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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
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`Case No. IPR2013-00395
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`______________________________________________________
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`SECOND DECLARATION OF DR. JOHN W. BRANTIGAN, M.D.
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-145
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`Page 1 of 34
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`NUVASIVE 1017
`NuVasive v. Medtronic
`IPR2013-00395
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`I, Dr. John W. Brantigan, M.D., of Shaw Island, WA, declare that:
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`INTRODUCTION
`1.
`On June 24, 2013, I provided an initial Declaration in each of the IPR2013-
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`00395 and IPR2013-00396 proceedings. See Ex. 1001 for IPR2013-00395 and Ex. 1101
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`for IPR2013-00396. I reaffirm the opinions stated in that Declaration. I provide this Second
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`Declaration in response to statements made in the April 11, 2014 Patent Owner’s Response
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`and the accompanying April 10, 2014 Declaration of Dr. Charles L. Branch, Jr. (“Branch
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`Declaration”) submitted in this proceeding. In this Second Declaration, I will respond to
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`some of the technical errors and mischaracterizations of my prior testimony that are
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`contained in the Patent Owner Response and supporting Branch Declaration.
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`2.
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`I have reviewed the '696 patent (Ex. 1002) and its prosecution history (Ex.
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`1003) from the view point of an experienced spine surgeon. Additionally, I have reviewed
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`the following patents and publications: (1) PCT Publication WO93/01771 to Senter et al.
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`(“Senter,” Ex. 1007); (2) PCT Publication WO 89/09035 to Brantigan (“Brantigan '035,” Ex.
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`1005); (3) U.S. Patent No. 5,192,327 to Brantigan (“Brantigan '327,” Ex.1006); (4) PCT
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`Publication WO90/00037 to Michelson (“Michelson '037,” Ex. 1008); (5) U.S. Pat. No.
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`5,443,514 to Steffee (“Steffee,” Ex. 1108); and (6) U.S. Patent No. 5,645,596 to Kim et al.
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`(“Kim,” Ex. 1110). I also have reviewed the Corrected Petition for Inter Partes Review in
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`each of the IPR2013-00395 and IPR2013-00396 proceedings, and my initial Declarations
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`signed on June 24, 2013 (Ex. 1001 for IPR2013-00395 and Ex. 1101 for IPR2013-00396). I
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`Page 2 of 34
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`also have reviewed the Patent Owner’s Response in each of the IPR2013-00395 and
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`IPR2013-00396 proceedings submitted on April 11, 2014, the accompanying Branch
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`Declaration (Ex. 2005), the other accompanying exhibits (including Exhibits 2003 (the
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`Brantigan ‘757 patent), 2004 (the Brantigan ‘772 patent), and 2009 (transcript of my April 7,
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`2014 Deposition in this proceeding), the transcript of the April 23, 2014 Deposition of Dr.
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`Branch (“Branch Depo.”) in this proceeding, and the December 20, 2013 Board Decision in
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`each of the IPR2013-00395 and IPR2013-00396 proceedings.
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`
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`SENTER IN VIEW OF BRANTIGAN ‘035
`3.
