PTAB

IPR2019-00361

Alphatec Holdings Inc v. NuVasive Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Spinal Fusion Implant and Method of Insertion
  • Brief Description: The ’334 patent discloses a spinal fusion system featuring a radiolucent implant for lateral insertion into an intervertebral space. The implant is characterized by specific dimensional properties, including a longitudinal length greater than 40 mm and a width of approximately 18 mm, and includes at least three radiopaque markers to aid in visualization.

3. Grounds for Unpatentability

Ground 1: Obviousness over Frey, Michelson, and Berry - Claims 6-9 and 18 are obvious over Frey in view of Michelson and Berry.

  • Prior Art Relied Upon: Frey (Application # 2002/0165550), Michelson (Patent 5,860,973), and Berry (a 1987 article in Spine).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that this ground builds upon a prior Federal Circuit-affirmed decision (IPR2013-00507) that found independent claim 1 of the ’334 patent invalid over the combination of Frey and Michelson. Frey taught a radiolucent PEEK spinal implant for lateral insertion with key features like radiopaque markers, a medial support, and first and second fusion apertures, thereby disclosing the additional limitations of dependent claims 6-9. Michelson taught using "long-and-narrow" modular implants that could be combined for insertion, providing the dimensional ratios of claim 1. To arrive at the specific "approximately 18 mm" width limitation of claim 18, Petitioner argued a POSITA would consult Berry, which provided well-known morphometric data on human vertebrae, including vertebral depth measurements.
    • Motivation to Combine: A POSITA would combine Frey and Michelson to gain the benefits of Michelson’s modular, minimally invasive approach (using a narrower implant) for Frey’s laterally-inserted implant, thereby increasing patient safety. A POSITA would then be motivated to consult a known anatomical data source like Berry, which expressly provided "data for implant design," to determine the optimal dimensions for such a modular implant to fit the lumbar spine, leading directly to the dimensions recited in claim 18.
    • Expectation of Success: A POSITA would have a high expectation of success because the combination involved applying known design principles (modularity from Michelson) to a known implant type (Frey) and tailoring it with standard, publicly available anatomical data (Berry) to achieve a predictable and functional result.

Ground 2: Obviousness over Brantigan, Baccelli, Berry, and Michelson - Claims 6-9 and 18 are 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 article in Spine), and Michelson (Patent 5,860,973).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued Brantigan served as a primary reference, disclosing a radiolucent, non-bone spinal implant for lateral insertion with a medial support structure bisecting a central aperture, meeting the limitations of claims 6-9. However, Brantigan did not explicitly teach radiopaque markers. Baccelli was introduced to remedy this deficiency, as it taught including multiple radiopaque markers in radiolucent implants (in the distal, proximal, and central regions) to allow surgeons to visualize the implant's position. Michelson was again relied upon for its teaching of making implants "narrower" for modular insertion to minimize invasiveness. Finally, Berry provided the known vertebral measurements that a POSITA would use to implement Michelson’s modular concept, arriving at the "approximately 18 mm" width of claim 18.
    • Motivation to Combine: A POSITA would combine Brantigan and Baccelli for the clear and predictable benefit of adding radiopaque markers to a radiolucent implant, which was a common practice to improve surgical outcomes. A POSITA would further be motivated to modify the resulting implant according to Michelson’s teachings to make it narrower and modular, thereby reducing incision size and patient discomfort. The known anatomical data in Berry would provide the necessary dimensions to implement this modification for the lumbar spine.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in this combination because adding markers for visualization was a well-known technique, and modifying implant dimensions for modularity was a known design choice with predictable advantages. The consequences of the combination were foreseeable.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial would be inappropriate because this petition was not cumulative of prior challenges to the ’334 patent. It contended that this was the Petitioner's first challenge and that claims 6-9 had never been subject to an IPR before. Furthermore, the argument against claim 18 was materially different from those in prior proceedings, as it relied on the "critical" teaching from Michelson regarding long-and-narrow modular implants, which had never been raised against claim 18 in any prior IPR.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 6-9 and 18 of Patent 8,187,334 as unpatentable.