Case IPR2013-00395
`U.S. Patent No. 8,444,696
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`NUVASIVE, INC.
`Petitioner
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`v.
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`WARSAW ORTHOPEDIC, INC.
`Patent Owner
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`Patent Number: 8,444,696
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
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`________________
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`Case IPR2013-00395
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`___________________________________________________
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`WARSAW’S MOTION FOR OBSERVATION REGARDING
`CROSS-EXAMINATION OF DR. BRANTIGAN
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`U.S. Patent No. 8,444,696
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`
`Patent Number: 8,444,696
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
`
`________________
`
`
`Case IPR2013-00395
`
`___________________________________________________
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`WARSAW’S MOTION FOR OBSERVATION REGARDING
`CROSS-EXAMINATION OF DR. BRANTIGAN
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`EXHIBITS
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`WARSAW2001 Affidavit of Mr. Luke Dauchot.
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`WARSAW2002 Affidavit of Mrs. Nimalka Wickramasekera.
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`WARSAW2003 U.S. Patent No. 4,834,757 to Brantigan
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`WARSAW2004 U.S. Patent No. 5,425,772 to Brantigan
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`WARSAW2005 Declaration of Dr. Charles L. Branch, Jr., M.D.
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`WARSAW2006 Curriculum vitae of Dr. Charles L. Branch, Jr., M.D.
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`WARSAW2007 Comparison of claim 1 of the ‘696 patent and claim 1 of the
`‘430 patent.
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`WARSAW2008 Comparison of claim 4 of the ‘696 patent and claim 4 of the
`‘430 patent.
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`WARSAW2009 Deposition transcript of Dr. John W. Brantigan, M.D. taken
`April 7, 2014.
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`WARSAW2010 Declaration of Lori Ferrell, CPA, CGMA.
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`WARSAW2011 CLYDESDALE® Spinal System Product Information.
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`1
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`Warsaw Orthopedic, Inc. (“Patent Owner”) submits this motion for
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`observation regarding cross-examination of Dr. Brantigan, the reply declarant of
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`Petitioner NuVasive, pursuant to the Board authorization provided via email
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`communication dated June 18, 2014. In lieu of taking an additional deposition of
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`Dr. Brantigan, the parties have agreed to Patent Owner’s use of the prior deposition
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`testimony (taken April 7, 2014) of Dr. Brantigan. Warsaw submits the following
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`observations based on Dr. Brantigan’s prior deposition testimony.
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`Observation 1
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`In Exhibit 2009 (at 81:2 to 82:20; and 86:15 to 87:7), Dr. Brantigan
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`concedes that adding ratchetings such as the nubs 122 of Brantigan ‘035 to the
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`intermediate ridges 68, 68a of the spinal disk implant 50 of Senter would cause
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`resistance to insertion thereof between the vertebrae 22a and 22b. This testimony
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`is relevant to the reply declaration of Dr. Brantigan at paragraphs 8 and 9 because
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`Dr. Brantigan now ignores the downside (specifically identified in Senter) of
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`adding ratchetings such as the nubs 122 to the intermediate ridges 68, 68a. Such
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`resistance to insertion is undesirable – Senter indicates that the ridges 68, 68a are
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`“preferably smooth, without serrations, to permit it to be surgically implanted.”
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`(Patent Owner’s Response at 36:1-5; and Senter (Ex. 1007) at 11:30-31.)
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`Furthermore, Dr. Brantigan in paragraph 8 of the reply declaration considers
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`adding ratchetings such as nubs 122 to the intermediate ridges 68, 68a would be a
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`2
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`“belt-and-suspenders” approach, but such an approach is contrary to the express
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`teachings of Senter.
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`Observation 2
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`In Exhibit 2009 (at 92:22-24), Dr. Brantigan indicates that, when placing
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`bone in an opening of the modified spinal disk implant 50 of Senter, “you would
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`put as much bone in there as you could,” and “[t]hat bone would be tending to
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`bulge out beyond the confines of the implant.” This testimony is relevant to the
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`reply declaration of Dr. Brantigan at paragraph 11 because Dr. Brantigan now
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`asserts that “[o]ne of skill in the art would also have known before June 1995, as is
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`known today, that spinal fusion implants do not need to be loaded to the very
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`absolute top of the fusion aperture, in order to facilitate bone growth through the
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`implant from one adjacent vertebra to the other.” During insertion between the
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`vertebrae 22a and 22b, the bone filling the opening of the modified spinal disk
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`implant 50 of Senter would be subject to dislodgement. (Patent Owner’s Response
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`at 44:12-15.) Patent Owner submits that Dr. Brantigan’s changing testimony is
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`relevant to his credibility and to whether one of ordinary skill would modify the
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`spinal disk implant 50 of Senter as suggested by Petitioner NuVasive.
