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 .
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.
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.
Claim 8 is 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.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 and 14-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gallagher (US20210244095A1; filing date of 02/10/2020).
In regards to claim 1, Gallagher teaches a delivery system (heat-not-burn device) comprising,
a powered aerosol generating device (heat-not-burn aerosol-generating device) and an aerolizable material (an aerosol-forming substrate) [0019],
the aerolizable material (an aerosol-forming substrate) comprises at least one carboxylated active (cannabidiolic acid (CBDA)), and wherein the system (heat-not-burn device) is configured to provide for selective decarboxylation of the carboxylated active (cannabidiol (CBD) [0210].
Gallagher discloses a heat-not-burn aerosol-generating device. The device contains a capsule that comprises of an aerosol-forming substrate sandwiched in between first and second heaters. The device is able to determine a heater temperature value, obtain a target temperature value, and control a level of power provided to the heater. By determining the amount of power supplied to the heater, the heater can be controlled and thus allowing for selective decarboxylation [0040 and 0041/0043/0044].
In regards to claim 2, Gallagher teaches a delivery system of claim 1, wherein the aerolizable material (an aerosol-forming substrate) present in an article (capsule 800/900) which can be detachably connected to the device (heat-not-burn aerosol-generating device) [0205].
In regards to claim 3, Gallagher teaches a delivery system of claim 1, wherein the system comprises an aerosol generator (the first heater and the second heater) arranged to generate an aerosol from the aerolizable material (an aerosol-forming substrate) [0213].
In regards to claim 4, Gallagher teaches a delivery system of claim 3, wherein the aerosol generator (the first heater and the second heater) forms part of the article. (capsule 800/900 includes the first heater, the second heater, an aerosol-forming substrate) [0205].
In regards to claim 5, Gallagher teaches a delivery system of claim 3, wherein the aerosol generator (the first heater and the second heater) forms part of the device. (the aerosol-generating device 1000 may include a device body 1025, control circuitry 1045, and a power source 1035. The device body 1025 is configured to receive a capsule 800/900.) [0205].
In regards to claim 6 and 14, Gallagher teaches a delivery system of claim 3, wherein the aerosol generator comprises and is a heater. (the capsule 800/900 may include an aerosol-forming substrate sandwiched in between first and second heaters.) [0205].
In regards to claim 7, Gallagher teaches a delivery system of claim 6, wherein the device (aerosol generating device 1000) comprises a controller (control circuitry 1045) configured to control delivery of power (power source 1035) to the heater. (the control circuitry 1045 may instruct the power source 1035 to supply an electric current to the first electrode 1055 a, the second electrode 1055 b, the third electrode 1055 c, and/or the fourth electrode 1055 d.) [0213].
In regards to claim 8-10, Gallagher teaches a delivery system of claim 1, wherein the at least one carboxylated active is a cannabinoid present in carboxylated form (cannabidiolic acid (CBDA)), such as cannabidiolic acid (CBDA) and the one or more further cannabinoids in the decarboxylated form is cannabidiol (CBD) (cannabidiol (CBD)) [0210]. Gallagher teaches an instance where both cannabidiolic acid (CBDA) and cannabidiol (CBD) are present in the capsule [0211]. The capsule includes an aerosol-forming substrate sandwiched in between first and second heaters [0205]. The aerosol-forming substrate comprises of CBDA and CBD. heating
In regards to claim 15, Gallagher teaches a delivery system of claim 1, wherein the device is electrically powered. (the control circuitry 1045 may instruct the power source 1035 to supply an electric current to the first electrode 1055 a, the second electrode 1055 b, the third electrode 1055 c, and/or the fourth electrode 1055 d.) [0213].
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gallagher (US20210244095A1; filing date of 02/10/2020).
In regards to claim 11, Gallagher discloses all the claim limitations as set forth above.
Gallagher does not explicitly teach the ratio of Clam 11.
Gallagher teaches the conversion of cannabidiolic acid (CBDA) in the capsule to cannabidiol (CBD). Gallagher further teaches when both cannabidiolic acid (CBDA) and cannabidiol (CBD) are present in the capsule, the decarboxylation and resulting conversion will cause a decrease in cannabidiolic acid (CBDA) and an increase in cannabidiol (CBD) and at least 50% or 87% of the cannabidiolic acid (CBDA) may be converted to cannabidiol (CBD) [0211].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of Gallagher such that at least 50% of the CBDA will be converted to CBD because Gallagher teaches this in [0211]. At least 50% CBDA is also at least 50% CBD, which is also a 1:1 ratio or a greater amount of CBD to CBDA, which overlaps the claimed range from claim 11. See MPEP § 2144.05 (I)).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher (US20210244095A1; filing date of 02/10/2020) in view of Lopez (US20180289062A1).
In regards to Claim 12 and 13, Gallagher discloses all the claim limitations as set forth above.
Gallagher fails to disclose the aerolizable material further comprises a carrier constituent and optionally one or more flavors and the carrier constituent comprises one or more of propylene glycol and glycerol.
Lopez discloses an electronic cigarette for delivering inhalable aerosol. Lopez teaches a liquid solution comprises a formulation comprising cannabinoids [0139]. Suitable carriers (e.g., a liquid solutions) for the cannabinoids described herein include a medium in which a cannabinoid is soluble at ambient conditions, such that the cannabinoid does not form a solid precipitate. Examples include, but are not limited to, vegetable glycerin, glycerol, propylene glycol, trimethylene glycol, water, ethanol and the like, as well as combinations thereof [0141]. Lopez further teaches a cannabinoid liquid formulation, further comprising one or more flavorants [0007].
Lopez and Gallagher are analogous prior art to the current invention because they are concerned with the same field of endeavor, namely a device that generates aerosol.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gallgher’s cannabinoid-containing material to include the liquid carrier and flavourants of Lopez because Lopez teaches that choosing an acceptable liquid carrier, can result in better transfer efficiency [0152] and adjusting the flavor formulation, can positively affect the satisfaction in the individual user [0153].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH C NNABUGWU whose telephone number is (571)272-8791. The examiner can normally be reached Mon-Thurs. 8:30am-5:00pm.
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/H.C.N./Examiner, Art Unit 1747
/Christopher M Rodd/Primary Examiner, Art Unit 1766
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