There have been no substantial changes to patent eligibility law or practice under 35 U.S.C. § 101 since the U.S. Patent and Trademark Office's last guidance in October 2019. With legislative reform in Congress stalled, following are the factors most likely to alter the current status quo:

Patent Office proposal.  In a letter published on March 22, 2021, Senators Thom Tillis (R-NC)-the former chair and current ranking member of the Senate Subcommittee on Intellectual Property-and Tom Cotton (R-AR) requested that the USPTO introduce a pilot program under which an examiner would defer the examination of eligibility issues for a patent application until all issues under the other sections of the patent law have been resolved. This would alter current practice of compact examination, in which the examiner evaluates all of the issues in each Office action.

The senators argue that this resequencing of the examination issues would not result in less rigorous examination of eligibility, but rather would merely defer the issue until the resolution of the other issues had brought greater clarity to the examination. Such a program, if enacted, could lower overall patent prosecution costs by eliminating the need of applicants to prematurely (and perhaps unnecessarily) address eligibility concerns. The senators argue that it would likely also reduce the total number of eligibility rejections, since eligibility concerns would in many cases already have been addressed by the time the other issues are resolved. In late April, the USPTO agreed to establish a form of the pilot for use on a voluntary basis, though without a timeline for its enaction.

Pending cert petitions.  Since its landmark Alice decision in 2014, the U.S. Supreme Court has been exceedingly hesitant to revisit patent eligibility. In 2020, for example, the Court declined certiorari in BerkheimerVanda, AthenaTrading TechnologiesChargePointAatrix, and The Chamberlain Group. (In Athena, the justices denied cert despite a split 6-6 en banc opinion from the U.S. Court of Appeals for the Federal Circuit in which all the judges essentially entreated the Court and/or Congress to provide clarity to eligibility law.)

Currently, Ariosa and American Axle have pending petitions for cert. (Fenwick is tracking these cases on our Bilski blog.) Notably, American Axle, like Athena, involved a 6-6 split in denial of en banc rehearing at the Federal Circuit, as well as a stinging dissent from Judge Kimberly Ann Moore (Chief Judge beginning May 22, 2021), who wrote, "The Supreme Court often grants certiorari to resolve certain splits that render the state of the law inconsistent and chaotic. . What we have here is worse that a circuit split - it is a court bitterly divided. As the nation's lone patent court, we are at a loss as to how to uniformly apply § 101." Time will tell whether even this will be sufficient to induce the Supreme Court to overcome its apparent reluctance to revisit eligibility law.

Given the Court's track record thus far, a new eligibility decision in 2021 seems optimistic. Changes in USPTO procedure seem more likely, though even if enacted they may not go into effect until after 2021. Much also hinges on who is selected by President Biden to be the new Director of the USPTO, and there may be hesitancy from interim leadership to implement significant change in the meantime.

The Federal Circuit and § 101. Regardless of the current petitions for certiorari at the Supreme Court, the Federal Circuit continues to decide cases, the result of which is continuing evolution of § 101 jurisprudence. For example, in March, the Federal Circuit ruled on In re Stanford, invalidating claims to haplotype phase analysis. The broad reasoning of the case suggests that it may prove exceedingly difficult to convince courts that any bioinformatics inventions are patent-eligible.

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