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 .
Response to Arguments
Applicant’s response from 12/9/2025 is acknowledged.
Claim Rejections - 35 USC § 102
Applicant has amended the claims, and made arguments over the claims as amended. In view of Applicant’s claim amendments a modified rejection under 35 U.S.C. 103 has been made below.
Claim Rejections - 35 USC § 112
Applicant’s arguments have been considered, and have been found to be persuasive, in accordance with which the rejection is hereby withdrawn.
Claims 31-44 are pending, and have been examined herewith.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31-44 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0374489 A1 to Lee (hereinafter "Lee").
Regarding claims 31, 43, and further claims, which recite that the denatonium salt is denatonium acetate ((DA), claims 34, 35, 37-39, 41, 42 and 44), Lee teaches a method for treatment, or slowing down exacerbation of Prader-Willi syndrome, as well as of obesity that it is associated with, comprising administering orally a pharmaceutic composition comprising a denatonium salt, wherein the denatonium salt is selected from the group consisting of denatonium acetate (DA) denatonium citrate, denatonium maleate, denatonium saccharide, and denatonium tartrate (para [0149], “A clinical use for a combination orally ingested tablet or pill containing a bitter agent in combination with a sweet receptor antagonist beyond obesity is Prader-Willi Syndrome. Among the key hallmarks of this genetic disorder is a constant hunger drive and a lack of sense of satiety even after eating copious amounts of food. Therefore, the present disclosure provides a method for treating Prader-Willi Syndrome (PWS) comprising an anti-obesity oral formulation comprising (a) a bitter agent selected from the group consisting of denatonium benzoate (DB), denatonium chloride, denatonium saccharide, quinine, chloroquine, cromolyn, diphenidol, amarogentin, apomorphine, parthenolide, camphor, arborescin, artemorin, divinyl sulfoxide, picrotoxinin, aristolochic acid, falcarindiol, 3-caffeoylquinic-1,5-lactone (3-CQL), chlorogenic acid (CGA), and combinations thereof; (b) a sweet antagonist selected from the group consisting of lactisole, gymnemic acid, ziziphin, hodulcine, and combinations thereof; and (c) pharmaceutical excipients to facilitate a sustained release during transit through the GI tract.”; para [0013],"The present disclosure further provides a method for effecting weight loss, comprising administering an anti-obesity oral formulation comprising a bitter agent selected from the group consisting of denatonium salts including benzoate (DB)... acetate (DA), citrate (DCI), saccharide (DS), tartarate (DT), maleate (DM)... combinations thereof...").
With the amendment dated 12/09/2025 Applicant has deleted from claim 31 denatonium saccharide, and argued that in paragraph [0149], which specifically relates to a method for treating Prader-Willi Syndrome, there is only mention of “denatonium benzoate (DB), denatonium chloride, denatonium saccharide”, and that there is also language “[a] clinical use beyond obesity is Prader-Willi Syndrome”. The Examiner notes that this may be so, but that that the language “beyond obesity” in this particular context needs to be reads as “in addition to” to treatment of obesity, the method is further for treating Prader-Willi Syndrome. This is explicitly made evident by the follow-up sentence set out in bold in the preceding paragraph, which specifically discloses that the method for treating Prader-Willi Syndrome is with “an anti-obesity formulation”. There is no disclosure in Lee, which somehow sets the anti-obesity ingredients of denatonium salts as having different weight loss/ anti-obesity properties, based on which it is reasonable to conclude that the broader teachings of an anti-obesity oral formulation comprising a bitter agent selected from the group consisting of denatonium salts including benzoate (DB)... acetate (DA), citrate (DCI), saccharide (DS), tartarate (DT), maleate (DM)... combinations thereof... applied to the method of treating of Prader-Willi syndrome. In the alternative, it would have been obvious to a person of skill in the art, motivated by the above considerations, to use the broader group of denatonium salts of Lee for treating Prader-Willi syndrome with a reasonable expectation of success.
Regarding claims 32 and 40, Lee teaches the method of claim 1, wherein the pharmaceutical composition further comprises from about 0.5 g to about 5 g acetic acid (para (0010), "Preferably the dosage per day for an adult of the organic acid is from about 0.5 g to about 5 g... Most preferably, the organic acid is acetic acid"; para [0149], " Preferably, the oral formulation further comprises an organic acid selected from the group consisting of acetic acid...").
Regarding claims 33-35 and 39, Lee teaches the method of claim 1, wherein the daily dosage of the denatonium salt for an adult is from about 20 mg to about 5000 mg (para [0013], "... denatonium salts including... acetate (DA)... Preferably the daily dosage of DA or DC for an adult is from about 10 mg to about 400 mg..."). Regarding claim 38, for an average 70 kg man about 20 mg to about 5000 mg translates to about 0.29 mg/kg to about 71.43 mg/kg, which discloses an overlapping range with that of Applicant’s claim.
Regarding claim 37, Lee teaches wherein the denatonium salt is DA and the DA is administered in a daily dosage to achieve a concentration in the GI tract of from about 10 parts per billion to about 50 ppm. (claim 7, “ The anti-obesity formulation of claim 6, wherein the daily dosage of the denatonium salt for an adult is from about 10 mg to about 100 mg, or to achieve a concentration in the GI tract of from about 10 parts per billion to about 10 ppm”); which claim ultimately depends from claim 1: “An anti-obesity oral formulation comprising a bitter agent selected from the group consisting of denatonium salts including benzoate (DB), chloride (DC), acetate (DA), citrate (DCl), saccharide (DS), tartarate (DT), maleate (DM), 3-caffeoylquinic-1,5-lactone (3-CQL), chlorogenic acids (CGA), combinations thereof.”).
Regarding claims 36 and 39, Lee teaches the method of claim 1, wherein the daily dose of the denatonium salt is administered once per day, twice per day or three times per day (para [0157], "To ensure the adequate effect of the DB combination, 60 umol/kg (26.8 mg/kg) once daily for DB in the first two weeks of the study was used, and then switched to twice daily in the last two weeks of the study").
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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