MPEP § 2413 — MPEP § 2413
Current through: 2022-07-01

2413-Content of a “Sequence Listing XML” and Form and Format of the “Sequence Listing XML” File 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2400 

 Section 2413 
 

 
 
 
 
 
 2413 Content of a “Sequence Listing XML” and Form and
 Format of the “Sequence Listing XML” File [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) .] 

 In order to ensure consistency and uniformity of a
 “Sequence Listing XML,” 37 CFR 1.833 defines the content of the
 “Sequence Listing XML.” 37 CFR 1.834 details the specifics on
 the technical form and format of the .xml file containing the “Sequence Listing XML” XML
 file.
 

 
 2413.01 Parts of the “Sequence Listing XML” [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) .] 

 The constituent parts of the “Sequence Listing XML” are
 identified in multiple paragraphs of WIPO Standard ST.26 and have been specifically
 incorporated into the USPTO rules of practice at 37 CFR
 1.839 .
 

 
 2413.01(a) The “Sequence Listing XML” is a Single File
 Encoded Using Unicode UTF-8 [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. 

 
 (a) The “Sequence Listing XML” as required by §
 1.831(a) must be
 presented as a single file in XML 1.0 encoded using Unicode UTF–8, where the
 character set complies with paragraphs 40 and 41 and Annex IV of WIPO
 Standard ST.26 (incorporated by reference, see §
 1.839 ).
 

 
 *****

 

 
 

 According to 37 CFR
 1.833 , the entire “Sequence Listing XML” must be presented as a
 single file. WIPO Standard ST.26 specifies that the file must be encoded using
 Unicode UTF-8, with the following restrictions:
 

 
 (1) the information contained in the elements
 ApplicantName, InventorName and InventionTitle of the general information part,
 and the NonEnglishQualifier_value of the sequence data part, may be composed of
 any valid Unicode characters indicated in the XML 1.0 specification except the
 Unicode Control code points 0000-001F and 007F-009F. The reserved characters “,
 &, ‘, <, and > (Unicode code points 0022, 0026, 0027, 003C and 003E
 respectively), must be replaced as set forth the table below; and
 

 (2) the information contained in all other elements
 and attributes of the general information part and in all other elements and
 attributes of the sequence data part must be composed of printable characters
 (including the space character) from the Unicode Basic Latin code table (i.e.,
 limited to Unicode code points 0020 through 007E). The reserved characters “,
 &, ‘, <, and > (Unicode code points 0022, 0026, 0027, 003C and 003E
 respectively), must be replaced as set forth in the table below (WIPO Standard
 ST.26, paragraph 40).
 

 See MPEP §
 2413.01(f) for details about the “general information
 part” and MPEP § 2413.01(g) for details
 about the “sequence data part.”
 

 

 WIPO Standard ST.26 specifies that in an XML
 instance of a “Sequence Listing XML”, numeric character references must not be
 used and the following reserved characters must be replaced by the corresponding
 predefined entities when used in a value of an attribute or content of an
 element:
 

 
 
 List of Reserved Characters and
 Predefined Entities
 
 
 
 Reserved
 Character
 
 Predefined
 Entities
 
 

 
 
 
 < 
 < 
 

 
 > 
 > 
 

 
 & 
 &amp; 
 

 
 “ 
 " 
 

 
 ‘ 
 &apos; 
 

 
 
 Reproduced from WIPO Standard ST.26, paragraph 41. See
 also WIPO Standard ST.26, paragraph 41, footnote 1 of the WIPO standard for details
 about “numeric character references.” 
 

 The only character entity references permitted are
 the predefined entities set forth above (WIPO Standard ST.26, paragraph 41).
 

 

 
 2413.01(b) The “Sequence Listing XML” Must Be Valid
 According To the DTD [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) .] 

 
 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. 

 
 
 *****

 

 (b) The “Sequence Listing XML” presented in
 accordance with paragraph (a) of this section must further: 
 
 (1) Be valid according to the Document
 Type Definition (DTD) as presented in WIPO Standard ST.26, Annex II.
 
 

 
 

 
 *****

 

 
 

 37 CFR 1.833(b)(1) incorporates
 the DTD requirement of WIPO Standard ST.26 such that a “Sequence Listing XML” must
 conform to the Document Type Definition (the document that sets out the structure and
 use of elements and attributes in an XML compliant document) presented in Annex II of
 WIPO Standard ST.26. Use of the WIPO Sequence tool will enable a user to generate a
 “Sequence Listing XML” that conforms to the DTD in Annex II of WIPO Standard ST.26.
 See MPEP
 § 2418 .
 

 

 
 2413.01(c) The “Sequence Listing XML” Must Contain an
 XML Declaration [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. 

 
 
 *****

 

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

 

 (2) Comply with the requirements of WIPO
 Standard ST.26 to include: 
 
 (i) An XML declaration as
 defined in paragraph 39(a) of WIPO Standard ST.26; 
 

 
 

 
 

 
 *****

 

 
 

 WIPO Standard ST.26, paragraph 39(a), specifies that
 the first line of the XML instance must contain the XML declaration, which is: 
 

 <?xml version="1.0" encoding="UTF-8"?> 

 

 
 2413.01(d) The “Sequence Listing XML” Must Contain a
 DOCTYPE Declaration [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. 

 
 
 *****

 

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

 

 (2) Comply with the requirements of WIPO
 Standard ST.26 to include:
 
 
 *****

 

 (ii) A document type (DOCTYPE)
 declaration as defined in paragraph 39(b) of WIPO Standard
 ST.26;
 

 
 

 
 

 
 *****

 

 
 

 WIPO Standard ST.26, paragraph 39(b), specifies that
 the second line of the XML instance must contain the document type (DOCTYPE)
 declaration, which is: 
 

 <!DOCTYPE ST26SequenceListing PUBLIC "-//WIPO//DTD
 Sequence Listing 1.3//EN" "ST26SequenceListing_V1_3.dtd"> 
 

 

 
 2413.01(e) The “Sequence Listing XML” Must Contain a
 Root Element [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. 

 
 
 *****

 

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

 

 (2) Comply with the requirements of WIPO
 Standard ST.26 to include:
 
 
 *****

 

 (iii) A root element as defined in
 paragraph 43 of WIPO Standard ST.26; 
 

 
 

 
 

 
 *****

 

 
 

 WIPO Standard ST.26, paragraph 43, prescribes the root
 element of an XML instance to have the following attributes:
 

 
 List of File Attributes 
 
 
 Attribute 
 Description 
 Mandatory/Optional 
 

 
 
 
 dtdVersion 
 Version of the
 DTD used to create this file in the format “V#_#”, e.g., “V1_3”.
 
 Mandatory 
 

 
 fileName 
 Name of the
 sequence listing file.
 
 Optional 
 

 
 softwareName 
 Name of the
 software that generated this file.
 
 Optional 
 

 
 softwareVersion 
 Version of the
 software that generated this file.
 
 Optional 
 

 
 productionDate 
 Date of
 production of the sequence listing file (format “CCYY-MM-DD”).
 
 Optional 
 

 
 originalFreeTextLanguageCode 
 The language
 code (see reference in paragraph 9 to ISO 639-1:2002) for the single
 original language in which the language-dependent free text qualifiers
 were prepared.
 
