USPTO Issues New Procedure for Assessing Subject Matter Eligibility of Patent Claims

The U.S. Patent and Trademark Office (USPTO) recently released a guidance memorandum¹ to its examiners on a new procedure for assessing whether a patent claim contains subject matter eligible for patenting. The guidance was established in view of the U.S. Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc.^2,3 Importantly, the USPTO now requires that apparent products of nature, such as proteins, nucleic acids, organisms, or minerals, be "significantly different" than something that is naturally occurring to be eligible for patenting.

In the United States, subject matter eligible for patenting is described in 35 U.S.C. § 101 and includes "any new and useful process, machine, manufacture, or composition of matter."⁴ Courts have created judicial exceptions to these categories, including laws of nature, physical phenomena, and natural products.⁵ The scope of these exceptions is defined in part by the Supreme Court case Diamond v. Chakrabarty, which held that a bacterium comprising four plasmids added by scientists was patent eligible because it had "markedly different characteristics from any found in nature."⁶ In Myriad, the Supreme Court relied on Chakrabarty in holding that merely isolating naturally occurring DNA (i.e., breaking bonds) does not render such DNA patent eligible.⁷

While Myriad's holding was limited to isolated, naturally occurring DNA, the USPTO will now apply the "marked difference" standard used in Myriad and Chakrabarty to evaluate the patent eligibility of other potential natural products.⁸ According to the guidance, a "marked difference" must be a "significant difference," and an examiner that identifies a claim with an apparent natural product will ask whether the claim as a whole recites something significantly different than a naturally occurring object. This question applies to claims that recite not only nucleic acids, but also other subject matter that could be considered a natural product, such as proteins, organisms, and minerals. The claim will be analyzed using a factor-based analysis balancing test,⁹ and the guidance provides an exemplary list of six factors¹⁰ that weigh toward eligibility and six factors¹¹ that weigh against eligibility. A weighing of the totality of the relevant factors will be used to assess eligibility. The guidance also provides hypothetical examples in which the "significantly different" standard is applied.

Going forward, the exemplary list of factors for the factor-based analysis and the exemplary hypotheticals in the guidance should be consulted as a guide for drafting patent-eligible claims reciting subject matter that could be considered a natural product. Further developments in the case law in this area also should be considered. Whether courts extend the Myriad holding to subject matter beyond isolated, naturally occurring DNA remains to be determined.

¹ USPTO Memorandum, "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products," March 4, 2014.

² Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S., 133 S.Ct. 2107, 2116, 106 USPQ2d 1972 (2013). Myriad evaluated the patentability of patent claims to BRCA breast cancer susceptibility genes. The Supreme Court held that "genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material"; see also our WSGR Alert titled "Myriad: A Tempest in the Biotechnology Industry Teapot?" June 17, 2013.

³ The guidance supersedes the USPTO Memorandum "Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc.," June 13, 2013.

⁴ 35 U.S.C § 101.

⁵ See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

⁶ Id. at 310.

⁷ Myriad at 2116-17.

⁸ The guidance states that "[u]se of terms such as 'isolated,' 'recombinant,' or 'synthetic' does not automatically exclude the claim from the test."

⁹ If the claim recites or involves an abstract idea (either alone or in combination with other judicial exceptions), the examiner is instructed to use established procedures in Manual of Patent Examining Procedure (MPEP) § 2106(II) to assess eligibility.

¹⁰ Factors that weigh toward eligibility (significantly different):

a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).
c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).
d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).
e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application. (See MPEP 2106(II)(B)(1) for an explanation of the machine or transformation factors.)
f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional, or routine in the relevant field.

¹¹ Factors that weigh against eligibility (not significantly different):

g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.
h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.
i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).
j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional, or routine in the relevant field.
k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s).
l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.