`On pages 26-29 of the Patent Owner’s Response (IPR2013-00395), Warsaw
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`argues that the implant of Senter does not provide the claimed “upper and lower bearing
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`surfaces . . . .being convex.” See also Ex. 2005 at ¶ 35. This argument, however, appears
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`to be based upon a narrower interpretation of claims 1 and 4 than my earlier analysis (first
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`Brantigan Declaration at ¶ 29), and incorporates requirements into the claims that are not
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`present in the claim language. I understand that the December 20, 2013 Board Decision
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`stated that “the claim language does not require that the convexity be along the entire
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`length of the implant.” See Board Decision, p. 9. Based on my reading of the claims, I
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`agree with the Board’s interpretation that one of skill in the art in June of 1995 would not
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`have interpreted the claims to require that the convexity extend along the entire length of
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`the implant. As such, the plain meaning of the claim language (“upper and lower bearing
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`Page 3 of 34
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`surfaces . . . .being convex”) does not exclude the convexity shown in Senter. Additionally,
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`a person of ordinary skill in the art in June 1995 would not have recognized the claimed
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`convexity of the upper and lower bearing surfaces as being restricted to a specific degree of
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`convexity (“convex curvatures conforming to the anatomic endplates”). See Patent Owner’s
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`Response (IPR2013-00395) at pp. 16-17, 29; Ex. 2005, ¶ 35. If the claimed convexity of the
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`upper and lower bearing surfaces recited in claims 1 and 4 was restricted to only “convex
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`curvatures conforming to the anatomic endplates,” the requisite “curvature” of the bearing
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`surfaces would be patient-dependent, unknown, and undefined because the curvature of
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`anatomic endplates varies from patient to patient. Ex. 2005, ¶ 60 (describing the variations
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`in endplate curvature); Branch Depo. at 89:10-22.
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`MODIFICATION OF SENTER TO INCLUDE RATCHETINGS AS SUGGESTED BY
`BRANTIGAN ‘035
`4.
`On pages 33 to 34 of the Patent Owner’s Response (IPR2013-00395),
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`Warsaw implies that modification of the implant of Senter to include ratchetings, such as the
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`directional teeth 122 shown in Brantigan ‘035, on the convex upper and lower bearing
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`surfaces of Senter would cause forward movement of the implant once the implant is put in
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`place between two vertebrae. Additionally, in his deposition, Dr. Branch stated that
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`modifying Senter to include the ratchetings of Brantigan ‘035 would cause the implant to be
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`“propel[led]” toward the spinal cord once the implant is in place. See Branch Depo., 70:3-
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`19; see also Ex. 2005, ¶¶ 87, 91. A person of ordinary skill in the art would have
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`Page 4 of 34
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`recognized that this contention is not consistent with the clinical realities of inserting a spinal
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`implant before June 1995 (and even today).
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`5.
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`Contrary to pages 33 to 34 of the Patent Owner’s Response (IPR2013-00395)
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`and Dr. Branch’s testimony (Deposition p. 70:3-19 and Branch Declaration at ¶¶ 87, 91, and
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`others), such “ratchetings” as they are called in the Michelson ‘696 patent (which are more
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`commonly called “teeth” or directional teeth), oriented with a primary purpose of resisting
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`implant back-out as taught by the Brantigan ‘035 patent and other references, would not
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`“propel” an implant forward. Instead, such directional “ratchetings” or teeth resist both
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`implant back-out and forward movement of the implant, and a person of ordinary skill in the
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`art before June 7, 1995 would have recognized this plain fact. Of course, with directional
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`ratchetings or teeth, the resistance to forward movement of the implant can be less than the
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`resistance to implant back-out, but such ratchetings or teeth nevertheless resist forward
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`movement also. The resistance to movement in the forward direction is simply a matter of
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`physics and anatomy. The angling of the forward-facing ratchet face, in combination with
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`the presence of the ridge of the ratcheting which digs into the adjacent vertebrae end faces
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`when the adjacent vertebrae are forced against the bearing surfaces of the implant, causes
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`that resistance to the forward movement of the implant. See, e.g., Ex. 1005, 19:29-31
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`(teaching that such ratchetings “provid[e] a roughened surface, biting into and gripping” the
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`vertebral bone adjacent to the implant). This anchoring effect would be especially true for
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`anteriorly inserted implants such as Senter, in which it was common practice to distract the
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`Page 5 of 34
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`vertebrae apart during insertion of the implant and then remove the distraction after the
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`implant is finally seated to thereby cause the vertebrae to compress against the bearing
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`surface of the implant and its teeth. See Ex. 2009 85:12 to 87:12 (stating that, when using
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`anteriorly inserted interbody implants, “you generally distract the vertebral bodies apart and
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`the endplates apart”); Ex. 1007, p. 16:20-22 (“The spine 20 is typically distended slightly
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`during this final stage of insert . . . .”). Even in applications where forward resistance to
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`movement of the implant may not be needed (for example, if the disc annulus at the far side
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`of the disc space is still intact, thereby blocking forward movement of the implant out of the
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`disc space), the common design option of ratchetings or directional teeth provides
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`resistance to movement in the rearward (retraction) direction, in the forward (insertion)
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`direction, and even in a side-to-side direction (after the teeth “bite” or otherwise anchor into
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`the vertebral bone).
