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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 22, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “at least 500ppm”, and the claim also recites “an amount of from 0.05%w/w to 10%w/w” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 17 recites “wherein the stabilizing components are each present in an amount of at least 500 ppm” which is broader than the range “an amount of from 0.05%w/w to 10%w/w” recited in claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7, 17, 21, 25, 37, 43, 45-47, 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KOTTAYIL et al. (US 2009/0181080).
Kottayil teaches a packaged formulation comprising one or more cannabinoids including cannabidiol (CBD) (para. 0086) and a stabilizer comprising an antioxidant (para. 0083) such as propyl gallate (para. 0088, para. 0175). Kottayil teaches the packaging is impermeable to air (para. 0208). Kottayil teaches that the one or more stabilizing components are present in an amount of from about 0.001% to about 20%w/w (para. 0177) which incorporates the claimed range of from 0.05%w/w to 10%w/w based on the total weight of the packaged formulation.
Regarding claim 7, Kottayil teaches the cannabinoids further comprise cannabidiol and delta-8 tetrahydrocannabinol (para. 0086).
Regarding claim 17, Kottayil teaches the one or more stabilizing components are each present in an amount of about 0.001% to about 20% (para. 0177), which overlaps with the claimed range of at least 500 ppm.
Regarding claim 21, Kottayil teaches the packaged formulation further comprises a carrier constituent comprising propylene glycol (para. 0017).
Regarding claim 25, Kottayil teaches the packaged formulation further comprises a carrier constituent comprising propylene glycol (para. 0017).
Regarding claim 37, Kottayil teaches the cannabinoid is present in the packaged formulation in an amount of about 0.01 mg/ml to about 10 mg/ml (para. 0089) which overlaps with the claimed range of 5mg/ml or more.
Regarding claim 43, Kottayil teaches the packaged formulation further comprises one or more active constituents in addition to the cannabinoid (para. 0173).
Regarding claim 45, Kottayil teaches the packaged formulation takes the form of a liquid at about 25°C (para. 0014).
Regarding claim 46, Kottayil teaches the content of one or more specific cannabinoids is at least 80% of the initial content of one or more specific cannabinoids based on a mg/ml basis of the packaged formulation after 4 weeks at 40°C and 75% Relative Humidity (para. 0014).
Regarding claim 47, Kottayil reaches a method of producing a packaged formulation, wherein the method comprises combining each of the one or more cannabinoids and one or more stabilizing components so as to form the packaged formulation, wherein the one or more stabilizing components are combined to form a first mixture, optionally with one or more carrier constituents, and then the one or more cannabinoids is added to the first mixture to produce the formulation (Examples 4 and 5).
Regarding claim 51, Kottayil teaches the packaged formulation further comprises a carrier constituent in an amount of about 1 to about 30% (para. 0017) which overlaps with the claimed range of 30 %w/w or more.
Claim(s) 1, 7, 17, 21, 37, 43, 45-47 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by RISTEVSKI et al. (US 2022/0347118).
Ristevski teaches a packaged formulation comprising one or more cannabinoids including cannabidiol (CBD) (para. 0006) and a stabilizer comprising an antioxidant such as propyl gallate (para. 0022) in an amount of from about 0.3% to about 1.5%w/w (para. 0022) which falls into the claimed range of from 0.05%w/w to 10%w/w based on the total weight of the packaged formulation. Ristevski teaches the packaging is impermeable to air (para. 0117).
Regarding claim 7, Ristevski teaches the cannabinoids further comprise cannabidiol and THC (para. 0023).
Regarding claim 17, Ristevski teaches the one or more stabilizing components are each present in an amount of about 0.3% to about 1.5%w/w (para. 0022) which falls into the claimed range of at least 500 ppm.
Regarding claim 21, Ristevski teaches the packaged formulation further comprises a carrier constituent comprising triacetin (para. 0091).
Regarding claim 37, Ristevski teaches the cannabinoid is present in the packaged formulation in example amounts of 30 mg/ml, 100 mg/ml, and 250 mg/ml (para. 0089) which fall into the claimed range of 5mg/ml or more.
Regarding claim 43, Ristevski teaches the packaged formulation further comprises one or more active constituents in addition to the cannabinoid (para. 0038).
Regarding claim 45, Ristevski teaches the packaged formulation takes the form of a liquid at about 25°C (para. 0039).
