Generating (and displaying) further new data by an evaluation or interpretation of measurements: non-technical

The decision is based on an examination appeal and relates to a method for analyzing and displaying glucose monitoring data. The Applicant argued that the technical effect did not lie in a mere “presentation of information” but in that “new data was generated”, thus providing an “improved analysis of glucose monitoring data for guidance of a patient or physician.”

However, the Board disagreed and noted that taking of a sample on the patient is an interaction with “physical reality” and generating new data as a consequence of this interaction may result in “measurements” of a technical nature. However, generating (and displaying) further data by an evaluation or interpretation of these measurements amounts to “measurements” generated merely by a cognitive or mathematical exercise that is inherently non-technical. Thus, the application was refused.

Here are the practical takeaways from the decision: T 1741/22 (New medical data/ROCHE) of June 26, 2024, of the Technical Board of Appeal 3.5.05

Key takeaways

The invention

The invention relates to a system and method for analyzing glucose monitoring data indicative of a glucose level in a bodily fluid which is sampled for a person over multiple days within a specified measurement period (e.g., 24 hours). It determines a plurality of minimum glucose values and/or a plurality of maximum glucose values for a selected group or each of the respective sample times. These signals are used to output and display a graphical representation of the glucose values, allowing better insights for patients and physicians.

 

Is it patentable?

The Applicant argued that the distinguishing features were c and d, as follows

(c) [wherein the machine-readable instructions cause the data processing device to] for the plurality of continuous glucose profiles, determine a plurality of minimum glucose values and/or a plurality of maximum glucose values for a selected group or each of the plurality of respective sample times

(d) [wherein the machine-readable instructions cause the data processing device to] provide first display signals representing the plurality of minimum glucose values and/or the plurality of maximum glucose values for the selected group or each of the plurality of respective sample times;

And the applicant argued they were technical:

2.2 The appellants argued that the distinguishing features of claim 1 of auxiliary request 10 over D1 were features (c) and (d), i.e. determining and displaying minimum/maximum glucose values. They stated that the technical effect of the distinguishing features was to provide an “improved analysis of glucose monitoring data”. In particular, “the plurality of minimum/maximum glucose values may correspond to medically relevant outlier values”, which “would otherwise be averaged out in the context of known methods employing percentiles as in D1”. They emphasised that the technical effect did not lie in a mere “presentation of information” but in that “new data was generated”. Accordingly, they formulated the objective technical problem as providing a system for “improved analysis of glucose monitoring data for guidance of a patient or physician”.

But the Board disagreed:

2.3 However, the board is not convinced that features (c) and (d) contribute to the technical character of the invention.

2.3.1 The appellants persistently emphasised, also at the oral proceedings before the board, that the invention generated “new data” from glucose monitoring data. However, if the mere generation of “new data” were sufficient to contribute to the technical character of the invention, Article 52(2) and (3) EPC would contain meaningless limitations of patentable subject-matter, as e.g. mathematical methods are supposed to constantly generate “new data”.

2.3.2 A subset of “new data” that might have been relevant for assessing the contribution to the technical character of the invention in the context of the case at hand could have been a new “collection” of data practised on the human or animal body. Here, the board uses the word “collection” within the same meaning as in G 1/04 referring to “(i) the examination phase [of a diagnostic method] involving the collection of data” (G 1/04, Reasons 5). More recent jurisprudence of the Enlarged Board of Appeal seems to prefer the word “measurement” (G 1/19, Reasons 85 and 99), which involves the calculation of the physical state of an object (i.e. a certain glucose level in a “bodily fluid” in the case at hand). As stated in G 1/19 (Reasons 99), it is generally acknowledged that measurements have technical character since they are based on an interaction with physical reality, such as the human or animal body (see G 1/04, Reasons 6.4.1).

2.3.3 In the case at hand, features (c) and (d) do not involve the actual measurement of the respective glucose level in a bodily fluid. Instead, they process already measured and received continuous glucose monitoring data to generate and display further “new data“, namely a plurality of minimum/maximum glucose values, in order to support a physician in their purely intellectual deductive decision phases of diagnosis and therapy. Such subsequent processing of certain measurement data collected from the human or animal body is “predominantly of a non-technical nature” (ibid.). Thus, it cannot contribute to the technical character of the invention.

