MPEP § 1878 — MPEP § 1878
Current through: 2022-07-01

1878-Preparation of the Written Opinion of the International Preliminary Examining Authority 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 1800 

 Section 1878 
 

 
 
 
 
 
 1878 Preparation of the Written Opinion of the International
 Preliminary Examining Authority [R-07.2022]
 

 
 PCT Article 34 

 Procedure Before the International
 Preliminary Examining Authority 

 *****

 
 (2) 
 
 *****

 (c) The applicant shall receive at least one written
 opinion from the International Preliminary Examining Authority
 unless such Authority considers that all of the following conditions
 are fulfilled:
 

 (i) the invention satisfies the criteria set forth in
 Article
 33(1) ,
 

 (ii) the international application complies with the
 requirements of this Treaty and the Regulations in so far as checked
 by that Authority,
 

 (iii) no observations are intended to be made under
 Article 35(2) ,
 last sentence.
 

 
 

 
 *****

 

 
 37 CFR 1.484 Conduct of international preliminary examination. 

 
 (a) An international preliminary examination will be conducted
 to formulate a non-binding opinion as to whether the claimed invention has
 novelty, involves an inventive step (is non-obvious) and is industrially
 applicable.
 

 (b) International preliminary examination will begin in
 accordance with PCT Rule 69.1 .
 

 (c) No international preliminary examination will be conducted
 on inventions not previously searched by an International Searching
 Authority.
 

 (d) The International Preliminary Examining Authority will
 establish a written opinion if any defect exists or if the claimed invention
 lacks novelty, inventive step or industrial applicability and will set a
 non-extendable time limit in the written opinion for the applicant to
 reply.
 

 (e) The written opinion established by the International
 Searching Authority under PCT Rule
 43bis.1 shall be considered to be
 a written opinion of the United States International Preliminary Examining
 Authority for the purposes of paragraph (d) of this section.
 

 (f) The International Preliminary Examining Authority may
 establish further written opinions under paragraph (d) of this section.
 

 (g) If no written opinion under paragraph (d) of this section is
 necessary, or if no further written opinion under paragraph (f) of this
 section is to be established, or after any written opinion and the reply
 thereto or the expiration of the time limit for reply to such written
 opinion, an international preliminary examination report will be established
 by the International Preliminary Examining Authority. One copy will be
 submitted to the International Bureau and one copy will be submitted to the
 applicant.
 

 (h) An applicant will be permitted a personal or telephone
 interview with the examiner, which may be requested after the filing of a
 Demand, and must be conducted during the period between the establishment of
 the written opinion and the establishment of the international preliminary
 examination report. Additional interviews may be conducted where the
 examiner determines that such additional interviews may be helpful to
 advancing the international preliminary examination procedure. A summary of
 any such personal or telephone interview must be filed by the applicant or,
 if not filed by applicant be made of record in the file by the examiner.
 

 (i) If the application whose priority is claimed in the
 international application is in a language other than English, the United
 States International Preliminary Examining Authority may, where the validity
 of the priority claim is relevant for the formulation of the opinion
 referred to in Article 33(1) , invite
 the applicant to furnish an English translation of the priority document
 within two months from the date of the invitation. If the translation is not
 furnished within that time limit, the international preliminary report may
 be established as if the priority had not been claimed.
 

 
 

 
 PCT Rule 66 

 Procedure Before the International
 Preliminary Examining Authority 

 *****

 
 66.1bis Written Opinion of the International Searching
 Authority
 

 *****

 
 (a) Subject to paragraph (b), the written opinion
 established by the International Searching Authority under
 Rule 43bis.1 shall be
 considered to be a written opinion of the International Preliminary
 Examining Authority for the purposes of Rule
 66.2(a) .
 

 
 *****

 

 
 66.1 ter Top-up Searches
 

 The International Preliminary Examining Authority
 shall conduct a search ("top-up search") to discover documents referred to in
 Rule
 64 which have been published or have become available to
 the said Authority for search subsequent to the date on which the international
 search report was established, unless it considers that such a search would
 serve no useful purpose. If the Authority finds that any of the situations
 referred to in Article 34(3) or (4) or Rule
 66.1(e) exists, the top-up search shall cover only those
 parts of the international application that are the subject of international
 preliminary examination.
 

 

 *****

 
 66.4 Additional Opportunity for Submitting Amendments or
 Arguments
 

 
 (a) If the International Preliminary Examining Authority
 wishes to issue one or more additional written opinions, it may do so,
 and Rules 66.2 and 66.3 shall apply.
 

 
 *****

 

 

 A written opinion must be prepared by the International Searching
 Authority at the same time the international search report is prepared. The United
 States International Preliminary Examining Authority (IPEA/US) will consider the written
 opinion of the International Searching Authority to be the first written opinion of the
 IPEA and as such in most instances no further written opinion need be issued by the U.S.
 examiner handling the international preliminary examination before establishment of the
 international preliminary examination report, even if there are objections outstanding.
 The examiner is to take into consideration any comments or amendments made by the
 applicant when he/she establishes the international preliminary examination report.
 However, a further written opinion must be prepared if applicant files a response which
 includes a persuasive argument that the written opinion issued by the International
 Searching Authority was improper because of a negative opinion with respect to a lack of
 novelty, inventive step (non-obviousness) or industrial applicability as described in
 PCT Article 33(2)
 - (4) ; and which results in the examiner considering any of the
 claims to lack novelty, inventive step (non-obviousness) or industrial applicability as
 described in PCT
 Article 33(2) - (4) based on new art not necessitated by any
 amendment. Such a further written opinion should be established as the Written Opinion
 of the International Preliminary Examining Authority (Form PCT/IPEA/408).
 

