Trilateral Project 24.1-Biotechnology 033

(1)

In so far as a protein rarely has only one function, the claim may not be definite because the particular function of protein X intended is not clearly recited. For novelty considerations, "Recombinant" may not distinguish from the natural protein if there is no physical difference between the recombinant and natural protein.

(2)

The claim might be indefinite because the exact function of protein X is not defined. The claims must be read in light of the specification. In order to evaluate the claims with respect to percent identity, the specification must be reviewed for an explanation of how the percent identity is determined or defined. Sequence identity is not an objective property of any two or more sequence, 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 extents of sequence identity between the same two sequences. Thus, the examiners look to the specification and what is know in the art to determine the definiteness of such claims.

(3)

It is not clear what intended by "naturally obtainable", thus, the claim may be indefinite. Does this mean that the DNA must be isolated from nature and does not include a chemically synthesized version of the same DNA? Such a distinction is not meaningful because the DNA sequence would be identical whether isolated from nature or chemically synthesized. Thus, the phrase is confusing. The claim might be indefinite in failing to recite what function of protein X is intended. In order to determine the metes and bounds of the claim, much will depend upon what was disclosed in the application as filed. 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 the protein encoded by the nucleic acid.

(4)

The claim might be indefinite because the exact function of protein X intended is not clearly recited. Additionally, one would need to review the specification to determine if the terms of the claims are defined in the specification since the claims are read in light of the specification. One would evaluate the specification for the intended meaning of "inversion". Especially in a claim drawn to a protein, it would appear that "inversion" is indefinite. Here, presumably, the claim encompasses all variations which still have the function of protein X. While they are broad and encompass many proteins, "deletion", "substitution", "insertion" and "addition" appear to be definite.

(5)

The claim must be read in light of the specification and thus one would evaluate the specification for definitions of the claimed phrases. One would look to the specification and the state of the art for an art-accepted meaning of "allele" or "allelic mutant" for the particular protein being claimed and facts of the individual case.

The specification would have to be reviewed to determine whether or not "derivative" or "variant" is defined there. Generally, however, "derivative" and "variant" are not conventional terms used in the protein or nucleic acid art their meaning would not be definite. Clarity requires that one can ascertain the metes and bounds of the claim and be able to ascertain when a claim is infringed. In this situation, one would not know what is encompassed by "derivative" or "variant" of the claimed protein and thus the claim is indefinite. The claim is also indefinite because it is unclear whether the derivative is a derivative of the allele or a derivative of the amino acid sequence of Figure 1.

"Equivalent" is indefinite because it is unclear in what way or in what manner the protein or amino acid sequence is equivalent to that of the sequence.

Also, the claims might be indefinite because the function of protein X is not clearly recited.