Medicinal Invention (Draft)

(Provisional Translation) Examination Guidelines for Patent and Utility Model Part VII: EXAMINATION GUIDELINES FOR SPECIFIC TECHNICAL FIELD Chapter 3: Medicinal Invention 1. Description Requirements of a Description and Claims ……………………………………………………1 1.1 Claims ………………………………………………………………………………………………………1 1.1.1 Section 36(5) of the Patent Law …………………………………………….………………………………1 1.1.2 Section 36(6)(ii) of the Patent Law …………………………………………………………………………1 1.2 Detailed Description of the Invention …………………………………………………………………………2 1.2.1 Enablement Requirement …………………………………………………………………………………2 2. Requirements for Patentability ………………………………………………………………………………4 2.1 Industrial Applicability ………………………………………………………………………………………4 2.2 Novelty ………………………………………………………………………………………………………4 2.2.1 Basic Method of Determining whether a Claimed Medicinal Invention is Novel ……………………………4 2.2.1.1 Method of Judging Novelty ………………………………………………………………………………4 2.3 Inventive Step …………………………………………………………………………………………………8 2.3.1 Inventive Step regarding Medicinal Invention ………………………………………………………………8 2.3.1.1 Example of Concrete Practice Regarding Judgment of Inventive Step ……………………………………8 2.4 Patent Law Section 29bis ………………………………………………………………………………………9 2.4.1 Application of Patent Law Section 29bis regarding Medicinal Invention …………………………………10 2.4.1.1 Example of Concrete Practice Regarding Judgment of Patent Law Section 29bis for Medicinal Invention…………………………………………………………………10 2.5 Patent Law Section 39 ………………………………………………………………………………………10 2.5.1 About Application of Patent Law Section 39 regarding Medicinal Invention ……………………………10 2.5.1.1 Example of Concrete Practical Regarding Judgment of Patent Law Section 39(1), (3) for Medicinal Invention…………………………………………………………………10

3. Examples……………………………………………………………………………………………………11

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Chapter 3: Medicinal Invention In the present chapter, explanation will be made mainly for a matter which requires peculiar judgment and handling at the time of examination of application relative to the medicinal invention. The medicinal invention here means “invention of product” belonging to the medicinal field, out of the use invention defined in the Examination Guidelines, Part II, Chapter 2, 1.5.2(2) (Remark). 1. Description Requirements of a Description and Claims 1.1 Claims 1.1.1 Section 36(5) of the Patent Law

An invention stated in any claim shall not extend beyond the scope defined in a detailed description of the invention. Whether statements in claims comply with Section 36 (6) (i) of the Patent Law shall be determined based on a comparative examination between a claimed invention and the matters disclosed in a detailed description of an invention. (Refer to Examination Guidelines Part I, Chapter 1, 2.2.1) As typical Examples of Violation under Section 36 (6) (i), in case of matters disclosed in a detailed description of an invention cannot be extended or generalized to the scope of matters in a claimed invention even if taking into account common general technical knowledge as of the filing, the following cases are listed. (i) A claim concerns a pharmacological composition for healing nausea including compound A as an effective ingredient. The detailed description of the invention is provided with no pharmacological test and data demonstrating the effectiveness of compound A against nausea. Moreover, the effectiveness of compound A against nausea cannot be inferred in light of common general technical knowledge as of the filing. (Refer to Examination Guidelines Part I, Chapter 1, 2.2.1.1 Example 9), (ii) A patent is claimed comprehensively for a curing medicine for a specific purpose, which contains chemical compounds defined by appropriate properties as effective ingredients. According to the detailed description of the invention, however, only a limited number of compounds included in the claims were proven to be effective as a curing medicine for the said purpose. It is impossible for a person skilled in the art to theoretically conceive such effectiveness of all the compounds included in claims, in light of common general technical knowledge as of the filing. (Refer to Examination Guidelines Part I, Chapter 1, 2.2.1.1 example 7) (Tokyo High Court Judgment Hei-15.12.26 (Heisei 15 (Gyo-Ke) 104) 1.1.2 Section 36(6)(ii) of the Patent Law This Section is intended to make it clear that claim statements should be such that an invention for which a patent is sought can be clearly identified. Thus, it is necessary that an invention can be clearly identified from one claim.

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Considering the intent of Section 36(5) of the Patent Law, various forms of expression can be used in a claim by an applicant to define an invention for which a patent is sought. For example, in the case of “an invention of a product,” as well as Medical Invention, various forms of expression such as operation, function, quality, characteristics, method, usage and others can be used as matters to define an invention in addition to the forms of expression such as the combination of products or the structure of products.

