- United States Patent and Trademark Office Issues Interim Guidance for Patent Subject Matter Eligibility Concerning Process Claims Involving Laws of Nature
- August 9, 2012 | Author: Joey Tsu-Yi Chen
- Law Firm: Saul Ewing LLP - Baltimore Office
The U.S. Patent and Trademark Office has issued a guidance memorandum making clear that a claim that focuses on the use of a natural principle must include additional elements or steps demonstrating the claim's practical application—that is, at least one additional element must integrate the natural principle in such a significant way as to impose a meaningful limit on the scope of the claimed invention.
Earlier this month, the U.S. Patent and Trademark Office ("USPTO") issued a guidance memorandum following a landmark patent law decision by the United States Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ---, 132 S. Ct. 1289 (2012). In Mayo, the Supreme Court held the claimed processes, which concerned the use of thiopurine drugs to treat autoimmune diseases, patent-ineligible as they merely recited laws of nature and did not provide any additional features that amounted to genuine applications of those laws rather than efforts designed to monopolize them. The Court held that apart from informing a specific audience about certain laws of nature, the claims described well-understood, routine, conventional activity already employed in the prior art. In striking the claims, the Court made clear that in order to effect a patent-eligible transformation of a law of nature, one cannot simply recite a law of nature and say, "apply it."
On July 3, 2012, the USPTO issued its 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature ("2012 Interim Procedure for Laws of Nature"), which expanded and superseded its March 21, 2012 preliminary guidance.
Examiners are instructed to determine:
- Is the invention directed to a process?
- Is a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively, a "natural principle") a limiting element or step of this process?
- Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself?
In other words, as to query three, is the claim more than a restatement of a law of nature with the general instruction to simply "apply it?"
In the wake of Mayo, a claim that focuses on the use of a natural principle must include additional elements or steps demonstrating the claim's practical application—that is, at least one additional element must integrate the natural principle in such a significant way as to impose a meaningful limit on the scope of the claimed invention. The examiner will determine whether the claim amounts to significantly more than the natural principle itself. The additional elements cannot merely describe an insignificant extra-solution activity. Nor is it sufficient to recite only well-understood, routine, conventional activity previously engaged in by researchers in the field. Such a claim would fail the examiner's inquiry.
Claims that fail the examiner's practical application inquiry will be rejected under 35 U.S.C. § 101. In its response, the respondent should pay attention to the examiner's reasons for rejection concerning why the additional elements, when the claim is taken as a whole, fail to integrate the natural principle as to evince a practical application of the natural principle and/or that the claim amounts to significantly more than the natural principle itself. Examiners may find persuasive a respondent's arguments that the additional steps of a claim not only add something significantly more to the claim than merely describing the natural principle, but also are not routine, well-known or conventional. For example, in a Mayo-type setting involving diagnostic activity, steps that involve unconventional testing techniques or non-routine treatment steps could, in theory, satisfy this requirement.