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 .
Response to Amendment
The amendment filed on 04/16/2026 has been entered. Claims 1, 20, 21, and 36 have been amended. No claims have been cancelled nor newly added. Applicant’s amendments to the drawings, specification, and claims have overcome drawing, specification, and claim objections raised in the non-final rejection mailed on 12/16/2025. Claims 1-6,12-17,19-21 and 32-36 remain pending in the instant application.
Response to Arguments
Applicant's arguments filed 04/16/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Hays does not disclose a patient-operated user control by which the patient actively indicates that he or she wants more of the substance (Remarks at Page 16, 2nd – 3rd Paragraphs). Examiner notes that the Cameron reference is relied upon for this limitation. Accordingly, Applicant’s argument is found to be unpersuasive.
Applicant then argues that Cameron does not disclose a user control operable by the patient to
Indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller (Remarks Page 17, 2nd Paragraph). Specifically, Applicant argues that providing general user input through an ancillary interface is broader than a patient-actuated control that serves as a patient demand signal for more of the substance (Page 17, 3rd Paragraph). Examiner notes that the user control of Cameron does in fact serve as a patient demand signal for more of the substance as a user clearly desires more of the substance when actuating the device. Applicant further argues that Cameron’s device is a more general control input relating to vaporizer operation which does not provide an input to a controller in response to operation of the user control by the patient (Remarks Page 17, 3rd Paragraph – Page 18, 1st Paragraph). However, Examiner notes that Cameron’s ancillary device does provide control signals in response control by the user (Paragraph 0156 discloses the ancillary device 1538 transmits user inputs to processor 1508 using a wireless connection; Paragraph 0157 further discloses the user inputs may include remote control of the vaporizer (i.e. providing a dose to the user)). Thus it is examiner’s position that Cameron does teach allowing a user to input a demand for more of the vaporizable product to be provided to the user (Paragraph 0159 discloses allowing a user to vaporize the material at the vaporizing device). It then follows that Hays as modified by Cameron does disclose the claimed user-control/controller input relationship (Remarks at Page 18, 2nd – 3rd Paragraphs – Page 19, 1st Paragraph). Accordingly, Applicant’s arguments are found to be unpersuasive.
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.
Claims 1-5, 12-13, 16, 19-21, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over US20190125256A1 to Hays (hereinafter “Hays”) in view of US20160325055A1 to Cameron (hereinafter “Cameron”).
Regarding claim 1, Hays discloses a breathing system for a patient to inhale an analgesic, anesthetic and/or sedative substance from (Fig. 1 device 10), comprising:
a patient airway interface mountable on the patient so that inhaling and exhaling occur through the patient airway interface repetitively and consecutively (Fig. 3 drug delivery device 20; Paragraph 0019 discloses the drug delivery device can include any nasal cannula, breathing mask, or any other suitable medical device allowing the user to inhale the drug into the user’s respiratory system);
an adder configured to add the substance to gas to be inhaled (Fig. 1 electronically activated valve 16, container 22, drug supply device 30), wherein the substance is provided in volatile liquid form (Paragraph 0021 discloses the container 22 holds the drug which may include any medication or antidote; Examiner notes that the container is capable of holding a drug in volatile liquid form and that Fig. 1 shows the drug in a liquid form), and wherein the adder facilitates vaporisation of the substance into the gas (Paragraph 0022 discloses the drug supply device 30 may transport the drug from container 22 through drug delivery device 20 to the user, and that the drug supply device is configured to aerosolize or atomize (vaporize) the drug);
a controller (Fig. 2 controller 12),
wherein the controller is configured to:
store information indicative of a time of received inputs and/or of amounts of the substance added (Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user), control the adding by the adder dependent at least on:
the stored information indicative of the times of previously received inputs and/or of the amounts of the substance added further to the previously received inputs (Paragraph 0024 discloses the controller may activate the valve to supply drugs to the user; Paragraph 0029 discloses the controller may include a time configured to track the amount of time since last dose and dispensing based upon that sensed time; Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user).
