Appendix AI Administrative Instructions Under the PCT

(as in force from July 1, 2019) TABLE OF CONTENTS 1

PART 1 INSTRUCTIONS RELATING Section 204 Headings of the Parts of the TO GENERAL MATTERS Description Section 204 bis Numbering of Claims Section 101 Abbreviated Expressions and Section 205 Numbering and Identi®cation of Interpretation Claims upon Amendment Section 102 Use of the Forms Section 206 Unity of Invention Section 102 bis [Deleted] Section 207 Arrangement of Elements and Section 103 Languages of the Forms Used Numbering of Sheets of the by International Authorities International Application Section 104 Language of Correspondence Section 208 Sequence Listings Section 105 Identi®cation of International Section 209 Indications as to Deposited Application with Two or More Biological Material on a Applicants Separate Sheet Section 106 Change of Common Section 210 [Deleted] Representative Section 211 Declaration as to the Identity of Section 107 Identi®cation of International the Inventor Authorities and of Designated Section 212 Declaration as to the Applicant's and Elected Of®ces Entitlement to Apply for and Be Section 108 Correspondence Intended for the Granted a Patent Applicant Section 213 Declaration as to the Applicant's Section 109 File Reference Entitlement to Claim Priority of Section 110 Dates Earlier Application Section 111 Procedure and Considerations Section 214 Declaration of Inventorship in the Case of Excuse of the Section 215 Declaration as to Delay in Meeting Certain Time Non-Prejudicial Disclosures or Limits under Rule 82 quater Exceptions to Lack of Novelty Section 112 Ceasing of Effect under Articles Section 216 Notice of Correction or Addition 24(1)(iii) and 39(2), Review of a Declaration under Rule under Article 25(2) and 26ter Maintaining of Effect under Section 217 Corrections Concerning Articles 24(2) and 39(3) Expressions, Etc., Not to Be Section 113 Special Fees Payable to the Used in the International International Bureau Application under Rule 9.2 Section 114 [Deleted] Section 218 Processing of a Request for Section 115 Indications of States, Territories Omission of Information and Intergovernmental Referred to in Rules 48.2(l) and Organizations 94.1(e) PART 2 INSTRUCTIONS RELATING PART 3 INSTRUCTIONS RELATING TO THE INTERNATIONAL TO THE RECEIVING APPLICATION OFFICE Section 201 Language of the International Section 301 Noti®cation of Receipt of Application Purported International Section 202 [Deleted] Application Section 203 Different Applicants for Section 302 Priority Claim Considered Not Different Designated States to Have Been Made

1 Table of Contents and Editor©s Notes are added for the convenience of the reader; they do not form part of the Administrative

Instructions. AI-1 June 2020 MANUAL OF PATENT EXAMINING PROCEDURE

Section 303 Deletion of Additional Matter Section 313 Documents Filed with the in the Request International Application; Section 304 Invitation to Pay Fees before Manner of Marking the Date on Which They Are Due Necessary Annotations in the Section 305 Identifying the Copies of the Check List International Application Section 314 Correction or Addition of a Section 305 bis Preparation, Identi®cation and Priority Claim Under Rule Transmittal of the Copies of the 26 bis Translation of the International Section 315 Processing of Documents by the Application Receiving Of®ce under Rule Section 305 ter Identi®cation and Transmittal 26 bis.3(h- bis) of the Translation of an Earlier Section 316 Procedure in the Case Where the Application Furnished under International Application Lacks Rule 20.6(a)(iii) the Prescribed Signature Section 306 Delayed Transmittal of Search Section 317 Transmittal of a Notice of Copy Correction or Addition of a Section 307 System of Numbering Declaration under Rule 26ter.1 International Applications Section 318 Cancellation of Designations of Section 308 Marking of the Sheets of the Non-Contracting States International Application and of Section 319 Procedure under Rule 4.9(b) the Translation Thereof Section 320 Invitation to Pay Fees under Section 308 bis Marking of Later Submitted Rule 16 bis.1(a) Sheets Section 321 Application of Moneys Section 309 Procedure in the Case of Later Received by the Receiving Submitted Sheets Furnished for Of®ce in Certain Cases the Purposes of Incorporation Section 322 Invitation to Submit a Request by Reference for Refund of the Search Fee Section 310 Procedure in the Case of Later Section 323 Transmittal of Priority Submitted Sheets Not Furnished Documents to International for the Purposes of Bureau Incorporation by Reference Section 324 Copy of Noti®cation of the Section 310 bis Procedure in the Case of Later International Application Submitted Sheets Resulting in Number and the International the Correction of the Filing Date under Rule 20.2(c) International Filing Date under Section 325 Corrections of Defects under Rule 20.5(c) Rule 26.4 and Recti®cations of Section 310 ter Procedure in the Case of Later Obvious Mistakes under Rule Submitted Sheets Furnished 91 after the Expiration of the Section 326 Withdrawal by Applicant under Applicable Time Limit Referred Rule 90 bis.1, 90 bis.2 or to in Rule 20.7 90 bis.3 Section 311 Renumbering in the Case of Section 327 Ex Of®cio Correction of Deletion, Substitution or Request by the Receiving Of®ce Addition of Sheets of the Section 328 Noti®cations Concerning International Application and of Representation the Translation Thereof Section 329 Correction of Indications Section 312 Noti®cation of Decision Not to Concerning the Applicant's Issue Declaration that the Residence or Nationality International Application Is Section 330 Transmittal of Record Copy Considered Withdrawn Prevented or Delayed by National Security Prescriptions

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Section 331 Receipt of Con®rmation Copy Section 411 bis Receipt of Translation of Earlier Section 332 Noti®cation of Languages Application under Rule Accepted by the Receiving 20.6(a)(iii) Of®ce under Rules 12.1(a) and Section 412 Noti®cation of Lack of (c) and 12.4(a) Transmittal of Search Copy Section 333 Transmittal of International Section 413 Incorporations by Reference Application to the International under Rule 20, Corrections of Bureau as Receiving Of®ce Defects under Rule 26.4 and Section 334 Noti®cation to Applicant of Recti®cations of Obvious Submission of Demand after the Mistakes under Rule 91 Expiration of 19 Months from Section 413 bis Recti®cations of Obvious the Priority Date Mistakes under Rule 91 Section 335 [Deleted] Section 414 Noti®cation to the International Section 336 Waivers under Rules 90.4(d) Preliminary Examining and 90.5(c) Authority Where the Section 337 [Deleted] International Application is PART 4 INSTRUCTIONS RELATING Considered Withdrawn TO THE INTERNATIONAL Section 415 Noti®cation of Withdrawal BUREAU under Rule 90 bis.1, 90 bis.2, 90 bis.3, 90 bis.3 bis or 90 bis.4 Section 401 Marking of the Sheets of the Section 416 Correction of Request in Record Record Copy Copy Section 402 Correction or Addition of a Section 417 Processing of Amendments Priority Claim under Rule 26 bis under Article 19 Section 403 Transmittal of Protest against Section 418 Noti®cations to Elected Of®ces Payment of Additional Fees and Where the Demand Is Decision Thereon Where Considered Not to Have Been International Application Is Submitted or Made Considered to Lack Unity of Section 419 Processing of a Declaration Invention under Rule 26 ter Section 404 International Publication Section 420 Copy of International Number of International Application, International Application Search Report and Section 405 Publication of Noti®cations of Supplementary International Languages Accepted by the Search Report for the Receiving Of®ce under Rules International Preliminary 12.1(a) and (c) and 12.4(a) Examining Authority Section 406 Publication of International Section 421 Invitation to Furnish a Copy of Applications the Priority Document Section 406 bis Suggested English Translation Section 422 Noti®cations Concerning of the Title of the Invention Changes Recorded under Rule Section 407 The Gazette 92 bis.1 Section 408 Priority Application Number Section 422 bis Objections Concerning Changes Section 409 Priority Claim Considered Not in the Person of the Applicant to Have Been Made Recorded under Rule 92 bis.1(a) Section 410 Numbering of Sheets for the Section 423 Cancellation of Designations Purposes of International and Elections Publication; Procedure in Case Section 424 Procedure under Rule 4.9(b) of Missing Sheets Section 425 Noti®cations Concerning Section 411 Receipt of Priority Document Representation Section 426-429 [Deleted]

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Section 430 Noti®cation of Designations Searching Authority on the under Rule 32 Basis of a Translation of the Section 431 Publication of Notice of International Application Submission of Demand Section 510 Refund of Search Fee in Case of Section 432 Noti®cation to Applicant of Withdrawal of International Submission of Demand after the Application Expiration of 19 Months from Section 511 Recti®cations of Obvious the Priority Date Mistakes under Rule 91 Section 433 Waivers under Rule 90.4(d) Section 512 Noti®cations Concerning Section 434 Publication of Information Representation Concerning Waivers under Section 513 Sequence Listings Rules 90.4(d) and 90.5(c) Section 514 Authorized Of®cer Section 435 Communication of Publications Section 515 Modi®cation of Abstract in and Documents Response to Applicant's Section 436 Preparation, Identi®cation and Comments Transmittal of the Copies of the Section 516 Noti®cation to Applicant of Translation of the International Submission of Demand after the Application Expiration of 19 Months from PART 5 INSTRUCTIONS RELATING the Priority Date TO THE INTERNATIONAL Section 517 Waivers under Rules 90.4(d) SEARCHING AUTHORITY and 90.5(c) Section 518 Guidelines for Explanations Section 501 [Deleted] Contained in the Written Section 502 Transmittal of Protest against Opinion of the International Payment of Additional Fees and Searching Authority Decision Thereon Where Section 519 Noti®cation of Receipt of Copy International Application Is of International Application for Considered to Lack Unity of the Purposes of Supplementary Invention International Search Section 503 Method of Identifying Section 520 Withdrawal by Applicant under Documents Cited in the Rule 90 bis.3 bis International Search Report and the Written Opinion of the PART 6 INSTRUCTIONS RELATING International Searching TO THE INTERNATIONAL Authority PRELIMINARY Section 504 Classi®cation of the Subject EXAMINING AUTHORITY Matter of the International Section 601 Noti®cation to Applicant of Application Submission of Demand after the Section 505 Indication of Citations of Expiration of 19 Months from Particular Relevance in the the Priority Date International Search Report Section 602 Processing of Amendments by Section 506 [Deleted] the International Preliminary Section 507 Manner of Indicating Certain Examining Authority Special Categories of Section 603 Transmittal of Protest against Documents Cited in the Payment of Additional Fees and International Search Report Decision Thereon Where Section 508 Manner of Indicating the Claims International Application Is to Which the Documents Cited Considered to Lack Unity of in the International Search Invention Report Are Relevant Section 604 Guidelines for Explanations Section 509 International Search and Written Contained in the International Opinion of the International Preliminary Examination Report

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Section 605 File to Be Used for International Filed on Paper; Home Copy, Preliminary Examination Record Copy and Search Copy Section 606 Cancellation of Elections Section 706 Documents in Pre-Conversion Section 607 Recti®cations of Obvious Format Mistakes under Rule 91 Section 707 Calculation of International Section 608 Noti®cations Concerning Filing Fee and Fee Reduction Representation Section 708 Special Provisions Concerning Section 609 Withdrawal by Applicant under Legibility, Completeness, Rules 90 bis. 1, 90 bis. 2 or Infection by Viruses, Etc. 90 bis. 3 Section 709 Means of Communication with Section 610 Sequence Listings the Receiving Of®ce Section 611 Method of Identi®cation of Section 710 Noti®cation and Publication of Documents in the International Receiving Of®ces' Preliminary Examination Report Requirements and Practices Section 612 Authorized Of®cer Section 711 Electronic Records Management Section 613 Invitation to Submit a Request Section 712 Access to Electronic Records for Refund of Fees under Rule Section 713 Application of Provisions to 57.4 or 58.3 International Authorities and the Section 614 Evidence of Right to File International Bureau, and to Demand Noti®cations, Communications, Section 615 Invitation to Pay Fees before Correspondence and Other Date on Which They Are Due Documents Section 616 International Preliminary Section 714 Furnishing by the International Examination on the Basis of a Bureau of Copies of Documents Translation of the International Kept in Electronic Form; Application Designated Of®ces' Signature Section 617 Waivers under Rules 90.4(d) Requirements and 90.5(c) Section 715 Availability of Priority PART 7 INSTRUCTIONS RELATING Documents from Digital TO THE FILING AND Libraries PROCESSING IN Section 716 Request that Priority Document ELECTRONIC FORM OF Be Obtained from a Digital INTERNATIONAL Library under Rule 17.1(b- bis) APPLICATIONS PART 8 INSTRUCTIONS RELATING Section 701 Abbreviated Expressions TO OBSERVATIONS BY Section 702 Filing, Processing and THIRD PARTIES Communication in Electronic Section 801 Third Party Observation System Form of International Section 802 Filing of a Third Party Applications Observation Section 703 Filing Requirements; Basic Section 803 Availability of an Observation Common Standard and Related Information Section 704 Receipt; International Filing Section 804 Noti®cation of Receipt of an Date; Signature; Physical Observation to the Applicant Requirements and Comments by the Applicant Section 705 Home Copy, Record Copy and in Response to an Observation Search Copy Where Section 805 Communication of Observations International Application Is and Comments to International Filed in Electronic Form Authorities and Designated Section 705 bis Processing in Electronic Form Of®ces of International Applications Annex A FORMS Annex B UNITY OF INVENTION

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Annex C STANDARD FOR THE INCLUDED IN THE GAZETTE PRESENTATION OF UNDER RULE 86.1(i) NUCLEOTIDE AND AMINO Annex E INFORMATION TO BE ACID SEQUENCE LISTINGS PUBLISHED IN THE GAZETTE IN INTERNATIONAL PATENT UNDER RULE 86.1(v) APPLICATIONS UNDER THE Annex F STANDARD FOR THE PCT ELECTRONIC FILING AND Annex D INFORMATION FROM FRONT PROCESSING OF PAGE OF PUBLISHED INTERNATIONAL INTERNATIONAL APPLICATIONS APPLICATION TO BE AI Administrative Instructions Under the PCT

PART 1

INSTRUCTIONS RELATING TO GENERAL MATTERS

101 Abbreviated Expressions and (x) ªDirector Generalº means the Director Interpretation General as de®ned in Article 2(xx) of the Treaty; (xi) ªelectronicº technology includes that (a) In these Administrative Instructions: having electrical, digital, magnetic, optical or (i) ªTreatyº means the Patent Cooperation electromagnetic capabilities; Treaty; (xii) the expressions ªsequence listingº, (ii) ªRegulationsº means the Regulations ªsequence listing forming part of the international under the Treaty; applicationº and ªsequence listing not forming part (iii) ªArticleº means an Article of the Treaty; of the international applicationº have the same meaning as in Annex C. (iv) ªRuleº means a Rule of the Regulations; (b) The Annexes are part of these Administrative (v) ªInternational Bureauº means the Instructions. International Bureau as de®ned in Article 2(xix) of the Treaty; 102 Use of the Forms (vi) ªInternational Authoritiesº means the (a) Subject to paragraphs (b) to (k) and Section receiving Of®ces, the International Searching 103, the International Authorities shall use, or require Authorities, the International Preliminary Examining the use of, the mandatory Forms speci®ed below: Authorities, and the International Bureau; (i) Forms for use by the applicant: (vii) ªAnnexº means an Annex to these Administrative Instructions, unless the contrary clearly follows from the wording or the nature of PCT/RO/101 PCT/IPEA/401 the provision, or the context in which the word is (request Form) (demand Form) used; (ii) Forms for use by the receiving Of®ces: (viii) ªFormº means a Form contained in Annex A; 1 PCT/RO/103 PCT/RO/115 PCT/RO/152 (ix) ªWIPO Standardº means a Standard PCT/RO/104 PCT/RO/117 PCT/RO/153 established by the World Intellectual Property Organization; PCT/RO/105 PCT/RO/118 PCT/RO/154

1 Editor©s Note: Annex A is published separately by the World Intellectual Property Organization.

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PCT/RO/106 PCT/RO/123 PCT/RO/155 PCT/IB/321 PCT/IB/354 PCT/RO/107 PCT/RO/126 PCT/RO/156 PCT/IB/323 PCT/IB/356 PCT/RO/109 PCT/RO/133 PCT/RO/157 (v) Forms for use by the International PCT/RO/110 PCT/RO/136 PCT/RO/158 Preliminary Examining Authorities: PCT/RO/111 PCT/RO/143 PCT/RO/159 PCT/RO/112 PCT/RO/147 PCT/IPEA/402 PCT/IPEA/414 PCT/IPEA/440 PCT/RO/113 PCT/RO/150 PCT/IPEA/404 PCT/IPEA/415 PCT/IPEA/441 PCT/RO/114 PCT/RO/151 PCT/IPEA/405 PCT/IPEA/416 PCT/IPEA/442 (iii) Forms for use by the International PCT/IPEA/407 PCT/IPEA/420 PCT/IPEA/443 Searching Authorities: PCT/IPEA/408 PCT/IPEA/425 PCT/IPEA/444 PCT/IPEA/409 PCT/IPEA/431 PCT/ISA/201 PCT/ISA/212 PCT/ISA/234 PCT/IPEA/412 PCT/IPEA/436 PCT/ISA/202 PCT/ISA/217 PCT/ISA/235 (b) Slight variations in layout necessary in view PCT/ISA/203 PCT/ISA/218 PCT/ISA/236 of the printing of the Forms referred to in paragraph PCT/ISA/205 PCT/ISA/219 PCT/ISA/237 (a) in various languages are permitted. PCT/ISA/206 PCT/ISA/220 (c) Slight variations in layout in the Forms PCT/ISA/209 PCT/ISA/225 referred to in paragraph (a)(ii) to (v) are permitted PCT/ISA/210 PCT/ISA/233 to the extent necessary to meet the particular of®ce requirements of the International Authorities, in particular in view of the production of the Forms by PCT/SISA/501 PCT/SISA/504 PCT/SISA/507 computer or of the use of window envelopes. PCT/SISA/502 PCT/SISA/505 PCT/SISA/510 (d) Where the receiving Of®ce, the International PCT/SISA/503 PCT/SISA/506 Searching Authority and/or the International (iv) Forms for use by the International Preliminary Examining Authority are each part of Bureau: the same Of®ce, the obligation to use the Forms referred to in paragraph (a) does not extend to communications within that same Of®ce. PCT/IB/301 PCT/IB/325 PCT/IB/357 (e) The annexes to Forms PCT/RO/106, PCT/IB/304 PCT/IB/326 PCT/IB/358 PCT/RO/118, PCT/ISA/201, PCT/ISA/205, PCT/IB/305 PCT/IB/331 PCT/IB/360 PCT/ISA/206, PCT/ISA/210, PCT/ISA/219, PCT/IB/306 PCT/IB/332 PCT/IB/366 PCT/IB/313, PCT/IB/336, PCT/IPEA/404, PCT/IB/307 PCT/IB/335 PCT/IB/367 PCT/IPEA/405 and PCT/IPEA/415 may be omitted PCT/IB/308 PCT/IB/336 PCT/IB/368 in cases where they are not used. PCT/IB/310 PCT/IB/337 PCT/IB/369 (f) The notes attached to Forms PCT/RO/101 PCT/IB/311 PCT/IB/338 PCT/IB/370 (request Form), PCT/IB/375 (supplementary search PCT/IB/313 PCT/IB/339 PCT/IB/371 request Form) and PCT/IPEA/401 (demand Form) shall be distributed by the International Authorities PCT/IB/314 PCT/IB/344 PCT/IB/373 concerned together with the printed versions of those PCT/IB/315 PCT/IB/345 PCT/IB/374 Forms. The notes attached to Form PCT/ISA/220 PCT/IB/316 PCT/IB/346 PCT/IB/376 shall accompany the Form when sent to the PCT/IB/317 PCT/IB/349 PCT/IB/377 applicant. PCT/IB/318 PCT/IB/350 PCT/IB/378 (g) The use of Forms other than those referred PCT/IB/319 PCT/IB/351 PCT/IB/379 to in paragraph (a) is optional. PCT/IB/320 PCT/IB/353 PCT/IB/399

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(h) Where the request or the demand is presented 102 bis [Deleted] as a computer print-out, such print-out shall be prepared as follows: 103 Languages of the Forms Used by (i) the layout and contents of the request and International Authorities the demand when presented as computer print-outs shall correspond to the format of Forms PCT/RO/101 (a) The language of the Forms used by any (request Form) and PCT/IPEA/401 (demand Form) receiving Of®ce shall be the same as the language (ªthe printed Formsº), with the same information in which the international application is ®led, being presented on the corresponding pages; provided that: (ii) all boxes shall be drawn by solid lines; (i) where the international application is to double lines may be presented as single lines; be published in the language of a translation required (iii) the box numbers and box titles shall be under Rule 12.3(a) or 12.4(a), the receiving Of®ce included even where no information is supplied shall use the Forms in such language; therein; (ii) the receiving Of®ce may, in its (iv) the boxes for use by the International communications to the applicant, use the Forms in Authorities shall be at least as large as those on the any other language being one of its of®cial printed Forms; languages. (v) all other boxes shall be within one cm in (b) Subject to Section 104(b), the language or size of those on the printed Forms; languages of the Forms to be used by any International Searching Authority shall be speci®ed (vi) all text shall be 9 points or larger in size; in the applicable agreement referred to in Article (vii) titles and other information shall be 16(3)(b). clearly distinguished; (c) Subject to Section 104(b), the language or (viii) explanatory notes presented in italics languages of the Forms to be used by any on the printed Forms may be omitted. International Preliminary Examining Authority shall be speci®ed in the applicable agreement referred to (i) Other formats permitted for the presentation in Article 32(3). of the request and the demand as computer print-outs may be determined by the Director General. Any (d) The language of any Form used by the such format shall be published in the Gazette. International Bureau shall be English where the language of the international application is English, (j) The page-based layout of a Form generated and it shall be French where the language of the from a character-coded format shall be permitted if international application is French. Where the it is generated using a stylesheet provided by the language of the international application is neither International Bureau. English nor French, the language of any Form used (k) A Form may be transmitted by one Of®ce, by the International Bureau in its communications International Authority or the International Bureau to any other International Authority shall be English to another in character-coded format only, without or French according to the wishes of such Authority, its page based layout, if the recipient Of®ce, and in its communications to the applicant it shall Authority or Bureau has agreed to receive the be English or French according to the wishes of the information in such format and has agreed to applicant. generate any page based layout which may be required for the recipient Of®ce's ®le records. 104 Language of Correspondence

(a) The language of any letter from the applicant to the receiving Of®ce shall be the same as the language of the international application to which such letter relates, provided that, where the international application is to be published in the language of a translation required under Rule 12.3(a)

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or 12.4(a), any letter shall be in such language. 107 Identi®cation of International However, the receiving Of®ce may expressly Authorities and of Designated and Elected authorize the use of any other language. Of®ces (b) The language of any letter from an Of®ce or Authority to the International Bureau shall be (a) Whenever the nature of any communication English where the language of the international from or to the applicant, from or to any International application is English, and it shall be French where Authority or, before national processing or the language of the international application is examination has started, from or to any designated French. Where the language of the international or elected Of®ce so permits, any International application is neither English nor French, the Authority or any designated or elected Of®ce may language of any letter to the International Bureau be indicated in the communication by the two-letter shall be English or French, provided that any copy, code referred to in Section 115. sent to the International Bureau as a noti®cation (b) The indication of a receiving Of®ce, an addressed to it, of a Form sent to the applicant by International Searching Authority, an International the receiving Of®ce, the International Searching Preliminary Examining Authority or a designated Authority or the International Preliminary Examining or elected Of®ce shall be preceded by the letters Authority, does not require translation into English ªRO,º ªISA,º ªIPEA,º ªDO,º or ªEO,º respectively, or French. followed by a slant (e.g., ªRO/JP,º ªISA/US,º (c) Any communication from the applicant to ªIPEA/SE,º ªDO/EP,º ªEO/AUº). the International Bureau using ePCT shall be in English, French or the language of publication. The 108 Correspondence Intended for the Director General may determine that Applicant communications in such languages may also be submitted through other means of communication, (a) For the purpose of this Section, where there and may additionally expand the languages are two or more agents whose appointments are in permitted. Any such decisions by the Director force, ª®rst mentioned agentº means the agent ®rst General shall be published in the Gazette. mentioned in the document containing the appointments or, where the appointments are 105 Identi®cation of International contained in two or more documents, in that which Application with Two or More Applicants was ®led ®rst. (b) Where a sole applicant has appointed an Where any international application indicates two agent or agents under Rule 90.1(a), correspondence or more applicants, it shall be suf®cient, for the intended for the applicant from the International purpose of identifying that application, to indicate, Authorities shall, subject to paragraph (d), be in any Form or correspondence relating to such addressed to the agent or, where applicable, to the application, the name of the applicant ®rst named ®rst mentioned agent. in the request. The provisions of the ®rst sentence (c) Where there are two or more applicants, of this Section do not apply to the demand. correspondence intended for the applicants from the International Authorities shall, subject to paragraph 106 Change of Common Representative (d), be addressed:

Where a change is recorded under Rule 92 bis.1(a) (i) if no common agent has been appointed in the person of an applicant who was considered to under Rule 90.1 Ðto the common representative or, be the common representative under Rule 90.2(b), where applicable, to his agent or ®rst mentioned the new applicant shall be considered to be the agent; or common representative under Rule 90.2(b) if he is (ii) if the applicants have appointed a entitled according to Rule 19.1 to ®le an international common agent or common agents under Rule application with the receiving Of®ce. 90.1(a)Ðto that common agent or, where applicable, to the ®rst mentioned common agent.

