Trilateral Project 24.1-Biotechnology 034

In principle, the same criteria apply for the assessment of clarity with respect to recombinant proteins as already outlined above with respect to structural genes. One further aspect is to be mentioned, which is that a recombinant protein being defined only by having the function of a certain protein X would lack clarity even if said protein X is well known from the prior art, because it is completely ambiguous which function of the protein X is meant. A protein has several different functions, for example biological or immunological functions, and it would be thus better in this case to define a recombinant protein as having the same properties as protein X. Nevertheless, when referring to the properties of protein X the protein X itself has to be clearly defined - it must be either already known from the prior art or sufficiently characterized by structural features in the specification and in the claim (see 1.1.1.2.1(1)).

With regard to the other items concerning recombinant proteins the considerations will be the same as those already discussed in 1.1.1.2.1(1)-(5).