Q) Digital Media for Gene Sequence (MPEP 2400, Biotechnology)

by patentbar on May 11, 2007 · 5 comments

Note: Applicants must provide 1) a paper copy of the sequence, 2) a computer-readable copy of the sequence, and 3) a statement that the paper copy and computer readable copy are identical with an application that discloses nucleotide and/or amino acid sequence. (See Biotechnology MPEP 2400)

Test takers report a question regarding how many and what kind of digital media you can submit with a gene sequence.

Diskette
Magnetic tape
8mm Data Cartridge
Compact disc
Magneto Optical Disk

2421.02 Summary of the Requirements of the Sequence Rules

Basically, 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. Thus, 37 CFR 1.821 defines a “sequence” and a “Sequence Listing” for the purpose of the rules, the requirements for specific symbols, and formats for the “Sequence Listing,” the requirement for a computer readable form (CRF) of the “Sequence Listing,” and the deadlines for complying with the requirements. 37 CFR 1.822 to 37 CFR 1.824 set forth detailed descriptions of the requirements that are mandatory for the presentation of sequence data, and 37 CFR 1.825 sets forth procedures that are available to an applicant in the event that amendments to the sequence information or replacement of the computer readable copy become necessary. The sequence rules embrace all unbranched nucleotide

§ 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 requirements:

[…]

(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.

1 patentbar December 18, 2007 at 10:06 pm

Exam question – One on Nucleotide Sequence
The application has nucleotide sequences in it as a drawing. What are the requirements for entering the sequence for search purposes. I chose the answer where you just have to enter a CRF for the search requirement.
In studying this ahead of time, I surmised that there can be two situations:
1) Paper sequence in the application + CRF (one copy) OR
2) Sequence in the application on CD (two copies ) + CRF (one copy) = total of 3
Not sure if that is correct.

2 PHOSITA March 9, 2011 at 5:59 pm: Small correction regarding patentbar’s item (2):
Per § 1.821(c) Patent applications which contain disclosures of nucleotide and/or amino acid sequences must contain, as a separate part of the disclosure, a paper or compact disc copy (see § 1.52(e))….” The reference to § 1.52(e)(4) states: “Any compact disc must be submitted in duplicate unless it contains only the “Sequence Listing” in computer readable form required by § 1.821(e).”

Viewing that in relation to § 1.821(e) (“A copy of the “Sequence Listing” referred to in paragraph (c) of this section must also be submitted in computer readable form (CRF) in accordance with the requirements of § 1.824.”), leads me to conclude that only 1 CD must be submitted (plus some other CRF), but two could be submitted (one fulfilling part (c) and the other for part (e)).

3 maggie September 14, 2011 at 4:08 am