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 Amendment
The Response of 03/26/2026 is entered. Claim 38 is cancelled, rendering the objection to this claim moot.
Status of Claims
Claims 1-2, 6-7, 9-11, 15, 27-28, and 30-37 are pending.
Response to Arguments
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive.
Applicant attacks the rejection of record on two grounds: First, the base reference Anderson as modified by Benhalima would not render the claimed composition obvious. Second, the claimed combination produces unexpected effects. Neither of these arguments are persuasive.
Applicant disagrees with the findings of obviousness regarding the composition, particularly with the finding that the limitations that describe the ratios of nicotine, benzoic acid, lactic acid, and one or more organic acids selected from tartaric acid, fumaric acid, levulinic acid, malonic acid, and mixtures thereof.
The prior art includes at least the entire disclosures of Anderson and Benhalima, this is factor 1 of the obviousness analysis.
Anderson discloses liquid compositions for vaping devices that comprise an aerosol former, nicotine, and an acid, ([0011]). Anderson discloses the acid in the composition is operative on the aerosol to change the nicotine content in the gas phase of the composition during vaporization, to reduce perceived throat harshness, ([0012]-[013]). Anderson discloses using a combination of glycerin (glycerol) and propylene glycol as the aerosol former, ([0111]). Anderson discloses the acid may be one or more acids selected from a list that includes benzoic acid, lactic acid, levulinic acid, and tartaric acid, ([0064], [0114]). Thus, Anderson discloses compositions that include the required components of claim 1.
Anderson discloses a number of ranges for the acidic compound, where the acidic compound comprises between 2 and 10 acids, and the concentration of the acid is substantially between 0.25-2% by weight, ([0024]). Although Anderson suggests that the acidic compound may include substantially equal parts of each individual acid in the compound, ([0024]), the disclosure overall is not so limited, disclosing many compositions that have unequal wt%, including many compositions where the benzoic acid is included at an amount 0.1%, compared to other acids at multiples higher than this amount, ([0026], [0030]-[0032]). Anderson also discloses that the amount of acid wt% is correlated to the amount of nicotine wt%, the total acid ranges from 0.1-6%, and preferably 0.1-2% by weight, based on about a nicotine of 3 wt%, ([0117]).
While Anderson does not disclose the weight percentages of each acid component in the composition, Anderson guides one of ordinary skill in the art in selecting those weight percentages. The acid selection should be based not only on the performance in the device based on how it operates in the device, but also it should be selected to have minimal sensory impact and/or can be included at levels where its sensory impact becomes undetectable or unobjectionable, ([0058]). Thus, Anderson recognizes that the acid types chosen, and their amounts in the composition, impact the user’s flavor experience when inhaling the aerosol produced from the liquid aerosol composition, and should be selected based on the user’s preference for that sensory profile.
Benhalima teaches prior art vaping liquids are comprised of propylene glycol, glycerine, water (rarely added but present in other ingredients), flavorings, and nicotine in amounts which range from 0 to 20mg/ml, ([0010]-[0016]). Benhalima teaches that the effects of nicotine are well known, ([0018]). Benhalima teaches that the nature of the acid used allows for decorrelation of the sensation of throat tingling with other nicotine induced physiological effects, and that benzoic acid has a metallic taste that seems to be related to the sensation of tingling in the throat, where other acids have other effects, and the teaching of Benhalima is to provide various compositions of e-liquids to allow a user to choose the nicotine related parameter on which the user can act in smoking cessation, ([0019]-[0020]). Benhalima teaches ordinary experimentation is a way to determine the flavor profile, to add a component to a vaping base composition and observe any taste difference with the same composition in its absence, as recognized by a taste expert, ([0036]), and suggests a list of possible acids including lactic acid, tartaric acid, fumaric acid, levulinic acid, malonic acid at a weight concentration of less than 5% by weight, ([0037]).
