DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to applicant’s request for continued examination filed December 11, 2025. Claims 1, 24, and 28 have been amended. Claims 1-2, 4, 8-16, 18-25, 28, and 30-32 are pending and stand rejected.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 11, 2025 has been entered.
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.
Claims 1, 8-10, 13-16, 22-24, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150013695 A1 (hereinafter MCNEAL) in view of US 20160198759 A1 (hereinafter KUNTAWALA). KUNTAWALA was made of record on applicant’s information disclosure dated August 11, 2021.
Regarding claim 1, MCNEAL discloses a composition and apparatus for inhaling the composition (abstract). MCNEAL discloses (i) one or more solvents (¶8); (ii) one or more flavors (¶40); wherein the flavored vaporizable formulation contains water in an amount of from 0.05 to 10 wt.% based on the vaporizable formulation (¶32); wherein the solvent comprises glycerol and propylene glycol, where glycerol is present in a total amount from 5 to 40 wt.% based on the flavored vaporizable formulation and where propylene glycol, is present in a total amount from 5 to 40 wt.% based on the flavored vaporizable formulation (¶9, ¶37). MCNEAL further discloses wherein the flavored vaporizable formulation further comprises nicotine (¶41). MCNEAL further discloses wherein the flavored vaporizable formulation is a liquid (¶10, ¶22).
MCNEAL further teaches wherein the one or more flavors are present in a total amount of at least 0.1 wt.% based on the flavored vaporizable formulation (Claim 8, ¶40). MCNEAL discloses that the inhalable composition further comprises about 1 wt %, 5 wt %, 10 wt %, 15 wt %, 20 wt %, 25 wt %, 30 wt % (¶40). This encompasses a range of at least 0.1 wt. % as any amount greater than 0.1% is at least 0.1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
MCNEAL does not disclose (iii) one or more cyclodextrins nor wherein the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors.
KUNTAWALA teaches improved vaping fluids combined with cyclodextrin to enhance absorption and avoid irritation (abstract). KUNTAWALA teaches that a problem exists with aerosol particles not being efficiently absorbed and that can be dealt with by increasing the concentration of active ingredients, though this may cause irritation (¶16). KUNTAWALA teaches addition of cyclodextrin to e-fluid enhances the absorbability of active ingredients while suppressing any irritating tendency of the aerosol (¶16). KUNTAWALA further teaches, “more importantly, the addition of sufficient cyclodextrin to e-fluid enhances the absorption and bioavailability of any active ingredients while at the same time reducing any tendency towards irritation caused by the aerosol” (¶16). KUNTAWALA teaches the inclusion of “a and γ cyclodextrin are preferred” (¶17, emphasis added). KUNTAWALA teaches the cyclodextrin complexes form best with a molar excess of cyclodextrin (¶21). KUNTAWALA teaches that it has been found that a 2-3 fold molar excess works well (¶21).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include (iii) one or more cyclodextrins and wherein the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors as taught KUNTAWALA. A person of ordinary skill in the art would obviously include a cyclodextrin because doing so would to enhance absorption and avoid irritation (KUNTAWALA ¶16). The claim would have been obvious because “a person of ordinary skill has good reason to pursue the known options with his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Further a person would introduce the cyclodextrins in molar excess because doing so would cause the cyclodextrins to form best (KUNTAWALA ¶21) and adequate cyclodextrin is recired to enhase the absorption and reduce tendencies for irritation (KUNTAWALA ¶16).
Regarding claims 8-10, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses wherein the flavored vaporizable formulation contains water in an amount of from 0 to 5 wt.% based on the vaporizable formulation and wherein the flavored vaporizable formulation contains water in an amount of from 0 to 1 wt.% based on the vaporizable formulation and wherein the flavored vaporizable formulation contains water in an amount of from 0 to 0.1 wt.% based on the vaporizable formulation (¶32).