 Optional 
 

 
 nonEnglishFreeTextLanguageCode 
 The language
 code (see reference in paragraph 9 to ISO 63901:2002) for the
 NonEnglishQualifier_value elements.
 
 Mandatory when a
 NonEnglishQualifier_value element is present in the sequence
 listing
 
 

 
 
 Reproduced from paragraph 43 of WIPO Standard
 ST.26.
 

 

 

 
 2413.01(f) The “Sequence Listing XML” Must Contain a
 General Information Part [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. 

 
 
 *****

 

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

 

 (2) Comply with the requirements of WIPO Standard ST.26 to include:
 
 
 *****

 

 (iv) A general information part that complies with the requirements
 of paragraphs 45, 47, and 48, as applicable, of WIPO Standard
 ST.26
 

 
 

 
 

 
 *****

 

 
 

 WIPO Standard ST.26 prescribes that the general
 information part of the sequence listing must contain the following bibliographic
 elements:
 

 
 List of Patent Application Information
 Elements
 
 
 
 Element 
 Description 
 Mandatory/Optional 
 

 
 
 
 
 ApplicationIdentification 

 The ApplicationIdentification is
 composed of:
 

 IPOfficeCode ApplicationNumberText 

 
 
 The application identification for
 which the sequence listing is submitted
 

 ST.3 Code of the office of filing

 The application number as provided by
 the office of filing (e.g., PCT/IB2013/099999)
 

 
 
 Mandatory when a sequence listing is
 furnished at any time following the assignment of the application
 number
 

 Mandatory

 Mandatory

 
 

 
 FilingDate 
 The date of
 filing of the patent application for which the sequence listing is
 submitted (ST.2 format “CCYY-MM-DD”, using a 4-digit calendar year, a
 2-digit calendar month and a 2-digit day within the calendar month, e.g.,
 2015-01-31).
 
 Mandatory when a
 sequence listing is furnished at any time following the assignment of a
 filing date
 
 

 
 ApplicantFileReference 
 A single unique
 identifier assigned by applicant to identify a particular application,
 typed in the characters as set forth in paragraph 40 (b).
 
 Mandatory when a
 sequence listing is furnished at any time prior to assignment of the
 application number; otherwise, Optional
 
 

 
 EarliestPriorityApplicationId entification 
 The
 identification of the earliest priority application (also contains
 IPOfficeCode, ApplicationNumberText and FilingDate, see
 ApplicationIdentification above).
 
 Mandatory where
 priority is claimed
 
 

 
 ApplicantName 
 Name of the
 first mentioned applicant typed in the characters as set forth in
 paragraph 40 (a). This element includes the mandatory attribute
 languageCode as set forth in paragraph 47.
 
 Mandatory 
 

 
 ApplicantNameLatin 
 Where
 ApplicantName is typed in characters other than those as set forth in
 paragraph 40 (b), a translation or transliteration of the name of the
 first mentioned applicant must also be typed in characters as set forth
 in paragraph 40 (b).
 
 Mandatory where
 ApplicantName contains non-Latin characters
 
 

 
 InventorName 
 Name of the
 first mentioned inventor typed in the characters as set forth in
 paragraph 40 (a). This element includes the mandatory attribute
 languageCode as set forth in paragraph 47.
 
 Optional 
 

 
 InventorNameLatin 
 Where
 InventorName is typed in characters other than those as set forth in
 paragraph 40 (b), a translation or transliteration of the first mentioned
 inventor may also be typed in characters as set forth in paragraph 40
 (b).
 
 Optional 
 

 
 InventionTitle 
 Title of the
 invention typed in the characters as set forth in paragraph 40 (a) in the
 language of filing. A translation of the title of the invention into
 additional languages may be typed in the characters as set forth in
 paragraph 40 (a) using additional InventionTitle elements. This element
 includes the mandatory attribute languageCode as set forth in paragraph
 48. The title of invention should be between two to seven words.
 
 Mandatory in the
 language of filing. Optional for additional languages.
 
 

 
 SequenceTotalQuantity 
 The total number
 of all sequences in the sequence listing including intentionally skipped
 sequences (also known as empty sequences) (see paragraph 10).
 
 Mandatory 
 

 
 
 Reproduced from paragraph 45 of WIPO Standard
 ST.26.
 

 WIPO Standard ST.26, paragraph 47, specifies that the
 name of the applicant and, optionally, the name of the inventor must be indicated in
 the element ApplicantName and InventorName, respectively, as they are generally
 referred to in the language in which the application is filed. The appropriate
 language code (referenced in WIPO Standard ST.26, paragraph 9, which references the
 International Standard ISO 639-1:2002 for the codes for the representation of names
 of languages) must be indicated in the languageCode attribute for each element. Where
 the applicant name indicated contains characters other than those of the Latin
 alphabet permitted as set forth in paragraph 40(b), reproduced in
 MPEP
 § 2413.01(a) item (2), a transliteration or translation of
 the applicant name must also be indicated in characters of the Latin alphabet in the
 element ApplicantNameLatin. Where the inventor name indicated contains characters
 other than those of the Latin alphabet, a transliteration or a translation of the
 inventor name may also be indicated in characters of the Latin alphabet in the
 element InventorNameLatin.
 

 WIPO Standard ST.26, paragraph 48, provides that the
 title of the invention must be indicated in the element InventionTitle in the
 language of filing and may also be indicated in additional languages using multiple
 InventionTitle elements. The appropriate language code (see WIPO Standard ST.26,
 paragraph 9, which references the International Standard ISO 639-1:2002) must be
 indicated in the languageCode attribute of the element. See MPEP §
 2413.01(i) for more information about the InventionTitle
 element in a “Sequence Listing XML.”
 

 

 
 2413.01(g) The “Sequence Listing XML” Must Contain a
 Sequence Data Part [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. 

 
 
 *****

 

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

 

 (2) Comply with the requirements of WIPO Standard ST.26 to include:
 
 
 *****

 

 (v) A sequence data part that complies with the requirements of
 paragraphs 50–55, 57, 58, 60–69, 71–78, 80–87, 89–98, and 100,
 as applicable, of WIPO Standard ST.26 representing the
 nucleotide and/or amino acid sequences according to §
 1.832 .
 

 
 

 
 

 
 *****

 

 
 

 The sequence data part is the part of the “Sequence
 Listing XML” that contains each individual nucleotide or amino acid sequence that
 meets the definition for inclusion in a “Sequence Listing XML” together with
 sequence-associated data. WIPO Standard ST.26, paragraph 50, specifies that the
 sequence data part must be composed of one or more SequenceData elements, each
 element containing information about one sequence. 
 

 WIPO Standard ST.26, paragraph 51, specifies that
 each SequenceData element must have a mandatory attribute sequenceIDNumber, in which
 the sequence identifier (see MPEP § 2412.05(a) ) for each sequence
 is contained.
 

