`
`In re Patent of: Curran et al.
`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
`
`Attorney Docket No.: 108136.00033
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`DECLARATION OF RICHARD A. HYNES, M.D.
`REGARDING U.S. PATENT NO. 8,361,156
`
`MSD 1001
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION AND SCOPE OF WORK................................................1
`
`II. PROFESSIONAL BACKGROUND ...............................................................2
`
`III. BASIS FOR OPINION..................................................................................3
`
`IV. THE FIELD OF SPINAL FUSION IMPLANTS.......................................5
`
`V. THE LAW OF OBVIOUSNESS......................................................................8
`
`A. Distal Wall / Proximal Wall ..........................................................................11
`
`B. Releasably Mate ..............................................................................................12
`
`C. Extend Generally Perpendicular to Said Longitudinal Length .................13
`
`D. Elongate Body..................................................................................................14
`
`E. Generally Rectangular and Generally Oblong in Shape.............................14
`
`H. Oriented Generally Parallel to a Height of the Implant..............................15
`
`VIII. LEVEL OF ORDINARY SKILL IN THE ART ......................................16
`
`IX. THE SCOPE AND CONTENT OF THE PRIOR ART ..........................16
`
`A. U.S. Patent Appl. Pub. No. 2002/0165550 (“Frey”) .....................................16
`
`B. U.S. Patent Appl. Pub. No. 2003/0028249 (“Baccelli”)................................20
`
`C. U.S. Patent Appl. Pub. No. 2003/0139813 (“Messerli”)...............................21
`
`D. U.S. Patent No. 5,860,973 (“Michelson”) ......................................................21
`
`E. U.S. Patent Appl. Pub. No. 2003/0100950 (“Moret”)...................................23
`
`F. Synthes Vertebral Spacer-PR Brochure (“SVS-PR” or “SVS-PR
`Brochure”) ..............................................................................................................23
`
`
`
`G. Telamon Verte-Stack PEEK Vertebral Body Spacer Brochures
`(“Telamon”)............................................................................................................24
`
`X. DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE
`PRIOR ART AND THE OBVIOUSNESS OF THE ASSERTED CLAIMS ...26
`
`A. Claim 1 .............................................................................................................28
`
`B. Claim 2 .............................................................................................................37
`
`C. Claim 3 .............................................................................................................38
`
`D. Claim 4 .............................................................................................................39
`
`E. Claim 5 .............................................................................................................40
`
`F. Claim 6 .............................................................................................................48
`
`G. Claim 7 .............................................................................................................52
`
`H. Claim 8 .............................................................................................................54
`
`I. Claim 9 .............................................................................................................56
`
`J. Claim 10 ...........................................................................................................59
`
`K. Claim 11 ...........................................................................................................60
`
`L. Claim 12 ...........................................................................................................62
`
`M. Claim 13 ...........................................................................................................62
`
`N. Claim 14 ...........................................................................................................65
`
`O. Claim 19 ...........................................................................................................66
`
`P. Claim 20 ...........................................................................................................67
`
`Q. Claim 23 ...........................................................................................................68
`
`R. Claim 24 ...........................................................................................................69
`
`S. Claim 25 ...........................................................................................................72
`
`T. Claim 26 ...........................................................................................................74
`
`ii
`
`
`
`U. Claim 27 ...........................................................................................................76
`
`XI. ADDITIONAL REMARKS........................................................................78
`
`iii
`
`
`
`I.
`
`INTRODUCTION AND SCOPE OF WORK
`
`1.
`
`My name is Richard A. Hynes, M.D. I have been retained by
`
`petitioner Medtronic, Inc. in this Inter Partes Review (“IPR”) as an independent
`
`expert in the relevant art.
`
`2.
`
`I have been asked to provide my opinions and views on the materials I
`
`have reviewed in this IPR related to U.S. Patent No. 8,361,156 (the “‘156 patent”),
`
`and the scientific and technical knowledge regarding the same subject matter. I
`
`have been asked to consider what one of ordinary skill in the art would have
`
`understood from the ‘156 patent. I have also considered whether certain references
`
`disclose or suggest the features recited in the claims of the ‘156 patent. My
`
`opinions are set forth below.
