242794DOC EXAMINATION PROCEDURE 1 BASIC DIRECTION OF EXAMINATION THE

Implementing

242794.doc

EXAMINATION PROCEDURE

1. Basic Direction of Examination

The examination must be carried out with great care so that promptness, accuracy, fairness and transparency are secured. In particular, close attention should be paid to the following in the course of the examination.

(1) Examinations should be uniformly conducted in accordance with official guidelines for examinations such as the examination guidelines, the examination manuals, and the like.

(2) Regarding searches of prior art and determination of patentability of a claimed invention, efforts should be made to maintain and upgrade the quality of examinations.

(3) Examinations should be conducted so as to secure a completely mutual understanding between examiners and applicants (including their legal representatives, as termed hereinafter).

2.Basic Instructions

(1) Prior art search and determination of patentability should be carried out based on consideration of the trends of combined and advanced technology, while making full use of the shared knowledge of examiners.

(2) When there are any doubts about requirements for patentability, such as novelty, inventive step, etc. or about the description requirements of patent specifications during the examination, the examiners should notify the applicant and take positive action to fix the problem.

(3) In principle, the examiner should make a thorough study of an application in respect of all reasons for rejection referred to in Section 49 of the Patent Law before issuing the first notice for rejection.

(4) In principle, the reasons for rejection should be notified twice at most, and the first notice for rejection should be so served that the second notice for rejection communicates only such reasons for rejection as necessitated by an amendment which is made by the applicant in response to the first notice for rejection.

(5) The examiner's determination should be given to each of the claims since the invention for which a patent is sought is described in each claim of the application filed under the multiple claim system, and the exaimner should 'show thoroughly, clear and sufficient explanations of the reasons for rejection for each of the claims so as to enable the applicant to respond easily to the notice for rejection, for the reason that the amendment with regard to the claims is restricted after the final notice for rejection, and also should establish solid communication with the applicants through interview and other appropriate means.

(Note) When the examiner in charge has been replaced, notices for rejection or the details of the interview, once served or confirmed by the former examiner, should be respected in order to maintain the consistency of the examination. If the examiner in charge gives a decision which differs from that of the former examiner, (s)he should inform the applicant of the reasons thereof beforehand, if necessary, since this could possibly affect the interests of the applicant. Furthermore, if the examiner believes it necessary, the notice for rejection may be issued again.

3. Examination procedure

3.1 Subject of Examination

The subject of examination on patentability requirements in terms of novelty, inventive step, first-to-file, etc., among reasons for rejection under Patent Law Section 49, is a claimed invention. The finding of the claimed invention is made based on the statements of the claim.

3.2 Procedures

(1) Determination of whether the requirement of unity of invention is satisfied should be made first.

(2) Where the requirement of unity of invention is satisfied, the claimed inventions of the application should be examined in respect of the requirements for patentability of each claim in terms of novelty, inventive step, etc.

(3) If an application lacks unity of invention, the invention set forth in the first claim and those inventions having unity with said invention should be examined in respect of other requirements than the requirement for unity of invention. The claims lacking the requirement for unity of invention can be examined provided that no further work load is required.

(4) Requirements other than those for claims, such as requirements for description of specification are examined concurrently with the examination referred to in paragraphs (2) and (3) above.

(5) In the case of examination in (2) and (3) above, all the respective requirements should in principle be considered at the same time. For instance, even when the requirements for description of specification are not satisfied, examination should be made concurrently in respect of the requirement for patentability in terms of novelty, inventive step, etc., unless the description of the claimed invention is so obscure that the examination in respect of the requirements for novelty, inventive step, etc. cannot be made.

4. Prior Art Search

4.1 Subject of the Search

(1) The search should be directed to inventions set forth in the claims that meet the requirement for unity of invention. Notwithstanding the above, where the claimed inventions that do not meet the requirement for unity of invention can be examined without further work load, such inventions may be the subject of the search. The search should be directed to all the inventions set forth in the claims described in the patent specification as of the commencement of examination, ranging from a claim describing an invention of the broadest concept to one describing an invention of the narrowest concept.

 In a case where there are two or more alternatives involved in matters to define the invention and these alternatives are not similar in property or function, at least one more additional alternative similar in property or function should be chosen and searched. It is recommended that alternatives containing examples be chosen.

 In a case where a multiple dependent form claim is defined by referring to other proceeding claims and the other alternatives are not similar in property or function, then  is also applied.

(2) The examiner should have due regard to embodiments of the claimed invention (only those corresponding to constituent elements set forth in the claim).

(3) The search should cover the subject matter to which the claims are most likely to be directed after they have been amended, in addition to those to which the claims are directed, unless it requires excess work load in terms of search economy.

(4) Where the object, constitution and effects of the claimed invention are not sufficiently described such that a person skilled in the art to which the invention pertains can easily carry out the invention (in case of unduly broad claims), the examiner may exclude from a search effort a subject for which there is a reasonable ground that detailed explanation of the invention is not described sufficiently such that a person skilled in the art can easily carry out the invention.

(5) The search may be exempted for claims to which new matters have apparently been added, claims apparently directed to unpatentable subject matters, claims apparently involving non-statutory inventions, claims apparently involving industrially inapplicable inventions, and claims with descriptions so obscure that they failed to identify the inventions even with due regard to the description of the invention and drawings.

4.2 Scope of the Search

(1) The search, in principle, should consult all documents in the relevant technical fields to which each claimed invention pertains.

Relevant technical fields are:

A) technical fields which are determined in the light of such factors regarding the claimed invention as the fields of industrial application, the problems to be solved, and the matters to define the invention, and

B) technical fields which are determined in the light of such factors regarding individual elements of the claimed invention as their uses, their works, and their works, and their functions.