 When preparing Form PCT/IPEA/408, the classification of the subject
 matter inserted by the examiner in the header on the cover sheet shall be either:
 

 
 (A) that given by the International Searching Authority under
 PCT Rule
 43.3 , if the examiner agrees with such classification;
 or
 

 (B) that which the examiner considers to be correct, if the examiner
 does not agree with that classification.
 

 
 Both the International Patent Classification (IPC) and the CPC
 classification as required by the IPEA/US should be given.
 

 Since the IPEA/US will consider the written opinion of the
 ISA to be the first written opinion of the IPEA, item 1 of the cover sheet is marked
 accordingly. Further, since the written opinion of the ISA is considered to be the first
 written opinion, the written opinion of the IPEA needs to be indicated as a second
 opinion in item 2 of the cover sheet.
 

 A top-up search should be conducted by the IPEA to
 identify any additional prior art that has been published or has become available
 subsequent to the date of the establishment of the international search report. The
 purpose is to discover any intermediate prior art not available during the international
 search, i.e., a patent application published on or after the filing or, the valid
 priority date of the international application, but having an earlier filing or priority
 date. The top-up search should be differentiated from additional search. A top-up search
 is to find prior art which recently became available, which is not the same as
 additional search required as a result of a claim amendment to present additional
 features not previously claimed.
 

 A top-up search should be performed in all Chapter II
 examination, except where the examiner considers performing a top-up search would serve
 no useful purpose. This, however, should be a rare occurrence. For example, this is the
 case when it is decided that the international application, in its entirety, relates to
 subject matter on which the International Preliminary Examining Authority is not
 required to carry out an international preliminary examination, or that the
 international application is so unclear or the claims are so inadequately supported by
 the description that no meaningful opinion can be formed on the novelty, inventive step,
 or industrial applicability, of the claimed invention. The same applies when no
 international search report has been established for certain claims and it is thus
 decided not to carry out an international preliminary examination on these claims. Note,
 however, that when any of the above situations applies to only part of the claimed
 subject matter or where there is lack of unity of invention, a top-up search should
 still be carried out but restricted to those parts of the international application that
 are the subject of international preliminary examination. Another situation is when the
 IPEA considers that the documents cited in the International Search Report are
 sufficient to show there is lack of novelty on the entire subject matter. A further
 example where a top-up search is considered to serve no useful purpose is when the
 International Search Report cited novelty defeating X references and no amendment to the
 claims or comments on the application of art has been filed.
 

 If the claims in the international application lack unity,
 the examiner will first issue an invitation to pay further examination fees and then
 perform the top-up search on inventions for which examination fees have been paid. The
 invention paid for must not have been excluded from preliminary examination due to lack
 of international search in Chapter I.
 

 In an application where an Article 34 amendment has been
 filed but no basis can be located, and/or there is no letter explaining the basis, the
 top-up search may be limited to the scope of the claims forming the basis for the
 report.
 

 In cases where relevant documents have been discovered in
 a top-up search and the examiner intends to raise a new objection based on the
 documents, a second written opinion should be issued where the new objection was not
 necessitated by an amendment.
 

 I. BOX NO. I. — BASIS OF OPINION When completing Box No. I, item 1 of Form PCT/IPEA/408, the examiner
 must indicate whether or not the opinion has been established on the basis of the
 international application in the language in which it was filed. If a translation
 was furnished for the purpose of the international search, publication, or
 international preliminary examination, this must be indicated. The opinion will be
 established on the basis of any amendments, rectifications, priority and/or unity of
 invention holdings, and shall answer the questions concerning novelty, inventive
 step, and industrial applicability for each of the claims under examination.
 

 For the purpose of completing Box No. I, item 2, sheets of the
 description and drawings filed during Chapter I proceedings and stamped “SUBSTITUTE
 SHEET (RULE 26)”, “RECTIFIED SHEET (RULE 91)”, and “INCORPORATED BY REFERENCE (RULE
 20.6)” are considered to be originally filed/furnished pages and should be listed as
 originally filed/furnished pages. Only those amendments or rectifications to the
 description and drawings filed on the date of demand or after the filing of a demand
 should be listed as pages “received by this Authority on ______________.” Claims
 filed during the Chapter I proceedings and stamped “SUBSTITUTE SHEET (RULE 26)”,
 “RECTIFIED SHEET (RULE 91)”, and “INCORPORATED BY REFERENCE (RULE 20.6)” are also
 considered to be originally filed/furnished and should be listed as originally
 filed/furnished claim numbers.
 

 However, amended claims filed under PCT Article
 19 in response to the international search report are to be
 indicated as claim numbers as amended (together with any statement) under
 PCT Article
 19 . The International Bureau (IB) marks, in the upper
 right-hand corner of each replacement sheet submitted under PCT Article
 19 , the international application number, the date on which
 that sheet was received under PCT Article 19 and, in the
 middle of the bottom margin, the words 
 "AMENDED
 SHEET (ARTICLE 19)."
 
