DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1-2, 5, 9, 11, 13-14, 16-18, 20-21, 23, and 25-28 are pending. Claims 18, 20-21, 23, and 25-27 are withdrawn. Claims 1, 16-18, 21, 23, 25, and 27 have been amended. Claim 28 is new.
Response to Amendments
The Examiner acknowledges Applicant's response filed on 8/15/2025 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see pages 7-8 of Remarks filed 8/15/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. The Applicant has amended claim 1 to include limitations that were not previously presented and are not anticipated by Zhang. Therefore, the rejection has been withdrawn.
Applicant's arguments, see pages 8-9 of Remarks filed 8/15/2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Arnold teaches away from using tobacco-derived nicotine. This argument is not persuasive as applicant is not claiming tobacco-derived nicotine. To the contrary, claim 1 has been amended to require synthetically derived nicotine. As such, Arnold is not needed for teaching tobacco-derived nicotine.
Applicant argues that Arnold teaches away from using the (R)-nicotine isomer. This argument is not persuasive as Arnold discloses multiple embodiments using the (R)-nicotine isomer (“in some embodiments, the synthetic nicotine may include the R-isomer in an amount greater than 5 wt %, for example, greater than 7 wt %, or greater than 10 wt %”, ¶ 0046).
Applicant argues that the claimed formulation produces unexpected results. Applicant’s evidence for these allegedly unexpected results is an example in which a composition containing 3% (R)-nicotine was considered better than compositions comprising 0%, 5%, and 10% (R)-nicotine. This argument is not persuasive at least because Applicant has not submitted evidence that these allegedly unexpected results are commensurate in scope with claimed range (MPEP § 716.02(D)). Applicant claimed a range of (R)-nicotine of from 1% to about 4.5% by weight, and the single example of 3% does not encompass this entire range.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5, 9, 11, 13-14, 16-17, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold (US 2017/0112182 A1).
Regarding claim 1, Arnold discloses an aerosolizable formulation (“composition suitable for vaporizing”, ¶ 0003) comprising
one or more aerosol-forming agents (“solvents” such as “glycerin”, ¶ 0053); and
nicotine (“nicotine”, ¶ 0003);
wherein the nicotine comprises (R)-nicotine in an amount less than 3% by weight of the total nicotine, and wherein the nicotine is synthetically derived nicotine (“as a portion of the total amount of nicotine present in the composition, the synthetic nicotine may be present in an amount of . . . up to about 100 wt %”, ¶ 0017; “synthetic nicotine that has been resolved to include a ratio of S isomer to R isomer of greater than 97:3”, ¶ 0048, which is synthetic nicotine that comprises (S)-nicotine in an amount greater than 97% by weight of the total synthetic nicotine and (R)-nicotine in an amount less than 3% by weight of the total synthetic nicotine; therefore, the nicotine is synthetically derived nicotine that comprises (R)-nicotine in an amount less than 3% by weight of the total nicotine). Since the range less than 3% overlaps the claimed range of about 1% to about 4.5%, a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Regarding claim 2, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold discloses wherein the nicotine comprises (R)-nicotine in an amount less than 3% by weight of the total nicotine, as discussed in the rejection of claim 1 above. Since the range less than 3% overlaps the claimed range of about 2% to about 4%, a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Regarding claim 5, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold further discloses wherein the nicotine is present in an amount of from about 0.1% to about 10% by weight of the aerosolizable formulation (“about 0.001 wt% to about 0.50 wt% . . . nicotine based on the total weight of the composition”, ¶ 0016). Since the range about 0.001% to about 0.50% overlaps the claimed range of about 0.1% to about 10%, a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Regarding claim 9, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold discloses wherein the one or more aerosol-forming agents is glycerol (“glycerin”, ¶ 0053).
Regarding claim 11, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold further discloses wherein the one or more aerosol-forming agents are present in a total amount of at least about 50% by weight of the aerosolizable formulation (“about 50 wt% to about 99.99 wt% . . . based on the total weight of the composition”, ¶ 0053). Since the range about 50% to about 99.99% falls within the claimed range of at least about 50%, the range is anticipated (MPEP § 2131.03).
Regarding claim 13, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold further discloses wherein the aerosolizable formulation further comprises water (“water”, ¶ 0054).
Regarding claim 14, Arnold discloses the aerosolizable formulation according to claim 13, as stated above. Arnold further discloses wherein the water is present in an amount of from about 0.1% to about 30% by weight of the aerosolizable formulation (“about 0.1 to about 10 wt% . . . based on the total weight of the vaping composition”, ¶ 0054). Since the range about 0.1% to about 10% falls within the claimed range of about 0.1% to about 30%, the range is anticipated (MPEP § 2131.03).
Regarding claim 16, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold further discloses wherein the aerosolizable formulation further comprises one or more flavoring agents (“flavoring agent”, ¶ 0063).
Regarding claim 17, Arnold discloses the aerosolizable formulation according to claim 16, as stated above. Arnold further discloses wherein the one or more flavoring agents is menthol (“menthol”, ¶ 0063).
Regarding claim 28, Arnold discloses the aerosolizable formulation according to claim 1, as stated above. Arnold further discloses wherein the nicotine comprises at least about 96% synthetically derived (S)-nicotine, no greater than about 4% synthetically derived (R)-nicotine by weight of the total nicotine (“as a portion of the total amount of nicotine present in the composition, the synthetic nicotine may be present in an amount of . . . up to about 100 wt %”, ¶ 0017; “synthetic nicotine that has been resolved to include a ratio of S isomer to R isomer of greater than 97:3”, ¶ 0048, which is synthetic nicotine that comprises (S)-nicotine in an amount greater than 97% by weight of the total synthetic nicotine and (R)-nicotine in an amount less than 3% by weight of the total synthetic nicotine; therefore, the nicotine is synthetically derived nicotine that comprises (R)-nicotine in an amount less than 3% by weight of the total nicotine).
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.
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/C.G.C./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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