(2) Notwithstanding the above, the examiner may, for reasons of search economy, omit sections of the scope of the search as far as the likelihood of finding any relevant documents in such sections is not deemed high on the basis of his knowledge and experience in the relevant technical fields.

4.3 Search Strategy

(1) The examiner should carry out the search paying close attention to the pertinent official examination guidelines in terms of novelty, inventive step and first-to-file (Section 29^b^is and 39), and try to thoroughly discover all relevant prior art documents within the scope of the search.

(2) The examiner should give precedence to the technical fields in which the probability of finding relevant prior art documents is considered highest.

Normally, it would be appropriate to start the search with technical fields most relevant to embodiments of the claimed invention (only those corresponding to constituent elements set forth in the claim) and to gradually extend the search to other less relevant technical fields.

(3) Whether or not to extend the scope of search to the fields with less relevance should be determined depending on whether there is a possibility of finding relevant prior art documents which may reasonably deny patentability, while taking account of the search results already obtained.

(4) Searching "Specified Invention" first leads to an efficient examination of all the claimed inventions since it provides reference information for examination of novelty and inventive step of other claimed inventions.

In particular, where the search reveals the presence of novelty and inventive step related to Specified Invention, no further search will be required for other claims involving all indispensable constituent features of the Specified Invention and additional limitations because the inventions set forth in such claims are also deemed to have novelty and inventive step.

(5) The examiner should continuously evaluate the results of his search, and if necessary, reformulate the subjects of the search accordingly.

(6) When documents have been found clearly demonstrating lack of novelty in the entire subject matter of the claimed invention and its embodiments (only those corresponding to constituent elements set forth in the claim) described in the description of the invention, or when documents have been found showing prior art of which difference from the embodiment is difference in embodied means to solve a problem and is deemed very minor, the search may be stopped at this point without searching for the remainder of the scope of search as to the claim concerned.

(Note) In the application of paragraph (6), the search may be stopped when a document has been found clearly demonstrating lack of novelty in one or more embodiment (only those corresponding to constituent elements set forth in the claim) of the claimed invention, or when documents have been found showing prior art of which difference from the embodiment is difference in embodied means to solve a problem and is deemed very minor (hereinafter referred to as "documents denying novelty etc.").

Nevertheless, where the search can be conducted for other embodiments (only those corresponding to constituent elements set forth in the claim) without further work load, further search is desirable.

(7) The search may be stopped when the possibility of finding more relevant prior art documents becomes very low in the scope of the search.

(Note):

1) In the application of paragraph (7), the search should preferably be continued where there is a high possibility of discovering documents denying novelty, etc. of the embodiments of the claimed invention (only those corresponding to constituent elements set forth in the claim).

2) Where a claimed invention covers a wide range of chemical compounds expressed in Markush formula and has many embodiments, and where it is very difficult for the examiner to search the full scope of search without undue effort, under the assumption that all reasonable efforts were made to conduct the search, the search may be completed without carrying out the full scope of the search if either of the following conditions (i) or (ii) apply, the search may be terminated before finishing the full scope of the search.

(i)At least one prior art document denying novelty etc. must have been found with regard to at least one of the groups of chemical compounds which are expressed as alternatives in the claim and which involve chemical compounds indicated as working examples (namely the groups of chemical compounds expressed as specific alternatives corresponding to working examples).

(ii) A search of all the groups of chemical compounds shown as specific alternatives corresponding to the above examples has already been carried out, and at least one prior art document which denies the novelty, etc. has already been found.

4.4 Record of Search Results

Record of the search results which an applicant could use as a reference for making amendment in response to a notice for rejection, should be made with respect to A) technical fields searched (expressed using the International Patent Classification Symbols) and B) relevant prior art documents, and should be attached to the non-final notice for rejection after the first prior art search.

For instance, records should be made with respect to other than documents cited in the notice for rejection, documents deemed useful for determining the novelty and inventive step though not directly denying the novelty and inventive step of claimed inventions, and documents covering disclosures with a high probability of being incorporated in the claim after amendment.

The record of search results is not construed as constituting a reason for rejection.

(Notes): In a case where the search is terminated half-way in accordance with Note , for the above 4.3(7), such a note is described in “Records of search results”.

5. Notice for Rejection

In the Patent Law, a notice for rejection is classified into two categories in view of the provisions governing periods for effective amendments to and amendable contents of a specification and drawings.

One of the categories is a notice for rejection to be notified first to an applicant under Section 50 of the Patent Law (hereinafter referred to as the "non-final notice for rejection"; Patent Law Section 17^b^is(1)(i)). The other of the categories is the notice for rejection to be served last in the case where, after a notice for rejection had been served, further notice for rejection was served (hereinafter referred to as the "final notice for rejection"; Patent Law Section 17^b^is(1)(ii)).

After a final notice for rejection has been served, the amendable scope of a claim is restricted under Section 17^b^is(4) and 17^b^is(5) of the Patent Law.

A "non-final notice for rejection," in principle, is defined as a notice for rejection to be notified to an applicant with reasons for rejection for the first time. Therefore, in addition to a first notice for rejection, a subsequent notice for rejection served on the applicant for reasons for rejection not necessitated by amendments made in response to the first notice for rejection is also a "non-final notice for rejection."

A "final notice for rejection," in principle, means a notice indicating only reasons for rejection which is necessitated by amendments made in response to the non-final notice for rejection.

5.1 Non-Final Notice for Rejection

(1) The examiner should find and communicate all reasons for rejection at the time of serving the first notice for rejection.

(2) If an application lacks unity of invention, in principle, the examiner should find and communicate reasons for rejection concerning requirements other than the unity of invention with respect to the invention set forth in the first one of the claims and those claimed inventions having the unity with the said invention, unless the claims lacking the unity of invention can be examined without additional work load of examination.

A notice for rejection should be drafted in such a way as to distinguish between claims which have not been examined for requirements other than unity of invention and those examined for such requirements. All reasons for rejection which have been found should be described.

