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 .
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 25, 2026 has been entered.
Status of the Claims
Claims 1-4, 7-17, and 19 are pending and are subject to this Office Action. Claims 1, 7, 9, 14 are amended. Claim 5-6, 18, and 20 are cancelled.
Response to Amendments
The amendments to the claims filed on February 25, 2026 are acknowledged.
Response to Arguments
Applicant's arguments, see pgs 6-10, filed February 23, 2026, are directed to the result effective variable argument on the previous Final Rejection involving Guo, Keqiang, and Luzenberg. In response to the arguments, Examiner has provided a new grounds of rejection which does not include Guo, Keqiang, or Luzenberg. As such, the arguments are moot.
The following is a modified rejection based on amendments made to the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Khoe (US 4,064,253 A).
Regarding Claim 1, Khoe, directed to alkaloids (col 2, ln 22-25) and atomizable compositions (col 1, ln 59-64, If the anti-snore composition can be provided as a spray or a dusting powder (aerosols), the product is necessarily capable of being atomized) teaches an areca nut-flavored product (col 1, ln 29 – col 2, ln 26, The present invention relates to an anti-snore composition containing arecoline or a pharmaceutically acceptable salt thereof; It is reasonably understood that a product comprising an arecoline salt as claimed, would yield an areca nut-flavored product), comprising
an arecoline salt (col 1, ln 29 – col 2, ln 26, The present invention relates to an anti-snore composition containing arecoline or a pharmaceutically acceptable salt thereof),
wherein the arecoline salt has a mass percentage of 2-10% based on a total mass of the areca nut- flavored product (col 3, ln 7-16, Example IV describes a preferred embodiment wherein 50 sucking tablets of 1 g each are manufactured. Each tablet may contain 0.1 to 2 g of effective component per tablet. At 0.1 g of effective component (arecoline salt) in a 1 g tablet, the arecoline salt has a mass percentage of 10% based on a total mass of the areca nut- flavored product),
wherein the product is an aerosol generation substrate configured to be atomized to generate a smokable aerosol (col 1, ln 59-64, The form in which the medicine is administered should be adapted to local applications. So e.g. tablets can be utilized particularly sucking tablets, soluble tablets, dusting powders, sprays, pencils, preparations on a resin base with delayed effect, infusion liquid and preferably gargles. If the anti-snore composition can be provided as a spray or a dusting powder (i.e. particles of solid/liquid entrained in a gas, or aerosols), the product is an aerosol generation substrate which is necessarily capable of being configured to be atomized to generate a smokable aerosol).
The range for the arecoline salt mass percentage disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claims 2-4, Khoe teaches the product according to claim 1, wherein the arecoline salt is neutralized arecoline with a complex acid, wherein the complex acid of the arecoline salt is at least one selected from the group consisting of: hydrobromic acid (col 2, ln 9-21; The salt may be arecoline hydrobromide),
but does not teach the product wherein the arecoline and the complex acid have a molar ratio of n; n has a value of 0<n<10.
While Khoe does not teach the limitation of Claim 4, Claim 2 is considered a product-by-process claim. The determination of patentability is based upon the product structure or composition itself. The patentability of a product or apparatus does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even if the prior product was made by a different process. In this instance, Khoe teaches a compositionally equivalent product comprising an arecoline salt, and the product of Khoe is capable of being made in the claimed manner. Additionally, because Claims 3 and 4 further modify claim 2, Claims 3-4 are similarly considered product-by-process claims, and the product of Khoe is capable of being made in the claimed manner.
Claim 8 is considered a product-by-process claim. The determination of patentability is based upon the product structure or composition itself. The patentability of a product or apparatus does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even if the prior product was made by a different process. In this instance, Khoe teaches a compositionally equivalent product, and the product of Khoe is capable of being made in the claimed manner.
Regarding Claim 15, Khoe teaches the product according to claim 1, wherein the aerosol generation substrate is a solid phase configured to generate a smokable aerosol when heated below an ignition point col 1 59-64, The form in which the medicine is administered should be adapted to local applications. So e.g. tablets can be utilized particularly sucking tablets, soluble tablets, dusting powders, sprays, pencils, preparations on a resin base with delayed effect, infusion liquid and preferably gargles. The anti-snore composition can be provided as a dusting powder (i.e. particles of solid entrained in a gas). Abehasera does not mention burning, combustion, or ignition of the solid substance, and therefore, it is reasonably understood that a smokable aerosol is formed by heating the vaporizable substance below its ignition point).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Khoe (US 4,064,253 A) as applied to Claim 1, in view of Bowen (US 2021/0186082 A1).
