Medtronic Inc v. Barry Mark

1. Case Identification

• Case #: IPR2015-00782
• Patent #: 8,361,121
• Filed: February 20, 2015
• Petitioner(s): Medtronic, Inc.
• Patent Owner(s): Mark A. Barry, M.D.
• 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 systems and methods for correcting spinal deformities by applying manipulative forces to vertebrae via implanted pedicle screws. The invention relates to using tools with handles to engage and rotate multiple pedicle screws simultaneously, often employing two such tools on opposite sides of the spine connected by a cross-linking member, in conjunction with a spinal rod system.

3. Grounds for Unpatentability

Ground 1: Obviousness of Claims 1-4 over the Lenke References in view of Jackson, Lin, Cotrel, and Aubin

• Prior Art Relied Upon: Lenke References (a 2001 surgical video, a 2003 slide presentation, and a chapter from the Masters Techniques in Orthopaedic Surgery textbook), Jackson (Application # 2005/0245928), Lin (6,565,568), Cotrel (5,219,349), and Aubin (Application # 2005/0033291).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the Lenke References collectively teach the foundational method of correcting scoliosis, including implanting pedicle screws, using multiple "apical derotators" (tools with handles) to engage and rotate vertebrae, and using a contoured spinal rod. Petitioner asserted that Jackson and Lin teach a pedicle screw cluster tool with mechanically linked handles that move in unison, addressing a key limitation. Cotrel was cited for its express teaching of connecting two separate derotation tools with a cross-linking member. Finally, Aubin and the well-known Cotrel-Dubousset technique were cited to demonstrate that rotating a spinal rod along its length to correct spinal deviation was a standard and obvious procedure at the time of invention.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine the elements from these references to create a safer, more effective, and more ergonomic surgical system. For example, a POSITA would integrate the linked handles from Jackson or Lin into the Lenke procedure to ensure simultaneous and uniform force application. Similarly, adding the cross-linking member from Cotrel was presented as a known method to evenly distribute forces, reducing the risk of damage to the vertebrae. Incorporating the rod rotation technique from Aubin was argued to be an obvious step to achieve better three-dimensional spinal correction.
  • Expectation of Success: The combination involved integrating known surgical tools and techniques from the same field, each performing its expected function. Therefore, a POSITA would have had a high expectation of success in creating a predictable system that yielded improved surgical results.

Ground 2: Obviousness of Claims 1-4 over Jackson in view of Lin, the Lenke References, Cotrel, and Aubin

• Prior Art Relied Upon: Jackson (’928 application) as the primary reference, in view of Lin (’568 patent), the Lenke References, Cotrel (’349 patent), and Aubin (’291 application).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Jackson teaches a pedicle screw cluster tool with handles (knobs) that can apply force perpendicular to the spine, which would inherently cause the claimed vertebral rotation. To the extent Jackson’s handles were not considered sufficiently designed for grasping, Lin was cited as disclosing an ergonomic levering handle for the same purpose of applying simultaneous rotational force. The Lenke References were used to show the context of using two such derotation tools simultaneously on opposite sides of the spine. Cotrel again supplied the teaching of a cross-linking member, and Aubin provided the final step of rotating the spinal rod.
  • Motivation to Combine: A POSITA would be motivated to modify the tool disclosed in Jackson to create a complete surgical system. This would include using two tools for bilateral correction as shown in the Lenke References, adding a handle like that in Lin for better ergonomics, incorporating a cross-linking member from Cotrel for stability and even force distribution, and performing the standard rod rotation step taught by Aubin. The motivations cited were to improve surgical efficiency, reduce surgeon workload, and enhance patient safety by combining the best features of known devices.
  • Expectation of Success: As all references originate from the specific field of spinal surgery and address similar problems, a POSITA would have reasonably expected that combining their respective features would result in a successful and predictable surgical system.

4. Key Claim Construction Positions

• "handle means": This term was central to Petitioner's argument. Petitioner argued for a broad construction: "a part that is designed especially to be grasped by the hand or that may be grasped by the hand." Petitioner contended this construction was necessary because a narrower interpretation could exclude a preferred embodiment depicted in the ’121 patent itself and was the basis for a denial of a prior IPR on the same patent. This broad construction was argued to be critical for the prior art handles (e.g., the knobs of Jackson) to meet the claim limitation.
• Means-Plus-Function Terms: For terms like "spinal rod engagement means" and "spinal rod fixation means," Petitioner provided primary constructions based on their plain and ordinary meaning. However, Petitioner also offered alternative means-plus-function constructions for the Board’s consideration, proposing specific corresponding structures from the ’121 patent’s specification should the Board deem them function-limited terms.

5. Key Technical Contentions (Beyond Claim Construction)

• Petitioner advanced a key technical argument that the tool in the Jackson reference, which discloses applying force "perpendicular to the direction in which distraction or compression of the vertebra is effected," would inherently cause rotation of the vertebrae. It was argued that applying such a downward or upward force to pedicle screws offset from the vertebrae's central axis would, as a matter of physics, produce a rotational moment, thereby teaching the claimed "simultaneously rotating" limitation for scoliotic correction.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. § 325(d) would be inappropriate, despite a previously denied petition on the same patent (IPR2014-01211). Petitioner asserted that this petition was not "the same or substantially the same" as the prior one because it directly addressed the specific deficiency identified by the PTAB in its previous decision—namely, the failure to adequately demonstrate the "handle means" limitation. This petition presented new arguments, new prior art combinations, and new evidence specifically tailored to overcome that prior rejection.

7. Relief Requested

• Petitioner requests institution of inter partes review for Claims 1-4 of the ’121 patent.