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
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`__________________
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`Case IPR2013-00395
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`______________________________________________________
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`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
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`Case IPR2013-00395
`U.S. Patent No. 8,444,696
`Our Ref. 13958-0113IP1
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`TABLE OF CONTENTS
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`
`Introduction ........................................................................................................ 1 
`I. 
`II.  Claim interpretations........................................................................................... 1 
`A.  “opening” (claims 1, 2, 4 and 5) ........................................................................ 1 
`B.  “upper and lower bearing surfaces” (claims 1, 3, 4 and 6) ................................. 1 
`III.  Grounds 3-4: Senter teaches “upper and lower bearing surfaces . . . being
`convex” ........................................................................................................... 2 
`IV.  Grounds 3-4: One of ordinary skill would have been motivated to modify Senter’s
`implant to include Brantigan ‘035’s ratchetings to improve Senter’s stated
`objective to “inhibit dislocation (movement) of the implant … after
`implantation.” .................................................................................................. 4 
`V.  Grounds 3-4: One of ordinary skill would have been motivated to modify Senter’s
`implant to include the openings of Brantigan ‘035 for receiving “bone growth
`material” to promote bone growth. ................................................................... 7 
`VI.  Ground 5: One of ordinary skill would have been motivated to modify Michelson
`‘037’s implant to include the convex surfaces of Wagner because there is no
`indication that Michelson ‘037’s implant is intended only for use in treating a
`degenerative disc having lost its bi-convex appearance. .................................. 9 
`VII. Ground 5: One of ordinary skill would have been motivated to modify Michelson
`‘037’s implant to include both Brantigan ‘035’s ratchetings and Wagner’s
`convex curvature to improve Michelson ‘037’s stated objective to “resist
`dislodgement.” ............................................................................................... 10 
`VIII. Ground 5: One of ordinary skill would have been motivated to combine the
`teachings of Michelson ‘037, Wagner, and Brantigan ‘035 as there is no
`requirement that all teachings of a prior art reference must be incorporated if
`one feature is incorporated. ............................................................................ 11 
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`IX.  Grounds 3-4 and 5: Warsaw’s arguments against the combining of prior art
`features is directly contradicted by any argument that supports the written
`description requirement for the claims. .......................................................... 13 
`X.  Grounds 3-4 and 5: Warsaw’s secondary considerations arguments for
`patentability based on commercial success cannot pass scrutiny. ................. 14 
`XI.  Conclusion ....................................................................................................... 15 
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`EXHIBIT LIST
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`IPR2013-00395
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`NUVASIVE1001
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`NUVASIVE1002
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`NUVASIVE1003
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`NUVASIVE1004
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`NUVASIVE1005
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`NUVASIVE1006
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`NUVASIVE1007
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`NUVASIVE1008
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`NUVASIVE1009
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`NUVASIVE1010
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`NUVASIVE1011
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`Declaration of Dr. John W. Brantigan, M.D.
`
`U.S. Patent No. 8,444,696 to Michelson (“the ‘696 patent”)
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`Select Prosecution History of the ‘696 patent (Serial No.
`13/235,998)
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`U.S. Patent No. 5,645,596 to Kim et al. (“Kim”)
`
`PCT Publication WO 89/09035 to Brantigan (“Brantigan ‘035”)
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`U.S. Patent No. 5,192,327 to Brantigan (“Brantigan ‘327”)
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`PCT Publication WO93/01771 to Senter et al. (“Senter”)
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`PCT Publication WO90/00037 to Michelson (“Michelson ‘037”)
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`U.S. Patent No. 5,306,309 to Wagner et al. (“Wagner”)
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`Select prosecution history of inter partes reexamination
`proceedings on U.S. Patent No. 8,021,430 (Control No.
`95/002,380)
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`Plaintiffs’ Disclosure of Asserted Claims and Infringement
`Contentions re U.S. Patent No. 8,444,696, from Warsaw
`Orthopedic, Inc. et al. v. NuVasive, S.D. Cal., Case No. 3:12-
`cv-02738-CAB (MDD)
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`NUVASIVE1012
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`Affidavit of Frank E. Scherkenbach in Support of Pro Hac Vice
`Admission
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`NUVASIVE1013
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`NUVASIVE1014
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`NUVASIVE1015
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`NUVASIVE1016
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`NUVASIVE1017
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`NUVASIVE1018
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`Reserved
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`Reserved
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`First surface feature shape example Introduced during
`deposition of Dr. Charles Branch
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`Annotated Second surface feature shape example Introduced
`during deposition of Dr. Charles Branch
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`Second Declaration of Dr. John W. Brantigan, M.D.
