b) Assessment of "substantial health risks" 

In T 663/02 the board held that the step of "injecting the magnetic resonance contrast agent into a vein remote from the artery" may be considered as representing a minor routine intervention which did not imply a substantial health risk when carried out with the required care and skill. Such acts would be ruled out from the scope of the application of the exclusion clause pursuant to Art. 53(c) EPC following the narrow understanding advocated by the Enlarged Board of Appeal (G 1/04 and G 1/07). A possible way of assessing health risks is to use a risk matrix permitting the levels of likelihood and health impact of a complication of a medical act with regard to a large number of patients to be combined, so as to obtain statistical health risk scores which may be used to decide what action should be taken.

However, in T 1075/06 the board held that venipuncture of blood donors and the extraction of blood from a donor's body represent substantial physical interventions on the body which require professional medical expertise to be carried out and which entail a substantial health risk even when carried out with the required professional care and expertise. A method claim comprising steps encompassing such procedures is a method for treatment of the human body by surgery.

Similarly, in T 1695/07 the board held that a blood manipulation process involving the continuous removal of blood from a patient, its subsequent flowing through a circulating line of an extracorporeal circuit and its re-delivery to the patient was a method of treatment of the human body by surgery. It stated that even when the process was carried out with the required medical professional care and expertise, it involved "substantial health risks" for the patient. A health risk was considered to qualify as "substantial" whenever it went beyond the side effects associated with treatments such as tattooing, piercing, hair removal by optical radiation, micro abrasion of the skin as mentioned in G 1/07. A factual analysis of absolute or relative risks and their likelihood of occurrence based on objective evidence was hardly feasible and should therefore not be required.

In T 2699/17 the application related to the guided expansion of an elastomeric material within the sulcus of a tooth. In this way, the gingiva was retracted from the tooth, such that an appropriate impression of the tooth could be obtained, which was then used in the manufacture of the crown restoration. The criteria as defined in G 1/07 were applied and the board found that minor injury of the epithelium could occur. It then had to examine whether the method qualified as "substantial physical intervention on the body", i.e. whether the health risk was a substantial health risk within the meaning of G 1/07. For that evaluation, different approaches had been suggested in the case law, namely, the 'risk matrix' in decision T 663/02 and a 'more abstract risk criterion' in decision T 1695/07. The board followed the latter approach, which was limited to the question "Is a certain health risk present?" and "Is it substantial?" The board held that the risks here were at a level equal to those present in the methods which G 1/07 considered not to involve a substantial health risk (see also T 467/18).

In T 434/15 the inventions concerned apheresis, a method in which blood was removed from a person, passed through an apparatus for separating and collecting a particular constituent of the blood (in the present case, stem/progenitor cells) and re-transfused without the collected constituent. The fact that a certain method was routine for a highly specialised centre could not, according to the board, automatically lead to the conclusion that such a method would generally be a safe and routine technique. Apheresis was held to be a method using invasive techniques that allowed for extra corporeal manipulation of an organ of the human body. There were considerable health risks involved. Furthermore, apheresis could not be considered to be a generally safe, simple, routine procedure. Consequently, apheresis had to be seen as a method of surgery within the meaning of Art. 53(c) EPC.