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
Acknowledgement is made of the response filed on April 23, 2026. In that response, claims 3, 4, 6-9, and 11 were amended and claims 1, 2, 5, and 10 were cancelled. Claims 3, 4, 6-9, and 11 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 3 is objected to because of the following informalities: a line break should precede the last “wherein” clause for consistency. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: some limitations which are identical to that in claim 3 is repeated (components d and g), but others are not (the three “wherein” clauses). To avoid confusion and for consistency, either all the limitations or only the narrowing amendments should be recited. Appropriate correction is required.
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.
Claim(s) 3, 4, 6-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (US 20160120224) in view of Watanabe (US 20210112855) and Bertrand (Bertrand, P., et al., Physical and chemical assessment of 1,3 Propanediol as a potential substitute of propylene glycol in refill liquid for electronic cigarettes. Sci Rep 8, 10702 (2018)).
Mishra teaches a hydrogel composition for e-vaping cartridge, comprising a flavorant at about 0.2-15% by weight, a vapor former at about 20-90% by weight, water at about 5-40 % by weight, e.g., about 10%, a biopolymer, and nicotine (title; abstract; paras.0007-08, 0014-15, 0059, 0070-73). Flavorants include those in instant claim 8 such as menthol and fruit flavors (paras.0020, 0058, 0072), some of which are antioxidants, e.g., menthol and cinnamon. The hydrogel may be ethanol free (para.0021). Biopolymers include polysaccharides such as agar, pectin, and sodium alginate which are thickeners and protect a mucosal surface (para.0073). Biopolymers comprise about 0.01-2 % by weight (para.0073), and flavorant, i.e., antioxidants, comprise about 0.2-15% by weight, e.g., about 1% (para.0072). Their sum therefore ranges between 0.21-17% by weight of the hydrogel, which range includes that in claim 4 and overlaps that in claim 3.
The “vapor former includes a diol and glycerin, the hydrogel including the diol and glycerin in range of ratios between about 1:4 and 4:1, the diol being one of propylene glycol, 1,3-propanediol, and combinations thereof” (para.0017(emphasis added)). The vapor former comprises about 20-90% by weight of the hydrogel (para.0012). The ratio of diol or 1,3-propanediol to glycerol in the present claims range from 6.5 – 0.5 (65/10 – 20/40). The range of ratio that Mishra teaches is about 1:4 and 4:1 (para.0017), i.e., about 0.25 to 4. Thus the ranges substantially overlap. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding “does not contain propylene glycol” in claim 3, first it is noted that Mishra teaches “diol being one of propylene glycol, 1,3-propanediol, and combinations thereof”, and nowhere requires propylene glycol. The “one of” indicates the two diols are alternatives, not requirements. Furthermore Bertrand teaches that 1,3-propanediol produces “less thermal decomposition by-products”, “seems to have better flavoring properties than glycerol and propylene glycol”, and “seems to induce quite similar aerodynamic properties compared to propylene glycol” (abstract; see title, Tables 1-3, Figs.5, 6, and accompanying text). Therefore the skilled person would have been motivated to use 1,3-propanediol only as the vapor former.
Mishra does not specifically teach an example formulation comprising one of the protective substance in claim 3, or refer to glycerin as “glycerol”. However glycerin and glycerol are the same chemical compound and differ by the level of purity and contextual usage. Cosmetic arts tend to use the term glycerin, whereas chemical arts use the term glycerol. Therefore the skilled person would understand glycerin and glycerol are interchangeable unless expressly stated otherwise.
Watanabe is drawn to aroma cartridge for “heating-type smoking appliance” (title; abstract; para.0001). The cartridge preferably comprises polysaccharide-based gels (paras.0068, 0268), including polysaccharides such as guar gum and agar (para.0068), which Mishra also teaches as thickening agent (para.0073). The gels also comprise flavorings, β-cyclodextrins “for causing temporary residence of the flavoring agent, microcrystalline cellulose having moldability and ease of release from a die or the like, sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, or another food antimicrobial preservative for storage stability” (para.0269; see para.0262).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to modify the teachings of Mishra and Watanabe and include β-cyclodextrins or microcrystalline cellulose in Mishra’s hydrogel compositions as recited in the instant claim(s). The skilled person would have been motivated to do so because both Mishra and Watanabe are drawn to hydrogel compositions for liquid-type electronic cigarettes, and Watanabe teaches using β-cyclodextrins and or microcrystalline cellulose. The skilled person would have been motivated to do so to ensure “temporary residence of the flavoring agent” or provide “moldabilty and ease of release from a die” during manufacture.
Also, substituting equivalents known for the same purpose, where the equivalency has been recognized in the prior art, presents strong evidence of obviousness; an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. MPEP §2144.06 (II) (citations omitted). Watanabe teaches carboxymethyl cellulose along with biopolymers such as gums and agar (para.0068). Mishra teaches these as thickening agent (para.0073). Therefore substituting carboxymethyl cellulose in Mishra’s hydrogel would have been prima facie obvious to one of ordinary skill in the art.
