PTAB

IPR2016-00507

Smith & Nephew Inc v. Arthrex Inc

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Petition
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1. Case Identification

2. Patent Overview

  • Title: Suture Anchor with Internal Suture Securing Feature
  • Brief Description: The ’755 patent discloses a suture anchor assembly for attaching soft tissue to bone. The invention purports to solve the problem of suture abrasion by replacing traditional proximal eyelets with a suture-securing structure, such as a transverse anchor pin, located inside the hollow body of the anchor.

3. Grounds for Unpatentability

Ground 1: Claims 1-13 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 discloses a suture anchor assembly that is nearly identical to the ’755 patent, as it was designed to solve the same problem of suture abrasion by using a suture-securing structure recessed within the anchor body. Dreyfuss teaches all key elements, including a cannulated body with a drive socket. The sole distinction identified during prosecution was that Dreyfuss used a flexible suture loop as its internal support, whereas the ’755 patent claims a "rigid support." Foerster was cited to remedy this distinction, as it explicitly discloses a rigid, transverse anchor pin disposed across the inner diameter of a hollow anchor body to secure a suture.
    • Motivation to Combine: A POSITA would combine these references as a simple substitution of one known suture-securing element (Foerster's rigid pin) for another (Dreyfuss's flexible loop) to achieve a predictable result. Petitioner asserted several motivations for this substitution, including reduced manufacturing complexity and cost, streamlined FDA regulatory approval by using a single material (metal) for all components, improved performance due to lower friction compared to a suture loop, and greater tensile strength.
    • Expectation of Success: A POSITA would have had a high expectation of success, as the combination involved substituting known components that performed the same function in their respective designs to achieve the known benefit of a protected, internal suture-securing structure.

Ground 2: Claims 1-13 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 a similar argument to Ground 1, using Dreyfuss as the primary reference for the overall anchor design. To supply the claimed "rigid support," Petitioner cited Goble ’397, which discloses a suture anchor with an internal, rigid gear assembly mounted on an axle within the anchor’s central bore. This gear assembly serves as a rigid structure for securing a suture, analogous to the claimed anchor pin.
    • Motivation to Combine: A POSITA would combine Dreyfuss with Goble ’397 to gain a specific performance advantage. The gear assembly in Goble ’397 acts as a uni-directional lock, preventing the suture from slipping back after being tightened. This feature provides surgeons with superior control during tissue re-attachment, as it eliminates the need to maintain constant tension on the suture. This clear functional benefit would have motivated a POSITA to incorporate Goble '397's rigid locking mechanism into the improved anchor body design of Dreyfuss.
    • Expectation of Success: The combination was argued to be a predictable substitution of one internal securing element for another to add a known functional advantage, leading to a high expectation of success.

Ground 3: Claims 1-13 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: Petitioner asserted that Morgan teaches a suture anchor with the claimed rigid internal support (a "retainer 40" pin) extending across a central bore. However, Morgan's design includes a male drive head and an external suture loop eyelet, the very features Dreyfuss was designed to improve upon to prevent suture abrasion from countersinking. Dreyfuss teaches the solution: replacing the male drive head with a female drive socket at the proximal end and using a recessed suture-securing structure.
    • Motivation to Combine: A POSITA would combine the references to solve the known problems associated with Morgan's design. Dreyfuss provides the express reasoning to modify Morgan by replacing its male drive head with Dreyfuss's female socket, thereby eliminating the need for countersinking and preventing suture abrasion. Petitioner argued a POSITA would then use Morgan's already-present internal retainer pin as the suture-securing structure, as it would be protected within the bore, consistent with the teachings of Dreyfuss. This combination was argued to be a simple substitution of known drive mechanisms to achieve a predictable result.
    • Key Aspects: Petitioner highlighted that during prosecution of a grandparent application to the ’755 patent, the PTAB had concluded that modifying Morgan with the drive mechanism of Dreyfuss was obvious because it was a "combination of familiar elements... that would yield predictable results."

4. Key Claim Construction Positions

  • "a passage" / "an internal passage": Petitioner proposed this term be construed as "a path fully surrounded by the anchor body." This construction was based on the specification's use of "bore" and dictionary definitions, ensuring the path for the suture is internal to the anchor structure.
  • "rigid support": Petitioner proposed this term be construed as "a distinct and inflexible part of the suture anchor assembly." This construction was critical to distinguish the claimed invention from the flexible suture loop disclosed in Dreyfuss, a key distinction relied upon by the patent owner during prosecution.
  • "anchor stop" and "drive stop": Petitioner proposed these terms be construed based on their function: a portion of the anchor body ("anchor stop") and a portion of the driver ("drive stop") that abut to impede further insertion of the driver into the anchor body. This was based on descriptions in the ’755 patent of a shoulder within the anchor bore impeding the distal end of the driver.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-13 of the ’755 patent as unpatentable under 35 U.S.C. §103.