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
Claims 1, 2, 26, 29 and 31-32 are amended. Claims 17, 20-21, 23-24, 27, 30 and 33-34 are cancelled. Claims 22, 25-26, 28-29 and 31-32 are withdrawn. Claims 1-16 and 18-19 are presently examined.
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 1-7, 9-16 and 18-19 are rejected under 35 U.S.C. 103 as being obvious over Warchol (NZ 536863) in view of Kuntawala (US 2016/0198759) and Bowen (US 9,215,895) and Fuisz (US 2018/0199618) and Mishra (US 11,311,048) and Perrier (US 6,524,595).
Regarding claims 1-7 and 9-16, Warchol discloses an aqueous based formulation containing 5000 mg nicotine, at least 60 g of water, and a pH that is adjusted to 5.0 using citric acid (page 17, lines 4-9). The formulation comprises at least 90 percent water by weight (page 18, lines 20-23) and at least 90 percent of the nicotine is in the monoprotonated form at a pH of 5.0 (page 7, lines 20-28). It is evident that citric acid is water soluble since it would otherwise be unable to reduce the pH of the water-based formulation. It is evident that water makes up at least 90% of the weight of the solution since the solution is 100 mL at room temperature and contains only water, about 1 g of solid components, and citric acid (page 17, lines 4-9), which is evidently primarily made of water as well and would not be added in a significant amount. Warchol does not explicitly disclose (a) adding a cyclodextrin to the formulation, (b) a specific nicotine weight, (c) a specific ratio of nicotine and acid, (d) one or more flavors, (e) the cyclodextrin being substituted β-cyclodextrin, and (f) forming an aerosol from the formulation at a temperature below 50 °C.
Regarding (a), Kuntawala teaches an e-fluid [0015] having a cyclodextrin added to it to increase the absorbability of active ingredients while suppressing any irritating tendency of the aerosol [0016]. The cyclodextrin is α, β, or γ-cyclodextrin [0017].
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the formulation of Warchol with the cyclodextrin of Kuntawala. One would have been motivated to do so since Kuntawala teaches that adding a cyclodextrin to an e-fluid increases the absorbability of active ingredients while suppressing any irritating tendency of the aerosol.
Regarding (b), Fuisz teaches an aerosolizable tobacco wax (abstract) having a nicotine concentration of less than 0.5% for users seeking lower nicotine delivery [0079]. One of ordinary skill in the art would recognize that Fuisz refers to a weight percentage since Fuisz measures other compositions by weight ([0197], [0198]) and nowhere refers to volumetric or molar percentages.
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to lower the nicotine concentration of modified Warchol to values within the range of Fuisz. One would have been motivated to do so since Fuisz teaches a nicotine concentration that allows a user to seek lower nicotine delivery.
Regarding (c), Bowen teaches a nicotine salt liquid formulation for generating an inhalable aerosol (abstract) having a 1:1 molar ratio of nicotine to acid (column 12, lines 20-39) to produce a greater satisfaction than free base nicotine (column 7, lines 51-67, column 8, lines 1-14). The acid can be either benzoic acid (column 16, lines 6-13), or citric acid (column 10, lines 15-48).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the acid of modified Warchol at the ratio of Bowen. One would have been motivated to do so since Bowen teaches a nicotine salt formulation that produces a greater satisfaction than free base nicotine.
In combination with the teaching of Fuisz that the nicotine is present at up to 0.5 wt%, it is evident that, when the acid is benzoic acid, the acid is present at about 0.38 wt%, when the acid is citric acid, the acid is present at about 0.59 wt %, and, when the acid is phosphoric acid, the acid is present at about 0.30 wt %.
Regarding (d), Mishra teaches a device having a reservoir containing a first pre-vapor formulation that is vaporized (abstract) in liquid form including a flavoring (column 10, lines 19-24). The flavoring is present at about 1% to about 12% by weight (column 10, lines 64-67, column 11, lines 1-14).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the formulation of modified Warchol with the flavorant of Mishra. One would have been motivated to do so since Mishra teaches a suitable flavorant amount for a vaporized material.
