Code of Federal Regulations (alpha)

CFR /  Title 37  /  Part 1  /  Sec. 1.823 Requirements for nucleotide and/or amino acid

(a)(1) If the ``Sequence Listing'' required by Sec. 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. The sheet or sheets presenting a sequence listing may not include material other than part of the sequence listing. A fixed-width font should be used exclusively throughout the ``Sequence Listing.''

(1) If the ``Sequence Listing'' required by Sec. 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. The sheet or sheets presenting a sequence listing may not include material other than part of the sequence listing. A fixed-width font should be used exclusively throughout the ``Sequence Listing.''

(2) If the ``Sequence Listing'' required by Sec. 1.821(c) is submitted on compact disc: The ``Sequence Listing'' must be submitted on a compact disc in compliance with Sec. 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 (Sec. 1.52(e)(1)(iii)). The specification must contain an incorporation-by-reference of the Sequence Listing as required by Sec. 1.52(e)(5). The presentation of the ``Sequence Listing'' and other materials on compact disc under Sec. 1.821(c) does not substitute for the Computer Readable Form that must be submitted on disk, compact disc, or tape in accordance with Sec. 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 <110through <170shall only be set forth at the beginning of the ``Sequence Listing.'' The following table illustrates the numeric identifiers. ----------------------------------------------------------------------------------------------------------------

Mandatory (M) or optional

Numeric identifier Definition Comments and format (O).----------------------------------------------------------------------------------------------------------------<110.......... Applicant............... Preferably max. of 10 names; M.

one name per line;

preferable format: Surname,

Other Names and/or Initials.<120.......... Title of Invention...... ............................. M.<130.......... File Reference.......... Personal file reference...... M when filed prior to

assignment of appl. number.<140.......... Current Application Specify as: US 07/999,999 or M, if available.

Number. PCT/US96/99999.<141.......... Current Filing Date..... Specify as: yyyy-mm-dd....... M, if available.<150.......... Prior Application Number Specify as: US 07/999,999 or M, if applicable include

PCT/US96/99999. priority documents under 35

USC 119 and 120.<151.......... Prior Application Filing Specify as: yyyy-mm-dd....... M, if applicable.

Date.<160.......... Number of SEQ ID NOs.... Count includes total number M.

of SEQ ID NOs.<170.......... Software................ Name of software used to O.

create the Sequence Listing.<210.......... SEQ ID NO::.... Response shall be an integer M.

representing the SEQ ID NO

shown.<211.......... Length.................. Respond with an integer M.

expressing the number of

bases or amino acid residues.<212.......... Type.................... Whether presented sequence M.

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

<220to <223feature section.<213.......... Organism................ Scientific name, i.e., Genus/ M

species, Unknown or

Artificial Sequence. In

addition, the ``Unknown'' or

``Artificial Sequence''

organisms shall be further

described in the <220to <223feature

section.<220.......... Feature................. Leave blank after <220. <221-223provide for a description ``Xaa,'' or a modified or

of points of biological unusual L-amino acid or

significance in the modified base was used in a

sequence.. sequence; if ORGANISM is

``Artificial Sequence'' or

``Unknown''; if molecule is

combined DNA/RNA''<221.......... Name/Key................ Provide appropriate M, under the following

identifier for feature, conditions: if ``n,''

preferably from WIPO ``Xaa,'' or a modified or

Standard ST.25 (1998), unusual L-amino acid or

Appendix 2, Tables 5 and 6. modified base was used in a

sequence.<222.......... Location................ Specify location within M, under the following

sequence; where appropriate conditions: if ``n,''

state number of first and ``Xaa,'' or a modified or

last bases/amino acids in unusual L-amino acid or

feature. modified base was used in a

sequence.<223.......... Other Information....... Other relevant information; M, under the following

four lines maximum. 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.<301.......... Authors................. Preferably max of ten named O.

authors of publication;

specify one name per line;

preferable format: Surname,

Other Names and/or Initials.<302.......... Title................... ............................. O.<303.......... Journal................. ............................. O.<304.......... Volume.................. ............................. O.<305.......... Issue................... ............................. O.<306.......... Pages................... ............................. O.

<307.......... Date.................... Journal date on which data O.

published; specify as yyyy-

mm-dd, MMM-yyyy or Season-

yyyy.<308.......... Database Accession Accession number assigned by O.

Number. database including database

name.<309.......... Database Entry Date..... Date of entry in database; O.

specify as yyyy-mm-dd or MMM-

yyyy.<310.......... Patent Document Number.. Document number; for patent- O.

type citations only. Specify

as, for example, US 07/

999,999.<311.......... Patent Filing Date...... Document filing date, for O.

patent-type citations only;

specify as yyyy-mm-dd.<312.......... Publication Date........ Document publication date, O.

for patent-type citations

only; specify as yyyy-mm-dd.<313.......... Relevant Residues....... FROM (position) TO (position) O.<400.......... Sequence................ SEQ ID NO should follow the M.

numeric identifier and

should appear on the line

preceding the actual

sequence.---------------------------------------------------------------------------------------------------------------- [63 FR 29636, June 1, 1998, as amended at 65 FR 54681, Sept. 8, 2000; 68 FR 38630, June 30, 2003]