A few weeks ago (mid-October 2019), the USPTO released an updated (view here) patent subject matter eligibility guidance (PEG) along with new examples related to personalized medicine, therapeutic methods, and pharmaceutical products.
The October update is essentially a clarification of the January 2019 guidance.
This update analyzes five areas of the 35 U.S.C. §101 analysis and procedure in detail, and is accompanied by four new hypothetical § 101 examples, an index of all such examples published since early 2015, and an updated spreadsheet of § 101 court cases.
This new guidance addresses the following points:
(I) evaluating whether a claim recites a judicial exception;
(II) the groupings of abstract ideas enumerated in the 2019 PEG;
(III) evaluating whether a judicial exception is integrated into a practical application;
(IV) the prima facie case and the role of evidence with respect to eligibility rejections; and
(V) the application of the 2019 PEG in the patent examining corps.
The PEG includes treatment/prophylaxis considerations and discusses the following factors:
- the particularity or generality of the treatment or prophylaxis;
- whether the limitation(s) have more than a nominal or insignificant relationship to the exception(s); and
- whether the limitation(s) are merely extra-solution activity or a field of use
Under the first factor, the guidance explains that the treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications and that also recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” would be considered eligible. Conversely, a claim that recites the same abstract idea and “administering a suitable medication to a patient” would not.
Under the second factor, the guidance discusses that the treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). For example, consider a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis (a life-threatening medical condition), and that also recites, “treating a patient having a blood glucose level over 250 mg/dl with insulin.” This administration step is particular and integrates the law of nature into a practical application. Alternatively, consider a claim that recites the same law of nature and also recites “treating a patient having a blood glucose level over 250 mg/dl with aspirin.” Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots).
Under the third factor, the guidance states that the treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. For example, consider a claim that recites (a) administering rabies and feline leukemia vaccines to a first group of domestic cats in accordance with different vaccination schedules, and (b) analyzing information about the vaccination schedules and whether the cats later developed chronic immune-mediated disorders to determine a lowest-risk vaccination schedule. Step (b) falls within the mental process grouping of abstract ideas enumerated in Section I of the 2019 PEG. While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. Conversely, consider a claim reciting the same steps (a) and (b), but also recites step (c) “vaccinating a second group of domestic cats in accordance with the lowest-risk vaccination schedule.” Step (c) applies the exception, in that the information from the mental analysis in step (b) is used to alter the order and timing of the vaccinations so that the second group of cats have a lower risk of developing chronic immune-mediated disorders. Step (c) thus integrates the abstract idea into a practical application.
The guidance provides some examples (see Example 43 on the application of this guidance to claims relating to the treatment of a specific kidney disease). Unfortunately, the new guidance left out a discussion or examples of diagnostic method claims capable of overcoming ineligibility rejections.
Please contact me at email@example.com with questions or comments.
Silvia Salvadori, PhD