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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/04/2025 has been entered.
Response to Amendment
The office action is in response to Applicant’s amendment filed on 12/04/2025.
Claims 36, 38-39, and 42 are amended.
Claims 36-55 are pending and are subject to this Office Action.
Claims 49-55 have been withdrawn as being directed to a non-elected group.
Response to Arguments
Applicant' s arguments, see pages 5-9, filed 12/04/2025, with respect to the rejection of claims 36-48 under 35 U.S.C. 103, have been fully considered and are not persuasive. The Applicant has amended claim 36 to include the carrier constituents comprises glycerol, propylene glycol or combinations thereof and the aerosolizable material comprises less than 12%w/w water. The Applicant argues that the amendments made to claim 36 further clarify the composition of the aerosolizable material and the scope of the claims is enabled by the specification and that the rejection to claims 36-48 are not obvious over Lopez.
On page 6, the Applicant argues that Example 2 of the Applicant’s disclosure specifically discloses separate aerosolizable formulations that include a combination of polyethylene glycol and glycerol and various percentages of water and that it is clear the composition is unusable if the material comprises water in amounts of about 12%w/w or more.
The Examiner agrees that the Applicant’s disclosure teaches usable formulations comprising less than 12%w/w water, however the amendments do not overcome the enablement rejection because Example 2, while teaching examples comprising acceptable amounts of water weight percentages for ensuring solubility of cannabidiol, does not teach the turbidity of those measurements. There is still no explanation for how the specific amounts claimed result in the claimed turbidity. The only example that teaches an acceptable turbidity in the range claimed is example 3 and there is no water amounts disclosed in those samples. There is still an undue amount of experimentation required to discover what amounts of water, amount and specific cannabinoid, and amount and specific carriers that are needed to recreate the claimed turbidity because it is unclear what combination of the constituents results in a turbidity of less than 10 NTU and less than 1 NTU as claimed.
On page 6, the Applicant further argues that the application as filed describes a method where at least one cannabinoid is combined with at least one carrier constituent and that the method is comparable in methodology disclosed in Lopez, thus the exemplary disclosure is provided for formulating aerosolizable formulations.
The Examiner respectfully does not find the Applicant’s arguments persuasive.
First, Lopez does indeed teach a method similar to the Applicant’s disclosure, just does not disclose the turbidity of the resulting aerosolizable material. Not only does the Applicant’s instant disclosure not enable the claims in a way for the aerosolizable material to not be recreated without undue experimentation, but Lopez teaches all the requirements and components of the aerosolizable material of claim 1 and there is no apparent reason for Lopez to not also be able to teach a similar turbidity as claimed.
Second, Example 3 has a very limited number of samples that have a suitable turbidity. There are only three samples provided within the claimed turbidity. Since there are a limited number of samples for such a broad claim, there would clearly be undue experimentation to determine what amounts and types of cannabinoid compounds, carriers and non-cannabinoid compounds are needed to get a certain turbidity. Just because there is methodology in the Applicant’s disclosure, does not mean there is adequate methodology that would enable one with ordinary skill in the art to recreate claim 36 without undue experimentation. Therefore, the methodology, Example 2, and Example 3 do not overcome the enablement rejection because an undue amount of experimentation would need to be done to create what is claimed in claim 36.
Third, as previously stated in the final rejection dated 09/05/2025, Sample 2 shows how a carrier may reduce turbidity, but it does not show whether a required amount or type of carrier is needed to reduce turbidity by a certain amount or if it specifically is solely the carrier that reduces the turbidity. For example, Sample 2 does not explain if the reduction in PG, the lowered amount of CBD isolate, or the addition of glycerol from Sample 1 to Sample 2 is what resulted in the lowered turbidity. It is not clear what is lowering the turbidity and therefore an undue amount of experimentation would be needed to replicate what is claimed.
On pages 6-7, the Applicant argues that Lopez would not make obvious the claimed turbidity because even though Lopez teaches the same cannabinoid purity and the same composition constituents, the Applicant argues that cannabinoid preparations are well known to have solubility issues with aqueous solvents and while an extract may be homogenous and free of particulates, that does not mean such components would not form when formulated into an aerosolizable formulation.