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(d) Where an agent has or agents have been by the name of the month, and by the Arabic number appointed under Rule 90.1(b), (c) or (d)(ii), of the year. The receiving Of®ce, where the applicant paragraphs (b) and (c) shall apply to correspondence has not done so, or the International Bureau, where intended for the applicant relating to the procedure the applicant has not done so and the receiving before the International Searching Authority or the Of®ce fails to do so, shall, after, above, or below International Preliminary Examining Authority, as any date indicated by the applicant in the request, the case may be, as if those paragraphs referred to repeat the date, in parentheses, by indicating it by the agent or agents so appointed. two-digit Arabic numerals each for the number of (e) Where, in accordance with paragraph (c), the day and for the number of the month followed correspondence intended for the applicants from the by the number of the year in four digits, in that order International Authorities is to be addressed to the and with a period, slant or hyphen after the digit common representative but the indication required pairs of the day and of the month (for example, ª20 under Rule 4.5(a)(ii) has not been provided for the March 2004 (20.03.2004),º ª20 March 2004 common representative, correspondence shall be (20/03/2004),º or ª20 March 2004 (20-03-2004)º). addressed: 111 Procedure and Considerations in the (i) to the ®rst applicant named in the request who is entitled according to Rule 19.1 to ®le an Case of Excuse of the Delay in Meeting international application with the receiving Of®ce Certain Time Limits under Rule 82 quater and in respect of whom the indication required under Rule 4.5(a)(ii) has been provided; or, if there is no (a) Where the receiving Of®ce, the International such applicant, Searching Authority, the Authority speci®ed for supplementary search, the International Preliminary (ii) to the applicant ®rst named in the request Examining Authority, or the International Bureau who is entitled according to Article 9 to ®le an receives a request under Rule 82 quater for the international application and in respect of, whom excuse of a delay in meeting a time limit, it shall the indication required under Rule 4.5(a)(ii) has been promptly: provided; or, if there is no such applicant, (i) communicate its decision whether or not (iii) to the applicant ®rst named in the request to excuse such a delay to the interested party; and in respect of whom the indication required under Rule 4.5(a)(ii) has been provided. (ii) where applicable, transmit a copy of such a request, a copy of any evidence furnished and of 109 File Reference its decision to the International Bureau. (b) An interested party desiring to have delays (a) Where any document submitted by the excused due to general unavailability of electronic applicant contains an indication of a ®le reference, communications services must establish that the that reference shall not exceed 25 characters in outage of electronic communications services length and may be composed of either letters of the affected a widespread geographical area rather than Latin alphabet or Arabic numerals, or both. The being a localized problem, that it was unexpected or hyphen character ("-") may also be used as a unforeseen, and that there was no alternative separator between alphanumeric characters. communication means available to him. (b) Correspondence from International Authorities intended for the applicant shall indicate 112 Ceasing of Effect under Articles 24(1)(iii) any such ®le reference. and 39(2), Review under Article 25(2) and Maintaining of Effect under Articles 24(2) 110 Dates and 39(3)

Any date in the international application, or used in (a) Each national Of®ce shall, in its capacity as any correspondence emanating from International designated Of®ce, notify the International Bureau Authorities relating to the international application, once a year of: shall be indicated by the Arabic number of the day,

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(i) the number of international applications noti®cation shall preferably contain the reasons for in respect of which, during the preceding calendar the decision of the designated or elected Of®ce. year, the time limit applicable under Article 22 has 113 Special Fees Payable to the International expired; Bureau (ii) the number of international applications in respect of which, during the preceding calendar (a) The special publication fee provided for in year, the requirements provided for in Article 22 Rule 48.4 shall be 200 Swiss francs. have not been complied with before the expiration (b) The special fee provided for in Rule 91.3(d) of the time limit applicable under that Article, with shall be payable to the International Bureau and shall the consequence that the effects of the international be 50 Swiss francs plus 12 Swiss francs for each applications concerned have ceased under Article sheet in excess of one. Where that fee has not been 24(1)(iii). paid prior to the expiration of the time limit under (b) Each national Of®ce shall, in its capacity as Rule 91.3(d), the request for recti®cation, the reasons elected Of®ce, notify the International Bureau once for refusal by the authority and any further brief a year of: comments submitted by the applicant shall not be published. Where the last sentence of Rule 91.3(d) (i) the number of international applications applies and the said fee has not been paid before the in respect of which, during the preceding calendar time of the communication of the international year, the time limit applicable under Article 39(1) application under Article 20, a copy of the request has expired; for recti®cation shall not be included in that (ii) the number of international applications communication. in respect of which, during the preceding calendar (c) The special fee provided for in Rule year, the requirements provided for in Article 39(1) 26 bis.2(e) shall be payable to the International have not been complied with before the expiration Bureau and shall be 50 Swiss francs plus 12 Swiss of the time limit applicable under that Article, with francs for each sheet in excess of one. the consequence that the effects of the international applications concerned have ceased under Article 114 [Deleted] 39(3). (c) Where, under Article 25(2), the designated 115 Indications of States, Territories and Of®ce decides that the refusal, declaration or ®nding Intergovernmental Organizations referred to in Article 25(1) was not justi®ed, it shall promptly notify the International Bureau that it will The indication of a State, territory, or treat the international application as if the error or intergovernmental organization shall be made either omission referred to in Article 25(2) had not by its full name, by a generally accepted short title occurred. The noti®cation shall preferably contain which, if the indications are in English or French, the reasons for the decision of the designated Of®ce. shall be as appears in WIPO Standard ST.3 (d) Where, under Article 24(2) or under Article (Recommended Standard Two-Letter Code for the 39(3), the designated or elected Of®ce maintains the Representation of Countries, and of Other Entities effect provided for in Article 11(3), it shall promptly and International Organizations Issuing or notify the International Bureau accordingly. The Registering Industrial Property Titles), or by the two-letter code as appears in that Standard. 1

PART 2

INSTRUCTIONS RELATING TO THE INTERNATIONAL APPLICATION

1 Editor©s Note: Published in the WIPO Handbook on Industrial Property Information and Documentation.

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201 Language of the International 204 bis Numbering of Claims Application The number of each claim referred to in Rule 6.1(b) The language in which the international application shall preferably be preceded by the expression is ®led shall preferably be indicated in the request. ªClaimº (for example, ªClaim 1º, ªClaim 2º, ªClaim 3º). 202 [Deleted] 205 Numbering and Identi®cation of Claims 203 Different Applicants for Different upon Amendment Designated States (a) Amendments to the claims under Article 19 (a) Different applicants may be indicated for or Article 34(2)(b) may be made either by cancelling different States designated for a regional patent. one or more entire claims, by adding one or more new claims or by amending the text of one or more (b) Where a particular State has been designated of the claims as ®led. Where a claim is cancelled, for both a national patent and a regional patent, the no renumbering of the other claims shall be required. same applicant or applicants shall be indicated for In all cases where claims are renumbered, they shall both designations. be renumbered consecutively in Arabic numerals. 204 Headings of the Parts of the Description (b) The applicant shall, in the letter referred to in Rule 46.5(b) or Rule 66.8(c), indicate the (a) The headings of the parts of the description differences between the claims as ®led and the shall preferably be as follows: claims as amended or, as the case may be, (i) for matter referred to in Rule 5.1(a)(i), differences between the claims as previously ªTechnical Fieldº; amended and currently amended. He shall, in particular, indicate in the said letter, in connection (ii) for matter referred to in Rule 5.1(a)(ii), with each claim appearing in the international ªBackground Artº; application (it being understood that identical (iii) for matter referred to in Rule 5.1(a)(iii), indications concerning several claims may be ªDisclosure of Inventionº or ªSummary of grouped), whether: Inventionº; (i) the claim is unchanged; (iv) for matter referred to in Rule 5.1(a)(iv), (ii) the claim is cancelled; ªBrief Description of Drawingsº; (iii) the claim is new; (v) for matter referred to in Rule 5.1(a)(v), ªBest Mode for Carrying out the Invention,º or, (iv) the claim replaces one or more claims where appropriate, ªMode(s) for Carrying out the as ®led; Inventionº or ªDescription of Embodimentsº; (v) the claim is the result of the division of (vi) for matter referred to in Rule 5.1(a)(vi), a claim as ®led; ªIndustrial Applicabilityº; (vi) the claim replaces one or more claims (vii) for matter referred to in Rule 5.2(a), as previously amended; ªSequence Listingº; (vii) the claim is the result of the division of (viii) for matter referred to in Rule 5.2(b), a claim as previously amended. ªSequence Listing Free Textº. 206 Unity of Invention (b) The heading ªTitle of Inventionº shall preferably precede the title of the invention. The determination by the International Searching Authority, the International Preliminary Examining Authority and the designated and elected Of®ces whether an international application complies with

June 2020 AI-12 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 211

the requirement of unity of invention under Rule 13 international application or not forming part of the shall be made in accordance with Annex B. international application, shall comply with Annex C. 207 Arrangement of Elements and Numbering of Sheets of the International 209 Indications as to Deposited Biological Application Material on a Separate Sheet

(a) In effecting the sequential numbering of the (a) To the extent that any indication with respect sheets of the international application in accordance to deposited biological material is not contained in with Rule 11.7, the elements of the international the description, it may be given on a separate sheet. application shall be placed in the following order: Where any such indication is so given, it shall preferably be on Form PCT/RO/134 and, if furnished (i) the request; at the time of ®ling, the said Form shall, subject to (ii) the description (if applicable, including paragraph (b), preferably be attached to the request the sequence listing free text referred to in Rule and referred to in the check list referred to in Rule 5.2(b) but excluding the sequence listing part of the 3.3(a)(ii). description referred to in item (vi) of this paragraph): (b) For the purposes of designated Of®ces, (iii) the claims; which have so noti®ed the International Bureau (iv) the abstract; under Rule 13 bis.7(a), paragraph (a) applies only if the said Form or sheet is included as one of the (v) if applicable, the drawings; sheets of the description of the international (vi) if applicable, the sequence listing part application at the time of ®ling. of the description. 210 [Deleted] (b) The sequential numbering of the sheets shall be effected by using the following separate series of 211 Declaration as to the Identity of the numbering: Inventor (i) the ®rst series applying to the request only and commencing with the ®rst sheet of the request; (a) Any declaration as to the identity of the (ii) the second series commencing with the inventor, referred to in Rule 4.17(i), shall be worded ®rst sheet of the description (as referred to in as follows: paragraph (a)(ii)) and continuing through the claims ªDeclaration as to the identity of the inventor until the last sheet of the abstract; (Rules 4.17(i) and 51 bis.1(a)(i)): (iii) if applicable, a further series applying to the sheets of the drawings only and commencing with the ®rst sheet of the drawings; the number of in relation to [this] international application each sheet of the drawings shall consist of two [No. PCT/¼], ¼ (name) of ¼ (address) is Arabic numerals separated by a slant, the ®rst being the inventor of the subject matter for which the sheet number and the second being the total protection is sought by way of [the] [this] number of sheets of drawings (for example, 1/3, 2/3, international applicationº 3/3); (b) This declaration need not be made if the (iv) if applicable, a further series applying name and address of the inventor are otherwise to the sequence listing part of the description, indicated in the request. commencing with the ®rst sheet of that part. (c) This declaration may, where applicable, be 208 Sequence Listings combined, in accordance with Section 212(b), with the declaration referred to in Section 212(a). Any sequence listing, whether on paper or in electronic form, whether forming part of the

AI-13 June 2020 § 212 MANUAL OF PATENT EXAMINING PROCEDURE

212 Declaration as to the Applicant's (vii) transfer of entitlement from ¼ (name) to Entitlement to Apply for and Be Granted a ¼ (name) by way of ¼ (specify kind Patent of transfer), dated ...

(a) Any declaration as to the applicant's (viii) the applicant's name changed from ¼ entitlement, as at the international ®ling date, to (name) to ¼ (name) on ¼ (date)º apply for and be granted a patent, referred to in Rule 4.17(ii), shall be worded as follows, with such inclusion, omission, repetition and re-ordering of (b) The declaration referred to in paragraph (a) the matters listed as items (i) to (viii) as is necessary may, where applicable, be combined with the to explain the applicant's entitlement: declaration referred to in Section 211(a), in which case the introductory phrase shall be worded as ªDeclaration as to the applicant's entitlement, follows and the remainder of the combined as at the international ®ling date, to apply for declaration shall be worded as prescribed in and be granted a patent (Rules 4.17(ii) and paragraph (a): 51 bis.1(a)(ii)), in a case where the declaration under Rule 4.17(iv) is not appropriate: ªCombined declaration as to the applicant's entitlement, as at the international ®ling date, to apply for and be granted a patent (Rules in relation to [this] international application 4.17(ii) and 51 bis.1(a)(ii)) and as to the identity [No. PCT/¼], of the inventor (Rules 4.17(i) and 51 bis.1(a)(i)), in a case where the declaration ¼ (name) is entitled to apply for and be under Rule 4.17(iv) is not appropriate:º granted a patent by virtue of the following: 213 Declaration as to the Applicant's (i) ... (name) of ... (address) ¼ is the inventor Entitlement to Claim Priority of Earlier of the subject matter for which protection is Application sought by way of [the] [this] international application Any declaration as to the applicant's entitlement, as at the international ®ling date, to claim priority of the earlier application, referred to in Rule 4.17(iii) (ii) ¼ (name) [is] [was] entitled as employer , shall be worded as follows, with such inclusion, of the inventor, ¼ (inventor's name) omission, repetition and re-ordering of the matters listed as items (i) to (viii) as is necessary to explain (iii) an agreement between ¼ (name) and ¼ the applicant's entitlement: (name), dated ¼ ªDeclaration as to the applicant's entitlement, as at the international ®ling date, to claim the (iv) an assignment from ¼ (name) to ¼ priority of the earlier application speci®ed (name), dated ¼ below, where the applicant is not the applicant who ®led the earlier application or where the (v) consent from ¼ (name) in favor of ¼ applicant's name has changed since the ®ling (name), dated ¼ of the earlier application (Rules 4.17(iii) and 51 bis.1(a)(iii)): (vi) a court order issued by ¼ (name of court), effecting a transfer from ¼ (name) to ¼ in relation to [this] international application (name), dated ¼ [No. PCT/¼],

June 2020 AI-14 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 214

... (name) is entitled to claim priority of earlier This declaration is directed to the application No. ¼ by virtue of the following: international application of which it forms a part (if ®ling declaration with application). (i) the applicant is the inventor of the subject matter for which protection was sought by way This declaration is directed to international of the earlier application application No. PCT/¼ (if furnishing declaration pursuant to Rule 26 ter ). (ii) ¼ (name) [is] [was] entitled as employer of the inventor, ¼ (inventor's name) I hereby declare that the above-identi®ed international application was made or (iii) an agreement between ¼ (name) and ¼ authorized to be made by me. (name), dated ¼ I hereby acknowledge that any willful false (iv) an assignment from ¼ (name) to ¼ statement made in this declaration is punishable (name), dated ¼ under 18 U.S.C. 1001 by ®ne or imprisonment of not more than ®ve (5) years, or both. (v) consent from ¼ (name) in favor of ¼ (name), dated ¼ Name: ¼

(vi) a court order, issued by ¼. (name of Residence: ¼ (city and either US state, if court), effecting a transfer from ¼ (name) to applicable, or country) ¼ (name), dated ¼ Mailing Address: ¼ (vii) transfer of entitlement from ¼ (name) to ¼ (name) by way of ¼ (specify kind of Inventor's Signature: ¼ (The signature transfer), dated ¼ must be that of the inventor, not that of the agent) (viii) the applicant's name changed from ¼ (name) to ¼ (name) on ¼ (date)º Date: ¼º

214 Declaration of Inventorship (b) Where there is more than one inventor and all inventors do not sign the same declaration (a) A declaration of inventorship, referred to in referred to in paragraph (a), each declaration shall Rule 4.17(iv), that is made for the purposes of the indicate the names of all the inventors. designation of the United States of America shall be (c) Any correction or addition under Rule worded as follows: 26 ter.1 of a declaration referred to in paragraph (a) ªDeclaration of inventorship (Rules 4.17(iv) shall take the form of a declaration referred to in that and 51 bis.1(a)(iv) ) for the purposes of the paragraph and be signed by the inventor. In addition, designation of the United States of America: any such correction should be entitled ªSupplemental declaration of inventorship (Rules 4.17(iv) and 51 bis.1(a)(iv))º. I hereby declare that I believe I am the original inventor or an original joint inventor of a claimed invention in the application.

AI-15 June 2020 § 215 MANUAL OF PATENT EXAMINING PROCEDURE

215 Declaration as to Non-Prejudicial 217 Corrections Concerning Expressions, Disclosures or Exceptions to Lack of Novelty Etc., Not to Be Used in the International Application under Rule 9.2 Any declaration as to non-prejudicial disclosures or exceptions to lack of novelty shall be worded as (a) Where the receiving Of®ce, the International follows, with such inclusion, omission, repetition Searching Authority or the Authority speci®ed for and re-ordering of the matters listed as items (i) supplementary search receives corrections aimed at to (iv) as is necessary: complying with Rule 9.1, it shall: (i) indelibly mark, in the upper right-hand ªDeclaration as to non-prejudicial disclosures corner of each replacement sheet, the international or exceptions to lack of novelty (Rules 4.17(v) application number and the date on which that sheet and 51 bis.1(a)(v)): was received; (ii) indelibly mark, in the middle of the in relation to [this] international application bottom margin of each replacement sheet, the words [No. PCT/¼], ªSUBSTITUTE SHEET (RULE 9.2)º or their equivalent in the language of publication of the international application; ¼ (name) declares that the subject matter claimed in [the] [this] international application (iii) indelibly mark on the letter containing was disclosed as follows: the correction or accompanying any replacement sheet the date on which that letter was received;

(i) kind of disclosure (include as applicable): (iv) keep in its ®les a copy of the letter containing the correction or, when the correction is contained in a replacement sheet, the replaced sheet, (a) international exhibition a copy of the letter accompanying the replacement sheet, and a copy of the replacement sheet; (b) publication (v) unless the circumstances in item (vi) apply, promptly transmit any letter and any replacement sheet to the International Bureau and a (c) abuse copy thereof to the receiving Of®ce, the International Searching Authority and the Authority speci®ed for (d) other: ... (specify) supplementary search, as applicable; (vi) where transmittals under Article 12(1) (ii) date of disclosure: ... have not yet been made, the receiving Of®ce shall transmit any letter and any replacement sheet to the International Bureau together with the record copy (iii) title of disclosure (if applicable): ... and, except where the international application is considered withdrawn and Rule 29.1(iii) applies, a (iv) place of disclosure (if applicable): ...º copy of the said letter or replacement sheet to the International Searching Authority together with the search copy. The record copy and the search copy 216 Notice of Correction or Addition of a shall contain any replaced sheet. Declaration under Rule 26ter (b) Where the International Bureau receives corrections under paragraph (a) from the receiving Any notice referred to in Rule 26 ter.1 shall consist Of®ce, the International Searching Authority or the of a replacement sheet containing a corrected Authority speci®ed for supplementary search, the declaration, or of an additional sheet containing a International Bureau shall transfer the correction to declaration, and an accompanying letter explaining the record copy, together with the indication of the the correction or addition. date on which the Of®ce or Authority received the

June 2020 AI-16 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 218

letter, or shall insert the replacement sheet in the information contained in its ®le under Rule 94.1(e), record copy. Any letter and any replaced sheet shall it shall: be kept in the ®le of the international application. (i) indelibly mark, in the upper right-hand Where the International Bureau receives corrections corner of each replacement sheet, the international under paragraph (a) from the receiving Of®ce or the application number and the date on which that sheet International Searching Authority, it shall, where was received; applicable, promptly transmit a copy of any letter and replacement sheet to the Authority speci®ed for (ii) indelibly mark, in the middle of the supplementary search. bottom margin of each replacement sheet, the words ªSUBSTITUTE SHEET (RULE 48.2(l))º (where (c) Where the International Bureau receives from the replacement sheet contains an omission under the applicant corrections aimed at complying with Rule 48.2(l)) or ªSUBSTITUTE SHEET (RULE Rule 9.1, it shall: 94.1(e))º (where the replacement sheet contains an (i) indelibly mark, in the upper right-hand omission under Rule 94.1(e)) or their equivalent in corner of each replacement sheet, the international the language of publication of the international application number and the date on which that sheet application; was received; (iii) indelibly mark on the letter containing (ii) indelibly mark, in the middle of the the omission or accompanying any replacement sheet bottom margin of each replacement sheet, the words the date on which that letter was received; ªSUBSTITUTE SHEET (RULE 9.2)º or their (iv) keep in its ®les the letter containing the equivalent in the language of publication of the proposed omission or, where the proposed omission international application; is contained in a replacement sheet, the replaced (iii) indelibly mark on the letter containing sheet, the letter accompanying the replacement sheet, the correction or accompanying any replacement and the replacement sheet; sheet the date on which that letter was received; (v) promptly transmit a copy of any (iv) keep in its ®les the letter containing the replacement sheet to the receiving Of®ce, the correction or, when the correction is contained in a International Searching Authority, the Authority replacement sheet, the replaced sheet, the letter speci®ed for supplementary search or the accompanying the replacement sheet and, the International Preliminary Examining Authority replacement sheet; (where the replaced sheet is also contained in the (v) promptly transmit a copy of any letter ®le of the international application held by that and any replacement sheet to the receiving Of®ce, Of®ce or Authority). the International Searching Authority and the (b) Where the International Bureau decides not Authority speci®ed for supplementary search, as to omit information from international publication applicable. under Rule 48.2(l) or to provide access to information contained in its ®le under Rule 94.1(e), 218 Processing of a Request for Omission of it shall proceed as indicated under paragraph (a)(i), Information Referred to in Rules 48.2(l) and (iii) and (iv). 94.1(e) (c) Section 311, paragraphs (a) to (c) shall apply (a) Where the International Bureau decides to mutatis mutandis to any deletion, substitution or omit information from international publication addition of a sheet of the international application under Rule 48.2(l) or not to provide access to received by the International Bureau. PART 3

INSTRUCTIONS RELATING TO THE RECEIVING OFFICE

AI-17 June 2020 § 301 MANUAL OF PATENT EXAMINING PROCEDURE

301 Noti®cation of Receipt of Purported 304 Invitation to Pay Fees before Date on International Application Which They Are Due

Before the determination under Article 11(1), the If the receiving Of®ce ®nds, before the date on receiving Of®ce may notify the applicant of the which they are due, that the transmittal fee, the receipt of the purported international application. international ®ling fee (including any supplement The noti®cation should indicate the date of actual per sheet over 30) or the search fee are lacking in receipt and the international application number of whole or in part, it may invite the applicant to pay the purported international application referred to in the missing amounts within one month from the date Section 307 as well as, where useful for purposes of of receipt of the international application. identi®cation, the title of the invention. 305 Identifying the Copies of the 302 Priority Claim Considered Not to Have International Application Been Made (a) Where, under Rule 11.1(a), the international Where the receiving Of®ce declares, under Rule application has been ®led in one copy, the receiving 26 bis.2(b), that a priority claim is considered not to Of®ce shall, after preparing under Rule 21.1(a) the have been made, that Of®ce shall enclose the priority additional copies required under Article 12(1), mark, claim concerned within square brackets, draw a line (i) the words ªRECORD COPYº in the upper between the square brackets, while still leaving left-hand corner of the ®rst page of the original copy, legible the indications concerned, and enter, in the margin, the words ªNOT TO BE CONSIDERED (ii) in the same space on one additional copy, FOR PCT PROCEDURE (RO)º or their equivalent the words ªSEARCH COPY,º and in the language of publication of the international (iii) in the same space on the other such copy, application, and shall notify the applicant the words ªHOME COPY,º or their equivalent in accordingly. If copies of the international application the language of publication of the international have already been sent to the International Bureau application. and the International Searching Authority, the (b) Where, under Rule 11.1(b), the international receiving Of®ce shall also notify that Bureau and application has been ®led in more than one copy, that Authority. the receiving Of®ce shall choose the copy most suitable for reproduction purposes, and mark the 303 Deletion of Additional Matter in the words ªRECORD COPY,º or their equivalent in the Request language of publication of the international application, in the upper left-hand corner of its ®rst (a) Where, under Rule 4.19(b), the receiving page. After verifying the identity of any additional Of®ce deletes ex of®cio any matter contained in the copies and, if applicable, preparing under Rule request, it shall do so by enclosing such matter 21.1(b) the home copy, it shall mark, in the upper within square brackets and entering, in the margin, left-hand corner of the ®rst page of one such copy, the words ªDELETED BY ROº or their equivalent the words ªSEARCH COPY,º and, in the same space in the language of publication of the international on the other such copy, the words ªHOME COPY,º application, and shall notify the applicant or their equivalent in the language of publication of accordingly. If copies of the international application the international application. have already been sent to the International Bureau and the International Searching Authority, the 305 bis Preparation, Identi®cation and receiving Of®ce shall also notify that Bureau and Transmittal of the Copies of the Translation that Authority. of the International Application (b) The receiving Of®ce shall not delete ex (a) Where a translation of the international of®cio any indication made in declarations referred application is furnished under Rule 12.3, the to in Rule 4.17 which are contained in the request. receiving Of®ce shall:

June 2020 AI-18 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 308

(i) be responsible for the prompt preparation 305 ter Identi®cation and Transmittal of the of any additional copies required where the Translation of an Earlier Application translation is furnished in less than the number of Furnished under Rule 20.6(a)(iii) copies required for the purposes of this paragraph, and shall have the right to ®x a fee for performing Where a translation of an earlier application is that task and to collect such fee from the applicant; furnished under Rule 20.6(a)(iii), the receiving (ii) mark the words ªRECORD COPY - Of®ce shall mark the words ªTRANSLATION OF TRANSLATION (RULE 12.3)º in the upper EARLIER APPLICATION (RULE 20.6(a)(iii))º in left-hand corner of the ®rst page of the original copy the upper left-hand corner of the ®rst page of the of the translation and transmit that copy to the translation and, after having made a ®nding under International Bureau; Rule 20.6(b) or (c), transmit the translation to the International Bureau. (iii) mark the words ªSEARCH COPY - TRANSLATION (RULE 12.3)º in the same space 306 Delayed Transmittal of Search Copy on one additional copy of the translation which, together with a copy of the request marked ªSEARCH COPYº under Section 305(a)(ii), is Where the search copy will be transmitted to the considered pursuant to Rule 23.1(b) to be the search International Searching Authority after the date on copy, and transmit such search copy to the which the record copy is transmitted to the International Searching Authority; and International Bureau, the receiving Of®ce shall notify the International Bureau. The noti®cation may (iv) mark the words ªHOME COPY- be made by marking a check-box provided for this TRANSLATION (RULE 12.3)º in the same space purpose on the request. on the other such copy of the translation, and keep that copy in its ®les. 307 System of Numbering International (b) The receiving Of®ce may, when marking the Applications copies of the translation under paragraph (a), use, instead of the words referred to in that paragraph, Papers purporting to be an international application the equivalent of those words in the language of under Rule 20.1(a) shall be allocated an international publication of the international application. application number, consisting of the letters ªPCT,º (c) Where a translation of the international a slant, the two-letter code referred to in Section 115, application is furnished under Rule 12.4, the indicating the receiving Of®ce, a four-digit receiving Of®ce shall: indication of the year in which such papers were ®rst received, a slant and a six-digit number, allotted in (i) be responsible for the prompt preparation sequential order corresponding to the order in which of any additional copies required where the the international applications are received (e.g., translation is furnished in less than the number of ªPCT/SE2004/000001º). Where the International copies required for the purposes of this paragraph, Bureau acts as receiving Of®ce, the two-letter code and shall have the right to ®x a fee for performing ªIBº shall be used. that task and to collect such fee from the applicant; (ii) mark the words ªRECORD COPY ± 308 Marking of the Sheets of the TRANSLATION (RULE 12.4)º in the upper International Application and of the left-hand corner of the ®rst page of the original copy Translation Thereof of the translation and transmit that copy to the International Bureau; and (a) Upon receipt of papers purporting to be an (iii) mark the words ªHOME COPY ± international application, the receiving Of®ce shall TRANSLATION (RULE 12.4)º in the same space indelibly mark the date of actual receipt on the on the other such copy of the translation, and keep request of each copy received. that copy in its ®les. (b) The receiving Of®ce shall indelibly mark the international application number referred to in

AI-19 June 2020 § 308 bis MANUAL OF PATENT EXAMINING PROCEDURE

Section 307 in the upper right-hand corner of each (i) indelibly mark, in the middle of the sheet of each copy of the purported international bottom margin of each later submitted sheet, the application and of any translation of the international words ªINCORPORATED BY REFERENCE application furnished under Rules 12.3 or 12.4. (RULE 20.6)º, or their equivalent in the language (c) If a positive determination is made under of publication of the international application; Rule 20.2, the receiving Of®ce shall mark on the (ii) notify the applicant that the element or request the name of the receiving Of®ce and the part contained in the later submitted sheets is words ªPCT International Applicationº or ªDemande considered to have been contained in the internationale PCTº. If the of®cial language of the international application or purported international receiving Of®ce is neither English nor French, the application on the date when sheets were ®rst words ªInternational Applicationº or ªDemande received and that that date has been accorded or internationaleº may be accompanied by a translation retained, as the case may be, as the international of these words in the of®cial language of the ®ling date; receiving Of®ce. (iii) keep in its ®les a copy of the later (d) If a negative determination is made under submitted sheets marked under item (i) and of the Rule 20.4 or a declaration is made under Article notice under Rule 20.6(a); 14(4), the letters ªPCTº shall be deleted by the receiving Of®ce from the indication of the (iv) where transmittals under Article 12(1) international application number on any papers have already been made, notify the International marked previously with that number, and the said Bureau and the International Searching Authority number shall be used without such letters in any accordingly, and transmit the later submitted sheets future correspondence relating to the purported marked under item (i) to the said Bureau and a copy international application. thereof to the said Authority; 308 bis Marking of Later Submitted Sheets (v) where transmittals under Article 12(1) have not yet been made, attach the later submitted sheets marked under item (i) and the notice under The receiving Of®ce shall indelibly mark any sheet Rule 20.6(a) to the record copy and a copy thereof containing an element referred to in Article to the search copy. 11(1)(iii)(d) or (e), or a part referred to in Rule 20.5(a), received on a date later than the date on (c) Where later submitted sheets referred to in which sheets were ®rst received (ªlater submitted paragraph (a) are received within the applicable time sheetº), in the upper right-hand corner of each sheet, limit referred to in Rule 20.7 and the receiving Of®ce with the international application number referred makes a ®nding under Rule 20.6(c), the receiving to in Section 307 and the date of actual receipt of Of®ce shall, subject to Section 310 bis : that sheet. (i) effect the required correction of the international ®ling date or accord as the international 309 Procedure in the Case of Later ®ling date the date of receipt of the later submitted Submitted Sheets Furnished for the Purposes sheets; of Incorporation by Reference (ii) notify the applicant that the content of the later submitted sheets is not considered to have (a) This Section applies, subject to paragraph been contained in the international application or (f), to later submitted sheets which accompany a purported international application on the date when notice con®rming under Rule 20.6 that an element sheets were ®rst received and that the international or part embodied in those sheets was incorporated ®ling date has been accorded as, or corrected to, as by reference. the case may be, the date on which the new sheets (b) Where later submitted sheets as referred to were received; in paragraph (a) are received within the applicable (iii) keep in its ®les a copy of the later time limit referred to in Rule 20.7 and the receiving submitted sheets and of the notice under Rule Of®ce makes a ®nding under Rule 20.6(b), the 20.6(a); receiving Of®ce shall:

June 2020 AI-20 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 310

(iv) where transmittals under Article 12(1) 310 Procedure in the Case of Later have already been made, notify the International Submitted Sheets Not Furnished for the Bureau and the International Searching Authority Purposes of Incorporation by Reference accordingly and transmit a copy of the corrected ®rst and last sheets of the request, the later submitted (a) This Section applies to later submitted sheets sheets and the notice under Rule 20.6(a) to the said which do not accompany a notice con®rming under Bureau and a copy thereof to the said Authority; Rule 20.6 that an element or part embodied in those (v) where transmittals under Article 12(1) sheets was incorporated by reference. have not yet been made, attach the later submitted (b) Where later submitted sheets as referred to sheets and the notice under Rule 20.6(a) to the record in paragraph (a) are received within the applicable copy and a copy thereof to the search copy. time limit referred to in Rule 20.7 and where the (d) Where later submitted sheets referred to in international ®ling date is to be accorded under Rules paragraph (a) are received within the applicable time 20.3(b)(i) or 20.5(b), or corrected under Rule 20.5(c), limit referred to in Rule 20.7 but the purported the receiving Of®ce shall, subject to Section 310 bis international application still does not ful®ll the : requirements of Article 11(1), the receiving Of®ce (i) accord the international ®ling date in shall proceed as provided in Rule 20.4, but not before accordance with Rules 20.3(b)(i) or 20.5(b), or effect the expiration of the time limit under Rule 20.7. the required correction of the international ®ling (e) Where later submitted sheets referred to in date in accordance with Rule 20.5(c), as the case paragraph (a) are received after the expiration of the may be; applicable time limit referred to in Rule 20.7, the (ii) notify the applicant of the correction or receiving Of®ce shall proceed as provided in Section the according of the international ®ling date effected 310 ter . under item (i); (f) Where later submitted sheets referred to in (iii) keep in its ®les a copy of the later paragraph (a) are received but a missing element or submitted sheets; part contained in those sheets cannot be incorporated (iv) where transmittals under Article 12(1) by reference in the international application under have already been made, notify the International Rules 4.18 and 20.6 because of the operation of Rule Bureau and the International Searching Authority 20.8(a), the receiving Of®ce shall: accordingly and transmit a copy of the corrected ®rst (i) inform the applicant that the notice under and last sheets of the request and the later submitted Rule 20.6(a) con®rming the incorporation by sheets to the said Bureau and a copy thereof to the reference of the missing element or part has been said Authority; disregarded: (v) where transmittals under Article 12(1) (ii) proceed in accordance with Section have not yet been made, attach the later submitted 310(b), which shall apply mutatis mutandis, as if sheets to the record copy and a copy thereof to the the notice under Rule 20.6(a) were a correction search copy. furnished under Rule 20.3(b)(i), or a missing part (c) Where later submitted sheets referred to in furnished under Rules 20.5(b) or (c), as the case may paragraph (a) are received within the applicable time be; and limit referred to in Rule 20.7 but the purported (iii) proceed in accordance with Section international application still does not ful®ll the 310 bis(b) where the applicant requests, within the requirements of Article 11(1), the receiving Of®ce time limit under Rule 20.5(e), that the missing part shall proceed as provided in Rule 20.4. concerned be disregarded. (d) Where later submitted sheets referred to in paragraph (a) are received after the expiration of the applicable time limit referred to in Rule 20.7, the receiving Of®ce shall proceed as provided in Section 310 ter .

