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that is made up of one or more noncontiguous segments of a larger sequence or segments from different sequences shall be presented as a separate sequence.

[63 FR 29635, June 1, 1998]

§ 1.823 Requirements for nucleotide and/or ^amino acid sequences as part of the application papers.

(a) The “Sequence Listing" required by §1.821(c), setting forth the nucleotide and/or amino acid sequences and associated information in accordance with paragraph (b) of this section, must begin on a new page and must be titled "Sequence Listing". The "Sequence Listing" preferably should be numbered independently of the numbering of the remainder of the application. Each page of the "Sequence Listing" should contain no more than 66 lines and each line should contain no more than 72 characters. A fixed-width font should be used exclusively throughout the "Sequence Listing."

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(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.

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<150

Prior Application

Number.

<151>

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Specify as: US 07/999,999 or PCT/US96/ | M, if available.

M, if available.

Specify as: US 07/999,999 or PCT/US96/ M, if applicable include priority docu-
99999.
ments under 35 USC 119 and 120.
M, if applicable.

Prior Application Fil- Specify as: yyyy-mm-dd

Count includes total number of SEQ ID M.
NOS.

Name of software used to create the Se- | O.
quence Listing.

<10

SEQ ID NO:#:

Response shall be an integer represent- M.
ing the SEQ ID NO shown.

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Respond with an integer expressing the M.
number of bases or amino acid resi-
dues.

Whether presented sequence molecule is M.
DNA, RNA, or PRT (protein). If a nu-
cleotide sequence contains both DNA
and RNA fragments, the type shall be
“DNA." In addition, the combined DNA/
RNA molecule shall be further de-
scribed in the <220> to <223> feature
section.
Scientific name, i.e. Genus/ species, Un- M
known or Artificial Sequence. In addi-
tion, the "Unknown" or "Artificial Se-
quence" organisms shall be further de-
scribed in the <220> to <223> feature
section.

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[63 FR 29636, June 1, 1998]

§ 1.824 Form and format for nucleotide and/or amino acid sequence submissions in computer readable form. (a) The computer readable form required by §1.821(e) shall meet the following specifications:

(1) The computer readable form shall contain a single "Sequence Listing" as either a diskette, series of diskettes, or other permissible media outlined in paragraph (c) of this section.

(2) The "Sequence Listing" in paragraph (a) (1) of this section shall be submitted in American Standard Code

for Information Interchange (ASCII) text. No other formats shall be allowed.

(3) The computer readable form may be created by any means, such as word processors, nucleotide/amino acid sequence editors or other custom computer programs; however, it shall conform to all specifications detailed in this section.

(4) File compression is acceptable when using diskette media, so long as the compressed file is in a self-extracting format that will decompress on one of the systems described in paragraph (b) of this section.

(5) Page numbering shall not appear within the computer readable form version of the “Sequence Listing” file.

(6) All computer readable forms shall have a label permanently affixed thereto on which has been hand-printed or typed: the name of the applicant, the title of the invention, the date on which the data were recorded on the computer readable form, the operating system used, a reference number, and an application serial number and filing date, if known.

(b) Computer readable form submissions must meet these format requirements:

(1) Computer: IBM PC/XT/AT, compatibles, or Apple Macintosh;

or

(2) Operating System: MS-DOS, Unix or Macintosh;

(3) Line Terminator: ASCII Carriage Return plus ASCII Line Feed;

(4) Pagination: Continuous file (no "hard page break" codes permitted);

(c) Computer readable form files submitted may be in any of the following media:

(1) Diskette : 3.50 inch, 1.44 Mb storage; 3.50 inch, 720 Kb storage; 5.25 inch, 1.2 Mb storage; 5.25 inch, 360 Kb storage.

(2) Magnetic tape: 0.5 inch, up to 24000 feet; Density: 1600 or 6250 bits per inch, 9 track; Format: Unix tar command; specify blocking factor (not "block size"); Line Terminator: ASCII Carriage Return plus ASCII Line Feed.

(3) 8mm Data Cartridge: Format: Unix tar command; specify blocking factor (not "block size"); Line Terminator: ASCII Carriage Return plus ASCII Line Feed.

(4) CD-ROM: Format: ISO 9660 or High Sierra Format

(5) Magneto Optical Disk: Size/Storage Specifications: 5.25 inch, 640 Mb.

(d) Computer readable forms that are submitted to the Office will not be returned to the applicant.

[63 FR 29637, June 1, 1998]

§ 1.825 Amendments to or replacement of sequence listing and computer readable copy thereof.

(a) Any amendment to the paper copy of the "Sequence Listing" (§1.821(c)) must be made by the submission of substitute sheets. Amendments must be accompanied by a statement that indicates support for the amendment in the application, as filed, and a statement that the substitute sheets include no new matter.

(b) Any amendment to the paper copy of the "Sequence Listing," in accordance with paragraph (a) of this section, must be accompanied by a substitute copy of the computer readable form (§1.821(e)) including all previously submitted data with the amendment incorporated therein, accompanied by a statement that the copy in computer readable form is the same as the substitute copy of the "Sequence Listing."

(c) Any appropriate amendments to the "Sequence Listing" in a patent; e.g., by reason of reissue or certificate of correction, must comply with the requirements of paragraphs (a) and (b) of this section.

(d) If, upon receipt, the computer readable form is found to be damaged or unreadable, applicant must provide, within such time as set by the Commissioner, a substitute copy of the data in computer readable form accompanied by a statement that the substitute data is identical to that originally filed.

[63 FR 29638, June 1, 1998]

APPENDIX A TO SUBPART G TO PART 1-SAMPLE SEQUENCE LISTING

<110> Smith, John

Smith, Jane

<120> Example of a Sequence Listing

<130> 01-00001

<140> US 08/999,999

<141> 1998-02-28

<150> EP 91000000

<151> 1997-12-31

<160> 2

<170> PatentIn ver. 2.0

<210> 1

<211> 403

<212> DNA

<213> Paramecium aurelia

<220>

<221> CDS

<222> 341..394

<300>

<301> Doe, Richard

<302> Isolation and Characterization of a Gene Encoding a

Protease from Paramecium sp.

<303> Journal of Fictional Genes

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