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`6.
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`Again responsive to pages 33 to 34 of the Patent Owner’s Response
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`(IPR2013-00395) and Dr. Branch’s testimony (Deposition p. 70:3-19 and Branch
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`Declaration at ¶¶ 87, 91, and others), in the process of advancing an implant (such as
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`Senter’s implant) into the space between two adjacent vertebrae, it is not “ratchetings” or
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`teeth on the implant that would somehow “propel” an implant forward into position. In other
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`words, there is no “ratcheting” movement forward of an implant by the implant’s
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`“ratchetings” in the typical sense of the word “ratcheting” (e.g., ratcheting teeth that interact
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`with a pawl or other indexing structure). Rather, the implant would be advanced or pushed
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`Page 6 of 34
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`into position between the adjacent vertebrae by the surgeon using an inserter tool (applying
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`an insertion force against the trailing end of the implant), as was conventional before June
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`7, 1995 and as plainly described in prior art references cited above. See also My First
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`Declaration in IPR2013-00395, Ex. 1001, ¶¶ 31, 38, and 43. In that sense, the label that the
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`Michelson ‘696 patent gives to the feature of anti-migration implant “teeth”—in particular, the
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`label of “ratchetings”—is a misnomer. The teeth or “ratchetings” on the implant bearing
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`surfaces do not ratchet or propel movement in any direction in the typical sense of the word
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`“ratcheting,” and a person of ordinary skill in the art before June 7, 1995 would have
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`recognized this fact. That typical use of the term “ratcheting” is not what is at play with the
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`so-called “ratchetings” or directional teeth on the implant having teeth shown in the ‘696
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`patent (e.g., Figure 9), or any of the prior art implants of record that have “ratchetings” or
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`teeth. See Ex. 1005 at FIGS. 18-19; 19:25 to 20:3; 20:30-33; and 21:1-5; Ex. 1108 at FIG.
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`3; 2:54-59.
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`7.
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`A person of ordinary skill in the art before June 7, 1995 would also have
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`understood that, during the procedure when an implant is implanted and put into place
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`between two adjacent vertebrae, the patient is not in a standing or seated position, but
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`rather is in a lying position, for example in a supine position (as with Senter’s anteriorly
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`inserted implant), a prone position, or lateral decubitus (on one side) position. In other
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`words, the full weight of the patient’s body is not causing the two adjacent vertebrae to
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`compress the disc space where the implant is to be positioned. Also, in many cases
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`Page 7 of 34
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`(including Senter and other anteriorly inserted implants), the two adjacent vertebrae are
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`distracted apart before and during the time that the implant is inserted. See My Prior
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`Deposition Testimony, Ex. 2009, 85:12 to 87:12; Ex. 1007, p. 16:20-22. As such, contrary
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`to pages 33 to 34 of the Patent Owner’s Response (IPR2013-00395) and Dr. Branch’s
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`testimony (Deposition p. 70:3-19 and Branch Declaration at ¶¶ 87, 91, and others), a person
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`of ordinary skill in the art before June 7, 1995 would have understood that the resistance to
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`both forward and rearward movement is less during the time of initial implant insertion than
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`it is later when distraction is removed (allowing the directional teeth or ratchetings of the
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`implant “bite” into the adjacent vertebrae) and when the full force of the patient’s weight
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`causes the two adjacent vertebrae to even further bear upon the implant. Ex. 1005, 19:29-
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`31.
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`8.
