Nextremity Solutions Inc v. Extremity Medical LLC

1. Case Identification

• Case #: IPR2022-00802
• Patent #: 8,303,589
• Filed: April 1, 2022
• Petitioner(s): Nextremity Solutions, Inc.
• Patent Owner(s): Extremity Medical, LLC
• Challenged Claims: 59

2. Patent Overview

• Title: FIXATION SYSTEM, AN INTERMEDULLARY FIXATION ASSEMBLY AND METHOD OF USE
• Brief Description: The ’589 patent discloses an orthopedic fixation system for bones and joints. The system includes a first screw member coupled at a fixed angle to a second intramedullary member, and an instrument that removably couples to the second member via circumferentially spaced recesses to facilitate implantation.

3. Grounds for Unpatentability

Ground 1: Claim 59 is anticipated by Brumfield under 35 U.S.C. §102(b)

• Prior Art Relied Upon: Brumfield (Patent 4,827,917).
• Core Argument:
  • Prior Art Mapping: Petitioner argued that Brumfield discloses a fixation system for compressing bone that meets every limitation of claim 59. Brumfield’s lag screw 50 is the claimed “first screw member,” and its intramedullary rod 20 is the “second member.” The rod 20 includes a bore (holes 28, 30) at an angle to its longitudinal axis for receiving the lag screw 50. An insertion tool 80 serves as the claimed “instrument” for coupling the screw to the rod. Critically, Petitioner asserted that the final limitation, “first and second circumferentially spaced recesses adapted for coupling to said instrument,” is explicitly disclosed as slots 42 on the head of rod 20. These slots 42 are engaged by prongs 82 on the tool 80 to align the instrument for surgery. Both the rod and screw are shown residing within a femur, satisfying the final claim limitations.

Ground 2: Claim 59 is anticipated by Marcus under 35 U.S.C. §102(b)

• Prior Art Relied Upon: Marcus (Patent 4,622,959).
• Core Argument:
  • Prior Art Mapping: Petitioner contended that Marcus also discloses every element of claim 59 in a system for femur fractures. Marcus’s screw 51 is the “first screw member,” and its intramedullary nail 10 is the “second member.” The nail 10 has an angled bore (openings 40, 45) for receiving screw 51. A screw guide and drilling jig (Fig. 6) serves as the claimed “instrument” for guiding the screw into the nail. Petitioner argued that the claimed “first and second circumferentially spaced recesses” are taught as grooves 68 and 70 in the upper end of the nail head. These grooves are designed to engage lugs 116 on the jig to accurately align the instrument circumferentially and axially. The system is shown implanted entirely within the femur bone.

Ground 3: Claim 59 is anticipated by Chandran under 35 U.S.C. §102(b)

• Prior Art Relied Upon: Chandran (Patent 6,579,293).
• Core Argument:
  • Prior Art Mapping: Petitioner argued that Chandran, which discloses a fixation assembly for foot and ankle bones, also anticipates claim 59. Chandran’s oblique screw 130 or 150 is the “first screw member,” and its vertical rod 110 is the “second member.” The rod 110 includes a slanted hole 119 (the “bore”) that forms an angle with the rod’s main axis. An alignment jig 230 is the claimed “instrument,” used to drill the hole and insert the screw. Petitioner asserted that the claimed “recesses” are disclosed as slots 129 on the rod 110. These slots 129 are specifically taught to “accommodate alignment fins 270” on the jig, allowing the jig to be securely coupled to and rotated around the rod. The rod and screw are shown residing within the tibial and calcaneum bones.

4. Key Claim Construction Positions

• Preamble Not Limiting: Petitioner argued that the preamble phrase, “A fixation system for compressing bone,” is not a limitation of claim 59. It was asserted that the phrase merely states an intended use for a structurally complete invention defined in the claim body. Petitioner noted that during prosecution, the Patentee did not rely on this phrase to distinguish over prior art (Chang) that did not explicitly mention compression, thereby conceding its non-limiting nature.
• Proposed Term Constructions: For purposes of the IPR, Petitioner proposed constructions based on ordinary meaning:
  • "screw member": A threaded device used in bone surgery for fixation.
  • "recesses": An indentation, cleft, including a groove.
  • "coupling": The act of bringing or coming together; pairing. Petitioner argued this does not require permanent fixation, as the instrument in the ’589 patent is slidably coupled and later removed.

5. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claim 59 of the ’589 patent as unpatentable.