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II.6. Time limit for completing the International search Art.18(1) PCT The International search report must be ready within the prescribed time limit. R42.1 PCT The International search report (or the declaration replacing it according to Art.17(2)(a) PCT), must be completed by the ISA by the later of: - Three months of the receipt of the search copy by the ISA Under R23.1(a) PCT the search copy is transmitted to the ISA by the RO up to 13 months from the priority*. - Nine months from the priority date * If there are multiple priorities, this time limit is calculated from the earliest priority date (Art.2(xi)(b) PCT). If no priority is claimed, this time limits is calculated from the International filing date (Art.2(xi)(c) PCT). Publication of search report R42.1 PCT should ensure that the International search report is prepared in time to be published with the International application according to Art.21(2)(a) PCT (18 months after the priority). The publication of the application along with the search report 18 months after the priority is called an A1 publication (Art.21(2)(a) PCT and R48.2(a) PCT). Under R42.1 PCT the ISA always has at the very least three months to perform the search from the date of receipt of the search copy of the application. Normally, the RO transmits the search copy to the ISA within the time limit according to R23.1(a) PCT (13 months from the priority) and the applicant has used the full priority period of twelve months. Where this is the case, the ISA must complete the search within three months of this date, making a time limit for completion of the International search of 16 months from the priority. Where the RO forwards the search copy of the application to the ISA later than 13 months (i.e. it does not observe R23.1(a) PCT), this pushes the three month time limit for preparation of the search report beyond 16 months, and if the search copy arrives at the ISA later than 15 months after the priority, then the time limit for preparing the search report expires after publication (since later than 15 months plus 3 months becomes later than 18 months after the S&E-GL 15.68 II.7. priority - which is after publication - Art.21(2)(a) PCT). Where the time limit of R42.1 PCT is not met and the search report is not available at the time of publication the application is published without the search report (A2 publication R48.2(g) PCT). The search report is then published separately later (A3 - publication - R48.2(g) PCT). Late s. report and 3 rd party observations Where the IB transmits third party observations to the ISA in time for these to be considered in the preparation of the search report [A.I. 805(a) ], any prior art provided in those observations may be cited in the search report. Third party observations can only be made on the application after it is published [A.I. 802(a)(ii) - see V.9]. In most cases the search report is prepared and forwarded to the IB before publication [see above] and thus before any observations can be filed. The observations will only be sent to the ISA by the IB if the IB has not yet received the search report by the time the observation is made [A.I. 805(a) ]. Application not searched This section relates to cases where the application relates entirely or in part to subject matter which the ISA is not required to search, or where all or part of the application fails to comply with the requirements of the PCT to such an extent that a meaningful search cannot be carried out. In such cases, the ISA will not search the application (or the part of the application affected) and will issue a declaration to inform the applicant and the IB of this. Where only part of the claimed invention is searched, the search report will be limited to exclude documents relevant to the affected part and this "partial search report" will be accompanied by a declaration. Those parts of the application which are not searched, need not be subject to the WO-ISA or to International Preliminary Examination (R66.1(e) PCT). It is the policy of the EPO not to prepare a WO- ISA or to perform International Preliminary Examination on subject matter which has not been searched [Euro-PCT Guide 382]. 114