(3) All reasons for rejection concerning claims which satisfy the requirement for unity of invention should be notified concurrently at the time of serving the first notice for rejection as far as possible, except in the following cases:

1) A case where the description of the invention in an application is extremely obscure, to such an extent that it is difficult to examine requirements for patentability such as novelty or inventive step;

In such a case, the reasons for rejection related to requirements for description of specification, etc. alone should be notified, expressly stating that the requirements for patentability in terms of novelty, inventive step, etc. have not been examined.

2) Cases where it is apparent that new matters have been added to the claim, where the claim is apparently directed to unpatentable subject matter, where the subject matter set forth in the claim is apparently a non-statutory invention, or where the claimed invention is apparently not industrially applicable;

In such cases, the reasons for rejection concerning these cases alone should be notified, expressly stating that the requirements for patentability in terms of novelty, inventive step, etc. have not been examined.

(Explanation)

Only when an application is deemed to fall under "apparently" any of the cases mentioned above, an examination of the requirements for patentability in terms of novelty, inventive step, etc. may be exempted because a determination on cases involving uncertainty might be changed later even without amendments.

3) A case where any claimed invention apparently fails to meet requirements for patentability such as novelty or inventive step, and where there are only minor descriptive deficiencies in the specification or drawings of which correction would not violate Section 17^b^is;

In such a case, it is not necessary to point out reasons for rejection related to such minor descriptive deficiencies when referring to the reasons for rejection concerning the requirements for patentability with regard to the claim in the first notice for rejection.

(Explanation)

In such a case, it is expected that minor descriptive deficiencies in the specification and drawings may be corrected by amendments in response to the notice for rejection to the effect that the claimed invention fails to meet the requirements for patentability. Even where the descriptive deficiency remains uncorrected and is pointed out later in the final notice for rejection, an amendment in response to the final notice is permitted if it is an amendment to the claim which is deemed as "correction of errors in the description" or "clarification of an ambiguous description" under Section 17^bis(4)(iii) and 17^bis(4)(iv) or an amendment to the description of invention. They are then processed in the manner as described above.

(4) Except for reasons for rejection which cannot be determined on the basis of individual claims (e.g. unity of invention, insufficiency of overall description in the specification), the reasons for rejection due to lack of novelty, or inventive step, etc. should be indicated for each claim in order to distinguish between claims bearing reasons for rejection and those which do not.

(5) The examiner should indicate reasons for rejection clearly and thoroughly to assist the understanding of applicants, paying close attention to the following:

1) Cited relevant prior art

(i) Reference documents should be identified so as not to cite unnecessary parts as reasons for rejection. Therefore, the particular passage relied upon, if any, should be specified.

(ii) When determining relevant prior arts to be cited in the notice for rejection out of the prior arts discovered, prior arts most relevant to the claimed invention should be chosen, taking its embodiments into account.

(iii) Citations of two or more prior arts with the same or similar contents against a single claim could incur extra cost and time for an applicant. Therefore, no excessive citations should be attempted, more than those which are essential to logically justify the reasons for rejection.

 In a case where the description of the specifications and drawings violate the provision of the Patent Law Section 36 (4) or 36 (6), the notice for rejection should specify which part of the application is deficient and the specific reasons therefor.

(6) In a case where prompt and exact examination is difficult, notification by an examiner can be given under the provision of the Patent Law Section 194(1) (Submission of document, etc.), and an applicant can be required to submit of documents and other articles necessary for examination.

For example,

 When it is difficult to identify the claimed invention because of the confusing make-up of the invention or the overwhelming volume of the specifications, an examiner can require the applicant to submit a reference to clarify the make-up of the invention, such as a document to explain which part of each example corresponds to each function for defining the invention, or papers that briefly explain the gist of the invention.

 In a case where it is difficult to understand a written argument submitted by the applicant after notification of reasons for refusal, and it is agreed that such difficulties will have a significant effect on whether the application for patent is approved or not, an examiner may require the applicant to submit a document that explains the assertion in written argument more clearly.

 An examiner may require the applicant to provide models, samples or certified experimental results, together with a notice of rejection within the designated time limit if they are necessary for examination.

(Note):

“if they are necessary for examination” means a case in which detailed description of the invention does not explain the invention in a manner sufficiently clear and complete for the examination to be carried out by a person skilled in this area, because operations or effects of the invention described in the claim can not be confirmed.

In this case, without requiring the applicant to submit samples individually, an examiner will only notify of the reasons for refusal, stating that detailed description of the invention does not describe the invention in a manner sufficiently clear and complete for it to be examined by a person skilled in this area, because operations or effects of the claimed invention can not be confirmed, with the proviso that the above will not be applied if operational effect is confirmed by submission of samples.

In a case where an examiner judges that samples, etc. of the patent application for which the reasons for refusal have already been notified are necessary for examination as the result of receiving written argument, the examiner may require the applicant to submit the samples individually.

In a case where amendment of the specifications or drawings makes the detailed description of the invention sufficiently clear and complete for it to be examined by a person skilled in the area, or this amendment is merely used as reference in examination, samples will not be required to be submitted.

(6) Suggestion of amendment, etc.

Suggestions should be made on amendments or divisions of the application when notifying reasons for rejection if it is expected to facilitate a response by the applicant to the notice and thereby contribute to a prompt and appropriate examination. Notwithstanding, it must be noted that such suggestions do not produce any legal effect, and that the manner of describing claims is to be left to the applicant's own desires and responsibility.

5.2 Final Notice for Rejection

A "final notice for rejection" is defined as the last notice for rejection in the case where, after a notice for rejection had been notified, a further notice for rejection was notified. (Section 17^b^is(1)(ii) of the Patent Law) In principle, the "final notice for rejection" notifies only the reasons for rejection which are necessitated by amendments made in response to a previous non-final notice for rejection.

