PTAB

IPR2016-00508

Smith & Nephew Inc v. Arthrex Inc

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1. Case Identification

2. Patent Overview

  • Title: Suture Anchor Assembly
  • Brief Description: The ’755 patent discloses a suture anchor assembly for attaching soft tissue to bone. The invention purports to solve the prior art problem of suture abrasion by replacing a conventional proximal eyelet with a suture-securing structure, such as a transverse anchor pin, positioned within a hollow internal passage of the anchor body.

3. Grounds for Unpatentability

Ground 1: Claims 14-30 are obvious over Dreyfuss in view of Foerster

  • Prior Art Relied Upon: Dreyfuss (Application # 2003/0065361) and Foerster (Patent 7,090,690).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Dreyfuss, an application by one of the ’755 patent’s inventors, identified the same suture abrasion problem and proposed a nearly identical solution: a suture anchor with a cannulated female drive socket and an internal suture-securing structure. However, Dreyfuss’s securing structure was a flexible suture loop. Foerster disclosed a hollow suture anchor with a rigid, transverse "primary pin" disposed across its inner diameter for securing a suture. Petitioner contended that combining Dreyfuss’s anchor body and drive system with Foerster’s rigid pin would result in an anchor meeting all limitations of independent claim 14, including the "internal passage" and the "rigid suture support."
    • Motivation to Combine: A POSITA would have been motivated to replace the flexible suture loop in Dreyfuss with the well-known rigid pin of Foerster as a simple substitution of one known element for another to yield a predictable result. Petitioner asserted several additional motivations:
      • Reduced manufacturing complexity and cost compared to forming passageways and securing a suture loop.
      • Streamlined regulatory approval by allowing for an all-metal construction, avoiding separate toxicity tests for the polyester suture loop.
      • Improved performance by creating less friction on the tissue-securing suture than a suture-on-suture interface.
      • Increased strength, as a fixed pin can withstand more tension than a knotted suture loop.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the combination involved substituting known components that performed the same function in a predictable manner.

Ground 2: Claims 14-30 are obvious over Dreyfuss in view of Goble ’397

  • Prior Art Relied Upon: Dreyfuss (Application # 2003/0065361) and Goble ’397 (Patent 5,702,397).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative to Ground 1, arguing that a POSITA would have found it obvious to replace Dreyfuss’s flexible suture loop with the rigid gear and axle assembly disclosed in Goble ’397. This rigid gear assembly, when placed inside the internal passage of the Dreyfuss anchor, would serve as the claimed "rigid suture support." The remainder of the claim limitations would be met by the Dreyfuss anchor body and its associated driver, similar to the logic in Ground 1.
    • Motivation to Combine: Petitioner argued the substitution would have been an obvious design choice, as both Dreyfuss’s loop and Goble ’397’s gear assembly perform the same basic function of securing a suture internally. The primary motivation for this specific combination was the significant performance advantage offered by the Goble ’397 gear. Its uni-directional mechanism locks the suture, preventing slippage and allowing a surgeon to tighten tissue without maintaining constant tension, thereby providing superior control during surgery.
    • Expectation of Success: A POSITA would have expected success in combining these elements to create a functional anchor that predictably incorporated the known benefits of the uni-directional gear mechanism.

Ground 3: Claims 14-30 are obvious over Morgan in view of Dreyfuss

  • Prior Art Relied Upon: Morgan (Application # 2002/0056269) and Dreyfuss (Application # 2003/0065361).

  • Core Argument for this Ground:

    • Prior Art Mapping: Morgan disclosed a suture anchor with a rigid internal retainer pin (retainer 40) that meets the "rigid suture support" limitation. However, Morgan’s anchor featured a male drive head at its proximal end, a design that Dreyfuss explicitly criticized for requiring countersinking and causing suture abrasion. Petitioner argued it would have been obvious to modify Morgan by replacing its male drive head with the female drive socket taught by Dreyfuss. This combination would result in an anchor assembly meeting all limitations of claim 14.
    • Motivation to Combine: A POSITA would have been motivated to apply Dreyfuss's teachings to Morgan to solve the specific problems that Dreyfuss identified. Dreyfuss provided the explicit reasoning for replacing a male drive head with a female drive socket—to eliminate the need for countersinking and to protect the suture by having it exit through a central bore. Petitioner also highlighted a PTAB decision in a related application that found a similar combination of Morgan and Dreyfuss to be obvious.
    • Expectation of Success: The modification was a straightforward substitution of one known drive mechanism for another to achieve the predictable and known benefits described in Dreyfuss.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 14-30 over Pierson (Patent 6,648,903) in view of Goble ’523 (Patent 5,411,523), and over the combination of Pierson, Goble ’523, and Morgan. These grounds relied on similar theories of combining known drive mechanisms with anchors having internal suture-securing pins.

4. Key Claim Construction Positions

  • "an internal passage" (claim 14): Petitioner proposed this term be construed as "a path fully surrounded by the anchor body." This construction was argued as consistent with the specification's use of "bore" and dictionary definitions, and was important for mapping the fully enclosed central bores of the prior art references to the claim language.
  • "rigid suture support" (claim 14): Petitioner proposed this term be construed as "a distinct and inflexible part of the suture anchor assembly." This construction was central to the obviousness arguments, as it was used to distinguish the claimed invention from Dreyfuss's flexible suture loop while encompassing the inflexible pins and gear assemblies of the secondary references (Foerster, Goble ’397, and Morgan).

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 14-30 of Patent 8,801,755 as unpatentable under 35 U.S.C. §103.