In re Patent of:
`U.S. Patent No.:
`Issue Date:
`Appl. Serial No.:
`Filing Date:
`Title:
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Michelson
`8,444,696
`May 21, 2013
`13/235,998
`September 19, 2011
`ANATOMIC SPINAL IMPLANT HAVING ANATOMIC BEARING SURFACES
`
` Attorney Docket No.: 13958-0113IP2
`
`DECLARATION OF Dr. JOHN W. BRANTIGAN, M.D.
`
`I, Dr. John W. Brantigan, M.D., of Shaw Island, WA, declare that:
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`QUALIFICATIONS
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`1.
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`I am an orthopaedic surgeon board certified by the American Board of Orthopaedic
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`Surgery, and I have extensive experience in spine surgery. I received my medical degree from the Johns
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`Hopkins University in 1970. I performed an internship at the Department of Surgery, University of
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`Minnesota from 1970-1971, a residency in general surgery at the University of Utah from 1973-1974, a
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`residency at Shriners Hospital for Crippled Children (Spokane, WA) from 1976-77, and a residency in
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`orthopaedic surgery at the University of Washington from 1974-1978. From 1978 to 1990, I was in private
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`practice as an orthopaedic surgeon at Immanuel Medical Center (Omaha, NE), Memorial Hospital of Dodge
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`County (Fremont, NE), and St. Joseph Hospital (Omaha, NE). From 1990 to 1992, I was an orthopaedic
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`surgeon at Cleveland Spine and Arthritis Center of Lutheran Medical Center (Cleveland, OH). From 1992
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`to 1997, I served as the Associate Professor of Orthopaedic Surgery and Chief of Spinal Reconstructive
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`Surgery at Creighton University (Omaha, NE). In 1997, I returned to private practice as an orthopaedic
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`surgeon at South Texas Orthopaedic and Spinal Surgery Associates (San Antonio, TX), after which I retired
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`in 2004. I have performed over 1,000 spinal surgeries, including hundreds of surgeries involving spinal
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`fusion implants. I provided training to others in various spine surgical techniques in the U.S., England,
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`Germany, France, Sweden, Norway, Belgium, Spain, Italy, Netherlands, Japan, Korea, Taiwan, Venezuela,
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`Mexico, New Zealand, and Australia. I participated in more than twenty teaching trips to Japan, each
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`lasting more than a week and visiting universities and hospitals throughout the country. I am listed as an
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`inventor on at least 7 U.S. patents and additional foreign patents, including 5 U.S. patents directly related to
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`spinal fusion implants I invented in the 1980s and early 1990s. I have published over 70 publications,
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`including nearly 50 publications pertaining to spinal implants and spinal surgical methods (many of which
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`were published in the early 1990s). I also co-edited the textbook INTERVERTEBRAL FUSION USING CARBON
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`FIBER REINFORCED POLYMER IMPLANTS, Quality Medical Publishing, Inc., St. Louis, 2006. Additionally, I was
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`awarded a Distinguished Alumnus Award from Johns Hopkins University in 2009 for my many years of
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`work related interbody fusion devices.
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`2.
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`Based upon my knowledge and experience in this field, I am aware of the needs and the
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`challenges orthopaedic surgeons face in performing spinal fusion procedures. I routinely performed and
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`observed these spinal fusion procedures, and I am familiar with the various types of spinal fusion implants
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`that were used in 1995 and earlier. I have personal knowledge of what was considered by my peers and
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`me to be ordinary and conventional design options for spinal fusion implants prior to June 7, 1995, and
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`indeed I personally invented and then used a number of spinal fusion implants during the 1980s and early
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`1990s. One of my implant inventions is still being offered to surgeons by DePuy Synthes under the name
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`ALIF I/F CAGE® system. See http://www.depuy.com/uk/healthcare-professionals/product-details/
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`brantigan-alif-if-cage-system. I am keenly aware of the conventional design options that were available to
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`persons of ordinary skill during the early 1990s. I was a practicing spine surgeon prior to June 7, 1995 and
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`I am familiar with the state of spinal fusion surgery prior to June 7, 1995. I have formulated my analysis on
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`this matter based on this personal experience and what was considered standard and conventional by one
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`skilled in the art prior to June 7, 1995.
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`3.
