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 Status
Claims 1-24 are pending for examination.
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered.
Applicant’s arguments with respect to the objection of claim 15 at paragraph 2 of page 12 have been fully considered and are persuasive. The objection has been withdrawn.
In response to applicant's argument with respect to claim 1 from pages 14-15 that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In this case, Mellinger teaches the mobile device 204 communicatively receives nicotine consumption information from the NRT 202 and records that information (See. Fig. 2). The mobile device further receives manually logged nicotine consumption information from one or more of second nicotine products (e.g., cigarette or e-cigarette, skin-patch, chewing gum). Fig. 21 shows a history of nicotine consumption wirelessly received from the NRT device and from one of the second nicotine products (e.g., cigarette) logged by the user.
Mellinger teaches the NRT device is configured to transmit nicotine consumption to the mobile device / server but fails to teach the second nicotine product is configured to transmit the nicotine consumption information to the mobile device as required by the limitation “wherein the at least two dispensers are configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device” in claim 1.
However, in the same field of therapy, Cameron teaches a mobile device 1308 / server 1310 that is configured to receive nicotine consumption from a plurality of different vapor devices 1302 (e.g., vape-bot, micro-vapor device, a vapor pipe, e-cigarette or vaporizer) and/or a vapor device 300 that includes 2 different types of nicotine substances 206a, 206b with different strength. See Fig. 1 – Fig. 14, para [0132], “The method 1400 can comprise determining a current substance strength consumed by a user of the one of the plurality of electronic vapor devices based on the usage data at 1420. The electronic vapor device can comprise one or more of a vape-bot, a micro-vapor device, a vapor pipe, e-cigarette, a hybrid handset and vapor device. Receiving usage data from one of a plurality of electronic vapor devices can comprise one or more of cellular communication, WiFi communication, Bluetooth® communication, and satellite communication.” and para [0076], “FIG. 3 illustrates a vaporizer 300 that comprises the elements of the vaporizer 200 with two containers 202a, and 202b containing a vaporizable material, for example a fluid. In an aspect, the fluid can be the same fluid in both containers or the fluid can be different in each container. In an aspect the fluid can comprise a substance such as nicotine. In an aspect, the fluid can comprise a nicotine strength of 42 mg/mL, 36 mg/mL, 18 mg/mL, 12 mg/mL, 6 mg/mL, 3 mg/mL, and the like.”.
Cameron’s vapor device delivers nicotine by heating the material into vapor form as shown in Fig. 2 - Fig. 7 and Mellinger’s NRT device delivers nicotine by spraying the nicotine in liquid form as disclosed in para [0069]. These two types of devices deliver nicotine in two different application forms.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger mobile device to further receive nicotine information from an electronic vapor device as taught by Cameron to accurately track nicotine consumption without user inputs.
Accordingly, claim 1 is rejected in view of the teachings and suggestions disclosed by the Mellinger and Cameron references, combined with the motivation to automatically track nicotine consumption without user inputs. The corresponding method claim 17 is also rejected for the same reason as claim 1 and their dependent claims 2-6, 9, 14, 16, 18-20 and 23-24 are not allowable in view of claims 1 and 17.
In response to applicant's argument with respect to claims 10-13 and 15 from page16 to 17 that Businelle fails to cure the deficiencies of Mellinger in view of Cameron, Mellinger teaches the user manually logs skin patch and/or chewing gum consumption (para [0068]) but fails to expressly teach the at least one of the at least two dispensers is configured as a patch and/or chewing gum dispenser that transmits skin patch and/or chewing gum consumption to a mobile device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger in view of Cameron’s nicotine dispensers with an additional skin patch dispenser as taught by Businelle to accurately track skin patch and/or chewing consumption without user inputs.
Accordingly, claims 10-13 and 15 are rejected in view of the teachings and suggestions disclosed by the Mellinger, Cameron and Businelle references, combined with the motivation to automatically track nicotine consumption from skin patch dispenser and/or chewing gum dispenser without user inputs.