Regarding (e), Perrier teaches cyclodextrins that are used as a vector for an active ingredient (abstract) that uses substituted alpha, beta, and gamma cyclodextrin (column 3, lines 48-67) to avoid the poor solubility in an aqueous phase (column 1, lines 12-18) that unsubstituted alpha, beta, and gamma cyclodextrin have (column 1, lines 7-11).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the substituted cyclodextrin of Perrier instead of the α, β, or γ-cyclodextrin of modified Warchol. One would have been motivated to do so since Perrier teaches substituted cyclodextrins that serve as a vector for an ingredient in aqueous solutions by dissolving in the solution.
Regarding (f), one of ordinary skill in the art would expect the formulation of modified Warchol to be capable of forming an aerosol at a temperature below 50 °C since it has a composition that is very similar or identical to the claimed composition, and that the claimed formulation is therefore obvious over modified Warchol. See MPEP § 2144.09 I.
Regarding claims 18 and 19, Mishra teaches that the flavorant is menthol (column 8, lines 63-67, column 9, lines 1-20).
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over Warchol (NZ 536863) in view of Kuntawala (US 2016/0198759) and Bowen (US 9,215,895) and Fuisz (US 2018/0199618) and Mishra (US 11,311,048) and Perrier (US 6,524,595) as applied to claim 1 above, as further evidenced by PubChem (already of record).
Regarding claim 8, modified Warchol teaches all the claim limitations as set forth above. Warchol additionally discloses that the acid can be phosphoric acid (page 8, lines 23-25). Modified Warchol does not explicitly teach the solubility of phosphoric acid in water.
PubChem teaches that the solubility of citric acid in water is 548 g/100 g at 20 °C (section 3.2.7, Solubility), which exceeds the claim limitation.
Response to Arguments
Regarding the rejections under 35 USC 103, applicant’s arguments have been fully considered but they are not persuasive. Applicant argues (a) that the rejection is formulated based on hindsight reasoning, (b) that Perrier is not directed to aerosolizable formulations, and that one of ordinary skill in the art would therefore not know how to combine it with the other cited references, (c) that the cited references do not teach the formulation producing an aerosol at a temperature below 50 °C, and (d) that the dependent claims are allowable due to dependence on an allowable claim.
Regarding (a), 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). In this case each of the references teaches separate motivation to combine that reference with the other references. Applicant only provides specific arguments regarding the modifications in view of Perrier which are discussed further below.
Regarding (b), one of ordinary skill in the art would recognize many similarities between Perrier and the other references. Most fundamentally, Warchol is an aqueous formulation, and Perrier is specifically directed to using specific types of cyclodextrins that improve poor solubility in an aqueous phase (column 1, lines 12-18) compared to unsubstituted alpha, beta, and gamma cyclodextrin have (column 1, lines 7-11). Warchol and Kuntawala teach an unsubstituted cyclodextrin being dissolved in an aqueous solution, and Perrier would therefore be directly improving that solution. Furthermore, one of ordinary skill in the art would not expect the substituted cyclodextrin of Perrier to be unsuitable for use in an aerosol generation device since all cyclodextrins have the same basic structure and even Kuntawala teaches many different cyclodextrins. This would support the conclusion that the modification in view of Perrier would have a reasonable expectation of success as required by MPEP § 2143.02. A reasonable expectation of success is not a guarantee of success but merely a reasonable belief.
Regarding (c), as set forth above, this limitation is considered to be met since it is a property of the claimed formulation, and the prior art teaches a very similar or identical formulation.
Regarding (d), all examined claims, including the examined independent claim, are rejected as set forth above.
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 RUSSELL E SPARKS whose telephone number is (571)270-1426. The examiner can normally be reached Monday-Friday, 9:00 am-5 pm.
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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755
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