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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
Status of the Claims
Claims 1-2, 5, 9, 11, 13-14, 16-18, 20-21, 23, and 25-29 are pending. Claims 18, 20-21, 23, and 25-27 are withdrawn. Claims 1, 18, 21, 23, 25, and 27 have been amended. Claim 29 is new.
Response to Arguments
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive.
Applicant argues that “[w]hile combinations of synthetic nicotine and tobacco derived (or naturally sourced) nicotine are described in Arnold, . . . it is evident that Arnold teaches away from using the (R)-nicotine isomer” (top of Page 8 of Remarks). 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). Further, Applicant acknowledges Arnold teaching compositions comprising (R)-nicotine multiple times later in the Remarks (e.g., “While there are some embodiments in Arnold teaching the use of the (R)-nicotine isomer” (Page 9 of Remarks), and “Applicant submits that while there are disclosures in Arnold where R-nicotine is used” (Page 9 of Remarks)).
Applicant further argues that specific examples in Tables 1 and 2 indicate that “there is a clear preference for the use of synthetic (S)-nicotine only” and that this constitutes both a teaching away from using tobacco-derived nicotine and a teaching away from the use of synthetic (R)-nicotine (top of Page 9 of Remarks). This argument is not persuasive as “preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments” (MPEP § 2123(II)).
Applicant’s paragraphs beginning “Tables 1 and 2” on Page 9 and “While there are some” on Page 10 are duplicates of paragraphs on Pages 8 and 9, respectively, and the arguments therein are not persuasive for the same reasons stated above.
Applicant argues that the single data point of allegedly unexpected results for 3% (R)-nicotine is commensurate in scope with the claimed range of 1% to about 4.5% because the “Non-obviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data” (Page 10 of Remarks). This argument is not persuasive because Applicant has not presented evidence that a single data point (i.e., “3%”) constitutes a “range” or that a person having ordinary skill in the art could determine a “trend” from only a single data point.
Applicant argues that a skilled person would “reasonably understand that the advantages associated with the composition comprising 3% (R)-nicotine would extend across the scope of the claimed range (1% to 4.5%) and be superior to compositions comprising 0% and 5% (R)-nicotine” (Page 11 of Remarks). This argument is not persuasive as it is an allegation for which Applicant has not provided evidence, and “Arguments presented by applicant cannot take the place of evidence in the record” (MPEP § 2145(I)).
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.
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, 5, 9, 11, 13-14, 16-17, and 28-29 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 (regarding the proportion of synthetically derived nicotine to naturally 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 . . . 99.5% or greater”, and “When less than 100 wt % of the nicotine in the composition is synthetic, the remaining portion of the nicotine may be tobacco-derived nicotine.”, ¶ 0017, therefore, the total nicotine is 99.5% or greater synthetically derived nicotine and 0.5% or less naturally derived nicotine; regarding the proportion of R and S isomers within the synthetically derived nicotine, “synthetic nicotine that has been resolved to include a ratio of S isomer to R isomer of greater than 97:3”, ¶ 0048, therefore, the synthetically derived nicotine comprises greater than 97% synthetically derived (S)-nicotine and less than 3% synthetically derived (R)-nicotine, and the total nicotine comprises greater than 96.5% synthetically derived (S)-nicotine and less than 3% synthetically derived (R)-nicotine; regarding the proportion of R and S isomers within the synthetically derived nicotine, “Notably, naturally sourced nicotine (i.e., that derived from tobacco leaves) generally has an undetectable or small amount of the R isomer, and typically the naturally sourced tobacco mainly includes the S isomer. Indeed, naturally sourced tobacco typically has an S to R isomer ratio of greater than 50: 1.”, ¶ 0050, therefore, the naturally derived nicotine comprises greater than 98% naturally derived (S)-nicotine and less than 2% naturally derived (R)-nicotine, and the total nicotine comprises 0.5% or less synthetically derived (S)-nicotine and less than 0.01% synthetically derived (R)-nicotine; combining the less than 3% synthetically derived (R)-nicotine with the less than 0.01% naturally derived (R)-nicotine results in a total (R)-nicotine in an amount less than 3% by weight of the total nicotine, see table below). 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)).
Arnold further discloses wherein the nicotine comprises
(i) synthetically derived (R)-nicotine (see table below) and
(ii) a mixture of synthetically derived (S)-nicotine and naturally derived (S)-nicotine (see table below).
