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 .
Priority
This application, filed on October 23, 2024, is a continuation application of International Application No. PCT/US23/20279, filed April 27, 2023, which claims benefit under 35 U.S.C. 119(e), 120, and/or 365 to US Provisional Application No. 63/335,701, filed on April 27, 2022.
Information Disclosure Statement
The information disclosure statements (IDSs) filed on October 23, 2024 and June 10, 2026 have been acknowledged and considered.
Specification Objections
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means,” “said,” “comprising,” and “selected from the group consisting of” should be avoided.
The abstract recites phrases that can be implied: “There is disclosed” and “There is further disclosed.” The abstract recites legal phraseology: “comprising” and “selected from the group consisting of.” The abstract has more words than the maximum amount allowed.
Appropriate correction is required. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The disclosure is objected to because of the following informalities: there is a typographical error on page 11, line 15 of the instant specification.
The word “anhydropus” is recited where it should be read as “anhydrous.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 4-5 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 1 recites, “a bitter-agonist compound selected from the group consisting of denatonium salts, denatonium acetate (DA)…”
Claim 4 recites, “denatonium acetate monohydrate (DA).”
Thus, claims 1 and 4 use the shorthand “(DA)” to refer to different compounds.
Claim 4 depends indirectly from claim 1.
Claim 5 depends directly from claim 4 and indirectly from claim 1.
Claim 5 recites, “(DA)” and “DA.”
Claim 1 is indefinite because it recites “denatonium salts” as a broad genus and proceeds to recite species of that genus. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “denatonium salts”, and the claim also recites species of denatonium salts. The claim is considered indefinite because there is a question or doubt as to whether the composition (a) includes alternative denatonium salts, other than the species recited, or (b) includes merely the species recited. Examiner recommends omitting the recited species and maintain the recitation of the genus “denatonium salts” as a class of bitter agonist compounds, as claim 2 recites the same species.
Claim 4 is indefinite because it repeats the shorthand “(DA)” for a different compound, i.e., “denatonium acetate monohydrate,” than the one initally introduced in claim 1, i.e. “denatonium acetate”.
Claim 5 is indefinite because it uses the same shorthand to refer to different compounds. Further, it is unclear why the shorthand DA is recited with and without a parenthetical; i.e., it is unclear what significance that distinction implies.
Appropriate correction is required for the rejected claims.
Claim Rejections - 35 USC § 102
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN1820752 (Cite No. 1 in IDS filed June 10, 2026 - Translated Version) (“Liang”).
Claim 1 recites a composition comprising a controlled pharmaceutical substance selected from codeine, fentanyl, etc., at least two gel forming excipients selected from a water soluble anionic polysaccharide, carboxymethylcellulose, etc., and a bitter-agonist compound selected from chlorpheniramine, famotidine, etc. The instant specification includes Xantural as one of the preferred excipients, i.e., xanthan gum (Spec., p. 8, lines 15-20).
Liang teaches a composition comprising codeine phosphate (controlled pharmaceutical), chlorpheniramine malaxate (bitter-agonist), carboxymethylcellulose (gel-forming excipient), and xanthan gum (water-soluble anionic polysaccharide gel-forming excipient) (p.6, Embodiment 7). Although Liang does not characterize the composition as “abuse-deterrent,” the composition contains the required components of instant claim 1 and therefore one of ordinary skill in the art would consider the composition as being capable of being abuse-deterrent. Further, “abuse-deterrent” is intended use language in the preamble and is not given much patentable weight because it does not provide further structure to the composition (MPEP §2111.02).
Accordingly, claim 1 is anticipated by Liang.
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.
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 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Liang in view of Bloxham et al., Front. Physiol. 11:431 (“Bloxham”), further in view of WO2020010166 (“Lee”).
Liang teaches an oral liquid sustained-release preparation that contains codeine and chlorpheniramine. Liang teaches Embodiment 7 which includes codeine phosphate, chlorpheniramine malaxate, carboxymethylcellulose, and xanthan gum (p. 6, Embodiment 7). Liang teaches the oral liquid sustained-release preparation contains codeine and chlorpheniramine, in the range of 0.01%-5.0% of codeine and 0.001%-5.0% of chlorpheniramine (p.2, Summary of the invention).
Liang does not teach the specifically claimed bitter agents: denatonium salts like denatonium benzoate or denatonium acetate.
