Prosecution Insights
Last updated: May 29, 2026
Application No. 17/111,158

DIAGNOSIS AND TREATMENT FOR RESPIRATORY TRACT DISEASES

Non-Final OA §103§DOUBLEPATENT
Filed
Dec 03, 2020
Priority
Jan 27, 2012 — provisional 61/591,425 +4 more
Examiner
PERREIRA, MELISSA JEAN
Art Unit
1618
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The United States Government AS Represented By The Department Of Veterans Af
OA Round
7 (Non-Final)
52%
Grant Probability
Moderate
7-8
OA Rounds
0m
Est. Remaining
78%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
432 granted / 829 resolved
-7.9% vs TC avg
Strong +26% interview lift
Without
With
+25.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
28 currently pending
Career history
868
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
76.3%
+36.3% vs TC avg
§102
1.8%
-38.2% vs TC avg
§112
4.0%
-36.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 829 resolved cases

Office Action

§103 §DOUBLEPATENT
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/26/26 has been entered. Claims Status Claims 1,4,5,7-13,15,18,19,21,36-38,41 and 49 are pending in the application. Claims 1,4,5,7-13,15,21,36-38 and 41 are withdrawn from consideration. Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. Claim 18,19 and 49 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tizzano et al. (PNAS (2010) 107, 3210-3215) in view of Liggett et al. (US 2013/0131108A1) and Gulbransen et al. (J. Neurophysiol. 99: 2929-2937, 2008) and in further view of LeMahieu et al. (US 2008/0066739A1), Margolskee et al. (US 6,540,978B1), Sohi et al. (Drug Dev. Ind. Pharm. 2004, 30, 429- 448) and Kurtz et al. (US 5,232,735). Tizzano et al. (PNAS (2010) 107, 3210-3215) discloses a 10-20 mM denatonium composition that is used for activation of the innate immune system to combat the bacterial invasion in the upper respiratory tract as SCCs in the upper respiratory tract respond to the presence of denatonium (bitter tastant) (abstract; p3211, left column, first paragraph; Fig. 2). The 10-20 mM denatonium composition encompasses the 20 mM denatonium of the instant claims. The respiratory epithelium of the nasal cavity houses a significant population of solitary chemosensory cells (SCCs) which respond to the wide variety of irritants including local neurogenic inflammatory responses (p3210, left column). The epithelium houses a population of trigeminally innervated SCCs that express T2R bitter taste receptors, including the Tas2R family of receptors (abstract; p3210, left column). The SCCs respond to the presence of denatonium using a PLC-mediated cascade to generate an increase in intracellular Ca2+ (abstract; p3210, right column, second paragraph) and encompasses treatment of the upper respiratory tract of the instant claims as Tizzano et al. envisioned examining the response of SCCs of the upper respiratory tract with denatonium. The SCC cells responded robustly to the 10-20 mM denatonium (p3211, left column, first paragraph). Certain substances, such as denatonium activate the trigeminal peptidergic fibers that innervate the SCCs and will also evoke local neurogenic inflammatory changes that are crucial to the immediate epithelial and/or local immune response to the presence of bacterial agents (p3211-3212, Respiratory Responses to Intranasal Stimulation by Bitter Compounds). The trigeminal capsaicin-sensitive nerve fibers release CGRP and substance P into the surrounding mucosa, resulting in local inflammation, including activation of the innate immune system, to combat the bacterial invasion (p3214, right column, third full paragraph). The activation of the innate immune system to combat the bacterial invasion encompasses the stimulation in innate antimicrobial response of the instant claims. Also, the denatonium encompasses the denatonium of the instant claims, has the same properties and is capable of the same functions, such as treating an infection of the upper respiratory tract and stimulating an innate antimicrobial response in the respiratory tract. Tizzano et al. does not disclose a therapeutic topical composition or a pharmaceutically acceptable carrier. Liggett et al. (US 2013/0131108A1) discloses bitter tastants comprising denatonium, quinine, etc. (p1, [0010-0012]) that bind to bitter taste receptors, such as T2Rs and evoke an increase in [Ca2+] (p2, [0015]; p4, [0037]; p5, [0049]; p6, [0054]; p7, [0063]). The bitter tastant can be provided in a pharmaceutical composition delivered in the form of an inhalant, such as aerosol spray, nebulizer, vaporizer; oral delivery; patches, etc. (p1, [0010]; p4, [0041]; p5, [0044]; p6, [0053]; claim 4). The pharmaceutical composition comprises one or more pharmaceutically acceptable carriers, such as saline, buffered saline, etc. (p4, [0041]) that encompass the pharmaceutically acceptable topical carrier of the instant claims. At the time of the invention it would have been