 WIPO Standard ST.26 specifies that the SequenceData
 element must contain a dependent element INSDSeq, consisting of further dependent
 elements as follows:
 

 
 List of INSDSeq Dependent
 Elements
 
 
 
 Element 
 Description 
 Mandatory 
 Mandatory/Not
 Included
 
 

 
 
 
 Sequences 
 Intentionally Skipped Sequences 
 

 
 
 
 INSDSeq_length 
 Length of the
 sequence
 
 Mandatory 
 Mandatory with
 no value
 
 

 
 INSDSeq_moltype 
 Molecule
 type
 
 Mandatory 
 Mandatory with
 no value
 
 

 
 INSDSeq_division 
 Indication that
 a sequence is related to a patent application
 
 Mandatory with
 the value “PAT”
 
 Mandatory with
 no value
 
 

 
 INSDSeq_feature-table 
 List of
 annotations of the sequence
 
 Mandatory 
 Must NOT be
 included
 
 

 
 INSDSeq_sequence 
 Sequence 
 Mandatory 
 Mandatory with
 the value “000”
 
 

 
 
 Reproduced from paragraph 52 of WIPO Standard
 ST.26.
 

 See MPEP §
 2412.05(a) for information about intentionally skipped
 sequences. 
 

 WIPO Standard ST.26, paragraph 53, specifies that the
 element INSDSeq_length must disclose the number of nucleotides or amino acids of the
 sequence contained in the INSDSeq_sequence element.
 

 WIPO Standard ST.26, paragraph 54, specifies that the
 element INSDSeq_moltype must disclose the type of molecule that is being represented.
 For nucleotide sequences, including nucleotide analogue sequences, the molecule type
 must be indicated as DNA or RNA. For amino acid sequences, the molecule type must be
 indicated as AA.
 

 WIPO Standard ST.26, paragraph 55, specifies that for
 a nucleotide sequence that contains both DNA and RNA segments of one or more
 nucleotides, the molecule type must be indicated as DNA. The combined DNA/RNA
 molecule must be further described in the feature table, using the feature key
 “source” and the mandatory qualifier “organism” with the value “synthetic construct”
 and the mandatory qualifier “mol_type” with the value “other DNA.” Each DNA and RNA
 segment of the combined DNA/RNA molecule must be further described with the feature
 key “misc_feature” and the qualifier “note,” wherein the qualifier value indicates
 whether the segment is DNA or RNA.
 

 WIPO Standard ST.26, paragraph 57, specifies that the
 element INSDSeq_sequence must disclose the sequence. Only the appropriate symbols set
 forth in Table 1: List of Nucleotides Symbols and Table 3: List of Amino Acids
 Symbols (see MPEP § 2412.03(a) ) must be included
 in the sequence. The sequence must not include numbers, punctuation or whitespace
 characters.
 

 I. FEATURE TABLE According to WIPO Standard ST.26, a “feature
 table” “contains information on the location and roles of various regions within a
 particular sequence. A feature table is required for every sequence, except for
 any intentionally skipped sequence, in which case it must not be included. The
 feature table is contained in the element INSDSeq_feature-table, which consists of
 one or more INSDFeature elements.” (WIPO Standard ST.26, paragraph 60). 
 

 WIPO Standard ST.26 specifies that each INSDFeature
 element that comprises the feature table describes one feature, and consists of
 dependent elements as follows:
 

 
 List of INSDFeature Dependent
 Elements
 
 
 
 Element 
 Description 
 Mandatory/Optional 
 

 
 
 
 INSDFeature_key 
 A word or
 abbreviation indicating a feature
 
 Mandatory 
 

 
 INSDFeature_location 
 Region of the
 sequence which corresponds to the feature
 
 Mandatory 
 

 
 INSDFeature_quals 
 Qualifier
 containing auxiliary information about a feature
 
 Mandatory where
 the feature key requires one or more qualifiers, e.g., source; otherwise,
 Optional
 
 

 
 
 Reproduced from paragraph 61 of WIPO Standard
 ST.26.
 

 II. FEATURE KEYS WIPO Standard ST.26, paragraph 62, specifies that
 Annex I contains the exclusive listing of feature keys that must be used when
 preparing and submitting a “Sequence Listing XML,” along with an exclusive listing
 of associated qualifiers and an indication as to whether those qualifiers are
 mandatory or optional. Section 5 of Annex I of WIPO Standard ST.26 provides the
 exclusive listing of feature keys for nucleotide sequences and Section 7 of Annex
 I of WIPO Standard ST.26 provides the exclusive listing of feature keys for amino
 acid sequences.
 

 III. MANDATORY FEATURE KEYS WIPO Standard ST.26, paragraph 63, specifies that
 the “source” feature key is mandatory for all nucleotide sequences and for all
 amino acid sequences, except for any intentionally skipped sequence. Each sequence
 must have a single “source” feature key spanning the entire sequence. Where a
 sequence originates from multiple sources, those sources may be further described
 in the feature table, using the feature key “misc_feature” and the qualifier
 “note” for nucleotide sequences, and the feature key “REGION” and the qualifier
 “note” for amino acid sequences.
 

 IV. FEATURE
 LOCATION WIPO Standard ST.26, paragraph 64, specifies that
 the mandatory element INSDFeature_location must contain at least one location
 descriptor, which defines a site or a region corresponding to a feature of the
 sequence in the INSDSeq_sequence element. Amino acid sequences must contain one
 and only one location descriptor in the mandatory INSDFeature_location element.
 Nucleotide sequences may have more than one location descriptor in the mandatory
 INSDFeature_location element when used in conjunction with one or more location
 operator(s) (more information about location descriptors is discussed below).
 

 WIPO Standard ST.26, paragraph 65, specifies that
 the location descriptor can be a single residue number, a region delimiting a
 contiguous span of residue numbers, or a site or region that extends beyond the
 specified residue or span of residues. The location descriptor must not include
 numbering for residues beyond the range of the sequence in the INSDSeq_sequence
 element. For nucleotide sequences only, a location descriptor can be a site
 between two adjacent residue numbers. Multiple location descriptors must be used
 in conjunction with a location operator when a feature corresponds to
 discontinuous sites or regions of a nucleotide sequence (more information about
 location descriptors and operators is discussed below).
 

 WIPO Standard ST.26, paragraph 66, specifies that
 the syntax for each type of location descriptor is indicated in Tables (a)-(c)
 below, where x and y are residue numbers, indicated as positive integers, not
 greater than the length of the sequence in the INSDSeq_sequence element, and x is
 less than y. 
 

 (a) Location descriptors for nucleotide and amino
 acid sequences:
 

 
 Location Descriptors for Nucleotide
 and Amino Acid Sequences
 
 
 
 Location
 descriptor type
 
 Syntax 
 Description 
 

 
 
 
 Single
 residue number
 
 x 
 Points to a
 single residue in a sequence.
 
 

 
 Residue
 numbers delimitating a sequence span
 
 x. .y 
 Points to a
 continuous range of residues bounded by and including the starting and
 ending residues.
 
 

 
 Residues
 before the first or beyond the last specified residue number
 
 
 <x

 >x

 <x. .y

 x. .>y

 <x. .>y

 
 Points to a
 region including a specified residue or span of residues and extending
 beyond a specified residue. The '<' and '>' symbols may be used
 with a single residue or the starting and ending residue numbers of a
 span of residues to indicate that a feature extends beyond the
 specified residue number.
 