`
`3.
`
`My opinions are guided by my appreciation of how a person of
`
`ordinary skill in the art would have understood the claims of the ’156 patent at the
`
`time of the alleged invention, which I have been asked to initially assume is March
`
`29, 2004, the earliest filing date potentially attributable to the ’156 patent.
`
`4.
`
`Based on my experience and expertise it is my opinion that certain
`
`references as discussed in detail below disclose or suggest all the features recited in
`
`the claims of the ’156 patent, that any differences from these prior references are
`
`trivial, and that these claims combine well known features to provide predictable
`
`results.
`
`
`
`II.
`
`PROFESSIONAL BACKGROUND
`
`5.
`
`I am an orthopedic surgeon board certified by the American Board of
`
`Orthopaedic Surgery and trained in spine surgery. I earned a B.A. degree in
`
`Biology from Rutgers, my M.S. degree in Biology from American University, and
`
`my M.D. degree from Rutgers Medical School. I completed a general surgery
`
`internship and orthopedic residency at Tripler Army Medical Center in Honolulu,
`
`Hawaii and later completed a spine fellowship at Beth Israel Hospital in Boston. I
`
`am a diplomat of the American Board of Orthopedic Surgery and the American
`
`Board of Spine Surgeons. I am currently president and a spine surgeon at The
`
`B.A.C.K. Center in Melbourne, Florida. Previously, I was the Chief of the
`
`Department of Surgery at the Holmes Regional Medical Center in Melbourne,
`
`Florida.
`
`6. With respect to the specific subject matter at issue in this IPR,
`
`intervertebral spinal fusion, I have extensive experience. I have performed
`
`between 4000 to 5000 lumbar and cervical fusion procedures over the past 20
`
`years. I have published several papers on the subject of spine surgery, and am a
`
`frequent instructor to visiting surgeons on spinal surgical approaches and
`
`techniques of spinal fusion. I consult for several spine companies in many areas,
`
`including design, development and surgical approaches and surgical instruction. A
`
`2
`
`
`
`true and correct copy of my current curriculum vitae is submitted in this IPR as
`
`Exhibit MSD 1011.
`
`7.
`
`I also have specific experience designing a spinal fusion implant,
`
`before the middle of 2003, now called Saber and marketed by Depuy Spine, a
`
`Johnson & Johnson company. The Saber design is an elongated generally
`
`rectangular implant made of a poly-ether-ether-ketone (“PEEK”) composite and
`
`including teeth to resist retropulsion, large medial and lateral openings to allow
`
`vascularization to the graft material inserted in a large aperture in the product, and
`
`also including tantalum beads (one in the proximal end and one in the distal end) to
`
`assist in viewing the placement of the implant when viewed on X-rays. The large
`
`open design provided increased area for bone graft material to be placed. The
`
`implant also included a threaded opening for releasable attachment to an insertion
`
`tool. A brochure describing the commercialized design is attached to this
`
`declaration as Appendix A.
`
`8.
`
`Although I am being compensated at my usual rate of 500 dollars per
`
`hour, for the time I spend on this matter, no part of my compensation is dependent
`
`on the outcome of this proceeding. As mentioned above, I consult for several
`
`spine companies, including for Medtronic’s spine division.
`
`III. BASIS FOR OPINION
`
`3
`
`
`
`9.
`
`My opinions set forth in this declaration are based on my education,
`
`training, and experience as described above as well as the information pertaining to
`
`the ‘156 patent and other references described below.
`
`10.
`
`In preparing this declaration, I have reviewed the ‘156 patent,
`
`including its specification, figures, claims, and file history. I have also reviewed
`
`the file history U.S. Patent Appl. Ser. No. 11/093,409 (the “‘409 application”), the
`
`parent application to which the ‘156 patent claims priority.
`
`11.