obvious to one of ordinary skill in the art to provide and administer the denatonium bitter tastant of Tizzano et al. in a pharmaceutically acceptable carrier to a subject via inhalation as taught by Liggett et al. for the advantage of binding denatonium to T2R bitter taste receptors expressed on SCCs for increase in [Ca2+] and the activation of the innate immune system to combat the bacterial invasion of the upper respiratory tract. The inhalable denatonium pharmaceutical composition of Liggett et al. is delivered to the respiratory tract and therefore, it would have been predictable to one of ordinary skill in the art that the inhaled denatonium solution initially binds to bitter taste receptors present in the upper respiratory tract and further evokes an increase in Ca2+ to treat an upper respiratory tract infection, with a reasonable expectation of success. Tizzano et al. does not disclose PTC is at a concentration of 1 mM. Gulbransen et al. (J. Neurophysiol. 99: 2929-2937, 2008) discloses the classic bitter compound phenylthiocarbamide (PTC) elicits a large increase in [Ca2+] in TRPM5- and gustducin-GFP+ cells. The PTC (15 mM) is investigated and is compared to denatonium for which component of nasal trigeminal chemosensitivity is mediated through SCCs (abstract; Table 2; p2932, Ca2+ responses in TRPM5-GFP cells; p2933, left column, first paragraph; p2935, right column, second full paragraph). Liggett et al. further discloses that effective amounts of bitter tastants in a pharmaceutical formulation will vary depending on the bitter tastants being used and the condition or disease being treated, as well as factors such as age of the subject and other medications being taken. The concentrations of bitter tastants delivered to a subject in a unit dose will generally range from about 0.05 mg to about 100 mg, or a value within this range (p5, [0045]). At the time of the invention it would have been obvious to one ordinarily skilled in the art to substitute the denatonium of Tizzano et al. for the PTC of Gulbransen et al. and prepare an inhalable pharmaceutical composition for delivery to the respiratory tract to examine the increase in intracellular [Ca2+] and as both Tizzano et al. and Gulbransen et al. are drawn to examining the response of SCCs to classic bitter-tasting stimulants. At the time of the invention it would have been obvious to one ordinarily skilled in the art to examine different amounts of PTC to examine the increase in [Ca2+] as Liggett et al. teaches that the amount of bitter tastant to be administered to a subject depends on the bitter tastants being used and the condition or disease being treated, as well as factors such as age of the subject and other medications being taken. Furthermore, it is obvious to vary and/or optimize the amount of PTC provided in the composition, according to the guidance provided by Liggett et al., to provide a composition having the desired properties such as evoking an increase in [Ca2+]. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, 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). Tizzano et al. does not disclose an antibiotic. LeMahieu et al. (US 2008/0066739A1) discloses the method of administering a drug to the respiratory system of a patient (p2, [0018]). The drug is administered in a nebulized or aerosol form via inhalation (p2, [0015]; p26, [0071-0073],[0076]). The drug includes propylthiouracil, quinine, etc. (p20, table 2; claim 8). The drugs may be combined with antibiotics (p25, [0063]; claim 8), such as tobramycin inhalable solution (p25, [0065]). At the time of the invention it would have been obvious to one ordinarily skilled in the art to include an antibiotic in an inhalable bitter tastant pharmaceutical composition as LeMahieu et al. teaches of the combination of antibiotics (e.g. tobramycin) and a bitter tastant for the method of administering a drug to the respiratory system of a patient for the advantage of a combination therapy and Liggett et al. teaches of combination therapy for the administration to a respiratory tract (p12, [0090]). It would have been predictable to one of to one of ordinary skill in the art that the inhalable bitter tastant pharmaceutical composition comprising an antibiotic (e.g. tobramycin) contacts the upper respiratory tract prior to contacting the lower respiratory tract wherein the bitter tastant (e.g. denatonium) is available for binding the SCCs in the upper respiratory tract. It would have been predictable to one of ordinary skill in the art to combine an antibiotic with a bitter tastant, such as denatonium as the substitution of one known bitter tastant for another known bitter tastant, such as quinine provides combination of prior art elements to yield a treatment of the respiratory system via a combination therapy. Tizzano et al. does not disclose sweet taste receptor antagonists of the instant claim 19. Margolskee et