The Examiner respectfully does not find the arguments persuasive.
First, the Examiner notes that it is unclear if the instant disclosure removes such components to prevent a higher turbidity than claimed or if the formulation comes clear as a result from the chosen percentages and materials formulated.
Second, Lopez teaches motivation and desire to create a low turbidity and does indeed teach components that form during formulation are minimized or altogether avoided. Lopez teaches a water clear formulation and explicitly discloses “the cannabinoid formulation is provided to minimize or avoid tarry residues during subsequent extract formation steps” ([0073]), therefore it would indeed be obvious to one of ordinary skill in the art that an aerosolizable formulation void of tarry residues would create a formulation within the turbidity claimed, or at the very least be motivated to do so.
On page 7, the Applicant further argues that Lopez does not recognize the issue of cannabinoid stability to the same level as that of the present application.
The Examiner respectfully does not find the arguments persuasive.
First, Lopez does not need to teach the stability of the cannabinoid because the stability of the cannabinoid is not the only factor that affects a composition and a compositions turbidity. A number of factors affect the stability and the turbidity of cannabinoid compositions and therefore Lopez does not need to recognize the issue of cannabinoid stability to the same level of the present application.
Further, the stability of the cannabinoid is not claimed and therefore not a requirement of the formulation. Lopez does not need to teach the stability of the cannabinoid in order to teach the required turbidity. It is clear in Example 3 of Applicant’s disclosure that the turbidity readings are not dependent on the stability of the cannabinoid because the only materials in Example 3 are the carrier constituent and the cannabinoid. Water and thus the stability of the cannabinoid in the water has nothing to do with the Examples provided, hence why there is an enablement issue.
The following is modified rejection based on amendments made to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 36-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an aerosolizable material comprising a cannabinoid and at least one carrier constituent, does not reasonably provide enablement for a claimed turbidity of the aerosolizable material being 10 NTU or less, how this turbidity is maintained when additional constituents are added to the aerosolizable material, how the 12%w/w of water affects the turbidity, and how the aerosolizable material is formulated and maintained to have the turbidity claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue” (MPEPE 2164.01 (a)). These factors are: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. The factors are discussed below as they apply to the instant invention.
Claim 36 is extremely broad and the scope is bigger than what is claimed because the aerosolizable material is described as only having at least one cannabinoid and at least one carrier constituent, wherein the carrier constituent comprises propylene glycol or combinations thereof, and the aerosolizable material comprises less than about 12%w/w water, resulting in an aerosolizable material that has a turbidity of about 10 NTU or less. The dependent claims 38-48 further detail specific carrier constituents and cannabinoids, weight percent’s of constituents, and even add additional constituents to the aerosolizable material after the turbidity has already been claimed. The scope is greater than what is claimed because specific constituents and additional constituents added to the aerosolizable material can affect the claimed turbidity. There are numerous factors that can affect the turbidity of a material, including the method of formulating the aerosolizable material and how the materials are added/combined to maintain the claimed turbidity, both of which are not described in the instant specification.
In the prior art Lopez (Lopez CA 2941961 A1, as cited in the IDS dated 04/08/2022), discloses the same aerosolizable material with all of the same constituents ([0061]-[0065]) and is merely silent to a turbidity of the material. Therefore, one of ordinary skill in the art would find it obvious that Lopez could also teach a same turbidity as claimed since the aerosolizable material described in claim 36 is extremely broad and already described in Lopez. In addition, Lopez discloses some embodiments where the cannabinoid or cannabinoid formulation is water clear in appearance in order to avoid or minimize tarry residues during formation steps ([0073]) and it would be obvious that one of ordinary skill in the art would be motivated to have a formulation with a low turbidity for these reasons.
