throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`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
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Attorney Docket No.: 108136.00029
`
`
`DECLARATION OF RICHARD A. HYNES, M.D.
`REGARDING U.S. PATENT NO. 8,361,156
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`

`
`
`
`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”) .................................................................................. 18
`
`C. U.S. Patent Appl. Pub. No. 2003/0139813 (“Messerli”)................................................................................. 20
`
`D. U.S. Patent No. 5,860,973 (“Michelson”) ........................................................................................................ 20
`
`E. U.S. Patent Appl. Pub. No. 2003/0100950 (“Moret”) .................................................................................... 21
`
`F.
`
`Synthes Vertebral Spacer-PR Brochure (“SVS-PR” or “SVS-PR Brochure”) .......................................... 22
`
`G. Telamon Verte-Stack PEEK Vertebral Body Spacer Brochures (“Telamon”) .......................................... 23
`
`X. DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE PRIOR ART
`AND THE OBVIOUSNESS OF THE ASSERTED CLAIMS ................................................ 25
`
`A. Claim 1 .............................................................................................................................................................. 27
`
`B. Claim 2 .............................................................................................................................................................. 36
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`

`
`
`
`C. Claim 3 .............................................................................................................................................................. 37
`
`D. Claim 4 .............................................................................................................................................................. 38
`
`E. Claim 5 .............................................................................................................................................................. 39
`
`F. Claim 6 .............................................................................................................................................................. 45
`
`G. Claim 7 .............................................................................................................................................................. 49
`
`H. Claim 8 .............................................................................................................................................................. 50
`
`I.
`
`Claim 9 .............................................................................................................................................................. 52
`
`J. Claim 10 ............................................................................................................................................................ 55
`
`K. Claim 11 ............................................................................................................................................................ 57
`
`L. Claim 12 ............................................................................................................................................................ 58
`
`M. Claim 13 ............................................................................................................................................................ 59
`
`N. Claim 14 ............................................................................................................................................................ 60
`
`O. Claim 19 ............................................................................................................................................................ 62
`
`P. Claim 20 ............................................................................................................................................................ 63
`
`Q. Claim 23 ............................................................................................................................................................ 64
`
`R. Claim 24 ............................................................................................................................................................ 65
`
`S. Claim 25 ............................................................................................................................................................ 68
`
`T. Claim 26 ............................................................................................................................................................ 70
`
`U. Claim 27 ............................................................................................................................................................ 72
`
`XI. ADDITIONAL REMARKS ........................................................................................... 74
`
`
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`2
`
`

`
`
`
`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.
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`

`
`
`
`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 Orthopaedic 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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`2
`
`

`
`
`
`true and correct copy of my current curriculum vitae is submitted in this IPR as
`
`Exhibit MSD 1112.
`
`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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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.
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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.,
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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 length of the
`
`implant extending from the proximal wall to the distal wall is greater than the
`
`maximum width of the implant, as defined by greatest distance between the two
`
`sidewalls. 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
`
`understood by their plain and ordinary meanings except where construed in the
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`10
`
`

`
`
`
`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.
`
` Distal Wall / Proximal Wall
`
`27.
`
`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”),
`
`to which the ‘156 patent claims priority, the United States Patent and Trademark
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`11
`
`

`
`
`
`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
`
`the art would understand that the broadest reasonable construction the term
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`12
`
`

`
`
`
`“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
`
`dimension measured from end to end of the implant, or in other words, from the
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`13
`
`

`
`
`
`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
`
`term “generally rectangular and generally
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`14
`
`

`
`
`
`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
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`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
`
`degree in Mechanical or Biomedical Engineering or equivalent and at least two to
`
`three years of experience with interbody spinal fusion implants or a medical degree
`
`or the equivalent and at least two to three years of experience with interbody spinal
`
`fusion implants and related procedures. A person of ordinary skill in the relevant
`
`art need not necessarily have formal education if they have an equivalent amount
`
`of experience in medical device design. So, for example, approximately four years
`
`of medical device design experience could replace an undergraduate degree in that
`
`field.
`
`IX. THE SCOPE AND CONTENT OF THE PRIOR ART
`
`A. U.S. Patent Appl. Pub. No. 2002/0165550 (“Frey”)
`
`ACTIVE 22114455v3 08/14/2013 2:12 PM
`
`16
`
`

`
`
`
`36. Frey was published on November 7, 2002, more than one year prior to
`
`the earliest filing date of the ‘156 patent. I understand that Frey therefore is prior
`
`art to the ‘156 patent.
`
`37. Frey describes an intervertebral spinal fusion implant constructed
`
`from a biocompatible, radiolucent material. See Frey, at ¶¶ [0156], [0181]. The
`
`Frey implant has a generally elongated shape with a longitudinal length that is
`
`greater than its maximum lateral width, and includes a distal wall (designated as
`
`leading end wall 1406), a proximal wall (designated as trailing end wall 1408), and
`
`two sidewalls (designated as posterior wall 1402 and anterior wall 1404). See
`
`Frey, at ¶ [0151]. The implant is described for use in various “approaches to the
`
`disc space, such as lateral, anterior or antero-lateral approaches” for insertion of
`
`implant 1400 as well as “for insertion from a poster-lateral or uni-lateral approach
`
`into [a] disc space . . . .” Frey, at ¶ [0150].
`
`38. The upper and lower bearing surfaces of the Frey implant contain
`
`anti-migration elements that come in contact with the first and second vertebrae.
`
`See id., at ¶ [0153]. The anti-migration elements are used to “increase frictional
`
`resistance between the adjacent vertebral endplate and the bearing surface 1410,
`
`1412 to resist posterior and anterior migration of implant 1400 in the disc

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket