Source: https://www.uspto.gov/web/offices/pac/mpep/s1878.html
Timestamp: 2019-04-20 15:23:39+00:00

Document:
37 CFR 1.484 Conduct of international preliminary examination.
(a) An international preliminary examination will be conducted to formulate a non-binding opinion as to whether the claimed invention has novelty, involves an inventive step (is non-obvious) and is industrially applicable.
(b) International preliminary examination will begin in accordance with PCT Rule 69.1.
(c) No international preliminary examination will be conducted on inventions not previously searched by an International Searching Authority.
(d) The International Preliminary Examining Authority will establish a written opinion if any defect exists or if the claimed invention lacks novelty, inventive step or industrial applicability and will set a non-extendable time limit in the written opinion for the applicant to reply.
(e) The written opinion established by the International Searching Authority under PCT Rule 43bis.1 shall be considered to be a written opinion of the United States International Preliminary Examining Authority for the purposes of paragraph (d) of this section.
(f) The International Preliminary Examining Authority may establish further written opinions under paragraph (d) of this section.
(g) If no written opinion under paragraph (d) of this section is necessary, or if no further written opinion under paragraph (f) of this section is to be established, or after any written opinion and the reply thereto or the expiration of the time limit for reply to such written opinion, an international preliminary examination report will be established by the International Preliminary Examining Authority. One copy will be submitted to the International Bureau and one copy will be submitted to the applicant.
(h) An applicant will be permitted a personal or telephone interview with the examiner, which may be requested after the filing of a Demand, and must be conducted during the period between the establishment of the written opinion and the establishment of the international preliminary examination report. Additional interviews may be conducted where the examiner determines that such additional interviews may be helpful to advancing the international preliminary examination procedure. A summary of any such personal or telephone interview must be filed by the applicant or, if not filed by applicant be made of record in the file by the examiner.
(i) If the application whose priority is claimed in the international application is in a language other than English, the United States International Preliminary Examining Authority may, where the validity of the priority claim is relevant for the formulation of the opinion referred to in Article 33(1), invite the applicant to furnish an English translation of the priority document within two months from the date of the invitation. If the translation is not furnished within that time limit, the international preliminary report may be established as if the priority had not been claimed.
A written opinion must be prepared by the International Searching Authority at the same time the international search report is prepared. The United States International Preliminary Examining Authority (IPEA/US) will consider the written opinion of the International Searching Authority to be the first written opinion of the IPEA and as such in most instances no further written opinion need be issued by the U.S. examiner handling the international preliminary examination before establishment of the international preliminary examination report, even if there are objections outstanding. The examiner is to take into consideration any comments or amendments made by the applicant when he/she establishes the international preliminary examination report. However, a further written opinion must be prepared if applicant files a response which includes a persuasive argument that the written opinion issued by the International Searching Authority was improper because of a negative opinion with respect to a lack of novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2) - (4); and which results in the examiner considering any of the claims to lack novelty, inventive step (non-obviousness) or industrial applicability as described in PCT Article 33(2) - (4) based on new art not necessitated by any amendment. Such a further written opinion should be established as the Written Opinion of the International Preliminary Examining Authority (Form PCT/IPEA/408).
(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 classification as required by the IPEA/US should be given.
Since the IPEA/US will consider the written opinion of the ISA to be the first written opinion of the IPEA, item 1 of the cover sheet is marked accordingly. Further, since the written opinion of the ISA is considered to be the first written opinion, the written opinion of the IPEA needs to be indicated as a second opinion in item 2 of the cover sheet.
A top-up search should be conducted by the IPEA to identify any additional prior art that has been published or has become available subsequent to the date of the establishment of the international search report. The purpose is to discover any intermediate prior art not available during the international search, i.e., a patent application published on or after the filing or, the valid priority date of the international application, but having an earlier filing or priority date. The top-up search should be differentiated from additional search. A top-up search is to find prior art which recently became available, which is not the same as additional search required as a result of a claim amendment to present additional features not previously claimed.
In cases where relevant documents have been discovered in a top-up search and the examiner intends to raise a new objection based on the documents, a second written opinion should be issued where the new objection was not necessitated by an amendment.
When completing Box No. I, item 1 of Form PCT/IPEA/408, the examiner must indicate whether or not the opinion has been established on the basis of the international application in the language in which it was filed. If a translation was furnished for the purpose of the international search, publication, or international preliminary examination, this must be indicated. The opinion will be established on the basis of any amendments, rectifications, priority and/or unity of invention holdings, and shall answer the questions concerning novelty, inventive step, and industrial applicability for each of the claims under examination.
For the purpose of completing Box No. I, item 2, sheets of the description and drawings filed during Chapter I proceedings and stamped “SUBSTITUTE SHEET (RULE 26)”, “RECTIFIED SHEET (RULE 91)”, and “INCORPORATED BY REFERENCE (RULE 20.6)” are considered to be originally filed/furnished pages and should be listed as originally filed/furnished pages. Only those amendments or rectifications to the description and drawings filed on the date of demand or after the filing of a demand should be listed as pages “received by this Authority on ______________.” Claims filed during the Chapter I proceedings and stamped “SUBSTITUTE SHEET (RULE 26)”, “RECTIFIED SHEET (RULE 91)”, and “INCORPORATED BY REFERENCE (RULE 20.6)” are also considered to be originally filed/furnished and should be listed as originally filed/furnished claim nos. or pages.
