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1878.01 < Preparation of the Written Opinion >in International Applications Having an International Filing Date Before January 1, 2004< [R-2] - 1800 Patent Cooperation Treaty
1878.01 < Preparation of the Written Opinion >in International Applications Having an International Filing Date Before January 1, 2004< [R-2]
>[Note: In international applications filed on or after January 1, 2004, the first written opinion is usually prepared by the International Searching Authority (see MPEP §§ 1845- 1845.01), and a further written opinion may be prepared by the International Preliminary Examining Authority (see MPEP § 1878.]<
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.
*****
>Former<
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 promptly upon receipt of a proper Demand in an application for which the United States International Preliminary Examining Authority is competent, for which the fees for international preliminary examination ( § 1.482) have been paid, and which requests examination based on the application as filed or as amended by an amendment which has been received by the United States International Preliminary Examining Authority. Where a Demand requests examination based on a PCT Article 19 amendment which has not been received, examination may begin at 20 months without receipt of the PCT Article 19 amendment. Where a Demand requests examination based on a PCT Article 34 amendment which has not been received, applicant will be notified and given a time period within which to submit the amendment.
(1) Examination will begin after the earliest of:
(i) Receipt of the amendment;
(ii) Receipt of applicant's statement that no amendment will be made; or
(iii) Expiration of the time period set in the notification.
(2) No international preliminary examination report will be established prior to issuance of an international search report.
(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) If no written opinion under paragraph (d) of this section is necessary, 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.
(f) An applicant will be permitted a personal or telephone interview with the examiner, which must be conducted during the non-extendable time limit for reply by the applicant to a written opinion. 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 as a part of the reply to the written opinion or, if applicant files no reply, be made of record in the file by the examiner.
(g) 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 examination report may be established as if the priority had not been claimed.
A written opinion must be prepared if the examiner:
(A) Considers that the international application has any of the defects described in PCT Article 34(4);
(B) Considers that the report should be negative with respect to any of the claims because of a lack of novelty, inventive step (non-obviousness) or industrial applicability;
(C) Notices any defects in the form or contents of the international application under the PCT;
(D) Considers that any amendment goes beyond the disclosure in the international application as originally filed;
(E) Wishes to make an observation on the clarity of the claims, the description, the drawings or to question whether the claims are fully supported by the description;
(F) Decides not to carry out the international preliminary examination on a claim for which no international search report was issued; or
(G) Considers that no acceptable amino acid sequence listing is available in a form that would allow a meaningful international preliminary examination to be carried out.
The applicant must be notified on Form PCT/IPEA/408 of the defects found in the application. The examiner is further required to fully state the reasons for his/her opinion ( PCT Rule 66.2(b)) and invite a written reply, with amendments where appropriate ( PCT Rule 66.2(c)), setting a time limit for the reply of normally 2 months.
The examiner should insert the words "first" or "second", as the case may be, in the space provided on page 1 of the written opinion.
ITEM I. BASIS OF OPINION
Applicant has two opportunities to amend the international application prior to international preliminary examination. Under PCT Article 19, the applicant is entitled to one opportunity to amend the claims of the international application by filing amendments with the International Bureau within 2 months of the mailing of the international search report. See PCT Rule 46.1. Applicant is also permitted to make amendments before the International Preliminary Examining Authority under PCT Article 34(2)(b) and PCT Rule 66.1. Any amendment, however, that does not accompany the filing of the Demand but is filed later may not be considered unless it reaches the examiner before he/she takes up the application for examination.
>When completing Box 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 search, this must be indicated.< For the purpose of completing Box I, Item 1, ** substitute and/or rectified sheets of the specification and drawings filed during Chapter I proceedings are considered to be originally filed pages/sheets and should be listed as originally filed pages/sheets. Only those amendments or rectifications to the specification and drawings filed on the date of Demand or after the filing of a Demand should be listed as later filed pages/sheets. Substitute and/or rectified sheets of claims filed during the Chapter I proceedings are also considered to be originally filed pages/sheets and should be listed as originally filed pages/sheets. However, amended sheets of claims filed under Article 19 in response to the international search report are to be indicated as pages/sheets as amended under Article 19. Only those amendments, or rectifications to the claims filed on the date of Demand or after the filing of a Demand should be listed as later filed pages/sheets. **>The examiner must also indicate, in Box I, item 3, if any of the amendments filed resulted in the cancellation of any pages of the description, any of the claims or drawings, or any pages of the sequence listing and/or any 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 I, item 4 and explain the reasons for this determination in the Supplemental Box.<.
