Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in In re: John L. Couvaras, No. 2022-1489 (June 14, 2023), affirming the Patent Trial and Appeal Board’s rejection of Couvaras’ pending claims because the claimed invention was unpatentable as obvious.
Couvaras’ proposed invention included methods of increasing prostacyclin release in the systemic blood vessels of a human with essential hypertension to improve blood pressures. This increase was achieved by administering two commonly used antihypertensive agents: a GABA-a agonist and an Angiotensin II Receptor Blocker (“ARB”). Following the Examiner’s finding that the pending claims were not patentable because the effects were a result of an expected outcome of using antihypertensive agents, Couvaras appealed to the Board, which affirmed the rejection. The Board held the effect of an increased prostacyclin release was inherent and Couvaras failed to provide evidence supporting a finding of any objective indicium. Couvaras appealed.
The Federal Circuit affirmed. Couvaras raised three issues on appeal. The Court first addressed Couvaras’ argument that the Board erred in affirming that a skilled artisan would have had a motivation to combine the art. The Court held that Couvaras’ knowledge that GABA-a agonists and ARBs have long been known as essential treatments for hypertension treatments was sufficient to establish a motivation to combine because “the idea of combining [these compounds] flows logically from their having been individually taught in the prior art.”
Next, Couvaras argued that the claimed mechanism of action was unexpected, and the Board erred in holding the claimed method was inherent. The Court rejected this argument, holding that these mechanisms were simply a result that naturally flowed from the administration of the mixture of compounds. Accordingly, the recitation of various mechanistic steps for known compounds to yield a known result could not overcome a prima facie case of obviousness despite the nature of that mechanism being unexpected.
Lastly, the Court rejected Couvaras’ argument that the Board erred in weighing objective indicia of nonobviousness. To establish unexpected results, the Court held Couvaras would have needed to establish that the co-administration of antihypertensive agents provided an unexpected benefit such as “better control of hypertension, less toxicity to patients, or the ability to use unsurprisingly low dosages”. Since no evidence of such benefits was established, the Court sided with the Board that no evidence of unexpected results existed. The Court rejected Couvaras’ other objective indicia of nonobviousness arguments.
Coauthored by Thomas Leach & Edward Choi.