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`Transcript of the Deposition of Dr. Charles Branch
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`TABLE OF AUTHORITIES
`Monsanto Co., v. Pioneer Hi-Bred Int’l, Inc., IPR2013-00022, Paper No. 43
` (PTAB Apr. 11, 2013) ........................................................................................................... 2
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`Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983) ............................... 15
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`I.
`Introduction
`
`Warsaw’s arguments for patentability of claims 1-6 rely upon improper claim
`
`interpretations and misinterpretations of the prior art. Thus, all claims 1-6 are invalid upon
`
`the grounds 3-5 for which this Board has instituted review.
`
`II.
`
`Claim interpretations
`
`A. “opening” (claims 1, 2, 4 and 5)
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`
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`Warsaw’s claim interpretation is overly narrow and should be rejected. Moreover,
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`Warsaw does not rely on its construction of “opening” in its arguments for claims 1 and 4.
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`Therefore, the Board should decline Warsaw’s request for a construction. Claims 1 and 4
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`do not require the unclaimed limitation forwarded by Warsaw and such a limitation should
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`not be read into the claims. See Ex. 1017 ¶ 20.
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`B. “upper and lower bearing surfaces” (claims 1, 3, 4 and 6)
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`Warsaw’s claim interpretation is in direct contradiction to the interpretation adopted
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`by this Board in its Institution Decision that “there may be more tha[n] a single bearing
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`surface” as demonstrated by FIG. 14 of the ‘696 patent and that “the claim language does
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`not require that convexity to be along the entire length of the implant.” Inst. Dec., p. 9.
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`First, there is no requirement in the claim language that the bearing surfaces extend across
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`the entire length of the implant. Such a narrow interpretation of the term “bearing surfaces”
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`is wholly inconsistent with the embodiment pictured in FIG. 14 of the ‘696 patent which
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`shows multiple upper and lower bearing surfaces on a single implant, as pointed out by the
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`Board in its Institution Decision. Ex. 1002, FIG. 14, 9:20-29; Inst. Dec. p. 9. Second,
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`Warsaw’s proposed narrowing of the claim to require the convex curvature to “conform[] to
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`the anatomic endplates of the adjacent vertebrae along the entire length thereof” has no
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`basis in the claim language and is inconsistent with a broadest reasonable interpretation of
`
`the plain meaning of “upper and lower bearing surfaces . . . being convex.” Ex. 1017 ¶ 3.
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`Warsaw references the declaration of Dr. Branch in support of this narrowing claim
`
`interpretation, however, Dr. Branch offers only unsupported, conclusory statements—no
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`data or the requisite rationale to support his conclusions. Ex. 2005 ¶35. As the Board has
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`made clear, such conclusory statements are entitled to little or no weight in these
`
`proceedings. See Monsanto Co. v. Pioneer Hi-Bred Int’l, Inc., IPR2013-00022, Paper No.
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`43 (PTAB Apr. 11, 2013), 4 (quoting 37 C.F.R § 42.65(a)). The Board was correct in its
`
`institution decision that the claimed convex bearing surfaces need not extend the entire
`
`length of the implant.
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`III.
`
`Grounds 3-4: Senter teaches “upper and lower bearing surfaces . . . being
`convex”
`Warsaw contends Senter’s implant does not satisfy this claim recitation, yet the only
`
`argument Warsaw offers in support of this position is that Senter’s convex ridges 68 and
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`68a are not curved to “conform[] to the anatomic endplates of the adjacent vertebrae along
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`the entire length thereof,.” (PO Resp. pp. 29) But as discussed in section II.B, supra, there
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`is no requirement in the claim language that the implant “bear[] against anatomic endplates
`
`of the adjacent vertebrae” or that the bearing surfaces “conform[] to the anatomic endplates
`
`of the adjacent vertebrae,” and importing such narrowing limitations from the ‘696 patent
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`specification would be inconsistent with the broadest reasonable interpretation standard and
`
`the Board’s interpretation of this claim language. See Ex. 1017 ¶¶ 3, 30; Inst. Dec., p. 9.
