Diagnostic and Immunization Claims in Classen
Two types of method claims were at issue in Classen: claims directed to immunizing a mammalian subject on a schedule that presented the lowest risk of chronic immune-mediated disorders, and claims directed to evaluating immunization schedules that minimize the risk of an autoimmune disorder.
Not so surprisingly, in August 2011, the court in Classen held on remand that the method claims reciting the physical step of immunizing a mammalian subject were patent-eligible, even though other evaluating parts of the claims may have included a mental step. The majority reasoned that similar to treatment claims, the immunizing step was directed to a specific, tangible application, and thus, transformative under Prometheus, and the presence of an additional mental step was not fatal.
In contrast, method claims for determining an immunization schedule by gathering, reviewing, and comparing known immunization results found in the scientific literature, without a physical immunization step, were merely data gathering directed to an intangible mental process, and thus, were patent-ineligible.
The Classen decision at this point is still quite consistent with the Prometheus and Myriad decisions, providing that, to be patent-eligible under the transformative test, a method claim directed to a diagnostic tool or therapeutic treatment or immunization must include an active physical modification step that is central to the purpose of the claimed method.