ITEM II. PRIORITY
Item II of Form PCT/IPEA/408 is to inform applicant of non-establishment of a request for priority.
If applicant fails to furnish a copy or translation of the earlier application, whose priority has been claimed, within the time limit set by the examiner pursuant to PCT Rule 66.7, check box No. 1 and then check the first box of the subsection if applicant failed to furnish a copy of the earlier application whose priority has been claimed, and check the second box in the subsection if applicant failed to furnish a translation of the earlier application whose priority has been claimed.
When the claim for priority has been found invalid (e.g., the claimed priority date is more than one year prior to the international filing date and the notification under PCT Rule 4.10(d) has been provided or all claims are directed to inventions which were not described and enabled by the earlier application), check box No. 2 of Item II and indicate why the claim for priority has been found invalid following No. 3 "Additional observations". The examiner is reminded that when some claims in an international application are directed to an invention which was disclosed in the earlier application, the priority claim is valid provided that a copy and/or translation of the earlier application have/has been filed and the filing date of the earlier application is one year or less from the filing date of the international application.
ITEM III. NON-ESTABLISHMENT OF OPINION ON NOVELTY, INVENTIVE STEP AND INDUSTRIAL APPLICABILITY
Item 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.
If some or all of the claims of an application relate to subject matter which does not require international preliminary examination, check the appropriate box, indicate which claims relate to that subject matter and specify the reasons.
If some or all of the claims of an application are so unclear that no meaningful opinion could be formed, check the appropriate box, indicate which claims are unclear and specify the reasons.
If some or all of the claims are so inadequately supported by the description that no meaningful opinion could be formed, check the appropriate box.
If no international search report has been established for certain claims, check the appropriate box and indicate the claim numbers.
ITEM IV. LACK OF UNITY OF INVENTION
Item 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 invention, 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 Item 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 Item 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.
ITEM V. REASONED STATEMENT WITH REGARD TO NOVELTY, INVENTIVE STEP, AND INDUSTRIAL APPLICABILITY OF CLAIMS
In Item 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).
Item V is the main purpose of the Written Opinion. All claims without fatal defects are treated on the merits in Item V as to novelty, inventive step (nonobviousness) and industrial applicability.
The treatment of claims in Item V is similar in format to an Office action in a U.S. national patent application except that the words "rejection" and "patentability" are never used in a written opinion. On the international level, all written opinions are nonbinding and a patent does not issue; what does issue is an international preliminary examination report (IPER), which is nonbinding on the Elected States.
Examiner statements in Item V can be positive or negative. If the claims define over the prior art and meet the test of novelty, inventive step (nonobviousness) and industrial applicability, a statement equivalent to detailed reasons for allowance in a corresponding U.S. national application should be provided, indicating how the claims meet the tests of novelty, inventive step and industrial applicability. Form paragraphs 18.04 and 18.04.01 may be used for this purpose.
¶ 18.04 Meets Novelty and Inventive Step
Claim [1] the criteria set out in PCT Article 33(2)- (3), because the prior art does not teach or fairly suggest [2].
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and insert the verb --meet-- or --meets--, as appropriate.
2. In bracket 2, insert the details of the claimed subject matter that render it unobvious over the prior art.
3. If the claims also meet the industrial applicability criteria set out in PCT Article 33(4), this form paragraph should be followed by form paragraph 18.04.01.
4. If the claims do not meet the industrial applicability criteria set out in PCT Article 33(4), this form paragraph should be followed by form paragraph 18.03.
¶ 18.04.01 Meets Industrial Applicability
Claim [1] the criteria set out in PCT Article 33(4), and thus [2] industrial applicability because the subject matter claimed can be made or used in industry.
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --meet-- or -- meets--, as appropriate.
2. In bracket 2, insert --have-- or --has--, as appropriate.
3. If the claims meet all of the requirements of PCT Article 33(2)-(4), use form paragraph 18.04 before this form paragraph to provide positive statements for novelty and inventive step under PCT Article 33(2)-(3).
