UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC.
`Petitioner
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`v.
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`NUVASIVE, INC.
`Patent Owner
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`Case IPR2013-00506
`Patent 8,361,156
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`PATENT OWNER NUVASVE INC.’S
`PRELIMINARY RESPONSE
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`

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`Patent No. 8,361,156
`Preliminary Response
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`TABLE OF CONTENTS
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`I. 
`II. 
`III. 
`IV. 
`V. 
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`VI. 
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`IX. 
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`X. 
`
`INTRODUCTION ......................................................................................................... 1 
`BACKGROUND OF THE ‘156 PATENT INVENTIONS .............................................. 3 
`STANDARD FOR GRANTING INTER PARTES REVIEW.......................................... 7 
`MEDTRONIC’S PETITION IS DEFECTIVE UNDER 37 C.F.R. § 42.22 ..................... 9 
`MEDTRONIC FAILED TO SHOW WHY PROPOSED GROUNDS 1-2 ARE NOT
`REDUNDANT WITH ONE ANOTHER ...................................................................... 10 
`MEDTRONIC FAILED TO SHOW WHY PROPOSED GROUNDS 1-5 ARE NOT
`REDUNDANT WITH THE OTHER GROUNDS SET FORTH IN THE
`COUNTERPART IPR CASE NO. IPR2013-00506.................................................... 12 
`VII.  MEDTRONIC FAILED TO SHOW THE PRIMARY REFERENCES (SVS-PR AND
`TELAMON) CITED IN GROUNDS 1-2 ARE PRIOR ART PUBLICATION ................ 14 
`A. 
`Medtronic failed to show the primary reference (SVS-PR) cited in Ground 1
`was publicly available before the priority date of the ‘156 patent. ................. 14 
`Medtronic failed to show the primary references (Telamon) cited in Ground 2
`were publicly available before the priority date of the ‘156 patent. ................ 15 
`VIII.  THE PRIOR ART COMBINATIONS CITED BY MEDTRONIC UNDER ALL
`GROUNDS 1-2 FAILS TO PROVIDE THE CLAIMED IMPLANT WHERE THE
`LONGITUDINAL LENGTH IS GREATER THAN 40 MM, AS RECITED IN CLAIM 5 18 
`A. 
`All Grounds relying upon Frey against claim 5 fail to disclose or suggest the
`claimed implant having a longitudinal length greater than 40 mm ................. 19 
`The proposed combinations in Grounds 1-2 (regardless of whether relying
`upon Frey or Michelson to modify the primary implant) would not provide the
`claimed implant having a longitudinal length greater than 40 mm, as required
`by independent claim 5. ................................................................................. 23 
`ALL GROUNDS PROPOSED AGAINST CLAIM 12 FAIL TO DISCLOSE OR
`SUGGEST THE CLAIMED IMPLANT WHERE THE UPPER AND LOWER
`SURFACES ARE GENERALLY PARALLEL TO ONE ANOTHER ........................... 30 
`CONCLUSION .......................................................................................................... 32 
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`B. 
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`B. 
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`CERTIFICATE OF SERVICE ........................................................................................
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`Patent No. 8,361,156
`Preliminary Response
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`Case Law
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`
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`TABLE OF AUTHORITIES
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`In re Kubin, 561, F.3d 1351 (Fed. Cir. 2009) .................................................................. 10, 11
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`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed. Cir. 2012) .................. 7
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`In re Wyer, 655 F.2d 221, 226 (CCPA 1981) ....................................................................... 14
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`Carella v. Starlight Archery, 804 F.2d 135, 139 (Fed. Cir. 1986) ......................................... 14
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`Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373 (Fed. Cir. 2003) ............................ 22
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`Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629 (Fed. Cir. 2011) .............................. 22
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`In re Oelrich, 666 F.2d 578 (CCPA 1981) ............................................................................ 22
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`In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) ................................................... 18, 25, 29
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`In re Ratti, 270 F.2d 810, 813 (CCPA 1959) ........................................................... 19, 29, 30
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`Decisions of the Patent Trial and Appeal Board
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`MicroStrategy, Inc. v. Zillow, Inc., IPR2013-00034, (PTAB Apr. 2, 2013) ................. 8, 11, 12
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`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00003,
`(PTAB Oct. 25, 2012) ..................................................................................... 8, 11, 12
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`Statutes
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`35 U.S.C. § 314 (2012) ........................................................................................................... 7
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`35 U.S.C. § 316 (2012) ........................................................................................................... 7
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`Rules and Regulations
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`37 C.F.R. § 42.108 (2013) ...................................................................................................... 7
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`Patent No. 8,361,156
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`Case IPR2013-00506
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`Attorney Docket No: 13958-0116IP2
`37 C.F.R. § 42.22 ......................................................................................................... 2, 9, 10
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`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012) .................................................... 7, 8, 14, 15, 18
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`MPEP § 2128 ........................................................................................................................ 16
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`Patent No. 8,361,156
`Preliminary Response
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`EXHIBITS
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`Exhibit Description
`Ex. #
`NUVA 2101 U.S. Patent No. 7,905,840 to Pimenta et al.
