1823    The Description [R-07.2015]

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.

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PCT Administrative Instructions Section 204

Headings of the Parts of the Description

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) for matter referred to in Rule 5.2(a), "Sequence Listing";
  • (viii) for matter referred to in Rule 5.2(b), "Sequence Listing Free Text."

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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 C.F.R. 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," "Industrial Applicability," "Sequence Listing," and "Sequence Listing Free Text," where applicable.

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

13bis.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 after 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    Nucleotide and/or Amino Acid Sequence Listings, and Tables Related to Sequence Listings [R-07.2015]

PCT Rule 5

The Description

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5.2 Nucleotide and/or Amino Acid Sequence Disclosure

  • (a) Where the international application contains disclosure of one or more nucleotide and/or amino acid sequences, the description shall contain a sequence listing complying with the standard prescribed by the Administrative Instructions and presented as a separate part of the description in accordance with that standard.
  • (b) Where the sequence listing part of the description contains any free text as defined in the standard provided for in the Administrative Instructions, that free text shall also appear in the main part of the description in the language thereof.

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 one or more nucleotide and/or amino acid sequences, the International Searching Authority may invite the applicant to furnish to it, for the purposes of the international search, a sequence listing in electronic form complying with the standard provided for in the Administrative Instructions, unless such listing in electronic form is already available to it in a form 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) Where at least part of the international application is filed on paper and the International Searching Authority finds that the description does not comply with Rule 5.2(a), it may invite the applicant to furnish, for the purposes of the international search, a sequence listing in paper form complying with the standard provided for in the Administrative Instructions, unless such listing in paper form is already available to it in a form and manner acceptable to it, whether or not the furnishing of a sequence listing in electronic form is invited under paragraph (a), and to pay, where applicable, the late furnishing fee referred to in paragraph (c), within a time limit fixed in the invitation.
  • (c) The furnishing of a sequence listing in response to an invitation under paragraph (a) or (b) 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, provided that a late furnishing fee may be required under either paragraph (a) or (b) but not both.
  • (d) If the applicant does not, within the time limit fixed in the invitation under paragraph (a) or (b), 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 (b) 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).
  • (f) Where the International Searching Authority finds that the description does not comply with Rule 5.2(b), it shall invite the applicant to submit the required correction. Rule 26.4  shall apply mutatis mutandis to any correction offered by the applicant. The International Searching Authority shall transmit the correction to the receiving Office and to the International Bureau.

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.

13ter.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 on paper or in electronic form, whether forming part of the international application or not forming part of the international application, shall comply with Annex C.

I.    REQUIREMENTS FOR SEQUENCE LISTINGS

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. 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. The International Searching Authority and the International Preliminary Examining Authority may, in some cases, invite the applicant to furnish a listing complying with that standard. The applicant may also be invited to furnish a listing in an electronic form (text) provided for in the PCT Administrative Instructions. 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 EFS-Web 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 EFS-Web filed international application (PCT) 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.

II.    TABLES RELATED TO SEQUENCE LISTINGS

Tables related to a sequence listing must be an integral part of the description of the international application (PCT), and must not be included in the sequence listing part or the drawing part. Such tables will be taken into account when calculating the application sheet count, and excess sheet fees may be required. When applicant submits tables related to a sequence listing in an international application (PCT) via EFS-Web, the tables must be in a PDF file. If applicant submits tables related to a sequence listing in a text file, such tables will not be accepted as part of the international application (PCT). For more information, see Sequence Listings and Tables Related Thereto in International Applications Filed in the United States Receiving Office, 1344 OG 50 (July 7, 2009). If applicant submits tables related to a sequence listing in a text file, such tables will not be accepted as part of the international application (PCT).