AI-21 June 2020 § 310 bis MANUAL OF PATENT EXAMINING PROCEDURE

310 bis Procedure in the Case of Later under Rule 20.5(e) to the said Bureau and a copy Submitted Sheets Resulting in the Correction thereof to the said Authority; of the International Filing Date under Rule (vi) where transmittals under Article 12(1) 20.5(c) have not yet been made, notify the International Bureau accordingly and attach the later submitted (a) Where, following the receipt of later sheets marked under item (ii), the notice under Rule submitted sheets referred to in Sections 309(a) or 20.6(a) and the request under Rule 20.5(e) to the 310(a) within the applicable time limit referred to record copy. in Rule 20.7, the international ®ling date has been corrected under Rule 20.5(c), the receiving Of®ce 310 ter Procedure in the Case of Later shall, in addition to proceeding under Sections Submitted Sheets Furnished after the 309(c)(i) to (iii), or 310(b)(i) to (iii), as the case may Expiration of the Applicable Time Limit be: Referred to in Rule 20.7 (i) draw the attention of the applicant to the procedure available under Rule 20.5(e); Where later submitted sheets referred to in Sections 309(a) or 310(a) are received after the expiration of (ii) proceed under Sections 309(c)(iv) or (v), the applicable time limit referred to in Rule 20.7, or 310(b)(iv) or (v), as the case may be, but only the receiving Of®ce shall: after the expiration of the time limit under Rule 20.5(e) and only where the applicant has not made (i) notify the applicant of the fact and of the date a request under that Rule. of receipt of the later submitted sheets, and of the (b) Where the applicant requests within the time fact that they will not be considered for the PCT limit under Rule 20.5(e) that the missing part procedure; concerned be disregarded, the receiving Of®ce shall: (ii) indelibly mark, in the middle of the bottom (i) restore the international ®ling date to that margin of each sheet containing the missing element which had applied prior to its correction under Rule or part concerned, the words ªNOT TO BE 20.5(c); CONSIDERED (RULE 20.7)º, or their equivalent (ii) indelibly mark, in the middle of the in the language of publication of the international bottom margin of each sheet containing the missing application; part concerned, the words ªNOT TO BE (iii) keep in its ®les a copy of the later submitted CONSIDERED (RULE 20.5(e))º, or their equivalent sheets marked under item (ii) and, where applicable, in the language of publication of the international of the notice under Rule 20.6(a); application; (iv) where transmittals under Article 12(1) have (iii) notify the applicant that the missing part already been made, notify the International Bureau is considered not to have been furnished and that the accordingly, and transmit the later submitted sheets international ®ling date has been restored to that marked under item (ii) and, where applicable, the which had applied prior to its correction under Rule notice under Rule 20.6(a) to the said Bureau; 20.5(c); (v) where transmittals under Article 12(1) have (iv) keep in its ®les a copy of the later not yet been made, notify the International Bureau submitted sheets marked under item (ii) and of the accordingly, and attach the later submitted sheets request made under Rule 20.5(e); marked under item (ii) and, where applicable, the (v) where transmittals under Article 12(1) notice under Rule 20.6(a) to the record copy. have already been made, notify the International 311 Renumbering in the Case of Deletion, Bureau and the International Searching Authority Substitution or Addition of Sheets of the accordingly, and transmit a copy of the corrected ®rst and last sheets of the request, the later submitted sheets marked under item (ii) and the request made

June 2020 AI-22 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 313

International Application and of the 312 Noti®cation of Decision Not to Issue Translation Thereof Declaration that the International Application Is Considered Withdrawn (a) The receiving Of®ce shall, subject to Section 207, sequentially renumber the sheets of the Where the receiving Of®ce, after having noti®ed the international application when necessitated by the applicant under Rule 29.4(a) of its intent to issue a addition of any new sheet, the deletion of entire declaration under Article 14(4), decides not to issue sheets, a change in the order of the sheets or any such a declaration, it shall notify the applicant other reason. accordingly. (b) The sheets of the international application shall be provisionally renumbered in the following 313 Documents Filed with the International manner: Application; Manner of Marking the (i) when a sheet is deleted, the receiving Necessary Annotations in the Check List Of®ce shall either include a blank sheet with the same number and with the word ªDELETED,º or (a) Any power of attorney, any priority its equivalent in the language of publication of the document, any fee calculation sheet and any separate international application, below the number, or sheet referred to in Section 209(a) containing insert, in brackets, below the number of the indications as to deposited biological material, ®led following sheet, the number of the deleted sheet with with the international application shall accompany the word ªDELETEDº or its equivalent in the the record copy; any other document referred to in language of publication of the international Rule 3.3(a)(ii) shall be sent only at the speci®c application; request of the International Bureau. If any document which is indicated in the check list as accompanying (ii) when one or more sheets are added, each the international application is not, in fact, ®led at sheet shall be identi®ed by the number of the the latest by the time the record copy leaves the preceding sheet followed by a slant and then by receiving Of®ce, that Of®ce shall so note on the another Arabic numeral such that the additional check list and the said indication shall be considered sheets are numbered consecutively, starting always as if it had not been made. with number one for the ®rst sheet added after an unchanged sheet (e.g., 10/1, 15/1, 15/2, 15/3, etc.); (b) Where, under Rule 3.3(b), the receiving when later additions of sheets to an existing series Of®ce itself completes the check list, that Of®ce of added sheets are necessary, an extra numeral shall shall enter, in the margin, the words ªCOMPLETED be used for identifying the further additions (e.g., BY ROº or their equivalent in the language of 15/1, 15/1/1, 15/1/2, 15/2, etc.). publication of the international application. Where only some of the indications are completed by the (c) In the cases mentioned in paragraph (b), it is receiving Of®ce, the said words and each indication recommended that the receiving Of®ce should write, completed by that Of®ce shall be identi®ed by an below the number of the last sheet, the total number asterisk. of the sheets of the international application followed by the words ªTOTAL OF SHEETSº or their (c) Any sequence listing not forming part of the equivalent in the language of publication of the international application, whether on paper or in international application. It is further recommended electronic form, that is furnished for the purposes of that, at the bottom of any last sheet added, the words the international search to the receiving Of®ce ªLAST ADDED SHEETº or their equivalent in the together with the international application or language of publication of the international subsequent to the ®ling of the international application should be inserted. application, shall be transmitted to the International Searching Authority together with the search copy. (d) Paragraphs (a) to (c) shall apply mutatis Where such a sequence listing is received by the mutandis to any translation of the international receiving Of®ce after the transmittal of the search application furnished under Rule 12.3 or 12.4. copy, that sequence listing shall be promptly transmitted to the International Searching Authority.

AI-23 June 2020 § 314 MANUAL OF PATENT EXAMINING PROCEDURE

314 Correction or Addition of a Priority a replacement sheet from the applicant in which that Claim Under Rule 26 bis part has been removed, it may decide not to transmit the entire document or part thereof to the (a) Where the applicant, in a notice submitted International Bureau and proceed as indicated under to the receiving Of®ce, corrects or adds a priority paragraph (a)(i) and (iv) as applicable, or invite the claim under Rule 26 bis , that Of®ce shall enter the applicant to submit such a replacement sheet. Where correction or addition in the request, draw a line the applicant submits a replacement sheet within the through, while still leaving legible, any indication time limit set by the receiving Of®ce, the receiving deleted as a result of the correction, and enter, in the Of®ce proceeds as indicated under paragraph (a). margin, the letters ªRO.º Where the applicant does not submit a replacement sheet within the time limit set by the receiving (b) The applicant and, if copies of the Of®ce, the receiving Of®ce may either transmit the international application have already been sent to document containing that part and the request under the International Bureau and the International Rule 26 bis.3(h- bis) to the International Bureau, or Searching Authority, that Bureau and that Authority decide not to transmit the entire document or part shall be promptly noti®ed by the receiving Of®ce thereof to the International Bureau under Rule of any correction or addition of a priority claim under 26 bis.3(h- bis). Rule 26 bis and of the date on which it received such correction or addition. (c) Where the receiving Of®ce ®nds on its own decision that information in a part of a document 315 Processing of Documents by the meets the requirements in Rule 26 bis.3(h- bis), it Receiving Of®ce under Rule 26 bis.3(h- bis) may either invite the applicant to submit a replacement sheet in which that part has been (a) Where the receiving Of®ce receives a request removed and proceed as indicated under paragraph under Rule 26 bis.3(h- bis) and decides not to (b), or decide not to transmit the entire document or transmit a document or part thereof to the part thereof to the International Bureau. International Bureau, it shall (d) Where the receiving Of®ce receives a request indelibly mark on the request under Rule under Rule 26 bis.3(h- bis), but nevertheless decides 26 bis.3(h- bis) the date on which that request was to transmit that document or part thereof to the received; International Bureau, it shall proceed as indicated (ii) indelibly mark, in the upper right-hand under paragraph (a)(i), (ii) and (iv), and promptly corner of each replacement sheet received, the transmit the request under Rule 26 bis.3(h- bis) and international application number and the date on any proposed replacement sheet to the International which that sheet was received; Bureau. (iii) indelibly mark, in the middle of the 316 Procedure in the Case Where the bottom margin of each replacement sheet received, International Application Lacks the the words ªSUBSTITUTE SHEET (RULE Prescribed Signature 26 bis.3(h- bis))º or their equivalent in the language of publication of the international application; Where, under Article 14(1)(a)(i), the receiving Of®ce (iv) keep in its ®les a copy of the request ®nds that the international application is defective under Rule 26 bis.3(h- bis), and, where applicable, in that it lacks the prescribed signature, that Of®ce the replaced sheet, and a copy of the replacement shall send to the applicant, together with the sheet; invitation to correct under Article 14(1)(b), a copy of the relevant sheet of the request part of the (v) promptly transmit any replacement sheet international application. The applicant shall, within to the International Bureau. the prescribed time limit, return said copy after (b) Where the receiving Of®ce receives a request af®xing thereto the prescribed signature. under Rule 26 bis.3(h- bis) and ®nds that information in a part of a document meets the requirements in this Rule, but the receiving Of®ce has not received

June 2020 AI-24 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 323

317 Transmittal of a Notice of Correction or 320 Invitation to Pay Fees under Rule Addition of a Declaration under Rule 26ter.1 16 bis.1(a)

If a notice under Rule 26 ter.1 is submitted by the When issuing an invitation under Rule 16 bis.1(a), applicant to the receiving Of®ce, that Of®ce shall the receiving Of®ce shall, if it received moneys from mark the date of receipt on the notice and transmit the applicant before the due date, inform the it promptly to the International Bureau. The notice applicant of the fees to which those moneys have shall be considered to have been received by the been applied. International Bureau on the date marked. 321 Application of Moneys Received by the 318 Cancellation of Designations of Receiving Of®ce in Certain Cases Non-Contracting States (a) The receiving Of®ce shall, to the extent that The receiving Of®ce shall cancel ex of®cio the it has received instructions from the applicant as to designation of any State which is not a Contracting the fees to which it shall apply moneys received by State, shall enclose that designation within square it from the applicant, apply those moneys brackets, shall draw a line between the square accordingly. brackets while still leaving the designation legible, (b) Where the receiving Of®ce receives moneys shall enter, in the margin, the words ªCANCELLED from the applicant which, together with any other EX OFFICIO BY ROº or their equivalent in the moneys so received, are not suf®cient to cover in language of publication of the international full the transmittal fee (if any), the international application, and shall promptly notify the applicant ®ling fee and the search fee (if any), the receiving accordingly. If the record copy has already been sent Of®ce shall, to the extent that it has not received to the International Bureau, the receiving Of®ce shall instructions from the applicant as to the fees to which also notify that Bureau. it shall apply the moneys which are available for the purpose, apply those moneys in payment, 319 Procedure under Rule 4.9(b) successively, of the fees set out below to the extent that they are due and unpaid and in the order in (a) Where the receiving Of®ce ®nds that the which they appear below: request contains an indication under Rule 4.9(b) that (i) the transmittal fee; the designation of a State is not made but the request does not contain a priority claim to an earlier national (ii) the international ®ling fee; application ®led in that State, the receiving Of®ce (iii) the search fee. shall promptly notify the applicant accordingly and shall draw the applicant's attention to Rule 26 bis . 322 Invitation to Submit a Request for Refund of the Search Fee (b) If the receiving Of®ce does not, before the expiration of the time limit under Rule 26 bis.1(a), receive a notice correcting or adding a priority claim The receiving Of®ce may, before making a refund to an earlier national application ®led in the State, of the search fee under Rule 16.2, ®rst invite the the designation of which is not made, it shall cancel applicant to submit a request for the refund. ex of®cio the indication under Rule 4.9(b), shall enclose that indication in square brackets, draw a 323 Transmittal of Priority Documents to line between the square brackets while still leaving International Bureau the indication legible, enter, in the margin, the words ªCANCELLED EX OFFICIO BY ROº or their (a) Any priority document which is submitted equivalent in the language of publication of the to the receiving Of®ce under Rule 17.1(a) shall be international application, and promptly notify the transmitted by that Of®ce to the International Bureau applicant accordingly. If the record copy has already together with the record copy or, if received after been sent to the International Bureau, the receiving the record copy has been sent to the International Of®ce shall also notify that Bureau.

AI-25 June 2020 § 324 MANUAL OF PATENT EXAMINING PROCEDURE

Bureau, promptly after having been received by that and the international ®ling date under Rule 20.2(c) Of®ce. shall also include, if the priority of an earlier (b) Where the priority document is issued by the application is claimed in the international receiving Of®ce and the applicant has, not later than application, the date of ®ling ± as indicated in the 16 months after the priority date, requested the international application ± of that earlier application. receiving Of®ce under Rule 17.1(b) to prepare and If the priority of several earlier applications is transmit it to the International Bureau, the receiving claimed, the earliest ®ling date shall be indicated. Of®ce shall, promptly after receipt of such request (ªrequest for priority documentº) and, where 325 Corrections of Defects under Rule 26.4 applicable, the payment of the fee referred to in that and Recti®cations of Obvious Mistakes under Rule, transmit the priority document to the Rule 91 International Bureau. Where such request for priority document has been made but the required fee has (a) Where the receiving Of®ce receives a not been paid, the receiving Of®ce shall promptly correction of defects under Rule 26.4 or authorizes notify the applicant that the request for priority a recti®cation of an obvious mistake under Rule 91, document will be considered not to have been made it shall: unless the fee is paid not later than 16 months after (i) indelibly mark, in the upper right-hand the priority date or, in the case referred to in Article corner of each replacement sheet, the international 23(2), not later than at the time the processing or application number and the date on which that sheet examination of the international application is was received; requested. (ii) indelibly mark, in the middle of the (c) When transmitting a priority document, the bottom margin of each replacement sheet, the words receiving Of®ce shall notify the International Bureau ªSUBSTITUTE SHEET (RULE 26)º (where the of the date on which it received the priority replacement sheet contains a correction of defects document or the request for priority document. under Rule 26) or ªRECTIFIED SHEET (RULE (d) Where a request for priority document has, 91)º (where the replacement sheet contains the under paragraph (b), been considered not to have recti®cation of an obvious mistake under Rule 91) been made, the receiving Of®ce shall promptly or their equivalent in the language of publication of notify the International Bureau. Where the receiving the international application; Of®ce fails to notify the International Bureau (iii) indelibly mark on the letter containing accordingly within 17 months from the priority date, the correction or recti®cation, or accompanying any the receiving Of®ce shall prepare and transmit the replacement sheet, the date on which that letter was priority document to the International Bureau even received; though the required fee has not been paid by the applicant. (iv) keep in its ®les a copy of the letter containing the correction or recti®cation or, when (e) Where a request for priority document has the correction or recti®cation is contained in a been received by the receiving Of®ce later than 16 replacement sheet, the replaced sheet, a copy of the months after the priority date, or where such request letter accompanying the replacement sheet, and a has, under paragraph (b), been considered not to copy of the replacement sheet; have been made, the receiving Of®ce shall promptly notify the applicant accordingly, directing attention (v) subject to item (vi), promptly transmit to the requirements of Rule 17.1(a). any letter and any replacement sheet to the International Bureau, and a copy thereof to the 324 Copy of Noti®cation of the International International Searching Authority; Application Number and the International (vi) where transmittals under Article 12(1) Filing Date under Rule 20.2(c) have not yet been made, transmit any letter and any replacement sheet to the International Bureau The copy, sent to the International Bureau, of the together with the record copy and, except where the noti®cation of the international application number international application is considered withdrawn

June 2020 AI-26 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 328

and Rule 29.1(iii) applies, a copy of the said letter (d) If the search copy has not yet been sent to or replacement sheet to the International Searching the International Searching Authority and a priority Authority together with the search copy. The record claim is withdrawn under Rule 90 bis.3, the receiving copy and the search copy shall contain any replaced Of®ce shall transmit a copy of the notice effecting sheet. withdrawal to the International Searching Authority together with the search copy. (b) Where the receiving Of®ce refuses to authorize the recti®cation of an obvious mistake 327 Ex Of®cio Correction of Request by the under Rule 91, it shall proceed as indicated under Receiving Of®ce paragraph (a)(i), (iii) and (iv) and promptly transmit any letter and any proposed replacement sheet to the (a) Subject to paragraph (d), where the record International Bureau. If the record copy has not yet copy has not yet been sent to the International been sent to the International Bureau, any letter and Bureau and the request requires correction because any proposed replacement sheet shall be transmitted it contains an inconsistency or a minor defect such together with the record copy. as non-compliance with the requirement for indications under Section 115, the receiving Of®ce 326 Withdrawal by Applicant under Rule may correct the request ex of®cio. If the receiving 90 bis.1, 90 bis.2 or 90 bis.3 Of®ce does so, it shall notify the applicant accordingly. (a) The receiving Of®ce shall promptly transmit to the International Bureau any notice from the (b) When making a correction under paragraph applicant effecting withdrawal of the international (a), the receiving Of®ce shall enter, in the margin, application under Rule 90 bis.1, of a designation the letters ªRO.º Where any matter is to be deleted, under Rule 90 bis.2 or of a priority claim under Rule the receiving Of®ce shall enclose such matter within 90 bis.3 which has been ®led with it together with square brackets and shall draw a line between the an indication of the date of receipt of the notice. If square brackets while still leaving the deleted matter the record copy has not yet been sent to the legible. Where any matter is to be replaced, both the International Bureau, the receiving Of®ce shall ®rst and second sentences of this paragraph shall transmit the said notice together with the record apply. copy. (c) The receiving Of®ce shall check the number (b) If the search copy has already been sent to of characters of the ®le reference, if any, and shall the International Searching Authority and the delete any characters beyond the number permitted international application is withdrawn under Rule by Section 109. 90 bis.1 or a priority claim is withdrawn under Rule (d) The receiving Of®ce shall not make any ex 90 bis.3, the receiving Of®ce shall promptly transmit of®cio correction to declarations referred to in a copy of the notice effecting withdrawal to the Rule 4.17 which are contained in the request. International Searching Authority. 328 Noti®cations Concerning Representation (c) If the search copy has not yet been sent to the International Searching Authority and the (a) Where a power of attorney or a document international application is withdrawn under Rule containing the revocation or renunciation of an 90 bis.1, the receiving Of®ce shall not send the appointment is submitted to the receiving Of®ce and search copy to the International Searching Authority the record and search copies have already been and shall, subject to Section 322, refund the search transmitted, the receiving Of®ce shall immediately fee to the applicant unless it has already been notify the International Bureau and the International transferred to the International Searching Authority. Searching Authority by sending them a copy of the If the search fee has already been transferred to the power of attorney or document and request the International Searching Authority, the receiving International Bureau to record a change in the Of®ce shall send a copy of the request and of the indications concerning the agent or common notice effecting withdrawal to that Authority. representative under Rule 92 bis.1(a)(ii).

AI-27 June 2020 § 329 MANUAL OF PATENT EXAMINING PROCEDURE

(b) If the record copy and/or search copy have COPYº or their equivalent in the language of not yet been transmitted by the receiving Of®ce, a publication of the international application on the copy of the power of attorney or document bottom of the ®rst page of the request and on the containing the revocation or renunciation of an ®rst page of the description. The marking under appointment shall be transmitted by the receiving Section 325 is not required in such a case. The Of®ce with the record copy and/or search copy. international application as received by facsimile 329 Correction of Indications Concerning machine transmission shall constitute the record copy. The con®rmation copy shall be transmitted to the Applicant's Residence or Nationality the International Bureau in addition to the record copy. Where, in response to an invitation to correct a defect under Article 11(1)(i), evidence is submitted 332 Noti®cation of Languages Accepted by indicating to the satisfaction of the receiving Of®ce that, in fact, the applicant had, on the date on which the Receiving Of®ce under Rules 12.1(a) and the international application was actually received, (c) and 12.4(a) the right to ®le an international application with that receiving Of®ce, the invitation shall be considered (a) Each receiving Of®ce shall notify the to be an invitation to correct a defect under Article International Bureau of the language or languages 14(1)(a)(ii) and Rule 4.5 in the prescribed indications which, having regard to Rule 12.1(b), it is prepared concerning the applicant's residence and/or to accept under Rule 12.1(a) for the ®ling of nationality, and the applicant may correct those international applications. indications accordingly. If such correction is made, (b) Each receiving Of®ce shall notify the no defect shall be considered to exist under Article International Bureau of any change to the 11(1)(i). information noti®ed under paragraphs (a), (d) and (e). If the change means that 330 Transmittal of Record Copy Prevented or Delayed by National Security Prescriptions (i) the receiving Of®ce is no longer prepared to accept the ®ling of international applications in a (a) Where prescriptions concerning national language that it had previously noti®ed the security prevent the transmittal of the record copy International Bureau that it was prepared to accept; by the receiving Of®ce to the International Bureau or under Rule 22.1(a), the receiving Of®ce shall notify the applicant and the International Bureau (ii) the receiving Of®ce is no longer prepared accordingly. to accept the translation of international applications into a language of publication that it had previously (b) The noti®cations under paragraph (a) shall noti®ed the International Bureau that it was prepared be sent before the expiration of 13 months from the to accept; or priority date. Where the receiving Of®ce believes that national security clearance is imminent, it may (iii) the receiving Of®ce is no longer postpone the sending of the noti®cations, but shall prepared to accept the ®ling of requests in a language send them before the expiration of 17 months from that it had previously noti®ed the International the priority date if no clearance has been given by Bureau that it was prepared to accept, that time. the effective date of such change shall be two months 331 Receipt of Con®rmation Copy after the date of publication of the noti®cation of the change in the Gazette pursuant to Section 405 or Where, subject to Rule 92.4, the receiving Of®ce such later date as may be determined by the receiving receives an international application by facsimile Of®ce. machine transmission and subsequently receives the original of that international application, it shall mark (c) Nothing in paragraph (a), (b), (d) or (e) such original with the words ªCONFIRMATION prevents any receiving Of®ce from accepting, in a particular case,

June 2020 AI-28 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 336

(i) the ®ling of an international application (c) The national Of®ce: in a language that it has not noti®ed the International (i) need not proceed under Rule 19.4(b) Bureau that it is prepared to accept; or having regard to Rule 19.4(a)(i) to (iii) if the Of®ce (ii) the translation of an international requires payment of the fee referred to in Rule application into a language of publication that it has 19.4(b) and the applicant does not pay that fee; not noti®ed the International Bureau that it is (ii) shall not proceed under Rule 19.4(b) prepared to accept; or having regard to Rule 19.4(a)(iii) if the International (iii) the ®ling of a request in a language that Bureau as receiving Of®ce does not agree to, or if it has not noti®ed the International Bureau that it is the applicant does not authorize, the transmittal of prepared to accept. the international application under Rule 19.4(a)(iii). (d) Each receiving Of®ce concerned shall notify 334 Noti®cation to Applicant of Submission the International Bureau of the language or languages of Demand after the Expiration of 19 Months which it is prepared to accept under Rule 12.4(a) for from the Priority Date the translation of international applications into a language of publication. Where the demand is submitted after the expiration (e) Each receiving Of®ce shall notify the of 19 months from the priority date to a receiving International Bureau of the language or languages Of®ce and the time limit under Article 22(1), as in which it is prepared to accept under Rule 12.1(c) for force from April 1, 2002, does not apply in respect the ®ling of requests. of all designated Of®ces, the receiving Of®ce shall:

333 Transmittal of International Application (i) promptly notify the applicant accordingly, to the International Bureau as Receiving directing attention to the fact that the time limit under Of®ce Article 39(1)(a) does not apply, and that Article 22(1), as in force until March 31, 2002, continues (a) Where a national Of®ce intends to proceed to apply in respect of any such designated Of®ce, under Rule 19.4(b) having regard to Rule 19.4(a)(i) and or (ii), it shall, if it requires payment of the fee (ii) proceed under Rule 59.3. referred to in Rule 19.4(b) and that fee has not already been paid, promptly invite the applicant to 335 [Deleted] pay that fee within a time limit of 15 days from the date of the invitation. 336 Waivers under Rules 90.4(d) and 90.5(c) (b) Where a national Of®ce intends to proceed under Rule 19.4(b) having regard to Rule 19.4(a)(iii), (a) Where, in accordance with Rule 90.4(d), a it shall promptly request the International Bureau as receiving Of®ce waives the requirement under Rule receiving Of®ce to agree to the transmittal of the 90.4(b) that a separate power of attorney be international application. The International Bureau submitted to it, the receiving Of®ce shall notify the as receiving Of®ce shall promptly respond to that International Bureau accordingly. request. If the International Bureau as receiving (b) Where, in accordance with Rule 90.5(c), a Of®ce agrees to the transmittal, the national Of®ce receiving Of®ce waives the requirement under Rule shall promptly invite the applicant: 90.5(a)(ii) that a copy of a general power of attorney (i) if the transmittal has not already been be attached to the request or any separate notice, the authorized by the applicant, to submit to that Of®ce, receiving Of®ce shall notify the International Bureau within a time limit of 15 days from the date of the accordingly. invitation, an authorization of the transmittal, and, (c) A receiving Of®ce may require a separate (ii) if the Of®ce requires payment of the fee power of attorney, or a copy of a general power of referred to in Rule 19.4(b) and that fee has not attorney, in particular instances even if the receiving already been paid, to pay that fee within the time Of®ce has waived the requirement in general. limit referred to in item (i).

