2.2 Judicial Exceptions & the Alice/Mayo Framework

2.2 Judicial Exceptions & the Alice/Mayo Framework

Even if a claim falls within one of the four statutory categories of 35 U.S.C. § 101, it may still be ineligible if it is directed to a judicial exception. The Supreme Court has long recognized that certain subject matter must remain in the public domain for all creators to use.

The Three Judicial Exceptions

The Supreme Court has established three unpatentable judicial exceptions:

1. Laws of Nature (e.g., gravity, $E = mc^2$, mathematical principles governing physics)
2. Natural Phenomena & Products of Nature (e.g., wild plants, naturally occurring minerals, un-modified genomic DNA)
3. Abstract Ideas (e.g., mathematical formulas, mental concepts, fundamental economic relationships)

Supreme Court Landmark Precedents

• Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012): Held that claims setting forth correlations between blood metabolite levels and therapeutic drug dosages recited a law of nature. Merely adding routine, conventional blood-testing steps failed to supply an inventive concept.
• Alice Corp. Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014): Formulated the definitive two-step framework for patent eligibility, holding that implementing financial settlement hedging methods on a generic computer was directed to an unpatentable abstract idea.

---

The USPTO 2019 Revised Guidance Framework (MPEP § 2106)

To standardize eligibility examinations, the USPTO promulgated the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), incorporated into MPEP § 2106. The USPTO framework evaluates eligibility through a structured decision flow:

Step 1 ──> Step 2A Prong 1 ──> Step 2A Prong 2 ──> Step 2B

Step 1: Statutory Category Check

Determines whether the claim falls within a statutory category (process, machine, manufacture, composition of matter). If no, the claim is rejected as non-statutory.

Step 2A Prong 1: Recitation of a Judicial Exception

Examiners analyze whether the claim recites a law of nature, natural phenomenon, or abstract idea. Under the 2019 PEG, abstract ideas are strictly limited to three enumerated groupings:

• Mathematical Concepts: Mathematical formulas, mathematical calculations, algorithms, equations.
• Certain Methods of Organizing Human Activity: Fundamental economic practices (hedging, commercial transactions), managing financial relationships, risk mitigation, advertising, marketing, regulatory compliance, game rules.
• Mental Processes: Concepts performed in the human mind (observing, evaluating, calculating mentally, judging, classifying data without dedicated hardware execution).

If the claim does not recite a judicial exception, the claim passes § 101 (Eligible at Step 2A).

Step 2A Prong 2: Integration into a Practical Application

If a judicial exception is recited, the examiner must evaluate whether the exception is integrated into a practical application:

• Does the claim apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the exception, such that the claim as a whole is not directed to the exception itself?

Examples of Practical Application Integration (MPEP § 2106.04(d)):

• Improving the functioning of a computer or other technology/technical field.
• Applying a law of nature or natural phenomenon to a specific treatment protocol for a patient.
• Effecting a physical transformation of a physical article or substance.
• Implementing a judicial exception with a specific structural machine element that meaningfully restricts the claim.

CRITICAL USPTO RULE: If the claim integrates the exception into a practical application at Step 2A Prong 2, the claim is NOT directed to the judicial exception. The claim is ELIGIBLE under 35 U.S.C. § 101 at Step 2A, and the examination under Step 2B is bypassed completely!

Step 2B: Inventive Concept / "Significantly More"

If the claim recites a judicial exception AND fails to integrate it into a practical application at Step 2A Prong 2, the claim is "directed to" an exception. The examiner must then proceed to Step 2B to evaluate whether the claim recites an inventive concept ("significantly more").

• Elements examined individually and as an ordered combination.
• Well-Understood, Routine, Conventional Activity (WURC): Generic computer hardware performing basic data storage, transmission, or display is WURC in the art and does not provide an inventive concept.
• Procedural Rule (Berkheimer v. HP Inc., 881 F.3d 1360): Whether an element or combination of elements represents well-understood, routine, conventional activity in the relevant field is a question of fact. An examiner must support a WURC finding with factual evidence or official notice.

---

Summary Table of USPTO Eligibility Decision Flow (MPEP § 2106)