 

 
 
 Reproduced from paragraph 66 of WIPO Standard
 ST.26.
 

 (b) Location descriptors for nucleotide sequences
 only:
 

 
 Location Descriptors for Nucleotide
 Sequence Only
 
 
 
 Location
 descriptor type
 
 Syntax 
 Description 
 

 
 
 
 A site
 between two adjoining nucleotides
 
 x^y 
 Points to a
 site between two adjoining nucleotides, e.g., endonucleolytic cleavage
 site. The position numbers for the adjacent nucleotides are separated
 by a carat (^). The permitted formats for this descriptor are x^x+1
 (for example 55^56), or, for circular nucleotides, x^1, where “x” is
 the full length of the molecule, i.e. 1000^1 for circular molecule
 with length 1000.
 
 

 
 
 Reproduced from paragraph 66 of WIPO Standard
 ST.26.
 

 (c) Location descriptors for amino acid sequences
 only:
 

 
 Location Descriptors for Amino Acid
 Sequences Only
 
 
 
 Location
 descriptor type
 
 Syntax 
 Description 
 

 
 
 
 Residue
 numbers joined by an intrachain cross-link
 
 x. .y 
 Points to
 amino acids joined by an intrachain linkage when used with a feature
 that indicates an intrachain cross-link, such as “CROSSLNK” or
 “DISULFID”.
 
 

 
 
 Reproduced from paragraph 66 of WIPO Standard
 ST.26.
 

 WIPO Standard ST.26 specifies that the
 INSDFeature_location element of nucleotide sequences may contain one or more
 location operators. A location operator is a prefix to either one location
 descriptor or a combination of location descriptors corresponding to a single but
 discontinuous feature, and specifies where the location corresponding to the
 feature on the indicated sequence is found or how the feature is constructed. A
 list of location operators is provided in the table below with their descriptions.
 Location operators can be used for nucleotides only.
 

 
 Location Operators 
 
 
 Location
 syntax
 
 Location
 description
 
 

 
 
 
 join
 (location, location ,..., location)
 
 The indicated
 locations are joined (placed end-to-end) to form one contiguous
 sequence.
 
 

 
 order
 (location, location,...,location)
 
 The elements
 are found in the specified order but nothing is implied about whether
 joining those elements is reasonable.
 
 

 
 complement
 (location)
 
 Indicates that
 the feature is located on the strand complementary to the sequence
 span specified by the location descriptor, when read in the 5’ to 3’
 direction or in the direction that mimics 5’ to 3’ direction.
 
 

 
 
 Reproduced from paragraph 67 of WIPO Standard
 ST.26.
 

 WIPO Standard ST.26, paragraph 68, specifies that
 the join and order location operators require that at least two comma-separated
 location descriptors be provided. Location descriptors involving sites between two
 adjacent residues, i.e. x^y, must not be used within a join or order combination
 of locations. Use of the join location operator implies that the residues
 described by the location descriptors are physically brought into contact by
 biological processes (for example, the exons that contribute to a coding region
 feature).
 

 WIPO Standard ST.26, paragraph 69, specifies that
 the location operator “complement” can be used in combination with either “join”
 or “order” within the same location. Combinations of “join” and “order” within the
 same location must not be used. See paragraph 70, examples of WIPO Standard
 ST.26.
 

 WIPO Standard ST.26, paragraph 71, specifies that
 in an XML instance of a “Sequence Listing XML” , the characters “<” and “>” in
 a location descriptor must be replaced by the appropriate predefined entities,
 “<” and “>”, respectively (see MPEP §
 2413.01(a) regarding the predefined entities).
 

 V. FEATURE
 QUALIFIERS WIPO Standard ST.26, paragraph 72, specifies that
 qualifiers are used to supply information about features in addition to that
 conveyed by the feature key and feature location. There are three types of value
 formats to accommodate different types of information conveyed by qualifiers,
 namely: 
 

 
 (a) free text (see MPEP §§
 2413.01(g) , subsection IX and
 2413.01(h) , for more detail
 about “free text”); 
 

 (b) controlled vocabulary or enumerated values
 (e.g., a number or date); and 
 

 (c) sequences. 

 
 WIPO Standard ST.26, paragraph 73, specifies that
 Section 6 of Annex I contains the exclusive listing of qualifiers and their
 specified value formats, if any, for each nucleotide sequence feature key and
 Section 8 of Annex I contains the exclusive listing of qualifiers and their
 specified value formats, if any, for each amino acid sequence feature key.
 

 WIPO Standard ST.26, paragraph 74, specifies that
 any sequence encompassed by 37 CFR 1.831(b) (see
 MPEP § 2412.03 ) that is provided as a qualifier value
 must be separately included in the “Sequence Listing XML” and assigned its own
 sequence identifier as described in MPEP §
 2412.05(a) .
 

 VI. MANDATORY FEATURE
 QUALIFIERS WIPO Standard ST.26, paragraph 75, specifies that
 one mandatory feature key, i.e., “source” requires two mandatory qualifiers,
 “organism” and “mol_type.” Some optional feature keys also require mandatory
 qualifiers. See Annex I of WIPO Standard ST.26, Sections 5 and 7, for listings of
 feature keys with mandatory qualifiers. 
 

 VII. QUALIFIER
 ELEMENTS WIPO Standard ST.26 specifies that the element
 INSDFeature_quals contains one or more INSDQualifier elements. Each INSDQualifier
 element represents a single qualifier and consists of three dependent elements and
 one optional attribute, as shown below:
 

 
 List of INSDQualifier Dependent
 Elements
 
 
 
 Element/Attribute 
 Description 
 Mandatory/Optional 
 

 
 
 
 INSDQualifier_name 
 Name of the
 qualifier (see Annex I, Sections 6 and 8).
 
 Mandatory 
 

 
 INSDQualifier_value 
 Value of the
 qualifier, if any, in the specified format (see Annex I, Sections 6
 and 8) and composed in the characters as set forth in paragraph
 40(b).
 
 Mandatory,
 when specified (see paragraph 87 and Annex I, Sections 6 and
 8)
 
 

 
 NonEnglishQualifier_value 
 Value of the
 qualifier, if any, in the specified format (see Annex I, Sections 6
 and 8) and composed in the characters as set forth in paragraph
 40(a).
 
 Mandatory,
 when specified (see paragraph 87 and Annex I, Sections 6 and
 8)
 
 

 
 NonEnglishQualifier_value 
 Value of the
 qualifier, if any, in the specified format (see Annex I, Sections 6
 and 8) and composed in the characters as set forth in paragraph
 40(a).
 
 Mandatory,
 when specified (see paragraph 87 and Annex I, Sections 6 and
 8)
 
 

 
 id 
 A qualifier
 with a language-dependent free text value may be uniquely identified
 by using the optional XML attribute 'id' in the element INSDQualifier
 (see paragraph 87(d)). The value of the 'id' attribute must start with
 the letter 'q' and continue with any positive integer. The value of an
 'id' attribute must be unique to one INSDQualifier element, i.e. the
 attribute value must only be used once in a sequence listing
 file.
 