On the other hand, since a claim should be stated in such a manner that an invention for which a patent is sought can be clearly identified from a single claim according to the provision of Section 36(6)(ii), it should therefore be noted that such a definition of an invention is allowed as long as the claimed invention can be clearly identified. As Medical Invention belongs to the technical field where the structure of a product can hardly be predicted from its function, work, property or characteristics (hereinafter referred to “function or characteristics, etc.”), it should be noted that the scope of an invention tends to be unclear, in case as a result of a defining effective ingredient by its function or characteristics, and when a person skilled in the art cannot conceive of a concrete product with such a function, etc., from the statements in a claim defining the product by its function, etc., by taking into account of the common general technical knowledge as of the filing, the scope of the invention is deemed unclear. In case where a claim directed to a use invention (Refer to Part II: Chapter 2. 1.5.2(2)) explicitly includes a statement to mean a use of a product and the statement does not express a specific use but a general use, it should not be deemed a violation of Section 36(6)(ii) merely because the statement expresses a general use (i.e., merely because the scope of the claim is relatively broad) unless the expression makes unclear the invention for which a patent is sought. (For example, not a “pharmaceutical substance for disease X comprising...” but ”a pharmaceutical substance comprising...”)

The detailed description of the invention, however, shall comply with the provision of Section 36(4). (Refer to Examination Guidelines, Part I, Chapter 1, 2.2.2.2) It should be noted that the medicinal invention can be described in a Claim as the invention of a product as follows: Example 1: A medicine for Disease Z containing an effective ingredient A. Example 2: A medical composition for Disease Y containing an effective ingredient B. Example 3: A medicine for Disease W containing effective ingredients combined an effective ingredient C and an effective ingredient D. Example 4: A kit for Disease V consisting of an injection agent comprising an effective ingredient E, an oral agent comprising an effective ingredient F, and an agent comprising an auxiliary ingredient G. 1.2 Detailed Description of the Invention 1.2.1 Enablement Requirement

As a medical invention belongs to a technical field where it is generally difficult to infer how to make and use a product on the basis of its structure, normally one or more representative embodiments or working examples are necessary which enable a person skilled in the art to carry out the invention.

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(Refer to Examination Guidelines, Part I, Chapter 1, 3.2.1 (1)) As the working examples supporting the use, a description of the result for pharmacological tests is usually required.

Hereinafter, shown are operation examples about the description of the result of the

pharmacological tests enough to support a medicinal property.

(1) Description of the Result of Pharmacological Tests Since the result of the pharmacological test is to confirm the pharmacological effect in the claimed medicinal invention, all as follows ; (i) which compound is (ii) applied to what sort of pharmacological test system is applied, (iii) what sort of result is obtained, and (iv) what sort of relationship the pharmacological test system has with the medicinal use of the claimed medicinal invention, should be made sufficiently clear, in principle. It should be noted that the result of the pharmacological test should be described with numerical data as a general rule, but when the result cannot be described with the numerical data on account of the nature of the pharmacological test system, there may be a case where objective description of the degree which can be seen to be equivalent to the numerical data, for example, description of the objective observation result by a doctor could be accepted. Furthermore, as the pharmacological test system employed, a clinical test, an animal experiment, and in-vitro test are listed. (2) Example of Case where Reasons for Refusal is Notified (a) Lack of Description of Pharmacological Test Result Generally, since it is difficult to predict whether the compound is actually usable for a specific medicinal use only from the name and chemical structure of the compound, it is still difficult for those skilled in the art to predict whether the compound is actually usable for the specific medicinal use, when the pharmacological test result is not described even if an effective quantity, a dosing method, and formulation method are described in the description originally attached to the request. Accordingly, in such a case, Reasons for Refusal is notified in principle. It should be noted that even if the pharmacological test result is submitted afterward, the Reasons for Refusal are not recovered. (Published as examples 3 to 5 in Tokyo High Court Judgment Hei 10.10.30 (Heisei 8 (Gyo-Ke) 201) “Judgment on Antiemetic Drug”: Examination Guidelines Part I, Chapter 1 5. Book of Examples 5.3, Tokyo High Court Judgment Hei 14.10.1 (Heisei 13 (Gyo-Ke) 345, Tokyo High Court Judgment Hei 15.12.22 (Heisei 13 (Gyo-Ke) 99) (b) In Case of not to confirm an Existence of Pharmacological Effect of a Claimed Medicine, on Account of not to specified the Compound Used in The Pharmacological Test It should be noted that, for example, when the compound used in the pharmacological test system described in the description originally attached to the request is only described as being “any of a plurality of the compounds”, and specification thereof is not made of which compound is specifically used, the case comes under the case where (i) in the above-described “(1) Description of the Result of Pharmacological Tests” is not clear, and there are many cases where existence of the pharmacological

