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2422.07 Requirements for Compliance, Statements Regarding New Matter, and Sanctions for Failure to Comply - 2400 Biotechnology
2422.07 Requirements for Compliance, Statements Regarding New Matter, and Sanctions for Failure to Comply
37 CFR 1.821(g) requires compliance with the requirements of 37 CFR 1.821(b) through (f), as discussed above, if they are not satisfied at the time of filing under 35 U.S.C. 111(a) or at the time of entering the national stage of an international application under 35 U.S.C. 371, within the period of time set in a notice requiring compliance. Failure to comply will result in the abandonment of the application. Submissions in reply to requirements under this paragraph must be accompanied by a statement that the submission includes no new matter. Such a statement may be made by the applicant. Extensions of time in which to reply to a requirement under this paragraph are available pursuant to 37 CFR 1.136. When an action by the applicant is a bona fide attempt to comply with these rules and it is apparent that compliance with some requirement has inadvertently been omitted, the applicant may be given a new time period to correct the omission. See 37 CFR 1.135(c).
Provisional applications filed under 35 U.S.C. 111(b) need not comply with 37 CFR 1.821 through 1.825, however, applicants are encouraged to file a Sequence Listing as defined in 37 CFR 1.821(c) for ease of identification of the sequence information contained in the provisional application.
37 CFR 1.821(h) requires compliance with the requirements of 37 CFR 1.821(b) through (f), as discussed above, within the time period prescribed in a notice requiring compliance in an international application filed in the United States Receiving Office under the Patent Cooperation Treaty (PCT), if the above noted requirements are not satisfied at the time of filing. Submissions in reply to requirements under this paragraph must be accompanied by a statement that the submission does not include matter which goes beyond the disclosure in the international application as filed. Such a statement may be made by an applicant. International applications that fail to comply with any of the requirements of 37 CFR 1.821(b)-(f) will be searched to the extent possible without the benefit of the information in computer readable form. See PCT Administrative Instructions Section 513(c).
The requirement to submit a statement that a submission in reply to the requirements of this section does not include new matter or matter which goes beyond the disclosure in the application as filed is not the first instance in which the applicant has been required to ensure that there is not new matter upon amendment. The requirement is analogous to that found in 37 CFR 1.125 regarding substitute specifications. When a substitute specification is required because the number or nature of amendments would make it difficult to examine the application, the applicant must include a statement that the substitute specification includes no new matter. The necessity of requiring a substitute "Sequence Listing," or pages thereof, is similar to the necessity of requiring a substitute specification and, likewise, the burden is on the applicant to ensure that no new matter is added. Applicants have a duty to comply with the statutory prohibition ( 35 U.S.C. 132 and 35 U.S.C. 251) against the introduction of new matter.
It should be noted that the treatment accorded errors in sequencing or any other errors prior to the implementation date of the sequence rules will be no different for those applications filed on or after the implementation date of these rules. The correction of errors in sequencing or any other errors that are made in describing an invention are, as they have always been, subject to the statutory prohibition ( 35 U.S.C. 132 and 35 U.S.C. 251) against the introduction of new matter.
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