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 IPR2014-00487
`Patent 8,361,156
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`NUVASIVE INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
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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 IPR2014-00487
`Patent 8,361,156
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`NUVASIVE INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
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`Patent No. 8,361,156
`Patent Owner Response
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`TABLE OF CONTENTS
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`EXHIBITS ............................................................................................................................... iii
`I.
`INTRODUCTION ......................................................................................................... 1
`II.
`CLAIM 1 IS NOT RENDERED OBVIOUS BY THE PRIOR ART ................................ 3
`III.
`CONCLUSION .......................................................................................................... 11
`CERTIFICATE OF SERVICE ............................................................................................... 12
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`Patent No. 8,361,156
`Patent Owner Response
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`Cases
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`TABLE OF AUTHORITIES
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`K/S HIMPP v. Hear-Wear Techs., LLC,
`___ F.3d ___, Slip Op. at 8 (Fed. Cir. May 27, 2014) ........................................................ 9
`KSR International Co. v. Teleflex Inc. (KSR),
`550 U.S. 398, 82 USPQ2d 1385 (2007) ............................................................................. 9
`Medtronic, Inc. v. NuVasive, Inc.,
`Case IPR2013-00504 ......................................................................................................... 1
`Medtronic, Inc. v. NuVasive, Inc.,
`Case IPR2013-00506 ......................................................................................................... 1
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`ii
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`Patent No. 8,361,156
`Patent Owner Response
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`EXHIBITS
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`Description
`Exhibit No.
`Nuvasive-2001 Petition for Inter-Partes Review (Paper No. 3, IPR2013-
`00504)
`Nuvasive-2002 Decision - Denying Institution of Inter Partes Review - 37
`CFR 42.108 (Paper No. 8, IPR2013-00504)
`Nuvasive-2003 Redacted Engineering Drawings (Exhibit 2023 from
`IPR2013-00506)
`Nuvasive-2004 Selected Portions of Transcript from Videotaped
`Deposition of Steven DeRidder, taken on behalf of
`Nuvasive, Inc. on April 17, 2014
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`iii
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`Patent No. 8,361,156
`Patent Owner Response
`I.
`INTRODUCTION
`For a third time and after having had essentially the same petition previously denied
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`by the Board, Medtronic, Inc. (“Medtronic”) seeks inter partes review of claims 1-14, 19, 20,
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`and 23-27 of U.S. Patent No. 8,361,156 (“the ‘156 patent”). NuVasive asserted its ’156
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`patent against Medtronic in a counterclaim of a lawsuit initiated by Medtronic.1 The claims
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`of the ‘156 patent are tailored to a unique combination of features collectively provided in a
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`spinal implant—features particularly suited for implant insertion in a lateral, trans-psoas
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`surgical approach path.
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`Medtronic previously filed two petitions for inter partes review of the ’156 patent, both
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`challenging the same subset of claims as the present Petition, namely, claims 1-14, 19, 20,
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`and 23-27. See IPR2013-00504 (“the ’504 IPR”); IPR2013-00506 (“the ’506 IPR”). The
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`Board granted Medtronic’s petition as to these claims in the ’506 IPR, but denied
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`Medtronic’s petition in the ’504 IPR, agreeing with NuVasive that Medtronic did “not address
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`the limitation that the ‘implant has a maximum lateral width extending from said first sidewall
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`to said second sidewall along a medial plane that is generally perpendicular to said
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`1 That district court case is currently stayed as it relates to the ’156 patent in light of
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`the Board’s institution of inter partes review of the same claims that are the subject of
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`Medtronic’s instant Petition. See Medtronic, Inc. v. NuVasive, Inc., Case IPR2013-00506.
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`1
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`Case IPR2014-00487
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`Attorney Docket No: 13958-0116IP3
`longitudinal length,’ as required by claim 1.” ‘504 IPR, Paper No. 008, Decision Denying
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`Institution of IPR, at 7-8. The Board further found that “Medtronic does not specify how the
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`maximum lateral width extends between the two sidewalls along the medial plane of the
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`implant [in Frey].” Id. at 7.
