June 2014
Conveying Possession of at Least One Embodiment Meeting Construction of Disputed Claim Provides Sufficient Written Description Support in Interference Proceeding
| Judges: Lourie, Reyna (author), Wallach |
| [Appealed from Board] |
In Tobinick v. Olmarker, No. 13-1499 (Fed. Cir. May 19, 2014), the Federal Circuit reversed the Board’s finding of lack of adequate written description for the term “administered locally” because it was not supported by substantial evidence.
U.S. Patent Application No. 12/714,205 (“the ’205 application”) to Edward Tobinick (“Tobnick”) claims methods for treating spinal nerve injuries, such as those associated with herniated discs. When the tissue surrounding a spinal disc tears, the disc becomes herniated and leaks nucleus pulposus, a gel-like substance, into the epidural space of the spine. The nucleus pulposus secretes a molecule called tumor necrosis factor-α (“TNF-α”) that injures the nerves passing through the epidural space when it contacts them, causing back pain or numbness. The ’205 application claims methods of treating these injuries by administering a TNF-α inhibitor. In 2011, Tobinick copied claims from U.S. Patent Nos. 7,708,995 (“the ’995 patent”) and 7,811,990 (“the ’990 patent”) to Kjell Olmarker and Bjorn Rydevik (collectively “Olmarker”) in order to request an interference proceeding. The copied claims also recite the step of administering a TNF-α inhibitor, but require that the inhibitor is “administered locally.” Slip op. at 4.
During the interference proceeding, the Board construed the term “administered locally” to mean administered “directly to the site where [the TNF-α inhibitor] is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.” Id. at 5 (alteration in original). Under this construction, the Board found that the ’205 application does not describe a “local” administration because it describes administering a TNF-α inhibitor near the site of an injury and not directly to the site of the injury (i.e., the herniated disc). Thus, the Board concluded that the copied claims were invalid for lack of written description, and therefore dismissed the interference proceeding because Tobinick lacked standing to bring the interference counts.
On appeal, the Court agreed with the Board’s construction of “administered locally,” but found that the ’205 application did describe at least one embodiment that met the Board’s construction.
“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 ’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.” Slip op. at 11-12.
First, the Court agreed with the Board’s construction of “administered locally” as administration “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.” Id. at 8. Because claim terms in an interference proceeding are construed in the context of their originating disclosure—and not the interfering application—the Court relied on the specifications in the ’995 and ’990 patents to construe the claim term in dispute. The Court agreed with the Board’s conclusion that the disputed claims cover administration of TNF-α inhibitor directly to the site of the nerve injury, which was consistent with expert testimony that both Tobinick and Olmarker had presented to the Board, describing “local” as the site where the medicine is intended to act. Id. Based on this construction, the Court explained that the Board’s construction did not exclude administration of a TNF-α inhibitor “adjacent to” a herniated disc. Id. This is so because nucleus pulposus leaking from a herniated disc injures the nerve roots of the adjacent discs; thus, adjacent discs may be where the TNF-α inhibitor “is intended to act.” Id.
Next, the Court found that the ’205 application described at least one embodiment that met the Board’s construction of “administered locally.” The Court noted that the ’205 application describes both local and systemic administration of a TNF-α inhibitor, and describes “perispinal” administration as a preferred form of local administration. Id. at 10. While the specification’s definition of “perispinal” included both local and nonlocal techniques, the Court found that did not render all perispinal administration techniques nonlocal. In particular, the Court noted an embodiment of perispinal administration in which a TNF-α inhibitor is administered by an epidural injection adjacent to the site of the disc herniation. The Court found that this epidural injection is “administered locally” because the epidural space is “where the nucleus pulposus is causing the symptoms of the nerve disorder” and where the TNF-α inhibitor is “intended to act.” Id. at 10-11. Because the ’205 application need only disclose to one of ordinary skill in the art at least one embodiment that met the Board’s construction of “administered locally,” the Court held that the evidence did not support the Board’s finding of lack of adequate written description.
Thus, the Court reversed the Board’s decision to dismiss the interference proceeding, and remanded for further proceedings.