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`The function served by the convexly curved bearing surfaces of Senter’s implant is to
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`“lock the implant 50 or 74 into place [to] prevent dislocation of the implant.” Ex. 1007, 17:5-
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`7. As with the convex surfaces described in the ‘696 specification, the convex ridges 68,
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`68a of Senter “aid in avoiding dislocation of the implant 50.” Id. 17:8-9; 12:3-5. The only
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`difference in the way the implant of Senter and the convexly curved embodiments of the
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`‘696 achieve this shared goal is that Senter’s implant is curved to match a concave groove
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`created by a surgeon rather than an anatomic concavity of adjacent vertebrae.
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`Furthermore, conformity with concave end plates is clearly not a necessary feature
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`for convex implants. Patients have varying concavity of endplates and spinal implants were
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`not historically and are still not today manufactured specific to the particular vertebral
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`concavity of each individual patient. See Ex. 1017, ¶ 3. For example, the convexity of the
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`Clydesdale implant sold by Warsaw is not designed to match the concavity of vertebrae as it
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`has a very small convexity in comparison to other convex implants, such as the example in
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`FIG. 14 of the ‘696 patent. See also Ex. 1018, pp. 29-30; 89-90.
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`‘696 Patent Fig. 14 
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`Clydesdale Implant 
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`Therefore, in addition to being recited nowhere in claims 1-6, the requirement that convex
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`surfaces “conform[] to the anatomic endplates of the adjacent vertebrae along the entire
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`length thereof” is not necessary for a successful convex implant. Ex. 1017, ¶ 3.
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`IV.
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`Grounds 3-4: One of ordinary skill would have been motivated to modify
`Senter’s implant to include Brantigan ‘035’s ratchetings to improve
`Senter’s stated objective to “inhibit dislocation (movement) of the implant
`… after implantation.”
`Warsaw is wrong when it contends at p. 32 of its Response that Senter teaches
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`away from Brantigan ‘035 and that “modifying the spinal disk implant 50 of Senter to include
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`ratchetings such as the nubs 122 of Brantigan ‘035 . . . would undermine the functions of
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`the spinal disk implant.” First off, Warsaw twists Dr. Brantigan’s statement that the
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`ratchetings of Brantigan ‘035 “accommodate forward move[ment]” by implying that such
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`ratchetings would somehow propel the implant forward after placement. This is not true.
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`During implantation the vertebrae are distracted (i.e., spread apart) to allow for insertion of
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`the implant. See Ex. 2009, 85:12 to 87:12; Ex. 1017, ¶¶ 7, 18. Distraction of adjacent
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`vertebrae decreases resistance to both forward and rearward movement of an implant
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`during the time of the implant procedure in comparison to the resistance provided by the
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`ratchetings once in place. Ex. 1017, ¶ 7. During his deposition, Warsaw’s expert agreed
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`that vertebral bodies are distracted during insertion and that resistance to movement is
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`minimal during this insertion procedure due to lack of contact between the ratchets and the
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`vertebral bodies. Ex. 1018, pp. 69-70. It is during insertion that ratchets accommodate
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`forward movement. Ex. 1017, ¶¶ 6-7. One in place, the so-called “one-way ratchetings” or
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`teeth resist both implant back-out and forward movement (and side-to-side movement) of
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`the implant by digging into the surrounding vertebrae. Ex. 1017, ¶¶ 4-9. Although
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`directional ratchetings do offer greater resistance in one direction over another, such
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`ratchetings still function to resist movement in both directions, and certainly do not “propel”
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`the implant in any direction. Id. ¶ 5. Senter does not teach away from Brantigan ‘035.
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`Further, one of skill in the art would not have been dissuaded from combining
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`Brantigan ‘035’s ratchetings with Senter’s convex ridges 68, 68a because, as indicated by
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`Dr. Brantigan in his declaration, Senter’s convex ridges 68 and 68a would have prevented
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`movement of the implant—after implantation—even if Senter were modified to include
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`conventional ratchetings. Ex. 1001, ¶¶ 36-38. Warsaw fails to recognize the different
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`circumstances during insertion and after implantation. During insertion, the ratchets on
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`convex ridge 68 would accommodate forward movement. After implantation, the ratchets
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`dig into the vertebrae and resist movement of the implant relative to the vertebrae. Ex.
