Trilateral Project 24.1-Biotechnology 042

1.1.1.2.1(2)

This type of claim language is vague and indefinite (35 U.S.C Sec. 112, second paragraph) unless the application describes the method used to determine any particular level of sequence identity. Sequence identity is not an objective property of any two or more sequences, but is a value obtained after performing some type of sequence comparison. Since there are many different algorithms for comparing sequences and since these algorithms contain variables, it is often possible to arrive at different amounts of sequence identity between the same two sequences.

Accordingly, it is necessary for the patent application to specify how sequence identity is defined for that particular patent application. Of course, the reference to a DNA encoding protein X in the example does not apply to this question because the question is limited to regulatory sequences.

1.1.1.2.1(3)

An important requirement is a recitation of, or reference to, hybridization conditions. This can be done in a variety of ways. In connection with the source of the DNA, much will depend upon what was disclosed in the application as it was filed to determine the scope of an allowable claim. In general, some indication of the hybridization conditions is needed and may be accompanied by a recitation of a function of either the nucleic acid or of the protein encoded by the nucleic acid. For regulatory sequence claims, the regulatory function or binding characteristics (i.e., binding of the regulatory DNA to a regulatory factor) may be recited in the claim along with the hybridization conditions.

1.1.1.2.1(4)

In a claim drawn to a regulatory sequence it would be necessary to look to the specification for guidance in connection with the actual limits for additions, substitutions, or deletions.