MPEP § 2434 — Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences (Annotated Rules)

§2434 Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

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

This page consolidates and annotates all enforceable requirements under MPEP § 2434, 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.

Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

This section addresses Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences.

Key Rules

Topic

Statutory Authority for Examination

4 rules
StatutoryInformativeAlways
[mpep-2434-8e5f5bed10b7b59d6e9dd3be]
Examination of Patent Applications Containing Nucleotide Sequences
Note:
All pending applications with nucleotide sequences are subject to examination, but supplemental restriction requirements will not be advanced in applications that have already received an action on their merits unless there are extenuating circumstances.

All pending applications are subject to Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits in the absence of extenuating circumstances. For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions will be considered for restriction, rejoinder, and examination practice in accordance with the standards set forth in MPEP Chapter 800. Claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden in the same manner as claims to any other type of molecule.

Jump to MPEP SourceStatutory Authority for ExaminationSequence Listing ContentExamination Procedures
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[mpep-2434-55f907f0a3966306f62c49c6]
Supplemental Restriction Not Advanced For Merit Actions
Note:
This rule states that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits, unless there are extenuating circumstances.

All pending applications are subject to Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits in the absence of extenuating circumstances. For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions will be considered for restriction, rejoinder, and examination practice in accordance with the standards set forth in MPEP Chapter 800. Claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden in the same manner as claims to any other type of molecule.

Jump to MPEP SourceStatutory Authority for ExaminationSequence Listing ContentExamination Procedures
StatutoryInformativeAlways
[mpep-2434-7864fddf506d40e700f22cbd]
Restriction and Examination of Polynucleotide Inventions
Note:
For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions are subject to restriction, rejoinder, and examination practices as outlined in MPEP Chapter 800.

All pending applications are subject to Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits in the absence of extenuating circumstances. For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions will be considered for restriction, rejoinder, and examination practice in accordance with the standards set forth in MPEP Chapter 800. Claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden in the same manner as claims to any other type of molecule.

Jump to MPEP SourceStatutory Authority for ExaminationSequence Listing ContentExamination Procedures
StatutoryInformativeAlways
[mpep-2434-b6af674db260b02503ada9d4]
Claims to Polynucleotides Treated Like Other Molecules
Note:
Claims to polynucleotide molecules are examined for independence, relatedness, distinction, and burden in the same manner as claims to other types of molecules.

All pending applications are subject to Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits in the absence of extenuating circumstances. For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions will be considered for restriction, rejoinder, and examination practice in accordance with the standards set forth in MPEP Chapter 800. Claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden in the same manner as claims to any other type of molecule.

Jump to MPEP SourceStatutory Authority for ExaminationSequence Listing ContentExamination Procedures
Topic

Restriction and Election

1 rules
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[mpep-2434-6728e8f5cf9f1bfa09529746]
Different Proteins Require Independent Claims
Note:
When polynucleotide molecules encoding different proteins are claimed, each nucleotide sequence is considered a distinct invention requiring separate claims.

Polynucleotide molecules defined by their nucleic acid sequence (hereinafter “nucleotide sequences”) that encode different proteins are structurally distinct chemical compounds. These sequences are thus deemed to normally constitute independent and distinct inventions within the meaning of 35 U.S.C. 121. Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement pursuant to 35 U.S.C. 121 and 37 CFR 1.141 et seq.

Jump to MPEP Source · 37 CFR 1.141Restriction and ElectionSequence Listing ContentSequence Listing Format
Topic

Distinct Inventions (MPEP 802.01)

1 rules
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[mpep-2434-001320abeaf191ffbb9aeb0d]
Nucleotide Sequences Are Independent Inventions
Note:
Each nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement.

Polynucleotide molecules defined by their nucleic acid sequence (hereinafter “nucleotide sequences”) that encode different proteins are structurally distinct chemical compounds. These sequences are thus deemed to normally constitute independent and distinct inventions within the meaning of 35 U.S.C. 121. Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement pursuant to 35 U.S.C. 121 and 37 CFR 1.141 et seq.

Jump to MPEP Source · 37 CFR 1.141Distinct Inventions (MPEP 802.01)Basis for Restriction (MPEP 802)Restriction and Election
Topic

Article 19 Amendment Scope

1 rules
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[mpep-2434-19a42e0ac029e57fbd86919f]
Claims Containing Nucleotide Sequences Lacking Unity of Invention Must Be Amended
Note:
Claims in international PCT and national stage applications that contain nucleotide sequences lacking unity of invention must be amended according to MPEP § 1850.

See MPEP § 1850 for treatment of claims containing nucleotide sequences that lack unity of invention in international applications filed under the Patent Cooperation Treaty (PCT) and national stage applications filed under 35 U.S.C. 371.

Jump to MPEP SourceArticle 19 Amendment ScopeAmendments in National StageUnity of Invention Standard

Citations

Primary topicCitation
Statutory Authority for Examination35 U.S.C. § 111(a)
Distinct Inventions (MPEP 802.01)
Restriction and Election
35 U.S.C. § 121
Article 19 Amendment Scope35 U.S.C. § 371
Distinct Inventions (MPEP 802.01)
Restriction and Election
37 CFR § 1.141
Article 19 Amendment ScopeMPEP § 1850

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