`
`I have also reviewed several prior art patents, patent applications, and
`
`other publications. These include U.S. Patent Appl. Pub. No. 2002/0165550 to
`
`Frey (“Frey”), U.S. Patent Appl. Pub. No. 2003/0028249 to Baccelli (“Baccelli”),
`
`U.S. Patent Appl. Pub. No. 2003/0139813 to Messerli (“Messerli”), U.S. Patent
`
`Appl. Pub. No. 2003/0100950 to Moret (“Moret”), U.S. Patent No. 5,860,973 to
`
`Michelson (“Michelson”),a brochure published and publicly available in May 2002
`
`that described the Vertebral Spacer-PR manufactured by Synthes (the “SVS-PR”),
`
`and two brochures published and publicly available in 2003 that described the
`
`Telamon Verte-Stack PEEK Vertebral Body Spacer manufactured by Medtronic
`
`(the “Telamon”). I have also reviewed the other documents mentioned below. I
`
`have provided a chart, attached to this declaration as Appendix B, that provides a
`
`short summary of the key attributes of these prior art publications, highlighting the
`
`many similarities of these disclosures.
`
`4
`
`
`
`12.
`
`Further, I did also consider and analyze physical products and their X-
`
`Ray characteristics under radiographic inspection such as the NuVasive CoRoent
`
`XL that I understand NuVasive has alleged is an embodiment of the claims of the
`
`‘156 patent. I also considered the Medtronic Clydesdale implant that NuVasive
`
`has alleged infringes the ‘156 patent. I have further considered embodiments of
`
`the prior art, including a PEEK Telamon implant and a PEEK Medtronic
`
`Boomerang, which is very similar to the Frey application disclosures. Although
`
`my review of these products supports my conclusions, my opinions expressed in
`
`this declaration also stand on their own, independent of my consideration of these
`
`physical products.
`
`13.
`
`I have also considered the declaration of Steve DeRidder, a co-
`
`inventor named on the Frey application. Although my opinion is independent of
`
`Mr. DeRidder’s, I note that his opinion supports my conclusions.
`
`IV. THE FIELD OF SPINAL FUSION IMPLANTS
`
`14.
`
`The spine is a flexible structure that extends from the base of the skull
`
`to the tail bone. It contains 33 interconnected bones called vertebrae. Each
`
`vertebra is connected to the vertebra above and below at a facet joint. Each
`
`vertebra is separated from the vertebra above or below by a cushion-like,
`
`fibrocartilage called an intervertebral disc. There are 23 intervertebral discs in the
`
`human body: six in the cervical region (i.e., neck); 12 in the thoracic region (i.e.,
`
`5
`
`
`
`middle back); and five in the lumbar region (i.e., lower back). The human spinal
`
`column is configured so that the intervertebral discs act as shock absorbers for the
`
`spine. In addition, intervertebral discs act as ligaments that hold vertebrae
`
`together. Intervertebral discs also work with the facet joint to allow for slight
`
`movement of the spine; together, these structures allow the spine to bend, rotate
`
`and, or twist.
`
`15.
`
`The spinal structure can become damaged as a result of degeneration,
`
`dysfunction, disease and, or trauma. More specifically, the spine may exhibit disc
`
`collapse, abnormal curvature, asymmetrical disc space collapse, abnormal
`
`alignment of the vertebrae and/or general deformity. Disc collapse, abnormal
`
`curvature, mal-alignment or deformity may lead to imbalance in the sagittal and
`
`coronal planes with resultant concomitant kyphosis and/or scoliosis. This may
`
`result in nerve compression, disability and overall instability and pain. Where a
`
`patient suffers from instabilities in the spine that cause pain and/or deformity,
`
`surgical intervention may be required.
`
`16.
