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Rules Summary

Under the Sequence Harmonization Act of 1998, most worldwide Patent Offices require essentially any sequence of four (4) or more amino acids or ten (10) or more nucleotides disclosed in a patent application (specification, claims, abstract and figures) be submitted in USPTO/PCT standard format.




The rules specify (summarized):

  • The Sequence Listing must be submitted in both paper and computer-readable forms; the Sequence Listing diskette must not contain, however, any of the word processing codes used to create the paper copy.
  • Every sequence disclosed in the specification, claims, abstract and figures, even if described as prior art or not claimed, must appear in the Sequence Listing.
  • The period for responding to the "Notice to Comply with Requirements for Patent Applications Containing ... Sequence Disclosures" is only one or two months from the day the PTO mails the Notice.
  • Each sequence is given an ID number in the Sequence Listing which must be cited (e.g., "SEQ ID NO: 1") at each place in the specification, figure description, claims or abstract where that sequence is disclosed.
  • Nucleotide sequences must be presented as single stranded, 5' to 3', left to right sequences, even though, by convention, complementary DNA is written as 3' to 5', left to right sequences.
  • Amino acids encoded by a nucleic acid sequence must be listed directly below the corresponding nucleotides, as well as appear as a separate file (SEQ ID NO:).
  • "Xaa" residues and "n" nucleotides must be specifically identified.