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`Observation 3
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`In Exhibit 2009 (at 94:1-22), Dr. Brantigan indicates that the portion of the
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`intermediate ridges 68, 68a of the spinal disk implant 50 of Senter removed to
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`provide the opening therethrough would be filled with bone-growth promoting
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`material, and that a portion of the bone-growth promoting material that now
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`occupies the cut-away of the intermediate ridge 68 would extend above the
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`posterior ledge 60. Regarding the bone-growth promoting material that extends
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`above that posterior ledge 60, Dr. Brantigan in Exhibit 2009 (at 96:7-8) indicates
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`that “I believe that some of the bone would be scraped off.” This testimony is
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`relevant to the reply declaration of Dr. Brantigan at paragraphs 13 and 14 because
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`Dr. Brantigan now disparages the dislodgement problem identified by Patent
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`Owner. The bone-growth promoting material filling the cut-away of intermediate
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`ridge 68 would not be protected during insertion of the modified spinal disk
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`implant 50 between the vertebrae 22a and 22b. (Patent Owner’s Response at
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`44:12-15.) As seen in Petitioner NuVasive’s modified Fig. 3 of Senter
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`(Petitioner’s Corr. Petition ‘395 at page 14), the abrupt transition of the
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`intermediate ridge 68 with the posterior ledge 60 does not provide such protection.
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`Furthermore, Dr. Brantigan (reply declaration at paragraph 13) now asserts that,
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`since Medtronic, Inc. (Patent Owner’s parent company) does not identify
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`dislodgement problems associated with the Clydesdale implant, the dislodgement
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`problems identified by Patent Owner regarding the modified spinal disk implant 50
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`of Senter are not actually a problem. In making these assertions, Dr. Brantigan
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`does not acknowledge his previous indication (“I believe that some of the bone
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`4
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`would be scraped off”), and he ignores the differences between the modified spinal
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`disk implant 50 of Senter and the Clydesdale implant.
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`Observation 4
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`In Exhibit 2009 (at 113:16 to 114:24), Dr. Brantigan indicates that the
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`design objectives of pyramids 76 of the engagement region 74 of Wagner are
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`probably met including preventing the spinal disk implant 50 from shifting
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`positions and moving forward, backward, and side-to-side from the proper position
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`established by the surgeon. Dr. Brantigan in Exhibit 2009 (at 120:13-15) also
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`agreed that “[f]or [the spinal disk implant 50 of] Wagner to be stable in the disk
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`space, it relies on the engagement region of his pyramids to sink into the
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`cancellous bone.” Furthermore, Dr. Brantigan in Exhibit 2009 indicated that the
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`nubs 122 of Brantigan ‘035 were “designed to particularly avoid retropulsion” (at
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`128:9), and that the nubs 122 “substantially inhibit retropulsion” and “[o]nce
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`they’re in place, they do provide some resistance with motion in the opposite
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`direction [in the direction of insertion] but less resistance to motion” (at 126:18-21).
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`This testimony is relevant to the reply declaration of Dr. Brantigan at paragraph 16
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`because Dr. Brantigan now asserts that the nubs 122 of Brantigan ‘035 “can also
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`provide an anchoring effect in multiple directions (forward, backward, and side-to-
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`side) after ‘biting into’ the vertebrae and provide increased resistance to the
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`implant backing out.” In comparison to the reply declaration, Dr. Brantigan is
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`5
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`somewhat muted in his previous testimony regarding the capabilities of the nubs
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`122 in providing the resistance to motion in the direction of insertion. In reality,
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`the nubs 122 provide diminished capabilities in comparison to the engagement
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`region 74 with the pyramids 76. (Patent Owner’s Response at 54:19-20.) In
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`making his assertions in the reply declaration, Dr. Brantigan does not acknowledge
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`his previous somewhat muted description of the capabilities of the nubs 122, and
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`he ignores the diminished capabilities of the nubs 122 in comparison to the
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`engagement region 74 with the pyramids 76.