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`Not satisfied that the Board instituted review of claims 1-14, 19, 20, and 23-27 of the
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`’156 patent in the ’506 IPR, Medtronic filed this petition, which is essentially a duplicate of its
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`previously denied petition in the ’504 IPR. Importantly, Medtronic has not adequately
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`addressed the deficiencies identified by the Board in its previous denial regarding the Frey
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`prior art reference. Medtronic has merely added a few annotations to the Frey reference,
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`but that proves insufficient. Indeed, when actually measured, Medtronic’s proposition that
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`the Frey prior art teaches an implant having “a maximum lateral width extending from said
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`first sidewall to said second sidewall along its medial plane” proves false. This is
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`confirmed by the redacted engineering drawings for Medtronic’s Boomerang-P Cage – an
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`embodiment of the Frey patent. See Ex. 2003. And, Medtronic’s attorney argument that it
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`would have been obvious to modify Frey to conform to Claim 1 of the ’156 patent is
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`supported only by conclusory statements by its proffered witness, Dr. Hynes (Exhibit 1001).
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`Indeed, there is no reasonable basis grounded in facts articulated by Medtronic or Dr.
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`Hynes as to why a person of skill in 2003 would have modified the Frey implant as
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`Medtronic now suggests.
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`2
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`Case IPR2014-00487
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP3
`Accordingly, Medtronic’s third Petition for IPR of claims 1-14, 19, 20, and 23-27 of
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`the ‘156 patent fails to establish a reasonable likelihood that it would prevail with respect to
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`at least one of the claims challenged in the Petition.2 This Petition should be denied.
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`In addition, should the Board wish to take up the issue of redundancy, NuVasive
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`notes that the present Petition is directed to the very same claims as the instituted ’506 IPR
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`proceeding mentioned above. Petitioner contends that “the grounds in this Petition are not
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`redundant to those in the granted ’506 IPR because those grounds are based on different
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`prior art references and different arguments.” Petition, at 3. Patent Owner respectfully
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`notes that Medtronic’s argument is not a proper rationale against a finding of redundancy. If
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`it were, the Board would rarely deny petitions based on redundancy.
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`II.
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`CLAIM 1 IS NOT RENDERED OBVIOUS BY THE PRIOR ART
`Claim 1 of the ‘156 patent requires, in part, an implant where the “longitudinal length
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`is greater than said maximum lateral width,” with “a medial plane that is generally
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`perpendicular to said longitudinal length,” and having “a maximum lateral width extending
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`from said first sidewall to said second sidewall along its medial plane” Ex. 1013, ’156
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`patent, claim 1.
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`2 Medtronic’s Petition here also fails for all the reasons articulated in NuVasive’s
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`preliminary response in Case IPR2013-504.
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`3
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`Case IPR2014-00487
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP3
`As it did previously, Petitioner relies on Published U.S. Patent Application No.
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`2002/165550 to Frey (“Frey”) as the primary reference in combinations 1-4, and relies on
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`Frey as one of two secondary references in combination 5. See Petition, at 4; see also Ex.
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`2002, ’504 IPR, Paper No. 008, Decision Denying Institution of Inter Partes Review, at 5. In
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`combinations 1-4, Petitioner relies exclusively on Frey for the “a maximum lateral width
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`extending from said first sidewall to said second sidewall along its medial plane” limitation.
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`See Petition, at 14-15, 19, 37-39, 43. Even in combination 5, Medtronic relies only on Frey
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`for the “a maximum lateral width extending from said first sidewall to said second sidewall
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`along its medial plane” limitation. See Petition, at 46, 48.
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`In denying Medtronic’s previous petition, the Board expressly found that “Medtronic
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`does not specify how the maximum lateral width extends between two sidewalls along the
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`medial plane of the implant.” See Ex. 2002, ’504 IPR, Paper No. 008, Decision Denying
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`Institution of Inter Partes Review, at 7. The Board further found that “the maximum lateral
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`width, as shown in annotated Figure 63, is not at the midpoint of the longitudinal length, but
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`is closer to one end of the implant than the other. Stated differently, Medtronic does not
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`explain how the maximum lateral width of the implant is along a medial plane that is
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`generally perpendicular to the longitudinal length, as required by independent claim 1.” Id.
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`at 8. Annotated Figure 63 from Medtronic’s prior petition is reproduced below for reference:
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`Patent Owner Response
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`Ex. 2001, ’504 IPR Petition, at 18.
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`Medtronic now attempts to “cure any noted deficiencies in Petitioner’s previously
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`filed [’504 IPR] petition” by further annotating Figure 63 from Frey in an attempt to show that
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`Frey’s maximum lateral width is along the medial plane. Medtronic fails. As shown below,
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`the maximum lateral width of Frey is not along the medial plane it has identified in its
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`labeling of the figure, but rather is closer to one end of the implant than the other, as
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`Medtronic originally drew in its ’504 IPR petition, shown above. Medtronic’s newly
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`annotated Figure 63 in the present Petition, reproduced below, is further annotated below
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`by Patent Owner (with the green line) to show that the maximum lateral length is located
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`near one of the side arrows added by Medtronic, not at the arrow along the medial plane as
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`identified by Medtronic.
