What are the requirements for the “organism” qualifier in a “Sequence Listing XML”?

The “organism” qualifier in a “Sequence Listing XML” is used to disclose the source or origin of the sequence. According to MPEP 2413.01(g):

“The organism qualifier, i.e., ‘organism’ for nucleotide sequences and ‘organism’ for amino acid sequences must disclose the source, i.e., a single organism or origin, of the sequence. Organism designations should be selected from a taxonomy database.”

The requirements for the “organism” qualifier include:

  • If the sequence is naturally occurring and the source organism has a Latin genus and species designation, that designation must be used as the qualifier value.
  • If the genus is known but the species is unspecified or unidentified, use the Latin genus followed by “sp.”
  • If the Latin organism genus and species designation is unknown, use “unidentified” and provide any known taxonomic information in the “note” qualifier.
  • For non-naturally occurring sequences, use “synthetic construct” as the organism qualifier value.

The “organism” qualifier is mandatory for all nucleotide and amino acid sequences, except for intentionally skipped sequences.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2413.01 - Parts Of The "Sequence Listing Xml", Patent Law, Patent Procedure
Tags: Organism Qualifier, sequence listing xml, Source Organism, Taxonomy