UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`
`Case IPR2013-00208
`
`DECLARATION OF DR. ROBERT E. JACOBSON, M.D.
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1
`
`NUVASIVE 1030
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00208
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`
`Case IPR2013-00208
`
`DECLARATION OF DR. ROBERT E. JACOBSON, M.D.
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1
`
`NUVASIVE 1030
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00208
`
`
`
`I, Dr. Robert E. Jacobson, M.D., of Miami, Florida, declare that:
`
`I. Qualifications
`
`1.
`
`I am a neurosurgeon with a specialty in spine surgery including spinal
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`discectomy and fusion procedures. I graduated from medical school in 1969, and
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`performed general neurosurgery residencies with a research concentration on spine from
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`1970 through 1975. I also performed a clinical fellowship in cervical and lumbar spine
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`surgery under Professor Henk Verbiest from July 1975 to March 1976 in Utrecht,
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`Netherlands. I am the inventor of the spinal surgery methods and equipment described,
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`among other places, in U.S. Patent No. 4,545,374 ('''374 patent") (Exhibit 1004), entitled
`
`"Method and instruments for performing a percutaneous lumbar diskectomy," which is a
`
`patent I had filed on September 3, 1982, and which issued on October 8, 1985.
`
`2.
`
`I have been asked to provide rebuttal testimony to the declaration testimony
`
`of Dr. Barton Sachs regarding what is disclosed in my '374 patent. In this regard, I have
`reviewed ,m 75-93 of Dr. Sachs' declaration (Exhibit 2038, hereafter "Dr. Sachs Oed"),
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`where he provides his opinions regarding my '374 patent. I am very familiar with my own
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`'374 patent, although I reviewed my '374 patent again as part of my study in providing this
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`declaration. I also reviewed other documents referenced in my testimony set forth below.
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`3.
`
`Dr. Sachs, in his declaration, states that "[t]hough Jacobson uses the word
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`'lateral,' the term does not mean direct lateraL" Dr. Sachs Oed, 1f 75. Dr. Sachs also
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`states that "Jacobson does not teach a direct lateral approach to the spine," and further
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`1
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`1
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`
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`states that he "believe[s] he [Dr. Jacobson] is teaching a similar approach that is
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`posterolateral." Dr. Sachs Oecl., ~ 76. Copied below is the figure from Dr. Sachs
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`declaration where he illustrates a "posterolateral approach," and also illustrates a "direct
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`lateral approach."
`
`Direct Lateral Approach
`
`Posterolateral Approach
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`Sow'ce: http: //home. comcast.netl~~wnor/peritoneum.htm
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`4.
`
`I agree with Dr. Sachs that a posterolateral approach (as labeled in the figure
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`copied above from his declaration) is different from a direct lateral approach (as also labeled
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`in the figure copied above). (I note, however, that approaches referred to as "posterolateral"
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`may be, and in fact are typically, more posterior than the posteriolateral approach shown in
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`the figure above.) I disagree, however, with Dr. Sachs' opinion that my '374 patent teaches
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`a posterolateral approach and not a direct lateral approach. My '374 patent clearly teaches
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`a direct lateral approach, not a posterolateral approach. Indeed, the approach that I had
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`developed and used at the time was a direct lateral approach, not a posterolateral
`
`approach.
