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 .
Claim Status
Claims 1-11, 13, and 25-32 are pending. Claim 13 is withdrawn. Claims 1-11, and 25-32 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group I and the species AF-353 in the reply filed on June 18th, 2026, is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species is not allowable. Therefore, the Markush-type claim is rejected and claims to the non-elected invention/species are held withdrawn from further consideration. Search and examination are limited to subject matter embracing the elected species. Any subject matter discussed outside this scope was discovered incidental to the search and is presented in the interest of compact prosecution.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 18th, 2026.
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 1-11 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.
Instant claim 1 recites a method of reducing bitter taste attributed to a bitter taste of an active pharmaceutical ingredient (API) in a medicament, nutrient, and/or dietary supplement, said method comprising administration of the taste-masking composition… wherein the taste-masking composition is formulated for oral administration and is administered prior to the or with the administration of the medicament and/or dietary supplement to the subject in a need thereof, and wherein said taste-masking composition is administered before the administration of the medicament, nutrient, and/or the dietary supplement to a subject in a need thereof. It is unclear whether the method requires the taste-masking composition to be administered prior to the administration of the medicament and/or dietary supplement as one limitation recites administration prior to or with the medicament or supplement and the following limitation only provides for administration before said medicament or supplement.
Claims 2-11 are rejected for failing to obviate the indefiniteness of claim 1.
Claims 6 and 7 are further rejected for claiming a “derivative” or “derivatives” of the purinergic receptor inhibitor. Merriam Webster provides the following definitions for derivative (“Derivative.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/derivative. Accessed 2 Sep. 2026.):
PNG
media_image1.png
114
727
media_image1.png
Greyscale
.
The term derivative is a relative term therefore it is unclear what compounds would be embraced by claims.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 30 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 30 recites the method according to claim 1 wherein the taste-masking composition is administered as the same time with the administration of the nutrient; however, claim 1 requires that the taste-masking composition be administered before the administration of the nutrient.
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.
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.
Claim(s) 1-6, 8-11, 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009025793 A2 by Li et al. in view of WO 2017160569 A1 by Hawley et al. as evidenced by Cleveland Clinic. Dysgeusia. Last updated April 19th, 2024. Retrieved August 26th, 2026, from https://my.clevelandclinic.org/health/diseases/22047-dysgeusia.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches compositions that comprise compounds that block or inhibit bitter tastes. Li et al. state (paragraph [0024]):
Based thereon, the invention relates to the use of this and related compounds according to the invention in foods, beverages, medicaments and other ingestibles in order to alleviate the bitter taste thereof, including bitter tase elicited by unidentified bitter ligands or compounds wherein bitterness involves the activation of multiple bitter receptors or bitter compounds wherein the receptor specificity thereof is undetermined.
Regarding instant claims 1, 30, and 32, Li et al. specify that the composition contains one or more pharmaceutically acceptable carriers and is a food, beverage or medicament for human consumption (page 392, claim 131). The prior art teaches a method for alleviating bitter taste comprising administering the compounds and provides use of the composition alone or together with another substance (page 392, claim 125; paragraph [0086]).
Regarding instant claims 5 and 8, the prior art states, “an amount sufficient to alleviate or reduce the bitter taste associated with a composition, e.g., an ingestible composition, is added to the composition to alleviate or reduce the bitter taste associated with the composition as compared to compositions that are prepared without the compounds of the present invention, as judged by human beings or animals” (paragraph [00111]).
Regarding instant claim 10, the prior art teaches the task-masking composition as a supplement, nutraceutical, pharmaceutical and over-the-counter medication, (paragraph [0086]).
Regarding instant claim 11, Li et al. note that the prior art compounds can be added to food or beverage products or formulations in the form of coatings (paragraph [0091]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses a method of alleviating bitter taste associated with a medicament by administering a composition for oral consumption however the reference is silent to the use of a purinergic receptor inhibitor.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Hawley et al. disclose pyrimidine compounds as P2X3 and/or P2X2/3 antagonists and discloses these compounds for use in treating taste disorders including dysgeusia (paragraph [0013]). The reference discloses purinergic receptor inhibitors such as compound 4 shown below which is embraced by instant claims 1-4 and 6 (page 49):
PNG
media_image2.png
142
518
media_image2.png
Greyscale
.
The Cleveland Clinic defines dysgeusia as a taste disorder wherein people with the condition may feel that all foods taste metallic, sweet, sour, or bitter as cites medication as one of the causes for the condition (page 1).