`
`It is well known that one method used to treat such degenerated,
`
`diseased or otherwise damaged spinal columns and vertebrae is the removal of all
`
`or a portion of the vertebral disc and inserting a spinal implant to restore normal
`
`disc height and spine orientation, and repair the defective spinal anatomy by
`
`maintenance of the reorientation by the fusion of one vertebrae to the adjacent
`
`6
`
`
`
`level. Additionally, when desired, it is common practice to implant bone grafts,
`
`osteoconductive and/or osteoinductive material into the intervertebral space to
`
`enhance arthrodesis, bone growth and fusion, between the two vertebrae adjacent
`
`to the intervertebral space. Accordingly, it was known to manufacture implants
`
`with a cavity for receipt of bone grafts, osteoconductive and/or osteoinductive
`
`material. Such practice was known prior to the use of non-bone implants, when
`
`early bone graft methods used femoral allograft rings. The center of the ring was a
`
`cavity and one would insert osteoconductive and osteoinductive materials into the
`
`cavity to enhance fusion.
`
`17.
`
`The use of radiographic markers in spinal implants formed from
`
`radiolucent materials was well known prior to the earliest filing date of the ‘156
`
`patent. For example, U.S. Patent Nos. 3,829,904, 3,891,997, 3,922,726, 4,123,806,
`
`4,224,698, 4,450,592, 5,405,402, 5,425,762, and 5,476,880 disclose such markers
`
`in various sizes and shapes, orientations and locations. Radiopaque markers are
`
`helpful in facilitating radiographic assessment of the location, orientation,
`
`positioning and any migration of the intervertebral spinal fusion implant during
`
`and after implantation.
`
`18.
`
`The construction of spinal fusion implants out of PEEK and similar
`
`materials was also well known in the prior art well before the earliest filing date of
`
`7
`
`
`
`the ‘156 patent. For example, U.S. Patent Nos. 5,425,772, and 6,096,080 disclose
`
`the use of PEEK in the construction of spinal fusion implants.
`
`V.
`
`THE LAW OF OBVIOUSNESS
`
`19.
`
`I understand that a patent claim can be invalid for any one of several
`
`reasons, including on the ground of obviousness. This ground of invalidity relates
`
`to "prior art," which involves information that existed at some time before the
`
`filing date of a patent application. The prior art may include, for example, devices,
`
`publications, or patents.
`
`20.
`
`I understand that the description in a written prior art reference does
`
`not need to be in the same words as the claim, but all of the physical requirements
`
`of the claim must be there either explicitly or inherently. That is, they must either
`
`be stated or implied, so that someone of ordinary skill in the relevant field looking
`
`at that reference would be able to understand and use that information.
`
`21. A patent claim is invalid as obvious if the claimed invention would
`
`have been obvious to a person of ordinary skill in the art at the time the invention
`
`was made, which in the absence of earlier proof is presumed to be the date the
`
`patent application was filed. I understand that this means that even if all the
`
`requirements of the claim cannot be found in a single prior art reference, a person
`
`of ordinary skill in the art who knew or who had access to all of the relevant prior
`
`8
`
`
`
`art could have come up with the claimed invention by, for example, applying
`
`common sense to combine or rearrange the features of that prior art.
`
`22.
`
`I understand that in evaluating whether a claim would have been
`
`obvious, one must put himself in the position of a person of ordinary skill in the
`
`art, i.e., the technical field of the invention. The person of ordinary skill is a
`
`hypothetical concept. He is not a genius. He thinks along the lines of conventional
`
`wisdom. It should be remembered, however, that a person of ordinary skill is also
`
`a person of ordinary creativity, not an automaton.
`
`23. One may also consider whether the invention was merely the
`
`predictable result of using prior art elements according to their known function. In
`
`addition, one may consider whether there is some teaching or suggestion in the
`
`prior art to make the modification or combination of elements in the patent. One
`
`may also consider whether the claimed invention would have been obvious to try.
`
`VI. THE ‘156 PATENT
`
`24.
`
`I have reviewed the overview of the ‘156 patent set forth in Section
`
`IV.A. of the Petition for IPR. In my opinion, the overview accurately describes the
`
`claims of the ‘156 patent.
`
`25.
`
`The ‘156 patent describes a spinal fusion implant of non-bone
`
`construction that is positionable in the interbody space between adjacent vertebrae.
