
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`D. Claim 4 .............................................................................................................................................................. 38
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`E. Claim 5 .............................................................................................................................................................. 39
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`F. Claim 6 .............................................................................................................................................................. 45
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`G. Claim 7 .............................................................................................................................................................. 49
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`H. Claim 8 .............................................................................................................................................................. 50
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`I.
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`Claim 9 .............................................................................................................................................................. 52
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`J. Claim 10 ............................................................................................................................................................ 55
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`K. Claim 11 ............................................................................................................................................................ 57
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`L. Claim 12 ............................................................................................................................................................ 58
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`M. Claim 13 ............................................................................................................................................................ 59
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`N. Claim 14 ............................................................................................................................................................ 60
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`O. Claim 19 ............................................................................................................................................................ 62
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`P. Claim 20 ............................................................................................................................................................ 63
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`Q. Claim 23 ............................................................................................................................................................ 64
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`R. Claim 24 ............................................................................................................................................................ 65
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`S. Claim 25 ............................................................................................................................................................ 68
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`T. Claim 26 ............................................................................................................................................................ 70
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`U. Claim 27 ............................................................................................................................................................ 72
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`XI. ADDITIONAL REMARKS ........................................................................................... 74
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`I.
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`INTRODUCTION AND SCOPE OF WORK
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`1. My name is Richard A. Hynes, M.D. I have been retained by
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`petitioner Medtronic, Inc. in this Inter Partes Review (“IPR”) as an independent
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`expert in the relevant art.
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`2.
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`I have been asked to provide my opinions and views on the materials I
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`have reviewed in this IPR related to U.S. Patent No. 8,361,156 (the “‘156 patent”),
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`and the scientific and technical knowledge regarding the same subject matter. I
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`have been asked to consider what one of ordinary skill in the art would have
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`understood from the ‘156 patent. I have also considered whether certain references
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`disclose or suggest the features recited in the claims of the ‘156 patent. My
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`opinions are set forth below.
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`3. My opinions are guided by my appreciation of how a person of
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`ordinary skill in the art would have understood the claims of the ’156 patent at the
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`time of the alleged invention, which I have been asked to initially assume is March
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`29, 2004, the earliest filing date potentially attributable to the ’156 patent.
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`4.
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`Based on my experience and expertise it is my opinion that certain
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`references as discussed in detail below disclose or suggest all the features recited in
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`the claims of the ’156 patent, that any differences from these prior references are
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`trivial, and that these claims combine well known features to provide predictable
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`results.
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`II.
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`PROFESSIONAL BACKGROUND
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`5.
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`I am an orthopedic surgeon board certified by the American Board of
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`Orthopaedic Surgery and trained in spine surgery. I earned a B.A. degree in
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`Biology from Rutgers, my M.S. degree in Biology from American University, and
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`my M.D. degree from Rutgers Medical School. I completed a general surgery
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`internship and orthopedic residency at Tripler Army Medical Center in Honolulu,
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`Hawaii and later completed a spine fellowship at Beth Israel Hospital in Boston. I
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`am a diplomat of the American Board of Orthopaedic Surgery and the American
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`Board of Spine Surgeons. I am currently president and a spine surgeon at The
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`B.A.C.K. Center in Melbourne, Florida. Previously, I was the Chief of the
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`Department of Surgery at the Holmes Regional Medical Center in Melbourne,
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`Florida.
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`6. With respect to the specific subject matter at issue in this IPR,
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`intervertebral spinal fusion, I have extensive experience. I have performed
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`between 4000 to 5000 lumbar and cervical fusion procedures over the past 20
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`years. I have published several papers on the subject of spine surgery, and am a
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`frequent instructor to visiting surgeons on spinal surgical approaches and
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`techniques of spinal fusion. I consult for several spine companies in many areas,
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`including design, development and surgical approaches and surgical instruction. A
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`true and correct copy of my current curriculum vitae is submitted in this IPR as
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`Exhibit MSD 1112.
