Hopeful Prospects for Clarity in Section 101 of the Patent Act

Since the U.S. Supreme Court decision in Alice Corp. Pty. Ltd. v. CLS Bank Intl, USPTO examiners, inventors, and patent practitioners, alike, have been navigating through a “sometimes murky” understanding of subject matter eligibility.

In an attempt to provide clarity and predictability, the USPTO has released several iterations of subject matter eligibility guidelines that include examples of patent eligible and ineligible subject matter. On January 07, 2019, the USPTO released its most recent set of guidelines that expressly outline a list of eligible subject matter groupings, along with a “practical application” test that can be used to identify patent-eligible claims that seemingly apply, rely, or use a recited judicial exception.

Recently, however, the U.S. Court of Appeals for the Federal Circuit chose to distance itself from the USPTO’s guidelines, albeit an earlier version (May 2016). In Cleveland Clinic Foundation v. True Health v Diagnostics LLC (Appeal 2018-1218 (Fed. Cir., April 01, 2019)), the Federal Circuit affirmed a district court decision in finding a diagnostic test patent claim ineligible. Notably, the Cleveland Court stated that “[w]hile we greatly respect the PTO’s expertise on all matters relating to patentability, we are not bound by its guidance.” See, id. at p. 13.

While the Court’s decision not to defer to the USPTO for guidance and instead rely on its own case law is understandable, the dichotomy between statutory interpretations of the USPTO and U.S. Federal Courts has left many inventors and patent practitioners confused. Instead of relying on a common set of rules and interpretations for patent prosecution and patent validity, inventors and patent practitioners are being asked to adhere to one set of guidelines for prosecuting patent applications and a contrasting set of rulings to argue validity before U.S. Federal Courts.

Fortunately, steps have been taken to help resolve these differences. On April 17, 2019, members of Congress published a bipartisan, bicameral framework for statutory reform of Section 101 of the Patent Act. Among the proposals, the framework suggests providing a closed list of subject matter category exclusions, similar to those proposed by the USPTO in its recent guidance of January 07, 2019. A draft outline of the Section 101 reform further suggests creating a “practical application” test to ensure that statutorily ineligible subject matter is narrowly construed and making clear that eligibility is determined by considering each and every element of a claim, without regard to considerations otherwise addressed by Sections 102, 103, and 112 of the Patent Act.

In any event, the publication of a framework for statutory reform is a good first step towards developing a clear and predictable solution. If anything, it provides inventors and patent practitioners with a clear indication that Congress has clarity on the problem, and with any luck should project the same on a framework solution.