Regarding claim 13, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses wherein the one or more flavors are selected from the group consisting of (4-(para- )methoxyphenyl)-2-butanone, vanillin, y-undecalactone, menthone, 5-propenyl guaethol, menthol, para-mentha-8-thiol-3-one and mixtures thereof (¶36, ¶40).
Regarding claim 14, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses wherein the flavor includes menthol (¶36, ¶52).
Regarding claim 15, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses wherein the one or more flavors are present in a total amount of no greater than 2wt.% based on the flavored vaporizable formulation (claim 8, ¶40).
Regarding claim 16, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses wherein the one or more flavors are present in a total amount of from 0.01 to 1 wt.% based on the flavored vaporizable formulation (Claim 8, ¶40). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 22, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses vaporizing the flavored vaporizable formulation (Figs. 1-2, ¶8, ¶10).
Regarding claim 23, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses (a) a container (Fig. 2, cartridge 106).
Regarding claim 24, MCNEAL discloses an apparatus for pulmonary delivery of an inhalable composition (Abstract). MCNEAL discloses (a) a vaporizer for vaporizing liquid for inhalation by a user of the electronic vapor provision system (Fig. 1, vaporizer apparatus 100, ¶53); (b) a power supply comprising a cell or battery for supplying power to the vaporizer (Fig. 2, power supply 112, ¶54, ¶72); and (c) a flavored vaporizable formulation comprising (Fig. 2, composition housed in cartridge 106, ¶55). MCNEAL discloses (i) one or more solvents (¶8); (ii) one or more flavors (¶40); wherein the flavored vaporizable formulation contains water in an amount of from 0.5 to 10 wt.% based on the vaporizable formulation (¶32); wherein the solvent comprises glycerol and propylene glycol, where glycerol is present in a total amount from 5 to 40 wt.% based on the flavored vaporizable formulation and where propylene glycol, l is present in a total amount from 5 to 40 wt.% based on the flavored vaporizable formulation (¶9, ¶37). MCNEAL further discloses wherein the flavored vaporizable formulation further comprises nicotine (¶41). MCNEAL further discloses wherein the flavored vaporizable formulation is a liquid (¶10, ¶22).
MCNEAL further teaches wherein the one or more flavors are present in a total amount of at least 0.1 wt.% based on the flavored vaporizable formulation (Claim 8, ¶40). MCNEAL discloses that the inhalable composition further comprises about 1 wt %, 5 wt %, 10 wt %, 15 wt %, 20 wt %, 25 wt %, 30 wt % (¶40). This encompasses a range of at least 0.1 wt. % as any amount greater than 0.1% is at least 0.1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
MCNEAL does not disclose (iii) one or more cyclodextrins nor wherein the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors.
KUNTAWALA teaches improved vaping fluids combined with cyclodextrin to enhance absorption and avoid irritation (abstract). KUNTAWALA teaches that a problem exists with aerosol particles not being efficiently absorbed and that can be dealt with by increasing the concentration of active ingredients, though this may cause irritation (¶16). KUNTAWALA teaches addition of cyclodextrin to e-fluid enhances the absorbability of active ingredients while suppressing any irritating tendency of the aerosol (¶16). KUNTAWALA further teaches, “more importantly, the addition of sufficient cyclodextrin to e-fluid enhances the absorption and bioavailability of any active ingredients while at the same time reducing any tendency towards irritation caused by the aerosol” (¶16). KUNTAWALA teaches the inclusion of “a and γ cyclodextrin are preferred” (¶17, emphasis added). KUNTAWALA teaches the cyclodextrin complexes form best with a molar excess of cyclodextrin (¶21). KUNTAWALA teaches that it has been found that a 2-3 fold molar excess works well (¶21).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include (iii) one or more cyclodextrins and wherein the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors as taught KUNTAWALA. A person of ordinary skill in the art would obviously include a cyclodextrin because doing so would to enhance absorption and avoid irritation (KUNTAWALA ¶16). The claim would have been obvious because “a person of ordinary skill has good reason to pursue the known options with his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Further a person would introduce the cyclodextrins in molar excess because doing so would cause the cyclodextrins to form best (KUNTAWALA ¶21) and adequate cyclodextrin is recired to enhase the absorption and reduce tendencies for irritation (KUNTAWALA ¶16).
