Key points
- The case was publication code [B] by the Board, i.e. of general interest. "Claim 1 of auxiliary request 10 contains the following limiting features (board's labelling):
- Essentially, the system has a display to display minimum and maximum values from 24 hours of received "continuous glucose monitoring data" (from a wearable glucose measurement device, I guess). The system itself is not a continuous glucose monitor.
- "The appellants [proprietors] 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. [D1 shows percentiles]. [The proprietors] 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". "
- The question is whether these features provide for an inventive step. The Board approaches it from the question of whether the features provide a technical contribution ("contribute to the technical character of the invention").
- As an aside, a test of the Board's reasoning is if it makes sense if the distinguishing feature was "calculating the third harmonic eigenvalue" (instead of minimum/maximum, just making up a fancy term here) and the clear and convincing evidence is that this value, hidden in what was considered random noise before the invention, turns out to be life-saving information. That helps to distinguish between 'this is obvious for any scientist in the field but I don't have the right prior art at hand' and 'it is very smart but not technical'.
- The Board: "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"."
- The Board then sets out that steps C and D are not actual measurement steps and are not, for that reason, technical.
- Note that even including a technical measurement step may not necessarily mean that the further steps of processing the resulting data are automatically technical in the sense of G1/19 (T 0489/14, r.7.4).
- "The appellants [proprietors] referred to T 2681/16 and to the Guidelines for Examination in the EPO in support of their view. "
- Dealing with the argument based on the GL first in this post: "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)."
- I will quote the relevant parts in G1/04 in full. It would have been helpful if the TBA had identified the relevant sentences - especially because G 1/04 was about Art. 52(4) EPC 1973, i.e. about industrial applicability, not about non-inventions of Art. 52(2) EPC 1973.
- I will highlight below some parts of G1/04, cited paragraphs, that are at first sight a bit at odds with the TBA's reasoning based on the same paragraphs of G1/04, to the extent I can understand the TBA's reasoning in all its brevity.
- G 1/04: "5.3 Since diagnostic methods referred to in Article 52(4) EPC are inventions within the meaning of Article 52(1) EPC (cf. point 4 above), it follows that, in a situation where the deductive medical or veterinary decision phase is a purely intellectual exercise, i.e. a step of a non-technical nature, such a method must necessarily further include preceding steps (cf. point 5 above) of a technical nature, in order to satisfy the requirements of Article 52(1) EPC. The subject-matter of a claim including technical and non-technical features may satisfy the requirements of Article 52(1) EPC if the non-technical features interact with the technical features in order to bring about a technical effect (cf. T 603/89 (OJ EPO 1992, 230), point 2.5 of the Reasons).
- "6.3 In the judgment of the Enlarged Board of Appeal, the qualification of an activity as having a diagnostic character may not depend on who is involved. The wording of Article 52(4) EPC is unequivocal in that the exclusion relates only to the method, and not to the person carrying out the method. Furthermore, no indication can be found in the preparatory documents to the EPC which would restrict the exclusion of diagnostic methods from patentability to a certain group of persons such as medical or veterinary practitioners. Also, as already mentioned under point 6.1 above, defining the medical or veterinary practitioner on a European level within the framework of the EPC is difficult if not altogether impossible. To allow the grant of a European patent to depend on the involvement of such a person would therefore introduce legal uncertainty into the patent granting procedure. Thus, whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or non-medicinal support staff, the patient himself or herself or an automated system. This also reflects the well-known fact that technological advances penetrate human and veterinary medicine and the medical and veterinary profession. Today, and more than at any time before, technology is about to fundamentally alter how and by whom health care is administered, with the result that human and veterinary medicine is gradually being reshaped by technology. In a changing medical or veterinary environment brought about by technological progress, the need for reconsidering the relationship between medical or veterinary practitioners and non-medicinal support staff will become more pressing than ever before. This will have implications for the non-medicinal support staff in terms of profile and expansion in that a great variety of diagnostic and other information will have to be procured and gathered by these persons. Moreover, no distinction should be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it. The reason for this judgment lies in the fact that, again contrary to the requirement of legal certainty, the assessment of the factual and legal situation in connection with these issues could change considerably in time. As has been mentioned under point 6.1 above, consideration might be given to exploring the possibility of protecting the activities of medical and veterinary practitioners by other means on the national level."