al. (US 6,540,978B1) discloses a combination of bitter taste inhibitors/inhibitor sweeteners and bitter compounds/tastants wherein the bitter taste inhibitors/inhibitor sweeteners are used as flavor enhancers in foods, cosmetics, and pharmaceuticals by decreasing the perception of bitterness associated with the co-administered bitter compounds/tastants (abstract; column 3, lines 52-59; column 4, lines 1-12; column 11, lines 38-44; column 13, lines 28-30). The bitter compounds/tastants include denatonium benzoate (DEN), quinine, etc. (column 7, lines 1-15) wherein naturally occurring bitter tastants are typically active in the range of 10-500 mM, but particularly potent tastants have thresholds for detection as low as 10-100 nM. DEN is used in in vitro assays at a concentration of 5 mM (column 7, lines 51-60; column 18, lines 6-9). The amount of bitterness inhibitor added to a composition comprising a bitter tastant may vary depending on the amount of the bitter tastant present (column 11, lines 61-65). Sohi et al. (Drug Dev. Ind. Pharm. 2004, 30, 429-448) discloses taste masking of orally administered bitter drugs (title; abstract). A pleasing taste of bitter-tasting compounds would provide an acceptable degree of palatability, improved performance and acceptability of an oral formulation as taste masking provides bitterness reduction and inhibition (abstract; p430, left column, first paragraph; p430, General Taste Masking Practices in Oral Pharmaceuticals). Several tasteless/sweetness inhibitors are being actively pursued as bitterness inhibitors. Lactisole, a sweetness inhibitor, possesses great potential in the taste masking of pharmaceuticals (p431, right column, first paragraph). Kurtz et al. (US 5,232,735) discloses sweetness inhibitors that are substantially tasteless are bitter taste inhibitors or blockers, such as 2-(4-methoxyphenoxy)propanoic acid (i.e. lactisole) (abstract; column 2, lines 30-34; column 3, lines 20-53). The sweetness inhibitors can be added to pharmaceuticals (column 8, lines 7-26). At the time of the invention it would have been obvious to one of ordinary skill in the art to utilize the lactisole sweetness inhibitor of Sohi et al. or Kurtz et al. to mask the taste of a denatonium nebulizer, aerosol, vaporizer, etc. formulation administered via inhalation to a subject as the lactisole advantageously reduces the bitterness taste of bitter drugs, as taught by Sohi et al. and Margolskee et al. teaches of adding bitter taste inhibitors/inhibitor sweeteners to pharmaceuticals for the advantage of decreasing the perception of bitterness associated with the co-administered bitter compounds/tastants. It would have been predictable to one of ordinary skill in the art to include the bitter taste inhibitors/inhibitor sweeteners, such as the lactisole sweetness inhibitor of Sohi et al. or Kurtz et al. in the denatonium composition, with a reasonable expectation of success, as it is a known and common technique to utilize analogous sweetness inhibitors with effective taste masking abilities to provide the advantage of a palatable, improved and pharmaceutical formulations with reduced bitterness. Response to Arguments Applicant's arguments filed 1/23/26 have been fully considered but they are not persuasive. Applicant asserts that Tizzano does not teach of a topical composition or pharmaceutically acceptable carriers and that Liggett does not teach upper respiratory tract infections but is directed to enhancing airway dilation and/or relieving bronchoconstriction to treat COPD. The reference of Tizzano was used to teach of a 20 mM denatonium composition that is used for activation of the innate immune system to combat the bacterial invasion in the upper respiratory tract as SCCs in the upper respiratory tract respond to the presence of denatonium (bitter tastant). The SCCs respond to the presence of denatonium by generating an increase in intracellular Ca2+. The reference of Liggett et al. was used to teach of denatonium pharmaceutical compositions that are delivered to the respiratory tract via aerosol spray, nebulizer, vaporizer. The denatonium (bitter tastant) binds to bitter taste receptors in the respiratory tract to evoke an increase in Ca2+. At the time of the invention it would have been obvious to one of ordinary skill in the art to administer the denatonium bitter tastant solution of Tizzano et al. in a pharmaceutically acceptable carrier to a subject via inhalation as taught by Liggett et al. for the advantage of binding denatonium to T2R bitter taste receptors expressed on SCCs in the upper respiratory tract for increase in [Ca2+] and the activation of the innate immune system to treat an upper respiratory tract infection. The inhalable denatonium pharmaceutical composition of Liggett et al. is delivered to the respiratory tract and therefore, it would have been predictable to one of ordinary skill in the art