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IPR2016-00818

Smith & Nephew Inc v. Arthrex Inc

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1. Case Identification

2. Patent Overview

  • Title: Method of Interference Fixation for Anterior Cruciate Ligament Reconstruction
  • Brief Description: The ’986 patent is directed to a method for anterior cruciate ligament (ACL) reconstruction. The method involves securing a ligament graft within a tibial tunnel using a bioabsorbable interference screw designed to create an interference fit.

3. Grounds for Unpatentability

Ground 1: Anticipation over the ’977 Patent - Claims 1-6 are anticipated by Patent 6,629,977 under 35 U.S.C. §102(b).

  • Prior Art Relied Upon: The ’977 patent (Patent 6,629,977).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ’986 patent was not entitled to its claimed priority date. The parent applications, which share the same specification, allegedly failed the written description requirement of §112 because they described the invention as being limited to a tapered interference screw and disparaged conventional non-tapered screws. During prosecution of the ’986 patent, the claims were broadened to remove the taper requirement, encompassing a genus of both tapered and non-tapered screws. Petitioner contended this new genus was unsupported by the original disclosure. Without priority, the ’986 patent’s effective filing date is April 2005. The ’977 patent, which issued from the same family in October 2003, therefore became §102(b) prior art. Because the ’977 patent’s specification is identical and discloses the species of a tapered screw, it anticipated the broader genus claims of the ’986 patent.

Ground 2: Obviousness over Ross - Claims 1-3 and 5-6 are obvious over Patent 5,470,334.

  • Prior Art Relied Upon: Ross (Patent 5,470,334).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Ross disclosed a bioabsorbable interference screw for securing a ligament in a bone tunnel that met every structural element of the screw recited in claim 1, including an elongated threaded body and a trilobe drive socket with radially extending slots. Ross also described the conventional use of its screw in ACL reconstruction, explicitly teaching most of the claimed method steps. For limitations not explicitly disclosed, such as the screw "substantially longitudinally filling" the tibial tunnel or engaging cortical bone, Petitioner argued a person of ordinary skill in the art (POSA) would have understood them to be implicitly disclosed or an obvious result of applying the Ross screw in a standard surgical procedure.
    • Motivation to Combine: This ground did not involve a combination. Petitioner argued a POSA would have been motivated to use the Ross screw in the conventional manner described to achieve secure graft fixation, which was its intended purpose.
    • Expectation of Success: A POSA would have had a high expectation of success, as the ground asserted the routine application of a known device (the Ross screw) for its intended purpose (ACL reconstruction) using conventional, well-established surgical techniques.

Ground 3: Obviousness over Endo-Fix - Claims 1-3 and 5-6 are obvious over the Endo-Fix brochure.

  • Prior Art Relied Upon: Endo-Fix (a 1995 sales brochure from Acufex).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued the Endo-Fix sales brochure, distributed before 1998, was a printed publication under §102(b). The brochure allegedly disclosed a bioabsorbable, conically-shaped interference screw for ACL reconstruction that met all structural elements of claim 1. This included an elongated threaded body, threads extending substantially the entire length, and a "six-star" Torx drive socket with a plurality of radially extending slots. While the brochure did not detail the surgical method, Petitioner argued the claimed steps represented the conventional and expected use of the Endo-Fix screw, which a POSA would have implicitly understood or found obvious.
    • Motivation to Combine: This ground was not based on a combination. The motivation was to use the commercially available Endo-Fix screw for its intended purpose in a standard ACL reconstruction, as admitted to be conventional by the ’986 patent itself.
    • Expectation of Success: A POSA would have expected the Endo-Fix screw to perform as advertised in a conventional ACL surgery, yielding predictable and successful graft fixation.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combining Ross with Hannay (Patent 3,575,080) to teach the specific hex-core drive socket of claims 3-4, and combining Endo-Fix with Weiler (a 1998 journal article) and Hannay to teach alternative drive socket configurations. These grounds relied on theories of design choice and predictable substitution to address specific dependent claim limitations.

4. Key Claim Construction Positions

  • "screw substantially longitudinally fills the tibial tunnel" (claim 1): Petitioner argued this phrase should be interpreted broadly to mean the screw is long enough to achieve the patent's stated goals: engaging cortical bone and securing a sufficient portion of the graft to avoid needing multiple screws. This construction was proposed to prevent the independent claim from being improperly limited by the narrower, specific numerical range ("all but the top 5-10 mm") recited in dependent claim 6.
  • "body" (claim 1) versus "tip" (claim 5): Petitioner contended that the screw's "body" and "tip" are distinct components, as claim 5 requires the tip to have a different characteristic (a greater taper) than the body. This interpretation was argued as being consistent with the specification and impacted the analysis of limitations related to the body, such as the requirement for threads extending from the proximal to the distal end of the body.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-6 of Patent 7,322,986 as unpatentable.