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`I am not, and never was, an employee or clinical research consultant for NuVasive, Inc. I
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`have been engaged in the present matter to provide my independent analysis of the issues raised in the
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`above-mentioned inter partes review of U.S. Patent No. 8,444,696 (“the ‘696 patent”). I was previously
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`engaged by NuVasive to provide fact testimony about my implant inventions in connection with NuVasive’s
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`pending challenge to the validity of another of Dr. Michelson’s implant patents (U.S. Pat. No. 5,860,973). I
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`received no compensation for this declaration beyond my normal hourly compensation based on my time
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`actually spent studying the matter, and I will not receive any added compensation based on the outcome of
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`this inter partes review of the ‘696 patent.
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`4.
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`While I am not an expert in patent law, I have reviewed the ‘696 patent and its prosecution
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`history from the view point of an experienced spine surgeon. Additionally, I have reviewed the following
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`publications: (1) U.S. Pat. No. 5,607,424 to Tropiano (“Tropiano”); (2) U.S. Pat. No. 5,015,247 to Michelson
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`(“Michelson ‘247”); (3) PCT Pub. No. WO89/009035 to Brantigan (“Brantigan ‘035”); (4) PCT Pub. No.
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`WO95/008306 to Beckers and the certified English translation thereof (collectively referred to as “Beckers”);
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`and (5) U.S. Pat. No. 5,443,514 to Steffee (“Steffee”). I am listed as an inventor on the Brantigan ‘035
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`reference. I also have reviewed additional references cited in this Declaration but not included in the list
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`above.
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`5.
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`My findings below and my conclusions concerning the lack of novelty or non-obviousness
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`of the spinal implants claimed by the ‘696 patent, as explained below, are based on my education,
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`experience, and background in the fields discussed above.
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`
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`BACKGROUND KNOWLEDGE ONE OF SKILL IN THE ART WOULD HAVE HAD PRIOR TO THE
`FILING OF THE ‘696 PATENT
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`6.
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`By way of background, the human spine is made up of 33 vertebrae, including 24
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`articulating vertebrae and nine fused vertebrae of the sacrum and coccyx. The articulating vertebrae have
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`discs positioned between adjacent vertebrae which allow the articulation movement. Each disc forms a
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`joint that allows slight movement of the vertebrae, and acts as a ligament to hold the vertebrae together.
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`Spinal fusion is a surgical procedure that fuses adjacent vertebrae to one another or to an intermediate
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`implant (e.g., via bone ingrowth) so that the adjacent vertebrae act as a single construct with no relative
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`motion. This is done in some cases to eliminate motion in the spine to decrease or eliminate back pain
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`created by the motion, and in other cases to correct various spinal deformities. By the 1980s, spinal fusion
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`procedures typically involve removing all or a portion of an intervertebral disc (sometimes referred to as a
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`"discectomy"), and implanting a fusion implant in the disc space to cause bone growth between two
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`adjacent vertebrae.
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`7.
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`The ‘696 patent is entitled “Anatomic Spinal Implant Having Anatomic Bearing Surfaces,”
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`and its disclosure relates to spinal fusion implants that are inserted into a disc space between adjacent
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`vertebrae of patients with degenerative disc disease. Implants of this type were invented at least as early
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`as the early 1980’s, and provide structural stability while bone grows between the adjacent vertebrae to
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`fuse them together. Specifically, the ‘696 patent discloses an assortment of isolated embodiments of
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`spinal fusion implants, which in some cases, are mutually exclusive to one another both in terms of
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`structure and implantation techniques. Compare ‘696 patent at FIGS. 13-17 (showing one implant 300 that
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`is much wider than it is tall, and is thus not rotated after insertion into the disc space as shown in FIG. 7a),
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`with FIGS. 18-23 (showing an alternative implant 400 that is taller than it is wide and is inserted using the
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`conventional insert-and-rotate implantation technique as described at col. 10, lines 53-64). The ‘696 patent
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`claims priority through seven generations of patents, the first of which was filed on June 7, 1995 (now U.S.
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`Patent No. 5,609,635), and which, in turn, was a continuation-in-part of an earlier application family going
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`back to June 28, 1988 (published as the Michelson ‘037 reference). Unlike the related U.S. Patent No.
