throbber
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 IPR2013-00504
`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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`
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`TABLE OF CONTENTS
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`Case IPR2013-00504
`Attorney Docket No: 13958-0116IP1
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`I. 
`II. 
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`III. 
`IV. 
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`V. 
`
`B. 
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`C. 
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`D. 
`
`INTRODUCTION ......................................................................................................... 1 
`THE ‘156 PATENT CLAIMS AN IMPLANT WITH A UNIQUE COMBINATION OF
`STRUCTURES PARTICULARLY SUITED FOR A LATERAL, TRANS-PSOAS
`APPROACH ................................................................................................................ 3 
`STANDARD FOR GRANTING INTER PARTES REVIEW.......................................... 7 
`THE PRIOR ART CITED BY MEDTRONIC UNDER ALL GROUNDS 1-5 FAILS TO
`DISCLOSE OR SUGGEST THE CLAIMED MAXIMUM LATERAL WIDTH
`EXTENDING ALONG A MEDIAL PLANE, AS RECITED IN CLAIM 1 ........................ 8 
`A. 
`The references advanced in Ground 1 fail to disclose or suggest the claimed
`maximum lateral width extending along a medial plane, as required by
`independent claim 1. ...................................................................................... 11 
`The references advanced in Ground 2 fail to disclose or suggest the claimed
`maximum lateral width extending along a medial plane, as required by
`independent claim 1. ...................................................................................... 14 
`The references advanced in Ground 3 fail to disclose or suggest the claimed
`maximum lateral width extending along a medial plane, as required by
`independent claim 1. ...................................................................................... 15 
`The references advanced in Ground 4 fail to disclose or suggest the claimed
`maximum lateral width extending along a medial plane, as required by
`independent claim 1. ...................................................................................... 16 
`The references advanced in Ground 5 fail to disclose or suggest the claimed
`maximum lateral width extending along a medial plane, as required by
`independent claim 1. ...................................................................................... 17 
`THE PRIOR ART CITED BY MEDTRONIC UNDER ALL GROUNDS 1-5 FAILS TO
`DISCLOSE OR SUGGEST THE CLAIMED IMPLANT WHERE THE LONGITUDINAL
`LENGTH IS GREATER THAN 40 MM, AS RECITED IN CLAIM 5 ........................... 18 
`A. 
`The references advanced in Grounds 1-2 and 4-5 fail to disclose or suggest
`the claimed implant having a longitudinal length greater than 40 mm, as
`required by independent claim 5. ................................................................... 19 
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`E. 
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`i
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`VI. 
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`B. 
`The “alternative” argument in Ground 3 relies upon an improper modification
`to Frey’s implant, and the resulting combination of references in Ground 3
`would not provide the claimed implant having a longitudinal length greater
`than 40 mm, as required by independent claim 5. ......................................... 23 
`THE PRIOR ART CITED BY MEDTRONIC UNDER ALL GROUNDS 1-5 FAILS TO
`DISCLOSE OR SUGGEST THE CLAIMED IMPLANT WHERE THE UPPER AND
`LOWER SURFACES ARE GENERALLY PARALLEL TO ONE ANOTHER, AS
`RECITED IN CLAIM 12 ............................................................................................. 28 
`VII.  MEDTRONIC FAILED TO SHOW WHY PROPOSED GROUNDS 1-5 ARE NOT
`REDUNDANT WITH ONE ANOTHER ...................................................................... 30 
`VIII.  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.................................................... 32 
`CONCLUSION .......................................................................................................... 34 
`CERTIFICATE OF SERVICE ........................................................................................
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`IX. 
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`ii
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`Patent No. 8,361,156
`Preliminary Response
`
`Case Law
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`
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`TABLE OF AUTHORITIES
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`Case IPR2013-00504
`Attorney Docket No: 13958-0116IP1
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`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed. Cir. 2012) .................. 7
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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, 24, 27
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`In re Ratti, 270 F.2d 810, 813 (CCPA 1959) ........................................................... 18, 27, 28
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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) ..................... 31, 32
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`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00003,
`(PTAB Oct. 25, 2012) ......................................................................................... 31, 32
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`Statutes
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`35 U.S.C. § 103 (2012) ............................................................................. 7, 11, 14, 15, 16, 17
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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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`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012) .......................................................... 7, 8, 11, 18
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`iii
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`Patent No. 8,361,156
`Preliminary Response
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`
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`EXHIBITS
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`Case IPR2013-00504
`Attorney Docket No: 13958-0116IP1
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`Exhibit Description
`Ex. #
`NUVA 2001 U.S. Patent No. 7,905,840 to Pimenta et al.
