MPEP § 2410.01 — Conditions of Deposit (Annotated Rules)

§2410.01 Conditions of Deposit

USPTO MPEP version: BlueIron's Update: 2026-01-17

This page consolidates and annotates all enforceable requirements under MPEP § 2410.01, 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.

Conditions of Deposit

This section addresses Conditions of Deposit. Primary authority: 37 CFR 1.808(b). Contains: 2 requirements, 1 permission, and 1 other statement.

Key Rules

Topic

Compliance with Budapest Treaty

2 rules
StatutoryRequiredAlways
[mpep-2410-01-1728271f3359619f7f36baa5]
Deposit Restrictions Must Be Removed on Grant
Note:
All restrictions on access to deposited biological material must be removed upon grant of the patent, with no variations accepted.

It should be noted that this exception to the general rule that all restrictions will be removed must be strictly followed and that no variations of this explicit exception will be accepted as meeting the conditions of this section. Although this exception is consistent with the provisions in the Budapest Treaty and its implementing regulations (Rule 11.4), other conditions on accessibility are permitted under the Budapest Treaty as prescribed by national law. Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).

Jump to MPEP SourceCompliance with Budapest TreatyBudapest Treaty DepositsDeposit of Biological Materials
StatutoryPermittedAlways
[mpep-2410-01-c56102a579163697d40100a2]
Budapest Treaty Deposit Compliance
Note:
The rule permits deposit conditions under the Budapest Treaty as long as access restrictions are not removed upon patent grant.

It should be noted that this exception to the general rule that all restrictions will be removed must be strictly followed and that no variations of this explicit exception will be accepted as meeting the conditions of this section. Although this exception is consistent with the provisions in the Budapest Treaty and its implementing regulations (Rule 11.4), other conditions on accessibility are permitted under the Budapest Treaty as prescribed by national law. Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).

Jump to MPEP SourceCompliance with Budapest TreatyBudapest Treaty DepositsDeposit of Biological Materials
Topic

Access to Deposited Material

1 rules
StatutoryInformativeAlways
[mpep-2410-01-7a7d53697748f47236d1ea04]
Deposit of Biological Material Must Be Accessible and Unrestricted Upon Patent Grant
Note:
The deposit must allow access during the patent application process and remove all restrictions upon granting the patent.
37 CFR 1.808 requires that the deposit of biological material be made under two conditions:
  • (A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and
  • (B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent.
Jump to MPEP Source · 37 CFR 1.808Access to Deposited MaterialDeposit of Biological MaterialsAccess During Application Pendency
Topic

Deposit of Biological Materials

1 rules
StatutoryRequiredAlways
[mpep-2410-01-f694726086421c7b1ef1c0ba]
Conditions for Sample Requests During Patent Term
Note:
The depositor can require samples of deposited biological materials to be provided only if a request meets specific conditions during the patent's term.
The one exception that is permitted is specified in 37 CFR 1.808(b) which permits the depositor to contract with the depository to require that samples of a deposited biological material shall be furnished only if a request for a sample, during the term of the patent, meets any one or all of the three conditions specified in this paragraph. These conditions are:
  • (A) the request is in writing or other tangible form and dated; and/or
  • (B) the request contains the name and address of the requesting party and the accession number of the deposit; and/or
  • (C) the request is communicated in writing by the depository to the depositor along with the date on which the sample was furnished and the name and address of the party to whom the sample was furnished.
Jump to MPEP Source · 37 CFR 1.808(b)Deposit of Biological MaterialsDeposit Identification in ApplicationReference to Deposit in Specification
Topic

PTAB Contested Case Procedures

1 rules
StatutoryInformativeAlways
[mpep-2410-01-c3cb94da3a717b04163308e9]
Request for Sample Must Notify Depositor
Note:
The depository must communicate a written request for a sample to the depositor, including the date of sample furnishing and the recipient's details.

The one exception that is permitted is specified in 37 CFR 1.808(b) which permits the depositor to contract with the depository to require that samples of a deposited biological material shall be furnished only if a request for a sample, during the term of the patent, meets any one or all of the three conditions specified in this paragraph. These conditions are:

(C) the request is communicated in writing by the depository to the depositor along with the date on which the sample was furnished and the name and address of the party to whom the sample was furnished.

Jump to MPEP Source · 37 CFR 1.808(b)PTAB Contested Case ProceduresAccess to Deposited MaterialDeposit of Biological Materials

Citations

Primary topicCitation
Access to Deposited Material35 U.S.C. § 122
Access to Deposited Material37 CFR § 1.14
Access to Deposited Material37 CFR § 1.808
Deposit of Biological Materials
PTAB Contested Case Procedures
37 CFR § 1.808(b)
Compliance with Budapest TreatyEx parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990)

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: 2026-01-17