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`In the case of an implant with convex bearing surfaces, where Senter’s
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`convex bearing surface is secured within a concave groove formed in the vertebrae (Senter
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`at p. 17:8-9), the convexity of the bearing surface also serves to resist forward migration of
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`the implant. Therefore, contrary to pages 33 to 34 of the Patent Owner’s Response
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`(IPR2013-00395) and Dr. Branch’s testimony (Deposition p. 70:3-19 and Branch
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`Declaration at ¶¶ 87, 91, and others), putting “ratchetings” or other teeth on a surface of an
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`implant convex bearing surface was considered by persons of ordinary skill in the art before
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`June 7, 1995 to be a “belt-and-suspenders” approach to making sure the implant does not
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`migrate from the position where it is initially implanted in the disc space. See Ex. 1007, p.
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`Page 8 of 34
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`17:5-13; Ex. 1009, FIG. 7, 5:64-65 and 7:24-28. Thus, a person of ordinary skill in the art
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`before June 7, 1995 would have recognized that applying the traditional implant teeth
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`shown in the Brantigan ‘035 patent (which again, are called “ratchetings” in the ‘696 patent)
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`to the top and bottom convex bearing surfaces of the Senter implant (refer to ¶¶37-38 of the
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`June 24, 2013 Brantigan Declaration) would also serve as a “belt-and-suspenders”
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`approach to making sure the implant does not migrate (forward, backward, or side-to-side)
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`from the position where it is implanted.
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`9.
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`In summary, and responsive to pages 33 to 34 of the Patent Owner’s
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`Response (IPR2013-00395) and Dr. Branch’s testimony (Deposition p. 70:3-19 and Branch
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`Declaration at ¶¶ 87, 91, and others), the convex bearing surfaces of Senter’s implant
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`seated between the adjacent vertebrae would continue to assist in the prevention of forward
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`migration of the implant toward the spinal cord once in place, even if modified to include the
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`traditional feature of ratchetings or directional teeth that was known in field of implant design
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`before 1995. In addition, a person of ordinary skill in the art before June 7, 1995 would
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`have recognized that those ratchetings or directional teeth would, once the implant is in the
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`surgeon’s selected position, “bite into” the concave surfaces of the adjacent vertebrae so as
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`to prevent movement of the implant in both the forward direction and the reverse (or back-
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`out) direction. See, e.g., Ex. 1005, 19:29-31. Additionally, even if any slight movement of
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`the implant were to occur (in an unlikely scenario, for example, before fusion between the
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`two adjacent vertebrae has fully formed), such movement would be minor for the reasons
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`Page 9 of 34
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`explained above (e.g., probably less than half the length of one ratcheting) and the angled
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`configuration of the ratchetings of Brantigan ‘035 would bias the implant to move back into
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`the original placed position such that the ratchetings would rest within the original “bite”
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`grooves in the vertebrae created by the teeth/ratchetings after the initial placement of the
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`implant. This coupling of the ratchetings with the original “bite” grooves in the adjacent
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`vertebrae created by the ratchetings would be an additional means of accomplishing
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`Senter’s stated goal of “lock[ing] the implant 50 or 74 into place [to] prevent dislocation of
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`the implant.” Ex. 1007 17:6-7. One of skill in the art before June 1995 would have
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`considered convex bearing surfaces and anti-migration directional teeth (called “ratchetings”
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`in the ‘696 patent) as two traditional tools in an implant design toolbox before June 1995,
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`and would not have considered these different implant migration tools inconsistent with one
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`another such that they could not be used in the same implant.
