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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on April 9, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim recites that the composition “is delivered…” This recitation does not limit the parent claim which is drawn to a product because “delivery” of the product of the parent claim does not change the product itself. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5-6, and 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dedhiya et al. (US Patent No. 6,747,058) in view of Cowan et al. (US PGPub No. 2003/0185762 – henceforth Cowan B) as evidenced by the Ethanol 200 Proof MSDS (2009) and the Propylene glycol data sheet (1999).
Dedhiya et al. teach a solution envisioned for aerosol delivery via inhalation composed of delta-9-tetrahydrocannabinol (THC) in ethanol, water, and propylene glycol (see abstract and column 3 lines 60-67; instant claims 14-15). A volume ratio of 10 to 70 parts ethanol, 10 to 30 parts water, and 30 to 80 parts propylene glycol is recited, where the THC is present at 0.1 to 25 mg/ml (see claims 1-3; instant claims 1, 6, 8-9, 10-11, and 13). Given a density of 0.79 g/ml for ethanol as well as a density of approximately 1 g/ml for both propylene glycol and water, these ranges correspond to 0.08 to 0.55 g/ml ethanol, 0.1 to 0.3 g/ml water, and 0.3 to 0.8 g/ml propylene glycol (see Ethanol 200 Proof MSDS page 1 and Propylene glycol data sheet page 1 section 8; instant claims 1, 10-11, and 13). Examples detail solutions where polypropylene glycol, a taught equivalent to propylene glycol, is employed in combination with ethanol and water to produce solutions with 10 mg/ml THC (see column 3 lines 60-67 and examples 1-7; instant claim 1). Dedhiya et al. teach that higher proportions of ethanol beyond about 10%v/v produced solutions, particularly when the water proportion exceeded 10%v/v (see column 5 lines 22-27). The ethanol may be provided as 190 proof (see column 3 lines 63-64; instant claim 12). Surface tension of the composition is not detailed.
Cowan B teaches liquid solution formulations for aerosol delivery of an active via inhalation (see abstract). They note the ability to generate uniform droplets from liquid carriers via electrohydrodynamic sprayers for ease of delivery over nebulizers (see paragraphs 4-7). However, the high surface tension of water in such carriers has previously limited the applicable compositions (see paragraphs 8 and 12). Cowan B goes on to teach the desire for the surface tension for such compositions to be in the range of 20 to 40 mN/m (dyne/cm) and the inclusion of derivatized carbohydrate surfactant compounds to lower the surface tension when water is present (see paragraph 21-27 and 82). They also teach a more preferred range of 25 to 30 mN/m (dyne/cm) (see paragraph 82). The carriers envisioned by Cowan B are composed of water, pharmaceutically acceptable excipient, 0 to 40%v/v ethanol, 0 to 50%v/v co-solvent, and 0.05 to 10%v/v derivatized carbohydrate surfactant (see claim 1). The co-solvent is envisioned as propylene glycol as well as glycerol (see claim 9; instant claim 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the composition of Dedhiya et al. where the surface tension is made to be within the range taught by Cowan B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g., ability to deliver uniform droplets via electrohydrodynamic sprayer). Cowan B envision all the components taught in the vehicle of Dedhiya et al. in their vehicle, thus the addition of their derivatized carbohydrate surfactant to achieve their desired and preferred surface tension would have been obvious. The ranges of proportions for the ethanol, propylene glycol, and THC as well as the surface tension overlap with those instantly claimed, thereby rendering the claimed ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). In addition, attaining a solution is detailed as a result effective based upon the ethanol proportion and would have been obvious to optimize as a matter of routine experimentation. The additional inclusion of glycerol as a cosolvent along with propylene glycol would have been obvious in light of Cowman B as the simple substitution of one known element for another in order to yield a predictable outcome. The recitation of “treating” in instant claim 16 embraces treating or ameliorating any symptom of the recited conditions (see instant specification paragraph 31). Dedhiya et al. state that THC acts as an appetite stimulant in patients with HIV/AIDS, thus their modified THC containing composition is able to be used for this purpose (see column 1 lines 10-18). Therefore claims 1-3, 5-6, and 8-16 are obvious over Dedhiya et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet.
Claims 1-6 and 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dedhiya et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet as applied to claims 1-3, 5-6, and 8-16 above, and further in view of Wright et al. (US PGPub No. 2019/01314296).
Dedhiya et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet render obvious the limitations of instant claims 1-3, 5-6, and 8-16. Glycerol is not taught at the instantly claimed proportion.
Wright et al. teach an aqueous preparation of cannabinoids such as THC and CBD (see abstract). They further detail the inclusion of glycerol at 5 to 50 mg/ml to make the preparation isotonic (see paragraph 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the glycerol as taught by Wright et al. to the composition of Dedhiya et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet to make the solution isotonic. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1-6 and 8-16 are obvious over Dedhiya et al. in view of Cowan B and Wright et al. as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet.