4. If the claims have industrial applicability but lack novelty and inventive step, use this form paragraph and additionally use form paragraph 18.01.
5. If the claims have industrial applicability and novelty but lack inventive step, use this form paragraph and additionally use one or more of form paragraphs 18.02, 18.02.01 and 18.02.02, as appropriate.
6. If the claims do not have industrial applicability, use form paragraph 18.03 instead of this form paragraph.
If, on the other hand it is the opinion of the examiner that some or all claims lack novelty, inventive step, or industrial applicability, specific reasons must be given similar to those used in U.S. national applications. If the claims lack inventive step over a combination of references, the reasons must explain why one of ordinary skill in the art would have been motivated to combine the teachings of the applied references.
Form paragraphs 18.01, 18.02, 18.02.01, 18.02.02, and 18.03 may be used, as appropriate, to explain the negative statements listed in Item V.
¶ 18.01 Lacks Novelty
Claim [1] novelty under PCT Article 33(2) as being anticipated by [2].
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.
2. In bracket 2, insert name of prior art relied upon.
¶ 18.02 Lacks Inventive Step - One Reference
Claim [1] an inventive step under PCT Article 33(3) as being obvious over [2]. [3]
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.
2. In bracket 2, insert name of prior art relied upon.
3. In bracket 3, add reasoning.
¶ 18.02.01 Lacks Inventive Step - Two References
Claim [1] an inventive step under PCT Article 33(3) as being obvious over [2] in view of [3]. [4]
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.
2. In bracket 2, insert name of PRIMARY prior art relied upon.
3. In bracket 3, insert name of SECONDARY prior art relied upon.
4. In bracket 4, add reasoning.
¶ 18.02.02 Lacks Inventive Step - Additional Reference
Claim [1] an inventive step under PCT Article 33(3) as being obvious over the prior art as applied in the immediately preceding paragraph and further in view of [2]. [3]
Examiner Note
1. This form paragraph may follow either 18.02 or 18.02.01.
2. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.
3. In bracket 2, insert name of additional prior art relied upon.
4. In bracket 3, add reasoning.
¶ 18.03 Lacks Industrial Applicability
Claim [1] industrial applicability as defined by PCT Article 33(4). [2]
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --lack-- or --lacks--, as appropriate.
2. In bracket 2, add reasoning.
Examiners are encouraged to indicate any amendments which applicant could present which would avoid a negative statement in the international preliminary examination report.
All international applications where an examination has been demanded 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 an Item V statement must be made of record in Item 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 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 the newly cited reference will be sent to the applicant and one copy will be retained in the Chapter II file.
ITEM VI. CERTAIN DOCUMENTS CITED
Item VI provides a convenient manner of listing two different types of documents:
(A) Published documents - 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.
ITEM VII. CERTAIN DEFECTS IN THE INTERNATIONAL APPLICATION
In Item VII, defects in the form and content of the international application are identified.
Examples of defects that would be listed in Item VII are:
(A) Informalities such as misplaced and/or omitted drawing numerals, misspelled words, grammatical errors, etc.
(B) ** Improper multiple-dependent claims ( PCT Rule 6.4) if not indicated under Item III.
The following form paragraphs are used in Box VII of PCT/IPEA/408 or PCT/IPEA/409 "Certain defects in the international application" for noting technical defects.
¶ 18.08 Drawing Objections - Defects
The drawings are objected to under PCT Rule 66.2(a)(iii) as containing the following defect(s) in the form or content thereof: [1]
Examiner Note
In bracket 1, insert identification of defects in drawings.¶ 18.08.01 Drawing Is Required
The subject matter of this application admits of illustration by drawing to facilitate understanding of the invention. Applicant is required under PCT Article 7(1) to furnish a drawing.
¶ 18.09 Description Defective
The description is objected to as containing the following defect(s) under PCT Rule 66.2(a)(iii) in the form or contents thereof: [1]
Examiner Note
In bracket 1, insert the technical problem, e.g., misspelled word.¶ 18.10 Claims Defective
Claim [1] objected to under PCT Rule 66.2(a)(iii) as containing the following defect(s) in the form or contents thereof: [2]
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.
