Patents on Herniated Disc Treatment Return to PTAB for Interference Assessment

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By Tony Dutra  

May 19 — A patent application disclosing drug administration in an area surrounding the source of pain is adequate written description support for “local” administration, the U.S. Court of Appeals for the Federal Circuit ruled on May 19.

The court reversed the judgment of the Patent Trial and Appeal Board in an interference case related to priority of inventorship of treating herniated disc injuries using a group of drugs known as TNF-alpha inhibitors.

Priority Challenge Dismissed Early

Edward Tobinick's interfering patent application (U.S. Patent Application No. 12/714,205) challenged Kjell Olmarker and Bjorn Rydevik's patents (U.S. Patent Nos. 7,708,995 and 7,811,990) on the use of TNF-alpha inhibitors for treating a nerve disorder, such as a nerve root injury caused by a herniated disc.

The board construed the term “administered locally” to mean administering the drug directly to the location where the nucleus pulposus—a substance in the middle of the spinal disc—is causing the symptoms. In contrast, Tobinick's application described “local” to include “administration of medication near the site of injury followed by diffusion or travel of the medication to the site of the injury.”

The PTAB thus granted Olmarker's motion for judgment that Tobinick's claims were unpatentable under 35 U.S.C. §112, ¶1. Tobinick appealed.

‘Local' Defines a Space, Not One Spot

The Federal Circuit, in an opinion written by Jimmie V. Reyna, affirmed the claim construction judgment but determined that the '205 application included adequate support.

The application discusses “perispinal” administration, which can be as much as 10 centimeters around the nucleus pulposus, the court acknowledged.

However, the court allowed that “local” included “the epidural space adjacent to a herniated disc, which is the location where nucleus pulposus causes nerve injury,” and it noted that the application specifically disclosed an epidural injection “to the anatomic area adjacent to the disc herniation.”

“While the ‘perispinal' administration discussed in the '205 application certainly covers more than just local administration techniques, this does not render all perispinal techniques non-local,” the court said. “The '205 application need only reasonably convey to one skilled in the art that Tobinick had possession of at least one embodiment that meets the Board's construction of local administration.”

The court remanded for further proceedings.

Judges Alan D. Lourie and Evan J. Wallach joined the opinion.

Robert W. Hahl of Neifeld IP Law PC, Alexandria, Va., represented Tobinick. Todd R. Walters of Buchanan, Ingersoll & Rooney PC, Alexandria, Va., represented Olmarker.

To contact the reporter on this story: Tony Dutra in Washington at

To contact the editor responsible for this story: Naresh Sritharan at

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