PTAB

IPR2018-00429

OrthoPediatrics Corp v. K2M Inc

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1. Case Identification

2. Patent Overview

  • Title: Manually Operated Rod Reduction Device
  • Brief Description: The ’816 patent relates to a manually operated surgical instrument, or "rod reducer," for use in spinal fusion surgery. The device is designed to grasp a bone screw and reduce (i.e., lower) a spinal rod into a receiving slot in the head of that screw using a screw jack mechanism.

3. Grounds for Unpatentability

Ground 1: Claims 16, 18, 19, 21, and 22 are anticipated by Iott under 35 U.S.C. § 102

  • Prior Art Relied Upon: Iott (Application # 2006/0247630).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Iott’s "rod reducer instrument 300" discloses every limitation of the challenged claims. The instrument's housing (comprising sleeve 22 and attachment sleeve 306), grasping members (arms 72, 74 of an inner sleeve), rotatable member (rotation shaft 302), and rod contact member (reducer shaft 304) were mapped to the corresponding elements of independent claim 16. Petitioner asserted that Iott’s components are arranged and function precisely as claimed, including the axial translation of the rod contact member along a defined plane in response to the rotation of the rotatable member. The features of dependent claims 18, 19, 21, and 22 were also argued to be expressly or inherently disclosed in Iott's device.

Ground 2: Claims 16, 18, 19, 21, and 22 are anticipated by Runco under §102

  • Prior Art Relied Upon: Runco (Application # 2006/0079909).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Runco’s "instrument 400," designed for engaging a bone anchor and positioning a spinal rod, meets all limitations of the challenged claims. Runco’s bone anchor engaging tool 412 was identified as the claimed housing, which includes first and second grasping jaw members (418A and 418B). The instrument’s rod adjusting tool 414 was shown to contain both the claimed rotatable member (proximal component 423) and the rod contact member (distal component 419). As in the challenged claims, rotation of Runco's rotatable member causes the rod contact member to advance axially and push a spinal rod into position. Petitioner further mapped the grasping features and component positioning required by the dependent claims to Runco's disclosures.

Ground 3: Claims 16, 18, 19, 21, and 22 are obvious over Trudeau in view of Pond under §103

  • Prior Art Relied Upon: Trudeau (Application # 2006/0089651) and Pond (Application # 2006/0036255).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative interpretation of Trudeau’s device. Petitioner argued a person of ordinary skill in the art (POSITA) would identify Trudeau’s "drive rod 140" as the claimed rotatable member and its "tool shaft 120" as the claimed rod contact member. This interpretation requires viewing Trudeau’s separate "rod securing device 30" (effectively a cap) as removed. Pond discloses a rod reducer that functions by directly contacting the rod with a shaft, without an intermediate cap or set screw.
    • Motivation to Combine: A POSITA would combine these teachings to simplify Trudeau's design by removing the unnecessary rod securing device. Pond provides the motivation for this modification by teaching the utility of a simpler direct-contact mechanism. This modification would enable a surgeon to temporarily position a spinal rod for adjustment before final fixation, a technique taught by Pond and identified as an advantage in the ’816 patent specification itself.
    • Expectation of Success: A POSITA would have a high expectation of success because removing the cap from Trudeau’s tool shaft is a simple mechanical simplification. It constitutes the mere omission of a component to eliminate its function, which would not alter the fundamental rod-pushing operation of the device.
  • Additional Grounds: Petitioner asserted an additional anticipation challenge (Ground 3 in the petition) against claims 16, 18, 19, 21, and 22 based solely on Trudeau (Application # 2006/0089651).

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 16, 18, 19, 21, and 22 of the ’816 patent as unpatentable.