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`Observation 5
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`In Exhibit 2009, Dr. Brantigan indicated that the nubs 122 of Brantigan ‘035
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`were “designed to particularly avoid retropulsion” (at 128:9), and that the nubs 122
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`“substantially inhibit retropulsion” and “[o]nce they’re in place, they do provide
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`some resistance with motion in the opposite direction [in the direction of insertion]
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`but less resistance to motion” (at 126:18-21). This testimony is relevant to the
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`reply declaration of Dr. Brantigan at paragraph 17 because Dr. Brantigan now
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`unequivocally asserts that Dr. Branch’s indication that providing the nubs 122 on
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`the modified spinal fusion implant 10 of Michelson ‘037 would cause the resulting
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`implant to be susceptible to forward and side-to-side movement “is not true and is
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`not consistent with the clinical realities of inserting a spinal implant before June
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`1995 (and even today).” In comparison to the reply declaration, Dr. Brantigan is
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`6
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`somewhat muted in his previous testimony regarding the capabilities of the nubs
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`122 in providing resistance to motion in the direction of insertion. Before Dr.
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`Brantigan’s somewhat muted description of the capabilities of the nubs 122, Dr.
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`Brantigan in Exhibit 2009 (at 126:8-11) agreed that “Brantigan’s ‘035 nubs,
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`however, only prevent movement in one direction.” Patent Owner submits that Dr.
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`Brantigan’s changing and contradictory testimony is relevant to his credibility and
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`to whether one of ordinary skill would modify the spinal fusion implant 10 of
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`Michelson ‘037 as suggested by Petitioner NuVasive.
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`Observation 6
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`In Exhibit 2009, Dr. Brantigan indicated that the nubs 122 of Brantigan ‘035
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`were “designed to particularly avoid retropulsion” (at 128:8-9), and that the nubs
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`122 “substantially inhibit retropulsion” and “[o]nce they’re in place, they do
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`provide some resistance with motion in the opposite direction [in the direction of
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`insertion] but less resistance to motion” (at 126:18-21). Dr. Brantigan in Exhibit
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`2009 (at 126:8-11) also contradictorily agreed that “Brantigan’s ‘035 nubs,
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`however, only prevent movement in one direction.” This testimony is relevant to
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`the reply declaration of Dr. Brantigan at paragraph 18 because Dr. Brantigan now
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`unequivocally asserts that “directional ‘ratchetings’ or teeth [i.e., nubs 122 of
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`Brantigan ‘035] resist both implant back-out and forward movement of the implant,
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`and a person of ordinary skill in the art before June 7, 1995 would have recognized
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`7
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`this plain fact.” Patent Owner submits that Dr. Brantigan’s changing and
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`contradictory testimony is relevant to his credibility and to whether one of ordinary
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`skill would modify the spinal fusion implant 10 of Michelson ‘037 as suggested by
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`Petitioner NuVasive.
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`Observation 7
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`In Exhibit 2009 (at 123:12-15), Dr. Brantigan agreed that he hasn’t “shown
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`any piece of prior art with a convex upper or lower surface and ratchetings on
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`those convex surfaces.” This testimony is relevant to the reply declaration of Dr.
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`Brantigan at paragraph 19 because Dr. Brantigan now indicates that putting
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`ratchetings (such as the nubs 122 of Brantigan ‘035) on the top and bottom convex
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`bearing surface of the modified spinal fusion implant 10 of Michelson ‘037 would
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`serve as a “belt-and-suspenders” approach to prevent migration of the implant.
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`Patent Owner submits that, if the features of independent claims 1 and 4 could
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`simply be equated to those available for a “belt-and-suspenders” approach, one
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`would expect all of these features to be incorporated into at least one of Dr.
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`Brantigan’s own patents, which they were not.
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`Observation 8
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`In Exhibit 2009 (at 173:2), Dr. Brantigan indicated “I believe so” in
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`response to the following question (at 172:23-25): “[s]o you saw that lots of
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`people are selling implants that appear to fall within the scope of what you've been
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`studying in the '696 patent; correct?” This testimony is relevant to the reply
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`declaration at paragraph 28 because Dr. Brantigan now asserts that “I disagree with
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`the mischaracterization of my testimony as suggesting that there has been
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`significant adoption of spinal fusion implants that appear to fall within the scope of
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`the ‘696 patent.” Patent Owner submits that Dr. Brantigan’s testimony in Exhibit
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`2009 speaks for itself.
