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 Objections
Claims 5, 12, 13, 15, 19, 20 and 26-29 are objected to because of the following informalities:
Claim 5: the recitation “wherein the health hub controls”, should read ---wherein the health hub is configured to control---, to avoid reciting method like steps in a system claim.
Claim 12: the recitation “wherein the health hub controls”, should read ---wherein the health hub is configured to control---, to avoid reciting method like steps in a system claim.
Claim 13: the recitation “wherein the testing device obtains”, should read ---wherein the testing device is configured to obtain---, and “the testing information indicates”, should read ---the testing information is configured to indicate---, to avoid reciting method like steps in a system claim.
Claim 15: the recitation “wherein the pod includes an identifier indicating an identity of the pod, the identity indicating”, should read ---wherein the pod includes an identifier configured to indicate an identity of the pod, the identity configured to indicate---, to avoid reciting method like steps in a system claim.
Claim 19: the recitation of “delivery device provides”, should read ---delivery device is configured to provide---, to avoid reciting method like steps in a device claim.
Claim 20: the recitation of “device monitors” and “and provides” should read, ---device is configured to monitor--- and ---and configured to provide--- to avoid reciting method like steps in a device claim.
Claim 26 is improperly dependent on Claim 25, a cancelled claim in a preliminary amendment. For the purposes of examination, it is interpreted that Claim 26 depends from independent Claim 22.
Claim 27: the recitation of “monitors”, should read ---is configured to monitor---, to avoid reciting method like steps in a device claim.
Claim 28: the recitation “interfaces” should read ---is configured to interface--- to avoid reciting method like steps in a device claim.
Claim 29: the recitation “interface is used” should read ---is configured to be used---, to avoid reciting method like steps in a device claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 7, 11-14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobs (WO 2023288022 A1).
Regarding claim 1, Jacobs discloses a smoking cessation system, comprising: a nicotine delivery device configured to deliver a mixture in an aerosol form to a user, the mixture including nicotine, varenicline, or bupropion (Jacobs [0007]; a delivery system for providing an aerosol mixture to a user in a treatment program for quitting smoking, [0008]; where the substance in the mixture includes nicotine);
a health hub configured to communicate with the nicotine delivery device and to control operation of the nicotine delivery device based on information (Jacobs [0092]; the user device ‘15’ can be a smart phone, computer, etc., and can provide treatment program information (based on information), controlling the delivery device ‘100’, the delivery device ‘100’, can be running through an app (health hub), [0091]; communication of the user device ‘15’ to the delivery device ‘100’, [0129]; interacting with the app (communicating) and interacting with the treatment program (communicating through the app – health hub to the delivery device));
and one or more additional devices configured to communicate one or more items of the information to the health hub (Jacobs [0092]; where the user device (one or more additional devices) ‘15’ can be a smart phone and running through an app (health hub) – thereby communicating information to the health hub about the treatment program (one or more items) and controlling the delivery device).
Regarding claim 2, Jacobs further discloses the smoking cessation system according to claim 1, wherein the one or more additional devices includes a smartphone used by the user (Jacobs [0092]; where the one or more additional devices (user device ‘15’) can be a smart phone used by the user).
Regarding claim 7, Jacobs further discloses the smoking cessation system according to claim 2, wherein the health hub is an application on the smartphone (Jacobs [0092]; the user device ‘15’ can be a smart phone, computer, etc., and can provide treatment program information (based on information), controlling the delivery device ‘100’, the delivery device ‘100’, can be running through an app (health hub) – on the smartphone).
Regarding claim 11, Jacobs further discloses the smoking cessation system according to claim 1, wherein the one or more additional devices includes a testing device configured to obtain testing information from the user as the one or more items of the information (Jacobs [0097]; where the sensor ‘17’ (additional device) communicates the characteristics to the delivery system ‘100’, and the user device ‘15’, where the characteristics are a characteristic of a user like in their blood, sweat, urine, saliva to test sugar levels, nicotine levels, pH, level of a drug/medicament/hormone and the like, making the sensor a testing device with an item of information – the characteristics as stated before).
