Trilateral Project 24.1-Biotechnology 038

The definition of such a claim will be identical to cases relating to structural genes. ( See 1.1.1.2.1(2) - (4).)

DNA probes for analysis possess essential properties to hybridize selectively to polynucleotides to be detected or analyzed. For being a DNA probe for analysis, therefore, the DNA needs to satisfy the below requirements 1) and 2).

• 1) The DNA can strictly hybridize with polynucleotides to be detected (originating from a DNA sequence encoding polypeptide A).
  
• 2) The DNA does not, under the same condition, hybridize with polynucleotides originating from a DNA sequence encoding similar polypeptide A'.

When claims are specified by identity (homology) or hybridization, these claims may contain, in addition to the original DNA fragment, homological or hybridized DNA fragments having largely different sequences from the original one, depending on the extent of the identity (homology), hybridizing conditions, etc. In such cases, it is unlikely that such homological or hybridized DNAs satisfy the requirements described in 1) and 2) above, being used as probes.

Concerning the claims relating to addition/deletion/substitution, when a nucleotide in any position of the DNA fragment is added, deleted or substituted with another, it is likely that its original function would be lost, that is, the requirements described under 1) and 2) would not be satisfied.

Consequently, enablement requirement is generally considered not to be satisfied in many cases where DNA probes for analysis are specified by homological sequences, hybridization sequences and addition/deletion/substitution sequences.

In a case where a DNA probe is specified by an amino acid sequence, an infinite number of corresponding DNA sequences are expected. It is highly unlikely that all such DNA sequences would be useful as probes. In such a case, undue experimentation would be required to carry out the claimed invention. Generally, such a claim would not be allowed because the enablement requirement is not satisfied.