Regarding claim 46, Ristevski teaches the content of one or more specific cannabinoids is at least 80% of the initial content of one or more specific cannabinoids based on a mg/ml basis of the packaged formulation after 4 weeks at 40°C and 75% Relative Humidity (para. 0039).
Regarding claim 47, Ristevski reaches a method of producing a packaged formulation, wherein the method comprises combining each of the one or more cannabinoids and one or more stabilizing components so as to form the packaged formulation, wherein the one or more stabilizing components are combined to form a first mixture, optionally with one or more carrier constituents, and then the one or more cannabinoids is added to the first mixture to produce the formulation (para. 0103).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 29, 33, 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over KOTTAYIL et al. (US 2009/0181080) in view of CRUMRINE (US 2021/0401746).
Kottayil teaches a packaged formulation comprising one or more cannabinoids including cannabidiol (CBD) (para. 0086) and a stabilizer comprising an antioxidant (para. 0083) such as propyl gallate (para. 0088, para. 0175). Kottayil teaches the packaging is impermeable to air (para. 0208). Kottayil teaches that the one or more stabilizing components are present in an amount of from about 0.001% to about 20%w/w (para. 0177). Kottayil teaches the packaged formulation further comprises a carrier constituent comprising propylene glycol (para. 0017).
Crumrine teaches a packaged formulation (para. 0132) comprising one or more cannabinoids (abstract) and a stabilizing component such as tert-butylhydroquinone or propyl gallate (para. 0109). Crumrine teaches the packaging is impermeable to air (para. 0132).
Regarding claim 29, Crumrine teaches the packaged formulation further comprises a carrier constituent comprising one or more of glycerol, propylene glycol, 1,3-butylene glycol, and erythritol (para. 0015). It would have been obvious to one of ordinary skill in the art to substitute the propylene glycol of Kottayil with glycerol because Crumrine teaches that glycerol is a known equivalent of propylene glycol for the purpose of a carrier constituent (para. 0015).
Regarding claim 33, Crumrine teaches the packaged formulation further comprises a carrier constituent comprising one or more of glycerol, propylene glycol, 1,3-butylene glycol, and erythritol (para. 0015). It would have been obvious to one of ordinary skill in the art to substitute the propylene glycol of Kottayil with a combination of glycerol and propylene glycol because Crumrine teaches that a combination of glycerol and propylene glycol is a known equivalent of propylene glycol for the purpose of a carrier constituent (para. 0015).
Regarding claim 41, Crumrine teaches the packaged formulation additionally comprises one or more terpenes selected from pinene, geraniol, linalool, limonene, and myrcene and mixtures thereof (para. 0173).
It would have been obvious to one of ordinary skill in the art to include one or more terpenes selected from pinene, geraniol, linalool, limonene, and myrcene and mixtures thereof in the composition of Kottayil because Crumrine teaches that they cat as an emulsifier (para. 0173).
Claim(s) 49, 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over KOTTAYIL et al. (US 2009/0181080) in view of BUCHBERGER (US 2014/0283825).
Kottayil teaches a packaged formulation comprising one or more cannabinoids including cannabidiol (CBD) (para. 0086) and a stabilizer comprising an antioxidant (para. 0083) such as propyl gallate (para. 0088, para. 0175). Kottayil teaches the packaging is impermeable to air (para. 0208). Kottayil teaches that the one or more stabilizing components are present in an amount of from about 0.001% to about 20%w/w (para. 0177).
Buchberger teaches an inhaler comprising a smoking composition. Buchberger teaches that the container with liquid material is stored with argon gas in the container (para. 0062). It would have been obvious to one of ordinary skill in the art to use a small volume of argon gas in the container of Kottayil because Buchberger teaches that this protects the liquid material from oxidation (para. 0062).
Although Buchberger is silent to the volume percentage of the gas in the container, it would have been obvious to one of ordinary skill in the art to minimize the amount of gas in the container to maximize the amount of product in the container, therefore it would have been obvious to one of ordinary skill in the art o set the volume of gas no greater than 20% of the total volume of the container. Additionally, figure 25 of Buchberger shows the liquid container (4) is nearly full.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over KOTTAYIL et al. (US 2009/0181080) in view of VANGARA et al. (US 2017/022434).
