Trilateral Project 24.1-Biotechnology 161

Where a claim includes a statement defining a product by its manufacturing process (product-by-process), such a statement is appropriate to be construed as meaning a product per se, because the claim, as a whole, is directed to a product. (Implementing Guidelines I-2-1.5.1.3(3))

Consequently, if it is possible to manufacture an identical product by a manufacturing process which is different from the description in the claims, and if this product has been described in prior art document or prior application, it is determined that novelty is not present.

Similarly, with respect to the field of genetic engineering, if a protein, which is the same as the claimed invention not only in its amino acid sequence but also in its sugar chains, has already been obtained (isolated and purified) by a different manufacturing process in prior art document or prior application, the novelty is not present in both cases a and b because there is no distinction as chemical substances between the claimed protein and the same protein.

However, in cases where a prior art document or a prior application merely suggests that a protein exists naturally but it does not disclose that the protein has been purified to the extent that the said protein becomes substantially only one component, a later filed invention relating to said protein specified by amino acid sequence, which is produced as a recombinant protein by using recombinant DNA technology, has novelty.