USPTO Releases Interim Guidance on Eligibility
Late Monday, the U.S. Patent and Trademark Office (USPTO) released its much anticipated 2014 Interim Guidance on Patent Subject Matter Eligibility for determining subject matter eligibility under 35 U.S.C. § 101 in view of the United States Supreme Court's Myriad, Mayo and Alice Corp decisions. This new guidance 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 issued in view of Myriad and Mayo, and supplements the June 25, 2014 Preliminary Examination Instructions issued in view of Alice Corp.
The Interim Eligibility Guidance sets forth a two-step process in which the claimed invention:
1. must be directed to one of the four statutory categories (i.e., a process, machine, manufacture or composition of matter); and
2.must not be wholly directed to subject matter encompassing a judicially recognized exception, which is determined using a two-part analysis. That two-part analysis requires:
- determining whether the claim is directed to a law of nature, a natural phenomenon, or an abstract; and
- determining whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.
The Interim Eligibility Guidance also includes examples based on Supreme Court decisions such as Myriad, Mayo and Alice Corp., among others, that analyze claims for subject matter eligibility. The USPTO also released Nature-Based Product Examples for use in conjunction with the 2014 Interim Eligibility Guidance that provide illustrative analysis of claims directed to nature-based inventions (e.g. cells, chemicals, proteins, antibodies). Examples for claims directed to abstract ideas are to be released soon.
The USPTO also introduced the "Streamlined Eligibility Analysis" that may be implemented where the claim recites meaningful limitations along with a judicial exception that limit its practical application. The Streamlined Eligibility Analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to preempt others from using or practicing the judicial exception.
In practice, applicants should include limitations in method claims reciting judicial exceptions to limit its practical application, and thus, trigger analysis under the Streamlined Eligibility Analysis. For example, claims could be limited to a particular subset of patients, a specific disease, a specific analytical method, etc. to avoid preempting others from using the judicial exception. Applicants could also include limitations to ensure that the claim amounts to significantly more than the judicial exception. For example, for claims to compositions incorporating natural products, applicants should include additional features such as different structural characteristics that may result in different functional characteristics that add significantly more to the natural product.