Medtronic Inc v. Barry Mark

1. Case Identification

• Case #: IPR2014-01211
• Patent #: 8,361,121
• Filed: July 27, 2014
• Petitioner(s): Medtronic, Inc.
• Patent Owner(s): Mark A. Barry, MD
• Challenged Claims: 1-4

2. Patent Overview

• Title: System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions
• Brief Description: The ’121 patent discloses a surgical system and method for correcting spinal deformities like scoliosis. The invention involves using first and second pedicle screw cluster derotation tools on opposite sides of the spine, connecting their handles with a cross-linking member, and applying manipulative force to simultaneously rotate multiple vertebrae into proper alignment.

3. Grounds for Unpatentability

Ground 1: Obviousness over Lenke Surgical Technique References - Claims 1-4 are obvious over the Video, Slides, and/or MTOS in view of the ’328 application, the ’349 patent, and the ’291 application.

• Prior Art Relied Upon: Lenke Video (a 2001 surgical video), Lenke Slides (a 2003 presentation handout), MTOS (a 2003 book chapter), Trautwein (Application # 2003/0065328), White (’349 patent), and Shluzas (Application # 2005/0033291).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the primary references (Video, Slides, MTOS), which describe Dr. Lawrence Lenke's surgical technique and were often distributed together, collectively teach most elements of the challenged claims. This includes implanting sets of pedicle screws, using derotation tools with handles to engage the screws, and applying manipulative force to correct spinal curvature. Petitioner asserted these references show surgeons manually grasping and moving multiple individual derotator handles simultaneously. The combination further discloses using two sets of tools on opposite sides of the spine.
  • Motivation to Combine: A POSITA would combine the primary Lenke references with Trautwein to add a mechanical linkage between the individual tool handles. The motivation was to improve upon the manual method by ensuring uniform force application, achieving simultaneous movement of the vertebrae, and reducing surgeon workload, all of which were predictable outcomes. A POSITA would also add the cross-linking member taught by White between the tools on opposite sides of the spine to ensure force is evenly distributed to the pedicles, preventing damage. Finally, a POSITA would incorporate the well-known rod rotation maneuver taught by Shluzas to achieve better initial alignment before final derotation.
  • Expectation of Success: Petitioner asserted success was expected, as the combination involved applying known techniques and components for their intended, predictable purposes in the same field of endeavor.

Ground 2: Obviousness over Michelson in view of Surgical Technique References - Claims 1-4 are obvious over the ’928 application in view of the Slides and/or MTOS, the ’349 patent, and the ’219 application.

• Prior Art Relied Upon: Michelson (Application # 2005/0245928), Lenke Slides (a 2003 presentation handout), MTOS (a 2003 book chapter), White (’349 patent), and an alternative reference (’219 application).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Michelson serves as the primary reference, disclosing a system for aligning vertebrae that includes a derotation tool with multiple screw engagement members and handles that are already mechanically linked by cross-action members. Michelson was alleged to teach the core claimed concept of a tool that facilitates simultaneous manipulation of multiple pedicle screws via a linked handle mechanism. It also discloses implanting pedicle screws and using a spinal rod.
  • Motivation to Combine: A POSITA would modify the system of Michelson by incorporating the well-known rod rotation maneuver detailed in the MTOS chapter to improve the correction of scoliotic deformities, a technique widely understood since the 1980s. A POSITA would also find it obvious to use two of Michelson's tools—one on each side of the spine—as taught by the Lenke Slides and MTOS, because this constitutes a simple duplication of parts to perform a bilateral procedure, ensuring equal force application and a safer, more effective outcome. The cross-linking member from White would be added between the two tools for the same reasons of force distribution as argued in Ground 1.
  • Expectation of Success: The combination was argued to be a predictable integration of known surgical tools and techniques to achieve the common goal of spinal correction.

• Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 2) based on the Video/Slides/MTOS in view of the '928 application and '349 patent, relying on a similar motivation to add a mechanical linkage as argued in Ground 1.

4. Key Claim Construction Positions

• "spinal rod engagement means," "spinal rod fixation means," "handle means": Petitioner argued for the plain and ordinary meaning for these terms under the broadest reasonable interpretation standard (e.g., "handle means" is "a part that is designed especially to be grasped by the hand"). However, anticipating that the Patent Owner would assert they are means-plus-function terms under 35 U.S.C. §112, ¶ 6, Petitioner provided detailed alternative constructions. This dual argument proposed that if the Board found them to be means-plus-function elements, the claimed function and corresponding structure were still disclosed in the prior art.
• "mechanically linked": Petitioner proposed the construction "joined by a physical connection or physically joined." This interpretation was based on the patent’s figures and dictionary definitions and was central to arguments that prior art tools with interconnected components met this claim limitation.
• "a second group of vertebrae lateral to the first group of vertebrae": Petitioner argued this phrase lacks a reasonably certain meaning because vertebrae are arranged longitudinally, not laterally. However, for the purpose of the IPR, Petitioner presumed it refers to the contralateral sides of a group of vertebrae, consistent with the patent’s figures showing tools placed on the left and right sides of the spine.

5. Relief Requested

• Petitioner requests institution of an inter partes review for claims 1-4 of the ’121 patent and cancellation of these claims as unpatentable under 35 U.S.C. §103.