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`5,609,635, I understand that the ‘696 patent does not claim priority back to the June 28, 1988 application
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`family.
`
`8.
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`The stated main difference between earlier spinal fusion implants (such as Dr. Michelson’s
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`earlier 1988 patent application family published as the Michelson ‘037 reference) and the ‘696 patent is the
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`disclosure in the latter of implants having a lordotic design, meaning they have a “wedge-shape” in an
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`elevation side view. See, e.g., ‘696 patent at col. 1:27-2:8 (citing to the earlier 1988 patent application
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`family); FIGS. 3-4, 7A, 9, 14, 18, 20, 25, and 30-32. Such a “wedge-shape” implant, given that it is
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`implanted with the higher end of the wedge in the anterior, or front, portion of the disc space, helps to
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`maintain the “lordosis,” or forward curve, of the lower (lumbar) spine. These “wedge-shape” implants were
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`well known by the time of Dr. Michelson’s June 1995 patent filing, and in fact were commonly used in spinal
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`fusion procedures employing the traditional insert-and-rotate implant structures before June 1995.
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`9.
`
`In the late 1980s and early 1990s (and long before the ‘696 patent’s alleged priority date of
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`June 7, 1995), I invented and developed a number of new spinal fusion implants. See, e.g., U.S. Patent
`
`4,743,256; U.S. Patent 4,834,757; U.S. Patent 4,878,915; PCT Publication WO 89/09035 (the “Brantigan
`
`‘035” reference, and claiming priority to U.S. Patent 4,834,757 but having a different specification); U.S.
`
`Patent 5,192,327 (the “Brantigan ‘327” reference); U.S. Patent 5,425,772. My implant designs ushered in a
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`new era of spinal fusion implant design and provided those of ordinary skill in the art at the time with a set
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`of basic design options that were well-understood by spine surgeons and implant designers by the early
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`1990s. For example, the Brantigan ‘035 reference provides examples non-bone fusion constructs having
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`large chambers for retaining bone ingrowth material (e.g., to promote fusion) while also disclosing a
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`number of additional options that added convenience for the surgeon or improved safety for the patent.
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`See, e.g., Brantigan ‘035 at pp. 19-21; FIGS. 2-3 and 6-10 (showing the addition of a recessed portion and
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`threaded hole in the trailing face of the implant—regardless of whether the implant was cylindrical or non-
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`cylindrical in shape—for purposes of providing a convenient and mechanically secure connection with a
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`releasable inserter instrument); FIGS. 18-19 (illustrating the option of using of ratchetings along the upper
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`and lower bearing surfaces of, and around the bone fusion aperture of, a spinal fusion implant for purposes
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`of inhibiting the implant from backing out of the disc space after implantation). The Brantigan ‘035
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`reference was published in October 1989, and thus by the early 1990s, the various design options
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`disclosed in the Brantigan ‘035 reference were not considered to be exclusive to the implants shown in my
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`patent drawings, but instead these implant design options were considered by those of ordinary skill in the
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`art to be basic design choices or “add-ons” that were available to all implant designers for use in their spinal
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`fusion implants.
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`10.
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`After the publication of my inventions in the Brantigan ‘035 reference and before the
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`alleged June 7, 1995 priority date of the ‘696 patent, a number of other implant designers proposed
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`additional design options to the overall shape of spinal fusion implant, including the express suggestion to
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`use of “convex” curvatures on the upper and lower bearing surfaces for purposes of conforming to the slight
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`concavity of the vertebral endplates or for other mechanical securement purposes. See, e.g., U.S. Patent
`
`No. 5,645,596 (the “Kim” reference); PCT Publication WO93/01771; U.S. Patent No. 5,306,309 at col. 7:25-
`
`28; U.S. Patent No. 5,514,180; PCT Publication WO95/08306 and its English translation (collectively
`
`referred to as the “Beckers” reference); and U.S. Patent No. 5,607,424 (the “Tropiano” reference). Many of
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`these publications show that it was common for the convexity and orientation of the upper and lower
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`bearing surfaces to be selected to maintain the natural curvature of the spine (e.g., lordosis of the spine in
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`the lumbar region). Each of these publications also show that, by the early 1990s and certainly before June
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`7, 1995, interbody spinal implants of different shapes with outwardly convex curvatures for the upper and
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`lower bearing were known to persons of ordinary skill in the art. Indeed, based on my knowledge and
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`experience in this field and my review of the references cited above, the use of convexly bowed upper and
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`lower bearings surfaces for spinal fusion implants was understood by the early 1990s to be yet another a
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`basic design choice or “add-on” available to implant designers.