 
 See PCT Administrative Instructions
 Section 417 . Applicant’s submission of a timely amendment to the
 claims alleged to be under Article 19 is accepted under
 Article
 34 (not Article 19 ) unless the
 International Bureau has indicated the amendments were accepted under
 Article
 19 . Only those claims filed on the date of demand or after
 the filing of a demand should be listed as claim numbers 
 "received by this Authority on
 ______________."
 
 
 
 

 Further, if the opinion has been based on a nucleotide and/or amino
 acid sequence disclosed and necessary to the claimed invention, the examiner must
 indicate the purpose for which the sequence listing was filed (i.e., whether as part
 of the international application or solely for purposes of international search),
 the time of filing/furnishing the sequence listing (i.e., whether filed on the
 international filing date or subsequently), and the format of the sequence listing
 (i.e., whether filed on paper or in the form of an image file (PDF) and/or in
 electronic form (Annex C/ST.25 text file)). If more than one version or copy of the
 sequence listing is filed, the examiner must indicate in item 2 whether the
 applicant has provided the required statement indicating that the information in the
 subsequent or additional copies are identical to that in the application as filed or
 does not go beyond the application as filed, as appropriate. Item 3 is available for
 providing additional comments.
 

 The examiner must also indicate, in Box No. I, item 3, if any of the
 amendments filed resulted in the cancellation of any pages of the description, any
 of the claims, any sheets and/or figures of the drawings, or any of sequence
 listing. If the examiner considers any of the amendments to go beyond the original
 disclosure, or they were not accompanied by a letter indicating the basis for the
 amendment in the application as filed, the examiner must point this out in Box No.
 I, item 4 and explain the reasons for this determination in the Supplemental Box.
 New matter which appears on a replacement sheet will be disregarded for the purpose
 of establishing the opinion. However, the remainder of the replacement sheet,
 including any amendments which do not constitute new matter, will be taken into
 consideration for the purpose of establishing the opinion. Box No. I, item 5 needs
 to be marked if the opinion is established taking into account the rectification of
 an obvious mistake under PCT Rule 91 . Further, Box No.
 I, item 6 needs to be marked if the opinion is established taking into account the
 supplementary international search report(s) from the specified Supplementary
 International Searching Authority(ies) (SISA).
 

 II. BOX NO. II. — PRIORITY Where the priority document is provided by the applicant in
 compliance with PCT Rule 17.1 after the preparation of the search report and
 the written opinion of the ISA, any written opinion of the IPEA and/or the
 international preliminary examination report should reconsider the validity of the
 priority claim. Where the priority document is a foreign document and it is not
 already in the file, the IPEA may request a copy of the document from the IB and, if
 necessary, a translation from the applicant. In the meantime, if the outcome of the
 examination requires the issuing of an opinion, that opinion should be issued
 without waiting to obtain the priority document and/or the translation. An
 appropriate comment should be made under the heading 
 "Additional observations, if necessary"
 
 
 in
 Box No. II of the written opinion. If the IPEA needs a copy of the priority
 document, and the priority document was not filed with the IPEA in its capacity as a
 national office and is not available to the IPEA from a digital library in
 accordance with the Administrative Instructions, then the IPEA may request the IB to
 furnish such copy. PCT Rule 66.7(a) . If the priority document is in a foreign
 language, the IPEA may invite applicant to furnish a translation within two months
 of such invitation. PCT Rule 66.7(b) . Failure to
 furnish the copy of the priority document or translation may result in the IPEA
 establishing the written opinion of the IPEA and/or the IPER as if the priority had
 not been claimed. This is indicated by checking the appropriate boxes in item 1 of
 Box No. II in the opinion or report. 
 

 III. BOX NO. III. — NON-ESTABLISHMENT OF OPINION ON NOVELTY, INVENTIVE STEP AND
 INDUSTRIAL APPLICABILITY Box No. III of Form PCT/IPEA/408 is intended to cover situations
 where some or all claims of an application are so unclear or inadequately supported
 by the description that the question of novelty, inventive step (nonobviousness),
 and industrial applicability cannot be considered, or where the international
 application or claims thereof relate to subject matter which does not require
 international preliminary examination, or where no international search report has
 been established for the claims.
 

 Box No. III of Form PCT/IPEA/408 should be filled out in accordance
 with the instructions for Box No. III of Form PCT/ISA/237 provided in
 MPEP §
 1845.01 .
 

 IV. BOX NO. IV. — LACK OF UNITY OF INVENTION Box No. IV of Form PCT/IPEA/408 should be used by the examiner to
 notify applicant that lack of unity of invention has been found.
 

 Subsection 1 of Box IV is to be completed to indicate applicant's
 response to an invitation to restrict or pay additional fees. Under subsection 1,
 check the first box if the applicant restricted the claims to a particular group.
 Check the second box if the applicant paid additional fees for examination of
 additional inventions. Check the third box if the additional fees were paid under
 protest. The fourth box should not be checked. Check the fifth box if the applicant
 neither restricted nor paid additional fees (i.e., there was no response to the
 invitation to restrict or pay additional fees or the response was not timely).
 

 Subsection 2 of Box IV is to be completed if the examiner determines
 that unity of invention is lacking but chooses not to invite the applicant to
 restrict or pay additional fees.
 