Hays does not disclose a user control operable by the patient to indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller, the user control being coupled to the controller to provide inputs thereto in response to operation of the user control by the patient, and controlling the device based on a most recently received input from the user control. However, Cameron teaches an atomizer which has a user control operable by the patient to indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller, the user control being coupled to the controller to provide inputs thereto in response to operation of the user control by the patient (Fig. 15 ancillary device 1538; Paragraph 0156 discloses the ancillary device can be electronically coupled (via a wired or wireless coupling) to a processor 1508 to allow the user to control the atomizer based on user input by varying ratios of the atomized drug; Paragraph 0157 discloses functions of the ancillary device can be built directly into the assembly 1502).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Hays to further include an electronically coupled user control to the controller to indicate the patient wants more of the substance, as taught by Cameron, in order to provide remote control over the vaporization device (Paragraph 0157). Examiner notes the ancillary device of Cameron would be connected to the controller/processor of Hays to control the dosages provided of medicine to the patient in addition to being able to run automatically.
Regarding claim 2, Hays in view of Cameron discloses the breathing system of claim 1, and Hays as modified by Cameron further discloses wherein the controller is configured to: determine, dependent on said stored information and the most recently received input (Examiner notes that Hays as modified by Cameron would allow the user to input whether they wanted more medicine), to increase or decrease the amount of the substance added to the gas; and control the adder accordingly (Paragraph 0030 discloses the device may prevent administration of the drug to the user based on time elapsed since the drug was last administered).
Regarding claim 3, Hays in view of Cameron discloses the breathing system of claim 2, and Hays as modified by Cameron further discloses wherein the controller is configured to increase the amount of the substance added to the gas if a frequency of the inputs over a predetermined first time period is greater than a first threshold, and/or to decrease the amount of the substance added to the gas if the frequency of the inputs over a predetermined second time period is less than a second threshold (Cameron Paragraph 0162 discloses the processor calculates an incremental dose, and will reduce the amount of medicine vaporized if a cumulative does is approaching any threshold that calls for a reduction of the vaporization ratio).
Regarding claim 4, Hays in view of Cameron discloses the breathing system of claim 1, and Hays as modified by Cameron further discloses wherein the controller is coupled to an alerting unit (Fig. 2 mobile alert device 24), wherein the controller is configured to determine an alert condition (Paragraph 0032-0033 discloses the alert device may be included in the controller and is activated by the controller), by the alerting unit, and to cause communication of the alert condition to the patient and/or an operator (Paragraph 0032 discloses the mobile alert device can send a notification to a mobile phone; Examiner notes the mobile phone could be in possession of a clinician and/or patient) dependent on at least one of the following rules being met:
Regarding claim 5, Hays in view of Cameron discloses the breathing system of claim 1, and Hays further discloses wherein the adder is arranged to spread the substance, to increase surface area thereof, thereby to facilitate evaporation of the substance (Paragraph 0024 discloses the container 22 may contain a venturi valve to assist in increasing velocity while exiting the container; Examiner notes the liquid leaving container becomes atomized and thus inherently increases the surface area as the liquid is vaporized).
Regarding claim 12, Hays in view of Cameron discloses the breathing system of claim 1, and Hays further discloses further comprising an airway coupled to the patient airway interface (Fig. 2 tubing associated with drug delivery device 20) including an opening for intake of gas (Fig. 1 where the tubing of 20 meets with drug supply device 30; Paragraph 0023 discloses the pressurized gas container may include any gas), wherein inhalation causes intake of said gas into the airway (Paragraph 0019 discloses inhalation allows for introduction of the drug into the user’s system), wherein the adder is arranged to add the substance to the gas in the airway (Fig. 2 container 22 releases vaporized drug into the airway along with the gas from device 30).