A turbidity measurement and reading for a formulation has a small degree of predictability, however the instant specification provides little guidance or direction on how that turbidity is achieved. There is little guidance on what methods are performed to achieve and/or maintain that turbidity during formulation and the only explanation provided regarding the specific turbidity in the instant specification is that a turbidity above 10 NTU means a constituent in the formulation is unstable (page 3). See MPEP 2164.03. Undue experimentation would be required by one of ordinary skill in the art to generate a specific turbidity. There needs to be ample evidence for a relevant person in the art to perform the claimed invention (MPEP 2164.05(b))
Three working examples are provided in the instant specification (page 23) with aerosolizable formulations and measured turbidities; however it is not disclosed in a manner that one skilled in the art would be able to practice it without an undue amount of experimentation. In reBorkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310, 115 USPQ2d 2012, 2023 (Fed. Cir. 2015) ( “Only a sufficient description enabling a person of ordinary skill in the art to carry out an invention is needed.”). While applicant provides a working example for the cannabinoid and carrier constituent (not the water weight disclosed), there is a lack of how that working example is achieved and therefore there is no enabling disclosure for how one could create similar results. See MPEP 2164.02. It is further noted there are no working examples provided with the claimed turbidity and the claimed water weight percentage and thus there is not enough information provided for one of ordinary skill in the art to recreate the formulation without undue experimentation.
There is some quantity of experimentation, the instant specification provides three samples with measured turbidities, however these samples are not examples of reasonable experimentation because how the aerosolizable material is formulated to create the claimed turbidity is not mentioned and remains unclear. As a result, the quantity of experimentation required of a person having ordinary skill in the art to determined how to practice the invention and to determine the scope of the limitation of the formulation comprising a turbidity of 10 NTU or less would be undue in the absence of further guidance. See MPEP 2164.06 II.
Claim 37 is similarly rejected for reciting a turbidity of 1 NTU or less, and claims 38-48 are rejected by virtue of their dependency.
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 36-37 and 39-48 are rejected under 35 U.S.C. 103 as being unpatentable over Lopez (CA 2941961 A1, as cited in the IDS dated 04/08/2022).
In regards to claim 36, Lopez, directed to an aerosolizable material for an aerosol device, discloses an aerosolizable material comprising a cannabinoid ([0061]-[0063]) and a liquid carrier solution (i.e., carrier constituent) ([0065]).
Lopez further discloses the cannabinoid for cannabinoid formulation is "water clear" in appearance in order to avoid or minimize the foundation of tarry residues during the subsequent extract formation steps ([0073]).
In addition, the instant specification discloses three samples that comprise carrier constituents propylene glycol and/or glycerol as well as a cannabinoid that is 98.5% pure or less (page 23). Lopez discloses an aerosolizable formulation with the same carrier constituents ([0059]-[0065]) and a purity of the cannabinoid capable of being 95% to 99% pure ([0073]), which is the same cannabinoid purity as disclosed in the instant specification.
While Lopez is silent in regards to a turbidity of the formulation, Lopez discloses the same aerosolizable material with a similar composition (at least one cannabinoid and at least one carrier constituent), the same carrier constituents described in the instant specification, and the same purity of a cannabinoid, therefore it would be obvious to one of ordinary skill in the art that a similar composition would have a similar turbidity as claimed, since turbidity is a measurement based on the composition of the material, and thus a turbidity of 10 NTU or less is considered prima facie obvious.
In addition, while Lopez does not explicitly disclose the turbidity value, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the formulations turbidity since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed turbidity is critical and has unexpected results. In the present invention, one would have been motivated to optimize the formulations turbidity motivated by the desire to maintain a “water clear” formulation and the desire for the cannabinoid formulation to minimize or avoid tarry residues during subsequent extract formation steps ([0073]).
Lopez further discloses water as an optional constituent in the formulation ([0057]) and therefore it would be obvious to one of ordinary skill in the art that Lopez discloses a formulation comprising less than 12%w/w as claimed since Lopez does not require water.
In regards to claim 37, Lopez discloses a similar aerosolizable material with the same constitutes, therefore it would be obvious to one of ordinary skill in the art that a similar formulation would read on a claimed turbidity of 1 NTU or less as explained above.
