PTAB

IPR2018-01548

OrthoPediatrics Corp. v. K2M, Inc.

Title: Rod Reducer for Orthopedic Surgery
Brief Description: The ’664 patent discloses devices and methods for orthopedic surgery, specifically a manually operated rod reducer used to advance a spinal rod into a receiving slot on the head of a bone screw. The device generally comprises a body with elongated grasping members to secure the device to a bone anchor and a rotatable member that, when turned, advances a rod contact member to push the spinal 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 element of the challenged claims. Trudeau describes a "rod persuader device" for advancing a spinal rod towards a "pedicle screw fixture" (the bone anchor). Petitioner mapped the key limitations of independent claims 1, 8, 12, and 17 to specific components in Trudeau. Trudeau’s "drive rod subassembly" was identified as the claimed "rotatable member," its "rod securing device" as the "rod contact member," its opposed "jaws" as the "elongated grasping members," and its "pedicle screw fixture" as the "bone anchor." Petitioner asserted that Trudeau teaches coupling the device to the anchor, rotating the drive rod to cause linear movement, and advancing the spinal rod into the anchor's housing (yoke), thereby anticipating the claimed methods, kits, and systems.

Prior Art Relied Upon: Trudeau (Application # 2006/0089651) and Justis (Application # 2007/0213714).
Core Argument for this Ground:
- Prior Art Mapping: This ground addressed claims requiring a "plurality" of bone anchors and rod reduction devices. Petitioner contended that while Trudeau teaches the fundamental rod reducer and its use with at least one anchor, Justis explicitly discloses a system using a plurality of rod reducing devices (anchor extensions) with a plurality of bone anchors. Justis teaches that a connecting element can be "serially advanced through the other spaces 102 defined by the other anchors 300 and extensions 100."
- Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine the teachings of Trudeau and Justis because both relate to positioning a connecting rod along the spine. A POSITA would have been motivated to use a plurality of Trudeau's specific rod reducers in the manner taught by Justis to gain the advantage of separately adjusting the connecting rod's position relative to each individual bone anchor, a known desirable surgical outcome.
- Expectation of Success: Since both references describe rod reduction devices for spinal surgery, a POSITA would have had a high expectation of success in using multiple units of the Trudeau device as part of a system, as taught by Justis, to achieve the predictable result of multi-point rod placement and adjustment.

Prior Art Relied Upon: Sparker (Patent D346,217) and Trudeau (Application # 2006/0089651).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Sparker, a design patent for a "combined hook holder and rod mover for spinal surgery," discloses the basic structure of a rod reducing device, including a body, elongated grasping members, and a threaded shaft (rotatable member). However, Sparker is silent on the specific method of operation. Trudeau explicitly teaches the method claimed in the ’664 patent: rotating a member to threadably advance a rod contact member, which in turn pushes a rod into a bone anchor.
- Motivation to Combine: A POSITA would have been motivated to combine these references because they are in the same field of spinal surgery and address the same problem of reducing a rod. It would have been obvious to apply the specific, detailed method of operation from Trudeau to the structurally similar device in Sparker to achieve the intended and predictable function of rod reduction.
- Expectation of Success: Modifying Sparker's device to operate according to the method in Trudeau would have been a simple application of a known technique to a known device to achieve an expected result.

"extending through the housing": Petitioner noted that in related IPR proceedings involving a related patent, the Board had construed this term as "extending through the fixed portion of the rod reducing device that defines the body through passage." Petitioner stated it did not request a different construction for this petition, accepting the Board’s prior interpretation for the purpose of its arguments.
"grasping": Petitioner argued that no other terms required construction. It noted that the Patent Owner had previously sought construction for the term "grasping" in the related IPRs, but the Board found it was not necessary to resolve the controversy. Petitioner adopted this position, arguing the term’s plain meaning was sufficient.

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