What is the Alice/Mayo two-step test for patent eligibility?

The Alice/Mayo two-step test is the framework courts and the USPTO apply to determine whether a patent claim is directed to patent-eligible subject matter under 35 U.S.C. 101. It takes its name from Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), which established the framework, and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), which extended it to computer-implemented inventions. Every patent practitioner will encounter this test in examination, post-grant review, and litigation.

The statutory foundation

35 U.S.C. 101 provides that whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. The statute covers a broad set of invention types, but the Supreme Court has recognized three categories of subject matter that fall outside its scope: laws of nature, natural phenomena, and abstract ideas. These are judicial exceptions: the text of Section 101 does not mention them, but the Court treats them as implied limits on what Congress intended to protect.

The concern underlying these exceptions is that monopolizing laws of nature, natural phenomena, and abstract ideas might impede rather than promote innovation because these are the basic tools of scientific and technological work. A patent that ties up a fundamental natural law or a basic mathematical formula would prevent all others from building on those foundations. Importantly, while preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining patent eligibility, and the absence of complete preemption does not establish that a claim is patent eligible. A narrowly preemptive claim can still fail if it claims a judicial exception without something more.

The three judicial exceptions

Abstract ideas

Under the USPTO's 2019 Revised Patent Subject Matter Eligibility Guidance, abstract ideas fall into three groupings:

• Mathematical concepts: mathematical relationships, mathematical formulas or equations, and mathematical calculations.
• Certain methods of organizing human activity: fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior or relationships between people.
• Mental processes: concepts that can be performed in the human mind or by a human using pen and paper, including observation, evaluation, judgment, or opinion.

In Bilski v. Kappos, 561 U.S. 593 (2010), the Supreme Court held that a method for hedging risk against price fluctuations in commodity trading was an unpatentable abstract idea, while declining to categorically bar all business method patents. Bilski foreshadowed the Alice/Mayo framework but left the precise scope of the abstract idea exception unresolved; Mayo and Alice filled in the structure.

Laws of nature

Laws of nature include scientific principles, mathematical formulas expressing natural relationships, and correlations observed in nature, such as the metabolite-dosage correlations at issue in Mayo v. Prometheus. Because the discoverer did not create these relationships, a patent that covers them forecloses all future applications of what was already embedded in the world.

Natural phenomena

Natural phenomena include products of nature and naturally occurring materials, such as isolated DNA sequences as established in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

Mayo v. Prometheus: the framework's origin

Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), involved patents on processes for determining proper thiopurine drug dosages in autoimmune disease treatment by measuring metabolite levels in patient blood and correlating those measurements to drug efficacy and toxicity risks.

The Supreme Court held that the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm were laws of nature that exist independent of human action. The additional process steps of administering the drug, measuring metabolites, and interpreting the results involved only well-understood, routine, conventional activity previously engaged in by researchers in the field, and therefore added nothing significant to the underlying natural correlations.

The Mayo Court held that a patent cannot simply state a law of nature while adding the words "apply it"; an application of a law of nature to a known structure or process may deserve patent protection only if the claim does more than this. With that, Mayo established a two-step framework for distinguishing patent-eligible applications of judicial exceptions from attempts to claim the exceptions themselves: first, determine whether the claim is directed to a law of nature, natural phenomenon, or abstract idea; second, determine whether the claim adds something more than the judicial exception itself.

Alice Corp.: extending the framework to software

Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), involved patents on a computer-implemented scheme for mitigating settlement risk in financial transactions by using a third-party intermediary to ensure both parties satisfied their obligations before settlement occurred.

Applying the Mayo framework, the Court held that Alice's claims were directed to the abstract idea of intermediated settlement. Merely implementing that abstract idea on a generic computer did not transform it into patent-eligible subject matter, because an abstract idea does not become nonabstract by limiting the invention to a particular field of use or technological environment such as the Internet or a computer.

Alice settled a contested question: a practitioner cannot rescue an ineligible method claim simply by recasting it as a system claim or a computer-readable medium claim. The eligibility analysis looks through the form of the claim to the substance of what is being claimed.

The two-step test in detail

The USPTO's examination guidelines organize the Alice/Mayo analysis into Steps 2A and 2B. These steps sit within a broader framework that first confirms the claim fits a statutory category (process, machine, manufacture, or composition of matter). Most software and business-method claims clear that threshold without difficulty; the real work is in Steps 2A and 2B.

Step 2A: Is the claim directed to a judicial exception?

