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2427.01 Form Paragraphs - 2400 Biotechnology
2427.01 Form Paragraphs
See MPEP § 608.05 for form paragraphs which should be used when notifying applicant that a compact disc submitted in accordance with 37 CFR 1.52(e) (i.e., containing a computer program listing, Sequence Listing, and/or table) does not comply with all of the requirements of the 37 CFR 1.52(e). See also MPEP § 608.05(b) for form paragraphs which should be used when a table submitted on compact disc does not comply with 37 CFR 1.52(e).
In order to expedite the processing of applications, minor errors pertaining to compliance with the sequence rules may be handled with the first Office action. Examples of minor errors are: when the "Sequence Listing" under 37 CFR 1.821(c) is submitted on compact disc, missing statement in the transmittal letter stating that the two compact discs are identical, missing an incorporation-by-reference of the "Sequence Listing" in the specification, or missing a listing of the files and required information in the transmittal letter; missing statement in the transmittal letter stating that the sequence listing information in computer readable form is identical to the written (on paper or compact disc) "Sequence Listing," etc. Since the application is ready for examination, the examiner may act on the application and include any objections to the application based on minor errors related to the "Sequence Listing" with his/her Office action. In addition to the form paragraphs reproduced in MPEP § 608.05 and § 608.05(b), the following form paragraphs are particular to Sequence Listings and should be used as appropriate when notifying applicant of errors in the Sequence Listing:
24.01 - This form paragraph should be used for the first mailing of a Notice to Comply.
24.02 - This form paragraph should be used for the first mailing of a CRF Diskette Problem Report.
24.03 - This form paragraph should be used when an applicant has made a bona fide attempt to comply but the reply generates an error listing from the Scientific and Technical Information Center (STIC). This should be used for a second mailing to applicant unless it is evident that there has been a deliberate omission; this form paragraph may also be used to extend the period for reply for the initially mailed notice.
24.04 - This form paragraph should be used when there has been a deliberate omission in the reply or where the reason the reply is incomplete cannot be characterized as an apparent oversight or instance of inadvertence.
24.05 - This form paragraph should be used whenever there is no statement in the transmittal letter that the sequence listing information recorded in computer readable form is identical to the written (on paper or compact disc) sequence listing.
24.05.01 - This form paragraph should be used whenever an amendment is filed with a CRF and there is no statement in the transmittal letter stating that the Sequence Listing information recorded in the CRF is identical to the written sequence listing.
¶ 24.01 Cover Letter for Use With Notice To Comply With Sequence Rules
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below or on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. [1]
Applicant is given ONE MONTH, or THIRTY DAYS, whichever is longer, from the mailing date of this letter within which to comply with the sequence rules, 37 CFR 1.821 - 1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 CFR 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136(a). In no case may an applicant extend the period for reply beyond the SIX MONTH statutory period. Direct the reply to the undersigned. Applicant is requested to return a copy of the attached Notice to Comply with the reply.
Examiner Note
1. Use this form paragraph only for the initial communication to the applicant. Use either form paragraph 24.03 or 24.04 for subsequent communications.
2. In bracket 1, insert how the application fails to comply with the requirements of 37 CFR 1.821 through 1.825.
3. Conclude action with appropriate form paragraph(s) 7.100-7.102.
4. When mailing the Office action, attach a Notice To Comply With Requirements for Patent Applications Containing Nucleotide And/Or Amino Acid Sequence Disclosures, along with a marked-up copy of the Raw Sequence Listing, if any.
¶ 24.02 Cover Letter for Use with CRF Diskette Problem Report
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). A computer readable form (CRF) of the sequence listing was submitted. However, the CRF could not be processed by the Scientific and Technical Information Center (STIC) for the reason(s) set forth on the attached CRF Diskette Problem Report.
Applicant is given ONE MONTH, or THIRTY DAYS, whichever is longer, from the mailing date of this letter within which to comply with the sequence rules, 37 CFR 1.821 - 1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 CFR 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136(a). In no case may an applicant extend the period for reply beyond the SIX MONTH statutory period. Direct the reply to the undersigned. Applicant is requested to return a copy of the attached CRF Diskette Problem Report with the reply.