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`5
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`Patent No. 8,361,156
`Patent Owner Response
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`See Petition, at 19, further annotated by Patent Owner with green line. If we assume that
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`the maximum longitudinal length (as identified by Medtronic above) of Figure 63 is 36 mm,
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`then the width of the red line along the medial plane is approximately 12 mm, whereas the
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`maximum width along the green line added above is 12.7 mm. This is reasonable given
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`that the radius of curvature of the inward curve located on the posterior side of the implant
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`(i.e., on the lower side of the implant in the figure) is smaller than the radius of curvature of
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`the bowing located on the anterior side of the implant (i.e., on the upper side of the implant
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`in the figure). This difference in radius of curvature means that the implant will actually
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`become wider, at least for some part of the implant, as you move from the center of the
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`implant toward its extremities.
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`This conclusion is confirmed by an analysis of the redacted specification drawings
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`for Medtronic’s Boomerang-P cage, which is an embodiment of the Frey patent. See Ex.
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`2004, DeRidder Depo., at 40:12-20; see also Ex. 2003, at 2. Below is an annotated
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`specification drawing for Medtronic’s 36 mm Boomerang-P implant which identifies the
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`Attorney Docket No: 13958-0116IP3
`“longitudinal length” (red line), the “lateral width along the medial plane” (blue line), and the
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`“maximum lateral width” (green line) of the Boomerang-P implant, as those have been
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`defined by Medtronic in the present Petition.
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`Maximum lateral width
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`Lateral width at medial
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`See Ex. 2003, at 2, annotated by Patent Owner. If it is assumed that the longitudinal length
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`(red line) is 36 mm,3 then the lateral width along the medial plane (blue line) is
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`approximately 12.8 mm, and the maximum lateral width (green line) is approximately
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`3 Exhibit 2003, which is a collection of redacted specification drawings for
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`Medtronic’s Boomerang-P “8 x 36 mm 7o” cages, indicates in its title that the “longitudinal
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`length” (as defined by Medtronic) of the cage is 36 mm. Ex. 2003, at 2. The 8 mm measure
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`is a reference to the height of the cage, not the “width” as that term is used in this context.
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`Attorney Docket No: 13958-0116IP3
`13.23 mm. As discussed above, this is reasonable given that the radius of curvature of the
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`inward curve on the posterior side of the Boomerang-P cage (the lower side in the figure
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`above) is smaller than the radius of curvature of the bowing on the anterior side of the cage
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`(the upper side in the figure above). Thus, Medtronic’s assertion that the maximum lateral
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`width of the implant depicted in Frey runs along the “medial plane” is false.
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`Implicitly admitting that Frey does not teach a maximum lateral width “along the
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`medial plane,” Medtronic argues in the alternative that it would have been obvious for one
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`of skill in the art to modify Frey to include the maximum lateral width “in the middle portion of
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`the implant”4 for three reasons: (1) ease of manufacturing; (2) easy insertion of the device;
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`and (3) to better fill the disc space. See Petition, at 14-15. Petitioner’s proof is deficient in
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`numerous respects. It does not attempt to show what the Frey implant would look like if it
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`were redesigned to comport with the scope of the claims (i.e., so that the implant’s
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`maximum lateral width would be “in the middle portion of the implant,” as it states); and it
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`does not show if or how the function of the implant would change if redesigned. See
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`Petition at 15-16 and 19. Indeed, even the cited “evidence” in support of the attorney
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`4 Medtronic does not argue that it would have been obvious to modify Frey to include
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`the maximum lateral width “along the medial plane,” rather “in the middle portion of the
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`implant.” Petition, at 14-15.
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`Case IPR2014-00487
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`Attorney Docket No: 13958-0116IP3
`obviousness arguments are conclusory statements made by an alleged expert with no
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`support or rational underpinnings. See KSR International Co. v. Teleflex Inc. (KSR), 550
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`U.S. 398, 418, 82 USPQ2d 1385, 1396 (2007) (“‘[R]ejections on obviousness cannot be
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`sustained by mere conclusory statements; instead, there must be some articulated
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`reasoning with some rational underpinning to support the legal conclusion of obviousness.’”
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`quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)); K/S
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`HIMPP v. Hear-Wear Techs., LLC, ___ F.3d ___, Slip Op. at 8 (Fed. Cir. May 27, 2014)
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`(holding that “the Board cannot accept general conclusions about what is ‘basic knowledge’
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`or ‘common sense’ as a replacement for documentary evidence for core factual
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`findings in a determination of patentability. To hold otherwise would be to embark down
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`a slippery slope which would permit the examining process to deviate from the well-
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`established and time-honored requirement that rejections be supported by evidence.”
