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 .
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 2, 2026 has been entered.
Status of the Claims
Claims 16-20, 22-24, 26, and 28-29 are pending and are subject to this Office Action. Claim 16 is amended. Claims 1-15, 21, 25, and 27 are cancelled. Claims 28-29 are withdrawn.
Response to Amendments
The amendments to the claims filed on January 2, 2026 are acknowledged.
Response to Arguments
Applicant's arguments, see pgs 5-10, filed January 2, 2026, with respect to the rejection(s) of
claims 16-24, and 26 under 35 U.S.C. 103 have been fully considered and but they are not persuasive.
On pg. 5-8, Applicant argues that Arnold does not disclose the limitation: “wherein the nicotine formulation is a liquid nicotine formulation” because the disclosures in Arnold, [0069] would have led a person of ordinary skill in the art away from providing sodium stearate in a liquid nicotine formulation. Examiner respectfully disagrees with the arguments because Arnold states that plasticizers and softeners can be added to adjust the viscosity of the nicotine replacement composition, wherein the desired viscosity or softness of the composition may vary depending on the intended application of the nicotine replacement composition, and those of ordinary skill in the art would be readily capable of selecting an appropriate plasticizer and/or softener and an appropriate amount of these excipients in order to achieve the desired properties (Arnold, [0069]). While some of the discussion in Arnold, [0069] is directed to adjusting the viscosity of an edible or chewable nicotine product, the disclosure of an exemplary embodiment does not prevent one of ordinary skill in the art from using sodium stearate as a plasticizer/softener for nicotine replacement composition having a different intended application (i.e. a vaporizable/aerosolizable composition, Arnold, [0086]). As such the arguments are unpersuasive.
The following is a modified rejection based on amendments made to the claims.
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 16-24, and 26 is rejected under 35 U.S.C. 103 as being unpatentable over Arnold (US 2017/0189388 A1) in view of Fuisz (US 2019/0045834 A1) and Li (US 2017/0079322 A1).
Regarding Claim 16, Arnold, directed to vaporizable compositions ([0004]-[0005], [0073], [0075]; The nicotine replacement composition can be vaporized), teaches a nicotine formulation for an aerosol-generating system ([0004]-[0005], [0073], [0075]; The nicotine replacement composition can be aerosolized or vaporized by the coil or heating element of a vaporizer. [0011], The nicotine replacement composition comprises synthetic nicotine), the nicotine formulation comprising:
one or more water-miscible polyhydric alcohols ([0055]-[0058], The nicotine replacement composition comprises a solvent such as propylene glycol or glycerin. Glycerin and propylene glycol are water-miscible polyhydric alcohols);
one or more metal salts ([0069], The nicotine replacement composition comprises a plasticizer such as sodium stearate (a metal salt));
one or more water-soluble organic acids ([0062]-[0063], The composition comprises a pH adjusting agent, which may be lactic acid (a water soluble organic acid)); and
water ([0056]),
wherein the one or more water-soluble organic acids comprise one or more carboxylic acids selected from acetic acid, lactic acid, malic acid, malonic acid, and pyruvic acid ([0062]-[0063], The composition comprises a pH adjusting agent, which may be lactic acid),
wherein the one or more metal salts are selected from the group consisting of metal benzoates, metal cinnamates, metal cycloheptanecarboxylates, metal levulinates, metal propanoates, metal stearates, and metal undecanoates ([0069], The nicotine replacement composition comprises a plasticizer such as sodium stearate),
wherein the nicotine formulation has a water content of greater than or equal to about 1 percent by weight ([0056]), and
wherein the nicotine formulation has a water-miscible polyhydric alcohol content of greater than or equal to about 80 percent by weight ([0055]-[0058], The nicotine replacement composition comprises a solvent such as propylene glycol or glycerin. The amount of solvent present may be about 50 wt % to about 99.99 wt %, based on the total weight of the composition),
wherein the nicotine formulation is a liquid nicotine formulation ([0086]),
but does not teach the nicotine formulation i) wherein the nicotine formulation has a metal salt content of greater than or equal to about 0.5 percent by weight, ii) wherein the nicotine formulation has a water-soluble organic acid content of between about 0.5 percent and about 4 percent by weight, and iii) wherein the nicotine formulation has a viscosity at 25°C of greater than or equal to about 25 Pa-s.
The ranges for the water-miscible polyhydric alcohol content and the water content disclosed by the prior art overlap the claimed ranges, and therefore the claimed ranges are considered prima facie obvious. See MPEP § 2144.05 (I).