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`iv
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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 IPR2013-00504
`Attorney Docket No: 13958-0116IP1
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`
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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 IPR2013-00506, and addresses the exact
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`same claims as the IPR2013-00504 petition (namely, claims 1-14-19, 20 and 23-27). In
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`addition, a related patent (U.S. Patent No. 8,187,334) was asserted by NuVasive in the
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`same infringement lawsuit against Medtronic and its affiliates, and Medtronic has also filed
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`two inter partes review petitions against that patent as well. See IPR2013-00507; IPR2013-
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`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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`For the reasons discussed below, Medtronic’s two petitions on the ‘156 patent
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`should be denied in their entirety. The present petition in particular includes multiple
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`instances in which claim limitations were never analyzed or in which Medtronic’s arguments
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`contradict themselves. For example, regarding the single independent claim 1 of the ‘156
`1
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`patent, all of the proposed grounds for rejection (Grounds 1-5) rely upon Frey’s implant
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`1400 for most of the claim elements, including the important claim limitation of “a maximum
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`lateral width extending . . . along a medial plane.” With regard to this claim limitation,
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`although Medtronic’s Petition illustrates the location of Frey’s “maximum lateral width” and
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`the location of Frey’s “medial plane,” the “maximum lateral width” is not “along” the medial
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`plane, as the claim requires. See Petition at pp. 18 and 20. Moreover, even though
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`Medtronic points out clearly that the “maximum lateral width” is not “along” the “medial
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`plane” (but instead, is entirely offset from that plane), Medtronic does not even attempt to
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`address this important claim limitation. This is not simply an oversight where the Board can
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`fill in the clear gaps in the Petition. These are important claim limitations that Petitioner
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`should have addressed, but did not because it cannot.
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`Moreover, regarding dependent claim 5, Medtronic takes the unsupported position in
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`Grounds 1-3 and 5 that Frey’s implant 1400 (depicted in FIGS. 59-65) has a length that is
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`inherently (i.e., “necessarily”) greater than 40 mm. Even a cursory review of FIG. 65 shows
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`that Frey’s implant 1400 has a preferred length that is much less than the width (side to
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`side) of the vertebrae, thus showing that the length of Frey’s implant is far less than 40 mm
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`and is certainly not “necessarily” greater than 40 mm. Also, regarding dependent claim 12,
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`Medtronic contradicts itself by asserting that the upper and lower surfaces of Frey’s implant
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`“are generally parallel to one another” even though—on the very next page of the Petition—
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`Medtronic takes the opposite position. Indeed, Medtronic even provides an illustration (in
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`the analysis of claim 13) showing that the upper and lower surfaces of Frey’s implant are
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`not parallel, but instead have a dramatic intended slope relative to one 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.
`
`THE ‘156 PATENT CLAIMS AN IMPLANT WITH A UNIQUE COMBINATION OF
`STRUCTURES PARTICULARLY SUITED FOR A LATERAL, TRANS-PSOAS
`APPROACH
`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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`muscle—a muscle that was historically avoided by most spine surgeons—located on each
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`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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`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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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`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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`5
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`Patent No. 8,361,156
`Preliminary Response
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`Case IPR2013-00504
`Attorney Docket No: 13958-0116IP1
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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 IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`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
`7
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`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 “prior art lacks a material
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`limitation in all of the independent claims.” Practice Guide, 77 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 Frey’s implant 1400 that discloses “a maximum lateral width extending . . .
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`along a medial plane,” but then Medtronic subsequently admits that indeed Frey’s maximum
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`lateral width is plainly offset from the medial plane and thus does not extend along the
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`medial plane. Simply put, none of the proposed Ground 1-5 as charted in Medtronic’s
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`Petition provides the claimed “maximum lateral width extending . . . along a medial plane”
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`(as recited in the sole independent claim of the ‘156 patent)—i.e., a material limitation in
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`every claim of the ‘156 patent. Accordingly, 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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`IV.
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`THE PRIOR ART CITED BY MEDTRONIC UNDER ALL GROUNDS 1-5 FAILS TO
`DISCLOSE OR SUGGEST THE CLAIMED MAXIMUM LATERAL WIDTH
`EXTENDING ALONG A MEDIAL PLANE, AS RECITED IN CLAIM 1
`Medtronic contends that the alleged prior art renders each claim of the ‘156 patent
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`obvious over various combinations of references. While NuVasive disputes Medtronic’s
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`interpretation of several of these references, these arguments need not be addressed in this
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`paper because Medtronic fails to cite any combination of references that disclose a
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`“maximum lateral width extending . . . along a medial plane” as recited in independent
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`claim 1—the sole independent claim of the ‘156 patent.