Regarding claim 28, MCNEAL discloses (i) one or more solvents (¶8); (ii) one or more flavors (¶40); wherein the flavored vaporizable formulation contains water in an amount of from 0 to 10 wt.% based on the vaporizable formulation (¶32); wherein the solvent comprises glycerol and propylene glycol, where glycerol is present in a total amount from 5 to 40 wt.% based on the flavored vaporizable formulation and where propylene glycol, l is present in a total amount from 5 to 40 wt.% based on the flavored vaporizable formulation (¶9, ¶37). MCNEAL further discloses wherein the flavored vaporizable formulation further comprises nicotine (¶41). MCNEAL further discloses wherein the flavored vaporizable formulation is a liquid (¶10, ¶22).
MCNEAL further teaches wherein the one or more flavors are present in a total amount of at least 0.1 wt.% based on the flavored vaporizable formulation (Claim 8, ¶40). MCNEAL discloses that the inhalable composition further comprises about 1 wt %, 5 wt %, 10 wt %, 15 wt %, 20 wt %, 25 wt %, 30 wt % (¶40). This encompasses a range of at least 0.1 wt. % as any amount greater than 0.1% is at least 0.1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
MCNEAL does not disclose (iii) one or more cyclodextrins or wherein the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors or wherein use of the one or more cyclodextrins for increasing solubility of the flavor comprises combining the one or more cyclodextrins with the one or more solvents and the flavor.
KUNTAWALA teaches improved vaping fluids combined with cyclodextrin to enhance absorption and avoid irritation (abstract). KUNTAWALA teaches that a problem exists with aerosol particles not being efficiently absorbed and that can be dealt with by increasing the concentration of active ingredients, though this may cause irritation (¶16). KUNTAWALA teaches addition of cyclodextrin to e-fluid enhances the absorbability of active ingredients while suppressing any irritating tendency of the aerosol (¶16). KUNTAWALA further teaches, “more importantly, the addition of sufficient cyclodextrin to e-fluid enhances the absorption and bioavailability of any active ingredients while at the same time reducing any tendency towards irritation caused by the aerosol” (¶16). KUNTAWALA teaches the inclusion of “a and γ cyclodextrin are preferred” (¶17, emphasis added). KUNTAWALA teaches the cyclodextrin complexes form best with a molar excess of cyclodextrin (¶21). KUNTAWALA teaches that it has been found that a 2-3 fold molar excess works well (¶21). KUNTAWALA teaches examples of combining the cyclodextrin, a flavor, and a solvent beginning at ¶28.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include (iii) one or more cyclodextrins and wherein the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors and wherein use of the one or more cyclodextrins for increasing solubility of the flavor comprises combining the one or more cyclodextrins with the one or more solvents and the flavor as taught KUNTAWALA. A person of ordinary skill in the art would obviously include a cyclodextrin because doing so would to enhance absorption and avoid irritation (KUNTAWALA ¶16). The claim would have been obvious because “a person of ordinary skill has good reason to pursue the known options with his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Further a person would introduce the cyclodextrins in molar excess because doing so would cause the cyclodextrins to form best (KUNTAWALA ¶21) and adequate cyclodextrin is required to enhance the absorption and reduce tendencies for irritation (KUNTAWALA ¶16).
Regarding claim 30, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL further discloses wherein the one or more solvents consist of (i) water and (ii) glycerol and/or propylene glycol (¶9). MCNEAL discloses that the composition includes water and glycerol and/or propylene glycol to produce an aqueous solution (¶9). Water is considered to be a universal solvent.
