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 .
Status of the Claims
Claims 1-4, and 6-20 are pending and are subject to this office action. Claim 5 is cancelled. Claims 21-32 are withdrawn from consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Response to Amendment
The Examiner acknowledges the Applicant’s response filed on 02/27/2026 containing amendments and remarks to the claims.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive.
On pg. 7, Applicant argues that McNeal fails to disclose a formulation wherein the weight ratio of water to propylene glycol is from 40:60 to 50:50, as required by claim 1, because only a small portion of the ranges overlap to meet the requirements in claim 1. The Examiner disagrees. A small proportion of the ranges that overlap with the claimed ranges does not preclude a disclosure of embodiments that overlap with the claimed ranges. The claimed ranges overlap with the ranges taught by the prior art and are therefore considered prima facie obvious (See MPEP 2144.05).
On pg. 7, Applicant argues that McNeal fails to disclose a formulation comprising 10 to 60wt% water and a weight ratio of water to propylene glycol is from 40:60 to 50:50, as required by claim 1, because the formulations provided in Tables 1-3 do not disclose the claimed weight ratio range. The Examiner disagrees because the prior office action did not rely upon the formulations in Tables 1-3 for disclosing the claimed weight ratio range. McNeal discloses an inhalable composition (“aerosolisable formulation”) comprising 1-50 wt% propylene glycol, and 10 to 90 wt% water ([0009, 0025, 0032, 0037]), as stated in the prior office action pg. 4. The claimed ranges of weight percentages result in a weight ratio of water to propylene glycol of 10:30 to 90:1. The claimed weight ratio range lies within the range taught by McNeal and is therefore considered prima facie obvious. The Examiner notes that the disclosure of McNeal is not limited to the inhalable formulations in Tables 1 to 3. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments, and patents are relevant for all they contain.
On pg. 6-7, Applicant argues that McNeal does not provide motivation to modify the weight ratio of water to propylene glycol to improve the solubility of caffeine. However, as discussed above, the claimed range lies within the range taught by McNeal and is therefore considered prima facie obvious. Further, a person having ordinary skill in the art, in view of McNeal, could have selected any combination of propylene glycol content and water content reasonably suggested by the prior art with a reasonable expectation of success, absent evidence to the contrary.
Therefore, the rejection below is maintained and modified based on Applicant’s amendment.
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.
Claims 1-4, 6-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over McNeal (US 20150013695 A1, as cited on IDS dated 06/28/2024).
Regarding claim 1, McNeal discloses an inhalable composition (“aerosolisable formulation”, [0009, 0022]), comprising:
1 to 10 wt% caffeine HCl ([0037]),
1-50 wt% propylene glycol ([0025]), and
10 to 90 wt% water ([0032]).
The claimed range of water amount overlaps with the range taught by the prior at and is therefore considered prima facie obvious.
McNeal does not explicitly disclose a weight ratio of water to propylene glycol of 40:60 to 50:50. However, McNeal discloses a multi component composition comprising ranges of caffeine, propylene glycol, and water. Therefore, a person having ordinary skill in the art would recognize the disclosed ranges include embodiments having a composition having a range of weight ratios of water to propylene glycol that overlap with the claimed range of 40:60 to 50:50 and is therefore considered prima facie obvious. For example, the disclosed ranges include an embodiment having 30 wt% propylene glycol and 30 wt% water (i.e. a weight ratio of water to propylene glycol of 50:50).
Regarding claims 2-4, McNeal discloses the inhalable composition comprises about 1 to 10 wt% caffeine HCl ([0009, 0037]). The claimed ranges overlap with the range taught by the prior art and are therefore considered prima facie obvious.
Regarding claims 6-7, McNeal discloses the inhalable composition comprises 10 to 90 wt% water ([0032]). The claimed ranges overlap with the range taught by the prior art and are therefore considered prima facie obvious.
Regarding claims 8-12, McNeal discloses the inhalable composition comprises 0 to 50 wt% glycerol ([0026]). The claimed ranges overlap with the range taught by the prior art and are therefore considered prima facie obvious.
Regarding claims 13-15, McNeal discloses the inhalable composition comprises 0 to 50 wt% propylene glycol ([0025]). The claimed ranges overlap with the range taught by the prior art and are therefore considered prima facie obvious.
Regarding claim 16, McNeal discloses an inhalable composition comprising one of more flavorings ([0040]).
Regarding claim 18, McNeal discloses the inhalable composition comprises one of more flavorings in an amount of about 1 to 30 wt% ([0040]). The claimed range overlaps with the range taught by the prior art and is therefore considered prima facie obvious.
Regarding claim 19, McNeal discloses the inhalable composition comprises one or more surfactants to aid in solubility and stability of formulation constituents ([0044]). The specification defines a solubilizing agent as a material that increases the solubility of caffeine in the formulation (pg. 12). Therefore, the surfactant added to aid in the solubility of the formulation constituents disclosed by McNeal is considered to meet the claim limitation of a solubilizing agent.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over McNeal (US 20150013695 A1, as cited on IDS dated 06/28/2024) as applied to claim 16 above, further in view of Xi (US 20110005535 A1, as cited on IDS dated 03/02/2023).
Regarding claim 17, McNeal discloses an inhalable composition comprising one of more flavorings ([0040]).
McNeal does not explicitly disclose the one or more flavors are selected from the group consisting of (4-(para-)methoxyphenyl)-2- butanone, vanillin, γ-undecalactone, menthone, 5-propenyl guaethol, menthol, para-mentha-8- thiol-3-one and mixtures thereof.
However, Xiu, directed to an atomizing e-liquid (abstract), discloses:
An atomizing e-liquid comprising polyethylene glycol, polypropylene glycol, and a taste modifier ([0039])
The taste modifier comprises menthol or vanillin ([0042).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify McNeal by using menthol or vanillin as a flavoring as taught by Xiu because both McNeal and Xiu are directed to aerosol formulations, Xiu teaches menthol and vanillin can be used as taste modifiers, and this involves applying a known flavoring to a similar formulation to yield predictable results.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McNeal (US 20150013695 A1, as cited on IDS dated 06/28/2024) as applied to claim 16 above, further in view of Blondino (US 20050079137 A1).
Regarding claim 20, McNeal discloses the inhalable composition comprises one or more surfactants to aid in solubility and stability of formulation constituents ([0044]).
McNeal does not explicitly disclose the solubilizing agent is benzyl alcohol, triacetin, or mixtures thereof.
However, Blondino, directed to an aerosol formulation (abstract, [0001]), discloses:
A liquid aerosol formulation comprising benzyl alcohol as a solubilizer ([0030])
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify McNeal by using benzyl alcohol as a solubilizing agent as taught by Blondino because both McNeal and Blondino are directed to aerosol formulations, McNeal discloses the formulation comprises surfactants to aid in solubility of the formulation, Blondino teaches benzyl alcohol is a known solubilizer in an aerosol formulation, and one having ordinary skill in the art would be motivated to look to similar aerosol formulations for different solubilizing agents and this involves applying known solubilizing agent to a similar aerosol formulation to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Larson (US 20250344763 A1) discloses a formulation for use in a vaporizer ([0006]) comprising:
0-10 wt% caffeine ([0080]),
0-98 wt% water ([0077]), and
and 0-80 wt% propylene glycol ([0093]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN FAITH DEZENDORF whose telephone number is (571)272-0155. The examiner can normally be reached M-F 8am-430pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at (571) 270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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