`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NUVASIVE, INC.
`
`Petitioner
`
`V.
`
`WARSAW ORTHOPEDIC, INC.
`
`Patent Owner
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`
`Case IPR2013-00206
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`DECLARATION OF DR. JOHN W. BRANTIGAN, M.D.
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`Mail Stop “PATENT BOARD"
`Patent Trial and Appeal Board
`US, Patent and Trademark Office
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`I
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`Nuvasive, Inc. v. Warsaw Orthopedic, Inc.
`|PR2013-00206
`
`NUVASIVE 1031
`
` 1
`
`NUVASIVE 1031
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`
`
`
`I, Dr. John W. Brantigan, M.D., of Shaw Island, WA, declare that:
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`QUALIFICATIONS
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`1.
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`I am an orthopaedic surgeon board certified by the American Board of
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`Orthopaedic Surgery and fellowship trained in spine surgery.
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`I received my medical degree
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`from the Johns Hopkins University in 1970.
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`I performed an internship at the Department of
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`Surgery, University of Minnesota from 1970-1971, a residency in general surgery at the
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`University of Utah from 1973-1974, a residency at Shriners Hospital for Crippled Children
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`(Spokane, WA) from 1976-77, and a residency in orthopaedic surgery at the University of
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`Washington from 19744978. From 1978 to 1990, I was in private practice as an
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`orthopaedic surgeon at Immanuel Medical Center (Omaha, NE), Memorial Hospital of
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`Dodge County (Fremont, NE), and St. Joseph Hospital (Omaha, NE). From 1990 to 1992, I
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`was an orthopaedic surgeon at Cleveland Spine and Arthritis Center of Lutheran Medical
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`Center (Cleveland, OH). From 1992 to 1997', I served as the Associate Professor of
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`Orthopaedic Surgery and Chief of Spinal Reconstructive Surgery at Creighton University
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`(Omaha, NE).
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`In 1997, I returned to private practice as an orthopaedic surgeon at South
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`Texas Orthopaedic and Spinal Surgery Associates (San Antonio, TX), after which I retired in
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`2004.
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`I have performed over ‘I ,000 spinal surgeries, including hundreds of surgeries
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`involving spinal fusion implants.
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`_ 2.
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`I am listed as an inventor on at least? U.S. patents and additional foreign
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`patents, including 5 U.S. patents directly related to spinal fusion implants I invented in the
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`‘I
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` 2
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`
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`1980s and early 1990s.
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`I have published over 70 publications, including nearly 50
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`publications pertaining to spinal implants and spinal surgical methods (many of which were
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`published in the early 1990s).
`
`I
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`3.
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`I am the sole named inventor of U.S. Patent No. 5,192,327 to Brantigan (“my
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`‘327 patent") (Ex. NUVASIVEiO06), which is addressed by the declaration of Dr. Barton L.
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`Sachs (Ex. WARSAW2038) submitted in support of the Patent Owner‘s Responses
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`regarding U.S. Patent No. 8,251,997 (Cases IPR2013—00206 and |PR20i3—O0208).
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`4.
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`Based upon my knowledge and experience in this field, I am aware of the
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`needs and the challenges orthopaedic surgeons face in performing spinal fusion
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`procedures.
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`I routinely performed and observed these spinal fusion procedures, and I am
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`familiar with the various types of spinal fusion implants that were used in 1995 and earlier,
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`and indeed I personally invented and then used a number of spinal fusion implants during
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`the 19805 and early 1990s.
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`5.
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`I am not, and never was, an employee or clinical research consultant for
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`Nuvasive, Inc.
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`I have been engaged in the present matter to provide my independent
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`analysis of the issues raised by the declaration of Dr. Barton L. Sachs, and in particular
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`statements in Dr. Sachs’ declaration about my ‘327 patent and my prior testimony.
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`I
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`received no compensation for this declaration beyond mynormal hourly compensation
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`based on my time actually spent studying the matter, and I will not receive any added
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` 3
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`
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`compensation based on the outcome of the abovementioned inter partes review of the ‘997
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`patent.
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`6.
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`The statements in my declaration are based on my education, experience,
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`and background in the fields discussed above and upon my review of the documents cited
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`by Dr. Sachs in his declaration.
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`in this declaration I do not attempt to address all of Dr.
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`Sachs’ statements and no inference should be drawn from my not addressing a particular
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`statement.
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`7.
