2424 Requirements for Nucleotide and/or Amino Acid Sequences as Part of the Application Papers
37 C.F.R. 1.823 Requirements for nucleotide and/or amino acid sequences as part of the application.
- (a)
- (1) If the "Sequence Listing" required by § 1.821(c) is submitted on paper: The "Sequence Listing," setting forth the nucleotide and/or amino acid sequence and associated information in accordance with paragraph (b) of this section, must begin on a new page and must be titled "Sequence Listing." The pages of the "Sequence Listing" preferably should be numbered independently of the numbering of the remainder of the application. Each page of the "Sequence Listing" shall contain no more than 66 lines and each line shall contain no more than 72 characters. A fixed-width font should be used exclusively throughout the "Sequence Listing."
- (2) If the "Sequence Listing" required by § 1.821(c) is submitted on compact disc: The "Sequence Listing" must be submitted on a compact disc in compliance with § 1.52(e). The compact disc may also contain table information if the application contains table information that may be submitted on a compact disc (§ 1.52(e)(1)(iii) ). The specification must contain an incorporation-by-reference of the Sequence Listing as required by § 1.52(e)(5). The presentation of the "Sequence Listing" and other materials on compact disc under § 1.821(c) does not substitute for the Computer Readable Form that must be submitted on disk, compact disc, or tape in accordance with § 1.824.
- (b) The "Sequence Listing" shall, except as otherwise indicated, include the actual nucleotide and/or amino acid sequence, the numeric identifiers and their accompanying information as shown in the following table. The numeric identifier shall be used only in the "Sequence Listing." The order and presentation of the items of information in the "Sequence Listing" shall conform to the arrangement given below. Each item of information shall begin on a new line and shall begin with the numeric identifier enclosed in angle brackets as shown. The submission of those items of information designated with an "M" is mandatory. The submission of those items of information designated with an "O" is optional. Numeric identifiers <110> through <170> shall only be set forth at the beginning of the "Sequence Listing." The following table illustrates the numeric identifiers.
| Numeric Identifier | Definition | Comments and format | Mandatory (M) or Optional (O) |
|---|---|---|---|
| <110> | Applicant...................... | Preferably max. of 10 names; one name per line; preferable format: Surname, Other Names and/or Initials. | M. |
| <120> | Title of Invention.......... | ............................................................. | M. |
| <130> | File Reference............... | Personal file reference......................... | M when filed prior to assignment or appl. number |
| <140> | Current Application Number. | Specify as: US 07/999,999 or PCT/US96/99999. | M, if available. |
| <141> | Current Filing Date....... | Specify as: yyyy-mm-dd...................... | M, if available. |
| <150> | Prior Application Number. | Specify as: US 07/999,999 or PCT/US96/99999. | M, if applicable include priority documents under 35 U.S.C. 119 and 120 |
| <151> | Prior Application Filing Date. | Specify as: yyyy-mm-dd ..................... | M, if applicable |
| <160> | Number of SEQ ID NOs. | Count includes total number of SEQ ID NOs................................................. | M. |
| <170> | Software....................... | Name of software used to create the Sequence Listing. | O. |
| <210> | SEQ ID NO:#:.............. | Response shall be an integer representing the SEQ ID NO shown. | M. |
| <211> | Length........................... | Respond with an integer expressing the number of bases or amino acid residues. | M. |
| <212> | Type.............................. | Whether presented sequence molecule is DNA, RNA, or PRT (protein). If a nucleotide sequence contains both DNA and RNA fragments, the type shall be "DNA." In addition, the combined DNA/ RNA molecule shall be further described in the <220> to <223> feature section. | M. |
| <213> | Organism...................... | Scientific name, i.e. Genus/ species, Unknown or Artificial Sequence. In addition, the "Unknown" or "Artificial Sequence" organisms shall be further described in the <220> to <223> feature section. | M. |
| <220> | Feature.......................... | Leave blank after <220>. <221-223> provide for a description of points of biological significance in the sequence. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is "Artificial Sequence" or "Unknown"; if molecule is combined DNA/RNA. |
| <221> | Name/Key..................... | Provide appropriate identifier for feature, preferably from WIPO Standard ST.25 (1998), Appendix 2, Tables 5 and 6. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence. |
| Numeric Identifier | Definition | Comments and format | Mandatory (M) or Optional (O) |
| <222> | Location........................ | Specify location within sequence; where appropriate state number of first and last bases/amino acids in feature. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence. |
| <223> | Other Information......... | Other relevant information; four lines maximum............................................. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is "Artificial Sequence" or "Unknown"; if molecule is combined DNA/RNA. |
| <300> | Publication Information | Leave blank after <300> | O. |
| <301> | Authors......................... | Preferably max. of ten named authors of publication; specify one name per line; preferable format: Surname, Other Names and/or Initials. | O. |
| <302> | Title............................... | ............................................................. | O. |