AI-29 June 2020 § 337 MANUAL OF PATENT EXAMINING PROCEDURE

(d) A receiving Of®ce which has noti®ed the 337 [Deleted] International Bureau under paragraph (a) or (b) shall notify the International Bureau of any change to the information noti®ed under those paragraphs. PART 4

INSTRUCTIONS RELATING TO THE INTERNATIONAL BUREAU

401 Marking of the Sheets of the Record considered to lack unity of invention and the decision Copy thereon by the International Searching Authority or the International Preliminary Examining Authority, (a) The International Bureau shall, upon receipt as the case may be, it shall proceed according to such of the record copy, mark the date of receipt of the request. record copy in the appropriate space on the request. (b) If the receiving Of®ce has failed to mark any 404 International Publication Number of sheet as provided in Sections 311 and 325, the International Application marking which has not been made may be inserted by the International Bureau. The International Bureau shall assign to each published international application an international 402 Correction or Addition of a Priority publication number which shall be different from Claim under Rule 26 bis the international application number. The international publication number shall be used on (a) Where the applicant, in a notice submitted the published international application and in the to the International Bureau, corrects or adds a Gazette entry. It shall consist of the two-letter code priority claim under Rule 26 bis , that Bureau shall ªWOº followed by a four-digit indication of the year enter the correction or addition in the request, draw of publication, a slant, and a serial number consisting a line through, while still leaving legible, any of six digits (e.g., ªWO 2004/123456º). indication deleted as a result of the correction, and enter, in the margin, the letters ªIBº. 405 Publication of Noti®cations of Languages (b) [Deleted] Accepted by the Receiving Of®ce under Rules (c) The applicant, the receiving Of®ce and the 12.1(a) and (c) and 12.4(a) International Searching Authority shall be promptly noti®ed by the International Bureau of any correction The International Bureau shall promptly publish in or addition of a priority claim under Rule 26 bis and the Gazette any noti®cation under Section 332(a), of the date on which it received such correction or (b), (d) or (e). addition. 406 Publication of International Applications 403 Transmittal of Protest against Payment of Additional Fees and Decision Thereon (a) International applications shall be published Where International Application Is on a given day of the week. Considered to Lack Unity of Invention (b) International applications may be published, for the purposes of Article 21, on paper or wholly Where, under Rules 40.2(c) or 68.3(c), the or partly in electronic form. International Bureau receives a request from the applicant to forward to any designated or elected (c) Details concerning the publication of Of®ce the texts of both the protest against payment international applications, and the form and of additional fees as provided for in Articles 17(3)(a) particulars of the front page of each published and 34(3)(a) where the international application is international application, shall be decided by the Director General, after consultation with the Of®ces

June 2020 AI-30 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 410

or Authorities which have a direct interest in those shall indicate the said date in the international details. publication by including on the front page of the published international application next to the 406 bis Suggested English Translation of the priority application number the words ªFURNISHED Title of the Invention LATE ON... (date),º and the equivalent of such words in the language in which the international (a) Where the international application is to be application is published if that language is other than published in a language other than English and a English. translation of the application into English is not required under Rule 12.3(a), the applicant may (c) If the priority application number has not furnish a suggested translation of the title of the been furnished at the time of the completion of the invention into English to the International Bureau technical preparations for international publication, before the expiration of 14 months from the priority the International Bureau shall indicate that fact by date. including on the front page of the published international application in the space provided for (b) (b) The International Bureau shall, to the the priority application number the words ªNOT extent possible, take the suggested translation into FURNISHEDº and the equivalent of such words in account in the preparation of the translation referred the language in which the international application to in Rule 48.3(c) if it is received within the time is published if that language is other than English. limit speci®ed in paragraph (a). 409 Priority Claim Considered Not to Have 407 The Gazette Been Made (a) The Gazette referred to in Rule 86.1 shall be published in electronic form on the Internet. It may Where the International Bureau declares, under Rule be made available by any other electronic means as 26 bis.2(b), that a priority claim is considered not to determined by the Director General after consultation have been made, that Bureau shall enclose the with the Of®ces and Authorities which have a direct priority claim concerned within square brackets, interest in the means by which the Gazette is draw a line between the square brackets, while still published. leaving legible the indications concerned, and enter, in the margin, the words ªNOT TO BE (b) In respect of each published international CONSIDERED FOR PCT PROCEDURE (IB)º or application, the Gazette shall contain the contents their equivalent in the language of publication of the speci®ed in Rule 86.1(i), the contents speci®ed in international application, and shall notify the Rule 86.1(iv), and the data indicated in Annex D. applicant accordingly. The International Bureau shall (c) The information referred to in Rule 86.1(v) also notify the receiving Of®ce and the International shall be that which is indicated in Annex E. Searching Authority. (d) Details concerning the form and further particular content of the Gazette shall be decided by 410 Numbering of Sheets for the Purposes the Director General after consultation with Of®ces of International Publication; Procedure in and Authorities which have a direct interest in those Case of Missing Sheets details. (a) In the course of preparing the international 408 Priority Application Number application for international publication, the International Bureau shall sequentially renumber the (a) [Deleted] sheets to be published only when necessitated by the (b) If the number of the earlier application addition of any new sheet, the deletion of entire referred to in Rule 4.10(a)(ii) (ªpriority application sheets or a change in the order of the sheets. numberº) is furnished after the expiration of the Otherwise, the numbering provided under Section prescribed time limit, the International Bureau shall 207 shall be maintained. inform the applicant and the designated Of®ces of (b) Where a sheet has not been ®led or is not to the date on which the said number was furnished. It be taken into consideration for the purposes of

AI-31 June 2020 § 411 MANUAL OF PATENT EXAMINING PROCEDURE

international processing under Section 310 bis or and Recti®cations of Obvious Mistakes under 310 ter , the International Bureau shall include an Rule 91 indication to that effect in the published international application. (a) Where the International Bureau receives from 411 Receipt of Priority Document the receiving Of®ce a letter containing a correction of any defects under Rule 26.4, or a replacement (a) The International Bureau shall, in respect of sheet and the letter accompanying it, the any priority document received or obtained by it, International Bureau shall transfer the correction to record the date on which the priority document has the record copy, together with the indication of the been received or obtained by it, and notify the date on which the receiving Of®ce received the applicant and the designated Of®ces accordingly. letter, or shall insert the replacement sheet in the The noti®cation should indicate whether the priority record copy. Any letter and any replaced sheet shall document was or was not submitted, transmitted, or be kept in the ®le of the international application. obtained in compliance with Rule 17.1(a), (b) or (b) Paragraph (a) shall apply mutatis mutandis (b- bis), and with respect to the designated Of®ces, to recti®cations of obvious mistakes under Rule 91 should preferably be made together with the authorized by the receiving Of®ce, by the noti®cation under Rule 47.1(a- bis ). International Searching Authority or, where a (b) Where the priority document has been demand has been made, by the International submitted, transmitted, or obtained but not in Preliminary Examining Authority. compliance with Rule 17.1(a), (b) or (b- bis), the (b- bis) Where the International Bureau receives International Bureau shall, in the noti®cation under from the receiving Of®ce, under Sections 309(c)(iv), paragraph (a) of this Section, direct the attention of 310(b)(iv), or 310 bis(b)(v), corrected sheets of the the applicant and the designated Of®ces to the request or later submitted sheets, the International provisions of Rule 17.1(c). Bureau shall transfer any correction to the record copy and insert any later submitted sheets in the 411 bis Receipt of Translation of Earlier record copy. Application under Rule 20.6(a)(iii) (c) Where the International Bureau is noti®ed by the International Searching Authority under Rule The International Bureau shall indicate the words 43.6 bis(b) that the recti®cation of an obvious ªTRANSLATION (RULE 20.6(a)(iii))º, or their mistake authorized under Rule 91 has not been taken equivalent in French, on any translation received into account for the purposes of the international under Rule 20.6(a)(iii). search, the International Bureau shall notify the designated Of®ces and, where a demand has been 412 Noti®cation of Lack of Transmittal of made, the International Preliminary Examining Search Copy Authority accordingly. (d) Where the International Bureau is noti®ed If the International Bureau does not receive from the by the International Preliminary Examining International Searching Authority a noti®cation Authority under Rule 70.2(e) that the recti®cation under Rule 25.1 within two months from the date of of an obvious mistake authorized under Rule 91 has receipt of the record copy, the International Bureau not been taken into account for the purposes of the shall remind the receiving Of®ce to transmit the international preliminary examination, the search copy to the International Searching Authority. International Bureau shall notify the elected Of®ces A copy of the reminder shall be sent to the accordingly. International Searching Authority. 413 bis Recti®cations of Obvious Mistakes 413 Incorporations by Reference under Rule under Rule 91 20, Corrections of Defects under Rule 26.4 (a) Where the International Bureau authorizes a recti®cation under Rule 91, it shall:

June 2020 AI-32 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 415

(i) indelibly mark, in the upper right-hand 415 Noti®cation of Withdrawal under Rule corner of each replacement sheet, the international 90 bis.1, 90 bis.2, 90 bis.3, 90 bis.3 bis or application number and the date on which that sheet 90 bis.4 was received; (ii) indelibly mark, in the middle of the (a) The fact of withdrawal by the applicant of bottom margin of each replacement sheet, the words the international application under Rule 90 bis.1, of ªRECTIFIED SHEET (RULE 91)º or their designations under Rule 90 bis.2, or of a priority equivalent in the language of publication of the claim under Rule 90 bis.3, together with the date on international application; which the notice effecting withdrawal reached the International Bureau, the International Preliminary (iii) indelibly mark on the letter containing Examining Authority or the receiving Of®ce, shall the recti®cation or accompanying any replacement be recorded by the International Bureau and sheet the date on which that letter was received; promptly noti®ed by it to the receiving Of®ce, the (iv) keep in its ®les a copy of the letter applicant, the designated Of®ces affected by the containing the recti®cation or, when the recti®cation withdrawal and, where the withdrawal concerns the is contained in a replacement sheet, the replaced international application or a priority claim and sheet, a copy of the letter accompanying the where the international search report, or the replacement sheet, and a copy of the replacement declaration referred to in Article 17(2)(a), and the sheet. written opinion of the International Searching Authority have not yet issued, the International (b) Where the International Bureau refuses to Searching Authority. However, where the withdrawal authorize a recti®cation under Rule 91, it shall concerns the international application and where the proceed as indicated under paragraph (a)(i), (iii) and notice effecting withdrawal was ®led with the (iv). receiving Of®ce before the sending of the record (c) Where the International Bureau authorizes copy to the International Bureau, that Bureau shall or refuses to authorize the recti®cation of an obvious send the noti®cations referred to in the preceding mistake under Rule 91, it shall notify the applicant, sentence and in Rule 24.2(a) to the receiving Of®ce the International Searching Authority, where a and the applicant only. demand has been made, the International Preliminary (b) If, at the time of the withdrawal of the Examining Authority, as well as the designated or international application under Rule 90 bis.1, or of elected Of®ces accordingly and, where the a priority claim under Rule 90 bis.3, a demand has International Bureau refuses to authorize a already been submitted and the international recti®cation, the noti®cation shall also include the preliminary examination report has not yet issued, reasons for the refusal. the International Bureau shall, unless the notice 414 Noti®cation to the International effecting withdrawal was submitted to the Preliminary Examining Authority Where the International Preliminary Examining Authority, International Application is Considered promptly notify the fact of withdrawal to that Withdrawn Authority, together with the date on which the notice effecting withdrawal has reached the International Bureau or the receiving Of®ce. If a demand has been submitted and the international application is considered withdrawn under Article (c) If, at the time of the withdrawal of the 14(1), (3) or (4), the International Bureau shall international application under Rule 90 bis.1, or of promptly notify the International Preliminary a priority claim under Rule 90 bis.3, a supplementary Examining Authority, unless the international search request has already been submitted and the preliminary examination report has already issued. supplementary international search report has not yet been established, the International Bureau shall promptly notify the fact of withdrawal to the Authority speci®ed for supplementary search, together with the date on which the notice effecting

AI-33 June 2020 § 416 MANUAL OF PATENT EXAMINING PROCEDURE

withdrawal has reached the International Bureau or made under Article 19 was received, shall notify the the receiving Of®ce. applicant of that date and indicate it in any (d) The fact of withdrawal by the applicant of publication or copy issued by it. the supplementary search request under Rule (b) The International Bureau shall mark, in the 90 bis.3 bis, together with the date on which the upper right-hand corner of each replacement sheet notice effecting withdrawal was, or was considered submitted under Rule 46.5(a), the international to have been, submitted to the International Bureau, application number, the date on which that sheet was shall be promptly noti®ed by that Bureau: received under Rule 46.1 and, in the middle of the (i) to the applicant, and bottom margin, the words ªAMENDED SHEET (ARTICLE 19).º It shall keep in its ®les any (ii) to the Authority speci®ed for replaced sheet and the letter accompanying the supplementary search, unless the notice effecting replacement sheet or sheets. withdrawal was submitted to that Authority. (c) The International Bureau shall insert any (e) The fact of withdrawal by the applicant of replacement sheet or sheets in the record copy. the demand or of one or more elections under Rule 90 bis.4, together with the date on which the notice (d) If, at the time when the demand is received effecting withdrawal was, or was considered to have by the International Bureau, the international search been, submitted to the International Bureau, shall be report and the written opinion of the International promptly noti®ed by that Bureau: Searching Authority have been established and no amendments under Article 19 have been made, the (i) to the applicant, International Bureau shall inform the International (ii) to each elected Of®ce affected by the Preliminary Examining Authority accordingly, unless withdrawal, except where it has not yet been noti®ed the Authority has informed the International Bureau of its election, and that it wishes not to be so noti®ed. (iii) in the case of withdrawal of the demand 418 Noti®cations to Elected Of®ces Where or of all elections, to the International Preliminary the Demand Is Considered Not to Have Been Examining Authority, unless the notice effecting Submitted or Made withdrawal was submitted to that Authority. 416 Correction of Request in Record Copy Where, after any elected Of®ce has been noti®ed of its election under Article 31(7), the demand is (a) Where the request requires correction as a considered not to have been submitted or made, the consequence of the withdrawal of a designation or International Bureau shall notify the said Of®ce of a change made under Rule 92 bis , the accordingly. International Bureau shall make the necessary correction in the record copy and shall notify the 419 Processing of a Declaration under Rule applicant and the receiving Of®ce accordingly. 26 ter (b) When making a correction under paragraph (a), the International Bureau shall enter, in the (a) Where any declaration referred to in Rule margin, the letters ªIB.º Where the correction 4.17, or any correction thereof under Rule 26 ter.1, involves the deletion or replacement of some matter, is submitted to the International Bureau within the the International Bureau shall enclose such matter time limit under Rule 26 ter.1, the International within square brackets and shall draw a line between Bureau shall indicate the date on which it received the square brackets while still leaving the deleted or the declaration or correction and insert the additional replaced matter legible. sheet or replacement sheet in the record copy. (b) The International Bureau shall promptly 417 Processing of Amendments under Article notify the applicant, the receiving Of®ce and the 19 International Searching Authority of any declaration corrected or added under Rule 26 ter.1. (a) The International Bureau shall record the date on which, under Rule 46.1, any amendment

June 2020 AI-34 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 422

(c) The International Bureau shall not make any report and, where applicable, a copy of the English ex of®cio correction to declarations referred to in translation of the said report to the International Rule 4.17 which are contained in the request. Preliminary Examining Authority (Rule 45 bis.8(c)). (d) Where any declaration referred to in Rule In cases where, instead of the supplementary 4.17, or any correction thereof under Rule 26 ter .1, international search report, a declaration under is submitted to the International Bureau after the Article 17(2)(a) was issued, references in the expiration of the time limit under Rule 26 ter.1, the preceding sentence to the supplementary International Bureau shall notify the applicant international search report shall be considered accordingly and inform the applicant that such a references to the said declaration. declaration or correction should be submitted directly 421 Invitation to Furnish a Copy of the to the designated Of®ce or Of®ces concerned. Any Priority Document declaration referred to in Rule 4.17(iv), signed as prescribed in Section 214, which is submitted to the Where a request for a copy of the application whose International Bureau after the expiration of the time priority is claimed in the international application is limit under Rule 26 ter.1 shall be returned to the made under Rule 43 bis.1(b) by the International applicant. Searching Authority or, under Rule 66.7(a), by either 420 Copy of International Application, the International Searching Authority, or the International Search Report and International Preliminary Examining Authority Supplementary International Search Report before the International Bureau has received the for the International Preliminary Examining priority document under Rule 17.1, the International Bureau shall, unless the applicable time limit referred Authority to in Rule 17.1(a) has already expired, inform the applicant of such request and remind him of the (a) Where the International Preliminary requirements of Rule 17.1. Examining Authority is not part of the same national Of®ce or intergovernmental organization as the International Searching Authority, the International 422 Noti®cations Concerning Changes Bureau shall, promptly upon receipt of the Recorded under Rule 92 bis.1 international search report or, if the demand was received after the international search report, (a) The International Bureau shall give promptly upon receipt of the demand, send a copy noti®cations concerning changes recorded by it of the international application, the international under Rule 92 bis.1(a), except changes which are search report and, where applicable, a copy of the the subject of noti®cations under Section 425: English translation of the said report to the (i) to the receiving Of®ce; International Preliminary Examining Authority. In (ii) as long as the international search report, cases where, instead of the international search or the declaration referred to in Article 17(2)(a), and report, a declaration under Article 17(2)(a) was the written opinion of the International Searching issued, references in the preceding sentence to the Authority have not been established, to the international search report shall be considered International Searching Authority; references to the said declaration. (iii) to the designated Of®ces unless the (b) Where an Authority speci®ed for change can be duly re¯ected in the published supplementary search has established a international application used for the purposes of supplementary international search report under Rule the communication under Article 20; 45 bis.7, and the International Preliminary Examining Authority is not part of the same national (iv) as long as the international preliminary Of®ce or intergovernmental organization as the examination report has not been established, to the Authority speci®ed for supplementary search, the International Preliminary Examining Authority; International Bureau shall, promptly upon receipt of (v) to the elected Of®ces, unless the change the supplementary international search report, send can be duly re¯ected in the published international a copy of the supplementary international search

AI-35 June 2020 § 422 bis MANUAL OF PATENT EXAMINING PROCEDURE

application used for the purposes of the (b) The International Bureau shall cancel ex communication under Article 20; of®cio: (vi) to the applicant; where the change (i) the election of any State which is not a consists of a change in the person of the applicant, designated State; the noti®cation shall be sent to the earlier applicant (ii) the election of any State not bound by and the new applicant, provided that, where the Chapter II of the Treaty, if the International earlier applicant and the new applicant are Preliminary Examining Authority has failed to do represented by the same agent, one noti®cation only so. shall be sent to the said agent. (c) The International Bureau shall enclose the (b) Where Rule 92 bis.1(b) applies, the cancelled election within square brackets, draw a International Bureau shall notify the applicant line between the square brackets while still leaving accordingly and, if the change was requested by the the election legible, enter, in the margin, the words receiving Of®ce, that Of®ce. ªCANCELLED EX OFFICIO BY IBº or their equivalent in French, and notify the applicant and, 422 bis Objections Concerning Changes in if the election is in the demand, the International the Person of the Applicant Recorded under Preliminary Examining Authority accordingly. Rule 92 bis.1(a) 424 Procedure under Rule 4.9(b) (a) Where a change recorded by the International Bureau under Rule 92 bis.1(a): (a) Where the International Bureau ®nds, if the Receiving Of®ce has failed to do so, that the request (i) consists of a change in the person of the contains an indication under Rule 4.9(b) that the applicant, and designation of a State is not made but the request (ii) the request under Rule 92 bis.1(a) was does not contain a priority claim to an earlier national not signed by or on behalf of both the earlier and the application ®led in that State, the International new applicant, and Bureau shall promptly notify the applicant (iii) the earlier applicant objects to the change accordingly and shall draw the applicant's attention in writing, to Rule 26 bis . (b) If the International Bureau does not, before the change under Rule 92 bis.1(a) shall be considered the expiration of the time limit under Rule as if it had not been recorded. 26 bis.1(a), receive a notice correcting or adding a (b) Where paragraph (a) applies, the priority claim to an earlier national application ®led International Bureau shall notify all those who in the State, the designation of which is not made, received a noti®cation under Section 422(a) it shall cancel ex of®cio the indication under Rule accordingly. 4.9(b), shall enclose that indication in square brackets, draw a line between the square brackets 423 Cancellation of Designations and while still leaving the indication legible, enter, in Elections the margin, the words ªCANCELLED EX OFFICIO BY IBº or their equivalent in French, and notify the (a) The International Bureau shall, if the applicant and the receiving Of®ce accordingly. receiving Of®ce has failed to do so, cancel ex of®cio 425 Noti®cations Concerning Representation the designation of any State which is not a Contracting State, shall enclose that designation within square brackets, draw a line between the Where a power of attorney or a document containing square brackets while still leaving the designation the revocation or renunciation of an appointment is legible, enter, in the margin, the words submitted to the International Bureau, the ªCANCELLED EX OFFICIO BY IBº or their International Bureau shall immediately notify the equivalent in French, and notify the applicant and receiving Of®ce, the International Searching the receiving Of®ce accordingly. Authority, the Authority speci®ed for supplementary search and the International Preliminary Examining

June 2020 AI-36 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 434

Authority by sending them a copy of the power of the expiration of 19 months from the priority date attorney or document and shall record a change in and the time limit under Article 22(1), as in force the indications concerning the agent or common from April 1, 2002, does not apply in respect of all representative under Rule 92 bis . In the case of a designated Of®ces, the notice shall also indicate that renunciation of an appointment, the International fact. Bureau shall also notify the applicant. Where the 432 Noti®cation to Applicant of Submission International Bureau receives a noti®cation of Demand after the Expiration of 19 Months concerning representation under Section 328, it shall immediately notify the Authority speci®ed for from the Priority Date supplementary search and the International Preliminary Examining Authority accordingly. Where the demand is submitted after the expiration of 19 months from the priority date and subsequently 426-429 [Deleted] transmitted to the International Bureau under Rule 59.3(a), or is submitted after the expiration of 19 months from the priority date to the International 430 Noti®cation of Designations under Rule Bureau, and the time limit under Article 22(1), as in 32 force from April 1, 2002, does not apply in respect of all designated Of®ces, the International Bureau Where the effects of any international application shall, together with the noti®cation sent to the are extended to a successor State under Rule 32.1(a), applicant under Rule 59.3(c)(i) or the invitation sent the International Bureau shall promptly, but not to the applicant under Rule 59.3(c)(ii), as the case before the international publication of the may be: international application, effect the communication under Article 20 to the designated Of®ce concerned, (i) promptly notify the applicant accordingly, and notify that Of®ce under Rule 47.1(a- bis ) directing attention to the fact that the time limit under Article 39(1)(a) does not apply, and that Article 431 Publication of Notice of Submission of 22(1), as in force until March 31, 2002, continues Demand to apply in respect of any such designated Of®ce, (ii) proceed under Rule 59.3. (a) For international applications in respect of which a demand is ®led before January 1, 2004, the 433 Waivers under Rule 90.4(d) publication in the Gazette of information on the demand and the elected States concerned, as referred (a) Where, in accordance with Rule 90.4(d), the to in Rule 61.4, as in force until December 31, 2003, International Bureau waives the requirement under shall consist of a notice indicating that a demand has Rule 90.4(b) that a separate power of attorney be been submitted prior to the expiration of 19 months submitted to it, the International Bureau shall publish from the priority date and, as applicable, indicating a notice of this fact in the Gazette. that all eligible States have been elected or, where (b) The International Bureau may require a not all eligible States have been elected, indicating separate power of attorney in particular instances those eligible States which have not been elected. even if the International Bureau has waived the (b) For international applications in respect of requirement in general. which a demand is ®led on or after January 1, 2004, 434 Publication of Information Concerning the publication in the Gazette of information on the Waivers under Rules 90.4(d) and 90.5(c) demand and the elected States concerned, as referred to in Rule 61.4, as in force from January 1, 2004, (a) Any waivers of the requirement under Rule shall consist of a notice indicating that a demand has 90.4(b) that a separate power of attorney be been submitted prior to the expiration of the submitted, or any changes to the information, applicable time limit under Rule 54 bis.1(a) and that noti®ed to the International Bureau under Sections all Contracting States which were designated and 336(a), 517(a), or 617(a) shall be promptly published were bound by Chapter II of the Treaty have been in the Gazette. The effective date of any change shall elected. Where the demand is made subsequent to

AI-37 June 2020 § 435 MANUAL OF PATENT EXAMINING PROCEDURE

be two months after the date of publication of the (c) Pursuant to Rule 93 bis.1(b), where so agreed change in the Gazette, or such later date as may be between the International Bureau and the Of®ce determined by the International Bureau. concerned, the communication of documents under (b) Any waivers of the requirement under Rule Rule 93 bis.1 shall be considered to be effected at 90.5(a)(ii) that a copy of a general power of attorney the time when the International Bureau makes the be attached to the request, the demand or any document available to that Of®ce in electronic form separate notice, or any changes to the information, via the International Bureau's electronic data noti®ed to the International Bureau under Sections exchange services. 336(b), 517(b), or 617(b) shall be promptly published (d) Technical details concerning the in the Gazette. The effective date of any change shall communication of publications under Rule 87.1 and be two months after the date of publication of the of documents under Rule 93 bis.1 shall be agreed change in the Gazette, or such later date as may be between the International Bureau and the Authority determined by the International Bureau. or Of®ce concerned. 435 Communication of Publications and 436 Preparation, Identi®cation and Documents Transmittal of the Copies of the Translation of the International Application (a) Subject to paragraph (b), publications under Rule 87.1 and documents under Rule 93 bis.1 shall Where, for the purposes of a supplementary be communicated in electronic form via the international search, a translation of the international International Bureau's electronic data exchange application is furnished under Rule 45 bis.1(c)(i), services. the International Bureau shall mark the words (b) Where so agreed between the International ªTRANSLATION (RULE 45 bis.1(c)(i))º in the Bureau and the Authority or Of®ce concerned, upper left-hand corner of the ®rst page of the publications under Rule 87.1 and documents under translation and transmit a copy of that translation to Rule 93 bis.1 may be communicated in other forms the Authority speci®ed for the supplementary search. and by other means. PART 5

INSTRUCTIONS RELATING TO THE INTERNATIONAL SEARCHING AUTHORITY

501 [Deleted] to the International Bureau a copy of both the protest and the decision thereon, as well as any request by 502 Transmittal of Protest against Payment the applicant to forward the texts of both the protest of Additional Fees and Decision Thereon and the decision thereon to the designated Of®ces. Where International Application Is Considered to Lack Unity of Invention 503 Method of Identifying Documents Cited in the International Search Report and the The International Searching Authority shall transmit Written Opinion of the International to the applicant, preferably at the latest together with Searching Authority the international search report, any decision which it has taken under Rule 40.2(c) on the protest of the Identi®cation of any document cited in the applicant against payment of additional fees where international search report shall be as provided in the international application is considered to lack WIPO Standard ST.14 (Recommendation for the unity of invention. At the same time, it shall transmit Inclusion of References Cited in Patent Documents).

