PTAB

IPR2018-00429

OrthoPediatrics Corp. v. K2M, Inc.

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1. Case Identification

  • Case #: IPR2018-00429
  • Patent #: 9,532,816
  • Filed: January 8, 2018
  • Petitioner(s): Orthopediatrics Corp.
  • Patent Owner(s): K2M, Inc.
  • Challenged Claims: 16, 18, 19, 21, and 22

2. Patent Overview

  • Title: Rod Reducing Device
  • Brief Description: The ’816 patent discloses a manually operated surgical instrument for use in orthopedic surgery, specifically for spinal fusion procedures. The device, a "rod reducer," is designed to grasp a bone screw and use a screw jack mechanism to lower or "reduce" a spinal rod into a receiving slot in the head of the bone screw.

3. Grounds for Unpatentability

Ground 1: Anticipation over Iott - 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, which was not considered during prosecution, discloses a vertebral stabilization system including a "rod reducer instrument 300" that contains every element of the challenged claims. Iott’s instrument comprises a housing (attachment sleeve 306 and sleeve 22), first and second grasping members (arms 72, 74 of an inner sleeve), a rotatable member (rotation shaft 302), and a rod contact member (reducer shaft 304). Petitioner asserted that these components are arranged and function in the same manner as those recited in independent claim 16. For example, rotation of Iott's shaft 302 causes axial translation of the reducer shaft 304 to force a spinal rod into position, meeting limitations [16-4] through [16-7]. The dependent claims were also allegedly disclosed, with Iott's arms 72 and 74 including retainer portions 82 and finger members 84 that meet the "grasping feature" of claim 18.

Ground 2: Anticipation over Runco - Claims 16, 18, 19, 21, and 22 are anticipated by Runco under 35 U.S.C. §102.

  • Prior Art Relied Upon: Runco (Application # 2006/0079909).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Runco, also not previously considered, discloses a rod reduction instrument 400 that anticipates all challenged claims. Runco’s instrument includes a housing (bone anchor engaging tool 412) with first and second grasping jaw members (418A, 418B). Internally, it features a rod adjusting tool 414 composed of a rotatable member (proximal component 423) and a rod contact member (distal component 419 with a rod engaging surface 421). Petitioner argued this structure maps directly onto the elements of claim 16, with rotation of component 423 causing the distal component 419 to translate axially and push a rod. For claim 18, Petitioner argued Runco’s disclosure of an implant engagement mechanism with a cylindrical pin (54A,B) on the jaw members constitutes the claimed "grasping feature."

Ground 3: Obviousness over Trudeau in view of Pond - Claims 16, 18, 19, 21, and 22 are obvious over Trudeau in view of Pond under 35 U.S.C. §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. Petitioner argued that a person of ordinary skill in the art (POSA) would have viewed Trudeau’s "rod persuader device 10" differently than argued for anticipation. In this view, the "rotatable member" of claim 16 corresponds only to Trudeau’s "drive rod 140," and the "rod contact member" corresponds to the "tool shaft 120." This interpretation required considering Trudeau’s "rod securing device 30" (a cap) as removed. Trudeau’s device, so modified, would still possess the housing and grasping jaws (60, 62) that meet the other limitations of claim 16.
    • Motivation to Combine: Petitioner argued a POSA would be motivated to modify Trudeau by removing the rod securing cap 30 to simplify the design, an obvious expedient to eliminate a non-essential function. Pond was cited as teaching the rationale for this modification. Pond discloses a reduction instrument that temporarily holds a rod in a reduced position, without a cap or set screw, allowing for adjustments before final fixation. The ’816 patent itself touts this capability as an advantage. Therefore, a POSA would look to a simpler design like that taught in Pond and be motivated to modify Trudeau by removing the cap 30, resulting in the claimed invention.
    • Expectation of Success: A POSA would have a high expectation of success because the modification is a simple deletion of a component to achieve a less complex, but still fully functional, rod reducer. The principle of operation remains unchanged, and Pond demonstrates the feasibility and utility of a rod reducer that functions without a cap to directly contact the rod.
  • Additional Grounds: Petitioner also asserted, as a separate ground, that claims 16, 18, 19, 21, and 22 are anticipated by Trudeau (Application # 2006/0089651) alone.

4. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 16, 18, 19, 21, and 22 of Patent 9,532,816 as unpatentable.