| <303> | Journal.......................... | ............................................................. | O. |
| <304> | Volume ......................... | ............................................................. | O. |
| <305> | Issue ............................. | ............................................................. | O. |
| <306> | Pages ............................ | ............................................................. | O. |
| <307> | Date.............. | Journal date on which data published; specify as yyyy- mm-dd, MMM-yyyy or Season- yyyy. | O. |
| <308> | Database Accession Number. | Accession number assigned by database including database name. | O. |
| <309> | Database Entry Date........ | Date of entry in database; specify as yyyy-mm-dd or MMM-yyyy. | O. |
| <310> | Patent Document Number. | Document number; for patent-type citations only. Specify as, for example, US 07/ 999,999. | O. |
| <311> | Patent Filing Date.............. | Document filing date, for patent-type citations only; specify as yyyy-mm-dd. | O. |
| <312> | Publication Date................ | Document publication date, for patent-type citations only; specify as yyyy-mm-dd. | O. |
| <313> | Relevant Residues............ | FROM (position) TO (position)........... | O. |
| <400> | Sequence....................... | SEQ ID NO should follow the numeric identifier and should appear on the line preceding the actual sequence. | M. |
2424.01 Informational Requirements for the Sequence Listing
37 CFR 1.823 sets forth the informational requirements for inclusion in the separate part of the disclosure on paper or compact disc (the "Sequence Listing") that must be submitted in accordance with 37 CFR 1.821(c). 37 CFR 1.823(a)(1) sets forth page and line length requirements for any "Sequence Listing" submitted on paper. The requirement to use a fixed width font to present sequence data is also set forth therein. This latter requirement is made to ensure that the desired sequence character spacing and numbering is maintained. 37 CFR 1.823(a)(2) requires any "Sequence Listing" submitted on compact disc to be in compliance with 37 CFR 1.52(e). The compact disc "Sequence Listing" submitted under 37 CFR 1.821(c) may also contain table information if the application contains table information that is over 50 pages. See 37 CFR 1.52(e)(1)(iii). 37 CFR 1.823(b) lists the items of information that are to be included in the "Sequence Listing" in the order in which those items are to appear. The numeric identifier for each item of information shall not include the explanatory information included in 37 CFR 1.823(b).
2424.02 Sequence Listing Numeric Identifiers
37 CFR 1.823(b) sets forth the order and presentation of the items of information in the Sequence Listing. Each item of information in the Sequence Listing must include the appropriate numeric identifier and its accompanying information as shown in the table below. Each item of information must begin on a new line with the numeric identifier enclosed in angle brackets. The submission of those items of information designated with an "M" is mandatory. The submission of those items of information designated with an "O" is optional. Numeric identifiers <110> through <170> must be set forth at the beginning of the Sequence Listing.
The following table illustrates the numeric identifiers. See MPEP § 2431 for a sample Sequence Listing.
| Numeric Identifier | Definition | Comments and format | Mandatory (M) or Optional (O) |
|---|---|---|---|
| <110> | Applicant...................... | Preferably max. of 10 names; one name per line; preferable format: Surname, Other Names and/or Initials. | M. |
| <120> | Title of Invention.......... | ............................................................. | M. |
| <130> | File Reference............... | Personal file reference......................... | M when filed prior to assignment or appl. number |
| <140> | Current Application Number. | Specify as: US 07/999,999 or PCT/US96/99999. | M, if available. |
| <141> | Current Filing Date....... | Specify as: yyyy-mm-dd...................... | M, if available. |
| <150> | Prior Application Number. | Specify as: US 07/999,999 or PCT/US96/99999. | M, if applicable include priority documents under 35 U.S.C. 119 and 120 |
| <151> | Prior Application Filing Date. | Specify as: yyyy-mm-dd ..................... | M, if applicable |
| <160> | Number of SEQ ID NOs. | Count includes total number of SEQ ID NOs................................................. | M. |
| <170> | Software....................... | Name of software used to create the Sequence Listing. | O. |
| <210> | SEQ ID NO:#:.............. | Response shall be an integer representing the SEQ ID NO shown. | M. |
| <211> | Length........................... | Respond with an integer expressing the number of bases or amino acid residues. | M. |
| <212> | Type.............................. | Whether presented sequence molecule is DNA, RNA, or PRT (protein). If a nucleotide sequence contains both DNA and RNA fragments, the type shall be "DNA." In addition, the combined DNA/ RNA molecule shall be further described in the <220> to <223> feature section. | M. |
| <213> | Organism...................... | Scientific name, i.e. Genus/ species, Unknown or Artificial Sequence. In addition, the "Unknown" or "Artificial Sequence" organisms shall be further described in the <220> to <223> feature section. | M. |
| <220> | Feature.......................... | Leave blank after <220>. <221-223> provide for a description of points of biological significance in the sequence. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is "Artificial Sequence" or "Unknown"; if molecule is combined DNA/RNA. |
