PTAB

IPR2014-01210

Medtronic Inc v. Barry Mark

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Petition
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1. Case Identification

2. Patent Overview

  • Title: System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions
  • Brief Description: The ’358 patent discloses methods and systems for correcting abnormal spinal curvatures. The invention involves implanting multiple pedicle screws into vertebrae, engaging them with specialized engagement members, and applying force via a handle means to simultaneously rotate the vertebrae into a corrected alignment, which is then secured with a spinal rod system.

3. Grounds for Unpatentability

Ground 1: Claims 1-5 are invalid under 35 U.S.C. §102/103 over the [’349](https://ai-lab.exparte.com/case/ptab/IPR2014-01210/doc/1005) patent.

  • Prior Art Relied Upon: Paes (Patent 5,219,349).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ’349 patent anticipates or, in the alternative, renders obvious all limitations of claims 1-5. Paes allegedly discloses a complete method for aligning vertebrae, including a "pedicle screw cluster derotation tool" with a handle and mechanically linked engagement members (shafts). Petitioner asserted that Paes teaches the implantation of pedicle screws, engagement with the tool, and application of force to the handle to manipulate the spine. Specifically, Petitioner contended that Paes explicitly discloses applying rotational forces ("anterior/posterior shear") to the vertebrae. This application of force via the linked handle mechanism to the engaged screws necessarily results in the simultaneous rotation of the vertebrae as required by claim 1.
    • Motivation to Combine (for §103 grounds): The petition argued that even if the simultaneous rotation was not explicitly or inherently disclosed, a person of ordinary skill in the art (POSITA) would have found it obvious to use the Paes device to perform such a movement. Since the Paes tool provides a rigid, linked connection between the handles and multiple screws, a POSITA would have naturally understood that applying a force to the handles would result in a coordinated, simultaneous movement of the engaged vertebrae to achieve spinal correction.
    • Expectation of Success: A POSITA would have had a high expectation of success, as applying force to a rigid, multi-point tool to achieve a predictable, coordinated movement of the underlying structures is a fundamental mechanical principle.

Ground 2: Claims 1-5 are obvious over the [’928](https://ai-lab.exparte.com/case/ptab/IPR2014-01210/doc/1006) application in view of MTOS.

  • Prior Art Relied Upon: Michelson (’928 application, Application # 2005/0245928) and the MTOS Chapter (Masters Techniques in Orthopaedic Surgery: The Spine, 2nd Edition, Chapter 17).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner asserted that the ’928 application discloses a vertebral correction system that meets most limitations of the challenged claims, including pedicle screws and a "pedicle screw cluster tool" with handles and engagement members. However, Petitioner contended that to the extent the ’928 application does not explicitly teach using the tool to apply force for simultaneous rotation to correct scoliosis, the MTOS chapter supplies this teaching. The MTOS chapter explicitly describes a surgical procedure where multiple vertebrae are rotated simultaneously by applying force to multiple pedicle screws specifically to correct a scoliotic spine. Petitioner argued that the combination of the tool from the ’928 application with the method from MTOS renders the claimed invention obvious.
    • Motivation to Combine: A POSITA would combine the ’928 application and MTOS because both relate to the same field of endeavor: spinal deformity correction. A POSITA seeking to perform the well-documented scoliotic correction procedure described in MTOS would have looked to available tools, such as the one disclosed in the ’928 application, to perform the simultaneous rotation. The combination represents using a known tool to implement a known technique to achieve a predictable result.
    • Expectation of Success: A POSITA would have expected success in combining these references, as it involved applying a known surgical technique with a tool designed for vertebral manipulation, both from the same technical field.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 1-5 over the ’928 application in view of a surgical Video and/or Slides, and claims 1-5 over the Video, Slides, and/or MTOS chapter in view of the ’328 application (Application # 2003/0065328). These grounds relied on similar arguments, substituting the secondary references to teach the step of simultaneous vertebral derotation.

4. Key Claim Construction Positions

  • "spinal rod engagement means": Petitioner proposed that under the broadest reasonable construction, this term means "a structure for contacting or interfacing with a spinal rod." Petitioner disputed the Patent Owner's litigation position that the term is a means-plus-function element but provided an alternative construction if the Board were to adopt that view.
  • "handle means": Petitioner argued the plain meaning is "a part that is designed especially to be grasped by the hand." As with the term above, Petitioner disagreed with a means-plus-function interpretation but offered an alternative construction where the function is facilitating simultaneous application of force and the structure is a handle with extending shafts or linked handles.
  • "mechanically linked": Petitioner proposed the construction "joined by a physical connection or physically joined," arguing this is supported by the specification's figures and dictionary definitions of the constituent words.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 1-5 of Patent 7,670,358 as unpatentable.