`
`See, e.g., ‘156 patent, at 1:66 to 2:2. As claimed, the spinal fusion implant of the
`
`9
`
`
`
`‘156 patent has a distal wall, a proximal wall, and two sidewalls, with the walls
`
`being at least partly constructed from a radiolucent material. The longitudinal
`
`length of the implant extending from the proximal wall to the distal wall is greater
`
`than the maximum lateral width of the implant, as defined by greatest distance
`
`between the two sidewalls along a medial plane of the implant that is perpendicular
`
`to the implant’s longitudinal length. The upper and lower surfaces of the implant
`
`contain anti-migration elements that come in contact with the first and second
`
`vertebrae. At least one fusion aperture that is longer than it is wide and extends
`
`from the top surface to the bottom surface is included in the implant. The claimed
`
`implant also contains at least two radiopaque markers oriented generally parallel to
`
`height of the implant, with at least one in the first sidewall and one in the second
`
`sidewall. In summary, the ‘156 patent generally combines well known features of
`
`intervertebral spinal fusion implants arranged in predictable ways. None of these
`
`features was new and their arrangement was also quite predictable and only a
`
`trivial change from prior spinal fusion implants, disclosing what was in my view
`
`common knowledge at the time.
`
`VII.
`
`INTERPRETATIONS OF THE ‘156 PATENT CLAIMS AT ISSUE
`
`26.
`
`I understand that, for the purposes of my analysis, the claim terms of
`
`the ‘156 patent are given their “broadest reasonable construction in light of the
`
`specification.” Stated another way, it is contemplated that the claim terms are
`
`10
`
`
`
`understood by their plain and ordinary meanings except where construed in the
`
`specification. I also understand that this “plain and ordinary meaning” is with
`
`respect to how one of ordinary skill in the art would interpret the claim language. I
`
`have followed these principles in my analysis. I discuss a few terms below and
`
`what I understand to be Petitioner’s constructions of these terms.
`
`A.
`
`27.
`
`Distal Wall / Proximal Wall
`
`Independent claim 1 of the ‘156 patent, from which every claim at
`
`issue depends, recites that the implant includes a “distal wall” and a “proximal
`
`wall.” ‘156 patent, at 12:40. In accordance with the claim interpretation principles
`
`I explained above, I believe that one of ordinary skill in the art would understand
`
`that the broadest reasonable construction of “distal wall” is the side or end of the
`
`implant that generally enters the patient first, that is -- the leading end wall,
`
`opposite the proximal or trailing end wall, and the end that is furthest from the
`
`surgeon upon insertion of the implant into the patient. It follows that one of
`
`ordinary skill in the art would understand that the “proximal wall” is the side or
`
`end of the implant that enters patient last, the end opposite of the distal wall, and
`
`the end that is the closest wall to the surgeon upon insertion of the implant into the
`
`patient.
`
`28.
`
`Further, it is my understanding that during prosecution of a parent
`
`patent application, U.S. Patent Appl. Ser. No. 11/093,409 (the “‘409 Application”),
`
`11
`
`
`
`to which the ‘156 patent claims priority, the United
`
`States Patent and Trademark Office (“USPTO”) took
`
`the position that the apertures (1044) shown in the
`
`prior art spinal fusion implant figures disclosed in
`
`U.S. Patent No. 6,830,570 to Frey (the “‘570
`
`patent”) – subsequently included in Frey, a
`
`continuation of the ‘570 patent – reproduced below
`
`are located on the proximal wall of the Frey implant.
`
`The Applicant did not challenge or otherwise take issue with the USPTO on its
`
`interpretation, thereby further supporting my opinion that the broadest reasonable
`
`construction of the terms “distal wall” and “proximal wall” include the regions, for
`
`example, of the Frey implant disclosed above where apertures 1044 and 1048 are
`
`located.
`
`It should be noted that in implants like those described in Frey the ends
`
`are fungible and may be interchangeable depending upon the manner in which they
`
`are inserted and the anatomy of the patient.
`
`B.