| <221> | Name/Key..................... | Provide appropriate identifier for feature, preferably from WIPO Standard ST.25 (1998), Appendix 2, Tables 5 and 6. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence. |
| Numeric Identifier | Definition | Comments and format | Mandatory (M) or Optional (O) |
| <222> | Location........................ | Specify location within sequence; where appropriate state number of first and last bases/amino acids in feature. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence. |
| <223> | Other Information......... | Other relevant information; four lines maximum............................................. | M, under the following conditions: if "n," "Xaa," or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is "Artificial Sequence" or "Unknown"; if molecule is combined DNA/RNA. |
| <300> | Publication Information | Leave blank after <300> | O. |
| <301> | Authors......................... | Preferably max. of ten named authors of publication; specify one name per line; preferable format: Surname, Other Names and/or Initials. | O. |
| <302> | Title............................... | ............................................................. | O. |
| <303> | Journal.......................... | ............................................................. | O. |
| <304> | Volume ......................... | ............................................................. | O. |
| <305> | Issue ............................. | ............................................................. | O. |
| <306> | Pages ............................ | ............................................................. | O. |
| <307> | Date.............. | Journal date on which data published; specify as yyyy- mm-dd, MMM-yyyy or Season- yyyy. | O. |
| <308> | Database Accession Number. | Accession number assigned by database including database name. | O. |
| <309> | Database Entry Date........ | Date of entry in database; specify as yyyy-mm-dd or MMM-yyyy. | O. |
| <310> | Patent Document Number. | Document number; for patent-type citations only. Specify as, for example, US 07/ 999,999. | O. |
| <311> | Patent Filing Date.............. | Document filing date, for patent-type citations only; specify as yyyy-mm-dd. | O. |
| <312> | Publication Date................ | Document publication date, for patent-type citations only; specify as yyyy-mm-dd. | O. |
| <313> | Relevant Residues............ | FROM (position) TO (position)........... | O. |
| <400> | Sequence....................... | SEQ ID NO should follow the numeric identifier and should appear on the line preceding the actual sequence. | M. |
2424.03 Additional Miscellaneous Requirements
Throughout 37 CFR 1.823(b), the items of information relating to patent applications and patent publications should be provided keeping in mind the appropriate standards that have been established by the World Intellectual Property Organization (WIPO). In general, an application should be identified by a country code, a number and a filing date, while a published patent document should be identified by a country code, a number and kind code. Proper citation of priority patent applications is covered in MPEP § 201.14(d). For published patent documents, the country code, number and kind code will appear on the front page of the document. Unpublished PCT applications are identified by the letters PCT, the country code of the Receiving Office, the last two digits of the year of filing and a number, e.g., PCT/AT81/00033, PCT/FR88/00100. A published PCT application is identified by the letters WO, the last two digits of the year of publication, a number and a kind code, e.g., WO82/02827A, WO88/06811A. Country codes from WIPO Standard ST.3 Annex A and kind codes from WIPO Standard ST.16 are reproduced in MPEP § 1851. Questions on proper citation of patent documents should be directed to the Search and Information Resources Administration, International Liaison Staff.
In 37 CFR 1.823(b), numeric identifier <110>, the item of information relating to "APPLICANT" should be limited to a maximum of the first ten named applicants in the application. Similarly, in numeric identifier <301>, the item of information relating to "AUTHORS" should be limited to a maximum of the first ten named authors in the publication.
In 37 CFR 1.823(b) "yyyy-mm-dd" is the format for the presentation of patent related date information in the "Sequence Listing." Other date information may also be presented as MMM-yyyy or Season-yyyy. The lower case letters designate numeric responses and the upper case letters designate alphabetical responses. As such, March 2, 1988, would be presented as 1988-03-02 or MAR 1988.
In numeric identifiers <220> - <223>, relating to "Features" or the description of the points of biological significance in a given sequence, it is recommended, but not required, that the information that is provided by the applicant conform to the controlled vocabulary that is set forth in GenBank's "Feature Representation in Nucleotide Sequence Data Libraries," Release 57.0, as may be amended. Further, the feature "LOCATION" should be specified using the syntax of the DDBJ/EMBL/GenBank Feature Table Definition. See MPEP § 2422 when filing in countries which adhere to WIPO Standard ST.25.
In numeric identifiers <300> - <312>, publication information for a given sequence is collected. The publication information encompasses both patent-type publications and non-patent literature publications. Numeric identifier <313>, Relevant Residues, is intended to collect information relating to the correspondence between a sequence set forth in the "Sequence Listing" and published sequence information. The starting (FROM) and end (TO) positions in the listed sequence that correspond to the published sequence information should be set forth.