Regarding Claim 7, Khoe teaches the product wherein the arecoline salt may be derived from inorganic or organic acids, such as salt of hydrobromic acid, salt of fumaric acid, tartrate, succinate, valerate, citrate, etc (col 2, ln 9-21). Khoe additionally demonstrates that arecoline is an alkaloid compound (col 2, ln 22-25),
but does not teach the product wherein the arecoline salt is arecoline benzoate.
Bowen, directed to alkaloids ([0124]), teaches a product comprising a pharmaceutically acceptable salt of an alkaloid ([0002], The present disclosure relates to a nicotine salt formulation comprising a nicotine salt in a biologically acceptable liquid carrier. [0124]-[0125], Nicotine is provided as a free base and combined with an acid to form the nicotine salt [0131], A suitable acid may have minimal or no toxicity to humans in the concentrations used. [0339], the formulation is non-toxic to a user of the electronic cigarette),
wherein the alkaloid may be provided as a free base and combined with an acid to form the pharmaceutically acceptable salt ([0124]-[0125], Nicotine is provided as a free base and combined with an acid to form the nicotine salt),
wherein the salt may be a salt of inorganic or organic acid such as benzoic acid ([0123], [0128], the suitable acid for nicotine salt formation is selected from the group comprising formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, citric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, benzoic acid, pyruvic acid, levulinic acid, tartaric acid, lactic acid, malonic acid, succinic acid, fumaric acid, finnaric acid, gluconic acid, saccharic acid, salicylic acid, sorbic acid, malonic acid, and malic acid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide arecoline benzoate as the arecoline salt because Khoe and Bowen are directed to alkaloids, Khoe states the arecoline salt may be a pharmaceutically acceptable salt of arecoline derived from inorganic or organic acids (Khoe, col 1, ln 29 – col 2, ln 26), Bowen demonstrates that alkaloids may be combined with benzoic acid (an organic acid) to yield a pharmaceutically acceptable benzoate salt (Bowen, [0124]-[0125], [0131], [0339]), Khoe demonstrates that arecoline is an alkaloid compound (Khoe, col 2, ln 22-25), and the disclosures in Bowen would have motivated one of ordinary skill in the art to provide the product of Khoe including the claimed salt.
Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Khoe (US 4,064,253 A) as applied to Claim 1, in view of Anlahr (US 2020/0093737 A1).
Regarding Claims 9-14, Khoe does not teach the product wherein the aerosol generation substrate further comprises a solvent and a flavoring agent, wherein the solvent is at least one selected from the group consisting of: propylene glycol, glycerol, polyethylene glycol 200, polyethylene glycol 400, dipropylene glycol ether, ethanol, water, triethyl citrate, triacetin, caprylic capric triglyceride, isopropyl alcohol, palm oil, peanut oil, corn oil and salad oil, wherein the solvent includes glycerol, and the glycerol in the aerosol generation substrate has a mass percentage of 0-90%, wherein the solvent includes propylene glycol, and the propylene glycol in the aerosol generation substrate has a mass percentage of 9-99.8%,
wherein the flavoring agent is at least one selected from the group consisting of: nerol, trans-2-hexenol, linalool, benzyl alcohol, 1-hexanol, leaf alcohol, alpha-terpineol, citronellol, beta-phenylethanol, linalool oxide, geraniol, isoamyl alcohol, octanol, hexanol, decanol, cinnamyl alcohol, heptanol, eugenol, maltol, ethyl maltol, thymol, isoeugenol, 2- methylbutyric acid, malic acid, n-valeric acid, n-hexanoic acid, edible acetic acid, n-caprylic acid, strawberry acid, butyric acid, citric acid, propionic acid, 3-methylvaleric acid, isovaleric acid, isoamyl acetate, amyl formate, geranyl formate, butyl formate, benzyl formate, formicacidhexenester, gamma-decanolactone, delta-nonalactone, gamma-octalactone, gamma- heptalactone, gamma-Undecalactone, delta-dodecalactone, benzaldehyde, strawberry aldehyde, cinnamaldehyde, furfural, citral, acetaldehyde, 3-methylthiopropanal, natural 3-mercapto-2- methylpentanal, isobutyraldehyde, trans-2-octenal, trans-2-nonenal, trans-2-decenal, trans,trans- 2,4-heptadienal, 2,5-dimethylpyrazine, 2-acetylfuran, 