Claims 1-3 and 5-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kottoyil et al. (US PGPub No. 2008/0112895) in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet.
Kottoyil et al. teach a solution envisioned for aerosol delivery via inhalation composed of delta-9-tetrahydrocannabinol (THC), also known as dronabinol in ethanol, water, and propylene glycol (see abstract and paragraphs 3, 14, and 114-115; instant claims 14-15). They detail a solution including ethanol at 35 %v/v, propylene glycol at 10 %v/v, water at 35 %v/v, as well as THC at 5 mg/ml (see examples 1 and 3 sample 3-A; instant claim 1). They go on to characterize the solution and note the presence of cannabidiol and an overall cannabinoid purity greater than 90% (see table 10; instant claims 7 and 9). Given a density of 0.79 g/ml for ethanol as well as a density of approximately 1 g/ml for both propylene glycol and water, the proportions correspond to 0.38 g/ml ethanol, 0.35 g/ml water, and 0.1 g/ml propylene glycol (see Ethanol 200 Proof MSDS page 1and Propylene glycol data sheet page 1 section 8; instant claims 1, 11, and 13). They further teach other examples with proportions of ethanol, propylene glycol and water near the highlighted example (see tables 2 and 3). Kottoyil et al. teach that greater stability could be is attained when a buffer is included as well as particular antioxidants (see paragraphs 276-277). Kottoyil et al. also teach that higher proportions of ethanol increase the solubility of the THC (see paragraph 276). The ethanol is not detailed as diluted, thus it is viewed as 200 proof (see table 2; instant claim 12). Surface tension of the composition is not detailed.
Cowan B teaches liquid solution formulations for aerosol delivery of an active via inhalation (see abstract). They note the ability to generate uniform droplets from liquid carriers via electrohydrodynamic sprayers for ease of delivery over nebulizers (see paragraphs 4-7). However, the high surface tension of water in such carriers has previously limited the applicable compositions (see paragraphs 8 and 12). Cowan B goes on to teach the desire for the surface tension for such compositions to be in the range of 20 to 40 mN/m (dyne/cm) and the inclusion of derivatized carbohydrate surfactant compounds to lower the surface tension when water is present (see paragraph 21-27 and 82). They also teach a more preferred range of 25 to 30 mN/m (dyne/cm) (see paragraph 82). The carriers envisioned by Cowan B are composed of water, pharmaceutically acceptable excipient, 0 to 40%v/v ethanol, 0 to 50%v/v co-solvent, and 0.05 to 10%v/v derivatized carbohydrate surfactant (see claim 1). The co-solvent is envisioned as propylene glycol as well as glycerol (see claim 9; instant claim 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the composition of Kottoyil et al., where the surface tension is made to be within the range taught by Cowan B. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g., ability to deliver uniform droplets via electrohydrodynamic sprayer). Cowan B envision claimed components that are also taught in the vehicle of Kottoyil et al. in their vehicle, thus the addition of their derivatized carbohydrate surfactant to achieve their desired and preferred surface tension would have been obvious. In addition to applying this surface tension modification to the highlighted example of Kottoyil et al., it also would have been obvious to apply it to other solution examples and optimize their values as a matter of routine experimentation, given the guidance concerning ethanol increasing THC solubility. The proportions for the ethanol, propylene glycol, and THC as well as the surface tension then meet or overlap with those instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Additionally, the inclusion of glycerol as a cosolvent along with propylene glycol would have been obvious in light of Cowman B as the simple substitution of one known element for another in order to yield a predictable outcome. The recitation of “treating” in instant claim 16 embraces treating or ameliorating any symptom of the recited conditions (see instant specification paragraph 31). Kottoyil et al. state that THC acts as an appetite stimulant in patients with HIV/AIDS, thus their modified THC containing composition is able to be used for this purpose (see paragraph 3; instant claim 16). Therefore claims 1-3 and 5-16 are obvious over Kottoyil et al. in view of Cowan B as evidenced by Ethanol 200 Proof MSDS and the Propylene glycol data sheet.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kottoyil et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet as applied to claims 1-3 and 5-16 above, and further in view of Wright et al.
Kottoyil et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet render obvious the limitations of instant claims 1-3 and 5-16. Kottoyil et al. envision the inclusion of tonicity modifying agents at up to 20 wt% and each that an isotonic formulation is preferred (see paragraphs 29 and 141). Glycerol is not taught at the instantly claimed proportion as the tonicity agent.
Wright et al. teach an aqueous preparation of cannabinoids such as THC and CBD (see abstract). They further detail the inclusion of glycerol at 5 to 50 mg/ml to make the preparation isotonic (see paragraph 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the glycerol as taught by Wright et al. to the composition of Kottoyil et al. in view of Cowan B as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet as the tonicity adjusting agent to make the solution isotonic. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement and as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1-16 are obvious over Kottoyil et al. in view of Cowan B and Wright et al. as evidenced by the Ethanol 200 Proof MSDS and the Propylene glycol data sheet.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
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