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effect in the claimed medicinal invention cannot be confirmed. 2. Requirements for Patentability 2.1 Industrial Applicability Medicinal invention does not come under “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.” despite that the application such as dosing to, or spreading on the human body is anticipated because the medicinal invention is “an invention of a product,” and comes under “the industrially applicable invention.” It should be noted that the medicinal invention intended to specify by modes of medical treatment such as combination of more than two medicines, dosing interval, given dose, is handled in the same way because it is also “an invention of a product.” (Refer to the Examination Guidelines Part II, Chapter 1, 2.1 “Industrial Applicability.” 2.2 Novelty 2.2.1 Basic Method of Determining whether a Claimed Medicinal Invention is Novel Medicinal invention is understood to be “an invention of a product” based on finding a property of a specific pharmacological property in one compound or one group of compounds (including a combination of a plurality of compounds (Remark)), and finding a new medicinal use of applying the property to a specific disease. Accordingly, the novelty of the medicinal invention is judged from two view points, namely, of one compound or one group of compounds having a specific property and of the medicinal use of such compound applied to a specific disease based on such property. The line of thought above is no different in the medicine combined with more than two medicines’

case. (Tokyo District Court Judgment Hei 4.10.23 (Heisei 2 (Wa) 12094), Tokyo High Court Judgment Hei 12.7.13 (Heisei 10 (Gyo-Ke) 308), Tokyo High Court Hei 12.2.10 (Heisei 10 (Gyo-Ke) 364) (Remark) A chemical substance (group) of which chemical structure is not specified such as extract from the natural product is handled in the same way as “one compound or one group of compounds.”) 2.2.1.1 Method of Judging Novelty (1) Finding of Claimed Medicinal Invention It is not different in the case of “Claim statements defining a product by its use (limitation by use)” in Examination Guidelines Part II, Chapter 2, 1.5.2(2). (2) Finding of a Cited Invention as provided in Patent Law Section 29(1)(i)-(iii)

Since the medicinal invention comprises one compound or one group of compounds having a

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specific property and medicinal use of applying such compound to a specific disease based on such property, it is necessary that both of the pertinent one compound or one group of compounds and medicinal use thereof are described in the publication (or equivalent to being described), in order to find that the medicinal invention is described in a publication.

Unless it is clear that an invention is described in a publication in such a manner that a person skilled in the art can make (or easily procurable) one compound or one group of compound for claimed medical invention in consideration of the common general knowledge as of the distribution of the publication, the invention shall not be deemed to be "a cited invention" under Section 29(1)(iii). (Refer to Examination Guidelines Part II, Chapter 2 1.5.3(3) (ii)). It should be noted that, for example, when the medicinal uses are listed just in a large number without any support in the pertinent publication, description is not made in the pertinent publication such that the technically meaningful medicinal use is clear and therefore the invention cannot be made as the cited invention. (Remark 1) Handling of “the medicinal invention made available to the public through telecommunication line,” refer to Examination Guidelines Part II, chapter 5. (Remark 2) Handling of “Publicly Known Medicinal Invention”, “Publicly Worked Medicinal Invention”, and “the medicinal invention made available to the public through telecommunication line”, is not different to “the medicinal invention described in the publication.” (3) Determining whether a Claimed Medicinal Invention is Novel For Determining whether a Claimed Medical Invention is novel, it is made in the way from (3-1) to (3-3), based on “Determining whether a Claimed Invention is Novel” in Examination Guidelines Part II, Chapter 2, 1.5.5 and “Method of Determining whether a Claimed Medical Invention is Novel” of this Chapter 2.2.1. (3-1) Regarding one compound or one group of compounds having a specific property When one compound or one group of compounds having a specific property of the claimed medicinal invention and one compound or one group of compounds of a cited invention are different, the novelty of the claimed medicinal invention is not denied. (3-2) Regarding medicinal use being application to a specific disease Even if one compound or one group of compounds of the claimed medicinal invention and one compound or one group of compounds of the cited invention are not different, the novelty of the claimed medicinal invention is not denied when the claimed medicinal invention and the cited invention are different in the medicinal use being application to a specific disease based on the property of such product. For example, when a claimed invention is “A medicine for disease Z comprising an effective ingredient A,” and a cited invention is “A medicine for disease X comprising an effective ingredient A,” the novelty of the claimed medicinal invention is not denied, in case it is cleared that the disease X and the disease Z are different diseases in the light of the common general knowledge at the filing. The line of thought about the difference of the medicinal use is as follows. (a) Even if the medicinal use of the claimed medicinal invention and the medicinal use of the cited

