PTAB

IPR2019-00546

Alphatec Holdings Inc v. NuVasive Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Spinal Fusion Implant and Method
  • Brief Description: The ’334 patent discloses a spinal fusion system comprising a radiolucent implant and an associated insertion instrument. The implant is made from a material like PEEK, is designed for lateral or other surgical approaches, and includes specific dimensional characteristics: a longitudinal length greater than 40 mm that is at least two and a half times its maximum lateral width. The claims also require at least three radiopaque markers positioned in the distal wall, proximal wall, and central region of the implant to aid in fluoroscopic visualization during and after surgery.

3. Grounds for Unpatentability

Ground 1: Obviousness over Frey, Michelson, and Baccelli - Claim 16 is obvious over Frey in view of Michelson and Baccelli.

  • Prior Art Relied Upon: Frey (Application # 2002/0165550), Michelson (Patent 5,860,973), and Baccelli (Application # 2003/0028249).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of Frey and Michelson teaches all limitations of the underlying independent claim 1, a finding previously affirmed by the Federal Circuit in a prior inter partes review (IPR). Frey disclosed a radiolucent PEEK implant with distal, proximal, and sidewalls, and taught including a "number of" radiopaque markers in these locations. Michelson disclosed "longer-than-wide" implants, expressly stating a preferred length of 42 mm for one embodiment and teaching the use of narrower modular implants that could be combined to span the disc space. Together, these references were argued to meet the material, structural, and dimensional limitations of claim 1. Petitioner asserted that the sole additional limitation of challenged claim 16—a fourth radiopaque marker positioned in the central region and spaced apart from the third marker—was explicitly disclosed by Baccelli. Baccelli taught a radiolucent implant with four markers (spikes and wires) located in the proximal wall, distal wall, and two spaced-apart positions within the central region of the sidewalls.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would have been motivated to incorporate Baccelli’s marker configuration into the implant of Frey and Michelson to improve surgical outcomes. Since Frey already established the general utility of using radiographic markers for X-ray assessment, Baccelli’s specific and advantageous arrangement of four markers offered a clear blueprint for enhancing the ability to visualize the implant's orientation and location. Petitioner contended that adding Baccelli’s markers to Frey's implant walls would allow surgeons to use an anterior-to-posterior X-ray to accurately check for alignment with the spinous process and lateral edges of the vertebrae.
    • Expectation of Success: Petitioner asserted the combination would yield a predictable result. Adding a well-understood feature (an additional radiopaque marker) from Baccelli to an existing implant design (Frey/Michelson) to achieve a known benefit (improved visualization) was a simple modification with a high expectation of success.

Ground 2: Obviousness over Brantigan, Baccelli, Berry, and Michelson - Claim 16 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 publication in Spine), and Michelson (Patent 5,860,973).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner presented an alternative combination starting with Brantigan, which disclosed a radiolucent spinal fusion implant for lateral insertion but lacked specific dimensional ratios and radiopaque markers. Michelson provided the motivation to make such implants "narrower" for modular insertion, thereby reducing surgical invasiveness. To properly size such a modular implant, a POSITA would consult known anatomical data like Berry, which provided direct dimensional measurements for human vertebrae. Petitioner demonstrated that using Berry's data (e.g., lumbar vertebra length >50 mm and width ~35 mm) and applying Michelson's teaching (halving the width to ~18 mm for modularity) directly resulted in an implant meeting claim 1's dimensional limitations (>40mm length and >2.5x length-to-width ratio). Finally, Baccelli provided the element missing from Brantigan by explicitly teaching the inclusion of four radiopaque markers in the claimed locations (proximal, distal, and two spaced-apart in the central region), thus satisfying the limitations of claim 16.
    • Motivation to Combine: A POSITA would have been motivated to combine these references to create a safer, more effective, and more easily visualized implant. The motivation to combine Brantigan with Michelson and Berry was to achieve the known clinical benefits of a minimally invasive, modular implant precisely sized for the patient's anatomy. Because Brantigan’s radiolucent implant would be difficult to see on an X-ray, a POSITA would have been immediately motivated to incorporate the well-known solution of adding radiopaque markers as taught by Baccelli to enable surgeons to visualize the implant's position and orientation.
    • Expectation of Success: Petitioner argued for a reasonable expectation of success, as the combination involved applying known design principles to a known implant type. Sizing an implant (Brantigan) using established anatomical data (Berry), modifying it for a known surgical technique (modularity from Michelson), and adding a standard feature for visibility (markers from Baccelli) were all predictable steps for a POSITA.
    • Key Aspects: Petitioner highlighted that the Patent Owner itself had previously and successfully relied on Brantigan and Berry in prior litigation to invalidate a related Michelson patent. In that prior proceeding, Patent Owner argued that Brantigan taught a laterally-inserted implant and Berry provided the relevant anatomical knowledge available to a POSITA.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that institution should not be denied on cumulative grounds because the challenges were new. It was asserted that this was the Petitioner's first challenge to claim 16 of the ’334 patent and that the specific prior art combinations relied upon—(1) Frey, Michelson, and Baccelli, and (2) Brantigan, Baccelli, Berry, and Michelson—were never considered by the patent examiner during prosecution or by the Board in any previous IPR proceeding.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claim 16 of Patent 8,187,334 as unpatentable under 35 U.S.C. §103.