In response to applicant's argument with respect to the new independent claim 7, Mellinger teaches the user manually logs skin patch consumption (para [0068]) but fails to expressly teach the least one of the at least two dispensers being configured as a nicotine patch dispenser for delivering nicotine patches, and wherein the patch dispenser of the at least two dispensers are configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger mobile device to further receive nicotine information from a skin patch dispenser as taught by Businelle to accurately track skin patch consumption without user inputs.
In contrast to the applicant’s argument that the best result of the combination would still require the user to manually enter the skin patch consumption into the mobile device, Businelle’s skin patch dispenser is configured to transmit the consumption information to a mobile device to enable automatic data logging without user input.
Accordingly, claim 7 is rejected in view of the teachings and suggestions disclosed by the Mellinger and Businelle references, combined with the motivation to automatically track nicotine consumption from skin patch dispenser without user inputs.
In response to applicant's argument with respect to the new independent claim 8, Mellinger teaches the user manually logs chewing gum consumption (para [0068]) but fails to expressly teach at least one of the at least two dispensers being configured as a nicotine chewing gum dispenser, and wherein the chewing gum dispenser of the at least two dispensers are configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger mobile device to further receive nicotine information from a chewing gum dispenser as taught by Businelle to accurately track chewing gum consumption without user inputs.
In contrast to the applicant’s argument that the best result of the combination would still require the user to manually enter the chewing gum consumption into the mobile device, Businelle’s chewing gum dispenser is configured to transmit the consumption information to a mobile device to enable automatic data logging without user input.
Accordingly, claim 8 is rejected in view of the teachings and suggestions disclosed by the Mellinger and Businelle references, combined with the motivation to automatically track nicotine consumption from chewing gum dispenser without user inputs.
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.
Claims 1-6, 9, 14, 16-20 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Mellinger (Pub. No.: US 2021/0338948 A1) in view of Cameron (Pub. No.: US 2017/0181474 A1).
Regarding claim 1, Mellinger teaches a system for monitoring the intake of substances including pharmaceutical substances or nicotine (Abstract, a nicotine replacement therapy that monitors the intakes of nicotine), comprising:
at least two dispensers for delivering the same substance, the at least two dispensers being configured to deliver the same substance in a different application form (Fig. 1, Fig. 21, para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example” and para [0282], “The 12-week NRT journey may also be customized for smokeless tobacco users, heated or non-combusted tobacco users, electronic cigarette users and/or vaping product users. For example, the 12-week NRT journey may be customized for nicotine consumption that may comprise nicotine from a cigarette, tobacco product, electronic cigarette with nicotine, and/or an alternate source, such as a skin patch, chewing gum, nasal spray, inhaler, lozenge/tablet, oral spray, and the like.”. The system tracks the user’s nicotine consumption from the nicotine replacement therapy (NRT) device 120 and other tobacco products. The NRT delivers nicotine in the form of oral spray and cigarette/tobacco delivers nicotine in the form of vapor.); and
a monitoring device connected to the at least one dispenser by a data link (Fig. 2A - 2B, para [0122], “Similarly, the NRT app and/or behavioral support app on the smartphone 204 and/or the computer resources 212 may analyze data from an actuation sensor on the device 202 indicative of NTR usage.”. The NRT 202 is connected to the smartphone 204 / server 212);
wherein the at least one dispenser is configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device (Fig. 2B, message 228, Fig. 1C, dose actuation sensor 144 and para [0017], “The device may include a dispense tracking detection mechanism for detecting and tracking the number of sprays. The device may include a mechanism to measure a dosage of the nicotine formulation dispensed associated with a pump or a spray. The dispense tracking mechanism may include a proximity sensor. For example, the device may include a carriage (e.g., magnetic carriage) mounted to move relative to the dispenser when contacted by the actuating member and a sensor (e.g., a magnetic sensor) configured to sense a movement of the carriage. The magnetic sensor may detect when the magnetic carriage is within a range. The dosage of the nicotine formulation that was dispensed may be determined based on a signal from the sensor. An indication of the dosage may be sent (e.g., to the processor in the device, or to another device via a transmitter). The device may include a transmitter for sending a signal indicating the amount of nicotine formulation consumed by the user.”. The NRT device transmits the consumed dosage to the smartphone 202); and
wherein the monitoring device is to configured to receive the data relating to the delivery of the substance from the at least two dispensers (para [0260], “FIG. 19 depicts an example flowchart for controlling the lockout mechanism. At 1906, nicotine consumption may be tracked, for example using techniques described herein. Nicotine consumption data may be determined based on the nicotine concentration of the nicotine formulation in the NRT device, the number of full actuations, partial actuations of the dispenser and associated actuation time, and/or cigarette/tobacco consumption data logged by the user.”) and to calculate a total quantity of the delivered substance (para [0348], “In an example, a total amount of nicotine consumed may be determined. The total amount of nicotine consumed may indicate the amount of nicotine that was previously consumed by a user.”. The mobile device determines the total nicotine quantity based on the NRT device measurement and cigarette/tobacco consumption logged by the user).