- The Board also " 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.". "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 [note; and these physical steps are not claimed in the patents] The [note: actually claimed steps of 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."
- "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. "
- G 1/19 r.98: "Calculated status information or physical properties concerning a physical object are information which may reflect properties possibly occurring in the real world. However, first and foremost, they are mere data which can be used in many different ways. There may exist exceptional cases in which such information has an implied technical use that can be the basis for an implied technical effect. Still, in general, data about a calculated technical effect is just data, which may be used, for example, to gain scientific knowledge about a technical or natural system, to take informed decisions on protective measures or even to achieve a technical effect. The broad scope of a claim concerning the calculation of technical information with no limitation to specific technical uses would therefore routinely raise concerns with respect to the principle that the claimed subject-matter has to be a technical invention over substantially the whole scope of the claims"
- G 1/19, r.128 mutatis mutandis: " In the Enlarged Board's view, calculated numerical data reflecting the physical behaviour of a system [from measurements] usually cannot establish the technical character of an invention in accordance with the COMVIK approach, even if the calculated behaviour adequately reflects the behaviour of a real system underlying the [measurement]. Only in exceptional cases may such calculated effects be considered implied technical effects (for example, if the potential use of such data is limited to technical purposes"
- See also r.98: "calculated status information or physical properties concerning a physical object are information which may reflect properties possibly occurring in the real world. However, first and foremost, they are mere data which can be used in many different ways. There may exist exceptional cases in which such information has an implied technical use that can be the basis for an implied technical effect. Still, in general, data about a calculated technical effect [?] is just data, which may be used, for example, to gain scientific knowledge about a technical or natural system, to take informed decisions on protective measures or even to achieve a technical effect. The broad scope of a claim concerning the calculation of technical information with no limitation to specific technical uses would therefore routinely raise concerns with respect to the principle that the claimed subject-matter has to be a technical invention over substantially the whole scope of the claims (see point E.I.b above, referring to T 939/92)."
- See also the broken technical chain fallacy as reviewed in T 1670/07: "the Board sees something of a well known argument that could be termed the "broken technical chain fallacy" after decision T 1741/08 - GUI layout/SAP. This decision dealt with the fairly common situation that arises in connection with graphic user interfaces (GUIs) where a technical effect might result from the user's reaction to information. The decision essentially concluded (see point 2.1.6) that a chain of effects from providing information to its use in a technical process is broken by the intervention of a user. In other words, the possible final technical effect brought about by the action of a user cannot be used to establish an overall technical effect because it is conditional on the mental activities of the user. This applies to the present case because any possible technical effect depends on the user's reaction to the itinerary."
- These observations are without prejudice to the question of whether claims involving the display of medical diagnostic data should benefit from the exception of G1/19 r.98 and r.128 of an implied technical use and effect of the calculated or displayed data, the possible argument being the potential use of the data is (practically, realistically) limited to medical purposes (methods of treatment of patients) and that medical purposes are technical purposes.
(a) A system for analysing glucose monitoring data indicative of a glucose level in a bodily fluid, comprising: an input device, a data processing device, an output device, a display device, and machine-readable instructions that are executed by the data processing device,
(b) [wherein the machine-readable instructions cause the data processing device to] receive continuous glucose monitoring data via the input device, the continuous glucose monitoring data indicating a glucose level sampled for a person in a bodily fluid at a plurality of sample times over a measurement time period in a continuous glucose level measurement, and comprising a plurality of continuous glucose profiles, each of the glucose profiles comprising a plurality of glucose values with a glucose value for each of the plurality of sample times over the measurement period, wherein the plurality of glucose profiles is determined on different days by sampling the glucose level on each day over the measurement period, wherein the measurement period is 24 hours;
(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;
(e) [wherein the machine-readable instructions cause the data processing device to] output the first display signals via the output device to the display device; and display a first graphical representation according to the first display signals on the display device."
EPO
The link to the decision and an extract of it can be found after the jump.
Order
For these reasons it is decided that:
The appeal is dismissed.
No comments:
Post a Comment
Do not use hyperlinks in comment text or user name. Comments are welcome, even though they are strictly moderated (no politics). Moderation can take some time.