Top 10 Points on Patent Applications That Refer to Nucleic Acid (Gene) Sequences or Protein Sequences

The points mentioned below apply both to where the nucleic acid or protein is claimed per se and also to situations where the invention somehow relates to use of sequences.

1.  Consider whether homologues of the sequences should be mentioned.  If so, then percentage homology ranges need to be provided and the description needs to refer to a specific algorithm that can be used to calculate the percentage homology.

2. Consider whether fragments of the sequences need to be mentioned.  If so, ranges of fragment lengths should be disclosed, and if fragments of homologues can be used then this should be made clear.

3. If homologues and/or fragments are relevant then basis should also be provided for limiting to functional sequences.  Functions apart from the natural function may also be relevant in the context of the invention.

4.  Thought should be given to claiming expression vectors that contain the sequence or express the sequence.

5.  Basis for limiting to ‘isolated’ forms of the sequence should be provided.

6.  Thought should be given to important mutants (homologues). Patent Offices are becoming increasingly strict in regards to homologues and, if possible, the application should contain details of areas that can or cannot be modified to give functional mutants.

7.  Normally it will be possible to claim antibodies that bind to novel proteins.  Thought should be given to antibodies that may cross-react to related proteins and how such antibodies could be excluded from the claims.  Antibody derivatives should also be claimed as well as use of the protein to make a specific antibody.

8. Thought should be given to claiming sequences with modified bases or amino acids.  Whether or not PNAs (peptide nucleic acids) should be claimed should also be considered.

9. Thought should be given to whether organisms containing the gene (e.g. transgenic animals or plants) should be claimed as well as organisms in which the gene has been knocked out.

10. Given the decision of the US Supreme Court in Association for Molecular Pathology v Myriad  ensure there is basis for limiting to non-natural nucleic acids, such as cDNA molecules and mutants.

You may also wish to see related articles Top 10 Observations on Antibodies and Top 10 Observations on US Restriction Requirements