Mellinger teaches the NRT device is configured to transmit nicotine consumption to the mobile device / server but fails to teach wherein the at least two dispensers are configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device.
However, in the same field of therapy, Cameron teaches a mobile device 1308 / server 1310 that is configured to receive nicotine consumption from a plurality of different vapor devices 1302 (e.g., vape-bot, micro-vapor device, a vapor pipe, e-cigarette or vaporizer) and/or a vapor device 300 that includes 2 different types of nicotine substances 206a, 206b with different strength. See Fig. 1 – Fig. 14, para [0132], “The method 1400 can comprise determining a current substance strength consumed by a user of the one of the plurality of electronic vapor devices based on the usage data at 1420. The electronic vapor device can comprise one or more of a vape-bot, a micro-vapor device, a vapor pipe, e-cigarette, a hybrid handset and vapor device. Receiving usage data from one of a plurality of electronic vapor devices can comprise one or more of cellular communication, WiFi communication, Bluetooth® communication, and satellite communication.” and para [0076], “FIG. 3 illustrates a vaporizer 300 that comprises the elements of the vaporizer 200 with two containers 202a, and 202b containing a vaporizable material, for example a fluid. In an aspect, the fluid can be the same fluid in both containers or the fluid can be different in each container. In an aspect the fluid can comprise a substance such as nicotine. In an aspect, the fluid can comprise a nicotine strength of 42 mg/mL, 36 mg/mL, 18 mg/mL, 12 mg/mL, 6 mg/mL, 3 mg/mL, and the like.”.
Cameron’s vapor device delivers nicotine by heating the material into vapor form as shown in Fig. 2 - Fig. 7 and Mellinger’s NRT device delivers nicotine by spraying the nicotine in liquid form as disclosed in para [0069]. These two types of devices deliver nicotine in two different application forms.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger system to further include an electronic vapor device as taught by Cameron to accurately track nicotine consumption without user inputs.
Regarding claim 2, Mellinger in the combination teaches the system as claimed in claim 1, wherein the substance contains nicotine (Fig. 19, step 1906).
Regarding claim 3, Mellinger in the combination teaches the system as claimed in claim 1, wherein the monitoring device has an indicating device and is configured to display the total quantity of the delivered substance on the indicating device (Fig. 12, para [0237], “At 1204, a program progress may be displayed. The program progress may indicate an amount of nicotine that a user may consume. For example, the program progress may indicate how much nicotine a user may consume and how much nicotine that the user has consumed.”).
Regarding claim 4, Mellinger in the combination teaches the system as claimed in claim 1, wherein the monitoring device is configured to calculate the total quantity of the delivered substance over a limited time period (Fig. 12, para [0237], “At 1204, a program progress may be displayed. The program progress may indicate an amount of nicotine that a user may consume. For example, the program progress may indicate how much nicotine a user may consume and how much nicotine that the user has consumed.” and para [0238], “At 1208, the interface may indicate which week out of a program a user may be in. For example, the interface may indicate that the user is in week 4 of a 12 week program.”.).
