Microsoft word - main issues frequently raised in the office action.doc

Main Issues Frequently Raised in the Office Action Han Sung International Patent & Law Office 1. Pharmacological Use in the Composition Claim [Art. 42(4) of KPA] A. Pharmaceutical composition comprising a novel compound • Use is not required to be defined in a composition claim if the characteristic inventiveness lies in a novel compound itself in the composition. • But, in practice, most examiners require applicant to define a pharmacological use in the composition claim, regardless of whether or not the compound in the composition is novel. B. Pharmaceutical composition comprising a known compound • In case characteristic inventiveness does not exist in an active compound nor in other ingredients of a pharmaceutical composition, use of the composition will be a unique characteristic of the invention. In the case, the use should be clear to a skilled person, and so should be defined by the name of disease. C. Can the pharmacological mechanism be regarded as sufficiently defining the use of • In principle, it is not regarded as sufficiently defining the use. But, if the mechanism is clear to a skilled artisan and the scope of protection is regarded as definite, the use of composition defined by such mechanism, i.e. anti-histamic agent, may be allowed. D. Pharmacological test data to support the claimed use • Though the pharmacological mechanism is proved by experimental data in the specification, the relationship between diseases in the claims and pharmacological mechanism should be clearly explained in the specification or supported by other reference(s). 2. Allowable Scope of Novel Compound [Art. 42(3) and 42(4) of KPA] • Characteristic substituents should be supported by exemplified compounds and equivalents • Conventional substituents need not be restricted, but should be conventionally reasonable. ※ In practice, the carbon number of alkyl or the kinds of aryl are required to be defined 3. Unacceptable Terms in the Claims [Art. 42(4) of KPA] • Most examiners tend to object to the above terms without considering characteristic of the invention. Since these terms have little significant effect to the scope of invention, we usually propose to change the objected terms to other allowable expressions having same - “optionally substituted” → “unsubstituted or substituted” - “A and/or B” → “A or B, or A and B” (‘or A and B’ is usually omitted) • The expression “use of ~” in the claims is not allowable on the ground that “use” is not a statutory patentable subject matter. We usually propose to change the expression to other allowable ones having same scope of protection. - Use of the compound (I) for manufacture of a medicament for treating amnesia → An agent for treating amnesia comprising an effective amount of the compound (I) 4. Experimental Data Supporting Claimed Use [Art. 42(3) of KPA] • Only representative compounds need to be tested for pharmacological activity, and other compounds having same general formula are assumed to have same or equivalent effect to the representative compounds unless the Examiner proves otherwise. • In a novel compound, the scope of compound defined by use may be much broader than supported by the examples. But, for a known compound whose characteristic inventiveness lies in a new use thereof, the scope of compound is limited to those for which the activity is proven, and close equivalents thereof. • If the safety of compound is doubtful, an Examiner may request an applicant to submit experimental data showing the safety of the compound. That is, safety (toxicity) data can be submitted during the examination procedure. 6. Dose and Administration Method [Art. 42(3) of KPA] • If the dose and administration method of a related compound were known in the art, the dose and administration method of the claimed compound having similar physico-chemical 7. Non-Quantitative Pharmacological Effect [Art. 42(3) of KPA] A. General statement such as “the present compounds show a very potent activity in ~” • If the pharmacological mechanism of the compound has been clearly established in the art, quantitative experimental data showing the compound’s pharmacological effect may not be required (e.g.: ‘the present cephalosporin derivatives show a broad antibiotic activity’). • But, if the claimed compounds are very similar to the known compounds, the examiner usually requires submitting comparative experimental data of proving higher effect in order B. Broad statement such as “the present compound has an IC50 from 0.1 nM to 1 µM” • Such broad statement on the activity of compounds is not regarded as enough to proving the effect of compounds. At least one example showing exact activity data of a representative compound should be shown in the originally filed specification. (3) The detailed explanation of the invention under paragraph (2)(iii) must state the purpose, construction and effect of the invention in such a manner that it may easily be carried out by a person with ordinary skill in the art to which the invention pertains. (4) The claim(s) under paragraph (2)(iv) must describe the matter for which protection is sought in one or more claims (referred to as "claim(s)"), and the claim(s) must comply with each of the (i) the claim(s) must be supported by a detailed explanation of the invention; (ii) the claim(s) must define the invention clearly and concisely; and (iii) the claim(s) must define only the features indispensable for the construction of the (5) Details on the drafting of claim(s) under paragraph (2)(iv) are prescribed by the Presidential The above summary is general information, and cannot be construed as specific answer for a case. If you have a specific question, please contact: Han Sung International Patent & Law Office Mail: Kang Nam P.O. Box 1793 Seoul 135 080 Korea


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