US Patent Office Issues Guidance Targeting Diagnostic-Related Patent Claims

With the Sequenom MaterniT21 patent litigation heading for the U.S. Supreme Court, the U.S. Patent and Trademark Office (USPTO) has requested public comment on its guidance for Examiners and the public that address patent eligibility issues relevant to the diagnostics industry. Earlier this month, the USPTO issued a notice in the federal register seeking comment on a May 2016 Subject Matter Eligibility Update and several Subject Matter Eligibility Examples for Life Sciences.

A blog posting from the Deputy Commissioner for Patent Examination Policy, Robert Bahr, explains that the life sciences examples “use hypothetical fact scenarios to illustrate exemplary analyses for subject matter eligibility in view of the Supreme Court decisions in Alice Corp., Mayo, and Myriad. The examples are designed to show various ways that patent claims can be drafted for eligibility, and thus assist patent applicants and patent examiners in resolving subject matter eligibility issues in the life sciences areas.” He also indicates the examples provided regarding diagnostics were specifically requested by stakeholders.

One of the examples, #31, titled Screening For Gene Alterations, addresses issues discussed in the 2013 U.S. Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. Another example, #29, titled Diagnosing and Treating Julitis addresses patent eligibility for diagnostic and treatment methods for a hypothetical autoimmune disease (i.e., Julitis). Each example describes and addresses patent

eligibility of multiple, actual or hypothetical patent claims. Example 29 addresses the judicial exception for law of nature or abstract ideas. Some claims were found eligible for patent protection because they “recite specific and unconventional reagents and/or treatments that amount to significantly more than the judicial exception.”

An examiner memorandum was also included in the latest guidance intended to achieve more consistent determinations of subject matter eligibility. The federal register notice makes clear that the guidance materials are not “substantive rulemaking and do not have the force and effect of law” but rather set forth policy based on office interpretation of the law and recent court decisions from the U.S. Supreme Court and the Federal Circuit. The examples are intended as a teaching tool for patent examiners and the public.

The guidance and examples are available to the public on the USPTO website. Written comments should be submitted to 2014_interim_guidance@uspto.gov and will be made available for public view on the USPTO website. The comment period is open-ended, and comments will be accepted on an ongoing basis.

Takeaway: The USPTO responds to debate regarding patent eligibility in the diagnostics arena and solicits public feedback.