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`MODIFICATION OF SENTER TO INCLUDE A BONE FUSION OPENING AS
`SUGGESTED BY BRANTIGAN ‘035
`10. On pages 44 to 45 of the Patent Owner’s Response (IPR2013-00395),
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`Warsaw contends that modifying Senter’s implant with a convex bearing surface to include
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`one or more large openings for receiving fusion promoting material (a known prior art
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`feature of Brantigan ‘035 and others) would cause bone filling inserted into the opening to
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`“necessarily extend above and below the surfaces of the anterior platforms 56, 56a and the
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`posterior ledges 60, 60a” and would therefore “not be protected by the leading end of the
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`Page 10 of 34
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`modified spinal disk implant 50 of Senter during insertion and would be subject to
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`dislodgement via contact with the superior and inferior vertebrae.” Alternatively, Warsaw
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`asserts that if “bone did not entirely fill the void created by the suggested opening, such
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`bone could be protected by the leading end of the modified spinal disk implant 50 of Senter
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`during insertion, but would be separated from the superior and inferior vertebrae 22a and
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`22b by significant gaps” thereby preventing successful fusion. Patent Owner’s Response
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`(IPR2013-00395) at pp. 44-45; see also Branch Decl. at ¶¶ 98-99. Based upon my
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`knowledge and experience in this field, I believe that a person of ordinary skill in the art
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`before June 1995 would have recognized that this alleged concern would not have been
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`problematic for an ordinary surgeon in 1995, and is not a problem now.
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`11.
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`The dislodgement problem theorized by Warsaw’s Response and Dr. Branch
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`ignores the traditional clinical practice for anteriorly inserted implants (including Senter’s
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`implant) in which the two adjacent vertebrae are distracted apart before and during the time
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`that the implant is inserted. See Ex. 2009 85:12 to 87:12; Ex. 1007, p. 16:20-22. Therefore,
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`if dislodgement of some of the fusion promoting substance from a top part of the fusion
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`opening might pose a legitimate risk, then an ordinary surgeon before June 1995 would
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`have readily known how to address that concern by distracting the two adjacent vertebrae
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`from one another so as to avoid such dislodgement. One of skill in the art would also have
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`known before June 1995, as is known today, that spinal fusion implants do not need to be
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`loaded to the very absolute top of the fusion aperture, in order to facilitate bone growth
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`Page 11 of 34
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`through the implant from one adjacent vertebra to the other, especially due to the bleeding
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`that would occur to fill minor gaps on both the upper and lower surfaces of Senter’s implant
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`during and after it is implanted. In addition, one of skill in the art would have known before
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`1995, that if the fusion promoting substance included cancellous bone, such cancellous
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`bone had a tendency to expand from its tightly packed state after the implant was placed
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`between the vertebrae, thereby also filling minor gaps that might exist between the implant
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`and the vertebral body. One of skill in the art would also have known before 1995, as would
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`also be known today, that some minor dislodgement of fusion promoting material may be
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`tolerated without compromising the ability of the fusion implant to carry out the fusion
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`process.
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`12.
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`Additionally, if the alleged dislodgement problem (conventional large fusion
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`“openings” through an implant with convex bearing surfaces) was in fact a legitimate
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`problem for ordinary surgeons before June 7, 1995, then that is a problem for which the
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`‘696 patent provides no solution. For example, although the ‘696 patent suggests an
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`“opening” to an internal chamber of the convex implant embodiment 300 (FIGS. 13-17 and
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`col. 9:48-51), it provides no guidance regarding the design of such “openings” that would be
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`appropriate in an implant having convex bearing surfaces. In particular, the ‘696 patent
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`discloses no protective structure on the leading end of an implant with convex bearing
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`surfaces or other protective mechanism so as to prevent dislodgement of fusion promoting
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`material from an opening in a convex surface during the implantation process. Further, the
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`Page 12 of 34
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`‘696 patent does not even describe where or how one or more “openings” would be
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`included in the implant 300 with convex bearing surfaces. For example, the ‘696 patent
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`does not disclose whether and how the then-conventional large openings like those shown
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`in implant 400 of the ‘696 patent (see Figures 18-23) would be incorporated into an implant
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`with convex bearing surfaces such as implant 300 of the ‘696 patent. Therefore, unless
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`Warsaw and Dr. Branch are contending that the ‘696 patent fails to enable ordinary
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`surgeons before June 1995 to overcome the alleged dislodgement problem, the lack of any
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`solution in the ‘696 patent about how to avoid dislodgement of materials from the “opening”
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`extending through the convex implant 300 supports the fact that avoiding this supposed
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`dislodgement problem was well within the level of ordinary skill in the art in 1995.
