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1878 MANUAL OF PATENT EXAMINING PROCEDURE<br />

(c) No international preliminary examination will be conducted<br />

on inventions not previously searched by an International<br />

Searching Auth<strong>or</strong>ity.<br />

(d) <strong>The</strong> International Preliminary Examining Auth<strong>or</strong>ity will<br />

establish a written opinion if any defect exists <strong>or</strong> if the claimed<br />

invention lacks novelty, inventive step Of industrial applicability<br />

and will set a non-extendable time limit in the written opinion f<strong>or</strong><br />

the applicant to reply.<br />

(e) If no written opinion under paragraph (d) of this section<br />

is necessary, <strong>or</strong> after any written opinion and the reply thereto <strong>or</strong><br />

the expiration of the time limit f<strong>or</strong> reply to such written opinion,<br />

an .international preliminary examination rep<strong>or</strong>t will beestablished<br />

by the International Preliminary Examining Auth<strong>or</strong>ity. One<br />

copy will be submitted to the International Bureau and one copy<br />

will be submitted to the applicant.<br />

(f) An applicant will be permitted a personal <strong>or</strong> telephone<br />

interyiew with the examiner, which must be conducted during the<br />

non-extendable time limit f<strong>or</strong> reply by the applicantto a written<br />

opinion. Additional interviews may be conducted where the<br />

examiner determines that such additional interviews may be helpful<br />

to advancing the international preliminary examination procedure.<br />

A summary of any such personal <strong>or</strong> telephone interview<br />

must be filed by the applicant as apart of the reply to the written<br />

opinion <strong>or</strong>, if applicant files no reply, be made of rec<strong>or</strong>d in the file<br />

by the examiner.<br />

(g) If the application whose pri<strong>or</strong>ity is claimed in the international<br />

application is in a language other than English, the<br />

United States International Preliminary Examining Auth<strong>or</strong>ity<br />

may, where the validity of the pri<strong>or</strong>ity claim is relevant f<strong>or</strong> the f<strong>or</strong>mulation<br />

of the opinion referred to in Article 33(1), invite the<br />

applicant to furnish an English translation of the pri<strong>or</strong>ity document<br />

within two months from the date of the invitation. If the<br />

translation is not furnished within thattime limit, the international<br />

preliminary examination rep<strong>or</strong>t may be established as if the pri<strong>or</strong>ity<br />

had not been claimed.<br />

A written opinion must be prepared ifthe examiner:<br />

(A) Considers that the international application<br />

has any of the defects described in PCT Article 34(4);<br />

(B) Considers that the rep<strong>or</strong>t should be negative<br />

with respect to any of the claims because of a lack of<br />

novelty, inventive step (non-obviousness) <strong>or</strong> industrial<br />

applicability;<br />

(C) Notices any defects in the f<strong>or</strong>m <strong>or</strong> contents of<br />

the international application under the PCT;<br />

(D) Considers that any amendment goes beyond<br />

the disclosure in the international application as <strong>or</strong>iginally<br />

filed;<br />

(E) Wishes to make an observation onthe clarity<br />

of the claims, the description, the drawings <strong>or</strong> to question<br />

whether the claims are fully supp<strong>or</strong>ted by the<br />

description;<br />

August 2001<br />

1800-106<br />

(F) Decides not to carry out the international pre'<br />

liminary examination on a claim f<strong>or</strong> which no International<br />

Search Rep<strong>or</strong>t was issued; <strong>or</strong><br />

(G) Considers that no acceptable amino acid<br />

sequence listing is available in a f<strong>or</strong>m that would<br />

allow a meaningful international preliminary examination<br />

to be carried out.<br />

<strong>The</strong> applicant must be notified on F<strong>or</strong>m PCTIIPEAJ<br />

408 of the defects found in the application. <strong>The</strong> examiner<br />

is further required to fully state the reasons f<strong>or</strong><br />

hislher opinion (PCT Rule 66.2(b» and invite a written<br />

reply, with amendments where appropriate (PCT<br />

Rule 66.2(c», setting a time limit f<strong>or</strong> the reply of n<strong>or</strong>mally<br />

2 months.<br />

<strong>The</strong> examiner should insert the w<strong>or</strong>ds "first" <strong>or</strong><br />

"second", as the case may be, in the space provided<br />

on page I of the written opinion.<br />

ITEM I. BASIS OF OPINION<br />

Applicant has two opp<strong>or</strong>tunities to amend the international<br />

application pri<strong>or</strong> to international preliminary<br />

examination. Under PCT Article 19, the applicant is<br />

entitled to one opp<strong>or</strong>tunity to amend the claims of the<br />

international application by filing amendments with<br />

the International Bureau within 2 months of the mailing<br />

of the international search rep<strong>or</strong>t. See PCT Rule<br />

46.1. Applicant is also permitted to make amendments<br />

bef<strong>or</strong>e the International Preliminary Examining<br />

Auth<strong>or</strong>ity under PCT Article 34(2)(b) and PCT Rule<br />

66.1. Any amendment, however, that does not accompany<br />

the filing of the Demand but is filed later may<br />

not be considered unless it reaches the examiner<br />

bef<strong>or</strong>e he/she takes up the application f<strong>or</strong> examination.<br />

F<strong>or</strong> the purpose of completing Box I, Item I, of<br />

F<strong>or</strong>m PCTIIPEAJ408, substitute and/<strong>or</strong> rectified<br />

sheets of the specification and drawings filed during<br />

Chapter I proceedings are considered to be <strong>or</strong>iginally<br />

filed pages/sheets and should be listed as <strong>or</strong>iginally<br />

filed pages/sheets. Only those amendments <strong>or</strong> rectifications<br />

to the specification and drawings filed on the<br />

date of Demand <strong>or</strong> after the filing of a Demand should<br />

be listed as later filed pages/sheets. Substitute and/<strong>or</strong><br />

rectified sheets of claims filed during the Chapter I<br />

proceedings are also considered to be <strong>or</strong>iginally filed<br />

pages/sheets and should be listed as <strong>or</strong>iginally filed<br />

pages/sheets. However, amended sheets of claims<br />

filed under Article 19 in response to the international<br />

'""q.;;;:;+&

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