Reasons of economy not applicable B-VIII, 3 & T1020/98 Note that the search cannot be limited for reasons of economy [that a search would be too time consuming or expensive]. Only the reasons given in the following sub-sections can justify a limitation of the search. II.7.1. Application not searched due to the presence of certain subject matter No search report Art.17(2)(a)(i) PCT If the ISA considers that the International application relates to subject matter which it is not required to search according to the Rules, then the ISA informs the applicant and the IB that no search report will be prepared. Partial search report Art.17(2)(b) PCT Where the subject matter in question appears in certain claims and not others, then only the claims affected are excluded from the search and the search report indicates which claims have not been searched (a partial search report) and cites the relevant documents for the other claims according to Art.18 PCT. Art.17(2)(b) PCT & R43.9 PCT Where certain subject matter is searched and other subject matter is not searched, the search report must indicate which claims have been searched and which have not. Claims may also relate in part to subject matter which the ISA is not obliged to search and in part to subject matter which should be searched. This means that Art.17(2)(b) PCT is applied mutatis mutandis to part of a claim, see the example given in S&E-GL 9.37. Excluded subject matter The subject matter which ISAs are not obliged to search is given in R39 PCT and corresponds to subject matter which is not considered patentable in many jurisdictions (including the EPC). The corresponding Article of the EPC, which forbids the patenting of the subject matter mentioned in R39 PCT is also given in II.7.1.1 to II.7.1.6 below. R39.1 PCT relating to: - scientific and mathematical theories - plant or animal varieties - essentially biological processes producing: - plants or - animals - schemes/rules/methods for doing business - schemes/rules/methods for mental acts - schemes/rules/methods for playing games - methods of treatment / diagnosis - presentations of information - computer programmes For further explanations see II.7.1.1 to II.7.1.6 below. Art.19 PCT Amendments not allowed PCT-AG I, 9.004 Where the ISA issues a declaration replacing the International search report under Art.17(2) PCT, the applicant is not permitted to make amendments under Art.19 PCT. This is only applies where no search is performed at all - see II.11. Limitation of examination The EPO applies R43bis.1(b) PCT and R66.1(e) PCT and limits the scope of the examination in the WO-ISA to exclude from examination subject matter not searched due to Art.17(2)(a)(i) PCT & R39.1 PCT. Furthermore, where the EPO also acts as IPEA, the same subject matter excluded from International search and from examination in the WO-ISA by R66.1(e) PCT, is also excluded from International preliminary examination according to Art.34(4)(a)(i) PCT & R67.1 PCT. R43bis.1(b) PCT [by reference to R70.2(d) PCT] & R66.2(a)(vi) PCT The WO-ISA or IPEA written opinion must indicate this limitation of the examination. However, for the detailed reasoning as to why the search was not complete, the WO- ISA may simply refer to the declaration (S&E-GL 9.40). Consequences in European phase T613/99 In the European regional phase, where the EPO acting as ISA has refused to search certain subject matter of the claims because they fall under the subject matter which may be excluded from the International search according to Art.17(2)(a)(i) PCT and R39.1 PCT, R86(4) EPC_1973 [now R137(5) EPC]* does not exclude such subject matter from forming the basis for further amendments in the European phase, even though it has not been searched (in this case the claims which were not searched in the PCT were 115

II.7.1.1. R39.1(i) PCT II.7.1.2. R39.1(ii) PCT II.7.1.3. R39.1(iii) PCT OJ 2001, 482 & OJ 2002, 260 reformulated into an allowable patentable form in the European regional phase). * According to R137(5) EPC, amended claims may not relate to unsearched subject matter which does not combine with the original claimed invention or group of inventions to form a single general inventive concept. This rule was introduced to prevent a broad description from acting as a reservoir for amendment of the claims. In particular it prevents applicants hiding the true invention in the description and only introducing it into the claims after the search. However, the above decision found that subject matter present in the claims on filing, but not searched, because it was excluded from search by R39.1 PCT, can still form the basis for amendment of the claims in the European procedure. Theories relating to scientific and mathematical theories See also Art.52(2)(a) EPC Plant, animal varieties relating to plant or animal varieties and essentially biological processes for the production thereof, except microbiological processes and the products thereof. See also Art.53(b) EPC Business methods etc relating to schemes, rules and methods of doing business, performing mental acts or playing games. See also Art.52(2)(c) EPC The EPO adopts a very strict approach with regard to applications for business methods. These are neither searched (R39.1(iii) PCT) nor examined (R67.1(iii) PCT) by the EPO as ISA and IPEA. II.7.1.4. R39.1(iv) PCT so commonplace that no citation is considered necessary. The EPO previously subjected business method applications originating from the US to a limitation of its competence as ISA and IPEA. This limitation of competence has been abolished [OJ 2014, A117] and the EPO will now act as ISA or IPEA for such applications. However, as indicated above, the EPO