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:
  1. Interaction with the human or animal body.
  2. Comparison against standard values.
  3. Finding significant deviations.
  4. 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 diagnostic steps if possible.
• Remember that the EPO applies a strict assessment of added subject matter.