Quick Navigation

 

Guidelines for Examination

 
 

4.2.1.3 Diagnostic methods

Diagnostic methods likewise do not cover all methods related to diagnosis. To determine whether a claim is directed to a diagnostic method within the meaning of Art. 53(c), it must first be established whether all of the necessary phases are included in the claim (G 1/04).

The claim must include method steps relating to all of the following phases:

(i)
the examination phase, involving the collection of data,
(ii)
the comparison of these data with standard values,
(iii)
the finding of any significant deviation, i.e. a symptom, during the comparison,
(iv)
the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (diagnosis for curative purposes stricto sensu).

If features pertaining to any of these phases are missing and are essential for the definition of the invention, those features are to be included in the independent claim (see Example 9 in Annex II of F‑IV). Due account should be taken of steps which may be considered to be implicit: for example, steps relating to the comparison of data with standard values (phase (ii)) may imply the finding of a significant deviation (phase (iii) - see T 1197/02). The deductive medical or veterinary decision phase (iv), i.e. the "diagnosis for curative purposes stricto sensu", is the determination of the nature of a medical or veterinary medicinal condition intended to identify or uncover a pathology; the identification of the underlying disease is not required (see T 125/02).

It is then necessary to establish which of the method steps have technical character. The final phase (iv), for example, is normally a purely intellectual exercise (unless a device capable of reaching the diagnostic conclusions can be used) and therefore not technical in character.

In order to fulfil the "practised on the human or animal body" criterion, each of the preceding technical method steps relating to phases (i) to (iii) must be performed on a human or animal body. So, for each technical method step, it must be ascertained whether an interaction with the human or animal body takes place. The type or intensity of the interaction is not decisive: this criterion is fulfilled if the performance of the technical method step in question necessitates the presence of the body. Direct physical contact with the body is not required.

It is noted that a medical or veterinary practitioner does not have to be involved, either by being present or by bearing the overall responsibility, in the procedure.

If all of the above criteria are satisfied, then the claim defines a diagnostic method practised on the human or animal body, and an objection will be raised under Art. 53(c).

Accordingly, methods for merely obtaining information (data, physical quantities) from the living human or animal body (e.g. X-ray investigations, MRI studies, and blood pressure measurements) are not excluded from patentability under Art. 53(c).