continues to refuse to search or examine claims directed to such subject matter. Methods of treatment / diagnosis relating to method of treatment* of the human or animal body by surgery or therapy and diagnostic methods. See also Art.53(c) EPC * The EPC explicitly forbids the patenting of methods of treatment of the human or animal body by surgery or therapy according to Art.53(c) EPC. When the EPO acts as ISA, it is not obliged to search claims directed to a method of treatment as such. However, when a claim formulated as a method of treatment relates to the use of a chemical compound for a method of treatment, the claim is searched taking into consideration how it could be reformulated in the European procedure according to the formulation Compound/composition X, for use in treatment of disease Y [Art.54(4)(5) EPC see also B-VIII, 2.1]. Effectively a method of treatment claim characterised by the use of a certain chemical compound or group of chemical compounds will be searched by the EPO as ISA as though drafted in an allowable Swiss type or product for use format. A method of treatment claim not patentable according to Art.53(c) EPC is for example: "A method of treating disease X, by administering compound Y" A product for use claim, considered allowable under Art.53(c) EPC reads thus: OJ 2007, 592 The EPO does not search business method claims where they contain no apparent technical character. - If, on the other hand, technical means appear in the claim, but are so conventional that they are widely available to everyone, the search report will contain a statement that such technical means are Compound/composition X, for use in treating disease Y Under the EPC, such a claim would be considered to be novel over the use of the same compound/composition in the treatment of a different disease [Art.54(5) EPC]. 116

B-VIII, 2.1 II.7.1.5. R39.1(v) PCT II.7.1.6. R39.1(vi) PCT II.7.2. The Swiss type claim is an old format for medicinal indications, considered allowable under Art.53(c) EPC and novel according to Art.54(5) EPC [over different medical uses] by the EPO Enlarged Board of Appeal (G5/83), for applications with a filing or earliest priority date before 29.01.2011 (G2/08). It reads thus: "Use of compound Y for the manufacture of a medicament, for the treatment of disease X" If, however, the claim relates to a method of treatment characterised by method features (e.g. a combination of pharmaceutical and physical treatment), then the EPO may refuse to search the claim. Note that dosage instructions can be a legitimate part of a properly formulated medicinal indication claim [Art.54(4) EPC and Art.54(5) EPC] and can be subject to patent protection at the EPO in this context [G2/08]. Consequently, the presence of dosage features in the claim would be very unlikely to lead to a claim which is not searched. Consequently, the reference to dosage instructions, which used to be present in this Guideline, has been removed in the light of this decision. Presentations of information relating to presentations of information. See also Art.52(2)(d) EPC. Computer programmes The ISA is not required to search applications relating to computer programmes, to the extent that the ISA is not equipped to search them. See also Art.52(2)(c) EPC. Application not searched due to serious deficiencies No search report Art.17(2)(a)(ii) PCT Where the application has a description and/or claims and/or drawings which fail to comply with the prescribed PCT requirements to such an extent that no meaningful search is possible, then the ISA issues a declaration informing the applicant and the IB that no search report will be made. Partial search report Art.17(2)(b) PCT Where the unsearchable subject matter appears in certain claims and not others, then only the claims affected are excluded from the search and the search report indicates which claims have not been searched (a partial search report) and cites the relevant documents for the other claims according to Art.18 PCT. Art.17(2)(b) PCT & R43.9 PCT Where certain subject matter is searched and other subject matter is not searched, the search report must indicate which claims have been searched and which have not. Frequently, some claims relate in part to subject matter which cannot be searched and in part to subject matter which can be searched. In such cases, Art.17(2)(b) PCT is applied mutatis mutandis to part of a claim, see the example given in S&E-GL 9.37. Deficiencies rendering meaningful search impossible Art.17(2)(a)(ii) PCT applies where the International application fails to conform to the requirements of the PCT, in particular those of clarity, conciseness and support of the claims (Art.6 PCT) and sufficiency of disclosure (Art.5 PCT) to such an extent, that the ISA is not able to perform a meaningful search. The EPO has, since 2000, adopted a very strict policy with regard to this kind of application in particular in the areas of chemistry, biotechnology and