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`Claim 1 recites that “said implant has a maximum lateral width extending … along a
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`medial plane that is generally perpendicular to said longitudinal length.” Properly
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`interpreted, this claim phrase requires that the maximum lateral width (side to side) of
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`the implant be at the longitudinal middle of the implant, not at a location on the
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`longitudinal axis that is offset from the longitudinal middle of the implant. This claim
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`interpretation is consistent with the dictionary definition of “medial,” which is “[r]elating to,
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`situated in, or extending toward the middle; median.” The American Heritage® Dictionary of
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`the English Language, Fourth Edition copyright ©2000 by Houghton Mifflin Company.
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`Updated in 2009 (provided at http://www.thefreedictionary.com/medial). This interpretation
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`is also consistent with the ‘156 patent specification, which discloses, in Figures 3 and 20 for
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`example, embodiments where the sides of the implant are outwardly bowing in a constant
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`manner along the length of the implant, and therefore the largest width of the implant is in
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`the longitudinal middle of the implant. In fact, the ‘156 patent discloses no embodiments
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`where the greatest lateral width is anywhere other than the longitudinal middle of the
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`implant. Further support is provided in the ‘156 patent claim 1 and specification by virtue of
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`the claimed “medial plane” being used later in the claim as a reference point to define the
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`position of the two claimed markers. In particular, claim 1 recites that the two claimed
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`markers each includes a location “proximate to said medial plane.” ‘156 patent at 12:65.
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`The ‘156 patent specification describes two central markers 9 that are aligned with the plane
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`at the longitudinal middle of the implant. See, e.g., ‘156 patent at Figure 3; see also Mark-
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`up of Figure 3 set forth above, labeling the medial plane.
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`Petitioner concedes the correctness of this interpretation, even though Medtronic
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`does not advance a specific claim interpretation on the “medial plane” point. In particular, in
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`its Petition on page 20 Medtronic specifically marks a “medial plane” in the Frey implant,
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`and marks it at the longitudinal middle of the Frey implant. In addition, on page 18 of the
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`Petition, the maximum lateral width is labeled, and that maximum width is offset from the
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`longitudinal middle of the implant. Importantly though, Medtronic does not advance any
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`contention that the labeled maximum lateral width (on page 18 of the Petition) is located
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`“along [the] “medial plane” of the implant, as claimed. As such, Medtronic has not offered
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`any argument or support for a medial plane being located other than at the longitudinal
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`middle of the implant.
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`All Grounds 1-5 expressly rely upon Frey’s implant 1400 for an alleged disclosure of
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`this “greatest width at the longitudinal middle of the implant” claim limitation, but Frey’s
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`implant 1400 is plainly lacking. Medtronic’s failure in this regard is dispositive, as the
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`alleged prior art lacks disclosure of a material limitation of the one and only independent
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`claim of the ‘156 patent. As such, the Board must deny inter partes review as to each
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`10
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`ground of invalidity advanced in Medtronic’s petition. See Practice Guide, 77 Fed. Reg.
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`48,756, 48,764 (Aug. 14, 2012).
`
`A.
`
`The references advanced in Ground 1 fail to disclose or suggest the
`claimed maximum lateral width extending along a medial plane, as
`required by independent claim 1.
`Through Ground 1 of its Petition, Medtronic contends that claim 1 of the ‘156 patent
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`is unpatentable under 35 U.S.C. § 103 by Frey (Exhibit MSD1003) in view of Baccelli
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`(Exhibit MSD1004). See Petition at p. 13. Medtronic concedes that this proposed
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`combination asserted in Ground 1 fails to provide a fusion implant having “a maximum
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`lateral width extending … along a medial plane,” as recited in claim 1, and does not even
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`attempt to argue the modification from the claim would have been obvious. Indeed, the
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`expert declaration of Richard Hynes, M.D., does not address the point.
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`Medtronic’s Petition relies upon Frey’s implant 1400 for a teaching of nearly all
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`structural elements of the implant body recited in claim 1 of the ‘156 patent (relying upon the
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`secondary reference (Baccelli) only for an alleged teaching related to the claimed location of
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`the first and second radiopaque markers—an unrelated issue that is not addressed herein).