Regarding claim 5, Mellinger in the combination teaches the system as claimed in claim 1, further including at least one of the following:
the monitoring device is configured to compare the total quantity of the delivered substance with a predefined maximum quantity and to output a warning message if the total quantity is reached and/or exceeded (Fig. 19, step 1908-1910, the mobile device outputs a lockout message); and/or
the monitoring device is configured to compare the total quantity of the delivered substance with an envisaged maximum quantity and to calculate what delivery quantity is still available on the current day, in the current week or in the current month (Fig. 12, para [0237], “At 1204, a program progress may be displayed. The program progress may indicate an amount of nicotine that a user may consume. For example, the program progress may indicate how much nicotine a user may consume and how much nicotine that the user has consumed.”).
Regarding claim 6, Mellinger in the combination teaches the system as claimed in claim 1, wherein at least one of the at least two dispensers is configured as a liquid dispenser for delivering the substance in liquid form as a non-atomized jet, as a spray jet or in droplet form (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example”).
Regarding claim 9, Mellinger in the combination teaches the system as claimed in claim 1, wherein at least one of the at least two dispensers is configured to deliver liquid cartridges, and the liquid cartridges are couplable to a delivery device (Figs. 3A – 3C, liquid vial 324, para [0156], “FIG. 3C depicts an example pumping mechanism that may be used by the smart NRT device. The pump mechanism 400 may comprise an intake tube for drawing liquid from within the main body of the vial 324;”).
Regarding claim 14, Mellinger in the combination teaches the system as claimed in claim 1, wherein at least one of the at least two dispensers is configured as a liquid dispenser (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example”) and at least one of the at least two dispensers is configured as a dispenser for delivering liquid cartridges (Figs. 3A – 3C, liquid vial 324, para [0156], “FIG. 3C depicts an example pumping mechanism that may be used by the smart NRT device. The pump mechanism 400 may comprise an intake tube for drawing liquid from within the main body of the vial 324;”).
Regarding claim 16, Mellinger in the combination teaches the system as claimed in claim 1, further including at least one of the following:
the data link is a WLAN or Bluetooth data link or a GSM, 3G, 4G or 5G mobile radio link (para [0079], “The transmitter 138 and receiver 140 may be configured to communicate via Bluetooth, for example”); and/or
the monitoring device and at least one of the at least two dispensers are configured for a coupling operation wherein an unambiguous code on the dispenser is read by a smartphone (para [0106], “The user may pair, via Bluetooth, a smart phone with the device 100. The user may use the phone to scan the QR code, and the phone may communicate the information to the controller 122 via communications devices 124. In examples, the information sensor 146 may also be suitable for writing information back onto the medium associated with the vial, such as with a read/writable NFC tag, for example.”); and/or
the monitoring device comprises a computer (Fig. 2A – 2B, smartphone 204).
Regarding claim 17, recites a method for claim 1. Therefore, it is rejected for the same reasons.
Regarding claim 18, Mellinger in the combination teaches the method as claimed in claim 17, further including detecting, with at least one of the at least two dispensers a handling of the dispenser, the handling being used to open a receiving chamber and sending data to the monitoring device as a reaction thereto (para [0017] and para [0106], “When a vial is inserted into the device 100, the information sensor 146 may read information encoded with the vial. The controller 122 may use that information to cross-reference and/or authenticate the vial. In an example, the function of the information sensor 146 may be performed via logic and programming to receive QR code information from a paired smartphone QR code reader. The user may pair, via Bluetooth, a smart phone with the device 100. The user may use the phone to scan the QR code, and the phone may communicate the information to the controller 122 via communications devices 124.”).
Regarding claim 19, Mellinger in the combination teaches the method as claimed in claim 17, further including detecting, with at least one of the at least two dispensers, a handling of the dispenser which causes the delivery of the substance, and sending data to the monitoring device as a reaction thereto (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example. The example NRT device 100 may include mechanical features such as a child-safe actuator and an internal, replaceable vial for holding the liquid, nicotine formulation.”).
