UNEXPECTED RESULTS VERSUS UNEXPECTED MECHANISM
| July 28, 2023
In Re: John L Couvaras
Decided June 14, 2023
Before Lourie, Dyk and Stoll.
Summary
This precedential decision serves as a good lesson on what is necessary to overcome an obviousness rejection based on unexpected results. The applicant in this decision, however, failed to overcome the rejection due to arguing an unexpected mechanism instead of unexpected results.
Background
The applicant appeals a decision from the Patent Trial and Appeal Board (PTAB) affirming the Examiner’s rejection of the pending claims as obvious over prior art. Representative claim 11 recites:
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. (emphasis added).
The applicant had conceded during prosecution that GABA-a agonists and ARBs had been known as essential hypertension treatments for many decades. The Examiner agreed and found that the claimed results (increased release of prostacyclin; activating the uninhibited GABA-a receptors; relaxing smooth muscle of the systemic blood vessels) were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.
On appeal to the PTAB, the applicant asserted that the prostacyclin increase was unexpected and that objective indicia had overcome any existing prima facie case of obviousness. The PTAB affirmed the rejection, holding that the claimed result of an increased prostacyclin release was inherent, and that the objective indicia arguments did not overcome the rejection because no evidence existed to support a finding of objective indicium.
Discussion
The PTAB’s legal determination is reviewed de novo, and the factual findings are reviewed for substantial evidence.
Couvaras asserts that (1) the Board erred in affirming that motivation to combine the art applied by the Examiner, (2) that the claimed mechanism of action was unexpected in that the Board erred in discounting its patentable weight by deeming it inherent, and (3) that the Board erred in weighing objective indicia of nonobviousness.
1. Motivation to Combine
As explained by the Examiner and affirmed by the Board, “[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.” Couvaras asserted that the Board’s reasoning was too generic. However, it is undisputed that the antihypertensive agents recited in the claims existed and were known to treat hypertension.
Couvaras also asserted that even if there had been a motivation to combine, such motivation would fail to identify a finite number of identified, predicted solutions. The CAFC dismissed this argument because (1) it was made in a footnote and thus waived, (2) there was no evidence presented regarding a “substantial number of hypertension treatment agent classes”, and (3) the Board’s conclusion was supported by substantial evidence.
Regarding a reasonable expectation of success, Couvaras did not present any arguments against the Examiner’s findings when the rejection was appealed.
2. Unexpected Mechanism of Action
Couvaras contends that because the increased prostacyclin release was unexpected, it cannot be dismissed as having no patentable weight due to inherency, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A.,865 F.3d 1348, 1355 (FED. Cir. 2017). This decision, however, held that unexpected properties may cause what may appear to be an obvious composition to be nonobvious, not that the unexpected mechanisms of action must be found to make the known use of known compounds nonobvious. As stated in the opinion:
We have previously held that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012) (citation omitted); see also In re Huai-Hung Kao, 639 F.3d 1057, 1070–71 (Fed. Cir. 2011) (holding that a “food effect” was obvious because the effect was an inherent property of the composition). While mechanisms of action may not always meet the most rigid standards for inherency, they are still simply results that naturally flow from the administration of a given compound or mixture of compounds. Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.”
3. Weighing objective indicia of nonobviousness
To establish unexpected results, Couvaras needed to show that the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages. The CAFC agreed with the Board that no such benefits have been shown, and therefore no evidence of unexpected results exists.
Takeaways
- Evidence needs to be presented to rebut a prima facie rejection. It seems that the applicant was attempting to assert that the combined use of the 2 agents provided unexpected results (better than what would be expected) based on synergy. As set forth in MPEP 716.02, greater than expected results are evidence of nonobviousness.
MPEP 716.02(a)
Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating “synergism”). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).
It seems that no evidence was presented to support the applicant’s argument of synergy. In reviewing the prosecution history, there were two interviews with the primary Examiner, one of which also included the Supervisory Examiner (SPE)[1]. In the interview summary, the Examiners indicated that the claims were too broad in that there were no amounts recited, no dose regime and/or no specific agents recited. It seems that a successful outcome could have been possible if evidence had been presented which was commensurate in scope with the claims.
- Once an Examiner establishes a prima facie rejection, the burden shifts to the applicant to prove otherwise.
[1] It is never a good idea to call on the SPE to attend an interview with a Primary Examiner. This not only angers a Primary Examiner but also the SPE.
