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 1-22, 24-26, and 28 are pending and are subject to this office action. This office action is in response to Applicant’s remarks filed on 4/13/26.
No claims are amended.
Claims 22, 24-26, and 28 remain withdrawn.
Response to Arguments
Applicant's arguments (filed 4/13/26, pages 2-5) have been fully considered but are not persuasive. Applicant argues: (1) Rabinowitz 2014 does not explicitly teach or suggest that the formulation includes at least 50% water, (2) an ordinary skilled person in the art is not taught that water should be used in excess over glycerol and/or propylene glycol and, (3) in the only composition presented in Rabinowitz 2014 that includes water, the amount of water used is significantly less than the claimed 50% water.
Regarding argument (1), Rabinowitz 2014 explicitly teaches that the formulation may include at least 50 wt.% based on the aerosolized formulation of water. Rabinowitz 2014 [0038] teaches that the solvent may be water. Rabinowitz 2014 [0039] further teaches that the solvent in the composition may broadly range from 25% to 99.5%. Moreover, Rabinowitz 2014 [0039] explicitly identifies one possible range that the composition may comprise from about 50% to 99.5% of a solvent or solvent mixture. Thus, the combination of Rabinowitz 2014 [0038] and [0039] explicitly teaches that the composition may comprise water in an amount of at least 50 wt.% based on the aerosolized formulation, similarly as claimed.
Regarding argument (2), Rabinowitz 2014 [0040] further explicitly teaches that the ratios of multiple solvents in a solvent mixture may vary and that they may vary in a ratio ranging from 3:2 up to 10:1. Thus, where Rabinowitz 2014 [0038] and [0039] explicitly disclose that water, when incorporated as a lone solvent, may exceed 50 wt.% based on the aerosolized formulation, it is clear from Rabinowitz 2014 [0040] that the quantity of water in a mixture of solvents may exceed that of the other solvents in the mixture. While Rabinowitz 2014 does not explicitly disclose an example or preferred embodiment where a mixture of solvents comprises water and glycerol and/or propylene glycol such that water is present in excess of the glycerol and/or propylene glycol, the broad teaching of Rabinowitz 2014 discloses the combination as a possible combination among other known combinations of solvents. Rabinowitz 2014 [0040] also further explicitly states that the choice of solvent mixture suitable for a particular composition may be based on both the teachings of Rabinowitz 2014 and in combination with general knowledge in the art. Therefore, it would be obvious to one of ordinary skilled in the art that water may be used in combination with, and in excess over, glycerol and/or propylene glycol.
Regarding argument (3), the MPEP states “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” See MPEP § 2123(II). Here, the single example presented in Example 4 of Rabinowitz 2014 does not negate the broader teaching of Rabinowitz 2014. Moreover, one of ordinary skill in the art would understand that further combinations of the solvent mixtures are not just possible, but explicitly disclosed by the teachings of Rabinowitz 2014 [0040]. Thus, Example 4 of Rabinowitz 2014 merely discloses a single possible embodiment of the solvent mixture taught by Rabinowitz 2014 [0038]-[0040] and does not limit the solvent mixture disclosure of Rabinowitz 2014 to a single embodiment.
The following rejections are maintained.
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 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinowitz 2014 (US 20140345635 A1), in view of Kuntawala (US 20160198759 A1) and Demain (US 5144964 A).
Regarding Claim 1, Rabinowitz 2014 discloses an aerosolized formulation ("The composition may comprise nicotine, at least one solvent, and at least one ion pairing agent, and may be vaporized to form a condensation aerosol" Abstract) comprising:
water in an amount of at least 50 wt.% based on the aerosolized formulation (A solvent, such as water, may comprise up to 99.5wt% of the particles formed from the solution. [0038]-[0040]);
glycerol, propylene glycol, or mixtures thereof (The solvent may comprise glycerol or propylene glycol. [0038]. Compositions may comprise a mixture of two or more solvents. [0038]. Therefore, it would have been obvious to one having ordinary skill in the art that the solvent may comprise a combination of water and glycerol, propylene glycol, or mixtures thereof. It is noted that the solvent ratios do not have to be equal and therefore water may be present in greater amounts than the glycerol, propylene glycol, or mixtures thereof ([0040]),
at least one active agent ("Compositions according to the present disclosure may comprise nicotine" [0035]-[0037]);
wherein the aerosol has a D50 particle size distribution from 2 µm to 6 µm (The aerosol particles may have a mass median aerodynamic diameter between 2 µm and 4 µm. [0057]).
