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From Intellectual Property Law Daily, June 11, 2018

Derotational spinal surgery tool not made unpatentable by prior patent for tool for displacing vertebrae

By David Yucht, J.D.

The Court of Appeals for the Federal Circuit has affirmed the Patent Trial and Appeal Board’s conclusions that an application for a spinal surgery tool and a chapter in a spinal surgery procedures book did not render obvious the challenged claims of certain spinal surgery related patents (the ’358 and ’072 patents). The surgical tool is used for displacing vertebrae during minimally invasive spinal surgery. The book chapter from Masters Techniques in Orthopaedic Surgery: The Spine (MTOS), describes techniques of using pedicle screws in the spine using multiple vertebral derotation maneuvers (but not explicitly discussing manipulating multiple posts simultaneously), The’358 and ’072 patents are for a device using pedicle screws connected to a handle during open spinal surgery during which multiple posts connected to the vertebrae are simultaneously rotated. However, the Federal Circuit vacated the Board’s determination that a video demonstration previously distributed at three conferences did not qualify as prior art, and remanded for further proceedings, requiring the Board to determine whether the media constituted publicly-accessible publications for prior art purposes. If so, the Board must consider this media and decide whether these references, together with the other pertinent materials, rendered obvious the subject patent claims (Medtronic, Inc. v. Barry, June 11, 2018, Chen, R.).

Medtronic manufactures tools used in spinal surgeries. A spine surgeon sued Medtronic for patent infringement, alleging that Medtronic’s products infringed a group of his patents. Medtronic then petitioned for, and the Board instituted, inter partes review proceedings for all claims in both patents.

Patents at issue. The surgeon’s patents—U.S. Patent Nos. 7,670,358 (the ’358 Patent) and 7,776,072 (the ’072 Patent)— were for a method of ameliorating spinal column conditions, such as scoliosis. The purported invention spread corrective derotational forces across multiple vertebrae simultaneously. The system included pedicle screws implanted in the pedicle regions of vertebrae to which a surgeon, during an open procedure and using a derotation tool, would apply derotational forces by grasping linked handles as a group. The ’072 Patent was a continuation-in-part of the application that led to the ’358 Patent and shared substantially the same specification.

Prior art. Medtronic’s U.S. Patent Application No. 2005/0245928 (the ’928 application)— common to all of Medtronic’s asserted grounds of obviousness on appeal—describes a tool used during minimally invasive spinal surgery for displacing vertebrae, relative to each other. The patent application did not mention simultaneously derotating multiple vertebrae. Medtronic asserted that this application was relevant prior art which rendered the surgeon’s inventions unpatentable.

Medtronic also asserted that MTOS was prior art. MTOS was a book chapter describing techniques of using pedicle screws in the spine. In one technique taught in MTOS, a surgeon would place correcting posts on pedicle screws on both the convex and concave sides of the spinal curve and use these posts to apply manipulative force in a spinal derotation procedure. MTOS described performing multiple vertebral derotation maneuvers to derotate the spine but did not explicitly discuss manipulating multiple posts simultaneously.

Medtronic also distributed a video demonstration and related slide presentation to spinal surgeons at three industry conferences in 2003. These presentations depicted derotation surgeries that used pedicle screws and other instrumentation to correct scoliosis. The video consisted of a narrated derotation surgery. The slides included information about the use of pedicle screws in derotation surgeries.

Obviousness. The Federal Circuit found that substantial evidence supported the Board’s finding that the ’928 application alone did not disclose the Simultaneously Rotating limitation. It noted that the ’928 application required multiple motions to apply force to more than one guide tube relative to another, which drew vertebrae closer together or farther apart. In contrast, all of the challenged claims required a handle means to apply "simultaneous" force to a first set of pedicle screws to rotate the vertebrae. Moreover, the Medtronic patent was designed to be used during minimally invasive procedures and was not designed to correct scoliosis. The Federal Circuit also agreed with the Board’s assessment that Medtronic failed to cite to any particular passage or figures from MTOS that explicitly disclosed the simultaneous application of manipulative force technique.

Printed publications. The Federal Circuit vacated the Board’s finding that the Video and Slides were not publicly accessible printed publications, and remanded for further proceedings. The record did not show that the Board fully considered all relevant factors. The Board did not address programs in Colorado Springs and St. Louis, which were attended by at least 75 surgeons, and where, according to Medtronic’s expert, the materials were distributed without restrictions. Although the Board found that disclosure to a small group of experts in a members-only meeting in Arizona was insufficient to compel a finding that the Video and Slides were publicly available, its analysis was silent on the wider distribution that occurred at the Colorado Springs and St. Louis programs. Nor did the Board address whether the disclosure of the materials at the programs was intended to remain confidential.

This case is Nos. 17-1169 and 17-1170.

Attorneys: Mark Christopher Fleming (Wilmer Cutler Pickering Hale and Dorr LLP) for Medtronic, Inc. John C. Alemanni (Kilpatrick Townsend & Stockton LLP) for Mark A. Barry.

Companies: Medtronic, Inc.

MainStory: TopStory Patent FedCirNews

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