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 .
DETAILED ACTION
Claim 1-2 are pending
Receipt and consideration of Applicants' remarks/arguments filed on 04/30/2026 is acknowledged and have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Gan et al. (WO 2024/235165 and its English equivalent AU 2024271467 (provided as NPL) priority date: 5/12/2023. 9/22/2023, 11/17/2023, 1/8/2024 and 2/1/2024)
Instant claims are drawn A compound and a pharmaceutically acceptable salt thereof, wherein the compound is selected from the group consisting of (R)-N-(8-(7-fluoro-1-methyl-2- oxo-1,2,3,4-tetrahydroquinolin-6-yl)-3,4-dihydro-2H-pyrano[3,2-c]pyridin-4-yl-4- d)propionamide and (R)-N-(8-(7-fluoro-1-methyl-2-oxo-1,2,3,4-tetrahydroquinolin-6- yl)-3,4-dihydro-2H-pyrano[3,2-c]pyridin-4-yl)propionamide (of the following structures) and a pharmaceutical composition comprising these compounds and a pharmaceutically acceptable excipient.
Compound 4 and Compound 8 from the instant disclosure.
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Gan et al. discloses nitrogen-containing heterocyclic compounds which includes the instantly claimed compounds ([0260], page 38, 7th row, 3rd compound, Claim 22, page 168 , 5th row,2nd compound)
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They further provides a use of the above compound, a stereoisomer thereof, or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for treating a disease associated with an aldosterone synthase inhibitor [0261]. They disclose their compounds prepared for oral administration comprising 20% PEG400, 10% solutol and 70% water which anticipates the pharmaceutical composition claimed in instant claim 2
Therefore the compounds and composition disclosed by Gan et al. fully anticipates instant claims 1-2.
Response to Arguments - 35 USC § 102
Applicants traverse the above rejection with the following arguments:
1. The Gan compound was drawn out of an extensively broad genus structure (shown below):
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Even the narrower subgenus (out of more than a dozen) potentially encompasses countless numbers of compounds (see also paragraph [0246]):
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Gan described the synthesis of 40 compounds and tested less than half of them for biological activities. The Gan compound is not one of them. Rather, it was merely drawn as one of the more than 150 compounds in the same paragraph [0260] cited by the Examiner.
2. There is no other description of the Gan compound in Gan. Without description or guidance as to how it might have been synthesized (most of the examples belong to different subgenera), how the stereochemistry might be obtained or resolved, or whether it has any biological activities, the public could not have been in possession of the Gan compound at the time of the present invention.
First, it is noted the instantly claimed compounds as noted in the above rejection is explicitly recited by Gan et al.. Regardless, however, the fact that these compounds are listed among 150 other compounds used to treat similar conditions does not negate the fact that Gan et al. . expressly and unequivocally identifies these two compounds.. Applicant is reminded that a reference that clearly names the claimed species anticipates the claim no matter how many other species are named. Please reference MPEP §2131.02, which states, "A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Exparte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that 'the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds as described” as that term is used in 35 U.S.C. §102(a), in that publication'). Id. at 1718. See also In re Simvaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982). See also In re Simvaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982)."
Gan et al. accordingly expressly discloses the instantly claimed claimed specie with activity and as such anticipates the instant claims and the anticipation rejection is maintained.
Conclusion
Claims 1-2 are rejected. No claims are allowed
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA M RAO whose telephone number is (571)270-5315. The examiner can normally be reached on M-F 8.30 am -4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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