2. In bracket 2, identify the technical deficiency.
ITEM VIII. CERTAIN OBSERVATIONS ON THE INTERNATIONAL APPLICATION
In Item 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.
If the claims, the description, or the drawings are so unclear, or the claims are so inadequately supported by the description, that no meaningful opinion can be formed on the question of novelty, inventive step (nonobviousness) or industrial applicability, the applicant is so informed in Item III ( PCT Article 34(4)(a)(ii)). Reasons for the examiner's opinion that the claims, description and drawings, etc., lack clarity must also be provided.
If the above situation is found to exist in certain claims only, the provisions of PCT Article 34(4)(ii) shall apply to those claims only.
If the lack of clarity of the claims, the description, or the drawings is of such a nature that it is possible to form a meaningful opinion on the claimed subject matter, then it is required that the examiner consider the claims and render a written opinion on novelty, inventive step, and industrial applicability in Item V of Form PCT/IPEA/408.
Since the claims of an international application are not subject to a rejection on either art or indefiniteness consistent with U.S. practice, observations by the examiner with regard to clarity of the claims, the description and the drawings will be treated in the form of an objection in the written opinion in Item VIII.
The following form paragraphs are used in Box VIII "Certain observations on the international application" of PCT/IPEA/408 and PCT/IPEA/409 for noting objections which are substantive rather than merely technical in nature.
¶ 18.11 Drawing Objections - Lack Clarity
The drawings are objected to under PCT Rule 66.2(a)(v) as lacking clarity under PCT Article 7 because: [1]
Examiner Note
In bracket 1, insert reasons why the drawings lack clarity, e.g., inaccurate showing.¶ 18.12.01 Claims Objectionable - Inadequate Written Description
Claim [1] objected to as lacking clarity under PCT Rule 66.2(a)(v) because the claim [2] not fully supported by the description. The application, as originally filed, did not describe: [3]
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s), and the verb --is-- or --are--, as appropriate.
2. In bracket 2, pluralize "claim" if needed, and insert the verb --is-- or --are--.
3. In bracket 3, identify subject matter not described in the application as filed.
¶ 18.13.01 Claims Objectionable - Non-Enabling Disclosure
Claim [1] objected to as lacking clarity under PCT Rule 66.2(a)(v) because the claim [2] not fully supported by the description. The description does not disclose the claimed invention in a manner sufficiently clear and complete for the claimed invention to be carried out by a person skilled in the art because: [3]
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.
2. In bracket 2, pluralize "claim" if needed, insert the verb --is-- or --are--.
3. In bracket 3, identify the claimed subject matter that is not enabled and explain why it is not enabled.
¶ 18.14.01 Claims Objectionable - Lack of Best Mode
Claim [1] objected to under PCT Rule 66.2(a)(v) because the claim [2] not fully supported by the description. The description fails to set forth the best mode contemplated by the applicant for carrying out the claimed invention as required by PCT Rule 5.1(a)(v) because: [3].
Examiner Note
1. In bracket 1, pluralize "claim" if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.
2. In bracket 2, pluralize "claim" if needed, and insert the appropriate verb --is-- or --are--.
3. In bracket 3, insert the objection and reasons.
¶ 18.15 Claims Objectionable - Indefiniteness
Claim [1] objected to under PCT Rule 66.2(a)(v) as lacking clarity under PCT Article 6 because claim [2] indefinite for the following reason(s): [3]
Examiner Note
1. In brackets 1 and 2, pluralize "claim" if needed, insert claim no.(s) and the appropriate verb --is-- or --are--.
2. In bracket 3, insert reasons.
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) 8 months from the date of payment of the handling fee referred to in PCT Rule 57.1 and the preliminary examination fee referred to in PCT Rule 58.1(a); or
(C) 8 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 first written opinion. See 37 CFR 1.484(d) and MPEP § 1878.02.
AUTHORIZED OFFICER
Every written opinion must be signed by an examiner having at least partial signatory authority.
The first document prepared by the examiner in most international applications during the international preliminary examination proceedings will be the written opinion. Normally only in those international applications where all the formal matters are proper and the claims are directed to inventions which have novelty, inventive step and industrial applicability will an international preliminary examination report be established without a written opinion having been issued first.
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