June 2020 AI-38 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 507

combined with one or more other such documents, 1 Any document cited in the international search such combination being obvious to a person skilled report may be referred to in a shortened form in the in the art. written opinion of the International Searching Authority, provided that the reference to the 506 [Deleted] document is unambiguous. 507 Manner of Indicating Certain Special 504 Classi®cation of the Subject Matter of Categories of Documents Cited in the the International Application International Search Report

(a) Where the subject matter of the international (a) Where any document cited in the application is such that classi®cation thereof requires international search report refers to an oral more than one classi®cation symbol according to disclosure, use, exhibition, or other means referred the principles to be followed in the application of to in Rule 33.1(b), the separate indication required the International Patent Classi®cation to any given by that Rule shall consist of the letter ªOº placed patent document, the international search report shall next to the citation of the document. Category "O" indicate all such symbols. shall be accompanied by one of the categories "X", (b) Where any national classi®cation system is "Y" or "A". used, the international search report may indicate all (b) Where any document cited in the the applicable classi®cation symbols also according international search report is a published application to that system. or patent as de®ned in Rule 33.1(c), the special (c) Where the subject matter of the international mention required by that Rule shall consist of the application is classi®ed both according to the letter ªEº placed next to the citation of the document. International Patent Classi®cation and to any (c) Where any document cited in the national classi®cation system, the international international search report is not considered to be of search report shall, wherever possible, indicate the particular relevance requiring the use of categories corresponding symbols of both classi®cations ªXº and/or ªYº as provided in Section 505 but opposite each other. de®nes the general state of the art, it shall be (d) The version of the International Patent indicated by the letter ªAº placed next to the citation Classi®cation applicable at the time the international of the document. application is published under Article 21 shall be (d) Where any document cited in the used whenever feasible. international search report is a document whose 505 Indication of Citations of Particular publication date occurred earlier than the Relevance in the International Search Report international ®ling date of the international application, but later than the priority date claimed (a) Where any document cited in the in that application, it shall be indicated by the letter international search report is of particular relevance, ªPº next to the citation of the said document. the special indication required by Rule 43.5(c) shall Category ªPº shall be accompanied by one of the consist of the letter(s) ªXº and/or ªYº placed next categories ªXº, ªYº or ªAº. to the citation of the said document. (e) Where any document cited in the (b) Category ªXº is applicable where a international search report is a document whose document is such that when taken alone, a claimed publication date occurred after the ®ling date or the invention cannot be considered novel or cannot be priority date of the international application and is considered to involve an inventive step. not in con¯ict with the said application, but is cited for the principle or theory underlying the invention, (c) Category ªYº is applicable where a document which may be useful for a better understanding of is such that a claimed invention cannot be considered the invention, or is cited to show that the reasoning to involve an inventive step when the document is or the facts underlying the invention are incorrect,

1 Editor's Note: Published in the WIPO Handbook on Industrial Property Information and Documentation.

AI-39 June 2020 § 508 MANUAL OF PATENT EXAMINING PROCEDURE

it shall be indicated by the letter ªTº next to the (i) where the cited document is relevant to citation of the document. one claim, the number of that claim; for example, (e-bis) Where any document cited in the ª2º or ª17º; international search report is a document cited by (ii) where the cited document is relevant to the applicant in the international application, it shall two or more claims numbered in consecutive order, be indicated by the letter ªDº next to the citation of the number of the ®rst and last claims of the series the document. Category ªDº shall be accompanied connected by a hyphen; for example, ª1-15º or by one of the categories indicating the relevance of ª2-3º; the cited document. (iii) where the cited document is relevant to (f) Where in the international search report any two or more claims that are not numbered in document is cited for reasons other than those consecutive order, the number of each claim placed referred to in paragraphs (a) to (e -bis), for example: in ascending order and separated by a comma or Ð a document which may throw doubt on commas; for example, ª1, 6º or ª1, 7, 10º; a priority claim, (iv) where the cited document is relevant to Ð a document cited to establish the more than one series of claims under (ii), above, or publication date of another citation, to claims of both categories (ii) and (iii), above, the series or individual claim numbers and series placed such document shall be indicated by the letter ªLº in ascending order using commas to separate the next to the citation of the document and the reason several series, or to separate the numbers of for citing the document shall be given. individual claims and each series of claims; for example, ª1-6, 9-10, 12-15º or ª1, 3-4, 6, 9-11º. (g) Where a document is a member of a patent family, it shall, whenever feasible, be mentioned in (b) Where different categories apply to the same the international search report in addition to the one document cited in an international search report in cited belonging as well to this family and should be respect of different claims or groups of claims, each preceded by the sign ampersand (&). Members of a relevant claim or group of claims shall be listed patent family may also be mentioned on a separate separately opposite each indicated category of sheet, provided that the family to which they belong relevance. Each category and each relevant claim or shall be clearly identi®ed and that any text matter group of claims may be separated by a line. on that sheet, if not in the English language, shall The following example illustrates the situation also be furnished to the International Bureau in where a document is of particular relevance under English translation. Section 505(b) as to claims 1 to 3 and under Section (h) A document whose contents have not been 505(c) as to claim 4, and indicates the general state veri®ed by the search examiner but are believed to of the art under Section 507(c) as to claims 11 and be substantially identical with those of another 12: document which the search examiner has inspected, may be cited in the international search report in the manner indicated for patent family members in the ®rst sentence of paragraph (g). 508 Manner of Indicating the Claims to Which the Documents Cited in the International Search Report Are Relevant

(a) The claims to which cited documents are relevant shall be indicated by placing in the appropriate column of the international search report:

June 2020 AI-40 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 513

509 International Search and Written (iii) indelibly mark on the letter containing Opinion of the International Searching the recti®cation or accompanying any replacement Authority on the Basis of a Translation of the sheet the date on which that letter was received; International Application (iv) keep in its ®les a copy of the letter containing the recti®cation or, when the recti®cation Where the International Searching Authority has is contained in a replacement sheet, the replaced carried out the international search and established sheet, a copy of the letter accompanying the the written opinion on the basis of a translation of replacement sheet, and a copy of the replacement the international application transmitted to that sheet; Authority under Rule 23.1(b), the international (v) promptly transmit any letter and any search report and the written opinion of the replacement sheet to the International Bureau and a International Searching Authority shall so indicate. copy thereof to the receiving Of®ce. 510 Refund of Search Fee in Case of (b) Where the International Searching Authority Withdrawal of International Application refuses to authorize a recti®cation under Rule 91, it shall proceed as indicated under paragraph (a)(i), (a) Where the international application is (iii), and (iv) and promptly transmit any letter and withdrawn or is considered withdrawn before the any proposed replacement sheet to the International International Searching Authority has started the Bureau. international search, that Authority shall, subject to 512 Noti®cations Concerning Representation paragraphs (b) and (c), refund the search fee to the applicant. Where a power of attorney or a document containing (b) If the refund referred to in paragraph (a) is the revocation or renunciation of an appointment is not compatible with the national law of the national submitted to the International Searching Authority, Of®ce acting as International Searching Authority that Authority shall immediately notify the and as long as it continues to be not compatible with International Bureau by sending it a copy of the that law, the International Searching Authority may power of attorney or document and request the abstain from refunding the search fee. International Bureau to record a change in the (c) The International Searching Authority may, indications concerning the agent or common before making a refund under paragraph (a), ®rst representative under Rule 92 bis.1(a)(ii). invite the applicant to submit a request for the refund. 513 Sequence Listings

511 Recti®cations of Obvious Mistakes under (a) Where the International Searching Authority Rule 91 receives a correction of a defect under Rule 13 ter.1(f), it shall: (a) Where the International Searching Authority authorizes a recti®cation under Rule 91, it shall: (i) indelibly mark, in the upper right-hand (i) indelibly mark, in the upper right-hand corner of each replacement sheet, the international corner of each replacement sheet, the international application number and the date on which that sheet application number and the date on which that sheet was received; was received; (ii) indelibly mark, in the middle of the (ii) indelibly mark, in the middle of the bottom margin of each replacement sheet, the words bottom margin of each replacement sheet, the words ªSUBSTITUTE SHEET (RULE 13 ter.1(f))º or their ªRECTIFIED SHEET (RULE 91)º or their equivalent in the language of publication of the equivalent in the language of publication of the international application; international application as well as an indication of the International Searching Authority as provided for in Section 107(b);

AI-41 June 2020 § 514 MANUAL OF PATENT EXAMINING PROCEDURE

(iii) indelibly mark on the letter containing (ii) where the sequence listing which does the correction, or accompanying any replacement not form part of the international application but was sheet, the date on which that letter was received; furnished for the purposes of the international search (iv) keep in its ®les a copy of the letter is in electronic form, transmit one copy thereof to containing the correction or, when the correction is the International Bureau together with the copy of contained in a replacement sheet, the replaced sheet, the international search report. If that listing in a copy of the letter accompanying the replacement electronic form is ®led on a physical medium in less sheet, and a copy of the replacement sheet; than the number of copies required by the International Searching Authority, that Authority (v) promptly transmit any letter and any shall be responsible for the preparation of the replacement sheet to the International Bureau, and additional copy and shall have the right to ®x a fee a copy thereof to the receiving Of®ce. for performing that task and to collect such fee from (b) Where the international search report and the applicant. the written opinion of the International Searching (f) Any International Searching Authority which Authority are based on a sequence listing not requires, for the purposes of the international search, forming part of the international application but the furnishing of a sequence listing in electronic furnished for the purposes of the international search, form shall notify the International Bureau the international search report and the written accordingly. In that noti®cation, the Authority shall opinion of the International Searching Authority specify the means of transmittal of the sequence shall so indicate. listing in electronic form accepted by it in (c) Where a meaningful international search accordance with Annex F. The International Bureau cannot be carried out and a meaningful written shall promptly publish details of the noti®cation in opinion, as to whether the claimed invention appears the Gazette. to be novel, to involve an inventive step (to be 514 Authorized Of®cer non-obvious) and to be industrially applicable, cannot be established because a sequence listing is not available to the International Searching Authority The of®cer of the International Searching Authority in the required form, that Authority shall so state in responsible for the international search report, as the international search report or declaration referred referred to in Rule 43.8, and for the written opinion to in Article 17(2)(a), and in the written opinion. of the International Searching Authority, as referred to in Rule 43 bis.1(b), means the person who actually (d) The International Searching Authority shall performed the search work and prepared the search indelibly mark, on the ®rst sheet of any sequence report and the written opinion of the International listing on paper which does not form part of the Searching Authority, or another person who was international application but was furnished for the responsible for supervising the search and the purposes of the international search, the words establishment of the written opinion. ªSEQUENCE LISTING NOT FORMING PART OF THE INTERNATIONAL APPLICATIONº or 515 Modi®cation of Abstract in Response to their equivalent in the language of publication of the Applicant's Comments international application. Where such sequence listing is furnished in electronic form on a physical The International Searching Authority shall inform medium, that Authority shall physically label that the applicant and the International Bureau of any medium accordingly. modi®cations made by it to an abstract under Rule (e) The International Searching Authority shall: 38.3.

(i) keep in its ®les one copy of any sequence listing, whether on paper or in electronic form, which does not form part of the international application but was furnished for the purposes of the international search; and

June 2020 AI-42 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 601

516 Noti®cation to Applicant of Submission (d) An International Searching Authority which of Demand after the Expiration of 19 Months has noti®ed the International Bureau under paragraph from the Priority Date (a) or (b) shall notify the International Bureau of any change to the information noti®ed under those paragraphs. Where the demand is submitted after the expiration of 19 months from the priority date to an 518 Guidelines for Explanations Contained International Searching Authority and the time limit in the Written Opinion of the International under Article 22(1), as in force from April 1, 2002, Searching Authority does not apply in respect of all designated Of®ces, that Authority shall: For the purposes of establishing the written opinion of the International Searching Authority, Section (i) promptly notify the applicant accordingly, 604shall apply mutatis mutandis. directing attention to the fact that the time limit under Article 39(1)(a) does not apply, and that Article 22(1), as in force until March 31, 2002, continues 519 Noti®cation of Receipt of Copy of to apply in respect of any such designated Of®ce, International Application for the Purposes of Supplementary International Search (ii) proceed under Rule 59.3. 517 Waivers under Rules 90.4(d) and 90.5(c) The Authority speci®ed for supplementary search shall promptly notify the International Bureau and (a) Where, in accordance with Rule 90.4(d), an the applicant of the fact and the date of receipt of International Searching Authority waives the the copy of the international application for the requirement under Rule 90.4(b) that a separate power purposes of the supplementary international search. of attorney be submitted to it, the International Searching Authority shall notify the International 520 Withdrawal by Applicant under Rule Bureau accordingly. 90 bis.3 bis (b) Where, in accordance with Rule 90.5(c), an International Searching Authority waives the The Authority speci®ed for supplementary search requirement under Rule 90.5(a)(ii) that a copy of a shall promptly transmit to the International Bureau general power of attorney be attached to any separate any notice from the applicant effecting withdrawal notice, it shall notify the International Bureau of the supplementary search request under Rule accordingly. 90 bis.3 bis which has been ®led with it. The Authority speci®ed for supplementary search shall (c) An International Searching Authority may mark the notice with the date on which it was require a separate power of attorney, or a copy of a received. general power of attorney, in particular instances even if the International Searching Authority has waived the requirement in general. PART 6

INSTRUCTIONS RELATING TO THE INTERNATIONAL PRELIMINARY EXAMINING AUTHORITY

601 Noti®cation to Applicant of Submission the time limit under Article 22(1), as in force from of Demand after the Expiration of 19 Months April 1, 2002, does not apply in respect of all from the Priority Date designated Of®ces, the International Preliminary Examining Authority shall promptly notify the (a) Where the demand is submitted after the applicant accordingly, directing attention to the fact expiration of 19 months from the priority date and that the time limit under Article 39(1)(a) does not

AI-43 June 2020 § 602 MANUAL OF PATENT EXAMINING PROCEDURE

apply, and that Article 22(1), as in force until March sheet, without obscuring the marking made under 31, 2002, continues to apply in respect of any such item (ii), the words ªSUPERSEDED designated Of®ce. REPLACEMENT SHEET (RULE 70.16(b))º or, as (b) Where the demand is submitted after the applicable, the words ªACCOMPANYING LETTER expiration of 19 months from the priority date to an (RULE 70.16(b))º; International Preliminary Examining Authority (v) annex to the copy of the international which is not competent for the international preliminary examination report which is transmitted preliminary examination of the international to the International Bureau any replacement sheet application, and the time limit under Article 22(1), and letter as provided for under Rule 70.16; as in force from April 1, 2002, does not apply in respect of all designated Of®ces, that Authority shall: (vi) annex to the copy of the international preliminary examination report which is transmitted to the applicant a copy of each replacement sheet (i) promptly notify the applicant accordingly, and letter as provided for under Rule 70.16. directing attention to the fact that the time limit under (b) Section 311(b)(ii) relating to the numbering Article 39(1)(a) does not apply, and that Article of replacement sheets shall apply when one or more 22(1), as in force until March 31, 2002, continues sheets are added under Rule 66.8. to apply in respect of any such designated Of®ce, (c) Where the International Preliminary (ii) proceed under Rule 59.3. Examining Authority receives from the applicant a 602 Processing of Amendments by the copy of a purported amendment under Article 19 International Preliminary Examining submitted after the time limit set forth in Rule 46.1, Authority the International Preliminary Examining Authority may consider such an amendment as an amendment (a) The International Preliminary Examining under Article 34 in which case it shall inform the Authority shall: applicant accordingly. (d) Where the International Preliminary Examining Authority receives a copy of an (i) indelibly mark, in the upper right-hand amendment under Article 19, paragraphs (a) and (b) corner of each replacement sheet submitted under shall apply mutatis mutandis. Rule 66.8, the international application number and the date on which that sheet was received; 603 Transmittal of Protest against Payment (ii) indelibly mark, in the middle of the of Additional Fees and Decision Thereon bottom margin of each replacement sheet, the words Where International Application Is ªAMENDED SHEETº or their equivalent in the Considered to Lack Unity of Invention language of the demand as well as an indication of the International Preliminary Examining Authority The International Preliminary Examining Authority as provided for in Section 107(b); shall transmit to the applicant, preferably at the latest together with the international preliminary (iii) keep in its ®les any replaced sheet, any examination report, any decision which it has taken replacement sheet, whether or not superseded, any under Rule 68.3(c) on the protest of the applicant letter accompanying such sheets and any letter against payment of additional fees where the referred to in the last sentence of Rule 66.8(b); international application is considered to lack unity (iv) where any superseded replacement sheet of invention. At the same time, it shall transmit to and letter relating to such superseded replacement the International Bureau a copy of both the protest sheet are to be annexed to the international and the decision thereon, as well as any request by preliminary examination report under Rule 70.16(b), the applicant to forward the texts of both the protest indelibly mark, in addition to the markings referred and the decision thereon to the elected Of®ces. to in items (i) and (ii), in the middle of the bottom margin of each superseded replacement sheet and of each letter relating to a superseded replacement

June 2020 AI-44 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 607

604 Guidelines for Explanations Contained (i) indelibly mark, in the upper right-hand in the International Preliminary Examination corner of each replacement sheet, the international Report application number and the date on which that sheet was received; (a) Explanations under Rule 70.8 shall clearly (ii) indelibly mark, in the middle of the point out to which of the three criteria of novelty, bottom margin of each replacement sheet, the words inventive step (non-obviousness) and industrial ªRECTIFIED SHEET (RULE 91)º or their applicability referred to in Article 35(2), taken equivalent in the language of the demand as well as separately, any cited document is applicable and an indication of the International Preliminary shall clearly describe, with reference to the cited Examining Authority as provided for in Section documents, the reasons supporting the conclusion 107(b); that any of the said criteria is or is not satis®ed. (iii) indelibly mark on the letter containing (b) Explanations under Article 35(2) shall be the recti®cation or accompanying any replacement concise and preferably in the form of short sentences. sheet the date on which that letter was received; 605 File to Be Used for International (iv) keep in its ®les a copy of the letter Preliminary Examination containing the recti®cation or, when the recti®cation is contained in a replacement sheet, the replaced Where the International Preliminary Examining sheet, a copy of the letter accompanying the Authority is part of the same national Of®ce or replacement sheet and a copy of the replacement intergovernmental organization as the International sheet; Searching Authority, the same ®le shall serve the (v) annex to the copy of the international purposes of international search and international preliminary examination report which is transmitted preliminary examination. to the International Bureau any replacement sheet and any letter as provided for under Rule 70.16; 606 Cancellation of Elections (vi) annex to the copy of the international (a) The International Preliminary Examining preliminary examination report which is transmitted Authority shall cancel ex of®cio: to the applicant a copy of each replacement sheet and any letter as provided for under Rule 70.16. (i) the election of any State which is not a designated State; (b) Where the recti®cation of an obvious mistake is not taken into account by the International (ii) the election of any State not bound by Preliminary Examining Authority pursuant to Rule Chapter II of the Treaty. 66.4 bis , and the Authority so indicates in the (b) The International Preliminary Examining international preliminary examination report in Authority shall enclose that election within square accordance with Rule 70.2(e), it shall proceed as brackets, shall draw a line between the square indicated under paragraph (a), provided that the brackets while still leaving the election legible and words ªRECTIFIED SHEET (RULE 91) ± NOT shall enter, in the margin, the words ªCANCELLED CONSIDERED FOR REPORT (RULE 66.4 bis)º EX OFFICIO BY IPEAº or their equivalent in the shall be used when marking in accordance with language of the demand, and shall notify the paragraph (a)(ii). applicant accordingly. (c) Where the recti®cation of an obvious mistake 607 Recti®cations of Obvious Mistakes under is not taken into account by the International Rule 91 Preliminary Examining Authority pursuant to Rule 66.4 bis , and the Authority is not able to so indicate in the international preliminary examination report (a) Where the International Preliminary in accordance with the second sentence of Rule Examining Authority authorizes a recti®cation of 70.2(e), it shall proceed as indicated under paragraph an obvious mistake under Rule 91, it shall: (a)(i) to (iv) and forward any replacement sheet and any letter containing the recti®cation or

AI-45 June 2020 § 608 MANUAL OF PATENT EXAMINING PROCEDURE

accompanying any replacement sheet to the form, that Authority shall so state in the written International Bureau. The International Bureau will opinion and in the international preliminary promptly notify the elected Of®ces accordingly. examination report. 608 Noti®cations Concerning Representation (c) The International Preliminary Examining Authority shall indelibly mark, on the ®rst sheet of Where a power of attorney or a document containing any sequence listing on paper which does not form the revocation or renunciation of an appointment is part of the international application but was furnished submitted to the International Preliminary Examining for the purposes of the international preliminary Authority, that Authority shall immediately notify examination, the words ªSEQUENCE LISTING the International Bureau by sending it a copy of the NOT FORMING PART OF THE power of attorney or document and request the INTERNATIONAL APPLICATIONº or their International Bureau to record a change in the equivalent in the language of publication of the indications concerning the agent or common international application. Where such sequence representative under Rule 92 bis.1(a)(ii). listing is furnished in electronic form on a physical medium, that Authority shall physically label that medium accordingly. 609 Withdrawal by Applicant under Rules 90 bis. 1, 90 bis. 2 or 90 bis. 3 (d) The International Preliminary Examining Authority shall keep in its ®les one copy of any The International Preliminary Examining Authority sequence listing, whether on paper or in electronic shall promptly transmit to the International Bureau form, which does not form part of the international any notice from the applicant effecting withdrawal application but was furnished for the purposes of the of the international application under Rule international preliminary examination. 90 bis.1(b), of a designation under Rule 90 bis.2(d), (e) Any International Preliminary Examining or of a priority claim under Rule 90 bis.3(c) which Authority which requires, for the purposes of the has been ®led with it. The International Preliminary international preliminary examination, the furnishing Examining Authority shall mark the notice with the of a sequence listing in electronic form shall notify date on which it was received. the International Bureau accordingly. In that noti®cation, the Authority shall specify the means 610 Sequence Listings of transmittal of the sequence listing in electronic form accepted by it in accordance with Annex F. (a) Where the written opinion of the The International Bureau shall promptly publish International Preliminary Examining Authority or details of the noti®cation in the Gazette. the international preliminary examination report is (f) Where the national Of®ce or based on a sequence listing not forming part of the intergovernmental organization that acted as the international application but furnished for the International Searching Authority also acts as the purposes of the international preliminary International Preliminary Examining Authority, any examination, the written opinion and the sequence listing not forming part of the international international preliminary examination report of the application but furnished to that Of®ce or International Preliminary Examining Authority shall organization for the purposes of the international so indicate. search shall be considered to have been furnished to (b) Where a meaningful written opinion of the it also for the purposes of the international International Preliminary Examining Authority preliminary examination. cannot be established, or a meaningful international 611 Method of Identi®cation of Documents preliminary examination cannot be carried out, as to whether the claimed invention appears to be novel, in the International Preliminary Examination to involve an inventive step (to be non-obvious) and Report to be industrially applicable, because a sequence listing is not available to the International Any document cited in the international preliminary Preliminary Examining Authority in the required examination report which was not cited in the

June 2020 AI-46 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 617

international search report shall be cited in the same handling fee or the international preliminary form as required under Section 503 for international examination fee are lacking in whole or in part, it search reports. Any document cited in the may invite the applicant to pay the missing amounts international preliminary examination report which within the time limit under Rule 57.3 or 58.1(b), as was previously cited in the international search report the case may be. may be cited in a shortened form, provided that the reference to the document is unambiguous. 616 International Preliminary Examination on the Basis of a Translation of the 612 Authorized Of®cer International Application

The of®cer of the International Preliminary Where the International Preliminary Examining Examining Authority responsible for the Authority has carried out international preliminary international preliminary examination report, as examination on the basis of a translation of the referred to in Rule 70.14, means the person who international application furnished to that Authority actually performed the examination work and under Rule 55.2(a) or, in the case referred to in Rule prepared the international preliminary examination 55.2(b), transmitted, under Rule 23.1(b), to the report or another person who was responsible for national Of®ce or intergovernmental organization supervising the examination. of which that Authority is part, the international preliminary examination report shall so indicate. 613 Invitation to Submit a Request for Refund of Fees under Rule 57.4 or 58.3 617 Waivers under Rules 90.4(d) and 90.5(c)

The International Preliminary Examining Authority (a) Where, in accordance with Rule 90.4(d), an may, before making a refund under Rule 57.4 or International Preliminary Examining Authority 58.3, ®rst invite the applicant to submit a request for waives the requirement under Rule 90.4(b) that a the refund. separate power of attorney be submitted to it, the International Preliminary Examining Authority shall 614 Evidence of Right to File Demand notify the International Bureau accordingly. (b) Where, in accordance with Rule 90.5(c), an Where a demand is considered as not having been International Preliminary Examining Authority made under Rule 61.1(b) by the International waives the requirement under Rule 90.5(a)(ii) that Preliminary Examining Authority because the a copy of a general power of attorney be attached to applicant appeared, on the basis of the indication the demand or any separate notice, it shall notify the made in the demand, not to have the right to ®le a International Bureau accordingly. demand with that Authority under Rule 54 but (c) An International Preliminary Examining evidence is submitted indicating to the satisfaction Authority may require a separate power of attorney, of the International Preliminary Examining Authority or a copy of a general power of attorney, in particular that in fact, an applicant had, on the date on which instances even if the International Preliminary the demand was received, the right to ®le the demand Examining Authority has waived the requirement in with that Authority, the International Preliminary general. Examining Authority shall regard the requirements under Article 31(2)(a) as having been ful®lled on (d) An International Preliminary Examining the date of actual receipt of the demand. Authority which has noti®ed the International Bureau under paragraph (a) or (b) shall notify the 615 Invitation to Pay Fees before Date on International Bureau of any change to the Which They Are Due information noti®ed under those paragraphs.

If the International Preliminary Examining Authority ®nds, before the date on which they are due, that the

AI-47 June 2020 § 701 MANUAL OF PATENT EXAMINING PROCEDURE

PART 7

INSTRUCTIONS RELATING TO THE FILING AND PROCESSING IN ELECTRONIC FORM OF INTERNATIONAL APPLICATIONS

701 Abbreviated Expressions (b) Subject to this Part, an international application that is ®led, processed or communicated For the purposes of this Part and Annex F, unless in electronic form shall not be denied legal effect the contrary clearly follows from the wording, the merely because it is in electronic form. nature of the provision or the context: (c) [Deleted]

(i) ªelectronic packageº means a package of one 703 Filing Requirements; Basic Common or more electronic ®les assembled for the purposes Standard of transmission of one or more documents in electronic form; (a) An international application may, subject to this Part, be ®led in electronic form if the receiving (ii) ªelectronic document formatº means the Of®ce has noti®ed the International Bureau in presentation or arrangement of the information in a accordance with Rule 89 bis.1(d) that it is prepared document in electronic form; to receive international applications in such form. (iii) ªmeans of transmittal,º in connection with (b) An international application ®led in a document in electronic form, means the manner electronic form shall be: in which a document is transmitted, for example, by electronic means or physical means; (i) in an electronic document format that has been speci®ed by the receiving Of®ce in accordance (iv) ªelectronic signatureº means information with Annex F or that complies with the basic in electronic form which is attached to, or logically common standard; associated with, a document in electronic form, which may be used to identify the signer and which (ii) ®led by a means of transmittal that has indicates the signer's approval of the content of the been speci®ed by the receiving Of®ce in accordance document; with Annex F or that complies with the basic common standard; (v) ªbasic common standardº means the basic common standard for electronic ®ling of (iii) in the form of an electronic package, international applications provided for in Annex F; appropriate to the means of transmittal, that has been speci®ed by the receiving Of®ce in accordance with (vi) ªcommunicationº of an international Annex F or that complies with the basic common application or other document has the same meaning standard; as in Rule 89 bis.3; (iv) prepared and ®led using electronic ®ling (vii) words and expressions whose meanings are software that has been speci®ed by the receiving explained in Annex F have the same meanings in Of®ce in accordance with Annex F or that complies this Part. with the basic common standard; and 702 Filing, Processing and Communication (v) free of viruses and other forms of in Electronic Form of International malicious logic in accordance with Annex F or that Applications complies with the basic common standard. (c) An international application ®led in (a) The ®ling, processing and communication electronic form shall, for the purposes of Article of international applications ®led in electronic form, 14(1)(a)(i), be signed by the applicant using a type and the processing and communication in electronic of electronic signature that has been speci®ed by the form of international applications ®led on paper, receiving Of®ce in accordance with Annex F or, shall be in accordance with this Part and Annex F.