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`Indeed, Medtronic’s Petition even provides an illustration showing the location of the
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`“Maximum Lateral Width” of Frey’s implant 1400:
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`11
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`Patent No. 8,361,156
`Preliminary Response
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`Case IPR2013-00504
`Attorney Docket No: 13958-0116IP1
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`Medtronic admits the
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`location of the “Maximum
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`Lateral Width”
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`In this analysis, Medtronic
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`never contends the
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`“Maximum Lateral Width”
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`extends along the medial
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`plane
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`See Petition at p. 18. As shown in the portion of Medtronic’s chart reproduced above, the
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`claim element plainly requires “a maximum lateral width extending … along a medial plane”
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`(refer to the left side of the chart), but Medtronic never contends that Frey’s implant provides
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`such a structure (refer the right side of the chart). Instead, Medtronic merely asserts that
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`“Frey provides that the implant has … a maximum lateral width extending from the first side
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`wall to the second sidewall,” sidestepping the full claim limitation set forth on the left side of
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`the chart (and as recited in claim 1).
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`Medtronic’s Petition is silent on page 18 about whether the alleged “maximum lateral
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`width” of Frey’s implant 1400 extends “along a medial plane.” It does not. In fact, Medtronic
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`admits this fact only two pages later in its Petition—illustrating the “Medial Plane” of Frey’s
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
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`Attorney Docket No: 13958-0116IP1
`implant 1400 being located in a manner offset and spaced apart from the previously
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`illustration location of Frey’s “Maximum Lateral Width”:
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`Medtronic admits the location of the
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`“Medial Plane” of the implant 1400
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`(aligned with the central axis of central
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`See Petition at p. 20.
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`hole 1427)
`Here, Medtronic’s admitted location for the “medial plane” of Frey’s implant 1400
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`illustrated on page 20 of the Petition can be readily applied to Medtronic’s illustration of
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`Frey’s implant 1400 providing on page 18 of the Petition, which reveals a fundamental flaw
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`in Medtronic’s analysis of claim 1:
`
`See Petition at p. 18 (modified to show Medtronic’s admitted location for the “Medial Plane”
`
`of the implant 1400). Accordingly Medtronic openly admits (and even illustrates)—and
`
`NuVasive fully agrees—that Frey’s maximum lateral width of the implant 1400 does not
`
`
`
`
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`13
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
`
`Attorney Docket No: 13958-0116IP1
`extend along the medial plane as required by claim 1, but instead it is entirely offset from
`
`and spaced apart from the medial plane.
`
`Thus, even if Frey’s implant 1400 was modified to include Baccelli’s first and second
`
`radiopaque markers (as proposed in Ground 1), the resulting combination as proposed in
`
`Ground 1 of Medtronic’s Petition would lack disclosure of a material limitation of the one and
`
`only independent claim of the ‘156 patent. For this reason alone, the Board must deny inter
`
`partes review as to Ground 1 in Medtronic’s petition.
`
`B.
`
`The references advanced in Ground 2 fail to disclose or suggest the
`claimed maximum lateral width extending along a medial plane, as
`required by independent claim 1.
`Medtronic’s separate combination of references set forth in Ground 2 of the Petition
`
`also fails to disclose this same aforementioned material limitation of claim 1. Through
`
`Ground 2 of its Petition, Medtronic contends that claim 1 of the ‘156 patent is unpatentable
`
`under 35 U.S.C. § 103 by Frey in view of Baccelli and in further view of Messerli (Exhibit
`
`MSD1007). See Petition at p. 36. With respect to independent claim 1, Medtronic relies on
`
`the same analysis as discussed in Ground 1:
`
`See Petition at p. 37. In other words, the same fundamental flaw in Ground 1 (Frey’s
`
`implant 1400 is lacking the claimed “maximum lateral width extending … along a medial
`
`
`
`
`
`14
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`

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`Patent No. 8,361,156
`
`Case IPR2013-00504
`Preliminary Response
`
`Attorney Docket No: 13958-0116IP1
`plane”) is simply incorporated directly into Medtronic’s analysis for Ground 2. Medtronic’s
`
`analysis in Ground 2 focuses exclusively on dependent claim 24, and it does nothing to cure
`
`the clear shortcomings in Medtronic’s analysis of independent claim 1. Accordingly,
`
`Medtronic’s proposed Ground 2 should be rejected for the same reasons discussed above
`
`with respect to Ground 1. See Section IV.A., supra.
`
`C.
`
`The references advanced in Ground 3 fail to disclose or suggest the
`claimed maximum lateral width extending along a medial plane, as
`required by independent claim 1.
