MPEP § 2413.01(h) — Language Dependent Free Text Qualifier Values in the English Language

Ninth Edition, Revision 01.2024 · last revised R-01.2024

[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b). Formatting representations of XML (eXtensible Markup Language) elements in this section appear different than shown in Standard ST.26, which may be accessed at: www.wipo.int /export/sites/www/standards/en/pdf/03-26-01.pdf.]

37 CFR 1.833 Requirements for a “Sequence Listing XML” for nucleotide and/or amino acid sequences as part of a patent application filed on or after July 1, 2022.

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  • (b) The “Sequence Listing XML” presented in accordance with paragraph (a) of this section must further:

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    • (3) Include an INSDQualifier_value element with a value in English for any language-dependent free text qualifier as defined by paragraphs 76 and 85–87 of WIPO Standard ST.26, and as required by § 1.52(b)(1)(ii).

WIPO Standard ST.26, paragraph 3(n), uses the term “free text” to mean a type of value format for certain qualifiers, presented in the form of a descriptive text phrase or other specified format.

WIPO Standard ST.26, paragraph 3(o), uses the term “language-dependent free text” to mean the free text value of certain qualifiers that may require translation for international, national or regional procedures.

WIPO Standard ST.26, paragraph 85, provides that free text is a type of value format for certain qualifiers presented in the form of a descriptive text phrase or other specified format with reference to the controlled vocabulary found in Annex I of WIPO Standard ST.26. See MPEP § 2413.01(g), subsection IX.

WIPO Standard ST.26, paragraph 86, requires that the use of free text be limited to short terms indispensable for the understanding of a characteristic of the sequence. For each qualifier other than the “translation” qualifier, the free text must not exceed 1000 characters.

WIPO Standard ST.26, paragraph 87, specifies that language-dependent free text is the free text value of certain qualifiers that is language-dependent in that it may require translation for international, national, regional procedures. Qualifiers with language-dependent free text values for nucleotide sequences are identified below:

Table 5: List of Qualifiers with Language-Dependent FreeText Values for Nucleotide Sequences
Section Language-Dependent Free Text Qualifier
6.3 bound_moiety
6.5 cell_type
6.8 clone
6.9 clone_lib
6.11 collected_by
6.14 cultivar
6.15 dev_stage
6.18 ecotype
6.21 frequency
6.22 function
6.24 gene_synonym
6.26 haplogroup
6.28 host
6.29 identified_by
6.30 isolate
6.31 isolation_source
6.32 lab_host
6.36 mating_type
6.41 note
6.45 organism
6.47 phenotype
6.49 pop_variant
6.50 product
6.66 serotype
6.67 serovar
6.68 sex
6.69 standard_name
6.70 strain
6.71 sub_clone
6.72 sub_species
6.73 sub_strain
6.75 tissue_lib
6.76 tissue_type
6.81 variety

Reproduced from Table 5 of WIPO Standard ST.26, Annex I, Section 6.

Qualifiers with a language-dependent free text values for amino acid sequences are identified below:

Table 6: List of Qualifiers with Language-Dependent Free Text Values for Amino Acid Sequences
Section Language-Dependent Free Text Qualifier
8.2 note
8.3 organism

Reproduced from Table 6 of WIPO Standard ST.26, Annex I, Section 8.

  • (a) Language-dependent free text must be presented in the INSDQualifier_value element in English, or in the NonEnglishQualifier_value element in a language other than English, or in both elements. Note that if an organism name is a Latin genus and species name, no translation is required. Technical terms and proper names originating from non-English words that are used internationally are considered English for the purpose of the value of the INSDQualifier_value element (e.g., ‘in vitro’, ‘in vivo’).
  • (b) If a NonEnglishQualifier_value element is present in a sequence listing, the appropriate language code (see WIPO Standard ST.26 at paragraph 9, which references the International Standard ISO 639-1:2002) must be indicated in the nonEnglishFreeTextLanguageCode attribute in the root element (see List of File Attributes reproduced in MPEP § 2413.01(e)). All NonEnglishQualifier_value elements in a single sequence listing must have values in the language indicated in the nonEnglishFreeTextLanguageCode attribute. The NonEnglishQualifier_value element is permitted only for qualifiers that have a language-dependent free text value format.
  • (c) Where NonEnglishQualifier_value and INSDQualifier_value are both present for a single qualifier, the information contained in the two elements must be equivalent. One of the following conditions must be true: NonEnglishQualifier_value contains a translation of the value of INSDQualifier_value; or, INSDQualifier_value contains a translation of the value of NonEnglishQualifier_value; or, both elements contain a translation of the qualifier value from the language specified in the originalFreeTextLanguageCode attribute (see List of File Attributes reproduced in MPEP § 2413.01(e)).
  • (d) For qualifiers with a language-dependent free text value, the INSDQualifier element may include an optional attribute id. The value of this attribute must be in the format “q” followed by a positive integer, e.g. “q23”, and must be unique to one INSDQualifier element, i.e. the attribute value must only be used once in a “Sequence Listing XML” file (WIPO Standard ST.26, paragraph 87).

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