Regarding claim 13, Hays in view of Cameron discloses the breathing system of claim 1, and Hays further discloses wherein the adder further comprises: a vaporisation unit configured to vaporise the substance (Fig. 2 container 22 releases vaporized drug into the airway along with the gas from device 30); and a flow control configured to prevent or permit flow of the gas with the substance in into the patient airway interface from the vaporisation unit (Fig. 1 electronically activated valve 16; Paragraph 0024 discloses the valve 16 allows the drugs to be supplied to the user), and to permit or prevent flow of gas without the substance into the patient airway interface (Examiner notes that if the electronically activated valve is closed, gas would be prevented from flowing which would also stop the substance from container 22 from being entrained into any air flow the patient receives), wherein the controller is coupled to the flow control and is configured to control the flow control (Paragraph 0024 discloses the controller is connected to and actuates valve 16).
Regarding claim 16, Hays in view of Cameron discloses the breathing system of claim 1, and Hays as modified by Cameron further discloses wherein the user control is operable by the patient to indicate that the patient wants more of the substance and in response to stimuli provided by a stimuli provider coupled to the controller further comprising the stimulus provider (Fig. 15 ancillary device 1538; Paragraph 0156 discloses the ancillary device can be electronically coupled (via a wired or wireless coupling) to a processor 1508 to allow the user to control the atomizer based on user input; Paragraph 0156 also discloses the an amplifier/speaker of the ancillary device can be coupled to the processor which generates audio stimulus when the ancillary device is operated; Examiner notes the speaker/transducer is the stimulus provider).
Regarding claim 19, Hays in view of Cameron discloses the breathing system of claim 1, and Hays further discloses wherein at least one of: the adder and the controller; are mounted on the patient airway interface, so as to be mountable on a face of the patient (Examiner notes the container 22, supply device 30 and electric valve 16 are mounted to the patient airway interface; Examiner notes the container, drug delivery device, and electric valve are indirectly mounted to the user’s face via the drug delivery device 20).
Regarding claim 20, Hays in view of Cameron discloses the breathing system of claim 1, and Hays further discloses wherein the controller is configured to control the adding unit to add the substance to gas at least a background rate (Paragraph 0029 discloses the controller includes a timer to control dispensing of the drugs based on time elapsed since the drug was last administered).
Regarding claim 21, Hays discloses a method in a breathing system for a patient to inhale an analgesic, anesthetic and/or sedative substance from (Fig. 1 device 10; Paragraphs 0002 and 0007 discloses methods for administering a drug), the breathing system comprising:
a patient airway interface mounted on the patient so that inhaling and exhaling occur through the patient airway interface repetitively and consecutively (Fig. 3 drug delivery device 20; Paragraph 0019 discloses the drug delivery device can include any nasal cannula, breathing mask, or any other suitable medical device allowing the user to inhale the drug into the user’s respiratory system);
an adder for adding the substance to gas to be inhaled (Fig. 1 electronically activated valve 16, container 22, drug supply device 30), wherein the substance is provided in volatile liquid form (Paragraph 0021 discloses the container 22 holds the drug which may include any medication or antidote; Examiner notes that the container is capable of holding a drug in volatile liquid form and that Fig. 1 shows the drug in a liquid form), and wherein the adder facilitates vaporising of the substance into the gas (Paragraph 0022 discloses the drug supply device 30 may transport the drug from container 22 through drug delivery device 20 to the user, and that the drug supply device is configured to aerosolize or atomize (vaporize) the drug);
a controller (Fig. 2 controller 12),
wherein the controller is configured to store information indicative of a time of received inputs and/or of amounts of the substance added (Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user), wherein the method comprises:
controlling the adding by the adder dependent at least on:
and the stored information indicative of the times of previously received inputs and/or of the amounts of the substance added further to the previously received inputs (Paragraph 0024 discloses the controller may activate the valve to supply drugs to the user; Paragraph 0029 discloses the controller may include a time configured to track the amount of time since last dose and dispensing based upon that sensed time; Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user).
