Federal Circuit IP

2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence

Published September 18, 2024

A Notice by the Patent and Trademark Office on 07/17/2024

Background:

While the Alice/Mayo test for analyzing subject matter eligibility has not changed, this guidance update provides a discussion of how to evaluate AI inventions under Step 2A, Prong One and Prong Two. Three examples (Examples 47-49) are provided.  Example 49 is discussed here.

Claims of Example 49:

  1. A post-surgical fibrosis treatment method comprising: (a) collecting and genotyping a sample from a glaucoma patient to a provide a genotype dataset; (b) identifying the glaucoma patient as at high risk of post-implantation inflammation (PI) based on a weighted polygenic risk score that is generated from informative single-nucleotide polymorphisms (SNPs) in the genotype dataset by an ezAI model that uses multiplication to weight corresponding alleles in the dataset by their effect sizes and addition to sum the weighted values to provide the score; and

(c) administering an appropriate treatment to the glaucoma patient at high risk of PI after microstent implant surgery.

  1. The method of claim 1, wherein the appropriate treatment is Compound X eye drops.

Claim 1 is ineligible:

  • Step 2A, Prong One: Limitation (b) recites an abstract idea
  • Step 2A, Prong Two: The additional elements do not integrate the recited exception into a practical application.
  • Limitation (a) is an insignificant extra-solution activity that amounts to mere data gathering incidental to (b).
  • Although limitation (c) indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated or what the treatment is. Therefore, (c) amounts only to a generic instruction to apply the exception or to a mere indication of the field of use in which the abstract idea is performed.
  • Step 2B: The claim as a whole does not amount to significantly more than a generic instruction to apply the judicial exception.

Claim 2 is eligible.

  • Step 2A, Prong Two: The limitation in claim 2 is a particular treatment for a medical condition such that the claim as a whole integrates the judicial exception into a practical application.

Takeaways:

Be specific about the treatment step.  Although Compound X is new here, it does not have to be for the claim to be patent eligible under the Guidance.  The guidance points out that “Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity,” which should be done in Step 2B.  Therefore, a conventional treatment may make the claim patent eligible under Step 2A, Prong Two.  This Example does not deviate from the current practice of the PTO in evaluating eligibility for this type of claim.