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invention are different in expression, the novelty of the claimed medicinal invention is denied, when they are judged to come under (i) or (ii) described hereunder if the common general technical knowledge at the time of patent application is taken into consideration. (i) In case the novelty is taken out as representative curative use (remark) by working mechanism thereof; (ii) In case the novelty is inevitably generated by closely related pharmacological effect. [Example of (i) above] (Cited invention) Bronchodilator → (Claimed medicinal invention) asthma preparation (Cited invention) Vasodilator → (Claimed medicinal invention) Hypotensive agent (Cited invention) Coronary vessel dilator → (Claimed medicinal invention) Therapeutic agent for Angina (Cited invention) Histamine liberation inhibitor → (Claimed medicinal invention) Anti-allergy drug (Cited invention) Histamine H-2 receptor inhibitor → (Claimed medicinal invention) Therapeutic agent for Gastric ulcer (Remark) Representative curative use indicates the case where substantial coincidence with the working mechanism is observed. [Example of (ii) above] (Cited invention) Cardiotonic agent → (Claimed medicinal invention) Diuretic agent (Cited invention) Antiflash agent → (Claimed medicinal invention) Painkiller (Remark) In the interpretation of the examples (ii) above, although there is one compound or one group of compounds inevitably having two or more medicinal uses in the field of medical treatment, it is also well known that all the compounds having a first medicinal use coming under (ii) above do not have necessarily a second medicinal use. Accordingly, when the novelty of the medicinal use of the medicinal invention of the present patent application in such a case is considered, it is necessary to consider the common general knowledge at the filing regarding structure-activation-correlation or the like of the pertinent one compound or a group of compounds. (b) When the medicinal use of the cited invention is expressed by a more specific concept of the medicinal use of the claimed medicinal invention, the novelty of the claimed medicinal invention is denied. [Example] (Cited invention) Antipsychotic agent → (Claimed medicinal invention) Agent acting on central nervous system (Cited invention) Therapeutic agent for Lung cancer → (Claimed medicinal invention) Anticancer agent (c) When the medicinal use of the cited invention is expressed by a generic concept of the medicinal

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use of the claimed medicinal invention, and the medicinal use of the claimed medicinal invention expressed by the more specific concept is taken out from the common general knowledge at the filing, the novelty of the claimed medicinal invention is denied. (Remark) Conceptually, it is not interpreted that the medicinal use expressed by the more specific concept can be taken out only from the thing that the medicinal use expressed by the more specific concept is included in the medicinal use expressed by the generic concept, or the thing that the medicinal use expressed by the more specific concept can be listed from the medicinal use expressed by the generic concept. (d) When the medicinal use of the claimed medicinal invention is only but one expressed by the working mechanism by which the medicinal use of the cited invention is newly found, the novelty of the claimed medicinal invention is denied. [Example] (Cited invention) Antibacterial agent → (Claimed medicinal invention) Bacterial cell membrane formation inhibitor

(Remark) The medicinal use of the claimed medicinal invention corresponds to finding of the working mechanism of the medicinal use of the cited invention, and when seen from the standpoint of the medicinal use, both uses cannot be substantially distinguished. (e) In the claimed medicinal invention and the cited invention, there is no difference in the ingredient composition and the medicinal use of the both, and when the ingredient contained in the claimed medicinal invention is only but expressed by use-wise defining of the working mechanism of a part of the ingredient of the cited invention, the novelty of the claimed medicinal invention is denied. [Example] (Cited invention) Skin antiflash painkiller containing indomethacin and capsicum extract → (Claimed medicinal invention) Skin antiflash painkiller containing indomethacin and long term stability improving agent for indomethacin composed of capsicum extract (Remark) As long as ingredient constitution as the composition is the same, it is obvious that the ingredient contained by the skin antiflash painkiller of the both inventions performs the same action effect despite of subjective adding object. Accordingly, even if definition is made that the capsicum extract contained is a stabilizer for improvement of long-term stability of the indomethacin, it cannot be said that the invention is different from the invention described in the publication because of the definition. (Tokyo High Court Judgment Hei 13.12.18 (Heisei 13(Gyo-Ke) 107) (3-3) In case the claimed medicinal invention is a medicinal invention intended to specify by the mode of medical treatment such as dosing interval, given dose, or the like; and the claimed invention is different from the cited known invention in the mode of medical treatment such as dosing interval, given dose, or the like; described below as (a) or (b), in case the medicinal use applied to a specific disease based on one compound or a group of compounds having a specific property is accredited to be different between the claimed invention and the cited known invention, the claimed medicinal invention can have

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the novelty. (a) When it becomes clear that the claimed medicinal invention intended to specify by such mode of medical treatment is effective to a patient having, for example, a particular gene, and it becomes clear that it becomes possible for those skilled in the art to clearly distinguish the target patient groups of the both, which is specified hereunder, by a fact that the target patient group of the claimed medicinal invention is different from the target patient group which is not specifically specified in the cited invention. (b) In the claimed medicinal invention intended to specify by such mode of medical treatment, when it becomes possible for those skilled in the art to clearly distinguish the treated area of the claimed medicinal invention and the treated area of the cited invention as in the case when a specially suited part for treatment which is different from the cited invention is found.