 Optional
 
 
 

 
 
 Reproduced from paragraph 76 of WIPO Standard
 ST.26.
 

 VIII. ORGANISM AND MOL_TYPE
 QUALIFIERS WIPO Standard ST.26, paragraph 77, specifies that
 the organism qualifier, i.e., “organism” for nucleotide sequences (See Table 5:
 List of Qualifier Values for Nucleotide Sequences with Language-Dependent
 Free-Text Values reproduced in MPEP §
 2413.01(h) , Annex I, section 6, of WIPO Standard ST.26)
 and “organism” for amino acid sequences (see Table 6: List of Qualifiers for Amino
 Acid Sequences with Language-Dependent Free Text Values reproduced in
 MPEP § 2413.01(h) , Annex I, section 6, of WIPO Standard
 ST.26) must disclose the source, i.e., a single organism or origin, of the
 sequence. Organism designations should be selected from a taxonomy database.
 

 WIPO Standard ST.26, paragraph 78, specifies that
 if the sequence is naturally occurring and the source organism has a Latin genus
 and species designation, that designation must be used as the qualifier value. The
 preferred English common name may be specified using the qualifier “note” for
 nucleotide sequences and amino acid sequences, but must not be used in the
 organism qualifier value.
 

 WIPO Standard ST.26, paragraph 80, specifies that
 if the sequence is naturally occurring and the source organism has a known Latin
 genus, but the species is unspecified or unidentified, then the organism qualifier
 value must indicate the Latin genus followed by “sp”.
 

 WIPO Standard ST.26, paragraph 81, specifies that
 if the sequence is naturally occurring, but the Latin organism genus and species
 designation is unknown, then the organism qualifier value must be indicated as
 “unidentified”. Any known taxonomic information should be indicated in the
 qualifier “note” for nucleotide sequences and the qualifier “note” for amino acid
 sequences.
 

 WIPO Standard ST.26, paragraph 82, specifies that
 if the sequence is naturally occurring and the source organism does not have a
 Latin genus and species designation, such as a virus, then another acceptable
 scientific name (e.g., “Canine adenovirus type 2”) must be used as the organism
 qualifier value.
 

 WIPO Standard ST.26, paragraph 83, specifies that if
 the sequence is not naturally occurring, the organism qualifier value must be
 indicated as “synthetic construct.” Further information with respect to the way
 the sequence was generated may be specified using the qualifier “note” for
 nucleotide sequences and the qualifier “note” for amino acid sequences.
 

 WIPO Standard ST.26, paragraph 84, specifies that
 the “mol_type” qualifier for nucleotide sequences and “mol_type” qualifier for
 amino acid sequences must disclose the type of molecule represented in the
 sequence. These qualifiers are distinct from the element INSDSeq_moltype discussed
 above where INSDSeq_moltype for nucleotide sequences, including nucleotide
 analogue sequences must be indicated as DNA or RNA, and for amino acid sequences,
 must be indicated as AA:
 

 
 (1) For a nucleotide sequence, the “mol_type”
 qualifier value must be one of the following: “genomic DNA”, “genomic RNA”,
 “mRNA”, “tRNA”, “rRNA”, “other RNA”, “other DNA”, “transcribed RNA”, “viral
 cRNA”, “unassigned DNA”, or “unassigned RNA”. If the sequence is not
 naturally occurring, i.e. the value of the “organism” qualifier is
 “synthetic construct”, the “mol_type” qualifier value must be either “other
 RNA” or “other DNA”;
 

 (2) For an amino acid sequence, the “mol_type”
 qualifier value is “protein.” 
 

 IX. FREE TEXT WIPO Standard ST.26, paragraph 85, specifies 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 (see MPEP §
 2413.01(h) for the definition of “free text” and see
 Annex I of WIPO Standard ST.26 for controlled vocabulary).
 

 WIPO Standard ST.26, paragraph 86, specifies that
 the use of free text must be limited to a few 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,
 or regional procedures. Qualifiers for nucleotide sequences with a
 language-dependent free text value format are identified in Annex I, Table 5: List
 of Qualifiers with Language-Dependent FreeText Values for Nucleotide Sequences
 (reproduced in MPEP § 2413.01(h) ). Qualifiers
 for amino acid sequences with a language-dependent free text value format are
 identified in Annex I, Table 6: List of Qualifiers with Language-Dependent Free
 Text Values for Amino Acid Sequences (reproduced in MPEP §
 2413.01(h) ).
 

 X. CODING SEQUENCES WIPO Standard ST.26, paragraph 89, specifies that
 the “CDS” feature key may be used to identify coding sequences, i.e., sequences of
 nucleotides which correspond to the sequence of amino acids in a protein and the
 stop codon. The location of the “CDS” feature in the mandatory element
 INSDFeature_location must include the stop codon.
 

 WIPO Standard ST.26, paragraph 90, specifies that
 the “transl_table” and “translation” qualifiers may be used with the “CDS” feature
 key (see Annex I of WIPO Standard ST.26). Where the “transl_table” qualifier is
 not used, the use of the Standard Code Table (see Annex I, Section 9, Table 7 of
 WIPO Standard ST.26) is assumed.
 

 WIPO Standard ST.26, paragraph 91, specifies that
 the “transl_except” qualifier must be used with the “CDS” feature key and the
 “translation” qualifier to identify a codon that encodes either pyrrolysine or
 selenocysteine.
 

 WIPO Standard ST.26, paragraph 92, specifies that
 an amino acid sequence encoded by the coding sequence and disclosed in a
 “translation” qualifier that is encompassed by the description of sequences found
 in MPEP § 2412.03 must be included in the sequence listing
 and assigned its own sequence identifier. The sequence identifier assigned to the
 amino acid sequence must be provided as the value in the qualifier “protein_id”
 with the “CDS” feature key. The “organism” qualifier of the “source” feature key
 for the amino acid sequence must be identical to that of its coding sequence.
 

 XI. VARIANTS MPEP §
 2412.05(c) provides information about representation and
 inclusion of variants
 

 WIPO Standard ST.26, paragraph 93, specifies that a
 primary sequence and any variant of that sequence, each disclosed by enumeration
 of its residues and encompassed by the description of sequences found in
 MPEP § 2412.03 must each be included in the sequence
 listing and assigned its own sequence identifier.
 

 WIPO Standard ST.26, paragraph 94, specifies that
 any variant sequence, disclosed as a single sequence with enumerated alternative
 residues at one or more positions, must be included in the sequence listing and
 should be represented by a single sequence, wherein the enumerated alternative
 residues are represented by the most restrictive ambiguity symbol. See
 MPEP § 2412.05(b) , subsection II, for more information
 regarding representing alternative nucleotide residues and MPEP §
 2412.05(d) , subsection II, for more information
 regarding representing alternative amino acid residues.
 

 WIPO Standard ST.26, paragraph 95, specifies that
 any variant sequence, disclosed only by reference to deletion(s), insertion(s), or
 substitution(s) in a primary sequence in the sequence listing, should be included
 in the sequence listing. Where included in the sequence listing, such a variant
 sequence:
 

 
 (a) may be represented by annotation of the
 primary sequence, where it contains variation(s) at a single location or
 multiple distinct locations and the occurrence of those variations are
 independent;
 

 (b) should be represented as a separate sequence
 and assigned its own sequence identifier, where it contains variations at
 multiple distinct locations and the occurrence of those variations are
 interdependent; and
 

 (c) must be represented as a separate sequence
 and assigned its own sequence identifier, where it contains an inserted or
 substituted sequence that contains in excess of 1000 residues (see WIPO
 Standard ST.26, paragraph 86).
 

