Surgical nature of a method step 

In T 992/03 of 4 November 2010, 129Xe gas was used as part of the claimed method. The board observed that it was known that 129Xe could also be used as an anaesthetic, but found that this was irrelevant in assessing whether the claimed methods should be excluded from patentability under Art. 53(c) EPC. The Enlarged Board had clarified in G 1/07 that "there is an exclusion from patentability as a surgical method only if the health risk is associated with the mode of administration and not solely with the agent as such" and any anaesthetic effect of the 129Xe gas thus did not fall under the exclusion.

The question to be decided in T 663/02 was whether the step of "injecting the magnetic resonance contrast agent into a vein remote from the artery" had a surgical character. Citing G 1/07, the board concluded that the fact that an intravenous injection of a magnetic resonance contrast agent could be delegated by a physician to a qualified paramedical professional indicated that such an injection 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.

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.

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