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3.5 – MPEP 2400 Biotechnology

Biotechnology Patent Law

Biotechnology Patent Law

MPEP 2420 – Requirements for Nucleotide Sequences and/or Amino Acid Sequence Disclosures

Diversity and complexity of nucleotide and amino acid sequence data created problems with searching and analysis both inside and outside the office.  This complexity problem was solved with a creation of the sequence rules which creates:

  1. A standardized format for descriptions of nucleotide and amino acid sequence date.
  2. A requirement that sequence data be submitted in a computer readable form.

These rules went into effect on October 1, 1990 and was revised on July 1, 1998.

MPEP 2421.02 – Sequence Rules Requirements Summary

The sequence rules define a set of symbols and procedures that are both mandatory and the only way that an applicant is permitted to describe information about a sequence that falls within the definitions used in the rules.

These sequence rules include:

Nucleotide Sequences: All unbranched, All branched with ten or more bases and they must have four specifically defined nucleotide sequences.

Amino Acid Sequences: Non-D amino acid sequences with four or more amino acids.  There must be at least 5 specifically defined amino acid sequences.

MPEP 2425 – Form and Format for Nucleotide and/or Amino Acid Sequence Submissions in Computer Readable Form

Reference 37 C.F.R. § 1.824 which sets forth the requirements for sequence submissions in computer readable form.

Any computer operating system may be utilized to produce a sequence submission, provided that the system is capable of producing a file having the characteristics specified in 37 CFR § 1.824, and is capable of writing the properly formatted file to one of the acceptable electronic media.

If a given sequence and its associated information cannot practically or possibly fit on the electronic media required in 37 CFR § 1.824(c), an exception via a non-fee petition to waive this provision will normally be granted.

As set forth in 37 CFR § 1.824(d), the computer readable forms that are submitted in accordance with these rules will not be returned to the applicant. 37 CFR § 1.824(a)(6) requires the labeling, with appropriate identifying information, of the computer readable forms that are submitted in accordance with these rules.

(a) The computer readable form required by 37 C.F.R. § 1.821(e) shall meet the following requirements:

1) The computer readable form shall contain a single “Sequence Listing” as either a diskette, series of diskettes, or other permissible media.
2) The “Sequence Listing” 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 requirements.
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 (b).
5) Page numbering must not appear within the computer readable form version of the “Sequence Listing” file.
6) All computer readable forms must 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 number and filing date, if known. If multiple diskettes are submitted, the diskette labels must indicate their order (e.g., “1 of X”).

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

1) Computer Compatibility: IBM PC/XT/AT or Apple Macintosh;
2) Operating System Compatibility: MS-DOS, MS-Windows, Unix or Macintosh;
3) Line Terminator: ASCII Carriage Return plus ASCII Line Feed; and
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) Compact disc: 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.