PTAB

IPR2019-00894

Paragon 28 Inc v. Wright Medical Technology Inc

Key Events

Petition

petition

Title: Orthopedic Plates for Use in Clavicle Repair and Methods for Their Use
Brief Description: The ’443 patent describes orthopedic plate systems for the internal fixation of fractured bones. The invention combines bone plates having specific shapes, such as divergent arms and S-curves, with bone screws and corresponding screw holes that may include features like threads and guideways to assist in surgical placement.

Prior Art Relied Upon: Kay (Application # 2006/0173459) and Heinl (Patent 4,903,691).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Kay discloses a customizable orthopedic plate with a central trunk, linking portions, and divergent arms, teaching all limitations of the independent claims except for the requirement that the plate’s medial line describes an "S-curve." Heinl was cited as disclosing various orthopedic plate shapes, including a pre-contoured S-shaped plate, to accommodate different anatomical conditions. The combination of Kay’s customizable plate with Heinl’s known S-shape allegedly renders the claims obvious.
- Motivation to Combine: A POSITA would combine these references because Kay explicitly teaches that its plate is designed for three-dimensional contouring to accommodate individual bone shapes. Heinl provides a known and advantageous contour—the S-shape—for anatomical fitting. Petitioner argued a POSITA would have been motivated to apply Heinl’s known S-form curvature to Kay’s configurable plate to create a plate better suited for bones with complex shapes, like the clavicle.
- Expectation of Success: Because Kay discloses that its plate is specifically designed with features like "waist areas" to facilitate bending and contouring, a POSITA would have had a high expectation of success in forming the plate into the well-known S-shape taught by Heinl.

Prior Art Relied Upon: Kay (Application # 2006/0173459), Heinl (Patent 4,903,691), and Schneider (Application # 2006/0235400).
Core Argument for this Ground:
- Prior Art Mapping: This ground builds on the S-shaped plate established by the combination of Kay and Heinl. It adds Schneider to address the limitations of claims 9-11, which recite a "drill guide" and "guide ways" in the arm screw holes. Petitioner argued that Schneider teaches a bone plate with screw holes containing recesses (the claimed "guide ways") designed to accept and guide drilling bushings (the claimed "drill guide").
- Motivation to Combine: Kay mentions the use of "instruments" with its plate system but provides no specific details. Petitioner contended this would motivate a POSITA to look to the art for known instruments and corresponding plate features to improve the system. Schneider’s drill guide and guideway system represents such a known improvement. A POSITA would incorporate Schneider's features to improve surgical precision, reduce the need for extra components, and lower manufacturing costs.
- Expectation of Success: Petitioner asserted a POSITA would expect success because both Kay and Schneider describe similar orthopedic plate systems with variable angle screws, making the integration of Schneider’s screw hole features into the Kay/Heinl plate straightforward.

Prior Art Relied Upon: Kay (Application # 2006/0173459) and Schneider (Application # 2006/0235400).
Core Argument for this Ground:
- Prior Art Mapping: This ground challenges claims that do not require an S-curve. Petitioner argued that Kay provides the basic orthopedic plate system with an elongate trunk and asymmetric arms. Schneider was cited to teach the remaining key limitations, including threaded screw holes, screws with threaded heads for locking fixation, and a system including a drill guide with corresponding guideways in the screw holes.
- Motivation to Combine: The motivation is identical to that in Ground 2. A POSITA would be motivated to enhance Kay’s basic plate system by incorporating Schneider's advanced features for locking screws and guided drilling to achieve greater stability and improved functionality.
- Expectation of Success: The expectation of success was based on the fundamental similarities between the orthopedic systems disclosed in Kay and Schneider, which would suggest to a POSITA that their features were compatible and could be combined predictably.

Priority Date Challenge: A central contention of the petition is that the challenged claims are not entitled to the priority date of their parent 2006 application. Petitioner argued that two key limitations—the "S-curve" (claims 1, 3-8, etc.) and the "drill guide" with "guide ways" (claims 9-11 and 22-25)—were new matter added for the first time in a 2009 Continuation-In-Part (CIP) application.
Kay as Prior Art: Because the features were not disclosed in the 2006 application, Petitioner asserted the challenged claims’ effective filing date is that of the 2009 CIP. The 2006 application was published in August 2006 as the Kay reference. Therefore, Kay itself qualifies as prior art under pre-AIA 35 U.S.C. §102(b) against the challenged claims, forming the basis for all asserted obviousness grounds.

Petitioner requests institution of an inter partes review and cancellation of claims 1, 3-11, 15, 19, and 22-26 of the ’443 patent as unpatentable.