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 § 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. Claim(s) 1- 2, 4- 6 , 12, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka (US20190099581A1) . Regarding Claim 1 , Kuzelka teaches a vaporisation device for delivering a drug or pharmaceutically active agent to the body via the lungs [0003], c omprising a pressure chamber ( the combination of both ref #’s 128 and 102 , [0022 ], see also annotated FIG 1) , a controller (160, [0027], see FIG 1) , and a pressure sensor (pressure sensor 140, [0029]) for measuring an internal pressure within the pressure chamber ([0029], pressure sensor 140, sends pressure signal indicative of pressure with in vapor reservoir chamber to controller, although measuring is not explicitly disclosed in the embodiment in [0029], in [0066] Kuzelka discloses the pressure sensor 550 is measuring the pressure, therefore it would be obvious for a person of ordinary skill in the art to modify the pressure sensor 140 , which is sending the pressure signal , to also measure the internal pressure within the pressure chamber before sending the pressure signal , with a reasonable expectation of success , i.e., sensors sense and measure ) , wherein: the pressure chamber comprises a reservoir of volatile material ([0024] vapor reservoir contains gas which is a volatile material) , a heater electrically coupled to the controller ([0030] the controller may send a heater control signal to the heater; to receive the signal the heater must be coupled to the controller) and a choked flow outlet for allowing vapour to exit the pressure chamber under choked flow conditions (e.g., see [0030] one or more actuators are adjusted by the controller in response to signals indicative of the concentration of gasses [0029], which causes the controller to send a valve control signal to adjust a multipositional value to adjust the proportion of fresh pressurized gas provided, these multipositional valves are interpreted to be outlets that include/induce a choked flow that is configured to allow vapor to exit the pressure chamber under choked flow conditions , e.g., a person of ordinary skill in the art would understand these multipositional valves allow vapor to exit the pressure chamber under pressurized or choked flow conditions , choked flow is interpreted to include allowing pressurized gasses behind the choke point and to allow gasses to pass the choke point under lower pressure , similar to a breathing regulator on a scuba tank ) ; and, the controller is configured to control the heater in dependence on the measured internal pressure to cause vaporisation of the volatile material for the internal pressure to be sufficiently high that, in use, vapour exiting the pressure chamber through the choked flow outlet does so under choked flow conditions (e.g., the heater is configured such that the heat travels opposite the liquid flow, resulting in a dynamic balance of heat flux, liquid flow and evolved vapor, and the vapor is released as a controllable vapor flow into the pressure chamber, see [0023], this vapor is mixed in the pressure chamber and configured to be released as controlled by the controller as the controller makes adjustments to the actuators and multipositional valves which induce a choked flow of mixed gasses [0029]-[0030]. Regarding Claim 2 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches the controller is adapted to control the heater by providing a variable voltage to the heater (e.g., see [0030], the controller is configured to control the heating element by adjusting the voltage supplied to the heating element, as the controller adjusts the voltage the voltage would be variable) . Regarding Claim 4 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches a temperature sensor for measuring an internal temperature within the pressure chamber (see [0074], the reservoir temperature sensor is configured to send a reservoir temperature signal to the controller indicative of a temperature of the vapor reservoir. Although Kuzelka explicitly teaches this temperature sensor for measuring internal temperature in the embodiment in [0074], Kuzelka also teaches that the example embodiments disclosed are non-limiting to illustrating to the sc ope of the invention e.g., [0004]- [0005], therefore it would be obvious to modify the pressure chamber of claim 1 to include a temperature sensor for measuring an internal temperature within the pressure chamber as taught in [0074]) Regarding Claim 5 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, the controller is configured to trigger a temperature alert if the measured internal temperature is indicative of the reservoir of volatile material being depleted. ( Kuzelka teaches the controller is configured to modulate the electrical power applied to the heating element based on an error signal obtained between the measured and set volatile material available /present in the pressure chamber [0031]. Although Kuzelka fails to explicitly disclose the controller is configured to trigger the error or alert if the measured internal temperature is indicative of the reservoir of volatile being depleted, it would be obvious to a person of ordinary skill in the art to in view of the teachings of Kuzelka which teaches the controller is configured to trigger error signals which measures