1879 Preparation of the International Preliminary Examination Report [R-07.2022]

[Editor Note: This section discusses the July 2022 version of PCT/IPEA/409. For international applications having an international filing date before July 1, 2022, information regarding form PCT/IPEA/409 (revised January 2019) may be found in §1879 of the 10.2019 revision of the Ninth Edition of the MPEP published June 2020 at: www.uspto.gov/web/offices/pac/mpep/old/ mpep_E9R10.htm.]

The international preliminary examination report (otherwise known as International Preliminary Report on Patentability (Chapter II of the Patent Cooperation Treaty)) is established on Form PCT/IPEA/409.

The international preliminary examination report must be established within:

• (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, whichever expires last, as provided in PCT Rule 69.2.

To meet the 28-month date for establishing the report, Office practice is to complete internal processing by 27 months from the priority date in order to provide adequate time for reviewing, final processing and mailing. Thus, under normal circumstances, the applicant receives the report, at the latest, 2 months before national processing at the elected Offices may start. This ensures that he/she has time to consider whether, and in which elected Offices, he/she wants to enter the national stage and to take the necessary action.

The international preliminary examination report contains, among other things, a statement (in the form of simple “yes” or “no”), in relation to each claim which has been examined, on whether the claim appears to satisfy the criteria of novelty, inventive step (non-obviousness) and industrial applicability. The statement is, where appropriate, accompanied by the citation of relevant documents together with concise explanations pointing out the criteria to which the cited documents are applicable and giving reasons for the International Preliminary Examining Authority’s conclusions. Where applicable, the report also includes remarks relating to the question of unity of invention.

The international preliminary examination report identifies the basis on which it is established, i.e., whether, and if so, which amendments have been taken into account. Replacement sheets containing amendments under PCT Article 19 and/or PCT Article 34 which have been taken into account are attached as “annexes” to the international preliminary examination report. Amendments under PCT Article 19 which have been considered as reversed by an amendment under PCT Article 34 are not annexed to the report; neither are the letters which accompany replacement sheets.

Superseded amendments are not normally included. However, if a first replacement sheet is acceptable and a second replacement sheet for the same numbered sheet contains subject matter that goes beyond the original disclosure of the application as filed, the second replacement sheet supersedes the first replacement sheet, but both the first and second replacement sheets shall be attached to the international preliminary examination report. In this case, the superseded replacement sheets are to be marked as provided in PCT Administrative Instructions Section 602.

Before the preparation of the Chapter II report, 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. 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.

The international preliminary examination report may not express a view on the patentability of the invention. PCT Article 35(2) expressly states that “the international preliminary examination report shall not contain any statement on the question whether the claimed invention is or seems to be patentable or unpatentable according to any national law.”

Form PCT/IPEA/409 Cover Sheet. The classification of the subject matter placed on the cover sheet of the report shall be either (1) that given by the International Searching Authority under PCT Rule 43.3, if the examiner agrees with such classification, or (2) shall be 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 required by the IPEA/US should be given. The cover sheet will also include the date on which the report was completed and the name and mailing address of the International Preliminary Examining Authority. This information is generated automatically by the Official Correspondence (OC) software when preparing the report. In addition, the examiner must indicate the date on which the demand for international preliminary examination was submitted. The date of receipt of the demand is usually stamped on the first sheet of the demand (form PCT/IPEA/401).

I. BOX NO. I. BASIS OF REPORT

When completing Box No. I, item 1 of Form PCT/IPEA/409, the examiner must indicate whether or not the report 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 international preliminary examination report 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 later filed 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 Article 19 in response to the international search report are to be indicated as claim numbers as amended (together with any statement) under 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 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 report 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 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, any of the 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 report. 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 report.

Box No. I, item 5 needs to be marked if the report is established taking into account the rectification of an obvious mistake under PCT Rule 91.

Box No. I, item 6 needs to be marked whether or not top-up searches have been carried out by the International Preliminary Examining Authority. If the search was carried out, the date of the top-up search and whether additional relevant document discovered need to be indicated. If any document discovered in the top-up search is used to support any negative statement with respect to any of the claimed subject matter, it should be cited in Box No. V of the report. Documents that refer to an oral disclosure, use, exhibition or other means occurred prior to the international filing date and documents that refer to earlier patent document, but published on or after the international filing date, should be cited in Box VI of the report.

