MPEP § 1823.02
[Editor Note: The PCT Rules and Administrative Instructions reproduced in this section are applicable to international applications, including national phase applications, having an international filing date on or after July 1, 2022. For international applications having an international filing date before July 1, 2022, the applicable rules may be found at: www.wipo.int/export/sites/www/pct/en/docs/texts/ pct-regs2020.pdf and the applicable instructions may be found at www.wipo.int/wipolex/en/text/584509.]
*****
Rule 13ter.1 shall apply mutatis mutandis to the procedure before the International Preliminary Examining Authority.
No designated Office shall require the applicant to furnish to it a sequence listing other than a sequence listing complying with the standard provided for in the Administrative Instructions.
Any sequence listing, whether forming part of the international application or not forming part of the international application, shall comply with Annex C. Sequences and references to sequences included in the main part of the description, claims and drawings shall also comply with Annex C.
[Editor Note: This subsection is applicable to all international applications, including national phase applications, having an international filing date on or after July 1, 2022, that disclose one or more nucleotide and/or amino acid sequences as defined in WIPO Standard ST.26.]
Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in WIPO Standard ST.26, must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format as a separate part of the specification. This standardized format is set forth in WIPO Standard ST.26 and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in all IPOs of WIPO member states.
Where an international application, filed under the PCT, contains a disclosure of nucleotide and/or amino acid sequences that are required to be listed within a sequence listing, PCT Rule 5.2 requires that the description shall include a sequence listing part of the description complying with the standard provided for in the Administrative Instructions. In accordance with Section 208 of the Administrative Instructions, any sequence listing, whether forming part of the international application or not forming part of the international application, shall comply with Annex C of the Administrative Instructions. Where applicant has not provided a sequence listing in accordance with Annex C of the Administrative Instructions and the USPTO acts as International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), the ISA/IPEA may invite applicant to furnish a sequence listing, with a late furnishing fee, under PCT Rule 13ter . This invitation will specify a time limit for a proper response. A proper response to such an invitation would include, the submission of a sequence listing in accordance with Annex C of the Administrative Instructions, the late furnishing fee specified in 37 CFR 1.445(a)(5), and a statement to the effect that the sequence listing does not go beyond the disclosure of the international application as filed. If a sequence listing compliant with WIPO Standard ST.26 has not been furnished to the ISA/IPEA within the time limit set forth in the invitation, the ISA/IPEA will only search/examine the international application to the extent that a meaningful search or examination can be performed without the sequence listing. See PCT Rule 13ter.1(d). Where the application discloses sequences that are required to be within a sequence listing, it is advisable for the applicant to submit a sequence listing compliant with WIPO Standard ST.26 together with the international application on the international filing date rather than to wait for an invitation by the International Searching Authority or International Preliminary Examining Authority.
For a detailed discussion of the World Intellectual Property Organization (WIPO) Standard ST.26, see MPEP §§ 2412 - 2419, in particular MPEP § 2414.05.
For ease of access, WIPO Standard ST.26 can be found at: www.wipo.int/standards/en/ part_03_standards.html.
[Editor Note: This subsection is only applicable to international applications, including national phase applications, having an international filing date before July 1, 2022, that disclose one or more nucleotide and/or amino acid sequences as defined in WIPO Standard ST.25.]
Where an international application discloses one or more nucleotide and/or amino acid sequences, the description must contain a sequence listing complying with the standard specified in the Administrative Instructions. A copy of the Administrative Instructions in force before July 1, 2022 can be found at: www.wipo.int/wipolex/en/text/584509. The standard is set forth in detail in Annex C - Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in International Patent Applications Under the PCT. The standard allows the applicant to draw up a single sequence listing which is acceptable to all receiving Offices, International Searching and Preliminary Examining Authorities for the purposes of the international phase, and to all designated and elected Offices for the purposes of the national phase.
Under PCT Rule 5.2(a), the sequence listing must always be presented as a separate part of the description. When filing an international application (PCT) using the USPTO patent electronic filing system, the sequence listing part of the description may be submitted either as a single ASCII text file with a ".txt" extension (e.g., "seqlist.txt") or as a PDF file. Note that 100 megabytes is the size limit for submitting a sequence listing text file via the USPTO patent electronic filing system.
A single ASCII text file will serve both as the sequence listing part of the description under PCT Rule 5.2 and the electronic form under PCT Rule 13ter.1(a) in the absence of a PDF sequence listing file. The check list of the PCT Request (PCT/RO/101) provided via the USPTO patent electronic filing system together with the international application (PCT) must indicate that the sequence listing forms part of the international application. Furthermore, the statement as set forth in paragraph 4(v) of the AI Annex C (Administrative Instructions under the PCT, Annex C), that "the information recorded in electronic form furnished under PCT Rule 13ter is identical to the sequence listing as contained in the international application," is not required.
Submission of the sequence listing part of the description in a PDF file is not recommended because the applicant would also be required to supply a copy of the sequence listing in an ASCII text file to the appropriate authority for purposes of international search and/or international preliminary examination in accordance with paragraph 40 of AI Annex C. When a sequence listing is filed via the USPTO patent electronic filing system in a new PCT international application in both a PDF file and an ASCII text file, but the Request form Box No. IX does not indicate which one forms part of the international application, the PDF copy of the sequence listing will be considered to form part of the application and the ASCII text file will be considered an accompanying item for search purposes under PCT Rule 13ter.1(a) only.
In cases where a sequence listing does not meet the necessary requirements, such as it has been submitted in PDF format or .txt file does not comply with Annex C, the International Searching Authority and the International Preliminary Examining Authority may invite the applicant to furnish, within a fixed time limit, a sequence listing complying with the required standard. The invitation may also, in accordance with PCT Rule 13ter.1(c), request the payment of a late furnishing fee. Where such an invitation has been issued, the sequence listing and late fee must be submitted to the International Searching Authority or the International Preliminary Examining Authority. It is advisable for the applicant to submit a listing of the sequence in electronic form (text), if such a listing is required by the competent International Searching Authority or International Preliminary Examining Authority, together with the international application rather than to wait for an invitation by the International Searching Authority or International Preliminary Examining Authority.
The electronic form (text) is not mandatory in international applications to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority. However, if an electronic form (text) of a sequence listing is not provided, a search or examination will be performed only to the extent possible in the absence of the electronic form (text). The U.S. sequence rules (37 CFR 1.821 - 1.825 ) and the PCT sequence requirements are substantively consistent. In this regard, full compliance with the requirements of the U.S. rules will generally ensure compliance with the applicable PCT requirements. However, the requirements of 37 CFR 1.821 through 37 CFR 1.825 are less stringent than the requirements of WIPO Standard ST.25. See MPEP § 2422, subsection II, MPEP § 2422.03(a), subsection IV, and MPEP § 2422.07 for information specific to filing sequence listings in international applications.
For a detailed discussion of the U.S. sequence rules, see MPEP §§ 2420 - 2429.
The calculation of the international filing fee for an international application (PCT), including a sequence listing, filed via the USPTO patent electronic filing system is determined based on the type of sequence listing file. A sequence listing filed in an ASCII text file will not be included in the sheet count of the international application (PCT). A sequence listing filed in a PDF file will be included in the sheet count of the international application (PCT). Therefore, the sheet count for an international application (PCT) filed via the USPTO patent electronic filing system containing both a PDF file and a text file sequence listing will be calculated to include the number of sheets of the PDF sequence listing.