OsteoMed LLC v. Stryker European Operations Holdings LLC

1. Case Identification

• Case #: IPR2022-00486
• Patent #: 9,168,074
• Filed: January 28, 2022
• Petitioner(s): OsteoMed LLC
• Patent Owner(s): Stryker European Operations Holdings LLC
• Challenged Claims: 1, 7, 8, 10, 13, 15

2. Patent Overview

• Title: Intramedullary Implant
• Brief Description: The ’074 patent relates to an intramedullary implant for fusing two bones or bone fragments. The implant comprises a first threaded end for anchoring into a first bone part and a second end with a body portion and a plurality of outwardly projecting teeth for fixation in a second bone part.

3. Grounds for Unpatentability

Ground 1: Anticipation by Jackson - Claims 1, 10, and 13 are anticipated by Jackson under 35 U.S.C. §102.

• Prior Art Relied Upon: Jackson (G.B. Pat. Pub. No. 2,430,625).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Jackson’s joint fusion peg discloses every limitation of claims 1, 10, and 13. Jackson’s peg is an intramedullary implant with a first threaded end (conical limb 3) for anchoring and a second end (proximal limb 2) for anchoring in another bone. This second end has a body portion with a plurality of projecting flanges (teeth) that are spaced along its longitudinal axis, extend in the same direction, and are positioned on opposing sides (meeting the requirement for teeth extending in different directions). For claim 10, Jackson’s flanges are positioned at the same axial location. For claim 13, the cross-section of Jackson's conically shaped proximal limb is inherently non-circular.

Ground 2: Obviousness over Jackson and Coilard-Lavirotte - Claim 15 is obvious over Jackson in view of Coilard-Lavirotte.

• Prior Art Relied Upon: Jackson (G.B. Pat. Pub. No. 2,430,625) and Coilard-Lavirotte (Application # 2008/0132894).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Jackson discloses all elements of claim 15 except for the second end having an opening in a median portion. The purpose of this opening, as described in the ’074 patent, is to allow for elastic deformation to enhance anchoring. Coilard-Lavirotte, which addresses the same problem of fixing intramedullary implants in phalangeal joints, discloses an implant with elastically deforming anchoring branches that create an opening in the second end to improve fixation.
  • Motivation to Combine: A POSITA seeking to improve the anchoring and stability of Jackson’s implant would combine its features with the elastically deforming anchoring branches of Coilard-Lavirotte. This combination would utilize a known technique (elastic deformation for anchoring) from analogous art to improve a similar device and achieve the predictable result of better fixation.
  • Expectation of Success: A POSITA would have a clear expectation of success, as combining the known anchoring structures from both references was a straightforward application of established principles to achieve a well-understood benefit.

Ground 3: Obviousness over Carver and Coilard-Lavirotte - Claims 1, 7, 8, 10, 13, and 15 are obvious over Carver in view of Coilard-Lavirotte.

• Prior Art Relied Upon: Carver (Patent 7,041,106) and Coilard-Lavirotte (Application # 2008/0132894).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Carver discloses a base intramedullary implant with a threaded first end and a second end having a ribbed surface (plurality of teeth). However, Carver does not explicitly teach teeth extending in different directions, an opening in the median portion, or a non-circular cross-section. Coilard-Lavirotte supplies these missing elements. It teaches anchoring branches with anti-return teeth extending in different directions, an opening between the branches for elastic deformation, and the advantages of non-circular cross-sections for improved stability.
  • Motivation to Combine: A POSITA would combine Carver and Coilard-Lavirotte to improve the fixation and stability of Carver’s implant. The combination would solve the known problem of preventing implant rotation and loosening by incorporating Coilard-Lavirotte’s multi-directional, elastically deforming anchoring features and non-circular profile into Carver’s basic design.
  • Expectation of Success: The combination involved applying known anchoring features from one implant designed for foot joints to another, similar implant for the same application, leading to a high expectation of achieving improved, more secure fixation.
• Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 7, 8, and 13 as obvious over Jackson alone, and claims 1, 7, 8, 10, 13, and 15 as obvious over Pietrzak (a 2006 journal article) in view of Coilard-Lavirotte, relying on similar modification and combination rationales.

4. Key Claim Construction Positions

• "a body portion" (claim 1): Petitioner proposed this term be construed as "a portion of the second end that excludes a plurality of teeth." This construction is based on the claim language stating the teeth are "projecting from the body portion," which logically requires the teeth to be separate from the portion they project from.
• "a cross-section" (claim 13): Petitioner proposed this term be construed as "a section formed by a plane cutting through an object." Petitioner argued that because claim 13 does not specify an axis or angle for the cross-section, unlike other claims in the patent family, it should be given a broad scope to include any cross-section, not just one perpendicular to the longitudinal axis.

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under both §325(d) and §314(a) (Fintiv).
• Under §325(d), Petitioner contended that the specific combinations of prior art presented in the petition, particularly those including Jackson, Coilard-Lavirotte, and Pietrzak, were not considered by the examiner during prosecution.
• Under Fintiv, Petitioner argued that the factors weighed against denial because: (1) Petitioner intended to file a motion to stay the co-pending district court litigation; (2) no trial date was set in that litigation; and (3) the merits of the petition are strong, favoring institution.

6. Relief Requested

• Petitioner requests institution of an IPR and cancellation of claims 1, 7, 8, 10, 13, and 15 of the ’074 patent as unpatentable.