Whether a given notice is to be deemed as the final or non-final notice for rejection should be determined under paragraphs 5.2.1 and 5.2.2 below.

5.2.1 Cases Which Should Be Final Notice for Rejection

(1) A notice for rejection which notifies only the reasons for rejection necessitated by amendments made in response to a previous non-final notice for rejection.

(Explanation)

In the second or any subsequent notice for rejection, a notice which communicates only the reasons for rejection which are necessitated by amendment made in response to a previous non-final notice for rejection means that the examiner is required to further examine the contents of the application which have been changed by the amendments after the initial examination.

Thus, such a notice should be deemed as the final notice for rejection.

"Reasons for rejection necessitated by amendments" refers to the following:

(i) Reasons for rejection necessitated by amendments to specification or drawings (or a claim, provided that the examination of the claim has been made and that the statement to that effect is indicated in the non-final notice for rejection) made in response to the non-final notice for rejection.

(ii) Reasons for rejection of new claims added by amendments made in resp6nse to the non-final notice for rejection.

(Note 1): The amendment defined herein does not include correction of such minor errors in descriptions that do not necessitate changes in the results of the examination, such as changes between rejection and allowance, changes of reasons for rejection, etc.

(Note 2): Where notifying both the reasons for rejection necessitated by the amendment in response to the first notice for rejection and reasons for rejection not necessitated by the amendment at the same time, such a notice should be deemed as the non-final notice for rejection, but not as the final notice for rejection.

(Note3): In a case where new reasons for refusal based on prior art references are found on a claim terminated halfway during the search process in accordance to (Note) in 4.3(7), after the above reasons for refusal were dissolved by amendment, as a general rule these are given as the final notice for rejection.

(Examples)

A) With regard to description of the invention:

a. A case where new matters such as new examples have been introduced by amendments in response to the non-final notice

b. A case where the description has become obscure due to amendments in response to the non-final notice

B) With regard to claims:

a. A case where new reasons for rejection concerning lack of novelty or inventive step have become necessary to be notified due to amendments by which new technical elements have been added to examined claims

b. A case where new reasons for rejection concerning lack of novelty or inventive step have become necessary to be notified due to amendments by which claims have been broadened, altered or restricted by means of deleting or limiting technical elements in examined claims

c. A case where new reasons for rejection concerning lack of novelty, inventive step have become necessary to be notified due to amendments by which new unexamined claims have been added

d. A case where new matters have been introduced into examined claims by amendments, or where descriptions of the examined claims have become obscure due to amendments

e. A case where amendments have been made in a manner to conflict with the requirement for unity of invention

f. A case where, when amendments are made to a claim to which the reasons for rejection based on requirements for description of specification alone have been notified, with the statement to the effect that requirements for patentability such as novelty or inventive step have not been examined because the description of an application are extremely obscure, and examination on such patentability is difficult to be carried out, reasons for rejection concerning requirements for patentability are subsequently found with respect to the amended claim

g. A case where, when amendments are made to a claim to which the reasons for rejection based on the grounds that new matters have been added to the claim have been notified with the statement that the requirement for patentability such as novelty or inventive step has not been examined because it is clear that new matters are added to the claim and then, reasons for rejection concerning requirements for patentability are subsequently found with respect to the amended claim

(2) A communication notifying only such a reason for rejection as mentioned below should be deemed as a final notice for rejection.

(i) A case where, when reasons for rejection were notified after only a part of the claims was examined and other claims were not examined in terms of patentability due to lacking the unity of invention, and though reasons for rejection (including violation of the requirements for unity of invention) were overcome due to amendments to the claims, but the said other unexamined claims are still maintained in the application without being deleted or divided to a new divisional application, reasons for rejection are subsequently found with respect to such unexamined claims.

(Explanation)

Such a procedure should apply since it is practically the same as the further examination of new claims added by amendments.

(ii) A case where, when only reasons for rejection concerning patentability such as novelty, inventive step, etc. were notified, but not reasons for rejection concerning the description requirements, because only minor descriptive deficiencies were found other than reasons for rejection concerning patentability, and correction of such descriptive deficiencies are considered not to conflict with the provisions of Section 17^b^is, for example, amendments in the claims or the description of the invention admitting as those falling under Section 17^bis(4)(iii) and (iv), such as correction of errors in the description or clarification of an ambiguous description, and then, the specification remain unamended and reasons for rejection regarding requirements for description are

not overcome.

5.2.2 Cases Which Should Not Be Final Notice for Rejection

(Cases Which Should Be Non-Final Notice for Rejection)

(1) First notice for rejection

The first notice for rejection always falls in the non-final notice for rejection.

(2) Second or any subsequent notices for rejection are the non-final in the following cases:

(A)A case where the notice is not necessitated by amendments after the non-final notice for rejection:

Where a notice covers other than reasons for rejection necessitated by the amendment in response to the non-final notice for rejection, such a notice should be deemed as the non-final notice for rejection, but not the final notice (except those falling under the above-mentioned 5.2.1 (2)).

The followings are the non-final notice for rejection.

1) Reasons for rejection against a claim or a part of specification or drawings left unamended after the non-final notice for rejection, which the examiner should have pointed out in the non-final notice, may not be notified as the final notice for rejection, except for those to which paragraph 5.2.1 (2) above applies.

(Examples)

a. A case where reasons for rejection, such as descriptive deficiencies in the specification or drawings or lack of unity of invention, were overlooked upon serving the non-final notice for rejection regarding lack of novelty or inventive step, and therefore, any substantial amendments were not made to the deficiencies after the first notice, but where such reasons for rejection were found later, except for cases falling under the above-mentioned 5.2.1 (2) (ii).

b. A case where a reason for rejection was subsequently found with regard to a claim for which a statement that no reason for rejection was found had been notified in the first notice for rejection, though no amendment was made.

