Federal Circuit Holds Stanford’s Genetics Method Claims Abstract Under Section 101

On March 25, the Federal Circuit issued an opinion in In re Board of Trustees of the Leland Stanford Junior Univ., No. 2020-1288 (Fed. Cir. Mar. 25, 2021), affirming the Patent Trial and Appeal Board’s rejection of the patentability of claims directed to computerized methods to generate genetic data, a decision notable in the field of bioinformatics and personalized medicine.  

Stanford sought to patent claims directed to a “computerized method for inferring haplotype phase in a collection of unrelated individuals” comprising a number of steps: receiving genotype data, imputing an initial haplotype phase based on a statistical model, building a data structure describing a Hidden Markov Model, repeatedly randomly modifying at least one of the imputed initial haplotype phases, automatically replacing an imputed haplotype phase, extracting at least one final haplotype phase, and storing at least one final predicted haplotype phase. Id. at *4-5. Haplotype phase indicates the parent from whom a gene is inherited. The claimed method improved the accuracy of predicting haplotype phase as compared with existing high-throughput DNA sequencing methods that do not provide haplotype information. Id. at *2-3.

During oral argument last November, Stanford argued that its claims were not simply about “manipulating” data, but creating “new data” with the use of specific rules and machine learning techniques. The Federal Circuit questioned the validity of Stanford’s position, with Judge Reyna finding it akin to the argument that if you apply the mathematical formula 2+2 = 4, one could not argue that “4” is “newly created data.” On behalf of the PTO, the Solicitor argued that Stanford’s claims were directed to mathematical principles and, unlike McRo, Enfish and Finjan, did nothing to improve the computer itself, but was simply an invention of “narrow math.”

In its final written opinion, the Federal Circuit sided with the PTAB, holding that under Alice’s two-part test, Stanford’s claims were directed to an abstract idea and were not saved by any inventive concept. It held that the claims did not “involve practical, technological improvements extending beyond improving the accuracy of a mathematically calculated statistical prediction.” Id. at *10. It also found that “the recited steps of receiving, extracting, and storing data amount to well-known, routine, and conventional steps taken when executing a mathematical algorithm on a regular computer,” and the claims recite generic computer components that were in no way “specialized.” Id. at *12. Additionally, it held Stanford forfeited the argument that the clams allowed for “greater efficiency in computing haplotype phase” as it was not raised initially before the PTAB. Id. at *10.

The Federal Circuit’s opinion in Stanford follows its April 2020 opinion in CardioNet, LLC v. Infobionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020). There, the Federal Circuit held a medical device that used “variability determination logic” to identify atrial fibrillation and atrial flutter was patentable under Section 101. Id. at 1365. It held the claims were not abstract ideas that merely used computers as tools and that it was “difficult to fathom” how doctors would have applied the claimed logic mentally or manually. Id. at 1370-71. It also held that the asserted claims were directed to a “specific technological improvement—an improved medical device that achieves speedier, more accurate, and clinically significant detection of two specific medical conditions.” Id. at 1370.

Stanford’s efforts to make similar arguments failed to carry water here. Its arguments that certain claimed steps could not be done “solely in one’s mind” and that the claimed method improved detection of haplotype phase did not convince the Federal Circuit of patentability. Recent Section 101 decisions such as Stanford and CardioNet are important to keep in mind for practitioners who are drafting or litigating patents in the biotechnology field.