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 .]

34

Procedure Before the International Preliminary Examining Authority

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  • (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 C.F.R. 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 43 bis   .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.

66

Procedure Before the International Preliminary Examining Authority

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66.1bis Written Opinion of the International Searching Authority

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  • (a) Subject to paragraph (b), the written opinion established by the International Searching Authority under Rule 43 bis .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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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.

*****

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.

1878.01   Preparation of the Written Opinion in International Applications Having an International Filing Date Before January 1, 2004 [R-7]

[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) .]

34

Procedure Before the International Preliminary Examining Authority

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  • (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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Former

37 C.F.R. 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 (Form PCT/IPEA/408) 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 the cover sheet of the written opinion.

The classification of the subject matter provided by the examiner in the header of 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.   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 description 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 description 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. 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.

II.   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.

III.   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.

IV.   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.

V.   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.

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.

VI.   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.

VII.   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 - Defect in Form or Contents Thereof

The drawings contain 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 - Defect in Form or Contents Thereof

The description contains the following defect(s) in the form or contents thereof: [1]

Examiner Note:

In bracket 1, insert the technical problem, e.g., misspelled word.

¶ 18.10    Claims - Defect in Form or Contents Thereof

Claim [1] contain(s) the following defect(s) in the form or contents thereof: [2]

Examiner Note:

1. In bracket 1, pluralize "claim" if needed, and insert claim no.(s).

2. In bracket 2, identify the technical deficiency.

VIII.   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 Article 7  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 under PCT Article 6  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 under PCT Article 6  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 as required by PCT Article 5  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 Article 6  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 Article 6  as lacking clarity 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.

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) 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 .

X.   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.

1878.01(a)   Prior Art for Purposes of the Written Opinion and the International Preliminary Examination Report [R-6]

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  • (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.

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 43 bis .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.htm). 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 nonwritten 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-2]

Novelty is defined in PCT Article 33(2)  .

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 43 bis .1(b)   .

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

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

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.

*****

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 43 bis .1(b)   .

1878.01(a)(3)    Industrial Applicability for Purposes of the Written Opinion and the International Preliminary Examination Report [R-2]

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

33

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  • (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 43 bis .1(b)   .

1878.02   Reply to the Written Opinion of the ISA or IPEA [R-6]

34

Procedure Before the International Preliminary Examining Authority

*****

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

*****

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), 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 letter accompanying the replacement sheets shall draw attention to the differences between the replaced sheets and the replacement sheets 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.

66.9. Language of Amendments

  • (a) Subject to paragraphs (b) and (c), if the international application has been filed in a language other than the language in which it is published, any amendment, as well as any letter referred to in Rule 66.8  , shall be submitted in the language of publication.
  • (b) If the international preliminary examination is carried out, pursuant to rule 55.2  , on the basis of a translation of the international application, any amendment, as well as any letter referred to in paragraph (a), shall be submitted in the language of that translation.
  • (c) Subject to Rule 55.3  , if an amendment or letter is not submitted in a language as required under paragraph (a) or (b), the International Preliminary Examining Authority shall, if practicable, having regard to the time limit for establishing the international preliminary examination report, invite the applicant to furnish the amendment or letter in the required language within a time limit which shall be reasonable under the circumstances.
  • (d) If the applicant fails to comply, within the time limit under paragraph (c), with the invitation to furnish an amendment in the required language, the amendment shall not be taken into account for the purposes of the international preliminary examination. If the applicant fails to comply, within the time limit under paragraph (c), with the invitation to furnish a letter referred to in paragraph (a) in the required language, the amendment concerned need not be taken into account for the purposes of the international preliminary examination.

37 C.F.R. 1.485  Amendments by applicant during international preliminary examination.

  • (a) 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:
    • (1) Be made by submitting a replacement sheet in compliance with PCT Rules 10  and 11.1  to 11.13  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. Amendments that do not comply with PCT Rules 10  and 11.1  to 11.13  may not be entered
  • (b) If an amendment cancels an entire sheet of the international application, that amendment shall be communicated in a letter.

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 claims, 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  .

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)  ).

Replacement sheets must be in typed form.

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.