In response to the Prometheus decision rendered by the Supreme Court, the U.S. Patent and Trademark Office (USPTO) issued its 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (the “Interim Procedure”).

The Interim Procedure sets forth three “essential inquiries” in determining subject matter eligibility:

  • Inquiry No. 1:  Is the claimed invention directed to a process, defined as an act, or a series of acts or steps?  If no, this analysis is not applicable.
  • Inquiry No. 2:  Does the claim focus on use of a law of nature, a natural phenomenon or naturally occurring relation or correlation (collectively referred to as a natural principle herein)?  If no, this analysis is complete.
  • Inquiry No. 3:  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? (Is it more than a law of nature plus the general instruction to simply “apply it”?)  If no, the claim is not patent-eligible and should be rejected.

Regarding Inquiry No. 2, a natural principle is defined as “the handiwork of nature [that] occurs without the hand of man,” such as the disinfecting property of sunlight; the relationship between blood glucose levels and diabetes; and a correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood.  In particular, the Interim Procedure notes that “a claim that recites a correlation used to make a diagnosis focuses on a natural principle and would require further analysis” under Inquiry No. 3.

Regarding Inquiry No. 3, the Interim Procedure notes that the additional step must not be an “insignificant extra-solution activity” that imposes no meaningful limit on the performance of the claimed invention, such as an extra-solution activity that is unrelated to a natural correlation or does not integrate the natural correlation into the invention.  In addition, elements or steps that are well-understood, purely conventional and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficient.  The thrust of the analysis is that the claim must be limited so that it does not preempt the natural principle by covering every substantial practical application of that principle and that others are not foreclosed from using the natural principle for future innovation.  The Interim Procedure lists several factors useful for analyzing the additional steps/features in the claims for the purpose of addressing Inquiry No. 3. 

Practice Note:  The Interim Procedure will predominantly impact patent applications examined in Technology Center 1600, in particular, claims directed to diagnostic or screening methods, such as claims reciting a correlation between a biomarker and a disease risk.  Applicants should present arguments or amendments to show that the claims at issue are limited in scope, such that it does not preempt a natural principle and that others are not foreclosed from using the natural principle.  A showing that a particular step/feature is not routine, well-known or conventional will also be helpful.  Whether these guidelines will be subject to further revision in view of the Federal Circuit decision in CLS Bank International v. Alice Corp., (see IP Update, this issue) remains the same.