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`v
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`Patent No. 8,361,156
`Preliminary Response
`I.
`INTRODUCTION
`This Preliminary Response addresses one of two petitions for inter partes review that
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`Medtronic, Inc. (“Medtronic”) has sought against the ‘156 patent, which patent owner
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`NuVasive, Inc. (“NuVasive) asserted in an infringement action against Medtronic and its
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`affiliates. The other petition on the ‘156 patent is IPR2013-00504, and addresses the exact
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`same claims as the present petition in IPR2013-00506 (namely, claims 1-14-19, 20 and 23-
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`27). In addition, a related patent (U.S. Patent No. 8,187,334) was asserted by NuVasive in
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`the same infringement lawsuit against Medtronic and its affiliates, and Medtronic has also
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`filed two inter partes review petitions against that patent as well. See IPR2013-00507;
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`IPR2013-00508.
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`The claims of the ‘156 patent are directed to a spinal fusion implant positionable
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`within an interbody space located between a first vertebra and a second vertebra, or in
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`other words, in the disc space between two vertebral bodies. The claims specify a unique
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`combination of features that makes the spinal fusion implant particularly well suited for
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`introduction into the body, and to the spinal disc space, along a lateral, trans-psoas surgical
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`approach path. See, e.g., ‘156 patent at 5:29-31 and 11:58-63.
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`Not only are the merits of Medtronic’s Petition in this case lacking, but the numerous
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`alternative grounds proposed in the Petition are imprecisely stated and redundant. For
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`example, the Petition at page 3 lists “Ground 1” and “Ground 2,” but this listing includes
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`multiple redundancies (“or” and “and/or” alternative citations) that actually incorporate at
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`least nine combinations of references. The Petition simply fails to provide a clear statement
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`of the grounds for rejection that are proposed against the ‘156 patent claims, and certainly
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`provides no labeling for the nine or more redundant combinations (to the extent such
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`problematic and prejudicial ambiguity can be deciphered at all). For this reason, the Petition
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`is defective under 37 C.F.R. § 42.22 and must be denied in full. Alternatively, any
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`redundant prior art combinations must not be adopted.
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`Also, Medtronic’s Petition includes multiple instances in which claim limitations were
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`never analyzed or in which Medtronic’s arguments contradict themselves. In one example,
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`regarding dependent claim 5, Medtronic takes the unsupported position in Grounds 1-2 that
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`Frey’s implant 1400 (depicted in FIGS. 59-65) has a length that is inherently (i.e.,
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`“necessarily”) greater than 40 mm. Even a cursory review of FIG. 65 shows that Frey’s
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`implant 1400 is far less than 40 mm and is certainly not “necessarily” greater than 40 mm.
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`Further, all arguments against claim 5 rely upon Medtronic’s proposed modification to
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`increase the length of either the SVS-PR or Telamon implant to be greater than 40 mm,
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`which cannot withstand scrutiny because it would render the SVS-PR or Telamon implant
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`inoperable for its intended purpose and would furthermore require a change in the basic
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`principle under which the SVS-PR or Telamon construction was designed to operate.
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`Regarding dependent claim 12, Medtronic contradicts itself by asserting that the upper and
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`lower surfaces of Telamon’s and SVS-PR’s implants “are generally parallel to one another”
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`even though—on the very next page of the Petition—Medtronic contradicts itself and takes
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`Attorney Docket No: 13958-0116IP2
`the opposite position. Indeed, Medtronic even provides an illustration (in the analysis of
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`claim 13) showing that the upper and lower surfaces of Telamon’s and SVS-PR’s implants
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`are certainly not parallel, but instead have a dramatic and significant slope relative to one
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`another.