`
`Releasably Mate
`
`29. Claim 6 of the ‘156 patent, from which claims 7 and 8 depend, says
`
`that “the threaded receiving aperture is configured to releasably mate with an
`
`inserter tool.” ‘156 patent, at 13:17-18. In accordance with the claim
`
`interpretation principles I explained above, I believe that one of ordinary skill in
`
`12
`
`
`
`the art would understand that the broadest reasonable construction the term
`
`“releasably mate” as used in the ‘156 patent means “an impermanent stabilized
`
`connection.” In my opinion, such an interpretation is consistent with the ‘156
`
`patent specification, in which this term is used to describe the connecting
`
`relationship between the implant and insertion tool. See ‘156 patent, at 8:26-33
`
`(“In order to secure the spinal fusion implant 10 onto the threaded connector 24 of
`
`the inserter instrument 20, the clinician employs the thumbwheel 34 to rotate the
`
`inserter shaft 44 and threaded connector 24. The rotation of the threaded connector
`
`24 will releasably engage the receiving aperture of the spinal fusion implant 10 and
`
`stabilize the insertion instrument 20 relative to the spinal fusion implant 10.”).
`
`C.
`
`Extend Generally Perpendicular to Said Longitudinal
`
`Length
`
`30. Claim 20 recites that the plurality of ridges on the implant “extend
`
`generally perpendicular to said longitudinal length.” ‘156 patent, at 14:15-17. I
`
`believe that one of ordinary skill in the art would understand that the broadest
`
`reasonable meaning of this term is extending approximately in a direction that
`
`crosses a plane along the general direction of the longitudinal length of the implant
`
`at generally or roughly a right angle. The “longitudinal length,” although that term
`
`is somewhat redundant, in its broadest reasonable interpretation in this context and
`
`as is common when referring to a spinal fusion implant, is understood to mean the
`
`13
`
`
`
`dimension measured from end to end of the implant, or in other words, from the
`
`insertion or leading end, i.e., the distal end, to the trailing end, i.e., the proximal
`
`end. This understanding is also consistent with many common definitions of
`
`“length” as a distance or measurement from end to end. For example, Webster’s
`
`Third New International Dictionary of the English Language Unabridged (2002) at
`
`page 1293, defines “length” to mean “the extent from end to end.” Similarly, The
`
`New Shorter Oxford English Dictionary (1993) at page 1565 defines “length” as
`
`“the linear extend of anything as measured from end to end.”
`
`D.
`
`Elongate Body
`
`31. Claim 26 recites that the “elongate body of at least one of said
`
`radiopaque markers is shorter than said height extending from said upper surface to
`
`said lower surface.” ‘156 patent, at 14:38-40. I believe that one of ordinary skill
`
`in the art would understand that the broadest reasonable interpretation of the term
`
`“elongate body” means a body longer than it is wide.
`
`E.
`
`Generally Rectangular and Generally Oblong in Shape
`
`32. Claim 14 recites that the “first fusion aperture is one of generally
`
`rectangular and generally oblong in shape.”
`
`‘156 patent, at 13:41-43. I believe that one of
`
`ordinary skill in the art would understand that
`
`the broadest reasonable interpretation of the
`
`14
`
`
`
`term “generally rectangular and generally oblong in shape” is a shape having
`
`portions roughly approximating sides and being elongated in at least one
`
`dimension. My understanding is supported by my review of the file of the prior
`
`parent application of the ‘156 patent, in which I learned that the USPTO has
`
`previously taken the position that the fusion apertures (1018a, 1018b) shown in the
`
`Frey prior art spinal fusion implant figure reproduced above are generally
`
`rectangular and elongated in at least one direction.
`
`G.
`
`A Lateral Width of the Distal End of Said Distal Wall/A Lateral
`
`Width of Said Proximal End of Said Proximal Wall
`
`33.
`
`Claim 23 recites that the “maximum lateral width of said implant is
`
`greater than a lateral width of the distal end of said distal wall and is greater than a
`
`lateral width of the proximal end of said proximal wall.” ‘156 patent, at 14:24-27.
