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 .
This is the First Office Action on the Merits of US 18/557182 filed on 10/25/2023
which is a 371 of PCT/US2022/026381 filed on 04/26/2022 which claims US priority benefit of US Provisionals 63/305,037 filed on 01/31/2022, 63/245,925 filed on 09/19/2021, 63/229,499 filed on 08/04/2021 and 63/180,224 filed on 04/27/2021.
Election/Restrictions
Applicant’s election without traverse of invention Group I (e.g., claims 1-7, and 21-26) in the reply filed on May 26, 2026 is acknowledged.
Claims 8, 10, 12-14, and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 26, 2026.
Applicant’s election without traverse of Species (A) denatonium acetate, and Species (B) sitagliptin in the reply filed on May 26, 2026 is acknowledged. During search for the present claims, the species (A) denatonium saccharide was found in the prior art and is rejoined and examined along with species denatonium acetate.
Claims 22, 23 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 26, 2026.
Claims 9, 11, 15-18 are canceled. Claims 1-8, 10, 12-14, and 19-26 are pending.
Claims 8, 10, 12-14, 19-20, 22, 23 and 25 are withdrawn.
Claims 1-7, 21, 24, and 26 are under examination in this office action.
Information Disclosure Statement
The IDS statements filed on 10/13/2025 and 05/15/2024 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 21, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the denatonium salt" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 21 depends from claim 1 which does not recite a denatonium salt .
Claim 24 is indefinite because it depends from claim 22 and recites that the gut-signaling compound is sitagliptin (the elected species). Claim 22 does not provide antecedent basis for sitagliptin because sitagliptin is not a GLP-1 receptor agonist but rather is a dipeptidyl peptidase-4 (DPP-4) inhibitor class compound. Also, please note that claim 24 depends from a withdrawn claim. It would be remedial to change the dependency of claim 24 to a non-withdrawn claim which provides proper antecedent basis for the limitation of sitagliptin.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) 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. Claim 24 fails to include all the limitations of the claim upon which it depends because claim 24 depends from claim 22 which requires a GLP-1 receptor agonist whereas claim 24 recites a sitagliptin which is not a GLP-1 receptor agonist. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-2, 5, 7, 21, and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claims 1-2, 5, 7, 21, and 26 are drawn to a pharmaceutical composition comprising a “gut-signaling compound”. Thus, claims require the critically essential element of a genus of gut-signaling compounds. While showing possession for the compounds listed in dependent claims 3 and 4, neither the instant specification nor the state of the prior art provide a representative set of gut-signaling compound structures outside the subgenus of dependent claims 3 and 4 so that one of ordinary skill in the art would be able to envision whether a given compound structure would possess the property of being a gut-signaling compound.
For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. The MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not a sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as be structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXlS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
One cannot describe what one has not conceived. See Fiddles v. Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. For example, adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of isolating a compound. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4, 6-7, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baron et al (US2012/0177730 published July 12, 2012).
Regarding claim 1, Baron et al discloses a pharmaceutical composition comprising a combination of a bitter receptor agonist and a gut-signaling compound. For example, the Abstract recites a pharmaceutical composition comprising a bitter receptor agonist composition. In para 0405 the bitter receptor agonist is specified as denatonium saccharide. In para 1209 the composition having the bitter receptor agonist also includes a glucose lowering compound. In para 1211 the glucose-lowering compound is specified as sitagliptin. (See Abstract; para 405, 1209, 1211 just below.)
[Abstract] Provided herein are 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. Also provided herein are chemosensory receptor ligand compositions, including bitter receptor ligand compositions, and methods for the preparation thereof for use in the methods of the present invention. Also provided herein are compositions comprising metformin and salts thereof and methods of use.
[0405] In another aspect, the compositions described herein comprise a bitter receptor ligand selected from Denatonium benzoate, Denatonium saccharide, glycyrrhizic acid ammonium salt, Epigallocatechin, Epigallocatechin gallate, hyperforin, coptisine chloride, allyl methyl sulfide, rotterlin, curcumin, ellagic acid and embelin wherein the composition is adapted to release a therapeutically effective amount of the ligand to one or more regions of the intestine of a subject.
[1209] In another aspect, compositions of the embodiments described herein may be administered in combination with glucose-lowering compounds.
[1211] Drugs that decrease glucose level include but are not limited to glipizides, glyburides, exenatide (Byetta.RTM.), incretins, sitagliptin (Januvia.RTM.), pioglitizone, glimepiride, rosiglitazone, metformin, vildagliptin, saxagliptin (Onglyza.TM.), sulfonylureas, meglitinide (e.g., Prandin.RTM.) glucosidase inhibitor, biguanides (e.g., Glucophage.RTM.), repaglinide, acarbose, troglitazone, nateglinide, natural, synthetic or recombinant insulin and derivatives thereof, and amylin and amylin derivatives. In certain instances, chemosensory receptor ligand compositions provided herein are used in combination with biguanides. Biguanides include metformin, phenformin, buformin and related compounds. In certain instances, chemosensory receptor ligand compositions provided herein are used in combination with metformin.
In addition, Baron et al disclose several working examples using pharmaceutical compositions comprising sitagliptin. (See Examples 1-10.)
Regarding claim 2, Baron et al discloses that the bitter receptor agonist may be denatonium saccharide which is a rejoined species of instant claim 2. Baron et al does not explicitly teach denatonium acetate. (See para 405.)
Regarding claim 3, Baron et al discloses that the gut-signaling compound is a DPP-4 inhibitor, specifically a sitagliptin. (See para 1211 & Examples 1-10.)