 
 WIPO Standard ST.26, paragraph 96, specifies the
 proper use of feature keys and qualifiers for nucleic acid and amino acid sequence
 variants from the table List of Feature Keys and Qualifiers (reproduced in
 MPEP § 2412.05(c) ).
 

 WIPO Standard ST.26, paragraph 97, specifies that
 annotation of a sequence for a specific variant must include a feature key and
 qualifier, as indicated in the table in MPEP §
 2412.05(c) , and the feature location. The value for the
 “replace” qualifier must be only a single alternative nucleotide or nucleotide
 sequence using only the symbols in set forth Table 1: List of Nucleotides Symbols
 (see MPEP § 2413.01(a) ), or empty. A listing of alternative
 residues may be provided as the value in the “note” qualifier. In particular, a
 listing of alternative amino acids must be provided as the value in the “note”
 qualifier where “X” is used in a sequence, and represents a value other than “any
 one of ‘A’, ‘R’, ‘N’, ‘D’, ‘C’, ‘Q’, ‘E’, ‘G’, ‘H’, ‘I’, ‘L’, ‘K’, ‘M’, ‘F’, ‘P’,
 ‘O’, ‘S’, ‘U’, ‘T’, ‘W’, ‘Y’, or ‘V.’” A deletion must be represented by an empty
 qualifier value for the “replace” qualifier or by an indication in the “note”
 qualifier that the residue may be deleted. An inserted or substituted residue(s)
 must be provided in the “replace” or “note” qualifier. The value format for the
 “replace” and “note” qualifiers is free text and must not exceed 1000 characters.
 See below for sequences encompassed by the definition in MPEP §
 2412.03 that are provided as an insertion or a
 substitution in a qualifier value.
 

 WIPO Standard ST.26, paragraph 98, specifies that
 the symbols set forth in Tables 1 to 4 of Annex I, reproduced in
 MPEP §§ 2412.03(a) , 2412.03(c) , and 2412.05(b) , subsection III, should be used to represent
 variant residues where appropriate. For the “note” qualifier, where the variant
 residue is a modified residue not set forth in Tables 2 or 4 the complete
 unabbreviated name of the modified residue must be provided as the qualifier
 value. Modified residues must be further described in a feature table as described
 in MPEP § 2412.05(b) , subsection III for modified
 nucleotides and MPEP § 2412.05(d) , subsection
 III, for modified amino acids.
 

 WIPO Standard ST.26, paragraph 100, specifies that
 a sequence encompassed by the description of sequences found in
 MPEP § 2412.03 that is provided as an insertion or a
 substitution in a qualifier value for a primary sequence annotation must also be
 included in the sequence listing and assigned its own sequence identifier.
 

 

 
 2413.01(h) Language Dependent Free Text Qualifier
 Values in the English Language [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. 

 
 
 *****

 

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

 

 (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).
 

 
 

 
 2413.01(i) Title Element in “Sequence Listing
 XML” [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 .] 

 The element InventionTitle described in the table of
 elements of the general information part (reproduced in MPEP §
 2413.01(f) from WIPO Standard ST.26, paragraph 45) as a
 required element of the “general information” part of the “Sequence Listing XML” must
 be in the language of filing. It is possible for an applicant to provide more than
 one InventionTitle element of the general information part in more than one language.
 However, when the USPTO is the Receiving Office (RO/US) for an international
 application, the English language is required for the InventionTitle element and also
 for language-dependent free text of the “Sequence Listing XML.” (See
 MPEP
 § 2413.01(h) for more information about language-dependent
 free text.) If non-English language is presented to RO/US for a “Sequence Listing
 XML,” then RO/US will transfer the international application to the International
 Bureau, under PCT
 Rule 19.4 .
 

 

 

 
 2413.02 Form and Format of the XML file containing the
 “Sequence Listing XML” [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) .] 

 
 37 CFR 1.834 Form and format for nucleotide and/ or amino
 acid sequence submissions as the “Sequence Listing XML” in patent applications filed
 on or after July 1, 2022. 

 
 (a) A “Sequence Listing XML” encoded using Unicode UTF–8, created by any means
 ( e.g., text editors, nucleotide/amino acid sequence
 editors, or other custom computer programs) in accordance with §§
 1.831 through 1.833 , must:
 
 (1) Have the following compatibilities:
 
 (i) Computer compatibility: PC or Mac ® ;
 and
 

 (ii) Operating system compatibility: MS–DOS ® ,
 MS-Windows ® , Mac
 OS ® , or
 Unix ® /Linux ® .
 

 
 

 (2) Be in XML format, where all permitted printable characters (including the
 space character) and nonprintable (control) characters are defined in
 paragraph 40 of WIPO Standard ST.26 (incorporated by reference,
 see § 1.839 ).
 

 (3) Be named as *.xml, where “*” is one character or a combination of
 characters limited to upper- or lowercase letters, numbers, hyphens, and
 underscores, and the name does not exceed 60 characters in total,
 excluding the extension. No spaces or other types of characters are
 permitted in the file name.
 

 
 

 
 *****

 

 
 

 In order for the USPTO to be able to process the
 “Sequence Listing XML” .xml file, all characters must be encoded using Unicode UTF-8.
 The file must be compatible with PC or Mac ® computers using
 one of the following operating systems, MS–DOS ® ,
 MS-Windows ® , Mac OS ® , or
 Unix ® /Linux ® . The printable and
 non-printable characters in the .xml file are defined in paragraph 40 and 41 of WIPO
 Standard ST.26 (see MPEP § 2413.01(a) ) where Annex IV of
 WIPO Standard ST.26 provides a table of the CHARACTER SUBSET FROM THE UNICODE BASIC
 LATIN CODE TABLE FOR USE IN AN XML INSTANCE OF A SEQUENCE LISTING. 
 

 

 
 2413.03 How to Submit the “Sequence Listing
 XML” [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) .] 

 
 37 CFR 1.834 Form and format for nucleotide and/ or amino
 acid sequence submissions as the “Sequence Listing XML” in patent applications filed
 on or after July 1, 2022. 

 
 
 *****

 

 (b) The “Sequence Listing XML” must be in a single file containing the sequence
 information and be submitted either:
 
 (1) Electronically via the USPTO patent electronic filing system, where the
 file size must not exceed 100 MB, and file compression is not permitted;
 or
 

 (2) On read-only optical disc(s) in compliance with § 1.52(e) , where:
 
 (i) A file that is not compressed must be contained on a single
 read-only optical disc;
 

 (ii) The file may be compressed using
 WinZip ® , 7-Zip, or
 Unix ® /Linux ® 
 Zip;
 

 (iii) A compressed file must not be self-extracting; or

 (iv) A compressed XML file that does not fit on a single read-only
 optical disc may be split into multiple file parts, in accordance
 with the target read-only optical disc size, and labeled in
 compliance with § 1.52(e)(5)(vi) ;
 

 
 

 
 

 
 *****

 

 
 

 For submission of a “Sequence Listing XML” that is 100MB
 in size or less, the preferred method of submission is via the USPTO patent electronic
 filing system. Only the Patent Center system of the USPTO patent electronic filing
 system is capable of accepting .xml files. If the “Sequence Listing XML” is larger than
 100MB in size, then applicant may submit the .xml file on physical media using read-only
 optical discs (CDs or DVDs). “Sequence Listing XML” submissions on discs may be
 compressed if the resulting compressed file is non-self-extracting.
 

