Prosecution Insights
Last updated: August 16, 2026
Application No. 17/835,816

LIQUID ORAL COMPOSITION

Non-Final OA §103§112§DP
Filed
Jun 08, 2022
Priority
Dec 09, 2019 — CIP of 12/550,928 +1 more
Examiner
KESSIE, JENNIFER A
Art Unit
1747
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Nicoventures Trading Limited
OA Round
5 (Non-Final)
64%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
87%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
207 granted / 321 resolved
-0.5% vs TC avg
Strong +22% interview lift
Without
With
+22.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
72 currently pending
Career history
389
Total Applications
across all art units

Statute-Specific Performance

§101
2.5%
-37.5% vs TC avg
§103
54.1%
+14.1% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
11.5%
-28.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 321 resolved cases

Office Action

§103 §112 §DP
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 . Response to Arguments Applicant’s arguments presented in the pre-appeal brief filed 01/02/2026 have been fully considered. Applicant’s arguments concerning the prior-art rejection are persuasive. Accordingly, the prior-art rejection set forth in the Final Office Action is withdrawn. However, a new ground of rejection is presented herein based on Wilson in view of Kayamura, and Nielsen where applicable. Applicant’s arguments concerning the nonstatutory double patenting rejection are not persuasive. Applicant argues that present claim 1 is distinguished from the claims of U.S. Patent No. 12,550,928 because present claim 1 requires at least one humectant in an amount of about 12% to about 20% by weight. However, the recitation of a narrower humectant range does not establish that the presently claimed composition is patentably distinct from the patented composition. Claims 18 and 19 of U.S. Patent No. 12,550,928 recite a humectant in an amount of about 10% to about 20% by weight, which encompasses the presently claimed range of about 12% to about 20% by weight. Selecting the narrower range from the patented range would have been an obvious variation of the patented composition. Accordingly, the nonstatutory double patenting rejection is maintained. Claim Objections Claim 1 is objected to because of the following informalities: Claim 1 recites “at least one selected from the group consisting of sweeteners and alkali metal salts,” but later recites that “the one or more additional components selected from the group consisting of sweeteners, humectants, and alkali metal salts are present in a total amount of about 40% by weight or higher.” The later recitation of “humectants” is inconsistent with the amended Markush group, from which “humectants” was deleted. Appropriate correction is required to make the two recitations consistent. Appropriate correction is required. 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. 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. Claim 18 is 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 18 recites: “wherein the composition is adapted for spraying into the oral cavity.” The phrase “the oral cavity” renders the scope of the claim unclear because it lacks antecedent basis and no special definition is provided in the specification identifying which oral cavity is intended. It is therefore unclear whether the claim refers to a particular portion of the mouth or the oral cavity generally. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1, 5, 7–10, 12, 14, and 16–20 are rejected under 35 U.S.C. § 103 as being unpatentable over Wilson et al. (U.S. 5,498,426) in view of Kayamura et al. (U.S. 2013/0323390). Regarding claim 1, Wilson teaches a liquid composition (a “liquid antacid composition”) (col. 1, ll. 1–8) comprising: water in an amount of about 40% by weight or higher, based on the total weight of the composition (55.6243 wt.% water) (Example I, Table I, col. 5, ll. 15–35); a flavoring agent or an active ingredient or both a flavoring agent and an active ingredient (10.83 wt.% calcium carbonate, 0.06 wt.% vanilla crème flavor, and 0.0045 wt.% mint flavor) (Example I, Table I, col. 5, ll. 15–35); one or more additional components comprising at least one humectant in an amount of about 12% to about 20% by weight (5 wt.% glycerin and 11 wt.% sorbitol, for a total humectant amount of 16 wt.%) (Example I, Table I, col. 5, ll. 15–35). Wilson expressly identifies glycerin and sorbitol as humectants (col. 2, ll. 61–68); and at least one selected from the group consisting of sweeteners and alkali metal salts (15 wt.% sucrose, 0.25 wt.% potassium phosphate monobasic, and 0.08 wt.% potassium bicarbonate) (Example I, Table I, col. 5, ll. 15–35). Wilson does not expressly teach wherein the one or more additional components selected from the group consisting of sweeteners and alkali metal salts are present in a total amount of about 40% by weight or higher, based on the total weight of the composition. Wilson teaches sweetening agents in an amount of about 5% to about 40% by weight (col. 3, ll. 12–35), an alkali-metal phosphate salt in an amount of about 0.1% to about 2.0% by weight (col. 2, ll. 10–17), and an alkali-metal bicarbonate salt in an amount of about 0.05% to about 2.0% by weight (col. 2, ll. 18–25). The scope of Wilson’s disclosed amounts overlaps the lower portion of the claimed range because selecting the sweetening agent at about 40 wt.