the material present in the pressure chamber, to be modified to specifically trigger a temperature alert if the measured temperature indicates the material in the reservoir is no longer present (i.e., depleted). Regarding Claim 6 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches the controller is coupled to the reservoir pressure sensor which sends a pressure signal indicative of pressure in the vapor reservoir [0029], Kuzelka also teaches the controller measures the temperature via the heater control signal, which is configured to adjust the current or voltage to change the temperature which results in a change in the amount of liquid agent that is vaporized (pressurized) that is supplied to the patient (see [0029] and [0030] ). Therefore, it would be obvious to an ordinary artisan that Kuzelka teaches the controller is configured to trigger the temperature alert when the measured internal temperature is detected to increase above an expected temperature dependent on the measured internal pressure. Regarding Claim 12 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches a secondary chamber fluidly connectable to the pressure chamber via the choked flow outlet wherein the secondary chamber comprises an inlet valve through which gas may enter the secondary chamber and a mouthpiece through which fluid may exit the secondary chamber. (See annotated FIG 1 above) Regarding Claim 14 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches the pressure chamber comprises an internal valve movable between an open configuration and a closed configuration ( multipositional valves ([0029]-[0030]), such that when the internal valve is in the open position vapour is able to discharge from the pressure chamber through the choked flow outlet ( multipositional valve can be opened to discharge vapor from the pressure chamber [0029]-[0030]), and when the internal valve is in the closed position vapour is prevented from discharging from the pressure chamber through the choked flow outlet. (the vapor is released as a controllable vapor flow into the pressure chamber, see [0023], this vapor is mixed in the pressure chamber and configured to be released as controlled by the controller as the controller makes adjustments to the actuators and multipositional valves which induce a choked flow of mixed gasses [0029]-[0030]. Regarding Claim 15 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches an outlet chamber fluidly connected to the pressure chamber via the choked flow outlet, wherein the outlet chamber comprises an external valve movable between an open configuration and a closed configuration ( multipositional valves ([0029]-[0030], although Kuzelka does not explicitly disclose the value is external, it would be obvious to rearrange the position of the valve to be external. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. See MPEP § 2144.04 VI C. ), such that when the external valve is in the open position vapour is able to discharge from the outlet chamber through the external valve, (the vapor is released as a controllable vapor flow into the outlet chamber through the multipositionial valve, see [0023] and [0029]-[0030], this vapor is mixed in the pressure chamber and configured to be released as controlled by the controller as the controller makes adjustments to the actuators and multipositional valves which induce a choked flow of mixed gasses [0029]-[0030],. and when the external valve is in the closed position vapour is prevented from discharging from the outlet chamber through the external valve (e.g., when the multipositional valve is in the closed position vapor is prevented from discharging). Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka (US20190099581A1) in view of Wensley (US20140190496 A1) Regarding Claim 7 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka teaches the volatile material comprises a plurality of volatile material components ( liquid anesthesia agent that is vaporized , and mixed with the carrier gas [0020] , e.g., nitrous oxi de ) , and at least one of the volatile material components is a component with an associated sensory impact (e.g., anesthesia liquid includes a sensory impact, see [0021] . Although Kuzelka is silent to the specific agent that can be used in the device Wensley teaches vaporization devices that deliver pharmaceutically active agents to the body via the lungs and teaches that any pharmaceutically active agent can be used [0237] with vaporization devices and that suitable volatile inhalable agents can be selected from a plurality of e.g., halothane, isoflurane, desflurane, sevoflurane [0238] , and many others (See [0237]-[0301] ), Wensley also teaches nicotine [0297]) . I t would be obvious to a person of ordinary skilling the art before the filing date of the claimed invention to modify the volatile material components of Kuzelka to include a plurality of known suitable volatile material components as taught by Wensley (selected from a plurality of e.g., halothane, isoflurane, desflurane, sevoflurane etc [0238]) , because both Kuzelka and Wensley are directed to vaporization articles comprising pharmaceutically active inhalable agents, Kuzelka is silent in regards to suitable pharmaceutically active inhalable agents for use in the taught volatile material composition and one of ordinary skill in the art would be motivated to