Regarding claim 12, Jacobs further discloses the smoking cessation system according to claim 11, wherein the health hub controls the nicotine delivery device based on the testing information (Jacobs [0089]; where the sensor ‘17’ is in communication with the delivery system ‘100’ and the user device ‘15’, [0116]; where the hardware components of the sensor communicate the information over to the delivery device and allow for control based on the information sensed from the sensor (testing device with testing information), [0183]; “Also, in some embodiments, user data sensed by the sensor(s) 17 is communicated from the sensor(s) 17 to the delivery system 100 or the user device 15, and then it can be communicated to the server system 25, where it can be used to dynamically adjust the treatment program or monitor the patient’s progress in the treatment program”, [0092]; app uses sensor data and Jacobs [0092]; the user device ‘15’ can be a smart phone, computer, etc., and can provide treatment program information (based on information), controlling the delivery device ‘100’, the delivery device ‘100’, can be running through an app (health hub)).
Regarding claim 13, Jacobs further discloses the smoking cessation system according to claim 11, wherein the testing device obtains the testing information from plasma, blood, urine, saliva, interstitial fluid, skin, sweat, breath, hair, nails, tears, ear canal, nasal passage, oral passage, anal secretion or excrement, or stool of the user, and the testing information indicates a level of nicotine, cotinine, tans-3-hydroxycotinine, nornicotine, or carbon monoxide (Jacobs [0097]; where the sensor ‘17’ (additional device that is a testing device) communicates the characteristics to the delivery system ‘100’, and the user device ‘15’, where the characteristics are a characteristic of a user like in their blood, sweat, urine, saliva to test and indicate sugar levels, nicotine levels, pH, level of a drug/medicament/hormone and the like, making the sensor a testing device with an item of information – the characteristics as stated before).
Regarding claim 14, Jacobs further discloses the smoking cessation system according to claim 1, further comprising a pod configured to fit within the nicotine delivery device, wherein the mixture is stored in the pod (Jacobs [0085]; where the pod holds the substance that is in use for generating aerosol mixture, [0087]; delivery system ‘100’ (nicotinic delivery device) and pod ‘150’, [0093]; pod is within the delivery device (Jacobs Figure 3A)).
Regarding claim 19, Jacobs further discloses the smoking cessation system according to claim 1, wherein the nicotine delivery device provides additional information to the health hub (Jacobs [0084]; where the hardware controller can monitor and record the number of puffs (number of actuations) a user takes from the delivery device (which contains the mixture as previously cited above), determine a flow rate of air provided to the user during a puff (via a flow sensor – measurement components), determine a duration of each puff (the length of time of a certain amount of air flow), determine total inhaled time and determine an amount of substances ingested by the user (monitoring the amount of a mixture consumed by the user) based on its control of individual aerosolizers of the delivery device via sensors (measurement components) – providing the number of puffs (actuations) to control the aerosolizers of the delivery device – which is additional information, [0092]; the user device ‘15’ can be a smart phone, computer, etc., and can provide treatment program information (based on information), controlling the delivery device ‘100’, the delivery device ‘100’, can be running through an app (health hub), [0091]; communication of the user device ‘15’ to the delivery device ‘100’, [0129]; interacting with the app (communicating) and interacting with the treatment program (communicating through the app – health hub to the delivery device) – additional information to health hub from the user device).
Regarding claim 20, Jacobs further discloses the smoking cessation system according to claim 19, wherein the nicotine delivery device monitors a number of actuations implemented by the user and provides the number of actuations as the additional information (Jacobs [0084]; where the hardware controller can monitor and record the number of puffs (number of actuations) a user takes from the delivery device (which contains the mixture as previously cited above), determine a flow rate of air provided to the user during a puff (via a flow sensor – measurement components), determine a duration of each puff (the length of time of a certain amount of air flow), determine total inhaled time and determine an amount of substances ingested by the user (monitoring the amount of a mixture consumed by the user) based on its control of individual aerosolizers of the delivery device via sensors (measurement components) – providing the number of puffs (actuations) to control the aerosolizers of the delivery device – which is additional information).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (WO 2023288022 A1) in view of Cohen (US 20190387796 A1).
