37 CFR 1.823
Requirements for nucleotide and/or amino acid sequences as part of the application.
This document contains one section of Chapter 37 of the Code of Federal Regulations.
This page was last updated in November, 2005. You may return to
the main 37 CFR Index, or to the index
for one of the follow parts:
part 1 (patents);
part 2 (trademarks);
part 3 (assignments);
part 10 (representation); or
part 200+ (copyrights).
Previous Section (§1.822) | Next Section (§1.824)
§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. 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 § 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
Definition
Comments and format
Mandatory (M) or
identifier
optional (O).
<110>
Applicant
Preferably max. of 10
M.
names; one name per
line; preferable
format: Surname,
Other Names and/or
Initials
<120>
Title of Invention
M.
<130>
File Reference
Personal file
M when filed prior to
reference
assignment of appl.
number.
<140>
Current Application
Specify as: US
M, if available.
Number
07/999,999 or
PCT/US96/99999
<141>
Current Filing Date
Specify as: yyyy-mm-
M, if available.
dd
<150>
Prior Application
Specify as: US
M, if applicable
Number
07/999,999 or
include priority
PCT/US96/99999
documents under 35
U.S.C. 119 and 120.
<151>
Prior Application
Specify as: yyyy-mm-
M, if applicable.
Filing Date
dd
<160>
Number of SEQ ID NOs.
Count includes total
M.
number of SEQ ID NOs.
<170>
Software
Name of software used
O.
to create the
Sequence Listing
<210>
SEQ ID NO: # :
Response shall
M.
be an integer
representing the SEQ
ID NO shown
<211>
Length
Respond with an
M.
integer expressing
the number of bases
or amino acid
residues
<212>
Type
Whether presented
M.
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
<213>
Organism
Scientific name, i.e.
M
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
<220>
Feature
Leave blank after
M, under the
<220>. <221-223>
following conditions:
provide for a
if "n," "Xaa," or a
description of points
modified or unusual
of biological
L-amino acid or
significance in the
modified base was
sequence.
used in a sequence;
if ORGANISM is
"Artificial Sequence"
or "Unknown'; if
molecule is combined
DNA/RNA"
<221>
Name/Key
Provide appropriate
M, under the
identifier for
following conditions:
feature, preferably
if "n," "Xaa," or a
from WIPO Standard
modified or unusual
ST.25 (1998),
L-amino acid or
Appendix 2, Tables 5
modified base was
and 6
used in a sequence.
<222>
Location
Specify location
M, under the
within sequence;
following conditions:
where appropriate
if "n," "Xaa," or a
state number of first
modified or unusual
and last bases/amino
L-amino acid or
acids in feature
modified base was
used in a sequence.
<223>
Other Information
Other relevant
M, under the
information; four
following conditions:
lines maximum
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
Leave blank after
O.
Information
<300>
<301>
Authors
Preferably max of ten
O.
named 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
O.
data published;
specify as yyyy-mm-
dd, MMM-yyyy or
Season-yyyy
<308>
Database Accession
Accession number
O.
Number
assigned by database
including database
name
<309>
Database Entry Date
Date of entry in
O.
database; specify as
yyyy-mm-dd or MMM-
yyyy
<310>
Patent Document
Document number; for
O.
Number
patent-type citations
only. Specify as, for
example, US
07/999,999
<311>
Patent Filing Date
Document filing date,
O.
for patent-type
citations only;
specify as yyyy-mm-dd
<312>
Publication Date
Document publication
O.
date, for patent-type
citations only;
specify as yyyy-mm-dd
<313>
Relevant Residues
FROM (position) TO
O.
(position)
<400>
Sequence
SEQ ID NO should
M.
follow the numeric
identifier and should
appear on the line
preceding the actual
sequence