OrthoPediatrics Corp v. K2M Inc

1. Case Identification

• Case #: IPR2018-00521
• Patent #: 9,532,816
• Filed: January 22, 2018
• Petitioner(s): OrthoPediatrics Corp.
• Patent Owner(s): K2M, Inc.
• Challenged Claims: 16, 18, 19, 21, and 22

2. Patent Overview

• Title: Manually Operated Rod Reduction Device for Orthopedic Surgery
• Brief Description: The ’816 patent discloses a manually operated surgical instrument designed to reduce a spinal rod into a receiving slot in the head of a bone screw during orthopedic surgery. The device features a grasping fork assembly and a screw-jack mechanism where a rotatable member translates a rod contact member to push the spinal rod into its final position.

3. Grounds for Unpatentability

Ground 1: Anticipation over Whipple - Claims 16, 18, 19, 21, and 22 are anticipated by Whipple.

• Prior Art Relied Upon: Whipple (Application # 2006/0293692).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the rod reduction instrument disclosed in Whipple teaches every limitation of the challenged claims. Specifically, Whipple’s instrument 10 is a rod reducing device comprising a housing (coupling mechanism 100), first and second grasping members (arms 24, 50), a rotatable member that extends through the housing (tube 60), and a rod contact member at its distal end (distal end 64). Petitioner contended that rotation of Whipple’s tube 60 causes it and its distal end 64 to translate along the instrument's longitudinal axis, between and within the plane of the grasping arms, to reduce a spinal rod. Whipple was also argued to meet the limitations of the dependent claims: the grasping arms include features to engage a bone anchor (claim 18); distal movement of the rod contact member urges the rod towards the arms (claim 19); the rod contact member is positioned between the grasping arms (claim 21); and the rod contact member is attached to the distal end of the rotatable member (claim 22).

Ground 2: Anticipation over Varieur - Claims 16, 18, 19, and 21 are anticipated by Varieur.

• Prior Art Relied Upon: Varieur (Application # 2005/0149053).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Varieur’s instrument for positioning a spinal rod anticipates the key features of the independent claim. Varieur’s pivotally connected jaw members (18A, 18B) form an annular collar that functions as the claimed housing and grasping members. A rod adjusting tool 14 serves as the rotatable member, and a separate rod engaging member 90 acts as the rod contact member. Petitioner argued that rotation of the tool 14 causes both it and the rod engaging member 90 to translate axially through the housing and within the plane defined by the jaw members. This action reduces a spinal rod relative to a bone anchor, thereby meeting the limitations of independent claim 16. For the dependent claims, Petitioner mapped the cylindrical pins (54A,B) on the distal ends of Varieur's jaw members to the bone anchor grasping feature (claim 18), the axial advancement of the rod engaging member to the limitation of urging a rod distally (claim 19), and the position of the rod engaging member between the jaws to the limitation of claim 21.

Ground 3: Anticipation over Jackson - Claims 16, 18, 19, 21, and 22 are anticipated by Jackson.

• Prior Art Relied Upon: Jackson (Application # 2005/0192570).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner contended that Jackson’s surgical tool set for spinal rod installation discloses all challenged claim limitations. Jackson's intermediate guide tool 10 has an elongate body 84 (the housing) with two spaced side walls or legs (93, 94) that serve as grasping members. A separate closure installation tool 145 functions as the rotatable member, and a closure top 52 acts as the rod contact member. Petitioner argued that continued rotation of tool 145 drives the closure top 52 downward along the guide tool’s axis and between the grasping legs to urge a rod into a bone screw channel, anticipating claim 16. Jackson was also argued to disclose the dependent claim limitations: the guide tool legs include an attachment structure (113) for engaging a bone screw (claim 18); downward movement of the closure top urges the rod distally (claim 19); the closure top is positioned between the grasping legs (claim 21); and the installation tool has a socket (148) that grips the closure top, thereby attaching it (claim 22).

• Additional Grounds: Petitioner asserted numerous alternative grounds, including that claims are obvious over Whipple in view of Runco (Application # 2006/0079909) to teach a more secure, separate attachment of the rod contact member. Similar obviousness arguments were made over Varieur in view of Runco for claim 22, and over Jackson in view of Trudeau (Application # 2006/0089651) for claim 18.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be improper. It acknowledged a concurrently filed petition (IPR2018-00429) against the same patent but emphasized that the present petition relies on entirely different prior art references, combinations of art, arguments, and expert testimony, thereby presenting distinct unpatentability challenges for the Board’s consideration.

5. Relief Requested

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