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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/2026 has been entered.
Status of the Claims
Claims 36, 44, 47-54, and 56 are pending and are subject to this Office Action. Claims 49-54 have been withdrawn. Claims 37-38, 42-43, 45-46, and 57-59 have been cancelled. Claim 36 has been amended.
Response to Amendment
The Examiner acknowledges Applicant’s response filed on 1/23/2026 containing
amendments and remarks to the claims.
The previous objection to claims 42-43 has been withdrawn due to cancellation of claims 42-43.
The previous rejection of claims 36-38, 42-48, and 56-59 under 35 USC 112(a) has been withdrawn due to the claim amendment removing the limitation “cannabidiol is present in an amount sufficient to solubilize the one or more terpene(s) at a terpene concentration of at least 2% w/w based on the total amount of aerosolizable material”.
The previous rejection of claim 42 under 35 USC 112(d) has been withdrawn due to the cancellation of claim 42.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered but they are not persuasive.
On pages 7-8, the Applicant argues that the applicant has found that only certain ratios of propylene glycol and glycerol actually form a soluble formulation when cannabinoids and terpenes are added, which is in contrast to the disclosure in Llamas which states that the weight percentage of propylene glycol in the composition is the same as that recommended for polyethylene glycol-400. The Applicant further argues that it cannot be true that propylene glycol and vegetable glycol would behave in the same manner as polyethylene glycol 400, and therefore where a uniform composition may have been formed using CBD and polyethylene glycol 400, this does not inevitably result in a uniform CBD formulation being formed when propylene glycol or vegetable glycol are used.
The Examiner does not find this to be persuasive. The claims do not require a soluble formulation to be formed. Llamas clearly teaches that the emulsifier may be propylene glycol or vegetable glycol [0031] and that a combination of different emulsifiers may be used [0033]. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
On pages 8-9, the Applicant argues that the actual concentration of CBD is not defined in the examples, given that the weight of hemp oil is provided but no indication of CBD concentration. The Examiner does not find this to be persuasive because Llamas discloses the impurities in the hemp oil (see [0029]) and further discloses the wt% concentration of CBD ([0034]), and as such one of ordinary skill may determine the CBD concentration based on known densities of the components and known wt% off the components in the composition.
On page 9, the Applicant further argues that extremely broad ranges of CBD concentration are provided would inevitably yield an unstable formulation when introduced into propylene glycol and vegetable glycol carrier systems. Further, the Applicant argues that there is simply no disclosure in Llamas that considers the solubility and stability issues associated with high concentration cannabinoid terpene formulations based upon a propylene glycol and vegetable glycol carrier system. The Examiner does not find this to be persuasive because if the prior art teaches the composition as claimed, just because the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
The Applicant further argues that the present invention can solubilize both the cannabinoid and terpene component without the assistance of surfactants and other solubilizing agents. However, the claims of the instant application do not recite this, i.e. a composition without surfactants and other solubilizing agents. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The following is a modified rejection based on amendments 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, 44, 47-48, and 56 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 written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 36, the Applicant’s specification describes “the terpene is selected from pinene (alpha and beta), geraniol, linalool, limonene, carvone, eucalyptol, menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, germacrene, and mixtures thereof”. See page 5, lines 1-3 of the instant specification. However, there is nothing in the original disclosure wherein the one or more terpene(s) comprise camphene, as recited in claim 36. Therefore, the new limitation fails to comply with the written description requirement.
Further regarding claim 36, the Applicant’s specification describes that the w/w% amount of propylene glycol in the aerosolizable material can be substantially equal to or above a threshold C%, the threshold being defined according to a formula (page 4, line 8, of the instant specification) wherein A is the amount of the at least one cannabinoid present in the aerosolizable material in mg/ml (page 4, lines 4-10 of the instant specification). Further, the Applicant’s specification describes that the terpene would be selected on the basis of being soluble when present in a carrier constituent comprising propylene and glycol, where the w/w% amount of propylene glycol present in the aerosolizable material is based off the following relationship (page 4, line 28) wherein T is the amount of the at least one terpene present in the aerosolizable material in mg/ml (page 4, lines 20-26 of the instant specification). However, there is nothing in the original disclosure that describes where the threshold (C%) is defined according to the sum total of CA% and CT%. In fact, the instant specification teaches that C% is equal to the claimed CA% (see the formula on page 4, line 8) and is also equal to the claimed CT% (see the formula on page 4, line 28). However, there is nothing in the original disclosure about the sum total of CA% and CT% equating to C%. Therefore, the new limitation fails to comply with the written description requirement.
Claims 44, 47-48, and 56 are similarly rejected for being dependent on claim 36.
Claim Interpretation
Claims 36 recites the new limitation “wherein the propylene glycol concentration (w/w%) is equal to or above a threshold (C%), where the threshold (C%) is defined according to the sum total of CA% and CT%, which are determined according to the following formulae (see claim 36, page 2, lines 17-18), wherein A is the concentration (mg/ml) of the cannabinoid component and T is the concentration (mg/ml) of the one or more terpene(s) present in the aerosolizable material”. However, once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP § 2113.II.
Therefore, so long as the prior art teaches an aerosolizable material that comprises propylene glycol, a cannabinoid component, and a terpene, and the amount of propylene glycol is equal to or above a threshold C% that is calculated with the given claimed formulae, the prior art will meet the claim limitation. The prior art does not need to explicitly disclose the given formulae for how to determine the amount of propylene glycol concentration in the aerosolizable material, but just show an aerosolizable material with the claimed components in amounts that satisfy the claimed concentration requirements.
