Trilateral Project 24.1-Biotechnology 039

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. Thus, examiners look to the specification and what is known in the art to determine the definiteness of such claims.

1.1.1.2.1(3):

An important requirement is a recitation of, 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 metes and bounds 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.

1.1.1.2.1(4):

A probe claim for a claim like this would be very difficult to draft because encompassed within the claim are probes which may be specific for a region of the disclosed sequence that is varied. Since the variation is not specifically described or recited by the claim, it would not be possible for one of skill in the art to know whether a given probe was embraced by the claim (i.e., the claim would be vague and indefinite). A definition of the number of bases which may be added, deleted, or substituted will not add to the clarity of the claims because the nature and/or location of these changes would not necessarily be known.