After months of speculation as to the scope of the Supreme Court’s decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (USPTO) yesterday issued guidelines (hereinafter “Guidance”) for evaluating subject matter eligibility under 35 U.S.C. § 101. The Guidance supersedes the memorandum issued on June 13, 2013, which was the day that the Myriad decision was issued. The Guidance attempts to provide much needed clarity as to the USPTO’s stance on subject matter eligibility of isolated natural products, and explains away any apparent inconsistency in its application of Myriad to claims reciting non-nucleic acid subject matter. As explained by the USPTO, “[w]hile the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.” See Guidance at 1 (referencing Diamond v. Chakrabarty, 447 U.S. 303 (1980)).

  1. The Three-Part Test for Patent Eligibility

The Guidance lays out a three-part test for examiners to follow when determining patent-eligible subject matter. In step 1, the examiner must ask whether the claim is directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter. If yes, the examiner proceeds to step 2 to determine whether the claim recites or involves one or more judicial exceptions, such as, for example, an abstract idea, a law of nature/natural principle, a natural phenomena, and a natural product. If the examiner finds that the claim as a whole recites or involves a judicial exception, they must move on to controversial step 3, in which the examiner must determine whether the claim “as a whole” recites something “significantly different” than what falls within the judicial exception. See id. at 2. If the claim is determined to satisfy step 3, the claim is deemed patent eligible under 35 U.S.C. § 101. On the other hand, if the examiner determines that the claim does not rise to the level of a “significant difference,” the claim will be rejected as patent-ineligible subject matter.

  1. How to Analyze Whether a Claim Is “Significantly Different”

The Guidance devotes nearly fifteen pages of instruction, including seven specific examples or hypotheticals, to guide examiners in determining whether a claim recites something “significantly different” than the judicial exception. The Guidance indicates that a “significant difference” can be shown in multiple ways, such as by a showing that “(1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way . . . ; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature . . . .” Id. at 3-4 (emphases added). This begs the question: what elements or steps may be considered to “practically apply” the exception, how does one determine whether any such practical application is “significant,” and how does one determine the meaning of “markedly different”?

  1. The Factors

To aid examiners in answering such questions, the USPTO provides a list of six factors that weigh toward eligibility (i.e., a finding of significant difference) and a list of six factors that weigh toward ineligibility (i.e., a finding of no significant difference). The Guidance cautions examiners to “carefully consider every relevant factor and related evidence before making a conclusion,” and to balance the “totality of the relevant factors.” Id. at 4-5. The Guidance makes clear that not every factor will be relevant to every claim, and that developing case law may generate additional factors over time. Factors that weigh toward eligibility include, for example, situations where the claim recites elements or steps that narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception, and situations where the claim recites elements or steps that do more than describe the judicial exception with general instructions to apply or use the judicial exception. Factors that weigh against eligibility include, for example, situations where the claim recites elements or steps that are at a high level of generality such that substantially all practical applications of the judicial exceptions are covered, and situations where the claim recites elements or steps that are well understood, purely conventional, or routine in the relevant field. Importantly, one concern with the USPTO’s factors is that they are written in sufficiently generalized language so as to require further explanation. Take, for example, factor a), which relates to natural products. According to factor a), a “significant difference” is likely found where a product claim initially appears to be a natural product, but upon further analysis is determined to be “non-naturally occurring and markedly different in structure from naturally occurring products.” Id. at 4. Factor a), however, does not provide any clarity as to what is meant by “markedly different.” Similarly, factor j), which relates to elements or steps recited in a law of nature/natural phenomena, instructs the examiner to weigh against patent eligibility if the elements and/or steps are “well-understood, purely conventional or routine in the relevant field.” Id. at 5. However, factor j) provides no explanation as to the parameters of a well-understood, purely conventional, or routine element. It is likely that a differing of opinions will abound when determining whether a claim limitation meets these standards.

  1. The Examples

But the bulk of the Guidance is directed to hypotheticals that attempt to explain the factors. For instance, Example A relates to the “natural product” exception and poses the following two claims:

Claim 1: A stable energy-generating plasmid, which provides hydrocarbon degradative pathway.

Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Id. The Guidance states that step 3 of the required subject matter eligibility analysis was not met by claim 1, because the claim as a whole recites something that is not significantly different than what exists in nature. The Guidance explains that factor a) is not satisfied because there is no structural difference between the claimed plasmid and naturally occurring plasmids, and therefore the claimed plasmid is not “markedly different” that what exists in nature. This claim would thus be determined to be patent ineligible. On the other hand, claim 2, which recites a bacterium containing two naturally occurring plasmids, successfully meets step 3, since according to factor a), the bacterium is “markedly different” due to its structural and functional differences as compared to naturally occurring bacteria. See id. at 5-6. Thus, Example A provides at least some guidance with regard to the “natural product” exception, providing that structural and functional differences amount to marked differences that may weigh in favor of patent eligibility. Likewise, Example G is intended to provide guidance as to whether an element is “well-understood, purely conventional or routine in the art,” thus helping to clarify factors f) and j). Example G recites three claims relating to a natural principle:

Claim 1. A method for treating a mood disorder . . . , comprising: exposing the patient to sunlight . . . .

Claim 2. A method for treating a mood disorder . . . , comprising: exposing a patient to a synthetic source of white light . . . .

Claim 3. A method for treating a mood disorder . . . , comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a predetermined period ranging from 30-60 minutes . . . .

Id. at 15. The Guidance instructs that claims 1 and 2 do not satisfy step 3 of the subject matter eligibility analysis, in part, because the steps of exposing the patient to sunlight and exposing the patient to a synthetic source of white light are “well-understood, purely conventional or routine” according to factors f) and j). Thus, claims 1 and 2 would not be patent eligible. However, claim 3 satisfies step 3 of the test, in part, because positioning a patient at the recited distance from a filtered light source for the recited length of time is not well understood, purely conventional, or routine. Claim 3 would therefore be deemed patent eligible. See id. at 15-17. Thus, Example G provides at least some guidance with regard to the “natural law” exception, and in particular how to determine whether a particular element is “well-understood, purely conventional or routine.”

  1. Conclusion

Patent practitioners involved in prosecuting claims before the USPTO now have a tool for use in advising their clients as to the patent eligibility of claims relating to natural products, laws of nature, and natural phenomena. It remains to be seen whether the courts’ view of the law is consistent with the USPTO’s guidance, or whether the USPTO will be forced to issue subsequent guidance in accordance with new case law. To watch are the outcomes of the several suits filed by Myriad asserting claims relating to cDNA, primer pairs, and methods for detecting BRCA1/2 mutation, as well as suits by companies such as Counsyl and Quest Diagnostics seeking declaratory judgments of invalidity and noninfringement of many of the same patents asserted by Myriad. Other relevant Federal Circuit cases are slated for decisions this year. In the meantime, the USPTO’s handling of claims relating to natural products and laws of nature may be anticipated, and proactive strategies may be put into place to more cost-effectively provide clients with a realistic strategy for protecting valuable inventions.