Following consistent criticism from the Federal Circuit and the current director of the U.S. Patent and Trademark Office (USPTO), the USPTO has issued new proposed guidance for evaluating patent subject matter eligibility, effective January 7, 2019. Until this guidance, patent claims in the life science (e.g., diagnostics) and computer software spaces were nearly automatically found to be "directed to" a patent ineligible judicial exception, and then subjected to further analysis under the 2-prong Alice/Mayo test. While that two-prong test is still in effect, the application of the first step of the test, by the USPTO, has been revised.

Previously, if a patent claim recited language that related to (or described) a patent-ineligible judicial exception, that claim was typically concluded to be "directed to" the exception and frequently found ineligible. With the new guidance, the USPTO now requires examiners to analyze the claims for a “practical application” of the judicial exception prior to concluding that the claim is "directed to" that exception. The term “practical application” is a new term that has not been defined, however, the USPTO's commentary suggests that the USPTO intends the term to provide Examiners greater latitude to find claims reciting judicial exceptions to be patent eligible if they are found to have “practical application." It remains to be seen how the guidance will be applied, but there is reason to believe that the rate of rejections under 35 U.S.C. §101 will decrease in the coming years.

The USPTO guidance is ongoing and is currently subject to public comment. The public comment period is open until March 8, 2019. Comments should be sent by email.