MPEP § 1823 — MPEP § 1823
Current through: 2022-07-01

1823-The Description 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 1800 

 Section 1823 
 

 
 
 
 
 
 1823 The Description [R-01.2024]

 
 PCT Article 5 

 The Description 

 The description shall disclose the invention in a
 manner sufficiently clear and complete for the invention to be carried out by a
 person skilled in the art.
 

 

 
 PCT Rule 5 

 The Description. 

 
 5.1 Manner of the Description

 
 (a) The description shall first state the title of the
 invention as appearing in the request and shall:
 
 (i) specify the technical field to which the
 invention relates;
 

 (ii) indicate the background art which, as far as
 known to the applicant, can be regarded as useful for the
 understanding, searching and examination of the invention, and,
 preferably, cite the documents reflecting such art;
 

 (iii) disclose the invention, as claimed, in such
 terms that the technical problem (even if not expressly stated
 as such) and its solution can be understood, and state the
 advantageous effects, if any, of the invention with reference to
 the background art;
 

 (iv) briefly describe the figures in the drawings, if
 any;
 

 (v) set forth at least the best mode contemplated by
 the applicant for carrying out the invention claimed; this shall
 be done in terms of examples, where appropriate, and with
 reference to the drawings, if any; where the national law of the
 designated State does not require the description of the best
 mode but is satisfied with the description of any mode (whether
 it is the best contemplated or not), failure to describe the
 best mode contemplated shall have no effect in that State;
 

 (vi) indicate explicitly, when it is not obvious from
 the description or nature of the invention, the way in which the
 invention is capable of exploitation in industry and the way in
 which it can be made and used, or, if it can only be used, the
 way in which it can be used; the term “industry” is to be
 understood in its broadest sense as in the Paris Convention for
 the Protection of Industrial Property.
 

 
 

 (b) The manner and order specified in paragraph (a) shall be
 followed except when, because of the nature of the invention, a
 different manner or a different order would result in a better
 understanding and a more economic presentation.
 

 (c) Subject to the provisions of paragraph (b), each of the
 parts referred to in paragraph (a) shall preferably be preceded by an
 appropriate heading as suggested in the Administrative Instructions.
 

 
 

 *****

 

 
 PCT Administrative Instructions Section 204 

 Headings of the Parts of the
 Description 

 
 (a) The headings of the parts of the description should be as
 follows:
 

 
 
 (i) for matter referred to in Rule
 5.1(a)(i) , “Technical Field”; 
 

 (ii) for matter referred to in
 Rule
 5.1(a)(ii) , “Background Art”;
 

 (iii) for matter referred to in
 Rule
 5.1(a)(iii) , “Disclosure of Invention” or
 “Summary of Invention”; 
 

 (iv) for matter referred to in
 Rule
 5.1(a)(iv) , “Brief Description of Drawings”;
 

 (v) for matter referred to in
 Rule 5.1(a)(v) ,
 “Best Mode for Carrying out the Invention,” or, where appropriate,
 “Mode(s) for Carrying out the Invention” or “Description of
 Embodiments;
 

 (vi) for matter referred to in
 Rule
 5.1(a)(vi) , “Industrial Applicability”;
 

 (vii) [Deleted]

 (viii) [Deleted]

 
 

 (b) The heading “Title of Invention” shall
 preferably precede the title of the invention.
 

 
 *****

 

 
 PCT Administrative Instructions Section 209 

 Indications as to Deposited Biological
 Material on a Separate Sheet 

 
 (a) To the extent that any indication with respect to deposited
 biological material is not contained in the description, it may be given on
 a separate sheet. Where any such indication is so given, it shall preferably
 be on Form PCT/RO/134 and, if furnished at the time of filing, the said Form
 shall, subject to paragraph (b), preferably be attached to the request and
 referred to in the check list referred to in Rule
 3.3(a)(ii) . 
 

 (b) For the purposes of designated Offices, which have so
 notified the International Bureau under Rule 13
 bis.7(a) , paragraph (a) applies
 only if the said Form or sheet is included as one of the sheets of the
 description of the international application at the time of filing.
 