2) Where there is no amendment in response to the non-final notice, any subsequent notice changing the reason for rejection from the non-final notice may not be deemed as the final notice for rejection.

(Examples)

A case where there was no amendment in response to the first notice for rejection concerning lack of novelty or inventive step, but the reason for rejection was withdrawn either due to the applicant's written argument or at the examiner's own volition, and new reason for rejection is notified, citing new different prior art.

(Explanation):

In the case of paragraphs 1) and 2) above, it would be inappropriate to deem the cases as the final notices for rejection because these notices involve reasons for rejection which have already existed and should have been notified upon serving the non-final notice but were overlooked by the examiner and because no further examination is therefore to be newly required.

3) Even where there are amendments to a claim on which reasons for rejection such as lack of novelty or inventive step were notified in the non-final notice for rejection, any subsequent notice may not be deemed as the final notice for rejection as in the case of paragraph 2) above if such amendments to the claim does not change some of the technical elements described in a preamendment claim and if such notice for rejection is served citing new different prior arts in lieu of the prior art already cited solely for the unchanged technical elements.

However, this does not apply to a case where such technical elements are substantially changed due to amendments to other technical elements in the claim. This is because such substantial changes are equivalent to amendments to these technical elements.

(Explanation):

In this case, in view of the fact that no change was made to some of the technical elements and a notice for rejection had been served citing prior art irrelevant to the unchanged technical elements, it would be severe on applicants to treat the subsequent notice for rejection as the notice for rejection necessitated by amendments. The above procedure should thus be applied.

4) In the case of notifying reasons for rejection not necessitated by amendments in response to the non-final notice for rejection together with reasons for rejection necessitated by amendments in response to the non-final notice for rejection, such a notice should not be deemed as the final notice for rejection.

(B) A case where a notice for rejection should be non-final regardless of whether amendments were made or not after the non-final notice for rejection:

In the case of serving a notice for rejection which notifies only reasons for rejection necessitated by amendments made in response to the non-final notice for rejection, such a notice is, in principle, deemed as the final notice for rejection. The following notice, however, should be deemed as a non-final notice and not as the final notice.

1) In the event that a non-final notice for rejection was served without carrying out examination of requirements for patentability such as novelty or inventive step despite the absence of rational reasons justifying this exemption from examination (including absence of expressing statement that examination was made), and that reasons for rejection concerning patetability are to be notified in a subsequent notice, such subsequent notice should be deemed as the non-final notice for rejection, regardless of presence or absence of amendments in response to the previous notice.

(Note): Presence of rational reasons means that provisions under 5.1. (3) 1) and 2) are applicable to the case.

(Examples):

a. Where an only descriptive deficiency in the specification or drawings was pointed out in the first notice without examining the patentability such as novelty or inventive step, a notice for rejection regarding for patentability citing prior art is to be non-final regardless of whether amendments were made to the claims or not after serving the first notice for rejection, except for claims which were extremely obscure to such an extent that it is difficult to examine the requirements for patentability. (Refer to the above-mentioned 5.1 (3) 1) and examples B) f. in 5.2.1 (1).)

b. Where reasons for rejection regarding patentability were found in a claim for which completion of examination had not been indicated in the first notice for rejection, a notice of such reasons should be non-final regardless of the presence or absence of amendments in response to the first notice.

2) Where an implication of non-discovery of reasons for rejection had been made with respect to a certain claim in the non-final notice, and, despite the implication, the claim was so amended as to restrict, then, any subsequent notices for rejection should not be final if such notices notify reasons for rejection regarding requirements for patentability such as novelty or inventive step (except reason for rejection under Section 39) in respect of the particular claim.

(Example):

The case where a notice for rejection for lack of inventive step is subsequently served due to subsequent discovery of a new prior art with respect to a claim for which a statement implying the compliance with the requirements for patentability was formerly made in the first notice for rejection, and with regard to which as amendment was made to restrict, despite the implication.

(Explanation):

In either case of 1) and 2) above, the requirements for patentability such as novelty or inventive step were not examined upon serving the non-final notice for rejection, or the specific reasons for rejection were overlooked. In these circumstances, serving a subsequent notice for rejection regarding patentability in terms of novelty or inventive step as the final notice would be severe on applicants. The above procedure should thus be applied.

5.2.3 Notes on Final Notice for Rejection

(1) The final notice for rejection should be served according to the following procedures:

1) When serving the final notice, the notice shall contain the indication to the effect that it is "final" and the reason thereof. In the absence of such an indication, the notice may not be deemed as the "final notice for rejection."

2). The determination on requirements for patentability such as novelty or inventive step should be given with regard to each claim involved.

3) Where a written argument has been submitted by the applicant, subsequent notice should take such an argument into account, and expressly state relevant reasons for rejection clearly and thoroughly.

In particular, since the amendable scope is restricted with regard to the claim after the final notice 'has been served, the examiner should clearly specify the claimed invention having reason for rejection and, if deemed necessary, suggest permissible amendments in order to facilitate response to the notice.

(2) Furthermore, the final notice should be drafted by applying the relevant provisions of the above-mentioned 5.1 (non-final notice for rejection).

6. Interview with Applicants

(1) The examiner should positively respond to a request from an applicant for an interview so as to contribute to a prompt and appropriate examination by developing mutual understandings between the examiner and the applicant.

(2) To ensure that the interview procedures are transparent, the contents and results of discussions in the interview should be recorded and stored electronically for public inspection.

(3) Where the examiner communicates with an applicant by telephone, facsimile, etc., relevant records should be maintained and offered for public inspection.

7. Submission of Written Arguments and Amendments

7.1 Applicants' Responses

(1) Applicants may present not only written arguments and amendments, but also any other documents, including certificates on the result of experiment, as evidence that reasons for rejection have been overcome.