Further, Box No. I, item 7 needs to be marked if the report 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

Box No. II of Form PCT/IPEA/409 is to inform applicant of the establishment of the report as if the priority claim made in the international application had not been made. This may occur where:

• (A) the IPEA requested, but was not furnished, a copy of the earlier application whose priority is claimed (PCT Rule 66.7(a)), or
• (B) applicant failed to timely comply with an invitation to furnish a translation of the earlier application (PCT Rule 66.7(b)), or
• (C) the priority claim is found invalid or all claims are directed to inventions which were not described and enabled by the earlier application (PCT Rule 64.1), or
• (D) the priority claim has been withdrawn.

III. BOX NO. III. NON-ESTABLISHMENT OF OPINION WITH REGARD TO NOVELTY, INVENTIVE STEP OR INDUSTRIAL APPLICABILITY

Indications that a report has not been established on the questions of novelty, inventive step or industrial applicability, either as to some claims or as to all claims, are given in Box No. III on the Report. The examiner must specify that the report has not been established because:

• (A) the application relates to subject matter which does not require international preliminary examination;
• (B) the description, claims or drawings are so unclear that no meaningful opinion could be formed;
• (C) the claims are so inadequately supported by the description that no meaningful opinion could be formed;
• (D) no international search report has been established for the claims.

Where the report has not been established in relation to certain claims only, the claims affected must be specified.

If a meaningful opinion could not be formed without the nucleotide and/or amino acid sequence listing because it does not comply with WIPO Standard ST.26 and/or the applicant did not pay the late furnishing fee, if required, the examiner must indicate the reason for non-compliance.

IV. BOX NO. IV. LACK OF UNITY OF INVENTION

If the applicant has paid additional fees or has restricted the claims in response to an invitation to do so or if the applicant has failed to respond to the invitation to pay additional fees or restrict the claims, the international preliminary examination report shall so indicate. The examiner should indicate whether:

• (A) the claims have been restricted;
• (B) additional fees have been paid without protest;
• (C) additional fees have been paid by the applicant under protest;
• (D) the applicant has neither restricted the claims nor paid additional fees;
• (E) the examiner was of the opinion that the international application did not comply with the requirement of unity of invention but decided not to issue an invitation to restrict the claims or pay additional fees.

In addition, if the examiner is examining less than all the claims, the examiner must indicate which parts of the international application were, and which parts were not, the subject of international preliminary examination.

In the case where additional fees were paid under protest, the text of the protest, together with the decision thereon, must be annexed to the report by International Application Processing Division IPEA personnel if the applicant has so requested.

Where an indication has been given under item (E) above, the examiner must also specify the reasons for which the international application was not considered as complying with the requirement of unity of invention.

V. BOX NO. V. REASONED STATEMENT UNDER ARTICLE 35(2) WITH REGARD TO NOVELTY, INVENTIVE STEP, AND INDUSTRIAL APPLICABILITY; AND CITATIONS AND EXPLANATIONS SUPPORTING SUCH STATEMENT

The examiner must indicate whether each claim appears to satisfy the criteria of novelty, inventive step (nonobviousness), and industrial applicability. The determination or statement should be made on each of the three criteria taken separately. The determination as to any criteria should be negative if the criteria as to the particular claim is not satisfied. The examiner should always cite documents believed to support any negative determination as to novelty and inventive step. Any negative holding as to lack of industrial applicability must be fully explained. See the further discussion in MPEP § 1845.01 relating to Box No. V of Form PCT/ISA/237. The citation of documents should be in accordance with Administrative Instructions Sections 503 and 611. The procedure is the same as the procedure for search report citations. Explanations should clearly indicate, with reference to the cited documents, the reasons supporting the conclusions that any of the said criteria is or is not satisfied, unless the statement is positive and the reason for citing any document is easy to understand when consulting the document. If only certain passages of the cited documents are relevant, the examiner should identify them, for example, by indicating the page, column, or the lines where such passages appear. Preferably, a reasoned statement should be provided in all instances.