 
 

 

 
 37 CFR 1.435 The description. 

 
 (a) The application must meet the requirements as to the
 content and form of the description set forth in PCT Rules
 5 , 9 , 10 ,
 and 11 and sections 204 and
 208 of the Administrative Instructions. 
 

 (b) In international applications designating the United States
 the description must contain upon filing an indication of the best mode
 contemplated by the inventor for carrying out the claimed invention.
 

 
 

 The description must disclose the invention in a manner sufficiently
 clear and complete for it to be carried out by a person skilled in the art. It must
 start with the title of the invention as appearing in Box No. I of the request.
 PCT Rule
 5 contains detailed requirements as to the manner and order of
 the description, which, generally, should be in six parts. Those parts should have the
 following headings: “Technical Field,” “Background Art,” “Disclosure of Invention,”
 “Brief Description of Drawings,” “Best Mode for Carrying Out the Invention” or, where
 appropriate, “Mode(s) for Carrying Out the Invention,” and “Industrial Applicability,”
 where applicable. 
 

 For international applications having an international
 filing date before July 1, 2022, headings for “Sequence Listing” and “Sequence Listing
 Free Text” should also be used where applicable. See Section 204 of the Administrative
 Instructions (in effect before July 1, 2022), which may be found at: www.wipo.int/wipolex/en/text/584509 .
 

 For international applications having an international
 filing date on or after July 1, 2022, the description may include a sequence listing.
 Where applicable, the sequence listing should be included as a separate part of the
 description complying with the standard provided for in the PCT Administrative
 Instructions. 
 

 For more information on filing nucleotide and/or amino
 acid sequence listings, see MPEP § 1823.02 . For information on
 reference to deposited biological material, see MPEP § 1823.01 .
 

 The details required for the disclosure of the invention so that it can
 be carried out by a person skilled in the art depend on the practice of the national
 Offices. It is therefore recommended that due account be taken of national practice in
 the United States of America when the description is drafted. The need to amend the
 description during the national phase may thus be avoided.
 

 This applies likewise to the need to indicate the “best mode for
 carrying out the invention.” If at least one of the designated Offices requires the
 indication of the best mode (for instance, the United States Patent and Trademark
 Office), that best mode must be indicated in the description.
 

 A description drafted with due regard to what is said in these
 provisions will be accepted by all the designated Offices. It might require more care
 than the drafting of a national patent application, but certainly much less effort than
 the drafting of multiple applications, which is necessary where the PCT route is not
 used for filing in several countries.
 

 
 1823.01 Reference to Deposited Biological Material [R-07.2015]

 
 PCT Rule 13bis 

 Inventions Relating to Biological
 Material 

 
 13 bis .1 Definition
 

 For the purposes of this Rule, “reference to deposited
 biological material” means particulars given in an international application
 with respect to the deposit of a biological material with a depositary
 institution or to the biological material so deposited.
 

 

 
 13 bis .2 References (General)
 

 Any reference to deposited biological material shall be made
 in accordance with this Rule and, if so made, shall be considered as
 satisfying the requirements of the national law of each designated
 State.
 

 

 
 13 bis .3 References: Contents; Failure to Include
 Reference or Indication
 

 
 (a) A reference to deposited biological material shall
 indicate:
 
 (i) the name and the address of the depositary
 institution with which the deposit was made;
 

 (ii) the date of deposit of the biological
 material with that institution;
 

 (iii) the accession number given to the deposit by
 that institution; and
 

 (iv) any additional matter of which the
 International Bureau has been notified pursuant to
 Rule 13
 bis .7(a)(i) ,
 provided that the requirement to indicate that matter was
 published in the Gazette in accordance with
 Rule
 13bis.7(c) at
 least two months before the filing of the international
 application. 
 

 (b) Failure to include a reference to deposited
 biological material or failure to include, in a reference to
 deposited biological material, an indication in accordance
 with paragraph (a), shall have no consequence in any
 designated State whose national law does not require such
 reference or such indication in a national application.
 

