MPEP § 1848 — MPEP § 1848
Current through: 2022-07-01

1848-Sequence Listings 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 1800 

 Section 1848 
 

 
 
 
 
 
 1848 Sequence Listings [R-01.2024]

 [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 and instructions may be found at: www.wipo.int/pct/en/texts/ .]
 

 
 PCT Rule 13ter 

 Nucleotide and/or Amino Acid Sequence
 Listings 

 
 13 ter .1 Procedure before the International Searching
 Authority
 

 

 
 (a) Where the international application contains disclosure of
 nucleotide and/or amino acid sequences that, pursuant to the Administrative
 Instructions, are required to be included in a sequence listing, the
 International Searching Authority may invite the applicant to furnish to it,
 for the purposes of the international search, a sequence listing complying
 with the standard provided for in the Administrative Instructions, unless
 such listing is already available to it in a form, language and manner
 acceptable to it, and to pay to it, where applicable, the late furnishing
 fee referred to paragraph (c), within a time limit fixed in the
 invitation.
 

 (b) [Deleted]

 (c) The furnishing of a sequence listing in response to an
 invitation under paragraph (a) may be subjected by the International
 Searching Authority to the payment to it, for its own benefit, of a late
 furnishing fee whose amount shall be determined by the International
 Searching Authority but shall not exceed 25% of the international filing fee
 referred to in item 1 of the Schedule of Fees, not taking into account any
 fee for each sheet of the international application in excess of 30
 sheets.
 

 (d) If the applicant does not, within the time limit fixed in
 the invitation under paragraph (a), furnish the required sequence listing
 and pay any required late furnishing fee, the International Searching
 Authority shall only be required to search the international application to
 the extent that a meaningful search can be carried out without the sequence
 listing.
 

 (e) Any sequence listing not contained in the international
 application as filed, whether furnished in response to an invitation under
 paragraph (a) or otherwise, shall not form part of the international
 application, but this paragraph shall not prevent the applicant from
 amending the description in relation to a sequence listing pursuant to
 Article 34(2)(b) . 
 

 
 

 
 13 ter .2 Procedure before the International
 Preliminary Examining Authority 
 

 Rule 13 ter .1 shall apply
 mutatis mutandis to the procedure before the
 International Preliminary Examining Authority.
 

 

 
 13 ter .3 Sequence Listing for Designated
 Office
 

 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.
 

 

 

 
 PCT Administrative Instructions Section 513 

 Sequence Listings 

 
 (a) [Deleted]

 (b) Where the international search report and the written
 opinion of the International Searching Authority are based on a sequence
 listing not forming part of the international application but furnished for
 the purposes of the international search, the international search report
 and the written opinion of the International Searching Authority shall so
 indicate.
 

 (c) Where a meaningful international search cannot be carried
 out and a meaningful written opinion, as to whether the claimed invention
 appears to be novel, to involve an inventive step (to be non-obvious) and to
 be industrially applicable, cannot be established because a sequence listing
 is not available to the International Searching Authority in the required
 form, language and manner that Authority shall so state in the international
 search report or declaration referred to in Article
 17(2)(a) , and in the written opinion.
 

 (d) Where a sequence listing for the purposes of the
 international search is furnished on a physical medium, that Authority shall
 physically label that medium with the words “SEQUENCE LISTING NOT FORMING
 PART OF THE INTERNATIONAL APPLICATION” in accordance with the procedures in
 Annex C.
 

 (e) The International Searching Authority shall:
 
 (i) keep in its files one copy of any sequence listing
 which does not form part of the international application but was
 furnished for the purposes of the international search; and
 

 (ii) transmit one copy thereof to the International
 Bureau together with the copy of the international search report. If
 that listing is furnished on a physical medium in less than the
 number of copies required by the International Searching Authority,
 that Authority shall be responsible for the preparation of the
 additional copy and shall have the right to fix a fee for performing
 that task and to collect such fee from the applicant.
 

 
 

 (f) Each International Searching Authority shall
 notify the International Bureau of the means of transmittal of the sequence
 listing accepted by it in accordance with Annex F. The International Bureau
 shall promptly publish details of the notification in the Gazette.
 

 
 
 I. REQUIREMENTS FOR SEQUENCE LISTINGS UNDER WORLD INTELLECTUAL PROPERTY OFFICE
 STANDARD ST.26 (WIPO STANDARD ST.26) [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.
 

 The sequence listing part of the description must be an
 electronic file in WIPO Standard ST.26 XML format. Where sequences are included in a
 sequence listing, they are not required to also appear in the main part of the
 description. In the description, claims or drawings of the application, the sequences
 included in the sequence listing shall be referred to by the sequence identifier
 preceded by “SEQ ID NO:”, even if the sequence is also embedded in the description,
 claims or drawings.
 

 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 , 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 XML format
 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 .
 