Regarding the motivation to combine the purinergic receptor inhibitors of Hawley et al. with the taste-masking compounds of Li et al. MPEP 2144.06(I) states:
“"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Accordingly, a person of ordinary skill seeking to optimize the bitter-blocking effect to mask the taste of a bitter active pharmaceutical in a medicament or supplement would have been motivated to modify formulations of the taste-masking composition of Li et al. to include the P2X2/3 inhibitors of Hawley et al. and improve consumer satisfaction.
Regarding instant claim 9, Li et al. suggest using the disclosed taste-masking compounds at concentrations from about 0.001 ppm to about 100 ppm (paragraph [00112]). If the prior art composition were prepared in water with a density of approximately 1 g/mL, a composition where the taste-masking compound is present at 100 ppm would correspond to a dose of about 0.1 mg/mL of the active agent. A person of ordinary skill seeking to combine the two components and test the relative effects would have been motivated to test the purinergic receptor inhibitors of Hawley et al. in similar concentrations as taught for the T2R modulators of Li et al.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2009025793 A2 by Li et al. and WO 2017160569 A1 by Hawley et al. as evidenced by Cleveland Clinic. Dysgeusia. Last updated April 19th, 2024. Retrieved August 26th, 2026, from https://my.clevelandclinic.org/health/diseases/22047-dysgeusia. as applied to claims 1-6, 8-11, 30 and 32 above, and further in view of US 20070049609 A1 by Broka et al.
Li et al. and Hawley et al. as evidenced by Cleveland Clinic teach a method of reducing bitter taste attributed to a bitter taste of an API in a medicament, nutrient and/or dietary supplement comprising administering a taste-masking composition wherein said composition comprises a purinergic receptor inhibitor; however, the references do not suggest use of AF-353 of claim 7.
Broka et al. disclose diaminopyrimidine P2X3 and/or P2X2/3 receptor antagonists such as AF-353 of instant claim 7 (page 39, Table 1, compound 124). The pyrimidine purinergic inhibitor of Broka et al. is analogous to compound 4 of Hawley et al. but differs by having an -O- linker in the place of -S-. Accordingly, a person of ordinary skill seeking to optimize the combined taste-masking composition of Li et al. and Hawley et al. would have been motivated to test various P2X2/3 receptor inhibitors such as the compound of Broka et al.
Claim(s) 25-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009025793 A2 by Li et al. and WO 2017160569 A1 by Hawley et al. as evidenced by Cleveland Clinic. Dysgeusia. Last updated April 19th, 2024. Retrieved August 26th, 2026, from https://my.clevelandclinic.org/health/diseases/22047-dysgeusia. as applied to claims 1-6, 8-11, 30 and 32 above, and further in view of CN 113069550 A by Zhang et al. (citations refer to the machine translation).
Li et al. and Hawley et al. as evidenced by Cleveland Clinic teach a method of reducing bitter taste attributed to the bitter taste of an API in a medicament, nutrient and/or dietary supplement comprising administering a taste-masking composition; however, the combined references do not suggest administering the taste-masking composition before the aversive-tasting medicament, nutrient and/or dietary supplement.
Zhang et al. teach a “taste masking agent formulation for reversible masking of bitter taste in the oral cavity by pre-administration” (title) and disclose a method of masking the taste of a bitter Chinese medicine by rinsing the mouth in advance in accordance with instant claims 1 and 25-28 (abstract). The prior art notes that the formulation contains a taste-masking agent or anesthetic and describes testing the invention wherein subjects gargle the mouth wash formulation (page 2, claim 1). Zhang et al. further teach that the components of the composition such as menthol reversibly mask the bitter taste of drugs by anesthetizing nerves (last paragraph of page 4).
Li et al. teach that the taste-masking composition is suitable as an over-the-counter product such as a mouthwash (paragraph [0090]). Zhang et al. note that method of using the mouth wash requires an administration time of less than or equal to 60 seconds via gargling before administration of a drug, and that taste-masking effect is maintained to be more than or equal to 30 seconds and less than 30 minutes (page 1, claim 6). Accordingly, a person of ordinary skill seeking to expand the combined method of taste-masking a bitter medicament, nutrient and/or dietary supplement of Li et al. and Hawley et al. to provide for administration of the composition before the bitter-tasting drug would have been motivated to prepare the formulation with the taste-masking agents of Zhang et al. as a mouthwash to use as a pre-rinse. Zhang et al. teach that the composition maintains a taste-masking effect between 30 seconds and 30 minutes thus a person of ordinary skill using the combined invention could expect to achieve the desired effect with administering the taste-masking rinse at least 1-5 minutes prior to the administration of the medicament, nutrient and/or dietary supplement in accordance with instant claims 29 and 31.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Prosecution Insights