 
 

 
 

 

 
 13 bis .4 References: Time Limit for Furnishing
 Indications
 

 
 (a) Subject to paragraphs (b) and (c), if any of the
 indications referred to in Rule 13
 bis.3(a) is not included
 in a reference to deposited biological material in the international
 application as filed but is furnished to the International
 Bureau:
 
 (i) within 16 months from the priority date, the
 indication shall be considered by any designated Office to
 have been furnished in time;
 

 (ii) after the expiration of 16 months from the
 priority date, the indication shall be considered by any
 designated Office to have been furnished on the last day of
 that time limit if it reaches the International Bureau
 before the technical preparations for international
 publication have been completed.
 

 
 

 (b) If the national law applicable by a designated
 Office so requires in respect of national applications, that Office
 may require that any of the indications referred to in
 Rule
 13bis.3(a) be furnished
 earlier than 16 months from the priority date, provided that the
 International Bureau has been notified of such requirement pursuant
 to Rule 13bis.7(a)(ii) and
 has published such requirement in the Gazette in accordance with
 Rule
 13bis.7(c) at least two
 months before the filing of the international application. 
 

 (c) Where the applicant makes a request for early
 publication under Article
 21(2)(b) , any designated Office may consider
 any indication not furnished before the technical preparations for
 international publication have been completed as not having been
 furnished in time.
 

 (d) The International Bureau shall notify the applicant
 of the date on which it received any indication furnished under
 paragraph (a), and:
 
 (i) if the indication was received before the
 technical preparations for international publication have
 been completed, publish the indication furnished under
 paragraph (a), and an indication of the date of receipt,
 together with the international application;
 

 (ii) if the indication was received after the
 technical preparations for international publication have
 been completed, notify that date and the relevant data from
 the indication to the designated Offices.
 

 
 

 
 

 

 
 13 bis .5 References and Indications for the Purposes of
 One or More Designated States; Different Deposits for Different
 Designated States; Deposits with Depositary Institutions Other than
 Those Notified
 

 
 (a) A reference to deposited biological material shall
 be considered to be made for the purposes of all designated States,
 unless it is expressly made for the purposes of certain of the
 designated States only; the same applies to the indications included
 in the reference.
 

 (b) References to different deposits of the biological
 material may be made for different designated States.
 

 (c) Any designated Office may disregard a deposit made
 with a depositary institution other than one notified by it under
 Rule
 13bis.7(b) .
 

 
 

 

 
 13 bis .6 Furnishing of Samples
 

 Pursuant to Articles 23 and
 40 , no furnishing of samples of the deposited
 biological material to which a reference is made in an international
 application shall, except with the authorization of the applicant, take
 place before the expiration of the applicable time limits after which
 national processing may start under the said Articles. However, where the
 applicant performs the acts referred to in Articles
 22 or 39 after international
 publication but before the expiration of the said time limits, the
 furnishing of samples of the deposited biological material may take place,
 once the said acts have been performed. Notwithstanding the previous
 provision, the furnishing of samples of the deposited biological material
 may take place under the national law applicable by any designated Office as
 soon as, under that law, the international publication has the effects of
 the compulsory national publication of an unexamined national
 application.
 

 

 
 13 bis .7 National Requirements:
 Notification and Publication
 

 
 (a) Any national Office may notify the
 International Bureau of any requirement of the national law:
 
 (i) that any matter specified in
 the notification, in addition to those referred to in
 Rule
 13bis.3(a)(i) ,
 (ii) 
 and (iii) ,
 is required to be included in a reference to deposited
 biological material in a national application;
 

 (ii) that one or more of the
 indications referred to in Rule
 13bis.3(a) are
 required to be included in a national application as filed
 or are required to be furnished at a time specified in the
 notification which is earlier than 16 months from the
 priority date.
 

 
 

 (b) Each national Office shall notify the
 International Bureau of the depositary institutions with which the
 national law permits deposits of biological materials to be made for
 the purposes of patent procedure before that Office or, if the
 national law does not provide for or permit such deposits, of that
 fact.
 

 (c) The International Bureau shall
 promptly publish in the Gazette requirements notified to it under
 paragraph (a) and information notified to it under paragraph
 (b).
 