 Subsection 3 of Box IV is to be completed to indicate which claims
 were the subject of international preliminary examination. If all claims are to be
 examined, check the first box under subsection 3. If only some of the claims were
 the subject of international preliminary examination, check the second box under
 subsection 3 and identify the claim numbers.
 

 V. BOX NO. V. — REASONED STATEMENT WITH REGARD TO NOVELTY, INVENTIVE STEP, AND
 INDUSTRIAL APPLICABILITY OF CLAIMS In Box No. V, the examiner must list in summary form all claims
 with regard to the criteria of novelty (N), inventive step (IS), and industrial
 applicability (IA), and should be filled out in accordance with the instructions for
 Box No. V of Form PCT/ISA/237 provided in MPEP § 1845.01 . 
 

 In all cases, the application should be searched by the examiner at
 least to the point of bringing the previous search up to date. Prior art discovered
 in a search and applied in a reasoned statement in Box No. V must be made of record
 in Box No. V. Prior art already cited on the international search report need not
 again be cited on the written opinion or international preliminary examination
 report. The subsequently discovered prior art is to be cited in compliance with
 PCT Rule
 43.5 and PCT Administrative Instructions Section
 503 using the same citation format used on the international
 search report. One copy of each newly cited foreign patent document and non-patent
 literature reference will be sent to the applicant and one copy will be retained for
 the application file. The USPTO no longer mails paper copies of U.S. patents and
 U.S. patent application publications cited during the international stage of an
 international application, so paper copies of these documents need not be included
 in the file.
 

 VI. BOX NO. VI. — CERTAIN DOCUMENTS CITED Box No. VI provides a convenient manner of listing two different
 types of documents that were newly discovered and which were not applied in Box No.
 V: 
 

 
 (A) Published applications or patents which would constitute
 prior art for purposes of PCT Article 33(2) and
 (3) had they been published prior to the relevant
 date ( PCT
 Rule 64.1 ) but were filed prior to, or claim the
 priority of an earlier application which had been filed prior to, the
 relevant date ( PCT Rule 64.3 ) - by the
 application number or patent number as well as the publication date, filing
 date and priority date; and
 

 (B) Non-written disclosure - by the kind of disclosure, date of
 the disclosure and the date of the written disclosure referring to the
 non-written disclosure.
 

 
 As with the newly cited art in Box No. V, the subsequently
 discovered prior art is to be cited in compliance with PCT Rule 43.5 
 and Administrative Instructions Section 503 using the same
 citation format used on the international search report. Two copies of each newly
 cited foreign patent document and non-patent literature reference should be included
 in the application file when it is sent to PCT Operations for the mailing of the
 Form PCT/IPEA/408. One of the copies of each newly cited foreign patent document and
 non-patent literature reference will be sent to the applicant and one copy will be
 for the Chapter II file. The USPTO no longer mails paper copies of U.S. patents and
 U.S. patent application publications cited during the international stage of an
 international application, so paper copies of these documents need not be included
 in the file.
 

 VII. BOX VII. — CERTAIN DEFECTS IN THE INTERNATIONAL APPLICATION In Box No. VII, defects in the form and content of the
 international application are identified. Box No. VII should be filled out in
 accordance with the instructions for Box No. VII of Form PCT/ISA/237 provided in
 MPEP §
 1845.01 . 
 

 VIII. BOX NO. VIII. — CERTAIN OBSERVATIONS ON THE INTERNATIONAL APPLICATION In Box No. VIII, the examiner notifies the applicant of
 observations made as to the clarity of the claims, the description, the drawings, or
 on the question whether the claims are fully supported by the description. Box No.
 VIII should be filled out in accordance with the instructions for Box No. VIII of
 Form PCT/ISA/237 provided in MPEP § 1845.01 . 
 

 IX. TIME TO REPLY An invitation by the International Preliminary Examining Authority
 (IPEA) to applicant to reply to the examiner’s written opinion will normally set a
 2-month time limit for reply.
 

 However, PCT Rule 69.2 sets forth time
 limits for the IPEA to establish the international preliminary examination report
 (IPER). Accordingly, a 1-month time limit should be set by the examiner in
 situations when a 2-month time limit would risk delaying the date of establishment
 of the IPER beyond:
 

 
 (A) 28 months from the priority date; or

 (B) 6 months from the time provided under PCT Rule
 69.1 for the start of international preliminary
 examination; or
 

 (C) 6 months from the date of receipt by the IPEA of the
 translation furnished under PCT Rule 55.2 . 
 

 
 As a general rule, a 1-month time limit for reply to the written
 opinion should be set by the examiner if the written opinion (Form PCT/IPEA/408) has
 not been completed by the examiner within 24 months following the application’s
 
 "priority date"
 
 
 as
 defined in PCT
 Article 2 . 
 

 The United States rules pertaining to international preliminary
 examination of international applications do not provide for any extension of time
 to reply to a written opinion. See 37 CFR 1.484(d) - (f) and
 MPEP §
 1878.02 .
 

 X. AUTHORIZED OFFICER Every written opinion must be signed by an examiner having at least
 partial signatory authority.
 

 
 1878.01 Includes Subsections Regarding Prior Art,
 Novelty, Inventive Step, and Industrial Applicability for Purposes of the Written
 Opinion and the International Preliminary Examination Report [R-07.2022]
 

 
 1878.01(a) Prior Art for Purposes of the Written Opinion and the
 International Preliminary Examination Report [R-10.2019]
 

 
 PCT Article 33. 