2-ethyl-3(5 or 6)-dimethylpyrazine, 2,3,5,6- tetramethylpyrazine, 2,3,5-trimethylpyrazine, 2-acetylpyrazine, acetophenone, beta-ionone, damascenone No. 2 (Firmenich), butanedione, alpha-ionone, acetoin (acetyl methyl carbinol), acetoin (acetyl methyl carbinol), methyl heptenone, vanillin, ethyl vanillin, dihydrocoumarin, raspberry ketone, anisole, cedrol methyl ether, methyl-2-methyl-3-furyl disulfide, wintergreen oil, clove bud oil, 10-fold orange oil, Bois de rose oil, geranium oil, benzaldehyde, basil oil, ethyl vanillin, dihydrocoumarin, raspberry ketone, vanitrope, Tolu concrete, Peru concrete, oak extract, supercritical extract from espresso (water soluble), cocoa extract, coffee tincture, pandan leaf extract, vanilla extract, Labdanum concrete, orris oil or concrete, jasmine concrete, tree moss concrete (amber), tamarind extract, Zimbabwean tobacco extract, tobacco essence, burley tobacco extract, flue-cured tobacco absolute A, top note extract of flue-cured tobacco and top note extract of sun-cured tobacco, wherein the aerosol generation substrate is a liquid phase configured to be atomized by any one of a heating atomizer, an ultrasonic atomizer, an air compression atomizer or a press-type spraying device to generate an aerosol.
Anlahr, directed to atomizable compositions ([0046]), teaches an aerosol generation substrate ([0001], The invention relates to a stable pharmaceutical formulation for treating/preventing snoring. [0043]-[0046], The formulation may be provided as a liquid phase nasal or pharyngeal spray which can be atomized to generate an aerosol) comprising:
a solvent, wherein the solvent is at least one selected from the group consisting of: propylene glycol, glycerol, wherein the solvent includes glycerol, and the glycerol in the aerosol generation substrate has a mass percentage of 0-90%, wherein the solvent includes propylene glycol, and the propylene glycol in the aerosol generation substrate has a mass percentage of 9-99.8% ([0078], The present invention also provides stable pharmaceutical formulations according to the invention for nasal or pharyngeal administration, wherein the formulation comprises 2 to 50% w/v glycerol, 1 to 10% of a solubilizer. [0067], The solubilizer may be propylene glycol. [0037], [0041], The glycerol can be replaced with propylene glycol), and
a flavoring agent, wherein the flavoring agent is citric acid ([0064]-[0065], [0070]-[0071], Citric acid can be added as an antioxidant or pH regulator),
wherein the composition is a liquid phase configured to be atomized by any one of a heating atomizer, an ultrasonic atomizer, an air compression atomizer or a press-type spraying device to generate an aerosol ([0043]-[0046], The formulation may be provided as a liquid phase nasal spray which can be atomized to generate an aerosol. Regardless of the specific type of atomizer used to atomize the product, the composition taught by Ahlahr necessarily capable of being atomized by any one of the listed devices).
It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the product of Khoe wherein the composition comprises propylene glycol or glycerol as a solvent in the amounts taught by Anlahr such that the product is a liquid phase configured to be atomized by any one of a heating atomizer, an ultrasonic atomizer, an air compression atomizer or a press-type spraying device to generate an aerosol because Khoe and Anlahr are directed to atomizable compositions, Khoe states that the composition can be a spray for preventing or treating snoring (Khoe, col 1, ln 29-64), Anlahr demonstrates that a liquid phase spray for preventing or treating snoring can be generated by providing an active compound within a solvent such as propylene glycol or glycerol (Anlahr, [0067], [0078]), and this involves combining prior art elements according to known methods to yield predictable results.
It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the product of Khoe comprising citric acid as a flavoring agent because Khoe and Anlahr are directed to atomizable compositions, Anlahr demonstrates that citric acid can serve as an antioxidant or pH regulator for a liquid phase spray for preventing or treating snoring (Anlahr, [0064]-[0065], [0070]-[0071]), and this involves combining prior art elements according to known methods to yield predictable results.
