The US Patent and Trademark Office (USPTO) has released revised guidelines (referred to as the “2019 Revised guidelines”) for assessing subject matter eligibility, which came into effect on Monday 7 January 2019. The 2019 Revised Guidelines change how US patent examiners apply the second step of the US Supreme Court’s Alice/Mayo test, which determines whether a claim is “directed to” a judicial exception from patentability.
The current Alice/Mayo test
In order for an invention to be patentable in the US, the invention must fall within one of four categories of appropriate subject matter as defined by 35 U.S.C 101, namely, the invention must be a process, machine, manufacture or a composition of matter. In addition, the invention must not be directed to a “judicial exception”, unless the invention also includes additional limitations which amount to significantly more than the judicial exception. These “judicial exceptions” are abstract ideas, laws of nature and natural phenomena. However, the Supreme Court also considers that an invention should not be considered ineligible for a patent merely because it involves a judicial exception and, therefore, has set out a two-step test for determining the eligibility of claims. This two-step test can be summarised as follows:
1) determine whether the claim is directed to a process, machine, manufacture or composition of matter,
2A) determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e. a judicial exception). If no, then the claim is eligible subject matter. If yes,
2B) determine whether the claim recites additional elements that amount to significantly more than the judicial exception. If yes, the claim is eligible subject matter. If no, then the claim is not eligible subject matter.
In particular, Step 2B) involves considering whether the claim in question contains only additional elements which are well-understood, routine, conventional activity. If so, then the claim will be considered to be patent ineligible for not amounting to significantly more than the judicial exception.
The 2019 Revised Guidelines set out two changes to the existing test, in view of the concerns that patent stakeholders have expressed for a need for more clarity and predictability in the application of the Alice/Mayo test.
- Groupings of “abstract idea” subject matter
The USPTO has attempted to clarify what constitutes an abstract idea in view of inconsistencies in the approach of examiners to this assessment. Thus, the USPTO has set out, in the 2019 Revised Guidelines, that the abstract idea exception includes the following groups of subject matter, when recited per se in a claim limitation:
i) mathematical concepts – mathematical relationships, formulas or equations, and calculations; ii) certain methods of organising human activity – fundamental economic principles or practices, commercial or legal interactions, managing personal behaviour or relationships or interactions between people, and iii) mental processes – concepts performed in the human mind.
The 2019 Revised Guidelines state that claims which do not recite subject matter falling within these three groups should not be treated as reciting abstract ideas. However, the 2019 Revised Guidelines also acknowledges that there may be rare circumstances in which an examiner believes that a claim limitation which does not fall within one of these three groups should nonetheless be treated as reciting an abstract idea. As discussed further below, the 2019 Revised Guidelines set out the assessment to follow in such cases, to determine whether or not the claim in question is patent eligible.
- “Directed to” a judicial exception
The 2019 Revised Guidelines also attempt to more accurately and consistently identify claims which are patent eligible by identifying claims which recite a practical application of a judicial exception, rather than merely being “directed to” a judicial exception. This revised analysis replaces Step 2A of the above-mentioned Alice/Mayo test, and involves a two-pronged approach.
Prong 1: determine whether the claim recites a judicial exception (similar to previous Step 2A set out above). If no, then the claim is patent eligible. If yes, then proceed to Prong 2.
Prong 2: determine whether the claim recites additional elements that integrate the judicial exception onto a practical application of that exception. If yes, then the claim is patent eligible. If no, then proceed to step 2B of the current Alice/mayo test (se out above).
Thus, if the claim as a whole integrates the recited judicial exception into a practical application, then the claim is not “directed to” a judicial exception. The 2019 Revised Guidelines set out that a claim which so integrates a judicial exception will apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolise the judicial exception. In order to aid this assessment, the 2019 Revised Guidelines set out a non-exhaustive list of considerations (not included in this article) which may indicate that an additional element in the claim may integrate a judicial exception into a practical application. One such consideration is whether the additional element applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. It should be noted, however, that these considerations do not include whether or not the additional elements represent well-understood, routine, conventional activity, which continues to be assessed at Step 2B of the Alice/Mayo test. Thus, even conventional elements must be considered in prong 2 of revised Step 2A.
If a claim is determined to be directed to a judicial exception, and to not integrate the judicial exception into a practical application, then the examiner must proceed to Step 2B of the above-discussed Alice/Mayo test (which has not been changed in the 2019 Revised Guidelines). Namely, the examiner must determine whether the claim provides an inventive concept and recites additional elements that amount to significantly more than the judicial exception. The 2019 Revised Guidelines remind examiners that a claim which does not meaningfully integrate a judicial exception into a practical application (such that it does not pass Step 2A) may still include additional subject matter that is unconventional and, thus, an “inventive concept” at Step 2B, such that the claim may still be patent eligible.
It should be noted that the 2019 Revised Guidelines also introduces that, where the examiner considers that a claim limitation does not fall within the three new groupings of abstract ideas (discussed above), but should nonetheless be treated as reciting an abstract idea, then the examiner should proceed with revised Step 2A and Step 2B as if the claim limitation were an abstract idea. If the examiner determines that the claim limitation fails Step 2B, and that the claim does not provide an inventive concept, then the examiner must bring the application to the attention of the Technology Centre Director, who must then approve the rejection of the claim. The Director must also provide a justification for why the claim limitation is being treated as reciting an abstract idea.
The 2019 Revised Guidelines replace Step 2A of the Alice/Mayo test with a two-pronged test, and define three groups of subject matter considered to be abstract ideas. It is hoped that the 2019 Revised Guidelines will bring more certainty and clarity to the procedure for determining whether or not subject matter is patent eligible. In particular, it will be interesting to see how prong 2 of Step 2A is applied and what applications the USPTO will consider to be “practical applications”.