Updated subject matter eligibility guidance from the USPTO

On the same day that the Supreme Court’s opinion was handed down in Assoc. for Mol. Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), the U.S. Patent Office issued a “memorandum… to provide preliminary guidance” (“memorandum”) for Examiners to use in light of the Myriad holding. This memorandum indicated that further guidelines would be coming in the future, and on 4 March 2014 they finally arrived (“guidelines”). These guidelines apply most particularly to inventions that might fall into the “product of nature” and “law of nature” exceptions to subject matter eligibility; the guidelines are careful to make clear (pg. 1) that “[t]here is no change to examination of claims reciting an abstract idea, which should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II),” (emphasis in original). The guidelines supersede the previous memorandum, and answer important questions that the memorandum left unaddressed. The following points are worth noting:

(1)  Although the holding of Myriad only specifically addressed “naturally occurring DNA,” (Id. at 2111), the logic by which the Court arrived at this conclusion would appear to apply with equal force to other naturally occurring substances, such as proteins, lipids, viruses, etc. The initial post-Myriad memorandum was careful to confine itself only to the subject of nucleic acids (pg. 1, “Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof…” emphasis in original). Indeed, the PTO evidently still believes that Myriad’s holding applies only to nucleic acids (guidelines, pg. 1 “the holding in Myriad was limited to nucleic acids…”).

      Nevertheless, the new guidelines make clear that they apply beyond just nucleic acids (pg. 3, “If the claim recites or involves… something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself,” bold/italic in original, underlining added).

(2) The new guidelines provide a flow chart for determining subject matter eligibility, which ends with a multi-factor balancing test that the guidelines liken to the Wands factors for enablement determination. The guidelines strongly favor use of these Wands-like factors (pg. 3, “If there is any doubt as to whether the claim recites a judicial exception… the claim requires further analysis under Question 3. For example, if the claimed product is a protein or a mineral, then the analysis must proceed to Question 3…” emphasis in original).

This is true even when the analysis arguably could stop at Question 2. For example, page 5 of the new guidelines give the example of a claim “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.” It is at least possible that such a Pseudomonas exists in nature, but the guidelines are careful to make clear (pg. 6) that this possibility is not enough to sustain a §101 rejection. In this respect, the guidelines are following Myriad, where the court indicated in dictum that the mere theoretical possibility that something exists in nature is not enough to bring a claim into the “product of nature” exception. Myriad, 133 S. Ct. at 2119 n.8.

The multi-factor balancing test gives a number of points to consider, no one of which is supposed to be determinative. The points include:
Factors that weigh toward eligibility:

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.

AND

Factors that weigh against eligibility:

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.

As with most multi-factor tests, some factors appear in practice to matter more than others. For composition claims, all the work is done by factors (a) and (g) in the examples. For method claims, factors (b), (c), (h), and (i) appear to do most of the work. In the examples given, factor (e) appears somewhat superfluous (see, e.g. Example E, claim 2, pg. 13 and Example F, claim 1, pg. 14).

(3) Perhaps most significantly, the PTO has reaffirmed that the subject matter eligibility analysis must be conducted on the claim as a whole (guidelines pg. 3, “Question 3”). This is important, because some District Courts read Mayo Serv. v. Prometheus Labs, 132 S. Ct. 1289 (2012) to hold that claims should be broken up into “routine” and “novel” elements, with the “routine” elements playing no role in the §101 determination. See, e.g., Ariosa Diagnostics v. Sequenom, Inc., No. C11-06391, 2013 U.S. Dist. LEXIS 156554, at *27–30 (C.D. Cal. Oct. 30, 2013).

(4) Finally, it is worth considering two examples that the guidelines provide of claims that the PTO considers subject-matter eligible, even in view of Mayo. On pages 7 and 15 the following exemplary claims are provided:

A method of treating colon cancer, comprising:
administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days,
wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, 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 to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

The guidelines provide that both of these claims are patent eligible, despite the fact that at their inner-most core, the claims involve a law of nature (viz., the ability of amazonic acid to combat cancer in the first example, the ability of light exposure to treat a mood-disorder in the second). The guidelines explain that the additional limitations, in particular “10 days to 20 days,” “0.75 to about 1.25 teaspoons,” and “colon cancer” (as distinct from “cancer” more generally) (pg. 8) in the first example and “distance between 30–60 cm” and “filtering the ultra-violet (UV) rays” (pg. 17) in the second example create a significant difference between the claim and the bare recitation of the law of nature.

Therefore, when facing a subject matter eligibility rejection predicated on a law of nature exception, it seems worthwhile to add details such as dosage and disease to the independent claim (provided, of course, that there is written description support for the limitation). Ideally, one could create a series of independent claims that would dominate the entire field, even though each single independent claim would be restricted enough to be subject matter eligible. That is to say, instead of claiming a “method of treating cancer,” one can write the application to disclose every known cancer individually, and then claim different cancers in different claims.