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`7.
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`I also have specific experience designing a spinal fusion implant,
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`before the middle of 2003, now called Saber and marketed by Depuy Spine, a
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`Johnson & Johnson company. The Saber design is an elongated generally
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`rectangular implant made of a poly-ether-ether-ketone (“PEEK”) composite and
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`including teeth to resist retropulsion, large medial and lateral openings to allow
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`vascularization to the graft material inserted in a large aperture in the product, and
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`also including tantalum beads (one in the proximal end and one in the distal end) to
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`assist in viewing the placement of the implant when viewed on X-rays. The large
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`open design provided increased area for bone graft material to be placed. The
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`implant also included a threaded opening for releasable attachment to an insertion
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`tool. A brochure describing the commercialized design is attached to this
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`declaration as Appendix A.
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`8.
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`Although I am being compensated at my usual rate of 500 dollars per
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`hour, for the time I spend on this matter, no part of my compensation is dependent
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`on the outcome of this proceeding. As mentioned above, I consult for several
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`spine companies, including for Medtronic’s spine division.
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`III. BASIS FOR OPINION
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`9. My opinions set forth in this declaration are based on my education,
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`training, and experience as described above as well as the information pertaining to
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`the ‘156 patent and other references described below.
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`10.
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`In preparing this declaration, I have reviewed the ‘156 patent,
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`including its specification, figures, claims, and file history. I have also reviewed
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`the file history U.S. Patent Appl. Ser. No. 11/093,409 (the “‘409 application”), the
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`parent application to which the ‘156 patent claims priority.
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`11.
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`I have also reviewed several prior art patents, patent applications, and
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`other publications. These include U.S. Patent Appl. Pub. No. 2002/0165550 to
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`Frey (“Frey”), U.S. Patent Appl. Pub. No. 2003/0028249 to Baccelli (“Baccelli”),
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`U.S. Patent Appl. Pub. No. 2003/0139813 to Messerli (“Messerli”), U.S. Patent
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`Appl. Pub. No. 2003/0100950 to Moret (“Moret”), U.S. Patent No. 5,860,973 to
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`Michelson (“Michelson”),a brochure published and publicly available in May 2002
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`that described the Vertebral Spacer-PR manufactured by Synthes (the “SVS-PR”),
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`and two brochures published and publicly available in 2003 that described the
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`Telamon Verte-Stack PEEK Vertebral Body Spacer manufactured by Medtronic
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`(the “Telamon”). I have also reviewed the other documents mentioned below. I
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`have provided a chart, attached to this declaration as Appendix B, that provides a
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`short summary of the key attributes of these prior art publications, highlighting the
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`many similarities of these disclosures.
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`12. Further, I did also consider and analyze physical products and their X-
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`Ray characteristics under radiographic inspection such as the NuVasive CoRoent
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`XL that I understand NuVasive has alleged is an embodiment of the claims of the
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`‘156 patent. I also considered the Medtronic Clydesdale implant that NuVasive
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`has alleged infringes the ‘156 patent. I have further considered embodiments of
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`the prior art, including a PEEK Telamon implant and a PEEK Medtronic
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`Boomerang , which is very similar to the Frey application disclosures. Although
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`my review of these products supports my conclusions, my opinions expressed in
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`this declaration also stand on their own, independent of my consideration of these
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`physical products.
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`13.
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`I have also considered the declaration of Steve DeRidder, a co-
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`inventor named on the Frey application. Although my opinion is independent of
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`Mr. DeRidder’s, I note that his opinion supports my conclusions.
