On March 4, 2014 the United Stated Patent and Trademark Office (“Office”) issued a new Guidance for determining patent eligibility under 35 U.S.C. § 101. See 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products (“Guidance”); see also Eligibility Guidance Quick Reference Sheet (“Quick Reference”).

The Office issued the Guidance in response to the Supreme Court’s recent decisions in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). Guidance at 1. In both cases, the Court held claims invalid under 35 U.S.C. 101.

In Mayo, the Court invalidated method claims that recited administering a thiopurine drug to a patient, measuring the patient’s blood levels of a thiopurine metabolite, and adjusting the dosage of the drug based on the blood levels of the metabolite. 132 S. Ct. at 1295. The Court reasoned that abstract ideas, natural laws, and natural phenomena are not patentable and that a patient’s metabolism of a thiopurine drug was a natural process. Id. at 1293. The Court further reasoned that the claims did not do “significantly more than simply describe” that existing process. Id. at 1297.

In Myriad, the Court invalidated composition claims reciting isolated DNA sequences of genes that increase the risk of breast and ovarian cancer. 133 S. Ct. at 2107, 2113. The Court reasoned that the genes were products of nature. Id. The Court also expressed concern that Myriad’s claims pre-empted the entire field of genetic testing for these genes because isolating the claimed DNA sequences was necessary before testing could be performed. Id. at 2113-14. The Court did hold, however, that composition claims directed to synthetically created cDNA sequences were patent eligible because they were not naturally occurring. Id. at 2119.

In light of these holdings, the Guidance instructs examiners to consider three questions in evaluating the eligibility of a claim:

1) whether the claim is directed to one of the four statutory categories of eligible subject matter (i.e., a process, machine, manufacture, or composition of matter);

2) whether the claim recites or involves a “judicial exception” (e.g., abstract ideas, laws of nature, natural phenomena, and natural products); and

3) if the answer to question 2 is yes, whether the claim as a whole recites something significantly different than the judicial exception.

Guidance at 2-3; Quick Reference at 1.

Examiners are to reject claims that are (1) not directed to one of the four statutory categories of eligible subject matter or (2) do not recite something significantly different than a judicial exception. Id.

To aid examiners in determining whether a claim recites something significantly different than a judicial exception, the Guidance lists six factors that weigh in favor of patentability and six that weigh against. Quick Reference at 2.

In brief, a claim is more likely to be patentable if it recites a product that is not naturally occurring and is markedly different than a naturally occurring product, does not preclude the practical application of the underlying judicial exception by others, recites a machine or transformation, or recites elements or steps that add a feature to a judicial exception that is more than convention or well-understood in the field. Guidance at 3-4; Quick Reference at 2.

A claim is less likely to be patentable if it recites a product that is naturally occurring and not markedly different than a naturally occurring product, precludes the practical application of the underlying judicial exception by others, or recites in addition to the judicial exception only well-understood or conventional steps, a field of use, or insignificant extra-solution activity. Quick Reference at 2.

The Guidance contains 13 pages of examples illustrating how the three questions should be answered and which of the 12 factors apply for different claims. Guidance at 5-18. The Guidance also states that claims involving abstract ideas should be examined in accordance with MPEP § 2106(II). Guidance at 3; Quick Reference at 1.

The Guidance supersedes the June 13, 2013 memorandum to the corps entitled “Supreme Court Decision in Association for Molecular Pathalogy v. Myriad Genetics, Inc.” Guidance at 1.