`
`I believe it is clear - from the figures and the text of my '374 patent, especially in
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`2
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`2
`
`
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`view of the timeframe of the early 1980s during which I developed and had a patent filed on
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`my lateral procedure - that my '374 patent discloses a direct lateral approach. For
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`example, the patient in my method of the '374 patent is always placed in a lateral decubitus
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`(side) position, and the three access instruments including the final access cannula are
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`passed to the spine using a direct lateral approach. See, e.g., my '374 patent, Exhibit 1004,
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`column 5, lines 5-6 ("To begin the procedure, the patient 6 is placed in the lateral decubitus
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`position .... "), column 5, lines 27-28 ("As shown in FIG. 3, the needle is inserted laterally
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`through the patient's side above the pelvic crest .... "), column 5, lines 49-50 ("The speculum
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`10 is laterally inserted through body tissue .... "), column 5, lines 60-62 ("Once the speculum
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`is properly positioned, the surgeon spreads its jaw blades thereby creating a channel for
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`cannula insertion."), Figures 3-6. In this regard, Figure 5 is particularly clear in illustrating
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`the direct lateral nature of the approach, given that the distal end of the cannula 11 is
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`depicted in the figure with a straight horizontal line (i.e., not in perspective), thereby
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`indicating the view of the cannula 11 is a side view or in other words the cannula 11 lies in a
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`plane that is parallel with the page. Also in Figure 5, the transverse processes that extend
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`from the two vertebral bodies are sized to be about the same size, thus indicating the view
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`in Figure 5 of the spine is directly from the front of the spine. In addition, my '374 patent
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`describes that the entry to the disc space is from the side opposite the disc bulge, such that
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`the instruments pass all the way across the disc in order to get to the bulge. See, e.g., my
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`'374 patent, Exhibit 1004, column 7, line 67 to column 8, line 5. Extending instruments
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`3
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`3
`
`
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`across the disc to a bulge on the other side of the disc would not be possible with a
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`posterolateral approach and the instruments I describe in my '374 patent.
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`5.
`
`When I was in the process of developing the method shown in my '374 patent
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`during the early 1980s and working with attorneys from the law firm of Pennie & Edmonds
`
`on the patent application that became my '374 patent, the phrase "direct lateral" was not a
`
`phrase that I used in the technical parlance of my profession, and in fact, at that time I had
`
`never heard the phrase "direct lateral" to describe a 90 degree lateral approach to the spine.
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`Instead, in the early 1980s, I (and others) simply used the term "lateral" when referring to a
`
`90 degree lateral approach to the spine. When we wanted to refer to a posterolateral
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`approach to the spine (which was also known at the time), we called that approach a
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`posterolateral approach. It is only recently in the last few years that I first heard the phrase
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`"direct lateral" in referring to a 90 degree lateral approach.
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`6.
`
`The posterolateral approach to the spine was well known when I was doing
`
`my work developing my lateral method in the early 1980s. The posterolateral approach
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`dates back to the 1940s with procedures that made injections into the spinal disc. For
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`example, a posterolateral approach to the spine was used in the procedure discussed in the
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`background section of my '374 patent to inject a chymopapain enzyme into the disc with a
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`spinal needle. See my '374 patent, column 1, line 65 through column 2, line 5. In the
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`1980s, around the same time I was developing my lateral approach procedure, Dr. Parviz
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`Kambin was developing his posterolateral procedure that involves providing an access
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`4
`
`4
`
`
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`cannula for access to the disc space of the spine along a posterolateral approach, and that
`
`is described in his patents. See, e.g., Exhibit 1013, U.S. Patent No. 4,573,448 to Kambin,
`
`Figure 10 and column 5, lines 5-6; Exhibit 1048, U.S. Patent No. 5,395,317 to Kambin,
`
`Figures 10-12, column 2, lines 45-46 and column 3, lines 64-66. Dr. Kambin's
`
`posterolateral approach procedure was different from my direct lateral procedure. For
`
`example, my lateral procedure and Dr. Kambin's posterolateral procedure differed from one
`
`another in that they involved different anatomical considerations in accessing the spine, and
`
`Dr. Kambin's approach had certain advantages and disadvantages as compared to my
`
`direct lateral method described in my '374 patent. One of the advantages of my direct
`
`lateral approach, as compared to posterolateral approaches, is that my direct lateral
`
`approach provided for a larger access cannula to the spine that is anatomically impossible
`
`to place in a posterolateral position because the different anatomic structures composing
`
`"Kambin's triangle," the nerve root, the facet joint, and the annulus limit the size of the
`
`space. All posterolateral approaches ever used - from discograms, chymopapain, and
`
`percutaneous discectomy - go behind the exiting nerve root. My lateral approach goes
`
`anterior or ventral of the nerve root. This allows a larger access port or cannula and a true
`
`90 degree lateral approach to the disc space providing the ability to manipulate the
`
`instruments completely across the disc space side to side (right to left or left to right) in the
`
`coronal plane as well as front to back (posterior to anterior or vice-versa) in the saggital
`
`5
`
`5
`
`
`
`plane. For these reasons, my lateral approach was quite different from the posterolateral
`
`approaches then known.
