Key points
- Claim 8 reads as follows: "Method for providing information for glycemic control, namely a dose of insulin to be set, the method comprising the steps of:
receiving security data; validating the received security data; providing validation data corresponding to the validation of the received security data; and unlocking at least a predetermined function out of at least one first and at least one second processing function for execution based on the validation data, wherein the at least one first processing function is for adjusting profile parameters for a selected dose adjustment profile, and the at least one the second processing function is for stepwise adapting the dose of insulin based at least on the selected dose adjustment profile and thereby determining the value for the dose of insulin to be set based on received blood glucose value data, wherein the profile parameters for each different dose adjustment profile comprise a specific initial dose value, a specific time interval for increasing the dose, a specific dose increase step and a low blood glucose threshold value."
The Board's decision includes an explanation of the invention. "The contested patent relates to a medical device for providing... a dose of insulin to be set " "In order to prevent an unauthorised person from modifying the device (in particular modifying the dose adjustment profiles) or using it in a way which could be harmful to the user, the device is configured to prohibit the execution of one or both of the processing functions until successful validation of some security data, such as an activation key or a password".
"Although, as argued by the appellant [proprietor], the method steps recited in claim 8 as granted are phrased using terminology commonly encountered in the field of computer-implemented methods, the Board shares the respondent's view that all these steps can also be carried out by the sole human brain and that they do not necessarily require the use of technical means, even implicitly.
The example scenario presented by the respondent [opponent] in this respect is convincing. As submitted by the respondent, all the adjustment and adaptation steps of claim 8 could indeed be performed mentally by a user, e.g. on the basis of profile parameters memorised by the user. Obtaining and checking a password or a passport amounts to receiving and validating security data. A step of "unlocking a function for execution" takes place when the user decides to perform certain actions, such as the above-mentioned adjusting or adapting steps, only after having successfully validated the identity of another person, whereas the execution of these actions remains prohibited if the person is considered to be unauthorised.
The Board therefore concurs with the respondent that claim 8 as granted relates to a method for performing mental acts as such, which is excluded from patentability pursuant to Article 52(2)(c) EPC."
"Claim 8 of auxiliary request 1 explicitly stipulates that the method is "computer-implemented". As acknowledged by the respondent, the method has therefore a technical character and is not excluded from patentability under Article 52(2)(c) EPC."
The case is remitted to the OD for consideration of novelty and inventive step.
EPO
1. The contested patent
1.1 The contested patent relates to a medical device for providing information for glycemic control, namely a dose of insulin to be set (claim 1), and to a corresponding method (claim 8), computer program (claim 13) and computer program product (claim 14).
The device may help a user to achieve good glycemic control, which usually requires increasing the insulin dose from an initial dose to a final dose over a certain period of time until a specific blood glucose value has reached a target range (paragraph [0005]).
For this purpose, as defined in claim 1, profile parameters for different dose adjustment profiles, each comprising a specific initial dose value, a specific time interval for increasing the dose, a specific dose increase step and a specific low blood glucose threshold value, are stored in the device. Moreover, the device comprises data processing means arranged to execute:
- a first processing function for adjusting profile parameters for a selected dose adjustment profile, and
- a second processing function for stepwise adapting the insulin dose based at least on the selected dose adjustment profile and thereby determining the value for the insulin dose to be set based on a received blood glucose value data.
1.2 In order to prevent an unauthorised person from modifying the device (in particular modifying the dose adjustment profiles) or using it in a way which could be harmful to the user, the device is configured to prohibit the execution of one or both of the processing functions until successful validation of some security data, such as an activation key or a password (paragraphs [0157], [0192]-[0193]). For this purpose, the device further comprises validating means arranged to validate a received security data and to provide validation data corresponding to the validation of the received security data, and safety means arranged to unlock at least one predetermined function of the first and second processing functions for execution based on the validation data.
2. Main request - exclusion from patentability under Article 52(2)(c) EPC
Although, as argued by the appellant, the method steps recited in claim 8 as granted are phrased using terminology commonly encountered in the field of computer-implemented methods, the Board shares the respondent's view that all these steps can also be carried out by the sole human brain and that they do not necessarily require the use of technical means, even implicitly.
