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June 23, 2021 | By S&H
Posted in: S&H IP Blog | U.S. Court of Appeals For The Federal Circuit


By: Raph Y. Kim, Associate

In the two opinions issued in March (Appeal No. 2020-1012 (March 11) and 2020-1288 (March 25)), the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held that that biotechnological patent applications owned by Stanford University and involving computational methods for predicting genetic outcomes claim ineligible abstract ideas under 35 U.S.C. § 101 and affirmed two Patent Trial and Appeal Board determinations.

The cases involved two patent applications directed to processor-implemented, statistical methods for determining “haplotype phasing.” Haplotype phasing is a process for determining the parent from whom alleles (i.e., versions of a gene) are inherited.

Stanford University argued that the applications at issue “are in the field of bioinformatics,” “where computer and information processing techniques can be combined with biological and genetic information to detect and diagnose certain conditions.” Stanford University argued that this haplotype phasing techniques in the field of bioinformatics “promise[] to revolutionize personalized health care by tailoring risk modification, medications, and health surveillance to patients’ individual genetic backgrounds,” because the claimed methods “provide more accurate predictions of haplotype phase.

Stanford further argued that the claims were not abstract because they recite a specific method of predicting haplotype phase. Stanford argues that “claim 1 is not directed to an abstract idea because the specific application of the steps is novel and enables scientists to ascertain more haplotype information than was previously possible.”

Stanford also argued that the claimed subject matter of those in Finjan, McRO, and Enfish, which are upheld under § 101. For example, Stanford argued that haplotype phasing is a computer implemented field, and that under McRO, “improvements to computer implemented fields are considered technological improvements.”

However, the Federal Circuit affirmed the PTAB’s decision that claimed features are patent in eligible under § 101 based on the Supreme Court’s two-step Alice framework for patent eligibility.

Under the first step, the Federal Circuit held that Stanford’s claims recite no more than generic steps of implementing and processing calculations and do not recite a practical application or an improvement to a technological process of such calculations, even if the result of the calculation yield a more accurate haplotype prediction.

The Federal Circuit also held that, because the claims do not recite a practical application or technological improvement, Stanford’s claims are distinguished from those previously upheld by the court. The Federal Circuit provided that McRO’s claimed process created a sequence of synchronized, animated characters. Finjan’s claimed method drawn to a behavior-based virus scan that protects against viruses that have been “cosmetically modified to avoid detection by code-matching virus scans”. In Enfish, the claims were directed to “an innovative logical model for a computer database” that included a self-referential table allowing for greater flexibility in configuring databases, faster searching, and more effective storage.

The Federal Circuit held that the claims also failed Alice step two. The Federal Circuit held that the claims did not include an inventive concept and that the claimed steps are well-known, routine, and conventional. The Federal Circuit provided that claims reciting method steps carried out by a “computer system” with a “processor” and a “memory” are so general that “it is hard to imagine a patent claim that recites hardware limitations in more generic terms than the terms employed by claim 1.”

The Federal Circuit also provided that Stanford’s arguing the specific combination of claim features making the process novel are oversimplified by the PTAB in determining the patent eligibility under § 101 belongs to “novelty” under § 102, which is not “the touchstone of eligibility.” Federal Circuit explained that “a specific or different combination of mathematical steps yields more accurate haplotype predictions than previously achievable under the prior art is not enough to transform the abstract idea [] into a patent eligible application.”


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