Regarding the concentrations of the components (a) through (g), Mishra teaches ranges overlapping those in the instant claims. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive. Applicant argues that the sum of components (e) through (g) at 0.2-0.7% w/w is “a technical window not disclosed in or derivable from any cited prior art, …protective substances and antioxidants are most soluble, aerosol-stable, and bioavailable without altering aerosol physical properties”. (Remarks, 6 second para., April 23, 2026.)
In response it is noted that the argument does not refer to any data tending to support the claim that the range of 0.2-0.7% w/w attains all of the alleged advantages. “Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection.” MPEP §2145 (I). Here it does not appear that any of the disclosure or the record, including the Declaration filed April 23, 2026, concern Applicant’s “soluble, aerosol-stable, and bioavailable without altering aerosol physical properties” assertion.
Applicant next argues that Mishra’s flavorants are not disclosed as polyphenolic antioxidants. (Remarks, 6, April 23, 2026.)
In response it is noted that a “chemical composition and its properties are inseparable”. MPEP § 2112.01(II). Also “[s]omething which is old does not become patentable upon the discovery of a new property… [T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer…. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” MPEP §2112(I)(citations omitted). Here Mishra might not refer to flavorants as antioxidants; however the skilled person would have known of antioxidant effects of flavorants such as menthol. The mere description of menthol as an antioxidant in a claim however does not render the claim patentable.
Applicant next argues that Watanabe is drawn to nicotine-free compositions. (Remarks, 6).
It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Watanabe is drawn to aroma cartridges which are compatible with electronic cigarettes (title; abstract; parass.0002, 0018-19), and contains flavorants such as menthol which Mishra also teaches. Watanabe teaches that “β-cyclodextrin serves to cause temporary residence of the menthol,…” (para.0081) and using preservatives which the skilled person would recognize as beneficial.
Applicant next argues that Mishra teaches its composition to be used independently of the e-vaping device, and the compositions’ rheological properties are “fundamentally incompatible with open-atomizer systems”. (Remarks, 7-8).
In response it is noted that the features upon which applicant relies (i.e., use independently of an e-vaping device, and the compositions’ rheological properties) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Here the compositions are recited “for aerial administration” which both Mishra and Watanabe are drawn to.
Applicant further relies on the Declaration filed April 23, 2026 “together with the observational study attached thereto as Exhibit A” to argues that the “T-MAX composition, an example of the claimed composition” achieves superior nicotine delivery, safety, and tolerability. (Remarks, 8-9).
The Declaration has been reviewed. First, the single, specific T-MAX formulation at paragraph 5, according to the summary results described in paragraph 6, provides nicotine intensity and speed of nicotine perception which are similar to the tested conventional cigarette. However there is no discussion of whether the “traditional e-liquids” comprised the listed components in identical concentrations as the T-MAX formulation (e.g., differing from T-MAX only in propylene glycol), and how the study was conducted. Exhibit A was not provided in any of the April 23, 2026 filings. However because the Declaration does not reference any formulation other than T-MAX, availability of Exhibit A has not been deemed necessary to reach a determination of non-patentability at this time (see following paragraph).
Secondly, the evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention. MPEP § 2145 (citations omitted). As noted above the T-MAX formulation was a single formulation comprising specific concentrations of components (a) through (c), (e), and (f) in claim 3. T-MAX does not comprise components (d) and (g) in claim 3. Moreover claim 3 recites each of those components in ranges such as “10-50%” for water. The disclosure contains but two example formulations Ex.1 and Ex.2, differing from each other only in the presence versus absence of ethanol or component (d), and the component (e) used. Consequently there is no reasonable basis to extrapolate the data for the single T-MAX formulation, or Ex.1 and Ex.2 (parameters discussed in the Specification is different than for the T-MAX) to the comparatively expansive ranges for every one of the components (a) through (g) in the current claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3, 4, 6-9, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 10-15, and 17-20 of copending Application No. 18/548,533 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a composition comprising water, 1,3-propanediol, glycerol, nicotine, a flavoring, and a cyclodextrin. The two claim sets recite overlapping concentration ranges for each component. The difference is that the present claims recite ethanol, however they encompass 0% ethanol. The instant claims also recite a protective substance including cyclodextrin, which the ’533 application recites in dependent claims. The present claims further recite antioxidants. However the ‘533 application claims menthol, which is an antioxidant, as a flavoring in claim 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants requested reconsideration of the double patenting rejection(s) in light of the amendments and requested that the provisional rejection(s) be held in abeyance. (Remarks, 9).
The provisional double patenting rejection(s) is/are maintained for the reasons discussed herein. They will be maintained until Applicant submits properly executed terminal disclaimer or arguments that effectively overcome the rejection(s).
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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