The ranges for the glycerol and propylene glycol mass percentages disclosed by the prior art overlap the claimed ranges, and therefore the claimed ranges are considered prima facie obvious. See MPEP § 2144.05 (I).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Khoe (US 4,064,253 A) as applied to Claim 1, in view of Ruben (US 2021/0186082 A1).
Regarding Claim 16, Khoe does not teach the product wherein the product is a filter capsule used in an aerosol-generating article.
Ruben, directed to atomizable compositions ([0001], [0029]-[0031],Fig. 1A; The capsule 13 within filter portion 10A is configured to be ruptured during use to release a medicine contained within capsule 13 into a stream of smoke/air (aerosol). [0016], Ideally the medicine is in oil form so that the heat from the ignited organic material readily vaporizes (atomizes) the medicine for proper inhalation and absorption by the patient), teaches an aerosol generating article ([0029]-[0031], Fig. 1A; Cigarette (aerosol generating article) of Fig. 1A comprises an ignitable organic material 10B and the filter portion 10A) comprising:
a filter capsule containing a medicine ([0030]-[0031], Fig. 1A; Filter 10A comprises a breakable capsule 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the product of Khoe within a filter capsule used in an aerosol-generating article similarly taught by Ruben because Khoe and Ruben are directed to atomizable compositions, Ruben demonstrates that a medicine can be located within a filter capsule used in an aerosol generating article (Ruben, [0029]-[0031]), the product of Khoe is a medicine (Khoe, col 1, ln 59-64), and this involves combining prior art elements according to known methods to yield predictable results.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Khoe (US 4,064,253 A) as applied to Claim 1, in view of Akerman (US 2014/0363528 A1).
Regarding Claims 17 and 19, Khoe, directed to antisnore compositions (col 1, ln 11-14), teaches an areca nut-flavored product (col 1, ln 29 – col 2, ln 26, The present invention relates to an anti-snore composition containing arecoline or a pharmaceutically acceptable salt thereof; It is reasonably understood that a product comprising an arecoline salt as claimed, would yield an areca nut-flavored product), comprising
an arecoline salt (col 1, ln 29 – col 2, ln 26, The present invention relates to an anti-snore composition containing arecoline or a pharmaceutically acceptable salt thereof),
wherein the arecoline salt has a mass percentage of 0.02%-2%, or 0.1%-2%, based on a total mass of the areca nut-flavored product (col 3, ln 7-16, Example III describes a preferred embodiment wherein 1000 sucking tablets are manufactured from a mixture comprising 1-2 g of arecoline-HBr, 125 g of milk sugar, and 25 g of a tablet making agent. Within the starting mixture, the arecoline salt has a mass percentage of 0.66-1.32% based on a total mass of the mixture. It is reasonably understood that at least one of the tablets has a mass percentage of arecoline salt at 0.02-2% based on a total mass of the areca nut-flavored product),
wherein the product is can be provided as a tablet, spray, or gargle (col 1, ln 59-64, The form in which the medicine is administered should be adapted to local applications. So e.g. tablets can be utilized particularly sucking tablets, soluble tablets, dusting powders, sprays, pencils, preparations on a resin base with delayed effect, infusion liquid and preferably gargles. If the anti-snore composition can be provided as a spray or a dusting powder (i.e. particles of solid/liquid entrained in a gas, or aerosols), the product is an aerosol generation substrate which is necessarily capable of being configured to be atomized to generate a smokable aerosol).
Akerman, directed to antisnore compositions ([0001]), teaches an antisnore composition which can be provided as a chewing gum, a tablet, a spray, or a gargle ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the product of Khoe wherein the areca nut-flavored product is a chewing gum as taught by Akerman because Khoe and Akerman are directed to antisnore compositions, Akerman demonstrates that antisnore compositions can be administered to a user as a chewing gum (Akerman, [0055]), and this involves combining prior art elements according to known methods to yield predictable results.
The range for the arecoline salt mass percentage disclosed by the prior art overlaps the claimed ranges, and therefore the claimed ranges are considered prima facie obvious. See MPEP § 2144.05 (I).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hussain (EP 0389975 A1) teaches an areca nut-flavored product, comprising an arecoline salt, wherein the arecoline salt has a mass percentage of 2-10% based on a total mass of the areca nut- flavored product.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M. MARTIN whose telephone number is (703)756-1270. The examiner can normally be reached M-F 8:00-5:00.
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/J.M.M./
Examiner, Art Unit 1755
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755