 The International Preliminary
 Examination 

 *****

 
 (6) The international preliminary examination shall take
 into consideration all the documents cited in the international
 search report. It may take into consideration any additional
 documents considered to be relevant in the particular case.
 

 
 

 
 PCT Rule 64 

 Prior Art for International
 Preliminary Examination 

 
 64.1 Prior Art

 
 (a) For the purposes of Article
 33(2) and (3) , everything made available
 to the public anywhere in the world by means of written
 disclosure (including drawings and other illustrations) shall be
 considered prior art provided that such making available
 occurred prior to the relevant date.
 

 (b) For the purposes of paragraph (a), the relevant
 date shall be:
 
 (i) subject to items (ii) and (iii), the
 international filing date of the international
 application under international preliminary
 examination;
 

 (ii) where the international application
 under international preliminary examination claims the
 priority of an earlier application and has an
 international filing date which is within the priority
 period, the filing date of such earlier application,
 unless the International Preliminary Examining Authority
 considers that the priority claim is not valid;
 

 (iii) where the international application
 under international preliminary examination claims the
 priority of an earlier application and has an
 international filing date which is later than the date
 on which the priority period expired but within the
 period of two months from that date, the filing date of
 such earlier application, unless the International
 Preliminary Examining Authority considers that the
 priority claim is not valid for reasons other than the
 fact that the international application has an
 international filing date which is later than the date
 on which the priority period expired.
 

 
 

 
 

 

 
 64.2 Non-Written Disclosures

 In cases where the making available to the public
 occurred by means of an oral disclosure, use, exhibition or other
 non-written means (“non-written disclosure”) before the relevant date as
 defined in Rule 64.1(b) and
 the date of such non-written disclosure is indicated in a written
 disclosure which has been made available to the public on a date which
 is the same as, or later than, the relevant date, the non-written
 disclosure shall not be considered part of the prior art for the
 purposes of Article 33(2) and
 (3) . Nevertheless, the international preliminary
 examination report shall call attention to such non-written disclosure
 in the manner provided for in Rule 70.9 . 
 

 

 
 64.3 Certain Published Documents

 In cases where any application or any patent which
 would constitute prior art for the purposes of Article 33(2) and
 (3) had it been published prior to the relevant
 date referred to in Rule 64.1 was
 published on a date which is the same as, or later than, the relevant
 date but was filed earlier than the relevant date or claimed the
 priority of an earlier application which had been filed prior to the
 relevant date, such published application or patent shall not be
 considered part of the prior art for the purposes of Article 33(2) and
 (3) . Nevertheless, the international preliminary
 examination report shall call attention to such application or patent in
 the manner provided for in Rule 70.10 . 
 

 

 

 The above provisions apply mutatis mutandis 
 to the written opinion of the International Searching Authority. See
 PCT Rule
 43bis.1(b) .
 

 The relevant date for the purpose of considering prior art is
 defined in PCT
 Rule 64.1(b) as: 
 

 
 (A) the international filing date (subject to (B) and
 (C));
 

 (B) where the international application claims the priority
 of an earlier application and has an international filing date which is
 within the priority period, the filing date of such earlier application,
 unless the Authority considers that the priority claim is not valid;
 

 (C) where the international application claims the priority
 of an earlier application and has an international filing date which is
 later than the date on which the priority period expired but within the
 period of two months from that date, the filing date of such earlier
 application, unless the Authority considers that the priority claim is
 not valid for reasons other than the fact that the international
 application has an international filing date which is later than the
 date on which the priority period expired.
 

 
 When a potentially relevant document has been published between
 a claimed priority date of the application and its international filing date,
 the examiner is required to consider whether the claimed priority date is valid
 for the purposes of determining the 
 "relevant date"
 
 
 of the claims in the international
 application. For international applications filed on or after April 1, 2007, a
 priority date should not be considered invalid merely because the international
 application was not filed prior to the date of expiration of the priority
 period, provided that the international application is filed within the period
 of two months from the date of expiration of the priority period. Note that if
 there is time left for the applicant to perfect, correct or add a priority claim
 but there is insufficient time for the examiner to make a proper determination
 as to whether the priority claim is valid, due to the need to issue a timely
 written opinion by the International Searching Authority, the
 
 "relevant date"
 
 
 for
 the purposes of the written opinion will be based on the claimed priority date.
 See Chapter 11 of the International Search and Preliminary Examination
 Guidelines, which may be obtained from WIPO’s website ( www.wipo.int/pct/en/texts/gdlines.html ). In cases where any
 application or any patent which would constitute prior art for the purpose of
 international preliminary examination as to novelty and inventive step
 (nonobviousness) was published on or after the relevant date of the
 international application under consideration but was filed earlier than the
 relevant date or claimed the priority of an earlier application which was filed
 prior to the relevant date, the published application or patent is not to be
 considered part of the prior art for the purpose of international preliminary
 examination as to novelty and inventive step. Nevertheless, these documents are
 to be listed on Form PCT/ISA/237, PCT/IPEA/408, or PCT/IPEA/409, as appropriate
 under the heading “CERTAIN PUBLISHED DOCUMENTS”.
 

