b) The criterion "practised on the human or animal body" 

According to G 1/04 all method steps of a technical nature should satisfy the criterion "practised on the human or animal body", i.e. the performance of each and every one of these steps should imply an interaction with the human or animal body, necessitating the presence of the latter.

In G 1/04 the Enlarged Board of Appeal held that in a diagnostic method, the method steps of a technical nature belonging to the preceding steps which were constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practised on the human or animal body".

This criterion was to be considered only in respect of method steps of a technical nature. Thus, it did not apply to diagnosis for curative purposes stricto sensu, i.e. the deductive decision phase, which as a purely intellectual exercise could not be practised on the human or animal body.

Art. 52(4) EPC 1973 did not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfied the criterion "practised on the human or animal body" if its performance implied any interaction with the human or animal body, necessitating the presence of the latter. If the preceding technical method steps were performed by a device, this did not satisfy the criterion "practised on the human or animal body" (G 1/04).

In T 1197/02 the invention related to a method of assessing the presence of glaucomatous damage to the visual system of a subject. The board explained that since the criterion "practised on the human or animal body" in Art. 52(4) EPC 1973 was to be considered only in respect of method steps which are of a technical nature (G 1/04, OJ 2006, 334, points 6.4.1 and 6.4.4 of the Reasons), it neither applied to the deductive decision phase, nor to those steps which consisted in comparing the data collected in the examination phase with standard values and in finding a significant deviation resulting from the comparison. These activities were principally of a non-technical nature and normally not practised on the human or animal body. It followed that in most cases, only the step which referred to the examination phase and involved the collection of data could actually be of a technical nature and, therefore, concerned with the criterion "practised on the human or animal body". Additional intermediate steps which concerned for example the adjustment or preparation of the apparatus with which the collection of data would be performed could be introduced into a method claim for completeness. However, since these additional features were not part of one of the steps necessary for making the diagnosis, they were to be ignored when assessing the diagnostic character of the method. The issue of whether or not these intermediate features were of a technical nature and practised on the human or animal body was, therefore, irrelevant for this question.

In T 143/04 claim 1 at issue related to a method of diagnosing Alzheimer's disease in a living subject. The board noted that data processing using an automated apparatus was not actually part of the examination phase which involved the data collection phase, but it resulted from a subsequent, technical step, intermediate between the data collection and the comparison of these collected data with standard values. Such intermediate steps were not to be considered when assessing the diagnostic character of the method. The claim at issue included all the features of a diagnostic method practised on the human or animal body as defined in the opinion G 1/04. The patenting of such a method was prohibited by Art. 52(4) EPC 1973 (Art. 53(c) EPC).