(2) Where an applicant believes that the examiner's determination that a given notice is the "final notice for rejection" is wrongful, the applicant may argue his case in a written argument.

(3) Where an applicant has filed an amendment, the applicant may explain that the amendment is acceptable by clarifying the relation between the claims before and after the amendment.

7.2 Examiner

(1) The examiner should carefully review the details of the written arguments, amendments, etc. and determine if the earlier notice for rejection can be maintained.

Especially, when a written argument is submitted without any amendment in response to the notice for rejection, the examiner should conduct a careful review of the written argument and then determine if the reason for rejection specified in the notice can be maintained.

(2) Where an amendment is submitted in response to a non-final notice for rejection, the subject of the examination shall be the specification and drawings as amended. If new matters are introduced by an amendment in response to a non-final notice, relevant reasons for rejection should be notified the reason for rejection, if any.

In a case where there are other reasons for refusal, those reasons will be notified at the same time.

(3) Handling of written arguments and certificates on the result of experiment Although written arguments, certificates on the result of experiment etc. can not be substituted for the description of the invention in the specification, they can be used by applicants to explain or prove that the description in the specification as filed is correct and adequate. The contents should, therefore, be thoroughly considered using the following guidelines.

(4) Refer to paragraph 8. for details of procedures for handling amendments made in response to the final notice for rejection.

8. Examination of Amendments in Response to the Final Notice for Rejection

(1) The provisions of Section 17^b^is(4) are designed to ensure the results of earlier examinations are used effectively for examining an application amended in response to the final notice for rejection in order to establish examining procedures which grant patents promptly and appropriately, while considering the essential purpose of the patent system to fully protect the rights to the invention.

Since amendments which violate the provisions of Section 17^bis(4), if any, do not cause substantial problems to the contents of an invention, unlike addition of new matter, such amendments must not be retroactively dismissed after the examiner's decision of rejection or grant a patent despite a subsequent discovery that a violation under Section 17^b^is(4) has been overlooked.

In this respect, Section 17^b^is(4) differs from Section 17^bis(3) in the characteristics of the provisions.

Consequently, when applying the provisions of Section 17^b^is(4), reasonable consideration should be given to the essential purport of the Law, and excessively strict application of this provision should be avoided if examination of an application amended after the final notice for rejection can be promptly carried out by effectively using the results of earlier examination and the amended invention is deemed worthy of patent protection.

(2) Taking into account an applicant's argument by means of written argument and/or interview, the "final notice for rejection" is reviewed for propriety.

When the applicant's contention that the notice should have been a non-final notice and not the final one is deemed justified, the provisions of Sections 17^b^is(4) and 17^b^is(5) and Section 53 of the Patent Law should not be applied, and no amendment should be dismissed because these provisions are concerned with the final notice for rejection. (In this instance, note that violation of provisions of Section 17^bis(3) constitutes a reason for rejection.)

When reasons for rejection are not overcome or when new reasons for rejection have been found with regard to an application whose amendment has been accepted according to the above, the examiner should serve either the "final notice for rejection" or "the examiner's decision of rejection" unless otherwise deemed to be a "non-final notice," if the applicant asserts that the former notice should have been non-final and the applicant made the amendment on the preposition of that assertion.

In other cases, "non-final notice for rejection" should be served to applicants once again.

(3) Where it is deemed that a notice given as the final notice is appropriate, the amendments should first be reviewed for lawfulness.

Then, when any violation of the provisions of Sections 17^b^is(3) through 17^b^is(5) is discovered prior to publication of the examined application, the amendment should be dismissed by the examiner's decision under Section 53 of the Patent Law.

(4) The following amendments should be dismissed.

1) Amendments to specification and drawings which introduce new matters (Section 17^b^is(3), including cases where new matters mentioned in the final notice for rejection remain undeleted).

2) Amendments to a claim which do not aim at the following (a) to (d) (Section 17^b^is (4)):

(a) Deletion of a claim (Section 17^b^is(4) Item 1);

(b) Restriction of the scope of claim, provided that the amendment limits all or some of the matters necessary for defining the invention set forth in a claim, so long as the amended claim maintains the same field of industrial application for the invention and the same problems to be solved by the invention as those of the invention before the amendment (hereinafter referred to as "restriction of a claim with limitation of features." Item 2);

(d) Clarification of an ambiguous description, provided that the amendment is related to the matters mentioned in the reasons for rejection (Item 4).

3) Amendments to restrict a claim with limitation of features which do not make the

amended claimed invention patentable (Section 17^b^is(5)).

(5) The procedures of examining amendments are as follows:

1) Each matter of amendments made in response to the final notice for rejection is determined separately for whether or not it introduces new matter to the specification or drawings. Each claim is respectively examined for new matter.

2) An amendment to claims is not evaluated on whether or not it violates Sections 17^b^is(4) and 17^b^is(5) if such claims have been found to introduce new matters based on the decision of paragraph 1) above. For other claims, amendments to respective claims are evaluated on whether or not they satisfy items of Section 17^b^is(4)(i) to (iv). Where new matter has been introduced only to the description of the invention but not to a claim, the examiner should deter' mine whether or not amendments are aimed at items of Section 17^b^is(4)(i) to (iv) for every amended claim.

3) Where an amendment is found to fall within Section 17^b^is(4)(ii) (restriction of a claim with limitation of features) through the determination in paragraph 2), above, under Section 17^b^is(4)(i) to (iv), the amendment should be further determined as to whether or not it satisfies the requirements prescribed in Section 17^b^is(4).

4) Where amendments are found to be unacceptable through the determination in accordance with paragraphs 1) to 3) above, such amendments should be dismissed by a decision indicating all unacceptable amendments.

(6) Application of provisions of Section 17^b^is(3) and Section 53 Provisions in Section 17^b^is(3) and Section 53 dismiss the following amendments.

