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 2-4, 7-9, 11, 24, 25 and 28-34 are pending.
Claim 3, 9, 24, 25, 28-32 are withdrawn.
Response to Arguments
Applicant's arguments filed 7/24/2026 have been fully considered but they are not persuasive.
Applicant Argument A:
The Applicant argues that Example 4 of the Substitute Specification filed on May 8, 2017 shows that benzoic acid, under every test condition, shows less decomposition of nicotine compared to levulinic acid in the presence of polycarbonate and/ or polycarbonate, and that further data submitted in the Affidavit of Lada Tomcalova on March 6, 2026 show that the ability of benzoic acid to stabilize nicotine in the formulation was unexpectedly better than other organic acids, even though Table 3 of the Tomcalova Affidavit has a typo with respect to the Meq of acid.
Examiner Response A:
As the Applicant wants to support unexpected results with the March 6, 2026 Affidavit of Lada Tomcalova, the Applicant needs to resubmit the Affidavit with the correct information. The Office is unable to rely on an Affidavit with incorrect information to support unexpected results.
Response to Amendment
The Affidavit under 37 CFR 1.132 filed 3/6/2026 is insufficient to overcome the rejection of claims 2, 4, 7, 8, 11, 33 and 34 based upon Rabinowitz in view of Lechuga-Ballesteros and further in view of Andersson as set forth in the last Office action because: the experimental results fail to demonstrate the criticality of 5 wt% nicotine protonation, and show that the stated unexpected results occur only within the claimed range.
The experimental results test 0 wt% nicotine protonation, 5 wt% nicotine protonation and 99.95 wt% nicotine protonation. There is no testing done between 0 wt% nicotine protonation and 5 wt% nicotine protonation, showing unexpected results within the claimed range that are not present outside of the claimed range, hence supporting the criticality of 5 wt% nicotine protonation.
As stated in the Patent Board Decision dated 1/3/2025 on page 13, “Finally, in order for a showing of "unexpected results" to be probative evidence of non-obviousness, an applicant must establish that (1) there actually is a difference between the results obtained through the claimed invention and the prior art; and (2) that the difference would not have been expected by one skilled in the art at the time of invention. In re Freeman, 474 F.2d 1318, 1324 (CCPA 1973).
In this case, Rabinowitz discloses that a proper choice of ion pairing agent "may enhance the shelf life stability of the composition and/or electronic cigarette." Rabinowitz ¶ 42 (emphasis added). Thus, Rabinowitz appears to show that a protonated nicotine solution within the scope of claim 11 would have been expected to have an improved stability. See Pfizer, Inc. V. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (a proper evaluation of unexpected results includes a consideration of what the skilled artisan would have expected).”
Thus, the prior art supports nicotine protonation because it "may enhance the shelf life stability of the composition and/or electronic cigarette." Rabinowitz ¶ 42 (emphasis added). The Applicant has failed to show that only 5 wt% or more nicotine protonation results in an unexpected result which does not occur at any amount of nicotine protonation greater than 0 wt% nicotine protonation.
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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2, 4, 7, 8, 11, 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140345635 (RABINOWITZ hereinafter) in view of US2006/0018840 (LECHUGA-BALLESTEROS hereinafter) and further in view of WO 2004/076289 (ANDERSSON hereinafter).
Regarding claims 2, 4, 7, 8, 11, 33 and 34, Rabinowitz teaches an electronic vapor provision system, specifically an electronic cigarette (Fig. 1 A), comprising: a vaporization unit, or cartomizer, which comprises a heating element and a wick and a container (“tank”) ([0068]), wherein the container (“reservoir“) contains a nicotine solution ([0067]); and a battery (108).
Rabinowitz suggests the addition of acid, including levulinic and/or benzoic ([0048]), to the solution so that the solution includes nicotine in both free base (unprotonated) form and salt (protonated) form and to thereby optimize gas/particle portioning of nicotine to provide for deep lung deposition while generating a desirable amount of throat hit without irritation ([0043-0044]). It would have been obvious to one of ordinary skill in the art to optimize the total content of acid present in the solution and the balance of nicotine in unprotonated and protonated forms as a matter of routine experimentation to achieve the desired gas/particle portioning of nicotine to provide for deep lung deposition while generating a desirable amount of throat hit without irritation ([0043-0044]).
Rabinowitz does not expressly teach how much of the nicotine present in the solution is in protonated form forming the protonated nicotine solution.
Lechuga-Ballesteros teaches an aerosol formulation for inhalation comprising nicotine ([0004],[0007],[0009] and [0010]). Lechuga-Ballesteros teaches that the nicotine solution comprises free-base (unprotonated) nicotine and an organic acid ([0012]), wherein the organic acid is benzoic acid ([0042]), such that greater than 50 % of the free base nicotine is converted to a nicotine salt (protonated) form in combination with the organic acid ([0047)]. Lechuga-Ballesteros teaches that this aerosol formulation delivered to users through an inhalation device results in a nicotine delivery that is satisfactory to the user and delivers the nicotine in a manner that stimulated the nicotine delivery of a cigarette ([0010]). Thus, it would have been obvious for one of ordinary skill in the art at the time of filing to have applied the solution composition of Lechuga-Ballesteros to the electronic cigarette of Rabinowitz in order to achieve a nicotine delivery that is satisfactory to the user and delivers the nicotine in a manner that stimulated the nicotine delivery of a cigarette (Lechuga-Ballesteros, [0010]).
The combined teaching of Rabinowitz and Lechuga-Ballesteros is silent with respect to the material of the container.
Andersson teaches a container comprising nicotine for use in an inhaling device (abstract), wherein the container is comprised of polypropylene or polycarbonate (page 5, lines 29-33 through page 6, line 1). The instant specification states that the container materials that exhibit these properties are polycarbonate or polypropylene. Case law holds that a material and its properties are inseparable. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). It would have been obvious for one of ordinary skill in the art at the time of the invention to have made the nicotine container of the combined teaching of Rabinowitz and Lechuga-Ballesteros out of the material of the nicotine container of Andersson with a reasonable expectation of success and predictable results.
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 YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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