June 2020 AI-48 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 704

subject to Section 704(g), that complies with the (iii) any reference number or application basic common standard. number assigned to the purported application by the (d) A receiving Of®ce which has not noti®ed Of®ce; and the International Bureau in accordance with Rule (iv) a message digest, generated by the 89 bis.1(d) that it is prepared to receive international Of®ce, of the purported application as received; and applications in electronic form may nevertheless may, at the option of the Of®ce, also indicate or decide in a particular case to receive an international contain other information such as: application submitted to it in such form, in which case this Part shall apply accordingly. (v) the names and sizes of the electronic ®les received; (e) Any receiving Of®ce may refuse to receive an international application submitted to it in (vi) the dates of creation of the electronic electronic form if the application does not comply ®les received; and with paragraph (b), or may decide to receive the (vii) a copy of the purported application as application. received. (f) If, on 7 January 2002, the applicable national (b) Where the receiving Of®ce refuses in law and the technical systems of a national Of®ce accordance with Rule 89 bis.1(d) or Section 703(e) provide for the ®ling with it of national applications to receive a purported international application in electronic form according to requirements which submitted to it in electronic form, it shall, if are incompatible with any of items (ii) to (iv) of practicable having regard to the indications furnished paragraph (b): by the applicant, promptly notify the applicant (i) the provisions concerned shall not apply accordingly. in respect of the Of®ce in its capacity as a receiving (c) Promptly after receiving a purported Of®ce for as long as the incompatibility continues; international application in electronic form, the and receiving Of®ce shall determine whether the (ii) the Of®ce may instead provide for the purported application complies with the requirements ®ling with it of international applications in of Article 11(1) and shall proceed accordingly. electronic form according to that national law and (d) Where an international application ®led in those technical systems; provided that the Of®ce electronic form is not signed in compliance with informs the International Bureau accordingly by the Section 703(c), the application shall be considered date on which the Of®ce sends the International not to comply with the requirements of Article Bureau a noti®cation under Rule 89 bis.1(d) and in 14(1)(a)(i) and the receiving Of®ce shall proceed any case no later than 7 April 2002. The information accordingly. received shall be promptly published by the (e) Where an international application ®led in International Bureau in the Gazette. electronic form does not comply with Section 703(b) 704 Receipt; International Filing Date; but the receiving Of®ce decides, under Section Signature; Physical Requirements 703(e), to receive it, that non-compliance shall be considered to be non-compliance with the physical (a) The receiving Of®ce shall promptly notify requirements referred to in Article 14(1)(a)(v) and the applicant of, or otherwise enable the applicant the receiving Of®ce shall proceed accordingly, to obtain con®rmation of, the receipt of any having regard to whether compliance is necessary purported international application ®led with it in for the purpose of reasonably uniform international electronic form. The noti®cation or con®rmation publication (Rule 26.3) and satisfactory electronic shall indicate or contain: communications. (i) the identity of the Of®ce; (f) An international application ®led in electronic form may, in accordance with the provisions of Rule (ii) the date of receipt; 19.4, be transmitted by the Of®ce with which the application was ®led to the International Bureau as receiving Of®ce.

AI-49 June 2020 § 705 MANUAL OF PATENT EXAMINING PROCEDURE

(g) Where an international application ®led in 705 bis Processing in Electronic Form of electronic form was signed using a type of electronic International Applications Filed on Paper; signature that complies with the basic common Home Copy, Record Copy and Search Copy standard but that has not been speci®ed by the receiving Of®ce under Section 703(c), the Of®ce (a) Where an international application is ®led may require that any subsequent document or on paper, it may, subject to this Part, be processed correspondence submitted to it in electronic form be and kept as a complete and accurate copy in signed using a type of electronic signature that has electronic form prepared by the receiving Of®ce, been so speci®ed. If that requirement is not complied the International Searching Authority, the with, Rule 92.1(b) and (c) shall apply mutatis International Preliminary Examining Authority or mutandis. the International Bureau. 705 Home Copy, Record Copy and Search (b) Pursuant to paragraph (a) and for the Copy Where International Application Is purposes of Article 12, where an international Filed in Electronic Form application is ®led on paper: (i) the receiving Of®ce may keep a copy in (a) Where an international application is ®led electronic form referred to in that paragraph as the in electronic form as a wrapped and signed package home copy; in accordance with Annex F, the home copy and the record copy in relation to that application for the (ii) the International Bureau may keep a copy purposes of Article 12 shall each consist of a copy in electronic form referred to in that paragraph as in electronic form of that package. the record copy; (b) Where an international application is ®led (iii) the International Searching Authority in electronic form but is not ®led as a wrapped and may keep a copy in electronic form referred to in signed package in accordance with Annex F, the that paragraph as the search copy. home copy and the record copy in relation to that (c) Where a copy in electronic form is kept as application for the purposes of Article 12 shall each the record copy under paragraph (b)(ii), the original consist of a copy in electronic form of the application of the international application as ®led on paper shall as ®led. If the application as ®led was encrypted, be kept, for a period of at least 5 years from the the home copy and the record copy shall consist of international ®ling date, by the International Bureau the decrypted version. If the application as ®led was or, where so agreed by the receiving Of®ce and the infected by a virus or other form of malicious logic, International Bureau, by the receiving Of®ce on the home copy and the record copy shall consist of behalf of the International Bureau. The original shall the disinfected version. be marked with the words ªINTERNATIONAL (c) Where the international application is ®led APPLICATIONÐ ORIGINAL AS FILED ON in electronic form on a physical medium, the home PAPER (SECTION 705 bis )º or their equivalent in copy and the record copy shall not include the the language of publication of the international physical medium, but the receiving Of®ce shall, for application on the bottom of the ®rst page of the the purposes of Rule 93.1, retain the application as request and of the ®rst page of the description. originally ®led, together with the physical medium. (d) Where, before the expiration of the period (d) Where the International Searching Authority referred to in paragraph (c), the International Bureau has noti®ed the International Bureau in accordance ®nds, upon request for correction made by the with Rule 89 bis.1(d) that it is prepared to process applicant or otherwise, that a copy in electronic form international applications in electronic form, kept as the record copy under paragraph (b)(ii) is paragraphs (a) and (b) apply mutatis mutandis to not in fact a complete and accurate copy of the the search copy; otherwise, the search copy shall original kept under paragraph (c), it shall correct the consist of a copy of the application printed on paper record copy so as to bring it into conformity with by the receiving Of®ce. the original. If the receiving Of®ce, the International Searching Authority, the International Preliminary Examining Authority or a designated or elected

June 2020 AI-50 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 707

Of®ce considers that the International Bureau should format. Rule 26.4 shall apply mutatis mutandis to make a ®nding under the ®rst sentence of this the manner in which corrections under paragraph paragraph, it shall call the relevant facts to the (b) shall be requested. attention of the International Bureau. (c) Where the receiving Of®ce, the International (e) Where the International Bureau has corrected Searching Authority, the International Preliminary the record copy in accordance with paragraph (d), Examining Authority or the International Bureau it shall promptly notify the applicant, publish the discover what appears to be a correctable defect corrected international application together with a under paragraph (b), that Of®ce, Authority or revised front page, and publish a notice of this fact Bureau, as the case may be, may bring such defect in the Gazette. Section 422(a)(i) to (v) shall apply to the attention of the applicant, drawing attention mutatis mutandis with regard to the noti®cation of to the correction procedure under paragraph (b). the receiving Of®ce, the International Searching (d) The applicant and, if copies of the Authority, the International Preliminary Examining international application have already been sent to Authority and the designated and elected Of®ces. the International Bureau and the International 706 Documents in Pre-Conversion Format Searching Authority, that Bureau and that Authority shall be promptly noti®ed by the receiving Of®ce (a) Where, for the purposes of ®ling the of any correction under paragraph (b). If required, international application in electronic form, the the International Bureau shall notify the International document making up the international application Preliminary Examining Authority accordingly. has been prepared by conversion from a different Where a correction is made after the completion of electronic document format (ªpre-conversion the technical preparations for international formatº), the applicant may, if the receiving Of®ce publication, the International Bureau shall promptly so permits and the pre-conversion format is accepted publish any international application as so corrected for that purpose by that Of®ce, submit, together with together with a revised front page. the international application, the document in the (e) A correction under paragraph (b) shall be pre-conversion format, in which case: taken into account by the International Searching Authority for the purposes of the international search and the establishment of the written opinion, and by (i) the document in the pre-conversion format the International Preliminary Examining Authority shall be identi®ed as such and shall be accompanied for the purposes of international preliminary by a statement by the applicant that the international examination, if it is noti®ed to that Authority before application as ®led in electronic form is a complete it has begun to draw up the international search and accurate copy of the document in the report, the written opinion or the international pre-conversion format; preliminary examination report, as applicable, in (ii) the request shall preferably contain an which case the said report or opinion shall so indication that the document in the pre-conversion indicate. format is submitted under Section 706 together with (f) Paragraphs (a) to (e) shall apply mutatis the international application. mutandis to any document making up any element (b) Where it is found that the international of the international application referred to in Article application as ®led in electronic form is not in fact 3(2). a complete and accurate copy of the document in the pre-conversion format submitted under paragraph 707 Calculation of International Filing Fee (a), the applicant may, within 30 months from the and Fee Reduction priority date, request the receiving Of®ce to correct the international application so as to bring it into (a) Where an international application is ®led conformity with the document in the pre-conversion in electronic form, the international ®ling fee shall, subject to paragraph (a- bis), be calculated on the

AI-51 June 2020 § 708 MANUAL OF PATENT EXAMINING PROCEDURE

basis of the number of sheets that the application (i) the Of®ce is not required to disinfect the would contain if presented as a print-out complying purported application and may, under Section 703(e), with the physical requirements prescribed in Rule refuse to receive it; 11. 1 (ii) if the Of®ce decides under Section 703(e) (a-bis) Where a sequence listing is contained in to receive the purported application, the Of®ce shall an international application ®led in electronic form, use means reasonably available under the the calculation of the international ®ling fee shall circumstances to read it, for example, by disinfecting not take into account any sheet of the sequence it or preparing a backup copy under Section 706, listing if that listing is presented as a separate part and to store it in such a way that its contents may be of the description in accordance with Rule 5.2(a) ascertained if necessary; and is in the electronic document format speci®ed (iii) if the Of®ce ®nds that it is able to read in paragraph 40 of Annex C. and store the purported application as mentioned in (b) Item 4(b), (c), and (d) of the Schedule of item (ii), it shall determine whether an international Fees annexed to the Regulations shall apply to ®ling date should be accorded; reduce the fees payable in respect of an international (iv) if the Of®ce accords an international application ®led in electronic form with a receiving ®ling date to the application, it shall, if possible Of®ce which has noti®ed the International Bureau having regard to the indications furnished by the under Section 710(a) that it is prepared to receive applicant, promptly notify the applicant and, if international applications in electronic form or which necessary, invite the applicant to submit a substitute has decided to receive such an application in copy of the application free of infection; accordance with Section 703(d). (v) if the Of®ce accords an international 708 Special Provisions Concerning Legibility, ®ling date to the application, it shall prepare the Completeness, Infection by Viruses, Etc. home copy, the record copy and the search copy on the basis of the disinfected application, the backup (a) Where an international application is ®led copy or the substitute copy referred to in items (ii) in electronic form, the receiving Of®ce shall or (iv), as applicable, provided that the application promptly check whether the application is legible shall be stored by the Of®ce, as referred to in item and whether it appears to have been fully received. (ii), for the purposes of Rule 93.1. Where the Of®ce ®nds that all or part of the international application is illegible or that part of 709 Means of Communication with the the application appears not to have been received, Receiving Of®ce the international application shall be treated as not having been received to the extent that it is illegible (a) Where an international application is ®led or, where transmitted by electronic means, that the in electronic form and by electronic means of attempted transmission failed, and the Of®ce shall, transmittal, the receiving Of®ce shall, if practicable, if practicable having regard to the indications send any noti®cations, invitations and other furnished by the applicant, promptly notify the correspondence to the applicant by electronic means applicant accordingly. of transmittal in accordance with Annex F, or by such other means indicated by the applicant from (b) Where a purported international application among those offered by the Of®ce. is received in electronic form, the receiving Of®ce shall promptly check it for infection by viruses and (b) Where it appears to the receiving Of®ce that other forms of malicious logic. Where the Of®ce a noti®cation, invitation or other correspondence ®nds that the purported application is so infected: sent to the applicant by electronic means of transmittal was not successfully transmitted, the

1 Editor©s Note: Rule 11 leaves some ¯exibility as to the margins of the sheets (see Rule 11.6) and the size of the characters (see Rule 11.9(d)). The international ®ling fee should be calculated on the basis of the number of sheets that the application would contain if presented as a print-out complying with the minimum margin and character size requirements. In practice, however, the receiving Of®ce should not print-out the international application but rather rely on the number of pages of the international application as calculated by the electronic ®ling software and indicated in the request.

June 2020 AI-52 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 712

Of®ce shall, if practicable, promptly retransmit the alternatives when the electronic systems of the Of®ce noti®cation, invitation or other correspondence by are not available; the same or another means. (vi) the certi®cation authorities that are (c) At times when the electronic systems of the accepted by the Of®ce, and the electronic addresses receiving Of®ce are not available for the ®ling of of the certi®cate policies under which certi®cates documents in electronic form or by electronic means are issued; of transmittal, the Of®ce shall, if possible, promptly publish information to that effect by means (vii) the procedures relating to access to the reasonably available to it under the circumstances, ®les of international applications ®led or stored in for example, by including a notice on the Of®ce's electronic form. Internet site, if any. (b) The receiving Of®ce shall notify the 710 Noti®cation and Publication of Receiving International Bureau of any change in the matters previously indicated by it in a noti®cation under Of®ces' Requirements and Practices Section 705 bis(a) or paragraph (a) of this Section. (a) A noti®cation by a receiving Of®ce to the (c) The International Bureau shall promptly International Bureau under Rule 89 bis.1(d) and publish in the Gazette any noti®cation received by Section 703(a) that it is prepared to receive it under Section 705 bis(a) or paragraph (a) or (b) international applications in electronic form shall of this Section. indicate, where applicable: (d) The effective date of any change noti®ed (i) the electronic document formats under paragraph (b) shall be as speci®ed by the (including, where applicable, the versions of such receiving Of®ce in the noti®cation, provided that electronic document formats), means of transmittal, any change which restricts ®ling options shall not types of electronic packages, electronic ®ling be effective earlier than two months after the date software and types of electronic signature speci®ed of publication of the noti®cation of the change in by it under Section 703(b)(i) to (iv) and (c), and any the Gazette. options speci®ed by it under the basic common 711 Electronic Records Management standard; (ii) the conditions, rules and procedures (a) Records, copies and ®les in electronic form relating to electronic receipt, including hours of in relation to international applications shall be operation, choices for processes to verify or processed and, for the purposes of Rule 93, kept in acknowledge receipt, choices for electronic accordance with the requirements of authentication, communication of invitations and noti®cations, any integrity, con®dentiality and non-repudiation, and methods of online payment, details concerning any having due regard to the principles of electronic help desks, electronic and software requirements records management, set out in Annex F. and other administrative matters related to the ®ling (b) Upon request by the applicant or other in electronic form of international applications and interested party in relation to a particular related documents; international application, the receiving Of®ce shall, (iii) the kinds of documents which may be subject to any restrictions applicable under the Treaty transmitted to or by the Of®ce in electronic form; as to access by third parties, 1 certify that any (iv) whether and under what conditions the electronic records relating to that application are Of®ce accepts the ®ling, under Section 706(a) and maintained and stored by it in accordance with (f), of documents in pre-conversion formats and the paragraph (a). electronic document format(s) (including, where 712 Access to Electronic Records applicable, the versions of such electronic document format(s)) accepted by it under that Section; Access permitted by the Treaty, the Regulations or (v) procedures for noti®cation of applicants these Administrative Instructions to documents and procedures which applicants may follow as

1 Editor©s Note: Articles 30 and 38 and Rule 94 restrict access.

AI-53 June 2020 § 713 MANUAL OF PATENT EXAMINING PROCEDURE

contained in the ®le of an international application international applications in electronic form, the ®led, processed or kept in electronic form may, at International Bureau shall furnish to that Of®ce or the option of the national Of®ce or Authority a copy on paper of any document which intergovernmental organization concerned, be is kept by the International Bureau in electronic form provided by electronic means or in electronic form, and which that Of®ce or Authority is entitled to having due regard to the need to ensure the integrity receive. The International Bureau may also, upon and where applicable con®dentiality of data, the request by the Authority or Of®ce concerned, furnish principles of electronic records management set out such copy in electronic form. in Annex F, and the need to ensure security of the (b) Any designated Of®ce may require that any electronic networks, systems and applications of the document or correspondence submitted to it by the Of®ce or organization. applicant in electronic form be signed by the applicant using a type of electronic signature 713 Application of Provisions to speci®ed by it in accordance with Annex F. International Authorities and the 715 Availability of Priority Documents from International Bureau, and to Noti®cations, Digital Libraries Communications, Correspondence and Other Documents (a) For the purposes of Rules 17.1(b- bis), 17.1(d) (where appropriate, as applicable by virtue (a) The provisions of this Part, other than of Rules 17.1(c) and 82 ter.1(b)), 66.7(a) (where Sections 703(c), 704(c) to (g), 707, 708(b)(iii) to appropriate, as applicable by virtue of Rule (v), 710(a)(iv) and 714(b), shall, if they are capable 43 bis.1(b)) and 91.1(e), a priority document shall of applying but do not expressly apply to the be considered to be available from a digital library International Searching Authorities, the International to the International Bureau, a designated Of®ce, the Preliminary Examining Authorities and the International Searching Authority or the International International Bureau, apply mutatis mutandis to Preliminary Examining Authority, as the case may those Authorities and that Bureau. be: (b) The provisions of this Part, other than (i) if the Of®ce or Authority concerned has Sections 703(c), 704(c) to (f), 705, 705 bis(b) to (e), noti®ed the International Bureau, or the International 706, 707, 708(b)(iii) to (v) and 710(a)(iv), shall, if Bureau has declared, as the case may be, that it is they are capable of applying but do not expressly prepared to obtain priority documents from that apply to noti®cations, communications, digital library; and correspondence or other documents relating to international applications that are ®led, processed (ii) the priority document concerned is held or communicated in electronic form, apply mutatis in that digital library and the applicant has, to the mutandis to such noti®cations, communications, extent required by the procedures for accessing the correspondence or other documents relating to relevant digital library, authorized the Of®ce or international applications. Authority concerned or the International Bureau, as the case may be, to access that priority document. 714 Furnishing by the International Bureau (b) A noti®cation to the International Bureau of Copies of Documents Kept in Electronic under paragraph 12 of the Framework Provisions Form; Designated Of®ces' Signature for the Digital Access Service for Priority Requirements Documents 1 by (a) Where any International Searching Authority, (i) the International Bureau; or International Preliminary Examining Authority or (ii) an Of®ce in its capacity as designated designated Of®ce has not noti®ed the International Of®ce, International Searching Authority or Bureau in accordance with Rule 89 bis.1(d) or International Preliminary Examining Authority, Section 705 bis(a) that it is prepared to process

1 Editor's Note : Established by the International Bureau on 31 March 2009 and available from the WIPO website at: www.wipo.int/export/sites/www/das/en/pdf/framework_of_march_31_2009.pdf.

June 2020 AI-54 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 801

(i) shall identify the priority document that it is prepared to obtain priority documents via concerned in accordance with Rule 4.10(a); and the Digital Access Service shall be taken as a declaration or noti®cation under paragraph (a)(i) (ii) shall, where required, include the access that the International Bureau or Of®ce acting in the code provided to the applicant by the International relevant capacity will obtain priority documents Bureau or by the Of®ce with which the earlier through the Digital Access Service from any digital application was ®led. library which has been the subject of a noti®cation (b) Where the applicant, in accordance with Rule in accordance with paragraph 10 of the Framework 17.1(b- bis ) and paragraph (a) of this Section, Provisions, including libraries for which such a requests the International Bureau to obtain a priority noti®cation is subsequently made with effect prior document which, in accordance with Section 715(a), to the date on which the Of®ce or Bureau is is considered to be available from a digital library requested to retrieve the priority document. to it, but the International Bureau ®nds that the (c) An Of®ce or Authority which has given a priority document is in fact not available to it, the noti®cation to the International Bureau under International Bureau, shall notify the applicant, paragraph (a)(i) or (b) shall notify the International giving the opportunity to furnish the priority Bureau of any change in the information so noti®ed. document to it, or to ensure that the document is made available to it from a digital library, within a (d) The International Bureau shall promptly time limit of not less than two months from the date publish in the Gazette any noti®cation received by of the noti®cation or within the time limit speci®ed it under paragraph (a)(i) or (b) of this Section, any in Rule 17.1(a), whichever time limit expires later. declaration made by it under paragraph (a)(i) or (b), Where the priority document is furnished or becomes and any change in the information so declared. available to the International Bureau within that time (e) The effective date of any change published limit, the requirements of Rule 17.1(b- bis ) shall be under paragraph (d) shall be as speci®ed by the considered to have been met. If the priority document Of®ce or Authority concerned or by the International is not so furnished or does not become available Bureau, as the case may be, provided that any change within that time limit, the request that the document which restricts the ability of the applicant to request be obtained from a digital library shall be considered the Of®ce, the Authority or the International Bureau not to have been made. to obtain a priority document from the digital library (c) Where the applicant requests the International shall, except in the case where priority documents Bureau under Rule 17.1(b- bis ) to obtain a priority are no longer held in the digital library, not be document from a digital library but that request does effective earlier than two months after the date of not comply with the requirements of that Rule and publication of the change in the Gazette. paragraph (a) of this Section, or the priority 716 Request that Priority Document Be document concerned is not considered to be available Obtained from a Digital Library under Rule to it in accordance with Section 715(a), the International Bureau shall promptly inform the 17.1(b- bis) applicant accordingly. (a) Any request under Rule 17.1(b- bis ): PART 8

INSTRUCTIONS RELATING TO OBSERVATIONS BY THIRD PARTIES

801 Third Party Observation System invention claimed in the international application is new and/or involves an inventive step (ªthird party (a) The International Bureau shall provide an observation systemº). electronic system for third parties to make (b) The third party observation system: observations referring to prior art which they believe to be relevant to the question of whether the

AI-55 June 2020 § 802 MANUAL OF PATENT EXAMINING PROCEDURE

(i) shall provide a third party with the option (b) Any purported observation by a third party to remain anonymous; which, in the view of the International Bureau, appears not to be in compliance with paragraph (a) (ii) shall allow observations to include a brief shall not be treated as a third party observation. The explanation of the relevance of each prior art International Bureau shall inform the third party document referred to in the observation and to accordingly, unless the purported observation include a copy of the prior art document; appears to be a clear attempt at abuse of the system. (iii) may limit the number of prior art The purported observation shall not be open to public documents which may be referred to in one inspection and shall not be communicated to the observation; and applicant, any International Authority or any designated Of®ce. (iv) may limit the number of observations permitted to be made in relation to one international 803 Availability of an Observation and application, per third party and in total. Related Information (c) The International Bureau shall take technical steps to prevent abuse of the third party observation (a) Any third party observation shall be promptly system. made available for public inspection, with the exception that copies of prior art documents (d) The International Bureau may temporarily uploaded through the system shall be made available or inde®nitely suspend the use of the third party only to the applicant, competent International observation system if it considers it necessary to do Authorities and designated Of®ces. so. (b) Where the third party requests the 802 Filing of a Third Party Observation International Bureau to remain anonymous as provided in Section 801(b), the International Bureau (a) An observation by a third party made in shall not reveal any details of the third party to the relation to an international application shall: public, the applicant, any International Authority or (i) be submitted to the International Bureau any designated Of®ce. through the third party observation system as 804 Noti®cation of Receipt of an Observation provided in Section 801; to the Applicant and Comments by the (ii) be submitted between the date of Applicant in Response to an Observation international publication and 28 months from the priority date of the international application (a) The International Bureau shall notify the indicated; applicant when the ®rst third party observation is (iii) be in a language of publication, with the received in relation to an international application. exception that copies of submitted prior art If further observations are received, the International documents may be in any language; Bureau shall notify the applicant of the receipt of all further observations promptly after the expiration (iv) relate to the international application of 28 months from the priority date. indicated; (b) The applicant may, within 30 months from (v) refer to prior art; the priority date, submit comments in response to (vi) be free of viruses or other forms of any third party observation which has been received. malicious logic; The comments shall be submitted in English, French (vii) be free of comments or other matter not or the language of publication of the international relevant to the question of novelty or inventive step application, at the choice of the applicant, and shall of the invention claimed in the international be promptly made available for public inspection. application; and (viii) be free of comments or other matter which are an abuse of the third party observation system.

June 2020 AI-56 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT § 805

805 Communication of Observations and Comments to International Authorities and Designated Of®ces

(a) The International Bureau shall communicate any third party observation and any comment by the applicant promptly to the International Searching Authority speci®ed to carry out the international search, the International Searching Authority speci®ed to carry out the supplementary international search and the International Preliminary Examining Authority speci®ed to carry out the international preliminary examination, unless the international search report, the supplementary international search report or the international preliminary examination report, respectively, has already been received by the International Bureau. (b) Promptly after the expiration of 30 months from the priority date, the International Bureau shall communicate any third party observation and any comment by the applicant to all designated Of®ces, subject to Rule 93 bis . The designated Of®ces shall not be obliged to take either the observations or any comments into account during national processing. [Annexes follow]

AI-57 June 2020 MANUAL OF PATENT EXAMINING PROCEDURE

Annex A

FORMS

[Editor©s Note: This Annex, which is not reproduced Part III: Forms Relating to the International here, contains Forms for use by applicants and by Bureau; the International Authorities, including those referred to in Section 102 of the Administrative Part IV: Forms Relating to the International Instructions. It consists of ®ve Parts, as follows: Preliminary Examining Authority;

Part I: Forms Relating to the Receiving Of®ce; Part V: Request and Demand Forms.

Part II: Forms Relating to the International These forms are available from the WIPO website Searching Authority and to Authority Speci®ed for at: www.wipo.int/pct/en/forms .] Supplementary Search; [Annex B follows]

Annex B

UNITY OF INVENTION

(a) Unity of Invention. Rule 13.1 deals with the contains all the features of another claim and is in requirement of unity of invention and states the the same category of claim as that other claim (the principle that an international application should expression ªcategory of claimº referring to the relate to only one invention or, if there is more than classi®cation of claims according to the subject one invention, that the inclusion of those inventions matter of the invention claimed for example, product, in one international application is only permitted if process, use or apparatus or means, etc.). all inventions are so linked as to form a single (i) If the independent claims avoid the prior general inventive concept. art and satisfy the requirement of unity of invention, (b) Technical Relationship. Rule 13.2 de®nes no problem of lack of unity arises in respect of any the method for determining whether the requirement claims that depend on the independent claims. In of unity of invention is satis®ed in respect of a group particular, it does not matter if a dependent claim of inventions claimed in an international application. itself contains a further invention. Equally, no Unity of invention exists only when there is a problem arises in the case of a genus/species technical relationship among the claimed inventions situation where the genus claim avoids the prior art. involving one or more of the same or corresponding Moreover, no problem arises in the case of a ªspecial technical featuresº. The expression ªspecial combination/subcombination situation where the technical featuresº is de®ned in Rule 13.2 as subcombination claim avoids the prior art and the meaning those technical features that de®ne a combination claim includes all the features of the contribution which each of the inventions, considered subcombination. as a whole, makes over the prior art. The (ii) If, however, an independent claim does determination is made on the contents of the claims not avoid the prior art, then the question whether as interpreted in light of the description and drawings there is still an inventive link between all the claims (if any). dependent on that claim needs to be carefully (c) Independent and Dependent Claims. Unity considered. If there is no link remaining, an objection of invention has to be considered in the ®rst place of lack of unity a posteriori (that is, arising only only in relation to the independent claims in an after assessment of the prior art) may be raised. international application and not the dependent Similar considerations apply in the case of a claims. By ªdependentº claim is meant a claim which

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genus/species or combination/subcombination product and an independent claim for an apparatus situation. or means speci®cally designed for carrying out the (iii) This method for determining whether said process, unity of invention exists is intended to be applied even before the commencement of the international it being understood that a process is specially search. Where a search of the prior art is made, an adapted for the manufacture of a product if it initial determination of unity of invention, based on inherently results in the product and that an apparatus the assumption that the claims avoid the prior art, or means is speci®cally designed for carrying out a may be reconsidered on the basis of the results of process if the contribution over the prior art of the the search of the prior art. apparatus or means corresponds to the contribution the process makes over the prior art. (d) Illustrations of Particular Situations. There are three particular situations for which the method Thus, a process shall be considered to be specially for determining unity of invention contained in Rule adapted for the manufacture of a product if the 13.2 is explained in greater detail: claimed process inherently results in the claimed (i) combinations of different categories of product with the technical relationship being present claims; between the claimed product and claimed process. (ii) so-called ªMarkush practiceº; and The words ªspecially adaptedº are not intended to imply that the product could not also be (iii) intermediate and ®nal products. manufactured by a different process.