% together with the disclosed alkali-metal salts provides a total amount greater than about 40 wt.%. It has been held that overlapping ranges are prima facie evidence of obviousness. See MPEP § 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the amounts of Wilson’s sweetener and alkali-metal salts within the disclosed ranges to provide a combined amount of about 40% by weight or higher because Wilson teaches providing elevated soluble solids to enhance microbial stability (col. 2, ll. 35–44). Wilson further teaches that glycerin and sorbitol provide a humectant benefit and modify the water activity of the composition (col. 2, ll. 61–68), but does not expressly quantify the water activity as about 0.85 or lower. Kayamura is pertinent to the problem addressed by Wilson because both references concern improving the stability or preservability of water-containing ingestible compositions by controlling water activity. Kayamura teaches that microorganisms generally cannot proliferate in foods having a water activity of about 0.60 or less (¶ [0005]), that reducing water activity improves the preservability of water-containing products (¶ [0033]), and that combining glycerin with sugar alcohols provides a synergistic water-activity-reducing effect (¶ [0058]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the amounts and relative proportions of Wilson’s glycerin and sugar alcohol to reduce the water activity of the composition to about 0.85 or lower, including toward about 0.60 or less as taught by Kayamura, because doing so would predictably inhibit microbial proliferation and improve preservability, thereby furthering Wilson’s stated objective of enhancing microbial stability. Regarding claim 5, Modified Wilson teaches wherein the one or more additional components comprise at least one alkali metal salt (0.25 wt.% potassium phosphate monobasic and 0.08 wt.% potassium bicarbonate) and at least one sweetener (15 wt.% sucrose) (Wilson, Example I, Table I, col. 5, ll. 15–35). Regarding claim 7, Modified Wilson teaches wherein the one or more additional components comprise (i) at least one alkali metal salt selected from sodium chloride, sodium carbonate, sodium bicarbonate, and combinations thereof (sodium bicarbonate) (Wilson, col. 2, ll. 18–25) and (ii) at least one sugar alcohol (mannitol) (Wilson, col. 2, ll. 35–44). Regarding claim 8, Modified Wilson teaches wherein the one or more additional components comprise (ii) at least one sugar alcohol selected from xylitol and sorbitol (sorbitol, identified as a preferred sweetening agent) (Wilson, col. 3, ll. 29–35), and (iii) at least one humectant selected from glycerin and propylene glycol (glycerin) (Wilson, col. 2, ll. 61–68). Modified Wilson does not teach (i) at least one alkali metal salt selected from sodium chloride and sodium carbonate. Kayamura teaches sodium chloride as a salt suitable for incorporation into a water-containing ingestible composition (¶ [0099]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to include sodium chloride in modified Wilson’s composition, as taught by Kayamura, for adjusting flavor in the water-containing ingestible composition. Regarding claim 9, Modified Wilson teaches further comprising at least one artificial sweetener (saccharin) (Wilson, col. 3, ll. 12–35). Regarding claim 10, Modified Wilson teaches wherein the water content of the composition is about 40% to about 60% by weight (55.6243 wt.% water) (Wilson, Example I, Table I, col. 5, ll. 15–35). Regarding claim 12, Modified Wilson teaches wherein the active ingredient is selected from the group consisting of nutraceuticals (calcium carbonate) (Wilson, col. 2, ll. 1–9). Wilson’s calcium carbonate reads on a nutraceutical because it supplies calcium and provides an advantageous biological effect when orally administered. Regarding claim 14, Modified Wilson teaches wherein the composition is substantially free of tobacco material, excluding any nicotine component present (the complete liquid composition contains no tobacco material) (Wilson, Example I, Table I, col. 5, ll. 15–35). Regarding claim 16, Modified Wilson teaches wherein the composition has a pH of about 7 or greater (a pH of about 7.5 to about 8.5) (Wilson, col. 1, ll. 13–16). Regarding claim 17, Modified Wilson teaches wherein the composition has a pH of about 7 to about 9 (a pH of about 7.5 to about 8.5) (Wilson, col. 1, ll. 13–16). Regarding claim 18, Modified Wilson teaches wherein the composition is adapted for spraying into the oral cavity (a liquid pharmaceutical composition suitable for oral administration) (Wilson, col. 1, ll. 7–13). Modified Wilson teaches wherein the active ingredient is selected from the group consisting of nutraceuticals (calcium carbonate) (Wilson, col. 2, ll. 1–9). Wilson’s calcium carbonate reads on a nutraceutical because it supplies calcium and provides an advantageous biological effect when orally administered. Regarding claim 19, Modified Wilson teaches about 40% to about 60% by weight water (55.6243 wt.