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`11.
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`Furthermore, after the publication of my inventions in the Brantigan ‘035 reference and
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`before the alleged June 7, 1995 priority date of the ‘696 patent, a number of other implant designers
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`proposed additional design options for spinal fusion implant that provided the capability for inserting the
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`implant into the disc space in a first orientation and then rotating the implant 90-degrees to a final
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`orientation that engaged the adjacent vertebral endplates. See, e.g., U.S. Pat. No. 5,443,514 (the “Steffee”
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`reference); PCT Publication WO95/08306 (the “Beckers” reference); and U.S. Patent No. 5,607,424 (the
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`“Tropiano” reference). The Steffee reference describes the then-famous “Steffee ramp” implants that were
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`used throughout the 1990s, which were marketed by Acromed. The Steffee ramp implants were inserted
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`with the flat side toward the vertebral endplates and then rotate 90 degrees so that the wedge-shaped
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`bearing surfaces engaged the vertebral endplates and thereafter maintained the lordotic curvature of the
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`lumbar spine. As described in more detail below, the insert-and-rotate embodiments shown in the drawings
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`of the ‘696 patent (FIGS. 18-23 and 24-29, all of which show straight ramp surfaces with no convexity)
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`appear to be trivial variations of the Steffee ramp implants that were disclosed long before the alleged June
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`7, 1995 priority date of the ‘696 patent. Beckers and Tropiano also disclose implants having the capability
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`for the insert-and-rotate technique, but furthermore show the ordinary design choice of using convexly
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`bowed upper and lower bearings surfaces for such implants.
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`12.
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`Some of the spinal fusion implants shown and described in my previously mentioned
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`patent publications (refer above to ¶ 9) and in other previously mentioned patent publications (e.g., the
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`Steffee ramp implants mentioned above in ¶ 11) were actually manufactured and implanted in live human
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`patients (including surgeries that I performed using my patented implants) as part of successful spinal
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`fusion procedures. For example, my concepts shown in the Brantigan ‘035 publication served as the basis
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`for a new carbon fiber implant construct that was manufactured and used in a number of live human
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`patients during the early 1990s to provide groundbreaking and successful spinal fusion surgeries using a
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`non-bone construct specifically intended for the human spine. See Brantigan & Steffee, “A Carbon Fiber
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`Implant to Aid Interbody Lumbar Fusion--Two-year Results In The First 26 Patients,” SPINE vol. 18, pp.
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`2106-2117 (1993). To the best of my present knowledge and belief, none the implants illustrated in the
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`‘696 patent were ever actually manufactured and used by Dr. Michelson in live human patients. Rather,
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`based upon my knowledge and experience in this field and my review of the ‘696 patent, the implants
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`shown in the drawings of the ‘696 patent represent mere theory as to how known prior art implants (such as
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`Steffee, Beckers, and Tropiano) that all have the capability for the insert-and-rotate technique could be
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`modified to include the previously mentioned implant design options available in the early 1990s due to my
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`earlier patent publications (such as Brantigan ‘035) or due to other prior art publications (Michelson ‘037,
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`Michelson ‘247, Kim, etc.).
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`
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`INTERPRETATIONS OF THE ‘696 PATENT CLAIMS AT ISSUE
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`13.
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`I understand that, for purposes of my analysis, the terms appearing in the patent claims
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`should be interpreted according to their “broadest reasonable construction in light of the specification of the
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`patent in which it appears.” 37 C.F.R. § 42.100(b). I further understand that the words of the claims should
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`be given their plain meaning unless that meaning is inconsistent with the patent specification or the patent’s
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`history of examination before the Patent Office. I also understand that the words of the claims should be
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`interpreted as they would have been interpreted by a person of skill in the art at the time of the invention
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`was made (not today); because I do not know what the date that the invention as claimed was made by Dr.