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.
Claim(s) 36, 44, 47-48, and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Llamas (US2015/0181924, cited in IDS dated 4/8/2022) in view of Lopez (CA2941961, previously cited) as evidenced by Kozlowski (Kozlowski, Ryszard M. Mackiewicz-Talarczyk, Maria. (2020). Handbook of Natural Fibres, Volume 2 - Processing and Applications (2nd Edition) - 17.4.5 Terpenes. Elsevier).
Regarding claim 36, Llamas teaches:
An aerosolizable material ([0028]: composition that may be vaporized and heated by an electronic cigarette) comprising a cannabidiol ([0028]), a carrier constituent ([0028]: emulsifier), and one or more terpene(s) derivable from a phytocannabinoid producing plant ([0029]: where the cannabidiol is naturally derived from hemp oil may contain impurities such as myrcene).
Llamas teaches that the carrier constituent/emulsifier may be propylene glycol or vegetable glycol [0031] and that a combination of different emulsifiers may be used [0033]. The examiner notes that vegetable glycol is considered to be vegetable glycerin or vegetable glycerol as vegetable glycol is not a known compound and it is common for propylene glycol and vegetable glycerol to be listed as emulsifiers together.
Llamas does not appear to explicitly disclose wherein both glycerol and propylene glycol are present as carrier constituents.
However, Lopez, directed to a cannabinoid formulation for an electronic cigarette, teaches:
Known cannabinoid formulations with similar carrier solutions, such as propylene glycol and glycerol, that provide a general pain relief effect and therapeutic benefit [0049], [0059].
In some embodiments, the liquid carrier comprises 70% propylene glycol and 30% vegetable glycerin (claim 26).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Llamas by configuring the carrier constituent to comprise both propylene glycol and glycerol in amounts such as 30% propylene glycol and 70% glycerol as taught by Lopez, because both Llamas and Lopez are directed to electronic cigarettes, Lopez teaches known cannabinoid formulations that comprise similar components as Llamas, and this merely involved incorporating a known combination of emulsifiers a similar cannabinoid formulation to yield predictable results.
Llamas does not appear to explicitly disclose (I) wherein the one or more terpenes(s) comprise alpha pinene, beta pinene, camphene, or mixtures thereof, and (II) the concentration of the terpene, cannabidiol, and the propylene glycol.
In regard to (I), Llamas teaches that the cannabidiol is naturally derived from hemp oil, the cannabidiol may contain impurities, and the impurities may be any cannabinoids that are not cannabidiol or other natural components of hemp oil [0029].
As evidenced by Kozlowski, alpha pinene is a main terpene found in hemp oil (first paragraph under 17.4.5 Terpenes). Therefore, one of ordinary skill would reasonably conclude that the impurities of the cannabidiol would include alpha pinene, and thus Llamas would necessarily satisfy the limitation wherein the one or more terpenes(s) comprise alpha pinene, beta pinene, camphene, or mixtures thereof.
In regard to (II), Llamas further teaches:
the cannabidiol is present in a total amount by weight of about 0.1 to about 90% ([0034]),
the impurities within the cannabidiol which would include terpenes as discussed above may be less than 1% ([0040]), and
the emulsifier may be present in a total amount by weight of about 10% to 99.9% ([0036]) and as discussed above the emulsifier may be a combination of 70% propylene glycol and 30% glycerol as taught by Lopez.
Based on the densities of all the components, one of ordinary skill would be capable of determining approximate concentrations of terpenes, cannabidiol and propylene glycol. For example, at 5% cannabidiol and a terpene amount of 1% with the remainder being emulsifier, one of ordinary skill would reasonably arrive at a material in which cannabidiol is greater than 50mg/ml (e.g. ~53mg/ml), a terpene concentration would be less than 10 mg/ml (e.g. ~0.53 mg/ml), and propylene glycol concentration would be greater than the sum of the claimed formulae (e.g. greater than ~60mg/ml). As such, the prior art combination of record reasonably discloses an embodiment in which the claimed concentrations are met and the claimed aerosolizable material is considered obvious.
Regarding claim 44, Llamas teaches:
The composition is liquid (abstract), which reads on the claim limitation wherein the aerosolizable material is a liquid at about 25 C.
Regarding claim 47, Llamas teaches:
The composition may further comprise a flavor enhancer ([0038]), which is considered to read on the claim limitation wherein the aerosolizable materials further comprises one or more further constituents.
Regarding claim 48, Llamas teaches:
Flavor enhances may be chosen from the list comprising apple, cherry, spearmint, etc. ([0046]), which reads on the claim limitation wherein one or more further constituents is an olfactory active constituent.
Regarding claim 56, modified Llamas is silent to the turbidity of the aerosolizable material. However, in composition claims, if the composition is the same, it must have the same properties. See MPEP § 2112.01, II. Therefore, as modified Llamas yields the composition as claimed, and turbidity depends on the materials and amounts of material within the composition, it follows that where the prior art overlaps the claimed composition the prior art would have a similar or overlapping turbidity as claimed absent evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole A Szumigalski whose telephone number is (703)756-1212. The examiner can normally be reached Monday - Friday: 8:00 - 4:30 EST.
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/N.A.S./ Examiner, Art Unit 1755
/PHILIP Y LOUIE/ Supervisory Patent Examiner, Art Unit 1755