`
`7.
`
`Indeed, during the 1980s, there were often debates at conferences regarding
`
`the relative merits of my direct 90 degree lateral approach versus Dr. Kambin's
`
`posterolateral approach. In view of that background, I believe that it would have been well
`
`known among spine surgeons and others in the spinal medical community in the 1980s that
`
`posterolateral methods such as Dr. Kambin's approached the spine from a different angle
`
`as compared to my direct lateral procedure described in my '374 patent.
`
`8.
`
`In addition, shortly after I had developed my direct lateral procedure set forth
`
`in my '374 patent, I began teaching that procedure to other orthopedic and neurologic
`
`surgeons. In the 1980s, approximately 50 spine surgeons observed me perform the
`
`procedure described in my '374 patent, and many of them began doing the procedure
`
`themselves after the procedure. One of the first spine surgeons who observed me perform
`
`my direct lateral procedure was Dr. William A. Friedman, of the University of Florida, who is
`
`now Chairman of the Department of Neurosurgery at the University of Florida. He had
`
`heard me speak about my lateral method at a Florida Neurological Society meeting, and
`
`then invited me to the University of Florida to speak and perform the surgery on a patient
`
`with him using the same instruments and approach method set forth in my '374 patent.
`
`Following this visit and procedure, Dr. Friedman started performing the lateral surgeries as I
`
`had taught them to him, and he remained in contact with me while he was doing those
`
`6
`
`6
`
`
`
`procedures. In addition, and with my permission, Dr. Friedman authored one paper and co(cid:173)
`
`authored another describing my direct lateral procedure that is also described in my '374
`
`patent. See Exhibit 1036, Friedman, Percutaneous Discectomy: An Alternative to
`
`Chemonucleolysis?, NEUROSURGERY, Vol. 13, No.5, pp. 542-47 (1983) (stating at page 547
`
`that "[t]he author thanks Dr. Robert Jacobson for teaching him the percutaneous discectomy
`
`technique. Dr. Jacobson developed this methodology.") (hereafter "Friedman 1983 Paper");
`
`see also Exhibit 1037, Kanter and Friedman, Percutaneous Discectomy: An Anatomical
`
`Study, NEUROSURGERY, Vol. 16, No.2, pp. 141-147 (1985) (stating at page 146 that "[t]he
`
`authors recognize Dr. Robert Jacobson, who developed this methodology.") (hereafter
`
`"Kanter & Friedman 1985 Paper"). I believe it is clear from the figures and textual
`
`description in both of Dr. Friedman's papers from 1983 and 1985, respectively, that the
`
`direct lateral procedure shown in Dr. Friedman's papers is my direct lateral procedure as
`
`described in my '374 patent. See, e.g., Exhibit 1036, Friedman 1983 Paper, FIGS. 3-6, and
`
`p. 542, col. 2, line 4 through p. 544, col. 1, line 6; Exhibit 1037, Kanter & Friedman 1985
`
`Paper, FIGS. 1, 5 and 9-10, Table 1, and p.141, col. 1, line 1 through p.142, col. 1, line 11;
`
`Exhibit 1004, my '374 patent, throughout. I also believe it is clear that these papers
`
`(Exhibits 1036 and 1037) corroborate that my approach was a 90 degree lateral approach to
`
`the spine, as is shown for example in Figure 3 from Exhibit 1036 copied below:
`
`7
`
`7
`
`
`
`ll't'-Idl ~pe.: tl l.lm I" ~1"~l\CC 3~
`-' AnI!>"" rrndH o · shl)
`It.
