T 1791/22 - Therapeutic dose finding: sometimes inventive but as a rule routine

Key points

• Claim 1 of new auxiliary request 1 filed at the oral proceedings reads as follows:
  "1. A composition comprising a therapeutically effective amount of p-anisaldehyde for use to treat oral pharyngeal dysphagia.

• Dysphagia is a condition characterised by a decreased ability to swallow.

• "The appellant [opponent] argued that putting the envisaged treatment of oral pharyngeal dysphagia into clinical practice on the basis of in vitro data only would place an undue burden on the person skilled in the art. 

• The Board: "This argument does not succeed for the following reasons. ... After favourable in vitro results, dose-ranging studies would be the logical next step. ...  The appellant failed to provide a reason for serious doubt, substantiated by verifiable facts, that, in the case in hand, dose finding would present an unusual burden going beyond the routine work of the person skilled in the art. The fact that the application as filed does not specify a dosage range is not sufficient as a basis for serious doubt."
• "Dose finding for a medical use is, as a rule, considered to be a routine matter for the person skilled in the art. In the case at hand, the treatment elicits an immediate response, and the swallow reflex is a parameter that is easy to observe. Accordingly, dose-ranging studies would not be expected to present much difficulty."

EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t221791eu1