 The USPTO patent electronic filing system will prohibit
 an applicant from submitting both a “Sequence Listing XML” (a sequence listing that
 conforms to WIPO Standard ST.26 as implemented in 37 CFR
 1.831 through 1.835 ) and a “Sequence Listing” (a
 sequence listing that conforms to ST.25 as implemented in 37 CFR 1.821 
 through 1.825 ) in the same submission. Filing a “Sequence Listing” in a
 35 U.S.C. 111(a) application having a filing date on or after July 1, 2022, will result
 in a notice from the Office of Patent Application Processing (OPAP) informing applicant
 that the submission fails to comply with 37 CFR 1.831 through
 1.834 and will require submission of a “Sequence Listing XML.”
 See MPEP §
 2415.03 for addressing improper submission of a “Sequence
 Listing” that complies with 37 CFR 1.821 - 1.824 where a
 “Sequence Listing XML” that complies with 37 CFR 1.831 - 1.834 is
 required in a national nonprovisional application.
 

 To facilitate administrative processing of all papers
 and read-only optical discs associated with sequence rule compliance, all read-only
 optical discs, fees, and papers accompanying them filed in the Office should be marked
 “Mail Stop SEQUENCE.” Correspondence relating to the submission of a “Sequence Listing
 XML” may also be hand-delivered to the Customer Service Window. In cases of hand
 delivery to the Customer Service Window, the read-only optical disc enclosed in a hard
 case should be placed in a protective mailer. The use of staples and clips, if any,
 should be confined to carefully attaching the protective mailer to the submitted papers
 without contact or compression of the media. The labeling requirements of
 37 CFR
 1.52(e) and including the application number (if known), apply to
 all read-only optical disc submissions. For submission of a “Sequence Listing XML”
 larger than 100MB in size in a new application, it is recommended that the user file the
 application without the “Sequence Listing XML” using the USPTO patent electronic filing
 system to obtain the application number, and then file the “Sequence Listing XML” on
 read-only optical disc(s) in accordance with 37 CFR 1.52(e) on the same day by
 using Priority Mail Express® from the USPS in accordance with 37 CFR 1.10 , or
 hand delivery, in order to secure the same filing date for all parts of the application.
 In no situations should additional or complimentary electronic copies be delivered to
 examiners or other Office personnel. 
 

 

 
 2413.04 Requirements Regarding Incorporation By
 Reference of the “Sequence Listing XML” [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) .] 

 
 37 CFR 1.834 Form and format for nucleotide and/ or amino
 acid sequence submissions as the “Sequence Listing XML” in patent applications filed
 on or after July 1, 2022. 

 
 
 *****

 

 
 
 (c)(1) Unless paragraph (c)(2) of this section applies, when the “Sequence
 Listing XML” required by § 1.831(a) is submitted in XML file format via the
 USPTO patent electronic filing system or on a read-only optical disc (in
 compliance with § 1.52(e) ), then the specification
 must contain a statement in a separate paragraph ( see 
 § 1.77(b)(5) ) that incorporates by reference the
 material in the XML file identifying:
 
 (i) The name of the file;

 (ii) The date of creation; and

 (iii) The size of the file in bytes; or

 
 

 (2) If the “Sequence Listing XML” required by § 1.831(a) is submitted in XML file format via the
 USPTO patent electronic filing system or on a read-only optical disc (in
 compliance with § 1.52(e) ) for an international
 application during the international stage, then an incorporation by
 reference statement of the material in the XML file is not required.
 

 
 

 
 

 

 
 37 CFR 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 
 *****

 

 (c) The specification of a complete application,
 filed on the application filing date, with a “Sequence Listing XML” as required
 under § 1.831(a) , without an
 incorporation by reference of the material contained in the “Sequence Listing
 XML” file, must be amended to include a separate paragraph incorporating by
 reference the material contained in the “Sequence Listing XML” file, in
 accordance with § 1.77(b)(5)(ii) , except for
 international applications.
 

 
 *****

 

 
 

 Since the “Sequence Listing XML” is not the text of the
 specification, but rather is sequence data in an XML file format, an incorporation by
 reference statement is needed to ensure that the content of the “Sequence Listing XML,”
 submitted to the USPTO as an XML file, is considered part of the disclosure capable of
 providing 35
 U.S.C. 112(a) support for the disclosure and any claims relating
 to nucleotide and/or amino acid sequences. The incorporation by reference statement
 identifies: (i) the name of the file; (ii) the date of creation of the file; and (iii)
 the size of the file in bytes Note that this requirement pertaining to applicant
 submission of a “Sequence Listing XML” does not apply to a sequence listing that is part
 of an international application and communicated to the USPTO under PCT Article 20, for
 a national phase application. 
 

 The incorporation by reference statement of the material
 in an .xml file is required to be part of the specification so it is clear to the
 Office, the printer, and the public that the application as originally filed includes
 material on an .xml file. However, for international applications during the
 international phase, where a “Sequence Listing XML” is submitted via the USPTO patent
 electronic filing system or on read-only optical disc, no such incorporation by
 reference statement is required. 
 

 If an applicant submits a “Sequence Listing XML” with
 the complete specification but fails to include the required incorporation by reference
 paragraph, a notice can be issued by pre-examination requiring the incorporation by
 reference paragraph in the context of a substitute specification under 37 CFR 1.125.
 Similarly, the examiner could require applicant to amend the specification to include an
 incorporation by reference paragraph of the “Sequence Listing XML” file. See also form
 paragraph 24.24.26 .
 

 

 
 2413.05 Presumptions Regarding Compliance [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) .] 

 Neither the presence nor absence of information which is
 not required under the sequence rules will create a presumption that such information is
 necessary to satisfy any of the requirements of 35 U.S.C. 112 . Further, the grant of
 a patent on an application that is subject to 37 CFR
 1.831 through 37 CFR 1.835 constitutes a
 presumption that the granted patent complies with the requirements of these rules.
 

