PTAB

IPR2018-01548

OrthoPediatrics Corp v. K2M Inc

Key Events

Petition

petition

Title: Rod Reduction Device and Methods
Brief Description: The ’664 patent discloses a manually operated surgical device used to reduce, or lower, a metal rod into the receiving slot of a bone screw head, particularly during spinal fusion surgery. The device includes elongated grasping members to engage the bone screw and a rotatable member that advances a rod contact member to push the rod into place.

Prior Art Relied Upon: Trudeau (Application # 2006/0089651).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Trudeau, which was not considered during prosecution, discloses every limitation of the challenged claims. Trudeau describes a "rod persuader device" for advancing a spinal rod towards a pedicle screw fixture. Petitioner asserted that Trudeau’s "drive rod subassembly" is the claimed "rotatable member," its "rod securing device" is the claimed "rod contact member," and its pair of opposed "jaws" are the claimed "first and second elongated grasping members." The petition provided a detailed, element-by-element mapping showing that Trudeau’s device functions identically to the method and system claimed in the ’664 patent, including securing to a bone anchor and rotating a member to advance a rod.
- Key Aspects: The argument relied on a direct structural and functional correspondence between the device in Trudeau and the invention claimed in the ’664 patent, covering the method (claim 1), kit (claim 8), system (claim 12), and surgical construct (claim 17) claims.

Prior Art Relied Upon: Trudeau (Application # 2006/0089651) and Justis (Application # 2007/0213714).
Core Argument for this Ground:
- Prior Art Mapping: This ground addressed dependent claims requiring a plurality of rod reduction devices and bone anchors. Petitioner argued that Trudeau discloses the fundamental rod reduction device and its use with at least one bone anchor. Justis, also in the field of spinal surgery, explicitly discloses a system using a plurality of anchor extensions (rod reducers) with a plurality of bone anchors to "serially advance" a connecting rod.
- Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Trudeau and Justis because both address the same problem of positioning a spinal rod. A POSITA would have recognized the benefit taught by Justis—using multiple reducers to allow for independent adjustment at each vertebral anchor—and applied it to Trudeau’s device. This combination would improve surgical flexibility and address complex spinal deformities where precise, multi-point rod seating is necessary.
- Expectation of Success: A POSITA would have had a high expectation of success, as the combination merely involved using multiple, known rod-reducing devices as taught by Justis to gain a predictable surgical advantage. No technical hurdles would have prevented the use of several of Trudeau's devices in a single procedure.

Prior Art Relied Upon: Sparker (Patent D346,217) and Trudeau (Application # 2006/0089651).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner contended that Sparker discloses a "combined hook holder and rod mover for spinal surgery" that a POSITA would understand to be a rod reducing device. Sparker shows all the key structural elements, including a body, two elongated grasping members, and a threaded, rotatable member for actuation. While Sparker is a design patent and is less descriptive of its method of operation, Trudeau explicitly teaches the claimed method of using such a device.
- Motivation to Combine: A POSITA would look to a reference like Trudeau to understand the conventional method of operating a device like Sparker’s, as both are in the same narrow field of spinal rod reduction. It would have been obvious to apply Trudeau’s detailed operational method (e.g., coupling to a bone anchor, rotating the handle to advance the rod) to Sparker’s structurally similar device to achieve the intended and well-known function of seating a spinal rod.
- Expectation of Success: The combination would have been expected to succeed because it involved applying a standard, known surgical method (from Trudeau) to a tool (from Sparker) designed for that exact purpose.

Petitioner stated that no specific claim terms required construction for the purposes of the petition and that all terms should be given their broadest reasonable interpretation.
Petitioner noted that in a related inter partes review (IPR), the Patent Owner had proposed constructions for "grasping" and "extending through the housing." The Board in that case construed "extending through the housing" but found it unnecessary to construe "grasping."
For this petition, Petitioner accepted the Board's prior construction of "extending through the housing" as "extending through the fixed portion of the rod reducing device that defines the body through passage."

Petitioner requested the institution of an inter partes review and cancellation of claims 1, 3, 5, 6, 8-10, 12, and 15-19 of the ’664 patent as unpatentable.