Principles for the interpretation of the method Also an apparatus or means shall be considered to contained in Rule 13.2, in the context of each of be ªspeci®cally designed for carrying outº a claimed those situations are set out below. It is understood process if the contribution over the prior art of the that the principles set out below are, in all instances, apparatus or means corresponds to the contribution interpretations of and not exceptions to the the process makes over the prior art. Consequently, requirements of Rule 13.2. it would not be suf®cient that the apparatus or means is merely capable of being used in carrying out the Examples to assist in understanding the interpretation claimed process. However, the expression on the three areas of special concern referred to in ªspeci®cally designedº does not imply that the the preceding paragraph are set out below. apparatus or means could not be used for carrying (e) Combinations of Different Categories of out another process, nor that the process could not Claims. The method for determining unity of be carried out using an alternative apparatus or invention under Rule 13.2 shall be construed as means. permitting, in particular, the inclusion of any one of (f) ªMarkush Practice.º The situation involving the following combinations of claims of different the so-called ªMarkush practiceº wherein a single categories in the same international application: claim de®nes alternatives (chemical or (i) in addition to an independent claim for a non-chemical) is also governed by Rule 13.2. In this given product, an independent claim for a process special situation, the requirement of a technical specially adapted for the manufacture of the said interrelationship and the same or corresponding product, and an independent claim for a use of the special technical features as de®ned in Rule 13.2, said product, or shall be considered to be met when the alternatives are of a similar nature. (ii) in addition to an independent claim for a given process, an independent claim for an (i) When the Markush grouping is for apparatus or means speci®cally designed for carrying alternatives of chemical compounds, they shall be out the said process, or regarded as being of a similar nature where the following criteria are ful®lled: (iii) in addition to an independent claim for a given product, an independent claim for a process (A) all alternatives have a common specially adapted for the manufacture of the said property or activity, and

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(B)(1) a common structure is present, i.e., (ii) Unity of invention shall be considered to a signi®cant structural element is shared by all of be present in the context of intermediate and ®nal the alternatives, or products where the following two conditions are ful®lled: (B)(2) in cases where the common structure cannot be the unifying criteria, all (A) the intermediate and ®nal products alternatives belong to a recognized class of chemical have the same essential structural element, in that: compounds in the art to which the invention pertains. (1) the basic chemical structures of (ii) In paragraph (f)(i)(B)(1), above, the the intermediate and the ®nal products are the same, words ªsigni®cant structural element is shared by or all of the alternativesº refer to cases where the (2) the chemical structures of the two compounds share a common chemical structure products are technically closely interrelated, the which occupies a large portion of their structures, intermediate incorporating an essential structural or in case the compounds have in common only a element into the ®nal product, and small portion of their structures, the commonly (B) the intermediate and ®nal products shared structure constitutes a structurally distinctive are technically interrelated, this meaning that the portion in view of existing prior art, and the common ®nal product is manufactured directly from the structure is essential to the common property or intermediate or is separated from it by a small activity. The structural element may be a single number of intermediates all containing the same component or a combination of individual essential structural element. components linked together. (iii) Unity of invention may also be (iii) In paragraph (f)(i)(B)(2), above, the considered to be present between intermediate and words ªrecognized class of chemical compoundsº ®nal products of which the structures are not known mean that there is an expectation from the knowledge Ð for example, as between an intermediate having in the art that members of the class will behave in a known structure and a ®nal product the structure the same way in the context of the claimed invention. of which is not known, or as between an intermediate In other words, each member could be substituted of unknown structure and a ®nal product of unknown one for the other, with the expectation that the same structure. In order to satisfy unity in such cases, there intended result would be achieved. shall be suf®cient evidence to lead one to conclude (iv) The fact that the alternatives of a that the intermediate and ®nal products are Markush grouping can be differently classi®ed shall technically closely interrelated as, for example, when not, taken alone, be considered to be justi®cation the intermediate contains the same essential element for a ®nding of a lack of unity of invention. as the ®nal product or incorporates an essential (v) When dealing with alternatives, if it can element into the ®nal product. be shown that at least one Markush alternative is (iv) It is possible to accept in a single not novel over the prior art, the question of unity of international application different intermediate invention shall be reconsidered by the examiner. products used in different processes for the Reconsideration does not necessarily imply that an preparation of the ®nal product, provided that they objection of lack of unity shall be raised. have the same essential structural element. (g) Intermediate and Final Products. The (v) The intermediate and ®nal products shall situation involving intermediate and ®nal products not be separated, in the process leading from one to is also governed by Rule 13.2. the other, by an intermediate which is not new. (i) The term ªintermediateº is intended to (vi) If the same international application mean intermediate or starting products. Such claims different intermediates for different structural products have the ability to be used to produce ®nal parts of the ®nal product, unity shall not be regarded products through a physical or chemical change in as being present between the intermediates. which the intermediate loses its identity. (vii) If the intermediate and ®nal products are families of compounds, each intermediate

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compound shall correspond to a compound claimed (j) Rule 13.3 is not intended to constitute an in the family of the ®nal products. However, some encouragement to the use of alternatives within a of the ®nal products may have no corresponding single claim, but is intended to clarify that the compound in the family of the intermediate products criterion for the determination of unity of invention so that the two families need not be absolutely (namely, the method contained in Rule 13.2) remains congruent. the same regardless of the form of claim used. (h) As long as unity of invention can be (k) Rule 13.3 does not prevent an International recognized applying the above interpretations, the Searching or Preliminary Examining Authority or fact that, besides the ability to be used to produce an Of®ce from objecting to alternatives being ®nal products, the intermediates also exhibit other contained within a single claim on the basis of possible effects or activities shall not affect the considerations such as clarity, the conciseness of decision on unity of invention. claims or the claims fee system applicable in that Authority or Of®ce. (i) Rule 13.3 requires that the determination of the existence of unity of invention be made without (l) Examples giving guidance on how these regard to whether the inventions are claimed in principles may be interpreted in particular cases are separate claims or as alternatives within a single set out in the PCT International Search and claim. Preliminary Examination Guidelines. [Annex C follows]

Annex C

STANDARD FOR THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS IN INTERNATIONAL PATENT APPLICATIONS UNDER THE PCT

INTRODUCTION (i) the expression ªsequence listingº means a nucleotide and/or amino acid sequence listing 1. This Standard has been elaborated so as to which gives a detailed disclosure of the nucleotide provide standardization of the presentation of and/or amino acid sequences and other available nucleotide and amino acid sequence listings in information; international patent applications. The Standard is intended to allow the applicant to draw up a single (i-bis) the expression ªsequence listing sequence listing which is acceptable to all receiving forming part of the international applicationº means Of®ces, International Searching and Preliminary a sequence listing contained in the international Examining Authorities for the purposes of the application as ®led (as referred to in paragraph 3), international phase, and to all designated and elected including any sequence listing or part thereof which Of®ces for the purposes of the national phase. It is is included in the international application under intended to enhance the accuracy and quality of Rule 20.5(b) or (c), which is considered to have been presentations of nucleotide and amino acid sequences contained in the international application under Rule given in international applications, to make for easier 20.6(b), or which has been corrected under Rule 26, presentation and dissemination of sequences for the recti®ed under Rule 91 or amended under Article bene®t of applicants, the public and examiners, to 34(2); or a sequence listing included in the facilitate searching of sequence data and to allow international application by way of an amendment the exchange of sequence data in electronic form under Article 34(2)(b) of the description in relation and the introduction of sequence data onto to sequences contained in the international computerized databases. application as ®led (as referred to in paragraphs 3 bis and 3 ter); DEFINITIONS (i-ter) the expression ªsequence listing not 2. For the purposes of this Standard: forming part of the international applicationº means

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a sequence listing which does not form part of the sequence database providers (including scienti®c international application but is furnished for the names, quali®ers and their controlled-vocabulary purposes of the international search or international values, the symbols appearing in Appendix 2, Tables preliminary examination (as referred to in paragraphs 1, 2, 3 and 4, and the feature keys appearing in 4 and 4 bis); Appendix 2, Tables 5 and 6); (ii) sequences which are included are any (viii) ªcompetent Authorityº is the unbranched sequences of four or more amino acids International Searching Authority that is to carry out or unbranched sequences of ten or more nucleotides. the international search and to establish the written Branched sequences, sequences with fewer than four opinion of the International Searching Authority on speci®cally de®ned nucleotides or amino acids as the international application, or the International well as sequences comprising nucleotides or amino Preliminary Examining Authority that is to carry out acids other than those listed in Appendix 2, Tables the international preliminary examination on the 1, 2, 3 and 4, are speci®cally excluded from this international application. de®nition; SEQUENCE LISTINGS (iii) ªnucleotidesº embrace only those nucleotides that can be represented using the symbols set forth in Appendix 2, Table 1. Modi®cations, for Sequence Listing Forming Part of the International example, methylated bases, may be described as set Application forth in Appendix 2, Table 2, but shall not be shown explicitly in the nucleotide sequence; 3. A sequence listing which is contained in the (iv) ªamino acidsº are those L-amino acids international application as ®led: commonly found in naturally occurring proteins and (i) shall be presented as a separate part of the are listed in Appendix 2, Table 3. Those amino acid description, be placed at the end of the application, sequences containing at least one D-amino acid are preferably be entitled ªSequence Listingº, begin on not intended to be embraced by this de®nition. Any a new page and have independent page numbering; amino acid sequence that contains preferably, the sequence listing shall not be post-translationally modi®ed amino acids may be reproduced in any other part of the application; described as the amino acid sequence that is initially subject to paragraph 36, it is unnecessary to describe translated using the symbols shown in Appendix 2, the sequences elsewhere in the description; Table 3, with the modi®ed positions, for example, (ii) shall present the sequences represented hydroxylations or glycosylations, being described in the sequence listing and other available as set forth in Appendix 2, Table 4, but these information in the sequence listing in accordance modi®cations shall not be shown explicitly in the with paragraphs 5 to 35; amino acid sequence. Any peptide or protein that can be expressed as a sequence using the symbols (iii) if contained in an international in Appendix 2, Table 3, in conjunction with a application ®led in electronic form, shall be in an description elsewhere to describe, for example, electronic document format and ®led by a means of abnormal linkages, cross-links (for example, transmittal in accordance with paragraph 37. disul®de bridge) and end caps, non-peptidyl bonds, 3bis. Any correction under Rule 26, recti®cation etc., is embraced by this de®nition; under Rule 91 or amendment under PCT Article (v) ªsequence identi®erº is a unique integer 34(2) of the description submitted in relation to a that corresponds to the SEQ ID NO assigned to each sequence listing contained in the international sequence in the listing; application ®led on paper and any sequence listing included in the international application by way of (vi) ªnumeric identi®erº is a three-digit an amendment under Article 34(2)(b) of the number which represents a speci®c data element; description in relation to sequences contained in the (vii) ªlanguage-neutral vocabularyº is a international application ®led on paper shall be controlled vocabulary used in the sequence listing submitted in accordance with Rule 26.4, Rule 91 or that represents scienti®c terms as prescribed by Rule 66.8, respectively.

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3ter. Any correction under Rule 26, recti®cation (iii) if furnished on paper in accordance with under Rule 91 or amendment under Article 34(2)(b) Rule 13 ter.1(b), shall have independent page of the description submitted in relation to a sequence numbering; listing contained in the international application ®led in electronic form and any sequence listing included (iv) if furnished in electronic form, shall be in the international application by way of an in an electronic document format and ®led by a amendment under Article 34(2)(b) of the description means of transmittal in accordance with paragraph in relation to sequences contained in the international 39; application ®led in electronic form shall be submitted (v) if furnished in electronic form together in the form of a sequence listing in electronic form with the international application, shall be identical comprising the entire listing with the relevant to the sequence listing as contained in the application correction, recti®cation or amendment. Any such and be accompanied by a statement that ªthe sequence listing: information recorded in electronic form furnished (i) shall preferably be entitled ªSequence under Rule 13 ter is identical to the sequence listing Listing ± Correctionº, ªSequence Listing ± as contained in the international applicationº; Recti®cationº or ªSequence Listing ± Amendmentº, (vi) if furnished subsequently to the ®ling of as the case may be, and have independent page the international application, shall not go beyond the numbering; disclosure in the international application as ®led (ii) shall present the sequences represented and be accompanied by a statement to that effect; in the sequence listing and other available any such sequence listing shall contain only those information in the sequence listing in accordance sequences that were disclosed in the international with paragraphs 5 to 35; where applicable, the application as ®led. original numbering of the sequences in the 4bis. Any correction under Rule 26, recti®cation international application as ®led (as referred to in under Rule 91 or amendment under Article 34(2)(b) paragraph 5) shall be maintained; otherwise, the of the description submitted in relation to a sequence sequences shall be numbered in accordance with listing contained in the international application as paragraph 5; ®led and any sequence listing included in the (iii) shall be in an electronic document format international application by way of an amendment and ®led by a means of transmittal in accordance under Article 34(2)(b) of the description in relation with paragraph 38. to sequences contained in the international application as ®led shall be accompanied, for the Sequence Listing Not Forming Part of the International purposes of the international search or international Application preliminary examination, by a sequence listing in electronic form in an electronic document format in 4. A sequence listing furnished under Rule 13 ter accordance with paragraph 39, comprising the entire for the purposes of the international search or listing including any such correction, recti®cation international preliminary examination: or amendment, whenever this is required by the (i) shall preferably be entitled ªSequence competent authority, unless such listing in electronic Listing ± Rule 13 terº; form is already available to that authority in a form (ii) shall present the sequences represented and manner acceptable to it. Any such sequence in the sequence listing and other available listing in electronic form: information in the sequence listing in accordance (i) shall preferably be entitled ªSequence with paragraphs 5 to 35; where applicable, the Listing ± Correction ± Rule 13 terº, ªSequence original numbering of the sequences in the Listing ± Recti®cation ± Rule 13 terº or ªSequence international application as ®led (as referred to in Listing ± Amendment ± Rule 13 terº, as the case paragraph 5) shall be maintained; otherwise, the may be; sequences shall be numbered in accordance with (ii) shall present the sequences represented paragraph 5; in the sequence listing and other available information in the sequence listing in accordance

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with paragraphs 5 to 35; where applicable, the original numbering of the sequences in the For those sequences disclosed in the format speci®ed international application as ®led (as referred to in in option (iii), above, the amino acid sequence must paragraph 5) shall be maintained; otherwise, the be disclosed separately in the sequence listing as a sequences shall be numbered in accordance with pure amino acid sequence with a separate integer paragraph 5; sequence identi®er. (iii) shall be ®led by a means of transmittal Nucleotide Sequences in accordance with paragraph 39; Symbols to Be Used (iv) shall be identical to the corrected or amended sequence listing and be accompanied by a 8. A nucleotide sequence shall be presented only statement that ªthe information recorded in electronic by a single strand, in the 5'-end to 3'-end direction form furnished under Rule 13 ter is identical to the from left to right. The terms 3' and 5' shall not be corrected sequence listingº (or to the ªamended represented in the sequence. sequence listingº, as the case may be). 9. The bases of a nucleotide sequence shall be Where such sequence listing in electronic form and, represented using the one-letter code for nucleotide where applicable, such statement is not available to sequence characters. Only lower case letters in the competent authority, any such correction, conformity with the list given in Appendix 2, Table recti®cation or amendment need only be taken into 1, shall be used. account by that authority for the purposes of the 10. Modi®ed bases shall be represented as the international search or preliminary examination to corresponding unmodi®ed bases or as ªnº in the the extent that a meaningful search or preliminary sequence itself if the modi®ed base is one of those examination can be carried out without such listed in Appendix 2, Table 2, and the modi®cation sequence listing in electronic form. shall be further described in the feature section of PRESENTATION OF SEQUENCES the sequence listing, using the codes given in Appendix 2, Table 2. These codes may be used in 5. Each sequence shall be assigned a separate the description or the feature section of the sequence sequence identi®er. The sequence identi®ers shall listing but not in the sequence itself (see also begin with 1 and increase sequentially by integers. paragraph 32). The symbol ªnº is the equivalent of If no sequence is present for a sequence identi®er, only one unknown or modi®ed nucleotide. the code 000 should appear under numeric identi®er Format to Be Used <400>, beginning on the next line following the SEQ ID NO. The response for numeric identi®er <160> 11. A nucleotide sequence shall be listed with a shall include the total number of SEQ ID NOs, maximum of 60 bases per line, with a space between whether followed by a sequence or by the code 000. each group of 10 bases. 6. In the description, claims or drawings of the 12. The bases of a nucleotide sequence application, the sequences represented in the (including introns) shall be listed in groups of 10 sequence listing shall be referred to by the sequence bases, except in the coding parts of the sequence. identi®er and preceded by ªSEQ ID NO:º. Leftover bases, fewer than 10 in number at the end 7. Nucleotide and amino acid sequences should of non-coding parts of a sequence, should be grouped be represented by at least one of the following three together and separated from adjacent groups by a possibilities: space. (i) a pure nucleotide sequence; 13. The bases of the coding parts of a nucleotide sequence shall be listed as triplets (codons). (ii) a pure amino acid sequence; 14. The enumeration of the nucleotide shall start (iii) a nucleotide sequence together with its at the ®rst base of the sequence with number 1. It corresponding amino acid sequence. shall be continuous through the whole sequence in the direction 5' to 3'. It shall be marked in the right

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margin, next to the line containing the one-letter 19. A protein or peptide sequence shall be listed codes for the bases, and giving the number of the with a maximum of 16 amino acids per line, with a last base of that line. The enumeration method for space provided between each amino acid. nucleotide sequences set forth above remains 20. Amino acids corresponding to the codons in applicable to nucleotide sequences that are circular the coding parts of a nucleotide sequence shall be in con®guration, with the exception that the placed immediately under the corresponding codons. designation of the ®rst nucleotide of the sequence Where a codon is split by an intron, the amino acid may be made at the option of the applicant. symbol should be given below the portion of the 15. A nucleotide sequence that is made up of codon containing two nucleotides. one or more non-contiguous segments of a larger 21. The enumeration of amino acids shall start sequence or of segments from different sequences at the ®rst amino acid of the sequence, with number shall be numbered as a separate sequence, with a 1. Optionally, the amino acids preceding the mature separate sequence identi®er. A sequence with a gap protein, for example pre-sequences, pro-sequences, or gaps shall be numbered as a plurality of separate pre-pro-sequences and signal sequences, when sequences with separate sequence identi®ers, with present, may have negative numbers, counting the number of separate sequences being equal in backwards starting with the amino acid next to number to the number of continuous strings of number 1. Zero (0) is not used when the numbering sequence data. of amino acids uses negative numbers to distinguish Amino Acid Sequences the mature protein. It shall be marked under the sequence every ®ve amino acids. The enumeration Symbols to Be Used method for amino acid sequences set forth above remains applicable for amino acid sequences that 16. The amino acids in a protein or peptide are circular in con®guration, with the exception that sequence shall be listed in the amino to carboxy the designation of the ®rst amino acid of the direction from left to right. The amino and carboxy sequence may be made at the option of the applicant. groups shall not be represented in the sequence. 22. An amino acid sequence that is made up of 17. The amino acids shall be represented using one or more non-contiguous segments of a larger the three-letter code with the ®rst letter as a capital sequence or of segments from different sequences and shall conform to the list given in Appendix 2, shall be numbered as a separate sequence, with a Table 3. An amino acid sequence that contains a separate sequence identi®er. A sequence with a gap blank or internal terminator symbols (for example, or gaps shall be numbered as a plurality of separate ªTerº or ª*º or ª.º) may not be represented as a sequences with separate sequence identi®ers, with single amino acid sequence, but shall be presented the number of separate sequences being equal in as separate amino acid sequences (see paragraph number to the number of continuous strings of 22). sequence data. 18. Modi®ed and unusual amino acids shall be OTHER AVAILABLE INFORMATION IN THE represented as the corresponding unmodi®ed amino SEQUENCE LISTING acids or as ªXaaº in the sequence itself if the modi®ed amino acid is one of those listed in 23. The order of the items of information in the Appendix 2, Table 4, and the modi®cation shall be sequence listings shall follow the order in which further described in the feature section of the those items are listed in the list of numeric identi®ers sequence listing, using the codes given in Appendix of data elements as de®ned in Appendix 1. 2, Table 4. These codes may be used in the 24. Only numeric identi®ers of data elements as description or the feature section of the sequence de®ned in Appendix 1 shall be used for the listing but not in the sequence itself (see also presentation of the items of information in the paragraph 32). The symbol ªXaaº is the equivalent sequence listing. The corresponding numeric of only one unknown or modi®ed amino acid. identi®er descriptions shall not be used. The Format to Be Used provided information shall follow immediately after the numeric identi®er while only those numeric

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identi®ers for which information is given need paragraph 5, above, and SEQ ID NO: 4 in the appear on the sequence listing. Two exceptions to example depicted in Appendix 3 of this Standard). this requirement are numeric identi®ers <220> and 26. In addition to the data elements identi®ed in <300>, which serve as headers for ªFeatureº and paragraph 25, above, when a sequence listing is ªPublication Information,º respectively, and are furnished at any time prior to the assignment of an associated with information in numeric identi®ers application number, the following data element shall <221> to <223> and <301> to <313>, respectively. be included in the sequence listing: When feature and publication information is provided in the sequence listing under those numeric identi®ers, numeric identi®ers <220> and <300>, <130> File reference respectively, should be included, but left blank. Generally, a blank line shall be inserted between 27. In addition to the data elements identi®ed in numeric identi®ers when the digit in the ®rst or paragraph 25, above, when a sequence listing is second position of the numeric identi®er changes. furnished at any time following the assignment of An exception to this general rule is that no blank an application number, the following data elements line should appear preceding numeric identi®er shall be included in the sequence listing: <310>. Additionally, a blank line shall precede any repeated numeric identi®er. <140> Current patent application Mandatory Data Elements <141> Current ®ling date 28. In addition to the data elements identi®ed in 25. The sequence listing shall include, in paragraph 25, above, when a sequence listing is ®led addition to and immediately preceding the actual relating to an application which claims the priority nucleotide and/or amino acid sequence, the following of an earlier application, the following data elements items of information de®ned in Appendix 1 shall be included in the sequence listing: (mandatory data elements):

<150> Earlier patent application <110> Applicant name <151> Earlier application ®ling date <120> Title of invention <160> Number of SEQ ID NOs 29. If ªnº or ªXaaº or a modi®ed base or <210> SEQ ID NO: x modi®ed/unusual L-amino acid is used in the <211> Length sequence, the following data elements are mandatory: <212> Type <213> Organism <400> Sequence <220> Feature <221> Name/key Where the name of the applicant (numeric identi®er <222> Location <110>) is written in characters other than those of <223> Other information the Latin alphabet, it shall also be indicated in 30. If the organism (numeric identi®er <213>) characters of the Latin alphabet either as a mere is ªArti®cial Sequenceº or ªUnknown,º the transliteration or through translation into English. following data elements are mandatory: The data elements, except those under numeric identi®ers <110>, <120> and <160>, shall be <220> Feature repeated for each sequence included in the sequence <223> Other information listing. Only the data elements under numeric identi®ers <210> and <400> are mandatory if no Optional Data Elements sequence is present for a sequence identi®er (see

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31. All data elements de®ned in Appendix 1, speci®ed by both the receiving Of®ce and the not mentioned in paragraphs 25 to 30, above, are competent authority. optional (optional data elements). 38. Any sequence listing in electronic form Presentation of Features referred to in paragraph 3ter shall be in an electronic document format that has been speci®ed by the 32. When features of sequences are presented receiving Of®ce (in the case of a correction) or by (that is, numeric identi®er <220>), they shall be the competent authority (in the case of a recti®cation described by the ªfeature keysº set out in Appendix or an amendment) for the purposes of ®ling of 2, Tables 5 and 6. international applications in electronic form, provided that any such listing shall preferably be in Free Text the electronic document format speci®ed in paragraph 40. Any such listing shall be ®led by a 33. ªFree textº is a wording describing means of transmittal which has been speci®ed by characteristics of the sequence under numeric the receiving Of®ce or the competent authority, as identi®er <223> (Other information) which does not applicable, for the purposes of this paragraph; if use language-neutral vocabulary as referred to in possible, it shall preferably be ®led by a means of paragraph 2(vii). transmittal which has been speci®ed by both the 34. The use of free text shall be limited to a few receiving Of®ce and the competent authority. short terms indispensable for the understanding of 39. Any sequence listing in electronic form the sequence. It shall not exceed four lines with a referred to in paragraphs 4 and 4 bis furnished for maximum of 65 characters per line for each given the purposes of the international search or data element, when written in English. Any further international preliminary examination shall be in the information shall be included in the main part of the electronic document format speci®ed in paragraph description in the language thereof. 40 and be ®led by a means of transmittal which has 35. Any free text should preferably be in the been speci®ed by the competent authority for the English language. purposes of this paragraph. REPETITION OF FREE TEXT IN MAIN PART OF 40. For the purposes of the international search DESCRIPTION and international preliminary examination, any sequence listing in electronic form shall be contained 36. Where the sequence listing forming part of within one electronic ®le encoded using IBM Code the international application contains free text, any Page 437, IBM Code Page 932 or a compatible code such free text shall be repeated in the main part of page to represent the sequence listing as set out in the description in the language thereof. It is paragraphs 5 to 36 with no other codes included. A recommended that the free text in the language of compatible code page, as would be required for, for the main part of the description be put in a speci®c example, Japanese, Chinese, Cyrillic, Arabic, Greek section of the description called ªSequence Listing or Hebrew characters, is one that assigns the Roman Free Textº. alphabet and numerals to the same hexadecimal SEQUENCE LISTINGS IN ELECTRONIC FORM positions as do the speci®ed code pages. 41. Any sequence listing in the electronic 37. Any sequence listing referred to in paragraph document format speci®ed in paragraph 40 shall 3 contained in an international application ®led in preferably be created by dedicated software such as electronic form shall be in an electronic document PatentIn. format and be ®led by a means of transmittal that has been speci®ed by the receiving Of®ce for the PROCEDURE BEFORE DESIGNATED AND ELECTED OFFICES purposes of ®ling of international applications in electronic form, provided that any such sequence 42. For the purposes of the procedure before a listing shall preferably be in the electronic document designated or elected Of®ce before which the format speci®ed in paragraph 40 and be ®led, if processing of an international application which possible, by a means of transmittal which has been contains the disclosure of one or more nucleotide