 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 2401-Introduction 

 2402-The Deposit Rules 

 2403-Deposit of Biological Material 
 2403.01-Material Capable of Self- Replication 

 2403.02-Plant Material 

 
 

 2404-Need or Opportunity to Make a Deposit 
 2404.01-Biological Material That Is Known and Readily Available to the Public 

 2404.02-Biological Material That Can Be Made or Isolated Without Undue Experimentation 

 2404.03-Reference to a Deposit in the Specification 

 
 

 2405-Acceptable Depository 

 2406-Time of Making an Original Deposit 
 2406.01-Description in Application Specification 

 2406.02-Deposit After Filing Date - Corroboration 

 2406.03-Possible Loss of U.S. Filing Date in Other Countries 

 
 

 2407-Replacement or Supplement of Deposit 
 2407.01-In a Pending Application 

 2407.02-After a Patent Has Issued 

 2407.03-Failure to Replace 

 2407.04-Treatment of Replacement 

 2407.05-Exemption From Replacement 

 2407.06-Replacement May Not Be Recognized 

 
 

 2408-Term of Deposit 

 2409-Viability of Deposit 

 2410-Furnishing of Samples 
 2410.01-Conditions of Deposit 

 2410.02-Certification of Statement of Availability of Deposit 

 
 

 2411-Examination Procedures 
 2411.01-Rejections Based on Deposit Issue 

 2411.02-Replies to Rejections Based on Deposit Issue 

 2411.03-Application in Condition for Allowance Except for Deposit 

 2411.04-[Reserved] 

 2411.05-Content of Application with Respect to Deposited Material 

 
 

 2412-The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include
 a Sequence Listing in XML file format 
 2412.01-Overview of the Sequence Rules 

 2412.02-Definition of “Sequence Listing XML” 
 2412.02(a)-“Enumeration of its residues” 

 
 

 2412.03-Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML” 
 2412.03(a)-“Specifically Defined” 

 2412.03(b)-“Amino Acid” 

 2412.03(c)-“Modified Amino Acid” 

 2412.03(d)-“Nucleotide” 

 2412.03(e)-“Modified Nucleotide” 

 
 

 2412.04-Use of Sequence Identifiers to Denote Sequences Disclosed in the Description, Drawings or Claims 

 2412.05-Representation and Symbols for Nucleotide and/or Amino Acid Sequences 
 2412.05(a)-Use of Sequentially Numbered Sequence Identifiers in the “Sequence Listing XML” 

 2412.05(b)-Representation and Symbols of Nucleotide Sequence Data 

 2412.05(c)-Representation and Inclusion of Variants 

 2412.05(d)-Representation and Symbols of Amino Acid Sequence Data 

 2412.05(e)-Presentation of Special Situations 

 
 

 2412.06-The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures 

 2412.07-Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences 

 
 

 2413-Content of a “Sequence Listing XML” and Form and Format of the “Sequence Listing XML” File 
 2413.01-Parts of the “Sequence Listing XML” 
 2413.01(a)-The “Sequence Listing XML” is a Single File Encoded Using Unicode UTF-8 

 2413.01(b)-The “Sequence Listing XML” Must Be Valid According To the DTD 

 2413.01(c)-The “Sequence Listing XML” Must Contain an XML Declaration 

 2413.01(d)-The “Sequence Listing XML” Must Contain a DOCTYPE Declaration 

 2413.01(e)-The “Sequence Listing XML” Must Contain a Root Element 

 2413.01(f)-The “Sequence Listing XML” Must Contain a General Information Part 

 2413.01(g)-The “Sequence Listing XML” Must Contain a Sequence Data Part 

 2413.01(h)-Language Dependent Free Text Qualifier Values in the English Language 

 2413.01(i)-Title Element in “Sequence Listing XML” 

 
 

 2413.02-Form and Format of the XML file containing the “Sequence Listing XML” 

 2413.03-How to Submit the “Sequence Listing XML” 

 2413.04-Requirements Regarding Incorporation By Reference of the “Sequence Listing XML” 

 2413.05-Presumptions Regarding Compliance 

 
 

 2414-Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files
 Under 37 CFR 1.835 
 2414.01-Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence
 Disclosures 

 2414.02-Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a) 

 2414.03-Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) 

 2414.04-Translation of “Sequence Listing XML” is Not an Amended “Sequence Listing XML” under 37 CFR 1.835(b) 

 2414.05-Notifications for Failure to Submit a “Sequence Listing XML” in an International Application under the PCT to be Searched
 by the United States International Searching Authority or Examined by International Preliminary Examination Authority 

 2414.06-Amendment of a “Sequence Listing XML” in a Patent 

 
 

 2415-Applicability date of “Sequence Listing XML” Requirements to Applications Based on Filing Date of Application and Procedures
 for Failure to Submit Correct Format of Sequence Listing 
 2415.01-Determining if a “Sequence Listing XML” Must be Submitted 

 2415.02-Provisional Applications Containing Disclosures of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.834 

 2415.03-Improper Submissions of “Sequence Listing” under 1.821(c) When a “Sequence Listing XML” was Required 

 
 

 2416-Form Paragraphs 

 2417-Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.26 

 2418-WIPO Sequence Tool 

 2419-Publishing of Patent Grants and Patent Application Publications with a “Sequence Listing XML” 
 2419.01-Patent Grants and Patent Application Publications Containing a Non-Lengthy “Sequence Listing XML” 

 2419.02-Patent Grants and Patent Application Publications Containing a Lengthy “Sequence Listing XML” 

 2419.03-Patent Grants and Patent Application Publications Containing a “Sequence Listing XML” of 1GB or Larger 

 
 

 2420-The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures under World
 Intellectual Property Office Standard ST.25 (WIPO ST.25) - the Sequence Rules 

 2421-Overview of the Sequence Rules under WIPO ST.25 
 2421.01-Definition of “Sequence Listing” and Computer Readable Form (CRF) 

 2421.02-Summary of the Requirements of the Sequence Rules 

 2421.03-Notification of a Failure to Comply 

 2421.04-[Reserved] 

 
 

 2422-Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.25 
 2422.01-Nucleotide and/or Amino Acids Disclosures Requiring a “Sequence Listing” 

 2422.02-The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures 

 2422.03-Sequence Listing Submission 

 2422.03(a)-“Sequence Listing” Submitted as ASCII Plain Text Files 

 2422.04-The Requirement for a Computer Readable Copy of the “Sequence Listing” 

 2422.05-[Reserved] 

 2422.06-Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form 

 2422.07-Requirements for Compliance and Consequences of Non-Compliance 

 2422.08-Presumptions Regarding Compliance 

 2422.09-[Reserved] 

 
 

 2423-Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.25 
 2423.01-Format and Symbols To Be Used in a “Sequence Listing” 

 2423.02-Depiction of Coding Regions 

 2423.03-Presentation and Numbering of Sequences 

 
 

 2424-Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25. 
 2424.01-Informational Requirements for the “Sequence Listing” 

 2424.02-“Sequence Listing” Numeric Identifiers 

 2424.03-Additional Miscellaneous Requirements 

 
 

 2425-Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.25 

 2426-Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 25 

 2427-Form Paragraphs for Applications Subject to WIPO ST.25 

 2428-Sample Statements under WIPO ST.25 

 2429-Helpful Hints for Sequence Rules Compliance under WIPO ST.25 

 2430-PatentIn Information 

 2431-Sample “Sequence Listing” under WIPO ST.25 

 2432-[Reserved] 

 2433-Box Sequence; Hand Delivery of a “Sequence Listing” and Computer Readable Forms 

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

 2435-Publishing of Patents and Patent Application Publications with a Lengthy “Sequence Listing” 

 

 

 
 

 
 
 

 
 

 

 
 
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 03/09/2026 20:50:46