Medtronic Inc v. NuVasive Inc

1. Case Identification

• Case #: IPR2014-00487
• Patent #: 8,361,156
• Filed: March 5, 2014
• Petitioner(s): Medtronic, Inc.
• Patent Owner(s): NuVasive, Inc.
• Challenged Claims: 1-14, 19, 20, and 23-27

2. Patent Overview

• Title: Systems and Methods for Spinal Fusion
• Brief Description: The ’156 patent describes a spinal fusion implant of non-bone construction designed for placement in the interbody space between vertebrae. The implant is made at least partly from a radiolucent material and includes specific features such as anti-migration elements and at least two radiopaque markers to aid in surgical placement and visualization.

3. Grounds for Unpatentability

Ground 1: Obviousness over Frey and Baccelli - Claims 1-8, 10-14, 19, 20, and 23-27 are obvious 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: Petitioner argued that Frey, which was not cited during prosecution, discloses the core structural features of the ’156 patent’s independent claim 1. This includes a spinal fusion implant made of a radiolucent material (PEEK), having distal and proximal walls, two sidewalls, and upper and lower surfaces with anti-migration elements. Frey also allegedly teaches an implant where the longitudinal length is greater than the maximum lateral width along a medial plane and includes at least one fusion aperture that is longer than it is wide. While Frey discloses radiopaque markers, Petitioner contended Baccelli more specifically teaches the claimed arrangement of at least first and second radiopaque markers extending into the first and second sidewalls at positions proximate to the medial plane for surgical tracking. Dependent claims related to specific dimensions, a threaded receiving aperture, and material (PEEK) were also argued to be disclosed or suggested by Frey.
  • Motivation to Combine: Petitioner asserted that a person of ordinary skill in the art (POSITA) would combine the teachings of Frey and Baccelli to enhance surgical outcomes. Both references are in the same field of spinal fusion implants and expressly teach using radiographic markers to track implant placement. A POSITA would have been motivated to incorporate Baccelli’s specific marker configuration into Frey’s implant design to gain additional, more precise information regarding the implant's orientation and location during and after surgery.
  • Expectation of Success: The combination was presented as a predictable integration of known elements, where Frey’s implant structure would be enhanced by Baccelli’s known marker technique, yielding no unexpected results and thus ensuring a high expectation of success.

Ground 2: Obviousness over Frey, Baccelli, and Michelson - Claims 1-14, 19, 20, and 23-27 are obvious over Frey in view of Baccelli and Michelson.

• Prior Art Relied Upon: Frey (Application # 2002/0165550), Baccelli (Application # 2003/0028249), and Michelson (Patent 5,860,973).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground builds upon the Frey and Baccelli combination from Ground 1, adding Michelson as an additional reference. Petitioner argued that Michelson provides teachings for limitations that may not be explicitly met by the primary combination. Specifically, Michelson was cited for disclosing an implant with a longitudinal length greater than 40 mm (claim 5), anti-migration ridges oriented perpendicular to the implant’s length (claim 20), a wider-than-tall implant configuration (claim 24), and a threaded receiving aperture with lateral grooves for tool engagement (claims 5, 6, and 8). These features in Michelson were presented as alternatives or enhancements to the base design taught by Frey.
  • Motivation to Combine: A POSITA would be motivated to combine Michelson with Frey and Baccelli because all three references address spinal implants for lateral or antero-lateral approaches. Michelson’s specific dimensions (e.g., length > 40 mm) are suitable for spanning the lumbar disc space, a goal also described in Frey. A POSITA would have looked to Michelson’s established designs for tool engagement features and anti-migration surfaces to improve the stability and insertion technique of the implant disclosed by Frey, resulting in a predictable and effective final product.
  • Expectation of Success: The proposed combination involved applying known features from Michelson to the well-understood implant design of Frey, with each element performing its known function, leading to a high expectation of success.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Frey, Baccelli, and Messerli (Application # 2003/0139813) for dimensional characteristics; Frey, Baccelli, and Moret (Application # 2003/0100950) for alternative radiopaque marker placements; and Baccelli in view of Frey and/or Michelson, which primarily reversed the roles of the main prior art references.

4. Key Claim Construction Positions

• Distal Wall / Proximal Wall: Petitioner proposed that under the broadest reasonable construction, the "distal wall" is the leading end of the implant that enters the patient first, and the "proximal wall" is the trailing end. This construction was central to mapping the structures of the Frey implant, which uses terms like "leading end wall" and "trailing end wall," to the claim language.
• Extend Generally Perpendicular to Said Longitudinal Length: This term was construed as extending approximately in a direction that crosses a plane along the implant's length at roughly a right angle. This broad interpretation was important for arguing that features like the anti-migration ridges in Baccelli and the maximum lateral width plane in Frey met the corresponding claim limitations.
• Releasably Mate: Petitioner argued this term should be construed as "an impermanent stabilized connection," consistent with its use in the patent to describe the connection between the implant and an insertion tool. This construction was used to map Frey's disclosure of a threaded receiving aperture for an inserter tool to the claims.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be inappropriate, despite the denial of a previous petition (IPR2013-00504) that asserted similar grounds. Petitioner contended that this new petition cured the specific deficiencies identified by the PTAB in its previous decision. The petition was submitted with new arguments and evidence to explicitly explain how the prior art met limitations the PTAB previously found unaddressed, particularly regarding the location of the maximum lateral width in the Frey reference.

6. 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.