AI-67 June 2020 MANUAL OF PATENT EXAMINING PROCEDURE

and/or amino acid sequences has started (see Rule Table 1: List of Nucleotides 13 ter.3): Table 2: List of Modi®ed Nucleotides (i) any reference to the receiving Of®ce or the competent authority shall be construed as a Table 3: List of Amino Acids reference to the designated or elected Of®ce Table 4: List of Modi®ed and Unusual concerned; Amino Acids (ii) any reference to a sequence listing which Table 5: List of Feature Keys Related to is included in the international application by way Nucleotide Sequences of a recti®cation under Rule 91 or an amendment Table 6: List of Feature Keys Related to under Article 34(2)(b) of the description in relation Protein Sequences to sequences contained in the application as ®led shall be construed to also include any sequence Appendix 3: Specimen Sequence Listing listing included in the application, under the national [Appendices 1 to 3 to Annex C follow] law applied by the designated or elected Of®ce concerned, by way of a recti®cation (of an obvious mistake) or amendment of the description in relation to sequences contained in the application as ®led; Annex C, Appendix 1 Numeric Identi®ers (iii) any reference to a sequence listing furnished for the purposes of international search or Only numeric identi®ers as de®ned below may be international preliminary examination shall be used in sequence listings submitted in applications. construed to also include any such listing furnished The text of the data element headings given below to the designated or elected Of®ce concerned for the shall not be included in the sequence listings. purposes of national search or examination by that Of®ce; Numeric identi®ers of mandatory data elements, that is, data elements which must be included in all (iv) the designated or elected Of®ce sequence listings (see paragraph 25 of this Standard: concerned may invite the applicant to furnish to it, items 110, 120, 160, 210, 211, 212, 213 and 400) within a time limit which shall be reasonable under and numeric identi®ers of data elements which must the circumstances, for the purposes of national search be included in circumstances speci®ed in this and/or examination, a sequence listing in electronic Standard (see paragraphs 26, 27, 28, 29 and 30 of form complying with this Standard, unless such this Standard: items 130, 140, 141, 150 and 151, and listing in electronic form is already available to that 220 to 223) are marked by the symbol ªM.º Of®ce in a form and manner acceptable to it. Appendices Numeric identi®ers of optional data elements (see paragraph 31 of this Standard) are marked by the Appendix 1: Numeric Identi®ers symbol ªO.º Appendix 2: Nucleotide and Amino Acid Symbols and Feature Table

Numeric Numeric Mandatory (M) or Optional Comment Identi®er Identi®er (O) Description <110> Applicant name M where the name of the applicant is written in characters other than those of the Latin alphabet, the same shall also be indicated in characters of the Latin alphabet either as a mere transliteration or through translation into English

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Numeric Numeric Mandatory (M) or Optional Comment Identi®er Identi®er (O) Description <120> Title of M Invention <130> File reference M, in the circumstances speci®ed see paragraph 26 of this Standard in paragraph 26 of this Standard <140> Current patent M, in the circumstances speci®ed see paragraph 27 of this Standard; the current patent application in paragraph 27 of this Standard application shall be identi®ed, in the following order, by the two-letter code indicated in accordance with WIPO Standard ST.3 and the application number (in the format used by the industrial property Of®ce with which the current patent application is ®led) or, for an international application, by the international application number <141> Current ®ling M, in the circumstances speci®ed see paragraph 27 of this Standard; the date shall be date in paragraph 27 of this Standard indicated in accordance with WIPO Standard ST.2 (CCYY MM DD) <150> Earlier patent M, in the circumstances speci®ed see paragraph 28 of this Standard; the earlier patent application in paragraph 28 of this Standard application shall be identi®ed, in the following order, by the two-letter code indicated in accordance with WIPO Standard ST.3 and the application number (in the format used by the industrial property Of®ce with which the earlier patent application was ®led) or, for an international application, by the international application number <151> Earlier M, in the circumstances speci®ed see paragraph 28 of this Standard; the date shall be application in paragraph 28 of this Standard indicated in accordance with WIPO Standard ST.2 ®ling date (CCYY MM DD) <160> Number of SEQ M ID NOs <170> Software O <210> Information for M response shall be an integer representing the SEQ ID SEQ ID NO: x NO shown <211> Length M sequence length expressed in number of base pairs or amino acids <212> Type M type of molecule sequenced in SEQ ID NO: x, either DNA, RNA or PRT; if a nucleotide sequence contains both DNA and RNA fragments, the value shall be ªDNAº; in addition, the combined DNA/RNA molecule shall be further described in the <220> to <223> feature section <213> Organism M Genus Species (that is, scienti®c name) or ªArti®cial Sequenceº or ªUnknownº <220> Feature M, in the circumstances speci®ed leave blank; see paragraphs 29 and 30 of this in paragraph 29 and 30 of this Standard; description of points of biological Standard signi®cance in the sequence in SEQ ID NO: x) (may

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Numeric Numeric Mandatory (M) or Optional Comment Identi®er Identi®er (O) Description be repeated depending on the number of features indicated) <221> Name/key M in the circumstances speci®ed see paragraph 29 of this Standard; only those keys in paragraph 29 of this Standard as described in Table 5 or 6 of Appendix 2 shall be used <222> Location M, in the circumstances speci®ed see paragraph 29 of this Standard; - from (number in paragraph 29 of this Standard of ®rst base/amino acid in the feature) - to (number of last base/amino acid in the feature) - base pairs (numbers refer to positions of base pairs in a nucleotide sequence) - amino acids (numbers refer to positions of amino acid residues in an amino acid sequence) - whether feature is located on the complementary strand to that ®led in the sequence listing <223> Other M, in the circumstances speci®ed see paragraphs 29 and 30 of this Standard; any other information: in paragraphs 29 and 30 of this relevant information, using language neutral Standard vocabulary, or free text (preferably in English); any free text is to be repeated in the main part of the description in the language thereof (see paragraph 36 of this Standard); where any modi®ed base or modi®ed/unusual L-amino acid appearing in Appendix 2, Tables 2 and 4, is in the sequence, the symbol associated with that base or amino acid from Appendix 2, Tables 2 and 4, should be used <300> Publication O leave blank; repeat section for each relevant information publication <301> Authors O <302> Title O title of publication <303> Journal O journal name in which data published <304> Volume O journal volume in which data published <305> Issue O journal issue number in which data published <306> Pages O journal page numbers on which data published <307> Date O journal date on which data published; if possible, the date shall be indicated in accordance with WIPO Standard ST.2 (CCYY MM DD) <308> Database O accession number assigned by database including accession database name number <309> Database entry O date of entry in database; the date shall be indicated date in accordance with WIPO Standard ST.2 (CCYY MM DD) <310> Document O document number, for patent type citations only; the number full document shall specify, in the following order, the two-letter code indicated in accordance with WIPO Standard ST.3, the publication number

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Numeric Numeric Mandatory (M) or Optional Comment Identi®er Identi®er (O) Description indicated in accordance with WIPO Standard ST.6, and the kind-of-document code indicated in accordance with WIPO Standard ST.16 <311> Filing date O document ®ling date, for patent-type citations only; the date shall be indicated in accordance with WIPO Standard ST.2 (CCYY MM DD) <312> Publication date O document publication date; for patent-type citations only; the date shall be indicated in accordance with WIPO Standard ST.2 (CCYY MM DD) <313> Relevant O residues in SEQ ID NO: x: from to <400> Sequence M SEQ ID NO: x should follow the numeric identi®er and should appear on the line preceding the sequence (see Appendix 3)

Annex C, Appendix 2 Nucleotide and Amino Acid Symbols and Feature Table

Table 1: List of Nucleotides

Symbol Meaning Origin of designation a a adenine g g guanine c c cytosine t t thymine u u uracil r g or a purine y t/u or c pyrimidine m a or c amino k g or t/u keto s g or c strong interactions 3H-bonds w a or t/u weak interactions 2H-bonds b g or c or t/u not a d a or g or t/u not c h a or c or t/u not g v a or g or c not t, not u n a or g or c or t/u, unknown, or any other

Table 2: List of Modified Nucleotides

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Symbol Meaning ac4c 4-acetylcytidine chm5u 5-(carboxyhydroxymethyl)uridine cm 2©-O-methylcytidine cmnm5s2u 5-carboxymethylaminomethyl-2-thiouridine cmnm5u 5-carboxymethylaminomethyluridine d dihydrouridine fm 2©-O-methylpseudouridine gal q beta, D-galactosylqueuosine gm 2©-O-methylguanosine i inosine i6a N6-isopentenyladenosine m1a 1-methyladenosine m1f 1-methylpseudouridine m1g 1-methylguanosine m1i 1-methylinosine m22g 2,2-dimethylguanosine m2a 2-methyladenosine m2g 2-methylguanosine m3c 3-methylcytidine m5c 5-methylcytidine m6a N6-methyladenosine m7g 7-methylguanosine mam5u 5-methylaminomethyluridine mam5s2u 5-methoxyaminomethyl-2-thiouridine man q beta, D-mannosylqueuosine mcm5s2u 5-methoxycarbonylmethyl-2-thiouridine mcm5u 5-methoxycarbonylmethyluridine mo5u 5-methoxyuridine ms2i6a 2-methylthio-N6-isopentenyladenosine ms2t6a N-((9-beta-D-ribofuranosyl-2-methylthiopurine-6-yl)carbamoyl)threonine mt6a N-((9-beta-D-ribofuranosylpurine-6-yl)N-methylcarbamoyl)threonine mv uridine-5-oxyacetic acid-methylester o5u uridine-5-oxyacetic acid osyw wybutoxosine p pseudouridine q queuosine s2c 2-thiocytidine s2t 5-methyl-2-thiouridine s2u 2-thiouridine s4u 4-thiouridine t 5-methyluridine t6a N-((9-beta-D-ribofuranosylpurine-6-yl)-carbamoyl)threonine

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Symbol Meaning tm 2©-O-methyl-5-methyluridine um 2©-O-methyluridine yw wybutosine x 3-(3-amino-3-carboxy-propyl)uridine, (acp3)u

Table 3: List of Amino Acids

Symbol Meaning Ala Alanine Cys Cysteine Asp Aspartic Acid Glu Glutamic Acid Phe Phenylalanine Gly Glycine His Histidine Ile Isoleucine Lys Lysine Leu Leucine Met Methionine Asn Asparagine Pro Proline Gln Glutamine Arg Arginine Ser Serine Thr Threonine Val Valine Trp Tryptophan Tyr Tyrosine Asx Asp or Asn Glx Glu or Gln Xaa unknown or other

Table 4: List of Modified and Unusual Amino Acids

Symbol Meaning Aad 2-Aminoadipic acid bAad 3-Aminoadipic acid bAla beta-Alanine, beta-Aminopropionic acid Abu 2-Aminobutyric acid 4Abu 4-Aminobutyric acid, piperidinic acid Acp 6-Aminocaproic acid Ahe 2-Aminoheptanoic acid Aib 2-Aminoisobutyric acid bAib 3-Aminoisobutyric acid

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Symbol Meaning Apm 2-Aminopimelic acid Dbu 2,4 Diaminobutyric acid Des Desmosine Dpm 2,2©-Diaminopimelic acid Dpr 2,3-Diaminopropionic acid EtGly N-Ethylglycine EtAsn N-Ethylasparagine Hyl Hydroxylysine aHyl allo-Hydroxylysine 3Hyp 3-Hydroxyproline 4Hyp 4-Hydroxyproline Ide Isodesmosine aIle allo-Isoleucine MeGly N-Methylglycine, sarcosine MeIle N-Methylisoleucine MeLys 6-N-Methyllysine MeVal N-Methylvaline Nva Norvaline Nle Norleucine Orn Ornithine

Table 5: List of Feature Keys Related to Nucleotide Sequences

Key Description allele a related individual or strain contains stable, alternative forms of the same gene which differs from the presented sequence at this location (and perhaps others) attenuator (1) region of DNA at which regulation of termination of transcription occurs, which controls the expression of some bacterial operons; (2) sequence segment located between the promoter and the ®rst structural gene that causes partial termination of transcription C_region constant region of immunoglobulin light and heavy chains, and T-cell receptor alpha, beta, and gamma chains; includes one or more exons depending on the particular chain CAAT_signal CAAT box; part of a conserved sequence located about 75 bp up-stream of the start point of eukaryotic transcription units which may be involved in RNA polymerase binding; consensus=GG (C or T) CAATCT CDS coding sequence; sequence of nucleotides that corresponds with the sequence of amino acids in a protein (location includes stop codon); feature includes amino acid conceptual translation con¯ict independent determinations of the ªsameº sequence differ at this site or region D-loop displacement loop; a region within mitochondrial DNA in which a short stretch of RNA is paired with one strand of DNA, displacing the original partner DNA strand in this region; also used to describe the displacement of a region of one strand of duplex DNA by a single stranded invader in the reaction catalyzed by RecA protein D-segment diversity segment of immunoglobulin heavy chain, and T-cell receptor beta chain

June 2020 AI-74 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT

Key Description enhancer a cis-acting sequence that increases the utilization of (some) eukaryotic promoters, and can function in either orientation and in any location (upstream or downstream) relative to the promoter exon region of genome that codes for portion of spliced mRNA; may contain 5©UTR all CDSs, and 3©UTR GC_signal GC box; a conserved GC-rich region located upstream of the start point of eukaryotic transcription units which may occur in multiple copies or in either orientation; consensus=GGGCGG gene region of biological interest identi®ed as a gene and for which a name has been assigned iDNA intervening DNA; DNA which is eliminated through any of several kinds of recombination intron a segment of DNA that is transcribed, but removed from within the transcript by splicing together the sequences (exons) on either side of it J_segment joining segment of immunoglobulin light and heavy chains, and T-cell receptor alpha, beta, and gamma chains LTR long terminal repeat, a sequence directly repeated at both ends of a de®ned sequence, of the sort typically found in retroviruses mat_peptide mature peptide or protein coding sequence; coding sequence for the mature or ®nal peptide or protein product following post-translational modi®cation; the location does not include the stop codon (unlike the corresponding CDS) misc_binding site in nucleic acid which covalently or non-covalently binds another moiety that cannot be described by any other Binding key (primer_bind or protein_bind) misc_difference feature sequence is different from that presented in the entry and cannot be described by any other Difference key (con¯ict, unsure, old_sequence, mutation, variation, allele, or modi®ed_base) misc_feature region of biological interest which cannot be described by any other feature key; a new or rare feature misc_recomb site of any generalized, site-speci®c or replicative recombination event where there is a breakage and reunion of duplex DNA that cannot be described by other recombination keys (iDNA and virion) or quali®ers of source key (/insertion_seq, /transposon, /proviral) misc_RNA any transcript or RNA product that cannot be de®ned by other RNA keys (prim_transcript, precursor_RNA, mRNA, 5©clip, 3©clip, 5©UTR, 3©UTR, exon, CDS, sig_peptide, transit_peptide, mat_peptide, intron, polyA_site, rRNA, tRNA, scRNA, and snRNA) misc_signal any region containing a signal controlling or altering gene function or expression that cannot be described by other Signal keys (promoter, CAAT_signal, TATA_signal, -35_signal, -10_signal, GC_signal, RBS, polyA_signal, enhancer, attenuator, terminator, and rep_origin) misc_structure any secondary or tertiary structure or conformation that cannot be described by other Structure keys (stem_loop and D-loop) modi®ed_base the indicated nucleotide is a modi®ed nucleotide and should be substituted for by the indicated molecule (given in the mod_base quali®er value) mRNA messenger RNA; includes 5© untranslated region (5©UTR), coding sequences (CDS, exon) and 3© untranslated region (3©UTR)

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Key Description mutation a related strain has an abrupt, inheritable change in the sequence at this location N_region extra nucleotides inserted between rearranged immunoglobulin segments old_sequence the presented sequence revises a previous version of the sequence at this location polyA_signal recognition region necessary for endonuclease cleavage of an RNA transcript that is followed by polyadenylation; consensus=AATAAA polyA_site site on an RNA transcript to which will be added adenine residues by post-transcriptional polyadenylation precursor_RNA any RNA species that is not yet the mature RNA product; may include 5© clipped region (5©clip), 5© untranslated region (5©UTR), coding sequences (CDS, exon), intervening sequences (intron), 3© untranslated region (3©UTR), and 3© clipped region (3©clip) prim_transcript primary (initial, unprocessed) transcript; includes 5© clipped region (5©clip), 5© untranslated region (5©UTR), coding sequences (CDS, exon), intervening sequences (intron), 3© untranslated region (3©UTR), and 3© clipped region (3© clip) primer_bind non-covalent primer binding site for initiation of replication, transcription, or reverse transcription; includes site(s) for synthetic, for example, PCR primer elements promoter region on a DNA molecule involved in RNA polymerase binding to initiate transcription protein_bind non-covalent protein binding site on nucleic acid RBS ribosome binding site repeat_region region of genome containing repeating units repeat_unit single repeat element rep_origin origin of replication; starting site for duplication of nucleic acid to give two identical copies rRNA mature ribosomal RNA; the RNA component of the ribonucleoprotein particle (ribosome) which assembles amino acids into proteins S_region switch region of immunoglobulin heavy chains; involved in the rearrangement of heavy chain DNA leading to the expression of a different immunoglobulin class from the same B-cell satellite many tandem repeats (identical or related) of a short basic repeating unit; many have a base composition or other property different from the genome average that allows them to be separated from the bulk (main band) genomic DNA scRNA small cytoplasmic RNA; any one of several small cytoplasmic RNA molecules present in the cytoplasm and (sometimes) nucleus of a eukaryote sig_peptide signal peptide coding sequence; coding sequence for an N-terminal domain of a secreted protein; this domain is involved in attaching nascent polypeptide to the membrane; leader sequence snRNA small nuclear RNA; any one of many small RNA species con®ned to the nucleus; several of the snRNAs are involved in splicing or other RNA processing reactions source identi®es the biological source of the speci®ed span of the sequence; this key is mandatory; every entry will have, as a minimum, a single source key spanning the entire sequence; more than one source key per sequence is permissable stem_loop hairpin; a double-helical region formed by base-pairing between adjacent (inverted) complementary sequences in a single strand of RNA or DNA

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Key Description STS Sequence Tagged Site; short, single-copy DNA sequence that characterizes a mapping landmark on the genome and can be detected by PCR; a region of the genome can be mapped by determining the order of a series of STSs TATA_signal TATA box; Goldberg-Hogness box; a conserved AT-rich septamer found about 25 bp before the start point of each eukaryotic RNA polymerase II transcript unit which may be involved in positioning the enzyme for correct initiation; consensus=TATA(A or T)A(A or T) terminator sequence of DNA located either at the end of the transcript or adjacent to a promoter region that causes RNA polymerase to terminate transcription; may also be site of binding of repressor protein transit_peptide transit peptide coding sequence; coding sequence for an N-terminal domain of a nuclear-encoded organellar protein; this domain is involved in post-translational import of the protein into the organelle tRNA mature transfer RNA, a small RNA molecule (75-85 bases long) that mediates the translation of a nucleic acid sequence into an amino acid sequence unsure author is unsure of exact sequence in this region V_region variable region of immunoglobulin light and heavy chains, and T-cell receptor alpha, beta, and gamma chains; codes for the variable amino terminal portion; can be made up from V_segments, D_segments, N_regions, and J_segments V_segment variable segment of immunoglobulin light and heavy chains, and T-cell receptor alpha, beta, and gamma chains; codes for most of the variable region (V_region) and the last few amino acids of the leader peptide variation a related strain contains stable mutations from the same gene (for example, RFLPs, polymorphisms, etc.) which differ from the presented sequence at this location (and possibly others) 3©clip 3©-most region of a precursor transcript that is clipped off during processing 3©UTR region at the 3 end of a mature transcript (following the stop codon) that is not translated into a protein 5©clip 5©-most region of a precursor transcript that is clipped off during processing 5©UTR region at the 5© end of a mature transcript (preceding the initiation codon) that is not translated into a protein -10_signal pribnow box; a conserved region about 10 bp upstream of the start point of bacterial transcription units which may be involved in binding RNA polymerase; consensus=TAtAaT -35_signal a conserved hexamer about 35 bp upstream of the start point of bacterial transcription units; consensus=TTGACa [ ] or TGTTGACA [ ]

Table 6: List of Feature Keys Related to Protein Sequences

Key Description CONFLICT different papers report differing sequences VARIANT authors report that sequence variants exist VARSPLIC description of sequence variants produced by alternative splicing MUTAGEN site which has been experimentally altered MOD_RES post-translational modi®cation of a residue

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Key Description ACETYLATION N-terminal or other AMIDATION generally at the C-terminal of a mature active peptide BLOCKED undetermined N- or C-terminal blocking group FORMYLATION of the N-terminal methionine GAMMA-CARBOXYGLUTAMIC of asparagine, aspartic acid, proline or lysine ACID HYDROXYLATION METHYLATION generally of lysine or arginine PHOSPHORYLATION of serine, threonine, tyrosine, aspartic acid or histidine PYRROLIDONE CARBOXYLIC ACID N-terminal glutamate which has formed an internal cyclic lactam SULFATATION generally of tyrosine LIPID covalent binding of a lipidic moiety MYRISTATE myristate group attached through an amide bond to the N-terminal glycine residue of the mature form of a protein or to an internal lysine residue PALMITATE palmitate group attached through a thioether bond to a cysteine residue or through an ester bond to a serine or threonine residue FARNESYL farnesyl group attached through a thioether bond to a cysteine residue GERANYL-GERANYL geranyl-geranyl group attached through a thioether bond to a cysteine residue GPI-ANCHOR glycosyl-phosphatidylinositol (GPI) group linked to the alpha-carboxyl group of the C-terminal residue of the mature form of a protein N-ACYL DIGLYCERIDE N-terminal cysteine of the mature form of a prokaryotic lipoprotein with an amide-linked fatty acid and a glyceryl group to which two fatty acids are linked by ester linkages DISULFID disul®de bond; the `FROM' and `TO' endpoints represent the two residues which are linked by an intra-chain disul®de bond; if the `FROM' and `TO' endpoints are identical, the disul®de bond is an interchain one and the description ®eld indicates the nature of the cross-link THIOLEST thiolester bond; the `FROM' and `TO' endpoints represent the two residues which are linked by the thiolester bond THIOETH thioether bond; the `FROM' and `TO'endpoints represent the two residues which are linked by the thioether bond CARBOHYD glycosylation site; the nature of the carbohydrate (if known) is given in the description ®eld METAL binding site for a metal ion; the description ®eld indicates the nature of the metal BINDING binding site for any chemical group (co-enzyme, prosthetic group, etc.); the chemical nature of the group is given in the description ®eld SIGNAL extent of a signal sequence (prepeptide)

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Key Description TRANSIT extent of a transit peptide (mitochondrial, chloroplastic, or for a microbody) PROPEP extent of a propeptide CHAIN extent of a polypeptide chain in the mature protein PEPTIDE extent of a released active peptide DOMAIN extent of a domain of interest on the sequence; the nature of that domain is given in the description ®eld CA_BIND extent of a calcium-binding region DNA_BIND extent of a DNA-binding region NP_BIND extent of a nucleotide phosphate binding region; the nature of the nucleotide phosphate is indicated in the description ®eld TRANSMEM extent of a transmembrane region ZN_FING extent of a zinc ®nger region SIMILAR extent of a similarity with another protein sequence; precise information, relative to that sequence is given in the description ®eld REPEAT extent of an internal sequence repetition HELIX secondary structure: Helices, for example, Alpha-helix, 3(10) helix, or Pi-helix STRAND secondary structure: Beta-strand, for example, Hydrogen bonded beta-strand, or Residue in an isolated beta-bridge TURN secondary structure Turns, for example, H-bonded turn (3-turn, 4-turn or 5-turn) ACT_SITE amino acid(s) involved in the activity of an enzyme SITE any other interesting site on the sequence INIT_MET the sequence is known to start with an initiator methionine NON_TER the residue at an extremity of the sequence is not the terminal residue; if applied to position 1, this signi®es that the ®rst position is not the N-terminus of the complete molecule; if applied to the last position, it signi®es that this position is not the C-terminus of the complete molecule; there is no description ®eld for this key NON_CONS non consecutive residues; indicates that two residues in a sequence are not consecutive and that there are a number of unsequenced residues between them UNSURE uncertainties in the sequence; used to describe region(s) of a sequence for which the authors are unsure about the sequence assignment

[Annex C, Appendix 3, follows] Annex C, Appendix 3 Specimen Sequence Listing

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[Annex D follows]

Annex D

INFORMATION FROM FRONT PAGE OF PUBLISHED INTERNATIONAL APPLICATION TO BE INCLUDED IN THE GAZETTE UNDER RULE 86.1(i)

The following information shall be extracted from the front page of the publication of the international 1.32 declaration under Article 17(2) publication for each published international 1.33 claims amended under Article 19(1) application and shall, in accordance with Rule 1.34 statement under Article 19(1) 86.1(i), appear in the corresponding entry of the Gazette: 1.35 [ Deleted] 1.36 request for recti®cation under the 1. as to the international publication: ®rst sentence of Rule 91.3(d) 1.1 the international publication number 1.37 information concerning the 1.2 the date of the international publication incorporation by reference of an element or part as referred to in Rule 48.2(b)(v) 1.3 an indication whether the following items were published in the published international 1.38 information concerning a priority application: claim under Rule 26 bis.2(d) 1.31 international search report

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1.39 information concerning a request 4.2 their mailing address(es) under Rule 26 bis.3 for restoration of the right of 5. as to the designated States: priority 5.1 their names 1.4 the language in which the international 5.2 the indication of any wish for a regional application was ®led patent 1.5 the language of publication of the 5.3 the indication that every kind of international application protection available is sought, unless otherwise 2. as to the international application: indicated 2.1 the title of the invention 6. as to a statement concerning non-prejudicial 2.2 the symbol(s) of the International Patent disclosure or exception to lack of novelty: Classi®cation (IPC) 6.1 the date of the disclosure 2.3 the international application number 6.2 the place of the disclosure 2.4 the international ®ling date 6.3 the kind of the disclosure (e.g., 3. as to any priority claim: exhibition, scienti®c publication, conference reports, etc.) 3.1 the application number of the earlier application 6.4 the title of the exhibition, publication or conference 3.2 the date on which the earlier application was ®led 7. as to any indication in relation to deposited biological material furnished under Rule 13 bis 3.3 where the earlier application is: separately from the description: 3.31 a national application: the country 7.1 the fact that such indication is published in which the earlier application was ®led 7.2 the date on which the International 3.32 a regional application: the authority Bureau received such indication entrusted with the granting of regional patents under the applicable regional patent treaty and, in the case 8. as to any declaration referred to in Rule 4.17 referred to in Rule 4.10(b)(ii), a country party to the which was received by the International Bureau Paris Convention for the Protection of Industrial before the expiration of the time limit under Rule Property for which that earlier application was ®led 26 ter.1: 3.33 an international application: the 8.1 the fact that such a declaration was made receiving Of®ce with which it was ®led and a reference to the applicable item in Rule 4.17 under which it was made 4. as to the applicant, inventor and agent: [Annex E follows] 4.1 their name(s)

Annex E

INFORMATION TO BE PUBLISHED IN THE GAZETTE UNDER RULE 86.1(v)

1. The time limits applicable under Articles 22 4. The provisions of the national laws of and 39 in respect of each Contracting State. Contracting States concerning international-type 2. The list of the non-patent literature agreed search. upon by the International Searching Authorities for 5. The text of the agreements entered into inclusion in the minimum documentation. between the International Bureau and the 3. The names of the national Of®ces which do International Searching Authorities or the not wish to receive copies under Article 13(2)(c). International Preliminary Examining Authorities.

June 2020 AI-82 ADMINISTRATIVE INSTRUCTIONS UNDER THE PCT

6. The names of the national Of®ces which Searching and Preliminary Examining Authorities entirely or in part waived their rights to any under Rules 39 and 67. communication under Article 20. 12. Requirements of designated and elected 7. The names of the Contracting States which Of®ces under Rules 49.5 and 76.5 in relation to the are bound by Chapter II of the PCT. furnishing of translations. 8. Index of concordance of international 13. The dates de®ning the period referred to in application numbers and international publication Rule 32.1(b) during which the international numbers, listed according to international application application, whose effects may be extended to a numbers. successor State under Rule 32.1, must have been 9. Index of applicants' names giving, for each ®led. name, the corresponding international publication 14. The criteria for restoration of the right of number(s). priority applied by receiving Of®ces under Rule 10. Index of international publication numbers, 26 bis.3 or designated Of®ces under Rule 49 ter.2, grouped according to the International Patent and any subsequent changes in that respect. Classi®cation symbols. 11. Indication of any subject matter that will not [Annex F follows] be searched or examined by the various International Annex F

STANDARD FOR THE ELECTRONIC FILING AND PROCESSING OF INTERNATIONAL APPLICATIONS

[Editor©s Note: Annex F consists of nine main Appendix III Basic Common Standard for Electronic sections and four appendices, the titles of which are Filing reproduced below. The full text of Annex F and its Appendices are set out in two separate documents Appendix IV Use of Physical Media for the E-PCT available from the WIPO Web site at: Standard http://www.wipo.int/pct/en/texts/index.html.]

1. Introduction [End of Appendix, Annex and document] 2. The E-PCT standard: Overview and vision 3. E-PCT submission structure and format 4. IA documents packaging 5. Transmission 6. Electronic ®ling software 7. [Deleted] 8. Principles of electronic records management 9. Abbreviated expressions, interpretation and glossary

Appendix I XML DTDs for the E-PCT Standard

Appendix II PKI Architecture for the E-PCT Standard

AI-83 June 2020