Tobinick v. Olmarker  

The U.S. Court of Appeals for the Federal Circuit reversed the Patent Trial and Appeal Board (PTAB), finding that the disclosure of a single embodiment falling with the scope of the claims was sufficient to show that the inventors had possession of the invention. Tobinick v. Olmarker, Case No. 13-1499 (Fed. Cir., May 19, 2014) (Reyna, J.)

In an interference proceeding, both parties claimed methods of treating spinal nerve injuries by locally administering—for example, via epidural—a TNF-α inhibitor therapeutic.  Spinal discs contain a fluid called “nucleus pulposus,” which, when discs are herniated, leaks into the epidural space and often causes nerve damage and pain in other discs nearby.  Pain is caused by TNF-α present in this fluid, and thus inhibitors of TNF-α are effective pain treatments.

In the context of an interference, claims are construed in light of the originating disclosure, not the interfering application.  Based on the senior party’s intrinsic evidence and also extrinsic evidence, the PTAB construed the claim term “administered locally” as administering the 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 PTAB found that the junior party’s application did not contain sufficient written description support because it did not describe local administration.  In particular, the PTAB found that the junior party’s application described “local” as including administration of a therapeutic near the injury site, followed by diffusion of the therapeutic to the injury site.  The PTAB agreed with Olmarker’s expert witness, finding that this method of administration did not fall within its construction.  The PTAB, therefore, concluded that the junior party’s application lacked written description support and dismissed the interference for lack of standing.

The Federal Circuit affirmed the PTAB’s construction, but reversed its finding of no written description.  First, the Federal Circuit clarified the limits of the PTAB’s construction, noting that the construction does not exclude administration adjacent to the site of disc herniation.  Indeed, since leakage of nucleus pulposus from a herniated disc can injure nerves in adjacent discs, administering a TNF-α inhibitor adjacent to a herniated disc “may well be where the inhibitor is ‘intended to act.’”

The Federal Circuit then explained that it was immaterial that the broad disclosure of “local” administration techniques in the junior party’s application may have included some techniques that are considered “non-local” under the claim construction.  Indeed, the application “need only reasonably convey to one skilled in the art that junior party’s had possession of at least one embodiment that meets the PTAB’s construction of local administration.”  Since the junior party’s application “plainly describes localized, epidural injection of a TNF-α inhibitor” adjacent to a herniated disc, the Federal Circuit found that the junior party’s application did, in fact, provide sufficient written description.

Practice Note: Although the Federal Circuit may not consider this case to be relevant in non-interference contexts, two of its findings could have general significance: (i) the Federal Circuit found that disclosure of even one single embodiment can provide sufficient written description support for a generic claim, not even mentioning the more burdensome “representative number” standard, and (ii) the Federal Circuit is open to reversing the PTAB, even when its finding is supported by substantial evidence such as expert witness testimony.