USPTO Memorandum – Subject Matter Eligibilty June 7, 2018
One June 7, 2018, the USPTO issued a Memorandum1 to the Examining Corps emphasizing that method of treatment claims can satisfy 35 U.S.C. §101 under the first step of the two-part Alice/Mayo analysis without requiring a showing of nonroutine or unconventional steps.
The Memorandum was prepared in light of the April 13, 2018 decision by the Federal Circuit in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals2. The patent in Vanda3 was directed towards a method of treating schizophrenia using iloperidone in which the dosage administered to the patient was based on a determination of whether or not the patient was a poor metabolizer of CYP2D6.
In Vanda, the Federal Circuit found that claims directed towards a method of treating schizophrenia were patent-eligible under the first step of the two-part Alice/Mayo analysis4 (i.e., the claims were not directed towards patent-ineligible subject matter). The Court distinguished Mayo, in which the claims were directed towards a diagnostic method, from the claims in Vanda, which were directed towards a method of treatment.
The inventors recognized the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed the application of that relationship. Unlike the claim at issue in Mayo, the claims here require a treating doctor to administer iloperidone in the amount of either (1) 12 mg/day or less or (2) between 12 mg/day to 24 mg/day, depending on the result of a genotyping assay5.
Based on the decision in Vanda, the USPTO Memorandum identified three important points regarding the determination of subject matter eligibility for method of treatment claims.
1. The claims in Vanda were examined as a whole, including the arguably conventional genotyping and treatment steps, when determining whether or not the claims were “directed to” a natural relationship between the patient’s genotype and the risk of QT prolongation.
2. The Supreme Court distinguished method of treatment claims from the diagnostic claims in Mayo and indicated that method of treatment claims (which apply natural relationships as opposed to being “directed to” them) were not implicated by its decision in Mayo and Myriad because they “confine their reach to particular applications.”
3. It was not necessary to determine whether or not the treatment steps were routine or conventional (Step 2B of Alice/Mayo) since the claimed subject matter was found patent eligible in Step 2A.
The Memorandum concludes that “the USPTO’s current subject matter eligibility guidance and training examples are consistent with the Federal Circuits’ decision in Vanda.” In particular, the Memorandum instructs the Examining Corps that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO’s subject matter eligibility guidance” and “(2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under 35 U.S.C. §101.6.”
2 Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018).
3 U.S. 8,586,610 (“the ‘610 patent”)
4 Mayo Collaborative Servs. V. Prometheus Labs, Inc./ 566 U.S. 66 (2012)
5 Vanda at p. 1135.
6 USPTO Memorandum at p. 2.