The example scenario presented by the respondent in this respect is convincing. As submitted by the respondent, all the adjustment and adaptation steps of claim 8 could indeed be performed mentally by a user, e.g. on the basis of profile parameters memorised by the user. Obtaining and checking a password or a passport amounts to receiving and validating security data. A step of "unlocking a function for execution" takes place when the user decides to perform certain actions, such as the above-mentioned adjusting or adapting steps, only after having successfully validated the identity of another person, whereas the execution of these actions remains prohibited if the person is considered to be unauthorised.
The Board therefore concurs with the respondent that claim 8 as granted relates to a method for performing mental acts as such, which is excluded from patentability pursuant to Article 52(2)(c) EPC.
3. Auxiliary request 1 - exclusion from patentability under Article 52(2)(c) EPC
Claim 8 of auxiliary request 1 explicitly stipulates that the method is "computer-implemented". As acknowledged by the respondent, the method has therefore a technical character and is not excluded from patentability under Article 52(2)(c) EPC.
4. Auxiliary request 1 - exception to patentability under Article 53(c) EPC
Paragraph [0160] of the patent discloses that, while "the dose setting unit 1930 activates the respective dose setting mechanism for setting the dose according to the received signals", the delivery of the dose to be administered is performed by a distinct "dose delivering unit 1940", which is "either activated by the user (...) or automatically activated". Hence, the step of "setting" a dose of insulin defined in claim 10 does not encompass the step of actually "delivering" it to the patient. Merely setting a dose has no effect on the latter.
It follows that, contrary to the respondent's view, the claimed method does not involve a therapeutic step and therefore does not fall within the exception to patentability of Article 53(c) EPC.
5. Auxiliary request 1 - clarity
5.1 The respondent objected that it was unclear how the computer-implemented method of claim 8 of auxiliary request 1 could encompass the step of physically "measuring a blood glucose value" defined in dependent claim 9. Even assuming that the measurement involved some additional ad hoc sensor, the claimed method was still unclear because claim 9 did not define which sub-steps were carried out by each of the computer and this additional sensor, and how both interacted. Claims 8 and 9 were therefore unclear.
5.2 The Board disagrees. It is common ground that physically performing a blood glucose measurement cannot be performed by a computer or generic data processing means alone, but instead requires additional dedicated technical means, such as the blood glucose measurement unit 110 disclosed in Figure 1 and paragraph [0071] of the patent.
The step of claim 9 thus implicitly involves the interaction of the computer on which the claimed method is implemented with such a dedicated blood glucose measurement unit.
In this context, and given that the method of claim 9 is also computer-implemented by virtue of the dependency on claim 8, the person skilled in the art who reads claim 9 with a mind willing to understand understands that the claimed step of "measuring a blood glucose value" only comprises sub-steps performed by the computer which, in combination with those - not claimed - performed by the dedicated measurement unit, enable a blood glucose value to be measured. Thus, like the other steps of claim 8, the measuring step of claim 9 exclusively comprises computer-implemented sub-steps, such as processing steps or steps in which the computer sends or receives signals or data to or from the measurement unit. In other words, the subject-matter of claim 9 covers a computer-implemented method in which the computer triggers or controls the measurement of a blood glucose value by a distinct measurement unit, but does not extend to what is performed (in particular physically) by the measurement unit itself.
The Board notes that this interpretation is supported by the description, according to which the blood glucose measurement is "triggered" by the receiving unit 120 which "sends a respective signal to the blood glucose measurement unit 110" (paragraph [0076]), and the receiving unit "forwards control signals" to this unit and receives data from it (paragraphs [0077]-[0078]).
In the Board's view, there is no lack of clarity arising from the fact that the interaction between the computer and the measurement unit is not specified in detail in claim 9. Contrary to the respondent's argument, this view is not inconsistent with the Guidelines F-IV, 3.9.2, which merely state that "[a]n objection under Art. 84 may also arise if the claims do not define which steps are carried out by the data processor or by the additional devices involved, as well as their interactions" (emphasis added by the Board), thereby leaving the question of clarity to be decided on a case-by-case basis.
The Board thus concludes that claims 8 and 9 are clear.
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