Rejection of Stanford’s diagnostic claims affirmed as “mental steps… not integrated into a practical application”, not including a “specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome”

In Re:  Board of Trustees of the Leland Stanford Junior University

Docket No. 2020-1012 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1012.OPINION.3-11-2021_1746411.pdf)

PROST, LOURIE, REYNA

March 11, 2021

Brief Summary:  Board decision finding Stanford’s diagnostic claims ineligible (“mental steps… not integrated into a practical application”, no “specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome”) affirmed. Summary:  Stanford appealed Board rejection of claims “directed to methods and computing systems for determining haplotype phase” for being patent ineligible under section 101 for “covering patent ineligible abstract mathematical algorithms and mental processes.”  The FC panel opinion explains that “[h]aplotype phasing…acts as an indication of the parent from whom a gene has been inherited.”  The Board applied the two-step Alice framework (Alice, US 2014), determining that “the eight steps in claim 1 are directed to either the ‘mental steps of receiving, storing, or providing information’ or ‘mathematical concepts’” (“receiving and analyzing information, which humans could process in their minds”) that are “not integrated into a practical application” (citing Enfish, FC 2016; McRO, FC 2016; rejected claims do not “improve computer technology”).  Under Alice step two, “[t]he Board found that the steps of receiving data, performing calculations using that data, storing the results, and providing the results upon request using a computer did not go beyond the well known, routine, and conventional” (“although the claims may provide a valuable contribution to science, that contribution does not go beyond patent ineligible mental processes and mathematical operations”).  Rejected claims include the steps of “determining a drug for treatment of at least one member of the family based on information regarding drug-variant-phenotype associations from a pharmacogenomics database” and “providing the determined drug in response to a request using a computer system”.  Dependent claims that “recite certain steps culminating in a final step of ‘providing the drug for treatment’” were also rejected and affirmed by the Board “because they ‘are not directed to a specific method of treatment, do not identify specific patients, do not recite a specific compound, do not prescribe particular doses, and do not identify the resulting outcome’”, distinguishing the claims from those in Vanda (FC 2018) that “were directed to a ‘specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.’”  The FC panel affirmed the Board decision, concluding the independent claim is “directed to an abstract mathematical calculation” (Synopsys, FC 2016), not “an improved technological process” (Alice step one) and “recites no steps that practically apply the claimed mathematical algorithm” (Alice step two; In re TLI, FC 2016 (generic computer components); Affinity Labs, FC 2016 (explaining that novelty does not necessarily avoid abstractness); “Without further limitations, these claims do nothing more than recite the haplotype phase algorithm and instruct, “apply it,” as the Supreme Court has prohibited.”)  The Board decision was therefore affirmed.