Sequence Listings: Which WIPO Version Applies

See the primary source.

Biotech filings that still point at an older ST.26 edition as the default are using a superseded pointer. USPTO incorporated the WIPO ST.26 revision approved December 8, 2023 into the sequence-listing rules, cited as 89 FR 36677. Applicants whose disclosures contain nucleotide or amino acid sequences are bound under 37 CFR Part 1. The change is effective on July 1, 2024.

Which ST.26 edition is incorporated now?

The incorporated version is already the live version for the sections the rule names. The DATES paragraph states that this final rule is effective on July 1, 2024, and that the incorporation by reference is approved as of July 1, 2024. A biotech docket that still points paralegals at an earlier incorporated edition as the default for new application disclosures is running a superseded pointer.

Coverage is limited to the sealed index of 1086 U.S. federal rules from 11 agencies published September 1, 2023 – September 1, 2026. That index is a snapshot, not a live WIPO handbook feed.

The Commerce Department issued the action under RIN 0651-AD80. It amends 37 CFR Part 1(b)(1), which identifies the version of WIPO Standard ST.26 that has been incorporated by reference. Current regulation text is in 37 CFR Part 1.

A law firm preparing sequence listings for filing on or after July 1, 2024 is inside the live incorporation. The rule does not say a later preparation date, by itself, lets a paralegal pick a different incorporated edition than the application-disclosure rules require.

Sequence-listing work is document production under a matter number, which is the same operational surface as client-intake automation for law firms: if the matter does not know which standard version governs, the XML that comes out is unowned.

What must a sequence listing follow after July 1?

According to the rule abstract, the USPTO is adopting version the applicable section of WIPO Standard ST.26, which was approved December 8, 2023, for incorporation by reference into the USPTO's regulations addressing application disclosures containing nucleotide and/or amino acid sequences. Among other enhancements, version the applicable section of ST.26 provides technical terminology consistency and improves descriptions. The USPTO first amended its rules in 2022 to incorporate by reference certain provisions of WIPO Standard ST.26. In addition to simplifying the process for applicants filing in multiple countries, the ST.26 requirement to submit a single sequence listing in eXtensible Markup Language (XML) format provides better preservation, accessibility, and sorting of the submitted sequence data for the public.

The incorporated version and its date are therefore version the applicable section, approved December 8, 2023, as the final rule states. Revised the applicable section(b)(1) identifies "WIPO Standard ST.26. WIPO Handbook on Intellectual Property Information and Documentation, Standard ST.26: Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) including Annexes I-VII, version the applicable section, approved December 8, 2023; IBR approved for §the applicable section through the applicable section."

The filing date of the application decides which standard governs, not the date the listing is prepared. The incorporation is approved as of July 1, 2024 for §the applicable section through the applicable section — the application-disclosure rules — not for a standalone XML file sitting on a paralegal's drive. The rule does not say that regenerating a listing on a later date, by itself, selects a different incorporated version than the application those sections govern. A listing prepared in June for an application that is filed after the July 1, 2024 incorporation is still an application disclosure under the sections the IBR names.

The USPTO had already created §the applicable section–the applicable section in a final rule published May 20, 2022, at an earlier Federal Register document, and had updated the applicable section(b)(1) to version the applicable section in a final rule published a date the sealed abstract does not restate here, at an earlier Federal Register document, as this preamble recites. Version the applicable section is the next pointer in that same incorporation chain.

WIPO Standard ST.26 is comprised of eight documents, as the preamble lists them: the main body; Annex I (controlled vocabulary); Annex II (Document Type Definition); Annex III (sequence listing specimen XML file); Annex IV (character subset from the Unicode Basic Latin Code Table); Annex V (additional data-exchange requirements for IPOs); Annex VI (guidance document with illustrated examples); and Annex VII (recommendations for transforming a sequence listing from WIPO Standard ST.25 format to ST.26 format, including guidance on how to avoid adding or deleting subject matter).

Revisions under version the applicable section affect the main body and Annex VI. In paragraph 3(f) of the main body, all instances of "3′-monophosphate" were changed to "5′-monophosphate" to be consistent with paragraph 3(g) and standard nucleotide naming conventions. Annex VI received the same terminology correction, scientific and grammatical corrections in Examples 14-1 and 30-2, two new examples demonstrating how sequences with inverted nucleotides should be included, and a simplified Example Index that removes the "Cross-referenced examples." The preamble states that the changes in version the applicable section are ministerial changes that will not have a meaningful substantive impact on disclosing parties.

The rule does not say ST.26 XML is optional for a disclosure that §the applicable section through the applicable section cover. The rule does not say a later ST.25 listing can be filed in place of the XML the standard requires. Annex VII exists because transformation from ST.25 is a known path; it is guidance on how to avoid adding or deleting subject matter, not a license to stay on ST.25.

The rule does not say a dollar penalty for a noncompliant listing. It does not say WIPO's website is a substitute for the incorporation in the applicable section.

WIPO provides free online public access to version the applicable section on its standards site, and the standard is also available on the USPTO Sequence Listing Resource Center, as the preamble notes. Those copies are how a paralegal reads the standard. The legally incorporated text for USPTO practice is the version the applicable section(b)(1) names.

Which docket habits still point at the old edition?

The misses are version-pointer misses. The rule does not publish a count of listings filed against the wrong edition, and this page does not invent one.

The first pattern is generating the XML under whatever version the desktop tool happens to have installed, then filing it into an application whose governing incorporation is different. The filing date of the application, through §the applicable section through the applicable section, is what the IBR attaches to. The date the listing was exported is not a version selector.