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`In paragraph 102, Dr. Sachs begins his assessment of my ‘327 patent by stating that
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`it “discloses ring-like prosthetic devices for anterior insertion and hemi-oval ring prosthetic
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`devices for posterior insertion.” I disagree that the implants taught by my ‘327 patent are
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`limited to anterior or posterior insertion. As discussed in greater detail in the following
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`paragraphs, the implants of my ‘327 patent are, as correctly described in the patent, for
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`“insert[ion] either anteriorly, posteriorly or laterally into the vertebral column while mounted
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`on the end of an insertion tool." Ex. NUVAS|VE1006 at 2:64-66. See also 5:30-35 (“The
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`individual plugs or the stack of plugs can be introduced anteriorly, laterally or posteriorly
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`depending upon conditions and the tool receiving recesses 13 and 23 of the plugs 11 and
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`21 can thus be positioned to meet the particular type of insertion into the vertebral
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`column"); 6:61—69 (“This stretches the remaining disc tissue and as illustrated in FIGS. 13
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`and 14, the plugs of this invention such as the plugs 11 or a stack of the plugs, are inserted
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`into the opened up disc space such as 70 between adjacent vertebrae 71 and 72, either
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`3
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` 4
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`
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`anteriorly, laterally or posteriorly while mounted on a tool 73 having a single end 73a
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`threaded into the internally threaded hole 13 of the plug 11 as illustrated in FIG. 13.")
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`8.
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`In paragraph 103, Dr. Sachs states, “Brantigan "327 does not disclose an implant
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`inserted in a direct lateral path." I disagree. My ‘327 patent describes lateral insertion of an
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`implant three times (cited above) and illustrates one example of the lateral insertion of an
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`oval implant in Figure 10.
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`9.
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`In paragraph 103, Dr. Sachs states “the only reference to “lateral” insertion of an
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`implant in Brantigan "327" is at 2:64-66.
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`I disagree. Lateral insertion of the disclosed
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`-implant is also described at 5:30-35 and 6:61-69 and Figure 10.
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`10.
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`In paragraph 103, Dr. Sachs states that I used the word "laterally" in my "327 patent
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`to mean “something much different than ‘direct |atera|'." I disagree.
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`In the context of the
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`‘327 patent, “lateral” means a lateral approach to the disc space as opposed to an anterior
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`or posterior approach as explained in greater detail below. Dr. Sachs goes on to argue in
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`paragraph 103 that because I used the term "lateral" in other publications and in my ‘757
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`patent to mean "to the side of the mid-sagittal line" that I used the term to mean the same
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`thing in my ‘327 patent. That is not the case.
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`In my ‘757 patent, I describe the implants as
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`“inserted laterally
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`of the vertebral column." Ex. 2042 at 1:54—55. This is different from my
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`‘327 patent, which describes the implant as being “inserted
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`laterally into the vertebral
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`column" - a direction of insertion. Ex. NUVASNE1006 at col. 2:64—66; 5:30-35 (“can be
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`introduced
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`laterally").
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`In the context of my ‘757 patent, the phrase “laterally of the
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`4
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` 5
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`
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`vertebral column” refers to the final resting position of the implants, not their direction of
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`insertion, which is posteriorly.
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`11.
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`in paragraph 104, Dr. Sachs elaborates on his argument that the word “latera|ly" in
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`my ‘327 patent means “to the side of the mid~sagittal line,” here contending that as used in
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`Figure 4 of my ‘757 patent, “|aterally" means “a posterior approach that is lateral to the mid-
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`sagittal line.” I disagree that the usage of “laterally" in my ‘757 patent applies to how the
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`word is used in my ‘327 patent. Laterally in the context of the ‘757 patent has one meaning
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`and in the context of the ‘327 patent, a different meaning. This difference in meaning is
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`apparent if one considers the use of the word “lateral” in the context of the ‘327 patent.
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`If
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`“laterally” in the ‘327 patent meant “posteriorly," as Dr. Sachs contends, then the phrases
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`which recite “anteriorly, posteriorly or laterally” in the ‘327 patent would be redundant and
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`would make no sense; they would read "inserted either anteriorly, posteriorly or laterally
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`[posterior|y].” See Ex. l\lUVAS|VE1006 at 2:64—66.
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`12.