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`(emphasis added; citations omitted)).
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`Petitioner argues that the modification to Frey would have been obvious “for ease of
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`manufacture.” Petition, at 15-16, citing Hynes Dec. ¶ 38. But Petitioner offers no
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`explanation of this “ease of manufacture” argument in its Petition or in the declaration of Dr.
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`Hynes. Moreover, there is no support for Dr. Hynes – a medical doctor – being qualified to
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`provide an opinion on the issue of manufacturing. In short, there is simply no evidentiary
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`support for this argument.
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`Case IPR2014-00487
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`Attorney Docket No: 13958-0116IP3
`Petitioner next argues that the modification to Frey would have been obvious “to
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`allow for easy insertion of the device during implantation.” See Petition, at 15-16, citing
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`Hynes Dec., ¶ 38. Here again, Petitioner offers no explanation as to why modifying the Frey
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`implant to meet the maximum lateral width claim limitation would “allow for easy insertion of
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`the device.” The Frey implant shown in Figure 63 is a TLIF (transforaminal lateral interbody
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`fusion) implant that is designed to be inserted using a width-constrained postero-lateral
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`approach. See Ex. 1003 (Frey), Figs. 53, 65 (illustrating the width constrained postero-
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`lateral, transforaminal approach to the vertebral disc space); see also ¶¶ 0004 and 0087.
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`Nowhere do Petitioner and its proffered expert acknowledge this fact. See Petition, at 15-
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`16; Hynes Dec. ¶ 38. Thus, Petitioner’s “easy insertion” argument is not only unexplained, it
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`is contrary to the teachings of Frey.
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`Finally, Petitioner argues that the modification to Frey would have been obvious “to
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`better fill the disc space, thus providing optimal load support capacity.” See Petition, at 16,
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`citing Frey, ¶ 0149, Hynes Dec., ¶ 38, and DeRidder Dec. ¶ 11. Here again, Petitioner
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`ignores that Frey is a TLIF implant designed for the space-constrained transforaminal
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`postero-lateral approach. As shown in Figure 53 of Frey, better fill of a disc space is not
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`always possible given the constraints associated with the transforaminal, postero-lateral
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`approach for which the Frey boomerang-shaped implant is designed. See Ex. 1003 (Frey),
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`Fig. 53. And again, the Hynes declaration at paragraph 38 provides merely conclusory
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`statements, without explanation, regarding the “better fill” argument. See Hynes Dec. ¶ 38.
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`Patent No. 8,361,156
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`Case IPR2014-00487
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP3
`Finally, the DeRidder declaration also provides only a conclusory statement regarding the
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`disclosure in Frey’s paragraph 0149, without explaining or supporting Medtronic’s
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`suggested modification of Frey. See DeRidder Dec. ¶ 11. Petitioner’s “better fill” argument
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`is unexplained, without evidentiary support, and contrary to the teachings of Frey.
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`Thus, Medtronic has not cured the deficiencies identified by the Board in its decision
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`denying institution of inter partes review in the ’504 IPR on the same grounds advanced in
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`this Petition. Medtronic still does not meet its burden to show that there is a reasonable
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`likelihood that it will prevail with respect to at least one of the claims challenged in the
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`Petition.
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`III.
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`CONCLUSION
`For the reasons set forth above, Medtronic’s Petition for inter partes review of claims
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`1–14, 19, 20, and 23–27 of the ’156 patent should be denied.
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`Date: June 13, 2014
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`Respectfully submitted,
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` /Stephen R. Schaefer, Reg. No. 37,927/
`Stephen R. Schaefer
`Reg. No. 37,927
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`Patent No. 8,361,156
`Patent Owner Response
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`CERTIFICATE OF SERVICE
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`Case IPR2014-00487
`Attorney Docket No: 13958-0116IP3
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on June 13, 2014, a complete and entire copy of this Nuvasive, Inc.’s
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`Patent Owner Preliminary Response was provided via email to the
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`Petitioner by serving the correspondence email address of record as
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`follows:
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`Jeff E. Schwartz
`1030 15th Street, NW
`Washington, DC 20005
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`Seth A. Kramer
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103
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`(Attorney Docket No. 108136.00033)
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`Email: ipdocket@foxrothschild.com
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`/Christine L. Rogers/
`Christine L. Rogers
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(650) 839-5092
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