EP 3 203 396 A1 relates to a system and method for analysing glucose monitoring data indicative of a glucose level, and a computer program product.
Brief outline of the case
The ED decided that the MR and AR 1 to 4 did not comply with Art 84 and 56 and, inter alia, refused the application as lacking IS over D1=US 2014/0188400 A1.
The board confirmed the refusal.
Claim 1 of the MR and AR 1-9 lacked clarity.
Claim 1 of AR 10 lacked IS.
We will only deal with IS in the present blog.
The applicants point of view on claim 1 of AR 10
The applicants argued that the distinguishing features of claim 1 of AR 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“.
The board’s decision on claim 1 of AR 10
The board was not convinced that features (c) and (d) contribute to the technical character of the invention.
The applicants persistently emphasised 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, Art 52(2) and (3) would contain meaningless limitations of patentable subject-matter, as e.g. mathematical methods are supposed to constantly generate “new data”.
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 like in diagnosis, cf. G 1/04.
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“. Thus, it cannot contribute to the technical character of the invention.
This interpretation of the Convention and of the conclusions of the EBA in G 1/04 and G 1/19, 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.
However, at the OP before the board, the appellants referred to T 2681/16 and to the Guidelines 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”
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 then accepted the technical effect alleged by the applicant “providing an overall measure of the glucose variability and a prediction of glycaemic events that were better than, or at least alternative to, those used in [the closest prior art]”. This technical effect was not achieved over the whole scope of the claim in a higher-ranking request, but was satisfied in a lower-ranking request.
Deviation from T 2681/16
The board was not in agreement with and deviated from the interpretation of the Convention given in T 2681/16. According to Art 20(1) RPBA, the board gave reasons for deviating from T 2681/16.
In particular, the board disagreed with the finding in T 2681/16 that providing an overall “measure” of the glucose variability and a prediction of glycaemic events amounts to a technical effect.
The board was 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 that “measurements” have technical character.
For the present board, a prerequisite for a “measurement” with technical character, within the meaning of the jurisprudence, 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.
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 glycaemic 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.
The Guidelines for Examination in the EPO G-II, 3.3, give, among “examples of technical contributions of a mathematical method”, providing a medical diagnosis by an automated system processing physiological measurements.
As providing a “medical diagnosis” – whether done by a physician or by an automated system – is devoid of any technical character, cf. 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. Art 20(2) RPBA.
In view of the above, the subject-matter of claim 1 of auxiliary request 10 does not involve an inventive step (Article 56 EPC).
Comments
EP 1 988 821 A1, underlying T 2681/16, is classified in A61B5/00 and was dealt with by board 3.2.02.
EP 3 203 396 A1, underlying the present decision, is classified in G06F19/00 and was dealt with by board 3.5.05.
The present board held that, the mere generation of further data from measurement data already collected from the human body is not a technical effect. This conclusion is not convincing.
The “new data” deriving from glucose monitoring data, i.e. the plurality of minimum and/or the maximum glucose values in the present application is comparable to the rate of variability prediction of glycaemic events in T 2681/16.
It is important from a physiological point of view to predict minimum glucose values (hypoglycaemia) and/or maximum glucose values (hyperglycaemia), as both states can be dangerous for a patient. The invention behind the present application relates thus to more than a mere play with data without a technical effect. The physiologic aspect of the “new” data has been completely missed by the present board.
Deciding that subsequent processing of certain measurement data collected from the human or animal body is “predominantly of a non-technical nature” is rather apodictic and bar from any physiologic reality.
It is to be noted that the subject-matter of T 1091/17, was classified in G06F19/00 and was decided by board 3.5.05. The same applies to T 1910/20 and T 335/21. Using decisions from the own board is a kind of self-prophecy and allows to justify anything which has to be justified. It would have been more convincing if decisions of different boards had been brought in the discussion.
It is difficult to understand that a difference in classification for similar subject-matter leads to such a different appreciation. The board 3.2.02 is much more able to determine whether the data has a relation with a physiological state and has thus a meaning going further than a mere play with data. Something went wrong when those different applications were classified at the EPO.
The Guidelines G-II, 3.3 might appear somehow obscure when they speak about “medical diagnosis”, but the present invention as well as that in T 2681/16 have a direct impact on the medical treatment of a patient and belong to what is envisaged under G-II, 3.3.
Comments
4 replies on “T 1741/22 – Dealing with glucose measurements after they have been taken is more than playing with data”
The Board’s position is overly restrictive. The physical meaning of the data is a key argument in favour of technical character. Another aspect of relevance is that the data are based on physical measurements, and are, as such, subject to uncertainties – in other words, are not pure numbers.
@ Mr Hagel,
To me the board’s position is not overly restrictive, it is plainly wrong. Although the new data is based on previous measurements and is not a direct consequence of these measurements, it reflects an important physiological variable for the patients concerned.
The present decision as well as the quoted decisions T 1091/17, T 1910/20 or T 335/21, are simply ignoring the physiological reality behind the measurements and their further exploitation.
The paragraph “ 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. Art 20(2) RPBA.” Is interesting in view of the clear trend in the Guidelines to remove existing references to case law and to not include them when the Guidelines amended in view of new (but non-referenced) case law or observed changes in trends in case law.
@ Roel,
In view of the rather diverging case law of the boards, not only in procedural matters, but also in substantive matters, I have some understanding for the Guideline drafters not to include too much reference to case law in the Guidelines.
It should not be forgotten that decisions quoted in the Guidelines are quasi binding for first instance divisions.
If there is a need for a decision in the Guidelines in the present matter, T 2681/16 is a good decision, and certainly not the present one as well as the three further decisions quoted.