The USPTO earlier this week issued a Memorandum to the Patent Examining Corps with the subject line “2012 Interim Procedure for Subject Matter Eligibility Analysis of Patent Claims Involving Laws of Nature“.

For life science companies, especially diagnostic companies or therapeutic companies attempting to patent processes, this USPTO memorandum may provide some insight into claims allowance in the wake of Mayo v Prometheus.

While the examination procedures are meant to guide USPTO examiners in the wake of the Prometheus decision, they will be supplanted by a final guidance once the Federal Circuit provides an opinion in the Myriad rehearing.

The memo sets forth an essential 3-part process posing these questions:

(1) Is the claimed invention a process? If so, then

(2) Does the claim focus on the use of a “natural principal”?. If yes,

(3) Does the claim include the “additional steps” or element combinations that move the invention beyond the natural principal, as demanded by the Prometheus decision?

If question 3 is reached and the answer is ‘yes’ then the claim is patent-eligible.

And now for the tough question: How does one determine if the additional steps or combination of elements in the claim are sufficient per Prometheus?

The memo refers to various examples, including diabetes testing: “The relationship between blood glucose levels and diabetes is a natural principle.  A correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood, is also considered a natural principle because, while it takes a human action to trigger a manifestation of the correlation, the correlation exists in principle apart from any human action. . .  A claim that sets forth the relationship between blood glucose levels and the incidence of diabetes would require additional steps that do significantly more to apply this principle than conventional blood sample testing or diagnostic activity based on recognizing a threshold blood glucose level.  Such additional steps could involve a testing technique or treatment steps that would not be conventional or routine.”

Michael Shuster