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`IV. THE FIELD OF SPINAL FUSION IMPLANTS
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`14. The spine is a flexible structure that extends from the base of the skull
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`to the tail bone. It contains 33 interconnected bones called vertebrae. Each
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`vertebra is connected to the vertebra above and below at a facet joint. Each
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`vertebra is separated from the vertebra above or below by a cushion-like,
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`fibrocartilage called an intervertebral disc. There are 23 intervertebral discs in the
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`human body: six in the cervical region (i.e., neck); 12 in the thoracic region (i.e.,
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`middle back); and five in the lumbar region (i.e., lower back). The human spinal
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`column is configured so that the intervertebral discs act as shock absorbers for the
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`spine. In addition, intervertebral discs act as ligaments that hold vertebrae
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`together. Intervertebral discs also work with the facet joint to allow for slight
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`movement of the spine; together, these structures allow the spine to bend, rotate
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`and, or twist.
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`15. The spinal structure can become damaged as a result of degeneration,
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`dysfunction, disease and, or trauma. More specifically, the spine may exhibit disc
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`collapse, abnormal curvature, asymmetrical disc space collapse, abnormal
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`alignment of the vertebrae and/or general deformity. Disc collapse, abnormal
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`curvature, mal-alignment or deformity may lead to imbalance in the sagittal and
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`coronal planes with resultant concomitant kyphosis and/or scoliosis. This may
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`result in nerve compression, disability and overall instability and pain. Where a
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`patient suffers from instabilities in the spine that cause pain and/or deformity,
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`surgical intervention may be required.
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`16.
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`It is well known that one method used to treat such degenerated,
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`diseased or otherwise damaged spinal columns and vertebrae is the removal of all
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`or a portion of the vertebral disc and inserting a spinal implant to restore normal
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`disc height and spine orientation, and repair the defective spinal anatomy by
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`maintenance of the reorientation by the fusion of one vertebrae to the adjacent
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`level. Additionally, when desired, it is common practice to implant bone grafts,
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`osteoconductive and/or osteoinductive material into the intervertebral space to
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`enhance arthrodesis, bone growth and fusion, between the two vertebrae adjacent
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`to the intervertebral space. Accordingly, it was known to manufacture implants
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`with a cavity for receipt of bone grafts, osteoconductive and/or osteoinductive
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`material. Such practice was known prior to the use of non-bone implants, when
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`early bone graft methods used femoral allograft rings. The center of the ring was a
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`cavity and one would insert osteoconductive and osteoinductive materials into the
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`cavity to enhance fusion.
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`17. The use of radiographic markers in spinal implants formed from
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`radiolucent materials was well known prior to the earliest filing date of the ‘156
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`patent. For example, U.S. Patent Nos. 3,829,904, 3,891,997, 3,922,726, 4,123,806,
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`4,224,698, 4,450,592, 5,405,402, 5,425,762, and 5,476,880 disclose such markers
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`in various sizes and shapes, orientations and locations. Radiopaque markers are
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`helpful in facilitating radiographic assessment of the location, orientation,
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`positioning and any migration of the intervertebral spinal fusion implant during
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`and after implantation.
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`18. The construction of spinal fusion implants out of PEEK and similar
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`materials was also well known in the prior art well before the earliest filing date of
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`the ‘156 patent. For example, U.S. Patent Nos. 5,425,772, and 6,096,080 disclose
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`the use of PEEK in the construction of spinal fusion implants.
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`V.
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`THE LAW OF OBVIOUSNESS
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`19.
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`I understand that a patent claim can be invalid for any one of several
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`reasons, including on the ground of obviousness. This ground of invalidity relates
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`to "prior art," which involves information that existed at some time before the
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`filing date of a patent application. The prior art may include, for example, devices,
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`publications, or patents.
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`20.
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`I understand that the description in a written prior art reference does
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`not need to be in the same words as the claim, but all of the physical requirements
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`of the claim must be there either explicitly or inherently. That is, they must either
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`be stated or implied, so that someone of ordinary skill in the relevant field looking
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`at that reference would be able to understand and use that information.
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`21. A patent claim is invalid as obvious if the claimed invention would
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`have been obvious to a person of ordinary skill in the art at the time the invention
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`was made, which in the absence of earlier proof is presumed to be the date the
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`patent application was filed. I understand that this means that even if all the
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`requirements of the claim cannot be found in a single prior art reference, a person
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`of ordinary skill in the art who knew or who had access to all of the relevant prior
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`art could have come up with the claimed invention by, for example, applying
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`common sense to combine or rearrange the features of that prior art.
