Stryker Corp v. OsteoMed LLC

1. Case Identification

• Case #: IPR2021-01453
• Patent #: 10,245,085
• Filed: August 30, 2021
• Petitioner(s): Stryker Corporation and Wright Medical Technology, Inc.
• Patent Owner(s): OsteoMed LLC
• Challenged Claims: 1-9

2. Patent Overview

• Title: Bone Plate with a Transfixation Screw Hole
• Brief Description: The ’085 patent discloses a system for securing two discrete bones across a joint. The system uses a bone plate with a transfixation screw hole designed to guide a screw through both bones to achieve fixation, particularly for repairing joints like the metatarsophalangeal joint in the foot.

3. Grounds for Unpatentability

Ground 1: Anticipation - Claims 1-3 and 6-9 are anticipated by Slater

• Prior Art Relied Upon: Slater (WO 2007/131287).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Slater, which discloses an ankle fusion plate for arthrodesis, teaches every limitation of independent claim 1. Slater’s plate comprises an elongate spine with first and second ends for attachment to two discrete bones (tibia and talus) on opposite sides of a joint. Petitioner asserted that Slater explicitly discloses a bridge portion that spans the joint and is thickened at the region of highest loading, corresponding to claim 1’s requirement for a thickened portion. Furthermore, Slater’s opening for an angled screw (opening 26 or 93) was identified as the claimed "aperture defining a transfixation screw hole" configured to direct a screw across the joint through both bones. Petitioner contended that Slater also discloses the additional limitations of dependent claims 2-3 (a transfixation lag screw) and 6-9 (screw positioning relative to the joint’s neutral bending axis, plate conformity to bone geometry, and specific transfixation angles).

Ground 2: Anticipation - Claims 1-8 are anticipated by Falkner

• Prior Art Relied Upon: Falkner (Application # 2005/00171544).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Falkner, which was not considered during prosecution, anticipates claims 1-8. Falkner teaches a bone plate system that can be used to fuse bones across a joint, such as the joint between the tibia and talus. Petitioner argued Falkner’s plate 22 meets the limitations of claim 1, including having first and second ends with attachment points, a bridge portion configured to span a joint, and a thickened portion to increase structural stability. The "oblique opening 44" in Falkner for receiving a threaded fastener 42 was argued to be the claimed transfixation screw hole, disposed at the thickened bridge portion and configured to direct a screw across the joint. Petitioner also contended that Falkner discloses the subject matter of dependent claims 2-8, including the use of a transfixation lag screw, a locking interface between the screw head and plate, positioning relative to compression/tension sides of the joint, and contouring the plate to bone geometry.

Ground 3: Obviousness - Claims 1-3 and 6-9 are obvious over Arnauld in view of Slater

• Prior Art Relied Upon: Arnauld (EP 1897509) and Slater (WO 2007/131287).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Arnauld, an arthrodesis plate for a metatarsophalangeal joint, discloses all elements of independent claim 1 except for the thickened bridge portion. Arnauld teaches a plate for securing two discrete bones across a joint with a transfixation screw hole. Slater was argued to supply the missing element, as it explicitly teaches thickening the bridge portion of a bone plate at the joint region to withstand the highest loading.
  • Motivation to Combine: A POSITA would combine Slater’s teaching of a thickened bridge portion with Arnauld’s plate to solve a known problem. Arnauld addresses the high bending stresses on plates used in metatarsophalangeal joints, and Slater teaches that maximum thickness should be at the joint region to counter high loading. Therefore, a POSITA would be motivated to incorporate Slater’s known strengthening technique into Arnauld’s plate to create a more simple, durable, and reliable fixation system for a high-stress joint.
  • Expectation of Success: A POSITA would have a reasonable expectation of success, as combining the references involved applying a known technique (thickening a high-stress area) to a known device (an arthrodesis plate) to improve a known property (strength), yielding a predictable result.
• Additional Grounds: Petitioner asserted additional obviousness challenges, including that claims 4 and 5 are obvious over Slater in view of Weaver (Patent 6,623,486), which teaches threaded locking screw holes. Another ground asserted claim 9 is obvious over Falkner in view of Arnauld, which provides specific transfixation angle ranges. A final ground asserted claims 4 and 5 are obvious over the combination of Arnauld, Slater, and Weaver.

4. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under §325(d), contending the PTO materially erred by not substantively considering Slater and Arnauld during prosecution, despite them being cited. Falkner was argued to be new art not previously before the Office.
• Petitioner also argued against discretionary denial under Fintiv, stating that the parallel district court litigations are in their infancy with no trial dates set and minimal investment. Petitioner further noted it would agree not to pursue the same invalidity grounds in litigation if the IPR is instituted, mitigating concerns of inefficiency and conflicting decisions.

5. Relief Requested

• Petitioner requests institution of inter partes review and cancellation of claims 1-9 of the ’085 patent as unpatentable.