INTELLECTUAL PROPERTY RIGHTS
NATIONAL LEGISLATION - USA
Patent Laws and Regulations
Regulations: Title 37, Chapter I (Subchapter A,
Parts 1, 3, 5, 7, 10, 15, and 15a and Subchapter B); Chapter IV and Chapter V,
Code of Federal Regulations
37 C.F.R. § 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) (l) 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, or compatibles, or Apple Macintosh;
(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.
[55 FR 18245, May 1, 1990; 63 FR 29620, 29637, June 1, 1998]
37 C.F.R. § 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.
[55 FR 18245, May 1, 1990; 63 FR 29620, 29638, June 1, 1998]
Example of a Sequence
Isolation and Characterization
of a Gene Encoding a Protease from Paramecium sp.
Journal of Fictional
1 - 7
ctactctcat ctactatctt ctttggatct ctgagtctgc ctgagtggta 60
ctggagatct ctcctctcac atgtgatcgt cgagactgac cgatagatcg 120
ctgagatagt cgagcccgta cgagacccgt cgagggtgac agagagtggg 180
cagagcgccg cgccggtgcg cgcgcgagtg cgcggtgggc cgcgcgaggg 240
agcggcggcg ctttccggcg cgcgcccgtc cgcccctaga cctgagaggt 300
ctcctcttca ctagagaggt ctatatatac atg gtt tca atg ttc 355
Met Val Ser Met Phe
tct tth aaa tgg cct gga ttt tgt ttg ttt gtt tgtttgctc 403
Ser Phe Lys Trp Pro Gly Phe Cys Leu Phe Val
<213> Paramecium aurelia
Ser Met Phe Ser Leu Ser Phe Lys Trp Pro Gly Phe Cys Leu
[24 FR 10332, Dec. 22, 1959, as amended at 54 FR 34880, Aug. 22, 1989; 55 FR 18245, May 1, 1990; 63 FR 29620, 29638, June 1, 1998]
(1) GENERAL INFORMATION:
(ii) TITLE OF INVENTION:
(iii) NUMBER OF SEQUENCES:
(iv) CORRESPONDENCE ADDRESS:
(v) COMPUTER READABLE FORM:
(A) MEDIUM TYPE:
(C) OPERATING SYSTEM:
(vi) CURRENT APPLICATION DATA:
(A) APPLICATION NUMBER:
(B) FILING DATE:
(vii) PRIOR APPLICATION DATA:
(A) APPLICATION NUMBER:
(B) FILING DATE:
(viii) ATTORNEY/AGENT INFORMATION:
(B) REGISTRATION NUMBER:
(C) REFERENCE/DOCKET NUMBER:
(ix) TELECOMMUNICATION INFORMATION:
(2) INFORMATION FOR SEQ ID NO: X:
(i) SEQUENCE CHARACTERISTICS:
(ii) MOLECULE TYPE:
--cDNA to genomic RNA;
--cDNA to mRNA;
--cDNA to tRNA;
--cDNA to rRNA;
--cDNA to snRNA;
--cDNA to scRNA;
--Other nucleic acid;
(v) FRAGMENT TYPE:
(vi) ORIGINAL SOURCE:
(C) INDIVIDUAL ISOLATE:
(D) DEVELOPMENTAL STAGE:
(F) TISSUE TYPE:
(G) CELL TYPE:
(H) CELL LINE:
(vii) IMMEDIATE SOURCE:
(viii) POSITION IN GENOME:
(B) MAP POSITION:
(C) IDENTIFICATION METHOD:
(D) OTHER INFORMATION:
(x) PUBLICATION INFORMATION:
(H) DOCUMENT NUMBER:
(I) FILING DATE:
(J) PUBLICATION DATE:
(K) RELEVANT RESIDUES:
(xi) SEQUENCE DESCRIPTION: SEQ ID NO: X:
[24 FR 10332, Dec. 22, 1959, as amended at 54 FR 34880, Aug. 22, 1989; 55 FR 18245, May 1, 1990]