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`22.
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`I understand that in evaluating whether a claim would have been
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`obvious, one must put himself in the position of a person of ordinary skill in the
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`art, i.e., the technical field of the invention. The person of ordinary skill is a
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`hypothetical concept. He is not a genius. He thinks along the lines of conventional
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`wisdom. It should be remembered, however, that a person of ordinary skill is also
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`a person of ordinary creativity, not an automaton.
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`23. One may also consider whether the invention was merely the
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`predictable result of using prior art elements according to their known function. In
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`addition, one may consider whether there is some teaching or suggestion in the
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`prior art to make the modification or combination of elements in the patent. One
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`may also consider whether the claimed invention would have been obvious to try.
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`VI. THE ‘156 PATENT
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`24.
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`I have reviewed the overview of the ‘156 patent set forth in Section
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`IV.A. of the Petition for IPR. In my opinion, the overview accurately describes the
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`claims of the ‘156 patent.
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`25. The ‘156 patent describes a spinal fusion implant of non-bone
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`construction that is positionable in the interbody space between adjacent vertebrae.
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`See, e.g., ‘156 patent, at 1:66 to 2:2. As claimed, the spinal fusion implant of the
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`‘156 patent has a distal wall, a proximal wall, and two sidewalls, with the walls
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`being at least partly constructed from a radiolucent material. The length of the
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`implant extending from the proximal wall to the distal wall is greater than the
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`maximum width of the implant, as defined by greatest distance between the two
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`sidewalls. The upper and lower surfaces of the implant contain anti-migration
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`elements that come in contact with the first and second vertebrae. At least one
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`fusion aperture that is longer than it is wide and extends from the top surface to the
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`bottom surface is included in the implant. The claimed implant also contains at
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`least two radiopaque markers oriented generally parallel to height of the implant,
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`with at least one in the first sidewall and one in the second sidewall. In summary,
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`the ‘156 patent generally combines well known features of intervertebral spinal
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`fusion implants arranged in predictable ways. None of these features was new and
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`their arrangement was also quite predictable and only a trivial change from prior
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`spinal fusion implants, disclosing what was in my view common knowledge at the
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`time.
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`VII. INTERPRETATIONS OF THE ‘156 PATENT CLAIMS AT ISSUE
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`26.
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`I understand that, for the purposes of my analysis, the claim terms of
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`the ‘156 patent are given their “broadest reasonable construction in light of the
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`specification.” Stated another way, it is contemplated that the claim terms are
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`understood by their plain and ordinary meanings except where construed in the
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`specification. I also understand that this “plain and ordinary meaning” is with
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`respect to how one of ordinary skill in the art would interpret the claim language. I
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`have followed these principles in my analysis. I discuss a few terms below and
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`what I understand to be Petitioner’s constructions of these terms.
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`A.
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` Distal Wall / Proximal Wall
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`27.
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`Independent claim 1 of the ‘156 patent, from which every claim at
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`issue depends, recites that the implant includes a “distal wall” and a “proximal
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`wall.” ‘156 patent, at 12:40. In accordance with the claim interpretation principles
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`I explained above, I believe that one of ordinary skill in the art would understand
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`that the broadest reasonable construction of “distal wall” is the side or end of the
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`implant that generally enters the patient first, that is -- the leading end wall,
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`opposite the proximal or trailing end wall, and the end that is furthest from the
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`surgeon upon insertion of the implant into the patient. It follows that one of
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`ordinary skill in the art would understand that the “proximal wall” is the side or
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`end of the implant that enters patient last, the end opposite of the distal wall, and
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`the end that is the closest wall to the surgeon upon insertion of the implant into the
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`patient.
