Diagnostic Method Claims at the European Patent Office

Video overview:

Why Claims can be Rejected

Diagnostic method claims can be refused if they include all four steps of the diagnostic process involving interaction with the human or animal body:
Interaction with the human or animal body.
Comparison against standard values.
Finding significant deviations.
Attribution of deviation to a clinical situation.
If any step is missing or no interaction with the body is claimed, the exclusion does not apply.

Drafting Tips to Overcome Rejection

Consider drafting claims without the final diagnosis step, e.g., focus on a new method of data collection.
Avoid steps requiring interaction with the body if possible; instead, define methods as performed in vitro or ex vivo.
If all four steps are claimed and interaction occurs, convert the claim into a first or second medical use claim, using a compound or composition. (Note: Diagnostic medical devices cannot be protected this way.)

Practical Reminders

The EPO applies a strict test for added subject matter — draft carefully to avoid post-filing issues.
Ensure the claims clearly separate the technical method from the excluded diag