Regarding claim 20, Mellinger in the combination teaches the system as claimed in claim 6, further including at least one of the following:
the at least one liquid dispenser has an actuating handle and is configured to detect an actuation of the actuating handle (para [0069], actuator 104); and/or
the at least one liquid dispenser has an attachment detachably coupled to a housing part of the liquid dispenser and is configured to detect the handling of the liquid dispenser; and/or
the at least one liquid dispenser has a liquid store containing the substance (Fig. 3A, liquid vail 324); and/or
the at least one liquid dispenser is configured as a pump dispenser.
Regarding claim 23, Mellinger in the combination teaches the system as claimed in claim 9, further including at least one of the following:
the at least one dispenser has a receiving chamber for receiving the liquid cartridges and a movable cover element, the movable cover element, in an opened position, permitting access to the receiving chamber and removal of a liquid cartridge (Fig. 3A, the NRT device has a chamber for receiving the vial 324), the at least one dispenser further including a sensor for detecting the opened position (para [0106], “ When a vial is inserted into the device 100, the information sensor 146 may read information encoded with the vial. The controller 122 may use that information to cross-reference and/or authenticate the vial. In an example, the function of the information sensor 146 may be performed via logic and programming to receive QR code information from a paired smartphone QR code reader.”); and/or
the at least one dispenser has an actuating handle permitting removal of an individual liquid cartridge from the at least one dispenser (Fig. 1, Fig. 3A, dispenser head 339 or actuator 104), and a sensor for detecting actuation of the actuating handle (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example.”).
Regarding claim 24, Mellinger in the combination teaches the method as claimed in claim 19, further including at least one of the following steps:
detecting application of a force and/or a displacement of an actuating handle with a sensor of the dispenser (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example. The example NRT device 100 may include mechanical features such as a child-safe actuator and an internal, replaceable vial for holding the liquid, nicotine formulation.”. TheNRT device detects the user depresses the actuator 104.); and/or
carrying out the delivery in liquid form as a non-atomized jet, as a spray jet or as droplets; or
carrying out the delivery in the form of a patch, a piece of chewing gum or a tablet, to be ingested by a user following the delivery; or
carrying out the delivery in the form of a liquid cartridge inserted into an applicator following the delivery.
Claims 10-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mellinger (Pub. No.: US 2021/0338948 A1) in view of Cameron (Pub. No.: US 2017/0181474 A1) as applied to claim 1, and further in view of Businelle (Pub. No.: 2023/0080576 A1).
Regarding claim 10, Mellinger in the combination teaches the system as claimed in claim 1, wherein at least one of the at least two dispensers is configured as a liquid dispenser (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example. The example NRT device 100 may include mechanical features such as a child-safe actuator and an internal, replaceable vial for holding the liquid, nicotine formulation.”. The NRT holds liquid vial).
Mellinger teaches the user manually logs skin patch consumption (para [0068]) but fails to expressly teach the at least one of the at least two dispensers is configured as a patch dispenser that transmits skin patch consumption to a mobile device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger in view of Cameron’s nicotine dispensers with an additional skin patch dispenser as taught by Businelle to accurately track skin patch consumption without user inputs.
Regarding claim 11, Mellinger in the combination teaches the system as claimed in claim 1, wherein the user manually logs skin patch and chewing gum consumption (para [0068]) but fails to expressly teach wherein at least one of the at least two dispensers is configured as a patch dispenser and at least one of the at least two dispensers is configured as a chewing gum dispenser or a tablet dispenser.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger in view of Cameron’s nicotine dispensers with additional skin patch and chewing gum dispensers as taught by Businelle to accurately track skin patch and chewing gum consumption without user inputs.
Regarding claim 12, Mellinger in the combination teaches the system as claimed in claim 1, at least one of the at least two dispensers is configured as a dispenser for delivering liquid cartridges (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example. The example NRT device 100 may include mechanical features such as a child-safe actuator and an internal, replaceable vial for holding the liquid, nicotine formulation.”. The NRT holds liquid vial).
Mellinger teaches the user manually logs skin patch consumption (para [0068]) but fails to expressly teach the at least one of the at least two dispensers is configured as a patch dispenser that transmits skin patch consumption to a mobile device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger in view of Cameron’s nicotine dispensers with an additional skin patch dispenser as taught by Businelle to accurately track skin patch consumption without user inputs.