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`1017, ¶¶ 5-9. Indeed, Warsaw has it backwards arguing that ratchets would “interfere” with
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`the forward movement during insertion of the implant (PO Resp. p. 36) and also arguing that
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`the ratchets would “afford movement” and thereby encourage dislocation after implantation
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`(PO Resp. p. 38).
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`Senter’s implant would provide a structure (convex ridges 68 and 68a) that resists
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`posterior migration of the implant after being finally seated by the surgeon both in its original
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`form and in its modified form (obvious modification to include conventional ratchetings as
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`described at ¶¶ 36-38 of Dr. Brantigan’s first declaration). The structure resulting from
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`modifying Senter’s spinal implant with conventional ratchetings would also enhance the
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`anchoring effects of the resulting implant by providing a “belt-and-suspenders” approach
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`that includes both ratchetings that would bite into the adjacent vertebrae (resistance to both
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`posterior and anterior migration) and the convex ridges 68, 68a of Senter which operate to
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`prevent migration of the implant after implantation. Ex. 1017, ¶¶ 7-9, 31-36. One of skill in
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`the art before 1995 would have considered convex bearing surfaces and anti-migration
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`teeth complimentary techniques for reducing movement of spinal implants and would not
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`have considered these different techniques inconsistent with one another such that they
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`could not be used in the same implant. Id. ¶¶ 8-9. Providing ratchets on convex ridges 68
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`and 68a would not undermine the function of the Senter implant 50.
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`V.
`Grounds 3-4: One of ordinary skill would have been motivated to modify
`Senter’s implant to include the openings of Brantigan ‘035 for receiving
`“bone growth material” to promote bone growth.
`Warsaw next argues that one of ordinary skill would not be motivated to implement
`
`Senter’s implant to include the bone growth promoting opening of Brantigan ‘035 because
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`Senter’s implant “is not itself a spinal fusion implant” and because the resulting implant
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`would not be effective. See PO Resp. pp. 42-44. Warsaw is wrong on both counts.
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`First, Senter states that the purpose of the implant is to “improve the fusion of the
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`adjacent vertebrae.” Ex. 1007, 17:15-17. Contrary to Warsaw’s assertion, it is not holes that
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`make an implant a fusion implant. A solid implant configured to receive bone ingrowth
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`therein, such as the one described in Senter, can also be a fusion implant, as is stated
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`explicitly by Senter. See also Ex. 1001, ¶ 28.
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`Second, the alleged “problem” with the modified implant—that the material in the
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`opening would not be protected by the leading edge—is not actually a problem at all.
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`Indeed, if this was a problem it would exist for all convexly curved spinal implants, including
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`the Clydesdale implant cited by Warsaw (PO Resp. p. 24). Ex. 1017, ¶¶ 10-14. For
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`example, the Clydesdale implant features a large internal opening that extends from a top
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`convex bearing surface to a bottom convex bearing surface. See Ex. 2011. As is clear
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`from the diagrams of the Clydesdale implant, the opening is not protected by any structure
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`on the leading edge of the implant. Therefore, if scraping off of fusion-promoting material at
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`an unprotected leading edge of such an opening were a real problem, this same problem
`
`would be present with the Clydesdale implant design. Ex. 1017, ¶ 13. Finally, if this
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`problem were real and not merely imagined by Warsaw, such a problem would exist if one
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`were to take the large fusion promoting substance holes 415 from the non-convex implant
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`400 shown in Figures 18-23 of the ‘696 patent, and incorporate the two large holes 415 in
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`the convex implant 300 shown in Figures 13-17 of the ‘696 patent (even though that
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`combination is not described or suggested in the ’696 patent). Ex. 1017, ¶ 12.
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`One of ordinary skill in 1995 would have understood how to use the fill material in the
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`openings of the convex surface as vertical holes through a spinal implant was a well-known
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`feature prior to June 1995. Ex. 1017, ¶¶ 10-11; Ex. 1018 pp.105-107. The traditional clinical
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`practice at the time for inserting spinal implants included distracting the two adjacent
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`vertebrae apart before and during the time that the implant is inserted. Ex. 1017, ¶ 11; Ex.
