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2423.03 Presentation and Enumeration of Sequences - 2400 Biotechnology

2423.03 Presentation and Enumeration of Sequences

37 CFR 1.822(c)(5) provides that nucleotide sequences shall only be represented by a single strand, in the 5′ to 3′ direction, from left to right. That is, double stranded nucleotides shall not be represented in the "Sequence Listing." A double stranded nucleotide may be represented as two single stranded nucleotides, and any relationship between the two may be shown in the drawings.

The procedures for presenting and numbering amino acid sequences are set forth in 37 CFR 1.822(d). Two alternatives are presented for numbering amino acid sequences. Amino acid sequences may be numbered with respect to the identification of the first amino acid of the first mature protein or with respect to the first amino acid appearing at the amino terminal. The enumeration procedure for nucleotides is set forth in 37 CFR 1.822(c)(6). Sequences that are circular in configuration are intended to be encompassed by these rules, and numbering procedures for them are provided in 37 CFR 1.822(c)(7) and (d)(4). The numbering procedures set forth in 37 CFR 1.822(c) and (d) are not necessarily intended to be consistent with all currently employed numbering procedures. The objective here is to establish a reasonable numbering procedure that can readily be followed and adhered to. These formatting procedures also reflect those that have been agreed to for electronic data exchange with the JPO and the EPO.

In 37 CFR 1.822(e) the procedures for presenting and numbering hybrid and gapped sequences are set forth. A sequence that is made up of one or more noncontiguous segments of a larger sequence or segments from different sequences, i.e., a hybrid sequence, shall be presented as a separate sequence. A "gap" for the purpose of this section is not intended to embrace a gap or gaps that is/are introduced into the presentation of otherwise continuous sequence information in, e.g., a drawing figure, to show alignments or similarities with other sequences. The "gaps" referred to in this section are gaps representing unknown or undisclosed regions in a sequence between regions that are known or disclosed. In the situation where a contiguous fragment of a sequence that has already been properly set forth in a "Sequence Listing" is discussed and/or claimed, the fragment does not need to be separately included in the "Sequence Listing." It may be referred to in the specification, claims or drawings as, e.g., "residues 2 through 33 of SEQ ID NO:12," assuming that SEQ ID NO:12 has been properly included in the "Sequence Listing."

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