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 6 in the Annex to F-IVExample 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).

Additionally, all method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis, i.e. phases (i)-(iii), must 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. Therefore, in most cases only phase (i), which relates to the examination phase and involves the collection of data, can actually be of a technical nature within the meaning of G 1/04 and therefore concerned with the criterion "practised on the human or animal body" (see T 1197/02, T 143/04, T 1016/10).

It is noted that 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, preparatory steps which concern the adjustment or preparation of the apparatus with which the collection of data will be performed may be comprised in a method claim. 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 the collection of 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 the assessment of whether a claimed method is a diagnostic method falling under the exception clause of Art. 53(c).

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 determine whether a method step of a technical nature to fulfilfulfils the criterion "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).

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