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