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`Michelson, I have used what I understand to be the filing date of the claimed priority patent application to
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`the ‘696 patent as the point in time for claim interpretation purposes, to the extent it matters. That date was
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`June 7, 1995. I have been asked to provide my interpretation of the following terms and phrases of the
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`‘696 patent set forth below.
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`14.
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`Claims 7 and 10 recite “portions of said first side and said second side being substantially
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`flat . . . wherein said substantially flat portions of said first side and said second side are symmetrical about
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`the first plane.” First, for purposes of my analysis, I have assumed the meaning of “substantially flat
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`portions” in this claim limitation includes first and second side surface portions that are either planar or
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`outwardly convex. In accordance with the claim interpretation principles set forth above, I believe that a
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`person of ordinary skill in the art would recognize the broadest reasonable interpretation of the
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`“substantially flat” portions in claims 7 and 10 to be planar surface portions because it is within the plain
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`meaning of the claim language (“substantially flat”) and because it is the only type of side portion
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`contemplated in all implant embodiments of figures 1-32 of the ‘696 patent. I have been informed that the
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`Patent Owner’s infringement contentions for the ‘696 patent submitted to the United States District Court for
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`the Southern District of California show that the Patent Owner is now asserting the claimed “substantially
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`flat portions” should include outwardly convex surfaces. Although the boundaries of the scope of the
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`claimed “substantially flat portions” are unclear if this claim limitation is interpreted to include side surface
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`portions that are outwardly convex (as mentioned above) and the ‘696 patent specification does not show
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`any implant with outwardly convex side surface portions, such outwardly convex side portions are included
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`in my analysis for this claim limitation due to the Patent Owner’s infringement contentions for the ‘696
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`patent.
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`15.
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`Claim 7 recites an additional limitation that “the converging angular relationship of said
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`upper and lower bearing surfaces maintaining the first vertebra and the second vertebra adjacent to said
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`upper and lower bearing surfaces in an angular relationship to maintain the desired lordosis between the
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`first vertebra and the second vertebra” (claim 7). This claim phrase is part of a recitation that requires the
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`first and second vertebrae to be actual claim elements (i.e., the plain language appears to require a portion
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`of the patient’s body), not merely a recitation of intended use. In particular, claim 7 affirmatively requires
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`the converging angular relationship of the upper and lower bearing surfaces to be “maintaining” (rather than
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`“adapted to maintain”) the first vertebra and the second vertebra” in an angular relationship. I have been
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`informed that the Patent Office guidelines forbid medical device claims, such as claim 7, from affirmatively
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`claiming a part of the patient’s body as an element of the claimed invention. In particular, I have been
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`informed that MPEP § 2105 explains “[i]If the broadest reasonable interpretation of the claimed invention as
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`a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that
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`the claimed invention is directed to nonstatutory subject matter.” Although the plain language appears to
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`be inconsistent from this Patent Office guideline, for purposes of my analysis under the broadest
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`reasonable interpretation standard, I have interpreted this claim phrase to be a functional recitation of
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`intended use in which the converging angular relationship is adapted to maintain the first and second
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`vertebrae adjacent to the upper and lower bearing surfaces in an angular relationship to maintain an
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`approximately natural lordosis curvature of those vertebrae of the spine.
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`
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`TROPIANO IN VIEW OF MICHELSON ‘247 AND BRANTIGAN ‘035 (CLAIMS 7-8 AND 10-11)
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`16.
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`The Tropiano reference is one of many prior art examples disclosing design options or
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`“add-ons” for the overall shape of spinal fusion implant, including Tropiano’s preferred option of equipping
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`the spinal fusion implant with outwardly “convex” curvatures on the upper and lower bearing surfaces so as
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`to more closely match the concavity of the vertebral endplates facing toward the disc space. See Tropiano
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`at FIGS. 1-3 and 5; col. 2:22-42 (“an arcuate structure that will stabilize the adjacent vertebrae”); col. 3:45-
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`50. Additionally, as described in more detail below, Tropiano also discloses an implant structure that is
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`taller than it is wide, and a person of ordinary skill in the art would having understood that Tropiano’s
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`implant structure is certainly capable of being inserted using the conventional insert-and-rotate implantation
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`technique that was publicized by Steffee and others in the early 1990s. See Tropiano at FIGS. 1-3.