With respect to i) and iii), Fuisz, directed to vaporizable compositions ([0002]), teaches a nicotine formulation for an aerosol-generating system ([0019]-[0020], [0031]; The tobacco wax composition can have a nicotine content of greater than 2%. The tobacco wax composition is vaporized in a system comprising a device and a pod containing the tobacco wax composition. Vaporization of the composition generates an aerosol), the nicotine formulation comprising:
one or more water-miscible polyhydric alcohols ([0019], [0082]; Glycerine and propylene glycol may be added to the tobacco wax as vapor agents.);
one or more metal salts ([0087]; Sodium stearate may be added to the tobacco wax as surfactant);
wherein the nicotine formulation has a metal salt content of greater than or equal to about 0.5 percent by weight ([0068], [0082], [0087], [0233]; The tobacco wax has a surfactant (sodium stearate) content of 0.01% to 5%. It is reasonably understood that the surfactant content is reported as a percentage by weight because Fuisz consistently reports amounts as percentages by weight/mass),
wherein the one or more metal salts are selected from the group consisting of metal benzoates, metal cinnamates, metal cycloheptanecarboxylates, metal levulinates, metal propanoates, metal stearates, and metal undecanoates ([0087]; Sodium stearate),
wherein the nicotine formulation has a viscosity at 25°C of greater than or equal to about 25 Pa-s ([0103], The tobacco wax composition has a viscosity at 25.4 °C of greater than or equal to about 12,500 cP (12.5 Pa-s). Regardless of the slight temperature difference of the viscosity measurement, it is reasonably understood that the viscosity range disclosed by Fuisz overlaps the claimed range because the upper limits of both ranges are unbounded).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the formulation of Arnold wherein the nicotine formulation has a metal salt content of greater than or equal to about 0.5 percent by weight taught by Fuisz because Arnold and Fuisz are directed to vaporizable compositions, Arnold states that metal salt is added as a plasticizer or softener, (Arnold, [0069]), wherein the desired viscosity or softness of the composition may vary depending on the intended application of the nicotine replacement composition, and those of ordinary skill in the art would be readily capable of selecting an appropriate plasticizer and/or softener and an appropriate amount of these excipients in order to achieve the desired properties (Arnold, [0069]), Fuisz demonstrates that providing a metal salt (specifically sodium stearate) at an amount greater than or equal to about 0.5 percent by weight helps to promote the mixing of two or more immiscible substances (Fuisz, [0087]), and the teaching in Fuisz would have motivated one of ordinary skill in the art to provide the formulation having the claimed metal salt content.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the formulation of Arnold wherein the nicotine formulation has a viscosity at 25°C of greater than or equal to about 25 Pa-s as taught by Fuisz because Arnold and Fuisz are directed to vaporizable compositions, Arnold states that the viscosity of the formulation may be adjusted based on the specific application of the formulation (Arnold, [0069], [0086]), Fuisz demonstrates that a nicotine formulation for use in an aerosol generating device may have a viscosity at 25°C of greater than or equal to about 25 Pa-s (Fuisz, [0103]), and the teaching in Fuisz would have motivated one of ordinary skill in the art to provide the formulation having the claimed viscosity.
The ranges for the metal salt content and viscosity disclosed by the prior art overlap the claimed ranges, and therefore the claimed ranges are considered prima facie obvious. See MPEP § 2144.05 (I).
Arnold in view of Fuisz does not teach the nicotine formulation ii) wherein the nicotine formulation has a water-soluble organic acid content of between about 0.5 percent and about 4 percent by weight.
With respect to ii), Li, directed to vaporizable compositions ([0002]), teaches a nicotine formulation for an aerosol-generating system ([0007]-[0008], Li discloses a vapor precursor comprising a mixture of a vapor former, nicotine, water, and an acid. The vapor precursor can be vaporized by a vaping device to generate an aerosol), the nicotine formulation comprising:
one or more water-miscible polyhydric alcohols ([0007]-[0008], The vapor precursor comprising a mixture of a vapor former, nicotine, water, and an acid. [0013], The vapor former includes both propylene glycol and glycerol/glycerin);
one or more water-soluble organic acids, wherein the one or more water-soluble organic acids comprise one or more carboxylic acids selected from acetic acid, lactic acid, malic acid, malonic acid, and pyruvic acid ([0007]-[0008], The vapor precursor comprising a mixture of a vapor former, nicotine, water, and an acid. [0021]-[0022], The acid may be one or more of pyruvic acid, lactic acid, acetic acid);
water ([0007]-[0008], The vapor precursor comprising a mixture of a vapor former, nicotine, water, and an acid);
wherein the nicotine formulation has a water-soluble organic acid content of between about 0.5 percent and about 4 percent by weight ([0007]-[0008], The vapor precursor comprising a mixture of a vapor former, nicotine, water, and an acid. [0021]-[0022], [0040], The acid may be one or more of pyruvic acid, lactic acid, acetic acid. The concentration of acids may be substantially 3.5%. Li consistently reports amounts by their weight percent of the vapor precursor (nicotine formulation)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the formulation of Arnold wherein the nicotine formulation has a water-soluble organic acid content of between about 0.5 percent and about 4 percent by weight as taught by Li because Arnold and Li are directed to vaporizable compositions, Arnold states that the acid is added as a pH adjusting agent, wherein determining the amount of the pH adjusting agent is well within the knowledge and skill of the ordinary artisan in this field (Arnold, [0062]-[0066]), Li demonstrates that a water-soluble organic acid content of between about 0.5 percent and about 4 percent by weight is suitable for a pH adjusting agent (Li, [0040], [0057]), and the teaching in Li would have motivated one of ordinary skill in the art to provide the formulation having the claimed water-soluble organic acid content.
