The United States Court of Appeals for the Federal Circuit recently decided a case arising out of an interference proceeding before the Patent Trial and Appeal Board (PTAB) relating to drug treatments for spinal nerve injuries. See Tobinick v. Olmarker (Fed. Cir., May 19, 2014).
Kjell Olmarker and Bjorn Rydevik (collectively “Olmarker”) are the named inventors on U.S. Patent Nos. 7,708,995 and 7,811,990. In order to provoke an interference, Edward Tobinick copied claims from the ‘995 patent and the ‘990 patent into his patent application.
In the USPTO proceeding, the Board construed “administered locally” as administering the claimed therapeutic compound “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.” Based on this construction, the Board found that Edward Tobinick’s patent application did not contain written description support for the interference count. Therefore, without written description support for the count, the Board concluded that Tobinick lacked standing for the interference proceeding, and dismissed the interference.
On appeal to the Federal Circuit, the parties dispute the meaning of “administered locally” and whether Tobinick’s patent application contains written description support for this claim limitation.
Both parties presented expert testimony to the Board, including similar medical dictionary definitions of “local.” Olmarker’s witness, Dr. Andersson, relied on dictionary evidence to contrast the definition of “local,” as “restricted to or pertaining to one spot; not general.” This lead Dr. Andersson to define “local administration” as administration “directly to the site where the medicine is intended to act,” whereas he defined “systemic administration” as administration in which “medicine is broadly distributed before reaching the site of action, such as being carried . . . by the vascular system.” Tobinick’s expert witness, Dr. Richardson, also relied on dictionary evidence, which defined “local” in essentially the same way as Dr. Andersson.
On the issue of claim interpretation, the Federal Circuit affirmed the Board.
Notwithstanding the ruling on claim interpretation, the Federal Circuit overruled the Board relative to its written description decision and subsequent dismissal. The Federal Circuit explained:
The [Tobinick] disclosure lists perispinal administration as a preferred form of localized administration of a TNF-α inhibitor. The specification defines perispinal administration as including a number of different administration techniques. One such technique is an epidural injection adjacent to the site of disc herniation…
A person of ordinary skill in the art would understand this type of epidural injection to be an injection into the location where the TNF-α is injuring spinal nerves… The ’995 specification recognizes that TNF-α in the epidural space harms adjacent nerve roots. Thus, an epidural injection adjacent to the site of disc herniation will administer the drug “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.”
(citations omitted).
The Federal Circuit accordingly found that Tobinick’s application contained sufficient written description support for local administration because it described administering the relevant therapeutic compound to the epidural space adjacent to a herniated spinal disc, which is the site where the compound “is intended to act” and “the location where the nucleus pulposus is causing the symptoms of the nerve disorder.”
The Federal Circuit reversed the Board’s decision to dismiss the interference and remanded the case for further proceedings at the PTAB.
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Tags: CAFC, Federal Circuit, interference, interference proceedings
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