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`Finally, in light of the “wedge-shaped” appearance of Tropiano’s implant from a side elevation view (FIG. 2)
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`and the identifiable lordotic spacing of the adjacent vertebrae shown in Tropiano’s FIG. 5 (described in
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`detail below), a person of ordinary skill in the art at the time would have recognized from Tropiano’s
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`teaching that the upper and lower bearing surfaces of the implant 10 are disposed in a converging angular
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`relationship toward each other and thus provide the capability of maintaining a lordotic relationship of
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`adjacent vertebrae when the implant is installed in the disc space:
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`See Tropiano at FIG. 5 (modified to show the implant of FIG. 2); col. 2:38-42. Based on my knowledge and
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`experience in this field and my review of the Tropiano reference, I believe that the person of ordinary skill in
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`the art at the time would have understood that Tropiano’s implant 10 provides a spinal fusion implant as
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`recited in the preambles of claims 7 and 10, including the “lordotic” type implant recited in the preamble of
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`claim 7.
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`17.
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`Not only does Tropiano show the well-known option of using convex bearing surfaces for
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`the spinal implant, but Tropiano’s implant 10 also provides a “first terminal part” and a “second terminal
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`part” as recited in each of independent claims 7 and 10. For example, Tropiano’s implant 10 in FIGS. 2-3
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`illustrates these claimed structures of the “first terminal part” and the “second terminal part”:
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`See Tropiano at FIGS. 2-3 (annotations shown above).
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`18.
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`Similarly, Tropiano’s implant 10 also provides the claimed “first side and an opposite
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`second side,” as perhaps best illustrated in Tropiano’s FIG. 3 (below). Both claims 7 and 10 provide the
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`identical recitations for the claimed first and second sides, including the recitations that “portions of said first
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`side and said second side being substantially flat” and that these “substantially flat potions” are symmetrical
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`about the first plane. Both claims 7 and 10 do not require the entire first and second sides to be
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`symmetrical about the first plane, but instead these claims describe that only those portions that are
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`characterized as the “substantially flat portions” of the first and second side are symmetrical about the first
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`plane. Based on my knowledge and experience in this field and my review of the Tropiano reference, I
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`believe that the person of ordinary skill in the art at the time would have understood that Tropiano’s implant
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`10 provides these claimed “substantially flat portions,” and most certainly does so when the term
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`“substantially flat” is interpreted under the broadest reasonable interpretation standard:
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`See Tropiano at FIG. 3; see also FIG. 1 (showing a substantially flat portion of the second side)
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`19.
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`Regarding the limitation recited in both claims 7 and 10 in which the implant is “adapted to
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`be inserted between the first vertebra and the second vertebra . . . and then rotated ninety degrees,”
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`Tropiano’s implant 10 provides this recited capability. I have been informed that the Patent Office
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`Guidelines indicate this type of “adapted to” limitation is interpreted as a functional recitation (under the
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`broadest reasonable interpretation standard), meaning that this limitation is describing a structure that is
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`capable of being “inserted between the first vertebra and the second vertebra . . . and then rotated ninety
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`degrees.” For example, I have been informed that MPEP § 2114 recites that this type functional language
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`(a “recitation with respect to the manner in which a claimed apparatus is intended to be employed”) is not
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`enough to differentiate the claimed implant from Tropiano’s implant if Tropiano’s implant teaches all the
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`structural limitations of the claim. Here, a person of ordinary skill in the art at the relevant time period would
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`have understood from Tropiano’s teaching that the implant 10 capable of being inserted with the first side
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`and the second side of the implant being oriented toward the first and second end plates, and then rotated
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`ninety degrees into an upright position. In particular, Tropiano’s implant 10 shares many of the same
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`structural features as the insert-and-rotate embodiments in the ‘696 patents, such as the width of
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`Tropiano’s implant 10 being substantially less than the height of the implant 10 (as shown by FIGS. 2-3),
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`the previously mentioned sides with “substantially flat portions” (as shown by FIGS. 1 and 3), and the
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`installed configuration in which the implant 10 is oriented in a final upright position in the disc space (as
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`shown in FIG. 4). Based on my knowledge and experience in this field and my review of Tropiano’s
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`teaching, I believe that the person of ordinary skill in the art at the time would have recognized that
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`Tropiano’s implant has the claimed structure that provides the capability to be inserted with the first and
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`second sides being oriented toward the first and second end plates, and then rotated ninety degrees into
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`final upright position (as illustrated below):
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`See Tropiano at FIG. 5 (modified to shown the view of the implant from FIG. 3 (at left) and the view of the
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`implant 10 from FIG. 2 (at right)).