 
 

 

 
 PCT Administrative Instructions Section 209 

 Indications as to Deposited Biological
 Material on a Separate Sheet 

 
 (a) To the extent that any indication with respect to
 deposited biological material is not contained in the description, it
 may be given on a separate sheet. Where any such indication is so given,
 it shall preferably be on Form PCT/RO/134 and, if furnished at the time
 of filing, the said Form shall, subject to paragraph (b), preferably be
 attached to the request and referred to in the check list referred to in
 Rule 3.3(a)(ii) .
 

 (b) For the purposes of designated Offices, which have so
 notified the International Bureau under Rule
 13bis.7(a) , paragraph (a)
 applies only if the said Form or sheet is included as one of the sheets
 of the description of the international application at the time of
 filing.
 

 
 
 REFERENCES TO DEPOSITED BIOLOGICAL MATERIAL IN THE CASE OF MICROBIOLOGICAL
 INVENTIONS The PCT does not require the inclusion of a reference to a
 biological material and/or to its deposit with a depositary institution in an
 international application; it merely prescribes the contents of any “reference
 to deposited biological material” (defined as “particulars given... with respect
 to the deposit of biological material... or to the biological material so
 deposited”) which is included in an international application, and when such a
 reference must be furnished. It follows that the applicant may see a need to
 make such a reference only when it is required for the purpose of disclosing the
 invention claimed in the international application in a manner sufficient for
 the invention to be carried out by a person skilled in the art that is, when the
 law of at least one of the designated States provides for the making, for this
 purpose, of a reference to a deposited biological material if the invention
 involves the use of a biological material that is not available to the public.
 Any reference to a deposited biological material furnished separately from the
 description will be included in the publication of the international
 application.
 

 A reference to a deposited biological material made in
 accordance with the requirements of the PCT must be regarded by each of the
 designated Offices as satisfying the requirements of the national law applicable
 in that Office with regard to the contents of such references and the time for
 furnishing them.
 

 A reference may be made for the purposes of all designated
 States or for one or only some of the designated States. A reference is
 considered to be made for the purpose of all designated States unless it is
 expressly made for certain designated States only. References to different
 deposits may be made for the purposes of different designated States.
 

 There are two kinds of indication which may have to be given
 with regard to the deposit of the biological material, namely:
 

 
 (A) indications specified in the PCT Regulations themselves;
 and
 

 (B) additional indications by the national (or regional)
 Office of (or acting for) a State designated in the international
 application and which have been published in the PCT
 Gazette ; these additional indications may relate not only
 to the deposit of the biological material but also to the biological
 material itself. 
 

 
 The indications in the first category are:

 (1) the name and the address of the depositary institution with
 which the deposit was made;
 

 (2) the date of the deposit with that institution; and

 (3) the accession number given to the deposit by that
 institution.
 

 U.S. requirements include the name and address of the depository
 institution at the time of filing, the date of the deposit or a statement that
 the deposit was made on or before the priority date of the international
 application and, to the extent possible, a taxonomic description of the
 biological material. See Annex L of the PCT Applicant’s Guide.
 

 The national laws of some of the national (or regional) Offices
 require that, besides indications concerning the deposit of a biological
 material, an indication be given concerning the biological material itself, such
 as, for example, a short description of its characteristics, at least to the
 extent that this information is available to the applicant. These requirements
 must be met in the case of international applications for which any such Office
 is a designated Office, provided that the requirements have been published in
 the PCT Gazette . Annex L of the PCT Applicant’s Guide
 indicates, for each of the national (or regional) Offices, the requirements (if
 any) of this kind which have been published.
 

 If any indication is not included in a reference to a deposited
 biological material contained in the international application as filed, it may
 be furnished to the International Bureau within 16 months after the priority
 date unless the International Bureau has been notified (and, at least 2 months
 prior to the filing of the international application, it has published in the
 PCT Gazette ) that the national law requires the
 indication to be furnished earlier. However, if the applicant makes a request
 for early publication, all indications should be furnished by the time the
 request is made, since any designated Office may regard any indication not
 furnished when the request is made as not having been furnished in time. 
 