Regarding claim 5, Jacobs further discloses the smoking cessation system according to claim 2, but is silent to biometric data from a user.
Cohen discloses devices and methods for cessation of nicotine addiction wherein:
the one or more items includes biometric data from the user, wherein the health hub controls the nicotine delivery device to suspend operation based on determining that the user is not an authorized user according to the biometric data (Cohen [0151]; where the vaporizer can verify/ authorize use and/ or age of the user, to provide authentication to enable operation of the vaporizer (controlling the nicotine delivery device for operation) via biometric authentication – biometric data (e.g. facial recognition) – thereby suspending operation if the user is not authorized according to the biometric data, where the app running (health hub) on a user device or the vaporizer can authenticate to a mobile device, [0071]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the smoking cessation system of Jacobs to include an authentication feature to suspend or allow operation of the delivery device as taught by Cohen, since, it allows for protection on the device to have the device be inoperable if stolen or to prevent others from using it for example (Cohen [0151]).
Regarding claim 6, Jacobs further discloses the smoking cessation system according to claim 5, wherein the biometric data is a thumbprint or facial recognition (Jacobs [0010]; fingerprint sensor that allows the delivery system to activate if the information provided by the fingerprint sensor matches the fingerprint of a specific user, and as modified Cohen [0151] - biometric authentication – biometric data (e.g. facial recognition)).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (WO 2023288022 A1) in view of Gauvin (WO2021189026A1).
Regarding claim 15, Jacobs further discloses the smoking cessation system according to claim 14, wherein the pod includes an identifier indicating an identity of the pod (Jacobs [0008]; where the pod has an ID chip allowing for the system to identify the pod and the substances contained therein, [0108]; ID chip identifies how much substance is left in the pod, and/ or the type of substance);
and a mixture in the pod (Jacobs [0085]; where the pod holds the substance that is in use for generating aerosol mixture, [0087]; delivery system ‘100’ (nicotinic delivery device) and pod ‘150’, [0093]; pod is within the delivery device (Jacobs Figure 3A)).
Jacobs is silent to the identity indicating a dosage of the pod.
Gauvin discloses identifiers with a pod comprising:
the identity indicating a dosage of the substance in the pod (Gauvin [0059]; where the identifier includes liquid amount for the dose, [0058]; where the identifier is for the pod and can be read by a dispenser apparatus and/ or by a user).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the smoking cessation system of Jacobs by including the identity indicating a dosage of the substance in the pod as taught by Gauvin for the mixture, since the identifier helps to provide information regarding the contents of the pod, and whether the pod has been used or unused (Gauvin [0057]).
Claims 22-24, 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (WO 2023288022 A1) in view of Mellinger (US 20210337881 A1).
Regarding claim 22, Jacobs discloses a nicotine delivery device, comprising: an aerosolization system configured to aerosolize a mixture for consumption by a user (Jacobs [0007]; a delivery system ‘100’ for providing an aerosol mixture to a user in a treatment program for quitting smoking, aerosolizer drivers provide the mixture based on the treatment program (aerosolization system), [0008]; where the substance in the mixture includes nicotine, [0081]; administering mixtures of substances via inhalation (consumption by a user));
a communication interface configured to communicate with a health hub that receives information about the user (Jacobs [0084]; where information generated from the delivery device is communicated to the user device via a Bluetooth link (communication interface configured to communicate), where certain information relating to the user’s use of the device is displayed on the user device ‘15’, Jacobs [0092]; where the user device (one or more additional devices) ‘15’ can be a smart phone and running through an app (health hub) – thereby communicating information to the health hub about the treatment program (receiving information about the user) and controlling the delivery device, “the user device 15 includes a display, and provides certain cessation program information to the user 30 on various graphical user displays (GUI’s) of the display based on the received information, for example, information relating the user’s progress”, [0130]; information about the user to show on a GUI of a smartphone, i.e. through the app (health hub));
and a processor (Jacobs [0007]; processor).
Jacobs is silent to a processor configured to inhibit the consumption by the user based on a control signal from the health hub.