It should be noted that, in the claimed medicinal invention intended to specify by such mode of medical treatment, when sufficiently clear distinction between the two is made possible for those skilled in the art by reflecting such mode of medical treatment to the dosage form, the claimed medicinal invention can have the novelty. (Example 8) When the claimed medicinal invention can be accurately distinguished by those skilled in the art as the cited invention and a product in the point that the dosing interval, given dose, or the like is made as a specified “kit for use in curing…” or the like, the claimed medicinal invention can have the novelty (Example 3). 2.3 Inventive Step 2.3.1 Inventive Step regarding Medicinal Invention It is not different in the case of “Inventive Step” in Examination Guidelines Part II, Chapter 2, 2. 2.3.1.1 Example of Concrete Practice Regarding Judgment of Inventive Step (1) Relation of the medicinal use with the working mechanism Even if the medicinal use of the claimed medicinal invention is different from the medicinal use of the cited invention, when relevance of the working mechanism between the both is taken out by the publicly known art or the common general knowledge at the filing, ordinarily, the inventive step of the medicinal invention of the present patent application is denied, so long as there is not any other ground such as advantageous effect or the like which enables anticipated admission of the inventive step. (2) Conversion of a medicine for animals other than human being to a medicine for human being A claimed medicinal invention, which is only a medicinal invention where one compound or a group of compounds of a cited invention which is for the same kind of or similar diseases of animals other human being is simply converted to a medicine for the human being, is ordinarily denied of the inventive step of the medicinal invention so long as there is no other ground permitting anticipated admission of the inventive step, such as an advantageous effect of the claimed invention, even if there is no suggestion in the contents of the cited invention about the pertinent conversion. Situation is the same with the conversion of the medicine for human being to the medicine for

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animals other than human being. (3) Medicine formulated by combining more than two medicinal ingredients In order to solve a problem well known to those skilled person in the art such as increase of medicinal effect, or reduction of side effect, optimization of the combination of more than two medicinal ingredients is an exertion of ordinary creative ability of those skilled in the art. When only these points are the difference between the claimed medicinal invention and the cited invention, ordinarily, the inventive step of the claimed medicinal invention is denied. For example, if the pertinent combination is: (i) combination of publicly known ingredients of which major action is the same,

(ii) combination of a major ingredient having a publicly know problem related to the efficacy thereof with a subordinate ingredient having publicly known ability to eliminate the problem (for example, in case of combination the major ingredient having a subordinate action which is publicly known and a subordinate ingredient of which ability of reducing the side effect which is publicly known), and

(iii) in cases such as combination of publicly known ingredients having a respective curative effects for a variety of symptoms arising from the major disease, and the like,

many of them can be logically supported that the claimed medicinal invention can be easily thought of by those skilled in the art based on the cited invention, and ordinarily the inventive step thereof is denied (Example 4 to 7) On the other hand, in the claimed medicinal invention specified by combination of more than two medicinal ingredients, when the combination of the ingredients is novel, and a remarkable effect is performed by combination of more than two of compounds or groups of compounds, the claimed medicinal invention can involve on the inventive step (Example 1 to 2). Although the medicine formulated by combining more than two medicinal ingredients can be assumed to be applied for the patent as “compound drug for use in curing … ,” “composition for use in curing…,” “…curative medicine characterized in that … and …are combined,” there is no fundamental difference in any of the cases as the judging method. (4) Medicine intended to be specified by mode of medical treatment such as dosing interval, given dose, or the like In order to solve a problem well known to those skilled person in the art such as increase of medicinal effect, or reduction of side effect, optimization of the mode of the use of the medicine (dosing interval, given dose, or the like) is an exertion of ordinary creative ability of those skilled in the art. When only these points are the differences between the claimed medicinal invention and the cited invention, and so long as there is no other ground enabling anticipated admission of the existence of the inventive step, ordinarily, the inventive step of the claimed medicinal invention is denied (Example 8). (Tokyo High Court Judgment Hei 13.3.28 (Heisei 12 (Gyo-Ke) 294) 2.4 Patent Law Section 29bis

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2.4.1 Application of Patent Law Section 29bis regarding Medicinal Invention It is not different in the case of “Patent Law Section 29bis” in Examination Guidelines Part II, Chapter 3. 2.4.1.1 Example of Concrete Practice Regarding Judgement of Patent Law Section 29bis for Medicinal Invention A claimed medicinal invention and an invention described in a prior application are deemed to be substantively identical if the difference is considered as a very minor difference (addition, deletion, or replacing of well-known or commonly used art, generating no new effects) in embodied means to solve a problem (i.e. substantially identical), such that they are different only in the form of the dosage. 2.5 Patent Law Section 39 2.5.1 About Application of Patent Law Section 39 regarding Medicinal Invention It is not different in the case of “Patent Law Section 39” in Examination Guidelines Part II, Chapter 4. 2.5.1.1 Example of Concrete Practice Regarding Judgment of Patent Law Section 39(1), (3) for Medicinal Invention In a case where the invention of prior application having generic concept has a relation with the invention of subsequent application having more specific concept, when matters admitted to be necessary for specifying the subsequent application is disclosed in the prior application, the invention of the subsequent application is the same as the invention of the prior application.

