c) Methods only concerning the operation of a device 

It is the established case law of the boards of appeal that a method which is only concerned with the operating of a device without any functional link between the claimed method and the effects produced by the device on the body does not qualify at all as a method for treatment within the meaning of Art. 52(4) EPC 1973 (Art. 53(c) EPC) (T 245/87, OJ 1989, 171, T 789/96, OJ 2002, 364). If, on the contrary, there is such a functional link the method is excluded from patentability (T 82/93, OJ 1996, 274, T 1680/08, T 141/15). In T 1075/06 the board explained that this principle, initially developed for devices for use in a therapeutic treatment (T 245/87, OJ 1989, 171), had been endorsed by the EBA for treatments by therapy as well as surgery (G 1/07).

According to the Enlarged Board in G 1/07, whether or not a claimed method only concerns the operation of a device without any functional link to the effects of the device on the body requires an evaluation of the overall technical circumstances of the case and is therefore a matter to be determined in the individual cases under consideration.

In T 1680/08 a non-invasive method and apparatus for optimising the respiration for atelectatic lungs was held to be a method for treatment by therapy, because there was a functional and indissociable link between the claimed method and any artificial ventilation practised on a connected patient.

In T 44/12 the board stated that, whether or not a method has to be considered a method for treatment of the human body by therapy is determined by the existence of a functional link or a direct influence of the method claimed in itself on a given therapy, such that the medical doctor's freedom of choice and of practice in this respect is hindered. In the present case the board considered that the subject-matter only concerned the operation of a device, without any functional link to the effects of the device on the body.

In T 699/12 the invention pertained to a method of verifying a radiotherapy treatment device. The board held that the claimed method only concerned the technical operation of a device without any functional link to the effects of the device on the body. While the intention of the claimed method was to verify the actual dose that the patient should receive, what was measured was the output dose of the radiation source and it was checked whether the radiation source worked as expected. In the claimed method there was no step that would influence the actual treatment of the patient. The medical practitioner was free to choose the next steps of treatment of a patient.

In T 944/15, the invention, as described, related to a data processing method for controlling a process of monitoring the position of at least a part of a patient's body during a radiation treatment by means of a computer. The board rejected the claim as being a medical method, even though the claim was restricted to a method implemented on a computer. It held that it was not the claimed scope, but the corresponding teaching of the invention which was decisive for establishing what the invention is, and, for the purpose of Art. 53(c) EPC, whether or not a claimed invention only concerned the operation of a device without any functional link to the effects of the device on the body (G 1/07). In conclusion and paraphrasing G 1/07, the board held that the claimed method was not merely directed to the control of the device, because the teaching of the invention was not complete without the steps of initiating the monitoring and using the result; their necessary consideration as part of the teaching of the invention meant that the claim defined a method of treatment excluded under Art. 53(c) EPC.

In T 2136/19 the board did not follow the line of argument of T 944/15. The invention concerned a method for assisting the positioning of a medical structure on the basis of two-dimensional image data. The board held that claim 1 did not recite any method step defining or encompassing a physical activity or action that constituted a method step for treatment of a human or animal body by surgery or therapy (G 1/07). The claimed method was strictly limited to a purely "passive" data processing method, which was carried out entirely and exclusively within a computer without causing any effect on the patient's body as a result. It was irrelevant that the claimed method may be performed after or even iteratively during a surgical intervention on the body. In any event, there would be no functional link between the claimed method and any effects of a surgical or therapeutic nature that would occur during this intervention. Therefore, in the absence of such a functional link, the claimed method as such did not qualify as a method for treatment of the human or animal body within the meaning of Art. 53(c) EPC.

In T 1526/17 the claim was directed to a method for operating a medical navigation system. The medical navigation system comprised a stationary marker device and an electronic device which was rigidly attached to the bone. Hence, its operation was not limited to mere data processing or calculation steps. The possibility that the bone is moved with the attached electronic device was not excluded from the claimed method by the wording of the claim. The board held that the output signal of the camera could only be analysed to calculate the first point if the camera assumed different positions during bone movement. Hence, the movement of the bone with the attached electronic device and the associated data acquisition were indispensable requirements for calculating the first point, even when the calculation involved some approximation and may be carried out after the movement is completed. Hence, said movement was to be considered an integral part of the claimed method. As a consequence, the claimed method comprised the step of pivoting the bone with the electronic device attached to it to produce the data for calculating point P1. The board considered the step of pivoting the bone to be a surgical step, because pivoting the exposed bone involved substantial health risks for the patient.

In T 318/21 the board held that neither G 1/07 nor the decisions cited therein, in point 4.3.2 of the Reasons, defined what was meant by "functional link" in the case of a surgical procedure. Furthermore, the presence or absence of a functional link was relevant solely in so far as the claimed method only concerned the operating of a device (G 1/07, point 4.3.2 of the Reasons, first paragraph). G 1/07 found that a method – even if the method was to be viewed as a method for operating a device – was excluded from patentability as a method for treatment by surgery if it comprised or encompassed a surgical step. In the case at hand, the surgical step – the movement of the endoscope inside the body – was not simply a preparatory step that was performed upstream and not part of the method. Rather, the movement of the endoscope was part of the claimed acquisition of data.