look to a similar reference to find suitable pharmaceutically active inhalable agents for a similar device, Wensley teaches known pharmaceutically active inhalable agents for a similar device and this merely involves applying suitable characteristics to a similar product with a reasonable expectation of success. . Regarding Claim 10 , modified Kuzelka teaches the claim limitations as set forth above. Additionally, Kuzelka is silent to suitable components of the volatile material and accordingly fails to teach the plurality of volatile material components are immiscible, However, Wensley teaches the plurality of volatile material components are immiscible (e.g., Wensley teaches organic liquids as components of the volatile material such as halothane (a known non polar organic liquid) as set forth above and also teaches the agent is mixed with other excipients or carriers such as water [0127], water is well known to not be miscible with non polar organic liquids such as halothane (e.g., oil and water) and is considered to be a volatile material component in the presence of a heater, other known polar solvent alternatives in [0127] ) and the controller is configured to cause a predetermined ratio of vapour phase volatile material component concentrations by controlling the heater. , ( [0043], the controller is configured to adjust the heater current or voltage via an injector control signal to titrate a predetermined ratio of vaporized material, by controlling the heater via power to the heater , see also [0044] ) Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka (US20190099581A1) and Wensley (US20140190496 A1) as set forth in claim 7 above and as evidenced by Bruce ( Bruce DL, Linde HW. Vaporization of mixed anesthetic liquids. Anesthesiology. 1984 Apr;60(4):342-6. doi : 10.1097/00000542-198404000-00010. PMID: 6703388. ) Regarding Claim 11 , modified Kuzelka teaches the claim limitations as set forth above. Additionally , although Kuzelka fails to teach the plurality of volatile material components are miscible and deviate from Raoult's Law, the controller is configured to cause a predetermined ratio of vapour phase volatile material component concentrations by controlling the heater. ([0043], Kuzelka teaches the controller is configured to adjust the heater current or voltage via an injector control signal to titrate a predetermined ratio of vaporized material, by controlling the heater via power to the heater, see also [0044]) Wensley teaches the plurality of volatile material components are miscible and deviate from Raoult's Law (e.g., Wensley teaches the pharmaceutically active inhalable agent can include halothane and isoflurane which are both relatively non-polar organic liquids and non-polar organic liquids are known to be miscible with each other , however halothane and isoflurane form non ideal solutions and don’t behave as ideal gasses when mixed in liquid form and therefore deviate from Raoults law as evidenced by Bruce ), Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka (US20190099581A1) in view of Fu (US 20190373679 A1). Regarding Claim 3 , modified Kuzelka teaches the claim limitations as set forth above. Kuzelka discloses the heater coupled to the controller and associated circuitry as set forth above, however, Kuzelka is silent to a suitable voltage regulator and thus Kuzelka fails to explicitly disclose a voltage regulator electrically coupled to the controller, wherein the heater is electrically coupled to the controller via the voltage regulator. Fu teaches an aerosol generating device with a heater and heater control circuitry with a controller coupled to the heater that includes a voltage regulator electrically coupled to the controller, wherein the heater is electrically coupled to the controller via the voltage regulator (see Fu, [0020] and [0036], which more specifically teaches the heater control circuitry is coupled to a voltage regulator which together is coupled to a control signal from the controller . ) Fu also teaches the voltage regulator regulates the output voltage of the battery which controls the discharge of the battery to the heating coil. Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to be motivated to modify the controller/heater circuitry of Kuzelka to include a voltage regulator electrically coupled to the controller as taught by Fu to control the discharge of the battery to the heating coil with a reasonable expectation of success. wherein the heater is electrically coupled to the controller via the voltage regulator in order to regulate the output voltage of the battery which controls the discharge of the battery to the heating coil (see Fu [0020], the heater is electrically coupled to the heater control circuitry (controller) which is coupled to the voltage regulator which is configured to regulate the output voltage (discharge) of the battery to the heating coil) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Michael T Fulton whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1998 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 7:00 - 4:30 ET . 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael H Wilson can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-3882 . 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. /M.T.F./ Examiner, Art Unit 1747 /Michael H. Wilson/ Supervisory Patent Examiner, Art Unit 1747