Leadership Insights on New Patent Commissioner’s Memo
By Warren D. Woessner, JD, PhD
Principal – Schwegman, Lundberg, Woessner
On May 4th, Robert W Bahr, Deputy Commissioner of the USPTO, sent a memo to the Examiners including 30 pages of Examples to illustrate the appropriate response to applications containing patent claims that contain “judicial exceptions” to the classes of invention broadly described in s. 101 of the patent statutes.
The 20 hypothetical examples were clearly intended both to conform PTO examination to the state of the law in a number of life sciences areas including vaccines, diagnostics, and natural products. Sixteen of the Examples were taken from real cases decided by the Federal Circuit or the Supreme Court.
In some respects, the Examples answered questions about patent-eligibility that patent Examiners and their attorneys have been asking for since the Supreme Court decisions in Mayo v. Prometheus and Alice v. CLS Bank were combined by the Supreme Court into the “Mayo/Alice Rule” last year.
This rule effectively bars patenting an invention such as a diagnostic test that depends on the discovery of a naturally-occurring correlation that leads to a diagnostic conclusion (such as the PSA assay) unless the claim contains a further inventive concept, such as an unconventional way to prepare the blood sample or to measure the biomarker.
The only method claims that do not contain natural correlations that would trigger this further evaluation are those drawn to methods of simply detecting a biomarker in a patient sample or drawn to medical treatment involving administering a drug and measuring its concentration or metabolite levels in the body. Such claims stop short of drawing a diagnostic conclusion. Therefore, while they may be patent-eligible under the Mayo/Alice rule, they fail to protect the heart of the inventor’s discovery and may also be unpatentable under other sections of the patent statutes.
The only escape from this trap is to examine the claim for additional steps defining an additional feature of the test that is not a “well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention.” Simply drawing blood and testing it using ELISA would not meet this additional requirement, since these activities are conventional and routine. The only Examples that the PTO finds patent eligible are ones that involve adding an unconventional detection step for the biomarker or treating the diagnosed condition with an unconventional treatment, such as a drug not known to be useful to treat the diagnosed condition.
This is a heavy burden for most inventors/applicants to meet, and amounts to adding a second invention to a claim that already provides a new correlation step (“If A, then B”) that may be of great commercial and medical value. However, the Federal Circuit has ruled that the recognition of the significance of the natural correlation cannot provide the further inventive concept required by the Mayo/Alice test.
This leaves applicants and their attorneys with the task of proving a negative – that at least one of the other steps of the claim were not routinely carried out by other scientists working in the field. One thing it clear. Patenting in the area of new diagnostic methods, including “companion diagnostics” that are the key to personalized medicine will be severely limited unless the courts or Congress repudiate the Mayo/Alice test, or substantially reduce its scope.