1. In order that the subject-matter of a claim relating to a
diagnostic method practised on the human or animal body falls
under the prohibition of Article 52(4) EPC, the claim is to
include the features relating to:
(i) the diagnosis for curative purposes stricto sensu
representing the deductive medical or veterinary decision phase
as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that
diagnosis, and
(iii) the specific interactions with the human or animal body
which occur when carrying those out among these preceding steps
which are of a technical nature.
2. Whether or not a method is a diagnostic method within the
meaning of Article 52(4) EPC may neither depend on the
participation of a medical or veterinary practitioner, by being
present or by bearing the responsibility, nor on the fact that
all method steps can also, or only, be practised by medical or
technical support staff, the patient himself or herself or an
automated system. Moreover, no distinction is to be made in this
context between essential method steps having diagnostic
character and non-essential method steps lacking it.
3. In a diagnostic method under Article 52(4) EPC, the method
steps of a technical nature belonging to the preceding steps
which are constitutive for making the diagnosis for curative
purposes stricto sensu must satisfy the criterion "practised on
the human or animal body".
4. Article 52(4) EPC does not require a specific type and
intensity of interaction with the human or animal body; a
preceding step of a technical nature thus satisfies the
criterion "practised on the human or animal body" if its
performance implies any interaction with the human or animal
body, necessitating the presence of the latter.