`" J
`t the '" h<Jlo& ... .ll m ICr~ p~\ce . Not' til IlL ~I(k of
`ttl 1~I~r31 as~ \
`,~40 F (." I\ (' h vh ~! tube. w il l H l)('a/' 1 pl;v "
`the I e rnia lloJ) II~ <.I
`\\'
`is m ~('rlrd .
`
`Accordingly, Dr. Friedman's papers corroborate that my direct lateral approach to the spine
`
`was a 90 degree direct lateral approach, not a posterolateral approach.
`
`9.
`
`In ,-r 88 of his declaration, Dr. Sachs makes reference to the discussion in my
`
`'374 patent where I state that my lateral access system may be used to perform other spinal
`
`procedures, including spinal fusion. See my '374 patent, column 6:9-13. Dr. Sachs states
`8
`
`8
`
`
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`that my '374 patent does not "ever expressly reference an implant for performing a fusion."
`
`Dr. Sachs declaration, ~ 88. Dr. Sachs then discusses a variety of things that may be
`
`implanted into a patient's intradiscal space in order to accomplish fusion, and appears to
`
`use the term "implant" in a narrow sense to conclude that my '374 patent's reference to
`
`fusion would not necessarily involve introduction of an implant into the patient. See Dr.
`
`Sachs declaration, ~~ 88-89.
`
`10.
`
`Responding directly to Dr. Sachs' testimony in ~~ 88-89 of his declaration:
`
`First, the method disclosed in my '374 patent teaches a surgical procedure in which an
`
`access cannula is provided to a spinal disc space. Spinal disc spaces, of course, are
`
`located in the anterior column of the spine. The purpose of my method in providing such an
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`access corridor to the disc space in the anterior column of the spine is to perform a spinal
`
`surgical procedure there. As such, the reference in my '374 patent to performing a fusion
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`procedure through my disclosed direct lateral access cannula would necessarily involve
`
`implanting something into the disc space that would be intended to remain in the disc space
`
`after surgery to facilitate inter-body fusion. Beginning in the early 1980's when I used my
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`lateral access system disclosed in my '374 patent to perform a direct lateral fusion
`
`procedure on patients, I used allograft bone dowels readily available to me (which I
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`customized/trimmed) as the implant I inserted laterally into the disc space to promote fusion
`
`between at least two adjacent vertebral bodies. Allograft bone dowels are implant
`
`structures that are made from bone obtained from cadaveric donors. In other words,
`
`9
`
`9
`
`
`
`allograft bone dowels are not obtained from the patient who was undergoing the fusion
`
`procedure and ultimately received the bone dowel implant. (If it comes from the patient,
`
`such bone dowels were and are referred to as autograft implants.). Allograft bone dowels
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`were readily available to me for use as implants in fusion procedures as early as 1972
`
`through the University of Miami Tissue Bank where I trained and did research with Dr.
`
`Theodore Malinin. I worked with allograft bone grafts from 1972 both in the research lab
`
`and clinically. At that time, because of the close association and proximity of the University
`
`of Miami Tissue Bank, we routinely used allograft bone dowels for Cloward cervical inter(cid:173)
`
`body fusion procedures, and so the concept of an intra-spinal allograft bone dowel was a
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`concept with which I was quite familiar by the time I was developing my lateral fusion
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`method in the early 1980's. Additionally, the hospital where I developed my percutaneous
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`discectomy technique was directly across the street from the Tissue Bank and I maintained
`
`my contact with them. We kept sterile bottled supplies of various size bone allograft in the
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`operating room so it was straight-forward to decide to place an allograft through the
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`percutaneous access cannula into the disc space. In a fusion procedure using my '374
`
`patented method, I would place one or more customized/trimmed allograft bone dowels
`
`across the disc space from side to side.
`
`11.
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true; and
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`further that these statements were made with the knowledge that willful false statements
`
`10
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`10
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`
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`and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of
`
`the Title 18 of the United States Code and that such willful false statements may jeopardize
`
`the validity of the application or any patents issued thereon.
`
`Dated: March J!! 2014
`
`By:
`
`11
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`11
`
`
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