The present decision contains some interesting statements on clarity.
Main request
Independent claim 3 of this request read:
3. Use of rimcazole for the preparation of a medicament for the preferential induction of apoptosis in a first population of cells compared to a second population of cells, wherein the cells of the first population are tumour cells.
[1] A 84 stipulates inter alia that the claims shall be clear.
[2] The meaning of a claim is determined from the skilled person’s point of view reading the claim with his/her background knowledge in the context of all of the claims and the whole specification.
[3] Claim 3 relates to the “[u]se of rimcazole for the preparation of a medicament for the preferential induction of apoptosis in a first population of cells compared to a second population of cells wherein the cells of the first population are tumour cells”.
[4] A claim directed to a second medical use is considered as clear only if the disease to be treated is clearly defined in it (for example decision T 1048/98 [2.1-5]).
In the present case the disease to be treated is defined in functional terms as “the preferential induction of apoptosis in a first population of cells compared to a second population of cells wherein the cells of the first population are tumour cells”. The question is whether or not the skilled person could clearly attribute a disease or group of diseases to this functional definition.
[5] In the board’s view, the skilled person reading this definition in claim 3 would be struck, on the one hand, by the explicit mention and the specific definition of the first population of cells and by the explicit mention, but absence of specific definition of the second population of cells, on the other hand.
[6] Had the disease in claim 3 be defined simply as, for example, the “induction of apoptosis in tumour cells” the skilled person would certainly, in particular in the context of the present application […], have implicitly complemented this explicit definition by considering that the type of cells which should not be affected by apoptosis are non-tumour cells and would thus have interpreted claim 3 as relating to the treatment of cancer.
However, the explicit, but unspecified reference to a second population of cells in claim 3 raises uncertainty about which cells, in addition to non-tumour cells, are concerned and thus which diseases in addition to cancer are defined by the expression at issue.
[7] Hence, the board concludes that claim 3 does not clearly and unambiguously define the disease or disorder to be treated with rimcazole. Therefore, the main request is refused because claim 3 does not fulfil the requirements of A 84.
Auxiliary requests 1 to 2
Claims 13 and 14 of this request read:
13. A kit comprising:(a) a composition comprising a sigma receptor ligand as defined in claim 1 in a pharmaceutically acceptable carrier; and(b) directions instructing administration of the composition in a manner which would result in the preferential induction of apoptosis in a first population of cells compared to a second population of cells, wherein the cells of the first population are tumour cells and the cells of the second population are non-tumour cells.
14. The kit of claim 13 wherein the kit is for the treatment of cancer.
[8] Claim 13 relates to a kit comprising, inter alia, “directions instructing administration of the composition in a manner which would result in the preferential induction of apoptosis in a first population of cells compared to a second population of cells, wherein the cells of the first population are tumour cells and the cells of the second population are non-tumour cells”.
[9] In view of the explicit indication in claim 13 of the induction of apoptosis in tumour cells, but not in non-tumour cells, the skilled person would prima facie, and in particular in the context of the present application […], perceive that claim 13 relates to a kit for the treatment of cancer […].
[10] Claim 14 is dependent on claim 13 and is directed to “[t]he kit of claim 13 wherein the kit is for the treatment of cancer.”
[11] Thus, prima facie and when regarded separately, the meaning of both claims 13 and 14 is clear, i.e. they both relate to the same subject-matter.
[12] However, as noted in point [2] above, the meaning of a claims is determined in the context of the whole application, i.e. also in context with other claims.
[12.1] When claim 13 is regarded in context with claim 14 an uncertainty about the meaning of claim 13 arises in because claim 14 is dependent on claim 13, yet covers the same subject-matter. Thus, since it is therefore not clear which subject-matter is defined by claim 13, an objection of lack of clarity arises.
[13] All the above observations apply equally to auxiliary request 2 in which claims 13 and 14 are identical with claims 13 and 14 of auxiliary request 1.
[14] Hence, auxiliary requests 1 and 2 are rejected because they do not fulfil the requirements of A 84.
So repeating a clear statement creates a lack of clarity. We-eeell...
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2 comments:
I think it is the first time that I read the expression "clearly and unambiguously", usually associated with Art. 123(2), in the context of Art. 84.
I might have argued something like: If claims 13 and 14 were meant to describe the same thing, why must one have to use different words?
I think that conciseness requirement of Art. 84 together with its implementing Rule 43, might have been more appropriate. If claim 14 is not a particular embodiment of claim 13 (since it is a repetition of the latter), then it does not satisfy the requirement of Art. 84.
The expression used in relation to A 123(2) is "directly and unambiguously" which differs from "clearly and unambiguously" used here in relation to A. 84.
With respect to A 123(2), "directly" and "unambiguously" have additional meanings, since something may be directly derivable, but still be ambiguous.
However, I fail to see what difference exists between "clearly" and "unambiguously", since I suppose that something clear must also be unambiguous. It seems to me a redundant repetition (would it thus be unclear for this reason?).
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