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`1018 pp. 69-70. Therefore, if dislodgement of fusion promoting substance were a legitimate
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`risk, then an ordinary surgeon before June 1995 would have known to address that concern
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`by distracting the two adjacent vertebrae from one another so as to avoid such
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`dislodgement. Ex. 1017, ¶ 11. Additionally, a spinal surgeon of ordinary skill prior to 1995
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`would have known that a spinal fusion implant would not need to be filled to the very top
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`with fusion promoting material in order to promote bone growth through the implant. Id.
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`Additionally one of ordinary skill at the time would have known that minor dislodgement of
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`fusion promoting material would be tolerable without compromising the ability of the fusion
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`implant to carry out the fusion process. Id.
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`Thus, the alleged problem with modifying the spinal implant of Senter to include one
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`or more large fusion openings as taught by the Brantigan ‘035 patent is not an issue, and
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`would not have dissuaded one of skill in the art from combining the teachings of Brantigan
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`‘035 with Senter.
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`VI.
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`Ground 5: One of ordinary skill would have been motivated to modify
`Michelson ‘037’s implant to include the convex surfaces of Wagner
`because there is no indication that Michelson ‘037’s implant is intended
`only for use in treating a degenerative disc having lost its bi-convex
`appearance.
`Warsaw’s assertion at pp.48-52 of its Response that the implants of Michelson ‘037
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`are only intended for “use for treatment of spinal disease occurring because of a
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`degenerative disc having lost its bi-convex appearance” has no basis in the specification of
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`Michelson ‘037 and is in fact a complete fabrication derived from the imagination of Dr.
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`Branch. Ex. 2005, ¶ 104. Nowhere does Michelson say that its implants are only for “use
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`for treatment of spinal disease occurring because of a degenerative disc having lost its bi-
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`convex appearance” or even state that they are ever intended for such use. Instead,
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`Michelson ‘037 states that the disclosed implant device “will fit any patient, anywhere
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`throughout the spine, in any vertebral disc space, and without alteration of that interspace
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`regardless of its natural size or shape.” Ex. 1008, p. 5:18-22 (emphasis added). Dr.
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`Branch’s conclusion is directly contradicted and should be given no weight. In fact, during
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`his deposition, Dr. Branch agreed that the intent of the Michelson ‘037 implant “is to fit any
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`patient” and that the implant “certainly could fit any patient anywhere throughout the spine.”
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`Ex. 1018, pp. 110, 113. Because Michelson ‘037 nowhere discloses or implies that its
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`implant is intended for use with “a degenerative disc having lost its bi-convex appearance”
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`and, in fact says the opposite, Warsaw’s assertion that one of ordinary skill would not be
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`motivated to include Wagner’s convex surfaces has no basis. Ex. 1017, ¶ 15.
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`If this reasoning offered by Warsaw that non-curved spinal implants and convexly
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`curved spinal implants can only be used to treat different spinal conditions, and that
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`teachings from such implants can never be combined, then there would equally be no
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`motivation to combine the ratchetings described in the ‘696 patent with relation to the non-
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`curved implant of FIG. 9 with the convex curvature of the implant shown in FIG. 14 (the
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`combination of these features never being taught by the ‘696 specification).
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`VII. Ground 5: One of ordinary skill would have been motivated to modify
`Michelson ‘037’s implant to include both Brantigan ‘035’s ratchetings and
`Wagner’s convex curvature to improve Michelson ‘037’s stated objective to
`“resist dislodgement.”
`Warsaw is wrong when it contends at pp. 48-52 of its Response that one of ordinary
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`skill would not have been motivated to modify Michelson ‘037’s implant to include the
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`ratchetings of Brantigan ‘035 with the convex curvature of Wagner because Michelson
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`‘037’s implant is already “self-stabilizing to resist dislodgement.” For the same reasons
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`discussed above in Section IV, one of ordinary skill would have been motivated to employ a
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`“belt-and suspenders” approach to preventing movement of the implant by including
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`Brantigan ‘035’s ratchetings to “prevent retraction” of the implant after insertion and
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`enhance Michelson ‘037’s stated goal of “resist[ing] dislodgement.” Ex. 1005, 20:30-21:3;
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`Ex. 1008, 7:17-19; Ex. 1017, ¶¶ 18-19.
