MPEP § 2411.02 — Replies to Rejections Based on Deposit Issue (Annotated Rules)

§2411.02 Replies to Rejections Based on Deposit Issue

USPTO MPEP version: BlueIron's Update: 2025-12-31

This page consolidates and annotates all enforceable requirements under MPEP § 2411.02, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Replies to Rejections Based on Deposit Issue

This section addresses Replies to Rejections Based on Deposit Issue. Primary authority: 35 U.S.C. 112, 37 CFR 1.809(b)(1), and 37 CFR 1.116. Contains: 4 requirements, 1 guidance statement, and 1 other statement.

Key Rules

Topic

Issue Fees

6 rules
StatutoryRequiredAlways
[mpep-2411-02-6988f6c5136bc5b80f4d1c75]
Requirement for Deposit of Biological Material
Note:
Applicant must deposit an acceptable original, replacement, or supplemental biological material deposit in accordance with regulations or assure the Office in writing that a deposit will be made by the issue fee payment date.

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b)(1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116 apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

Jump to MPEP Source · 37 CFR 1.809(b)(1)Issue FeesMaintenance Fee AmountsFee Requirements
StatutoryRequiredAlways
[mpep-2411-02-906c3230a49374b77843c410]
Nonresponsive Replies May Result in Abandonment
Note:
Replies to a rejection under 35 U.S.C. 112 regarding the absence of access to biological material that do not comply with specific requirements may result in abandonment of the application.

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b)(1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116 apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

Jump to MPEP Source · 37 CFR 1.809(b)(1)Issue FeesMaintenance Fee AmountsFee Requirements
StatutoryRequiredAlways
[mpep-2411-02-899df83cec1253697400f6ce]
Deposit Must Be Made or Assured
Note:
Applicant must make an acceptable deposit of biological material or assure the Office in writing that a deposit will be made by the issue fee payment date.

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b)(1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116 apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

Jump to MPEP Source · 37 CFR 1.809(b)(1)Issue FeesMaintenance Fee AmountsFee Requirements
StatutoryInformativeAlways
[mpep-2411-02-4ffaae8aa0eff042735535dd]
Requirements for Further Submissions After Final Rejection
Note:
Once a rejection is made final, the applicant must comply with the requirements of 37 CFR 1.116 for any further submissions.

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b)(1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116 apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

Jump to MPEP Source · 37 CFR 1.809(b)(1)Issue FeesMaintenance Fee AmountsFee Requirements
StatutoryRequiredAlways
[mpep-2411-02-933068aeb317025e63ebdf82]
Requirement for Written Assurance of Deposit
Note:
The Office will accept a written assurance that an acceptable deposit will be made within the required time and under conditions satisfying the rules.

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b)(1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116 apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

Jump to MPEP Source · 37 CFR 1.809(b)(1)Issue FeesMaintenance Fee AmountsFee Requirements
StatutoryRecommendedAlways
[mpep-2411-02-bcf29e1e2a324af53942ca9d]
Written Assurance for Biological Material Deposit
Note:
If an applicant provides a written assurance that an acceptable deposit will be made, the rejection under 35 U.S.C. 112 regarding lack of access to biological material should be removed.

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. The rejection will be repeated and made final until the requirements of 37 CFR 1.809(b)(1) are satisfied or the examiner is convinced that a deposit is not required for the claimed subject matter. Once the rejection is made final, the requirements of 37 CFR 1.116 apply to further submissions. The written assurance will be accepted by the Office if it clearly states that an acceptable deposit will be made within the required time and under conditions which satisfy these rules. In the case that an acceptable written assurance has been made by the applicant, the rejection under 35 U.S.C. 112 directed to the absence of access to the biological material should be removed.

Jump to MPEP Source · 37 CFR 1.809(b)(1)Issue FeesMaintenance Fee AmountsFee Requirements

Citations

Primary topicCitation
Issue Fees35 U.S.C. § 112
Issue Fees37 CFR § 1.116
Issue Fees37 CFR § 1.809(b)(1)

Source Text from USPTO’s MPEP

This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.

BlueIron Last Updated: 2025-12-31