When arguing against a rejection, it can be helpful to put the invention in context and explain technical problems solved by the invention. This approach can often lead naturally to discussions of how the cited prior art is unable to solve such technical problems, or how the state of the art is deficient in various applications. Such explanations can help the reader better appreciate the invention by understanding how it affects and improves the real world and perhaps even society. When viewed correctly, the understanding that comes about in this way can be powerful and persuasive.
Unfortunately, two issues abound. First, patent practitioners sometimes let explanations about the invention’s context or benefit bleed over into arguments about why a cited reference fails to show a specific claim limitation. Second, the USPTO often improperly responds to even properly presented reasoning by merging explanation of benefits with arguments about why a cited reference fails to show a specific claim limitation. This second issue is the topic explored in more detail below, and was on display in a recent case: appeal 2022-004265, application 16/065,441.
The fact pattern usually goes like this: the applicant points out benefits of the invention not achieved by the cited art (because the cited art is missing a feature or even when combined a feature is missing), and the USPTO responds that the alleged benefit is not in the claim. This red herring is all too often used by the USPTO in order to side-step deficiencies in the rejection and make it seem as if the applicant’s argument was at fault.
In appeal 2022-004265, the invention relates to compositions and methods for treating, ameliorating, and preventing anesthesia-induced hypothermia, which was known to cause serious complications, by administering an ion channel TRPV1 inhibitor. Claim 1 is reproduced below:
A method of preventing anesthesia-induced hypothermia in a mammalian subject in need thereof, comprising
administering to the subject an ion channel TRPV1 inhibitor before or during an induction phase of anesthesia, wherein anesthesia-induced hypothermia is caused by administration of general anesthesia selected from at least one of an inhalation anesthetic or an intravenous anesthetic.
The applicants (University of Arizona and Dignitary Health) appealed a rejection in which the examiner relied on a combination of references. The primary reference taught that anesthesia reduces core body temperature, that TRPV1 antagonists are well-known in the art for raising core body temperature, and that a TRPV1 antagonist can reverse anesthesia-induced decrease in body temperature. The applicants argued that the obviousness rejection improperly found that it would have been obvious to administer the TRPV1 antagonist prior to the start of anesthesia to raise core body temperature and prevent hypothermia.
The cited art admittedly did not disclose the claimed “timing” of administering before or during an induction phase of anesthesia. The applicant pointed out that no evidence was cited as showing or suggesting this timing aspect. Further, the applicant pointed out that the cited art had numerous confounding variables that could affect the results relied on by the examiner to make the combination, yet no guidance was provided in the reference as to how to parse out the effects of these confounding variables from the effects of the timing of the administration of the ion channel TRPV1 inhibitor. In other words, in order to even have any expectation that the claimed timing might be beneficial, the skilled artisan would have to isolate the various other factors affecting the results in the primary reference, including things like the subject’s temperature.
The PTAB dismissed these arguments since addressing the effects of these other variables are “not elements of the claimed method”:
This argument is unpersuasive because the only relevant difference between the claimed method and the method taught in McGaraughty is the timing of TRPV1 receptor antagonist administration relative to the induction phase of anesthesia. The other conditions recited by Appellant are not elements of the claimed method. Thus, even if these conditions affect thermoregulation, which Appellant does not provide evidence to support, Appellant’s claims encompass methods under these different conditions. Appellant’s claims do not “solve” for the variables recited in Appellant’s
argument and the prior art need not do so either. (Appeal Br. 11.)
So, be careful in drafting your arguments. Know that the USPTO will often resort to the “not in your claim” response when they have little else to rebut the arguments. One approach may be to anticipate such a response in the brief and proactively point out why this red herring type of response is inapplicable.