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`As with the combination of Senter’s convex ridges with Brantigan ‘035’s ratchetings,
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`one of ordinary skill would have recognized that the convex surfaces of Wagner and the
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`ratchetings of Brantigan ‘035 are two complimentary and non-exclusory options for
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`furthering Michelson ‘037’s goal of resist[ing] dislodgement.” Ex. 1017, ¶¶ 16-19; Ex. 1008,
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`7:17-19.
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`VIII. Ground 5: One of ordinary skill would have been motivated to combine the
`teachings of Michelson ‘037, Wagner, and Brantigan ‘035 as there is no
`requirement that all teachings of a prior art reference must be incorporated
`if one feature is incorporated.
`Warsaw’s assertion that adoption of the teachings of Wagner to modify Michelson
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`‘037 would preclude further modifications relying on the teachings of Brantigan ‘035 (PO
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`Resp. pp. 53-55) is patently off base as there is no requirement that all teachings of a prior
`
`art reference must be incorporated if one feature is incorporated. Warsaw argues that
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`modifying Michelson ‘037’s implant to include Wagner’s convex surface would also require
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`including Wagner’s pyramids 76, which would preclude addition of Brantigan ‘035’s
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`ratchetings. PO Resp. pp. 53-54. First off, there is no requirement that all teachings of a
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`prior art reference must be incorporated if one feature is incorporated, and Warsaw points to
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`no legal precedent stating such. Further, the ratchetings of Brantigan ‘035 are not a radical
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`departure from the pyramids of Wagner, but are merely a variation of Wagner’s pyramid that
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`serve the same purpose of preventing movement of the implant once the implant is in place.
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`Ex. 1005, 20:30-21:3; Ex. 1009, 6:2-12; Ex. 1017, ¶¶ 16-19. Indeed, Wagner states that the
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`engagement features can be any “three-dimensional features” extending above the bearing
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`faces before describing an embodiment that includes the “pyramids” as merely one example
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`of such “three-dimensional features.” Ex. 1009, 5:64-6:1. Warsaw’s expert agreed, during
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`his deposition, that ratchets fall within the scope of Wagner’s contemplated “three-
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`dimensional features.” Ex. 1018, pp. 118-119. Contrary to Warsaw’s assertion, the
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`ratchetings of Brantigan ‘035 do not cause “forward and side to side movement” of the
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`implant, but rather prevent movement in all directions, with a slightly higher resistance to
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`movement in a backward direction compared to other directions. Ex. 1017, ¶¶ 5-9, 19, 36.
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`As stated above, there is no requirement that the pyramids of Wagner be included in
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`the modified implant of Michelson ‘037 if the convex curvature of Wagner is included, and
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`one of ordinary skill would have recognized that the convex surfaces of Wagner and the
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`ratchetings of Brantigan ‘035 are two complimentary and non-exclusory options for
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`furthering Michelson ‘037’s goal of resist[ing] dislodgement.” Ex. 1017, ¶¶ 16-19; Ex. 1008,
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`7:17-19.
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` 
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`12
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`

`

`Case IPR2013-00395
`U.S. Patent No. 8,444,696
`Our Ref. 13958-0113IP1
` 
`IX.
`Grounds 3-4 and 5: Warsaw’s arguments against the combining of prior art
`features is directly contradicted by any argument that supports the written
`description requirement for the claims.
`With respect to Grounds 3-4 (Senter and Brantigan ‘035) and Ground 5 (Michelson
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`‘037, Wagner, and Brantigan ‘035), Warsaw’s multiple arguments that one of ordinary skill
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`would not have been motivated to combine the features of the various references are in
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`direct contradiction to any possible argument Warsaw has with respect to written description
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`support for claims 1-6, as the claimed combination of a convexly curved implant having one-
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`way ratchetings and an opening to permit for bone growth is nowhere to be found within any
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`individual embodiment of the ‘696 patent.
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`Warsaw’s characterization of the “invention” is a combination of features from
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`different isolated embodiments that aren’t described in the ‘696 specification as being
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`combined together in a single embodiment. Ex. 1001, ¶ 7, Ex. 1017, ¶¶28-29. For example,
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`the ‘696 patent discusses ratchetings with relation to the non-curved implant of FIG. 9 and
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`later discusses a convexly curved surface in a separate embodiment shown in FIG. 14.