Regarding claim 13, Mellinger in the combination teaches the system as claimed in claim 1, wherein at least one of the at least two dispensers is configured as a liquid dispenser (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example. The example NRT device 100 may include mechanical features such as a child-safe actuator and an internal, replaceable vial for holding the liquid, nicotine formulation.”. The NRT holds liquid vial).
Mellinger teaches the user manually logs chewing gum consumption (para [0068]) but fails to expressly teach the at least one of the at least two dispensers is configured as a chewing gum dispenser or a tablet dispenser that transmits chewing gum consumption to a mobile device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger in view of Cameron’s nicotine dispensers with an additional chewing gum dispenser as taught by Businelle to accurately track chewing gum consumption without user inputs.
Regarding claim 15, Mellinger in the combination teaches the system as claimed in claim 1, wherein at least one of the at least two dispensers is configured as a dispenser for delivering liquid cartridges (para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example. The example NRT device 100 may include mechanical features such as a child-safe actuator and an internal, replaceable vial for holding the liquid, nicotine formulation.”. The NRT holds liquid vial).
Mellinger teaches the user manually logs chewing gum consumption (para [0068]) but fails to expressly teach the at least one of the at least two dispensers is configured as a chewing gum dispenser or a tablet dispenser that transmits chewing gum consumption to a mobile device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger in view of Cameron’s nicotine dispensers with an additional chewing gum dispenser as taught by Businelle to accurately track chewing gum consumption without user inputs.
Claims 7-8 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Mellinger (Pub. No.: US 2021/0338948 A1) in view of Businelle (Pub. No.: 2023/0080576 A1).
Regarding claim 7, Mellinger teaches a system for monitoring the intake of substances including nicotine (Abstract, a nicotine replacement therapy that monitors the intakes of nicotine), comprising:
at least two dispensers for delivering the same substance, the at least two dispensers being configured to deliver the same substance in a different application form (Fig. 1, Fig. 21, para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example” and para [0282], “The 12-week NRT journey may also be customized for smokeless tobacco users, heated or non-combusted tobacco users, electronic cigarette users and/or vaping product users. For example, the 12-week NRT journey may be customized for nicotine consumption that may comprise nicotine from a cigarette, tobacco product, electronic cigarette with nicotine, and/or an alternate source, such as a skin patch, chewing gum, nasal spray, inhaler, lozenge/tablet, oral spray, and the like.”. The system tracks the user’s nicotine consumption from the nicotine replacement therapy (NRT) device 120 and other tobacco products. The NRT delivers nicotine in the form of oral spray and the skin patch delivers nicotine through skin absorption.); and
a monitoring device connected to the at least one dispenser by a data link (Fig. 2A - 2B, para [0122], “Similarly, the NRT app and/or behavioral support app on the smartphone 204 and/or the computer resources 212 may analyze data from an actuation sensor on the device 202 indicative of NTR usage.”. The NRT 202 is connected to the smartphone 204 / server 212);
wherein the at least one dispenser is configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device (Fig. 2B, message 228, Fig. 1C, dose actuation sensor 144 and para [0017], “The device may include a dispense tracking detection mechanism for detecting and tracking the number of sprays. The device may include a mechanism to measure a dosage of the nicotine formulation dispensed associated with a pump or a spray. The dispense tracking mechanism may include a proximity sensor. For example, the device may include a carriage (e.g., magnetic carriage) mounted to move relative to the dispenser when contacted by the actuating member and a sensor (e.g., a magnetic sensor) configured to sense a movement of the carriage. The magnetic sensor may detect when the magnetic carriage is within a range. The dosage of the nicotine formulation that was dispensed may be determined based on a signal from the sensor. An indication of the dosage may be sent (e.g., to the processor in the device, or to another device via a transmitter). The device may include a transmitter for sending a signal indicating the amount of nicotine formulation consumed by the user.”. The NRT device transmits the consumed dosage to the smartphone 202); and
wherein the monitoring device is configured to receive the data relating to the delivery of the substance from the at least two dispensers (para [0260], “FIG. 19 depicts an example flowchart for controlling the lockout mechanism. At 1906, nicotine consumption may be tracked, for example using techniques described herein. Nicotine consumption data may be determined based on the nicotine concentration of the nicotine formulation in the NRT device, the number of full actuations, partial actuations of the dispenser and associated actuation time, and/or cigarette/tobacco consumption data logged by the user.”) and to calculate a total quantity of the delivered substance (para [0348], “In an example, a total amount of nicotine consumed may be determined. The total amount of nicotine consumed may indicate the amount of nicotine that was previously consumed by a user.”. The mobile device determines the total nicotine quantity based on the NRT device measurement and cigarette/skin patch consumption logged by the user).
