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 § 103
Applicant’s arguments have been carefully considered, but have not been found to be persuasive. In fact, they were already briefly addressed in the Advisory action dated 3/11/2026, to which Applicant’s ongoing arguments lend no further credence.
First, the Examiner already addressed that Applicant’s hypothetical arguments on trying to rebut an “obvious to try” rationale completely miss the mark, because this is not the rationale, which was applied. The office action states so in clear language, and the Advisory action reaffirms this. Therefore, the Examiner will not be rebutting any hypothetical arguments on what Applicant continues to argue against, and which are not based on the record.
Second of all, the Examiner has been ongoing surprised, to say the least, to be taught by Applicant basics on obviousness law, such as the Graham factors. The Graham factors were all applied, and the office action itself is a clear testimony to that.
Third, it serves no legitimate purpose on this record for Applicant to be arguing that the Examiner based its obviousness rationale on a single sentence. She did not. She applied two full lengthy paragraphs of analysis, which build on this obviousness rationale applying the Graham factors, and articulated in detail why obviousness applies with specific factual underpinnings. Applicant is further reminded that motivation to combine need not be for the reasons contemplated by the inventor. This motivation need not be express and may flow from the prior art references themselves, the knowledge of one of ordinary skill in the art, or from the nature of the problem to be solved. Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed. Cir. 2000). See also In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) ("As long as some motivation or suggestion to combine the references is provided by the prior art taken as a whole, the law does not require that the references be combined for the reasons contemplated by the inventor."). See also In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996) (“[T]he motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness.”).
In support of this position, the Examiner of this position, the Examiner restates the two full paragraphs from the office action:
“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.”
Last but not least, Applicant is reminded again that the transitional phrase “comprising”, used in Applicant’s claims, is open-ended, and does not preclude the presence of additional ingredients, e.g. a sweet receptor antagonist with the bitter agent denatonium salt. Short of attorney argument, Applicant presents no factual underpinnings whatsoever, that this sweet receptor antagonist is required for the treatment of a hyperphagia disorder/ Prader-Willi syndrome, and that its removal from the formulation would somehow not be considered to treat the disorder/ syndrome, particularly where as here the combination of the prior art is that of a recited bitter agent with a sweet receptor antagonist, and where as such the latter agent appears to be involved in nothing else than taste masking.
Therefore, the Examiner has met her burden of proof, and Applicant has presented no legitimate argument, based on the law on facts, to rebut her prima facie case of obviousness. For the foregoing reasons, the rejections are still deemed to be proper, and are maintained.
Claims 31-40 and 42-48 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31-40 and 42-48 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, 42, 44 and 45), 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 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, 40 and 46, 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 claims 38 and 48, 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 claims.
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, 39 and 47, 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").
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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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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