October 18, 2016

Substantial Evidence Supports Determination of Reasonable Expectation of Success

By Bryan K. Wheelock, Principal

In In re Efthymiopoulos, [2016-1003] (October 18, 2016) the Federal Circuit affirmed the PTAB decision that the claimed invention relating to the administration or an anti-influeza drug “by inhalation through the mouth alone” was obvious.

There is no dispute that Von Itzstein I discloses the use of zanamivir to treat and prevent influenza. There is also no dispute that Von Itzstein II discloses several pages of different administration methods for an adjacent homologue of zanamivir to achieve the same result — treating or preventing influenza, expressly discloses administration through “oral,” “nasal,” or other forms “suitable for administration by inhalation,” among other methodologies.

Efthymiopoulos’s argument that a skilled artisan would not reasonably expect zanamivir to be effective if administered through oral inhalation is also unpersuasive.  The Federal Circuit found that substantial evidence supports the determination that a skilled artisan would have a reasonable expectation of success in combining the Von Itzstein references.  Efthymiopoulos further argued that the Board disregarded its evidence of unexpected results, namely the testimony of Dr. Hayden.  However the Federal Circuit found that the record showed that the Board thoroughly considered and discussed Dr. Hayden’s declaration in its decision and found that Dr. Hayden’s testimony was insufficient to overcome the prima facie case of obviousness.