1) An amendment introducing new matter in response to the final notice for rejection, and

2) An amendment which leaves undeleted new matter pointed out in the final notice for rejection.

If a new matter which has been included but has not been pointed out in the final notice for rejection remains undeleted even after an amendment, such amendment should not be dismissed and a notice for rejection should be served for the patent application, stating that the amendment introduced new matter.

(7) Application of provisions of Section 17his(5) and Section 53

1) Inventions to which the provisions are applicable

Section 126(3) (setting forth a provision that an invention constituted by the features described in the amended claim must be one which could have been patented independently at the time of filing of the patent application) is applied mutatis mutandis with necessary modifications in Section 17^b^is(5). The Section should be applied only to a case where an amendment falling within Section 17^bis(4)(ii) (restriction of a claim with limitation of features) was made. Accordingly, Section 17^b^is(5) should not be applied to an invention set forth in an unamended claim, nor to an invention set forth in a claim to which only correction of errors in the description (Section 17^bis(3)(iii)) or clarification of an ambiguous description (Section 17^bis(3)(iv)) has been made.

2) Provisions for determining whether the amended invention is patentable Provisions applied to determine whether or not a claimed invention with amendments, which restrict the claim with limitation of features, is patentable independently at the time of filing of the patent application, should be limited to Section 29, 29^b^is, 32, 36(4) and 36(6), and 39(1) to (4).

3) Notes

A) Provisions of Section 17^bis(5) and Section 53 dismiss amendments in the following cases:

(i) A case where reasons for rejection under provisions mentioned in paragraph 2), above, which have been pointed out in the final notice for rejection, has not been overcome even after amendment, or

(ii) A case where new reasons for rejection under provisions mentioned in paragraph 2), above, are discovered with regard to an amended claimed invention, though reasons for rejection against an invention set forth in the pre-amended claim were overcome by amendment to restrict the claim with limitation of features. For instance, 1) a case where reasons for rejection citing new prior arts or prior applications must be notified again, because the amendments were made so as to restrict a claim with limitation of features, and 2) a case where descriptive deficiencies are newly caused by the amendment.

(Explanation)

Where reasons for rejection indicated in the final notice for rejection can be maintained even after the amendment to restrict a claim with limitation of features is made, the apparent purport of the Patent Law is not to accept such an amendment and reject the amended application, but to dismiss such an amendment, as in the case of finding new reasons of rejection for amended claimed inventions, in order to ensure equitable treatment of applications. Therefore, the above procedure should be applied.

B) Notes on application of each provision

(a) Where requirements of Section 36 are not satisfied:

(i) Where a claimed invention, with amendments to restrict a claim with limitation of features, fails to meet the requirements under Section 36, such an amendment should be dismissed on the grounds of contravention of provisions of Section 36.

(ii) However, in a case where descriptive deficiencies still remain uncorrected in the specification or drawings with regard to an amended claimed invention, or, new descriptive deficiencies are caused by the amendment, although the invention relating to the claims meets the requirements of patentability such as novelty, inventive step, etc., if such descriptive deficiencies are so minor that they can be corrected by simple amendments and the description requirements of the specification can be satisfied and that the claimed invention can be patented, the examiner should give the applicant the further opportunity for further amendment by serving the final notice for rejection against such descriptive deficiencies after acceptance of the amendment.

(b) Where patentability requirement is not met under Sections 29, 29^b^is or 39:

(i) In principle, prior art cited in the final notice for rejection should be cited at the time of dismissal of amendment.

Notwithstanding the above, an additional citation of a new prior art, due to restriction of a claim with limitation of features, is allowed.

(ii) Furthermore, an amendment can be dismissed by indicating reasons why an application is not patentable by referring only to a prior art which was not cited in the final notice for rejection. In such a case, however, the prior art cited in the final notice for rejection may not necessarily be appropriate. It is therefore preferable to reconsider whether the final notice is pertinent and valid in accordance with paragraph 8.2, below, "Handling of applications after dismissal of amendments."

C) Upon deciding to dismiss an amendment, reasons for dismissal are given for each claim and for all the amendments to restrict a claim with limitation of features determined as unlawful under (5) above.

8.1 Handling of Applications after Acceptance of Amendments

(1) When amendments made in response to the final notice for rejection meet the requirements defined in Section 17^b^is(3) to 17^b^is(5), the examiner should accept the amendments and determine whether or not reasons for rejection pointed out in the final notice for rejection other than the reasons for rejection considered under Section 17^b^is(5) (and Sections 29, 29^b^is, 32, 36 or 39) have been overcome on the basis of the amended specification or drawings.

When such reasons for rejection have been overcome and no further reasons for rejection have been found, the examiner shall make a decision to grant a patent. When such reasons for rejection have not been overcome, the examiner should make a decision of rejection.

(2) Where, although the reasons for rejection stated in the final notice for rejection have been overcome by the amendment made, new reasons for rejection are found, such new reasons for rejection should be notified. Such notice constitutes a final notice for rejection if the notice should be so determined in the light of paragraph 5.2, above, for instance, in a case where such new reasons for rejection are necessitated by amendments made in response to the first notice for rejection etc. In other cases, a notice of such new reason for rejection should be a non-final notice for rejection.

(3) When a new notice for rejection has been served after acceptance of an amendment in response to the final notice for rejection, such an amendment shall not be retroactively dismissed even if the unacceptability of the amendment is discovered afterwards.

However, when it is found later that new matter has been introduced, the reason for rejection therefor should be notified.

(Explanation)

According to Section 53, 159(1) and 163(1) of the Patent Law, when unlawfulness of an amendment in response to the final notice for rejection is discovered, the patent registration or the examiner's decision of rejection, such an amendment shall not be retroactively dismissed, but shall be accepted in order to avoid further examination.

