PTAB

IPR2019-00896

Paragon 28 Inc v. Wright Medical Technology Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Orthopedic Plate for Use in Small Bone Repair
  • Brief Description: The ’278 patent discloses an orthopedic plate and screw system for internal fixation of fractured bones. The invention features a contoured bone plate with a central trunk and asymmetrically diverging arms, designed to receive polyaxial locking screws with threaded heads that create a mating interface with the plate’s screw holes.

3. Key Technical Contentions (Beyond Claim Construction)

  • Priority Date Challenge: Petitioner argued that the challenged claims are not entitled to the priority date of the 2006 parent application. It contended that key limitations—specifically the "threaded head" screw (claims 1-8) and the "S-curve" plate shape (claim 9)—were new matter introduced for the first time in a 2009 Continuation-in-Part (CIP) application. As such, Petitioner asserted the effective priority date for all challenged claims is February 24, 2009, which renders the published 2006 application (Kay) prior art under 35 U.S.C. §102(b).

4. Grounds for Unpatentability

Ground 1: Obviousness over Kay in view of Chan - Claims 1-8 are obvious over Kay in view of Chan.

  • Prior Art Relied Upon: Kay (Application # 2006/0173459) and Chan (Application # 2008/0140130).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner alleged that Kay, the published version of the ’278 patent’s parent application, discloses an orthopedic plate system with nearly all claimed features, including a central trunk, asymmetrically diverging arms, and polyaxial screw placement. However, Kay’s screws are non-locking. Chan was cited for its teaching of a bone plate system compatible with variable-angle locking screws having threaded heads that mate with threaded screw holes, a known solution to prevent screw back-out. The combination of Kay’s plate with Chan’s locking screw technology allegedly meets all limitations of claims 1-8.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references to improve the performance of Kay’s system. Kay’s stated goal is to increase "pullout strength," and Chan directly addresses the known problem of non-locking screws loosening. A POSITA would combine Chan’s established locking screw technology with Kay’s plate to enhance fixation and prevent screw loosening, thereby improving pullout strength.
    • Expectation of Success: The use of locking screws with threaded heads was a well-understood and common technique in orthopedic plates. A POSITA would have had a high expectation of success in incorporating Chan's locking screws into Kay's plate system, as it represented the application of a known solution to a known problem.

Ground 2: Obviousness over Kay, Chan, and Heinl - Claim 9 is obvious over Kay in view of Chan and Heinl.

  • Prior Art Relied Upon: Kay (Application # 2006/0173459), Chan (Application # 2008/0140130), and Heinl (Patent 4,903,691).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination of Kay and Chan to argue the unpatentability of claim 9, which adds the limitation that the plate has an "S-curve." Petitioner asserted that Heinl discloses a set of surgical instruments including several plates of different shapes and curvatures to adapt to various anatomical needs. Specifically, Heinl teaches and depicts a plate with an "S form."
    • Motivation to Combine: Kay explicitly teaches that its plate is designed for "three dimensional contouring to...accommodate individual variation in bone shape." A POSITA, seeking to adapt the Kay/Chan system for different fractures, would have been motivated to look to known, anatomically appropriate plate shapes. Heinl provides a known S-shaped plate for this purpose. Therefore, it would have been obvious to contour the customizable plate of Kay into the S-shape taught by Heinl to fit a specific bone, such as the clavicle.
    • Expectation of Success: Bending and contouring bone plates to match patient anatomy was a routine and predictable practice for orthopedic surgeons. A POSITA would expect that forming the Kay/Chan plate into a known S-curve as taught by Heinl would be a simple, successful modification.

Ground 3: Obviousness over Grusin in view of Fernandez - Claims 1-8 are obvious over Grusin in view of Fernandez.

  • Prior Art Relied Upon: Grusin (Patent 6,283,969) and Fernandez (Application # 2005/0165400).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued Grusin discloses a substantially T-shaped orthopedic plate that is pre-bent and includes many claimed features, such as a contoured inferior surface, a trunk portion, and a pair of arms. Fernandez discloses a variable-angle locking screw system where screws with threaded, spherical heads engage protrusions inside the screw holes to lock at a selected angle, providing a "polyaxial coupling." The combination of Grusin's plate with Fernandez's advanced locking screw technology allegedly renders claims 1-8 obvious.
    • Motivation to Combine: Grusin emphasized the importance of a "very solid connection" for its plate system. Fernandez teaches a known method for achieving strong fixation with the added benefit of allowing variable screw angles, which provides surgeons greater flexibility. A POSITA would combine Fernandez’s polyaxial locking screws with Grusin's plate to achieve the "solid connection" Grusin desired while gaining the well-known advantages of variable-angle screw placement.
    • Expectation of Success: Given the long history and known advantages of locking screws, a POSITA would have reasonably expected that incorporating the teachings of Fernandez into Grusin’s plate would successfully create a stronger, more versatile fixation system.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-9 of the ’278 patent as unpatentable.