Benhalima “does not from the outset exclude the presence of benzoic acid at low doses, rather within the limits defined by the health authorities (for example at a rate less than 0.1%)”, ([0046]). Benhalima discloses that preferably the composition comprises at least one acid in a content between 0.0001% and 4% by weight, with decreasing preferred ranges down to equal or less than 0.9% by weight, ([0045], [0054]). Benhalima in addition to limiting benzoic acid based on regulatory specified amounts, ([0045]), teaches ranges for the specific acid weight amounts separately in a composition, lactic acid ([0109] a preferred amount is less than or equal to 0.9% with ranges including amounts as low as 0.0001%), tartaric acid ([0108] a preferred amount is less than or equal to 0.9% with ranges including amounts as low as 0.0001%), fumaric acid ([0111] a preferred amount is less than or equal to 0.9% with ranges including amounts as low as 0.0001%), levulinic acid ([0107] a preferred amount is less than or equal to 0.9% with ranges including amounts as low as 0.0001%), malonic aci, ([0115] a preferred amount is less than or equal to 0.9% with ranges including amounts as low as 0.0001%). Benhalima also teaches a range of ratios for the nicotine to the acids, from 1:5 to 1:0.1, ([0107]-[0109], [0111], [0115]).
Benhalima is considered to teach using any combination of these acids, constrained by the ranges given which include total acid wt% and nicotine to acid ratio, to not only alter the presence of nicotine in the vapor phase, but also to change the sensory profile that a user would experience when vaping these compositions, where the changes in sensory profile are expected changes as a result of each discrete composition.
Regarding factor 2, Examiner determined that at least one composition as disclosed and taught by the references, reads directly on the Applicant’s claims. Applicant did not claim their composition based on weight percentages, nor are they required to do so. However, in terms of mole ratios the Anderson discloses a composition, as modified by Benhalima that reads on the claims, and provides motivation for providing a composition (and likely others) in that range to achieve a variety of sensory profiles that a user may desire. Thus, when determining the differences between the prior art and the claims at issue, the Examiner finds that the prior art discloses a range of compositions that overlaps the claimed invention and reasons to form compositions throughout the ranges claimed by Applicant.
Regarding factor 3, the level of ordinary skill in the art, the Examiner finds that this skill includes preparing compositions throughout the ranges disclosed in the prior art, conducting tasting experiments with users and trained taste experts to determine how compositions throughout the ranges disclosed in the prior art would change the sensory profile produced from those changes by using taste experts and user tasting panels, and selecting desirable (optimal) sensory profiles from the prepared compositions, which would identify to one of ordinary skill a number of compositions throughout the range of possible compositions that would be marketable to user’s that prefer sensory profiles corresponding to those compositions.
Generally, courts have held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). The claimed limitations appear to be those which would be identified through routine experimentation, rather than inventive skill.
Regarding the fourth factor, the Examiner considered the objective evidence found in the Application regarding obviousness or non-obviousness. This factor goes to the second part of Applicant’s argument that the claims are tied to unexpected effects. Reviewing the Application, the effects of the claims result in a changed flavor profile, ([0012]), this is considered to be an expected effect, Applicants disclose compositions excluding benzoic acid, ([0051] not claimed), and many other compositions that are also not claimed that have a sensory profile, ([0074], [0082]-[0084], [0103]-[0107]). Applicant also disclosing testing of compositions that meet the claimed limitations, ([0145]-[0152]). In paragraph ([0152]) Applicant observed that the effects of lowering nicotine impact are ensured even if benzoic acid is partially replaced by lactic acid and other organic acids. This observation is not considered unexpected based on the prior art disclosures of Anderson and Benhalima as discussed above.
The Examiner has considered the claimed invention as a whole, in the context of the prior art as would be understood by one of ordinary skill in the art. There is motivation for altering the compositions as claimed throughout the claimed ranges defined by mole ratios, and the change to the composition through the ranges appears to be expected rather than unexpected. The Examiner finds the claimed limitations to be obvious.
