Biotechnology (MPEP 2400)

by patentbar on December 5, 2007 · 3 comments

in MPEP 2400

Recent test takers report that submittal of nucleotide and/or amino acid sequence in an application (from MPEP 2422) appears on the Prometric Patent Bar Exam. The following sections of 37 CFR 1.821 are tested:

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.

37 CFR 1.821 Nucleotide and/or amino acid sequence disclosures in patent applications.

(c) Patent applications which contain disclosures of nucleotide and/or amino acid sequences must contain, as a separate part of the disclosure, a paper copy disclosing the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of §§ 1.822 and 1.823. This paper copy is hereinafter referred to as the “Sequence Listing.” Each sequence disclosed must appear separately in the “Sequence Listing.” Each sequence set forth in the “Sequence Listing” shall be assigned a separate sequence identifier. The sequence identifiers shall begin with 1 and increase sequentially by integers. If no sequence is present for a sequence identifier, the code “000” shall be used in place of the sequence. The response for the numeric identifier 160 shall include the total number of SEQ ID NOs, whether followed by a sequence or by the code “000.”

(e) A copy of the “Sequence Listing” referred to in paragraph (c) of this section must also be submitted in computer readable form in accordance with the requirements of § 1.824. The computer readable form is a copy of the “Sequence Listing” and will not necessarily be retained as a part of the patent application file. If the computer readable form of a new application is to be identical with the computer readable form of another application of the applicant on file in the Patent and Trademark Office, reference may be made to the other application and computer readable form in lieu of filing a duplicate computer readable form in the new application if the computer readable form in the other application was compliant with all of the requirements of these rules. The new application shall be accompanied by a letter making such reference to the other application and computer readable form, both of which shall be completely identified. In the new application, applicant must also request the use of the compliant computer readable “Sequence Listing” that is already on file for the other application and must state that the paper copy of the “Sequence Listing” in the new application is identical to the computer readable copy filed for the other application.

(f) In addition to the paper copy required by paragraph (c) of this section and the computer readable form required by paragraph (e) of this section, a statement that the content of the paper and computer readable copies are the same must be submitted with the computer readable form, e.g., a statement that “the information recorded in computer readable form is identical to the written sequence listing.”

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