The European Patent Office considered providing a confirmation element non-technical. Here are the practical takeaways from the decision T 1139/16 (Bestätigungselement/KARL STORZ) of 9.4.2019 of Technical Board of Appeal 3.5.05:
The application underlying the present decision relates to a system for controlling and/or monitoring devices during medical interventions in which, on the one hand, access to generally valid device configurations and device parameters that have been identified as optimal in a large number of comparable interventions is possible, but, on the other hand, it is also ensured that the the medical doctor has taken positive note of these during each individual intervention. Hence, the objective of the application is to avoid that configurations of medical device are used by a medical doctor without having reviewed them (cf. EP 1 995 679 A1, paras. -). This problem is allegedly solved by providing a confirmation element that allows a confirmation of parameters used for the devices during a medical intervention.
Fig. 1 of EP 1 995 679 A1
Translated claim 1 (main request)
1. Device for controlling and/or monitoring at least one device (22, 24, 26, 52) during a medical intervention, comprising:
– at least one control unit (12, 14) for controlling and/or monitoring the at least one device, and
– at least one display unit (42) for displaying data,
– wherein it is possible to access intervention-specific data which comprise at least data on the parameter values which are to be set in the at least one device during a predetermined intervention, characterized in that
– the parameter values are at least partially user-independently predetermined,
– the parameter values can be called up by a user for display by means of the display unit,
– and in that a confirmation element (19) is provided, by the actuation of which the predetermined parameter values for the at least one device are taken over.
Is it patentable?
The application was rejected by the first instance examining division due to lack of novelty in light of document D1. However, the Board in charge came to the conclusion that D1 does not anticipate the claimed subject-matter. However, the board argued that the subject-matter as claimed according to the main request only differs from D1 in feature (g) which reads “a confirmation element (19) is provided, by the actuation of which the predetermined parameter values for the at least one device are taken over”. According to the appellant, this distinguishing feature solves the objective technical problem of enabling a higher level of safety in a medical intervention:
1.6 Consequently, only feature (g) is new to D1. The appellant states that the distinguishing feature (g) solves the objective technical problem of enabling a higher level of safety in a medical intervention. According to the description (see page 5, last paragraph to page 6, second paragraph), feature (g) forces the treating surgeon, for example by asking “Do you agree with the selected parameter values?”, to take note of the predetermined parameters before their adoption, to critically evaluate them and to account for the suitability of the predetermined parameters for performing the specific intervention before actuating the confirmation element.
However, the Board in charge did not follow this line of argumentation and outlined the following:
1.6 (…) In its preliminary opinion, the Board pointed out that an examination or a critical evaluation of parameters as such is not of a technical nature, but of a cognitive or possibly of a legal nature. The appellant’s line of argumentation that a conscious confirmation of the parameters to be adopted contributes to a higher safety of the medical intervention therefore merely constitutes a so-called “broken technical chain fallacy” (see T 1670/07, para. 11)
Against this view the appellant argued as follows:
1.6 (…) However, the appellant further stated that a confirmation element was undoubtedly a technical feature and that the provision of a higher level of security in accordance with the invention did not require the user to be aware of it at all, but was already brought about by the creation of the confirmation element as such.
However, the Board in charge did not share this view and outlined:
1.6 This argument does not convince the Board, since the mere creation of a confirmation element independent of the concrete content of the information displayed to the user and independent of the subsequent cognitive processes or decisions of the user cannot contribute to higher security in the event of a medical intervention. It follows that the provision of a confirmation element according to feature (g) does not solve an objective technical problem.
Hence, the Board ruled that distinguishing feature (g) is only of non-technical nature and thus cannot contribute to inventive step. Hence, the Board in charge dismissed the appeal.
You can read the whole decision here: T 1139/16 (Bestätigungselement/KARL STORZ) of 9.4.2019.