 No check is made in the international phase to determine
 whether a reference has been furnished within the prescribed time limit.
 However, the International Bureau notifies the designated Offices of the date(s)
 on which indications, not included in the international application as filed,
 were furnished to it. Those dates are also mentioned in the publication of the
 international application. Failure to include a reference to a deposited
 biological material (or any indication required in such a reference) in the
 international application as filed, or failure to furnish it (or the indication)
 within the prescribed time limit, has no consequence if the national law does
 not require the reference (or indication) to be furnished in a national
 application. Where there is a consequence, it is the same as that which applies
 under the national law. 
 

 To the extent that indications relating to the deposit of a
 biological material are not given in the description, because they are furnished
 later, they may be given in the “optional sheet” provided for that purpose. If
 the sheet is submitted when the international application is filed, a reference
 to it should be made in the check list contained on the last sheet of the
 Request form. Should certain States be designated, e.g., Israel, Japan, Korea,
 Mexico, or Turkey , such a sheet must, if used, be included as one of the sheets
 of the description at the time of filing; otherwise the indications given in it
 will not be taken into account by the respective patent offices of those
 designated States in the national phase. Requirements of the various Offices are
 set forth in Annex L of the PCT Applicant’s Guide, available online at
 www.wipo.int/pct/en/appguide . If the sheet is furnished to
 the International Bureau later, it must be enclosed with a letter.
 

 Each national (or regional) Office whose national law provides
 for deposits of biological material for the purposes of patent procedure
 notifies the International Bureau of the depositary institutions with which the
 national law permits such deposits to be made. Information on the institutions
 notified by each of those Offices is published by the International Bureau in
 the PCT Gazette . 
 

 A reference to a deposit cannot be disregarded by a designated
 Office for reasons pertaining to the institution with which the biological
 material was deposited if the deposit referred to is one made with a depositary
 institution notified by that Office. Thus, by consulting the PCT
 Gazette or Annex L of the PCT Applicant’s Guide, the applicant can
 be sure that he has deposited the biological material with an institution which
 will be accepted by the designated Office. 
 

 International Searching Authorities and International
 Preliminary Examining Authorities are not expected to request access to
 deposited biological material. However, in order to retain the possibility of
 access to a deposited biological material referred to in an international
 application which is being searched or examined by such an Authority, the PCT
 provides that the Authorities may, if they fulfill certain conditions, ask for
 samples. Thus, an Authority may only ask for samples if it has notified the
 International Bureau (in a general notification) that it may require samples and
 the International Bureau has published the notification in the PCT
 Gazette . The only Authority which has made such a notification
 (and thus the only Authority which may request samples) is the Japan Patent
 Office. If a sample is asked for, the request is directed to the applicant, who
 then becomes responsible for making the necessary arrangements for the sample to
 be provided.
 

 The furnishing of samples of a deposit of a biological material
 to third persons is governed by the national laws applicable in the designated
 Offices. PCT
 Rule 13bis.6(b) , however, provides for
 the delaying of any furnishing of samples under the national law applicable in
 each of the designated (or elected) Offices until the start of the national
 phase, subject to the ending of this “delaying effect” brought about by the
 occurrence of either of the following two events:
 

 
 (A) the applicant has, after international publication of
 the international application, taken the steps necessary to enter the
 national phase before the designated Office.
 

 (B) international publication of the international
 application has been effected, and that publication has the same
 effects, under the national law applicable in the designated Office, as
 the compulsory national publication of an unexamined national
 application (in other words, the international application has qualified
 for the grant of “provisional protection”).
 

 
 

 
 1823.02 Filing Nucleotide and/or Amino Acid Sequence Listings in
 International Applications [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 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 .]
 

 
 PCT Rule 5 

 The Description 

 *****

 
 5.2 Nucleotide and/or Amino Acid Sequence
 Disclosure
 

 
 (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 description shall include a sequence listing
 part of the description complying with the standard provided for in
 the Administrative Instructions.
 

 (b) Language-dependent free text included in the
 sequence listing part of the description shall not be required to be
 included in the main body of the description.
 

 
 

 

 
 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
 13ter.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 208 

 Sequence Listings 

 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.
 

 
 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.
 

 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 .
 

 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 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.
 

 

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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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