Regarding claim 4, Baron et al discloses sitagliptin. (See para 1211 & Examples 1-10.)
Regarding claim 6, Baron et al discloses that the gut-signaling compound is sitagliptin.
Regarding claim 7, Baron et al discloses a pharmaceutically acceptable carrier. (See Abstract; para 405, 1209, 1211, Examples 1-10.)
Regarding claim 21, Baron et al discloses that the bitter receptor agonist may be denatonium saccharide which is a rejoined species of instant claim 2. Baron et al does not explicitly teach denatonium acetate. (See para 405.)
Thus, Baron et al anticipates claims 1-4, 6-7, and 21.
Claim(s) 1, 3, 4, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baron et al (US 20130177604, published July 11, 2013).
Regarding claims 1, 3, 4, 6, and 7, Baron et al disclose a pharmaceutical composition comprising sitagliptin and a bitter receptor ligand. See para 0029:
[0029] The methods disclosed herein may also further comprise the administration of an immediate-release, extended release or delayed-release formulation of one or more additional therapeutic agents, e.g., a DPP-IV inhibitor (e.g., sitagliptin, saxagliptin, berberine, vildagliptin, linagliptin, alogliptin, and the like), a chemosensory receptor ligand (e.g., a sweet receptor ligand, bitter receptor ligand, umami receptor ligand, sour receptor ligand, fat receptor ligand or bile acid receptor ligand), an anti-obesity or anti-diabetes agent, or a chemosensory receptor antagonist, e.g., lactisole. Non-limiting examples include embodiments further comprising the administration of 100 mg sitagliptin OD, or 50 mg sitagliptin BID. The delayed-release formulation can be a bilayer tablet, or a capsule with the two components as encapsulated mini-tablets. The delayed-release formulation may also further comprise an immediate release component that has a pH 5.0 enteric coating for the additional therapeutic agent.
Thus, Baron et al anticipates claims 1, 3, 4, 6, and 7.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 1-7, 21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Baron et al (above) in view of Lee et al (US2019/374489, published 12/12/2019; IDS ref)
Baron et al anticipates claims 1-4, 6-7, and 21 for reasons provided above.
Regarding claims 2, 5, 21, and 26, Baron et al differs from these claims because although it discloses the species of bitter receptor agonist being denatonium saccharide, in that it does not explicitly disclose that the bitter receptor agonist is denatonium acetate (DA).
Lee et al disclose oral pharmaceutical formulations for treating obesity comprising the bitter receptor agonist compounds of denatonium salts, including denatonium acetate and denatonium saccharide. (See Abstract; para 0009.) Lee et al disclose denatonium acetate is a preferred embodiment. (See Example 7; ref claims 8-19.)
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to use denatonium acetate as the type of bitter receptor agonist in a pharmaceutical composition comprising sitagliptin for the rationale of treating a patient for a glucagon-related condition such as Type II diabetes, obesity, or hyperlipidemia.
It would have been obvious for one of ordinary skill in the art to combine sitagliptin and either of the bitter receptor agonists denatonium acetate or denatonium saccharide in a pharmaceutical because Baron et al explicitly suggests combining a bitter receptor agonist in a pharmaceutical composition for treating diabetes and obesity together with sitagliptin and specify denatonium saccharide as a preferred type of bitter receptor agonist. Further, Lee et al disclose that oral pharmaceutical formulations for treating obesity comprising the bitter receptor agonist compounds of denatonium salts, including denatonium acetate and denatonium saccharide. (See Abstract; para 0009.) It would have been obvious to use the bitter receptor agonist compounds of denatonium salts, including denatonium acetate and denatonium saccharide as disclosed in Lee et al because Lee et al disclose denatonium acetate is a preferred embodiment in an oral pharmaceutical for use in treating obesity. (See Example 7; ref claims 8-19.)
In view of the high skill in the art it is considered that one of ordinary skill in the art having the cited references before the effective filing date would have had a reasonable expectation of success to make a pharmaceutical containing the known sitagliptin and a bitter receptor agonist, and specifically either of denatonium saccharide or denatonium acetate, to arrive at the presently claimed invention.
Thus, the claims as a whole are rendered obvious over the cited references.
Conclusion
No claim is allowed.
Related prior art which may be applied in a future office action if appropriate:
Goddard et al (WO 2011/160093; IDS ref)
Zheng et al (WO 2021/062061 published April 1, 2021.) This has same Assignee & inventors Zheng & Lee so qualifies for 102(b)(1)(A) & 102(b)(2)(C) exceptions.
Souter et al (US 20170067001.) See para 0050:
[0050] Non-limiting examples of suitable bittering agents include denatonium salts and derivatives thereof. The bittering agent may be a denatonium salt selected from the group consisting of denatonium chloride, denatonium citrate, denatonium saccharide, denatonium carbonate, denatonium acetate, denatonium benzoate, and mixtures thereof. The bittering agent may be denatonium benzoate, also known as phenylmethyl-[2-[(2,6-dimethylphenyl)amino]-2-oxoethyl]-diethylammonium benzoate, CAS no. 3734-33-6. Denatonium benzoate is commercially sold as BITREX®, available from Macfarlan Smith, Edinburgh, Scotland, UK.
Elekofehinti et al (Pathophysiology 2018 Vol 25 pages 327-333). Elekofehinti et al disclose that bitter melon (Momordica charantia) contains cucurbitacin (GLP-1r agonist) and charantin (DPP-4 inhibitor) and shows antidiabetic properties.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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