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3. Examples Remarks on examples (i) These examples are prepared for the purpose of explaining examination practices on medicinal invention. Please be noted that the descriptions of claims etc. in these examples are not necessarily exemplary cases since they are modified, for example simplified, to make the explanation easy to understand. (ii) Explanations in examples are made only on the requirements for novelty or inventive step, on the assumption that the claimed inventions, in principle, meet the requirements for description and enablement.

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3.1 Medicines having characteristics in combination of effective ingredients [Example 1] A medicine performing advantageous effect by combination of effective ingredients Claims [Claim 1] A anticancer drug formulated by combining a compound A with a compound B. [Claim 2] The anticancer drug according to Claim 1 wherein the anticancer drug is a compounding agent. [Claim 3] The anticancer drug according to Claim 1, wherein the anticancer drug is a kit composed of an agent containing the compound A and an agent containing the compound B. [Claim 4] The anticancer drug according to Claim 1 wherein the compound A is dosed through an administrating path selected from a group consisting of a vein path and a subcutaneous path, and the compound B is orally dosed, respectively with doses of 10 to 50mg/kg and 1 to 30mg/kg daily or three times in a week. Outline of Detailed Description of the Invention In the invention, synergistic anticancer effect is found by combined use of the compound A and the compound B. Furthermore, indications are made that the use is possible in a state of a compounding agent in which both compound A and compound B are mixed or in a state of a kit in which both compound A and compound B are not mixed, and that a synergistic anticancer effect is performed by taking the compound A and the compound B simultaneously or with a certain interval. In the embodiment, a description is made of the result of the pharmacological test showing performance of the synergistic anticancer effect. Result of Prior Art Search Although it is publicly known that the compound A and the compound B respectively perform anticancer effect, the anticancer agent using the compound A and the compound B in combination has not been described in any documents of the prior art. Furthermore, from the state of the art at the time of patent application, it is not possible to predict the performance of the synergistic anticancer effect by combined use of both of the compounds above-described. Outline of Reasons for Refusal No reason for refusal. [Explanation] When a synergistic anticancer effect exceeding the scope of the prediction made from the state of the art at the time of patent application by combined use of the compound A and the compound B is shown by the result of the pharmacological test or the like, there exists the inventive step. It should be noted that since the invention according to Claim 1 has the novelty and the inventive step in the combination of the compound A and the compound B, the invention which specifies a specific mode of the pertinent combination such as compounding agent, kit, or the like, like the inventions according to Claims 2 to 4 which quote Claim 1, it is judged that the inventions have the novelty and the inventive step in the same way as the invention according to Claim 1.

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[Example 2] A medicine performing advantageous effect by combination of effective ingredients Claim [Claim 1] An antidiabetic agent composition containing a compound A and a compound B. Outline of Detailed Description of the Invention In the invention, lowering of the side effects such as a weight gain or the like which have conventionally been observed when the compound A is independently used, is found by combined use of the compound A and the compound B. In the embodiment, description is made of the result of the pharmacological test showing lowering of the side effects. Result of Prior Art Search Although it is publicly known that the compound A and the compound B are respectively used as the antidiabetic agent, no description is made in any technical papers of the prior art of the antidiabetic agent composition by combined use of the compound A and the compound B. Furthermore, decrease in the side effects such as a weight gain or the like by combined use of the compound A and the compound B cannot be predicted from the state of the art at the time of patent application. Outline of Reasons for Refusal

No reason for refusal. [Explanation] When an effect of reducing the side effects exceeding the scope of prediction made from the state of the art at the time of patent application by combined use of the compound A and the compound B is shown by the result of the pharmacological test or the like, there exists the inventive step.

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[Example 3] A medicine which can be distinguished from a conventional medicine, although combination of effective ingredients thereof is publicly known Claim [Claim 1] A kit for 2-stage contraception applied for oral administration, comprising one-day dosage unit, wrapped in one wrapping unit spatially separated, containing two kinds of effective ingredients decided to dose orally one after another, each of which being spatially separated in the wrapping unit and stored so as to be able to be individually taken out, and the first effective ingredient being a tablet containing 0.01 to 0.04 mg of only the compound A as a one-day dose unit, and the second effective ingredient being a tablet containing 0.50 to 1.00 mg of the compound B as a one-day dose unit, total number of one-day dose units being equal to the total number of days of the required menstrual cycle, and the tablets containing the first effective ingredient being 4 to 6 day dose units and the tablets containing the second effective ingredient being 21 days dose units. Outline of Detailed Description of the Invention In the invention, found is more advantageous contraception effect than a case where the compound A and the compound B are used simply in combination, by dosing the compound A for the first 4 to 6 days of the menstrual cycle and the compound B for 21 days thereafter. In the embodiment, description is made of the result of the pharmacological test showing performance of advantageous contraception effect. Result of Prior Art Search It has been publicly known that an advantageous contraception effect is performed by taking the 0.01 mg for one dose of the compound A for an initial few days and continuously taking 0.75mg for one dose of the compound B for three weeks thereafter. Furthermore, in order that the medicine to be taken for a long term can be surely taken, it has been widely practiced to put the medicine of one dose into a tablet for the use in the pertinent period for making a kit therewith in the form of individual wrapping or the like. However, the kit having constitution of the invention has not been described in any document of the prior art. Outline of Reasons for Refusal It has been publicly known that advantageous contraception effect is performed by taking 0.01mg for one dose of the compound A for an initial few days and of 0.75mg for one dose of the compound B continuously for three weeks thereafter. Furthermore, since putting the medicine into the tablets to make the kit is widely practiced with medicines to be taken for a long term, it can be easily achieved by those skilled in the art to make the tablets containing above described required quantities of the compound A and the compound B and to make the kit with the tablets of the quantity which can be taken in a required period, in order to realize an advantageous contraception effect. Measures for Reasons for Refusal Ordinarily, the above described reasons for refusal cannot be withdrawn. [Explanation]

