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
This Application is a 371 of PCT/KR2022/006613, filed May 10, 2022 and claims foreign priority benefit of KR10-2021-0060942, filed May 11, 2021 in the Republic of Korea.
Claim Status
Claims 1-13 and 15 are currently pending and subject to examination.
Claim Rejections – Withdrawn
The rejection of claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn.
The above rejection is withdrawn as moot because claim 14 was cancelled.
The rejection of claim(s) 1-2, 4, 6-8, 10, and 13-15 under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US 12,338,237 B2) is withdrawn.
The rejection of claim(s) 1-2, 4, 6-8, 10, and 12-15 under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 12,338,237 B2) as applied to claims 1-2, 4, 6-8, 10, and 13-15 above is withdrawn.
The above rejections are overcome by Applicant’s statement of common ownership invoking the prior art exception under 35 U.S.C. 102(b)(2)(C).
The rejection of claim(s) 1-2, 4, 6-8, 10, and 12-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,338,237 B2 (herein “the ‘237 patent”) is withdrawn.
The rejection of claim(s) 1-2, 4-8, and 10-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,338,237 B2 (herein “the ‘237 patent”), as applied to claims 1-2, 4, 6-8, 10, and 12-15 above, in view of McCurdy & Cohen (“Bioisosterism”, Drug Design Org, Feb. 2007, p. 1-138) is withdrawn.
The rejection of claim(s) 1-3, 6-9, and 12-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. US 12,522,602 B2 (herein “the ‘602 patent”), as applied to claims 1-3, 6-9 and 15 above, and further in view of Borque et al. (WO 2012/129084 A2) (of record IDS cite no. 7) is withdrawn.
The above rejections were overcome by Applicant’s filing of an approved terminal disclaimer on May 26, 2026.
Claim Rejections – 35 U.S.C. 102– Previously Presented
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.”
The rejection of claim(s) 1-3, 6-9, 12-13 and 15 under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US 12,522,602 B2) is maintained.
Response to Arguments
The Applicant is required to reply to every ground of rejection in the prior Office Action (37 CFR 1.111). The reply filed on May 26, 2026 did not reply to the above ground of rejection and the period for reply has expired. Therefore, the rejection is maintained.
Reiterated Rejection
Claim(s) 1-3, 6-9, 12-13 and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US 12,522,602 B2).
The applied reference has common inventor(s) and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1 is directed towards a compound of formula 1:
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.
Kim teaches an overlapping genus:
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Kim, Specification, col. 4; subject matter of claim 1.
and species of compounds falling within the genus of formula 1. For example: (S)-quinuclidin-3-yl (5-(3-chloro-4-isopropoxyphenyl)-2,2- dimethyl-2,3-dihydro-1H-inden-1-yl)carbamate (Kim, Specification, col. 10, lines 28-29; claim 15). This compound has the following structure, falling within claim formula 1:
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(drawn by examiner).
Therefore, claim 1 is anticipated.
Claims 2-3, 6-9 and 12 read on this compound and are also anticipated for the reasons given in the rejection of claim 1.
Claim 13 is directed towards a pharmaceutical composition comprising the compound as claimed in claim 1 as an active ingredient. Claim 14 is directed towards a pharmaceutical composition as in claim 13, for preventing or treating Gaucher disease, Fabry disease, Tay-Sachs disease or Parkinson’s disease.
Kim teaches a pharmaceutical composition comprising the compound as in claim 1 as an active ingredient, and the indications Gaucher disease, Fabry disease, Tay-Sachs disease or Parkinson’s disease:
[T]he present invention includes, within its scope, a pharmaceutical composition for inhibiting glucosylceramide synthase (GCS), comprising a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof as an active ingredient. In an embodiment, the present invention provides a pharmaceutical composition for preventing or treating the diseases associated with GCS, such as Gaucher disease, Fabry disease, Tay-Sachs disease, Parkinson's disease, etc., comprising a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof as an active ingredient.
Kim, Specification, col. 22, lines 56-67; subject matter of claims 16-17.
Therefore, claims 13-14 are anticipated.
Claim 15 is directed towards a method for inhibiting glucosylceramide synthase in a mammal, comprising administering a therapeutically effective amount of the compound of claim 1 to the mammal in need thereof.
Kim teaches a method for inhibiting glucosylceramide synthase in a mammal, comprising administering a therapeutically effective amount of the compound of claim 1 to the mammal in need thereof:
The present invention includes, within its scope, a method for inhibiting glucosylceramide synthase (GCS) in a mammal, comprising administering a therapeutically effective amount of the compound of Formula 1 or pharmaceutically acceptable salt thereof to the mammal in need thereof.
Kim, Specification, col. 23, lines 50-54; subject matter of claim 18.
Therefore, claim 15 is anticipated.
Claim Objections – Dependent upon Rejected Base Claim
Claims 4-5 and 10-11 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.
Conclusion
Claim(s) 1-3, 6-9, 12-13 and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US 12,522,602 B2).
Claims 4-5 and 10-11 are objected to.
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 extension fee 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 HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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