Total Nicotine: 100%
Synthetically Derived Nicotine: 99.5% or greater of Total Nicotine (¶ 0017)
Synthetically Derived (R)-Nicotine: less than 3% of Synthetically Derived Nicotine (¶ 0048)
= less than 3% of Total Nicotine
Synthetically Derived (S)-Nicotine: greater than 97% of Synthetically Derived Nicotine (¶ 0048)
= greater than 96.5% of Total Nicotine
Naturally Derived Nicotine: Remainder (i.e., 0.5% or less) of Total Nicotine (¶ 0017)
Naturally Derived (R)-Nicotine: less than 2% of Naturally Derived Nicotine (¶ 0050)
= less than 0.01% of Total Nicotine
Naturally Derived (S)-Nicotine: greater than 98% of Naturally Derived Nicotine (¶ 0050)
= 0.5% or less of Total Nicotine
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 (in the example discussed in the rejection of claim 1 above, synthetically derived (S)-nicotine is 96.5% or greater of the total nicotine), no greater than about 4% synthetically derived (R)-nicotine by weight of the total nicotine (in the example discussed in the rejection of claim 1 above, synthetically derived (R)-nicotine is 3% or less of the total nicotine). The range 96.5% or greater falls within the range at least about 96%, and the range 3% or less falls within the range no greater than about 4% (see MPEP § 2131.03).
Alternatively 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 of from about 1% to about 4.5% by weight of the total nicotine (regarding the proportion of synthetically derived nicotine to naturally 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 . . . 5% or greater”, and “When less than 100 wt % of the nicotine in the composition is synthetic, the remaining portion of the nicotine may be tobacco-derived nicotine.”, ¶ 0017, therefore, the total nicotine is 5% or greater synthetically derived nicotine and 95% or less naturally derived nicotine; regarding the proportion of R and S isomers within the synthetically derived nicotine, “The above-described synthesis of nicotine produces a racemic mixture, i.e., a 50-50 mixture of the R and S isomers of nicotine. Thus, in some embodiments, the synthetic nicotine includes a ratio of the R-isomer to the S-isomer of 1:1.”, ¶ 0045, therefore, the synthetically derived nicotine comprises 50% synthetically derived (S)-nicotine and 50% synthetically derived (R)-nicotine, and the total nicotine comprises 2.5% or greater synthetically derived (S)-nicotine and 2.5% or greater synthetically derived (R)-nicotine; regarding the proportion of R and S isomers within the synthetically derived nicotine, “Notably, naturally sourced nicotine (i.e., that derived from tobacco leaves) generally has an undetectable or small amount of the R isomer, and typically the naturally sourced tobacco mainly includes the S isomer. Indeed, naturally sourced tobacco typically has an S to R isomer ratio of greater than 50: 1.”, ¶ 0050, therefore, the naturally derived nicotine comprises greater than 98% naturally derived (S)-nicotine and less than 2% naturally derived (R)-nicotine, and the total nicotine comprises 95% or less synthetically derived (S)-nicotine and less than 2% synthetically derived (R)-nicotine; combining the 2.5% or greater synthetically derived (R)-nicotine with the less than 2% naturally derived (R)-nicotine results in a total (R)-nicotine in an amount 2.5% or greater by weight of the total nicotine, see table below). Since the range 2.5% or greater overlaps the claimed range of about 1% to about 4.5%, a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Arnold further discloses wherein the nicotine comprises
(i) synthetically derived (R)-nicotine (see table below) and
(ii) a mixture of synthetically derived (S)-nicotine and naturally derived (S)-nicotine (see table below).
Total Nicotine: 100%
Synthetically Derived Nicotine: 5% or greater of Total Nicotine (¶ 0017)
Synthetically Derived (R)-Nicotine: 50% of Synthetically Derived Nicotine (¶ 0045)
= 2.5% or greater of Total Nicotine
Synthetically Derived (S)-Nicotine: 50% of Synthetically Derived Nicotine (¶ 0045)
= 2.5% or greater of Total Nicotine
Naturally Derived Nicotine: Remainder (i.e., 95% or less) of Total Nicotine (¶ 0017)
Naturally Derived (R)-Nicotine: less than 2% of Naturally Derived Nicotine (¶ 0050)
= less than 2% of Total Nicotine
Naturally Derived (S)-Nicotine: greater than 98% of Naturally Derived Nicotine (¶ 0050)
= 95% or less of Total Nicotine
Regarding claim 29, Arnold discloses the aerosolizable formulation according to the alternative rejection of claim 1, as stated above. Arnold further discloses wherein the nicotine comprises at least about 90% naturally derived (S)-nicotine (in the example discussed in the alternative rejection of claim 1 above, naturally derived (S)-nicotine is 95% or less of the total nicotine). Since the range 95% or less overlaps the claimed range of at least about 90%, a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Conclusion
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/COURTNEY G CULBERT/Examiner, Art Unit 1747
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