Paragon 28 Inc v. Treace Medical Concepts Inc

1. Case Identification

• Case #: PGR2026-00020
• Patent #: 12,268,428
• Filed: December 23, 2025
• Petitioner(s): Paragon 28, Inc.
• Patent Owner(s): Treace Medical Concepts, Inc.
• Challenged Claims: 1-30

2. Patent Overview

• Title: Instrumented Surgical Technique for Bunion Correction
• Brief Description: The ’428 patent discloses surgical methods for correcting bunion deformities. The methods generally involve inserting an instrument between the first and second metatarsals, cutting the ends of the first metatarsal and medial cuneiform bones, repositioning the first metatarsal to correct the deformity, and fusing the bones in the corrected position with a fixation device.

3. Grounds for Unpatentability

Ground 1: Anticipation by McGlamry - Claims 1-3, 6-8, 10-13, and 16-17 are anticipated under 35 U.S.C. §102 by McGlamry.

• Prior Art Relied Upon: McGlamry (McGlamry’s Comprehensive Textbook of Foot and Ankle Surgery, 4th Edition, 2013).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that McGlamry, a single authoritative textbook, described a complete instrumented bunion correction surgery (metatarsal-cuneiform arthrodesis) that disclosed every limitation of the challenged claims. Petitioner asserted that a person of ordinary skill in the art (POSA) would read the relevant chapters (e.g., Chapters 31 and 55) together as describing a single, cohesive procedure. McGlamry allegedly taught inserting a Freer elevator between the first and second metatarsals, using a sagittal saw to cut the ends of the first metatarsal and cuneiform while the elevator is in place, moving the first metatarsal in three anatomical planes (frontal, sagittal, transverse) to correct the deformity, and fixating the bones with known devices like screws and locking plates.
  • Key Aspects: For dependent claims, Petitioner mapped McGlamry’s use of a Weber clamp to the claimed "bone positioning guide" and its use of K-wires to the claimed method of rotating the metatarsal in the frontal plane.

Ground 2: Obviousness over McGlamry and Davidson - Claims 1-3, 6-13, and 16-17 are obvious over McGlamry in view of Davidson.

• Prior Art Relied Upon: McGlamry (2013 textbook) and Davidson (Application # 2009/0216089).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that even if McGlamry alone did not teach using an instrument as claimed, Davidson disclosed a specialized retractor designed for podiatric surgery, including bunion correction. Davidson’s retractor was taught to be inserted between the first and second metatarsals to protect soft tissues from the surgical saw and to act as a fulcrum during bone repositioning, thereby satisfying the limitations of claim 1 and the fulcrum limitation of claim 9.
  • Motivation to Combine: A POSA would combine Davidson’s specialized, foot-specific retractor with McGlamry’s surgical procedure as a simple substitution for the general-purpose Freer elevator disclosed in McGlamry. The motivation was to achieve predictable and well-established benefits, including improved safety by protecting adjacent tissues from the saw, better surgical exposure, and more stable control during bone manipulation. Petitioner argued these instruments were known to be interchangeable for such purposes.
  • Expectation of Success: A POSA would have a high expectation of success, as the combination involved using a known tool (Davidson's retractor) in its intended anatomical environment (between metatarsals) during a known procedure (McGlamry's bunion correction) to achieve its expected, predictable functions.

Ground 3: Obviousness over McGlamry and Fallin - Claims 4-5, 14-15, 17-21, and 23-30 are obvious over McGlamry in view of Fallin.

• Prior Art Relied Upon: McGlamry (2013 textbook) and Fallin (Application # 2016/0213384).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground focused on claims requiring a "bone preparation guide." Petitioner argued McGlamry described a "freehand" bone cutting technique, which was known to be imprecise. Fallin disclosed a bone preparation guide with cutting slots specifically for metatarsal-cuneiform fusion osteotomy. Fallin’s guide was positioned over the metatarsal and secured with fixation pins through fixation apertures to guide a saw blade, directly mapping to the limitations of claims 4, 5, and 18.
  • Motivation to Combine: A POSA would have been motivated to incorporate Fallin’s cutting guide into McGlamry’s procedure to solve the known problems and complications associated with freehand bone resection, such as imprecise cuts, significant bone shortening, and delayed unions. Using the guide would make the procedure safer, faster, more accurate, and more repeatable.
  • Expectation of Success: Success was predictable because applying a cutting guide to improve the precision of a known surgical procedure was a well-understood technique to solve a known problem. The surgical steps in McGlamry and Fallin were nearly identical, making the integration of the guide straightforward.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of McGlamry, Davidson, and Fallin; McGlamry and Tyber (Patent 8,328,806) for intramedullary implants; and McGlamry and DaCosta-219 (WO 2014/152219) for alternative intramedullary fixation.

4. Key Claim Construction Positions

• "fulcrum": Petitioner argued for the term’s plain and ordinary meaning as any "mechanical instrument" that maintains spacing between bones and about which another bone can pivot. This broad construction, supported by the specification’s examples (e.g., retractor, pin, osteotome), was central to Petitioner's argument that standard retractors and elevators found in the prior art, such as in McGlamry and Davidson, met this limitation.
• "bone positioning guide": Petitioner contended the plain meaning is a "device that is designed to move bone(s)." This construction allowed Petitioner to argue that conventional instruments like the Weber clamp disclosed in McGlamry, which are used to grasp and reposition bones, satisfied this claim element.

5. Arguments Regarding Discretionary Denial

• Petitioner stipulated that if the Post Grant Review (PGR) is instituted, it will not pursue in the parallel district court case any invalidity ground against the challenged claims that was raised or reasonably could have been raised in the petition. Petitioner argued that this stipulation weighs strongly against discretionary denial under §314(a) pursuant to the Fintiv factors, as it promotes efficiency and avoids duplicative efforts.

6. Relief Requested

• Petitioner requested institution of a Post Grant Review (PGR) and cancellation of claims 1-30 of the ’428 patent as unpatentable.