Additionally, while it is not clear if there are different unexpected effects produced by a composition that meets Applicant’s claimed limitation, it is noted that the unexpected effect must be commensurate with the scope of the claim. Here even if the taste profiles of the disclosed compositions of Table 31 were considered unexpected, the sensory profile would also depend on the weight percents of each component in the overall composition, which is not claimed. Simply put, the level of concentration/dilution of each component in the composition is considered to have an impact on the flavor profile, and this limitation is not claimed.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The Examiner proposed an example of an obvious composition that reads on the claims. The proposed composition, while reading on the mole ratio limitations, bears little relation to the weight percents from Applicant example compositions in Table 31, which Applicant presumably believes was used as a model for rejecting the claims. Note the weight percentages of the proposed combination and the Specification examples. They are not similar. The references teach wt% ranges. The Examiner reviewed the disclosed wt% ranges as modified by the teachings of Benhalima. The Examiner then determined if any of the obvious combinations of weight percentages resulted in mole ratios that read on the claimed limitations. This is not hindsight. The claims were rejected based on properly determining that the prior art disclosure, as understood by one of ordinary skill in the art, would read on 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.
Claims 1-2, 6-7, 9-11, 15, and 27-28, 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 2015/0313275 A1) in view of Benhalima et al. (US 2022/0142227 A1).
Regarding claims 1 and 15, Anderson discloses an electronic smoking article or vaping device that is configured to provide a pleasant sensory experience for smokers that is similar to the sensory experience enjoyed while smoking a lit end cigarette, ([0009]). Anderson discloses that the vaping device is configured to include a mixture of an aerosol former, nicotine, and an acid, ([0011]). Anderson discloses compositions where the concentration of nicotine is substantially between 1.5% and 6% by wt, ([0023]). Anderson discloses that the acid is operative upon the aerosol so as to reduce the amount of nicotine content in the gas phase of the aerosol in comparison to the aerosol being formed in the absence of the acid, ([0012]), and that the acid is operative on the aerosol so as to reduce the amount of perceived throat harshness in comparison to the aerosol formed in comparison to the aerosol in the absence of the acid, ([0013]). Anderson discloses that the term aerosol former describes any suitable known compound or mixture of compound that in use facilitates the formation of an aerosol and that is substantially resistant to thermal degradation at the operating temperature of the aerosol generating article, and that suitable aerosol formers include propylene glycol and glycerol, ([0110]). Anderson discloses an embodiment where the aerosol former is a combination of glycerin (glycerol) and propylene glycol, ([0111]). Anderson discloses that the embodiment need not include water, noting that the inclusion of water is optional, ([0112] meeting Applicant’s definition of a formulation comprising no substantially water), (see present Specification ([0059]). The embodiment may comprise one or more acids from a list of acids which includes benzoic acid, lactic acid, and tartaric acid, ([0114]). The liquid aerosol formulation optionally also includes a flavorant, ([0113]). Anderson does not disclose the discrete amount by weight of each acid component in the formulation.
Benhalima teaches vaping compositions comprising a vaping base composition, nicotine, at least one acid, and optionally at least one flavoring, ([0021]-[0025]), and is thus within the Applicant’s field of endeavor. Benhalima teaches the use of acids that have a neutral taste, recognized by a taste expert, in the vaping composition, such as lactic acid and tartaric acid, ([0036]-[0037]). The vaping base may comprise propylene glycol, ([0118])and glycerol, ([0019]), and may comprise substantially no water, ([0120] describing using 1% or less, and a range that includes 0%). Benhalima teaches that the composition may comprise at least one, two, or three acids, ([0052]). Benhalima teaches that the composition may comprise tartaric acid in an amount between 0.1% - 1% by weight, ([0075]). Benhalima teaches that the composition may comprise lactic acid in an amount between 0.1% - 1% by weight, ([0076]). Benhalima teaches that the composition may comprise benzoic acid but the amount of benzoic acid should be kept within limits defined by health authorities, such as less than 0.1%, ([0046]). Benhalima teaches that prior art compositions comprised nicotine in an amount between 0 mg/ml to 20 mg/ml, ([0016]), reasonably suggesting to one of ordinary skill in the art that no or low wt% of nicotine is compatible with the composition).