`
`I believe that one of ordinary skill in the art would understand that the broadest
`
`reasonable interpretation of these terms means that the maximum lateral width of
`
`the implant found in the middle of the implant is greater than a width of the most
`
`distal end of the distal wall extending in a direction from the first side wall to the
`
`second sidewall and is greater than a width of the most proximal end of the
`
`proximal wall extending in a direction from the first side wall to the second
`
`sidewall.
`
`H. Oriented Generally Parallel to a Height of the Implant
`
`15
`
`
`
`34.
`
`Independent claim 1 recites, in relevant part, that the implant includes
`
`“at least first and second radiopaque markers oriented generally parallel to a height
`
`of the implant.” ‘156 patent, at 12:62-63. I believe that one of ordinary skill in the
`
`art would understand that broadest reasonable interpretation of this term as
`
`oriented generally or roughly along the Y-axis (up and down) or oriented generally
`
`or roughly in a direction running from the top to the bottom, i.e., cephalad to
`
`caudal.
`
`VIII. LEVEL OF ORDINARY SKILL IN THE ART
`
`35. At the time of the alleged invention, a person of ordinary skill in the
`
`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.
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`U.S. Patent Appl. Pub. No. 2002/0165550 (“Frey”)
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`16
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`36.
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`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.
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`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 and includes a distal wall (designated
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`as leading end wall 1406), a proximal wall (designated as trailing end wall 1408),
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`and 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. As depicted in Figure 63 of Frey, the curvatures of the opposing
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`sidewalls of the implant are generally the same. I also note that Mr. DeRidder, a
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`co-inventor identified on Frey has also provided supporting testimony on this point
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`that is consistent with my opinion although I arrive at this conclusion
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`independently as well. As shown in the annotated figure below, this results in the
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`maximum lateral width of the implant, as measured from one sidewall to the
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`opposing sidewall in a direction perpendicular to that of the longitudinal length of
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`the implant, being located at least along the medial plane of the implant, including
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`17
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`
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`at the exact middle of the middle portion, as well as along the other areas of the
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`middle portion where the opposing sidewalls maintain a similar curve.
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`Additionally, to the extent that Frey does not explicitly teach that the lateral width
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`of the implant is the largest at the precise center of the implant, a person of
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`ordinary skill in the art would find it obvious to provide approximately the same
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`width along the entire middle portion of the implant as this allows for easy
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`insertion of the device during implantation. Further, it would have been obvious to
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`have the maximum lateral width of the implant located in its middle portion to
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`better fill the disc space, as this configuration provides optimal load support
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`capacity and helps to prevent implant subsidence. Under this situation, because the
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`middle portion of the implant encompasses the medial plane of the implant, the
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`maximum lateral width is necessarily found along this medial plane. Due to its
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`generally elongated shape, the implant includes a longitudinal length that is greater
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`than this maximum lateral width along the medial plane.
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`Medial Plane
`
`Maximum
`Lateral Width
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`Longitudinal Length
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`18
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`
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`39.
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`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 space.”
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`Id.
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`40.
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`Additionally, the Frey implant contains at least one fusion aperture
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`that extends from the top surface to the bottom surface, and is configured to allow
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`for fusion of the adjacent vertebrae. See id., at ¶ [0154]. Frey discloses that the
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`fusion aperture is generally rectangular and oblong in shape, and has a longitudinal
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`length that is greater than its lateral width. See id., at ¶ [0154]; Figure 63. Frey
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`further explains that bone grafts, bone morphogenetic protein or other
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`osteoinductive material may be placed in the fusion aperture to induce bone
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`growth. See id., at ¶ [0182].
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`41.
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`Frey also discloses the use of radiopaque markers in its distal and
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`proximal walls and at least one of its sidewalls for radiographic imaging. See id.,
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`at ¶ [0156]. The radiopaque markers of Frey are depicted as elongated bodies that
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`extend through the walls of the implant. See, e.g., id., at Figure 59. The markers
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`are used “to facilitate X-ray assessment of the locating and positioning of implant
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`1400 in the patient's body.” See id., at ¶ [0156].
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`19
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`42.
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`I also note that Mr. DeRidder, one of the co-inventors named in Fre