In regards to claim 39, Lopez discloses the aerosolizable material wherein a carrier constituent comprises propylene glycol ([0065]).
In regards to claim 40, Lopez discloses a molar ratio of liquid carrier constituents, which can be 100% propylene glycol, to cannabinoids being 2:1 ([0068] and [0095]). Thus, the amount of propylene glycol would be equal or above the threshold C%.
In regards to claim 41, Lopez discloses a molar ratio of propylene glycol to cannabinoids being 2:1, where the amount of cannabinoids would be 30% w/w of the material ([0096]). One with ordinary skill in the art would find it obvious that the remaining formulation would be propylene glycol and could be up to 70% w/w based on the total weight of the material, and thus the range disclosed by the prior art overlaps the claimed range of propylene glycol present in an amount of at least 50% w/w based on the total weight of the material and is therefore considered prima facie obvious.
In regards to claim 42, Lopez discloses the liquid carrier constituent can comprise 100% glycerol ([0059]).
Lopez discloses a molar ratio of the carrier constituent to cannabinoids being 2:1, where the amount of cannabinoids would be 30% w/w of the material ([0096]). One with ordinary skill in the art would find it obvious that the remaining formulation would be propylene glycol and could be up to 70% w/w based on the total weight of the material, and thus the range disclosed by the prior art overlaps the claimed range of glycerol present in an amount of at least 50% w/w based on the total weight of the material and is therefore considered prima facie obvious.
In regards to claim 43, Lopez discloses the carrier constituent can comprise 10 to 70% propylene glycol and 90 to 30% vegetable glycerin (i.e., glycerol) ([0059]).
In regards to claim 44, Lopez discloses the cannabinoid can be cannabidiol ([0062] and [0087]-[0088]).
In regards to claim 45, Lopez discloses a solution of cannabinoids in propylene glycol were mixed thoroughly together, where 1 g of cannabinoid was added to 2 mL of propylene glycol for a total volume of 3 mL. Lopez discloses at least 333 mg/mL of cannabinoid present in the aerosolizable material ([0094]-[0095]).
The range disclosed by the prior art overlaps the claimed range of the cannabinoid present in an amount of at least 5 mg/mL, and is therefore considered prima facie obvious.
In regards to claim 46, Lopez discloses the aerosolizable material is a cannabinoid liquid formulation ([0067]). Since Lopez discloses a liquid formulation, it would be obvious to one of ordinary skill in the art that the formulation would be a liquid at 25C, which is approximately room temperature and is the expected temperature of a room where an aerosol device is operated.
In regards to claims 47 and 48, Lopez discloses the flavor of the formulation is adjusted by adding “exogenous flavorants” (i.e., olfactory active constituents) ([0069]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez (CA 2941961 A1, as cited in the IDS dated 04/08/2022) as applied to claim 36 above, and further in view of Anastassov et al. (US-20160220593-A1).
In regards to claim 39, Lopez discloses the aerosolizable material wherein a carrier constituent comprises propylene glycol ([0065]) and further discloses the formulation further may comprise one or more flavorants ([0075]), but is silent to the formulation comprising the listed additional carrier constituents such as erythritol.
Anastassov, directed to a cannabinoid and sugar alcohol complex discloses the cannabinoid and sugar alcohol complex can be used in aerosol form ([0053]).
Anastassov further discloses the sugar alcohol includes widely used alcohols in food, cosmetics, and pharmaceutical preparations such as erythritol ([0035]).
Anastassov further discloses sugar alcohols, like erythritol, are mildly sweet in taste ([0035]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Lopez by making the compositions flavorant erythritol, as taught by Anastassov, because both are directed to aerosolizable cannabinoid formulations, Anastassov teaches erythritol is a known sweetener in the art ([0035]), and this merely involves applying a known technique of using a known flavorant of a similar product to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELEINE PAULINA DELACRUZ whose telephone number is (703)756-4544. The examiner can normally be reached Monday - Friday 8-5.
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/MADELEINE P DELACRUZ/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755