Paragon 28 Inc v. Treace Medical Concepts Inc

1. Case Identification

• Case #: PGR2026-00017
• Patent #: 12,268,397
• Filed: December 19, 2025
• Petitioner(s): Paragon 28, Inc.
• Patent Owner(s): Treace Medical Concepts, Inc.
• Challenged Claims: 1-30

2. Patent Overview

• Title: Surgical Methods and Devices for Bunion Correction
• Brief Description: The ’397 patent discloses devices and methods for correcting bunions, focusing on a multi-part bone cutting guide. The system uses a first guide attached to a first bone (e.g., metatarsal) for an initial cut, and a second guide, connected to the first via a bridge and rails, for a second cut on an adjacent bone (e.g., cuneiform).

3. Grounds for Unpatentability

Ground 1: Unpatentability of Claims 1-30 under 35 U.S.C. § 112

• Prior Art Relied Upon: N/A
• Core Argument for this Ground: Petitioner argued that claims 1-30 are unpatentable for lacking both written description and enablement.
  • Written Description: The petition asserted two primary deficiencies. First, independent claims require a "second bone cutting guide slot being attached to the metatarsal" by the same fixation pins used for the first guide. Petitioner contended this requires a direct connection, but the specification only discloses an indirect connection where the second guide is supported on rails extending from the first guide assembly. Second, dependent claims 3 and 21 recite a negative limitation that the first guide is removed before the second cut, which is contrary to the specification’s disclosure that the first guide remains in place and holds the bridge for the second guide.
  • Enablement: Petitioner argued the claims fail enablement for two reasons. First, the claims recite a broad genus of methods using any "first" and "second" guides, including physically separate and distinct guides. However, the specification only describes a single, narrow species where the guides are serially integrated. A person of ordinary skill in the art (POSA) would require undue experimentation to practice the full scope of the claims using disassociated guides. Second, the claims do not specify an order for the cutting and bone-adjusting steps, but the specification only enables a single sequence (both cuts performed before the final adjustment), failing to enable the full scope of the claimed method.

Ground 2: Obviousness over McGlamry and Augoyard - Claims 1-2, 4-10, 12-20, and 22-30

• Prior Art Relied Upon: McGlamry (a 2013 surgical textbook) and Augoyard (European Patent Application Publication No. 1508316).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that McGlamry taught a well-known bunion correction method (Lapidus procedure) involving the key surgical steps of the claims: cutting the metatarsal and cuneiform, adjusting their alignment, and fixating them to fuse in the corrected position. However, McGlamry described performing the bone cuts freehand, a difficult and complication-prone step. Augoyard taught a multi-part, interlocking bone cutting guide system used in an analogous surgery (metatarsal-phalanx) to ensure precise, corresponding cuts on adjacent bones. Petitioner contended that implementing Augoyard's cutting guide within McGlamry's surgical method renders the claimed method obvious.
  • Motivation to Combine: A POSA would combine these references to improve the known McGlamry procedure. Using a cutting guide like Augoyard's would increase the precision and repeatability of the bone cuts, thereby reducing known complications of the freehand method, such as significant bone shortening and delayed unions. This would make the surgery simpler, faster, and safer.
  • Expectation of Success: A POSA would have had a reasonable expectation of success in adapting Augoyard’s guide for the McGlamry procedure. Cutting guides were known to be adaptable across different anatomies, and the procedures were analogous, both involving cuts on the metatarsal and an adjacent bone. Only minor, predictable modifications to the geometry of Augoyard's second guide would have been necessary to accommodate the cuneiform instead of the phalanx.

Ground 3: Obviousness over McGlamry, Augoyard, and DaCosta - Claim 11

• Prior Art Relied Upon: McGlamry, Augoyard, and DaCosta (U.S. Design Patent No. D695,402).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground specifically addressed claim 11, which requires the cut on the metatarsal to be angled relative to the cut on the cuneiform. The combination of McGlamry and Augoyard taught making parallel cuts. DaCosta, a design patent for a "LAPIDUS CUT GUIDE," explicitly discloses a cutting guide with two sets of angled slots for making non-parallel cuts on adjacent bones in a bunion correction procedure.
  • Motivation to Combine: A POSA would have been motivated to modify the Augoyard guide to incorporate the angled slots of DaCosta. The choice between parallel and angled cuts was a known design variation for surgical cutting guides to achieve different correction outcomes. Substituting DaCosta's known angled-cut feature for Augoyard's parallel-cut feature was argued to be a predictable variation to achieve an angled result.

4. Key Claim Construction Positions

• "attached/attaching": Petitioner argued this term should be construed to mean "directly connected/connecting." This construction was asserted to be critical to the written description challenge. The petition contended that the specification consistently uses "attached" to describe direct physical connections (e.g., via pins, screws, or interference fits), while using distinct terms like "supported on" to describe indirect relationships, such as the second guide member resting on rails connected to the first.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under §314(a) by offering a stipulation. In the event the Board institutes review, Petitioner stipulated it would not pursue in the co-pending district court litigation any invalidity ground against the challenged claims that was raised or reasonably could have been raised in the petition. Petitioner asserted this stipulation addresses the concerns of Fintiv factor 4.

6. Relief Requested

• Petitioner requested institution of a Post-Grant Review and cancellation of claims 1-30 of the ’397 patent as unpatentable.