USPTO March 2014 Update to Guidance & Training for Evaluating Utility Patent Subject Matter Eligibility for Claims involving Nature, Natural Phenomena, & Natural Products


In response to recent U.S. Supreme Court decisions addressing utility patent subject matter eligibility under 35 U.S.C. § 101, the U.S. Patent & Trademark Office issued new guidance and training materials for patent examiners tasked with determining eligibility of machine, composition, manufacture and process claims “involving laws of nature,  natural phenomena, and natural products.”  The USPTO published the guidance memorandum and training slides, requesting public comment and suggestions for future examiner training.

The USPTO explained that the new guidance replaces current guidance for process claims involving laws of nature, based on Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012), and product claims reciting nucleic acids, based on Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013). In the USPTO’s view, Myriad impacted the Supreme Court’s stance on the inability to patent naturally occurring things by:

rel[ying] on [Diamond v. Chakrabarty, 447 U.S. 303 (1980)] as “central” to the eligibility inquiry, and re-affirm[ing] the Office’s reliance on Chakrabarty’s criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). Id. at 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119.

The new guidance does not change the analysis of claims reciting abstract ideas. The USPTO will continue to use existing guidance for such claims, as the law in this area is “unsettled” and the Supreme Court will consider the abstract idea judicial exception this year.  A Quick Reference Sheet summarizing the new guidance also is available. Additional information can be found here and comments can be sent to the USPTO via email to:

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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