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 .
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 4-10 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.
Claims 4, 5, 6, and 8 each refer to actuating a "button, switch, touchpad" (line 2 of each claim). It is unclear whether the claim requires the items in the alternative ("button, switch, or touchpad") or that all three items be present ("button, switch, and touchpad"). For the purpose of examination, it is assumed to require the items in the alternative (i.e. "or").
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.
Claims 1-4, 10, 13-17, 19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Schorr (US 20210023316) in view of Goldman (US 20150083146).
Regarding claim 1, Schorr discloses a delivery system (see inhaler) comprising
a powered aerosol generating device (inhaler 100, [0006,0196]) and an aerosolizable material (source material, [0006]),
wherein the aerosolizable material comprises at least one carboxylated active (THCA or CBDA, [0013]), and
wherein the aerosol generating device comprises at least one aerosol generator arranged to aerosolize the aerosolizable material to form an inhalable aerosol (see heating element 114; [0198]) and
a controller configured to facilitate delivery of power to the aerosol generator at more than one power level (see controller 130 controls temperature-time profile where application of power is controlled to provide different temperatures; [0203,0207,0208]).
Schorr discloses glycerin, propylene glycol and MCTs ([0272,0285]) but does not disclose the aerosolizable material as comprising a carrier constituent comprising triethyl citrate. In the same field of endeavor of aerosol generating systems, Goldman discloses providing a liquid base that acts as a carrier for oil-soluble compounds and/or resins, the carriers including propylene glycol, glycerol, and PEG ([0020]). Goldman further discloses providing a liquid solubilizer such as triethyl citrate to increase the solubility or dispersion of lipids or lipophilic material in hydrophilic compositions and to improve functional properties of a liquid composition for use in a personal vaporizer ([0021]; [0045]; claim 6). It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to have configured the aerosolizable material of Schorr to further comprise triethyl citrate to improve the functional properties of the liquid composition by increasing solubility/dispersion of lipophilic material ([0021]).
Regarding claim 2, Schorr discloses the controller is configured to apply different amounts of power where power is increased from one level to another ([0203,0207,0208]). The base or lowest level of power applied is construed as the claimed "normal power profile" whereas an increased power level is construed as the claimed "elevated power profile." A threshold power would exist between the two power levels.
Regarding claim 3, Schorr does not disclose the threshold power is greater than 5% of the normal power profile; however, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to have configured the threshold power as greater than 5% since Schorr discloses applying different amounts of power where power is increased from one level to another to provide different temperatures at the heating element ([0203,0207,0208]) and determining the optimum or workable increase in magnitude would involve only routine skill in the art. See MPEP 2144.05 (II). One would have been motivated to adjust the power levels to control the temperature of the heating element and to control the degree of decarboxylation and/or other heat activated reactions ([0195]).
Regarding claim 4, Schorr discloses selection of operation profile is made from the user interface ([0228]; operation profile sets power/temperature profile, [0207]) and the user interface includes a button or touchscreen for receiving input ([0214]).
Regarding claim 10, Schorr does not expressly disclose applying the elevated power profile for the current inhalation, next inhalation, and/or all subsequent inhalations; however, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention since Schorr discloses the controller is configured to receive and then implement the selected power profile ([0159,0223]).
Regarding claim 13, Schorr discloses the source material may be included in a holder (chip, capsule, pod, cartridge) and placed into the inhaler ([0196]).
Regarding claims 14 and 21, Schorr discloses an aerosol generator / heating element with vaporization chambers ([0198]).
Regarding claim 15, Schorr discloses CBDA ([0013]).
Regarding claims 16-17, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to have employed a source material with a further active in a decarboxylated form since Schorr discloses the first substance is at least one of THCA and cannabidiol (CBD) ([0012]); or at least one of THC and CBDA, [0013]), thus suggesting a combination of carboxylated and decarboxylated cannabinoids. As to claim 17, Schorr discloses CBD ([0012]).
Regarding claim 19, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to have provided the aerosolizable material with one or more flavors since Goldman discloses providing flavorants to provide a desired taste or smell when the composition is vaporized ([0036]).
Regarding claim 22, Schorr discloses electrically powered device ([0198]).
Claims 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schorr (US 20210023316) in view of Goldman (US 20150083146) as applied to claims above, and further in view of Hepworth (US 20210084986).