`
`In paragraph 104, Dr. Sachs references Fig. 31-7 in Exhibit WARSAW2055, which is
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`a book that I edited. Fig 31-7 does illustrate a Transforaminal Lumbar lnterbody Fusion
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`(TLIF) procedure in which two implants, which are embodiments the ‘757 patent, are
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`inserted posteriorly. Notably, the author does not describe this approach as a lateral
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`approach, but instead uses the phrase “bilateral” to describe the fact that the implants are
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`placed parallel to one another via a posterior approach and lateral to the vertebral column.
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` 6
`
`
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`“Bi|ateral" does not describe the direction of the surgical insertion approach, which is
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`posterior.
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`13.
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`In paragraph 104, Dr. Sachs references figure 12 of my ‘327 patent. He points out
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`that “[t]he threaded insertion hoie 13 is located on the anterior side of the plug, which
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`indicates the plug was inserted from an anterior approach.” Dr. Sachs thus contradicts his
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`previous position that lateral means inserted using a posterior approach. Notably, my ‘327
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`patents description of figure 12 makes no mention of the insertion direction.
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`instead, it
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`describes the ability of the hemioval implants to interdigitate when stacked, the use of a bar
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`15 to hold the stack upright, and that the hollow interior of the implants are filled with bone
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`graft material. Ex. NUVASlVE1006 at 6:41-59.
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`14.
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`In paragraph 104, Dr. Sachs references my testimony on cross examination during a
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`trial between Nuvasive and Warsaw. Ex. WARSAW2041 at 1522:21—-1523:1. He states
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`that my testimony “confirmed this interpretation of ‘laterat.”' While it is unclear which
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`interpretation Dr. Sachs is referencing, to the extent he contends it means that I defined
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`‘‘lateral'’ to mean a posterior or anterior insertion to the side of the rnid—saglttal plane, my
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`testimony, which immediately follows the testimony Dr. Sachs references is directly
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`contrary. Ex. WARSAW2041 at 1523:7510 (“Q. Okay. The mid—sagittal piane. So that's
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`something that crosses the vertebral body like that. Now, you've defined lateral to mean to
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`the side of that line; correct? A. No.")
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`In fact, I testified that my use of ‘‘lateral" in the ‘757
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` 7
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`
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`patent was specific to the context of my ‘757 patent, not that it was applicable to my later-
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`filed ‘327 patent. Ex. WARSAW2041 at 1524:17—19.
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`15.
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`In paragraph 105, Dr. Sachs writes that I “testified that the figures [figures 10 and 11
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`of my ‘327 patent] are not drawn correctly.’’ This earlier testimony was not referencing that
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`Figure 10 does not show a laterally inserted implant, but instead my comment was
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`specifically directed to the fact that the transverse processes in these illustrations “stick out
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`more than [they] should." Ex. WARSAW2041 at 155726-12.
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`I don‘t agree that this makes
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`“the teachings and disclosures [of my ‘327 patent] difficult to understand," as alleged by Dr.
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`Sachs in paragraph 105.
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`16.
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`In paragraph 105, Dr. Sachs states that “figures 10 and 11 of Brantigan are intended
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`to show the same implanted plug.” Dr. Sachs then suggests that these two figures are
`“inconsistent?” I disagree. The upper portion of figure 1t) of my ‘327 patent shows a pair of
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`my oval implants interdigitated and inserted laterally. In the lower portion of figure 10 of my
`‘327 patent we see a z—plasty annulotorny (58). This incision is used to gain access to the
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`disc space from an anterior approach. Thus, figure 10 shows both a lateral approach
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`(upper) and an anterior approach (lower). Figure 11 of my ‘327 patent illustrates the lower
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`intervertebrai space of figure 10 (prepared for an anterior insertion version of my implant),
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`not the upper portion of figure 10 that shows the laterally inserted implants. This is
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`demonstrated by the correlation of the element numbers (52 (vertebrae), 55 (vertebral disc),
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`56 (disc space) and 57 (lower vertebrae) between figures 10 and 11. See Ex.
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`7
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` 8
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`
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`NUVASNE1006 at 635-40.
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`if figure 11 was showing another view of the pair of oval
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`implants in figure 10, figure 11 would not show a single implant.