% water) (Wilson, Example I, Table I, col. 5, ll. 15–35); about 20% to about 30% by weight of one or more sugar alcohols (sorbitol, identified as a preferred sweetening agent in an amount of about 5% to about 40% by weight) (Wilson, col. 3, ll. 29–35). Wilson’s range overlaps the claimed range of about 20% to about 30% by weight. It has been held that overlapping ranges are prima facie evidence of obviousness. See MPEP § 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select sorbitol within the overlapping range of about 20% to about 30% by weight to provide sweetness and elevated soluble solids (Wilson, col. 2, ll. 35–44); about 12% to about 20% by weight of one or more humectants (glycerin in an amount of about 1% to about 15% by weight) (Wilson, col. 2, ll. 61–68). Wilson’s range overlaps the claimed range at about 12% to about 15% by weight. It has been held that overlapping ranges are prima facie evidence of obviousness. See MPEP § 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select glycerin within the overlapping range of about 12% to about 15% by weight to provide a humectant benefit and modify water activity (Wilson, col. 2, ll. 61–68); about 3% to about 10% by weight of one or more alkali metal salts (an alkali-metal phosphate salt in an amount of about 0.1% to about 2.0% by weight and an alkali-metal bicarbonate salt in an amount of about 0.05% to about 2.0% by weight) (Wilson, col. 2, ll. 10–25). The combined disclosed ranges extend to about 4% by weight and overlap the claimed range at about 3% to about 4% by weight. It has been held that overlapping ranges are prima facie evidence of obviousness. See MPEP § 2144.05(II). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the phosphate and bicarbonate salt amounts within the overlapping combined range to buffer the composition (Wilson, col. 2, ll. 10–25); and about 0.001% to about 10% by weight of one or more active ingredients, flavoring agents, or combinations thereof (0.06 wt.% vanilla crème flavor and 0.0045 wt.% mint flavor) (Wilson, Example I, Table I, col. 5, ll. 15–35). Modified Wilson does not expressly teach wherein the composition has a water activity of about 0.70 to about 0.85. Kayamura teaches improving the preservability of water-containing ingestible compositions by reducing water activity (¶ [0033]) and teaches that combining glycerin with sugar alcohols provides a synergistic water-activity-reducing effect (¶ [0058]). Kayamura further teaches experimentally evaluating the relationship between polyol composition and water activity and demonstrates compositions having water activities within the claimed range (¶¶ [0120]–[0122], Tables 1–2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the relative amounts of glycerin and one or more sugar alcohols in modified Wilson to obtain a water activity of about 0.70 to about 0.85 because Kayamura teaches that adjusting the polyol composition predictably provides water activities within the claimed range while improving preservability. Regarding claim 20, Modified Wilson teaches each limitation of claim 19 as set forth above and further teaches an active ingredient selected from the group consisting of nutraceuticals (calcium carbonate) (Wilson, col. 2, ll. 1–9). Modified Wilson does not teach about 0.001% to about 10% by weight of the active ingredient. Wilson teaches 10.83 wt.% calcium carbonate (Wilson, Example I, Table I, col. 5, ll. 15–35), rather than the claimed about 10 wt.%. The Examiner interprets 10.83 wt.% as sufficiently close to about 10 wt.% that one of ordinary skill in the art would not have considered there to be a significant difference between the two amounts in terms of the biological and therapeutic effect provided by the calcium carbonate, particularly because Applicant uses the term “about” without defining a narrower numerical boundary. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select about 10 wt.% calcium carbonate because doing so would provide predictable biological and therapeutic effects similar to those provided by 10.83 wt.% calcium carbonate. It has been held that a prima facie case of obviousness exists where the claimed and prior-art amounts do not overlap but are merely close. See MPEP § 2144.05(II). Regarding claim 23, Modified Wilson teaches wherein the composition is substantially free of aliphatic monoalcohols (the complete liquid composition contains no aliphatic monoalcohol) (Wilson, Example I, Table I, col. 5, ll. 15–35). Claims 11 and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over Wilson et al. in view of Kayamura et al., as applied to claim 1 above, and further in view of Nielsen et al. (US-20200397691-A1). Regarding claim 11, Modified Wilson teaches the composition of claim 1 as set forth above but does not teach comprising an aqueous tobacco extract. Nielsen teaches an aqueous oral liquid formulation containing water as a solvent (¶ [0105]) and further teaches incorporating tobacco or a tobacco blend into the liquid formulation as a flavor (¶ [0115]). Thus, Nielsen teaches tobacco-derived material incorporated into an aqueous liquid composition, corresponding to the claimed aqueous tobacco extract. Nielsen is in the same field of endeavor as modified Wilson because both concern orally administered aqueous liquid pharmaceutical compositions. Wilson further teaches that flavorants may be incorporated into its composition (col. 3, ll. 39–55). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to include Nielsen’s tobacco or tobacco-blend flavor in modified Wilson’s aqueous liquid pharmaceutical composition as a flavorant expressly contemplated by Wilson, thereby providing tobacco-derived material in an aqueous liquid composition corresponding to the claimed aqueous tobacco extract. Combining prior-art elements according to known methods to yield predictable results is prima facie evidence of obviousness. See MPEP § 2143(I)(A). Regarding claim 13, Modified Wilson teaches the composition of claim 1 as set forth above but does not teach comprising from about 0.001% to about 10% by weight of a nicotine component, calculated as the free base and based on the total weight of the composition. Nielsen teaches aqueous liquid pharmaceutical compositions containing nicotine base at 0.72 wt.%, 1.43 wt.%, and 2.86 wt.%, each falling within the claimed range (Table 4A). Nielsen further teaches that when nicotine is present as a nicotine salt, the nicotine amount is determined based on the equivalent amount of pure nicotine rather than the total mass of the salt, corresponding to calculation as the free base (¶ [0081]). Nielsen is in the same field of endeavor as modified Wilson because both concern orally administered aqueous liquid pharmaceutical compositions. Wilson further teaches that other pharmaceutical actives may be incorporated into its composition (col. 3, ll. 39–41). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to include Nielsen’s nicotine component in modified Wilson’s aqueous liquid pharmaceutical composition at the amounts taught by Nielsen as another pharmaceutical active expressly contemplated by Wilson, thereby providing nicotine within the claimed concentration range. Combining prior-art elements according to known methods to yield predictable results is prima facie evidence of obviousness. See MPEP § 2143(I)(A). 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 1, 5, and 7–20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–19 of U.S. Patent No. 12,550,928. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite the same liquid oral composition comprising water, an active ingredient or flavoring agent, sweeteners, humectants, alkali-metal salts, and a reduced water activity. In particular, claim 1 of the instant application recites a liquid oral composition comprising at least about 40% by weight water, a flavoring agent or active ingredient, sweeteners, humectants, and alkali-metal salts, wherein the composition has a water activity of about 0.85 or lower, the humectant is present in an amount of about 12% to about 20% by weight, and the sweeteners, humectants, and alkali-metal salts are present in a total amount of about 40% by weight or higher. Claim 1 of U.S. Patent No. 12,550,928 recites the same liquid oral composition comprising at least about 40% by weight water, a flavoring agent or active ingredient, at least one alkali-metal salt, at least one sugar alcohol, at least one humectant, and a water activity of about 0.85 or lower. Claim 4 of U.S. Patent No. 12,550,928 further recites that the sweeteners, humectants, and alkali-metal salts are present in a total amount of about 40% by weight or higher. Claim 18 of U.S. Patent No. 12,550,928 further recites a humectant in an amount of about 10% to about 20% by weight. The presently claimed humectant range of about 12% to about 20% by weight is encompassed by the patented range of about 10% to about 20% by weight. Accordingly, it would have been obvious to one of ordinary skill in the art to select the narrower humectant range of about 12% to about 20% by weight from the patented range while retaining the total amount of sweeteners, humectants, and alkali-metal salts at about 40% by weight or higher, as taught by patented claim 4. Thus, claim 1 of the instant application is not patentably distinct from claims 1 and 4 of U.S. Patent No. 12,550,928 in view of claim 18 thereof. Claim 5 of the instant application is not patentably distinct from claim 5 of U.S. Patent No. 12,550,928 because both claims recite that the additional components comprise at least one alkali-metal salt and at least one sweetener. The humectant amount recited through dependency from instant claim 1 is not patentably distinct for the reasons discussed above. Claim 7 of the instant application is not patentably distinct from claims 1 and 4 of U.S. Patent No. 12,550,928 in view of claim 18 thereof because the patented claims collectively recite the same composition comprising an alkali-metal salt selected from sodium chloride, sodium carbonate, sodium bicarbonate, and