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`Finally, all of these clear errors were copied into the Hynes Declaration. This raises
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`significant credibility issues with the declaration.
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`II.
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`BACKGROUND OF THE ‘156 PATENT INVENTIONS
`The claims of the ‘156 patent do not broadly claim all lateral fusion implants. To the
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`contrary, the ‘156 patent claims are specifically and reasonably tailored to a unique
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`combination of features collectively provided in a spinal implant for insertion in a lateral,
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`trans-psoas surgical approach path (an approach that is called XLIF, or eXtreme Lateral
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`Interbody Fusion, by NuVasive). See, e.g., ‘156 patent at 5:29-31, see also ‘156 patent at
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`Figure 20 and 11:58-66.
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`By way of background, a lateral approach to the spine is one that comes from the
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`side of the patient (as opposed to coming from the back or from the front of the patient,
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`called a posterior approach and an anterior approach, respectively). See, e.g., U.S. Patent
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`No. 7,905,840 (Exhibit NUVA2001), Figures 23-50 (illustrating an example lateral surgical
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`approach to the spine for a spinal fusion procedure). In addition, a so-called “trans-psoas”
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`approach is a lateral approach in the lower region of the spine (i.e., the lumbar region) that
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`passes through, and not around or to the side of, a large enervated muscle called the psoas
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`muscle—a muscle that was historically avoided by most spine surgeons—located on each
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`side of the spine in the lumbar region. See, e.g., id. at Figure 35 (illustrating a lateral, trans-
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`psoas approach that goes through the psoas muscle, labeled 220).
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`Among the unique combination of features recited in claim 1 of the ‘156 patent that
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`make the implant particularly well suited for the lateral, trans-psoas approach is the specific
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`recitation of a “maximum lateral width extending from [a] first sidewall to [a] second sidewall
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`along a medial plane that is generally perpendicular to [the implant’s] longitudinal length,” as
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`shown below:
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`4
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`See ‘156 patent at FIG. 3 (modified with labels above). As shown in Figure 3 of the ‘156
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`patent copied above, the first and second sidewalls of the implant are outwardly bowing,
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`and the maximum lateral width of the implant is along the medial plane, or in other words, at
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`the longitudinal center of the implant. That is because the implant, in its final implant
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`location, will lie in the disc space from side to side, after having been implanted there using
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`the lateral, trans-psoas approach. As such, the leading end of the implant is symmetrical
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`with the trailing end of the implant, with the largest width portion being located at the largest
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`width portion of the disc space. See ‘156 patent at FIG. 3. Between the two sidewalls, in
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`the disclosed embodiment, are two fusion apertures 2 that extend from the upper surface 33
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`of the implant to its lower surface. See id. at Figure 3. These apertures 2 allow a bony
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`bridge to form between the adjacent vertebrae and through the implant 10. See ‘156 patent,
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`col. 5:36-53.
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`In addition, the claimed implant (of independent claim 1) includes first and second
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`radiopaque markers that are each in opposite sidewalls of the implant and are “proximate to
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`said medial plane.” See ‘156 patent at 12:62-67. Again, FIG. 3 depicts one example:
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`Patent No. 8,361,156
`Preliminary Response
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`See ‘156 patent at FIG. 3 (modified with labels above). The positioning of the markers
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`specifically in the location proximate the medial plane enables the implant to be positioned –
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`using intra-operative imaging techniques such as X-ray or fluoroscopy – within the disc
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`space so that it is in the proper position longitudinally (equal portions are to one side of the
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`center of the disc space and the opposite side of the disc space), and so that its largest
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`width portion (i.e.., the medial plane of the implant) is in the longitudinal center of the disc
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`space. See ‘156 patent at 6:49-56 and 11:63-66.
