For the whole decision click here: o23306
Summary
The invention related to an electronic system for monitoring clinical drug trials which prompted a subject to take a drug at appropriate times (medical compliance) and also generated a diary form on which the subject was required to record information. The examiner objected that the original method claims did not relate to any advance which was not excluded under section 1(2) having regard to the test in CFPH LLC’s Application [2005] EWHC 1589, [2006] RPC 5. He was however prepared to accept an amended claim, in which the medical compliance prompting was halted if the subject failed to complete a diary form, as not excluded under section 1(2), but found it to lack inventive step in the light of prior art documents relating to electronic compliance systems (mainly for monitoring a patient’s usage of prescribed drugs). The hearing officer did not accept the applicants’ argument that halting compliance monitoring for failure to complete a diary form was inventive in the context of clinical trials, and found all claims to lack inventive step. He saw nothing in the specification which could constitute a patentable advance and refused the application.