Claims 2, 4, 18, 25, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over MCNEAL and KUNTAWALA as applied to claims 1, 8-10, 13-16, 22-24, 28, and 30 above and in further view of US 5144964 A (hereinafter DEMAIN).
Regarding claim 2, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL does not disclose wherein the total content of the one or more cyclodextrins is at least 1 wt.% based on the vaporizable formulation.
DEMAIN teaches that smoking compositions comprise incorporating 0.001-5 weight percent of the flavorant release additive (Col. 3, lines 41-51) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 4, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL does not disclose wherein the one or more cyclodextrins comprises at least one or more substituted cyclodextrins.
DEMAIN teaches that unsubstituted beta-cyclodextrins has a low water solubility as compared to the substituted beta-cyclodextrin (Col. 2, lines 61-68). DEMAIN therefore teaches that the preferred beta-cyclodextrin is one with ether substituents (Col. 3, lines 2-4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include wherein the one or more cyclodextrins comprises at least one or more substituted cyclodextrins as taught in DEMAIN. Doing so would provide increased water solubility (DEMAIN Col. 2, lines 61-68).
Regarding claim 18, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL does not disclose wherein formulation comprises 2-hydroxy-propyl-β-cyclodextrin.
DEMAIN which teaches substituted cyclodextrins (claim 16). Specifically DEMAIN teaches, “A β cyclodextrin derivative such as Molecusol HPB.TM. (Pharmatec, Inc.) or Encapsin HPB.TM. (American Maize Company) can form an aqueous solution with a concentration of 50% (w/v). The Molecusol HPB TM derivative contains about seven 2-hydroxypropoxy groups. The preferred β cyclodextrin derivatives of the present invention contain between about 1-7 C.sub.1 -C.sub.6 hydroxyalkyl ether substituents.” (Col. 2, lines 61-38 cont. Col. 3, lines 1-4)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include wherein the substituted cyclodextrins as taught in DEMAIN. Doing so would use a preferred water solubility molecule for inclusion of the flavor (DEMAIN Col. 2, lines 61-65 and Col. 3, lines 5-7). Also a person of ordinary skill in the art would select various known cyclodextrins (DEMAIN ¶ Col. 2, lines 61-65 cont. Col. 3, lines 1-4).
Regarding claim 25, modified MCNEAL discloses the electronic vapor provision system of claim 24. MCNEAL further discloses wherein the flavored vaporizable formulation is a flavored vaporizable formulation (¶40). MCNEAL does not disclose wherein the total content of one or more cyclodextrins is at least 1 wt.% based on the vaporizable formulation.
DEMAIN teaches that smoking compositions comprise incorporating 0.001-5 weight percent of the flavorant release additive (Col. 3, lines 41-51) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 31, modified MCNEAL disclose the flavored vaporizable formulation of claim 1 as discussed above. MCNEAL does not disclose wherein the one or more cyclodextrins are selected from the group consisting of substituted or unsubstituted (a)-cyclodextrin, substituted or unsubstituted (p)-cyclodextrin, substituted or unsubstituted (y)- cyclodextrin, and mixtures thereof.
DEMAIN teaches smoking compositions which contain a novel flavorant-release additive with a beta-cyclodextrin (abstract). DEMAIN teaches unsubstituted beta cyclodextrin that is a water solubility of only about 20 milligrams per milliliter of water at room temperature. Beta-cyclodextrin which is substituted with hydroxyalkyl groups has an increased solubility in water (Col. 2, lines 61-65). DEMAIN teaches that the inclusion of the beta cyclodextrin molecule contains the lipophilic organic flavor as an essential constituent (Col. 3, lines 5-7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include wherein the one or more cyclodextrins are selected from the group consisting of substituted or unsubstituted (a)-cyclodextrin, substituted or unsubstituted (p)-cyclodextrin, substituted or unsubstituted (y)- cyclodextrin, and mixtures thereof as taught MCNEAL. Doing so would use a preferred water solubility molecule for inclusion of the flavor (DEMAIN Col. 2, lines 61-65 and Col. 3, lines 5-7). The claim would have been obvious because “a person of ordinary skill has good reason to pursue the known options with his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 32, modified MCNEAL disclose the flavored vaporizable formulation of claim 1 as discussed above. MCNEAL does not disclose wherein the one or more cyclodextrins are selected from the group consisting of substituted (a)-cyclodextrin, substituted ()-cyclodextrin, substituted (y)-cyclodextrin, and mixtures thereof.