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`lfflgure 11 was referencing
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`the upper vertebrae, it would it identify vertebrae 51 and 52 rather than 52 and 57, it would
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`identify disc space 54 rather than 56 and it would not identify vertebral disc 55 because in
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`the upper space “all of the disc has been removed from the disc space 54." 6:20-21. A
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`side—by—side comparison of FIGS. 10-11 reveals these facts:
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`fig-9“
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`FIG. 10
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`I recognize that the Section Line XI-XI in figure 10 is incorrect and misplaced, but I believe
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`the following is clear from the two figures: (a) Figure 11 is not a perpendicular cross-
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`sectional view of what is shown in Figure 10, as is clear from the fact that Figure 11 shows
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`the same anterior-to~posterior (front-to-back) view that is shown in the lower portion of
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` 9
`
`
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`Figure 10, as illustrated by the transverse processes of vertebra 57 being shown also in
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`Figure 11 extending to the sides; and (b) Figure 11 shows the bottom two vertebrae 52 and
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`57 of Figure 10 (with 50 being labeled in both figures as the entire spinal column, or all
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`vertebrae in combination), and not the top two vertebrae 51 and 52 of Figure 10.
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`17.
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`In paragraph 106, Dr. Sachs contends that “[t]he implant or ‘plug’ depicted in Figures
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`10 and 11 is the same plug that is depicted in Figures 1, 4, 8, 10, and 11.” I disagree. The
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`figures show an illustrative variety of configurations of a modular design that can
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`accommodate an anterior or posterior or lateral surgical approach. For example, figure 8 is
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`different from figure 1.
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`In figure 1, the bridge (or connecting bar 15, shown in Figure 3)
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`inserts parallel to the shorter axis of the oval implant and parallel to the direction of inserter
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`hole 13. This design is shown in a stacked configuration in figure 4.
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`in figure 8, the
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`connecting bar 15 is perpendicular (not parallel) to the inserter hole 13. Thus, in contrast to
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`figure 4, the slots He in figure 8 are parallel to the longer axis of the oval and the inserter
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`hole is on the longer axis rather than the shorter axis of the oval. A spinal surgeon having
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`ordinary skill during the early 1990s (and even today) would have recognized that the
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`implant illustrated in figure 8 is analogous to the implant illustrated in the upper disc space
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`of figure 10, while the implant illustrated in figure 1 is analogous to the implant in the lower
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`disc space of Fig 10 as shown in detail in figure 11.
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`18.
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`In paragraph 108, Dr. Sachs argues that “if the dashed lines [on the left side of the
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`implants in figure 10] indicate ‘tool engagement mechanisms,’ the implant was likely
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`9
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`10
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`10
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`
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`inserted anteriorly and then rotated ninety degrees per the teachings of Dr. Brantigan." I
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`disagree. Dr. Sachs misinterprets the statement in my ‘327 patent that “the oval shape
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`simplifies the surgical procedure since it can be rotated or reversed and still fit the
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`vertebrae." NUVAStVE‘l006 at 2:24-25. This statement does not refer to rotation of the
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`implant after it is inserted into the disc space.
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`Instead, it means the implant is versatile
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`enough to be flipped over or spun ‘I80 degrees before insertion into the patient. Because
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`my ‘327 patent implant is symmetrical (with the exception of the inserter tool hole, which
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`some surgeons prefer not to use), the design simplifies the surgical procedure because it
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`makes it difficult to incorrectly insert the implant as there is no defined upper/lower surface
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`or frontlback to the implant. Moreover, it would be anatomically impossible to rotate the
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`implant of figure 10, even if doing so were physically possible, after placement in the patient
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`without a significant risk of damage to the great vessels andlor spinal cord.
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`If the implant of
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`figure 10 were small enough to be rotated in the body as Dr. Sachs suggests, it would then
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`be too small to be generally shaped and sized to conform with the disc space.
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`NUVASNE1006 at 4:5—8. As discussed below, such a small size would be contrary to the
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`disclosure of my ‘327 patent.
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`19.
`
`In paragraph 110, Dr. Sachs argues that “blood capiilaries in a vertebral body are
`
`concentrated in the center of the vertebral body where bone tends to be more cancellous." I
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`agree with this point, which is why my '327 patent implant has large apertures that overlay
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`the cancellous region of the vertebral body to facilitate bone ingrowth. See, e. g., Ex.
`
`10
`
`11
`
`
`11
`
`
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`NUVASlVE1006, col. 5:40-43. However, I disagree with Dr. Sachs’ contention that ‘“[i]f the
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`plug 11 did rest on the edges of the implant [sic “vertebral body"), the blood capillaries
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`would not grow into the grooves on the upper and lower surfaces of the implant." As
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`described in column 5, lines 22-29, the ridges of my implant would “bite into” the “hard end
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`faces” of the vertebral bodies so that the valleys would provide “gaps or troughs" for the
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`ingrowth. During such a surgery in a live patient, there was blood residing in some or all of
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`the valleys between the ridges of the implant, and those valleys were adjacent to the bone
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`graft material in the central aperture of the implant, thereby leading to capillary and bone
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`ingrowth into some or all of the “gaps or troughs” defined by the valleys. See
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`NUVASlVE1006, col. 5:22~29.