Hays does not disclose a user control operable by the patient to indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller, the user control being coupled to the controller to provide inputs thereto in response to operation of the user control by the patient, and controlling the device based on a most recently received input from the user control. However, Cameron teaches an atomizer which has a user control operable by the patient to indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller, the user control being coupled to the controller to provide inputs thereto in response to operation of the user control by the patient (Fig. 15 ancillary device 1538; Paragraph 0156 discloses the ancillary device can be electronically coupled (via a wired or wireless coupling) to a processor 1508 to allow the user to control the atomizer based on user input by varying ratios of the atomized drug; Paragraph 0157 discloses functions of the ancillary device can be built directly into the assembly 1502).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Hays to further include an electronically coupled user control to the controller to indicate the patient wants more of the substance, as taught by Cameron, in order to provide remote and manual control over the vaporization device (Paragraph 0157). Examiner notes the ancillary device of Cameron would be connected to the controller/processor of Hays to control the dosages provided of medicine to the patient in addition to being able to run automatically.
Regarding claim 34, Hays in view of Cameron discloses the breathing system of claim 1, and Hays as modified by Cameron further discloses wherein the user control is operable by the patient in a finger or bite action (Cameron Paragraph 0156 discloses the ancillary device 1538 may have a touch screen for the user to input commands; Examiner notes a touch screen would be a finger action).
Regarding claim 35, Hays in view of Cameron discloses the breathing system of claim 1, and Hays further discloses at least one sensor device for detecting a condition of the patient and providing sensor information indicative of the condition to the controller (Fig. 1 detection means 40; Paragraph 0018 discloses the detection means may be a respiration sensor), wherein the controller is configured to control the adder dependent also on the sensor information (Paragraph 0029 discloses the controller 12 may administer the drugs based on the sensed information), wherein the condition is one of: heart rate; blood pressure; oxygen saturation level; respiratory rate (Paragraph 0030 discloses the detection means detects the user’s respiration rate); and patient consciousness level.
Regarding claim 36, Hays discloses a breathing system for a patient to inhale an analgesic, anesthetic and/or sedative substance from (Fig. 1 device 10), comprising:
a patient airway interface mountable on the patient so that inhaling and exhaling occur through the patient airway interface repetitively and consecutively (Fig. 3 drug delivery device 20; Paragraph 0019 discloses the drug delivery device can include any nasal cannula, breathing mask, or any other suitable medical device allowing the user to inhale the drug into the user’s respiratory system); adding means for adding the substance to gas to be inhaled (Fig. 1 electronically activated valve 16, container 22, drug supply device 30), wherein the substance is provided in volatile liquid form (Paragraph 0021 discloses the container 22 holds the drug which may include any medication or antidote; Examiner notes that the container is capable of holding a drug in volatile liquid form and that Fig. 1 shows the drug in a liquid form), wherein the substance is provided in volatile liquid form (Paragraph 0021 discloses the container 22 holds the drug which may include any medication or antidote; Examiner notes that the container is capable of holding a drug in volatile liquid form and that Fig. 1 shows the drug in a liquid form), and wherein the adding means facilitates vaporisation of the substance into the gas (Paragraph 0022 discloses the drug supply device 30 may transport the drug from container 22 through drug delivery device 20 to the user, and that the drug supply device is configured to aerosolize or atomize (vaporize) the drug);
a control means (Fig. 1 controller 12), the user control being coupled to the control means to provide inputs thereto in response to operation of the user control by the patient (Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user),
wherein the control means is configured to:
store information indicative of a time of received inputs and/or of amounts of the substance added (Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user), control the adding by the adder means dependent at least on: and the stored information indicative of the times of previously received inputs and/or of the amounts of the substance added further to the previously received inputs (Paragraph 0024 discloses the controller may activate the valve to supply drugs to the user; Paragraph 0029 discloses the controller may include a time configured to track the amount of time since last dose and dispensing based upon that sensed time; Paragraph 0037 discloses the controller 12 may collect data for storage; Paragraph 0037 also discloses the data may include medication dosage delivered to the user and time since the last dosage was delivered to the user).