combinations thereof, at least one sugar alcohol, a humectant within a range encompassing the presently claimed range, and at least about 40% by weight total sweeteners, humectants, and alkali-metal salts. Claim 8 of the instant application is not patentably distinct from claim 7 of U.S. Patent No. 12,550,928 because both claims recite an alkali-metal salt selected from sodium chloride and sodium carbonate, a sugar alcohol selected from xylitol and sorbitol, and a humectant selected from glycerin and propylene glycol. The humectant amount recited through dependency from instant claim 1 is not patentably distinct for the reasons discussed above. Claim 9 of the instant application is not patentably distinct from claim 8 of U.S. Patent No. 12,550,928 because both claims further recite at least one artificial sweetener. Claim 10 of the instant application is not patentably distinct from claim 9 of U.S. Patent No. 12,550,928 because both claims recite a water content of about 40% to about 60% by weight. Claim 11 of the instant application is not patentably distinct from claim 10 of U.S. Patent No. 12,550,928 because both claims recite an aqueous tobacco extract. Claim 12 of the instant application is not patentably distinct from claim 11 of U.S. Patent No. 12,550,928 because both claims recite an active ingredient selected from a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, and combinations thereof. Claim 13 of the instant application is not patentably distinct from claim 12 of U.S. Patent No. 12,550,928 because both claims recite about 0.001% to about 10% by weight of a nicotine component, calculated as the free base and based on the total weight of the composition. Claim 14 of the instant application is not patentably distinct from claim 13 of U.S. Patent No. 12,550,928 because both claims recite that the composition is substantially free of tobacco material, excluding any nicotine component present. Claim 15 of the instant application is not patentably distinct from claim 14 of U.S. Patent No. 12,550,928 because both claims recite a water activity of about 0.70 to about 0.85. Claim 16 of the instant application is not patentably distinct from claim 15 of U.S. Patent No. 12,550,928 because both claims recite a pH of about 7 or greater. Claim 17 of the instant application is not patentably distinct from claim 16 of U.S. Patent No. 12,550,928 because both claims recite a pH of about 7 to about 9. Claim 18 of the instant application is not patentably distinct from claim 17 of U.S. Patent No. 12,550,928 because both claims recite that the composition is adapted for spraying into the oral cavity. Claim 19 of the instant application is not patentably distinct from claim 18 of U.S. Patent No. 12,550,928 because both claims recite: about 40% to about 60% by weight water; about 20% to about 30% by weight of one or more sugar alcohols; about 3% to about 10% by weight of one or more alkali-metal salts; about 0.001% to about 10% by weight of one or more active ingredients, flavoring agents, or combinations thereof; and a water activity of about 0.70 to about 0.85. Patented claim 18 recites about 10% to about 20% by weight humectant, which encompasses the presently claimed range of about 12% to about 20% by weight. Selecting the narrower presently claimed humectant range would have been an obvious variation of the patented composition. Claim 20 of the instant application is not patentably distinct from claim 19 of U.S. Patent No. 12,550,928 because both claims recite the same quantitative composition of claim 19 and further require the active ingredient to be selected from a nicotine component, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, and combinations thereof. Patented claim 19 recites about 10% to about 20% by weight humectant, which encompasses the presently claimed range of about 12% to about 20% by weight. Accordingly, the narrower humectant range does not render instant claim 20 patentably distinct. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached Monday - Thursday 7:00am - 5:00pm. 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 H Wilson can be reached at (571) 270-3882. 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. /JENNIFER A KESSIE/Examiner, Art Unit 1747 /Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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Prosecution Timeline

Show 6 earlier events
Mar 07, 2025
Response after Non-Final Action
Mar 26, 2025
Non-Final Rejection mailed — §103, §112, §DP
Jun 20, 2025
Response Filed
Nov 04, 2025
Final Rejection mailed — §103, §112, §DP
Jan 02, 2026
Response after Non-Final Action
Jan 02, 2026
Notice of Allowance
May 21, 2026
Response after Non-Final Action
Jul 27, 2026
Non-Final Rejection mailed — §103, §112, §DP (current)

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Prosecution Projections

5-6
Expected OA Rounds
64%
Grant Probability
87%
With Interview (+22.2%)
3y 1m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 321 resolved cases by this examiner. Grant probability derived from career allowance rate.

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