In In Re: Constantin Efthymiopoulos, Appeal No. 2016-1003, the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision affirming the Examiner’s rejection of all pending claims as obvious.
Applicant applied for a patent directed to methods of treating influenza by administering the drug zanamivir through oral inhalation. The Examiner rejected the claims as obvious in view of the prior art and Applicant appealed to the Board. The Board affirmed the Examiner’s rejection, finding that the prior art’s disclosure of administering zanamivir through “inhalation” encompassed both oral inhalation and nasal inhalation, therefore rendering the claims obvious. Applicant appealed to the Federal Circuit.
On appeal, Applicant argued that a skilled artisan would not have expected oral inhalation of zanamivir to be effective because oral inhalation delivers drugs to the lower respiratory tract and influenza affects the upper respiratory tract. Applicant also argued that the Board erred by failing to consider Applicant’s unexpected clinical results which showed that oral inhalation reduced influenza rates relative to intranasal inhalation. The Federal Circuit rejected both arguments and affirmed the Board’s finding of obviousness. Specifically, the Federal Circuit explained that although influenza primarily affects the upper respiratory tract, certain strains were known to attack the lower respiratory track and would therefore have provided a skilled artisan with a reasonable expectation of success. The court also noted that Applicant’s clinical study comparing oral inhalation to intranasal inhalation was not statistically significant. Judge Newman dissented from the majority on the basis that the prior art disclosure of “inhalation” without more was insufficient to provide a skilled artisan with a reasonable expectation of success.