The patent proprietor filed an appeal against the opposition division's decision to revoke the patent because the invention was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
The opposition division held that the invention was not sufficiently disclosed since
- there was no indication in the patent how the five parameters mentioned in claim 1 (specific initial dose value, specific time interval for increasing the dose, specific dose increase step, specific low blood glucose threshold value and specific target blood glucose value) might contribute to the claimed profile, and since
- the influence of the personalisation step on the profile was not disclosed.
Claim 1 of the patent as granted reads as follows.
"A method for configuring 4 process for determining a dose of insulin to be administered for glycemic control, wherein the dose is stepwise adapted, the method being characterised by the steps of:
defining different dose adjustment profiles for stepwise adapting the dose, wherein each of the different dose adjustment profiles is based at least on 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;
storing the different dose adjustment profiles;
selecting one of the stored different dose adjustment profiles based on specific requirements for stepwise adapting the dose; and
personalising the selected dose adjustment profile by defining at least a specific target blood glucose value for a specific user."
The present invention relates to a method for configuring a process for determining a dose of insulin to be administered for glycemic control. This method involves defining different dose adjustment profiles for stepwise adapting the dose, storing the dose adjustment profiles, selecting one of the dose adjustment profiles, and personalising the selected dose adjustment profiles by defining at least a specific target blood glucose value for a specific user.
Sufficiency of disclosure
Claim 1 relates to a method for configuring a process for determining a dose of insulin to be administered for glycemic control. The claimed method accounts for instructions of how to stepwise adapt a dose of insulin. These instructions are represented by a dose adjustment profile in which a specific initial dose value, a time interval for increasing the dose, a dose increase step, and a specific low blood glucose threshold value are defined.
It is undisputed that the person skilled in the art knows how to realise such profiles.
Furthermore, a procedure for defining a new algorithm including the parameters required by claim 1 is described in the patent in suit. This procedure includes the selection of templates to which the specific parameters or parameter sets have to be assigned. The Board agrees with the appellant that the patent does not have to provide an explicit example of an algorithm. It is rather sufficient that at least one way of establishing an algorithm is described.
The respondent alleged that claim 1 did not cover the definition of a profile which was composed of templates. The Board does not concur with this view. Claim 1 also covers profiles in which the specific parameters are assigned to templates; the use of templates does not render the teaching insufficient.
The description describes how the defined algorithms correspond to specific types of users and other boundary conditions. Hence, the person skilled in the art is taught which specific requirements are to be considered by the authorised person when selecting one of the stored dose adjustment profiles.
As described, a selected profile can be personalised by adjusting the target blood glucose value. Hence, in case that the selected profile already includes a defined target value, the personalising step of claim 1 merely requires that this target value is amended according to the needs of a specific patient. In case the target value is not yet defined in the selected profile, the personalising step consists of setting this target value to any value by the authorised person.
Hence, it can be derived from the patent that the selected dose adjustment profile is personalised by setting or amending the target blood glucose value. No further amendment of the selected profile is required by claim 1. The person skilled in the art would have no problem to define a target value and adjust the profile accordingly and thus to carry out the invention as claimed.
The decisions T 684/14 and T 723/10 referred to by the respondent are not pertinent to the present case since they relate to algorithms which are insufficiently disclosed because they are based on unknown parameters. On the contrary, in the present invention, the algorithm is defined by selecting values for specific parameters.
Hence, the ground of opposition under Article 100(b) EPC does not prejudice the maintenance of the patent according to the main request.
The case is remitted to the Opposition Division for further prosecution.