Mellinger teaches the user manually logs skin patch consumption (para [0068]) but fails to expressly teach the least one of the at least two dispensers being configured as a nicotine patch dispenser for delivering nicotine patches, and wherein the patch dispenser of the at least two dispensers are configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger mobile device to further receive nicotine information from a skin patch dispenser as taught by Businelle to accurately track skin patch consumption without user inputs.
Regarding claim 21, Businelle in the combination teaches the system as claimed in claim 7, further including at least one of the following:
the nicotine patch dispenser has a receiving chamber for receiving the nicotine patches (Fig. 7, NRT pill/patch chamber 116), a movable cover element, the movable cover element in an opened position permitting access to the receiving chamber and the removal of a nicotine patch (Fig. 3, para [0016], “The gate position sensor is configured to detect the gate opening and provide the onboard processing unit with a signal that the gate was opened to permit the release of a pill.”. The dispenser has a gate that dispenses the pill/patch), the nicotine patch dispenser further including a sensor for detecting the opened position (Fig. 7. gate position sensor 122); and/or
the nicotine patch dispenser has an actuating handle permitting removal of an individual nicotine patch from the nicotine patch dispenser, and a sensor for detecting actuation of the actuating handle; and/or
the nicotine patch dispenser is filled with a plurality of nicotine patches, each nicotine patch having a store containing the substance, the substance, when the nicotine patch is applied to the skin of a user, resting on the skin.
Regarding claim 8, Mellinger teaches a system for monitoring the intake of substances including nicotine (Abstract, a nicotine replacement therapy that monitors the intakes of nicotine), comprising:
at least two dispensers for delivering the same substance, the at least two dispensers being configured to deliver the same substance in a different application form (Fig. 1, Fig. 21, para [0069], “FIGS. 1A and 1B depict an example NRT device 100, in front and side views respectively. The device 100 may be or may include a nicotine oral spray device. To receive a dose of nicotine, the user grips the body 102 of the device 100 and depresses the actuator 104 (in the direction shown by arrow 106) while aiming the nozzle 108 to direct a mist of a nicotine formulation under the user's tongue, for example” and para [0282], “The 12-week NRT journey may also be customized for smokeless tobacco users, heated or non-combusted tobacco users, electronic cigarette users and/or vaping product users. For example, the 12-week NRT journey may be customized for nicotine consumption that may comprise nicotine from a cigarette, tobacco product, electronic cigarette with nicotine, and/or an alternate source, such as a skin patch, chewing gum, nasal spray, inhaler, lozenge/tablet, oral spray, and the like.”. The system tracks the user’s nicotine consumption from the nicotine replacement therapy (NRT) device 120 and other tobacco products. The NRT delivers nicotine in the form of oral spray and the gum delivers nicotine by chewing.); and
a monitoring device connected to the at least one dispenser by a data link (Fig. 2A - 2B, para [0122], “Similarly, the NRT app and/or behavioral support app on the smartphone 204 and/or the computer resources 212 may analyze data from an actuation sensor on the device 202 indicative of NTR usage.”. The NRT 202 is connected to the smartphone 204 / server 212);
wherein the at least one dispenser is configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device (Fig. 2B, message 228, Fig. 1C, dose actuation sensor 144 and para [0017], “The device may include a dispense tracking detection mechanism for detecting and tracking the number of sprays. The device may include a mechanism to measure a dosage of the nicotine formulation dispensed associated with a pump or a spray. The dispense tracking mechanism may include a proximity sensor. For example, the device may include a carriage (e.g., magnetic carriage) mounted to move relative to the dispenser when contacted by the actuating member and a sensor (e.g., a magnetic sensor) configured to sense a movement of the carriage. The magnetic sensor may detect when the magnetic carriage is within a range. The dosage of the nicotine formulation that was dispensed may be determined based on a signal from the sensor. An indication of the dosage may be sent (e.g., to the processor in the device, or to another device via a transmitter). The device may include a transmitter for sending a signal indicating the amount of nicotine formulation consumed by the user.”. The NRT device transmits the consumed dosage to the smartphone 202); and