telecommunications (see OJ 2000, 228). In these technical areas applicants often file applications with claims of such obscurity and great breadth that the examiner charged with the search is unable to determine what the claimed invention really is and consequently a search on the whole claimed scope is neither possible nor meaningful. These applications, often called "Complex Applications", usually warrant a partial search report limited to certain claimed subject matter which appears to represent the actual contribution which the applicant has made over the state of the art and this is usually derived from a dependent claim, or from the description. In cases of excessive numbers of claims, the examiner may refer to the description in an attempt to distil what has actually been invented (if anything). In the most serious cases no search report is issued at all (i.e. Art.17(2)(a)(ii) PCT is applied) and only a declaration replacing 117

the search report in accordance with Art.17(2)(a) PCT is issued. Risks for the applicant When Art.17(2) PCT is applied, the ISA can decide what to search and what not to search without any communication with the applicant [although the EPO has in place an informal consultation procedure, but this is not legally binding - OJ 2011, 327]. This is risky for the applicant, who cannot challenge this decision of the ISA. Furthermore, any subject matter excluded from the search need not be examined either in the WO- ISA or in PCT Chapter II (R66.1(e) PCT - the EPO makes strict use of this rule). The subject matter in question is only examined in as far as is necessary to demonstrate that it is so deficient that it cannot be searched or examined. This also carries the risk that the applicant might not be permitted to make amendments under Art.19 PCT - see paragraph below: This finding cannot be challenged in the International phase. However, the applicant may challenge the findings which underlie a limitation of the search in the national or regional phase. If the applicant successfully argues his case in examination at the EPO, the EPO may perform an additional search free of charge during examination proceedings (C-IV, 7.2). Art.19 PCT amendments not allowed PCT-AG I, 9.004 Where the ISA issues a declaration replacing the International search report under Art.17(2) PCT, the applicant is not permitted to make amendments under Art.19 PCT. For more details, see II.11. Challenge by applicant The applicant has no way of challenging the partial search report or the reasons behind it once it has been issued (unlike the case of lack of unity). Novelty overflow There are cases where a claim, although clear, is drafted in such a way that the examiner retrieves so many documents pertinent to the novelty of that claim, that to cite them all is not feasible (overflow). In such cases, it is not meaningful to cite all of them, since it is clear that such claims cannot be maintained in later examination proceedings. The applicant will have to limit his application to a dependent claim or other preferred embodiments present elsewhere in the application. Failure to file a sequence listing R5.2(a) PCT & R13ter.1(b) PCT Where the International application disclosures one or more nucleic acid or amino acid sequences and the applicant has not already provided this, the ISA can require the applicant to supply a paper sequence listing (where the application is filed at least in part, on paper). R13ter.1(a) PCT The ISA can also require the applicant to file an electronic sequence listing, where the applicant has not already supplied this. R13ter.1(d) PCT Where the applicant has failed to file a paper and/or electronic sequence listing and/or pay the required late furnishing fee on time, the ISA can limit the search to the extent that the search cannot be carried out without them [see S&E-GL 9.39 and II.13.1]. This possibility is used by the EPO, where a required electronic sequence listing is missing. Time limit for preparing a declaration of no search / partial search report R42.1 PCT The declaration of a "no search" according to Art.17(2)(a) PCT must be issued within the same time limit as the International search report [see II.6]. The WO-ISA in limitation cases S&E-GL 9.40 Where a declaration replacing the search report, or partial search report has been issued under Art.17 PCT, even if the ISA is not able to examine the issues of novelty, inventive step and industrial applicability, a WO-ISA is still prepared. For a "No Search" declaration replacing the search report, the WO-ISA simply addresses the issues which prevent an opinion on novelty, inventive step and industrial application from being given on the claimed subject matter. In the case of a partial search, the WO-ISA addresses novelty, inventive step and industrial application in as far as the application was searched (R66.1(e) PCT) and also addresses the issues which led to the search (and examination in the WO-ISA) being limited. 118