USPTO Subject Matter Eligibility Guidance, the Federal Circuit and Diagnostic Method Claims: Clear as Mud?
In our January 22, 2019 Blog Post related to the January 2019 USPTO Subject Matter Eligibility Guidance (“the Guidance”), we noted that 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.”1 More importantly, we commented that an Examiner may never have to consider whether additional elements “represent well-understood, routine, conventional activity” when determining whether the claim is directed to a judicial exception. 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. 2
We asked in our last posting, whether this new analysis runs afoul of the decision in Mayo. 3 The recent holding in Athena Diagnotics v. Mayo Collaborative Services, provides an example of how the Federal Circuit applies Mayo to diagnostic method claims, and how it may differ from the USPTO's approach.4
The subject matter at issue in Athena relates to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (“MuSK”).5 Claim 7, which is a dependent claim, was at issue in the appeal to the Federal Circuit. Claim 1, from which claim 7 depends, is also listed below:
1. A method for diagnosing neurotransmission or developmental disorders related to [MuSK] in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSK].
7. A method according to claim 1, comprising
contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid,
immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and
monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex,
wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to [MuSK].6
The district court determined that “the claims lacked an inventive concept, as the recited steps involved only standard techniques in the art.”7 Thus, the district court found the claims not to be patent eligible, under the holding in Mayo.8
In its review of the district court holding, the Federal Circuit agreed with Mayo that Athena’s claims are directed to a natural law, and thus not eligible for patenting.9 The Federal Circuit indicated that the “directed to” inquiry focuses on the claim as a whole. In this case, the Federal Circuit concluded that the claims “are directed to a natural law because the claimed advance was only the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law.”10 The Federal Circuit went on to discuss how Athena’s specification describes the “claimed concrete steps for observing the natural law as conventional.”11
Thus, the Federal Circuit, in its analysis to determine if the claim is “directed to” a natural law, clearly examined whether or not the additional steps were “routine or conventional.”12 Ultimately the court found that such steps involved detecting a natural law “with no meaningful non-routine steps.”13
The Federal Circuit panel in Athena thus included consideration of whether additional elements represent well-understood, routine, conventional activity when determining whether the claim was directed to a judicial exception. This appears to be in contrast to the Guideline's instruction not to include this consideration during the "directed to" inquiry.
While it is unclear how the courts will view issued personalized medicine claims examined under the Guidance, it appears that there is some desire to push the courts to examine what the boundaries of Mayo really are, or should be. As stated in Judge Newman’s dissent in Athena, it is her belief that “it is incorrect to excise from the claims any steps that are performed by conventional procedures,” and rather Athena’s claimed subject matter “is not a law of nature, but a man-made reaction sequence employing new components in a new combination to perform a new diagnostic procedure.”14 Ultimately Judge Newman stated “[t]he majority does not distinguish between the question of whether the claimed method as a whole is eligible, and the question of whether the separate steps use conventional procedures. Instead, my colleagues hold that since the separate procedures are conventional, it is irrelevant that the method as a whole is a new method.”15 Such an argument seems to be in line with USPTO’s suggestion that determination of whether additional steps are “routine and conventional” should be kept out of the analysis of whether or not a claim is “directed to” a natural process. It remains to be seen how future claims will be viewed by the Federal Circuit, but it does appear that claims allowed under the Guidance may stretch the constraints of Mayo, perhaps in support of Judge Newman’s concerns.
2 Id. at page 55 (emphasis added).
3 Mayo Collaborative Servs v. Prometheus Labs., Inc. 566 US 66 (2012).
4 Case No. 2017-2508, (Fed. Cir. February 6, 2019)
5 Id. at page 3.
6 Id. at pages 4-5.
7 Id. at page 7.
9 Id. at page 10.
10 Id. at page 12.
13 Id. at 13.
14 Id. Dissent at page 5.
15 Id. Dissent at page 9.
See the Opinion here.