2.3.4 This interpretation of the Convention and of the conclusions of the Enlarged Board of Appeal have also been adopted in earlier decisions of this board (see e.g. T 1091/17, Reasons 1.8; T 1910/20, Reasons 1 and 2; T 335/21, Reasons 1.2 and 1.3).

The Board also addressed the decision cited by the applicant T 2681/16:

2.3.5 However, at the oral proceedings before the board, the appellants referred to T 2681/16 and to the Guidelines for Examination in the EPO in support of their view. In particular, the appellants considered the case in T 2681/16 to be analogous to the case at hand. The competent board in that case dealt with distinguishing features related to an algorithm to process already acquired, i.e. measured, blood glucose data points. The board acknowledged that these features, when taken in isolation, were non-technical, and could support the presence of an inventive step only if they credibly contributed to producing a technical effect serving a technical purpose (Reasons 3.2.3). However, the board then accepted the technical effect alleged by the appellant (Reasons 3.2.4), namely “providing an overall measure of the glucose variability (i.e. equally sensitive to both hypo- and hyperglycemic events) and a prediction of glycemic events that were better than, or at least alternative to, those used in [the closest prior art]”. Whereas the board concluded that this technical effect was not achieved over the whole scope of the claim in a higher-ranking request (Reasons 3.2.5 ff.), it was satisfied that this effect was achieved over the whole scope of the claim in a lower-ranking request (Reasons 6.2.1).

2.3.6 This board is not in agreement with and therefore deviates from the interpretation of the Convention given in T 2681/16. According to Article 20(1) RPBA, should a board consider it necessary to deviate from an interpretation of the Convention given in an earlier decision of any Board, the grounds for this deviation shall be given, unless such grounds are in accordance with an earlier decision or opinion of the Enlarged Board of Appeal according to Article 112(1) EPC. In particular, the board disagrees with the finding in T 2681/16 that providing an overall “measure” of the glucose variability and a prediction of glycemic events amounts to a technical effect. The board is well aware of the tendency of applicants to use the word “measure(ment)” liberally in order to give inventions the veneer of technicality. This is mainly because it is generally acknowledged in the jurisprudence of the Boards of Appeal that “measurements” have technical character. Admittedly, the applicants’ use may indeed well correspond to the meaning of the word in common parlance. However, a prerequisite for a “measurement” with technical character, within the meaning of the jurisprudence of the Boards of Appeal, is an interaction with “physical reality” for the calculation of the physical state of an object, even if the measurement may be carried out indirectly, e.g. by means of measurements of another physical entity (see G 1/19, Reasons 99). In the present case and in the case underlying T 2681/16, where the “physical reality” is typically the “patient’s blood”, the interaction with the physical reality ends once blood glucose measurements are carried out, directly on the relevant physical entity “blood”, or indirectly e.g. on another bodily fluid. The provision of overall glucose variability and a prediction of glycemic events are mathematical steps or intellectual activities which take place in the absence of this interaction with the physical reality and are therefore not “measurements” in this sense. In other words, the taking of a sample on the patient is an interaction with “physical reality”. Generating new data as a consequence of this interaction may result in “measurements” of a technical nature. But generating (and displaying) further data by an evaluation or interpretation of these measurements (as done according to features (c) and (d) here) amounts to “measurements” generated merely by a cognitive or mathematical exercise that is inherently non-technical.

2.3.7 As to the Guidelines for Examination in the EPO (in its applicable version of March 2022 and also in its current version of March 2024), section G-II, 3.3, which relates to the technical contribution of mathematical methods, lists

“providing a medical diagnosis by an automated system processing physiological measurements”

among “examples of technical contributions of a mathematical method”. As providing a “medical diagnosis” – whether done by a physician or by an automated system – is devoid of any technical character (see e.g. G 1/04, Reasons 5.3 and 6.3), this example is clearly erroneous. As there is no further explanation, let alone a reference to any case law, the board sees no reason to speculate on how the Guidelines came up with this example (cf. Article 20(2) RPBA).

2.4 In view of the above, the subject-matter of claim 1 of auxiliary request 10 does not involve an inventive step (Article 56 EPC).

Therefore, the Board decided that the appeal was dismissed, and the patent application was refused.

More information

You can read the full decision here: T 1741/22 (New medical data/ROCHE) of June 26, 2024, of the Technical Board of Appeal 3.5.05

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