PTAB

IPR2019-00569

RTI Surgical Inc v. LifeNet Health

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Composite Bone Graft, Method of Making and Using Same
  • Brief Description: The ’158 patent discloses a composite bone graft for spinal fusion procedures. The graft is constructed from distinct portions of cortical and cancellous bone that are layered and held together by one or more bone pins, specifically avoiding the use of adhesives or demineralization.

3. Grounds for Unpatentability

Ground 1: Obviousness over Wolter and Grooms - Claims 1-12 are obvious over Wolter in view of Grooms.

  • Prior Art Relied Upon: Wolter (a 1987 publication titled "Bone Transplantation in the Area of the Vertebral Column") and Grooms (Application # 2002/0138143).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Wolter disclosed the core structure of the claimed graft: a composite "sandwich block" made of distinct, alternating layers of cortical and cancellous bone. Wolter’s graft, however, used one or more metal screws for assembly. Grooms taught the use of bone pins to hold distinct portions of an intervertebral bone graft together to form a unitary body. The combination of Wolter's layered graft structure with Grooms' bone pin fastener allegedly rendered the limitations of independent claims 1 and 2 obvious. Dependent claims adding features like specific wedge shapes (claims 3, 5), block shapes (claims 4, 6), surface texturing, and specific dimensions were argued to be obvious modifications based on known principles of implant design also taught in Grooms.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references by replacing Wolter's metal screw with Grooms' bone pin. The motivation was to create an all-bone graft, which avoids leaving a permanent foreign object (the metal screw) in the patient's spine and mitigates potential complications from screw loosening.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because Grooms explicitly taught that bone pins were a suitable and effective method for securing distinct portions of a composite bone graft together.

Ground 2: Obviousness over Wolter and Paul - Claims 1-2 and 11-12 are obvious over Wolter in view of Paul.

  • Prior Art Relied Upon: Wolter (1987 publication) and Paul (Patent 6,258,125).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented a similar argument to Ground 1, substituting Paul for Grooms. Petitioner asserted that Wolter taught the layered composite graft, while Paul taught assembling multi-part allogenic bone grafts using bone pins. Paul’s teaching of bone pins was presented as an alternative to Grooms for satisfying the "one or more bone pins" limitation. The argument also addressed claim 12 (allogenic bone), asserting that by the late 1990s, using allograft bone (as taught by Paul) was preferred over the autograft bone of Wolter for known advantages.
    • Motivation to Combine: The motivation was identical to that in Ground 1: to replace a metal fastener with a bone pin to create a fully resorbable, all-bone implant. Paul provided a clear example of using bone pins for this purpose in composite bone grafts.
    • Expectation of Success: Paul’s disclosure that bone pins are suitable for securing distinct graft portions provided a clear expectation of success for the combination.

Ground 3: Obviousness over Boyce and Grooms/Paul - Claims 1-2, 11-12, and 14 are obvious over Boyce in view of either Grooms or Paul.

  • Prior Art Relied Upon: Boyce (Patent 6,123,731), Grooms (Application # 2002/0138143), and Paul (’125 patent).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner contended that Boyce disclosed an osteoimplant with alternating layers of cortical and cancellous bone sections. However, Boyce taught bonding these sections together via a chemical cross-linking process that required demineralizing the bone surfaces. The claims of the ’158 patent explicitly require that the graft is not demineralized. Boyce also mentioned that mechanical fasteners like pins could be used to increase graft strength. Petitioner argued it would have been obvious to a POSITA to use the bone pins taught by Grooms or Paul to assemble the layered graft of Boyce, thereby completely replacing the chemical cross-linking method.
    • Motivation to Combine: A POSITA would be motivated to replace Boyce's chemical bonding with mechanical bone pins to avoid demineralization. Petitioner argued that demineralization was a known disadvantage because it weakens the bone, and using pins would result in a stronger, more reliable graft while also avoiding the cost and complexity of the demineralization process.
    • Expectation of Success: The expectation of success was high because Grooms and Paul taught that bone pins could be used solely to hold grafts together, without any need for adhesives or chemical bonding, demonstrating the viability of the proposed substitution.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combining Wolter with Paul and Coates (Patent 5,989,289) for claims with surface texturing (Ground 3), and various combinations of Wolter, Grooms, Paul, Kozak (Patent 5,397,364), and Boyce for claims reciting specific features like chamfered edges or discontinuous bone portions (Grounds 4, 5, and 6).

4. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under §325(d) for the ground based on Boyce. Although the Examiner considered Boyce during prosecution, Petitioner asserted the Examiner did not have the benefit of Grooms or Paul. Therefore, the specific combination of replacing Boyce's chemical cross-linking with the mechanical bone pins taught by Grooms or Paul was a new argument and combination of prior art that was not previously before the Office.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-15 of the ’158 patent as unpatentable.