The United States Patent and Trademark Office issued on May 6, 2016, updated guidance to its patent Examiners that would have an impact on patent applications covering diagnostic methods and natural products. The new guidance includes a memorandum to the examining corps detailing best practices for examining claims for subject matter eligibility and new Examples in the life sciences of what should be considered patent eligible and ineligible.

The Examples clarify the USPTO’s position on what is and is not patentable subject matter. These guidelines are not binding on the courts and, thus, claims issued in accordance with the guidance are subject to challenge in federal court. However, for those seeking patent protection, the USPTO Examiners rely on these statements of the USPTO’s interpretation of the Supreme Court and Court of Appeals for the Federal Circuit decisions to reject or allow claims in pending patent applications based upon subject matter eligibility. Failure of the USPTO to grant claims based on the reasoning in the guidance may also be appealed to the Federal Circuit.