MPEP § 803.04 — Nucleotide Sequences (Annotated Rules)

§803.04 Nucleotide Sequences

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

This page consolidates and annotates all enforceable requirements under MPEP § 803.04, 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.

Nucleotide Sequences

This section addresses Nucleotide Sequences.

Key Rules

Topic

Statutory Authority for Examination

5 rules
StatutoryInformativeAlways
[mpep-803-04-ed3a2f848914b389663da945]
Permitted Number of Nucleotide Sequences in Single Application
Note:
The Commissioner partially waived requirements to permit a reasonable number of nucleotide sequences to be claimed in a single patent application.

In 1996, the Commissioner of Patents and Trademarks decided sua sponte to partially waive the requirements of 37 CFR 1.141 et seq. and permit a reasonable number of such nucleotide sequences to be claimed in a single application. See Examination of Patent Applications Containing Nucleotide Sequences, 1192 OG 68 (November 19, 1996).

Jump to MPEP Source · 37 CFR 1.141Statutory Authority for ExaminationSequence Listing ContentExamination Procedures
StatutoryInformativeAlways
[mpep-803-04-7335b6af177e24a94b2f4193]
Examination of Patent Applications Containing Nucleotide Sequences
Note:
All pending patent applications with nucleotide sequences must now undergo examination according to the 2007 OG notice, with exceptions for national applications that have already received an action on merits.

In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). All pending applications are subject to the 2007 OG notice. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits for multiple nucleotide sequences 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-803-04-07d99c72345a26d8a59a4352]
Pending Applications Subject to 2007 OG Notice
Note:
All pending applications must adhere to the 2007 OG notice, with exceptions for national applications and those without extenuating circumstances.

In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). All pending applications are subject to the 2007 OG notice. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits for multiple nucleotide sequences 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 ContentSIR Patent Rights Waiver
StatutoryInformativeAlways
[mpep-803-04-827780effd1908837dc86a2c]
Restriction and Examination of Polynucleotide Inventions
Note:
For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions must be considered for restriction, rejoinder, and examination according to MPEP Chapter 800 standards.

In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). All pending applications are subject to the 2007 OG notice. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits for multiple nucleotide sequences 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 ContentSIR Patent Rights Waiver
StatutoryInformativeAlways
[mpep-803-04-4fc3263afe5e64cf3aedd90d]
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.

In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). All pending applications are subject to the 2007 OG notice. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits for multiple nucleotide sequences 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 ContentSIR Patent Rights Waiver
Topic

Sequence Listing Content

3 rules
StatutoryInformativeAlways
[mpep-803-04-2cd2823f6213beb32dab8a10]
Different Proteins Require Separate Inventions
Note:
Distinct nucleotide sequences encoding different proteins are considered separate inventions and 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 1.141Sequence Listing ContentSequence Listing FormatSequence Listing Requirements
StatutoryInformativeAlways
[mpep-803-04-85820ec8f2cb0fa40f5eca19]
Permitting Multiple Nucleotide Sequences in Single Application
Note:
The Commissioner of Patents and Trademarks partially waived requirements to allow a reasonable number of nucleotide sequences to be claimed in a single patent application.

In 1996, the Commissioner of Patents and Trademarks decided sua sponte to partially waive the requirements of 37 CFR 1.141 et seq. and permit a reasonable number of such nucleotide sequences to be claimed in a single application. See Examination of Patent Applications Containing Nucleotide Sequences, 1192 OG 68 (November 19, 1996).

Jump to MPEP Source · 37 CFR 1.141Sequence Listing ContentSequence Listing RequirementsStatutory Authority for Examination
StatutoryInformativeAlways
[mpep-803-04-c752050c4afaaed14ccd1f00]
Supplemental Restriction Not Advanced for Multiple Sequences
Note:
This rule states that supplemental restriction requirements will not be advanced in applications with multiple nucleotide sequences unless there are extenuating circumstances.

In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). All pending applications are subject to the 2007 OG notice. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits for multiple nucleotide sequences 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 SourceSequence Listing ContentSequence Listing RequirementsStatutory Authority for Examination
Topic

Distinct Inventions (MPEP 802.01)

1 rules
StatutoryInformativeAlways
[mpep-803-04-50166d07c0d524df12fc4fac]
Nucleotide Sequences Represent 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 Requirement (MPEP 802-803)
Topic

SIR Patent Rights Waiver

1 rules
StatutoryInformativeAlways
[mpep-803-04-c95546e8d5c292cf7e85dcf9]
Commissioner Rescinded Waiver for Nucleotide Sequences
Note:
The Commissioner for Patents rescinded the waiver for patent applications containing nucleotide sequences in 2007, subjecting all pending applications to new examination standards.

In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG 123 (March 27, 2007). All pending applications are subject to the 2007 OG notice. Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits for multiple nucleotide sequences 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 SourceSIR Patent Rights WaiverStatutory Invention Registration (Discontinued)Statutory Authority for Examination
Topic

Article 19 Amendment Scope

1 rules
StatutoryInformativeAlways
[mpep-803-04-ef93b0637b530928b48dca8d]
Treatment of Nucleotide Sequence Claims in PCT and National Stage Applications
Note:
This rule outlines how to handle claims containing independent and distinct nucleotide sequences in international applications filed under the Patent Cooperation Treaty (PCT) and national stage applications filed under 35 U.S.C. 371.

See MPEP § 1850 for treatment of claims containing independent and distinct nucleotide sequences 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 ScopePCT Claims FormatAmendments in National Stage

Citations

Primary topicCitation
SIR Patent Rights Waiver
Sequence Listing Content
Statutory Authority for Examination
35 U.S.C. § 111(a)
Distinct Inventions (MPEP 802.01)
Sequence Listing Content
35 U.S.C. § 121
Article 19 Amendment Scope35 U.S.C. § 371
Distinct Inventions (MPEP 802.01)
Sequence Listing Content
Statutory Authority for Examination
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