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 6-32 are pending and are subject to this office action. Claims 21-32 were previously withdrawn from consideration as being drawn to non-elected inventions.
Response to Arguments
The Examiner acknowledges the Applicant’s response filed on 07/08/2026 containing remarks to the claims.
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
On pg. 2-3, Applicant argues that McNeal does not reasonably suggest a formulation comprising a water to propylene glycol ratio of 40:60 to 50:50 as required by claim 1 because McNeal disclosing a water content range and propylene glycol range independently does not reasonably suggest a formulation having water to propylene glycol ratio. McNeal disclosing a water content and propylene glycol range in different sections of the disclosure does not preclude a person having ordinary skill in the art from recognizing the disclosed ranges include embodiments of 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. Additionally, while McNeal explicitly discloses embodiments varying ratios of solvents other than a mixture of water and propylene glycol (e.g. glycol, glycerol, etc.), the disclosure is not limited to preferred embodiments of McNeal’s invention.
On pg. 3-4, Applicant argues a person having ordinary skill in the art would not have selected the claimed water to propylene glycol ratio because McNeal discloses extraordinarily broad ranges and provides no basis to optimize the water to propylene glycol ratio. The Examiner disagrees because the rejection did not rely on routine optimization. The rejection relied upon McNeal disclosing compositions comprising ranges of caffeine, propylene glycol, and water and therefore the disclosed compositions have a range of ratios of water to propylene glycol. While McNeal does not explicitly disclose a ratio range of water to propylene glycol, McNeal discloses compositions where the water to propylene ratio is in a range that overlaps with the claimed range and therefore the claimed range is considered prima facie obvious.
On. pg. 4-5, Applicant argues McNeal teaches away from a water to propylene glycol ratio of 40:60 to 50:50 because the water to propylene glycol ratio in specific examples disclosed in McNeal are outside the claimed range. The Examiner disagrees because the disclosure of McNeal is not limited to the examples in Tables 1-3. 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 (MPEP 2123(I)-(II))
Therefore, the rejections below are maintained.
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/M.F.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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