Overview

The worldwide standard for submitting DNA and/or amino acid sequences disclosed in a patent application was amended in July 1998/January 1999. The following discussion is intended to provide your firm or company with an overview of the "old" sequence rules versus the "new" sequence rules.

The U.S. Patent and Trademark Office published its Final Sequence Rule, June 1, 1998, entitled "Requirements for Patent Application Containing Nucleotide Sequence and/or Amino Acid Disclosures" (see Federal Register 63:104, 29620-29643, June 1, 1998). Furthermore, WIPO published its final version of WIPO Standard ST.25, November 1, 1998, entitled "Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in Patent Applications." The amended U.S. rules under 37 C.F.R. §§1.821-825, as well as the corresponding foreign equivalents, were marshaled forward for the purpose of simplifying the sequence rules and creating an international, language neutral, standard for Sequence Listings.

These rules, which have effective dates of July 1, 1998, and January 1, 1999, respectively, still refer to applications containing DNA sequences that include at least ten nucleotides (four or more specific nucleotides) and/or four or more specific amino acids, which are filed after the respective effect dates. U.S. applications (with no additional sequence data) that claim benefit of a prior application under 35 U.S.C. 120 may still file a Sequence Listing under the "old" rules if so desired.

SUMMARY OF THE CHANGES

Although the amended U.S. and foreign sequence rules do not affect the substantive manner in which DNA and/or amino acid sequences must be submitted in U.S. or foreign Sequence Listings, the rules do affect the format of the submission quite substantially. A few of the more noticeable changes include (i) use of numeric identifiers to replace the language subject headings; (ii) movement of the paper copy of the Sequence Listing to the end of the application; (iii) lower case one-letter codes for nucleotide bases; and (iv) elimination of the topology and strandedness designation, and the mandatory inclusion of an organism designation. One proposed change that was not included in the new U.S. rules is the omission of prior art sequences from the Sequence Listing (i.e., publicly available sequences used for comparison purposes). These sequences must still be submitted in a U.S. Sequence Listing. In some instances, however, an accession number to a cited sequence may be placed in the application of a foreign case, which will thereby negate its inclusion in the listing (PCT, EPO, etc., not U.S.).

SUMMARY

This memo is intended only to provide you and your firm or company with a synopsis of the changes in the sequence rules as they pertain to the submission of DNA and/or amino acid sequences in both U.S. and foreign Sequence Listings. We urge you to address any case that requires the submission of a Sequence Listing as quickly as possible, so as to avoid costly extensions-of-time.