 II. REQUIREMENTS FOR SEQUENCE LISTINGS UNDER WORLD INTELLECTUAL PROPERTY OFFICE
 STANDARD ST.25 (WIPO ST.25) [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 contains disclosure of
 a nucleotide and/or amino acid sequence, the description must contain a listing of the
 sequence complying with the standard specified in Annex
 C of 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 . See MPEP § 1823.02 ,
 subsection II. If the International Searching Authority finds that an international
 application contains nucleotide and/or amino acid sequences in the disclosure, but finds
 that the description does not contain a sequence listing or that the sequence listing
 provided in the international application does not comply with the PCT Administrative
 Instructions Annex C , the International
 Searching Authority may invite the applicant to furnish a listing that complies with the
 standard and pay a late furnishing fee.
 

 An invitation from the International Searching Authority to furnish a
 sequence listing that complies with the standard specified in the Administrative
 Instructions and pay a late furnishing fee will specify a time limit for complying with
 the invitation. Any sequence listing furnished by the applicant in response to the
 invitation must be accompanied by a statement to the effect that the listing does not
 include matter which goes beyond the disclosure in the international application as
 filed and must be submitted to the International Searching Authority. If the applicant
 does not furnish the required sequence listing and pay any required late furnishing fee
 within the time limit specified in the invitation, the search undertaken by the
 International Searching Authority may be limited. See MPEP § 1823.02 ,
 subsection II.
 

 Any sequence listing provided after the international
 filing date and in response to the invitation to furnish a sequence listing by the
 International Searching Authority, is not considered part of the international
 application. If the applicant wishes to include such a listing as part of the
 international application, appropriate amendments to the description may be made later
 under PCT Article
 34 , provided that the applicant files a Demand for international
 preliminary examination and does not go beyond the disclosure in the international
 application as filed.
 

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 1801-Basic Patent Cooperation Treaty (PCT) Principles 

 1802-PCT Definitions 

 1803-Reservations Under the PCT Taken by, and Notifications of Incompatibility Made by, the United States of America 

 1804-[Reserved] 

 1805-Where To File an International Application 

 1806-Applicants and Inventors 

 1807-Agent or Common Representative and General Power of Attorney 

 1808-Change in or Revocation of the Appointment of an Agent or a Common Representative 

 1809-Access to the USPTO patent electronic filing system 

 1810-Filing Date Requirements 

 1811-[Reserved] 

 1812-Elements of the International Application 

 1813 - 1816-[Reserved] 

 1817-PCT Member States 

 1818-[Reserved] 

 1819-Earlier Search 

 1820-Signature of Applicant 

 1821-The Request 

 1822-[Reserved] 

 1823-The Description 
 1823.01-Reference to Deposited Biological Material 

 1823.02-Filing Nucleotide and/or Amino Acid Sequence Listings in International Applications 

 
 

 1824-The Claims 

 1825-The Drawings 

 1826-The Abstract 

 1827-Fees 
 1827.01-Refund of International Application Fees 

 
 

 1828-Priority Claim and Document 
 1828.01-Restoration of the Right of Priority 

 1828.02-Continuation or Continuation-in-Part Indication in the Request 

 
 

 1829-[Reserved] 

 1830-International Application Transmittal Letter 

 1831-[Reserved] 

 1832-License Request for Foreign Filing Under the PCT 

 1833-[Reserved] 

 1834-Correspondence 
 1834.01-Filing of Correspondence by Facsimile 

 1834.02-Irregularities in the Mail or Electronic Communications Service 

 
 

 1835-[Reserved] 

 1836-Rectification of Obvious Mistakes 

 1837 - 1839-[Reserved] 

 1840-The International Searching Authority 
 1840.01-The European Patent Office as an International Searching Authority 

 1840.02-The Korean Intellectual Property Office as an International Searching Authority 

 1840.03-The Australian Patent Office (IP Australia) as an International Searching Authority 

 1840.04-[Reserved] 

 1840.05-The Israel Patent Office (ILPO) as an International Searching Authority 

 1840.06-The Japan Patent Office (JPO) as an International Searching Authority 

 1840.07-The Intellectual Property Office of Singapore (IPOS) as an International Searching Authority 

 
 

 1841-[Reserved] 

 1842-Basic Flow Under the PCT 

 1843-The International Search 
 1843.01-Prior Art for Chapter I Processing 

 1843.02-Certain Subject Matter Need Not Be Searched 

 1843.03-No Search Required if Claims Are Unclear 

 1843.04-Procedure for Claims Not Required To Be Searched and for Claims That Are Unclear 

 1843.05-Time Limit for Establishing the International Search Report and the Written Opinion of the International Searching Authority 

 
 

 1844-The International Search Report 
 1844.01-Preparing the International Search Report (Form PCT/ISA/210) 

 
 

 1845-Written Opinion of the International Searching Authority 
 1845.01-Preparing the Written Opinion of the International Searching Authority (Form PCT/ISA/237) 

 1845.02-Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority,
 or the Declaration (Form PCT/ISA/220) 

 
 

 1846 - 1847-[Reserved] 

 1848-Sequence Listings 

 1849-[Reserved] 

 1850-Unity of Invention Before the International Searching Authority 

 1851-Identification of Patent Documents 

 1852-Taking Into Account Results of Earlier Search(es) 

