This decision concerns a European patent application relating to a system for storing and retrieving biomedical information. Here are the practical takeaways from the decision of T 1199/20 (Medical information service/ACTX) dated July 11, 2024, of Technical Board of Appeal 3.5.01.
Key takeaways
The invention
The claimed system stores biomedical information in a three-level hierarchical data structure. A node at each level is linked to one or more nodes at the adjacent level(s). Each clinical-action node stores medical information and one or more (Boolean) expressions specifying combinations of genomic variants for which the medical information is relevant. When queried for information about a patient, the system retrieves the medical information of those clinical-action nodes whose expressions match the patient’s genomic variants. The retrieved information may relate e.g. to the effectiveness or adverse effects of a medicament.
Fig. 15 of EP2962270
Here is how the invention was defined by claim 1 of auxiliary request 3 (which was relevant for assessing the inventive step):
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Claim 1 (auxiliary request 3)
Is it patentable?
The examining division refused the European patent application for inter alia lack of inventive step (Article 56 EPC) over the notoriously known prior art of a distributed information system.
The outcome was not changed after the appeal. The Board of Appeal made the following reasonings regarding auxiliary request 3:
2.3 The Board agrees that a generally known distributed information system can be taken as a starting point for assessing inventive step. Such a system comprises (virtual) data facilities for storing information and (virtual) servers for receiving user queries, retrieving and returning relevant information.
Claim 1 essentially differs by the data structure, specifying the types of stored data and their relationships.
The Board agrees with the examining division that the data structure is not technical. It describes the organisation of biological data at an abstract logical level, which is in the realm of information modelling (as noted in point 2.2 of the decision under appeal). Information modelling is an intellectual activity and cannot contribute to the technical character of the invention unless it serves a technical purpose (see e.g. T 49/99 – Information modelling/INTERNATIONAL COMPUTERS, point 7). As elaborated in more detail below, the Board does not consider that the claimed data structure serves such a purpose.
First: the claimed “medical information” is broad and can contain non-technical information
2.5 Firstly, they argued that retrieving medical information relevant to a patient’s genomic variants was a technical purpose since this information objectively described a human being. The appellant cited section G-II, 3.3 of the Guidelines for Examination, according to which the processing of biological data might serve a technical purpose, such as providing a medical diagnosis or estimating a genotype.
The Board agrees that in certain cases the provision of a medical diagnosis or a genotype estimate might be regarded as a technical purpose. However, the system of claim 1 retrieves “medical information”. This broad term encompasses administrative or financial details related to health care, such as information about suitable insurance policies or the cost of medical treatments. Therefore, the Board considers that retrieving such general information does not constitute a technical purpose for the claimed data structure.
The Board furthermore notes that claim 1 only defines the data structure, i.e. the types of stored data and their relations, but not the actual content of the stored information, i.e. which medical information, expressions and variants are stored and linked. The retrieved information, however, can only be as good as the stored information. Since the latter is not part of the claim, it is impossible to say anything about the relevance or objectivity of the retrieved medical information. Technical advantages or achievements that depend on the undisclosed content of stored information cannot form the basis for assessing inventive step (see e.g. T 1153/02 – Diagnostic system/FIRST OPINION, point 3.6).
2.6 In this context, the appellant asserted that the system of claim 1 did not merely retrieve pre-stored patient data but could infer new information about patients from their genomic data and the generic information stored in the data structure.
The Board notes, however, that the novelty of retrieved information does not make this information relevant. As claim 1 does not specify the stored content, it permits linking any variants to any medical information, potentially allowing the storage and retrieval of biologically meaningless or factually erroneous information.
Second: the data stored in the claimed data structure are not functional
2.7 Secondly, the appellant argued that the data structure was characterised by functional data indexing stored information by genetic variants. It defined a particular way of storing, retrieving, and processing data which affected the system’s storage space and processing speed. The appellant referred to earlier decisions, in particular T 1351/04 (File search method/FUJITSU) and T 1159/15 (Model determination system/Accenture), in which the boards of appeal had recognised such data structures as technical.
In the Board’s view, however, the data stored in the claimed data structure are not functional as they do not comprise or otherwise reflect any technical aspects of the system. Rather, the data structure defines a conceptual model of biological information that takes into account the inherent hierarchical properties of the modelled information.
2.8 Furthermore, the Board finds that decisions T 1351/04 and T 1159/15 are not relevant to the present case:
In T 1351/04, it was held that a data structure defining a search index was technical since the information it comprised was intended to control the computer by directing it to a certain memory location (see points 7.2 and 9). The information stored in the data structure of claim 1, however, is not intended to provide such a functionality. The system does not use the patient’s variants to access and retrieve clinical-action nodes. Instead, it retrieves clinical-action nodes based on clinical actions specified in the query and only uses the patient’s variants to assess the relevance of the retrieved information.
In T 1159/15, the invention related to a hierarchical data structure storing cognitive data as well as instructions for aggregating these data from a lower to a higher level. The deciding Board held that the instructions were functional data as they defined how the system responded to a query independently of the cognitive data (point 5). The data structure in claim 1, however, does not comprise any system instructions that are independent of the stored biological information.
The Board in case T 1159/15 further held that the data structure was technical because it defined a particular way of storing, retrieving and processing data which affected the storage space and the speed of processing (point 5.1). The present Board, however, notes that any data structure or algorithm (whether technical or not) when implemented on a computer would affect the computer’s storage space and speed of processing. Therefore, in the Board’s view, de facto changes in the memory usage or the processing speed are not suitable criteria for distinguishing between technical and non-technical features (see e.g. T 1227/05 – Circuit simulation/Infineon, point 3.2.5 and T 1954/08 – Marketing simulation/SAP, point 6.2).
Summary: the claimed data structure is an abstract model of biological information
2.9 In summary, the Board judges that the data structure in claim 1 is an abstract model of biological information. It does not contribute to the technical character of the invention because it neither serves a technical purpose nor involves any technical considerations about the internal functioning of the system. The Board thus agrees with the examining division that the data structure is non-technical and forms part of the requirements specification given to the skilled person for implementation. The Board considers that the claimed implementation amounts to straightforward automation of these requirements that would have been obvious to the skilled person.
Finally, the Board concluded that claim 1 of auxiliary request 3 lacks an inventive step. All the other requests could not overcome this objection. Hence, the European patent application was finally rejected.
More information
You can read the whole decision here: T 1199/20 (Medical information service/ACTX) dated July 11, 2024, of Technical Board of Appeal 3.5.01.