Rabinowitz 2014 discloses a category of “other ingredients” (The composition may comprise up to about 10% of one or more other agents, including but not limited to active agents such as pharmacologically-active agents. [0053]. The prior art discloses that certain absorption rates and absorption times may be selected to achieve preferred nicotine blood absorption levels. [0060]) but does not explicitly disclose an aerosolized formulation comprising one or more cyclodextrins.
Kuntawala teaches an aerosolized formulation comprising one or more cyclodextrins in an amount in the range of 0.5 to 5.0 molar ratio of cyclodextrin to the active ingredient ("Cyclodextrin is included to enhance absorption of the active ingredients as well as to limit any tendency of the inhaled aerosol to cause irritation" [0014]. "cyclodextrins are useful for sequestering hydrophobic molecules and for forming droplets in a nebulizer" [0016]. "cyclodextrin is effective in the range of 0.5 to 5.0 molar ratio of cyclodextrin to active ingredient." [0021]). Thus, where Rabinowitz 2014 teaches an active agent present in an amount of no greater than 1 wt.% (The amount of nicotine in the composition may range from about 0.1% to about 1% by weight. [0037]) and the molar masses of nicotine and cyclodextrins are constant and known by one having ordinary skill in the art, it would have been obvious to one of ordinary skill in the art to have selected the overlapping portion of the ranges disclosed by Kuntawala (See MPEP § 2144.05(I)).
Rabinowitz 2014 and Kuntawala do not teach the use of substituted cyclodextrins. However, Demain teaches a smoking composition comprising a flavorant-release additive (Col. 2, lines 21-44) wherein the additive comprises a water-soluble molecular inclusion complex of beta-cyclodextrin (Col. 2, lines 41-44). Furthermore, Demain teaches that a substituted beta-cyclodextrin is preferred over unsubstituted variants due to increased solubility in water (Col. 2, lines 55-68; Col. 3, lines 1-33).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the aerosol formulation of Rabinowitz 2014 with an additional ingredient such as a cyclodextrin in the range of 0.5 to 5.0 molar ratio of cyclodextrin to active ingredient as taught by Kuntawala and to modify the aerosol formulation of Rabinowitz 2014 with a substituted cyclodextrin as taught by Demain because Rabinowitz 2014, Kuntawala, and Demain are each directed to flavored nicotine formulations comprising active ingredients, Kuntawala teaches the use of cyclodextrins to enhance absorption of active ingredients inhaled in an aerosol, Demain teaches the use of substituted cyclodextrins due to the increased solubility, and this merely involves applying a known flavored nicotine formulations additive to a similar aerosol formulation to yield predictable results.
Regarding Claims 2 and 3, Rabinowitz 2014 further discloses an aerosolized formulation wherein water is present in an amount of at least 75 wt.% based on the aerosolized formulation and/or wherein water is present in an amount of at least 90 wt.% based on the aerosolized formulation (Water may comprise up to 99.5wt% of the particles formed from the solution. [0038]-[0040]).
Regarding Claims 4 and 5, Rabinowitz 2014 further discloses an aerosolized formulation wherein the active agent is present in an amount of no greater than 1 wt.% based on the aerosolized formulation and/or wherein the active agent is present in an amount from 0.01 to 0.6 wt.% based on the aerosolized formulation (The amount of nicotine in the composition may range from about 0.1% to about 0.6% by weight. [0037]).
Regarding Claim 6, Rabinowitz 2014 further discloses an aerosolized formulation wherein the active agent comprises nicotine (Disclosed is an inhalable aerosol comprising a liquid carrier and nicotine. [0006]).
Regarding Claim 7, Rabinowitz 2014 further discloses an aerosolized formulation wherein the D50 particle size distribution of the aerosol is from 3.5 µm to 5.5 µm (The aerosol particles may have a mass median aerodynamic diameter between 3.5 µm and 4 µm. [0057]).
