Publication Date


Document Type



In a span of four years, 2010-2014, the U.S. Supreme Court issued four decisions that have dramatically altered patent eligibility jurisprudence: Bilski, Mayo, Myriad, and Alice. Ever since Bilski was decided, the PTO has struggled to apply the new patent eligibility jurisprudence in a consistent and predictable manner. The two part framework for assessing patent eligibility, as set for in Alice and Mayo, is stated at a high level of abstraction, and the Supreme Court has given little concrete guidance as to how it is to be applied beyond the specific claims at issue in its precedent. At times, the Supreme Court’s explanation of patent eligibility seems internally inconsistent, for example with respect to method of treatment claims. Judges on the Federal Circuit have complained that Supreme Court precedent, particularly the Mayo decision, denies patent eligibility to some of the most important innovation occurring in medicine, particularly in the realm of diagnostics and personalized medicine, which could not have been what the Supreme Court intended. There have been increasing calls for the Supreme Court or Congress to intervene and straighten out what many consider to be a mess, including many of the judges on the Federal Circuit. The PTO in particular has struggled to implement the Supreme Court’s recent patent eligibility jurisprudence in a fair, predictable, and consistent manner. The PTO has responded to the challenge by issuing a series of guidance documents for use by its examiners in assessing patent eligibility, along with examples applying the guidance to specific hypothetical claims, mostly involving information technology and biotechnology. This guidance has been revised with each Supreme Court decision, and continues to evolve as the Federal Circuit issues precedential opinions applying the new patent eligibility standard in a variety of contexts. This Article reviews the most recent guidance and offers an assessment of where things stand after the PTO’s latest October 2019 Update with respect to examination for patent eligibility.

Publication Title

Biotechnology Law Report