On March 4, 2014, the U.S. Patent and Trademark Office (USPTO) released examination guidelines titled Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidelines). The USPTO issued the guidelines in view of the recent U.S. Supreme Court decisions Association for Molecular Pathology v. Myriad Genetics, Inc. (IP Update, Vol. 16, No. 6) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (IP Update, Vol. 15, No. 3).
The USPTO summarized the guidelines in a three question flowchart (found at http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf). The three questions include (1) whether the claim is directed to one of the four statutory categories, i.e., a process, machine, manufacture or composition; (2) does the claim recite or involve judicial exceptions (e.g., laws of nature/natural principles, natural phenomena and natural products); and (3) does the claim as a whole recite something significantly different than the judicial exceptions?
The guidelines listed 12 non-exclusive factors (six factors suggesting eligibility and six factors suggesting non-eligibility) to be considered when answering the third question. The weighing and consideration of the 12 factors should be conducted in a manner similar to the consideration of the Wands factors used to evaluate whether undue experimentation is required to make and use a claimed invention. The weight given to each factor depends upon the facts of the application.
The six factors in favor of eligibility are whether the claim:
- is a non-naturally occurring product and is markedly different in structure than naturally occurring products;
- recites elements or steps in addition to the judicial exception(s) that meaningfully limit claim scope;
- recites elements or steps that are more than nominally or tangentially related to the judicial exceptions(s);
- recites elements or steps that are more than merely applying or using the judicial exception(s);
- recites elements or steps that include a particular machine or transformation of a particular article; and
- recites one or more elements/steps that are not conventional in the relevant field.
The six factors that weigh against eligibility are whether the claim:
- is naturally occurring or not markedly different from naturally occurring products;
- recites elements or steps at a high level of generality;
- recites elements or steps that must be used to apply the judicial exception(s);
- recites elements or steps that are conventional in the relevant field;
- recites elements or steps that are insignificant; and
- recites elements or steps that are merely field of use.