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) and so excluded from patentability, it must first be established whether it includes all of the necessary phases (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 the 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 in the strict sense).

If features pertaining to any of these phases are missing and are essential for the definition of the invention, they must be included in the independent claim (see Example 6 in the annex to F‑IV). Due account must 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", involves determining the nature of a medical or veterinary medicinal condition with a view to identifying or uncovering a pathology; the identification of the underlying disease is not required (see T 125/02).

In addition, a method is only regarded as a diagnostic method within the meaning of Art. 53(c), and so excluded from patentability, if all method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis, i.e. phases (i)-(iii), satisfy the criterion "practised on the human or animal body". However, the steps of phases (ii) and (iii) which consist in comparing the data collected in the examination phase with standard values and in finding a significant deviation resulting from the comparison are not subject to this criterion, because these activities are predominantly of a non-technical nature and are normally not practised on the human or animal body. This means that, in most cases, only phase (i), i.e. the examination phase involving the collection of data, can actually be of a technical nature within the meaning of G 1/04 and so concerned by the criterion "practised on the human or animal body" (see T 1197/02, T 143/04, T 1016/10).

Only the steps strictly describing phases (i)-(iv) have to be taken into account in determining the diagnostic character of the claimed method. Additional, preparatory or intermediate steps which may be introduced into the claimed method are irrelevant for this question (see T 1197/02, T 143/04, T 1016/10). For example, a claim may comprise preparatory steps of adjusting or preparing the apparatus used to collect data. However, these additional features are not part of any of phases (i)-(iii), which are constitutive for making the diagnosis. Likewise, data processing using an automated apparatus is not actually part of the examination phase, which involves collecting data, but it results from a subsequent step, intermediate between data collection and the comparison of the collected data with standard values. The issue of whether or not such additional steps are of a technical nature and practised on the human or animal body is therefore irrelevant for assessing whether a claimed method is a diagnostic method falling under the exception clause of Art. 53(c).

For a method step of a technical nature to meet the criterion "practised on the human or animal body", there must be an interaction with the human or animal body. The type or intensity of the interaction is not decisive: the criterion is fulfilled if the performance of the method step in question necessitates the presence of the body. Direct physical contact with the body is not required.

A medical or veterinary practitioner does not have to be involved in the procedure, be it by being present or by bearing the overall responsibility.

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).