On January 4, 2019, the U.S. Patent and Trademark Office issued new guidance for evaluating patent subject matter eligibility, which became effective on January 7, 2019. The purpose of the 2019 guidance is to provide more clarity regarding how patent examiners determine whether a claim is patent eligible under the U.S. Supreme Court's two-step Alice/Mayo test.
Step 2A – determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception)
Step 2B – if a judicial exception, determine whether the claim recites additional elements that amount to significantly more than the judicial exception
Alice/Mayo STEP 2A
The 2019 guidance bifurcates Alice/Mayo Step 2A into a two-prong analysis:
PRONG ONE (Step 2A)
Abstract ideas are to be identified with reference to enumerated categories of subject matter by determining if the claimed subject is an abstract idea exception by falling in one the following three enumerated groupings:
- Mathematical concepts: Mathematical relationships, mathematical formulas or equations, mathematical calculations;
- Certain methods of organizing human activity: Fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
- Mental processes: Concepts performed in the human mind (including an observation, evaluation, judgment, or opinion).
If the claims do not fall within one of these subject matter groupings, the claim(s) "should not be treated as reciting abstract ideas," except in a "rare circumstance".
PRONG TWO (Step 2A)
If the claimed subject matter falls into a judicial exception, a determination is to be made as to whether the judicial exception is integrated into a practical application. Under the 2019 Guidance, examiners should "evaluate integration into a practical application by: (a) Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application."
The 2019 Guidance provides several illustrative examples of such practical integration:
- An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
- An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
- An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
- An additional element effects a transformation or reduction of a particular article to a different state or thing; and
- An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Furthermore, the guidance provides several examples in which a judicial exception has not been integrated into a practical application:
- An additional element merely recites the words "apply it" with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
- An additional element adds insignificant extra-solution activity to the judicial exception; and
- An additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
The 2019 guidance emphasizes that under Alice/Mayo Step 2A there is no consideration "of whether the additional elements represent well-understood, routine, conventional activity." This revised procedure now evaluates "integration" in Alice/Mayo Step 2A and specifically delays, until Alice/Mayo Step 2B, the analysis of well-understood, routine, conventional activity.
Alice/Mayo STEP 2B
The 2019 Guidance is intended to lead to more inventions being found to satisfy §101 at Step 2A, but an analysis under Step 2B still is required for claims determined to be directed to a judicial exception under Step 2A.
The 2019 Guidance specifically instructs patent examiners to abide by Berkheimer by reiterating “[A]n examiner should conclude that an element (or combination of elements) represents well-understood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry…[and] such a conclusion must be based upon a factual determination.”
The 2019 Guidance additionally states that under Step 2B, the consideration of whether additional claim elements are "well-understood, routine, and conventional' can weigh in favor of eligibility. The guidance illustrates such a scenario with data gathering steps that might be determined to be "insignificant extra-solution activity" under Step 2A, but determined to relate to an "inventive concept" under Step 2B if "the combination of steps gather data in an unconventional way."
The revised two-prong approach to Alice/Mayo Step 2A is intended to promote more accurate, predictable, and consistent application of the subject matter eligibility requirement of §101. As set forth in the 2019 Guidance, "[t]he USPTO is determined to continue its mission to provide predictable and reliable patent rights in accordance with this rapidly evolving area of the law," and its "ultimate goal is to draw distinctions between claims to principles in the abstract and claims that integrate those principles into a practical application."