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 .
Status of Claims
Receipt of Remarks/Amendments filed on 12/29/2025 is acknowledged. Claims 1-13 and 16 are amended. Claims 14-15 are cancelled. Claims 17-21 are new. Claims 1-13, 16-21 are under examination in this Office Action.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Rejection As Necessitated by the Amendment Filed 12/29/2025
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.
Claims 1-2, 4-6, 11-13, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pan et al. (CN 104026551 A; cited in IDS, machine translation from IP.com), hereinafter Pan.
Regarding Claims 1 and 11, Pan discloses a formula of non-sodium salt with a good salty feature, comprising out of 100 parts in total, 94-96.85 parts by weight potassium chloride, 1.0-1.1 parts of calcium phosphate, 0.8-3.1 parts of sodium glutamate, 0.05-0.3 part of one or a mixture of more of liquiritin, licorice glycosides sodium, licorice glycosides disodium and stevioside, 0.5-1.6 parts of one or a mixture of more of malic acid, citrate and succinate, 0.2 to 1.05 parts of one or a mixture of more of sodium inosinate and disodium guanylate (Abstract; Table in pp. 2-3; Claim 1). Pan teaches formulations of several non-sodium salts with flavor, has salty taste but no bitter flavor (Table in pp. 2-3; p. 3, 1st paragraph).
Regarding Claims 2 and 12, Pan expressly teaches 0.05% liquiritin in Formula 4, which is equivalent to 500 ppm and is within the claimed range.
Regarding Claims 4-5 and 16, Pan teaches one or more mixtures of liquiritin, liquiritin sodium, liquiritin disodium, and stevioside in its formulation (Claim 1). Stevioside is a steviol glycoside.
Regarding Claims 6 and 17, Pan teaches potassium chloride salt (Abstract; Table in pp. 2-3; Claim 1).
Regarding Claim 13, Pan teaches its formulation is for food application, providing less problematic salt product with saline taste (p. 4, 3rd paragraph).
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.
Claims 7-8 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pan as applied to Claims 1-2, 4-6, 11-12, and 16-17 above, and in view of Timko, M. (Nutritional Outlook; Of Record), hereinafter Timko.
Pan is silent on the bitter tastants non-animal protein and plant protein.
Timko relates the increasing presence of plant-based proteins in food and supplement market (p. 2).
Regarding Claims 7-8 and 18-19, Timko cures the deficiency by teaching that proteins derived from plant sources such as pea, rice, and chia, have unpleasant taste often hard to endure with bitter notes and vegetative aftertastes (pp. 2-3). Timko recognizes flavor masking as a tool to suppress this unpleasant taste using sweeteners and flavoring (pp. 3-4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Timko and Pan, and use the method and composition of Pan to mask the bitter notes and vegetative aftertaste in products containing plant proteins to mask the bitter notes and vegetative aftertastes.
Claims 3, 10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Pan as applied to Claims 1-2, 4-6, 11-12, and 16-17 above, and in view of Shi et al. (CN 112218542 A; machine translated in IP.com), hereinafter Shi.
Pan does not expressly teach pharmaceutical bitter tastant.
Shi is in the same field, and teaches a sweetener and a flavor composition with improved taste profile (Abstract). Shi teaches embodiments wherein its composition comprises at least one sweetener such as steviol glycoside, rubusoside, mogroside or liquiritigenin, making it compatible with Pan (p. 99, last paragraph).
Shi also understands the demand for low-salt foods and beverages, and the need to find a solution to improve saltiness without increasing sodium intake (p. 4, 5th paragraph).
Regarding Claims 3, 10, and 21, Shi discloses a method for producing flavoring agent or flavor enhancer for food, beverage, feed or pharmaceutical comprises adding one or more sweet taste enhancers and/or ingredients selected from eriodictyol, homoeriodictyol, naringin etc.(p. 140, #65, #67 #70, #72). Shi teaches that eriodictyol as a bitter-masking flavonoid glycoside (p. 35, last paragraph). Additionally, Shi teaches naringin and neohesperidin are flavonoid glycosides present in citrus fruits and grapefruit, and are responsible for the bitter taste of citrus juices along with limonin, but are good candidates for bitterness or sweetness enhancers, since they are effective in masking the bitterness of other compounds (p. 45, Section B8; p. 66, 3rd paragraph). Furthermore, Shi identified naringin as polyphenol antioxidants which can produce a variety of health benefits, including prevention of cancer, heart disease, and chronic inflammation, as well as mental and physical enhancement (p. 66, 2nd paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Shi with Pan and add bitter-masking compounds such as eriodictyol and naringin, while also imparting or enhancing sweetness. One would have been motivated to do so because Shi has taught that naringin provides health benefits as polyphenol antioxidant.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pan, as applied to Claims 1-2, 4-6, 11-12, and 16-17 above, and in view of Vesey, C. (Bitter to Better; Of record), hereinafter Vesey.
Pan does not expressly teach pharmaceutical bitter tastant.
Regarding Claim 9, Vesey relates that there is a gap between actual treatment success rates of pharmaceuticals and those believed to be achievable due partly to a lack of patient adherence. (p. 1). Vesey teaches that taste masking can contribute to improved drug acceptability and medication adherence, particularly in pediatric, geriatric, and other special patient populations by masking the bitter taste (pp. 2-4). Vesey teaches inclusion of flavoring and sweeteners in drug products as strategies for taste masking the unpleasant-tasting API (pp. 3-4, 10).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Vesey and Pan, and use the method and composition of Pan to mask the bitter and unpleasant taste of APIs in drug products, and thereby improve patient experience and adherence to medication regimen.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pan and Vesey, as applied to Claims 1-2, 4-6, 9, 11-12, and 16-17 above, and in further view of Bains, K. (WO2020061584A1), hereinafter Bains.
Pan and Vesey do not teach the specific pharmaceutical bitter tastant claimed.
Regarding Claim 20, Bains teaches sublingual dosage form comprising one or more bitter active agents (Claim 1). In one embodiment, the bitter active ingredient comprises erythromycin [00182].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the method of Pan, and incorporate the flavor-modifying compound in the dosage form containing API erythromycin, which Bains identified to be a bitter active ingredient, to mask its bitter and unpleasant taste, and thereby improve patient experience and adherence to medication regimen.
Response to Arguments:
Applicant argues that Tachdjian does not disclose methods that include the flavor-modifying compounds recited in independent Claim 1.
The crux of Applicant’s argument appears to be centered on Tachdjian not disclosing the amended feature of Claim 1, which now excludes isoliquiritigenin. The modified rejection supra no longer relies on Tachdjian, as necessitated by the amendment.
Conclusion
No claims are allowed.
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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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