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.