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.”

{ 3 comments… read them below or add one }

1 patentbarNo Gravatar December 18, 2007 at 9:21 pm

Test takers report – There was a question on Biotech sequence listings where it asked the format of the submission. The problem with this question is that 2400 points out two different kinds of submissions, and it’s not clear if they mean CRF or the regular sequence listing and if it’s possible to submit two different copies.

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2 studierNo Gravatar December 5, 2010 at 6:12 pm

I always find a bit of background helpful. Also, this shows you how to get from MPEP chapter 2400 to 37 CFR 1.821.

2420 The Requirements for Patent
Applications Containing Nucleotide
Sequence and/or Amino Acid
Sequence Disclosures – the
Sequence Rules

Prior to the effective date (October 1, 1990) and
implementation of the sequence rules (37 CFR 1.821
through 1.825), applications for patents that included
nucleotide or amino acid sequence information posed
special problems for the Office. While not related to
the disclosure requirements of an invention, problems
existed in the presentation, examination and printing
of nucleotide and amino acid sequence data that
appeared in patent applications because of the lack of
uniformity in submission of sequence data to the
Office and the impracticality of properly searching
and examining sequences submitted in paper form. In
summary, the diversity and complexity of nucleotide
and amino acid sequence data resulted in searching
and analysis difficulties both within the Office and
outside the Office, decreased accuracy of search and
reproduction and increased costs. These difficulties
made the development and implementation of the
sequence rules a critical necessity for the Office. As
such, the Office amended its regulations to establish a
standardized format for descriptions of nucleotide and
amino acid sequence data submitted as a part of patent
applications, in conjunction with the required submission
of that data in computer readable form.

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.

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3 studierNo Gravatar December 5, 2010 at 6:18 pm

1.821

(b) Patent applications which contain disclosures
of nucleotide and/or amino acid sequences, . . .
shall, with regard to the manner in which the
nucleotide and/or amino acid sequences are presented
and described, conform exclusively to the requirements
of §§ 1.821 through 1.825.

(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)) 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 or compact disc copy is referred to
elsewhere in this subpart as the “Sequence Listing.”

(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. The
computer readable form must be a copy of the
“Sequence Listing” and may not 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 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 this subpart.

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

(g) If any of the requirements of paragraphs
(b) through (f) of this section are not satisfied at the
time of filing under 35 U.S.C. 111(a) or at the time of
entering the national stage under 35 U.S.C. 371,
applicant will be notified and given a period of time
within which to comply with such requirements in
order to prevent abandonment of the application. Any
submission in reply to a requirement under this paragraph
must be accompanied by a statement that the
submission includes no new matter.

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