DEMAIN teaches smoking compositions which contain a novel flavorant-release additive with a beta-cyclodextrin (abstract). DEMAIN teaches unsubstituted beta cyclodextrin that is a water solubility of only about 20 milligrams per milliliter of water at room temperature. Beta-cyclodextrin which is substituted with hydroxyalkyl groups has an increased solubility in water (Col. 2, lines 61-65). DEMAIN teaches that the inclusion of the beta cyclodextrin molecule contains the lipophilic organic flavor as an essential constituent (Col. 3, lines 5-7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to include wherein the one or more cyclodextrins are selected from the group consisting of substituted (a)-cyclodextrin, substituted ()-cyclodextrin, substituted (y)-cyclodextrin, and mixtures thereof as taught MCNEAL. Doing so would use a preferred water solubility molecule for inclusion of the flavor (DEMAIN Col. 2, lines 61-65 and Col. 3, lines 5-7). The claim would have been obvious because “a person of ordinary skill has good reason to pursue the known options with his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over MCNEAL and KUNTAWALA as applied to claims 1, 8-10, 13-16, 22-24, 28, and 30 above and in further view of US 20160366927 A1 (hereinafter LIU).
Regarding claims 11-12, modified MCNEAL discloses the flavored vaporizable formulation of claim 1 as discussed above. MCNEAL does not disclose wherein the solvent is present in an amount of at least 75-90 wt.% based on the flavored vaporizable formulation.
LIU teaches a solvent for electronic cigarette liquid comprising triethyl citrate alone or in combination with a polyol (Abstract). LIU teaches that electronic cigarette liquid which is prepared with the solvent for electronic cigarette liquid provided by the present invention can generate greater amount of smoke (¶5) improving the user experience (¶24). LIU teaches that the solvent, triethyl citrate can be present 95% wt or more (¶7). Specifically LIU teaches that the solvent can have 20 wt % - 60 wt % of triethyl citrate; 30 wt %-50 wt % of propylene glycol; 10 wt %-50 wt % of glycerol (¶15-¶18). The formulation further comprises nicotine (¶22-23) and a flavor (¶42-¶43).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified MCNEAL to provide wherein the solvent is present in an amount of at least 75-90 wt.% based on the flavored vaporizable formulation. One would have been motivated to do so since LIU teaches that the solvent causes the electronic cigarette liquid to generate a greater amount of smoke an improve user experience. In the case where claimed ranges "overlap or lie inside ranges disclosed by prior art" a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over MCNEAL and KUNTAWALA as applied to claims 1, 8-10, 13-16, 22-24, 28, and 30 above and in further view of US 20070267033 A1 (hereinafter MISHRA).
Regarding claim 19, modified MCNEAL discloses the flavored vaporizable formulation according to claim 1. MCNEAL does not disclose wherein the one or more beta-cyclodextrins are present in a total amount of at least 7 wt.% based on the flavored vaporizable formulation.