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`Observation 9
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`In Exhibit 2009 (at 175:18-20), Dr. Brantigan indicated that “[h]e [Dr.
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`Michelson] put those elements together in a combination that I did not see all of
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`those elements at that time” in response to the following question (at 175:13-16):
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`“[b]ut did you ever see anybody make an implant or even describe an implant in a
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`patent or a publication that had the features that Dr. Michelson put together in his
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`claimed implant of the ‘696 patent before him?” This testimony is relevant to the
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`reply declaration of Dr. Brantigan at paragraph 29 because Dr. Brantigan now
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`complains that he disagrees with “the characterization of my testimony as
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`suggesting that the features of independent claims 1 and 4 were never combined
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`‘prior to Dr. Michelson’s invention.’” Patent Owner submits that Dr. Brantigan’s
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`testimony in Exhibit 2009 speaks for itself.
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`9
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`Observation 10
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`In Exhibit 2009, Dr. Brantigan (at 77:25 to 78:7) concedes that “[t]he angle
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`of the forward facets in the modified Senter implant in Paragraph 38 of [Dr.
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`Brantigan’s first] declaration is much larger than the angle of the forward facets
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`shown in Figure 19 of the Brantigan ‘035 reference.” Furthermore, when
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`questioned in Exhibit 2009 (at 78:9-18) why all of the nubs in the modified Senter
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`implant in Paragraph 38 of Dr. Brantigan’s first declaration are not all the same
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`size, Dr. Brantigan answered that the nubs were “intended to be” all the same size.
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`Moreover, Dr. Brantigan in Exhibit 2009 (at 78:24 to 79:5) agreed that “[w]hen
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`comparing the gaps in the nubs shown in the modified Senter implant in Paragraph
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`38 of [Dr. Brantigan’s first] declaration with Figure 19 out of the Brantigan ‘035
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`implant, there are no gaps between the nubs 122 in the Brantigan ‘035 reference.”
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`This testimony is relevant to the reply declaration of Dr. Brantigan at paragraph 29
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`because Dr. Brantigan now complains that Patent Owner pointed out that Dr.
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`Brantigan conceded that the modified Fig. 3 of Senter (in Paragraph 38 of Dr.
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`Brantigan’s first declaration) “does not reflect modifications of Senter according to
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`the teachings of Brantigan ‘035.” (Patent Owner’s Response at 35:5-6.)
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`Observation 11
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`When questioned in Exhibit 2009 (at 81:17-22) about whether putting nubs
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`122 on the implant of Senter would cause drag across the vertebral surface, Dr.
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`10
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`Brantigan answered “[a] bit of drag. Sure.” This testimony is relevant to the reply
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`declaration of Dr. Brantigan at paragraph 33 because Dr. Brantigan now indicates
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`regarding this earlier testimony, “I then testified that while addition of the
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`ratchetings to the spinal implant of Senter would not facilitate insertion, it would
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`also not interfere with insertion of the so-modified implant.”
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`Observation 12
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`In Exhibit 2009, Dr. Brantigan agreed (at 56:12-14) that “the orientation of
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`the nubs [122 of the plug implant 111 of Brantigan ‘035] allow movement in one
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`direction of insertion,” and agreed (at 56:15-17) that “the nubs’ orientation
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`prevents movement in the opposite direction.” Furthermore, Dr. Brantigan in
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`Exhibit 2009 agreed (at 56:24 to 57:7) that it was correct to say that
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`“Brantigan ‘035 does not teach placing features [on the plug implant 111] that
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`prevent movement in both directions.” When questioned in Exhibit 2009 (at
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`58:10-22) whether “the feature [in Brantigan ‘035] that actually stops the implant
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`from moving in the direction of insertion is the blind wall 116,” Dr. Brantigan
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`agreed. This testimony is relevant to the reply declaration of Dr. Brantigan at
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`paragraph 36 because Dr. Brantigan disagrees with Patent Owner’s
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`characterization of this testimony as indicating that the plug implant 111 of
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`Brantigan ‘035 is susceptible to movement.
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`11
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`Respectfully Submitted,
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`/Thomas H. Martin/
`Thomas H. Martin
`Registration No. 34,383
`Attorney for Patent Owner
`MARTIN & FERRARO, LLP
`1557 Lake O’Pines Street, NE
`Hartville, Ohio 44632
`Telephone: (330) 877-0700
`Facsimile: (330) 877-2030
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`Dated: June 26, 2014
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`12
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