Will Conversion from ST.25 to ST.26 be Possible?
Sequence Listings have been submitted to patent offices under WIPO Standard ST.25 for over 20 years. Applicants have processes in place for preparing such listings; however, on January 1, 2022, everything will change. In an ideal world, a simple process would convert compliant ST.25 sequence listings to the proper ST.26 format. Unfortunately, this ideal scenario is not possible for several reasons, some of which are outlined below.
1. The requirements for sequence inclusion are not the same. Sequences previously allowed under ST.25 are no longer permitted and vice versa. This means, ST.25 sequence listings may need to have sequences removed and/or added to be compliant.
2. ST.26 requires controlled vocabulary for DNA or RNA molecules in a mol_type qualifier (including genomic DNA, genomic RNA, mRNA, tRNA, rRNA, other DNA, other RNA, transcribed RNA, viral cRNA, unassigned DNA and unassigned RNA) which is information not present in ST.25 listings. It is suggested that the most generic value be selected to avoid added subject matter unless this information is clearly described in the application.
3. ST.26 includes default values for variant positions, specifically X or Xaa, which includes any of the 22 amino acids listed in Annex I. This default value, if not further defined, may represent added or deleted subject matter in comparison to the definitions of “any amino acid” in a ST.25 formatted listing. Caution will need to be used to ensure definitions of variables are carried over appropriately.
4. ST.25 sequence listings include uracil as “u” characters in RNA sequences. ST.26 will only permit inclusion of uracil as “t” characters.
5. ST.25 sequence listings may contain abbreviations for modified positions that are not present in the list of modified nucleotides/amino acids in ST.26. ST.26 only permits the inclusion of the full unabbreviated names for these modifications. If the abbreviation is known in the art and only represents a single modified nucleotide/amino acid, the unabbreviated name should not constitute new matter. If the abbreviated name is not known in the art or could represent more than one modified nucleotide/amino acid, compliance is not possible without introduction of added subject matter.
6. ST.25 contains feature keys that are not present in ST.26. Guidance has been provided for how to handle these feature keys to avoid adding or deleting subject matter, however, these items will need to be manually reviewed and entered and cannot simply be converted.
7. In ST.25, synthetic sequences were described as “artificial sequence”, whereas they will need to be listed as “synthetic construct” for ST.26. The same is true from “unknown” sequences which will now be classified as “unassigned.”
8. ST.25 allows for the inclusion of sequence publication information including but not limited to GenBank accession numbers. There are no equivalent fields in ST.26, therefore, this information would need to be included in the body of the application.
This list exemplifies some of the major difference when attempting to convert an ST.25 listing to ST.26, however, it is in no way comprehensive. Additional challenges are present involving some of the more intricate components of sequence listings.
If you have any questions regarding the transition to ST.26 on January 1, 2022, please do not hesitate to contact SmartBased IP Services.