The following claims were part of the application as filed:
15. An insulin preparation according to any of the preceding claims, comprising: 0 to 5 mg/ml, preferably 0 to 4 mg/ml, of a phenolic compound.
16. An insulin preparation according to claim 15, comprising: 0.5 to 4.0 mg/ml, preferably 0.6 to 4.0 mg/ml, of m-cresol or 0.5 to 4.0 mg/ml, preferably 1.4 to 4.0 mg/ml, of phenol, or a mixture thereof.
Independent claim 1 of the main request read:
1. A parenteral pharmaceutical formulation comprising an aqueous insulin preparation comprising:
Asp^B28 human insulin,
glycerol and/or mannitol,
5 to 100 mM of a halogenide,
a mixture of 0.5 to 4.0 mg/ml, preferably 0.6 to 4.0 mg/ml, of m-cresol and 0.5 to 4.0 mg/ml, preferably 1.4 to 4.0 mg/ml of phenol as phenoloic compounds, wherein the content of phenolic compounds is not more than 5 mg/ml, 10 to 40 μg Zn/100 U insulin, preferably 10 to 26 μg Zn/l00 U insulin, and a phosphate buffer.
This claim, some features of which were said to be based on claims 15 and 16 as filed, was attacked both for non compliance with A 123(2) and lack of clarity. According to the opponent, claim 15 as filed referred to “a phenolic compound”. The upper limit could therefore not support the upper limit of a total content of a mixture of more than one phenolic compounds (i.e. m-cresol and phenol).
The Board does not agree:
A 123(2)
[5] The board considers […] that the subject-matter of claims 15 and 16 of the application as published suffices for the amendment concerning the mixture of phenolic compounds to comply with the requirements of A 123(2). The dependency of claim 16 on claim 15 in the application as published and the explicit reference to a mixture of m-cresol and phenol unambiguously predetermine the notion “a phenolic compound” in claim 15 to be of generic nature and not to exclude the presence of different phenolic compounds in the insulin preparation.
[6] In view of the above considerations, the board is satisfied that claim 1 complies with the requirements of A 123(2).
A 84
[7] The respondent has argued that claim 15 as originally filed and the passage on page 5, line 22, refer merely to “0 to 5 mg/ml, ..., of a phenolic compound”. The upper range of 5 mg/ml in the amended claims 1 and 6 was therefore unclear as it referred to a total content of a mixture of more than one phenolic compounds (i.e. cresol and phenol).
[8] The board considers, however, as reiterated in point [5], that the dependency of claim 16 on claim 15 in the application as published and the explicit reference to a mixture of m-cresol and phenol in claim 16 predetermine the notion “a phenolic compound” in claim 15 unambiguously to be of generic nature and thus also to embrace different phenolic compounds present in the insulin preparation.
[9] As follows from the above considerations claims 1 and 6 are clear pursuant to A 84.
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1 comments:
Based on the claims (I did not study the patent itself) I tend to agree with the opponent here.
Claim 16 clearly recites:
cresol OR phenol within specific ranges of concentration OR a mixture thereof.
The concentration range of the mixture is not defined in the claim. I personally would interpret this claim as meaning that the mixture should also be in the concentration range of 0.5 to 4.
Thus, by widening to a concentration of "not more than 5" for the mixture, Article 123(2) appears to be infringed. Claim 16 indeed depends on claim 15, yet I don't see why a skilled person reading claims 15 and 16 would recognise that "a phenol" could also mean "a mixture of phenols" especially because claim 16 in fact claims two specific phenols.
Another interesting detail concerns claim 15 itself. It claims a concentration of 0-5 of a phenolic compound. If the concentration is "0" this claim does not have any change in the scope of the claims on which it depends.
Anyway, just my humble opinion ...
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