Mellinger discloses a smoking cessation system comprising:
a processor configured to inhibit the consumption by the user based on a control signal from the health hub (Mellinger [0003]; where the processor is configured to send a lockout mechanism signal to more to a non-operative position, [0110]; processor enables/ disables (inhibits) actuation of the mechanism for the user, [0113]; the system includes a smartphone with an app and communicates with the device and the smartphone containing the app (health hub with control signals), [0114]; health hub provides a user interface for a personalized journey, [0018]; where a signal may be received about the lockout condition from a smart phone (containing the health hub)).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the nicotine delivery device of Jacobs by including the processor inhibiting consumption by the user based on a control signal from the health hub as taught by Mellinger, since, it allows for the device to safely distribute amounts of the substance, if nearing a threshold of unwanted use for the treatment program (Mellinger [0016]), and because it provides the user with a personalized and dynamic journey guide for cessation (Mellinger [0071]).
Regarding claim 23, Jacobs further discloses the nicotine delivery device according to claim 22, wherein the aerosolization system includes a mesh nebulizer, pressurized metered-dose inhaler, or soft-mist inhaler (Jacobs [0187]; where the aerosolization system includes a mesh nebulizer).
Regarding claim 24, Jacobs further discloses the nicotine delivery device according to claim 22, further comprising one or more measurement components, wherein one of the one or more measurement components includes a temperature sensor (Jacobs [0120]; ‘158’ is a temperature sensor (one or more measurement component), density sensor ‘160’, [0084]; flow sensor, ambient pressure sensor, ambient temperature sensor).
Regarding claim 27, Jacobs further discloses the nicotine delivery device according to claim 24 wherein one or more of the one or more measurement components monitors an amount of the mixture consumed by the user (Jacobs [0084]; where the hardware controller can monitor and record the number of puffs (number of actuations) a user takes from the delivery device (which contains the mixture as previously cited above), determine a flow rate of air provided to the user during a puff (via a flow sensor – measurement components), determine a duration of each puff (the length of time of a certain amount of air flow – dosage with amount of mixture), determine total inhaled time and determine an amount of substances ingested by the user (monitoring the amount of a mixture consumed by the user) based on its control of individual aerosolizers of the delivery device via sensors (measurement components));
and the aerosolized mixture taken by the user (Jacobs [0007]; a delivery system for providing an aerosol mixture to a user in a treatment program for quitting smoking, [0008]; where the substance in the mixture includes nicotine, [0098]; consumption/ inhalation (taken by the user)).
Jacobs is silent to the measurement component monitoring a number of actuations of the nicotine delivery device corresponding to a dosage of the aerosolized mixture taken by the user.
Mellinger discloses a nicotine therapy device comprising:
a measurement component configured to monitor a number of actuations of the nicotine delivery device corresponding to dosage of substance taken by the user ( [0017]; the device includes a mechanism to measure a dosage (measurement component) corresponding to a dosage of the nicotine device dispensed associated with a pump or a spray (number of actuations corresponding to the dosage) taken by the user, the number of sprays and movements of the carriage of the nicotine device are tracked (monitoring via the measurement component)).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the nicotine delivery device of Jacobs by including a measurement component configured to monitor a number of actuations of the nicotine delivery device corresponding to dosage of substance taken by the user as taught by Mellinger, since it allows for the system to detect and track the number of actuations of the system and allows for the measurement to be transmitted to a processing device to indicate the amount of nicotine formulation consumed by the user.
Regarding claim 31, Jacobs further discloses the nicotine delivery device according to claim 22, further comprising a biometric reader configured to obtain biometric information from the user (Jacobs [0095]; where there is a fingerprint sensor (biometric reader) that is configured to obtain the fingerprints from a user (biometric information from the user)).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (WO 2023288022 A1) in view of Mellinger (US 20210337881 A1) and further in view of Ferrie (US 20220061399 A1).
Regarding claim 26, Jacobs further discloses the nicotine delivery device according to claim 25.
Jacobs is silent to the temperature sensor being configured to trigger the temperature control system based on detecting an overheat condition.
