The Federal Circuit provided a reminder last week that merely identifying an unappreciated consequence of a prior art method cannot confer non-obviousness on practice of methods that did not acknowledge that consequence, in In re Couvaras.
The appeal arose from a Patent Trial and Appeal Board affirming an Examiner's rejection that the claims of U.S. Application No. 15/131,442 were obvious. The claims were directed to a method for increasing prostacyclin release in systemic blood vessels when administered to a human having essential hypertension; the consequence was improved vasodilation. How this beneficial outcome was achieved as claimed was by co-administration of two art-recognized antihypertensive agents: a GABA-a agonist and an Angiotensin II Receptor Blocker ("ARB"). Claim 11 was included in the opinion as representative:
11. A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:
providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;
providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;
delivering the composition to the human individual's circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;
synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and
activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and
relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release.
(wherein the underlined limitations illustrate the distinctions relied upon by the patent applicant).
It was not disputed (before the Board or the Federal Circuit) that the two co-administered compounds were known in the art as treatment for essential hypertension ("for many, many decades"), supported if not compelled by the Examiner's citation of 10 prior art references disclosing such use. The Examiner rejected all pending claims based on his determination that the claimed results of the recited method ("increased prostacyclin release, activation of uninhibited GABA-a receptors, and smooth muscle relaxation") "naturally flowed from the claimed administration of the known antihypertensive agents."
The Board agreed and affirmed the rejection, unpersuaded by Applicant's argument that prostacyclin release was an unexpected result of the claimed methods. The Board also held that the claimed distinction was an inherent result from co-administration of the two known antihypertensive agents.
The Federal Circuit (not surprisingly) affirmed, in an opinion by Judge Lourie joined by Judge Dyk and Stoll. The opinion addresses three Appellant arguments: first, that the Board erred in affirming that the skilled worker would have had a motivation to combine the asserted prior art (and a reasonable expectation of success in doing so); second, that the claimed method of action would have been unexpected and that the Board improperly discounted the resulting patentable weight this fact was entitled to; and third, that prostacyclin production as a consequence of co-administration should have been weighed under the objective indicia rubric of Graham v. John Deere (and considered to overcome the asserted prima facie obviousness determination by the Examiner).
Applicant's first argument failed to persuade the panel that the Board erred on the principle that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose," citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). In addition, the Board relied on a prior art reference that taught "the use of ARBs 'in combination with other classes of antihypertensive agents to lower blood pressure,' but also that various guidelines 'acknowledge the need for multiple drug therapy in many patients to adequately lower blood pressure.'" The specificity of the motivation to combine arising from this reference satisfied the requirement, according to the opinion (and Applicant's arguments regarding whether the skilled worker would have had a reasonable expectation of success were waived in the Court's view because they had not been properly asserted or preserved below).
Regarding the second argument, that the Board had improperly "downgraded" the weight give the prostacyclin-releasing effect of co-administration because it was inherent, the panel rejected Applicant's reliance on Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017), because in that case the Federal Circuit had held "unexpected properties may cause what may appear to be an obvious composition to be nonobvious" (emphasis in opinion) which was not the same as Applicant's assertion here that "unexpected mechanisms of action must be found to make the known use of known compounds nonobvious." In the panel's view the mechanism of action "naturally flows" from co-administration and the "ultimate result" (decreasing blood pressure) was the same. Citing In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) and In re Huai-Hung Kao, 639 F.3d 1057, 1070–71 (Fed. Cir. 2011), the opinion states as settled law that "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent." Consequently, the panel held that the Board had properly determined that "the recitation of various mechanistic steps in the pending claims [were] insufficient to overcome the prima facie obviousness of the claimed methods."
Finally, the Federal Circuit rejected Applicant's arguments relating to the objective indicia, inter alia, because they did not show any unexpected benefits, such as "better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages." The panel also agreed that the evidence presented by Applicant regarding any of the other objective indicia (teaching away, failure of others, and the length of time between teaching co-administration of antihypertensive compounds in the art and the claimed invention) did not support overcoming the asserted prima facie obviousness case raised by the Examiner and affirmed by the Board.
In re Couvaras (Fed. Cir. 2023)
Panel: Circuit Judges Lourie, Dyk, and Stoll
Opinion by Circuit Judge Lourie