Regarding Claims 11-14, Rabinowitz 2014 further discloses an aerosolized formulation wherein the aerosolized formulation further comprises an acid; wherein the acid is selected from the group consisting of acetic acid, lactic acid, formic acid, citric acid, benzoic acid, pyruvic acid, levulinic acid, succinic acid, tartaric acid, sorbic acid, propionic acid, phenylacetic acid, and mixtures thereof; wherein the acid is selected from the group consisting of citric acid, benzoic acid, levulinic acid, sorbic acid, lactic acid, and mixtures thereof; and/or wherein the acid comprises citric acid (In some formulations, the composition includes an ion paring agent, said agent is selected from the group consisting of organic or inorganic acids such as citric acid. [0048]).
Regarding Claims 15-16, Rabinowitz 2014 further discloses an aerosolized formulation wherein a total content of acid present in the formulation is no greater than 1 mole equivalents based on the active agent and/or wherein a total content of acid present in the solution is no less than 0.01 mole equivalents based on the active agent (The mole fraction of the ion pairing agent is within a range of one-to-one to threefold less than the mole fraction of nicotine. [0050]).
Regarding Claims 17-19, Rabinowitz 2014 further discloses an aerosolized formulation further comprising one or more flavors; wherein the one or more flavors is selected from the group consisting of (4-(para- )methoxyphenyl)-2-butanone, vanillin, y-undecalactone, menthone, 5-propenyl guaethol, menthol, para-mentha-8-thiol-3-one, and mixtures thereof; and/or wherein the flavor comprises menthol (Possible flavorants which may be utilized include menthol, among other known and disclosed flavoring compounds. [0053]).
Regarding Claims 20-21, Rabinowitz 2014 further discloses an aerosolized formulation wherein the one or more flavors is present in a total amount of no greater than 2 wt.% based on the aerosolized formulation and/or wherein the one or more flavors is present in a total amount of from 0.01 to 1 wt.% based on the aerosolized formulation (The amount of flavorant in the composition may range from about 0.1% to about 1% by weight. [0037]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinowitz 2014 in view of Kuntawala and Demain as applied to Claim 1 above, and further in view of Rabinowitz 2003 (US 20030091511 A1).
Regarding Claim 8, Rabinowitz 2014 discloses aerosol particles having a mass median aerodynamic diameter of up to 4 µm. ([0057]), but does not explicitly disclose an aerosol wherein the D50 particle size distribution of the aerosol is from 4.5 µm to 5.5 µm.
Rabinowitz 2003 teaches an aerosol wherein the D50 particle size distribution of the aerosol is between 4.5 µm to 5.5 µm (Aerosol particles have a mass median aerodynamic diameter of up to 5 µm. [0012])
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the aerosol of Rabinowitz 2014 to have aerosol particles with a mass median aerodynamic diameter between 4.5 µm and 5 µm as taught by Rabinowitz 2003 because Rabinowitz 2014, Kuntawala, Demain, and Rabinowitz 2003 are all directed to aerosolized formulations for inhalation, Rabinowitz 2003 teaches the use of aerosolized particles up to 5 µm to deliver the active agent through inhalation of the aerosolized formulation ([0070]-[0075]), and this merely involves modifying a known aerosolized composition in a known manner to yield predictable results.
Regarding Claims 9 and 10, Rabinowitz 2003 further discloses an aerosol formulation wherein the aerosol has a D10 particle size distribution of at least 0.5 µm and/or wherein the aerosol has a D90 particle size distribution of no greater than 15 µm (The geometric standard deviation around the mass median aerodynamic diameter of the aerosol particles is less than 3.0 to less than 2.1. [0013]. Wherein the aerosol particles have a mass median aerodynamic diameter up to 5 µm [0012] with a geometric standard deviation less than 2.1 [0013], the aerosol will have a D10 particles size distribution greater than 0.5 µm and a D90 particle size distribution less than 15 µm.).
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 Jeffrey Buckman whose telephone number is (571)270-0888. The examiner can normally be reached Monday-Friday 9:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at (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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/JEFFREY A. BUCKMAN/ Examiner, Art Unit 1755
/PHILIP Y LOUIE/ Supervisory Patent Examiner, Art Unit 1755
