12/09DETAILED 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 .
Status of the Application
Claims 11-30 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 12/09/2025 are acknowledged. Claims 28-29 are amended. Claims under consideration in the instant office action are claims 11-30.
Applicants' arguments, filed 12/09/2025, have been fully considered but they are not deemed to be persuasive regarding the rejection of claims 15-19, 21-25, and 28-30 under 35 USC 103. The arguments regarding the rejection of claims 11-13 and 26-27 under 35 USC 102 have been considered and are deemed to be persuasive, and the rejection is withdrawn. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 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.
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 11-13, 15-19, 21-25, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Baron et al. (US 2019/0038576, as disclosed in IDS) in view of Cumming (US 2017 /0067002, as disclosed in IDS).
Baron et al. teaches “methods for treating conditions associated with a chemosensory receptor, including diabetes, obesity, and other metabolic diseases, disorders or conditions by administrating a composition comprising a chemosensory receptor ligand, such as a bitter receptor ligand.” (see abstract). Baron et al. teaches a method of weight loss (paragraph 0008). Baron et al. teaches denatonium benzoate as an exemplified bitter receptor ligand and citric acid as an exemplified sweet receptor ligand (paragraphs 0408, 0451). Baron et al. teaches such compositions in the form of a capsule (paragraph 0485). Baron et al. teaches oral formulations further comprising talc (paragraph 1225). Baron et al. teaches subjects that are afflicted with Prader-Willi syndrome (PWS) (paragraph 1163). Baron et al. teaches dosages of about 0.01 to about 100 mg/kg (paragraph 1137). Baron et al. teaches administration at a frequency of one to three times per day (paragraph 1633).
Baron et al. does not teach a method of effecting weight loss wherein denatonium acetate is administered.
Cumming is drawn towards compositions comprising aversive agents such as bittering agents (see abstract; paragraph 0002). Cumming teaches denatonium acetate as a suitable bittering agent (paragraph 0036).
It would have been obvious to one of ordinary skill in the art to effect weight loss wherein denatonium acetate is administered, as suggested by Cumming, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Baron et al. teaches that weight loss can be effected by the administration of bitter receptor ligands (see abstract; paragraph 0008), and denatonium acetate is a suitable bittering agent as taught by Cumming (paragraph 0036), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Regarding claims 15-17, 19, 21, 23-24, and 30, even though the range for dosages as taught by Baron et al. is not the same as the claimed dosages, Baron et al. does teach an overlapping range of dosages, and it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of dosages is well within the purview of those skilled in the art through routine experimentation, and it has been held that “it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the dosage in order to increase the efficacy of denatonium acetate.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
When the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope (i.e. claim 22). Additionally, when the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the therapeutic profile, as they are a direct result of the components of the composition and the mode of administration which are met by the art, whereby the resulting properties and effects would intrinsically be met. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). (MPEP 2111.04 I).
Response to Arguments
Applicant argues that “Nothing in Baron would lead a person of ordinary skill in the art to select and further modify either denatonium benzoate or denatonium saccharide to arrive at Applicant's claim 11.” The Examiner respectfully disagrees since Baron et al. teaches “methods for treating conditions associated with a chemosensory receptor, including diabetes, obesity, and other metabolic diseases, disorders or conditions by administrating a composition comprising a chemosensory receptor ligand, such as a bitter receptor ligand.” (see abstract). Although Baron et al. does not disclose denatonium acetate as a bitter receptor ligand, Cumming is drawn towards compositions comprising aversive agents such as bittering agents (see abstract; paragraph 0002). Cumming teaches denatonium acetate as a suitable bittering agent (paragraph 0036). One of ordinary skill in the art would have thus been motivated to select denatonium acetate based on the teachings of Baron et al. and Cumming.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that “Baron does not disclose sour anions and nowhere in Baron is it suggested that either denatonium benzoate or denatonium saccharide is a denatonium salt that comprises a sour anion. Further, there is no teaching or suggestion that either the benzoate or saccharide anion should be replaced with a different anion, much less with a sour anion. Cumming does not remedy this deficiency.” The Examiner respectfully disagrees since Baron et al. teaches bitter receptor ligands generally, and one of ordinary skill in the art would have been motivated to use denatonium acetate in the method of effecting weight loss disclosed by Baron et al. based on the teachings of Cumming.
Applicant also argues that “The Office has failed to provide evidence that a person of ordinary skill would have been motivated to modify the denatonium salt of Baron by replacing the benzoate anion with an acetate anion, which is a component of one of the hundreds of bittering agents disclosed in Cumming.” The Examiner respectfully disagrees since Cumming is relied on the teaching of the suitability of denatonium acetate as a suitable bittering agent (paragraph 0035), and is disclosed among a small group of denatonium salts totaling six. One of ordinary skill in the art would have thus been motivated to try denatonium acetate.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 11-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,835,505.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar methods of effecting weight loss comprising administering a bitter agent. U.S. Patent No. 10,835,505 is drawn towards formulations comprising a bitter agent selected from denatonium acetate, denatonium citrate, and denatonium maleate. U.S. Patent No. 10,835,505 teaches a method for effecting weight loss comprising a bitter agent selected from denatonium salts.
U.S. Patent No. 10,835,505 does not recite administering a denatonium salt that comprises a sour anion.
It would have been obvious to one of ordinary skill in the art to administer administering a denatonium salt that comprises a sour anion, as suggested by U.S. Patent No. 10,835,505, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since U.S. Patent No. 10,835,505 recites a method of effecting weight loss wherein an overlapping genus of denatonium salts are administered, with a reasonable expectation of success absent evidence of criticality of the particular steps.
Allowable Subject Matter
Claims 14 and 20 appear free of the prior art.
The following is a statement of reasons for the indication of allowable subject matter: claims 14 and 20 recite a formulation further comprising acetic acid, which is not obvious or anticipatory over the prior art.
Conclusion
Claims 11-30 are rejected.
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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691