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`The ‘156 patent also discloses example dimensions for the lateral implant, namely, a
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`width of approximately 18 mm, a height ranging between 8 and 16 mm, and a length
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`6
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`ranging between 40 and 45 mm. ‘156 patent, col. 11:58-63. The ‘156 patent also discloses
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`the lateral implant having upper and lower surfaces 31 and 33 (that is, the claimed upper
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`and lower surfaces 31 and 33 as set forth in claim 1 that include the anti-migration
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`elements) being, as recited in dependent claim 12, “generally parallel to one another.” This
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`distinguishes a class of prior art implants—recited instead in claim 13— that provide upper
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`and lower surfaces angled relative to one another, for example, for purposes of providing a
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`lordotic curvature of the spine. See ‘156 patent at cl. 13.
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`III.
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`STANDARD FOR GRANTING INTER PARTES REVIEW
`The Board may only grant a petition for inter partes review where “the information
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`presented in the petition . . . shows that there is a reasonable likelihood that the petitioner
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`would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. §
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`314(a); 37 C.F.R. § 42.108(c). Medtronic bears the burden of showing that this statutory
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`threshold has been met. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
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`48,756 (Aug. 14, 2012) [hereinafter “Practice Guide”] (“The Board . . . may institute a trial
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`where the petitioner establishes that the standards for instituting the requested trial are met
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`. . . .”). If inter partes review is granted, Medtronic also bears the burden of proving
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`unpatentability by a preponderance of the evidence. 35 U.S.C. § 316(e).
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`A party challenging a claim as obvious under 35 U.S.C. § 103 must show where
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`each claimed limitation is found in the prior art. See, e.g., Kinetic Concepts, Inc. v. Smith &
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`Nephew, Inc., 688 F.3d 1342, 1361 (Fed. Cir. 2012). Failure to do so defeats a claim of
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`Patent No. 8,361,156
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`Attorney Docket No: 13958-0116IP2
`obviousness. Id. The Office Patent Trial Practice Guide specifies that among the many
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`responses a patent owner can submit to a petition is that the “references asserted to
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`establish the claims are unpatentable are not in fact prior art” or that the “prior art teaches or
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`suggests away from a combination that the petitioner is advocating.” Practice Guide, 77
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`Fed. Reg. at 48,764.
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`As described in detail below, Medtronic argues in all of the proposed grounds for
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`rejection that the posterior side-by-side implants (Telemon implants or SVS-PR implants)
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`should be modified in a manner that would prevent Telemon’s and SVS-PR’s preferred
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`insertion method. Also, Medtronic’s Petition fails to establish that the Telemon reference
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`was readily available to the public (rather than being provided only confidentially to a limited
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`group via a pass-word protected web site). Similarly, Medtronic’s Petition provides
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`conflicting and inconclusive statements regarding the alleged publication date of the SVS-
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`PR reference. For at least these reasons, Medtronic’s Petition should be denied.
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`Moreover, further errors in the proposed rejections of the dependent claims, such as claims
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`5 and 12, are also present and pervasive across all of the proposed grounds set forth in
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`Medtronic’s Petition. Thus, even if Medtronic’s Petition is granted in part, Medtronic’s
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`Petition must be denied for those dependent claims.
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`Finally, the Board has previously indicated that inter partes review will not be
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`instituted on “redundant” grounds for rejection. See, e.g., MicroStrategy, Inc. v. Zillow, Inc.,
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`slip op. IPR2013-00034 (PTAB Apr. 2, 2013); Liberty Mut. Ins. Co. v. Progressive Cas. Ins.
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`Patent No. 8,361,156
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`Case IPR2013-00506
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`Attorney Docket No: 13958-0116IP2
`Co., slip op. CBM2012-00003 (PTAB Oct. 25, 2012). Here, Medtronic’s Petition alleges that
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`it presents only “Ground 1” and “Ground 2” in the Petition, but this allegation is misleading
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`and wrong. As described in detail below, Medtronic’s “two” Grounds for rejection in the
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`Petition actually incorporate at least nine combinations of references, with nearly all of them
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`characterized by Medtronic as being “or” alternatives to one another—an plain admission of
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`redundancy. For at least this reason, the Board should not adopt any of the at least nine
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`combinations of references that are deemed to be redundant, especially where the
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`Petitioner made no effort to explain why these combinations were not redundant.
