PTAB

IPR2013-00507

Medtronic Inc v. NuVasive Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: System and Methods for Spinal Fusion
  • Brief Description: The ’334 patent discloses a spinal fusion implant of non-bone construction for placement in the interbody space between vertebrae. The claimed implant is constructed from a radiolucent material, features specific dimensional characteristics including a length greater than 40 mm and at least 2.5 times its maximum width, includes anti-migration elements, at least one fusion aperture, and at least three specifically placed radiopaque markers for tracking during and after implantation.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3, 10, 14, 15, and 19-28 under 35 U.S.C. §102

  • Prior Art Relied Upon: Frey (Application # 2002/0165550).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Frey, which was not cited during prosecution, discloses every limitation of the challenged claims. Frey teaches a spinal fusion implant for lateral approaches with a radiolucent body, anti-migration elements, fusion apertures, and a receiving aperture for an insertion tool. Petitioner asserted that Frey’s disclosure of an implant sufficient to span a lumbar disc space inherently teaches a length greater than 40 mm. Furthermore, Petitioner contended that Frey’s scaled figures (e.g., Figs. 47, 55, 63) clearly disclose a longitudinal length at least 2.5 times greater than the implant's maximum lateral width. Frey was also alleged to disclose the required three radiopaque markers positioned in the distal wall, proximal wall, and central region of the implant. Dependent claims were also argued to be anticipated, such as by Frey's disclosure of PEEK material (claim 19) and anti-migration ridges (claim 10).

Ground 2: Obviousness of Claims 1-5, 10, 11, 14-17, and 19-28 over Frey in view of Baccelli

  • Prior Art Relied Upon: Frey (Application # 2002/0165550) and Baccelli (Application # 2003/0028249).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground primarily addressed dependent claims not anticipated by Frey alone. For claim 4, Petitioner argued that while Frey discloses a threaded receiving aperture, Baccelli explicitly teaches an aperture with a central axis oriented parallel to the implant’s longitudinal length. For claim 11, Baccelli was cited for teaching anti-migration ridges (teeth) that extend generally perpendicular to the implant’s length to prevent movement after implantation. Baccelli also provided alternative or supplemental disclosures for the use and orientation of radiopaque markers (claims 14-17), including elongate markers extending through the implant’s height.
    • Motivation to Combine: Petitioner contended a person of ordinary skill in the art (POSITA) would combine Frey and Baccelli to achieve predictable results. A POSITA would modify Frey’s implant to include the aperture orientation from Baccelli to better facilitate the lateral surgical approach disclosed in Frey. Both references are from the same field of intervertebral spinal fusion, teach the use of radiopaque markers for tracking, and provide space for bone growth material, creating a strong incentive to combine their respective features.
    • Expectation of Success: The combination was presented as a simple application of known mechanical elements from the same technical field to achieve the predictable result of an improved, more easily implantable and trackable spinal fusion device.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on Frey in combination with other references. These grounds relied on similar combination rationales, using secondary references to teach specific features:

    • Frey and Messerli (Application # 2003/0139813) was argued to render claims obvious, with Messerli teaching the dimensional ratio of length being at least 2.5 times the width.
    • Frey and Michelson (Patent 5,860,973) was argued to render claims obvious, with Michelson teaching specific implant dimensions (length > 40 mm), a wider-than-tall configuration, and anti-migration elements perpendicular to the implant's length.
    • Frey and Moret (Application # 2003/0100950) was argued to render claims obvious, with Moret providing an alternative teaching for the specific placement of radiopaque markers in the distal and proximal walls.

4. Key Claim Construction Positions

  • Distal Wall / Proximal Wall: Petitioner proposed that under the broadest reasonable construction, these terms should refer to the leading and trailing end walls of the implant, respectively. This construction was argued to be consistent with the prosecution history of a parent patent, where the USPTO located apertures shown in the Frey prior art on the proximal wall, a position the applicant implicitly accepted. This construction is critical for mapping Frey’s features to the claim limitations requiring markers and apertures on specific walls.
  • Releasably Mate: Petitioner proposed this term be construed as “an impermanent stabilized connection,” consistent with its use in the ’334 patent to describe the connection between the implant and an insertion tool. This construction supports the argument that the threaded connections disclosed in Frey and Baccelli meet the corresponding claim limitation.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-5, 10, 11, and 14-28 of the ’334 patent as unpatentable.