Hays does not disclose a user control operable by the patient to indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller, the device operable on a most recently received input received from the user control. However, Cameron teaches an atomizer which has a user control operable by the patient to indicate that the patient wants more of the substance and/or in response to stimuli provided by a stimuli provider coupled to the controller, the user control being coupled to the controller to provide inputs thereto in response to operation of the user control by the patient (Fig. 15 ancillary device 1538; Paragraph 0156 discloses the ancillary device can be electronically coupled (via a wired or wireless coupling) to a processor 1508 to allow the user to control the atomizer based on user input by varying ratios of the atomized drug; Paragraph 0157 discloses functions of the ancillary device can be built directly into the assembly 1502).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Hays to further include an electronically coupled user control to the controller to indicate the patient wants more of the substance, as taught by Cameron, in order to provide remote control over the vaporization device (Paragraph 0157). Examiner notes the ancillary device of Cameron would be connected to the controller/processor of Hays to control the dosages provided of medicine to the patient in addition to being able to run automatically.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hays in view of Cameron as applied to claim 5 above, and further in view of US20190358416A1 to Woias et al. (hereinafter “Woias”).
Regarding claim 6, Hays in view of Cameron discloses the breathing system of claim 5, but does not disclose wherein the adder comprises a material located for gas to flow over or through it, and from which the substance can evaporate, wherein the adder is configured to disperse the substance on and/or through the material. However, Woias teaches an inhaler which has comprises a material located for gas to flow over or through it, and from which the substance can evaporate, wherein the adder is configured to disperse the substance on and/or through the material (Fig. 4 liquid reservoir 18, liquid 2, wick 19; Paragraph 0107 discloses the wick may be made of cotton).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further include a cotton wick in the container of Hays, as taught by Woias, in order to assist the feed rate of the drug into the system (Paragraph 0107).
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hays in view of Cameron as applied to claim 13 above, and further in view of US20160136368A1 to Spandorfer (hereinafter “Spandorfer”).
Regarding claim 14, Hays in view of Cameron discloses the breathing system of claim 13, and Hays further discloses wherein the vaporisation unit comprise a vaporisation chamber (Fig. 1 interior of container 22). Hays in view of Cameron does not disclose wherein the flow control is configured with at least one gate, wherein the flow control including the at least one gate has a first configuration in which flow from the vaporisation chamber is prevented and flow from the airway is permitted, and a second configuration in which flow from the vaporisation chamber is permitted and flow from the airway is prevented, and wherein the flow control is controllable to move the flow control between the first and second configurations. However, Spandorfer teaches a ventilation circuit which has a flow control with at least one gate (Figs. 2 & 3 controller 50, bypass tubing 40, HME 30, valve 251, valve 252; Paragraph 0025 discloses the controller automatically opens and closes the valves to allow normal inhalation of gas or gas that has been humidified by the HME; Paragraph 0038 discloses switching between configurations when the controller knows the medicine has been delivered).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tubing of Hays to further include at least one gate and bypass tubing, as taught by Spandorfer, in order to providing multiples types of air to the user. Examiner notes that versatility of the Hays device would increase using this modification as the user would be able to have only pure air or have the option of the medicated air delivered to the user.
Hays as modified by Spandorfer discloses wherein the flow control including the at least one gate has a first configuration in which flow from the vaporisation chamber is prevented and flow from the airway is permitted (Examiner notes that the bypass tubing of Spandorfer would be located at a point before container 22 and then reconnect to the tubing at a point after container 22; Spandorfer valve 252 being closed would be the first configuration where air from the container of Hays would be blocked, and the bypass tubing containing only air would be delivered to the user), and a second configuration in which flow from the vaporisation chamber is permitted and flow from the airway is prevented (Spandorfer valve 251 being closed would be the second configuration where air from the container of Hays would be allowed, and the bypass tubing containing air and atomized drug would be delivered to the user), and wherein the flow control is controllable to move the flow control between the first and second configurations (Spandorfer Paragraph 0025 discloses the controller automatically opens and closes the valves).