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`. As such, when the outer perimeter edges of the implant of
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`my ‘327 patent rests on that cortical bone it can accommodate bone ingrowth while also
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`reserving the more cancellous region of the vertebral body for alignment with the large
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`fusion apertures of the implant. Of course, my ‘327 patent implant rests on this outer region
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`of the bone because it is denser than the cancellous bone of the vertebral body and can
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`therefore support greater mechanical loads.
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`20.
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`In paragraph 111, Dr. Sachs disagrees “that the length of the plugs in Brantigan ’327
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`is sized to occupy substantially the full transverse width of the vertebral bodies and is
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`greater than the depth of the disc space." I disagree with Dr. Sachs. While Dr. Sachs cites
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`to my trial testimony to support this argument that my ‘327 patent does not rest on the
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`outermost cortical ring edge of the vertebra (Ex. WARSAW2041 at 1520:9—10), he ignores
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`11
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`12
`
`
`12
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`
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`my subsequent testimony which directly contradicts his main assumption. Ex.
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`WARSAW2041 at 1521 :1 1-21 (“Q. Okay. It says, "the periphery of the oval ring is grooved
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`to accommodate ingrowth of blood capillaries." Do you see that? A. Yes. Q. Soto a person
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`of ordinary skill in the art reading this, we see that figure 1, this implant, is designed to fit
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`snuggly within the cortical ring; correct? A. No. Q. Well, you just testified that capillaries
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`don't grow out of the apophyseal ring, did you not? A. You are mischaracterizing human
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`anatomy")
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`In fact, as discussed above, capillaries do grow out of the cortical bone on the
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`perimeter of the vertebral body (because without capillaries in the cortical bone, it would be
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`nothing more than dead matter).
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`21.
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`In paragraph 112, Dr. Sachs argues "that an implant that is sized and shaped to
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`conform with an endplate would not span substantially the full transverse width of the
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`vertebral body." I disagree. My patent teaches that “[t]he device 10 is an oval ring plug 11
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`generally shaped and sized to conform with the disc space between adjoining vertebrae
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`in a vertebral column." Ex. 1006 at 4:5—8 (emphasis added). Human intervertebral discs rest
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`on the hard bone faces of the vertebrae. Given that my ‘327 patent implant was designed to
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`replace the disc with an implant of the same size and shape, 1 disagree with Dr. Sachs’
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`suggestion that my ‘327 patent is limited to implants substantially smaller than the disc
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`space. My ‘327 patent never says the implant should sit on the cancellous bone as Dr.
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`Sachs suggests; it describes just the opposite. Ex. NUVASNE1006 at 1:68-2:4 (“These
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`ring-like prosthetic devices are bottomed on the hard bone faces or end plates of adjacent
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`12
`
`13
`
`
`13
`
`
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`vertebrae and are generally oval shaped to conform with the general outline perimeter of the
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`vertebrae”).
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`22.
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`In paragraph 113, Dr. Sachs repeats his arguments about what “lateral" means in my
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`‘327 patent and his argument that my ‘327 patent only discloses implants that can be
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`inserted in anterior and posterior approaches.
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`l disagree with both of these arguments as
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`discussed above. ‘The term “lateral" does not mean “anterior" in my ‘327 patent, as
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`suggested in paragraph 113 by Dr. Sachs.
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`It means a ‘‘lateral‘' approach. The implants can
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`be inserted in a lateral approach and my ‘327 patent specifically says so, which I believe is
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`clear from figure 10 and reading 2:64-66, 5:30-35, 6:61-69.
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`23.
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`I hereby declare that all statements made herein of my own knowledge are true and
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`that all statements made on information and belief are believed to be true; and further that
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`these statements were made with the knowledge that willful false statements and the like so
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`made are punishable by fine or imprisonment, or both, under Section 1001 of the Title 18 of
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`the United States Code and that such willful false statements may jeopardize the validity of
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`the application or any patents issued thereon.
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`Dated: March 10, 2014
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`W
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`K7
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