PTAB

IPR2019-00362

Alphatec Holdings Inc v. NuVasive Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Spinal Fusion Implant of Non-Bone Construction
  • Brief Description: The ’156 patent discloses a spinal fusion implant of non-bone construction for positioning in an interbody space. The claimed implant features upper and lower surfaces with anti-migration elements, four walls (distal, proximal, and two sidewalls), at least one fusion aperture, and a longitudinal length that is greater than its maximum lateral width.

3. Grounds for Unpatentability

Ground 1: Obviousness over Brantigan, Baccelli, and Berry - Claims 1-3, 5, 9-10, 12-21, 23-24, and 27 are obvious over Brantigan in view of Baccelli and Berry.

  • Prior Art Relied Upon: Brantigan (Patent 5,192,327), Baccelli (Application # 2003/0028249), and Berry (a 1987 journal article in Spine).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Brantigan taught nearly all limitations of the independent claim, including a spinal fusion implant made of a radiolucent material (PEEK) suitable for lateral insertion. Brantigan’s implant was described as having four walls, ridged upper and lower surfaces for anti-migration, a central fusion aperture, and dimensions conforming to vertebral anatomy where length exceeds width. The key element missing from Brantigan was the use of radiopaque markers for visualization. Petitioner asserted that Baccelli remedied this deficiency by explicitly teaching the inclusion of radiopaque markers and spikes within the walls of a radiolucent (PEEK) implant to identify its position and presence during and after surgery. Finally, Petitioner contended that Berry, a widely cited morphometric study, provided the precise vertebral dimension data known to a person of ordinary skill in the art (POSA), confirming that an implant designed for the lumbar spine (as in Brantigan) would have a longitudinal length greater than its lateral width.
    • Motivation to Combine: A POSA would combine these references to solve a known problem. Brantigan’s implant is radiolucent, making it difficult for a surgeon to visualize post-implantation. Baccelli provided a well-known solution: adding radiopaque markers to a radiolucent implant. The motivation was to improve the implant's visibility on an X-ray, enabling surgeons to better assess the orientation and location of Brantigan’s laterally-inserted implant. Positioning markers in the sidewalls, as taught by Baccelli, would allow for precise alignment of the implant with the spinous process.
    • Expectation of Success: Petitioner argued a POSA would have a high expectation of success because the technique of adding radiopaque markers to medical implants to enhance visibility under X-ray was a simple, well-established, and predictable solution at the time.

Ground 2: Obviousness over Brantigan, Baccelli, Berry, and Michelson - Claim 9 is obvious over Brantigan in view of Baccelli, Berry, and Michelson.

  • Prior Art Relied Upon: Brantigan (Patent 5,192,327), Baccelli (Application # 2003/0028249), Berry (a 1987 journal article in Spine), and Michelson (Patent 5,860,973).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination in Ground 1 to specifically address the limitation in claim 9 requiring a "maximum lateral width of said implant is approximately 18 mm." Petitioner argued that while Brantigan taught a lateral implant and Berry provided vertebral dimensions, Michelson taught the specific benefits of using narrower, modular implants for lateral insertion. Michelson disclosed that using multiple narrower implants side-by-side in a modular fashion could increase patient safety and minimize the invasiveness of the procedure.
    • Motivation to Combine: A POSA would be motivated to modify Brantigan's implant according to Michelson's teachings to achieve the known benefits of a minimally invasive, modular surgical approach. To determine the appropriate dimensions for such a "narrower" implant, the POSA would consult the anatomical data in Berry. Petitioner asserted that by taking the average vertebral widths disclosed in Berry (approx. 32-35 mm) and halving them for a modular, two-implant approach as suggested by Michelson, a POSA would arrive at a lateral width of approximately 16-17.5 mm, which falls within the claimed range of "approximately 18 mm."
    • Expectation of Success: Success was expected as this involved applying known surgical principles (modular implants for less invasive surgery) and using standard anatomical data to predictably size a known type of implant.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial would be inappropriate because the petition was not cumulative of prior challenges to the ’156 patent. Petitioner asserted that prior IPRs, filed by an unrelated party, relied on different prior art combinations that focused on posteriorly-inserted implants. This petition, in contrast, was based on Brantigan, which discloses a laterally-inserted implant, directly addressing arguments the Patent Owner made on appeal in the prior litigation. Furthermore, Petitioner noted that the Baccelli reference was never considered during original prosecution or in any prior post-grant proceeding and that the current petition challenges claims not addressed in prior IPRs.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-3, 5, 9-10, 12-21, 23-24, and 27 of the ’156 patent as unpatentable.