Trilateral Project 24.1-Biotechnology 041

The definition of such a claim is similar to that of structural genes. (See 1.1.1.2.1(2) - (4).)

Generally, the length of a nucleotide sequence corresponding to actual regulatory function in sequence confirmed to possess some regulatory function is extremely shorter than that of structural genes.

Therefore, claims relating to regulatory sequences specified by identity (homology) or hybridization may contain, in addition to the original DNA sequence, homological or hybridized DNA sequences having largely different sequence from the original one, depending on the hybridizing conditions and the degree of identity (homology). In such cases, it is unlikely that each of such DNAs would possess the function of the regulatory sequence.

With regard to the claims relating to regulatory sequence specified by addition/deletion/substitution, it is likely that its original function would be lost when a nucleotide in any position of the nucleotide sequence corresponding to the regulatory function is added, deleted or substituted with another.