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`13.
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` To further illustrate that the dislodgement problem theorized by Warsaw and
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`Dr. Branch (Patent Owner’s Response (IPR2013-00395) at pp. 44-45; Branch Decl. at ¶¶
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`98-99) is, in fact, not a problem, the Medtronic Clydesdale spinal implant has one very large
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`opening for receiving fusion-promoting material, and that one large hole extends from a top
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`convex bearing surface of the implant to a bottom convex bearing surface of the implant:
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`Page 13 of 34
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`See Ex. 2010, Appendix A. As shown in the diagram of the Medtronic Clydesdale implant
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`shown directly above, the leading edge of the one large hole in the Clydesdale implant is
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`not protected by any structure on the leading edge of the implant. As such, if dislodgment
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`of bone fusion promoting substance from a large fusion hole during the insertion of a convex
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`implant was an actual problem, that same problem would also be present with the
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`Clydesdale implant design. I am not aware of Medtronic ever notifying the surgeon
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`community that dislodgement of the bone growth promoting substance is a problem with its
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`Clydesdale implant, and I think it unlikely that this is a problem.
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`14.
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`Therefore, the alleged dislodgment problem with modifying the spinal implant
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`of Senter to include one or more large fusion openings as taught by the Brantigan ‘035
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`patent would not have been a problem for practicing surgeons before June 1995 (especially
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`when the disc space is distracted during implant insertion as taught by Senter), and would
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`not have been a reason why an ordinary implant designer before June 1995 would have
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`Page 14 of 34
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`avoided adding a traditional bone fusion aperture to the Senter implant, especially given the
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`bone fusion benefits described in Brantigan ‘035 and otherwise known by ordinary surgeons
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`before June 1995.
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`MODIFICATION OF MICHELSON ‘037 TO INCLUDE CONVEX BEARING SURFACES AS
`SUGGESTED BY WAGNER
`15. On pages 47-52 of the Patent Owner’s Response (IPR2013-00395), Warsaw
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`argues that the image of the implant 10 in FIGS. 1a-c of Michelson ‘037 “implies its use for
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`treatment” for a disc space that “lost its bi-convex appearance.” See also Ex. 2005, ¶¶ 60,
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`104. In other words, Warsaw argues that Michelson ‘037’s implant is limited for use only in
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`circumstances in which vertebral endplates are essentially flat or have otherwise lost their
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`bi-concave appearance. Id. Based upon my knowledge and experience in this field, I
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`believe that a person of ordinary skill in the art before June 1995 would have recognized
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`that Michelson ‘037’s teaching is not so limited and that Michelson ‘037 expressly teaches
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`the opposite. Namely, Michelson ‘037 teaches that the disclosed implant device “will fit any
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`patient, anywhere throughout the spine, in any vertebral disc space, and without alteration
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`of that interspace regardless of its natural size or shape.” Ex. 1008, p. 5:18-22. All of
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`Warsaw’s arguments that limit the use of Michelson ‘037’s implant (including the
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`contentions that it then would not be modified to provide convex bearing surfaces as
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`suggested in Wagner) are inconsistent with the express teaching found in the Michelson
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`Page 15 of 34
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`‘037 patent and what a person of ordinary skill in the art before June 1995 would have
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`understood from such a teaching.
