PTAB

IPR2025-00225

Globus Medical Inc v. Spinelogik Inc

Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Interbody Fusion Implants and Delivery Tools
  • Brief Description: The ’805 patent relates to an apparatus for spinal fusion, comprising an interbody fusion implant (fusion member), anchoring members to secure it to vertebral bodies, and a delivery mechanism for positioning the implant. The delivery mechanism is configured to extend outside the patient’s body during the procedure.

3. Grounds for Unpatentability

Ground 1: Anticipation/Obviousness over Blain - Claims 1-6, 11, 12, and 15-17 are anticipated by or obvious over Blain.

  • Prior Art Relied Upon: Blain (Patent 8,172,854).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Blain, which teaches an instrument guide for delivering an interbody fusion implant, discloses every limitation of the challenged claims. Blain's "interbody fusion implant 2" was mapped to the claimed "fusion member," and its "instrument guide 14" was mapped to the "delivery mechanism." Blain’s implant has channels for fasteners, and its delivery guide has corresponding guide tubes that align with the implant channels. The fasteners (anchoring members) are described as securing the implant to bone, thereby preventing decoupling. For the limitation requiring the delivery mechanism to extend outside the patient’s body, Petitioner asserted that Blain's handheld, screwdriver-like handle 20 would be understood by a Person of Ordinary Skill in the Art (POSA) to be manipulated from outside the patient, a trivial design choice for all such surgical tools.
    • Motivation to Combine (for §103 grounds): To the extent any limitation was found not to be explicitly disclosed, Petitioner argued it would have been obvious to modify Blain. Specifically, making the instrument shaft long enough to extend outside the body was presented as an obvious modification based on common sense and the general knowledge of a POSA to facilitate a minimally invasive procedure and avoid radiation exposure from fluoroscopy.
    • Expectation of Success (for §103 grounds): A POSA would have a reasonable expectation of success in lengthening the instrument shaft, as it involved only a simple dimensional change with predictable results.

Ground 2: Obviousness over Blain and Bray - Claims 1-6, 11, 12, and 15-17 are obvious over Blain in view of Bray.

  • Prior Art Relied Upon: Blain (Patent 8,172,854) and Bray (Patent 7,985,255).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground asserted that to the extent Blain’s anti-rotation feature was deemed insufficient to teach "preventing decoupling" or "locking" as claimed, the combination with Bray rendered the claims obvious. Blain taught the base implant and delivery system. Bray was cited for its teaching of an improved anti-backout mechanism—a restraining plate that covers the screw heads to prevent them from backing out—and its use of a concave, spherical seat for the anchor heads.
    • Motivation to Combine (for §103 grounds): A POSITA would combine Bray’s simpler and more robust restraining plate with Blain’s system to improve it. Petitioner argued that Blain's anti-rotation mechanism (a lobe on the fastener head mating with a recess) was more complex to machine and less effective than Bray’s overlay-type locking plate, which was a well-known and common solution to the known problem of fastener backout. This combination would predictably result in a more reliable locking mechanism. Further, a POSITA would be motivated to incorporate Bray’s spherical anchor seat to allow for polyaxial screw angulation and better seating, a known benefit.
    • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success, as it involved substituting one known locking mechanism for another and incorporating a standard spherical screw seat, yielding predictable improvements.

Ground 3: Obviousness over Blain and Steffee - Claims 5 and 16 are obvious over Blain (with or without Bray) in view of Steffee.

  • Prior Art Relied Upon: Blain (Patent 8,172,854), Steffee (Patent 4,790,303), and optionally Bray (Patent 7,985,255).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground specifically addressed the "curved" channel limitation in claims 5 and 16. To the extent this limitation is construed to require a channel that follows a curved path (and not just one with a circular opening), Petitioner argued this feature would be obvious by combining Blain with Steffee. Steffee taught the use of rigid, curved, barbed fasteners to improve fusion reliability by resisting migration forces that affect straight anchors.
    • Motivation to Combine (for §103 grounds): A POSITA would be motivated to replace Blain’s straight, threaded fasteners with Steffee’s rigid curved anchors to solve the well-known problem of post-surgical implant and anchor migration. Steffee expressly teaches that its curved fasteners resist migration. To accommodate Steffee's rigid curved anchors, a POSITA would necessarily and obviously modify the corresponding channels in Blain’s implant and delivery guide to have a complementary curved path, as a rigid anchor cannot traverse a straight channel. Blain itself contemplates non-linear guide members.
    • Expectation of Success (for §103 grounds): Success would be expected, as it required modifying channel shapes to match the known shape of a curved anchor, using basic machining principles to achieve the known benefit of reduced migration.

4. Key Claim Construction Positions

  • "each channel of the fusion member is curved" (claims 5, 16): Petitioner argued that under the broad interpretation advanced by the Patent Owner in co-pending litigation, this term covers any channel with any curvature. This includes channels with a circular opening, a tube-like inner wall, or a radially inward concave surface (like a spherical seat). Petitioner demonstrated that the prior art meets these interpretations but also provided an obviousness argument (Ground 3) for the narrower construction requiring the channel to follow a curved path.
  • "housing" (claims 2-4): Petitioner argued a POSA would understand a housing to be a component that protects, covers, supports, or contains another component. Under this construction, Blain's guide tubes and device coupler constitute a "delivery housing" because they contain and guide the anchoring members (fasteners).

5. Arguments Regarding Discretionary Denial

  • Petitioner stipulated that if the Patent Trial and Appeal Board institutes the IPR, Petitioner will not pursue in the co-pending district court proceeding any invalidity grounds that were raised or reasonably could have been raised in the petition. This stipulation was made to address potential discretionary denial under §314(a) based on Fintiv factors.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-6, 11, 12, and 15-17 of the ’805 patent as unpatentable.