The European Patent Office considered a self-controlling documentation for validated processes non-technical. Here are the practical takeaways from the decision T 2315/16 (Validiertes Verfahren/IMC) of 5.7.2019 of Technical Board of Appeal 3.5.05:
The application underlying the present decision relates to monitoring of validated preparation processes. In more detail, In health care facilities, patients are allegedly repeatedly infected due to the use of contaminated medicine in their treatment. It is therefore necessary for such medicine to be reprocessed according to a validated reprocessing procedure before they are used with patients. However, especially when using complex processing agents, such as computer-controlled sterilizers or disinfection devices in combination with manual substeps, it is not possible for a user to carry out a complete review of all relevant process parameters, since the users of a documentation system for the validated reprocessing procedure are usually medical assistants, whose technical background is not sufficient for such an assessment. Hence, there is a need of a computer-implemented system for monitoring the reprocessing of medicine (cf. EP 2 685 396 A1, paras. -).
Fig. 1 of EP 2 685 396 A1
Translated claim 1 (main request)
1. A computer system (1000) for monitoring the reprocessing of medicine according to a validated procedure comprising:
a recording module (1001) configured to receive measured values (M1, M2) from at least one reprocessing means (2001, 2002) used in the validated method, the measured values comprising technical parameters (101, 102) relevant to the validated method;
a documentation module (1002) for acquiring at least one release instruction for a release decision regarding the processing means (2001, 2002) used of the validated process, wherein the release decision is based on verification and documentation of the complete and correct process flow of the validated process;
characterized in that
an evaluation module (1005) is configured to at least partially prevent the acceptance of the release instruction if at least one measured value (M1, M2) of a technical parameter (101, 102) relevant for the validated method lies outside a predefined tolerance range during the verification, this verification taking place in real time.
Is it patentable?
During first instance prosecution, two different lines of argumentation were presented by the examining division why the claimed subject-matter would lack an inventive step:
1.1 The appealed decision contains two alternative objections under Article 56 EPC, the first of which describes the invention as pure automation of a business method by ordinary technical means. […]
1.2 The second objection is based on D1 as the closest prior art. The appealed decision regards the subject-matter of claim 1 of the main request as essentially the automation of a process known from D1 by means of a computer system. […]
Concerning the first line of argumentation, the Board in charge argued that the claimed invention is a system for monitoring the reprocessing of medicine in a validated process and therefore not a business method.
With respect to the second line of argumentation, wherein the claimed subject-matter would simply refer to an automation of a known process, the Board agreed and outlined:
1.3 According to the established case law of the Boards of Appeal, the mere automation of functions previously performed by humans is in line with the general trend in technology and is not considered inventive (see “Case law of the Boards of Appeal of the European Patent Office”, 8th edition, 2016, I.D.9.18.4).
Against this view the appellant argued as follows:
1.4 On the other hand, the appellant points out that in D1 the release is only carried out by one person and, in the case of pure automation, the release would therefore also have to take place automatically. However, an automation and the request from D1 for release by a person would be contradictory, because in the case of a fully automated release, the processing would take place according to a non-validated procedure. The appellant adds that the skilled person would already fail at the release step during automation. He would also try to automate the release by a human, but the automation of mental activities is not possible.
However, the Board in charge did not share this view and outlined:
1.5 The appellants view is clearly based on the assumption that a process is only automated if no human being is involved in any of its steps. However, this is not what the case-law and the Chamber understand by the term “automation”.
Hence, the Board confirmed the first instance decision that the claimed subject-matter lacks an inventive step and thus dismissed the appeal.
You can read the whole decision here: T 2315/16 (Validiertes Verfahren/IMC) of 5.7.2019.