 1853-Amendment Under PCT Article 19 

 1854 - 1855-[Reserved] 

 1856-Supplementary International Searches 

 1857-International Publication 

 1858-[Reserved] 

 1859-Withdrawal of International Application, Designations, or Priority Claims 

 1860-International Preliminary Examination Procedure 

 1861-[Reserved] 

 1862-Agreement With the International Bureau To Serve as an International Preliminary Examining Authority 

 1863-[Reserved] 

 1864-The Demand and Preparation for Filing of Demand 
 1864.01-Amendments Filed Under PCT Article 34 

 1864.02-Applicant’s Right To File a Demand 

 1864.03-States Which May Be Elected 

 1864.04-Agent’s Right To Act 

 
 

 1865-Filing of Demand 

 1866-[Reserved] 

 1867-Preliminary Examination Fees 

 1868-Correction of Defects in the Demand 

 1869-Notification to International Bureau of Demand 

 1870-Priority Document and Translation Thereof 

 1871-Processing Amendments Filed Under Article 19 and Article 34 Prior to or at the Start of International Preliminary Examination 

 1872-Availability of the International Application File for International Preliminary Examination by the Examining Corps 

 1873-[Reserved] 

 1874-Determination if International Preliminary Examination Is Required and Possible 

 1875-Unity of Invention Before the International Preliminary Examining Authority 
 1875.01-Preparation of Invitation Concerning Unity 

 1875.02-Reply to Invitation Concerning Lack of Unity of Invention 

 
 

 1876-Notation of Errors and Informalities by the Examiner 
 1876.01-Request for Rectification and Notification of Action Thereon 

 
 

 1877-Nucleotide and/or Amino Acid Sequence Listings During the International Preliminary Examination 

 1878-Preparation of the Written Opinion of the International Preliminary Examining Authority 
 1878.01-Includes Subsections Regarding Prior Art, Novelty, Inventive Step, and Industrial Applicability for Purposes of the Written
 Opinion and the International Preliminary Examination Report 
 1878.01(a)-Prior Art for Purposes of the Written Opinion and the International Preliminary Examination Report 
 1878.01(a)(1)-Novelty for Purposes of the Written Opinion and the International Preliminary Examination Report 

 1878.01(a)(2)-Inventive Step for Purposes of the Written Opinion and the International Preliminary Examination Report 

 1878.01(a)(3)-Industrial Applicability for Purposes of the Written Opinion and the International Preliminary Examination Report 

 
 

 
 

 1878.02-Reply to the Written Opinion of the ISA or IPEA 

 
 

 1879-Preparation of the International Preliminary Examination Report 
 1879.01-Time Limit for Preparing Report 

 1879.02-Transmittal of the International Preliminary Examination Report and Related Documents 

 1879.03-Translations 

 1879.04-Confidential Nature of the Report 

 
 

 1880-Withdrawal of Demand or Election 

 1881-Receipt of Notice of Election and Preliminary Examination Report by the United States Patent and Trademark Office 

 1882 - 1892-[Reserved] 

 1893-National Stage (U.S. National Application Filed Under 35 U.S.C. 371) 
 1893.01-Commencement and Entry 
 1893.01(a)-Entry via the U.S. Designated or Elected Office 
 1893.01(a)(1)-Submissions Required by 30 Months from the Priority Date 

 1893.01(a)(2)-Article 19 Amendment (Filed With the International Bureau) 

 1893.01(a)(3)-Article 34 Amendments (Filed with the International Preliminary Examining Authority) 

 1893.01(a)(4)-Claim Amendment (Filed With the U.S. Designated or Elected Office) 

 
 

 1893.01(b)-Applicant for a U.S. National Stage Application 

 1893.01(c)-Fees 

 1893.01(d)-Translation 

 1893.01(e)-Inventor’s Oath or Declaration 

 
 

 1893.02-Abandonment 

 1893.03-Prosecution of U.S. National Stage Applications Before the Examiner 
 1893.03(a)-How To Identify That an Application Is a U.S. National Stage Application 

 1893.03(b)-The Filing Date of a U.S. National Stage Application 

 1893.03(c)-The Priority Date, Priority Claim, and Priority Papers for a U.S. National Stage Application 

 1893.03(d)-Unity of Invention 

 1893.03(e)-Documents Received from the International Bureau and Placed in a U.S. National Stage Application File 
 1893.03(e)(1)-Title of the Invention 

 
 

 1893.03(f)-Drawings and PCT Rule 11 

 1893.03(g)-Information Disclosure Statement in a National Stage Application 

 
 

 
 

 1894-[Reserved] 

 1895-A Continuation, Divisional, or Continuation- in- Part Application of a PCT Application Designating the United States 
 1895.01-Handling of and Considerations in the Handling of Continuations, Divisions, and Continuations-In-Part of PCT Applications 

 
 

 1896-The Differences Between a National Application Filed Under 35 U.S.C. 111(a) and a National Stage Application Submitted Under
 35 U.S.C. 371 

 

 

 
 

 
 
 

 
 

 

 
 
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 03/09/2026 20:50:37