VI. BOX NO. VI. CERTAIN DOCUMENTS CITED

If the examiner has discovered, or the international search report has cited, a relevant document which refers to a non-written disclosure, and the document was only published on or after the relevant date of the international application, the examiner must indicate on the international preliminary examination report:

• (A) the date on which the document was made available to the public;
• (B) the date on which the non-written public disclosure occurred.

The examiner should also identify any published application or patent which would constitute prior art for purposes of PCT Article 33(2) and (3) had it been published prior to the relevant date (PCT Rule 64.1) but was filed prior to, or claims the priority of an earlier application which had been filed prior to, the relevant date (PCT Rule 64.3). For each such published application or patent the following indications should be provided:

• (A) its date of publication;
• (B) its filing date, and its claimed priority date (if any).

The Report may also indicate that, in the opinion of the International Preliminary Examining Authority, the priority date of the document cited has not been validly claimed ( PCT Rule 70.10).

Guidelines explaining to the examiner the manner of indicating certain special categories of documents as well as the manner of indicating the claims to which the documents cited in such report are relevant are set forth in Administrative Instructions Sections 507(c), (d), and (e) and 508.

VII. BOX NO. VII. CERTAIN DEFECTS IN THE INTERNATIONAL APPLICATION

If, in the opinion of the examiner, defects existing in the form or contents of the international application have not been suitably solved at the prescribed time limit for establishing the international preliminary examination report, the examiner may include this opinion in the report, and if included, must also indicate the reasons therefor. See the further discussion in MPEP § 1845.01 relating to Box No. VII of Form PCT/ISA/237.

VIII. BOX NO. VIII. CERTAIN OBSERVATIONS ON THE INTERNATIONAL APPLICATION

If, in the opinion of the examiner, the clarity of claims, the description, and the drawings, or the question as to whether the claims are fully supported by the description have not been suitably solved at the prescribed time limit for establishing the international preliminary examination report, the examiner may include this opinion in the report, and if included, must also indicate the reasons therefor. See the further discussion in MPEP § 1845.01 relating to Box No. VIII of Form PCT/ISA/237.

IX. FINALIZATION OF THE INTERNATIONAL PRELIMINARY EXAMINATION REPORT

The name of the authorized officer responsible for the report must be indicated. Pursuant to Administrative Instructions Section 612, an “authorized officer” is the person who actually performed the examination work and prepared the international preliminary examination report or another person who was responsible for supervising the examination. Thus, an examiner need not have signatory authority in order to be named as an authorized officer on the examination report. However, the “file copy” of the international preliminary examination report must be signed by a primary examiner.

The total number of sheets of the international preliminary examination report, including the cover sheet, must be indicated on the cover sheet. In addition, the annexes, if any, must accompany the international preliminary examination report.

For annexes to be sent to the applicant and to the International Bureau, an indication must be made regarding the total sheets of the following: sheets of the description, claims and/or drawings which have been amended and/or sheets containing rectifications authorized by the IPEA, unless those sheets were superseded or cancelled, and any accompanying letters (see PCT Rules 46.5, 66.8, 70.16, 91.2, and PCT Administrative Instructions Section 607); sheets containing rectifications, where the decision was made by the IPEA not to take them into account because they were not authorized by or notified to the IPEA at the time when the IPEA began to draw up the report, and any accompanying letters (PCT Rules 66.4bis, 70.2(e), 70.16 and 91.2); and superseded sheets and any accompanying letters, where the IPEA either considered that the superseding sheets contained an amendment that goes beyond the disclosure in the international application as filed, or the superseding sheets were not accompanied by a letter indicating the basis for the amendments in the application as filed, as indicated in item 4 of Box No. I and the Supplemental Box (see PCT Rule 70.16(b)).

For annexes to be sent to the International Bureau only, an indication must be made regarding the total of the type and number of electronic carrier(s) containing a sequence listing, in electronic form only, as indicated in the Supplemental Box Relating to Sequence Listing (see paragraph 3bis of Annex C of the PCT Administrative Instructions).