DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-16 are pending.
Claims 15 and 16 are currently amended by a preliminary amendment filed on
12/27/2025.
Claims 1-16 have been examined.
Claims 1-16 are rejected.
Priority
Priority to PCT/JP2021/024254 filed on 06/25/2021, which claims priority to Japanese patent application 2020-110975 filed on 05/26/2020 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/02/2023 and 07/26/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Drawings
The drawings filed on 12/27/2022 are accepted.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takada et al. (Canadian Patent Application Publication 2759073 A1, Published 11/04/2010).
Takada et al. teach compound
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exerts an antiarrhythmic action and useful as a drug (paragraphs 0002 and 0064).
Claim limitations “for drug-induced bradycardia and bradyarrythmia”, “wherein the drug-induced bradyarrhythmia is bradyarrhythmia induced by an S1P receptor modulator”, “wherein the drug-induced bradyarrhythmia is bradyarrhythmia induced by an S1P1 receptor modulator”, “wherein the drug-induced bradyarrhythmia is bradyarrhythmia induced by fingolimod”, “wherein the drug-induced bradyarrhythmia is bradyarrhythmia induced by siponimod”, “wherein the drug-induced bradyarrhythmia is bradyarrhythmia induced by β-blocker”, “wherein the drug-induced bradyarrhythmia is bradyarrhythmia induced by propranolol”, “wherein the drug-induced bradyarrhythmia is any of the following bradycardias: (a) sinus bradycardia, (b) sinus arrest, (c) sinoartrial block, (d) atrioventricular block, (e) sinus node dysfunction, (f) bradycardic heart failure, and (g) bradycardic atrial fibrillation”, “wherein the drug-induced bradyarrhythmia is sinus bradycardia or atrioventricular block”, “wherein the drug-induced bradyarrhythmia is sinus bradycardia”, “wherein the drug-induced bradyarrhythmia is atrioventricular block”, “is for the purpose of prevention”, “is for the purpose of termination”, “for drug-induced bradycardia and bradyarrhythmia is a therapeutic agent for drug-induced bradyarrythmia”, and “for drug-induced bradycardia and bradyarrhythmia is a therapeutic agent for bradyarrythmia”, are intended use limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art teaches a structurally identical compound for therapeutic use and therefore would function exactly the same as the instant claims and be capable of the same use as recited in the instant product claims. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claim limitation “a compound having a KACh channel inhibitory action”, is an inherent property of the compound (I) of the instant claims, as described in the instant specification on page 5 lines 5-6. The prior art compound is structurally identical to the instant claimed compound. Therefore, the compound of the prior art would also inherently possess the same property. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”). “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Therefore, the instant claims are anticipated by the teachings of the prior art.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto et al. (Effects of the Selective KACh Channel Blocker NTC-801 on Atrial Fibrillation in a Canine Model of Atrial Tachypacing: Comparison With Class Ic and III Drugs, Published 05/2014).
Yamamoto et al. teach, “These results suggest that KACh channel blockers such as NTC-801 might be more effective as antiarrhythmic therapy for AF with electrical remodeling” (page 426, column 2, paragraph 1).
Claim limitation “for drug-induced bradycardia and bradyarrythmia”, is an intended use limitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art teaches a structurally identical compound for therapeutic use and therefore would function exactly the same as the instant claims and be capable of the same use as recited in the instant product claims. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the instant claim is anticipated by the teachings of the prior art.
Conclusion
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614