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the composition of Anderson according to the teachings of Benhalima. One of ordinary skill in the art would have recognized that modifying the range of nicotine wt% from Anderson to a lower percentage would be desirable, because some customers may reasonably want a lower dose of nicotine (such as customers looking to reduce their nicotine consumption). Generally, one of ordinary skill in the art would have recognized that the selection of the acids to use, their respective amounts, and the total amounts would have both an effect on the amount of nicotine in the vapor, but also the sensory and taste experienced when vaping the liquid composition. Altering the amounts and selection of acids within the ranges taught by the prior art is considered obvious, to achieve differences in these parameters. Benhalima recognizes that while the liquid composition may comprise benzoic acid, (Benhalima explicitly reciting that the invention does not exclude the presence of benzoic acid), it should be kept at a wt% of less than 0.1%, ([0046]). Benhalima teaches that while the overall acid wt % of the acids should be between 0.1% and 1% by wt, when using lactic acid and tartaric acid should be between 0.1% and 1% by weight, ([0075]-[0076]), reasonably suggesting that the composition of each acid may be used within a range of 0.1% and 1% by weight, such that the cumulative total of all the acid is still within 0.1% and 1% by weight. Thus, it would be obvious to modify the liquid composition of Anderson as taught by Benhalima to arrive at a liquid composition of: Nicotine at 0.5% by wt, Benzoic Acid at 0.09% by wt, lactic acid at 0.175 by wt, and tartaric acid at 0.09% by wt, with a vaping base of propylene glycol and glycerol, where the composition comprises substantially no water.
The molecular weight of nicotine is known to be 162.236, the molecular weight of benzoic acid is known to be 122.123, the molecular weight of lactic acid is known to be 90.078, and the molecular weight of tartaric acid is known to be 150.087. To convert a composition where percentages are given in wt% to mol%, it is known to divide the wt% of each material by its corresponding molecular weight.
The following table converts the composition, from wt% to mole wt%.
Component
Wt%
Molecular Wt
Mole %
Nicotine
0.5
162.236
0.0031
Benzoic Acid
0.09
122.123
0.00074
Lactic Acid
0.175
90.078
0.0019
Tartaric Acid
0.09
150.087
0.00060
The mole ratio of nicotine to the sum of lactic acid and other acids is: 1 to 0.825, which falls within the claimed range of 1:0.9 to 1:0.3.
The mole ratio of lactic acid to tartaric acid (an other acid) is 3.24 to 1, which falls within the claimed range of 4:1 to 2:1.
Regarding claims 2 and 30, modified Anderson discloses the liquid composition according to claim 1. The mole ratio of the nicotine to the total mole of benzoic acid, lactic acid, and tartaric acid in the liquid composition of modified Anderson above is 1:1.064, which meets the claimed range of 1:0.85 to 1:1.15.
Regarding claims 6 and 31, modified Anderson discloses the liquid composition according to claim 1. The modified composition comprises tartaric acid as one of the organic acids selected in the liquid composition of claim 1.
Regarding claims 7 and 32, modified Anderson discloses the liquid composition according to claim 1. The mole ratio of the nicotine to benzoic acid in the liquid composition of modified Anderson above is 1:0.24, which meets the claimed range of 1:07 to 1:0.15.
Regarding claims 9 and 33, modified Anderson discloses the liquid composition according to claim 1. The modified composition uses tartaric acid, see the rejection of claim 1 above. This acid inherently has a solubility in glycerol of 0.32 mol/kg or more in molality, (show for instance in Applicant’s Specification ([0134]-[0137] Tables 27-28).
Regarding claims 10, 27-28, 34 and 36-37, modified Anderson discloses the liquid composition according to claim 1.
Anderson discloses that the embodiment need not include water, noting that the inclusion of water is optional, ([0112] meeting Applicant’s definition of a formulation comprising no substantially water), (see present Specification ([0059]).
Benhalima teaches that the liquid composition may comprise no water, by disclosing a range of water that includes 0%, ([0120]).
Regarding claims 11 and 35, modified Anderson discloses the liquid composition according to claim 1. Anderson discloses that the liquid aerosol formulation optionally also includes a flavorant, ([0113]). Benhalima teaches that the composition may comprise a flavoring, ([0044]).
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 DANIEL E VAKILI whose telephone number is (571)272-5171. The examiner can normally be reached Monday - Friday 7:30 am - 4:30 pm.
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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.
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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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