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`MODIFICATION OF MICHELSON ‘037 TO INCLUDE RATCHETINGS AS SUGGESTED
`BY BRANTIGAN ‘035
`16. On pages 52-55 of the Patent Owner’s Response (IPR2013-00395), Warsaw
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`argues that, if the implant of Michelson ‘037 was modified to include convex bearing
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`surfaces as suggested by Wagner, then the resulting combination must necessarily be
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`limited to also including Wagner’s “pyramids” rather than any other conventional type of
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`engagement features. See also Ex. 2005, ¶¶ 105-108. Based upon my knowledge and
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`experience in this field, I believe that a person of ordinary skill in the art before June 1995
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`would have recognized that Wagner’s teaching for engagement features is not so limited
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`and that the available design options for conventional engagement features included
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`directional teeth (as suggested, for example, by Brantigan ‘035). In particular, Wagner first
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`suggests that the engagement features can be any “three-dimensional features” extending
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`above the bearing faces, and then discloses that the depicted “embodiment” of such three-
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`dimensional features includes the “pyramids.” Ex. 1009, 5:64-6:1. A person of ordinary skill
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`in the art before 1995 would not have concluded that “pyramids” are the only option
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`available (or even the best available option) for implementing three-dimensional
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`engagement features on convex bearing surfaces. Furthermore, as described in my June
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`24, 2013 Declaration (¶¶47-48), a person of ordinary skill in the art before 1995 would have
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`Page 16 of 34
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`recognized that the directional teeth or ratchetings suggested in Brantigan ‘035 were
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`another traditionally available option for such “three-dimensional features” on the implant’s
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`bearing surfaces and that such directional teeth or ratchetings can also provide an
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`anchoring effect in multiple directions (forward, backward, and side-to-side) after “biting into”
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`the vertebrae and provide increased resistance to the implant backing out. Ex. 1005, 19:25
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`to 20:3, 21:1-5; FIGS. 18-19. The ordinary implant designer before June 1995 was more
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`than capable of applying Wagner’s suggestion for convex bearing surfaces while also
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`considering and implementing Brantigan’s suggestion for ratchetings on the bearing
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`surfaces.
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`17. On pages 54 to 55 of the Patent Owner’s Response (IPR2013-00395),
`
`Warsaw implies that implementing traditional ratchetings, such as the directional teeth 122
`
`shown in Brantigan ‘035, on the convex upper and lower bearing surfaces of the modified
`
`Michelson ‘037 implant would cause the implant to be “susceptible to forward and side to
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`side movement.” Additionally, in his Declaration, Dr. Branch stated that implementing the
`
`traditional ratchetings of Brantigan ‘035 on the modified Michelson ‘037 implant would cause
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`the implant to be “susceptible to forward and side to side movement.” See Ex. 2005,
`
`¶¶108-109. Again, for the same reasons described above in ¶¶ 6-11, this contention is not
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`true and is not consistent with the clinical realities of inserting a spinal implant before June
`
`1995 (and even today). Additionally, although it is possible that such directional teeth or
`
`ratchetings can afford forward or side-to-side movement during the insertion process (when
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`Page 17 of 34
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`
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`the implant is attached to the inserter tool and moved under manual force from the
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`surgeon), it was known that these structures would provide an anchoring effect in multiple
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`directions (forward, backward, and side-to-side) after reaching the final position and “biting”
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`into the vertebral bone. See Ex. 1005, 19:25 to 20:3, 21:1-5; FIGS. 18-19.
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`18. Contrary to pages 54 to 55 of the Patent Owner’s Response (IPR2013-00395)
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`and Dr. Branch’s testimony (Deposition p. 70:3-19 and Branch Declaration at ¶¶ 108, 109,
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`and others), such directional “ratchetings” as they are called in the Michelson ‘696 patent
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`(which are more commonly called “teeth”), do not “propel” an implant forward. Instead, such
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`directional “ratchetings” or teeth resist both implant back-out and forward movement of the
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`implant, and a person of ordinary skill in the art before June 7, 1995 would have recognized
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`this plain fact. See, supra, ¶¶ 7-11; see also Ex. 1005, 19:29-31 (teaching that such
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`ratchetings “provid[e] a roughened surface, biting into and gripping” the vertebrae adjacent
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`to the implant). This anchoring effect (resisting both forward, rearward migration, and side-
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`to-side migration) would be especially true for anteriorly inserted implants such as
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`Michelson ‘037, in which it was common practice to slightly distract the vertebrae apart
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`during insertion of the implant and then remove the distraction after the implant is finally
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`seated to thereby cause the vertebrae to compress against the bearing surface of the
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`implant and any of its teeth. See Ex. 2009 85:12 to 87:12 (stating that, when using
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`anteriorly inserted interbody implants, “you generally distract the vertebral bodies apart and
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`the endplates apart”); Ex. 1008, p.9:8-10 (“mild distraction”).