However, amended claims filed under PCT Article 19 in response to the international search report are to be indicated as claim nos. or 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 PCT Administrative Instructions Section 417. Applicant’s submission of a timely amendment to the claims alleged to be under Article 19 is accepted under Article 34 (not Article 19) unless the International Bureau has indicated the amendments were accepted under Article 19. Only those claims filed on the date of demand or after the filing of a demand should be listed as claim nos. or 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 format of the material (i.e., on paper/image or in electronic form (text)) and the time of filing/furnishing (i.e., contained in the international application as filed, filed together with the international application in electronic form (text), or furnished subsequently to the IPEA). If more than one version or copy of the sequence listing is filed, the examiner must indicate in item 2 whether the applicant has provided the required statement indicating that the information in the subsequent or additional copies are identical to that in the application as filed or does not go beyond the application as filed, as appropriate. Item 3 is available for providing additional comments.
The examiner must also indicate, in Box No. I, item 3, if any of the amendments filed resulted in the cancellation of any pages of the description, any of the claims, any sheets and/or figures of the drawings, or any of sequence listing. If the examiner considers any of the amendments to go beyond the original disclosure, or they were not accompanied by a letter indicating the basis for the amendment in the application as filed, the examiner must point this out in Box No. I, item 4 and explain the reasons for this determination in the Supplemental Box. New matter which appears on a replacement sheet will be disregarded for the purpose of establishing the opinion. However, the remainder of the replacement sheet, including any amendments which do not constitute new matter, will be taken into consideration for the purpose of establishing the opinion. Box No. I, item 5 needs to be marked if the opinion is established taking into account the rectification of an obvious mistake under PCT Rule 91. Further, Box No. I, item 6 needs to be marked if the opinion is established taking into account the supplementary international search report(s) from the specified Supplementary International Searching Authority(ies) (SISA).
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.
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.
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.
In Box No. V, the examiner must list in summary form all claims with regard to the criteria of novelty (N), inventive step (IS), and industrial applicability (IA), and should be filled out in accordance with the instructions for Box No. V of Form PCT/ISA/237 provided in MPEP § 1845.01.
In all cases, the application should be searched by the examiner at least to the point of bringing the previous search up to date. Prior art discovered in a search and applied in a reasoned statement in Box No. V must be made of record in Box No. V. Prior art already cited on the international search report need not again be cited on the written opinion or international preliminary examination report. The subsequently discovered prior art is to be cited in compliance with PCT Rule 43.5 and PCT Administrative Instructions Section 503 using the same citation format used on the international search report. One copy of each newly cited foreign patent document and non-patent literature reference will be sent to the applicant and one copy will be retained for the application file. The USPTO no longer mails paper copies of U.S. patents and U.S. patent application publications cited during the international stage of an international application, so paper copies of these documents need not be included in the file.
(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 application file when it is sent to PCT Operations for the mailing of the Form PCT/IPEA/408. One of the copies of each newly cited foreign patent document and non-patent literature reference will be sent to the applicant and one copy will be for the Chapter II file. The USPTO no longer mails paper copies of U.S. patents and U.S. patent application publications cited during the international stage of an international application, so paper copies of these documents need not be included in the file.
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.
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.
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.
(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.
Every written opinion must be signed by an examiner having at least partial signatory authority.
The above provisions apply mutatis mutandis to the written opinion of the International Searching Authority. See PCT Rule 43bis.1(b).
(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.html). 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.
Novelty is defined in PCT Article 33(2).
Inventive step is defined in PCT Article 33(3).
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.
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.
Industrial applicability is defined in PCT Article 33(4).
(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.
A reply to the written opinion of the ISA in the form of arguments and/or amendments will be considered by the IPEA if a demand has been filed with the IPEA. 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 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.
Any amendment to the claims in reply to a written opinion must be made by submitting a replacement sheet or sheets containing a complete set of claims in replacement of all the claims originally filed or previously amended under Articles 19 or 34, as the case may be in accordance with PCT Rule 66.8. The replacement sheet or sheets shall be accompanied by a letter which: (i) shall identify the claims which, on account of the amendments, differ from the claims originally filed, and shall draw attention to the differences between the claims originally filed and the claims as amended; (ii) shall identify the claims originally filed which, on account of the amendments, are cancelled; (iii) shall indicate the basis for the amendments in the application as filed.
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)).
Generally, the replacement sheets should be in typed form and contain the changes in clean copy without any underlining and/or bracketing. A marked-up copy may be included as part of the remarks, along with the clean copy.
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.
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.

References: § 1845
 § 1845
 V. 
 § 1845
 § 1845
 § 1878
 § 1871