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`IV. MEDTRONIC’S PETITION IS DEFECTIVE UNDER 37 C.F.R. § 42.22
`In this case, Medtronic’s Petition asserts that only two grounds (“Ground 1” and
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`“Ground 2”) are proposed in the Petition, but this assertion mischaracterizes issues raised in
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`the Petition and the precise relief request by the Petition. Medtronic’s Grounds 1-2 actually
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`include at least nine redundant combinations of references:
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`In this Petition, nine different
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`proposed combinations are
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`characterized as only two
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`“Grounds.”
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`Patent No. 8,361,156
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`Case IPR2013-00506
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`Attorney Docket No: 13958-0116IP2
`See Petition at p. 3. Medtronic did not even bother to individually label the nine or more
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`combinations of references as different “Grounds” (i.e., “Grounds 1-9”). Rather, Medtronic
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`simply threw the proverbial “darts at a board” in a haphazard listing of seemingly random
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`prior art combination, assuming that the Board will decipher the list on its own and separate
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`the legitimate from the absurd. Kubin, 561 F.3d at 1359. Worse yet, the various
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`combinations listed for “Ground 1” and “Ground 2” (shown above) as shown on page 3 of
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`the Petition do not even match the subsequent summary charts on pages 14 and 37-38 of
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`the Petition.
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`Such a Petition document must be labeled as defective, not celebrated and adopted.
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`The Rules plainly required Medtronic to list “the precise relief requested,” which must
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`include properly labeled and isolated Grounds for rejection that can be independently
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`analyzed and then adopted or not adopted by the Board. See 37 C.F.R. § 42.22. No such
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`precision is provided here. Rather, the listing of “Ground 1” and “Ground 2” above is the
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`exact type of imprecise statement that the Rules were meant to forbid. For at least these
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`reasons, Medtronic’s Petition is defective under 37 C.F.R. § 42.22 and must be denied in
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`full.
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`V.
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`MEDTRONIC FAILED TO SHOW WHY PROPOSED GROUNDS 1-2 ARE NOT
`REDUNDANT WITH ONE ANOTHER
`As previously described, the Board has implemented a redundancy doctrine in which
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`inter partes review will not be instituted on “redundant” grounds for rejection. See, e.g.,
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`MicroStrategy, slip op. IPR2013-00034 (PTAB Apr. 2, 2013); Liberty Mut., slip op.
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`CBM2012-00003 (PTAB Oct. 25, 2012). Again, Medtronic’s Petition asserts that only two
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`grounds (“Ground 1” and “Ground 2”) are proposed in the Petition, but this assertion is
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`simply misleading and wrong. Medtronic’s Grounds 1-2 actually include at least nine
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`redundant combinations. See Petition at p. 3.
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`The Petition provides no meaningful explanation as to why these nine or more
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`combinations are not redundant. Indeed, the Petition does not even label these nine or
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`more redundant combinations of references as different “Grounds” (i.e., “Grounds 1-9”).
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`Such a crude listing of seemingly random combinations of references (as shown in the
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`listing above of Grounds 1-2 is nothing more than “a defendant merely throw[ing]
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`metaphorical darts at a board filled with combinatorial prior art possibilities.” Kubin, 561 F.3d
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`at 1359.
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`In one undeniable example of redundancy, “Ground 1” is based upon the SVS-PR
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`reference, which shows a posterior-insertion implant nearly identical in structure and in its
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`insertion technique to the redundant Telamon reference cited in “Ground 2.” Medtronic
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`never alleges any meaningful difference between the disclosure of these two primary
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`references for Grounds 1-2, both of which disclose nothing more than the side-by-side
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`posterior plug implants that Medtronic and others were marketing in 2004-2007 while
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`NuVasive was innovating spine surgery and changing the entire market with the safe and
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`reproducible lateral, transpsoas spinal fusion implant and surgery. Such redundancy
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`Patent No. 8,361,156
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`Case IPR2013-00506
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`Attorney Docket No: 13958-0116IP2
`between the disclosure of these two primary references for Grounds 1-2 appears to do
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`nothing more than unnecessarily add to the issues that must be addressed by Patent Owner
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`and the Board in any subsequent communications. If the Petitioner wants to impose such
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`burdens on Patent Owner and the Board, the Petitioner must at least explain why these nine
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`or more combinations of references were not redundant. No such showing was provided in
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`the Petition.
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`For at least this reason, the Board should not adopt any of the at least nine
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`combinations of references listed under Grounds 1-2 that are deemed to be redundant,
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`especially where the Petitioner made no effort to explain why these nine combinations of
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`references were not redundant.