 In determining whether there is inventive step, account should
 be taken of what the applicant acknowledges in his/her description as known.
 Such acknowledged prior art should be regarded as correct and used during
 preliminary examination where appropriate.
 

 For oral or non-written disclosure, see PCT Rules
 64.2 and 70.9 . 
 

 
 1878.01(a)(1) Novelty for Purposes of the Written Opinion and the
 International Preliminary Examination Report [R-08.2012]
 

 Novelty is defined in PCT Article 33(2) . 
 

 
 PCT Article 33 

 The International Preliminary
 Examination 

 *****

 
 (2) For the purposes of the international
 preliminary examination, a claimed invention shall be considered
 novel if it is not anticipated by the prior art as defined in
 the Regulations.
 

 
 *****

 

 The above provisions apply mutatis
 mutandis to the written opinion of the International Searching
 Authority. See PCT Rule
 43bis.1(b) .
 

 

 
 1878.01(a)(2) Inventive Step for Purposes of the Written Opinion
 and the International Preliminary Examination Report [R-08.2012]
 

 Inventive step is defined in PCT Article
 33(3) . 
 

 
 PCT Article 33 

 The International Preliminary
 Examination 

 *****

 
 (3) For purposes of the international preliminary
 examination, a claimed invention shall be considered to involve
 an inventive step if, having regard to the prior art as defined
 in the Regulations, it is not, at the prescribed relevant date,
 obvious to a person skilled in the art.
 

 
 *****

 

 
 PCT Rule 65 

 Inventive Step or
 Non-Obviousness 

 
 65.1 Approach to Prior Art

 For the purposes of Article
 33(3) , the international preliminary
 examination shall take into consideration the relation of any
 particular claim to the prior art as a whole. It shall take into
 consideration the claim’s relation not only to individual documents
 or parts thereof taken separately but also its relation to
 combinations of such documents or parts of documents, where such
 combinations are obvious to a person skilled in the art.
 

 

 
 65.2 Relevant Date

 For the purposes of Article
 33(3) , the relevant date for the
 consideration of inventive step (non-obviousness) is the date
 prescribed in Rule 64.1 .
 

 

 

 The above provisions apply mutatis
 mutandis to the written opinion of the International Searching
 Authority. See PCT Rule
 43bis.1(b) .
 

 

 
 1878.01(a)(3) Industrial Applicability for Purposes of the
 Written Opinion and the International Preliminary Examination Report [R-08.2012]
 

 Industrial applicability is defined in PCT Article
 33(4) . 
 

 
 PCT Article 33. 

 The International Preliminary
 Examination 

 *****

 
 (4) For the purposes of the international
 preliminary examination, a claimed invention shall be considered
 industrially applicable if, according to its nature, it can be
 made or used (in the technological sense) in any kind of
 industry. “Industry” shall be understood in its broadest sense,
 as in the Paris Convention for the Protection of Industrial
 Property.
 

 
 *****

 

 The above provisions apply mutatis
 mutandis to the written opinion of the International Searching
 Authority. See PCT Rule
 43bis.1(b) .
 

 

 

 

 
 1878.02 Reply to the Written Opinion of the ISA or IPEA [R-07.2015]

 
 PCT Article 34 

 Procedure Before the International
 Preliminary Examining Authority 

 *****

 
 (2) 
 
 (d) The applicant may respond to the written
 opinion.
 

 
 

 
 *****

 

 
 PCT Rule 66 

 Procedure before the International
 Preliminary Examining Authority 

 *****

 
 66.3 Formal Response to the International Preliminary
 Examining Authority
 

 
 (a) The applicant may respond to the invitation
 referred to in Rule 66.2(c) of
 the International Preliminary Examining Authority by making
 amendments or - if he disagrees with the opinion of that Authority -
 by submitting arguments, as the case may be, or do both.
 

 (b) Any response shall be submitted directly to the
 International Preliminary Examining Authority.
 

 
 *****

 

 
 66.4. bis Consideration of Amendments, Arguments and
 Rectifications of Obvious Mistakes
 

 Amendments, arguments and rectifications of obvious
 mistakes need not be taken into account by the International Preliminary
 Examining Authority for the purposes of a written opinion or the
 international preliminary examination report if they are received by,
 authorized by or notified to that Authority, as applicable, after it has
 begun to draw up that opinion or report.
 

 

 
 66.5 Amendment

 Any change, other than the rectification of an obvious
 mistake, in the claims, the description, or the drawings, including
 cancellation of claims, omission of passages in the description, or omission
 of certain drawings, shall be considered an amendment.
 

 

 
 66.6 Informal Communications with the
 Applicant
 

 The International Preliminary Examining Authority may, at
 any time, communicate informally, over the telephone, in writing, or through
 personal interviews, with the applicant. The said Authority shall, at its
 discretion, decide whether it wishes to grant more than one personal
 interview if so requested by the applicant, or whether it wishes to reply to
 any informal written communication from the applicant.
 

 *****

 

 
 66.8 Form of Amendments

 
 (a) Subject to paragraph (b), when amending the
 description or the drawings, the applicant shall be required to
 submit a replacement sheet for every sheet of the international
 application which, on account of an amendment, differs from the
 sheet previously filed. The replacement sheet or sheets shall be
 accompanied by a letter which shall draw attention to the
 differences between the replaced sheets and the replacement sheets,
 shall indicate the basis for the amendment in the application as
 filed and shall preferably also explain the reasons for the
 amendment.
 

