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Does USPTO Subject Matter Eligibility Guidance Muddy the Personalized Medicine Waters?

The USPTO’s recently revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 (“the Guidance”),1 provides some clarity to Examiners and Applicants as to what constitutes an “abstract idea.” While the Guidance identifies several abstract ideas that fall within the scope of a “Judicial Exception” during Prong One of the Alice/Mayo test (Step 2A of the Guidance), the Guidance specifically indicates that:

For laws of nature and natural phenomena, Prong One does not represent a change. Examiners should continue to following existing guidance to identify whether a claim recites one of these exceptions, and if it does, proceed to Prong Two of the 2019 Revised Patent Subject Matter Eligibility Guidance in order to evaluate whether the claim integrates the law of nature or natural phenomenon into a practical application.2

Thus, no changes were made to the Prong One analysis of personalized medicine claims that include natural processes. The changes in the Guidance to Prong Two of the test, however, reveal some potential inconsistencies with regard to established case law regarding such personalized medicine-based inventions.

In Prong Two of Step 2A of the Guidance, an Examiner is tasked with evaluating “whether the claim as a whole integrates the recited judicial exception into a practical application of the exception.”3 If the Examiner determines that the judicial exception is integrated “such that the claim is more than a drafting effort designed to monopolize the judicial exception,” then the claim is not directed to a judicial exception, and the eligibility analysis ends. 4

On the other hand, if the Examiner determines that the claim is in fact directed to a judicial exception, then it must be determined if the claim is nonetheless patent eligible under Step 2B. Under this step, the Examiner considers if the claim contains additional elements that provide “significantly more” than the recited judicial exception, and thus provide an inventive concept.5

Perhaps the most important outcome of this revised guidance with regard to step 2A is that an Examiner may never have to consider whether additional elements “represent well-understood, routine, conventional activity.” If the Examiner feels that the additional claim elements, no matter how routine or conventional, make the claim not directed to the judicial exception, then the analysis stops. The claim is determined to be patent eligible. As stated in the Guidance:

Examiners should note, however, that revised Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. Instead, analysis of well-understood, routine, conventional activity is done in Step 2B.
Because revised Step 2A does not evaluate whether an additional element is well-understood, routine, conventional activity, examiners are reminded that a claim that includes conventional elements may still integrate an exception into a practical application, thereby satisfying the subject matter eligibility requirement of Section 101.6

What is not clear, however, is whether this new analysis runs afoul of the decision in Mayo.7 The claims in Mayo represent a basic, personalized medicine approach to the use of a judicial exception – the natural process of the body metabolizing a drug substance. The representative claim in Mayo recited:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.8

The Court in Mayo looked to determine “whether the patent claims add enough to their statements of the correlations to allow the process they describe to qualify as patent-eligible processes that apply natural laws.”9 In reviewing previous patent eligibility cases, the Court specifically mentioned that in nearly each case “simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.”10

While Mayo noted that “additional steps consist[ing] of well-understood, routine, conventional activity . . . are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities,”11 it now appears that the USPTO Guidance allows for the addition of such steps to provide evidence that a claim is not “directed to” a judicial exception. In fact, the Examiner may never even consider if the additional steps in a claim are routine, if it is determined that such steps make the claim not directed to the judicial exception.

It remains to be seen how the courts will view claims allowed under the Guidance. However, it may be prudent for practitioners drafting claims in the personalized medicine field to include steps in dependent claims, for example, that would not be considered “routine or conventional.” Otherwise, granted patent claims that include routine steps, even if they may support the conclusion that the claim is not “directed to” the judicial exception under the Guidance, may find a different outcome when they are reviewed by a court following the holdings in Mayo.

1 2019 Revised Patent Subject Matter Eligibility Guidance,” Federal Register Vol. 84, No. 4 (January 7, 2019)
2 Id. at page 54.
3 Id.
4 Id.
5 Id. at page 56.
6 Id. at page 55 (emphasis added).
7 Mayo Collaborative Servs v. Prometheus Labs., Inc. 566 US 66 (2012).
8 Id. at 74-75.
9 Id. at 77.
10 Id. at 82.
11 Id. at 79-80.