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`VI. MEDTRONIC FAILED TO SHOW WHY PROPOSED GROUNDS 1-5 ARE NOT
`REDUNDANT WITH THE OTHER GROUNDS SET FORTH IN THE
`COUNTERPART IPR CASE NO. IPR2013-00506
`As explained above, the Board has indicated that inter partes review will not be
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`instituted on “redundant” grounds for rejection. See, e.g., MicroStrategy, slip op. IPR2013-
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`00034 (PTAB Apr. 2, 2013); Liberty Mut., slip op. CBM2012-00003 (PTAB Oct. 25, 2012).
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`Nothing in the Board’s previous decisions indicates that a Petitioner can flout this
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`redundancy doctrine merely by dividing redundant grounds for rejection into different
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`Petition documents.
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`Here, Medtronic filed two IPR Petitions on the same day against the same exact
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`claims of the ‘156 patent, without any meaningful explanation as to why these multiple
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`Patent No. 8,361,156
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`Case IPR2013-00506
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`Attorney Docket No: 13958-0116IP2
`combinations spread across two IPR Petitions are not redundant. In total, the two Petitions
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`apparently attempt to propose seven different prior art combinations against claim 1, with
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`many of the further combinations proposed against the dependent claims being admittedly
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`nothing more than “or” alternatives to one another:
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`In the first Petition (IPR2013-
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`00504), five redundant grounds
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`were proposed against claim 1
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`and most dependent claims.
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`In the second Petition (IPR2013-
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`00506), at least nine prior art
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`combinations were proposed,
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`include multiple “or” alternatives
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`listed under the same “Ground.”
`See August 2013 Petition for IPR2013-00504 at p. 3; August 2013 Petition for IPR2013-
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`
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`00506 at pp. 14 and 37-38. These two Petitions provide no meaningful explanation as to
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`why these multiple combinations spread across two IPR Petitions are not redundant.
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`For at least this reason, the Board should not adopt any of Grounds 1-5 in IPR2013-
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`00504 that are deemed to be redundant with nine or more redundant combination listed
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`
`
`13
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`under “Ground 1” and “Ground 2” in IPR2013-00506, especially where the Petitioner made
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`no effort to explain why these Grounds were not redundant.
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`VII. MEDTRONIC FAILED TO SHOW THE PRIMARY REFERENCES (SVS-PR AND
`TELAMON) CITED IN GROUNDS 1-2 ARE PRIOR ART PUBLICATION
`As previously described, the Office Patent Trial Practice Guide specifies that among
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`the many responses a patent owner can submit to a petition is that the “references asserted
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`to establish the claims are unpatentable are not in fact prior art.” Practice Guide, 77 Fed.
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`Reg. at 48,764. Here, all of the various combinations of references falling under “Ground 1”
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`and “Ground 2” of Medtronic’s Petition rely upon “SVS-PR” or “Telamon” literature, but
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`Medtronic did not provide sufficient showing that those exact documents had been
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`“disseminated or otherwise made available to the extent that persons interested and
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`ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.”
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`In re Wyer, 655 F.2d 221, 226 (CCPA 1981).
`
`A.
`
`Medtronic failed to show the primary reference (SVS-PR) cited in
`Ground 1 was publicly available before the priority date of the ‘156
`patent.
`All of the various combinations of references falling under “Ground 1” of Medtronic’s
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`Petition relied upon a brochure referred to as “SVS-PR.” Medtronic provides no objective
`
`evidence that this particular brochure was publicly available before the priority date of the
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`‘156 patent. See Carella v. Starlight Archery, 804 F.2d 135, 139 (Fed. Cir. 1986) (holding
`
`that there was no proof that either the advertisement or mailer was accessible to any
`
`
`
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`member of the public before the filing date, so the advertisement or mailer was not available
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`to support a rejection of the claim).
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`In particular, the Petition provides only the bald assertion that the SVS-PR document
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`was a “publicly available brochure as of May 2002,” but there is no citation to any evidence
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`to support this assertion. See Petition at p. 4. The Hynes Declaration provides a conflicting
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`statement regarding the publication date of the SVS-PR brochure, thereby further
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`highlighting the ambiguity and confusion as to exactly when this particular brochure was
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`published. See Hynes Declaration at ¶ 52 (stating that the SVS-PR brochure was “publicly
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`available as of June 2002”—a date different than that asserted in Medtronic’s Petition).
