12 years ago

June 10, 2013

In view of the general issue of patent-eligibility and frequency of rejections under 35 USC 101 in currently pending pharmaceutical and biotechnology patent applications involving patient response assays and biomarker assays, the following approaches may be helpful in resolving and avoiding such rejections.

Under the law deriving from the decision in Mayo v. Prometheus, 566 U.S. ___ (2012), claims that are directed merely to a method of dosing a patient with an agent to determine a response that may be subsequently utilized for deciding treatment or prognosis, or to a method of determining from a patient sample a biomarker for a specific condition, are taken to be patent-ineligible subject matter under 35 USC 101 of the U.S. Patent Law, as simply embodying a “natural principle” (a “natural” stimulus-physiological response event, or a “natural” genetic constitution).

There are various approaches to overcoming rejections based on 35 USC 101 “natural principle” grounds. 

One such approach is to incorporate in the claim an affirmative recitation of administration of a therapeutic agent based on the results of the earlier screening methodology.

Another approach to impart patent-eligibility under 35 USC 101 is to include in the claim the steps of processing of a biological sample from the patient, e.g., by forming an antibody complex with the specimen, and then processing the complexed specimen to identify a disease state or condition, or conducting a chemical reaction of the specimen with a reagent to form a reaction product that then is measured to characterize the patient, or to determine therapeutic intervention.

Steven J. Hultquist, Principal

Hultquist IP

© 2013 Hultquist, PLLC