The second pattern is treating version the applicable section as optional because the preamble calls the changes ministerial. Ministerial is a description of impact, not an exemption. the applicable section(b)(1) now names version the applicable section.

The third pattern is shipping a ST.25-style listing and planning to "convert later." Annex VII is transformation guidance, including how to avoid adding or deleting subject matter. It is not a substitute for the XML the abstract describes as the ST.26 requirement.

The fourth pattern is inverted-nucleotide sequences that were never mapped to the new Annex VI examples. Version the applicable section added those examples for a reason. A listing that ignores them is not using the incorporated guidance document.

The fifth pattern is a matter file that never records which ST.26 version was used. When a continuation is prepared a year later, no one can tell whether the parent listing matches the incorporation that governed the parent. That is the same lost-artifact problem as an unsigned intake packet; see law-firm client intake and conflict-check comparison for how firms already try to keep a named owner on each artifact.

How should a biotech desk check its listing templates?

A biotech patent paralegal can score open sequence-listing matters against the final rule as follows.

1. List every unfiled or in-progress application disclosure that contains nucleotide and/or amino acid sequences under §the applicable section through the applicable section.

2. Record the application's filing date, not the XML export date, as the date that selects the governing incorporation.

3. For disclosures governed by the July 1, 2024 IBR, confirm the tool is set to ST.26 version the applicable section, approved December 8, 2023.

4. Confirm the output is a single XML sequence listing, not a leftover ST.25 file.

5. If a transformation from ST.25 is in the file, read Annex VII for added or deleted subject matter and route that question to the responsible attorney.

6. Check inverted-nucleotide sequences against the Annex VI examples version the applicable section added.

7. Confirm paragraph 3(f) terminology uses 5′-monophosphate consistently with paragraph 3(g).

8. Store the version string in the matter file next to the XML.

WIPO Sequence is WIPO's tool for preparing ST.26 sequence listings in XML. It can generate the listing the standard describes; the operator still has to select the version that the applicable section(b)(1) names for the application being filed. Patent Center is the USPTO electronic filing and application-management system. It is how the XML is submitted with the application; it does not choose the ST.26 version. The rule does not say either tool is a substitute for the incorporation.

A related docket habit is the same named-owner pattern used in law-firm billing automation: the listing has a matter, a version, and an attorney who will stand behind added or deleted subject matter if Annex VII is in play.

How does a sequence-listing queue get a named owner?

Reconcile the matter docket against the change: each open matter maps to the filing, appearance, or fee the rule now requires and its due date. US Tech Automations flags matters still running on the superseded procedure and routes the correction to the responsible attorney.

Superseded procedure here is a sequence-listing template still pinned to an earlier incorporated edition for disclosures that the applicable section(b)(1) now points at version the applicable section, or a matter that treats the XML export date as the version selector. US Tech Automations can flag those matters and route them. It does not validate XML against ST.26 and it does not decide whether a transformation from ST.25 added subject matter.

What can be automated is the pointer mismatch after July 1, 2024: tool version versus filing date versus the IBR sentence. What needs a human is whether the disclosure is a sequence listing under §the applicable section through the applicable section, and whether a transformation added or deleted subject matter. US Tech Automations does not make those calls.

Key Takeaways

• The USPTO incorporation rule at 89 FR 36677, RIN 0651-AD80, is effective July 1, 2024, and amends 37 CFR Part 1.

• The incorporated version is WIPO Standard ST.26 version the applicable section, approved December 8, 2023, IBR-approved for §the applicable section through the applicable section.

• The filing date of the application, through those disclosure sections, decides which standard governs; the rule does not say the date a listing is prepared, standing alone, selects the version.

• Version the applicable section changes are described as ministerial (terminology, Annex VI examples, inverted nucleotides) and as not having a meaningful substantive impact on disclosing parties.

• The rule does not say a dollar penalty for a noncompliant listing, and it does not say ST.25 remains the filing format for disclosures those sections cover.

Sequence-listing questions from prosecution teams

Which version is now incorporated?

Version the applicable section of WIPO Standard ST.26, approved December 8, 2023, as the applicable section(b)(1) is revised by 89 FR 36677.

When did the new incorporation take effect?

The final rule is effective on July 1, 2024. The incorporation by reference is approved as of July 1, 2024. The document was published May 3, 2024.

If a listing is prepared in June and the application is filed in July, which version applies?

The incorporation attaches to §the applicable section through the applicable section, which address application disclosures. The rule does not say the preparation date, standing alone, selects a different version than those application-disclosure rules require.

Are the version the applicable section changes substantive?

The preamble states that the changes are ministerial changes that will not have a meaningful substantive impact on disclosing parties. They still update the incorporated text.

Does this rule let an applicant keep filing ST.25 listings?

The abstract describes the ST.26 requirement as a single sequence listing in XML. Annex VII addresses transformation from ST.25, including how to avoid adding or deleting subject matter. The rule does not say ST.25 remains the required filing format for the disclosures §the applicable section through the applicable section cover.

Where is the official text?

The primary source is 89 FR 36677, document number 2024-09618, RIN 0651-AD80, published May 3, 2024. Current text is in 37 CFR Part 1. Source: Federal Register / eCFR.

Disclaimer

This article is for informational purposes only. It is not legal or tax advice and does not create an attorney-client relationship. Sequence-listing requirements depend on the application being filed. Consult a qualified professional before acting.

Every date, citation, RIN, CFR reference, and figure in these posts is copied verbatim from the Federal Register and eCFR as of the snapshot date. Nothing is estimated, modeled, or extrapolated. This is not legal or tax advice.

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Source: Federal Register (89 FR 36677); current text via eCFR, 37 CFR Part 1.

Last reviewed: May 3, 2024

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