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`Neither the Petition nor the questionable opinion of Dr. Hynes cites to any objective proof of
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`this alleged publication date of this particular brochure.
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`While NuVasive disputes Medtronic’s interpretation of the ‘156 patent claims and the
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`SVS-PR document in combination with various other references, these arguments need not
`
`be addressed in this paper because Medtronic fails to that the particular SVS-PR document
`
`cited in the Petition was in fact publicly available before the priority date of the ‘156 patent.
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`As such, the Board must deny inter partes review as to Ground 1 as proposed in
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`Medtronic’s petition. See Practice Guide, 77 Fed. Reg. at 48,764 764 (“the references . . .
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`are not in fact prior art.”).
`
`Medtronic failed to show the primary references (Telamon) cited in
`Ground 2 were publicly available before the priority date of the ‘156
`patent.
`
`15
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`B.
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`Regarding Ground 2, all of the various combinations of references falling under this
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`category relied upon a “Telamon Brochure” and a “Telamon Guide,” which were then
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`improperly referred to in Medtronic’s Petition as an imaginary single document called
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`“Telamon.” Here again, Medtronic provided no objective evidence that these particular
`
`documents were publicly available before the priority date of the ‘156 patent.
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`To be clear, Medtronic never presented evidence showing that the “Telamon”
`
`documents were publicly accessible to any skilled artisan in the public who sought a copy,
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`but instead access to these documents was highly restricted at a password-protected
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`website (www.MySpineTools.com). See Phelps Decl. at Appendix B (“available on
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`MySpinetools.com”). The documents available on this site were intentionally limited only to
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`Medtronic’s customers and employees. See http://www.myspinetools.com (providing an
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`express statement from Medtronic that [“t]his is a protected and restricted site for Medtronic
`
`customers and employees only” and that “[a]ny attempt to access this site without
`
`authorization is a violation of state and federal law”). Simply put, these documents were not
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`“publicly posted” for access by ordinary members of the public seeking a copy. See MPEP
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`§ 2128 (“Prior art disclosures on the Internet or on an on-line database are considered to be
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`publicly available as of the date the item was publicly posted.” (emphasis added)).
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`Thus, Medtronic made it clear to ordinary members of the public that the Telamon
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`documents and other such materials on Medtronic’s password-protected website are not
`
`
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`readily accessible. It is highly improper, albeit convenient, for Medtronic to tell the public
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`one thing while telling the Board in the case the exact opposite.
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`Medtronic’s Petition erroneously contends that the Phelps Declaration shows
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`evidence of the publication date for the Telamon documents. It does not. To the contrary,
`
`Ms. Phelps relies exclusively on a memorandum provided in Appendix B of the Phelps
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`Declaration, but the memorandum shows only that Medtronic employees receive copies of
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`Telamon materials:
`
`Medtronic employees,
`
`not ordinary members of
`
`the public.
`
`
`
`See Phelps Decl. at Appendix B. Nothing in the Phelps Declaration provides evidence that
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`the exact “Telamon” documents included in Medtronic’s Petition were openly and publicly
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`accessible to ordinary members of the public who sought a copy. Rather, as described
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`above, Medtronic made significant security efforts to prevent such a public distribution of the
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`materials.
`
`While NuVasive disputes Medtronic’s interpretation of the ‘156 patent claims and the
`
`Telamon documents in combination with various other references, these arguments need
`
`not be addressed in this paper because Medtronic fails to that the particular Telamon
`17
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Preliminary Response
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`Attorney Docket No: 13958-0116IP2
`documents cited in the Petition were in fact publicly available before the priority date of the
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`‘156 patent. As such, the Board must deny inter partes review as to Ground 2 as proposed
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`in Medtronic’s petition. See Practice Guide, 77 Fed. Reg. at 48,764 (“the references . . .
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`are not in fact prior art.”).
`
`VIII. THE PRIOR ART COMBINATIONS CITED BY MEDTRONIC UNDER ALL
`GROUNDS 1-2 FAILS TO PROVIDE THE CLAIMED IMPLANT WHERE TH