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1878 Preparation of the Written Opinion of the International Preliminary Examining Authority in International Applications Having an International Filing Date On or After January 1, 2004 [R-6] - 1800 Patent Cooperation Treaty
1878 Preparation of the Written Opinion of the International Preliminary Examining Authority in International Applications Having an International Filing Date On or After January 1, 2004 [R-6]
[Note: The regulations under the PCT were changed effective January 1, 2004. Corresponding changes were made to Title 37 of the Code of Federal Regulations. See January 2004 Revision of Patent Cooperation Treaty Application Procedure, 68 FR 59881 (Oct. 20, 2003), 1276 O.G. 6 (Nov. 11, 2003). The discussion of the procedures in effect for international applications filed prior to January 1, 2004, has been moved from this section to MPEP § 1878.01.]
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.
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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*****
PCT RULE
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).
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PCT RULE
66.4 Additional Opportunity for Submitting Amendments or Argument(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.
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In applications having an international filing date on or after January 1, 2004, 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) 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 on 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 U.S. classification should be given. <
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____." Sheets of 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 pages and should be listed as originally filed/furnished pages.<
However, amended sheets of claims filed under PCT Article 19 in response to the international search report are to be indicated as pages 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 Administrative Instructions Section 417. Only those pages of claims filed on the date of demand or after the filing of a demand should be listed as pages "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 type of material (i.e., a sequence listing and/or tables related thereto), the format of the material (i.e., on paper or in electronic form) and the time of filing/furnishing (i.e., contained in the international application as filed, filed together with the international application in electronic form, or furnished subsequently to the IPEA). If more than one version or copy of the sequence listing and/or table relating thereto is filed, the examiner must indicate 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.
<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, drawings, sequence listing or< tables related to the sequence listing. If the examiner considers any of the amendments to go beyond the original disclosure, 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. >Further, 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.<
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.
If in reply to an invitation to restrict, applicant restricted the claims to a particular group, check the first box under subsection 1. If applicant paid additional fees for examination of additional inventions, check the second box under subsection 1. If the additional fees were paid under protest, check the third box under subsection 1. If applicant neither restricted nor paid additional fees in reply to the objection of lack of unity of invention, check the fourth box under subsection 1.
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 applications where the examiner has determined that an additional written opinion is required, 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 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 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.<
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) Nonwritten disclosure - by the kind of disclosure, date of the disclosure and the date of the written disclosure referring to the nonwritten 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 PCT Chapter II 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, in applications filed on or after January 1, 2004, 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.
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