MISHRA teaches electrically heated cigarettes with a flavor-releasing additive that includes cyclodextrin (abstract). MISHRA teaches that the cyclodextrin is used to protect the flavoring from exposure to the atmosphere and reduce migration of the flavoring (¶19). MISHRA teaches examples where the cyclodextrin is within the range of 20% to 30% (¶25-¶26).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified MCNEAL to provide wherein the one or more substituted or unsubstituted beta-cyclodextrins are present in a total amount of at least 7 wt.% based on the flavored vaporizable MISHRA. MISHRA teaches the inclusion of cyclodextrins for reducing the migration of flavoring (¶19) and provides ranges for the formulation (¶25-¶26). The value of 20% to 30% overlaps with the claimed range of at least 7%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over MCNEAL and KUNTAWALA as applied to claims 1, 8-10, 13-16, 22-24, 28, and 30 above and in further view of US 20120171184 (hereinafter SZENTE).
Regarding claims 20-21, modified MCNEAL disclose the flavored vaporizable formulation of claim 1 as discussed above. Modified MCNEAL does not disclose wherein the one or more cyclodextrins are present in an amount of 2-10 wt.%.
SZENTE teaches cyclodextrin in an aqueous beverage in a concentration range of 0.01-75% w/v (¶6). SZENTE additionally teaches exterior surfaces having a high density of hydrophilic chemical groups that hydrogen bond with water (¶51) and that biologically active components having high hydrogen bonding with water improve activity of biological cell systems by increasing hydration (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified PANDYA or MCNEAL to provide cyclodextrin ranges from 2 to 10. One would have been motivated to do so since SZENTE teaches that cyclodextrin improves the hydration of biological cell systems. In the case where claimed ranges "overlap or lie inside ranges disclosed by prior art" a prima facie case of obviousness exists. (See MPEP 2144.05 (I)).
Response to Arguments
Applicant’s arguments, filed December 11, 2025, with respect to the rejection(s) of claims 1-2, 4, 8-10, 13-16, 18-19, 22-25, and 30-32 under 35 USC 103 in view of MCNEAL, DEMAIN, and KUNTAWALA have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of MCNEAL and KUNTAWALA.
Applicant argues, “Present claim 1 includes the feature that the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors. Appellant has found that the addition of the one or more flavors in a molar excess with respect to the one or more cyclodextrins may result in the one or more flavors precipitating from the formulation. To prevent this from occurring, the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors in the formulation. For example, Applicant's specification teaches: We have found that the addition of the one or more flavors in a molar excess with respect to the one or more cyclodextrins may result in the one or more flavors precipitating from the formulation. Therefore in one aspect, the one or more cyclodextrins are present in a molar excess with respect to the one or more flavors. (Substitute Specification, pg. 22, lines 12-15). This use of one or more cyclodextrins in the claimed amount overcomes the problem of precipitation of flavors in aerosolizable formulations..”
KUNTAWALA teaches that cyclodextrin is used in vaping fluids when combining active ingredients with hydrophilic solvents and flavors (¶14). KUNTAWALA teaches that cyclodextrin is included to enchase absorption of the active ingredient and limit any tendency of the inhaled aerosol to cause irritation (¶14, ¶16). KUNTAWALA further teaches that the cyclodextrin is known in the art for sequestering hydrophobic molecules and for forming droplets, but it is now appreciated that cyclodextrins also promote aerosol formation and reduce irritation (¶16). Applicant’s argument that the teaching of the molar excess in relation to the active ingredient in (¶21) does not detract from the teaching of the molar excess of the cyclodextrin itself. Further all ingredients, including caffeine, impart a flavor and are therefore broadly considered to be a flavor. Additionally, since KUNTAWALA recognizes other advantages beyond enhancing absorption of the active ingredient, namely formation of the aerosol, the addition of cyclodextrin in molar excess is broadly taught for advantages beyond the stabilization of the active ingredient. Further, a person of ordinary skill in the art would use cyclodextrin to stabilize all additives in the fluid. Finally, KUNTAWALA provides examples on page 3 where the formulas of the e-fluid are provided. The caffeine in example 1 is at a concentration of 0.05M, cyclodextrin is at 0.2M, clearly in molar excess. The flavor is a “trace”. This formulation inherently teaches a molar excess of cyclodextrin to flavor. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). A link between the molar ratios of the cyclodextrin to the flavor is established in the formulation tables and shows a clear molar excess of cyclodextrin to flavor.