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`28. Further, it is my understanding that during prosecution of a parent
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`patent application, U.S. Patent Appl. Ser. No. 11/093,409 (the “‘409 Application”),
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`to which the ‘156 patent claims priority, the United States Patent and Trademark
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`Office (“USPTO”) took the position that the apertures
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`(1044) shown in the prior art spinal fusion implant
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`figures disclosed in U.S. Patent No. 6,830,570 to Frey
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`(the “‘570 patent”) – subsequently included in Frey,
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`a continuation of the ‘570 patent – reproduced below
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`are located on the proximal wall of the Frey implant.
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`The Applicant did not challenge or otherwise take
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`issue with the USPTO on its interpretation, thereby
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`further supporting my opinion that the broadest reasonable construction of the
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`terms “distal wall” and “proximal wall” include the regions, for example, of the
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`Frey implant disclosed above where apertures 1044 and 1048 are located. It
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`should be noted that in implants like those described in Frey the ends are fungible
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`and may be interchangeable depending upon the manner in which they are inserted
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`and the anatomy of the patient.
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`B. Releasably Mate
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`29. Claim 6 of the ‘156 patent, from which claims 7 and 8 depend, says
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`that “the threaded receiving aperture is configured to releasably mate with an
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`inserter tool.” ‘156 patent, at 13:17-18. In accordance with the claim
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`interpretation principles I explained above, I believe that one of ordinary skill in
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`the art would understand that the broadest reasonable construction the term
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`“releasably mate” as used in the ‘156 patent means “an impermanent stabilized
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`connection.” In my opinion, such an interpretation is consistent with the ‘156
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`patent specification, in which this term is used to describe the connecting
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`relationship between the implant and insertion tool. See ‘156 patent, at 8:26-33
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`(“In order to secure the spinal fusion implant 10 onto the threaded connector 24 of
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`the inserter instrument 20, the clinician employs the thumbwheel 34 to rotate the
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`inserter shaft 44 and threaded connector 24. The rotation of the threaded connector
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`24 will releasably engage the receiving aperture of the spinal fusion implant 10 and
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`stabilize the insertion instrument 20 relative to the spinal fusion implant 10.”).
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`C.
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`Extend Generally Perpendicular to Said Longitudinal
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`Length
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`30. Claim 20 recites that the plurality of ridges on the implant “extend
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`generally perpendicular to said longitudinal length.” ‘156 patent, at 14:15-17. I
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`believe that one of ordinary skill in the art would understand that the broadest
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`reasonable meaning of this term is extending approximately in a direction that
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`crosses a plane along the general direction of the longitudinal length of the implant
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`at generally or roughly a right angle. The “longitudinal length,” although that term
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`is somewhat redundant, in its broadest reasonable interpretation in this context and
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`as is common when referring to a spinal fusion implant, is understood to mean the
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`dimension measured from end to end of the implant, or in other words, from the
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`insertion or leading end, i.e., the distal end, to the trailing end, i.e., the proximal
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`end. This understanding is also consistent with many common definitions of
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`“length” as a distance or measurement from end to end. For example, Webster’s
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`Third New International Dictionary of the English Language Unabridged (2002) at
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`page 1293, defines “length” to mean “the extent from end to end.” Similarly, The
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`New Shorter Oxford English Dictionary (1993) at page 1565 defines “length” as
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`“the linear extend of anything as measured from end to end.”
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`D.
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`Elongate Body
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`31. Claim 26 recites that the “elongate body of at least one of said
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`radiopaque markers is shorter than said height extending from said upper surface to
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`said lower surface.” ‘156 patent, at 14:38-40. I believe that one of ordinary skill
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`in the art would understand that the broadest reasonable interpretation of the term
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`“elongate body” means a body longer than it is wide.
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`E. Generally Rectangular and Generally Oblong in Shape
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`32. Claim 14 recites that the “first fusion aperture is one of generally
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`rectangular and generally oblong in shape.”