`Medtronic’s separate combination of references set forth in Ground 3 of the Petition
`
`also fails for the exact same reasons. Through Ground 3 of its Petition, Medtronic
`
`contends that claim 1 of the ‘156 patent is unpatentable under 35 U.S.C. § 103 by Frey in
`
`view of Baccelli and further in view of Michelson (Exhibit MSD1005). See Petition at p. 38.
`
`With respect to independent claim 1, Medtronic relies on the same analysis as discussed in
`
`Ground 1:
`
`
`See Petition at p. 38. In other words, the same fundamental flaw in Ground 1 (Frey’s
`
`implant 1400 is lacking the claimed “maximum lateral width extending … along a medial
`
`plane”) is incorporated directly into Medtronic’s analysis for Ground 3. Medtronic’s analysis
`
`in Ground 3 focuses exclusively on dependent claims 5, 6, 8, 9, 20, and 24, and it does
`
`
`
`15
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
`
`Attorney Docket No: 13958-0116IP1
`nothing to cure the significant flaw for Medtronic’s analysis of independent claim 1.
`
`Accordingly, Medtronic’s proposed Ground 3 should be rejected for the same reasons
`
`discussed above with respect to Ground 1. See Section IV.A., supra.
`
`D.
`
`The references advanced in Ground 4 fail to disclose or suggest the
`claimed maximum lateral width extending along a medial plane, as
`required by independent claim 1.
`Through Ground 4 of its Petition, Medtronic contends that claim 1 of the ‘156 patent
`
`is unpatentable under 35 U.S.C. § 103 by Frey in view of Baccelli and further in view of
`
`Moret (Exhibit MSD1006). See Petition at p. 43. Yet again, this Ground 4 fails for the same
`
`reasons as Ground 1. With respect to independent claim 1, Medtronic relies on the same
`
`analysis as discussed in Ground 1:
`
`
`See Petition at p. 43. In other words, the same fundamental flaw in Ground 1 (Frey’s
`
`implant 1400 is lacking the claimed “maximum lateral width extending … along a medial
`
`plane”) is simply incorporated directly into Medtronic’s analysis for Ground 4. Medtronic’s
`
`analysis in Ground 4 focuses exclusively on dependent claim 3, and it does nothing to cure
`
`the clear shortcomings in Medtronic’s analysis of independent claim 1. Accordingly,
`
`Medtronic’s proposed Ground 4 should be rejected for the same reasons discussed above
`
`with respect to Ground 1. See Section IV.A., supra.
`
`16
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
`
`Attorney Docket No: 13958-0116IP1
`E.
`The references advanced in Ground 5 fail to disclose or suggest the
`claimed maximum lateral width extending along a medial plane, as
`required by independent claim 1.
`Finally, Ground 5 fails for the same reasons as Ground 1. Through Ground 5 of its
`
`Petition, Medtronic contends that claim 1 of the ‘156 patent is unpatentable under 35 U.S.C.
`
`§ 103 by Baccelli in view of Frey. See Petition at p. 45. With respect to this previously
`
`described element (i.e., element “1[E]”) of independent claim 1, Medtronic relies on the
`
`same erroneous analysis as discussed in Ground 1:
`
`For Ground 5, Medtronic
`
`simply incorporates the
`
`same erroneous analysis
`
`of Frey’s implant (describe
`
`
`See Petition at p. 48. Yet again, the same fundamental flaw in Ground 1 (Frey’s implant
`
`above)
`
`1400 is lacking the claimed “maximum lateral width extending … along a medial plane”) is
`
`simply incorporated directly into Medtronic’s analysis for Ground 5. Medtronic’s analysis in
`
`Ground 5 focuses other elements of claim 1, and it does nothing to cure the previously
`
`described shortcomings in Medtronic’s analysis for element “1[E]” of independent claim 1.
`
`For at least this reason, Medtronic’s proposed Ground 5 should be rejected for the same
`
`reasons discussed above with respect to Ground 1. See Section IV.A., supra.
`17
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`Patent No. 8,361,156
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`Case IPR2013-00504
`Preliminary Response
`
`Attorney Docket No: 13958-0116IP1
`In summary regarding all Grounds 1-5, Medtronic’s Petition proposes only prior art
`
`combination that would fail to provide a “maximum lateral width . . . extending along a
`
`medial plane,” as recited in claim 1. Thus, a material limitation of the sole independent
`
`claim of the ‘156 patent is missing from the prior art. This alone is sufficient for the Board to
`
`deny instituting inter partes review, and is indeed dispositive. See Practice Guide, 77 Fed.
`
`Reg. 48,756, 48,764 (Aug. 14

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