18.1 Biological Deposits & Sequence Listings

18.1 Biological Deposits & Sequence Listings

Why biotechnology has special disclosure mechanics

The ordinary requirements of 35 U.S.C. § 112(a) apply to biotechnology: the application must show possession of the claimed invention and teach a skilled person to make and use it without undue experimentation. Some biological material cannot be adequately reproduced from words, structures, and laboratory steps alone. A cell line, hybridoma, plasmid, microorganism, or other self-replicating material may be unavailable to the public and difficult to describe so another laboratory can recreate it.

Rules 1.801–1.809 allow a deposit of biological material to supplement the written disclosure. A deposit is not automatically required in every biotechnology case. It becomes important when access to the particular material is necessary to practice the invention and the material is not otherwise known and readily available. If the disclosure enables the invention without access to a sample, the absence of a deposit is not itself a defect.

Timing and sufficiency of a deposit

A deposit made before filing offers the clearest evidence that the material existed and was available to support the disclosure. The rules can permit a deposit during pendency, but it must be completed early enough to satisfy the examiner and all regulatory statements before issue. A late deposit cannot add an invention that was absent from the application as filed. The original specification must identify and describe the material with sufficient correlation to show that the deposited material is what the application disclosed.

The applicant supplies the accession number, deposit date, name and address of the depository, and a description linking the deposit to the specification. The depository must be able to maintain and furnish viable samples for the required period. An International Depositary Authority recognized under the Budapest Treaty is commonly used because one qualifying deposit can be recognized by member offices.

Public access, viability, and replacement

The rules require irrevocable authorization for the depository to furnish samples under the specified conditions once the patent issues, and access can arise earlier in circumstances defined by the rules. The deposit must remain available for at least the regulatory storage period. The applicant cannot use private contract restrictions to defeat the access required for the patent disclosure.

If deposited material becomes nonviable, contaminated, or unavailable, the patent owner or applicant may need a replacement deposit. A replacement must represent the same biological material and be accompanied by required statements. Replacing the sample is not permission to substitute a materially different organism or construct; that would raise identity and new-matter concerns.

Sequence listings: ST.26 versus ST.25

Separate rules govern nucleotide and amino-acid sequence disclosures. For applications filed on or after July 1, 2022, Rules 1.831–1.835 require a sequence listing in WIPO Standard ST.26 XML when the application contains sequences within the defined thresholds and exclusions. The listing is a structured XML file, not the older text-format listing used under ST.25. Earlier applications generally remain governed by the transition rules applicable to their filing date.

An ST.26 listing organizes sequences, feature annotations, source information, residues, and permitted qualifiers in a machine-readable form. The applicant files it as a separate part of the disclosure through the accepted electronic channel and refers to it in the specification as required. The rules distinguish a compliant XML sequence listing from tables or narrative sequence discussion that may also appear in the application.

The relevant filing date is the application’s actual filing date, not the date of a later response. A continuation filed after July 1, 2022 generally must satisfy ST.26 even if its parent used ST.25, while retaining substantive support from the parent remains a separate § 120 question.

Missing parts, corrections, and new matter

Formal defects—invalid XML, missing required qualifiers, or an inconsistent sequence identifier—can be corrected during prosecution. But 35 U.S.C. § 132 prohibits new matter. A corrected listing may clarify or reformat information already present; it cannot introduce a sequence never disclosed, change residues to create a new embodiment, or supply a functional relationship missing from the original specification while retaining the original filing benefit.

The examiner can require a compliant listing and may suspend or delay examination until it is supplied. A listing helps searching and examination, but it does not by itself prove utility, enablement, written description, or patent eligibility.

Comparison checklist

For an exam scenario, ask first whether physical access is needed, then whether the deposit existed and is properly identified. For sequence problems, anchor the governing format to the application filing date and conduct a separate new-matter analysis.