6.6. Reproducibility without undue burden
6.6.2 Routine selection
Reproducibility is not impaired if the selection of the values for various parameters is a matter of routine and/or if further information is supplied by examples in the description (T 107/91).
The board in T 764/14 concluded that the skilled person was able, based on common general knowledge and corresponding routine variation of experimental conditions, to complement the information contained in paragraph [0031] of the patent in suit and, thus, to determine (possibly with some slight uncertainty but) without undue burden the surface Na baseline value for a given carrier.
In T 1170/20, relating to a reach-through claim, the respondent (patent proprietor) argued, inter alia, that if a metal having a particular thermal capacity or electrical resistance were claimed, it would not be necessary to disclose a list of all possible metals or alloys with that parameter. The board was not convinced by this argument, maintaining that it was to be decided on a case-by-case basis whether the required effort involved solely the skilled person's ordinary skill and routine practice or constituted an undue burden. The difference between the example put forward by the respondent and the claimed insulating gases was that the former could be identified by the skilled person using their standard knowledge and skill, but the latter could not.
In T 552/22 the board stated that overexpression of SetA in E. coli was one way of performing the claimed invention that was disclosed in the patent. However, claim 1 was not limited to the overexpression of SetA. While the patent mentioned SetB and SetC, it reported no data on these two proteins or any explanation, reasoning or technical basis. The skilled person wanting to perform the claimed invention had to test the Set family members including SetB and SetC with no guarantee that any of the tested proteins would work. In view of the case law summarised by the board, this amounted to an undue burden, even if it involved routine experimentation.
See also T 2164/21 in which neither the application as filed nor common general knowledge provided the skilled person with any information that would reliably guide them to the amino acid substitutions which resulted in an antibody fulfilling the functional requirements of the claim. The fact that methods for generating an antibody with a specific mutation, methods for assessing deamidation and methods for antigen-binding activity were described in the application, were well known to the skilled person of the application and were routine on the priority date of the application did not mean that the invention could be put into practice without undue burden. If the skilled person could only determine by conducting experiments whether they had selected a parameter (in this case, the amino acid replacing the glycine) in such a way that a satisfactory result would be achieved (in this case, an antibody with reduced susceptibility to deamidation and 70% or more of the antigen-binding activity of the original antibody) without the confidence that such result could be achieved at all, this constituted an undue burden, even if it involved routine experimentation.
See also chapter II.C.6.6.8 "Calibration and identifiable measurement method".