MPEP § 2404.03 — Reference to a Deposit in the Specification (Annotated Rules)

§2404.03 Reference to a Deposit in the Specification

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

This page consolidates and annotates all enforceable requirements under MPEP § 2404.03, 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.

Reference to a Deposit in the Specification

This section addresses Reference to a Deposit in the Specification. Primary authority: 35 U.S.C. 112, 35 U.S.C. 132), and 35 U.S.C. 132. Contains: 1 prohibition and 1 other statement.

Key Rules

Topic

Components Required for Filing Date

2 rules
StatutoryProhibitedAlways
[mpep-2404-03-6466ed67653af2ebbf8bae8f]
Reference to Biological Material Does Not Imply Deposit Requirement
Note:
The mere reference to a biological material in the specification does not imply that a deposit is required for satisfying 35 U.S.C. 112, but may form the basis for making a deposit after filing if required.

37 CFR 1.802(c) specifically provides that the mere reference to a biological material in the specification disclosure or the actual deposit of such material does not create any presumption that such referenced or deposited material is necessary to satisfy 35 U.S.C. 112, or that a deposit in accordance with these regulations is or was required. It should be noted, however, that a reference to a biological material, present in an application upon filing, may form the basis for making a deposit, where required, after the filing date of a given application but that the reference to the biological material, itself, cannot be added after filing without risking the prohibited introduction of new matter (35 U.S.C. 132). See the discussion of the Lundak application in MPEP § 2406.01.

Jump to MPEP Source · 37 CFR 1.802(c)Components Required for Filing DateFiling Date RequirementsPatent Application Content
StatutoryInformativeAlways
[mpep-2404-03-4398b355f03c9bdc9b22fe74]
Reference to Biological Material Cannot Create Deposit Necessity
Note:
A reference to biological material in the specification does not create a presumption that such material is necessary for satisfying 35 U.S.C. 112, and cannot be added after filing without risking new matter introduction.

37 CFR 1.802(c) specifically provides that the mere reference to a biological material in the specification disclosure or the actual deposit of such material does not create any presumption that such referenced or deposited material is necessary to satisfy 35 U.S.C. 112, or that a deposit in accordance with these regulations is or was required. It should be noted, however, that a reference to a biological material, present in an application upon filing, may form the basis for making a deposit, where required, after the filing date of a given application but that the reference to the biological material, itself, cannot be added after filing without risking the prohibited introduction of new matter (35 U.S.C. 132). See the discussion of the Lundak application in MPEP § 2406.01.

Jump to MPEP Source · 37 CFR 1.802(c)Components Required for Filing DateFiling Date RequirementsPatent Application Content

Citations

Primary topicCitation
Components Required for Filing Date35 U.S.C. § 112
Components Required for Filing Date35 U.S.C. § 132
Components Required for Filing Date37 CFR § 1.802(c)
Components Required for Filing DateMPEP § 2406.01

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