PTAB

IPR2022-01066

Arthrex Inc v. P Tech LLC

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Deformable Fastener System
  • Brief Description: The ’259 patent relates to fastener systems for securing body tissues. The system includes a flexible hollow fastener made from biocompatible fibers and a flexible elongated fastening member, such as a suture, that extends through the fastener to be tensioned by a user.

3. Grounds for Unpatentability

Ground 1: Obviousness over Fumex - Claims 1, 3, 4, 6-8, 10, 11, 13-16, 18-20, 22, 24, and 26 are obvious over Fumex.

  • Prior Art Relied Upon: Fumex (Patent 6,511,498).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Fumex, which describes a surgical bone anchoring system, discloses every element of the challenged claims. Fumex’s deformable, tubular sleeve is the claimed flexible hollow fastener; its suture thread is the flexible elongated fastening member with two legs extending from the sleeve; and its ancillary instrument with a rod is the claimed introducer with a pushrod. Petitioner asserted that Fumex teaches that its sleeve, made of a material like polyester braid, deforms from a first configuration to a second (a ball shape) upon tensioning the suture legs, thereby securing it in bone tissue. It also teaches the suture sliding through the sleeve during this process.
    • Motivation to Combine (for §103 grounds): As a single-reference ground, the motivation is inherent in Fumex’s own disclosure. However, for the limitation requiring a polyethylene suture, Petitioner argued it would have been obvious to a person of ordinary skill in the art (POSITA) to substitute the polyester suture disclosed in Fumex with a well-known, high-strength polyethylene suture, as Fumex allows for any suitable surgical thread.
    • Expectation of Success (for §103 grounds): A POSITA would have expected success in using a polyethylene suture with the Fumex device, as such sutures were common, and their properties were well-suited for the orthopedic applications described.

Ground 2: Obviousness over Fumex in view of Grafton - Claims 1, 3, 4, 6-8, 10, 11, 13-16, 18-20, 22, 24, and 26 are obvious over Fumex in view of Grafton.

  • Prior Art Relied Upon: Fumex (Patent 6,511,498) and Grafton (Application # 2003/0050666).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground was presented as an alternative to Ground 1, specifically addressing the limitation that the fastening member (suture) is fabricated in part with polyethylene. While Fumex discloses a bone anchoring system with a deformable sleeve and suture, it suggests polyester or polyamide threads. Grafton explicitly teaches a high-strength surgical suture with a multifilament cover formed of braided strands of ultra-high molecular weight polyethylene and polyester.
    • Motivation to Combine (for §103 grounds): A POSITA would combine Grafton's high-strength polyethylene-based suture with Fumex's bone anchoring device. Fumex allows the user to choose any suitable suture, and Grafton's suture is described as "ideally suited for most orthopedic procedures," the very field of use for Fumex's device. The desire for a higher-strength suture for certain repairs would provide the motivation.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success, as Grafton's suture is a flexible thread designed for use with suture anchors like the one disclosed in Fumex. The combination involved using a known suture material with a known type of anchor.

Ground 5: Obviousness over Fumex in view of Bonutti ’395 - Claims 23 and 25 are obvious over Fumex in view of Bonutti ’395.

  • Prior Art Relied Upon: Fumex (Patent 6,511,498) and Bonutti ’395 (Patent 6,238,395).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground targets claims 23 and 25, which require the introducer's pushrod to be "flexible." Fumex discloses an introducer with a linear rod and contemplates its use in bone holes of "any wall shape," which could be non-linear. Bonutti ’395 explicitly discloses a flexible pusher member designed to insert a suture anchor around a bend in a non-linear hole drilled in bone.
    • Motivation to Combine (for §103 grounds): A POSITA seeking to use Fumex's device in a non-linear bone passage would be motivated to modify its linear rod to be flexible. Bonutti '395 provides a known solution for this exact problem: a flexible pushrod for navigating curved passages. This combination represents the application of a known technique (flexible rod) to improve a similar device (Fumex's introducer) in a predictable way.
    • Expectation of Success (for §103 grounds): Success was predictable, as making the rod flexible would allow it to navigate curved holes while still performing its primary function of pushing the sleeve and suture into place.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations of Fumex with Bonutti ’875 (to explicitly teach a knotless system); Fumex with Stone (to teach using multiple sutures); and Fumex with Stone and To (to teach fixing a suture to the fastener and connecting multiple fasteners).

4. Key Claim Construction Positions

  • "flexible hollow fastener is knotless" (claims 7 and 18): Petitioner proposed that this term means "a suture-restraining structure that can be retained in place without tying a knot at the site where the fastener is secured." This construction was based on the prosecution history of a related application, where the Examiner understood a "knotless" fastener to be one held in position by means other than a knot, such as by resilient force from the surrounding tissue.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under Fintiv. The core reasons were that the parallel district court litigation was in a very early stage, with no trial date set and no discovery having occurred. Petitioner stated that a trial was unlikely to occur before a Final Written Decision in the IPR.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-26 of Patent 10,376,259 as unpatentable.