 (b) Where the amendment consists in the deletion of
 passages or in minor alterations or additions, the replacement sheet
 referred to in paragraph (a) may be a copy of the relevant sheet of
 the international application containing the alterations or
 additions, provided that the clarity and direct reproducibility of
 that sheet are not adversely affected. To the extent that any
 amendment results in the cancellation of an entire sheet, that
 amendment shall be communicated in a letter which shall preferably
 also explain the reasons for the amendment.
 

 (c) When amending the claims,
 Rule 46.5 shall
 apply mutatis mutandis . The set of claims
 submitted under Rule 46.5 as
 applicable by virtue of this paragraph shall replace all the claims
 originally filed or previously amended under Articles
 19 or 34 , as the case
 may be.
 

 
 

 

 

 
 37 CFR 1.485 Amendments by applicant during international preliminary
 examination. 

 The applicant may make amendments at the time of
 filing the Demand. The applicant may also make amendments within the time limit
 set by the International Preliminary Examining Authority for reply to any
 notification under § 1.484(b) or to any written
 opinion. Any such amendments must be made in accordance with PCT Rule
 66.8 .
 

 

 A reply to the written opinion of the ISA in the form of arguments
 and/or amendments will be considered by the IPEA if a demand has been filed with the
 IPEA. All amendments in reply to a written opinion must be received within the time
 limit set for reply in order to be assured of consideration in the international
 preliminary examination report. Amendments filed at or before expiration of the
 period for reply will be considered. Since the examiner will begin to draw up the
 international preliminary examination report rather promptly after the time period
 expires, amendments filed after expiration of the reply period may not be
 considered. However, as indicated in MPEP § 1871 , there may be
 situations where it is advisable, to the extent possible, to take such amendments or
 arguments into account, for example, where the international preliminary examination
 report has not yet been completed and it is readily apparent to the examiner that
 consideration of the late-filed response would result in the issuance of a favorable
 report. In view of the short time period for completion of preliminary examination,
 applicants are strongly encouraged to file any amendments promptly.
 37 CFR
 1.484(d) does not allow for extensions of time to reply to a
 written opinion. The policy of not allowing extensions of time is to ensure that the
 USPTO can meet its treaty deadline for transmission of the international preliminary
 examination report. 
 

 Any change, other than the rectification of obvious mistakes in the
 claims, the description, or the drawings, including the cancellation of claims,
 omission of passages in the description or omission of certain drawings will be
 considered an amendment ( PCT Rule 66.5 ). The Patent and
 Trademark Office when acting as the International Preliminary Examining Authority
 will not accept any non-English applications or amendments.
 

 Any amendments to the description and the drawings in reply to a
 written opinion must (1) be made by submitting a replacement sheet for every sheet
 of the application which differs from the sheet it replaces unless an entire sheet
 is cancelled and (2) include a description of how the replacement sheet differs from
 the replaced sheet in accordance with PCT Rule 66.8 . 
 

 Any amendment to the claims in reply to a written
 opinion must be made by submitting a replacement sheet or sheets containing a
 complete set of claims in replacement of all the claims originally filed or
 previously amended under Articles 19 or
 34 , as the case may be in accordance with PCT Rule
 66.8 . The replacement sheet or sheets shall be accompanied by a
 letter which: (i) shall identify the claims which, on account of the amendments,
 differ from the claims originally filed, and shall draw attention to the differences
 between the claims originally filed and the claims as amended; (ii) shall identify
 the claims originally filed which, on account of the amendments, are cancelled;
 (iii) shall indicate the basis for the amendments in the application as filed.
 

 In the particular case where the amendment cancels claims, passages
 in the description or certain drawings resulting in the cancellation of an entire
 sheet, the amendment must be submitted in the form of a letter cancelling the sheet
 ( PCT Rule
 66.8(a) ). 
 

 Generally, the replacement sheets should be in typed form and
 contain the changes in clean copy without any underlining and/or bracketing. A
 marked-up copy may be included as part of the remarks, along with the clean
 copy.
 

 Any paper submitted by the applicant, if not in the form of a
 letter, must be accompanied by a letter signed by the applicant or agent
 ( PCT Rule
 92.1 ). The letter must draw attention to the differences
 between the replaced sheet and the replacement sheet. 
 

 The examiner should make sure that amendments filed in accordance
 with the PCT, which are necessary to correct any deficiencies notified to the
 applicant, do not go beyond the disclosure of the international application as
 filed, thus violating PCT Article 34(2)(b) . In other
 words, no amendment should contain matter that cannot be substantiated by the
 application as originally filed. In a situation where new matter is introduced by
 amendment in reply to a written opinion, the international preliminary examination
 report will be established as if the amendment had not been made, and the report
 should so indicate. It shall also indicate the reasons why the amendment goes beyond
 the disclosure ( PCT Rule 70.2(c) ). Although new matter which appears on a
 replacement sheet will be disregarded for the purpose of establishing the report,
 the remainder of the replacement sheet, including any amendments which do not
 constitute new matter, will be taken into consideration for the purpose of
 establishing the report.
 