that an inhaled denatonium solution contacts and binds to bitter taste receptors present in the upper respiratory tract upon airway dilation and further evokes an increase in Ca2+, prior to entering the lower respiratory tract, with a reasonable expectation of success. Applicant asserts that Liggett does not in fact teach routes of administration and the use of pharmaceutically acceptable carriers for treatment of infections of the upper respiratory tract and stimulating an innate antimicrobial response in the upper respiratory tract. Liggett delivers bitter tastant to smooth muscle cells that are located in the walls of bronchi and bronchioles which are part of the lower respiratory tract and not the upper respiratory tract. The reference of Liggett was not used to teach of treatment of infections in the upper respiratory tract but was used to teach that stated above. Liggett teaches that denatonium is delivered to the respiratory tract via aerosol spray, nebulizer, vaporizer, thereby contacting the upper respiratory tract prior to entering the lower respiratory tract wherein the denatonium is available for binding to the SCCs in the upper respiratory tract. Applicant asserts that Liggett defines “bitter tastants” as “any compound… that binds to a bitter tastant receptor present on the surface of an airway smooth muscle cell and, via such binding, relaxes the airway smooth muscle cell.” The reference of Liggett teaches that the bitter tastants comprise denatonium, etc. that encompass the denatonium of the instant claims, has the same properties and is capable of the same functions. The reference of Liggett does teach that they examined and identified compounds that modulate function of bitter taste receptors expressed on the surface of airway smooth muscle cells but that does not negate the bitter tastant compounds inherent properties and can modulate bitter taste receptors on other types of cells. Liggett further teaches that the bitter taste receptors targeted by the bitter tastants include T2R or TAS2R. The reference of Tizzano et al. teaches of targeting T2R bitter taste receptors with denatonium, as well as that stated above. Therefore, at the time of the invention it would have been obvious to one of ordinary skill in the art that the denatonium of Tizzano et al. and Liggett is capable of targeting T2R bitter taste receptors expressed on different types of cells. Applicant asserts that Tizzano does not teach antibiotics and LeMahieu does not teach antibiotics for the treatment of upper respiratory tract infections. The reference of Tizzano was not used to teach of antibiotics but that stated above. The reference of LeMahieu was used to teach that bitter tastants are used in combination with antibiotics, such as tobramycin as an inhalable solution (nebulizer, aerosol) for the method of administering a drug to the respiratory system of a patient as well as that stated above. At the time of the invention it would have been obvious to one ordinarily skilled in the art to include an antibiotic in an inhalable denatonium pharmaceutical composition as LeMahieu et al. teaches of the combination of antibiotics (e.g. tobramycin) and a bitter tastant for the advantage of a combination therapy wherein the composition contacts the upper respiratory tract prior to contacting the lower respiratory tract and denatonium is available for binding to the T2R bitter taste receptors expressed on SCCs in the upper respiratory tract. Applicant asserts that Margolskee, Sohi, Kurtz do not teach upper respiratory tract infections. The references of Margolskee et al., Sohi et al. and Kurtz et al. were used to teach of the combination of bitter taste inhibitors/inhibitor sweeteners and bitter tastants (e.g. denatonium) for the advantage of decreasing the perception of bitterness associated with the bitter tastants. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying- online/eterminal-disclaimer. Claims 18,19 and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2,4-6,9 and 10 of U.S. Patent No. 10,881,698 in view of Tizzano et al. (PNAS (2010) 107, 3210-3215). The U.S. Patent No. 10,881,698B2 comprises a bitter taste receptor agonist composition combined with an antibiotic that encompasses the active ingredient of the instant claims combined with at least one antibiotic. The bitter taste receptor agonists comprises denatonium, PROP, PTC, homoserine lactone, NaSCN, quinine, etc. that encompasses the denatonium, PROP, PTC, homoserine lactone, NaSCN, quinine, etc. of the instant claims, have the same properties and are capable of the same function, such as stimulating an innate antimicrobial response in the upper respiratory tract of a subject. The bitter taste receptor agonist composition of U.S. Patent No. 10,881,698B2 is formulated for delivery as an inhalant, nasal spray, lavage, solutions, etc. that encompasses the topical formulation of the instant claims. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). U.S. Patent No. 10,881,698B2 does not disclose the concentration of denatonium is 20 mM. The reference of Tizzano et al. (PNAS (2010) 107, 3210-3215) discloses a 10-20 mM denatonium composition as well as that stated above. It would have been predictable to one of ordinary skill in the art to prepare a 20 mM composition of bitter taste receptor agonist, such as denatonium with a reasonable expectation of success as Tizzano et al. teaches of 10-20 mM denatonium composition for the advantage of for targeting bitter taste receptors expressed on SCC cells. Furthermore, it is obvious to vary and/or optimize the amount of denatonium provided in the composition, according to the guidance provided by Tizzano et al., to provide a composition having the desired properties such as for increase in [Ca2+] and the activation of the innate immune system to combat the bacterial invasion of the upper respiratory tract. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, 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). Claims 18,19 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 17/996,853 in view of LeMahieu et al. (US 2008/0066739A1) and Tizzano et al. (PNAS (2010) 107, 3210-3215). Copending Application No. 17/996,853 comprises a formulation of a bitter taste receptor agonist for application to a mucosal surface of an upper respiratory cavity that encompasses a topical composition for treatment of an upper respiratory tract of the instant claims. The bitter taste receptor agonists comprise denatonium, PROP, PTC, homoserine lactone, NaSCN, quinine, etc. that encompasses the denatonium, PROP, PTC, homoserine lactone, NaSCN, quinine, etc. of the instant claims, have the same properties and are capable of the same function, such as stimulating an innate antimicrobial response in the upper respiratory tract of a subject. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Copending Application No. 17/996,853 does not disclose an antibiotic. LeMahieu et al. (US 2008/0066739A1) discloses the method of administering propylthiouracil, quinine, etc. to the respiratory system of a patient in a nebulized or aerosol form via inhalation. The propylthiouracil, quinine, etc. may be combined with antibiotics as well as that stated above. At the time of the invention it would have been obvious to one ordinarily skilled in the art to include an antibiotic in an inhalable bitter tastant pharmaceutical composition as LeMahieu et al. teaches of the combination of antibiotics (e.g. tobramycin) and a bitter tastant for the method of administering a drug to the respiratory system of a patient for the advantage of a combination therapy. Copending Application No. 17/996,853 does not disclose the concentration of denatonium is 20 mM. The reference of Tizzano et al. (PNAS (2010) 107, 3210-3215) discloses a 10-20 mM denatonium composition as well as that stated above. It would have been predictable to one of ordinary skill in the art to prepare a 20 mM composition of bitter taste receptor agonist, such as denatonium with a reasonable expectation of success as Tizzano et al. teaches of 10-20 mM denatonium composition for targeting bitter taste receptors expressed on SCC cells. Furthermore, it is obvious to vary and/or optimize the amount of denatonium provided in the composition, according to the guidance provided by Tizzano et al., to provide a composition having the desired properties such as for increase in [Ca2+] and the activation of the innate immune system to combat the bacterial invasion of the upper respiratory tract. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, 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). This is a provisional nonstatutory double patenting rejection. Conclusion No claims are allowed at this time. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2. 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, Michael Hartley can be reached at 571-272-0616. 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. /MELISSA J PERREIRA/ Examiner, Art Unit 1618
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Prosecution Timeline

Show 10 earlier events
Mar 05, 2025
Response after Non-Final Action
Jun 20, 2025
Non-Final Rejection mailed — §103, §DOUBLEPATENT
Aug 28, 2025
Response Filed
Nov 26, 2025
Final Rejection mailed — §103, §DOUBLEPATENT
Jan 23, 2026
Response after Non-Final Action
Feb 26, 2026
Request for Continued Examination
Mar 03, 2026
Response after Non-Final Action
Apr 17, 2026
Non-Final Rejection mailed — §103, §DOUBLEPATENT (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

7-8
Expected OA Rounds
52%
Grant Probability
78%
With Interview (+25.8%)
3y 9m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 829 resolved cases by this examiner. Grant probability derived from career allowance rate.

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