wherein the monitoring device is configured to receive the data relating to the delivery of the substance from the at least two dispensers (para [0260], “FIG. 19 depicts an example flowchart for controlling the lockout mechanism. At 1906, nicotine consumption may be tracked, for example using techniques described herein. Nicotine consumption data may be determined based on the nicotine concentration of the nicotine formulation in the NRT device, the number of full actuations, partial actuations of the dispenser and associated actuation time, and/or cigarette/tobacco consumption data logged by the user.”) and to calculate a total quantity of the delivered substance (para [0348], “In an example, a total amount of nicotine consumed may be determined. The total amount of nicotine consumed may indicate the amount of nicotine that was previously consumed by a user.”. The mobile device determines the total nicotine quantity based on the NRT device measurement and cigarette/chewing gum consumption logged by the user).
Mellinger teaches the user manually logs chewing gum consumption (para [0068]) but fails to expressly teach at least one of the at least two dispensers being configured as a nicotine chewing gum dispenser, and wherein the chewing gum dispenser of the at least two dispensers are configured to detect an action associated with the delivery of the substance and, in reaction hereto, to transmit data relating to the delivery of the substance to the monitoring device.
However, in the same field of dispenser, Businelle teaches a pill tracking dispenser 102 configured to track the consumption of the nicotine replacement therapy (NRT) stored in the dispenser. The NRT includes skin patches and/or gums. See Figs. 1-9, abstract, para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Mellinger mobile device to further receive nicotine information from a chewing gum dispenser as taught by Businelle to accurately track chewing gum consumption without user inputs.
Regarding claim 22, Businelle in the combination teaches the system as claimed in claim 8, further including at least one of the following:
the nicotine chewing gum dispenser has a casing containing packaging with individual pieces of nicotine chewing gum, wherein the packaging is drawable out of the casing to permit removal of a piece of nicotine chewing gum, and a pulling out of the packaging, or release of a block in order to be able to pull out the packaging, is detectable by a sensor; and/or
the nicotine chewing gum dispenser has a receiving chamber for receiving a piece of nicotine chewing gum and a movable cover element, the movable cover element in an opened position permitting access to the receiving chamber and removal of a piece of nicotine chewing gum, the nicotine chewing gum dispenser having a sensor for detecting the opened position; and/or
the nicotine chewing gum dispenser has an actuating handle, the actuating handle permitting an individual piece of nicotine chewing gum to be removed from the nicotine chewing gum dispenser, the nicotine chewing gum dispenser having a sensor for detecting actuation of the actuating handle; and/or
the nicotine chewing gum dispenser is filled with a plurality of pieces of nicotine chewing gum, each of the pieces of nicotine chewing gum or containing the substance (para [0004], “Nicotine replacement therapy comes in various forms including a skin patch, lozenges, and gum.” and para [0018], “The pill tracking dispenser 102 is configured to track the dispensation of an oral medication 108 in the form of pills, lozenges, tablets, capsules or other solid forms of medication (referred to generically as “pills” in this disclosure).”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Skoda (Pub. No.: 2020/0137570 A1) taches a nicotine dispenser system that is configured to track the use of the nicotine dispenser to determine the consumption of nicotine.
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 ZHEN Y WU whose telephone number is (571)272-5711. The examiner can normally be reached Monday-Friday, 10AM-6PM, EST.
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/ZHEN Y WU/Primary Examiner, Art Unit 2685
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