PTAB

IPR2013-00506

Medtronic Inc v. NuVasive Inc

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Systems and Methods for Spinal Fusion
  • Brief Description: The ’156 patent discloses a spinal fusion implant for positioning in the interbody space between vertebrae. The implant is constructed of a radiolucent material and features a specific geometry including distal, proximal, and side walls, anti-migration elements on its upper and lower surfaces, at least one fusion aperture, and at least two radiopaque markers for visibility during and after surgery.

3. Grounds for Unpatentability

Ground 1: Obviousness over SVS-PR and Secondary References - Claims 1-14, 19-20, and 23-27 are obvious over SVS-PR in view of Baccelli, Frey, Michelson, and/or Telamon.

  • Prior Art Relied Upon: SVS-PR (Synthes Vertebral Spacer-PR Brochure), Baccelli (Application # 2003/0028249), Frey (Application # 2002/0165550), Michelson (Patent 5,860,973), and Telamon (Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure and Implantation Guide).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the SVS-PR brochure, the primary reference, disclosed nearly all elements of independent claim 1. SVS-PR taught a spinal fusion implant made of a biocompatible radiolucent polymer with distal, proximal, and side walls; anti-migration "saw-tooth" patterns on its upper and lower surfaces; and a "single axial canal" serving as the fusion aperture. To meet the limitation of claim 1 requiring first and second radiopaque markers extending into the sidewalls, Petitioner relied on Baccelli. Baccelli taught an implant with radiopaque spikes that extend into the sidewalls, proximate to a medial plane, for identifying the implant's position during surgery. For dependent claims, Petitioner asserted that other references taught the missing features. For instance, modifying the SVS-PR implant to have a threaded receiving aperture (claims 6-7) was obvious in view of Frey, Michelson, and Baccelli, all of which disclosed threaded apertures for engaging an inserter tool. Similarly, modifying the implant’s dimensions to be greater than 40 mm long (claim 5) or approximately 18 mm wide (claim 9) was obvious over Michelson, which taught these dimensions to increase stability for lateral insertion.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the radiopaque markers taught by Baccelli with the SVS-PR implant to solve a known problem: improving the surgeon's ability to track the implant's orientation and location during and after surgery. Petitioner contended this was a simple application of a known element (markers) to a similar device to achieve a predictable improvement in functionality. Likewise, a POSITA would be motivated to incorporate a threaded aperture from Frey or Michelson into the SVS-PR implant to provide more axial stability during implantation, a known design need.
    • Expectation of Success: A POSITA would have reasonably expected success in these combinations because they involved applying known, predictable solutions to improve existing implant designs without changing their fundamental principles of operation.

Ground 2: Obviousness over Telamon and Secondary References - Claims 1-14, 19-20, and 23-27 are obvious over Telamon in view of Baccelli, Frey, Michelson, and/or SVS-PR.

  • Prior Art Relied Upon: Telamon (Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure and Implantation Guide), Baccelli (Application # 2003/0028249), Frey (Application # 2002/0165550), Michelson (Patent 5,860,973), and SVS-PR.
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that the Telamon brochure, as the primary reference, disclosed a PEEK spinal fusion implant that met most limitations of claim 1. Telamon taught an implant with the claimed wall structure, anti-migration elements, a fusion aperture, and radiolucent PEEK construction. While Telamon disclosed radiopaque tantalum markers, Petitioner again relied on Baccelli for its specific teaching of markers extending into the first and second sidewalls proximate to a medial plane. This combination allegedly rendered claim 1 obvious. For dependent claims requiring dimensional or structural modifications, Petitioner relied on the same secondary references as in Ground 1. For example, for claim 8's pair of lateral grooves on the proximal wall, Petitioner argued it would have been obvious to combine Telamon with the similar teachings of SVS-PR or Michelson to create the required inserter interface.
    • Motivation to Combine: The motivation to combine Telamon with Baccelli was identical to that in Ground 1: to improve intraoperative visualization by incorporating a known marker configuration into a similar base implant. The motivation to add features like lateral grooves from SVS-PR or specific dimensions from Michelson was driven by the well-understood need to improve insertion stability and tailor implant size for specific surgical approaches (e.g., lateral insertion), which represented routine design optimization.
    • Expectation of Success: A POSITA would have expected these combinations to work predictably. Modifying the Telamon implant with Baccelli's markers or SVS-PR's inserter grooves involved combining familiar elements according to known methods to achieve predictable results and would have constituted no more than the exercise of ordinary skill.

4. Key Claim Construction Positions

Petitioner argued for the broadest reasonable construction for several key terms, asserting these constructions were consistent with the specification and prosecution history.

  • Distal Wall / Proximal Wall: Petitioner proposed construing "distal wall" as the leading end of the implant that enters the patient first and "proximal wall" as the trailing end that enters last. This construction was central to mapping features on the prior art implants to the correct claimed locations.
  • Releasably Mate: Proposed as "an impermanent stabilized connection," specifically referencing the connection between the implant and its insertion tool. This interpretation was used to argue that prior art engagement features, such as threaded apertures, met this limitation.
  • Generally Rectangular and Generally Oblong in Shape: Construed broadly as a shape having portions roughly approximating sides and being elongated in at least one dimension. Petitioner noted that the PTO had adopted a similar construction during prosecution of a parent application, which was critical for arguing that the fusion apertures in the prior art met this limitation.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-14, 19-20, and 23-27 of the ’156 patent as unpatentable.