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`20.
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`To the extent that the trailing face of Tropiano’s implant does not include the claimed
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`trailing face having a recessed portion “intersecting each of said first and second sides and being
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`configured to receive an insertion instrument for inserting said implant between the first vertebra and the
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`second vertebra” (as recited in both claims 7 and 10), such a feature was a well-known design option by
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`the early 1990s for use in most interbody spinal implants. Indeed, one of Dr. Michelson’s prior art patent
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`publications (Michelson ‘247) shows an example of such a recessed portion (actually, two recessed
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`portions), and further the Michelson ‘247 reference expressly teaches the tangible benefits of implementing
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`such a feature on interbody spinal implants so that (by the early 1990s) this feature was recognized as an
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`ordinary and conventional design option for nearly any interbody spinal implant. In particular, Michelson
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`‘247 discusses a spinal fusion implant 50 as shown in FIGS. 4 and 4A-D that includes a driver engaging
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`element 70 comprising “a raised rectangular portion 63 and a central threaded opening 65, for engaging the
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`insertion instrument, shown in FIG. 4c and FIG. 4d.” See Michelson ‘247 at 8:52-61. A portion of FIG. 4 of
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`the Michelson ‘247 reference illustrates that each of the recessed portions intersect the opposing sides of
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`the spinal fusion implant:
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`Michelson ‘247 at FIG. 4. The Michelson ‘247 reference was published in 1991, and this design option for
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`the trailing face of spinal fusion implants was not considered to be exclusive to the particular implants
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`shown in Michelson ‘247, but instead this implant design option was considered by those of ordinary skill in
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`the art in the early 1990s to be a basic design choice or known “add-on” that was available to implant
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`designers for use in their spinal fusion implants.
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`21.
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`Based on my knowledge and experience in this field and my review of Tropiano and
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`Michelson ‘247, I believe that a person having ordinary skill in the art prior to the alleged priority date of the
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`‘696 patent (June 7, 1995) would have considered it to be an obvious choice to modify Tropiano’s implant
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`so that the implant includes recessed portions along the trailing face (as suggested by Michelson ‘247).
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`Indeed, the skilled artisan would have been prompted to modify Tropiano’s implant so that the implant
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`includes recessed portions along the trailing face of the implant (example illustrated below) so that the
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`insertion and removal tool “locks onto the implant” and allows for greater mechanical advantage during
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`Page 15 of 49
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`manipulation and installation of the implant. See Michelson ‘247 at col. 9:1-3; 10:15-17. Also, the skilled
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`artisan would have been prompted to modify Tropiano’s implant so that the implant includes recessed
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`portions along the trailing face of the implant (in addition to Tropiano’s threaded opening 39) so that a
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`surgeon could readily engage/disengage a threaded tool into the central threaded opening 39 while
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`maintaining the orientation of the implant (with the portion of the inserter tool that mates with the recessed
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`portions). One example of the modification to Tropiano’s implant so that the implant includes recessed
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`portions along the trailing face (as suggested by Michelson ‘247) is illustrated below:
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`See Tropiano at FIG. 2 (modified above to show one example of the recessed portion that intersects the
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`first and side sides, as suggested by Michelson ‘247). Here, the person of ordinary skill in the art would
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`have achieved this minor modification by merely using a known technique (e.g., Michelson ‘247’s express
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`suggestion to equip the trailing end of a spinal fusion implant with a recessed portion that intersects
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`opposing sides of the implant and furthermore mates with the inserter tool) to improve a similar device
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`(Tropiano’s spinal fusion implant) in the same way for purposes of providing the convenient mating with the
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`releasable inserter tool (again, as explained by Michelson ‘247 and widely known in the prior art by the
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`early 1990s).
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`22.
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`Regarding the claimed “opening . . . to permit for the growth of bone through said implant
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`from the first vertebra to the second vertebra” as recited in each of claims 7 and 10, Tropiano’s implant 10
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`again shows that this was a typical feature found in most spinal fusion implants befor