PTAB

IPR2016-00412

DePuy Synthes Sales Inc v. Bonutti Skeletal Innovations LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Implantable Device for Bone Association
  • Brief Description: The ’363 patent discloses an implantable apparatus for spinal fusion procedures. The invention consists of a polymeric support body, typically a wedge-shaped cage designed to be inserted into the intervertebral space, and a metallic mounting strip used to affix the body to the adjacent vertebrae with screws. The support body includes a central opening to be packed with bone growth material to facilitate fusion.

3. Grounds for Unpatentability

Ground 1: Claims 1-3, 14, 44, 45, 47, 48, and 50 are obvious over Benezech in view of Bray.

  • Prior Art Relied Upon: Benezech (French Application # FR 2,747,034) and Bray (WO 97/20526).
  • Core Argument for this Ground: Petitioner argued that Benezech discloses a complete intersomatic vertebral fusion system that teaches nearly all elements of the challenged claims. The few remaining limitations, relating to specific dimensions and features, were well-known in the art and explicitly taught by Bray as simple design choices to improve implant performance.
    • Prior Art Mapping: Petitioner asserted that Benezech discloses the core invention of independent claim 1: an implantable device with a polymeric body (cage) and a metallic mounting strip (plate) connected to its trailing end. Benezech also shows the body having a leading end, trailing end, upper/lower surfaces, a central opening for bone growth, and a wedge shape (an acute angle between the upper and lower surfaces, relevant to claim 44). Petitioner contended that Bray supplies the missing limitations, specifically teaching an implant where the body width is greater than its length to match vertebral anatomy. Bray also teaches a specific lordotic angle of approximately 13 degrees (satisfying the 1-20 degree range of claim 45) and a plurality of straight openings for bone growth (relevant to claim 50).
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Bray's dimensional teachings with Benezech’s system for the predictable purpose of improving anatomical fit. It was common knowledge that vertebral endplates are wider than they are deep; therefore, modifying Benezech's cage to have a greater width than length, as taught by Bray, was an obvious design choice to optimize fit, increase the area for bone growth, and ensure proper load distribution on the stronger peripheral bone. Likewise, incorporating Bray’s specific lordotic angle was a routine modification to adapt Benezech’s general implant for the known clinical goal of restoring spinal curvature.
    • Expectation of Success: A POSITA would have had a high expectation of success, as the combination merely involved applying known, predictable solutions (anatomical sizing, lordotic correction) from Bray to the conventional implant design of Benezech to achieve improved, but expected, results.

Ground 2: Claims 1-3, 14, 44, 45, 47, 48, and 50 are obvious over Benezech in view of the AcroMed Brochure and/or Tisserand.

  • Prior Art Relied Upon: Benezech (French Application # FR 2,747,034), the AcroMed Brochure (a 1998 product brochure), and Tisserand (French Patent # FR 2,727,003).
  • Core Argument for this Ground: This ground presented an alternative combination to prove obviousness, arguing that commercially available products and other patents from the relevant time period also taught the features missing from Benezech. It reinforced that these features were common and their combination with a system like Benezech's was an obvious design path.
    • Prior Art Mapping: As in Ground 1, Benezech provided the foundational implant system. Petitioner argued that the AcroMed Brochure and Tisserand both explicitly disclose implants with a body width greater than body length. For example, the AcroMed Cervical I/F Cage is disclosed with a 16 mm lateral width and a 13 mm anterior-posterior length. These references also teach other dependent claim limitations. For claim 3 (first depth less than second depth), both references disclose implants with a thicker trailing wall. For claim 45 (acute angle between 1-20 degrees), the AcroMed cage teaches a seven-degree wedge, and Tisserand teaches an angle of approximately four degrees. For claim 50 (a second opening for bone growth), both references show cages with two straight openings created by a median partition.
    • Motivation to Combine: A POSITA would combine the teachings of the AcroMed Brochure and/or Tisserand with Benezech for the same primary reason as with Bray: to conform the implant to vertebral anatomy for a better fit. Additional motivations were presented for other features. For instance, a POSITA would have been motivated to create a thicker trailing wall (as in AcroMed/Tisserand) to provide a more robust surface for attaching surgical inserter tools and to better distribute compressive forces onto the harder anterior cortical bone, thereby reducing the risk of the implant subsiding into the softer vertebral bone over time.
    • Expectation of Success: The proposed modifications were routine engineering choices aimed at enhancing a standard implant design. Combining features from existing products (AcroMed) and patents (Tisserand) with Benezech’s system would have predictably resulted in a stronger, better-fitting implant, which was a well-understood goal in the art.

4. Key Claim Construction Positions

  • "mounting strip": Petitioner argued that the broadest reasonable construction of "mounting strip" encompasses the "plate" disclosed in Benezech. This construction was critical to establishing that Benezech taught the foundational elements of claim 1. Petitioner noted that the Patent Owner did not dispute this interpretation in a related IPR proceeding (IPR2015-01333) involving the same patent and prior art.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-3, 14, 44, 45, 47, 48, and 50 of the ’363 patent as unpatentable.