Examiner Note
1. Use this form paragraph only for the initial communication to the applicant. Use either form paragraph 24.03 or 24.04 for subsequent communications.
2. Conclude action with appropriate form paragraph(s) 7.100-7.102.
3. When mailing the Office action, attach the CRF Diskette Problem Report.
¶ 24.03 Compact Disc/CRF Submission Is Not Fully Responsive, Bona Fide Attempt
The reply filed [1] is not fully responsive to the Office communication mailed [2] for the reason(s) set forth below or on the attached Notice To Comply With The Sequence Rules or CRF Diskette Problem Report.
Since the above-mentioned reply appears to be bona fide, applicant is given a TIME PERIOD of ONE (1) MONTH or THIRTY (30) DAYS from the mailing date of this notice, whichever is longer, within which to supply the omission or correction in order to avoid abandonment. EXTENSIONS OF THIS TIME PERIOD MAY BE GRANTED UNDER 37 CFR 1.136(a).
Examiner Note
1. This form paragraph may be used whether or not the six-month period for reply has expired. It is intended for use whenever a bona fide reply has been submitted. This practice does not apply where there has been a deliberate omission of some necessary part of a complete reply or where the reason the reply is incomplete cannot be characterized as an apparent oversight or apparent inadvertence. Under such cases the examiner has no authority to grant an extension if the six-month period for reply has expired. Use form paragraph 24.04 under such circumstances.
2. In bracket 1, insert the date of the reply and in bracket 2, insert the mail date of the communication requiring compliance.
3. When mailing the Office action, attach a Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures, if any, along with a marked-up copy of the Raw Sequence Listing, or CRF Diskette Problem Report.
4. See 37 CFR 1.135(c), 1.821(g); MPEP §§ 710.02(c), 711.02(a), 714.02 and 714.03.
¶ 24.04 Compact Disc/CRF Submission Is Not Fully Responsive
The communication filed [1] is not fully responsive to the communication mailed [2] for the reason(s) set forth below or on the attached Notice To Comply With The Sequence Rules or CRF Diskette Problem Report.
If a complete reply has not been submitted by the time the shortened statutory period set in the communication mailed [3] has expired, this application will become abandoned unless applicant corrects the deficiency and obtains an extension of time under 37 CFR 1.136(a). In no case may an applicant extend the period for reply beyond the SIX MONTH statutory period.
Examiner Note
1. This form paragraph may not be used when the six month period for reply has expired. Use this form paragraph in the situation where, in the reply (within the six-months), there has been a deliberate omission of some necessary part of a complete reply. When the reply appears to be bona fide, but through an apparent oversight or inadvertence failed to provide a complete reply, use form paragraph 24.03.
2. In bracket 1, insert the date of the reply and in brackets 2 and 3, insert the mail date of the communication requiring compliance.
3. When mailing the Office action, attach a Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures, if any, along with a marked-up copy of the Raw Sequence Listing, or CRF Diskette Problem Report.
¶ 24.05 CD-ROM/CD-R Requirements (Missing Sequence Listing/CRF Statement)
This application is objected to because it does not include the statement "the sequence listing information recorded in computer readable form is identical to the written (on paper or compact disc) sequence listing" and, where applicable, a statement that the submission includes no new matter, as required by 37 CFR 1.821(e), 1.821(f), 1.821(g), 1.825(b) or 1.825(d). Correction is required.
Examiner Note
Use this form paragraph when there is no statement in the transmittal letter stating that the sequence listing information recorded in the CRF is identical to the written sequence listing
¶ 24.05.01 CD-ROM/CD-R Requirements (Missing Sequence Listing/CRF Statement in an Amendment Filed with a CRF)
The amendment filed [1] is objected to because it does not include the statement "the sequence listing information recorded in computer readable form is identical to the written (on paper or compact disc) sequence listing" and, where applicable, a statement that the submission includes no new matter, as required by 37 CFR 1.821(e), 1.821(f), 1.821(g), 1.825(b) or 1.825(d). A statement that the sequence listing information is identical is required.
Examiner Note
1. Use this form paragraph when there is no statement in the transmittal letter stating that the sequence listing information recorded in the CRF is identical to the written sequence listing.
2. In bracket 1, insert the date of the amendment.
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