 INTERVIEWS The examiner or applicant may, after the filing of a demand and
 during the time limit for reply to the written opinion, request a telephone or
 personal interview. Only one interview is a matter of right, whether by
 telephone or in person. Additional interviews may be authorized by the examiner
 in a particular international application where such additional interview may be
 helpful to advance the international preliminary examination procedure.
 

 All interviews of substance must be made of record by using
 PCT/IPEA/428 Notice on Informal Communication with the Applicant.
 

 When an interview is arranged, whether by telephone or in
 writing, and whether by the examiner or by the applicant, the matters for
 discussion should be stated.
 

 The records of interviews or telephone conversations should
 indicate, where appropriate, whether a reply is due from the applicant or agent
 or whether the examiner wishes to issue an additional written opinion or
 establish the international preliminary examination report.
 

 If the applicant desires to reply to the written opinion, such
 reply must be filed within the time limit set for reply in order to assure
 consideration. No extensions to the time limit will be considered or granted. If
 no timely reply is received from the applicant, the international preliminary
 examination report will be established by the examiner, treating each claim
 substantially as it was treated in the written opinion. Replies to the written
 opinion which are not filed within the time limit set but which reach the
 examiner before the examiner takes up the application for preparation of the
 final report may be considered. Thus, only timely replies can be assured of
 consideration.
 

 The applicant may reply to the invitation referred to in
 Rule
 66.2(c) by making amendments or, if the applicant
 disagrees with the opinion of the authority, by submitting arguments, as the
 case may be, or both ( PCT Rule 66.3 ). 
 

 If applicant does not reply to the written opinion, the
 international preliminary examination report will be prepared in time for
 forwarding to the International Division in finished form by 27 months from the
 priority date.
 

 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 1801-Basic Patent Cooperation Treaty (PCT) Principles 

 1802-PCT Definitions 

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

 1804-[Reserved] 

 1805-Where To File an International Application 

 1806-Applicants and Inventors 

 1807-Agent or Common Representative and General Power of Attorney 

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

 1809-Access to the USPTO patent electronic filing system 

 1810-Filing Date Requirements 

 1811-[Reserved] 

 1812-Elements of the International Application 

 1813 - 1816-[Reserved] 

 1817-PCT Member States 

 1818-[Reserved] 

 1819-Earlier Search 

 1820-Signature of Applicant 

 1821-The Request 

 1822-[Reserved] 

 1823-The Description 
 1823.01-Reference to Deposited Biological Material 

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

 
 

 1824-The Claims 

 1825-The Drawings 

 1826-The Abstract 

 1827-Fees 
 1827.01-Refund of International Application Fees 

 
 

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

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

 
 

 1829-[Reserved] 

 1830-International Application Transmittal Letter 

 1831-[Reserved] 

 1832-License Request for Foreign Filing Under the PCT 

 1833-[Reserved] 

 1834-Correspondence 
 1834.01-Filing of Correspondence by Facsimile 

 1834.02-Irregularities in the Mail or Electronic Communications Service 

 
 

 1835-[Reserved] 

 1836-Rectification of Obvious Mistakes 

 1837 - 1839-[Reserved] 

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

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

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

 1840.04-[Reserved] 

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

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

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

 
 

 1841-[Reserved] 

 1842-Basic Flow Under the PCT 

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

 1843.02-Certain Subject Matter Need Not Be Searched 

 1843.03-No Search Required if Claims Are Unclear 

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

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

 
 

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

 
 

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

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

 
 

 1846 - 1847-[Reserved] 

 1848-Sequence Listings 

 1849-[Reserved] 

 1850-Unity of Invention Before the International Searching Authority 

 1851-Identification of Patent Documents 

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

 1853-Amendment Under PCT Article 19 

 1854 - 1855-[Reserved] 

 1856-Supplementary International Searches 

 1857-International Publication 

 1858-[Reserved] 

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

 1860-International Preliminary Examination Procedure 

 1861-[Reserved] 

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

 1863-[Reserved] 

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

 1864.02-Applicant’s Right To File a Demand 

 1864.03-States Which May Be Elected 

 1864.04-Agent’s Right To Act 

 
 

 1865-Filing of Demand 

 1866-[Reserved] 

 1867-Preliminary Examination Fees 

 1868-Correction of Defects in the Demand 

 1869-Notification to International Bureau of Demand 

 1870-Priority Document and Translation Thereof 

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

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

 1873-[Reserved] 

 1874-Determination if International Preliminary Examination Is Required and Possible 

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

 1875.02-Reply to Invitation Concerning Lack of Unity of Invention 

 
 

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

 
 

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

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

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

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

 
 

 
 

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

 
 

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

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

 1879.03-Translations 

 1879.04-Confidential Nature of the Report 

 
 

 1880-Withdrawal of Demand or Election 

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

 1882 - 1892-[Reserved] 

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

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

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

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

 
 

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

 1893.01(c)-Fees 

 1893.01(d)-Translation 

 1893.01(e)-Inventor’s Oath or Declaration 

 
 

 1893.02-Abandonment 

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

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

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

 1893.03(d)-Unity of Invention 

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

 
 

 1893.03(f)-Drawings and PCT Rule 11 

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

 
 

 
 

 1894-[Reserved] 

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

 
 

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

 

 

 
 

 
 
 

 
 

 

 
 
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