Prong One asks whether the claim recites, meaning sets forth or describes, a judicial exception. If no judicial exception is recited, the claim is eligible and the analysis ends.

Prong Two asks whether the claim integrates the recited judicial exception into a practical application; if additional elements in the claim accomplish this integration, the claim is patent eligible without proceeding to Step 2B. Integration exists when the additional elements meaningfully apply the exception to produce a concrete technological benefit, not merely as an instruction to implement the exception on generic equipment.

Step 2B: Is there something more?

If a claim is directed to a judicial exception after Prong Two, Step 2B asks whether the claim's additional elements, considered individually and as an ordered combination, amount to significantly more than the judicial exception itself, providing an inventive concept that transforms the nature of the claim into a patent-eligible application.

What does NOT satisfy Step 2B:

• Adding a generic computer or simply applying an abstract idea in a technological environment such as the Internet does not satisfy the significantly more requirement.
• Limiting a judicial exception to a particular field of use does not constitute significantly more than the exception itself.
• Mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea.

What CAN satisfy Step 2B:

A claim that improves an existing technological process or that achieves improvements in computer functionality, as opposed to merely automating a pre-existing process on a generic computer, can satisfy the significantly more requirement. The distinguishing feature is whether the claim ties the judicial exception to a specific technical solution to a specific technical problem, rather than claiming the exception broadly across all implementations.

Berkheimer: the evidentiary dimension

Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018), added an important evidentiary constraint to Step 2B. Following Berkheimer, a factual determination is required to support a conclusion that an additional element or combination of additional elements is well-understood, routine, conventional activity. Because conventionality is a factual question rather than a pure question of law, an examiner cannot resolve it by assertion alone when the record raises a genuine dispute.

The USPTO's guidance sets a demanding standard for that determination: an additional element is well-understood, routine, conventional activity only when the examiner can readily conclude, based on expertise in the art, that the element is widely prevalent or in common use in the relevant industry. An element that merely appears somewhere in the prior art does not automatically meet that bar.

Berkheimer matters because it gives practitioners a path to contest Step 2B rejections on factual grounds, not just legal argument. An examiner's conclusory assertion that additional elements are "routine and conventional" is contestable if the specification describes those elements as an advance over prior approaches.

The framework at a glance

If Prong 1 is NO (no judicial exception is recited), the claim is eligible. If both Prong 2 and Step 2B are NO, the claim is ineligible under Section 101.

Practical notes for practitioners

• Pin down the exception before responding. A valid Alice/Mayo rejection must identify specifically which judicial exception (and which sub-type) the claim is directed to. Vague labels such as "this is abstract" without articulating what abstract idea are contestable at the PTAB and on appeal. Forcing the examiner to be specific opens lines of argument about whether the identified concept is actually a judicial exception and whether the claim is actually "directed to" it.

• Argue Prong 2 before Step 2B. If the claim can be characterized as integrating a judicial exception into a practical application, eligibility is established without the additional burden of showing a genuine factual dispute about conventionality. Practical application arguments (Prong 2) are typically stronger than conventionality disputes (Step 2B) for claims that address a defined technical problem with a specific technical implementation.

• Use Berkheimer when the specification supports it. If the specification describes specific technical improvements that differ from prior art practice, include particularized language capturing those improvements in the claims. When a Step 2B rejection asserts routine and conventional character, challenge the factual basis by pointing to specification passages that describe the improvement as distinct from prior approaches. A conclusory examiner assertion is not sufficient to establish conventionality if the record shows otherwise.

• Do not conflate novelty with eligibility. A claim can be novel and non-obvious under Sections 102 and 103 and still fail Section 101. The eligibility analysis is independent of the novelty and obviousness analyses. Conversely, a claim that covers an abstract idea does not become eligible simply because it adds one novel element if that element is unrelated to the judicial exception itself.

• Draft with a concrete technical problem and a specific technical solution. Claims that frame the invention in terms of what technical problem is being solved and how the technology solves it are better positioned against Alice/Mayo challenges. Claims that describe only a result, without specifying how the technology achieves the result using anything other than a generic computer, face a higher risk of failing Prong 2 or Step 2B.

• Coordinate the claim language and the specification. The specification's description of the innovation shapes the eligibility analysis: it provides the factual foundation for arguing that the claim integrates the exception into a practical application, and it creates the evidentiary record that supports a Berkheimer challenge if the examiner asserts conventionality. Generic "computer-implemented" language in both the specification and the claims, without details about how the implementation works, removes that factual foundation.