Paris, October 31, 2018 - Two recently issued USPTO memorandums further clarify aspects of patent subject-matter eligibility under 35 USC 101. The Vanda memo specifies methods of treatment that should be considered to be patent eligible under step 2A of the Alice/Mayo test thereby avoiding any further analysis under step 2B, while the Berkheimer memo3 states that examiners must provide substantiated evidence when additional claim elements are considered to represent well-understood, routine, conventional activity in support of 35 USC 101 rejections under step 2B.
The Supreme Court's two-part "Alice/Mayo" test is currently used by the USPTO to evaluate patent eligibility under 35 USC 101. In this test, step 2A notably asks if claims are directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). If the response is YES, claims are then evaluated under step 2B, which asks if any element or combination of elements present in a claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception, thereby contributing to an inventive concept. If such elements are present, these claims become patent eligible under step 2B, despite the presence of a judicial exception under step 2A.
Two recently issued USPTO memorandums further clarify aspects of patent subject-matter eligibility under steps 2A and 2B of the Alice/Mayo test.
On June 7, 2018, the USPTO issued a memorandum relating to patent subject-matter eligibility of method of treatment claims in view of the Federal Circuit's decision in Vanda
Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018). Of particular interest to the medical field, this memo emphasizes three key points of the Vanda decision:
- claims, including any steps that may be potentially considered as conventional, were considered as a whole when determining if they were "directed to" a judicial exception under step 2A of the Alice/Mayo test,
- method of treatment claims which practically apply (as opposed to being "directed to") an observed natural relationship are patent eligible (in Vanda, the application of a drug to treat a particular disease) as they "confine their reach to particular applications," and
- claims that were considered to be patent eligible under step 2A, were not subject to further evaluation as to whether or not said treatment steps would be considered as routine or conventional in the art (i.e. under step 2B of the test).
The so-called "Vanda memo" concludes that "it is not necessary for "method of treatment" claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 USC 101" (emphasis added).
Thus, under the Vanda memo, patent eligibility of methods of treatment should be facilitated. It should be noted, however, that the same does not seem to apply to claims relating to diagnostic methods, as the claims at issue in Mayo (which were found to be patent ineligible) are clearly distinguished in this memo from those at issue in Vanda, and are qualified as having an "overall diagnostic focus."
The so-called Berkheimer memo (issued on April 19, 2018 further to the Federal Circuit's decision in Berkheimer v. HP Inc. 881 F.3d 1360 (Fed. Cir. 2018)) provides further guidance concerning step 2B of the Alice/Mayo test, indicating in particular that the question of whether or not additional claim elements (or combinations of claim elements) represent well-understood, routine, conventional activity is a factual issue.
The Berkheimer memo specifies that it is not because an additional claim element is known in the prior art that it is necessarily a well-understood, routine, conventional activity. Furthermore, in cases where an examiner considers an additional claim element to be a well-understood, routine, conventional activity, he/she must provide written support to this effect, specifically referencing one or more of the following:
- an express statement present in the specification indicating that a given element is a well-understood, routine, conventional activity (or similar) or a statement made by the applicant to this effect during prosecution,
- a citation of a relevant court decision among those discussed in the USPTO guidelines (specifically, in MPEP 2106.05(d)(II)), and/or
- a citation of a general reference book, review article, etc. (note that the disclosure of an additional element in a single patent publication would not be considered sufficient to demonstrate routine and conventional activity).
A further option is provided in this memo, according to which an examiner may take official notice that the additional element is a well-understood, routine, conventional activity in view of his/her personal knowledge. Should this be challenged by the applicant, the examiner must then provide one of the above-listed items.
As examiners must be able to support their reasoning under step 2B, the Berkheimer memo suggests that a claim may in fact be considered to recite "significantly more" in the absence of evidence to the contrary. Furthermore, applicants should not hesitate to request that examiners provide written evidence when an element is considered to be a well-understood, routine, conventional activity.
Conversely, applicants should take care to avoid indicating that claim elements are wellknown in the art in their applications, as well as during prosecution, to avoid inadvertently providing the examiner with written support (this would of course have to be done without affecting sufficiency of disclosure), unless the invention is considered as patent eligible under step 2A (e.g. methods of treatment).
The Vanda memo should ensure a more logical and predictable issuance of 35 USC 101 rejections by USPTO examiners with regard to method of treatment claims. Similarly, the Berkheimer memo should lead to more consistent prosecution as examiners provide written support when claim elements represent "well-understood, routine, conventional activity" should they arrive at step 2B of the Alice/Mayo test. The Berkheimer memo may furthermore turn out to have a particularly favorable impact on software patents, often considered as relating to abstract ideas under step 2A, in view of the additional support that should now be provided under step 2B. Time will tell!