The range for the water-soluble organic acid content disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 17, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 16. Fuisz further teaches the nicotine formulation wherein the nicotine formulation has a metal salt content of less than or equal to about 15 percent by weight ([0068], [0082], [0087], [0233]; The tobacco wax has a surfactant (sodium stearate) content of 0.01% to 5%. It is reasonably understood that the surfactant content is reported as a percentage by weight because Fuisz consistently reports amounts as percentages by weight/mass).
The range for the metal salt content disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 18, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 16. Arnold further teaches the nicotine formulation wherein the one or more metal salts are selected from the group consisting of metal cinnamates, metal cycloheptanecarboxylates, metal stearates, and metal undecanoates ([0069], The nicotine replacement composition comprises a plasticizer such as sodium stearate).
Regarding Claim 19, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 16. Arnold further teaches the nicotine formulation wherein the one or more metal salts comprise sodium stearate ([0069], The nicotine replacement composition comprises a plasticizer such as sodium stearate).
Regarding Claim 20, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 16. Arnold further teaches the nicotine formulation further comprising sodium stearate ([0069], The nicotine replacement composition comprises a plasticizer such as sodium stearate).
Fuisz further teaches the formulation wherein the nicotine formulation has a sodium stearate content of greater than or equal to about 0.25 percent by weight ([0068], [0082], [0087], [0233]; The tobacco wax has a surfactant (sodium stearate) content of 0.01% to 5%. It is reasonably understood that the surfactant content is reported as a percentage by weight because Fuisz consistently reports amounts as percentages by weight/mass).
The range for the sodium stearate content disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Regarding Claim 22, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 16. Arnold further teaches the nicotine formulation wherein the one or more water-miscible polyhydric alcohols comprise glycerine ([0055]-[0058], The nicotine replacement composition comprises a solvent such as propylene glycol and/or glycerin).
Regarding Claims 23-24, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 22. Arnold further teaches the nicotine formulation wherein the one or more water-miscible polyhydric alcohols comprise glycerine and propylene glycol ([0055]-[0058], The nicotine replacement composition comprises a solvent consisting of propylene glycol and glycerin),
but does not teach the formulation wherein a ratio of the weight percent glycerine content to the weight percent propylene glycol content of the nicotine formulation is greater than or equal to about 1.
It would have been obvious to one of ordinary skill in the art to configure to formulation wherein a ratio of the weight percent glycerine content to the weight percent propylene glycol content of the nicotine formulation is greater than or equal to about 1 because Arnold discloses that the solvent consists of glycerine, consists of propylene glycol, or consists of propylene glycol and glycerin (Arnold, [0058]). A person having ordinary skill in the art would have recognized that a solvent consisting of two substances can be provided in equal proportions, or wherein one substance has a greater amount (weight percentage) than the other. As there are only a finite number of options presented for the ratio of the weight percent glycerine content to the weight percent propylene glycol content, one of ordinary skill in the art would have had a reasonable expectation of success by selecting from this finite list of options, and thus it would have been obvious to try providing the formulation wherein a ratio of the weight percent glycerine content to the weight percent propylene glycol content of the nicotine formulation is greater than or equal to about 1, as claimed, because there are a finite number of identified, predictable solutions.
Regarding Claim 26, Arnold in view of Fuisz and Li teaches the nicotine formulation according to claim 16. Arnold further teaches the nicotine formulation wherein the nicotine formulation has a water content of less than or equal to about 10 percent by weight ([0056]).
The range for the water content disclosed by the prior art overlaps the claimed range, and therefore the claimed range is considered prima facie obvious. See MPEP § 2144.05 (I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M. MARTIN whose telephone number is (703)756-1270. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PHILIP Y. LOUIE can be reached on (571) 270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.M./
Examiner, Art Unit 1755
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755