On March 4th, the United States Patent and Trademark Office issued formal guidelines for the determination of patent-eligible subject matter in the wake of two recent U.S. Supreme Court cases: Association for Molecular Pathology v. Myriad Genetics, Inc., (“Myriad”) 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., (“Prometheus”) 566 U.S._, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). The guidelines make clear that claims covering all types of subject matter, not just DNA, will now be examined to determine if they are effectively drawn to something that is naturally occurring, like the claims the Supreme Court found to be patent-ineligible in Myriad.

The guidelines (“Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products,” available here) instruct U.S. patent examiners to expand the ruling in Myriad beyond DNA. In Myriad, the Supreme Court found patent claims directed to isolated DNA to be ineligible for patent protection because they failed to claim "significantly more" than naturally occurring DNA. The guidelines provide a new, three part test to determine whether a claim is directed to patent eligible subject matter.

First, an examiner is to determine whether “the claimed invention [is] directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter.” Guidelines, p. 2. Second, the examiner determines whether “the claim recite[s] or involve[s] one or more judicial exceptions ... [for example] abstract ideas, laws of nature/natural principles, natural phenomena, and natural products.” Id. at 2-3. Third, the examiner determines whether “the claim as a whole recite[s] something significantly different than the judicial exception(s).” Id. at 3.

It is the phrase “significantly different” that the USPTO seeks to clarify with the guidelines. To do this, the guidelines provide two explicit examples where significant differences may be found:

(1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception).
Guidelines, pp. 3-4.

The guidelines then instruct examiners to analyze various factors, reminding them that the analysis is one that requires weighing. Specifically, “[t]he determination of eligibility is not a single, simple determination, but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application.” Some factors that push claims toward patent eligibility include:

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.
Guidelines, p. 4.

Finally, the guidelines provide the examiner with a series of hypotheticals, and some alternate scenarios involving those hypotheticals. Id. pp. 5-18. The hypotheticals, much like those found in the USPTO’s Written Description Training Materials and 2010 KSR Guidelines Update, are an attempt to illustrate the new standards, in action, as they might apply to all types of subject matter, not just DNA. For example, the guidelines discuss the eligibility of claims directed to fireworks and to a medicine derived from the leaves of a tree. DNA is not ignored, as there are also examples dealing with the eligibility of DNA primers, plasmids, and bacteria.

The guidelines also attempt to deal with some of the uncertainty surrounding the holding in Prometheus. In Prometheus, the Supreme Court stated that methods of diagnosing are not eligible subject matter if they do nothing “more than simply state the law of nature while adding the words ‘apply it.’” Slip. Op. at 3. To clarify this holding, the guidelines provide two examples: (1) A method for determining whether a human patient has degenerative disease X and (2) A method for treating a mood disorder in a human patient.

Although not binding on the examiner, and not law, the guidelines should prove a valuable resource for patent practitioners. It is likely that most examiners will use the three part test set forth in the guidelines to determine whether a claim is directed to patent eligible subject matter, or something that is naturally occurring. Claims drafted to conform to the test may stand a greater chance of being found patent eligible than others.