Regarding claim 15, Hays in view of Cameron and Spandorfer discloses the breathing system of claim 14, and Hays further discloses wherein an intake of the vaporisation unit is coupled to the airway, such that gas in the vaporisation chamber is drawn from the airway (Fig. 1 tubing associated with drug delivery device 20 is coupled to the container 22 and the interior of container 22).
Regarding claim 17, Hays in view of Cameron and Spandorfer discloses the breathing system of claim 15, and Hays as modified by Spandorfer further discloses wherein the flow control and/or the controller is configured to increase or decrease gas flow via the vaporisation unit in inverse relation to increase or decrease of flow from the airway (Examiner notes that Hays as modified by Spandorfer has two configurations where the gas flow of the vaporization unit will be prevented or actuated dependent upon the open/closed states of valves; When one pathway is allowed to flow, the other pathway prevent from flowing (inverse relationship)).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Hays and Cameron as applied to claim 5 above, and further in view of Woias and US20220022546A1 to Inagaki et al. (hereinafter “Inagaki”).
Regarding claim 32, Hays in view of Cameron discloses the breathing system of claim 5, wherein the adder comprises: a reservoir of the substance (Fig. 1 container 22). Hays does not disclose a pump coupled to the reservoir, for pumping the substance from the reservoir, the controller being configured to control operation of the pump. However, Inagaki teaches an aerosol supply device which has a pump coupled to a reservoir to pump substance from the reservoir controlled by a controller (Fig. 2 pump 9, cartridge 4, controller 12; Paragraph 0096 discloses the controller controls the pump).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the container and controller of Hays to have a pump coupled to a reservoir, as taught by Inagaki, in order to provide control over the amount of drugs being dispensed to the user (Paragraph 0096).
Modified Hays does not disclose pumping a substance from the reservoir onto or into a material. However, Woias teaches an inhaler which has comprises a material located for gas to flow over or through it (Fig. 4 liquid reservoir 18, liquid 2, wick 19; Paragraph 0107 discloses the wick may be made of cotton).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further include a cotton wick in the container of Hays, as taught by Woias, in order to assist the feed rate of the drug into the system (Paragraph 0107).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Hays in view of Cameron as applied to claim 1 above, and further in view of US20140261415A1 to Acker et al. (hereinafter “Acker”).
Regarding claim 33, Hays in view of Cameron discloses the breathing system of claim 1, but does not disclose an operator control configured to enable input of a value for weight, estimated weight, height and/or pain level of the patient of a patient, the controller is configured to use the value in determining a rate of adding of the substance to gas to be inhaled subsequent to operation of the user control by the patient. However, Acker teaches a therapeutic gas delivery device with pulsed and continuous control based on a patient’s height and weight, where the controller uses the entered values to determine a rate of adding medicine to a gas subsequent to operation of the user control by the patient (CPU 115, user input device 117; Paragraphs 0050-0051 and 0054 discloses the user enters their weight and height to a user input device, and the control valves are operated to adjust the amount of drug given per breath based on the user’s parameters).
Therefore, it would have been obvious to one having ordinary skill in the art before effective filing date of the claimed invention to modify the ancillary device of modified Hays to include entering user parameters and controlling the amount of drug given to the user based on those parameters, as taught by Acker, in order to provide a rate of drug dosing customized to the user (Paragraph 0050).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-8869793-B1 to Spandorfer; US-20110308515-A1 to Snyder; US-20130206142-A1 to Dudley; and US-20190054260-A1 to Fahnert.
THIS ACTION IS MADE FINAL. 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 TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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