Ferrie discloses a smoking substitute system wherein:
the aerosolization system includes a temperature control system, and the temperature sensor is configured to trigger the temperature control system based on detecting an overheat condition (Ferrie [1094-1097]; where the controller is able to control the temperature in the system in response to the overheating condition, controller detects is temperature is above a threshold, and detects an overheating error when a temperature sensor detects that the threshold is exceeded, to control the system to not be overheating anymore, [0002]; aerosolization system with the delivery device).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the nicotine delivery device of Jacobs to include a temperature control system as taught by Ferrie, since, it allows for the temperature to be controlled in an error event where there is an overheating of the system which can be dangerous to the user (Ferrie [1094]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (WO 2023288022 A1) in view of Mellinger (US 20210337881 A1) and further in view of Cohen (US 20190387796 A1).
Regarding claim 28, Jacobs further discloses the nicotine delivery device according to claim 22, further comprising a pod interface and the nicotine delivery device interfaces with a pod storing the mixture at the pod interface (Jacobs Figure 3A; where the pod ‘150’ is inside of the delivery device, thereby having a pod interface to which it is the cavity of which the pod resides in, in the delivery device).
Jacobs is silent to the pod storing the mixture at the pod interface and the pod identity reader is configured to determine an identity of the pod.
Cohen discloses devices and methods for cessation of nicotine addiction comprising:
a pod identity reader (Cohen [0055]; where the cartridge can have a barcode marking to indicate information about the cartridge or contents within (pod identity reader));
the nicotine delivery device interfaces with a pod storing the mixture at the pod interface and the pod identity reader is configured to determine an identity of the pod (Cohen [0055]; where the cartridge (pod) can have a barcode marking to indicate information about the cartridge or contents within (pod identity reader) where the markings can be detected by the vaporizer – thereby interfacing with a pod to determine an identity of the pod).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the nicotine delivery device of Jacobs by including a pod identity reader that interfaces with the pod as taught by Cohen, since, it allows for the device’s information about the cartridge or contents within to be known (Cohen [0055]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (WO 2023288022 A1) in view of Mellinger (US 20210337881 A1), further in view of Cohen (US 20190387796 A1) and even further in view of Gauvin (WO2021189026A1).
Regarding claim 29, Jacobs further discloses the nicotine delivery device according to claim 28, wherein the identity of the pod is associated with a mixture stored by the pod (Jacobs [0084]; where the hardware controller can monitor and record the number of puffs (number of actuations) a user takes from the delivery device (which contains the mixture as previously cited above), determine a flow rate of air provided to the user during a puff (via a flow sensor – measurement components), determine a duration of each puff (the length of time of a certain amount of air flow – dosage with amount of mixture))
and the communication interface is used to communicate the identity of the pod to the health hub ([0120]; where the pod communicates with the delivery device, [0183]; where there is use data (e.g. from pod information/ pod ID chip), where the use data is communicated from the delivery device to the user device, Jacobs [0092]; the user device ‘15’ can be a smart phone, computer, etc., and can provide treatment program information (based on information), controlling the delivery device ‘100’, the delivery device ‘100’, can be running through an app (health hub), [0091]; communication of the user device ‘15’ to the delivery device ‘100’, [0129]; interacting with the app (communicating) and interacting with the treatment program (communicating through the app – health hub to the delivery device)).
Jacobs is silent to the identity indicating a dosage of the pod.
Gauvin discloses identifiers with a pod comprising:
the identity indicating a dosage of the substance in the pod (Gauvin [0059]; where the identifier includes liquid amount for the dose, [0058]; where the identifier is for the pod and can be read by a dispenser apparatus and/ or by a user).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the smoking cessation system of Jacobs by including the identity indicating a dosage of the substance in the pod as taught by Gauvin for the mixture, with the communication to the health hub, since the identifier helps to provide information regarding the contents of the pod, and whether the pod has been used or unused (Gauvin [0057]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Borschke (US 20110274628 A1): aerosol mixture with nicotine, bupropion and varenicline.
Nakano (EP 3777575 B1): alternate aerosol generation device, control and method.
Kilger (US 20210386125 A1): e-cigarette with authentication for nicotine delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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