Regarding claims 5-9, Schorr discloses selection of an operation profile is made from the user interface ([0228]; operation profile sets power/temperature profile, [0207,0195]) and the user interface includes a button or touchscreen for receiving input ([0214]). Schorr does not expressly disclose a dedicated button or profile of actuation. In the same field of electronic aerosol generating systems, Hepworth teaches providing a button or pad sensitive to the pressure applied wherein the level of force controls the level of power supplied from the electrical power supply to the vaporizer ([0039]; different force levels give different power profiles). Hepworth also discloses that, additionally or alternatively, a range of actuation inputs can be matched to variable power supply with a single rapid push or touch or a double touch can be matched to access a preset power supply mode ([0053]).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to have configured the system with a dedicated button with profile for actuation since Hepworth teaches controlling a level of power supplied using a button or touch pad wherein power level is adjusted based on force applied and/or number of touches applied ([0039,0053]).
Regarding claim 10, Schorr does not expressly disclose applying the elevated power profile for the current inhalation, next inhalation, and/or all subsequent inhalations; however, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention since Hepworth discloses providing dynamic power level control by which power can be altered during a puff by controlling actuation inputs ([0053]). One would have been motivated to adjust the release and quality of aerosol during the puff to achieve desired aerosol delivery.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Schorr (US 20210023316) in view of Goldman (US 20150083146) as applied to claims above, and further in view of Davidson (US 20220223247).
Regarding claims 11 and 12, Schorr does not disclose the controller as restricting or applying an elevated power profile according to a predetermined schedule; however, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date to have configured the system controller as claimed since (1) Davidson, similarly directed towards a vaporizer, discloses a controller configured to adjust a delivery regimen based on an activity schedule of the user (see Fig. 9, Fig. 10A; Davidson discloses operation adjusts degree of effect based on schedule; [0189,0208,0215,0222-0223,0230-0233]; e.g., restrict use when planning to drive soon); and (2) Schorr disclose the magnitude of effect is achieved by different operation profiles with different heating parameters, [0156-0160])--thus, it'd be obvious to restrict or apply elevated power profiles to achieve the desired effects at the scheduled times.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schorr (US 20210023316) in view of Goldman (US 20150083146) as applied to claim 16 above, and further in view of Cohen (WO 2016019353).
Regarding claim 18, Schorr discloses the first substance is at least one of THCA and cannabidiol (CBD) ([0012]); or at least one of THC and CBDA, [0013]), thus suggesting a combination of carboxylated and decarboxylated cannabinoids. Schorr does not expressly disclose the ratio of carboxylated active to decarboxylated further active; however, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention to have configured the ratio as claimed since Cohen similarly directed towards a vaporizer, teaches selecting a ratio of CBD and THC in an aerosolizable liquid to achieve a desired concentration of medically relevant cannabis compounds, said ratios ranging from CBD:THC 10:1 to 1:100 ([0067-0068]). One would have been motivated to select a liquid formulation to provide therapeutic, analgesic, or other effect ([0066]). Examiner notes that Schorr discloses heat causes the decarboxylation of the carboxylated active and thus one having ordinary skill in the art would readily appreciate adjusting the ratio of carboxylated and decarboxylated actives in the aerosolizable material would directly affect the ratio of cannabinoids in the delivered aerosol. Further, Examiner notes that the claimed ratio broadly encompasses almost the entire workable range of ratios.
Response to Arguments
Applicant’s arguments with respect to claims 1-19, 21, and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Schorr does not teach or suggest providing a carrier constituent comprising triethyl citrate in the aerosolizable material.
Examiner acknowledges that Schorr does not disclose triethyl citrate. New grounds of rejection are made in view of Goldman (US 20150083146), which discloses providing triethyl citrate to improve functional properties of a liquid composition for use in a vaporizer by increasing solubility and dispersion of lipophilic material ([0021]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hagen (US 20210392943) teaches that phytocannabinoid materials are often too viscous to work properly as vape compositions and it is conventional to admix with a carrier to reduce viscosity, wherein triethyl citrate is disclosed as a conventional carrier ([0054]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT C DYE whose telephone number is (571)270-7059. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Momper can be reached at (571) 270-5788. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT C DYE/Primary Examiner, Art Unit 3619
Prosecution Insights