Applicant further argues, “The Examiner relies on Demain for the teaching of cyclodextrins. Demain discloses that a complex of a flavorant (e.g., vanillin or ethyl vanillin) can be made with 2-hydroxypropyl-p-cyclodextrin. Vanillin is mixed with the hydroxypropyl-3-cyclodextrin (HPB cyclodextrin). The molar ratio of vanillin to HPB cyclodextrin is not generally discussed in Demain. However, in Example I, an inclusion complex of vanillin and HPB cyclodextrin is described. 100 mg vanillin is mixed with 2 ml of 45% w/w HPB cyclodextrin. We have calculated this to be roughly 10:1 vanillin to HPB cyclodextrin. 5:1 ethyl vanillin to HPB cyclodextrin is used in the 2nd example. In either case, the one or more cyclodextrins are present in a molar amount significantly less than the molar amount of flavorant. So, while Demain discloses cyclodextrin and flavors, Demain discloses using a molar excess of flavorant, not an excess of cyclodextrins as claimed.” This argument is moot as DEMAIN is no longer relied on for the teaching of cyclodextrins. However, KUNTAWALA teaches molar excess and teaching, suggestion, and motivation for doing providing molar excess. Applicant has attempted to invalidate KUNTAWALA by focusing on a specific embodiment in DEMAIN where the flavor is in excess. However, a preferred embodiment or alternate embodiment does not constitute a teaching away where the specification teaches more broadly. See MPEP 2123, II. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues, “The Office Action indicates that neither McNeal nor Demain disclose cyclodextrins in a molar excess with respect to flavors. The Examiner relies on Kuntawala for this teaching. Kuntawala discloses that "caffeine, other methyl xanthines and taurine ... can be stabilized as cyclodextrin complexes." Kuntawala also discloses that "it has been found that a 2-3 fold molar excess works well although cyclodextrin is effective in the range of 0.5 to 5.0 molar ratio of cyclodextrin to active ingredient." Applicant notes that caffeine, methyl xanthines, and taurine are defined as active ingredients. The solutions of Kuntawala can include "trace" amounts of flavor. In paragraph [0026], Kuntawala discloses that less than 0.1% by volume is a trace amount. The Office Action takes the position that Kuntawala would provide motivation to include excess cyclodextrins, with respect to the composition of McNeal/Demain. Kuntawala discloses the use of cyclodextrins for active agents, but not for inactive ingredients such as flavorants. We further note that Kuntawala discloses compositions that are formed with a vehicle that is an approximately 50% aqueous solution of a high boiling hydrophilic solvent.” This argument bolsters the argument of the prior art. If the flavors are found in trace amounts less than the active ingredients and those active ingredients are in molar excess with respect to cyclodextrin, the flavors must also be in molar excess. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues, “Kuntawala discloses that the compositions include about 50% water. Demain adds flavorant to an aqueous solution of cyclodextrin to form the complex. Furthermore, Demain teaches that hydroxy 3-cyclodextrins should be used because of the increased water solubility of these cyclodextrins. Neither reference teaches that cyclodextrin complexes can be formed in a composition having 0.05 to 10 wt.% water. There would not be an expectation that the cyclodextrins would form complexes when used in compositions having a low amount of water. The combined teachings of Demain and Kuntawala would direct the skilled person to ensure that the amount of water in the composition is at least 50%. The Office Action cannot simply choose the needed features (cyclodextrins and excess concentration) from the prior art while ignoring the significant difference in the water concentration.” This argument is moot because DEMAIN is no longer relied upon for teaching the limitations of claim 1. However, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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/STEPHANIE LYNN MOORE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747