Bloxham teaches a list of ligands known to activate cardiac specific type II taste receptor cells (T2R) proteins which act as sentinels to protect against ingestion of potentially toxic substances (p. 1, Extra-Oral Expression of Bitter T2Rs). Bloxham states: “According to the HGNC database, there are 39 genetically diverse and highly polymorphic TAS2R single exon genes that encode for 29 functional T2Rs (and 10 non-coding pseudogenes) in humans.” (pp. 7-8, Naturally Occurring Polymorphisms and Disease). Table 3 shows chlorpheniramine and denatonium benzoate both activate T2R 4, 10, 39, and 46 polymorphs.
Bloxham does not teach denatonium acetate.
Lee teaches oral formulations comprising a bitter agent selected from the group consisting of denatonium benzoate (DB), denatonium chloride (DC), denatonium saccharide (DS), denatonium acetate (DA), and combinations thereof, and formoterol (p. 1, lines 6-9). The amount of bitter agent is preferably in the amount from about 10 mg to about 100 mg (p. 2, lines 21-24, claim 6).
Liang, Bloxham, and Lee are considered analogous art to the claimed invention because they are in the same field of studying administration of bitter agents for desired outcomes. Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) to combine the prior art elements to arrive at the composition instantly claimed. It would have been prima facie obvious to formulate a composition including at least codeine and chlorpheniramine, as taught by Liang, and substitute chlorpheniramine for denatonium benzoate because, based on the teachings of Bloxham, chlorpheniramine and denatonium benzoate both target 4 of the same polymorphs of T2R, implicitly establishing them as equivalents (MPEP §2144.06(II)). Lee teaches that denatonium benzoate and denatonium acetate are equivalents as bitter agents and that they can be administered in an amount from about 10 mg to about 100 mg, which overlaps with the range instantly claimed (MPEP §2144.05(I)). Accordingly, claims 2 and 4-5 are prima facie obvious.
Regarding claim 3, Liang teaches the weight percent of chlorpheniramine ranges from 0.001%-5.0 %. As mentioned, based on the teachings of Bloxham, it would have been prima facie obvious to a PHOSITA to substitute denatonium benzoate for chlorpheniramine as they both target similar polymorphs of T2R. Therefore, substituting denatonium benzoate for chlorpheniramine, based on the teachings of Bloxham, and formulating the composition taught by Liang would have been prima facie obvious because the range taught by Liang overlaps with the amount of 50 ppm, which equates to 0.005 weight % (MPEP §2144.05(I)).
Regarding claim 6, Liang teaches Embodiment 7 includes carboxymethylcellulose and xanthan gum. Therefore, it would have been prima facie obvious to a PHOSITA to substitute denatonium benzoate for denatonium acetate, and thus substitute chlorpheniramine for denatonium acetate, based on the teachings of Lee and Bloxham to arrive at the composition instantly claimed.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Liang in view of Bloxham, Lee, and WO2018145071 (“Baker”).
The teachings of Liang, Bloxham, and Lee are discussed above and are incorporated by reference herein.
Regarding claims 7-10, Liang, Bloxham, and Lee do not teach including gel-forming excipients polyoxyl stearate, poloxamer 124, or gellan gum, nor does it teach that the ratio of poloxamer:polysaccharide:PEG ester is about 40:30:30.
Baker teaches abuse deterrent formulations having a controlled substance and at least two excipients. The excipients include for example PEG ester, poloxamer, water-soluble anionic polysaccharide, and carboxymethylcellulose (¶¶[0003]-[0005]). Baker also teaches that in the composition, the PEG ester is polyoxyl stearate; the poloxamer is poloxamer 124; and the water-soluble anionic polysaccharide is gellan gum. In some embodiments, the ratio of poloxamer:polysaccharide:PEG ester is about 40:30:30 (¶[0016]).
Liang, Bloxham, Lee, and Baker are considered analogous art to the claimed invention because they are in the same field of administering either bitter and/or abuse deterrent agents. Therefore, it would have been prima facie obvious to a PHOSITA to formulate a composition including at least codeine and chloropheniramine, as taught by Liang; substitute denatonium benzoate for denatonium acetate, and thus substitute chlorpheniramine for denatonium acetate, at an amount of at least 10 mg, based on the teachings of Lee and Bloxham, respectively; and include the excipients polyoxyl stearate, poloxamer 124, and gellan gum, as taught by Baker, to arrive at the composition instantly claimed. Baker also teaches the exact ratio instantly claimed to include in abuse deterrent composition the excipients poloxamer:polysaccharide:PEG ester in the amount of 40:30:30.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHIL CHANDER AGGARWAL whose telephone number is (571)272-7755. The examiner can normally be reached 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHIL CHANDER AGGARWAL/Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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