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 .
Priority
The present Application, filed December 1, 2023, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/JP2022/022536, filed June 2, 2022, which claims priority to Japanese Patent Application Nos. JP20212-021145 and JP2021-092795, filed February 15, 2022 and June 2, 2021, respectively.
Status of the Claims
In the amendment filed December 1, 2023, claims new claims 5-8 are added, and claims 3-4 are amended. Claims 1-8 are currently pending.
Information Disclosure Statement
The three information disclosure statements (IDSs) submitted on February 20, 2024, November 5, 2024, and January 9, 2025 are acknowledged.
Claim Objections
An objection is raised to claim 1:
Claim 1 is objected to because of the following informalities: the claim recites, “Y1, Y2, and Y3 are all represent (c1) a hydrogen atom,” at line 42. This is syntactically incorrect, as it includes two verbs (“are” and “represent”) where there should be only one. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 and 5 are anticipated by Savall:
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the non-patent publication, Synthesis of 2-arylbenzimidazoles via microwave Suzuki–Miyaura reaction of unprotected 2-chlorobenzimidazoles, Tetrahed. Lett., 49, pgs. 6667-6669 (2008) by Savall et al. (hereinafter, “Savall”).
Claim 1 is directed to compounds of Formula 1
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where the nine variable groups (R, R1, X, Y1-Y3, and Z1-Z4) are defined according to a defined number of alternative base moieties, most of which have a number of sub-alternatives. Claim 2 recites a compound of claim 1, where fewer alternative base moieties for Y1-Y3 and X are permitted.
Savall discloses the synthesis of a series of 2-arylbenzimidazoles via microwave-mediated Suzuki-Miyaura coupling of 2-chlorobenzimidazoles to either arylboronic acids or aryltrifluoroborate salts (Abstract). The test reactions focused on synthesis of the 2-methoxy pyridyl derivative (see, e.g. Table 5).
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Above: Table 5 of Savall.
Each of the reaction products shown in Table 5 of Savall is a compound of instant claims 1 and 2. For example, the first listed product, where R is exclusively hydrogen, is a compound of instant claim 2 where R1 is methyl (C1 alkyl) and each of Y1-Y3, R, and Z1-Z4 is hydrogen. Claims 1-2 are therefore anticipated.
Claims 3 and 5 recite a canine filariasis control agent for an animal, comprising the benzimidazole compound or a salt thereof according to claim 1 or claim 2, respectively, as an active ingredient. In the instance of claims 3 and 5, the preambular recitation of a “canine filariasis control agent for an animal” is not afforded patentable weight and is not regarded as further limiting the invention. This preambular recitation does not clearly limit the compositional makeup of the agent in any way, and is thus regarded as a mere statement of purpose or intended use. As such, claim 3 is regarded as effectively being directed only to a benzimidazole compound or salt thereof according to claim 1 or claim 2. Savall thus anticipates claims 3 and 5 for the same reason as described above for claims 1 and 2.
Allowable Subject Matter
Claims 4 and 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 4 and 6-8 are directed to various methods of using a canine filariasis control agent for an animal, or of controlling canine filariasis, all involving a step of administering an effective amount of a benzimidazole compound of claim 1 or claim 2 to the animal. Savall, which is directed to chemical synthetic methods, neither teaches nor suggests administration of a disclosed benzimidazole compound to an animal.
It is noted, however, that while claims 1 and 2, as presently written, encompass a very large number of compounds (conservatively, well into the millions), the instant disclosure expressly provides in vitro evidence of anti-filarial activity for only twelve of them, and those twelve do not necessarily exemplify the full scope of structural variation within the genera of claims 1 and 2. While this scenario would potentially raise an issue under 35 U.S.C. § 112(a), no evidence has been found in the art to suggest that variation of the substituents on the benzimidazole core structure would be likely to abrogate anthelmintic activity generally, or anti-filarial activity specifically. For this reason, no rejections under 35 U.S.C. § 112(a) are entered at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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