Wednesday, 1 August 2018

T 0292/85 - "At least one way of carrying out the invention" - #74

Citation rank: 74
No. of citations: 65

The invention in T 292/85 related to a biological invention and the claims included certain functionally defined elements, which covered various modifications, mutants, etc., which were not yet known or readily available at the time of filing.

The examning division decided in first instance that the claim was insufficiently disclosed, because the claims contradicted a suggested requirement that "all embodiments within the claims should be reproducible at will by the skilled person without having to make an invention".

The Board, however, considered that such a requirement does not exist under the EPC (see Reasons 3.1.2). The Board  referred to T 68/85 in which the possibility of using functional terminology in claims was approved if "such features cannot otherwise be defined more precisely without restricting the scope of the invention" and their reduction to practice was not an undue burden. This general principle would also apply to the field of biotechnology.

Regarding the terms "bacteria", "regulon" and "plasmid", which were characterised in the claims by their functions, the Board observed:
"What is also important in the present case is the irrelevancy of the particular choice of a variant within the functional terms "bacteria", "regulon" or "plasmid". It is not just that some result within the range of polypeptides is obtained in each case but it is the same polypeptide which is expressed, independent of the choice of these means. A term of this kind must, of course, be clear and enable the skilled person to find suitable specimens without undue difficulty. In the present application enough choice is available, although some vehicles and hosts are preferred for practical reasons." (Reasons 3.1.3)
The Board also stated that it would not be detrimental to sufficiency of disclosure, if some variants falling under the claims (e.g. certain combinations of bacteria, plasmids and regulons) were not operable, as long as there are suitable variants known to the skilled person through the disclosure or common general knowledge which provide the same effect for the invention.

It must be acknowledged, however, that there is an inherent conflict between the "one-way-of-carrying-out-the-invention" principle of T 292/85 and a statement in T 266/85, saying that
"... substantially any embodiment of the invention, as defined in the broadest claim, must be capable of being realised on the basis of the disclosure."
Which concept to apply seems to lie in the nature and circumstances of the particular case. In practical opposition cases, the standpoint a party takes seems to depend entirely on whether the party is the proprietor or the oppnent.

The difference between the inventions underlying T 292/85 and T 266/85 is that in T 292/85 all variants of the functionally defined "bacteria", "plasmids" and "regulons" resulted in the same product (i.e., the same polypeptide; see quote from Reasons 3.1.3, above), whereas in T 266/85 the variants were simply different chemical compositions falling under a broad generic claim (i.e., not the same product).

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Headnote:
1. An invention (here: biological) is sufficiently disclosed if at least one way is clearly indicated enabling the person skilled in the art to carry out the invention. Then the non-availability of some particular variants or unsuitability of some unspecified variants of a functionally defined component feature of the invention is immaterial to sufficiency as long as there are suitable variants known to the skilled person through the disclosure or common general knowledge which provide the same effect for the invention. The disclosure need not include specific instructions as to how all possible component variants within the functional definition should be obtained (cf. point 3.1.5 of the Reasons).

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