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`Page 18 of 34
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`19.
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`Also as previously described (refer above to ¶ 9), in the case of an implant
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`with convex bearing surfaces (such as Michelson ‘037’s modified implant as described in ¶¶
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`45-48 of the June 24, 2013 Brantigan Declaration), where the convex bearing surface
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`conforms with a concave surface in an adjacent vertebra end face, the convexity of the
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`bearing surface also serves to resist forward migration of the implant. Therefore, contrary to
`
`pages 54 to 55 of the Patent Owner’s Response (IPR2013-00395) and Dr. Branch’s
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`testimony (Deposition p. 70:3-19 and Branch Declaration at ¶¶ 108, 109, and others),
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`putting “ratchetings” or other teeth on a surface of an implant convex bearing surface was
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`considered by persons of ordinary skill in the art before June 7, 1995 to be a “belt-and-
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`suspenders” approach to making sure the implant does not migrate from the position where
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`it is initially implanted in the disc space. See Ex. 1009, FIG. 7, 5:64-65 and 7:24-28;
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`discussion herein supra, ¶¶ 8-9. A person of ordinary skill in the art before June 7, 1995
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`would have recognized that applying the traditional implant teeth shown in the Brantigan
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`‘035 patent (which again, are called “ratchetings” in the ‘696 patent) to the top and bottom
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`convex bearing surfaces of the modified Michelson ‘037 implant (refer to ¶¶ 47-48 of my first
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`Declaration) would also serve as a “belt-and-suspenders” approach to making sure the
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`implant does not migrate from the position where it is implanted.
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`
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`MODIFICATION OF STEFFEE TO INCLUDE OPENINGS AS SUGGESTED BY
`MICHELSON ‘037
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`Page 19 of 34
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`20. On pages 34 to 38 of the Patent Owner’s Response (IPR2013-00396),
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`Warsaw asserts that one of ordinary skill would not be motivated to modify the posterior
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`lumbar interbody fusion (PLIF) insert-and-rotate implant of Steffee to include the fusion-
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`promoting openings of Michelson ‘037 because Steffee teaches fusion between the vertebra
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`accomplished by bone growth between two PLIF implants (allegedly not through the
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`implants) and based on the false assertion that Steffee is not a spinal fusion implant. See
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`also Ex. 2005, ¶¶ 77-78. Based upon my knowledge and experience in this field, I believe
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`that a person of ordinary skill in the art before June 1995 would have recognized that
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`Steffee’s implant is a type of spinal fusion implant in which bone growth occurs through the
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`implant structure, and furthermore is generally analogous to other interbody fusion implants
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`such as Michelson ‘037. For example, Steffee explicitly teaches “using the spinal implant to
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`fuse together adjacent vertebrae of a spinal column.” Ex. 1108 1:7-8) (emphasis added).
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`Additionally, Steffee expressly teaches that the implant can be equipped with openings
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`through the implant “to provide for blood flow and bone growth from one side of the implant
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`10 to the other side of the implant.” Ex. 1108, 2:64-67. Contrary to Warsaw’s and Dr.
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`Branch’s assertion, it is not the direction of holes through an implant that make it a “fusion
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`implant,” but instead a person of ordinary skill in the art before June 1995 would have
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`recognized, as an ordinary surgeon would recognize today, that the Steffee implant and the
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`Michelson ‘037 implant were both implants used in the interbody space for purposes of
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`achieving spinal fusion between adja
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