When an amendment in response to the final notice for rejection which has been served is found unacceptable after notifying new reasons for rejection subsequent to acceptance of such an amendment in response to the final notice for rejection, such cases should be processed using the same procedures along with this purport.

8.2 Handling of Applications after Dismissal of Amendments

(1) Since the dismissal of an amendment leaves an application unamended, it is the reasons for rejection as pointed out in the final notice for rejection which was given for the pre-amended application that should be reviewed.

(2) The written argument presented by an applicant should be considered upon reassessment of the correctness of reasons for rejection pointed out in the final notice for rejection.

(3) Where the examiner finds it inappropriate to make an examiner's decision of rejection on the basis of the reasons pointed out in the final notice or to make a decision to grant a patent, a further notice for rejection should be served, citing better prior art in consideration of the prior art which was referred to as the reason for dismissing the amendment.

In this instance, a determination is made whether or not such a further notice should be deemed as the final or the non-final notice for rejection pursuant to the provisions of paragraph 5.2, including a determination of whether or not the new reasons for rejection are necessitated by amendment in response to the non-final notice for rejection. Furthermore, since the reasons for rejection are notified concurrently with the decision of dismissal of the amendment, it is necessary to expressly state that such reasons for rejection apply to the pre-amended application when drafting the notice for rejection.

9. Examiner's Decision of Rejection

(l) When the examiner deems that the notified reasons for rejection have still not been overcome even after reviewing the written argument or amendments in response to the notice for rejection, the examiner should make a decision of rejection regardless of whether or not the notice for rejection is a final one or a non-final one.

(2) In drafting an examiner's decision of rejection, all claims for which the notified reasons for rejection have still not been overcome should be indicated.

(3) The examiner should expressly state all the reasons for rejection which have still not been overcome in a written decision of rejection, together with the examiner's judgment on the applicant's written argument and the amendments.

(4) The examiner should refrain from making an unreasonable rejection, such as those with additional citation of a new prior art only to justify the notice for rejection served earlier.

In an examiner's decision of rejection, the examiner should not cite new prior art as a reason for rejection, except well-known or commonly used art.

10. ZENCHI Examination

(Reexamination Prior to Appeal Examination)

This paragraph sets forth procedures applicable to ZENCHI.

(1) In ZENCHI examination, the examiner should determine whether or not an amendment made at the time of demand for the appeal complies with the provisions of Section 17^b^is(3) to 17^b^is(5) of the Patent Law.

(2) An amendment made at the time of demand for appeal should be examined on the basis of the procedures applied to amendment in response to the final notice for rejection.

Specifically, the examination should be carried out in accordance with the provisions of paragraph 8 (Examination of Amendments in Response to the Final Notice for Rejection).

In this instance, the "final notice for rejection" in that paragraph should be replaced with "examiner's decision of rejection," and "amendments in response to the final notice for rejection" should be replaced with "amendments made at the time of demand for the appeal," and "reasons for rejection mentioned in the final notice for rejection" should be replaced with "reasons for examiner's decision of rejection."

(3) The purpose of ZENCHI examination is to re-assess the correctness of the examination of applications. ZENCHI examination not only examines the reasons for examiner's decision of rejection, but also examines if an application contains other reasons for rejection.

(4) Cases where an amendment made at the time of demand for appeal is not to be dismissed:

1) The examiner should determine whether or not the reasons for rejection have been overcome based on the amended specification and drawings, and the examiner should consider the reasons for demanding the appeal.

2) Where the examiner considers that reasons for rejection can be maintained despite amendments made at the time of demand for appeal, the original decision should be upheld, and the examiner should present the results of the examination to the Commissioner of the Patent Office.

All unovercome reasons for the examiner's decisions of rejection should be expressly indicated and explained in ZENCHI report, together with new reasons for rejection discovered later.

3) Where reasons for rejection have been overcome due to amendments made at the time of demand for appeal;

(i) A decision of publication of the examined application must be made provided that new reasons for rejection have not been found, or

(ii) Relevant reasons for rejection should be notified upon discovery of reasons for rejection which differ from the reasons indicated in the examiner's decision of rejection.

4) When notifying the reasons for rejection, specific reasons should be indicated for each claim so as to clearly distinguish between a claim with reasons for rejection and a claim without reasons for rejection, in accordance with paragraph 5 above (Notice for rejection).

(5) Cases where an amendment made at the time of demand for appeal is to be dismissed:

1) In ZENCHI examination, no decision shall be made to dismiss amendments under Section 53 of the Patent Law applied mutatis mutandis with necessary modifications in lieu of Section 163, unless making a decision to grant a patent.

2) Where any amendment made at the time of demand for appeal is to be dismissed, the correctness of the reasons for an examiner's decision of rejection of pre-amended applications should be reviewed.

3) The details of the reasons for demand for appeal should be considered when reviewing the correctness of the reasons for an examiner's decision of rejection.

4) When it is deemed appropriate to uphold the original decision, the results of the examination should be presented to the Commissioner of the Patent Office. The ZENCHI report should state the reasons for upholding the original decision together with reasons justifying the dismissal of the amendment made at the time of the demand for appeal.

Furthermore, new reasons for rejection if found later should also be stated.

5) Where the original decision cannot be upheld but a new reasons for rejection for pre-amended applications is found, the results of the examination should be reported to the Commissioner of the Patent Office. The ZENCHI report should state the new reasons for rejection, together with reasons justifying the dismissal of the amendment made at the time of demand for the appeal.

6) When the original decision cannot be upheld and no other reasons for rejection are found, a decision to grant a patent should be made after making a decision on the dismissal of the amendment.

(6) After reasons for rejection have been notified in ZENCHI examination, an examination should be conducted in accordance with provisions of the above-mentioned "6. Interview with Applicants, etc.;" "7. Submission of Written Arguments and Amendments" and "8. Examination of Amendments in Response to Final Notice for Rejection."

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