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`‘156 patent, at 13:41-43. I believe that one of
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`ordinary skill in the art would understand that
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`the broadest reasonable interpretation of the
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`term “generally rectangular and generally
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`oblong in shape” is a shape having portions roughly approximating sides and being
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`elongated in at least one dimension. My understanding is supported by my review
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`of the file of the prior parent application of the ‘156 patent, in which I learned that
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`the USPTO has previously taken the position that the fusion apertures (1018a,
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`1018b) shown in the Frey prior art spinal fusion implant figure reproduced above
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`are generally rectangular and elongated in at least one direction.
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`G.
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`A Lateral Width of the Distal End of Said Distal Wall/A Lateral
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`Width of Said Proximal End of Said Proximal Wall
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`33.
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` Claim 23 recites that the “maximum lateral width of said implant is
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`greater than a lateral width of the distal end of said distal wall and is greater than a
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`lateral width of the proximal end of said proximal wall.” ‘156 patent, at 14:24-27.
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`I believe that one of ordinary skill in the art would understand that the broadest
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`reasonable interpretation of these terms means that the maximum lateral width of
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`the implant found in the middle of the implant is greater than a width of the most
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`distal end of the distal wall extending in a direction from the first side wall to the
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`second sidewall and is greater than a width of the most proximal end of the
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`proximal wall extending in a direction from the first side wall to the second
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`sidewall.
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`H. Oriented Generally Parallel to a Height of the Implant
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`34.
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`Independent claim 1 recites, in relevant part, that the implant includes
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`“at least first and second radiopaque markers oriented generally parallel to a height
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`of the implant.” ‘156 patent, at 12:62-63. I believe that one of ordinary skill in the
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`art would understand that broadest reasonable interpretation of this term as
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`oriented generally or roughly along the Y-axis (up and down) or oriented generally
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`or roughly in a direction running from the top to the bottom, i.e., cephalad to
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`caudal.
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`VIII. LEVEL OF ORDINARY SKILL IN THE ART
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`35. At the time of the alleged invention, a person of ordinary skill in the
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`art related to the technology of the ‘156 patent would have had an undergraduate
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`degree in Mechanical or Biomedical Engineering or equivalent and at least two to
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`three years of experience with interbody spinal fusion implants or a medical degree
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`or the equivalent and at least two to three years of experience with interbody spinal
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`fusion implants and related procedures. A person of ordinary skill in the relevant
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`art need not necessarily have formal education if they have an equivalent amount
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`of experience in medical device design. So, for example, approximately four years
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`of medical device design experience could replace an undergraduate degree in that
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`field.
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`IX. THE SCOPE AND CONTENT OF THE PRIOR ART
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`A. U.S. Patent Appl. Pub. No. 2002/0165550 (“Frey”)
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`36. Frey was published on November 7, 2002, more than one year prior to
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`the earliest filing date of the ‘156 patent. I understand that Frey therefore is prior
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`art to the ‘156 patent.
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`37. Frey describes an intervertebral spinal fusion implant constructed
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`from a biocompatible, radiolucent material. See Frey, at ¶¶ [0156], [0181]. The
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`Frey implant has a generally elongated shape with a longitudinal length that is
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`greater than its maximum lateral width, and includes a distal wall (designated as
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`leading end wall 1406), a proximal wall (designated as trailing end wall 1408), and
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`two sidewalls (designated as posterior wall 1402 and anterior wall 1404). See
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`Frey, at ¶ [0151]. The implant is described for use in various “approaches to the
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`disc space, such as lateral, anterior or antero-lateral approaches” for insertion of
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`implant 1400 as well as “for insertion from a poster-lateral or uni-lateral approach
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`into [a] disc space . . . .” Frey, at ¶ [0150].
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`38. The upper and lower bearing surfaces of the Frey implant contain
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`anti-migration elements that come in contact with the first and second vertebrae.
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`See id., at ¶ [0153]. The anti-migration elements are used to “increase frictional
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`resistance between the adjacent vertebral endplate and the bearing surface 1410,
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`1412 to resist posterior and anterior migration of implant 1400 in the disc