PTO Issues New Draft Guidance For Determining Patent-Eligible Subject Matter

The United States Patent and Trademark Office (PTO) issued interim guidance for use by its personnel when determining patent-eligible subject matter under 35 U.S.C. § 101 ("Section 101"). The new guidance will alter the way patent examiners assess patent applications for subject matter eligibility, and may provide some relief to patent applicants and holders in the life sciences. The new guidance attempts to create a uniform approach to analyzing subject matter eligibility by incorporating the Supreme Court's decisions in Mayo,1 Myriad,2 and Alice,3 which collectively addressed the law regarding subject matter eligibility for life sciences, software, and business methods.

The PTO also issued a series of updated examples that illustrate the latest guidance for natural products, and announced plans to issue additional examples for abstract ideas and software-related patents in the coming weeks.

The new guidance offers patent applicants new opportunities for pursuing patent protection. Patent applicants can begin referring to the new guidance immediately when drafting new applications and responding to rejections under Section 101. Where possible, applicants may also wish to file claim amendments or additional continuing patent applications to recoup subject matter ceded in view of the previous PTO guidelines. Applicants should also consider whether to file or maintain any appeals in view of this new guidance.

BACKGROUND

35 U.S.C. § 101 states that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor..." The Supreme Court has long held that this section of the Patent Act contains important exceptions: "laws of nature, natural phenomena, and abstract ideas" are not patent eligible.4 The Supreme Court has been very active in this area of law in the past few years, and its recent decisions have attempted to further refine what constitutes patent-eligible subject matter.5

The PTO issued the new guidelines, entitled "2014 Interim Guidance on Patent Subject Matter Eligibility," to provide patent examiners with specific procedures for determining subject matter eligibility in view of the latest judicial decisions. The new guidance supplements the June 25, 2014 "Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp" and supersedes the March 4, 2014 "Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products." The PTO noted that many of the changes presented in the new guidelines were made in response to public comments concerning the original March 2014 procedure.

The PTO published the new guidance, which is effective immediately, in the Federal Register on December 16, 2014.6

THE NEW PROCEDURE

The new guidance alters the process of determining subject matter eligibility previously established in March 2014. As with the previous procedure, an examiner must begin by determining a claim's broadest...