An appeal was lodged by the patent proprietor (appellant) against the decision of the opposition division revoking European patent No. 2 074 141 ("the patent"). The patent is entitled "Protease resistant insulin analogues".
In the decision under appeal, the opposition division held that the subject-matter of the set of claims of the main request was not novel. The opposition division also held that claim 1 of each of auxiliary requests 1 to 23 did not meet the requirements of Article 123(2) EPC, Article 84 EPC and Rule 80 EPC.
With the statement of grounds of appeal, the appellant filed sets of claims of a main request, main request a, main request b, and of auxiliary requests 1, 1a, 1b, 2, 2a, 2b, 3, 3a, 3b, 4, 4a, 4b, 5, 5a, 5b, 6, 6a, 7, 7a, 7b. The appellant then withdrew all claim requests except for auxiliary request 6, auxiliary request 5, auxiliary request 5(b), auxiliary request 3, auxiliary request 3(b), auxiliary request 4, auxiliary request 4(b), auxiliary request 7 and auxiliary request 7(b) and requested that they be considered in that order.
The Board considers that auxiliary request 6 must be regarded as an alternative attempt to overcome novelty objections that were timely raised in the proceedings before the opposition division by the respondent. This request could and should have thus been filed in those proceedings, so the board decided not to admit auxiliary request 6 into the appeal proceedings.
Claim 1 of auxiliary requests 5 and 5(b) contains an identical disclaimer as claim 1 of auxiliary request 6. Therefore, the same reasoning as for auxiliary request 6 applies and the board decided not to admit auxiliary requests 5 and 5(b) into the proceedings.
The appellant argued that auxiliary requests 3 and 4 represented a legitimate response to the objection in the decision under appeal regarding a "generalisation of the B16 substituent". In their view, these requests had been filed as a direct response to the objections raised under Article 123(2) EPC against the B16 substituent, which were first substantiated only at the oral proceedings.
The appellant further stated that auxiliary request 3 was "closely related to Auxiliary Request 1 filed with the response to the opposition. In this request, position B16 was limited to Glu". The board notes that in claim 1 of auxiliary request 1, filed with the response to the opposition, B16 was limited to Gln, His or Glu and A14 was limited to Glu, Asp or His. In claim 1 of auxiliary request 3, however, the limitation of the B16 substituent to three alternative residues is replaced with a list of substitutions of eight alternative residues including B16 and, in addition, the A14 substituent is limited to two instead of three alternatives.
The appellant stated that auxiliary request 4, in which position B16 was also limited to Glu, corresponded to auxiliary request 1 as filed in response to the opposition, with the additional limitation that the insulin analogue was "human" insulin.
However, this statement is factually incorrect, since in claim 1 of the latter set of claims, B16 was to be chosen from Gln, His or Glu. Claim 1 of auxiliary request 1 filed during the oral proceedings before the opposition division at 13:00 o'clock was closer to auxiliary request 4, as it also restricted the B16 position to Glu. However, it also contained the requirement that B30 was deleted and that the insulin analogue was a "human" insulin. Since the appellant was in a position to react to an objection by filing a new auxiliary request 1 (at 13:00 o'clock of the oral proceedings) which contained the amendment "human insulin", the board considers that the claim request also in that respect could have been filed earlier.
In conclusion, the board finds that auxiliary requests 3 and 4 contain amendments which were filed for the first time in appeal and which attempt to address issues under Article 123(2) EPC and Article 54 EPC which were raised in time during the opposition proceedings. These requests could and should have thus been filed in those proceedings. The same reasoning applies to auxiliary requests 3(b) and 4(b).
The board therefore decided not to admit auxiliary requests 3, 3(b), 4 and 4(b) into the proceedings.
Regarding auxiliary requests 7 and 7(b), the appellant referred to the description which states that the modification B25His can be combined with a substitution of position A14 to either Glu, Asp or His, that is a list of three possibilities. The third substitution (B16Glu) is disclosed in a second list of eight "additional mutations".
The question to be asked in deciding on whether or not the amendment introduces subject-matter extending beyond the content of the application as filed is whether the selection of A14Asp and B25H is from a list of three possibilities and its combination with B16Glu from a list of eight possibilities is "within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of these documents as filed".
In the board's view, there is no pointer in the application to a combination of substituents as claimed. Instead, the combination represents a "singling out" from all of the possible combinations disclosed in the application as filed which was not disclosed. While the passage on page 23 provides a list of three substituents at position A14 in combination with B25 His, none of those is indicated as preferred. When consulting the rest of the application the skilled person, however, learns that instead A14 Glu is preferred. Glu is the only substitution which is singled out in embodiment 11 and most individualised examples contain Glu at position A14. The only individualised example referring to A14 Asp and B25 His does not contain B16 Glu but a deletion of B30, i.e. a combination not mentioned in claim 1. To arrive at the claimed subject-matter, the skilled person therefore had to choose a less preferred embodiment (A14 Asp and B25 His) and combine it with a further substituent (B16 Glu) from a list of eight alternatives. Moreover in the remainder of the application as filed, this feature (B16 Glu) always appears together with A14 Glu but not with A14 Asp. Furthermore, B16 Glu is always disclosed together with desB30 which is not mentioned in present claim. The combination of A14 Glu, B25 His and B16 Glu therefore constitutes a combination of substituents which was not disclosed in the application as filed.
Claim 1 of auxiliary requests 7 and 7(b) extends the subject-matter beyond the content of the application as filed (Article 123(2) EPC).
The appeal is dismissed.