Kottayil teaches a packaged formulation comprising one or more cannabinoids including cannabidiol (CBD) (para. 0086) and a stabilizer comprising an antioxidant (para. 0083) such as propyl gallate (para. 0088, para. 0175). Kottayil teaches the packaging is impermeable to air (para. 0326). Kottayil teaches that the one or more stabilizing components are present in an amount of from about 0.001% to about 20%w/w (para. 0177). Kottayil teaches the packaged formulation further comprises a carrier constituent comprising propylene glycol (para. 0017).
Vangara teaches a packaged formulation comprising one or more cannabinoids. Vangara teaches the formulation comprises propylene glycol in an amount of about 0.1 % to about 50% (para. 0041) which overlaps with the claimed range of at least about 50%. It would have been obvious to one of ordinary skill in the art to try the propylene glycol rang suggested by Vangara in the formulation of Kottayil because Kottayil teaches that the formulation has a pH of about 5 to about 10 (para. 0014) and Vangara teaches that about 0.1 % to about 50% propylene glycol is suitable for formulations having a pH of 5-8 (para. 0041).
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over KOTTAYIL et al. (US 2009/0181080) in view of CRUMRINE (US 2021/0401746) as applied to claim 29 above, and further in view of CAPELLI et al. (US 2021/0085666).
Kottayil as modified by Crumrine teaches a packaged formulation comprising one or more cannabinoids and a stabilizing component such as propyl gallate.
Capelli teaches a packaged formulation comprising one or more cannabinoids (para. 0040) and a stabilizing agent. Capelli teaches that the formulation comprises glycerol in an amount of at least 50% w/w based on the total weight of the packaged formulation (para. 0006). Capelli teaches that it is advantageous for gel compositions comprise a majority of an aerosol former such as glycerol (para. 0074) and Kottayil teaches that the formulation may have a gel composition (para. 0052).
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over KOTTAYIL et al. (US 2009/0181080) in view of CRUMRINE (US 2021/0401746) as applied to claim 33 above, and further in view of TILEY et al. (US 2018/0325164).
Kottayil as modified by Crumrine teaches a packaged formulation comprising one or more cannabinoids and a stabilizing component such as propyl gallate.
Tiley teaches a packaged formulation comprising one or more cannabinoids and a stabilizing component. Tiley teaches the formulation comprises a carrier having 60 to 100% propylene glycol and 0-40 %w/w glycerol (abstract) which incorporates the claimed range of 60 to 90%w/w propylene glycol and 40 to 10%w/w glycerol based on the total amount of propylene glycol and glycerol in the packaged formulation. It would have been obvious to one of ordinary skill in the art to try the ranges suggested by Tiley in the formulation of Kottayil because Tiley teaches that this facilitates the formation of vapor for inhalation (para. 0045).
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over KOTTAYIL et al. (US 2009/0181080) in view of CRUMRINE (US 2021/0401746) as applied to claim 41 above, and further in view of ALSAYAR et al. (US 2022/0129835).
Kottayil as modified by Crumrine teaches a packaged formulation comprising one or more cannabinoids and a stabilizing component such as propyl gallate. Crumrine teaches the packaged formulation additionally comprises one or more terpenes selected from pinene, geraniol, linalool, limonene, and myrcene and mixtures thereof (para. 0173).
Alsayer teaches a packaged formulation comprising one or more cannabinoids including terpenes (para. 0511). Alsayer teaches that the formulation comprises up to 15 mg/ml terpenes such as limonene (para. 0838) which incorporates the claimed range of up to about 10 mg/ml. It would have been obvious to one of ordinary skill in the art to try the terpene range suggested by Alsayer in the formulation of modified Kottayil because Crumrine teaches packaged formulation additionally comprises limonene (para. 0173).
Response to Arguments
Applicant's arguments filed April 10, 2026 have been fully considered but they are not persuasive.
Applicant argues pages 7-8 that Kottayil does not teach that the stabilizer is present in an amount of 0.05%w/w to 10%w/w; however, in paragraph 0177, Kottayil teaches that the stabilizer (i.e. anti-oxidant) is included in an amount of about 0.001%w/w to about 20%w/w, which incorporates the claimed range of 0.05%w/w to 10%w/w.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA SZEWCZYK whose telephone number is (571)270-5130. The examiner can normally be reached Mon-Fri 10 am - 6 pm.
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/CYNTHIA SZEWCZYK/Primary Examiner, Art Unit 1741
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