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Even if the combination per se of the compound A and the compound B is publicly known, when the pertinent kit can be distinguished from the conventional medicine as “a product” by describing as “kit for use in curing…” which specifies the given dose and the dose interval, the pertinent medicinal invention has the novelty. However, an absence or a presence of the inventive step is separately judged as above described.

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[Example 4] Combination of a component with another component having the same major action which is publicly known Claim [Claim 1] A liquid antiflatulent, wherein the YY bacterium is contained at a ratio of 1 x 106 to 1 x 108 cells per 1 to 30g of dietary fiber. Outline of Detailed Description of the Invention In the invention, an antiflatulent fortified of the intestine regulating function is formulated by combining the dietary fiber and the YY bacterium, both having the functions of the intestines. Furthermore, in Specification, the result of the pharmacological test of the case where the medicine for intestinal disorder having this combination is used is shown. However, no specific description is made of the synergistic effect thereof. Result of Prior Art Search It is publicly known that there is the intestine regulating function when 1 to 30g of the dietary fiber is taken or when 1 x 106 to 1 x 108 cells of the YY bacterium are taken, and the combined use of various kinds of conventional medicine for intestinal disorder is also publicly known. Outline of Reasons for Refusal Since the combined use of various kinds of conventional medicines for intestinal disorder is publicly known, it can be easily performed by those skilled in the art that one medicine for intestinal disorder is made by combining the YY bacteria having the intestine regulating function with the dietary fiber having the intestine regulating function in the same way, for the object of fortifying the intestine regulating function. Furthermore, it can also be suitably achieved by those skilled in the art to formulate a liquid medicine at the occasion in view of easiness of taking or the like, and therefore the effect thereof cannot be made as specially remarkable. Measures for Reasons for Refusal Ordinarily, the above-described reasons for refusal cannot be withdrawn.

Even if the synergistic effects are not described, when it could be made an inference that the synergistic effects superior to the cited invention from the description or drawings by those skilled persons in the art, the synergistic effect insisted or verified by applicant’s exhibiting experimental results by written opinion are taken into consideration

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[Example 5] Combination of a main component of which possession of a side effect is publicly known with a sub component whose ability to reduce the side effect is publicly known Claim [Claim 1] Therapeutic agent for a paclitaxel responsive tumor formulated by combining paclitaxel with a compound X in a quantity effective for suppressing a vomiting caused by administration of paclitaxel. Outline of Detailed Description of the Invention In the invention, it is found that the paclitaxel responsive tumor can be cured while suppressing the vomiting which is a side effect caused at the time of administrating the paclitaxel by using the paclitaxel together with the compound X at the same time. Result of Prior Art Search Although the paclitaxel is an excellent anti-tumor agent, it is publicly known that the vomiting is caused as the side effect at the time of administration thereof. On the other hand, it is publicly known that the compound X generally weakens the vomiting. Outline of Reasons for Refusal Since it is known that paclitaxel is used together, at the same time, with the subordinate compound for weakening the vomiting which is the side effect of the administration of paclitaxel, and furthermore the compound X is known as a compound for generally weakening the vomiting, the combined use of the paclitaxel with the compound X can be easily achieved by those skilled in the art, in order to weaken the vomiting which is the side effect of the administration of paclitaxel. Furthermore, by doing so, no specially remarkable effect more than the anticipation has been performed. Measures for Reasons for Refusal Ordinarily, the above-described reasons for refusal cannot be withdrawn.