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`Nowhere does the ‘696 patent depict an implant having a convexly curved surface, with
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`one-way ratchetings extending from the convexly curved bearing surface. Therefore, any
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`argument that Warsaw would necessarily need to rely on to show written description
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`support for claims 1-6 would negate any argument made by Warsaw in its patent owner’s
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`response that one of ordinary skill would not be motivated to combine the convexly curved
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` 
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`13
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`

`

`Case IPR2013-00395
`U.S. Patent No. 8,444,696
`Our Ref. 13958-0113IP1
` 
`bearing surface, ratcheting, and bone growth opening features recited in the various
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`references cited by the Petitioner.
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`Moreover, the claims of the ‘696 patent copy features (e.g., ratchetings on a convex
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`surface) that were in NuVasive’s CoRoent implant first introduced in 2004. This combination
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`of features (which had not existed prior to NuVasive’s CoRoent implant) was then copied by
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`the Clydesdale implant released in 2006. Meanwhile, the current claims of the ‘696 patent
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`were not formulated until 2011, after both the CoRoent XL and the Clydesdale were on the
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`market. Warsaw cannot credibly accuse NuVasive of “cherry-picking” features when the
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`‘696 specification does not disclose or suggest the combination of features that Warsaw
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`claimed for the first time 16 years after the filing date and long after NuVasive’s implants
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`entered the market.
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`X.
`
`Grounds 3-4 and 5: Warsaw’s secondary considerations arguments for
`patentability based on commercial success cannot pass scrutiny.
`Warsaw offers no proof that Medtronic’s Clydesdale implant, or any other successful
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`product, falls within the scope of any claims. PO Resp. p. 24. This deficiency is not
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`corrected by Dr. Branch’s declaration because nowhere does Dr. Branch even discuss the
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`Clydesdale implant. Thus, Warsaw has not even attempted to satisfy its burden of showing
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`that the commercially successful product embodies and is coextensive with the claimed
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`features in a patent. See Richdel, Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir.
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`1983). Additionally, even if the Clydesdale implant is covered by the claims of the ‘696
`
` 
`
`14
`
`

`

`Case IPR2013-00395
`U.S. Patent No. 8,444,696
`Our Ref. 13958-0113IP1
` 
`patent, Warsaw has made no attempt to identify a nexus between features claimed in the
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`‘696 patent and commercial success of the Clydesdale implant. Id. at 1578-79. Likewise,
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`Warsaw has made no attempt to show why the alleged success is not the result of heavy
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`promotion or advertising, a shift in advertising, consumption by purchasers normally tied to
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`applicant or assignee, the copying of NuVasive’s patented implants, or other business
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`events. As indicated by Warsaw’s expert, promotion by opinion leaders is an important
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`factor in the selection of surgical implants by surgeons. Ex. 1018, p. 149. This factor is
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`one of many which has not been accounted for or addressed by Warsaw. Warsaw’s
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`secondary considerations argument should be given no weight.
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`XI.
`
`Conclusion
`For the reasons discussed above, NuVasive requests that this Board find all claims
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`at issue in this proceeding (claims 1-6) invalid upon the grounds (3-5) for which this Board
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`has instituted review.
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`Respectfully submitted,
`
`
`
`
` /Michael T. Hawkins/
`Michael T. Hawkins, Reg. No. 57,867
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`Attorneys for Petitioner
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`
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`Dated: June 2, 2014
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`
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`
`
` /Stephen R. Schaefer, Reg. No. 37,927/
`Stephen R. Schaefer, Reg. No. 37,927
`
`(Trial No. IPR2013-00395)
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`15
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`CERTIFICATE OF SERVICE
`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
`that on June 2, 2014, a complete and entire copy of this Petitioner’s Reply to Patent
`Owner’s Response, with exhibits, were provided via email to the Petitioner by
`serving the correspondence email addresses of record as follows:
`
`
`Thomas H. Martin
`Wesley C. Meinerding
`Martin & Ferraro, LLP
`1557 Lake O’Pines Street, NE
`Hartville, OH
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`Nimalka Wickramasekera
`333 South Hope Street
`Los Angeles, CA 90071
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`Email: tmartin@martinferraro.com
`Email: docketing@martinferraro.com
`Email: nwickramasekera@kirkland.com
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`1
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`/Edward G. Faeth/
`Edward G. Faeth
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(202) 626-6420
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`