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[Example 6] Combination with a sub-compound having publicly known ability to eliminate a publicly known problem related to the efficacy of a main component ingredient Claim [Claim 1] A compounding agent for antiflash painkiller formulated by compounding 1 to 100 weight percent of caffeine and 0.2 to 20 weight percent of vitamin B1 active type derivative for the totaled quantity of diclofenac or its salts and acetaminophen. Outline of Detailed Description of the Invention In the invention, it is shown that the pain threshold value can be increased and the duration time of the function can be extended in the antipyretics function test by compounding caffeine and vitamin B1 active type derivative in the compounded antiflash painkiller formulated by combining diclofenac or its salts with acetaminophen. Result of Prior Art Search Publicly known is the compounding antiflash painkiller formulated by combining diclofenac or its salts with acetaminophen, and also known is that there is a so-called ceiling effect in which the antiflash effect does not increase while only the side effect increases, even if the quantity thereof is increased by more than a certain quantity, generally, in the non-steroidal type antiflash painkiller as such.

It is publicly known that, the pain threshold value can be increased to the same degree as the invention of the present application and the duration time of the effect can also be extended to the same degree as the invention of the present application in the analgestic effect test, by adding the caffeine and the vitamin B active type derivative to the non-steroidal type antiflash painkiller. Outline of Reasons for Refusal Since non-steroidal type antiflash painkiller formulated by combining diclofenac or its salts with acetaminophen is publicly known, and it is known that the pain threshold value can be increased and the duration time of the effect can be extended in the analgestic effect test by adding caffeine and vitamin B1 active type derivative to the non-steroidal type antiflash painkiller, combination of the caffeine with the vitamin B1 active type derivative in order to increase the effect of the non-steroidal type antiflash painkiller formulated by combining the diclofenac or its salts with acetaminophen was easily thought of by those skilled in the art, and it is admitted that the scope of the compounding quantities of the compounding ingredients was experimentally optimized by those skilled in the art. In addition, the effect thereof cannot be regarded as specially remarkable one. Measures for Reasons for Refusal Ordinarily, the above-described reasons for refusal cannot be withdrawn.

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[Example 7] Combination of components of which possession of respective efficacy for various symptoms caused by major disease is publicly known Claim [Claim 1] Therapeutic agent for AIDS which is formulated by combining azidothymidine (AZT), being an anti-HIV medicine, with penicillin. Outline of Detailed Description of the Invention In the invention, it is shown that, in order to cure a patient with AIDS which appears after being infected by HIV, combination of the anti-HIV medicine AZT and penicillin which is effective in curing pneumonia which is caused as one mode of the AIDS performs advantageous effect in curing AIDS. However, no specific description is made whatsoever of synergistic effect thereof. Result of Prior Art Search It is publicly known that azidothymidine (AZT) can be used as t herapeutic agent for AIDS. It is also publicly known that the pneumonia is caused as one mode of the AIDS. Outline of Reasons for Refusal It is known that the azidothymidine (AZT) is effective as therapeutic agent for AIDS, and also known that the pneumonia is easily caused as one mode of the AIDS. Furthermore, it is widely practiced to cure the pneumonia by use of a penicillin type antibiotic, to name a few, the penicillin. Accordingly, it is only a creative ability which can normally be displayed by those skilled in the art to use the combination of the anti-HIV medicine AZT in combination with the penicillin for the object of curing also the pneumonia which is caused as one mode of the AIDS, while suppressing the infection of the HIV which causes the AIDS when medically treating AIDS patients. Furthermore, no specially remarkable advantage beyond the anticipation has been performed by combined use of the both. Measures for Reasons for Refusal Ordinarily, the above-described reasons for refusal cannot be withdrawn.

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3.2 Medicine Having Characteristics in Dose Interval and Dose [Example 8] Medicine in which contents of effective ingredient are optimized Claims [Claim 1] A tablet medicine of immunopotentiating agent containing 550mg to 650mg of a compound Z or its pharmacologically admissive salts per a tablet. Outline of Detailed Description of the Invention In the invention, indicated is the formulation of the compound Z into a specific content in order to improve curative effect by increasing intracorporeal absorption rate of the compound Z which is the immunopotentiator. In the pharmacological test result in written description, it is specifically supported that the intracorporeal absorption rate is increased, and specially remarkable immunopotentiating function is described there only when the contents of the compound Z are 550mg, 600mg, and 650mg. Result of Prior Art Search It is known that the use of the compound Z as immunopotentiator is publicly known, and that the one dose is adjusted to 10mg to 30mg and the one dose is determined considering administration method, condition of the disease, or the like. However, it is unexpected that the claimed medicine formulated to tablet has a remarkable immunopotentiating effect by increasing an absorption rate into body in the light of the common general knowledge at the filing. Outline of Reasons for Refusal No reason for refusal. [Explanation] The claimed invention is specified by mode of medical treatment such as given doze. To reflect the mode of medical treatment to the tablet medicine which is containing said amount of given doze, those skilled in the art could distinguish the claimed invention from sited known invention.

It is unexpected that the claimed medicine formulated to tablet has a remarkable immunopotentiating effect by increasing an intracorporeal absorption rate in the light of the common general knowledge at the filing, so the claimed invention involves in an inventive step.